From owner-sci-resources@net.bio.net Sun Mar 02 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 1 March 1997 Date: 2 Mar 1997 23:28:00 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 105 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5fdui0$7e0@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending March 1, 1997. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: NSF March Bulletin Vol 24; No 7 File size (bytes): 48132 STIS Filename: bul9703.txt Document Type: Press Release Title: "BAKED ALASKA" MUD VOLCANO DISCOVERED IN NORTH ATLANTIC File size (bytes): 5789 STIS Filename: pr9717.txt Document Type: Program Guideline Title: NSF 97-44 - Operational Methods in Semiconductor Manufacturing File size (bytes): 17345 STIS Filename: nsf9744.txt Title: NSF 97-62 -- CHALLENGES IN COMPUTER AND INFORMATION SCIENCE AND ENGINEERING File size (bytes): 22688 STIS Filename: nsf9762.txt Document Type: Recruit Title: Program Director, AD-4 File size (bytes): 6653 STIS Filename: vex974a1.txt Title: Program Analyst, GS-343-13 File size (bytes): 7516 STIS Filename: vgs9739.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Bulletin Title: NSF March Bulletin Vol 24; No 7 File size (bytes): 48132 STIS Filename: bul9703.txt Document Type: Phone Book Title: NSF Alphabetical List File size (bytes): 114263 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Directory File size (bytes): 128207 STIS Filename: phnorg.txt Document Type: Program Guideline Title: NSF 96-06 DATABASE ACTIVITIES IN THE BIOLOGICAL SCIENCES File size (bytes): 36465 STIS Filename: nsf9606.txt Also available: nsf9606.doc ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf9606.txt, the text of your message should be as follows: get nsf9606.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9606.txt, you would enter: ftp> get nsf9606.txt If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Mon Mar 03 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH MAIL No Eguide on 2/28 Date: 4 Mar 1997 11:34:41 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 6 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5fhtgh$9ac@net.bio.net> NNTP-Posting-Host: net.bio.net $$MAIL BEGIN *********************************************************** The NIH Guide for Grants & Contract will not be published on February 28, 1997, the next issue of the NIH Guide will be March 7, 1997. Thank you. $$MAIL END************************************************************** $$MAIL END************************************************************** From owner-sci-resources@net.bio.net Sat Mar 08 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-042 - V26(07) 03/07/97 Date: 9 Mar 1997 15:15:04 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 342 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5fvg9o$cdl@net.bio.net> NNTP-Posting-Host: net.bio.net INNOVATION GRANT PROGRAM FOR APPROACHES IN HIV VACCINE RESEARCH NIH GUIDE, Volume 26, Number 7, March 7, 1997 PA NUMBER: PAR-97-042 P.T. 34; K.W. 0715008, 0765033, 0755020, 079000 National Institute of Allergy and Infectious Diseases Application Receipt Date: May 23, 1997 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) gives special consideration for funding to scientifically meritorious applications in response to our program announcements (PAs). PAs identify current areas of ongoing research emphasis for the NIAID. The NIAID, National Institutes of Health (NIH) on the recommendation of the AIDS Vaccine Research Committee (AVRC), seeks to implement a new program aimed at rapidly exploiting new scientific opportunities to broaden the base of scientific inquiry in areas related to vaccine discovery and development. This program announcement represents the first step in establishing the INNOVATION Grant Program. The NIAID invites applications, including those from researchers previously outside the field of AIDS research, for research projects that involve a high degree of innovation, risk and novelty-- as well as a clear promise of helping to improve vaccine design or evaluation-- in the following three general areas: 1) the structure/function of HIV envelope protein; 2) creation/improvement of animal models for vaccine evaluation and pathogenesis studies; and 3) mechanisms of directing antigen processing in vivo. This INNOVATION Grant Program utilizes a grant mechanism which provides the resources to carry out preliminary tests of feasibility for new research hypotheses, and a rapid and streamlined review and award process. This approach will be evaluated by the AVRC for suitability and responsiveness following this initial offering. If successful, other announcements may be made in the future. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Innovation Grant Program for Approaches in HIV Vaccine Research, is related to the priority areas of HIV infection, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473) through the Superintendent of Documents, government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, foreign for-profit and non-profit organizations, both public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Research projects will be supported with the exploratory/developmental research grant mechanism (R21). This mechanism provides short-duration support for preliminary studies of a highly speculative nature which are expected to yield, within this time frame, sufficient information upon which to base a well-planned and rigorous series of further investigations. Applicants may request up to two years of support and up to $150,000 per annum in direct costs, although with compelling justification exceptions can be made if specific costly reagents, animals, specimens or laboratory modifications are needed to perform these studies. Program staff may be able to advise prospective applicants concerning NIAID-sponsored resources which may be available to them. Please contact the program staff listed under INQUIRIES for further information. The award is non-renewable; however, applicants may elect to seek continuing support for this research through the R01 mechanism. RESEARCH OBJECTIVES After an initial examination of the state of the art of HIV vaccine discovery, the National Institute of Allergy and Infectious Diseases and the AIDS Vaccine Research Committee seek to broaden the base of scientific inquiry in three key scientific areas related to HIV vaccine discovery and development. o The structures of HIV envelope proteins as they relate to their function as immunogens. Examples of areas of interest include, but are not limited to: - Understanding the oligomeric structure of the envelope protein both free and on the virion; - Novel approaches to a detailed understanding of the structure of Env as it interacts with cellular receptors upon virus entry; - Development of methods to preserve native structure and evaluate different protein forms as immunogens; o Creation of new animal models for vaccine evaluation and pathogenesis studies, or innovations to improve existing animal models. Examples of areas of interest include, but are not limited to: - Methods to produce populations of primates that can accept grafts of hematopoietic cells (e.g., populations of macaques that are twins, or clonally-derived or otherwise rendered MHC-compatible); - Novel small animal models produced with transgene that render them sensitive to HIV infection. - Creation or study of SCID mice, or other animals, that would allow for analysis of protective cellular immune responses through passive transfer of cells from infected immunized, or exposed and uninfected humans or primates. o Mechanisms of directing in vivo antigen processing to maximize immune response. Examples of areas of interest include, but are not limited to: - Defining and comparing pathways of processing various HIV/SIV vaccine classes (e.g., subunit, recombinant, whole killed, live attenuated, DNA) by various antigen processing cells (e.g., APC subsets, macrophages, B cells); - Developing methods to expand, in vitro, each of the processing and/or presenting cells such that they can be charged with SIV/HIV vaccine candidates, ex vivo. - Developing assays to test the APC subsets for their ability to stimulate TH1, TH2, CTL and B cell responses; - Identifying cytokines and/or other molecules that improve APC functions; - Evaluating vaccine-charged APCs for their ability to induce relevant immunity, in vivo, (e.g., clearance of HIV infected cells, development of appropriate humoral/mucosal immunity). To help meet the research objectives defined by the AIDS Vaccine Research Committee, research applications intended to produce preliminary data or precedent for an idea or a concept are particularly encouraged. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects of the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR. 59 14508- 14513) and the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 5/95), the standard application form for research grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. Application kits may also be obtained electronically via the WWW at http://www.nih.gov/grants/phs398/phs398.html. Applicants must adhere to the format and requirements specified in the PHS 398 application kit, except as noted below. A modular budget application format will be pilot tested, in which budgets and justifications are simplified. Applicants may apply for up to two years of support at up to $150,000 per annum, and total direct costs may be requested in modular increments of $10,000. The form, ~Detailed Budget for Initial Budget Period (page 4 of the PHS 398 application kit, rev. 5/95),~ is not required and will not be accepted at the time of application. Applicants should use the form, ~Budget for Entire Proposed Period of Support (page 5 of the PHS 398 application kit, rev. 5/95),~ leaving blank the categorical budget table and providing only the requested total direct costs for each year and total direct costs for the entire proposed period of support. The budget justification should begin in the space provided, using continuation pages as necessary, and should justify the requested budget on the basis of overall requirements, scientific aims and scope of the proposed research. All project personnel (salaried or unsalaried) should be listed by name, role on project and per cent effort, and a narrative justification provided for each person based on his/her role on the project and proposed level of effort. All consultants should be identified by name and organizational affiliation and the services they will perform should be described. A narrative justification should be provided for any major budget items, other than personnel, which would be considered unusual for the scope of research; otherwise, no specific costs for items or categories should be shown. Applications exceeding $150,000 in requested total direct costs will also require a special justification, identifying the specific costly reagents, animals, specimens or laboratory modifications which are required. Key personnel and their level of effort must be specified, and biosketches provided. If consortium/contractual costs are requested, the percentage of the subcontract total costs (direct and indirect) relative to the total direct cost of the overall project should be specified. The subcontract budget justification should be prepared according to the instructions provided above. The research plan shall be limited to 10 pages, and any appendices to 10 pages. For purposes of identification and processing the application, mark ~YES~ in item 2 on the face page and enter the PA number PAR-97-042 and the title ~INNOVATION Grant Program for Approaches in HIV Vaccine Research.~ The completed, signed original and three (3) legible, single sided copies of the application must be sent or delivered to: Division of Research Grants, National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817-7710 (for express/courier service) At the same time, two complete copies of the application and all five copies of any appendices must be sent or delivered to: Dr. Dianne E. Tingley National Institute of Allergy and Infectious Diseases Solar Building, Room 4C07 6003 Executive Boulevard Rockville, MD 20852-7610 Telephone: (301) 496-2550 REVIEW CONSIDERATIONS Review Procedures Applications will be assigned on the basis of established PHS referral guidelines. Upon receipt, applications will be reviewed for completeness by the Division of Research Grants, NIH, and for responsiveness to the goals of the PA by NIAID staff. Incomplete applications will be returned to the applicant without further consideration. Applications will be evaluated for scientific and technical merit by appropriately constituted Scientific Peer Review Group(s) convened by the NIAID, in accordance with standard NIH review policies. As part of the initial merit review, all applications may undergo a process in which only those applications deemed to have the highest scientific merit will be assigned a priority score and receive a second level review by the National Advisory Council of the National Institutes of Allergy and Infectious Diseases. Review Criteria The Scientific Peer Review Group(s) will consider and score each application according to the following three dimensions of scientific merit, and will also assign an overall priority score for the application. Impact: The quality (e.g. innovativeness, significance, importance) of the idea/hypothesis and the relevance of the idea/concept to understanding host/pathogen interactions and vaccine development; Approach: The appropriateness of the methods, subjects, and materials chosen to produce data addressing the hypothesis; Feasibility: Prospects for accomplishing the objectives, given the requested budget and term of award, the qualifications and research experience of the Principal Investigator and staff, and the access to necessary resources. The Scientific Peer Review Group(s) also will examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to NIAID. The following will be considered in making funding decisions: the scientific and technical merit of the proposed project as determined by peer review, and the availability of funds. In the final selection of applications to be funded, consideration will be given to the ability to achieve balanced coverage of the scientific areas of emphasis recommended by the AIDS Vaccine Research Committee. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Carole A. Heilman., Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2A16 MSC 7620 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-0545 FAX: (301) 402-1505 Email: ch25v@nih.gov Direct inquiries regarding fiscal matters to: Jane Unsworth Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, 4B25 6003 Executive Blvd. Rockville, MD 20892-7610 Telephone: (301) 402-6824 Fax: (301) 480-3780 Email: ju3a@nih.gov Direct inquiries regarding review matters to: Dianne Tingley, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, 4C07 MSC 7610 6003 Executive Blvd. Rockville, MD 20892-7610 Telephone: (301) 496-2550 Fax: (301) 402-2638 Email: dt15g@nih.gov AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301(c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citation is both (No. 93.855 - Immunology, Allergy, and Transplantation Research and No. 93.856 - Microbiology and Infectious Disease Research ). Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sat Mar 08 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-041 - V26(07) 03/07/97 Date: 9 Mar 1997 15:14:47 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 394 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5fvg97$cbs@net.bio.net> NNTP-Posting-Host: net.bio.net PILOT GRANTS IN GERIATRICS NIH GUIDE, Volume 26, Number 7, March 7, 1997 PA NUMBER: PAR-97-041 P.T. 34; K.W. 0710010, 0710030 National Institute on Aging Application Receipt Dates: March 17, July 17, November 17, 1997 PURPOSE The Geriatrics Program of the National Institute on Aging (NIA) is seeking small grant (R03) applications to stimulate and facilitate research in underdeveloped topics in specific areas of aging research. This Small Grant (R03) Program provides support for pilot research that is likely to lead to a subsequent individual research project grant (R01) or a First Independent Research Support and Transition (FIRST) (R29) award application and/or a significant advancement of aging research. These R03 projects include, but are not limited to, research which is innovative and/or high risk. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Pilot Grants in Geriatrics, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-11474-0 or Summary Report: Stock No. 017-001-11473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign organizations and institutions are not eligible. Participation in the program by investigators at minority institutions is strongly encouraged. To be eligible for this award, the proposed Principal Investigator must, at a minimum, be an independent investigator at the beginning of her/his research career as defined by the eligibility requirements for a FIRST (R29) award. That is, they should be genuinely independent of a mentor. Individuals in the final stages of training may apply, but individuals can not be in a training status at the time the award is made. Established investigators proposing research unrelated to a currently funded research program are also eligible to apply for these grants. MECHANISM OF SUPPORT Applicants may request up to $50,000 (direct costs) for one year through the small grant (R03) mechanism. However, the grants will be awarded under Expanded Authorities and are eligible for a single one-year no cost extension. These awards are not renewable. Before completion of the R03, investigators are encouraged to seek continuing support for research through a research project grant (R01) or FIRST (R29) award. Salary support may be requested along with other costs and is included in the $50,000 (direct costs). Replacement of the Principal Investigator on this award is not permitted. RESEARCH OBJECTIVES The Small Grant program is designed to support new, junior, and established investigators interested in conducting research on underdeveloped topics in geriatrics and aging research. Collection of new data or secondary analysis of existing data are allowed. Topics of interest are limited to those listed below and applications not on these topics will be returned to the applicant without review. o Preliminary studies needed for epidemiologic research projects on genetic factors affecting longevity, active life expectancy, or rate of progression of age-related pathologies. Examples of such preliminary studies include, but are not limited to: analyses of existing familial, demographic, and/or epidemiologic data for feasibility and power calculations; pilot testing of proband-identification and recruitment strategies; identifying, determining the frequency of, and estimating the relative risk associated with specific polymorphisms at one or more loci of interest. (See also related program announcement on "Small Research Grants (R03) Program: Secondary Analysis in Demography and Economics of Aging," NIH Guide, Vol. 26, No. 3, January 31, 1997.) Direct inquiries on this topic to Dr. Evan Hadley at the address listed under INQUIRIES. o Preliminary clinical studies to explore potential benefits, feasibility, and/or risks of administering gonadal or adrenal androgens (e.g., testosterone, DHEA) or their analogs or secretagogues, to older persons whose levels of these factors are diminished or dysregulated relative to younger persons (either chronically or acutely) or to test other potential therapeutic benefits or risks of administering these agents to older people. Direct inquiries on this topic to Dr. Sherry Sherman at the address listed under INQUIRIES. o Clinically related studies focusing on a systems physiology or integrative approach in defining age-associated changes in the cardiovascular system and how these changes increase the risk of cardiovascular disease. Direct inquiries on this topic to Dr. Andre Premen at the address listed under INQUIRIES. o Preliminary clinical studies designed to contribute to the improvement of vaccines for use in elderly populations. This may include studies of methods to improve the immune response in older persons including alternate immunization schedules with existing vaccines or the use of new vaccines. Clinical studies designed to characterize immunosenescence in older human populations are also appropriate as they may contribute to the identification of potentially correctable deficiencies. Direct inquiries on this topic to Dr. Stanley Slater at the address listed under INQUIRIES. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. APPLICATION PROCEDURES The submission, review, and award schedule for the Small Grant Program for 1997/1998 is: Application Receipt Dates: Mar 17 Jul 17 Nov 17 Institute Committee Review: Jun-Jul Oct-Nov Feb-Mar Earliest Funding: Sep 97 Jan 98 May 98 Only one Small Grant application may be submitted by a Principal Investigator per receipt date. Applicants may not submit R01 or R29 applications on the same topic concurrent (to be considered at the same review cycle) with the submission of a Small Grant application. Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and prepared according to the directions in the application packet, with the exceptions noted below. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, e-mail: asknih@odrockm1.od.nih.gov. On the face page of the application: Item 2 Type "Pilot Grants (R03) in Geriatrics." Check the "YES" box. Sections 1-4: Do not exceed a total of ten pages for the following sections: specific aims, background and significance, progress report/preliminary studies, and experimental design and methods. Tables and figures are included in the ten page limitation. Applications that exceed the page limitation or PHS requirements for type size and margins (Refer to PHS 398 application for details) will be returned to the investigator without review. The ten page limitation does not include Sections 5-9 (Human Subjects, Consortia, Literature cited). "Just-in-time" (JIT) is an initiative of the National Institutes of Health (NIH) Extramural Reinvention Laboratory under the auspices of the National Performance Review and government-wide efforts to create a government that works better and costs less. JIT postpones the collection of certain information that currently must be included in all competing applications when submitted. The information for the applications with a likelihood of funding is submitted "just-in-time" for awards to be made. This program announcement is incorporating JIT procedures as described below. Some sections are modified and others in the application do not need to be completed for the submission of the application, but WILL be requested if your application receives a priority score in the fundable range. Form DD - Page 4 - DETAILED BUDGET PLAN FOR INITIAL BUDGET PERIOD Do not complete this form on page 4 of the PHS 398 (rev. 5/95). It is not required nor will it be accepted at the time of the application. Form EE - Page 5 - BUDGET FOR THE ENTIRE PROPOSED PROJECT Do not complete the categorical budget table form on page 5 in the PHS 398 (rev. 5/95). Only the requested total direct costs for each year and total direct costs for the entire proposed period of support should be shown. Begin the budget justification in the space provided, using continuation pages as needed. Budget Justification o List the name, role on project, and percent effort for all project personnel (salaried or unsalaried) and provide a narrative justification for each person based on his/her role on the project and proposed level of effort. o Identify all consultants by name and organizational affiliation and describe the services to be performed. o Provide a narrative justification for any major budget items, other than personnel, that are requested for the conduct of the project that would be considered unusual for the scope of the research. No specific costs for items or categories should be shown. o Indirect costs will be calculated at the time of the award using the institution's actual indirect cost rate. Applicants will be asked to identify the indirect cost exclusions prior to award. o If consortium/contractual costs are requested, provide the percentage of the subcontract total costs (direct and indirect) relative to the total direct costs of the overall project. The subcontract budget justification should be prepared following the instructions provided above. Biographical Sketch - A biographical sketch is required for all key personnel, following the modified instructions below. Do not exceed the two-page limit for each person. o Complete the education block at the top of the form page; o List current position(s) and those previous positions directly relevant to the application; o List selected peer-reviewed publications directly relevant to the proposed project, with full citation; o Provide information on research projects completed and/or research grants participated in during the last five years that are relevant to the proposed project. Title, principal investigator, funding source, and role on project must be provided. Other Support - Do not complete the other support page (format page 7 of the PHS 398 (rev. 5/95)). Information on active support for key personnel will be requested prior to award. Checklist - Do not submit the checklist page. For amended applications, applicants must complete the block in the upper right corner of the face page to indicate the previous grant number. A completed checklist will be required prior to award. Submit a signed original of the application, including the checklist, and three exact photocopies in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 -MSC-7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight service) In addition, to expedite the review of the application, submit two additional exact photocopies of the application directly to: Chief, Scientific Review Office National Institute on Aging Gateway Building Suite 2C212, MSC 9205 7201 Wisconsin Avenue Bethesda, MD 20892-9205 In order not to delay review, it is important that applicants comply with this request. REVIEW CONSIDERATIONS Small grant applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by a review committee of the National Institute on Aging, in accordance with the standard NIH peer review procedures. Applications will be evaluated with respect to the following criteria: o Importance of the area to aging research o Feasibility of the proposed exploratory research o Likelihood of the proposed pilot project leading to the development of an R01/R29 grant application, or significant advancement of aging research. o Adequacy of approach and scientific originality and significance o Appropriateness of the proposed budget and timetable in relation to the scope of the proposed research o Qualifications and research experience of the principal investigator. o Availability of resources necessary for the research, including any needed to supplement the budget. o The adequacy of the proposed means for protecting against or minimizing potential adverse effects upon humans, animals, or the environment. o Adequacy of adherence to guidelines for including gender and minority representation in any study population. AWARD CRITERIA Applications will compete for available funds with all other scored applications. The following will be considered in making funding decisions: o quality of the proposed project as determined by peer review; o availability of funds; o program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Evan Hadley, M.D. Geriatrics Program National Institute on Aging Gateway Building, Room 3E327 Bethesda, MD 20892-9205 Telephone: (303) 435-3044 FAX: (301) 402-1784 Email: hadleye@gw.nia.nih.gov Sherry Sherman, Ph.D. Endocrinology and Musculoskeletal Branch National Institute on Aging Gateway Building, Room 3E327 Bethesda, MD 20892-9205 Telephone: (301) 496-3048 FAX: (301) 402-1784 Email: shermans@gw.nia.nih.gov Andre Premen, Ph.D. Cardiovascular Research Program National Institute on Aging Gateway Building, Room 3E327 Bethesda, MD 20892-9205 Telephone: (301) 496-6761 FAX: (301) 402-1784 Email: premena@gw.nia.nih.gov Stanley L. Slater, M.D. Geriatrics Program National Institute on Aging Gateway Building, Room 3E327 Bethesda, MD 20892-9205 Telephone: (301) 496-6761 FAX: (301) 402-1784 Email: slaters@gw.nia.nih.gov Direct inquiries regarding fiscal matters to: Mr. David Reiter Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 7201 Wisconsin Avenue MSC 9205 Bethesda, MD 20892 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: David_Reiter@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410), as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sat Mar 08 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-040 - V26(07) 03/07/97 Date: 9 Mar 1997 15:14:28 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 402 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5fvg8k$car@net.bio.net> NNTP-Posting-Host: net.bio.net NIA PILOT RESEARCH GRANT PROGRAM IN NEUROSCIENCE AND BIOLOGY NIH GUIDE, Volume 26, Number 7, March 7, 1997 PA NUMBER: PAR-97-040 P.T. 34; K.W. 1002030, 1002006, 0710010 National Institute on Aging Application Receipt Dates: March 17, July 17, November 17, 1997 PURPOSE The National Institute on Aging (NIA) is seeking small grant (R03) applications to: (1) stimulate and facilitate the entry of promising new investigators into the neuroscience and biology of aging and (2) encourage established investigators to enter new targeted, high priority areas in these research fields. This Small Grant (R03) Program provides support for pilot research that is likely to lead to a subsequent individual research project grant (R01) or a First Independent Research Support and Transition (FIRST) (R29) award application and /or a significant advancement of aging research. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, NIA Pilot Research Grant Program in Neuroscience and Biology, is related to the priority areas of unintentional injuries, diabetes and chronic disabling conditions, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-11474-0 or Summary Report: Stock No. 017-001-11473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign organizations and institutions are not eligible. Participation in the program by investigators at minority institutions is strongly encouraged. Pilot project grants awarded through this Program Announcement may not be used to support thesis or dissertation research. To be eligible for this award as a new investigator in aging, the proposed Principal Investigator (PI) should be an independent investigator at the beginning of her/his career. If the applicant is in the final stages of training, it is permissible to apply for an R03 but awards cannot be made to anyone still in training status at the time of award. Established investigators proposing research unrelated to a currently funded research program are also eligible to apply for these grants. MECHANISM OF SUPPORT Applicants may request up to $50,000 (direct costs) for one year through the small grant (R03) mechanism. However, the grants will be awarded under Expanded Authorities and are eligible for a single one-year no cost extension. These awards are not renewable. Before completion of the R03, investigators are encouraged to seek continuing support for research through a research project grant (R01) or FIRST (R29) award. The award may not be used for salary support for the principal investigator, but may be used to support the costs of technicians or fellows to carry out the research. Replacement of the Principal Investigator on this award is not permitted. Revisions of applications previously reviewed under this initiative but unfunded are not permitted. RESEARCH OBJECTIVES The Small Grant program is designed to support independent basic and clinical scientists who are interested in entering the research fields of the neuroscience or biology of aging. Targeted aims For 1997, investigators may apply for a small grant to support research on one of the following topics relevant to aging research: o Age-related factors in HIV infection, latency, progression and severity; and the susceptibility of the aging nervous system to HIV infection and AIDS-associated opportunistic infections. o Immunobiology of aging including cellular and molecular approaches, as well as neural and neuroendocrine mechanisms and pathways modulating the aging immune system. o Molecular mechanisms regulating age-related alterations in gene expression including transcriptional, post-transcriptional, and translational processes and protein structural or conformational changes in either neural or non-neural tissues. o Development of novel biological resources for aging research (e.g., animal models, other models, molecular reagents and probes). o Basic underlying mechanisms of musculoskeletal aging (muscle, bone, cartilage). o Molecular basis of cardiovascular aging. o Nutritional factors and aging. o Biology of age-related prostate growth. o Mechanisms underlying changes in sleep and circadian processes in older organisms. o Neural mechanisms of age-related changes in attention and frontal lobe executive processes. o Mechanisms underlying changes in sensory and motor processing in the aging nervous system. o Novel tract-tracing procedures to identify age-related changes in neuronal connections and degeneration in post-mortem tissues. o Investigations into neuroglia function in aging that examine cellular and molecular factors controlling glial cell activation, death, neurotransmitter receptor and transport functions, and mitochondrial and other abnormalities leading to neuronal oxidative damage. Applications for support in areas other than those stated will be returned to the proposed Principal Investigator without review. The National Institute on Aging will modify the selected topic areas annually by reissuing the program announcement. Information on other initiatives supported by NIA may be found at the following internet address: http://www.nih.gov/nia . INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and prepared according to the directions in the application packet, with the exceptions noted below. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, Email: ASKNIH@ODROCKM1.OD.NIH.GOV. On the face page of the application: Item 2 Type "NIA PILOT RESEARCH GRANT PROGRAM IN NEUROSCIENCE AND BIOLOGY". Check the "YES" box. Only one Small Grant application may be submitted by a principal investigator per receipt date. Applicants may not submit R01 or R29 applications on the same topic concurrent (to be considered at the same review cycle) with the submission of a Small Grant application. The submission, review, and award schedule for this Small Grant Program for 1997 is: Application Receipt Dates: Mar 17 Jul 17 Nov 17 Institute Committee Review: Jun-Jul Oct-Nov Feb-Mar Earliest Funding: Sep 97 Jan 98 May 98 In a cover letter, identify the specific research topic relevant to your research from the bulleted items in the RESEARCH OBJECTIVES section of this program announcement. Also indicate whether you are a new investigator to aging or an established investigator entering a new area of aging research. Sections 1-4: Do not exceed a total of ten pages for the following sections: specific aims, background and significance, progress report/preliminary studies, and experimental design and methods. Tables and figures are included in the ten page limitation. Applications that exceed the page limitation or PHS requirements for type size and margins (Refer to PHS 398 application for details) will be returned to the investigator. The ten page limitation does not include Sections 5-9 (Human Subjects, Consortia, Literature cited). "Just-in-Time" Instructions: "Just-in-Time" (JIT) is an initiative of the National Institutes of Health Extramural Reinvention Laboratory under the auspices of the National Performance Review and government-wide efforts to create a government that works better and costs less. JIT postpones the collection of certain information that previously was included in all competing applications when submitted. The information for the applications with a likelihood of funding is submitted "just-in-time" for awards to be made. This delayed exchange of information significantly relieves the administrative burden for the 75 to 80 percent of applicants who will not receive an award. In addition, the information that is exchanged "just-in-time" for award will be current, rather than several months old as is currently the case (which often necessitates a request for updated information, e.g., for other support). Detailed Budget for Initial Budget Period - Do not complete form page 4 of the PHS 398 (rev. 5/95). It is not required nor will it be accepted at the time of application. In some cases it may be requested prior to award. Budget for Entire Proposed Period of Support - Do not complete the categorical budget table on form page 5 in the PHS 398 (rev. 5/95). Only the requested total direct costs for each year and total direct costs for the entire proposed period of support should be shown. Begin the budget justification in the space provided, using continuation pages as needed. Budget Justification o List the name, role on project and percent effort for all project personnel (salaried or unsalaried) and provide a narrative justification for each person based on his/her role on the project and proposed level of effort. o Identify all consultants by name and organizational affiliation and describe the services to be performed. o Provide a narrative justification for any major budget items, other than personnel, that are requested for the conduct of the project that would be considered unusual for the scope of research. No specific costs for items or categories should be shown. o Indirect costs will be calculated at the time of the award using the institution's actual indirect cost rate. Applicants will be asked to identify the indirect cost exclusions prior to award. o If consortium/contractual costs are requested, provide the percentage of the subcontract total costs (direct and indirect) relative to the total direct costs of the overall project. The subcontract budget justification should be prepared following the instructions provided above. Biographical Sketch - Biographical sketches are required for all key personnel, following the modified instructions below. Do not exceed the two-page limit for each person. o Complete the education block at the top of the form page; o List current position(s) and those previous positions directly relevant to the application; o List selected peer-reviewed publications directly relevant to the proposed project, with full citation; o Provide information on research projects completed and/or research grants participated in during the last five years that are relevant to the proposed project. Title, principal investigator, funding source, and role on project must be provided. Other Support - Do not complete the other support page (format page 7 of the PHS 398 (rev. 5/95)). Information on active support for key personnel will be requested prior to award. Checklist - Do not submit the checklist page. A completed checklist will be required prior to award. Submit a signed, original of the application, including the checklist, and three exact photocopies in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040-MSC-7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight service) In addition, to expedite the review of the application, submit two additional exact photocopies of the application directly to: Chief, Scientific Review Office National Institute on Aging Gateway Building Suite 2C212, MSC 9205 7201 Wisconsin Avenue Bethesda, MD 20892-9205 In order not to delay review, it is important that applicants comply with this request. Amended applications will not be allowed. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by a review group of NIA, in accordance with the standard NIH peer review procedures. Applications will be evaluated with respect to the following criteria: o Importance of the area to aging research. o Feasibility of the proposed exploratory research. o Likelihood of the proposed pilot project leading to the development of an R01/R29 grant application, or significant advancement of aging research. o Adequacy of approach and scientific originality and significance. o Potential for high gain, perhaps with high risk. o Appropriateness of the proposed budget and timetable in relation to the scope of the proposed research. o Qualifications and research experience of the principal investigator. o Availability of resources necessary for the research, including any needed to supplement the budget. o The adequacy of the proposed means for protecting against or minimizing potential adverse effects upon humans, animals, or the environment. o Adequacy of adherence to guidelines for including gender and minority representation in any study population AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o quality of the proposed project as determined by peer review o availability of funds o program priority INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. David B. Finkelstein Biology of Aging Program Telephone: (301) 496-6402 FAX: (301) 402-0010 Email: BAPquery@gw.nia.nih.gov Dr. Judy Finkelstein Neuroscience and Neuropsychology of Aging Program Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: NNAquery@gw.nia.nih.gov The address and general E-mail address for all the above is: National Institute on Aging Gateway Building, Suite 2C212 7201 Wisconsin Avenue MSC 9205 Bethesda, MD 20892 Email: NIAPILOT@gw.nia.nih.gov Direct inquiries regarding fiscal matters to: Robert Pike Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 7201 Wisconsin Avenue MSC 9205 Bethesda, MD 20892 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: pikeR@gw.nia.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance No. 93.866. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410), as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sat Mar 08 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-97-014 - V26(07) 03/07/97 Date: 9 Mar 1997 15:14:12 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 883 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5fvg84$ca3@net.bio.net> NNTP-Posting-Host: net.bio.net PIVOTAL CLINICAL TRIALS FOR CHEMOPREVENTION AGENT DEVELOPMENT NIH GUIDE, Volume 26, Number 7, March 7, 1997 RFA: CA-97-014 P.T. 34; K.W. 0715035, 0755015, 0740018 National Cancer Institute Letter of Intent Receipt Date: April 3, 1997 Application Receipt Date: May 22, 1997 PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI) invites applications to further the drug development efforts of the Chemoprevention Branch by carrying out intermediate-sized Phase II/III efficacy trials of promising chemopreventive agents in major cancer target organs, particularly prostate, breast, lung, colon, and bladder. Currently, most NCI-sponsored Phase II clinical trials enroll fewer than 100 participants and evaluate a spectrum of potential SEBs as study endpoints over a relatively brief study period (2 weeks 6 months). This is in contrast to the large Phase III clinical chemoprevention trials with tamoxifen, finasteride (Proscar), and aspirin conducted under the direction of the Community Oncology & Rehabilitation Branch or the Chemoprevention Branch which are enrolling 10,000 22,000 participants and evaluating clinical parameters, such as cancer incidence reduction, over many years. This comparison emphasizes the need for Phase II/III chemoprevention clinical trials of intermediate size and duration which are designed to establish the efficacy of promising agents and the validity of the most promising histopathologic and laboratory-based SEBs currently held to be "reasonably certain" predictors of cancer prevention. Because of the critical nature of the biomarkers used in Phases I IIb of clinic al chemopreventive drug development, the careful scientific conduct of these biomarker assessments is considered essential to progress in chemoprevention. Measurement of these biomarkers is crucial. It is anticipated that biomarkers validated through these intermediate Phase II/III studies could be used in future efficacy evaluations of new chemopreventive compounds and in clinical and regulatory decision-making. As described above, the intermediate-sized clinical trials supported through this RFA are a pivotal decision point in the NCI chemoprevention drug development program. The consensus view of a Working Group from the NCI and the FDA acknowledges that "the interim analysis of a validated surrogate endpoint of cancer incidence may facilitate the timely and cost-effective marketing of efficacious drugs (Kelloff et al., Cancer Epidemiol. Biomark. Prev. 4: 1-10, 1995)." Thus the efficacy and safety data from these studies potentially supports FDA marketing approval (NDA applications) for chemoprevention indications, and certainly facilitates decisions regarding the most appropriate recommendations for subsequent large, community-based efficacy studies. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000", a PHS-led national activity for setting priority areas. This RFA, Pivotal Clinical Trials for Chemoprevention Agent Development, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. For those respondents affiliated with the Community Clinical Oncology Program (CCOPs), it is suggested that proposals be submitted through the CCOPs mechanism. MECHANISM OF SUPPORT This RFA will use the cooperative agreement (U01) mechanism. The cooperative agreement is an assistance mechanism in which substantial involvement of the NCI with the recipient is anticipated during the performance of the planned activity. The nature of the NCI's involvement is described under SPECIAL REQUIREMENTS, 2. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant/awardee. The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated award date is September 1997. This RFA is a one-time solicitation. Future unsolicited competitive continuation applications will compete with all other investigator-initiated research applications and be peer reviewed by a study section in the Division of Research Grants (DRG), NIH. However, if it is determined that there is a sufficient continuing need, the NCI will invite recipients of awards made under this RFA in FY 97 to submit competitive continuing applications for review according to procedures described below under APPLICATION PROCEDURES and REVIEW CONSIDERATIONS. FUNDS AVAILABLE Approximately $3 million in total costs for the first year of support for the program will be committed specifically to fund applications submitted in response to this RFA. It is anticipated that 3-4 awards will be made. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of the awards will vary also. Awards and the level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, awards made pursuant to this RFA will be contingent on the continued availability of funds for this purpose. RESEARCH OBJECTIVES Background The purpose of this initiative is to enhance clinical cancer prevention research. This RFA seeks to build on information from Chemoprevention Branch contract-supported agent identification, preclinical testing, and Phase I and early Phase II clinical studies of promising agents by supporting their continued systematic development in longer, intermediate-sized Phase II/III clinical trials. The goals for these pivotal clinical studies comprise (1) expansion and refinement of information from the smaller Phase II trials on efficacy, participant recruitment and retention, adverse effects, and acceptability of treatment over time; (2) validation of surrogate endpoint biomarkers (SEBs) selected from experience in the Phase II studies; and (3) diversification of the target populations for the chemopreventive interventions. Results of these pivotal clinical trials may support New Drug Applications (NDAs) to the FDA, where appropriate, for chemoprevention indications and larger community-based cancer prevention clinical trials with incidence reduction endpoints. As our understanding of carcinogenesis increases, preventive interventions become increasingly practical for many primary cancer sites. While prevention of carcinogen exposures and lifestyle changes may eventually alter cancer incidence, pharmacologic interventions offer an attractive approach with the potential for more immediate results. The drug development process for these chemopreventive agents, in contrast to that for cancer therapy drugs, has unique requirements because of the generally good health status of their target populations, the anticipated long duration of use, and the low level of acceptable toxicity. The NCI's chemoprevention drug development program has the mission of identifying safe and effective chemical agents for preventing human cancer. This program is an applied drug development science effort with clinical trials as its endpoint. It begins with the identification of candidate agents for development and the characterization of these candidates for efficacy using in vitro and animal screens. Promising agents are then further tested in animal models to explore their potential for clinical application, with regard to both safety and efficacy. The most successful agents then progress to clinical trials. The ultimate goal of this process is to achieve accurate and reliable information on long-term efficacy and safety that will support marketing approval and widespread clinical use. In contrast to the development of therapeutic agents, the identification and validation of biomarkers characterizing the neoplastic process are key aspects of the chemoprevention drug development process. SEBs are defined as measurable and modulatable biological or chemical properties that are highly correlated to cancer incidence and that may serve as indicators of the likely incidence or progression of cancer. While traditional Phase I drug development studies focus on pharmacokinetics and tolerability of the investigational agent, Phase I chemoprevention studies are designed to develop and evaluate biologic markers of drug effect and SEBs, besides obtaining required pharmacokinetic and safety information. Phase II chemoprevention studies characterize dose-biomarker response and more common chronic toxicities, to identify safe and effective doses for further studies. When clearly defined and standardized biomarkers are not known, Phase IIa dose-response studies are undertaken to evaluate the feasibility of candidate biomarker measurements (for drug effects and/or SEBs) and to standardize assay conditions and develop quality control procedures. Phase IIb chemoprevention studies are done subsequently to establish the dose-response relationship of SEB modulation and the toxicities associated with chronic administration in order to select a safe and effective dose for Phase III clinical trials. Scope and Objectives This RFA will support Phase II/III randomized, placebo-controlled clinical trials to evaluate the chemopreventive efficacy of selected agents or regimens in target populations consistent with the Clinical Development Plans of the DCPC Agent Development Committee (see Journal of Cellular Biochemistry Supplement 20, 1994 and Supplement 26, 1996). Investigators may propose any cohort, intervention, or drug for which justification and developmental support can be provided. The following list is provided as an example only but for which preclinical, early clinical, drug supply, and regulatory support may be available: 1. Prevention of colorectal adenomas in patients having a history of colorectal adenomas or early stage colon carcinoma using selected nonsteroidal antiinflammatory drugs (NSAIDs, including less toxic derivatives), 2-difluoromethylornithine (DFMO), Oltipraz, or the combinations of calcium with vitamin D or an NSAID and of DFMO with an NSAID; 2. Prevention of prostatic intraepithelial neoplasia (PIN), its progression, and cancer incidence by antiandrogens (e.g., flutamide or bicalutamide), vitamin E, selenium, the combination of vitamin E with selenium, fluasterone (DHEA analog 8354), selected retinoids [e.g., all-trans-N-(4-hydroxyphenylretinamide) (4-HPR) or 9-cis-retinoic acid], or 5`-reductase inhibitors (e.g., finasteride); 3. Prevention of bronchial dysplasia, its progression, or second primary upper aerodigestive cancer in patients with a history of resected early stage NSCLC or laryngeal cancer by retinoids (e.g., 4-HPR, 9-cis-retinoic acid or all-trans retinoic acid, possibly in aerosolized formulations), Oltipraz, N-acetyl-l-cysteine (NAC), or the combinations of Oltipraz with NAC or 4-HPR; 4. Modulation of biomarkers (including mammographic patterns) and new proliferative or precancerous lesions in patients with atypical ductal or lobular hyperplasia or lobular carcinoma in situ by anti-estrogens, retinoids (e.g., 4-HPR or 9-cis-retinoic acid), fluasterone or low-dose DHEA, DFMO, or the combination of vitamin E with selenium; 5. Prevention of dysplastic oral leukoplakia, its progression, and oral cancer by Oltipraz (in chronic smokers), 4-HPR, DFMO or curcumin; 6. Prevention of cervical intraepithelial neoplasia (CIN II/III), its progression, and cervical cancers by 4-HPR, DFMO, Oltipraz, or selected NSAIDs; 7. Prevention of recurrence or new lesions in patients with Ta/T1 bladder carcinoma with or without TIS (post-BCG) by 4-HPR, DFMO, or selected NSAIDs; 8. Prevention of precancerous lesions in Barrett's esophagus, their progression, and esophageal cancers by DFMO, retinoids, or Oltipraz. 9. Progression of precancerous lesions of the skin, their progression, and skin cancer by DFMO, retinoids or Curcumin. Study endpoints should include changes in the most promising SEBs (such as those in preinvasive disease or proliferative disease), the development of new premalignant lesions, and, as appropriate, the occurrence of new invasive cancers. This emphasis on SEBs requires that the research team include strong collaborative support from the areas of pathology, biochemistry and molecular biology, and cancer biology and carcinogenesis. The clinical trial design should include an adequate number of participants and should be of sufficient duration to assure statistical power to address the study questions of chemopreventive efficacy, long-term safety and acceptability, and SEB validation. To this end, biostatistics and clinical trial design expertise should be included from the first efforts in study planning and design. Study size and duration will vary according to specific study hypotheses, target population, agent(s), and SEBs and other endpoints. SPECIAL REQUIREMENTS General Currently, most NCI-sponsored Phase II clinical trials enroll fewer than 100 participants and evaluate a spectrum of potential SEBs as study endpoints over a relatively brief study period (2 weeks 6 months). This is in contrast to the large Phase III clinical chemoprevention trials with tamoxifen, finasteride (Proscar ), and aspirin conducted under the direction of the Community Oncology and Rehabilitation Branch or the Chemoprevention Branch which are enrolling 10,000 22,000 participants and evaluating clinical parameters, such as cancer incidence reduction, over many years. This comparison emphasizes the need for Phase II/III chemoprevention clinical trials of intermediate size and duration which are designed to establish the efficacy of promising agents and the validity of the most promising histopathologic and laboratory-based SEBs currently held to be "reasonably certain" predictors of cancer prevention. Because of the critical nature of the biomarkers used in Phases I IIb of clinic al chemopreventive drug development, the careful scientific conduct of these biomarker assessments is considered essential to progress in chemoprevention. Measurement of these biomarkers is crucial. It is anticipated that biomarkers validated through these intermediate Phase II/III studies could be used in future efficacy evaluations of new chemopreventive compounds and in clinical and regulatory decision-making. As described above, the intermediate-sized clinical trials supported through this RFA are a pivotal decision point in the NCI chemoprevention drug development program. The consensus view of a Working Group from the NCI and the FDA acknowledges that "the interim analysis of a validated surrogate endpoint of cancer incidence may facilitate the timely and cost-effective marketing of efficacious drugs (Kelloff et al., Cancer Epidemiol. Biomark. Prev. 4: 1 10, 1995)." Thus the efficacy and safety data from these studies potentially supports FDA marketing approval (NDA applications) for chemoprevention indications, and certainly facilitates decisions regarding the most appropriate recommendations for subsequent large, community-based efficacy studies. Applications funded under this RFA will be supported through the cooperative agreement (U01) mechanism. An assistance relationship will exist between NCI and the awardees to accomplish the research objectives. As described more fully below, the recipients will have primary responsibility for the development and performance of the activity. However, there will be government involvement with regard to (1) assistance in securing an Investigational New Drug (IND) approval from the Food and Drug Administration (FDA), (2) coordination and assistance in obtaining the chemopreventive agent, and (3) monitoring of study safety and conduct. If an investigator anticipates requiring considerable assistance in obtaining the chemopreventive agent and/or in securing an IND permit from the FDA, such assistance should be sought in writing to and approved by the NCI Program Director, prior to submitting an application. Awards will not be made until all arrangements for obtaining the IND and the agent are completed. Cost of agent and necessary formulation should be included in the budget. Definitions Program Director - the NCI Program Staff official (see INQUIRIES section of this RFA) responsible for the stewardship and monitoring of the award. The Program Director may also function as the Staff Collaborator. Staff Collaborator - the NCI Program Staff Collaborator responsible for contributing expert advice on the scientific design and conduct of the research. Data Safety and Monitoring Committee - the committee composed of external, non-participating scientists appointed by the Principal Investigator to monitor patient safety, conduct data audits, and document progress to the NCI Program Director. Terms and Conditions of Award A. Applicability. These special Terms and Conditions of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS grant administration regulations in 45 CFR part 74 and 92, and other HHS, PHS and NIH grant administration policy statements. The administrative and funding instrument used shall be a cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NCI scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NCI purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with the above concept, the dominant role and prime responsibility for the activity reside with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NCI Staff Collaborator Under the cooperative agreement, a relationship will exist between the recipient of these awards and the NCI, in which the performers of the activities are responsible for the requirements and conditions described below, and agree to accept program assistance from a named NCI Staff Collaborator in achieving project objectives. Failure of an awardee to meet the performance requirements, including these special terms and conditions of award, or significant changes in the level of performance, may result in a reduction of budget, withholding of support, suspension and/or termination of the award. B. Awardee Rights and Responsibilities. The Awardee is responsible for: 1. Research design and protocol development, including definition of objectives and approaches, planning, implementation, participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results. 2. Establishing an external Data Safety and Monitoring Committee to review data. The Principal Investigator will name external, non-participating investigators to serve as members on a Data Safety and Monitoring Committee and schedule meetings periodically. The NCI Staff Collaborator will be a non-voting member. 3. Designating Protocol Chairs. The Principal Investigator shall designate a single Protocol Chairperson (if the P.I. does not assume this role). The Protocol Chairperson shall function as the scientific coordinator for the protocol and shall assume responsibility for developing and monitoring the protocol. All proposed protocol modifications will be submitted by the Chair through the Principal Investigator to the NCI Program Director, for review and approval, subject to negotiation with the awardee. 4. Implementing the data collection method and strategy. 5. Establishing mechanisms for quality control and monitoring. Awardees are responsible for ensuring accurate and timely assessment of the progress of each study, including development of procedures to ensure that data collection and management are: (1) adequate for quality control and analysis; (2) for clinical trials, as simple as appropriate in order to encourage maximum participation of physicians and patients and to avoid unnecessary expense; and (3) sufficiently staffed. 6. Submitting interim progress reports, when requested, to the NCI Program Director including as a minimum, summary data on protocol performance. The Data Safety and Monitoring Committee may require additional information. Such reports are in addition to the annual awardee noncompeting continuation progress report. 7. Establishing procedures, where applicable, to comply with FDA regulations of 21 CFR Part 312 for studies involving investigational agents and to comply with the requirements of 45 CFR Part 46 for the protection of human subjects. For IND's sponsored by the NCI, the Principal Investigator is responsible for obtaining approval from both the Institutional Review Board and the NCI Program Director to enroll patients and to change the protocol. The Principal Investigator is also responsible for all aspects of investigational drug acquisition, formulation, distribution, etc. 8. Cooperating in the reporting of the study findings. The NCI will have access to and may periodically review all data generated under an award. Where warranted by appropriate participation, plans for joint publication with NCI of pooled data and conclusions are to be developed by the Principal Investigator, as applicable. NIH policies governing possible co-authorship of publications with NCI staff will apply in all cases. In general, to warrant co-authorship, NCI staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; and (c) preparation and authorship of pertinent manuscripts. The awardee(s) will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS and NIH policies. C. NCI Staff Responsibilities It is expected that the dominant role and prime responsibility for the activity will reside with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NCI Staff Collaborator who will provide expert advice to the awardee(s) on specific scientific and/or analytic issues as described below. The NCI Staff Collaborator will be named later based upon the subject matter of the award. However, the NCI Program Director will retain overall programmatic responsibility for the award and will be the contact point for all facets of interaction with the awardee related to stewardship and monitoring of the award. NCI Program Staff responsibilities will include: 1. Interacting with the Principal Investigator(s) on a regular basis to monitor study progress. Monitoring may include: regular communications with the Principal Investigator and staff, periodic site visits for discussions with awardee research team, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Data Safety and Monitoring Committee and related meetings. The NCI retains, as an option, the right to act as Sponsor for an IND filed to support the clinical research and to conduct periodic external review of progress. 2. Participating in the Data Safety and Monitoring Committee meetings. The NCI Staff Collaborator will be an invited attendee and participant of the Data Safety and Monitoring Committee and, if applicable, subcommittees, but will not have a vote on any committee. 3. Serving as a resource with respect to other ongoing NCI activities that may be relevant to the protocol to facilitate compatibility and avoid unnecessary duplication of effort. 4. Involvement assisting in the design and coordination of research activities for awardees as elaborated below: a. Assisting by providing advice in the management and technical performance of the investigations, coordinating clearances for investigational agents held by NCI. The NCI reserves the right to crossfile or independently file an Investigational New Drug Application form with the FDA. b. Through participation in meetings/correspondence of the research team, with the agreement of the Principal Investigator, the NCI Staff Collaborator may assist in the design, development, and coordination of the research or clinical protocol, in the statistical evaluations of data, in the preparation of questionnaires and other data recording forms, and in the publication of results. c. Reviewing and approving protocols to insure they are within the scope of peer review and for safety considerations, as required by Federal regulations. The NCI Program Director will monitor protocol progress, and may request that a protocol study be closed to accrual for reasons including: (a) accrual rate insufficient to complete study in a timely fashion; (b) accrual goals met early; (c) poor protocol performance; (d) patient safety and regulatory concerns; (e) study results that are already conclusive; and (f) emergence of new information that diminishes the scientific importance of the study question. The NCI will not permit further expenditures of NCI funds for a study after requesting closure (except for patients already on-study). d. Reviewing and providing advice regarding the establishment of mechanisms for quality control and study monitoring. 5. Making recommendations for continued funding based on: a) overall study progress, including sufficient patient and/or data accrual; b) cooperation in carrying out the research (e.g., attendance at Data Safety and Monitoring Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements. D. Collaborative Responsibilities In addition to the interactions defined above, NCI Staff and Awardees shall share responsibility for the following activities: 1. Data Safety and Monitoring Committee. A Committee organized by the Principal Investigator will be the main oversight body of the clinical trial. The Data Safety and Monitoring Committee has primary responsibility to review progress, monitor patient accrual, data management, and patient safety, and cooperate on the publication of results. The Data Safety and Monitoring Committee will document progress in written reports to the NCI Program Director, and will provide periodic supplementary reports to designated NCI staff upon request. The Data Safety and Monitoring Committee will be composed of external, non-participating peer Investigators, including those of data coordinating/statistical centers, if any, and the NCI Staff Collaborator. An initial meeting of the Data Safety and Monitoring Committee will be convened early after award by the Principal Investigator. The final structure of the Data Monitoring Committee will be established at the first meeting; the Principal Investigator will not be a member or routine attendee of the Committee after the first meeting. The NCI Staff Collaborator will have nonvoting membership on the Committee, and as appropriate, its subcommittees. Such a Committee usually will meet at least yearly. A Chairperson, other than the NCI representative, will be selected by a vote of the members. The Chairperson is responsible for coordinating the Committee activities, for preparing meeting agendas, and for scheduling and chairing meetings. E. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NCI may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the awardee, a second member selected by NCI, and the third member selected by the two prior selected members. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is NIH policy that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 10-43) and supersedes and strengthens previous policies (Concerning the Inclusion of Women in Study Populations), which have been in effect since 1990. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register, March 28, 1994 (59 FR 14508-14513) and in the NIH GUIDE FOR GRANTS AND CONTRACTS, March 18, 1994, Volume 23, Number 11. LETTER OF INTENT Prospective applicants are asked to submit, by April 3, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the names of other key personnel, the participating institutions, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it is requested to provide an indication of the number and scope of applications and to avoid conflict of interest in the review. The letter of intent is to be sent to: Gary J. Kelloff, M.D. Division of Cancer Prevention and Control National Cancer Institute 6130 Executive Boulevard, Suite 201 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier services) Telephone: (301) 496-8563 FAX: (301) 402-0553 Email: kelloffg@dcpcepn.nih.nci.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/95) is to be used for these cooperative agreements. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The RFA label available in PHS-398 must be affixed to the bottom of the face page. Failure to use this label could delay processing of the application such that it may not reach the review committee in time for review. Additionally, the title of the RFA, PIVOTAL CLINICAL TRIALS FOR CHEMOPREVENTION AGENT DEVELOPMENT and the RFA number CA-97-014, must be typed in line 2 of the face page and the YES box must be marked. A signed, typewritten original of the application, including the Checklist and three signed, clear, and single-sided photocopies must be submitted in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the same time, two additional copies of the application must also be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Applications must be received by May 22, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. this does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Preparation of the Application The general instructions provided in PHS-398 for the preparation of applications must be used. Because the Terms and Conditions of Award (discussed in the SPECIAL REQUIREMENTS Section), will be included in all awards issued as a result of this RFA, it is critical that each applicant provide specific plans for responding to the terms and conditions of award and requirements stated in the RFA. Plans must take into account NCI staff involvement as well as how all the responsibilities of awardees will be fulfilled. The following items apply to all applications: 1. Clinical trial designs should include an adequate number of participants and should be of sufficient duration to assure statistical power to address the study questions of chemopreventive efficacy, long-term safety and acceptability, and surrogate endpoint biomarker (SEB) validation. To this end, biostatistics and clinical trial design expertise should be included from the first efforts in study planning and design. 2. A discussion of the evaluation of SEBs, including relevance to the test agent and target population should be provided. 3. A rationale for each test agent should be provided, including relevant epidemiological and laboratory data. Preclinical and clinical toxicity data should also be presented. Where the availability or safety of the agent are in doubt, the applicant should consult with the NCI Program Director or the manufacturer prior to preparing the application. As noted above, applicants anticipating the need of considerable assistance in obtaining the chemopreventive agent(s) to be studied or in securing IND approval, e.g. with respect to adequate preclinical toxicology data, should seek this assistance from the NCI Program Director in writing. The request should be made to the Program Director prior to submission of the application. 4. A rationale for selection of the target patient cohort and an estimate of the number of participants required to complete the clinical studies should be provided. Criteria and calculations used to estimate sample size should be included. The patient cohort should be described and its selection justified. The cohort should be defined, as appropriate by age, sex, race, dietary customs, education, geographic location, occupational or lifestyle risk factors, and relevance to a specific cancer problem or its prevention by the test agent. Accrual rate should be estimated. If multiple institutions are involved, the proposal should include verification of the co-investigators' willingness to participate, and pertinent additional information regarding the cooperating institutions' staff qualifications, resources, research plans, including patient availability and data flow, as well as corresponding budget requirements. 5. Clinical chemistry and biologic aspects of the studies should be completely described, including sample collection, storage, handling, analysis, and quality control. The methods and equipment to be used and the technical qualifications and experience of the personnel involved should be addressed. If these aspects of the studies are to be conducted by groups other than at the applicant's institution, a letter from the cooperating institutions indicating their willingness to participate should be included. 6. Any known or potential toxicity considerations should be described, along with the techniques and procedures to monitor any adverse events and dose modifications to be made based on toxicity. 7. Methods to monitor patient compliance and, as appropriate, methods to document nutrient intake should be specified. 8. A willingness to work cooperatively with the NCI Program Director in the implementation and conduct of the study should be indicated. 9. Applicants from institutions which have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC Program Director or Principal Investigator could be included with the application. REVIEW CONSIDERATIONS A. Review Procedures Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) for completeness and by the NCI for responsiveness. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the Request for Applications will be evaluated for scientific and technical merit in accordance with the review criteria stated below by an appropriate peer review group convened by the NCI. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. The review group will assess the scientific merit of the studies using the following review criteria: B. Review Criteria Review Criteria for the Proposed Clinical Trial o Scientific merit of the proposed research. This includes design, methodology (including considerations of toxicity, quality assurance, endpoint analyses, and power), and the clinical study protocol. o The significance and importance of the objectives. Basic and clinical scientific significance, as well as originality of the proposed research. Particularly important are the definition of the high-risk target populations and the evaluation biomarkers relative to clinical interventions. o Documentation of relevant prior successful accrual. o The qualifications of the Principal Investigator to serve as both the scientific and administrative leader of the proposed research. The Principal Investigator should be an established scientist with a substantial record of independent research. o The adequacy of the commitment (percent effort) of the Principal Investigator to the proposed research. There should be a specific commitment to both the scientific and administrative aspects of the proposed research though it is not mandatory that the Principal Investigator be a project leader of an individual research project. o The qualifications of Co-Investigators and support personnel. o The presence of an organizational and administrative structure appropriate for effective attainment of the proposed research objectives. o The mechanisms for internal quality control of the research. o The institutional environment in which the research is conducted, including the availability of space, equipment and patients as well as the physical proximity of participants. For applications involving more than one institution, the mechanisms for assuring close coordination and interaction are evaluated. o The adequacy of the proposed means for early detection of and protection against potential adverse effects upon humans and the environment. o The appropriateness of the statistical design and mechanism for the rigorous management and verification of research data. Adequacy of methods for data and tissue collection and analysis. Documentation of validated bioanalytical procedures (method sensitivity, specificity, quality control, etc.) and of prior experience with endpoints to-be-evaluated. o Adequacy of adherence to guidelines for including gender and minority representation in any study population. o The appropriateness of the budget. A realistic budget reflects the project leader's understanding of the scope of work. o Adequacy of plans for NCI Program staff involvement with the proposed research. AWARD CRITERIA The earliest feasible start date for the initial awards will be September 1997. Besides technical merit, NCI will base funding decisions on how well the applicant institutions meet the goals and objectives of the program described in the RFA, as well as on availability of resources and study populations. INQUIRIES Written and telephone inquiries concerning the RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Gary J. Kelloff, M.D. Division of Cancer Prevention and Control National Cancer Institute 6130 Executive Boulevard, Suite 201 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8563 FAX: (301) 402-0553 Email: kelloffg@dcpcepn.nih.nci.gov Inquiries regarding fiscal matters may be addressed to: Ms. Carolyn Mason Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Suite 243 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-7800 Ext. 259 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.399, Cancer Control. Awards will be made under authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410; as amended by Public Law 99-158, 42 USC 241 and 258); and administered under PHS grant policies and Federal Regulations 42 CFR Parts 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirement of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sat Mar 08 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-97-005 - V26(07) 03/07/97 Date: 9 Mar 1997 15:13:55 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 886 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5fvg7j$c9a@net.bio.net> NNTP-Posting-Host: net.bio.net CHEMOPREVENTION IN GENETICALLY-IDENTIFIED HIGH-RISK GROUPS: INTERACTIVE RESEARCH AND DEVELOPMENT PROJECTS NIH GUIDE, Volume 26, Number 7, March 7, 1997 RFA: CA-97-005 P.T. 34; K.W. 0740018, 0745003, 0715035, 0411005, 0710030 National Cancer Institute Letter of Intent Receipt Date: April 3, 1997 Application Receipt Date: May 22, 1997 PURPOSE The purpose of this initiative is to establish integrated, multidisciplinary research programs that define and evaluate chemopreventive strategies in asymptomatic subjects at high risk for cancer. This Request for Applications (RFA) seeks programs with administrative core functions supporting at least three independent but integrated research projects that share a common focus directed at designing and evaluating chemopreventive strategies in high-risk cohorts. This includes groups with on-going administrative clinical trials core functions and laboratory support such as cooperative groups, CCOP Research Bases and NCI designated cancer centers. At least two of the individual projects must involve Phase I/II or Phase II clinical chemoprevention trials or translational research needed for chemoprevention applications. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Chemoprevention in Genetically-Identified High-Risk Groups: Interactive Research and Development Projects, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. For those respondents affiliated with the Community Clinical Oncology Program (CCOPs), it is suggested that applications be submitted through the CCOPs mechanism. MECHANISM OF SUPPORT This RFA will use the research program cooperative agreement (U19) mechanism. The U19 is essentially the cooperative agreement version of the P01 (Program Project Grant) funding mechanism. Therefore the applicant should use the NCI P01 guidelines in preparing the application. The P01 guidelines are available from the NCI Referral Officer (Ms. Toby Friedberg), listed under APPLICATION PROCEDURES. The cooperative agreement is an assistance mechanism in which substantial involvement of the NCI program with the recipient is anticipated during the performance of the planned activity. The nature of the NCI's involvement is described under SPECIAL REQUIREMENTS and in the TERMS AND CONDITIONS section. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the awardee. The U19 cooperative agreement builds on the leadership of a key Principal Investigator and the interaction of the participating investigators to integrate the individual projects in a way that accelerates the acquisition of knowledge beyond that expected from the same projects conducted separately, without combined leadership or a common theme. Individual investigators may apply their specialized research capabilities to basic, developmental, and clinical aspects, as they relate to the focused, central theme of the overall project. This grant mechanism also offers a way to achieve economy of effort through the sharing of personnel, facilities, equipment, data, ideas, and concepts. The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated award date is September 1997. This RFA is a one-time solicitation. Future unsolicited competitive continuation applications will compete with all other investigator-initiated research applications and be peer reviewed by a study section in the Division of Research Grants (DRG), NIH. However, if it is determined that there is a sufficient continuing need, the NCI will invite recipients of awards made under this RFA in FY 97 to submit competitive continuing applications for review according to procedures described below under APPLICATION PROCEDURES and REVIEW CONSIDERATIONS. FUNDS AVAILABLE Approximately $3 million in total costs for support of the first year of the program will be committed specifically to fund applications submitted in response to this RFA. It is anticipated that three to four awards will be made. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated the sizes of awards will vary also. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, awards made pursuant to this RFA will be contingent on the continued availability of funds for this purpose. RESEARCH OBJECTIVES Background High risk for cancer may be attributable to inherited or acquired genetic lesions, lifestyle or environmental factors, or combinations of these parameters. Program components include, but are not limited to (1) definition of cohorts, (2) identification and characterization of early precancerous lesions/biomarkers that may contribute to defining cohorts, serve as endpoints for clinical studies, or both, and (3) clinical studies to evaluate the chemopreventive strategies. Successful programs will require expertise in general and molecular cancer epidemiology, genetics, molecular biology, descriptive and quantitative pathology, pharmacology, oncology, and clinical science with attendant capabilities in biostatistics, bioanalytical methodologies, data management and clinical trials management. Support of the translational research needed to bring relevant basic research findings to clinical application in the high-risk cohorts is a major objective. Increasing knowledge of the 20 40 year process of human carcinogenesis is providing many new opportunities for early intervention and prevention, and, specifically, for chemoprevention. A significant part of this knowledge is the association of increased cancer risk with inherited or acquired genetic lesions. Genetic predisposition includes well-characterized germline mutations, many of which are associated with lost tumor suppressor function. Examples are APC (familial adenomatous polyposis leading to colorectal cancer), BRCA1 and BRCA2 (breast and ovarian cancers), and p53 mutations resulting in Li-Fraumeni syndrome (multiple cancers including breast, colorectal, brain and leukemia). Other cancer-predisposing genes such as MLH1 and MSH2 (both linked to hereditary nonpolyposis colon cancer) cause defective DNA repair. Also, recent cancer epidemiology and pharmacogenetic studies have suggested the importance of genetic polymorphisms affecting the ability to detoxify carcinogens e.g., glutathione S-transferase (GSTM1, GSTM2, GSTP1), N-acetyltransferase (NAT1, NAT2), cytochrome P450 (CYP450IAI), and steroid 5 alpha-reductase type II (SRD5A2). Mutations and changes in expression of tumor suppressors acquired during carcinogenesis are also important. Similarly, oncogenes and growth factors activated by mutation or overexpressed during carcinogenesis (e.g., ras, EGFR, c-erbB2) are significant genetic lesions in cancer as are mutations in cyclin and cyclin-related genes implicated in cell cycle control. Besides these specific genetic lesions, general indicators of genetic susceptibility have been developed, for example, mutagen sensitivity as measured by bleomycin-induced DNA break frequency. Although it is not likely that any of these lesions will be eradicated by chemopreventive agents, their presence and activity may be decreased by damping the signal transduction pathways in which they participate, thereby selecting against proliferation of progeny cells containing the lesions or inducing apoptosis in these cells. Environmental, hormonal, lifestyle and other etiological factors contribute to cancer risk and may enhance the risks from genetic predisposition. It is estimated that while approximately 5 percent of cancers are due to genetic predisposition and 15 percent occur spontaneously, the remaining 80 percent are attributable to the environment and environmental-genetic interactions. Chemoprevention strategies should be useful in these situations to reduce mutational frequency and clonal evolution. For example, smokers who are continually exposed to gene-damaging agents may be good candidates for chemopreventive intervention with antimutagens. Also, women at high risk for breast cancer may benefit from chemopreventive intervention that controls breast cell proliferation. Scope and Objectives The purpose of this initiative is establishment of integrated, multidisciplinary research programs that define and evaluate chemopreventive strategies in subjects at high risk for cancer. This RFA is seeking programs with administrative core functions supporting at least three independent research projects which share a common focus directed at designing and evaluating chemopreventive strategies in high-risk cohorts. Program components might include, but are not limited to groups with on-going administrative clinical trials core functions and laboratory support such as cooperative groups, CCOP Research Bases and NCI designated cancer centers. The programs should be directed to further characterizing and defining high-risk cohorts for major cancers, such as those listed above. High-risk may be defined by clinical and epidemiological criteria, linkage analysis or DNA testing or combinations of these parameters. Applications using clinical criteria or linkage analysis should include provisions for tissue collection and storage for future DNA testing. Applicants are strongly encouraged to pursue research objectives consistent with the Clinical Development Plans for chemopreventive agents published by the NCI, DCPC Agent Development Committee (see Journal of Cellular Biochemistry Supplement 20, 1994 and Supplement 26, 1996) for which preclinical efficacy and toxicity information has been developed and for which IND support and drug are available. However, applications should reflect the interests and insights of the investigators. Examples of theme areas for which projects may be proposed, for the purpose of illustration only, might include the following: 1. Women at high risk for breast cancer with atypical epithelial hyperplasia or epithelial hyperplasia and one or more of aneuploidy, elevated PCNA, EGFR or hormone receptors, or mutated p53 by baseline fine-needle aspiration cytology might be randomized to chemopreventive treatment and placebo groups. Primary endpoints of treatment might include cytology, nuclear/nucleolar morphometry, PCNA, EGFR or hormone receptors, p53, and apoptosis (bcl-2/bax). Additional areas of investigation could include genetic analysis of BRCA-1, -2 relative to function and penetrance, LOH at 11q12-13, methylation, other risk factor analysis (e.g., hormone receptor types), and surveillance (e.g., as related to DCIS, LCIS, and ovarian cancer), or other basic research questions explored using animal model or cell culture techniques. Correlative studies using NMR, digital imaging mammography, sonoelastography, neoangiogenesis MRI, etc. could also be undertaken. 2. Patients with familial adenomatous polyposis coli who are found at baseline colonoscopy endoscopic biopsy to have 100 or more colorectal adenomas or APC truncation mutation and 10 or more colorectal polyps of which two or more are adenomas might be randomized to chemopreventive treatment (or compare treatments) and placebo groups. Primary endpoints of treatment might include colon polyp incidence, colon crypt proliferation kinetics, and apoptosis. Additional areas of investigation could include translational research involving the MIN and MSH mouse models and analysis of COX2 modulation through MIN and MOM pathways, analysis of aberrant crypt formation and zonal proliferation, and other areas relevant to HNPCC and mutational spectra. 3. Former smokers (30 or more pack years) with moderate/severe bronchial dysplasia on fluorescence bronchoscopy and random bronchial biopsy might be randomized to chemopreventive treatment and placebo groups. In addition to the primary endpoint of treatment, bronchial dysplasia grade, investigations might include nuclear polymorphism, ploidy, LOH at 3p and 5q, p53, rb, CDKN2, microsatellite instability, PCNA, telomerase, apoptosis, and GST. These investigations might be undertaken in biopsy material and in the context of developing transgenic animal models for lung dysplasia/cancer showing high frequencies of tumor mutations. At least two of the individual projects must be Phase I/II or Phase II clinical chemoprevention trials or translational research needed for chemoprevention applications. Phase II studies should include molecular biomarkers or other intermediate biomarkers as surrogate endpoints for cancer incidence (cancer incidence may be beyond the scope and/or duration of this initiative for most clinical situations). Translational research projects will primarily involve the characterization, quantitation and evaluation of the early molecular biomarkers that identify high-risk cohorts and serve as surrogate endpoints for cancer incidence in chemoprevention trials in these populations. The programs will build on existing resources for identifying and recruiting participants to the clinical studies (e.g., genetic testing programs, risk registries). The NCI will conduct a safety and protocol review of the studies prior to their initiation. This review is required to assure that all safety, conduct, monitoring, and reporting conform to FDA IND guidelines. The awardee institutions and Principal Investigators must agree to comply with the recommendations of the review. Core functions provided in the programs might include (1) tissue storage for later analysis, (2) a data management system with validated statistical and quality assurance procedures, and (3) safety and conduct monitoring of clinical trials with oversight by scientists with expertise in genetic and epidemiological research. SPECIAL REQUIREMENTS General High risk for cancer may be attributable to inherited or acquired genetic lesions, lifestyle or environmental factors, or combinations of these parameters. This initiative is to establish integrated, multidisciplinary research programs around a theme in an area of defining and evaluating chemopreventive strategies in subjects at high risk for cancer, including but not limited to, the definition of cohorts, the identification and characterization of early precancerous lesions/biomarkers for both cohort identification and endpoint analysis, and the clinical evaluation of chemopreventive strategies. This RFA is seeking programs with administrative core functions supporting at least three independent but integrated research projects which share a common focus directed at designing and evaluating chemopreventive strategies in high-risk cohorts. Studies may involve multiple institutions. This includes groups with on-going administrative clinical trials core functions and laboratory support such as cooperative groups, CCOP Research Bases and NCI designated cancer centers. At least two of the individual projects must involve Phase I/II or Phase II clinical chemoprevention trials or translational research needed for chemoprevention applications. Applications funded under this RFA will be supported through the cooperative agreement (U19) mechanism. An assistance relationship will exist between NCI and the awardees to accomplish the research objectives. It is expected that each submission will describe plans for a mixture of basic, developmental, and clinical research activities, all directed to the meet the objectives of this RFA. As described more fully below, the recipients will have primary responsibility for the development and performance of the research activities. However, there will be government involvement, particularly on clinical studies, with regard to (1) assistance in securing an Investigational New Drug (IND) approval from the Food and Drug Administration (FDA), (2) coordination and assistance in obtaining the chemopreventive agent, and (3) monitoring of study safety and conduct. If an investigator anticipates requiring considerable assistance in obtaining the chemopreventive agent and/or in securing an IND perm it from the FDA, documentation of such assistance from the NCI should be obtained, prior to submitting an application. Awards will not be made until all arrangements for obtaining the IND and the agent are completed. Cost of agent and necessary formulation should be included in the budget. Definitions Program Director - the NCI Program Staff official (see INQUIRIES section if this RFA) responsible for the stewardship and monitoring of the award. The Program Director may also function as the Staff Collaborator. Staff Collaborator - the NCI Staff Collaborator responsible for contributing expert advice on the scientific design and conduct of the research. Advisory Committee - the committee composed of external, non-participating scientists appointed by the Principal Investigator to oversee the research activities and provide advice to the Principal Investigator who is responsible for reporting progress to the NCI Program Director. Data Safety and Monitoring Committee - Composed of external, non-participating scientists assigned by the NCI Program Director to monitor patient safety, conduct data audits, and document progress to the NCI Program Director and Advisory Committee. Terms and Conditions of Award A. Applicability. These special Terms and Conditions of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS grant administration regulations in 45 CFR part 74 and 92, and other HHS, PHS and NIH grant administration policy statements. The administrative and funding instrument used shall be a cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NCI scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NCI purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with the above concept, the dominant role and prime responsibility for the activity reside with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NCI Staff Collaborator. Under the cooperative agreement, a relationship will exist between the recipient of these awards and the NCI, in which the performers of the activities are responsible for the requirements and conditions described below, and agree to accept program assistance from a named NCI Staff Collaborator in achieving project objectives. Failure of an awardee to meet the performance requirements, including these special terms and conditions of award, or significant changes in the level of performance, may result in a reduction of budget, withholding of support, suspension and/or termination of the award. B. Awardee Rights and Responsibilities. The Awardee is responsible for: 1. Research design and protocol development, including definition of objectives and approaches, planning, implementation, participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results. 2. Establishing an external Advisory Committee to oversee projects and review data. The Principal Investigator will name external, non-participating investigators to serve as members on an Advisory Committee and schedule meetings periodically. The NCI Staff Collaborator will be a non-voting member. 3. Designating Clinical Study Protocol Chairs. The Principal Investigator shall designate a single Protocol Chairperson (if the P.I. does not assume this role) for each protocol within the described research plan. The Protocol Chairperson shall function as the scientific coordinator for the protocol and shall assume responsibility for developing and monitoring the protocol. All proposed protocols and modifications will be submitted by the Chair through the Principal Investigator to the NCI Program Director, for review and approval, subject to negotiation with the awardees. 4. Implementing the data collection method and strategy. 5. Establishing mechanisms for quality control and monitoring. Awardees are responsible for ensuring accurate and timely assessment of the progress of each study, including development of procedures to ensure that data collection and management are: (1) adequate for quality control and analysis; (2) for clinical trials, as simple as appropriate in order to encourage maximum participation of physicians and patients and to avoid unnecessary expense; and (3) sufficiently staffed. 6. Submitting interim progress reports, when requested, to the NCI Program Director including as a minimum, summary data on protocol performance. The Advisory Committee may require additional information. Such reports are in addition to the annual awardee noncompeting continuation progress report. 7. Establishing procedures, where applicable, to comply with FDA regulations of 21 CFR Part 312 for studies involving investigational agents and to comply with the requirements of 45 CFR Part 46 for the protection of human subjects. For IND's sponsored by the NCI, the Principal Investigator is responsible for obtaining approval from both the Institutional Review Board and the NCI Program Director to enroll patients and to change the protocol. The Principal Investigator is also responsible for all aspects of investigational drug acquisition, formulation, distribution, etc. 8. Cooperating in the reporting of the study findings. The NCI will have access to and may periodically review all data generated under an award. Where warranted by appropriate participation, plans for joint publication with NCI of pooled data and conclusions, are to be developed by the Principal Investigator or Advisory Committee, as applicable. NIH policies governing possible co-authorship of publications with NCI staff will apply in all cases. In general, to warrant co-authorship, NCI staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; and (c) preparation and authorship of pertinent manuscripts. The awardee(s) will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS and NIH policies. C. NCI Staff Responsibilities It is expected that the dominant role and prime responsibility for the activity will reside with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NCI Staff Collaborator who will provide expert advice to the awardee on specific scientific and/or analytic issues as described below. The NCI Staff Collaborator will be named later based upon the subject matter of the award. However, the NCI Program Director will retain overall programmatic responsibility for the award and will be the contact point for all facets of interaction with the awardee related to stewardship and monitoring of the award. NCI Staff responsibilities will include: 1. Interacting with the principal investigator(s) on a regular basis to monitor study progress Monitoring may include: regular communications with the principal investigator and staff, periodic site visits for discussions with awardee research teams, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Advisory Committee and related meetings. The NCI retains, as an option, the right to act as Sponsor for an IND filed to support the clinical research and to conduct periodic external review of progress. 2. Participating in the Advisory Committee meetings. The NCI Staff Collaborator will be an invited attendee and a participant on the Advisory Committee and, if applicable, subcommittees, but will not have a vote on any committee. 3. Serving as a resource with respect to other ongoing NCI activities that may be relevant to the protocol to facilitate compatibility and avoid unnecessary duplication of effort. 4. Involvement assisting in the design and coordination of research activities for awardees as elaborated below: a. Assisting by providing advice in the management and technical performance of the investigations, coordinating clearances for investigational agents held by NCI. The NCI reserves the right to crossfile or independently file an Investigational New Drug Application form with the FDA. b. Through participation in the Advisory Committee and with the agreement of the Principal Investigator, the NCI Staff Collaborator may assist in the design, development, and coordination of the research or clinical protocol, in the statistical evaluations of data, in the preparation of questionnaires and other data recording forms, and in the publication of results. c. Reviewing and approving protocols to insure they are within the scope of peer review and for safety considerations, as required by Federal regulations. The NCI Program Director will monitor protocol progress, and may request that a protocol study be closed to accrual for reasons including: (a) accrual rate insufficient to complete study in a timely fashion; (b) accrual goals met early; (c) poor protocol performance; (d) patient safety and regulatory concerns; (e) study results that are already conclusive; and (f) emergence of new information that diminishes the scientific importance of the study question. The NCI will not permit further expenditures of NCI funds for a study after requesting closure (except for patients already on-study). d. Reviewing and providing advice regarding the establishment of mechanisms for quality control and study monitoring. 5. Making recommendations for continued funding based on: a) overall study progress, including sufficient patient and/or data accrual; b) cooperation in carrying out the research (e.g., attendance at Advisory Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements. D. Collaborative Responsibilities In addition to the interactions defined above, NCI Staff and Awardees shall share responsibility for the following activities: 1. Advisory Committee. An Advisory Committee organized by the Principal Investigator will be the main oversight body of the proposed research. The Advisory Committee has primary responsibility to oversee research activities and provide advice to the Principal Investigator. The Principal Investigator will document progress in written reports to the NCI Program Director, and will provide periodic supplementary reports upon request. The Advisory Committee will be composed of external, non-participating peer Investigators, including the NCI Staff Collaborator. An initial meeting of the Advisory Committee will be convened early after award by the Principal Investigator. The final structure of the Advisory Committee will be established at the first meeting. The NCI Staff Collaborator will attend and participate in the Advisory Committee, and as appropriate, its subcommittees but will not be a voting member of any committee. Such a committee usually will meet at least yearly. 2. Data Safety and Monitoring Committee. The NCI Program Director will facilitate and the awardee shall allow for interim data auditing and patient safety monitoring. The Data Safety and Monitoring Committee may assist in clinical protocol coordination and IND submission, subject to discussion with the Principal Investigator, and will review interim results periodically and report to NCI and the Advisory Committee, as appropriate. E. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NCI may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the awardee, a second member selected by NCI, and the third member selected by the two prior selected members. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is NIH policy that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 10-43) and supersedes and strengthens previous policies (Concerning the Inclusion of Women in Study Populations), which have been in effect since 1990. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register, March 28, 1994 (59 FR 14508-14513) and in the NIH GUIDE FOR GRANTS AND CONTRACTS, March 18, 1994, Volume 23, Number 11. LETTER OF INTENT Prospective applicants are asked to submit, by April 3, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the names of other key personnel, the participating institutions, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it is requested to provide an indication of the number and scope of applications and to avoid conflict of interest in the review. The letter of intent is to be sent to: Gary J. Kelloff, M.D. Division of Cancer Prevention and Control National Cancer Institute 6130 Executive Boulevard, Suite 201 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier services) Telephone: (301) 496-8563 FAX: (301) 402-0553 Email: kelloffg@dcpcepn.nih.nci.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/95) is to be used for these cooperative agreements. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The RFA label available in PHS-398 must be affixed to the bottom of the face page. Failure to use this label could delay processing of the application such that it may not reach the review committee in time for review. Additionally, the title of the RFA, CHEMOPREVENTION IN GENETICALLY-IDENTIFIED HIGH-RISK GROUPS: INTERACTIVE RESEARCH AND DEVELOPMENT PROJECTS, and the RFA number CA-97-005, must be typed in line 2 of the face page and the YES box must be marked. A signed, typewritten original of the application, including the Checklist and three signed, clear, and single-sided photocopies must be submitted in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892 BETHESDA, MD 20817 (for express/courier service) At the same time, two additional copies of the application must also be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Applications must be received by May 22, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. this does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Preparation of the Application The general instructions provided in PHS-398, in conjunction with the NCI P01 guidelines (available from the NCI Referral Officer listed in the APPLICATION PROCEDURES section of this RFA), should be used for the preparation of applications. Because the Terms and Conditions of Award (discussed in the SPECIAL REQUIREMENTS Section), will be included in all awards issued as a result of this RFA, it is critical that each applicant provide specific plans for responding to the terms and conditions of award and requirements stated in the RFA. Plans must take into account NCI staff involvement as well as how all the responsibilities of awardees will be fulfilled. The following items apply to all applications: 1. Clinical trial designs should include an adequate number of participants and should be of sufficient duration to assure statistical power to address the study questions of chemopreventive efficacy, long-term safety and acceptability, and surrogate endpoint biomarker (SEB) validation. To this end, biostatistics and clinical trial design expertise should be included from the first efforts in study planning and design. 2. A discussion of the evaluation of genetic lesions and SEBs, including relevance to the test agent and target population should be provided for the basic research and clinical components of the projects. 3. A rationale for each test agent should be provided, including relevant epidemiological and laboratory data. Preclinical and clinical toxicity data should also be presented. Where the availability or safety of the agent are in doubt, the applicant should consult with the NCI Program Director or the manufacturer prior to preparing the application. As noted above, applicants anticipating the need of considerable assistance in obtaining the chemopreventive agent(s) to be studied or in securing IND approval, e.g. with respect to adequate preclinical toxicology data, should seek this assistance from the NCI Program Director in writing. The request should be made to the Program Director prior to submission of the application. 4. A rationale for selection of the target patient cohort and an estimate of the number of participants required to complete the clinical studies should be provided. Criteria and calculations used to estimate sample size should be included. The patient cohort should be described and its selection justified. The cohort should be defined, as appropriate by age, sex, race, dietary customs, education, geographic location, occupational or lifestyle risk factors, and relevance to a specific cancer problem or its prevention by the test agent. Particularly, the genetic lesion under study should be carefully described and characterized. Accrual rate should be estimated. If multiple institutions are involved, the proposal should include verification of the co-investigators' willingness to participate, and pertinent additional information regarding the cooperating institutions' staff qualifications, resources, research plans, including patient availability and data flow, as well as corresponding budget requirements. 5. Clinical chemistry and biologic aspects of the studies should be completely described, including sample collection, storage, handling, analysis, and quality control. The methods and equipment to be used and the technical qualifications and experience of the personnel involved should be addressed. If these aspects of the studies are to be conducted by groups other than at the applicant's institution, a letter from the cooperating institutions indicating their willingness to participate should be included. 6. Any known or potential toxicity considerations should be described, along with the techniques and procedures to monitor any adverse events and dose modifications to be made based on toxicity. 7. Methods to monitor patient compliance and, as appropriate, methods to document nutrient intake should be specified. 8. A willingness to work cooperatively with the NCI Program Director in the implementation and conduct of the study should be indicated. 9. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC Program Director or Principal Investigator could be included with the application. REVIEW CONSIDERATIONS A. Review Procedures Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) for completeness and by the NCI for responsiveness. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the Request for Applications will be evaluated for scientific and technical merit in accordance with the review criteria stated below by an appropriate peer review group convened by the NCI. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. The review group will assess the scientific merit of the studies using the following review criteria: B. Review Criteria Review Criteria for the Overall Proposed Research o The significance and importance of the objectives. Basic and clinical scientific significance, as well as originality of the proposed research. o The qualifications of the Principal Investigator to serve as both the scientific and administrative leader of the overall proposed research. The Principal Investigator should be an established scientist with a substantial record of independent research. o The adequacy of the commitment (percent effort) of the Principal Investigator to the proposed research. There should be a specific commitment to both the scientific and administrative aspects of the proposed research though it is not mandatory that the Principal Investigator be a project leader of an individual research project. o The presence of an organizational and administrative structure appropriate for effective attainment of the proposed research objectives. o The mechanisms for internal quality control of the research. Adequacy of methods for data and tissue collection and storage. o The institutional environment in which the research is conducted, including the availability of space, equipment and patients as well as the physical proximity of program participants. o The appropriateness of the size of the proposed research. The proposed research should be large enough to achieve synergy and economies not provided by a collection of separate research grants. The proposed research must consist of three or more scientifically meritorious projects. On the other hand, the proposed research should be small enough to focus efforts on a central theme and to allow the effective scientific and administrative direction by the Principal Investigator. o Adequacy of adherence to guidelines for including gender and minority representation in any study population. Documentation of prior successful accrual. Review Criteria for Projects - The significance of the specific scientific objectives or hypotheses of the project in the context of the proposed research. o The quality of the experimental approach and research plan. This may be supported by results from preliminary or related studies. o The qualifications, experience and commitment (percent effort) of the project leader and investigators responsible for the individual research project. Project leaders must demonstrate a capability for independent research, often evidenced by a record of peer-reviewed support. o The adequacy of the proposed means for early detection of and protection against potential adverse effects upon humans, animals, or the environment. o The appropriateness of the statistical design and mechanism for the rigorous management and verification of research data. o The appropriateness of the budget. A realistic budget reflects the project leader's understanding of the scope of work. AWARD CRITERIA The earliest feasible start date for the initial awards will be September 1997. Besides technical merit, NCI will base funding decisions on how well the applicant institutions meet the goals and objectives of the program described in the RFA, as well as on availability of resources and study populations. INQUIRIES Written and telephone inquiries concerning the RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Gary J. Kelloff, M.D. Division of Cancer Prevention and Control National Cancer Institute 6130 Executive Boulevard, Suite 201 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8563 FAX: (301) 402-0553 Email: kelloffg@dcpcepn.nih.nci.gov Inquiries regarding fiscal matters may be addressed to: Ms. Carolyn Mason Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Suite 243 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-7800 Ext. 259 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.399, Cancer Control. Awards will be made under authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410; as amended by Public Law 99-158, 42 USC 241 and 258); and administered under PHS grant policies and Federal Regulations 42 CFR Parts 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirement of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sat Mar 08 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DK-97-008 - V26(07) 03/07/97 Date: 9 Mar 1997 15:13:16 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 459 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5fvg6c$c7t@net.bio.net> NNTP-Posting-Host: net.bio.net CHRONIC PROSTATITIS COLLABORATIVE CLINICAL STUDIES NIH GUIDE, Volume 26, Number 7, March 7, 1997 RFA: DK-97-008 P.T. 34; K.W. 0705075, 0785220, 0785035 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: March 17, 1997 Application Receipt Date: May 14, 1997 PURPOSE The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites research project grant (R01) applications for four collaborating Clinical Research Centers (CRC) and one biostatistical support center (BSC) to participate in an interactive chronic prostatitis clinical research group (CPCRG). Chronic prostatitis is a significant problem for many men and their family members. A recent NIDDK sponsored workshop on chronic prostatitis developed a system to classify patients with prostatitis with each category having distinct diagnostic criteria. The majority of patients with prostatitis are in the "chronic category" which is based upon specific characteristics of the prostatic fluid. The purpose of this Request for Applications (RFA) is to provide support for investigators to collaboratively study patient self-reported symptoms and the objective diagnostic findings in men with chronic prostatitis (i.e., pain or discomfort in the pelvic area, no demonstrable infection using routine clinical methodology). Emphasis should be placed on state-of-the-art techniques to characterize the prostatic secretions of men with chronic prostatitis. Another area of emphasis is the development and validation of a survey instrument to assess self-reported severity of illness in these men. Each participating CRC in collaboration with the other CRCs will develop and carry out uniform and standardized research protocols to study the biological characteristics of prostatic fluid in men with chronic prostatitis in the hopes of better defining the etiology of this condition. Prior to conducting such objective laboratory studies it will be necessary to develop and validate a symptom/severity questionnaire to characterize the subjective aspects of the disease. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Chronic Prostatitis Clinical Research Centers, is related to the priority areas of chronic disabling conditions and clinical prevention services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are especially encouraged. Foreign institutions must demonstrate special or unique areas of expertise in order to be considered competitive for an award. MECHANISM OF SUPPORT Support of this program will be through the NIH grants-in-aid research project grant (R01) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. FUNDS AVAILABLE For FY 1997, $1,100,000 will be committed to fund applications submitted in response to this RFA. It is anticipated that up to five awards for Clinical Research Centers (CRC) and one award for a Biostatistical Support Center (BSC) will be made under this RFA. The award for the clinical component of each Clinical Center will not exceed $140,000 direct costs for the first year (protocol development phase). The direct costs awarded for the BSC for the first year (protocol development phase) will not exceed $180,000 direct costs. It is anticipated that the length of award for all centers will be five years. The anticipated award date is September 30, 1997. The number of awards and level of support provided will be dependant upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIDDK, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Chronic prostatitis is a chronic, disabling condition affecting untold numbers of men of all ages and ethnic origins. The NIDDK recently sponsored a workshop that was designed to develop a plan to standardize and evaluate various methods of diagnosis and treatment of chronic prostatitis with a long term goal of preventing and effectively treating this condition. The workshop classified prostatitis into four clinical categories. Categories I through III are identified by chronic pain. In addition to pain, categories I and II are readily diagnosed by the presence of infection. In contrast, patients with Category III prostatitis do not have any demonstrable infection of the prostate as determined by conventional microbiological techniques. Abnormalities in the expressed prostatic secretions (EPS) are the primary objective feature. Chronic pain remains the primary subjective symptom. The majority of patients with prostatitis fall into category III (i.e., chronic pain and abnormal EPS). A copy of this workshop report is available from the urology program staff listed under INQUIRIES. Objectives and Scope for Clinical Centers The aim of this RFA is to develop an interactive research network of clinical centers that will validate survey and diagnostic tools which can be used in standardized clinical study protocols including clinical trials, of men who fit the criteria of category III chronic prostatitis (pain or discomfort in the pelvic area, no demonstrable infection using routine clinical methodology). The study population is limited to those men in Category III and, if necessary, appropriately matched controls. It is not the purpose of this RFA to study men with acute and recurrent bacterial prostatitis (using conventional terminology and diagnostic methodology). A high priority of this RFA is to encourage collaborative studies on the characteristics of semen and expressed prostatic secretions (EPS) in men with category III chronic prostatitis and to develop and validate survey instruments and a symptom index which assess the severity of illness in these men. Based on the recommendations of the Prostatitis Workshop, it is anticipated that applicants will propose multi center protocols to: o correlate the characteristics of expressed prostatic secretion (EPS) and/or seminal fluid evaluation in men with chronic prostatitis and with severity of illness; o develop and validate a uniform symptom index for chronic prostatitis, and o validate the diagnostic criteria established by the NIDDK workshop panel. Each of the participating centers will also develop protocols which will also address some of the other recommendations of the workshop which include: o development of a standardized treatment protocol for chronic prostatitis, o development and validation of outcome measures for the chronic prostatitis, o establishment of the relationship between chronic prostatitis, other prostate diseases and lower urinary tract symptoms (LUTS), and the o development of epidemiological studies. It will be advantageous for clinical centers to demonstrate previous clinical research experience both in recruiting patients into clinical studies and in developing and validating diagnostic and assessment tools. Objectives And Scope For The Biostatistical Support Center: Participating investigators will meet together and develop uniform study protocols to evaluate seminal fluid and EPS and to develop and validate a patient self-report symptom questionnaire. The data obtained from these linked studies will be sent to a BSC. The responsibilities of the BSC include, in collaboration with the PIs of the CRCs, development and writing of protocols for the studies and manuals of procedures. The BSC will receive and store all data generated by the CRCs. They will be responsible for assessing data quality, evaluating data collection techniques at the CRCs, establishing procedures for data transmission for the CRCs to the BSC and performing appropriate statistical analyses of the data. Study Design and Population It is envisioned that over the five year period of this project, several multi-center projects that address the important issues identified during the workshop will be developed and implemented by all the participating CRCs. The study population will be enrolled from persons who present with either a clinical diagnosis or the symptoms of chronic prostatitis (Category III) as defined within this RFA. It is envisioned that this population will encompass a broad range of age groups and include a significant minority representation. It is expected that each Clinical Center would have the ability to screen enough men to enroll at least 50 patients per year for three years for enrollment in the various assessment and outcomes validation protocols. It is expected that a single CRC may be participating in more than one validation protocol at the same time. The Principal Investigators of each center will have equal responsibility in developing validation and treatment protocols. One of the roles of the network is to develop strategies for rapid dissemination of validated protocols so they may be utilized by the entire clinical community. Applicants should propose at least two examples (conducted either concurrently or sequentially) of protocols requiring multi center participation. These are examples which they consider important and which address the objectives of the RFA. The proposals should briefly outline the rationale and background of the proposed studies, eligibility criteria, and baseline and outcome measures. Budget and Related Items All applications must include in their budget, expenses for three planning trips to Bethesda each year. All clinical center applications must include in their budget the costs of any laboratory studies which will not be covered by private payment. Applications for the CRCs and the Biostatistical Support Center should prepare five budget periods of 12 months each. The budget may be increased at three percent annually for each of the successive years. The awards of these budgets will be subjected to administrative review annually. Collaborative Organization The Principal Investigator of each Clinical Research Center and the Principal Investigator of the BSC will meet as an interactive committee three times in each year of the study. Collaborative protocols will be developed by this committee. Data will be submitted centrally to the BSC. SPECIAL INSTRUCTIONS FOR INCLUSION OF MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, the NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. For this application, no comment is necessary regarding inclusion of women. However, if minorities are not included in the study population, specific justification must be provided. Applications must address procedures that will be used to recruit and maintain minority population members into the study, the specific minority population that will be accessible for inclusion in the study, and the approximate percent of minority population that it is anticipated can be recruited. LETTER OF INTENT Prospective applicants are asked to submit, by March 17, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIDDK staff to estimate potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-37F2 - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8885 FAX: (301) 480-3505 Email: HaganA@ep.niddk.nih.gov APPLICATION PROCEDURES The research grant application from PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices for sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC-7910, Bethesda, MD 20892-7910, telephone 301-435-0714, email: asknih@odrockm1.od.nih.gov. The RFA label available in the PHS 398 (rev. 5/95) must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee on time for review. In addition, the RFA title and number must be typed of line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-37F - MSC 6600 Bethesda, MD 20892-6600 Applications must be received by April 17, 1997. If an application is received after this date it will be returned to the applicant without review. The Division of Research grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Diabetes and Digestive and Kidney Disease Advisory Council. Applicants are encouraged to submit and describe their own ideas on how best to meet the goals of the study. Applications will be judged primarily on the scientific quality of the application. Although the technical merit of the protocol is important, it will not be the sole criterion for selection of an application for award. Other considerations such as the importance and timeliness of the proposed studies, access to patients including minority populations, the discussion of considerations relevant to the RFA, expertise of the investigators, their capability to perform the work proposed, and a demonstrated willingness to work as part of the network will be part of the evaluation and funding criteria. The review group will also assess the following: Clinical Centers: o Scientific merit of the proposed studies; o Qualifications, experience, and commitment of key personnel including previous experience in relevant studies; o Viability of plans to recruit an adequate number of patients, including an appropriate representation of minorities; o Facilities, equipment and organizational structure to effectively implement protocols through the network; o Rationale and cost-effectiveness of the research approach proposed. o Appropriateness of the proposed budget. o For foreign applicants: opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries that are not readily available in the United States or which augment existing U.S. resources Biostatistical Support Center: o Organizational, administrative, and supervisory ability and statistical expertise to serve as a Biostatistical Support Center for the multi center interactive projects; o Qualifications, experience, and commitment of key personnel; o Facilities and equipment to function as a Biostatistical Support Center for an interactive network; o Cost-effectiveness of procedures proposed; o Appropriateness of the budget for the work proposed. AWARD CRITERIA Applications recommended by the NIDDK Advisory Council will be considered for award based upon (a) scientific and technical merit; (b) program balance, sufficient compatibility of features to make a successful collaborative program a reasonable likelihood and the geographic distribution of the participating centers; (c) availability of funds. The anticipated date of award is September 30, 1997. INQUIRIES Inquiries concerning this RFA are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: John W. Kusek, Ph.D. or Leroy M. Nyberg, Ph.D., M.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: KusekJ@ep.niddk.nih.gov NybergL@ep.niddk.nih.gov Direct inquiries regarding fiscal and administrative matters to: Ms. Trude Hilliard Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8859 FAX: (301) 480-3504 Email: HilliardT@ep.niddk.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free work place and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, heath care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sat Mar 08 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 07, pt. 1of1, 7 March 1997 Date: 9 Mar 1997 15:12:40 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 724 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5fvg58$c70@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 26, No. 7 - March 7, 1997 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N2 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** ASSESSMENT OF POTENTIAL COCAINE TREATMENT MEDICATIONS IN NONHUMAN PRIMATES (RFP N01DA-7-8073) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX R2 04/14/97 ************************************************* CHRONIC PROSTATITIS COLLABORATIVE CLINICAL RESEARCH STUDIES (RFA DK-97-008) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE KIDNEY DISEASES $$INDEX R3 05/22/97 ************************************************* CHEMOPREVENTION IN GENETICALLY-IDENTIFIED HIGH-RISK GROUPS: INTERACTIVE RESEARCH AND DEVELOPMENT PROJECTS (RFA CA-97-005) National Cancer Institute INDEX: CANCER $$INDEX R4 05/22/97 ************************************************* PIVOTAL CLINICAL TRIALS FOR CHEMOPREVENTION AGENT DEVELOPMENT (RFA CA-97-014) National Cancer Institute INDEX: CANCER $$INDEX P1 ********************************************************** NIA PILOT RESEARCH GRANT PROGRAM IN NEUROSCIENCE AND BIOLOGY (PAR-97-040) National Institute on Aging INDEX: AGING $$INDEX P2 ********************************************************** PILOT GRANTS IN GERIATRICS (PAR-97-041) National Institute on Aging INDEX: AGING $$INDEX P3 ********************************************************** INNOVATION GRANT PROGRAM FOR APPROACHES IN HIV VACCINE RESEARCH (PAR- 97-042) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES The NIH GUIDE is available electronically via LISTSERV subscription, and is also on the nih gopher (gopher.nih.gov) and the NIH web site (http://www.nih.gov). Alternative access is available through the NIH Grant Line via modem (data line 301/402-2221); contact Dr. John James at 301/435-2801 for details on the NIH Grant Line. All competing (new, renewal, amended (revised) applications for grants, cooperative agreements, and fellowships from the National Institutes of Health must be sent to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) ASKNIH is a service of the Division of Extramural Outreach & Information Resources, Office of Extramural Research, Office of the Director, NIH. ASKNIH is the point of contact for obtaining general information about NIH extramural research & research training programs, requesting publications, and learning more about obtaining the NIH GUIDE and other information on the NIH web site. ASKNIH is also the contact to which organizations should request application kits and forms. ASKNIH NATIONAL INSTITUTES OF HEALTH EMAIL: ASKNIH@odrockm1.od.nih.gov FAX: (301) 480-0525 TELEPHONE: (301) 435-0714 INQUIRIES ABOUT THE NOTICES, PAS, AND RFAS IN THIS PUBLICATION SHOULD BE DIRECTED TO THE NIH STAFF MEMBER IDENTIFIED AT THE END OF EACH ITEM. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 26, Number 7, March 7, 1997 P.T. 34; K.W. 1014004, 1014006 Department of Health and Human Services Notice is hereby given that the Office of Research Integrity (ORI) has made a final finding of scientific misconduct in the following case: James B. Boone, Jr., Ph.D., University of Missouri-Columbia: Based upon an investigation conducted by the University of Missouri- Columbia, information obtained by the Office of Research Integrity (ORI) during its oversight review, and Dr. Boone's own admission, ORI found that Dr. Boone, former Research Assistant Professor, Department of Veterinary Biomedical Sciences at the University of Missouri- Columbia, engaged in scientific misconduct by fabricating and falsifying data in biomedical research supported by a grant from the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH). Specifically, Dr. Boone fabricated the weights of individual, isolated muscles that, in fact, had not been separated by dissection, and falsely presented unrelated gamma counter results as having been obtained from the same individual muscles. He presented these data to his laboratory director as the results from two experiments that Dr. Boone admitted he did not complete. Dr. Boone committed additional falsifications in conducting research, including presenting: (1) a computer spread sheet that used the above described sets of the fabricated primary data of muscle weights and the falsified gamma counter results to generate false computations of blood flow in separate muscles; (2) a computer spread sheet for the statistical computations of the data from the two sets of fabricated and falsified reduced data; and (3) a histogram derived from the falsified reduced data that showed significant differences in some of the fabricated experimental measurements on individual muscles. Dr. Boone has accepted the ORI finding and has entered into a Voluntary Exclusion Agreement with ORI in which he has voluntarily agreed, for the three year period beginning February 10, 1997: (1) to exclude himself from serving in any advisory capacity to the Public Health Service (PHS), including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant; and (2) that any institution that submits an application for PHS support for a research project on which the respondent's participation is proposed or which uses the respondent in any capacity on PHS supported research must concurrently submit a plan for supervision of his duties. The supervisory plan must be designed to ensure the scientific integrity of the respondent's research contribution. The institution must submit a copy of the supervisory plan to ORI. No scientific publications were required to be corrected as part of this Agreement. For further information, contact: Acting Director, Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 26, Number 7, March 7, 1997 P.T. 42; K.W. 0783005 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human subjects. The meetings should be of special interest to those persons currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all other Public Health Service agencies. The current schedule includes the following: DATES: April 10-11, 1997 TITLE: Science to Practice: The Role of Research in Public Health LOCATION: The Robert W. Woodruff Health Sciences Center, 1440 Clifton Road, NE, Atlanta, GA 30322 SPONSORS: Emory University - School of Public Health, Atlanta, GA; Morehouse School of Medicine, Atlanta, GA; Centers for Disease Control and Prevention, Atlanta, GA REGISTRATION: Emory University School of Medicine Continuing Medical Education 1462 Clifton Road, NE, Suite 276 Atlanta, GA 30322 Telephone: (404) 727-5695 FAX: (404) 727-5667 REGISTRATION FEE: $75 DESCRIPTION: This program is a practical working session to explore issues in human subjects protection related to public health including surveillance, emergency responses, community-based research and international research. An outstanding faculty will present topics from the perspective of the public health researcher and the public health practitioner. Sessions will provide a panel format with ample time for audience questions and discussion. This program will be of interest to researchers in public health, epidemiology, health education, and the behavioral and social sciences, Institutional Review Board members, university and hospital administrators, lawyers, ethicists, health care practitioners, students, and other persons with interests in human subject protection issues. INQUIRIES For further information regarding these workshops or future NIH/FDA National Human Subject Protections Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks Office of Extramural Research 6100 Executive Boulevard, Suite 3B01 Rockville, MD 20892-7507 Telephone: (301) 496-8101 x233 FAX: (301) 402-0527 Email: RossD@od6100m1.od.nih.gov $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN N01DA-7-8073 ********************************************* ASSESSMENT OF POTENTIAL COCAINE TREATMENT MEDICATIONS IN NONHUMAN PRIMATES NIH GUIDE, Volume 26, Number 7, March 7, 1997 RFP AVAILABLE: N01DA-7-8073 P.T. 34; K.W. 0404009, 0745070 National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) is soliciting proposals from qualified organizations having in-house capability to screen potential pharmacotherapies for cocaine dependence in drug discrimination and self-administration paradigms in nonhuman primates. Proprietary test compounds will be evaluated in established protocols, and the resulting data will be utilized by the Cocaine Treatment Discovery Program of the NIDA Medications Development Division. Offerors must indicate possession of current DEA registration for Schedule II-V substances prior to award and apply for Schedule I registration at the time of award. It is anticipated that one (1) cost reimbursement, completion type contract will be awarded for a period of four years, with possibilities for one option year and other option quantities for additional followup studies. RFP No. N01DA-7-8073 will be available electronically on or about February 28, 1997, and may be accessed through the NIH Gopher and/or the Internet by using the following electronic mail addresses and instruction: 1. NIH Home Page (via the World Wide Web): Access the NIH Home Page by using http://www.nih.gov. Once you are at the NIH Home Page, select "Grants and Contracts"; select "NIH Gopher directory: listed under the "Contracts Page" section. Once at the NIH R&D Gopher, select "RFPs Available"; select "NIDA"; and select "RFP N01DA-7-8073". (URL: gopher://gopher.nih.gov:70/11/res/rd-rfp) 2. NIH Gopher: Point your Gopher client to GOPHER.NIH.GOV Port 70 (you should now be in the NIH Gopher). Select "Grant and Research Information"; select "R&D Request for Proposals (RFP)"; select "RFPs Available"; select "NIDA"; and, select "RFP N01DA-7-8073". Please note that the RFP for this acquisition will be streamlined to include only the Work Statement, deliverable and reporting requirements, special requirements and mandatory qualifications, Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Response to this RFP will be due on or about April 14, 1997. Any responsible offeror may submit a proposal which will be considered by the Government. This advertisement does not commit the Government to award a contract. INQUIRIES For further information contact, Kenneth E. Goodling Contracts Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 10-49 Rockville, MD 20857 Telephone: (301) 443-6677 FAX: (301) 443-7595 Email: kg25d@nih.gov $$R1 END ************************************************************ $$R2 BEGIN DK-97-008 FULL-TEXT ************************************** CHRONIC PROSTATITIS COLLABORATIVE CLINICAL RESEARCH STUDIES NIH GUIDE, Volume 26, Number 7, March 7, 1997 RFA AVAILABLE: DK-97-008 P.T. 34; K.W. 0705075, 0785220, 0785035 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: March 17, 1997 Application Receipt Date: May 14, 1997 PURPOSE The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites research project grant (R01) applications for five interactive Clinical Research Centers (CRC) and one biostatistical support center (BSC) to participate as an interactive chronic prostatitis clinical research group (CPCRG). The purpose of this request for applications (RFA) is to provide support for investigators to study patient self-reported symptoms and the objective diagnostic findings in men with chronic prostatitis (i.e., pain or discomfort in the pelvic area, no demonstrable infection using routine clinical methodology). One area of emphasis is the development of state-of-the-art techniques to characterize the prostatic secretions of men with chronic prostatitis. Another area of emphasis is the development and validation of a survey instrument to assess self-reported severity of illness in these men. For FY 1997, $1,100,000 will be committed to fund applications submitted in response to this RFA. It is anticipated that up to five awards for Clinical Research Centers (CRC) and one award for a Biostatistical Support Center (BSC) will be made under this RFA. The award for the clinical component of each Clinical Center will not exceed $140,000 direct costs for the first year (protocol development phase). The direct costs awarded for the BSC for the first year (protocol development phase) will not exceed $180,000 direct costs. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Chronic Prostatitis Clinical Research Centers, is related to the priority areas of chronic disabling conditions and clinical prevention services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. John W. Kusek, Ph.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301)-594-7717 FAX: (301)-480-3510 Email: KusekJ@ep.niddk.nih.gov $$R2 END ************************************************************ $$R3 BEGIN CA-97-005 FULL-TEXT ************************************** CHEMOPREVENTION IN GENETICALLY-IDENTIFIED HIGH-RISK GROUPS: INTERACTIVE RESEARCH AND DEVELOPMENT PROJECTS NIH GUIDE, Volume 26, Number 7, March 7, 1997 RFA AVAILABLE: CA-97-005 P.T. 34; K.W. 0740018, 0745003, 0715035, 0411005, 0710030 National Cancer Institute Letter of Intent Receipt Date: April 3, 1997 Application Receipt Date: May 22, 1997 PURPOSE The purpose of this initiative is to establish integrated, multidisciplinary research programs that define and evaluate chemopreventive strategies in asymptomatic subjects at high risk for cancer. This Request for Applications (RFA) seeks programs with administrative core functions supporting at least three independent but integrated research projects that share a common focus directed at designing and evaluating chemopreventive strategies in high-risk cohorts. This includes groups with on-going administrative clinical trials core functions and laboratory support such as cooperative groups, CCOP Research Bases and NCI designated cancer centers. At least two of the individual projects must involve Phase I/II or Phase II clinical chemoprevention trials or translational research needed for chemoprevention applications. It is anticipated that approximately $3 million in total costs will be committed specifically to fund three to four research program cooperative agreement (U19) awards in response to this RFA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Chemoprevention in Genetically-Identified High-Risk Groups: Interactive Research and Development Projects, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Gary J. Kelloff, M.D. Division of Cancer Prevention and Control National Cancer Institute 6130 Executive Boulevard, Suite 201 Bethesda, MD 20892 Telephone: (301) 496-8563 FAX: (301) 402-0553 Email: kelloffg@dcpcepn.nih.nci.gov $$R3 END ************************************************************ $$R4 BEGIN CA-97-014 FULL-TEXT ************************************** PIVOTAL CLINICAL TRIALS FOR CHEMOPREVENTION AGENT DEVELOPMENT NIH GUIDE, Volume 26, Number 7, March 7, 1997 RFA AVAILABLE: CA-97-014 P.T. 34; K.W. 0715035, 0755015, 0740018 National Cancer Institute Letter of Intent Receipt Date: April 3, 1997 Application Receipt Date: May 22, 1997 PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI) invites applications to further the drug development efforts of the Chemoprevention Branch by carrying out intermediate-sized Phase II/III efficacy trials of promising chemopreventive agents in major cancer target organs, particularly prostate, breast, lung, colon, and bladder. Approximately $3 million in total costs for the first year of support for the program will be committed specifically to fund three to four cooperative agreement (U01) applications submitted in response to this RFA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Pivotal Clinical Trials for Chemoprevention Agent Development, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221). The NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Gary J. Kelloff, M.D. Division of Cancer Prevention and Control National Cancer Institute 6130 Executive Boulevard, Suite 201 Bethesda, MD 20892 Telephone: (301) 496-8563 FAX: (301) 402-0553 Email: kelloffg@dcpcepn.nih.nci.gov $$R4 END ************************************************************ $$P1 BEGIN PAR-97-040 FULL-TEXT ************************************* NIA PILOT RESEARCH GRANT PROGRAM IN NEUROSCIENCE AND BIOLOGY NIH GUIDE, Volume 26, Number 7, March 7, 1997 PA AVAILABLE: PAR-97-040 P.T. 34; K.W. 1002030, 1002006, 0710010 National Institute on Aging PURPOSE The National Institute on Aging (NIA) is seeking small grant (R03) applications to: (1) stimulate and facilitate the entry of promising new investigators into the neuroscience and biology of aging and (2) encourage established investigators to enter new targeted, high priority areas in these research fields. This Small Grant (R03) Program provides support for pilot research that is likely to lead to a subsequent individual research project grant (R01) or a FIRST (R29) award application and/or a significant advancement of aging research. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, NIA Pilot Research Grant Program in Neuroscience and Biology, is related to the priority areas of unintentional injuries, diabetes and chronic disabling conditions, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-11474-0 or Summary Report: Stock No. 017-001-11473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Dr. David B. Finkelstein Biology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 2C212, MSC 9205 Bethesda, MD 20892 Telephone: (301) 496-6402 Email: BAPquery@gw.nia.nih.gov $$P1 END ************************************************************ $$P2 BEGIN PAR-97-041 FULL-TEXT ************************************* PILOT GRANTS IN GERIATRICS NIH GUIDE, Volume 26, Number 7, March 7, 1997 PA AVAILABLE: PAR-97-041 P.T. 34; K.W. 0710010, 0710030 National Institute on Aging PURPOSE The Geriatrics Program of the National Institute on Aging (NIA) is seeking small grant (R03) applications to stimulate and facilitate research in underdeveloped topics in specific areas of aging research. This Small Grant (R03) Program provides support for pilot research that is likely to lead to a subsequent individual research project grant (R01) or a FIRST (R29) award application and/or a significant advancement of aging research. These R03 projects include, but are not limited to, research that is innovative and/or high risk. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Pilot Grants in Geriatrics, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-11474-0 or Summary Report: Stock No. 017-001-11473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Evan Hadley, M.D. Geriatrics Program National Institute on Aging Gateway Building, Room 3E327 Bethesda, MD 20892-9205 Telephone: (301) 435-3044 FAX: (301) 402-1784 Email: hadleye@gw.nia.nih.gov $$P2 END ************************************************************ $$P3 BEGIN PAR-97-042 FULL-TEXT ************************************* INNOVATION GRANT PROGRAM FOR APPROACHES IN HIV VACCINE RESEARCH NIH GUIDE, Volume 26, Number 7, March 7, 1997 PA AVAILABLE: PAR-97-042 P.T. 34; K.W. 0715008, 0740070, 0765033, 0755020, 079000 National Institute of Allergy and Infectious Diseases Application Receipt Date: May 23, 1997 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) gives special consideration for funding to scientifically meritorious applications in response to program announcements (PAs). PAs identify current areas of ongoing research emphasis for the NIAID. The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) on the recommendation of the AIDS Vaccine Research Committee (AVRC), seeks to implement a new program aimed at rapidly exploiting new scientific opportunities to broaden the base of scientific inquiry in areas related to vaccine discovery and development. This program announcement represents the first step in establishing the Innovation Grant Program. The NIAID invites applications, including those from researchers previously outside the field of AIDS research, for research projects that involve a high degree of innovation, risk and novelty-- as well as a clear promise of helping to improve vaccine design or evaluation-- in the following three general areas: (1) the structure/function of HIV envelope protein; (2) creation/improvement of animal models for vaccine evaluation and pathogenesis studies; and (3) mechanisms of directing antigen processing in vivo. This Innovation Grant Program utilizes a grant mechanism which provides the resources to carry out preliminary tests of feasibility for new research hypotheses, and a rapid and streamlined review and award process. This approach will be evaluated by the AVRC for suitability and responsiveness following this initial offering. If successful, other announcements may be made in the future. Research projects will be supported with the exploratory/developmental research grant mechanism HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Innovation Grant Program for Approaches in HIV Vaccine Research, is related to the priority areas of HIV infection, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone: 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov) and the NIH Website (http://www.nih.gov) and by mail and email from the program contact listed below. Carole A. Heilman, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2A16 MSC 7620 Bethesda, MD 20892-7610 Telephone: (301) 496-0545 FAX: (301) 402-1505 Email: ch25v@nih.gov $$P3 END ************************************************************ From owner-sci-resources@net.bio.net Sat Mar 08 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 8 March 1997 Date: 9 Mar 1997 15:18:51 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 132 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5fvggr$d1v@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending March 8, 1997. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: NSF February Bulletin V-24; No.6 File size (bytes): 49545 STIS Filename: bul9702.txt Document Type: Form Title: Form 1263 -- NSF Grant Transfer Request Type: Forms -- NSF-wide File size (bytes): 5624 STIS Filename: form1263.txt Document Type: International Document Title: Special Scientific Report INT 97-10 #97-05 (February 19, 1997) File size (bytes): 10959 STIS Filename: int9710.txt Title: Special Scientific Report #97-04 INT 97-8-(February 12, 1997) File size (bytes): 6886 STIS Filename: int978.txt Title: 1997 NEDO GRANTS FOR INTERNATIONAL JOINT RESEARCH INT 97-9-TRM 97-03 File size (bytes): 3416 STIS Filename: int979.txt Document Type: Press Release Title: NSF POSTHUMOUSLY HONORS CARL SAGAN Distinguished Public Service Award Cites Scientist's Lifetime of Achievement File size (bytes): 3478 STIS Filename: pr9718.txt Document Type: Program Guideline Title: NSF 97-55 -- Graduate Research Fellowships File size (bytes): 92824 STIS Filename: nsf9755.txt Document Type: Recruit Title: Program Director File size (bytes): 7502 STIS Filename: vex973a1.txt Title: Staff Scientist for Oversight File size (bytes): 6850 STIS Filename: vex979.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Bulletin Title: NSF March Bulletin Vol 24; No 7 File size (bytes): 48132 STIS Filename: bul9703.txt Document Type: Letter Title: REULIST -- Current List of REU Sites File size (bytes): 103251 STIS Filename: reulist.txt Document Type: Phone Book Title: NSF Alphabetical List File size (bytes): 112743 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Alphabetical List File size (bytes): 112743 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Directory File size (bytes): 128131 STIS Filename: phnorg.txt Title: NSF Organization Directory File size (bytes): 128131 STIS Filename: phnorg.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg.txt, the text of your message should be as follows: get phnorg.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg.txt, you would enter: ftp> get phnorg.txt If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Mon Mar 17 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 15 March 1997 Date: 17 Mar 1997 16:01:17 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 102 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5gkm0d$bec@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending March 15, 1997. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: News Title: NSF SCIENCE FAIR `STARTERS' ON THE WEB File size (bytes): 4962 STIS Filename: tip97313.txt Document Type: Press Release Title: FIRST EVIDENCE THAT OZONE HOLE HARMS ANTARCTIC FISH File size (bytes): 3516 STIS Filename: pr9719.txt Title: When Satellites Mislead: Scientists Prescribe Caution File size (bytes): 4246 STIS Filename: pr9720.txt Document Type: Program Guideline Title: NSF 97-57 -- 1997 Presidential Awards for Excellence in Science, Mathematics & Engineering Mentoring File size (bytes): 12460 STIS Filename: nsf9757.txt Document Type: Recruit Title: Astronomer (Executive Assistant) File size (bytes): 5454 STIS Filename: vex978.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Form Title: Form 1263 -- NSF Grant Transfer Request File size (bytes): 11778 STIS Filename: form1263.txt Title: Form 1263 -- NSF Grant Transfer Request File size (bytes): 11778 STIS Filename: form1263.txt Document Type: Letter Title: REULIST -- Current List of REU Sites File size (bytes): 103351 STIS Filename: reulist.txt Document Type: Press Release Title: FIRST EVIDENCE THAT OZONE HOLE HARMS ANTARCTIC FISH File size (bytes): 3516 STIS Filename: pr9719.txt Title: When Satellites Mislead: Scientists Prescribe Caution File size (bytes): 4246 STIS Filename: pr9720.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve pr9720.txt, the text of your message should be as follows: get pr9720.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve pr9720.txt, you would enter: ftp> get pr9720.txt If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Thu Mar 20 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-045 - V26(08) 03/14/97 Date: 21 Mar 1997 14:42:38 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 305 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5gv2su$qs4@net.bio.net> NNTP-Posting-Host: net.bio.net PILOT PROJECTS OR FEASIBILITY STUDIES FOR GENOMIC MAPPING, SEQUENCING AND ANALYSIS NIH GUIDE, Volume 26, Number 8, March 14, 1997 PA NUMBER: PA-97-045 P.T. 34; K.W. 0755044, 0755045 National Human Genome Research Institute [NOTE: This program announcement supersedes the program announcement: (PA-94-046) Pilot Projects or Feasibility Studies for Genomic Analysis, NIH Guide for Grants and Contracts, Vol. 23, No.10, March 11, 1994.] PURPOSE The National Human Genome Research Institute (NHGRI), formerly the National Center for Human Genome Research, invites applications for pilot projects or feasibility studies to develop new, and/or to significantly improve existing, technologies that will accelerate the genome mapping, sequencing and analysis goals of the Human Genome Project (HGP) in the most expeditious and economical manner. The purpose of this program announcement is to encourage high risk/potential high payoff applications that are not yet developed fully enough to successfully compete for a standard R01 grant. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support for this program will be through the exploratory/development grants (R21) mechanism. Applicants may request up to two years of support. Projects will be limited to $100,000 (direct cost) per annum. These grants will not be renewable. Continuation of projects developed under this program will be through the regular grant program. RESEARCH OBJECTIVES Background and Objectives The NHGRI is currently engaged, along with several other federal, private, and international organizations, in a fifteen year research program called the Human Genome Project (HGP). The goals are to characterize the genomes of human and selected model organisms, to develop technologies to analyze the human genome, to examine the ethical, legal, and social implications of human genetics research, and to train scientists who will be able to utilize the tools and resources developed through the HGP to pursue biological studies that will improve human health. Significant progress toward completing these goals has been made in the past six years, with several having already been achieved. Continued progress toward and eventual completion of the HGP goals will require further technological advances in the areas of mapping, sequencing and analysis. Pilot projects can be a valuable means of promoting the development of new technologies that are scientifically sound, effective and cost-efficient. The NHGRI is interested in supporting technological advances in several areas of research, including the following: 1. Improved technologies for constructing genetic maps, such as developing new methods for rapid genotyping and developing new, easier-to-use markers; 2. Efficient technologies for identifying the nature and extent of sequence differences in human genomic DNA and for analyzing sequence variation within and among species; 3. New conceptual approaches for constructing physical maps of the genomes of other organisms and for constructing higher resolution maps for DNA sequencing ; 4. Improved technologies for reducing the cost of de novo seqeuncing and resequencing by at least an order of magnitude; 5. Novel approaches, both biological and computational, for interpreting the genome, with a special emphasis on technologies that are amenable to large-scale analysis and are genome-wide; and 6. New methods and tools for the analysis and interpretation of genomic data, as well as new data management systems. Prospective applicants are encourage to review the companion Program Announcement, PA-97-043, for a more detailed description of the types of research that address these topics. Proposals for the development of technology applications relevant to other research problems pertinent to the current or long-term goals of the HGP will be considered to be responsive to this announcement. Applicants responding to this program announcement are not required to have preliminary data. However, the research project must be well designed, must be scientifically and technically sound, and should propose alternative solutions. In the absence of preliminary data, applicants are encouraged to present any other information that can be considered as evidence of feasibility. The NHGRI encourages applications from scientists who have not traditionally been funded by the NHGRI, such as, chemists, engineers, physicists, mathematicians, and computer scientists. However, applicants whose expertise is primarily non-biological and who are interested in developing technology for genomic mapping, sequencing and analysis using non-biological tools are encouraged to interact closely with potential users of the technology. ADDITIONAL CONSIDERATIONS In planning research projects, applicants are urged to consider the following: Interdisciplinary Research. The problems that must be solved in genomic analysis may require technically demanding solutions. Accordingly, interdisciplinary approaches are particularly appropriate. The NHGRI encourages interdisciplinary collaborations between biologists from various sub-disciplines and non-biologists, such as chemists, physicists, information scientists, mathematicians and engineers. Instrumentation. Proposals for instrument development are expected to address the issues of access by groups other than the developers to any instruments developed through this program. In projects where instrumentation and/or software development are key components, investigators should specifically address (1) exportability to other laboratories, (2) access of other investigators to unique instruments, and (3) where appropriate, integration of individual components into systems. Evaluation of Technology. As technology matures it must be tested to demonstrate its capabilities and robustness. Plans for accomplishing such a test should be included in the application, if it is anticipated that the technology will reach the appropriate level of maturity by the end of the project period. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol 23, Number 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The title and number of this program announcement must be typed in Item 2 on the face page of the application. The completed original application and five legible copies should be delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants. NIH (or by the review group of the relevant Institute, Center, or Division), in accordance with the standard NIH peer review procedures. Following the scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. Review Criteria Scientific, technical, or medical significance and originality of proposed research; Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; Qualifications and research experience of the principal investigator and staff, particularly, but not exclusively, in the area of the proposed research; Availability of the resources necessary to perform the research; and Appropriateness of the proposed budget and duration in relation to the proposed research. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. In addition, applications assigned to the NHGRI will also take into consideration the following additional criteria: Potential for developing technology or strategies that will accelerate progress in mapping, sequencing, or analysis of the human genome and the genomes of other organisms; and Value of the proposed research for achieving the research goals of the National Human Genome Research Institute, while maintaining programmatic balance in the NHGRI grant portfolio. INQUIRIES Inquires are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcomed. Direct inquiries regarding programmatic issues to: David Benton, Ph.D. Genome Informatics Email: david_ benton@nih.gov Elise Feingold, Ph.D. Genomic Analysis Email: elise_feingold@.gov Bettie Graham, Ph.D. Genetic Mapping and Sequence Variation Email: bettie_graham@.nih.gov Jane L. Peterson, Ph.D. Large-Scale Sequencing Email: jane_peterson@nih.gov Jeffery Schloss, Ph.D. Technology Development/Genome Sequencing Email: jeff_schloss@nih.gov The address and telephone number for the staff listed above are: Building 38A, Room 614 National Human Genome Research Institute National Institutes of Health 38 Library Drive Bethesda, MD 20892-6050 Telephone: (301) 496-7531 Fax: (301) 480-2770. Inquiries about grants management/policy issues should be directed to: Ms. Jean Cahill Grants Management Officer National Human Genome Research Institute Building 38A, Room 613 National Institutes of Health 38 Library Drive Bethesda, MD 20892-6050 Telephone: (301) 402-0733 Email: jean_cahill@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.172. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Thu Mar 20 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA OD-97-005 - V26(08) 03/14/97 Date: 21 Mar 1997 14:41:41 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 745 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5gv2r5$qns@net.bio.net> NNTP-Posting-Host: net.bio.net CENTER FOR CHIROPRACTIC RESEARCH NIH GUIDE, Volume 26, Number 8, March 14, 1997 RFA: OD-97-005 P.T. 34; K.W. 0785030, 0715184, 0705050 Office of Alternative Medicine National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Child Health and Human Development Letter of Intent Receipt Date: April 9, 1997 Application Receipt Date: May 9, 1997 PURPOSE The Office of Alternative Medicine (OAM) was mandated by Congress in 1991 and permanently established within the Office of the Director, National Institutes of Health (NIH), through the National Institutes of Health Revitalization Act of 1993 (Public Law 103-43, Section 209). The mission of the OAM is to encourage and support the investigation of complementary and alternative medical (CAM) practices, with the ultimate goal of integrating validated alternative medical practices into health and medical care. The demographics, prevalence, and patterns of use of unconventional medicine in the United States have been described (New England J. Med. 328:246-352, 1993). The most relevant findings are the following: a) most people use unconventional therapies for chronic rather than life-threatening medical conditions; b) users of alternative therapies do not inform their primary care physicians; c) extrapolation to the United States population suggests that Americans made approximately 425 million visits to providers of unconventional therapy during 1990; and d) expenditures associated with alternative therapies appear similar to non-reimbursed expenses incurred for all hospitalizations in the United States. These findings indicate that alternative medicine modalities occupy a larger role in the self- health care of U.S. citizens than previously understood. Chiropractic is one of the most used forms of CAM by the U.S. Public. The goal of this RFA initiative is to encourage research of chiropractic by establishing a Center for Chiropractic Research. Such a Center will make available to investigators interested in chiropractic the resources necessary for the conduct of high quality research. HEALTHY PEOPLE 2000 The Public Health Service is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," an initiative for setting national health policy and priorities. Although Healthy People 2000 does not currently specify a CAM or Chiropractic objective, this RFA involves priority areas within the Healthy People 2000 objectives, which involve alternative medical health care. Applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic Colleges of Chiropractic or other chiropractic training institutions, either alone or in collaboration with other chiropractic institutions or with a conventional biomedical institution, including domestic for-profit and not-for- profit organizations, public and private organizations such as universities, colleges, hospitals, laboratories, units of State or local governments, Federally recognized Indian Tribal organizations, and eligible agencies of the Federal government. As the focus of this RFA is chiropractic medicine, substantive involvement of a College of Chiropractic or other chiropractic training institution is highly encouraged. Applications may include foreign components, but foreign organizations are not eligible to apply. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U24), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section "Terms and Conditions of Award." FUNDS AVAILABLE Approximately $500,000 in total costs (direct plus indirect) will be committed in the first year to fund one award from a qualified applicant. This award may be up to five funded years. This funding level is dependent on the receipt of applications of high technical and scientific merit, and the continued availability of funds. Because the nature and scope of applications may vary, it is anticipated that the award size could vary. RESEARCH OBJECTIVES Background The Office of Alternative Medicine (OAM) is mandated by Congress to identify and evaluate unconventional health care practices used by members of the U.S. public. Of these practices, chiropractic care is one of the mostly widely used by the public. Chiropractors are licensed in all fifty states, and chiropractic treatments for musculoskeletal disorders are often reimbursed by health insurance plans. It has been estimated that 5-10% of the U.S. population use chiropractic services at a cost of approximately $2 billion dollars, annually. One third to one half of these visits are for low-back pain. In recent years, there has been increased research on chiropractic care, some of which suggests the efficacy of spinal manipulation for certain type of low back pain. Although not systematically studied, major complications from chiropractic care appear to be rare. Nevertheless, there is a relative paucity of research on the efficacy and effectiveness of such chiropractic care for musculoskeletal disorders, including chronic pain, and little preclinical work on the biological mechanisms underlying chiropractic manipulation of the vertebral column. Purpose of the RFA A variety of health care providers employ the modalities of manipulation and mobilization for the treatment of musculoskeletal disorders; however, the expressed purpose of this RFA is to provide a mechanism to examine the potential effectiveness and validity of chiropractic therapies, and to provide clinical/scientific/technical assistance to chiropractic investigators as they develop their research projects. The establishment and support of a Center for Chiropractic Research, under the auspices of the OAM, will meet these objectives. The Center will support a multi-disciplinary group of researchers and clinicians to perform basic, preclinical, clinical, epidemiologic and or health services research of chiropractic. The Center will provide many of the resources necessary of the conduct of high quality research, including an environment for training future scientists. Finally, the Center will encourage collaboration between basic and clinical scientists, and between the chiropractic and conventional medical communities. In general, insufficient scientific data are currently available that address safety and efficacy questions for chiropractic care of musculoskeletal disorders, including chronic pain. Many chiropractic practitioners are not affiliated with research institutions currently able to provide the research infrastructure necessary to facilitate the study of chiropractic manipulations. Research conducted at the Center for Chiropractic Research will provide useful pilot data to determine the appropriateness of conducting larger studies on chiropractic approaches for the treatment of back maladies and related musculoskeletal disorders. It is expected that work begun at the Center will provide the basis for subsequent investigator- initiated research grant applications to the NIH. Center Concept The Center for Chiropractic Research is viewed as a first step in expanding the national infrastructure for research of chiropractic. It will support planning for new interdisciplinary programs involving experienced investigators from chiropractic and conventional medicine. It will provide clinical/scientific/technical assistance to investigators both on and off site. Key personnel must have expertise in areas such as biostatistics, computer processing, data management, protocol design, survey design, questionnaire development, basic laboratory evaluations, patient record data analysis, patient registries, development of databases, clinical and behavioral epidemiology, health education, health promotion and clinical trial methodology. The following personnel positions may be supported by the Center grant: Principal Investigator/Center Director (0.5 FTE), Administrative Manger/Assistant/Secretary (0.5 FTE),Computer Specialist/ Analyst/Biostatistician/Epidemiologist (0.5 FTE). Salaries of personnel should be charged to the grant in proportion to the time dedicated to Center activities. All positions must be adequately justified in the application, including a detailed description of the proposed duties and relevance to specific Center objectives. Specific objectives for the Center include: o Establishing linkage of academic centers with Chiropractic investigators; o Establishing a network of Chiropractic clinicians and investigators in specific topic areas; o Prioritizing performing research related to the chiropractic treatment of musculoskeletal disorders; o Linking investigators with common clinical interventions to each other and to technical expertise necessary to pursue research goals; o Establishing an advisory committee to provide program direction and advice to the principal investigator of the Center, including prioritization of research protocols; o Evaluate the feasibility of using data from chiropractic practitioners for research projects; o Developing a mechanism for scientific/technical merit review of proposed studies from investigators; o Developing a bibliographic resource on chiropractic topics to be made accessible to the public; o Develop workshops, seminars, etc. for training purposes; and o Acting as an institutional focus for training in research methodology, bioethics, biostatistics, clinical trial design, epidemiological studies, health services studies and basic laboratory methods. Chiropractic institutions that do not have the full capability within their own institution to respond to this RFA are encouraged to involve other institutions, both chiropractic and conventional, through consortium agreements. Research Focus Applications must include two research projects proposed for Center use. These projects may be up to three years in length. Projects already underway at the time of the application are applicable if not currently supported by the NIH. In addition, for each project, a justification for use of the Center is required, including an estimate of resources to be used. The Center will provide limited support for these research projects. A total of $200,000 (total cost) will be available in Year One for the research projects outlined in the application. Additional projects may be added in subsequent years up to $350,000 (total costs) per year for all projects. General purpose equipment, such as computers, and personnel will not be supported with these funds. It is expected that the project investigators will obtain additional funding to support their research and salaries through federal or other sources. Research topics include, but are not limited to, randomized, controlled clinical trials of chiropractic care for the treatment of musculoskeletal disorders, studies examining the rates and types of treatment complications, the amount and type of treatment necessary to achieve significant outcomes, cost-effectiveness analysis of chiropractic care and projects examining the underlying, biomedical/pathophysiological basis of chiropractic therapies. CENTER ACTIVITIES On a continuing basis, the Center will be expected to prioritize the top research areas concerning chiropractic medical treatments for musculoskeletal disorders including acute and chronic pain. This could be accomplished by holding research agenda conferences, conducting systematic reviews of the science in proposed areas of research, or by performing meta-analyses where appropriate. As part of the prioritization process, the Center is to establish and maintain a comprehensive bibliographic database on Chiropractic. The OAM will assist the Center in this endeavor. Eventually, the public will have access to this database through the Internet Within the first year, the Center should establish the infrastructure necessary to perform the research outlined in the application and begin this research. The Center will be expected to disseminate research findings in a timely manner through peer-reviewed publications. It is expected that new projects will begin by year three of the award up to a maximum of $350,000 (total costs) per year for all projects. Center investigators are encouraged to seek additional sources of research support. The Center must propose a mechanism for prioritizing research projects and a mechanism for scientific/ technical merit review of the projects. This can be in the form of a scientific advisory board or can employ independent reviewers, in a manner similar to that used at NIH. Center resources may only be used for projects prioritized and approved by the Center's Advisory Committee. Advisory Committee Center oversight is charged to an Advisory Committee (AC) to be appointed by the Principal Investigator on a rotating basis. The AC shall not be chaired by the Principal Investigator who will serve in an ex officio capacity only. The AC should meet at least quarterly and minutes of the meeting kept. These minutes shall be made available to NIH staff upon request. The AC should be a cross- section of eight to twelve individuals familiar with the Center's research activities. It is encouraged that the AC includes both faculty and non-faculty. However, all AC members should have training in either chiropractic medicine, conventional medicine or biomedical research. The AC shall include a biostatistician and epidemiologist to assist with the review of projects and the optimal approaches for subsequent data analysis. Besides prioritizing research projects submitted by Center or, if applicable, Consortium investigators, the AC should periodically review Center operations to ensure that Center resources are used for the most scientifically worthy projects. The AC should take an active role in encouraging younger faculty member to perform research and assist them in applying appropriate research concepts and methods. Support for the AC should be explicitly budgeted and justified. Clinical/scientific/technical Assistance Activities Each application must demonstrate the ability to provide clinical/scientific/technical assistance to potential chiropractic investigators and propose a plan for providing assistance to chiropractic investigators in the chosen program areas. These activities may include, but are not limited to, the following examples of assistance: o Choice of research methods appropriate to the chiropractic intervention; o Development of appropriate chiropractic protocols; o Study design; o Methods of data collection, management, and data analysis; o Quality control procedures; o Development of appropriate methods to assure safety of human subjects involved in research protocols; o Safety issues; o Case review methods; o Provide guidelines for applicants to use for clinical evaluation and data collection, e.g., NCI best case series; o Develop procedures for reporting adverse effects; o Preparation for Institutional Review Board approvals and FDA Investigational New Drug applications; and o Preparation for workshops, seminars, etc. for chiropractic investigators on relevant research topics. One purpose of this research program is to assist Chiropractic investigators in determining whether they have adequate preliminary data to propose specific defined pilot studies or make other applications for peer-reviewed research support. Training The Center is to serve as an environment for training health professionals in research on topics related to chiropractic. In addition, the Center should implement a program designed to introduce chiropractic students, residents and fellows to biomedical research in an effort to attract these individuals into research careers. Formal courses or seminars may be set up for this goal. The courses should be relevant to diverse areas of research and could include an array of topics, such as biostatistics, design of clinical trials, computer skills and bioethics. Student participation in ongoing research projects is also encouraged. Support for training should be explicitly budgeted and justified. The Center is expected to seek supplemental support for its training program through such mechanisms as the NIH National Research Service Award Institutional Research Training Grant (T32) or Individual Postdoctoral Fellowships (F32). SPECIAL REQUIREMENTS Applicants should propose an appropriate structure for the center application to meet the research goals and objectives stated above. The Principal Investigator (PI) must make a substantial commitment (e.g., 30%) to the Center. The PI or Director of the Center will be a member of a coordinating committee consisting of all PIs or Directors of OAM-supported Research Centers. The purpose of the Committee is to share experiences, discuss common problems and solutions, help in the development of networks of investigators, establish common guidelines and procedures for pilot studies and, where feasible, other activities. The Center for Chiropractic Research must agree to use any common guidelines and procedures agreed upon by the Coordinating Committee (e.g., process for systematic review of literature, bibliographic database management, structure of research opportunity disposition summaries, report formats, etc.). The PI or Director is expected to attend and participate in at least two, two-day Coordinating Committee planning/progress meetings per year in Bethesda or Rockville, Maryland. A scientific presentation of Center-supported research is required once a year at these meetings. Funds should be included in the budget to cover these trips. Any publications involving this OAM project must follow NIH publication policies, including citation of the NIH grant. The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator(s) as well as the institutional official at the time of award. TERMS AND CONDITIONS OF AWARD The administrative and funding instrument used for the Centers is a cooperative agreement (U24), an "assistance" mechanism in which substantial NIH scientific and programmatic involvement with the awardee is anticipated during the performance of the agreement. Under the cooperative agreement, the OAM purpose is to assist and stimulate the Center's planning and implementation by involvement in and working with the Center in a partner role. The OAM role is not to assume primary direction, responsibility, or a dominant operating role in the Center. Consistent with this concept, the primary role and total responsibility for Center programs resides with each Center. The Center and the OAM as noted below will share specific tasks and activities in completing the agreement. These special Terms of Award are in addition to and not in lieu of applicable U.S. Office of Management and Budget administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. 1. Awardee Rights and Responsibilities The Awardee will have primary and lead responsibilities for the project as a whole, but are expected to collaborate and cooperate with the Coordinating Committee, as well as with OAM and National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) staff. The Awardee is expected to prioritize, facilitate and support research, provide clinical/scientific/ technical assistance to potential Center (Consortium) investigators and initiate a training program as outlined in the application. The Awardee will establish an Advisory Committee to provide scientific and administrative oversight. The Advisory Committee will be composed of a cross-section of individuals knowledgeable in chiropractic medicine, conventional medicine or biomedical research, including a biostatistician and epidemiologist. These individuals are not limited to Center, or, if applicable, Consortium, faculty. The AC is expected to meet at least quarterly, with minutes of the meeting kept. The minutes will be made available to NIH staff upon request. The Advisory Committee is charged with both prioritizing projects submitted to the Center (or Consortium) and periodically reviewing Center (Consortium) activities to ensure that Center objectives, as outlined in the application, are being met. The Awardee is expected to initiate and maintain a comprehensive bibliographic database on chiropractic, with public access being the eventual goal.. Approximately every six months, the Center and OAM will electronically exchange collected citations The Awardee will retain custody of, and have primary rights to, the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. 2. NIH Staff Responsibilities The OAM Project Scientist will have substantial scientific and programmatic involvement in assisting the Awardee in the project, participating in technical assistance activities, referring members of the public to the Center for information or assistance, assisting in the development of bibliographic resources in Chiropractic, coordinating and involving NIH resources of clinically relevant activities outside of Chiropractic. NIAMS will designate a Program Officer and a Grants Management Specialist to provide administrative oversight of the grant, and will serve as scientific, technical, and programmatic advisors to the OAM during administration of this award. OAM Staff will assist the Center with the establishment and maintenance of the bibliographic database on Chiropractic. Approximately every six months, the OAM and Center will electronically exchange collected citations. Eventually, the public will have access to this database through the Internet. 3. Collaborative Responsibilities A Center Coordinating Committee, composed of the PIs of each OAM- supported Research Center and the OAM Director, or designated representative, has the primary responsibility for developing and implementing common procedures, guidelines, and criteria across centers, establishing common procedures and guidelines for pilot studies and other activities where feasible. The Center for Chiropractic Research agrees to use any common guidelines and procedures agreed upon by the Coordinating Committee (e.g., process for systematic review of literature, bibliographic database management, structure of research opportunity disposition summaries, report formats, etc.). The OAM Director, or designated representative, is a voting member of the Center Coordinating Committee and will serve as Chair. The Coordinating Committee will establish subcommittees as appropriate; OAM staff will provide assistance and support to the sub-committees as appropriate. The OAM Project Scientist will coordinate NIH Alternative Medicine activities with Center activities. 4. Arbitration Any disagreement that may arise on scientific and programmatic matters within the scope of the cooperative agreement and between award recipients and the OAM may be brought to arbitration. An arbitration panel will be composed of three members: one selected by the Center Principal Investigator; a second member selected by the OAM; and, the third member selected by the two prior selected members. This special arbitration procedure in no way effects the awardee's right to appeal an adverse action that is appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulation at 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided, that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 18, 1994 (FR 59 14508- 14513), and in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. LETTER OF INTENT Applicants are asked to submit, by April 1, 1997, a letter of intent that includes the number and title of this RFA; the name, address, and telephone number of the Principal Investigator (s); the identities of other key personnel and participating organizations or institutions, if any; and a title describing the proposed research. Although a letter of intent is not required, is not binding, and does not enter into the review of applications, the information that it contains will be especially helpful to the OAM in planning for the review of applications, estimating the potential work-load, and avoiding conflicts of interest in the review process. The letter of intent is to be sent to: Richard L. Nahin, Ph.D. Office of Alternative Medicine National Institutes of Health Building 31, Room 5B-38 Bethesda, MD 20892-2182 FAX: (301) 480-3519 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for this cooperative agreement. These forms are available at most institutional offices of sponsored research, from the OAM program administrator named above or from the World Wide Web at http://www.NIH.gov/grants/funding/funding.htm. Prior to writing the application, applicants should carefully read the instructions provided with form PHS 398 and this RFA. The total page limitation of the application, as specified in the instructions of the Form PHS 398, do not apply to this RFA. Applicants may spend up to 25 pages to describe Center activities and, in addition, up to 25 pages for each of the two research projects, excluding bibliographies. The two research projects should follow the PHS 398 format.. Each of the six points listed under Human Subjects in the PHS 398 application must be addressed for those studies involving human subjects. Although not required at the time of the application, Institutional Review Board and Institutional Animal Care and Use Committee must be obtained for each project listed, if appropriate, within 60 days of submission. The RFA label available in the PHS 398 application package must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a typewritten, signed original of the application, four signed photocopies, and the completed checklist in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, mail one additional complete copy of the application to the following RFA program administrator: Richard L. Nahin, Ph.D. Office of Alternative Medicine National Institutes of Health Building 31, Room 5B-38 Bethesda, MD 20892-2182 Applications must be received by May 9, 1997. If an application is received after the date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one previously reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must follow the guidance in the PHS Form 398 application instructions for preparation of revised applications, including an introduction addressing the previous critique. REVIEW CONSIDERATIONS General Considerations Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness by the OAM. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, OAM staff will return the application to the applicant. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the DRG in accordance with the NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council for NIAMS. Review Criteria An initial review group convened by the NIH DRG will assess the technical and scientific merit of the applications submitted based on three general areas: 1) the technical merit of the research proposals; 2) the institutional commitment and environment; and 3) the potential of the proposed center to enhance the level of chiropractic research. Below are specific criteria that will be evaluated by the reviewers. The final priority score will reflect the peer reviewers' overall assessment based on their judgements of these criteria: o Relevance to chiropractic and chiropractic research o Degree of substantive involvement of chiropractic training institutions o Scientific and technical merit of the proposed approaches for conducting the research projects o Adequate statistical, methodological and other appropriate scientific expertise, as dictated by the proposed research projects o Qualifications and clinical/research training and experience of the Principal Investigator and staff o Demonstration that the appropriate chiropractic community linkages exist o Availability of resources necessary to perform research assistance activities o Proposed organization and activities of the Advisory Committee, including description of process to prioritize research proposals; although it is not necessary to name members at this time, the process by which members will be chosen should be specified;. o Plans for the initiation and maintenance of a comprehensive bibliographic database on chiropractic; o Appropriateness of the proposed budget;. o Appropriateness of the proposed training plan;. o Evidence of the applicant institution's commitment to research and to the proposed Center; this can include, but is not limited to, office and laboratory space, clinical support, administrative support, faculty release from academic duties, support for Center training agenda, etc o Demonstrated willingness to work as part of the OAM Centers Coordinating Committee and with OAM and NIAMS staff; and o If a consortium is planned, the applicant must demonstrate the effectiveness of the relationships among the member institutions. The applicant should address both current relationships, as well as the functions and contributions of each consortium member in regards to proposed Center activities. In addition, the component institutions of the consortium must demonstrate adequate commitment to the Center. AWARD CRITERIA Applications recommended by the NIH Initial Review Group and by the appropriate national advisory council will be considered for award based on: a) scientific and technical merit as determined by peer review, b) program relevance and balance, c) availability of funds, d) responsiveness to the goals and objectives of the RFA. Award of funds for the approved future years of the grant will require submission of a noncompeting continuation application, PHS form 2590, to NIAMS at least two months prior to the anniversary date of the award. In addition, an annual progress reports must be submitted to the OAM in accordance with guidelines established by the Coordinating Committee. Failure to supply either the PHS form 2590 or the annual report in a timely manner will impede release of outyear funding. Schedule Letter of Intent Receipt Date: April 9, 1997 Application Receipt Date: May 9, 1997 Review by Advisory Council: September 4-5, 1997 Anticipated Award Date: September 30, 1997 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues should be directed to: Richard L. Nahin, Ph.D. Office of Alternative Medicine National Institutes of Health 9000 Rockville Pike Building 31, Room 5B-38 Bethesda, MD 20892-2182 Telephone: (301) 496-4792 FAX: (301) 480-3519 Email: NahinR@OD31EM1.OD.NIH.GOV Direct inquiries regarding fiscal matters to: Vicki L. Maurer Grants Management Specialist National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building Room 5AS.49A - MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-3504 FAX: (301) 480-5450 Email: maurerv@ep.niams.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.213. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99- 158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Parts 52 and 45 CFR Part 74 [and Part 92 when applicable for State and Local governments]. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Thu Mar 20 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-043 - V26(08) 03/14/97 Date: 21 Mar 1997 14:42:01 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 374 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5gv2rp$qoh@net.bio.net> NNTP-Posting-Host: net.bio.net RESEARCH ON THE ORIGINS AND PATHWAYS TO DRUG ABUSE NIH GUIDE, Volume 26, Number 8, March 14, 1997 PA NUMBER: PA-97-043 P.T. 34; K.W. 0404009, 0755030, 0710030 National Institute on Drug Abuse PURPOSE This program announcement encourages research exploring the origins of and pathways to drug abuse. Of particular interest are multidisciplinary, integrative and developmental approaches. A keen understanding of the factors and processes that predispose and protect an individual from drug abuse from initial use through different stages of drug involvement is essential to the successful prevention and treatment of drug abuse. Investigators from diverse scientific disciplines are encouraged to apply either individually (e.g. as individual projects) or collectively (e.g. as a program project). HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Research on the Origins and Pathways to Drug Abuse, is related to priority area of alcohol and other drugs. Potential applicants may obtain a copy of Healthy People 2000 (full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and nonprofit organizations, public and private, such as universities, colleges, hospitals, laboratories, research institutions, units of State of local governments, and eligible agencies of the Federal government. Applications from minority individuals, women and persons with disabilities are encouraged. Foreign applicants are not eligible for First Independent Research Support and Transition (FIRST) Awards. MECHANISM OF SUPPORT Support mechanisms include: Project Grants (R01), Small Grants (R03), Exploratory Grants (R21), First Independent Research Support and Transition Awards (R29), Program Projects (P01) and Research Centers (P20, P30, P50, and P60). Application for Research Centers must be in accordance with the NIDA guidelines for Research Center applications. Consultation with NIDA Program staff is encouraged prior to application. Please refer to the guidelines for the specific eligibility requirements for the Small Grant Program (R03), PA-91-08, the Exploratory Grant Program (R21), and First Independent Research Support and Transition (FIRST) Award (R29). Because the nature and scope of the research proposed in this program announcement may vary, it is anticipated the size of an award will vary also. RESEARCH OBJECTIVES Earlier attempts to understand the origins of drug abuse often utilized simple linear models in which susceptibility to drug involvement was construed and investigated in terms of the magnitude of a single risk factor or the sum of a limited set of identified risk factors. In more recent research, even when multiple contributive factors have been considered, the emphasis has commonly been on simple additive models of predispositional factors and these models have typically concentrated on factors from a single domain (i.e. the biological, the psychological/behavioral or the environmental). As a result, attempts to understand the origins and nature of drug abuse have typically been based on non-systemic models and have, for example, rarely considered the interaction of predispositional and protective factors or the interaction of factors from differing domains. In addition, factors have typically been assumed to be absolute, neither changing nor having different influences over time, across populations or cultures, at different stages of an individual's maturation and development, or at different points of one's drug involvement history (i.e. initiation, escalation, maintenance, relapse). Similarly, few studies have investigated the natural waxing and waning of drug involvement which typically occurs over the course of an individual using drugs. Lastly, models and research on the origins of drug abuse have often assumed that drug abuse and drug abusers are basically homogeneous, giving little attention, for example, to understanding individual differences in drug involvement, to identifying different patterns of drug involvement, or to differences in drug involvement associated with different drugs. Although etiological research to date has made much progress and produced critical information, further progress requires a sophisticated advance in the basic approaches being used. It is this next generation of research on the origins of and multiple pathways to drug abuse and the factors which determine individuals' susceptibility and/or resistance to each potential stage of drug involvement which this program announcement seeks to support. Investigators are encouraged to use biological, socio-cultural, psychological, and developmental perspectives in both cross-sectional and longitudinal studies to study the origins of and pathways to drug abuse. Research is needed to determine the interactions and cumulative impact of factors from the various domains (genetic, neurobiological, psychological, social and cultural, and environmental factors and processes) on the various potential stages of drug involvement (initiation, escalation, resistance to drug involvement and escalation, continuation, discontinuation, relapse and, recovery of drug abuse and dependence. Researchers are also encouraged to study the powerful and diverse effects of gender, culture, age, racial/ethnic minority group membership and other cross cutting influences on the various aspects, patterns, and stages of drug abuse. NIDA will continue to support a broad range of research on the origins of drug abuse; of particular interest are proposals which include or study at least some of the following: - multifactorial and multidimensional approaches which investigate the interaction of factors from different domains and the ways in which these interactions or systems influence drug involvement - predispositional and protective factors, processes, and systems particularly in terms of their interaction and the ways in which these interactions or systems influence drug involvement - a developmental perspective, particularly incorporating a multidimensional approach (factors and processes from different domains may vary in their influence on drug involvement depending of the developmental or maturational level of the individual) - the heterogeneity of drug abuse and drug abusers including different paths leading to drug abuse and different patterns of drug abuse - individual differences in drug abuse at the various stages of drug abuse involvement (and non-involvement) - context sensitivity investigating influences such as culture, historical time period, generation, familial constellations, etc. - the role of gender in drug involvement and the development of different patterns of drug involvement - the nature of drug abuse and the development of different patterns of drug involvement within the various racial/ethnic minority groups; including the role of community factors, the impact of immigration status, the influence of cultural assimilation, the effects of such factors as poverty, racism, poor housing conditions, limited educational and employment opportunities, etc. - subpopulations whom research has shown to be often involved with drug abuse such as school drop-outs, gang members, children of drug or alcohol abusers, homeless people, trauma survivors, individuals with various co-occurring psychopathologies, etc. - models which identify potentially effective points, targets and goals of successful prevention and treatment intervention for different populations - drug "careers" and/or lifespan involvement including the natural history of drug involvement and the effects of one period of drug involvement by an individual on subsequent drug stages and patterns of drug involvement - methods of "early" premorbid determination of the nature and degree of individuals' susceptibility to drug involvement and methods for the identification of individuals who might particularly benefit from early preventive intervention - the nature and extent to which consequences of drug abuse at one stage of involvement can facilitate or inhibit subsequent abuse, escalation or discontinuation, etc. - transitions at all stages of drug abuse - the contributions, and the factors and processes underlying the contributions of the use of legal psychoactive substances (tobacco, alcohol, prescribed psychoactives, over-the-counter medications, etc.) on subsequent illicit drug abuse - the relationship of drug abuse and its development to other frequently co-occurring problems, particularly: 1) pathological, dysfunctional, deviant, delinquent, criminal and other risky behaviors; 2) psychiatric disorders, dysfunctions and subclinical impairments, including psychological, cognitive, and affect and behavior regulation impairments - processes/characteristics hypothesized to be intrinsic to the development of drug abuse such as craving, self-medication, loss of control, compulsive behaviors, risk assessment, etc. and processes/characteristics hypothesized to be inherent in drug abuse resistance and recovery such as resilience, adaptiveness, responsiveness to intervention, etc.; underlying processes/characteristics which may have multiple manifestations, one of which may be drug abuse - phenomena which may be related to the development of drug abuse such as common sequences of drugs used by individuals during the escalation of their drug involvement over time, common combination of drugs used by abusers, spontaneous quitting, etc. - the convergence and/or divergence of phenomena observed in different domains; for example an investigation of possible neuro- biological mechanisms underlying a behavior commonly associated with drug abuse - organization of information about drug abuse into coherent conceptualizations and tests of the validity and utility of the resultant models and theories When appropriate, animal models of the above research areas are encouraged. Particularly encouraged are studies focusing on determinants of individual differences in drug involvement and the development of different drug abuse patterns as well as studies of correlates and markers of these individual differences. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact listed below. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892-7710, telephone 301/435-0714, email: asknih@odrockm1.od.nih.gov. The title and number of the announcement must be typed in Section 2 on the face page of the application. FIRST award applicants must include at least three sealed letters of reference attached to the face page of the original applications. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. FIRST award applications must use the Just-in-Time applications procedures; see NIH Guide, Volume 25, Number 10, March 29, 1996 and Volume 25, Number 16, May 17, 1996. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room MSC-7710 Bethesda, MD 20892-7710 Bethesda, MD 20817-7710 (for express/courier service) REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group conveneed in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score and receive a second level review by the appropriate national advisory council. R03 applications do not receive a second-level review. Review criteria include the following: o scientific, technical, or clinical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff; o appropriateness of the proposed budget and duration in relation to the proposed research and availability of the resources necessary to conduct the research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, and the safety of the research environment. Other review criteria may apply to specific mechanisms (e.g., P01, R21) and staff should be consulted for details. AWARD CRITERIA Applications will compete for available funds with all other approved applications. Quality of proposed project as determined by peer review, availability of funds, and program priority will be considered in making funding decisions. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Meyer D. Glantz, Ph.D. Associate Director for Science, Division of Epidemiology and Prevention Research, NIDA 5600 Fishers Lane, Room 9A-53 Rockville, MD 20857 Telephone: (301) 443-2974 Email: mg115g@nih.gov Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Chief, Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, Maryland 20857 Telephone: 301-443-6710 Email: gf6s@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act Section 301 (42 USC 241) and administered under PHS grants policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects," Title 45 CFR part 74 & 92, "Administration of Grants," and 45 CFR Part 46, "Protection of Human Subjects." Title 42 CFR Part 2 "Confidentiality of Alcohol and Drug Abuse Patient Records" may also be applicable to these awards. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Sections of the Code of Federal Regulations are available in booklet form from the U.S. Government Printing Office. Awards must be administered in accordance with the PHS Grants Policy Statement, (Revised, 10/90), which may be available from your office of sponsored research. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Thu Mar 20 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-044 - V26(08) 03/14/97 Date: 21 Mar 1997 14:42:21 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 536 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5gv2sd$qpo@net.bio.net> NNTP-Posting-Host: net.bio.net TECHNOLOGIES FOR GENOMIC MAPPING, SEQUENCING, AND ANALYSIS NIH GUIDE, Volume 26, Number 8, March 14, 1997 PA NUMBER: PA-97-044 P.T. 34; K.W. 0755044, 0744045 National Human Genome Research Institute National Institutes of Health [NOTE: This program announcement supersedes the following two program announcements: (PA-94-045) New and Improved Technologies for Genomic Mapping and Sequencing, NIH Guide for Grants and Contracts, Vol. 23, No. 10, March 11, 1994 and (PA-92-59) Genome Informatics Program, NIH Guide for Grants and Contracts, Vol. 21, No.12, March 27, 1992.] PURPOSE The National Human Genome Research Institute (NHGRI), formerly the National Center for Human Genome Research, solicits applications for research projects to develop new technologies, and/or significantly improve existing technologies, that will facilitate and accelerate the genome mapping, sequencing and analysis goals of the Human Genome Project (HGP) in the most expeditious and economical manner. The resources produced will be used to further studies of diseases and other biological phenomena. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign organizations are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards or program project (P01) grants. MECHANISM OF SUPPORT Support for this program will be through research project grants (R01), FIRST awards (R29), and program project grants (P01). RESEARCH OBJECTIVES Background and Objectives The NHGRI is currently engaged, along with several other federal, private, and international organizations, in a 15-year research program called the Human Genome Project (HGP). The goals are to characterize the genomes of human and selected model organisms, to develop technologies to analyze the human genome, to examine the ethical, legal, and social implications of human genetics research, and to train scientists who will be able to utilize the tools and resources developed through the HGP to pursue biological studies that will improve human health. Significant progress toward completing these goals has been made in the past six years, with several having already been achieved. The genetic mapping goals for both the human and the mouse have been met. Progress toward the human and mouse physical mapping goals is steady, with sufficient support in place to allow the achievement of these goals ahead of schedule. The NHGRI continues, however, to be interested in improving mapping technologies, particularly for high-throughput genotyping, expansion of genetic maps to higher density, and construction of high resolution physical maps that can serve as sequencing substrates. There has also been good progress toward completing the sequencing goals. The genomic sequence of both E. coli and S. cerevisiae have been determined (as have the sequences of several microbes that were not designated targets of the HGP), the sequence of C. elegans is expected to be finished by 1998, the complete sequence of D. melanogaster is expected to be finished shortly after the end of this century, and the genomic sequence of the human and substantial portions of the mouse genome are expected to be finished by 2005, the original target date. However, further reductions in sequencing costs and increases in throughput are needed, both to complete the human DNA sequence as inexpensively and accurately as possible, and to support the critical role that DNA sequencing will continue to play in biological research after the achievement of the goals of the HGP. Therefore, new approaches and technologies for both de novo sequencing and resequencing, as well as for optimization and integration of existing technologies, are still needed. Given the progress to date, increased attention is now being paid to the functional analysis of genomic DNA sequence, including the identification and understanding of all coding sequences, regulatory and other functional elements in genomic DNA from both human and selected model organisms. While a few technologies for functional analysis on a genomic basis are being developed at present, additional approaches and technologies for genomic interpretation that can be applied efficiently and economically at the level of an entire genome will be required for comprehensive analyses. Informatics will continue to play an important role in achieving all of these goals, as well as in ensuring the maintenance and accessibility of the forthcoming data. The development and application of new technologies for acquisition, management, analysis, and dissemination of genomic data are still required. Scope The NHGRI is interested in supporting technological advances in the following areas of research: (1) Refining Genetic Maps; (2) Analyzing Sequence Variation in Genomic DNA; (3) Improving Physical Maps; (4) Reducing the Cost of Genomic DNA Sequencing; (5) Interpreting Genomic Sequence; and (6) Improving Data Analysis and Management. Each of these areas is described below and examples of research that would be appropriate under this Program Announcement are listed. These lists are not meant to be all-inclusive. Projects addressing other research problems will be considered as long as they address the current or long-term goals of the HGP. What is most important is that applicants propose to develop new technology, or to significantly improve existing technologies, that will facilitate and accelerate genomic mapping, sequencing and analysis in an expeditious and economical manner. Technologies for Refining Genetic Maps Currently, the best genetic maps are based on microsatellite markers. Further improvement of genetic mapping technologies, such as the development of methods for rapid genotyping and the development of new, easier-to-use markers, is needed. Examples of research that address this goal are: Development of efficient technologies to generate DNA-based markers that are amenable to automated analysis; Development of new mapping technologies for accurate and rapid analysis of whole genomes or megabase regions of genomes; Development of high-throughput genotyping technologies that are accurate, rapid, efficient, and cost-effective; and Development of improved analytical methods for computing genetic maps and for mapping genomic regions responsible for complex phenotypes. Technologies for Analyzing Sequence Variation in Genomic DNA The first reference human genomic sequence will be completed within the next decade. This sequence will be a mosaic, being derived from several individuals whose DNA was used to construct clone libraries for sequencing. Having the reference sequence will provide experimentalists and computational biologists with a rich source of information about the basic structure of the genome. However, knowledge of sequence variation, both between individuals and between species, will be useful for the pursuit of many studies, including the genetic basis of complex phenotypes, gene function, population genetics, molecular evolution, diagnostics development, and treatment design and evaluation. Examples of research that address this goal are: Development of efficient technologies for rapidly identifying the nature and extent of sequence differences in human genomic DNA; and Development of technology to identify and analyze sequence variation within and among species. Technologies for Improving Physical Maps Resources are in place to complete the construction of a sequence tagged site (STS) map of the human genome at a resolution of 100 kilobases. However, new conceptual approaches to constructing physical maps of the genomes of other organisms and for constructing higher resolution maps for DNA sequencing are needed. Examples of research that addresses this goal are: Methods for the construction of clone libraries with DNA inserts that are large, stable, free of artifacts, and faithfully representative of genomic DNA; Methods for efficient, accurate and rapid generation of high resolution physical maps; and Methods for accurately measuring physical distances between markers on cloned and genomic DNA. Technologies for Genomic DNA Sequencing The sequencing goals of the HGP include both the complete sequencing of the genomes of the human and specific model organisms within the projected 15 years and substantial improvement of sequencing technology. Improved technology is needed for two reasons--to rapidly and inexpensively sequence other genomes (de novosequencing) and to determine sequence variation between large numbers of individuals (re-sequencing). A wide range of technological issues require attention, including automation, system and process integration, miniaturization, parallelization, sequencing accuracy, and efficient integration between physical mapping and sequencing. Examples of research that address this goal are: Development of new approaches to genomic sequencing; Improvement in current DNA sequencing technologies for high-throughput application, with an emphasis on improving cost-effectiveness; and Development of quantitative methods for assessing the local and long-range accuracy of DNA sequence. Applications for large-scale sequence production will not be considered responsive to this Program Announcement. Applicants who wish to pursue large-scale production sequencing should discuss their interest with program staff. New Technologies for the Interpretation of Genomic Sequences Within the next decade, the genomic sequence of both the human and many non-human organisms will become available for comprehensive analysis. A major challenge will be finding all genes, regulatory elements and other functional elements in the genomic sequences. Understanding how these genetic elements function presents an ever larger challenge. To accomplish this analysis systematically and efficiently, robust, high-throughput, cost-efficient strategies and methods will be required. It can be expected that, as in the past, both experimental ("wet bench") and computational approaches will fruitfully be applied to the identification and analysis of genomic features and functions. Several technologies to monitor gene expression on a genome-wide basis are beginning to emerge and these require further development. Additional novel approaches are needed to facilitate both biological and computational approaches to genome interpretation. Projects that address this goal should focus on technology development and be amenable to large-scale analysis and genome-wide studies. Examples of research that address this goal are: Improvement of technology for the generation of high quality, full-length cDNAs and the construction of representative cDNA libraries; Development of technology for the identification and/or mapping of all functional elements (both coding and non-coding) in a genome; Development of methods for the identification of the biological role that non-coding functional elements play in the cell; Systematic identification of the biological role that gene products (RNA and/or proteins) play in the cell, e.g., analysis of cellular localization of proteins, protein-protein or protein-nucleic acid interactions or comparative analysis of protein sequences and/or structures; Development/improvement of technology for the analysis of the expression patterns of gene products (RNA and/or proteins), e.g., measurement of steady-state levels of gene products in a given cell type, temporal or induced changes in patterns of gene product levels, or comparative levels of gene products in different cell types; and Development of methods to analyze genome organization and its effect on cellular functions. Highest priority will be given to the development of technologies that will be used to study the human genome and/or the genomes of S.cerevisiae, C.elegans, D. melanogaster and the mouse. Technology development projects that utilize other eukaryotic organisms will be considered, but direct applicability to the analysis of the human genome must be evident. Technologies for Data Analysis and Management The HGP will generate mapping, sequencing and related data from many laboratories. There is a continuing need to develop and improve appropriate computer tools and information systems for the collection, storage, retrieval and distribution of these data. New methods and tools for the analysis and interpretation of genomic data are needed, as well as new data management systems. Examples of research that address this goal are: Development of effective data management systems to support large-scale mapping and DNA sequencing projects--such research should be undertaken in the context of actual mapping and sequencing efforts, but may be supported by independent funding; Creation of database and/or software tools that provide easy access to up-to-date physical and genetic mapping and DNA sequencing information and allow linkage or integration of these data to related datasets (e.g., phenotypic, expression, structural data); Development of analytical tools that can be used in the assembly, analysis, and interpretation of genomic data; and Development of technology to accelerate the collection, storage, retrieval, analysis and distribution of genomic data. Because of the need to provide many of these resources to the larger scientific community, applications may request funds for distribution of software and database designs and for maintenance and user-support. Such requests must be adequately justified in the application. ADDITIONAL CONSIDERATIONS In planning research projects, applicants are strongly encouraged to consider the following: Interdisciplinary Research. The problems that must be solved in genomic analysis may require technically demanding solutions. Accordingly, interdisciplinary approaches are particularly appropriate. The NHGRI strongly encourages interdisciplinary collaborations between biologists from various sub-disciplines and non-biologists, such as chemists, physicists, information scientists, mathematicians and engineers. Sharing of Materials and Data. The sharing of materials and data in a timely manner is essential for optimal progress towards the goals of the HGP, for avoiding unnecessary duplication, and for facilitating application of genome resources in other areas of biomedical research. Public Health Service (PHS) policy requires that investigators make the results and accomplishments of funded activities publicly available. The advisors of the NIH and the DOE genome programs have also developed "NIH-DOE Guidelines for Access to Mapping and Sequencing Data and Material Resources" that address the special needs of the HGP. The guidelines call for materials and information from HGP-supported projects to be made available within six months from the time the data or materials are generated; more rapid sharing is encouraged. The guidelines can be found on the NHGRI Home Page: http://www.nhgri.nih.gov:80/Grants_info/Funding/Statements/data_relea se.html. If it is anticipated that an application submitted in response to this announcement will generate genomic data or materials suitable for sharing, then the application should include plans for sharing data and materials, for example by depositing cell lines, probes, sequence data, etc., into public repositories. Plans for sharing will become a condition of the award. Where appropriate, grantees may work with the private sector in making unique resources, such as clone libraries and probe screening services, available to the larger biomedical research community at reasonable cost. Investigators may request funds to defray the costs of sharing materials or submitting data to repositories in their applications. Such requests must be adequately justified. Instrumentation. Proposals for instrument development are expected to address the issues of access by groups other than the developers to any instruments developed through this program. In projects where instrumentation and/or software development are key components, investigators should specifically address (1) exportability to other laboratories, (2) access of other investigators to unique instruments, and (3) where appropriate, integration of individual components into systems. Evaluation of Technology. As technology matures it must be tested to demonstrate its capabilities and robustness. Plans for accomplishing such a test should be included in the application, if it is anticipated that the technology will reach the appropriate level of maturity by the end of the project period. Human Subjects. Applicants are urged to carefully review the DHHS regulations regarding human subjects. In general, many applications responding to this Program Announcement will involve human subjects, but others may be exempt according to DHHS regulations. Applications proposing to develop resources from human materials, such as libraries of cloned human DNA, that will eventually be utilized for large scale production projects are urged to adhere to the guidelines developed by NIH and DOE, "Guidance on Human Subjects Issues in Large-Scale DNA Sequencing." This document can be found on the NHGRI Home Page: http://www.NHGRI.nih.gov/Grant_info/Funding/Statements/large_scale.ht ml. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol 23, Number 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The title and number of this program announcement must be typed in Item 2 on the face page of the application. The completed original application and five legible copies must be delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants. NIH (or by the review group of the relevant Institute, Center, or Division), in accordance with the standard NIH peer review procedures. Following the scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. Review Criteria Scientific, technical, or medical significance and originality of proposed research; Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; Qualifications and research experience of the principal investigator and staff, particularly, but not exclusively, in the area of the proposed research; Availability of the resources necessary to perform the research; and Appropriateness of the proposed budget and duration in relation to the proposed research. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. In addition, for applications assigned to the NHGRI will also take into consideration the following additional criteria: Potential for developing technology or strategies that will accelerate progress in mapping, sequencing, or analysis of the human genome and the genomes of other organisms; Value of the proposed research for achieving the research goals of the National Human Genome Research Institute, while maintaining programmatic balance in the NHGRI grant portfolio; and Adequacy of any plans proposed for managing and sharing data, resources and technology in a timely manner. In addition to the above award criteria, applications from foreign institutions must present special opportunities that are not readily available in the United States. INQUIRIES Inquires are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcomed. Applicants who plan to submit applications with a direct cost of $500,000 or more must obtain approval from the institute staff prior to submission of the application Direct inquiries regarding programmatic issues to: David Benton, Ph.D. Genome Informatics Email: david_ benton@nih.gov Elise Feingold, Ph.D. Genomic Analysis Email: elise_feingold@.gov Bettie Graham, Ph.D. Genetic Mapping and Sequence Variation Email: bettie_graham@.nih.gov Jane L. Peterson, Ph.D. Large-Scale Sequencing Email: jane_peterson@nih.gov Jeffery Schloss, Ph.D. Technology Development/Genome Sequencing Email: jeff_schloss@nih.gov The address and telephone number for the staff listed above are: Building 38A, Room 614 National Human Genome Research Institute National Institutes of Health 38 Library Drive Bethesda, MD 20892-6050 Telephone: (301) 496-7531 Fax: (301) 480-2770. Inquiries about grants management/policy issues should be directed to: Ms. Jean Cahill Grants Management Officer National Human Genome Research Institute Building 38A, Room 613 National Institutes of Health 38 Library Drive Bethesda, MD 20892-6050 Telephone: (301) 402-0733 Email: jean_cahill@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.172. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Thu Mar 20 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 08, pt. 1of1, 14 March 1997 Date: 21 Mar 1997 14:41:24 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 401 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5gv2qk$qn5@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 26, No. 8 - March 14, 1997 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** HUMAN ANTI-HIV MONOCLONAL ANTIBODIES IN IMMUNOTHERAPY OF HIV - ADDENDUM (RFA HL-97-002) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 05/09/97 ************************************************* CENTER FOR CHIROPRACTIC RESEARCH (RFA OD-97-005) Office of Alternative Medicine National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Child Health and Human Development INDEX: ALTERNATIVE MEDICINE; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX P1 ********************************************************** RESEARCH ON THE ORIGINS AND PATHWAYS TO DRUG ABUSE (PA-97-043) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P2 ********************************************************** TECHNOLOGIES FOR GENOMIC MAPPING, SEQUENCING, AND ANALYSIS (PA-97- 044) National Human Genome Research Institute INDEX: HUMAN GENOME RESEARCH $$INDEX P3 ********************************************************** PILOT PROJECTS OR FEASIBILITY STUDIES FOR GENOMIC MAPPING, SEQUENCING AND ANALYSIS (PA-97-045) National Human Genome Research Institute INDEX: HUMAN GENOME RESEARCH The NIH GUIDE is available electronically via LISTSERV subscription, and is also on the nih gopher (gopher.nih.gov) and the NIH web site (http://www.nih.gov). Alternative access is available through the NIH Grant Line via modem (data line 301/402-2221); contact Dr. John James at 301/435-2801 for details on the NIH Grant Line. All competing (new, renewal, amended (revised) applications for grants, cooperative agreements, and fellowships from the National Institutes of Health must be sent to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) ASKNIH is a service of the Division of Extramural Outreach & Information Resources, Office of Extramural Research, Office of the Director, NIH. ASKNIH is the point of contact for obtaining general information about NIH extramural research & research training programs, requesting publications, and learning more about obtaining the NIH GUIDE and other information on the NIH web site. ASKNIH is also the contact to which organizations should request application kits and forms. ASKNIH NATIONAL INSTITUTES OF HEALTH EMAIL: ASKNIH@odrockm1.od.nih.gov FAX: (301) 480-0525 TELEPHONE: (301) 435-0714 INQUIRIES ABOUT THE NOTICES, PAS, AND RFAS IN THIS PUBLICATION SHOULD BE DIRECTED TO THE NIH STAFF MEMBER IDENTIFIED AT THE END OF EACH ITEM. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** HUMAN ANTI-HIV MONOCLONAL ANTIBODIES IN IMMUNOTHERAPY OF HIV - ADDENDUM NIH Guide, Volume 26, Number 8, March 14, 1997 RFA: HL-97-002 P.T. 34; K.W. 0760045, 0745045, 0715008 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: March 17, 1997 Application Receipt Date: April 18, 1997 PURPOSE This notice is an addendum to Request for Applications (RFA) HL-97-002, Human Anti-HIV Monoclonal Antibodies in Immunotherapy of HIV, which was published in the NIH Guide for Grants and Contracts, Vol. 25, No. 43, December 13, 1996. The purpose of this addendum is to inform potential applicants of an administrative modification regarding the "Mechanism of Support" described on page two of the RFA. In accordance with the specific application instructions, the MODULAR GRANT concept must be followed by applicants. As specified in the RFA, funds must be requested in $25,000 direct cost modules. However, instead of a maximum of eight modules per year ($200,000 total direct costs), the NHLBI has increased this number to a maximum of twelve modules ($300,000 total direct costs) in order to accommodate more costly research studies such as, but not limited to, primates. The number of modules (total direct costs), at any level, requested in the application must be fully justified. INQUIRIES Inquiries concerning this announcement are encouraged. The opportunity to clarify any issue or questions from potential applicants are welcome. Potential applicants may request a copy of sample budge pages. For programmatic issues, contact: Dr. Luiz H. Barbosa Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7950 Bethesda, MD 20892-7950 Telephone: (301) 435-0075 FAX: (301) 480-0868 Email: lb30o@nih.gov For fiscal matters, contact: Ms. Jane R. Davis Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0166 FAX: (301) 480-3310 Email: jane_davis@nih.gov $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN OD-97-005 FULL-TEXT ************************************** CENTER FOR CHIROPRACTIC RESEARCH NIH Guide, Volume 26, Number 8, March 14, 1997 RFA AVAILABLE: OD-97-005 P.T. 34; K.W. 0785030, 0715184, 0705050 Office of Alternative Medicine National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Child Health and Human Development Letter of Intent Receipt Date: April 9, 1997 Application Receipt Date: May 9, 1997 PURPOSE The Office of Alternative Medicine (OAM) was mandated by Congress in 1991 and permanently established within the Office of the Director, National Institutes of Health (NIH), through the National Institutes of Health Revitalization Act of 1993 (Public Law 103-43, Section 209). The mission of the OAM is to encourage and support the investigation of complementary and alternative medical (CAM) practices, with the ultimate goal of integrating validated alternative medical practices into health and medical care. The demographics, prevalence, and patterns of use of unconventional medicine in the United States have been described (New England J. Med. 328:246-352, 1993). The most relevant findings are the following: a) most people use unconventional therapies for chronic rather than life-threatening medical conditions; b) users of alternative therapies do not inform their primary care physicians; c) extrapolation to the United States population suggests that Americans made approximately 425 million visits to providers of unconventional therapy during 1990; and d) expenditures associated with alternative therapies appear similar to non-reimbursed expenses incurred for all hospitalizations in the United States. These findings indicate that alternative medicine modalities occupy a larger role in the self- health care of U.S. citizens than previously understood. Chiropractic is one of the most used forms of CAM by the U.S. Public. The goal of this RFA initiative is to encourage research of chiropractic by establishing a Center for Chiropractic Research. Such a Center will make available to investigators interested in chiropractic the resources necessary for the conduct of high quality research. Approximately $500,000 in total costs (direct plus indirect) will be committed in the first year to fund one cooperative agreement (U24) award from a qualified applicant. This award may be up to five funded years. HEALTHY PEOPLE 2000 The Public Health Service is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," an initiative for setting national health policy and priorities. Although Healthy People 2000 does not currently specify a CAM or Chiropractic objective, this RFA involves priority areas within the Healthy People 2000 objectives, which involve alternative medical health care. Applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Telephone: 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Richard L. Nahin, Ph.D. Office of Alternative Medicine National Institutes of Health Building 31, Room 5B-38 Bethesda, MD 20892-2182 Telephone: (301) 496-4792 FAX: (301) 480-3519 Email: NahinR@OD31EM1.OD.NIH.GOV $$R1 END ************************************************************ $$P1 BEGIN PA-97-043 FULL-TEXT ************************************** RESEARCH ON THE ORIGINS AND PATHWAYS TO DRUG ABUSE NIH Guide, Volume 26, Number 8, March 14, 1997 PA AVAILABLE: PA-97-043 P.T. 34; K.W. 0404009, 0755030, 0710030 National Institute on Drug Abuse PURPOSE This program announcement encourages research exploring the origins of and pathways to drug abuse. Of particular interest are multidisciplinary, integrative and developmental approaches. A keen understanding of the factors and processes that predispose and protect an individual from drug abuse from initial use through different stages of drug involvement is essential to the successful prevention and treatment of drug abuse. Investigators from diverse scientific disciplines are encouraged to apply either individually (e.g., as individual projects) or collectively (e.g., as a program project). Support mechanisms include: Project Grants (R01), Small Grants (R03), Exploratory Grants (R21), First Independent Research Support and Transition Awards (R29), Program Projects (P01) and Research Centers (P20, P30, P50, and P60). HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Research on the Origins and Pathways to Drug Abuse, is related to priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Meyer D. Glantz, Ph.D. Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-53 Rockville, MD 20857 Telephone: (301) 443-2974 Email: mg115g@nih.gov $$P1 END ************************************************************ $$P2 BEGIN PA-97-044 FULL-TEXT ************************************** TECHNOLOGIES FOR GENOMIC MAPPING, SEQUENCING, AND ANALYSIS NIH GUIDE, Volume 26, Number 8, March 14, 1997 PA AVAILABLE: PA-97-044 P.T. 34; K.W. 0755044, 0755045 National Human Genome Research Institute PURPOSE This program announcement supersedes the following two program announcements: PA-94-045, New and Improved Technologies for Genomic Mapping and Sequencing, NIH Guide, Vol. 23, No. 10, March 11, 1994 and PA-92-59, Genome Informatics Program, NIH Guide, Vol. 21, No. 12, March 27, 1992. The National Human Genome Research Institute (NHGRI), formerly the National Center for Human Genome Research solicits applications for research project grants (R01) and First Independent Research Support and Transition (FIRST) (R29) awards to develop new technologies, and/or significantly improve existing technologies, that will facilitate and accelerate the genome mapping, sequencing and analysis goals of the Human Genome Project (HGP) in the most expeditious and economical manner. The resources produced will be used to further studies of diseases and other biological phenomena. INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Bettie Graham, Ph.D. Genetic Mapping and Sequence Variation National Human Genome Research Institute Building 38A, Room 614 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: bettie_graham@.nih.gov $$P2 END ************************************************************ $$P3 BEGIN PA-97-045 FULL-TEXT ************************************** PILOT PROJECTS OR FEASIBILITY STUDIES FOR GENOMIC MAPPING, SEQUENCING AND ANALYSIS NIH GUIDE, Volume 26, Number 8, March 14, 1997 PA AVAILABLE: PA-97-045 P.T. 34; K.W. 0755044, 0755045 National Human Genome Research Institute PURPOSE This program announcement supersedes the program announcement: PAR- 94-046, Pilot Projects or Feasibility Studies for Genomic Analysis, NIH Guide, Vol. 23, No. 10, March 11, 1994. The National Human Genome Research Institute (NHGRI), formerly the National Center for Human Genome Research, invites applications for exploratory/developmental grants (R21) to develop new, and/or significantly improve existing, technologies that will accelerate the genome mapping, sequencing and analysis goals of the Human Genome Project (HGP) in the most expeditious and economical manner. The purpose of this program announcement is to encourage high risk/potential high payoff applications that are not yet developed fully enough to successfully compete for a standard R01 grant. INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Bettie Graham, Ph.D. Genetic Mapping and Sequence Variation National Human Genome Research Institute Building 38A, Room 614 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: bettie_graham@.nih.gov $$P3 END ************************************************************ From owner-sci-resources@net.bio.net Sun Mar 23 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: BIOSCI/bionet miniFAQ & Fundraiser Date: 23 Mar 1997 16:21:19 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 240 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <199703201000.CAA12756@net.bio.net> NNTP-Posting-Host: net.bio.net (LAST REVISION: 30-JUL-95) This BIOSCI "miniFAQ" is designed to answer the questions that come up the *most frequently*. The main BIOSCI FAQ (Frequently Asked Questions) is accessible on the World Wide Web at URL http://www.bio.net/. If you can not find an answer to your question in this or other documentation, the BIOSCI technical support staff answers e-mail queries sent to biosci-help@net.bio.net We can only answer questions about the use of the newsgroups and mailing lists. We unfortunately do not have the staff to do Internet information searches or answer scientific questions. Please post those to the appropriate BIOSCI/bionet newsgroups. Contents: -------- 0) BIOSCI NEEDS YOUR SUPPORT!! 1) Using the WWW to access the BIOSCI/bionet newsgroups. 2) What to do about "spams," i.e., junk mail, ads, etc. 3) Examples of subscribing and unsubscribing to the mailing lists. 4) The BIOSCI user address and research interest directory. 0) BIOSCI NEEDS YOUR SUPPORT!! ------------------------------ BIOSCI's government funding has been expended, and we are now operating solely from advertising revenue that we have raised from our Web site at http://www.bio.net/. We need just a few minutes of your time to help us serve you. You can do two important things which will take very little time for you individually and will immensely help us continue to help you. First, please use our WWW system at http://www.bio.net/ to access the archives. You can post or reply to messages via your Web browser as described in item #1 below. Your usage helps attract sponsors. If you contact any of our sponsors, please be sure to thank them for supporting BIOSCI. It is critical for them to get this feedback if they are to continue their sponsorship for the long term. Second, if you work for a company or organization that provides products or services of interest to the biology community, please pass this message on to your marketing or marketing communications department or other appropriate group. Please ask them to help support BIOSCI by sponsoring our Web site and explain the uses and benefits of the system to the biology community. If they are interested, they can then contact us for further information at our tech support address, biosci-help@net.bio.net. 1) Using the WWW to access the BIOSCI/bionet newsgroups. -------------------------------------------------------- As of 10 December 1995, all BIOSCI/bionet full newsgroups are accessible through the World Wide Web (WWW) at URL http://www.bio.net. One can read and reply publicly or privately to both recent postings and archived messages through one's Web browser if it is configured properly to send e-mail. Each newsgroup is equipped with its own WAIS index. The main BIOSCI home page also has access to the BIO-JOURNALS Table of Contents database WAIS index and the BIOSCI user address database described in another item further below. 2) What to do about "spams," i.e., junk mail, ads, etc. ------------------------------------------------------- BIOSCI is a set of parallel USENET newsgroups (the "bionet" groups), mailing lists, and a hypermail archive at URL http://www.bio.net/. The same postings are distributed on all media (except for a small number of mailing-list-only groups at net.bio.net). Unfortunately it is becoming a despicable practice on the Internet (by a few people out to make a fast buck) to do automated mass postings to thousands of newsgroups and mailing lists. These attempts to grab free advertising are refered to as "spams" in the usual, somewhat boneheaded, net terminology. USENET is more susceptible to this practice, and many spams originate on the USENET groups and then are passed on to the mailing lists. However, spammers also get lists of mailing addresses and hit these too, so neither medium is immune. What should you do personally if you get junk mail? --------------------------------------------------- Just delete it and move on without reading it further. Filing a protest is becoming increasingly useless because spammers are often disguising the addresses where the messages are sent from. Unless you really understand Internet mail systems, your attempt at protest by sending replies to the message will often end up being sent to the address of an innocent person that the spammer is victimizing. What can BIOSCI/bionet do to protect its newsgroups? ---------------------------------------------------- The only solution currently available is to moderate the newsgroup. If this newsgroup is already moderated, then you are in good shape. Moderation protects the USENET distribution from about 95% of the spams that are being sent to date and protects the mailing lists completely. Moderation means, however, that someone has to take the time to review each message before it goes out. We have set up software here that simply allows the moderator to forward to an address at net.bio.net messages that (s)he wishes to have distributed. This takes no more time than that needed to read the message and pass it on, say about 1 min. per message. Most newsgroups currently have a discussion leader who is responsible for their newsgroup. The discussions leaders and their e-mail addresses are listed in the BIOSCI Information Sheet which is available on the Web at http://www.bio.net/. If a newsgroup is being hit with too many junk postings, please contact the discussion leader for that group and see if there is interest in moderating the group. Please do not assume that by simply posting a complaint to the newsgroup itself, anyone on the BIOSCI staff will act on your complaint. With close to 100 newsgroups to run, the BIOSCI staff has to rely on the discussion leaders of each newsgroup to report problems directly to us at biosci-help@net.bio.net. We will moderate any of our newsgroups if the discussion leader tells us that the readership of the group wishes to do so and if a moderator is willing to do the work. For most BIOSCI/bionet groups, this entails only a few minutes of work each day. Moderating a newsgroup will resolve probably 95% of the junk postings on the USENET distribution. Unfortunately there are easy ways for determined spammers to override the moderation mechanism on USENET, but we can protect our e-mail subscribers from unwanted postings if the newsgroup is moderated. You can also access our newsgroups over the WWW at URL http://www.bio.net. While this Web interface will not stop spammers from trying to post to the groups, this will give you yet another way, besides using USENET news, to keep the junk out of your personal mail files. For those of you with local USENET news systems, the Web interface will also give you faster access to new newsgroups and recent postings. 3) Examples of subscribing and unsubscribing to the mailing lists. ------------------------------------------------------------------ PLEASE NOTE: The BIOSCI management does NOT act on subscription/unsubscription requests that are posted improperly to the newsgroups and mailing lists. People who do this only bother everyone on the lists to no avail. Please be sure to follow the proper procedures below. Gory details are in the BIOSCI Information sheets on the Web at http://www.bio.net. Below we give an example utilizing the METHODS-AND-REAGENTS list at both of our two BIOSCI sites: Users in the Americas and Pacific Rim countries who use the BIOSCI ------------------------------------------------------------------ node at computer net.bio.net: ---------------------------- A) Determine the "listname" which is the <=8 character mail address ^^^^^^^^^^^^^ for the group. These can be found in the BIOSCI Info. Sheet. For the METHODS-AND-REAGENTS group the mailing address is methods@net.bio.net. The listname is the portion of the address to the left of the @ sign, i.e., "methods". The listname is used with the "subscribe" and "unsubscribe" commands illustrated below. B) Mail all commands in the body of a mail message addressed to biosci-server@net.bio.net. Do NOT send commands to the newsgroup posting addresses! Leave the Subject: line blank, any text on it will be ignored. C) In the body of your message put one or more of the following commands with an "end" command on the last line, e.g., subscribe methods unsubscribe methods end Do NOT put your e-mail address or other text on these lines. The server only allows you to cancel your subscription if the address on your mail header matches the address on our mailing list. Please ask for help at biosci-help@net.bio.net if your address has changed, e.g., if you know you are on the list but the server tells you that you are not a member. Users in Europe, Africa, and Central Asia who use the BIOSCI node at -------------------------------------------------------------------- computer daresbury.ac.uk (also known as dl.ac.uk): ------------------------------------------------- To subscribe and unsubscribe to/from the BIOSCI lists, you need to specify the full USENET newsgroup name with "bionet-news." prepended. The USENET newsgroup names are listed in the BIOSCI Information sheet on the Web at http://www.bio.net/. For the METHODS-AND-REAGENTS list the USENET newsgroup name is bionet.molbio.methds-reagnts, thus the appropriate commands are sub bionet-news.bionet.molbio.methds-reagnts unsub bionet-news.bionet.molbio.methds-reagnts These commands are included in a message addressed to mxt@dl.ac.uk, NOT to the newsgroup mailing addresses. As usual, include the text in the body of the message as text on the Subject: line is ignored. To unsubscribe from all the lists at the UK node, use unsub bionet-news Please note that if the address in the list is different than the one in your mail message header, you will not be able to unsubscribe by this method. If you have problems, please mail biosci@daresbury.ac.uk. 4) The BIOSCI user address and research interest directory. ----------------------------------------------------------- Please take this opportunity to add your name, address, and research interest information to the BIOSCI User Address Database if you have not already done so. You can fill out the address form directly through our Web page at URL http://www.bio.net/adrform.html. The address database is reindexed nightly for WWW access (the URL is http://www.bio.net/). If you are not directly on the Internet but can reach it by e-mail, please use our waismail server to access the user directory. waismail use is described above. You can also request a user address form by e-mail from biosci-help@net.bio.net. Please check your database entry from time-to-time to see if your address information is still up-to-date. Because of our limited personnel resources, we ask that you resubmit a *complete* form to revise your entry; we only replace complete entries and do not have resources to edit old forms. Sincerely, Dave Kristofferson BIOSCI/bionet Manager biosci-help@net.bio.net From owner-sci-resources@net.bio.net Mon Mar 24 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 22 March 1997 Date: 24 Mar 1997 19:50:28 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 87 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5h7i24$t6v@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending March 22, 1997. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: News Title: NSF SCIENCE FAIR `STARTERS' ON THE WEB File size (bytes): 4961 STIS Filename: tip70313.txt Document Type: Press Release Title: Environments on Other Planets and Earth One and the Same? New NSF Funding Initiative Seeks Answers File size (bytes): 4332 STIS Filename: pr9721.txt Title: Govnews Project Takes Democracy Into Cyberspace File size (bytes): 3921 STIS Filename: pr9722.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: International Document Title: NSF/Tokyo Report: New Frontiers in Microbiology File size (bytes): 9075 STIS Filename: int976.txt Also available: int976.doc Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 112830 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Alphabetical Telephone Directory File size (bytes): 112830 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Directory File size (bytes): 128264 STIS Filename: phnorg.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg.txt, the text of your message should be as follows: get phnorg.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg.txt, you would enter: ftp> get phnorg.txt If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Wed Mar 26 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 09, pt. 1of1, 21 March 1997 Date: 27 Mar 1997 14:04:27 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 801 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5heqtb$3m2@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 26, No. 9 - March 21, 1997 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** PROGRAM EMPHASES FOR THE AHCPR SMALL PROJECT GRANT PROGRAM Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** PRIMARY IMMUNODEFICIENCY DISEASE REGISTRY (RFP NIAID-DAIT-97-11) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R2 05/22/97 ** *********************************************** NINR/ORMH MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD FOR MINORITY INVESTIGATORS (RFA NR-97-001) National Institute of Nursing Research Office of Research on Minority Health INDEX: NURSING RESEARCH; MINORITY HEALTH $$INDEX R3 07/16/97 ************************************************* AIDS-ONCOLOGY CLINICAL SCIENTIST DEVELOPMENT PROGRAM (RFA CA-97-009) National Cancer Institute INDEX: CANCER $$INDEX R4 07/18/97 ************************************************* MENTAL RETARDATION RESEARCH CENTERS - RECOMPETITION (RFA HD-97-003) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX P1 ********************************************************** BEHAVIORAL SCIENCE TRACK AWARDS FOR RAPID TRANSITION-NIDA (PAR-97- 046) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P2 ********************************************************** OPPORTUNITIES IN GENETICS AND NURSING RESEARCH (PA-97-047) National Institute of Nursing Research INDEX: NURSING RESEARCH $$INDEX P3 ********************************************************** SELF-CARE BEHAVIORS AND AGING (PA-97-048) National Institute on Aging National Institute of Nursing Research INDEX: NURSING RESEARCH ERRATA $$INDEX E1 PAR-97-042 *********************************************** INNOVATION GRANT PROGRAM FOR APPROACHES IN HIV VACCINE RESEARCH (PAR-97-042) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES The NIH GUIDE is available electronically via LISTSERV subscription, and is also on the nih gopher (gopher.nih.gov) and the NIH web site (http://www.nih.gov). Alternative access is available through the NIH Grant Line via modem (data line 301/402-2221); contact Dr. John James at 301/435-2801 for details on the NIH Grant Line. All competing (new, renewal, amended (revised) applications for grants, cooperative agreements, and fellowships from the National Institutes of Health must be sent to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) ASKNIH is a service of the Division of Extramural Outreach & Information Resources, Office of Extramural Research, Office of the Director, NIH. ASKNIH is the point of contact for obtaining general information about NIH extramural research & research training programs, requesting publications, and learning more about obtaining the NIH GUIDE and other information on the NIH web site. ASKNIH is also the contact to which organizations should request application kits and forms. ASKNIH NATIONAL INSTITUTES OF HEALTH EMAIL: ASKNIH@odrockm1.od.nih.gov FAX: (301) 480-0525 TELEPHONE: (301) 435-0714 INQUIRIES ABOUT THE NOTICES, PAS, AND RFAS IN THIS PUBLICATION SHOULD BE DIRECTED TO THE NIH STAFF MEMBER IDENTIFIED AT THE END OF EACH ITEM. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** PROGRAM EMPHASES FOR THE AHCPR SMALL PROJECT GRANT PROGRAM NIH GUIDE, Volume 26, Number 9, March 21, 1997 P.T. 34; K.W. 0730050, 1014006 Agency for Health Care Policy and Research PURPOSE The Agency for Health Care Policy and Research (AHCPR) encourages applications for the "AHCPR Small Project Grant Program" that address the AHCPR strategic goals outlined below. This program is described in Program Announcement (PA) PAR-96-028, published in the NIH Guide for Grants and Contracts, Vol. 25, No. 5, February 23, 1996. AHCPR seeks to work with the research community in collaboration with private and public organizations to generate and disseminate information to assist health care providers/practitioners, plans, purchasers, patients/consumers, and policymakers to achieve the goals set out below: o Help consumers make more informed choices. Identify patient/consumer needs, preferences, and uses of health care information; develop ways of improving the salience of information provided and consumers' ability to make decisions about health care plans, providers, and services; and assess the impact of improved consumer information on the quality and effectiveness of health care. o Determine what works best in clinical practice. Evaluate the effectiveness and patient outcomes of alternative approaches to the prevention, screening, diagnosis, treatment, and management of clinical conditions; synthesize and analyze evidence about effective clinical practice; and establish the relative cost- effectiveness of various treatments and strategies. o Measure and improve the quality of care. Develop more refined quality of care measures and improvement strategies; test the validity and reliability of measurement instruments and facilitate their use in different delivery settings and population subgroups; and assess the use of measures and tools in performance management systems and quality improvement activities. o Monitor and evaluate health care delivery. Analyze major factors affecting health care markets, such as health insurance, demographics, and other demand factors, changing private and public purchaser behavior, and changing legal and regulatory structures; monitor and analyze changes in the structure, organization and financial arrangements in these markets and the organizations within them; monitor and evaluate the impact of changing markets on health care delivery, access, quality, and cost; and develop model data standards and comprehensive information systems that facilitate study of how the health care system is working. o Improve the cost-effective use of health care resources. Clarify, standardize, and improve cost-benefit and cost-effectiveness analysis tools which can be used to better allocate resources; and develop resource allocation and microsimulation models, and other methodologies, which enable assessment of both the intended and unintended social, ethical, legal, and distributional effects of resource allocation decisions. o Assist health care policymaking. Develop nationally representative information on the use and costs of health services, including personal and public health services and delivery systems; and seek more efficient ways for public and private entities to collect and interpret health services data to enable systematic analysis of the effects of changes in the health care system on the health of the population and the effectiveness of service delivery. o Build and sustain the health services research infrastructure. Promote primary data collection, as well as secondary data analysis; and development of research methodologies (methods, measures, analytic tools) critical to advancement of the field of health services research. AHCPR particularly encourages projects on health issues that affect minority populations, women, and children, including: clinical conditions prevalent among racial/ethnic minority populations or unique to age or gender; disparities in access to care for minority groups; the impact of particular market changes or delivery and financing arrangements on minority populations, women, and children; and the unique health care needs of children and other vulnerable populations. The PA describes the small project grant program, which provides support for focused research projects, developmental studies, and high-risk projects. High-risk projects might employ techniques or theories from other fields not traditionally linked to health services research, including qualitative as well as quantitative analyses. This grant program is particularly relevant for new investigators as a means of encouraging individuals to enter the health services research field. Projects addressing the goals may draw on any appropriate data. A particularly rich data source is the Medical Expenditure Panel Survey (MEPS) supported by AHCPR. Data from the Household and Nursing Home components will be available for use by researchers beginning in March 1997, and available annually thereafter. Researchers who are interested in using these data for analyses to address project areas are encouraged to do so. Information on MEPS data is available from Karen Beauregard, Center for Cost and Financing Studies, AHCPR, Telephone: (301) 594-1406, ext. 1460. AHCPR also encourages the use of data from providers, managed care organizations, employers, and other industry sources. INQUIRIES Applicants may obtain copies of the grant application kit and PA from: Global Exchange, Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20814-3015 Telephone: (301) 656-3100 FAX: (301) 652-5264 AHCPR welcomes the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding program matters to the contacts listed by specific program areas under INQUIRIES in the PA. $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NIAID-DAIT-97-11 ***************************************** PRIMARY IMMUNODEFICIENCY DISEASE REGISTRY NIH GUIDE, Volume 26, Number 9, March 21, 1997 P.T. 34; K.W. 0715120, 0780030 RFP AVAILABLE: NIAID-DAIT-97-11 National Institute of Allergy and Infectious Diseases The Clinical Immunology Branch, Division of Allergy, Immunology, and Transplantation (DAIT), National Institute of Allergy and Infectious Diseases (NIAID) has a requirement for the acquisition of a registry for U.S. residents affected by several primary immunodeficiency diseases. The work will require expertise and knowledge of these diseases (including the complex clinical manifestations and the socioeconomic impact on affected families); interactions with individuals affected by these diseases, their physicians, and researchers in primary immunodeficiency diseases; and expertise and knowledge of all aspects of the operation of a registry. The diseases are: Severe Combined Immunodeficiency Disease (SCID), X- linked Agammaglobulinemia (XLA), Wiskott-Aldrich Syndrome (WAS), Common Variable Immunodeficiency (CVID), Chronic Granulomatous Disease (CGD), DiGeorge Anomaly, Leukocyte Adhesion Deficiency (LAD), and Hyper IgM Syndrome. The contract will have two components, A and B. The registry for SCID, XLA, WAS, CVID and CGD will comprise Part A, for which a single, completion type contract will be awarded. Part B describes activities for the Government to support at its option, which may include expansion of the registry to include any one, two, or all three of the diseases DiGeorge Anomaly, LAD, and Hyper IgM syndrome. It is anticipated that one cost-reimbursement, completion contract will be awarded for a period of five years. Request for Proposals (RFP) NIAID-DAIT-97-11 is available electronically and may be accessed through the NIH Home Page or the NIH Gopher by using the following electronic mail addresses and instructions: NIH Home Page (via the World Wide Web): Access the NIH Home Page by using http://www.nih.gov . Once you are at the NIH Home Page, select "Grants & Contracts", then under the "Contracts" page heading, select "Funding Opportunities" to access the "R&D Requests for Proposals (RFP)" in the gopher directory. Once in the gopher directory, select "RFPs Available:; "NIAID"; and finally, "RFP NIH- NIAID-DAIT-97-11." This RFP is only available via the NIH Home Page. Instructions for this acquisition and for proper submission are set forth at the Web Site mentioned above. Following proposal submission and the initial review process, offerors comprising the competitive range will be requested to provide additional documentation to the Contracting Officer. Responses to this RFP will be due on or about May 20, 1997. Any responsible offeror may submit a proposal which will be considered by the Government. This advertisement does not commit the Government to award a contract. INQUIRIES Questions regarding this RFP may be directed to: Rosemary Hamill Division of Allergy, Immunology, and Transplantation National Institute of Allergy and Infectious Diseases Federal Building, Room 3C07 Bethesda, MD 20892 Telephone: (301) 496-0384 Email: rh26v@nih.gov $$R1 END ************************************************************ $$R2 BEGIN NR-97-001 FULL-TEXT ************************************** NINR/ORMH MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD FOR MINORITY INVESTIGATORS NIH GUIDE, Volume 26, Number 9, March 21, 1997 RFA AVAILABLE: NR-97-001 P.T. 34; K.W. 0710030, 0785130 National Institute of Nursing Research Office of Research on Minority Health Application Receipt Date: May 22, 1997 PURPOSE The National Institute of Nursing Research (NINR) and the Office of Research on Minority Health (ORMH) invite career development grant applications (K01) to support the research career development of doctorally prepared minority nurse investigators in tenure-earning positions at Traditionally Minority Based Institutions (TMBIs) and at majority academic institutions in the biomedical and behavioral scientific mission areas of the NINR. The purpose of this program initiative is to: (1) foster the development of independent investigators in nursing research on the faculties of TMBIs and majority academic institutions; (2) stimulate nursing research and nursing research training at these institutions; and (3) encourage the development of qualified minority nurse investigators in academic research settings who can become effective role models for minority students. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, NINR/ORMH Mentored Research Scientist Development Award for Minority Investigators, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Laura A. James, Ph.D., R.N. Division of Extramural Activities National Institute of Nursing Research 45 Center Drive, Room 3AN-12 - MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-6906 FAX: (301) 480-8260 Email: LJAMES@ep.ninr.nih.gov $$R2 END ************************************************************ $$R3 BEGIN CA-97-009 FULL-TEXT ************************************** AIDS-ONCOLOGY CLINICAL SCIENTIST DEVELOPMENT PROGRAM NIH GUIDE, Volume 26, Number 9, March 21, 1997 RFA AVAILABLE: CA-97-009 P.T. 34; K.W. 0715008, 0715035, 0785140 National Cancer Institute Letter of Intent Receipt Date: April 25, 1997 Application Receipt Date: July 16, 1997 PURPOSE The National Cancer Institute (NCI) invites applications for Clinical Scientist Development Program awards (K12) to support institutional, multidisciplinary, training programs focused on the HIV/AIDS Oncology field. The goal of the program is to train a cadre of clinicians with the highly specialized skills necessary to address the clinical and research problems associated with AIDS-related malignancies. There is an important need for trained AIDS-Oncology specialists to exploit research opportunities, conduct patient-oriented research, and provide the clinical management skills necessary for advancement in this field. There will be approximately five awards made at a total cost level of $1.5 million for the first year, $3.0 million for years two and three, and $1.5 million for the fourth and final year. The maximum direct costs available per award for the first year of support of the program is $300,000. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS-led national activity for setting priority areas. This Request for Applications (RFA), AIDS-Oncology Clinical Scientist Development Program, is related to the priority area of human resource development in cancer research. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-0047-0 or Summary Report: Stock No. 017-00100473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Vincent J. Cairoli, Ph.D. Division of Cancer Treatment, Diagnosis, and Centers National Cancer Institute 6130 Executive Boulevard, Room 520, MSC 7390 Bethesda, MD 20892-7390 Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: VC14Z@NIH.GOV $$R3 END ************************************************************ $$R4 BEGIN HD-97-003 FULL-TEXT ************************************** MENTAL RETARDATION RESEARCH CENTERS - RECOMPETITION NIH GUIDE, Volume 26, Number 9, March 21, 1997 RFA AVAILABLE: HD-97-003 P.T. 04; K.W. 0715130, 0745027, 0745070, 0710030 National Institute of Child Health and Human Development Letter of Intent Receipt Date: May 16, 1997 Application Receipt Date: July 18, 1997 PURPOSE The National Institute of Child Health and Human Development (NICHD), through the Mental Retardation and Developmental Disabilities (MRDD) Branch, Center for Research for Mothers and Children (CRMC), invites research center core grant applications (P30) to develop new knowledge in the field of prevention, treatment, and amelioration of mental retardation and developmental disabilities. Four centers may be supported in response to this Request for Application (RFA). The estimated funds available for the first year of support for the entire program is $4.7 million total costs. The primary objective of the NICHD Mental Retardation Research Centers (MRRCs) is to provide support and facilities for a cohesive, interdisciplinary program of research and research training in mental retardation and related aspects of human development. NICHD has supported MRDD Research Centers through the provision of core grants (P30) which facilitate program coordination and support central research core facilities. Funds for the research projects using these core units come from independent sources including Federal, State and private organizations. This RFA seeks applications from existing MRRCs and from other institutions that have a comparable concentration of research in mental retardation. A major goal of the MRDD Branch's research program is to prevent and/or ameliorate mental retardation. In general, the degree of impairment associated with mental retardation varies in relation to the cause. Moderate and more severe mental retardation often results from problems that produce profound alterations in brain development and/or function. Diminished intellectual and adaptive capacity can often be traced to defective genes, teratogenic agents, infections, nutritional deficits, accidents, diseases and other disorders causing brain damage. A larger proportion of cases of mental retardation is related to environmental conditions and disorders of unknown etiology. These complex problems require integrated multidisciplinary approaches involving biomedical and behavioral sciences in a variety of settings. The purpose of an MR Research Center is to provide a research environment that facilitates interdisciplinary collaboration among investigators who are working in areas of relevance to the prevention and amelioration of mental retardation. Such research will cover a broad spectrum of scientific approaches ranging from laboratory research on fundamental processes of abnormal development to clinical and educational research in which persons with mental retardation are studied. It is thought that major solutions to the problems of mental retardation may be found as a result of multidisciplinary collaboration involving a variety of approaches in the MRRCs. As a result of the administrative and scientific organization within and across the network of MRRCs, opportunities for breakthroughs will be enhanced. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Mental Retardation Research Centers, is related to several priority areas including nutrition, alcohol and other drugs, mental health and mental disorders, environmental health, maternal and fetal health, HIV infection, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-011-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail and E-mail from the program contact listed below. Felix F. de la Cruz, M.D., M.P.H. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B-09 Bethesda, MD 20892 Telephone: (301) 496-1383 FAX: (301) 496-3791 Email: CRUZF@HD01.NICHD.NIH.GOV $$R4 END ************************************************************ $$P1 BEGIN PAR-97-046 FULL-TEXT ************************************* BEHAVIORAL SCIENCE TRACK AWARDS FOR RAPID TRANSITION-NIDA NIH GUIDE, Volume 26, Number 9, March 21, 1997 PA AVAILABLE: PAR-97-046 P.T. 34; K.W. 0404000, 0414000, 0414014, 0404009, 0414005 National Institute on Drug Abuse PURPOSE THE National Institute on Drug Abuse (NIDA) invites newly independent investigators to submit applications for small- scale, exploratory (i.e., pilot) research projects related to NIDA's behavioral sciences mission. The Behavioral Science Track Award for Rapid Transition (B/START-NIDA) will provide rapid review and funding decisions of applications. Experimentally-based research applications are encouraged across a wide variety of behavioral factors in drug abuse, including neurocognitive, cognitive and perceptual processes, psychosocial, and more broadly motivational, social and community factors in drug abuse. Given the role that drug abuse plays in HIV/AIDS transmission, studies applying basic behavioral science models and methods to address this issue are especially encouraged. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Behavioral Science Track Awards for Rapid Transition-NIDA, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Division of Basic Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-31 Rockville, MD 20857 Telephone: (301) 443-6300 FAX: (301) 594-6043 Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-38 Rockville, MD 20857 Telephone: (301) 443-6697 FAX: (301) 443-2317 Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-53 Rockville, MD 20857 Telephone: (301) 443-6504 FAX: (301) 443-2636 $$P1 END ************************************************************ $$P2 BEGIN PA-97-047 FULL-TEXT ************************************** OPPORTUNITIES IN GENETICS AND NURSING RESEARCH NIH GUIDE, Volume 26, Number 9, March 21, 1997 PA AVAILABLE: PA-97-047 P.T. 34; K.W. 1002019, 0785130, 1002008, 1014004 National Institute of Nursing Research PURPOSE The purpose of this Program Announcement (PA) is to integrate genetics and nursing research. Currently funded PHS-funded investigators with at least two years remaining on an NIH-funded research project grant (R01) are eligible. Nurse researchers are encouraged to collaborate with an ethicist, geneticist, molecular biologist, or an equivalent professional trained in genetic research. Likewise, PHS-funded genetic researchers in fields of ethics, genetics, molecular biology, or equivalent fields are encouraged to collaborate with a nurse researcher. Collaborations and consortia promoting the cross-fertilization of ideas are welcome. In such cases, each participant's contribution should be identified and well- integrated into the overall design. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Opportunities in Genetics and Nursing Research, is related to the priority areas of heart disease, chronic disabling conditions, and clinical prevention services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Hilary D. Sigmon, Ph.D., R.N. Division of Extramural Activities National Institute of Nursing Research 45 Center Drive, Room 3AN-18, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5970 FAX: (301) 480-8260 Email: hsigmon@ep.ninr.nih.gov $$P2 END ************************************************************ $$P3 BEGIN PA-97-048 FULL-TEXT ************************************** SELF-CARE BEHAVIORS AND AGING NIH GUIDE, Volume 26, Number 9, March 21, 1997 PA AVAILABLE: PA-97-048 P.T. 34; K.W. 0710010, 0730052, 0745035 National Institute on Aging National Institute of Nursing Research PURPOSE The National Institute on Aging (NIA) and National Institute of Nursing Research (NINR) invite qualified researchers to submit applications to investigate the nature, use, and outcomes of self- care activities. For the purposes of this Program Announcement, self-care is defined broadly. "Self-care" includes positive steps taken by individuals to either prevent disease or promote general health status through health promotion or lifestyle modification; medical self-care for the identification or treatment of minor symptoms of ill-health or the self-management of chronic health conditions; and steps taken by laypersons to compensate or adjust for functional limitations affecting routine activities of daily living. Research is encouraged on issues pertaining to the nature and extent of self-care practice by older adults; on stability and change of self-care behaviors over time; on the social, behavioral, and technological factors which facilitate or impede the development and maintenance of self-care; on the impact of self-care practice on health outcomes, including the potential for independent living and the relationship of self-care practice to the types and costs of formal health care utilization; and on the effectiveness of interventions to promote self-care, in response to acute conditions, and for the management of chronic illnesses and disabilities. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Self-Care Behaviors and Aging, is related to the priority area of age-related objectives for adults and older adults. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH website (http://www.nih.gov), and by mail and email from the program contact listed below. Dr. Marcia G. Ory Behavioral and Social Research Program National Institute on Aging 7201 Wisconsin Avenue Room 533 MSC 9025 Bethesda, MD 20892-9205 Telephone: (301) 402-4156 FAX: (301) 402-0051 Email: Marcia_Ory@NIH.GOV Dr. Lynn M. Amende Division of Extramural Activities National Institute of Nursing Research Building 45, Room 3AN12 Bethesda, MD 20892-6300 Telephone: (301) 594-6906 Email: LAMENDE@ep.ninr.nih.gov $$P3 END ************************************************************ ERRATA $$E1 BEGIN P3 19970307 APPEND PAR-97-042 BOTH ************************** INNOVATION GRANT PROGRAM FOR APPROACHES IN HIV VACCINE RESEARCH NIH GUIDE, Volume 26, Number 9, March 21, 1997 PA NUMBER: PAR-97-042 P.T. 34; K.W. 0715008, 0740070, 0765033, 0755020, 079000 National Institute of Allergy and Infectious Diseases Application Receipt Date: May 23, 1997 The following correction is issued for PAR-97-042, which was published int NIH GUIDE, Vol. 26, No. 7, March 7, 1997 The information provided under APPLICATION PROCEDURES limited the appendix to 10 pages. This is incorrect. The instructions provided in the PHS 398 application kit should be followed regarding Appendices. INQUIRIES Direct inquiries regarding programmatic issues to: Carole A. Heilman., Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2A16 MSC 7620 Bethesda, MD 20892-7610 Telephone: (301) 496-0545 FAX: (301) 402-1505 Email: ch25v@nih.gov $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Wed Mar 26 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-97-003 - V26(09) 03/21/97 Date: 27 Mar 1997 14:05:34 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 545 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5heqve$3qj@net.bio.net> NNTP-Posting-Host: net.bio.net MENTAL RETARDATION RESEARCH CENTERS NIH GUIDE, Volume 26, Number 9, March 21, 1997 RFA: HD-97-003 P.T. 04; K.W. 0715130, 0745027, 0745070, 0710030 National Institute of Child Health and Human Development Letter of Intent Receipt Date: May 16, 1997 Application Receipt Date: July 18, 1997 PURPOSE The National Institute of Child Health and Human Development (NICHD), through the Mental Retardation and Developmental Disabilities Branch (MRDD), Center for Research for Mothers and Children (CRMC), invites research center core grant applications (P30) as part of the Institute's Mental Retardation Research Program to develop new knowledge in the field of diagnosis, prevention, treatment, and amelioration of mental retardation and developmental disabilities. Four centers may be supported in response to this announcement. A Mental Retardation Research Center (MRRC) is a center to facilitate, through organization and operation, a program of biomedical and/or behavioral research related to mental retardation. Mental Retardation Research Center core grants support multidisciplinary research in areas which may lead to diagnosis, prevention, treatment, and/or amelioration of mental retardation and developmental disabilities. These grants fund core support services, administration, and development of a limited number of new research programs. The primary objective of the NICHD MRRCs is to provide support and facilities for a cohesive, interdisciplinary program of research and research training in mental retardation and related aspects of human development. Public Law 88-164, Title I, Part A authorized construction of mental retardation research centers. NICHD has provided partial support for a limited number of these centers through the provision of core grants (P30) which facilitate program coordination and support central research facilities. Funds for the research projects using these core facilities come from independent sources including Federal, State and private organizations. This announcement seeks applications not only from these constructed centers but also from other comparable institutions that meet the qualifications for a program of mental retardation research. A major goal of the MRDD Branch's Mental Retardation Research Centers is to prevent and/or ameliorate mental retardation. The degree of impairment associated with mental retardation varies in relation to the cause. Moderate and more severe mental retardation often results from problems that produce profound alterations in brain development and/or function. Diminished intellectual and adaptive capacity can often be traced to defective genes, teratogenic agents, toxic substances, infections, nutritional deficits, accidents, diseases and other disorders causing brain damage. A larger proportion of cases of mental retardation is related to environmental conditions and disorders of unknown etiology. These complex problems require integrated, multidisciplinary approaches involving biomedical and behavioral sciences in a variety of settings. Several mental retardation syndromes have been identified, and new ones are being discovered. Each requires fundamental research into the underlying processes, as well as studies designed to meet the unique needs of the afflicted children. Therefore, one of the missions of the MRDD Branch is to support research on the etiology, pathophysiology, epidemiology, diagnosis and evaluation, prevention, and treatment or amelioration of mental retardation. The purpose of a Mental Retardation Research Center is to provide a research environment which facilitates interdisciplinary collaboration among investigators who are working in areas of relevance to the prevention and amelioration of mental retardation. Such research will cover a broad spectrum of scientific approaches ranging from laboratory research on fundamental processes of normal and abnormal development, to clinical and behavioral research in which persons with mental retardation are studied. It is thought that major solutions to the problems of mental retardation may be found as a result of multidisciplinary collaboration involving a variety of approaches in the MRRCs. As a result of the administrative and scientific organization within a Center and across the network of MRRCs, opportunities for breakthroughs will be enhanced. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Application (RFA), Mental Retardation Research Centers, is related to several priority areas including nutrition, alcohol and other drugs, mental health and mental disorders, environmental health, maternal and fetal health, HIV infection, immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-011-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, and units of State or local governments. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. For the purpose of this RFA, the NICHD will not support more than one center grant (P30 ) in a given university or other applicant institution. MECHANISM OF SUPPORT Mental Retardation Research Center grants will be supported through the customary grant-in-aid mechanism. The application should be prepared in a manner consistent with the general guidelines presented in the publication titled P30 CENTER CORE GRANT GUIDELINES which are available from the MRDD Branch office listed below. Awards will be made for a period of five years. To be eligible for an award the Center must provide core support for a minimum of 10 projects funded from non-university sources. The cost of a center will be a material consideration in the selection of applications for funding. The total direct costs requested for the first year of a new Center Core Grant (P30) should not exceed $500,000. Renewal applications from existing P30 Centers may request initial year direct costs up to, but not exceeding, 120 percent of the Council recommended level of direct costs for the final year of the preceding project period, or $500,000 direct costs, whichever is greater. Budget increments for subsequent years generally will be limited to 4%. Budgets of new and renewal applications will be stringently reviewed within these guidelines. Applications with budget request exceeding these guidelines will be administratively withdrawn by NICHD and returned to the applicant. FUNDS AVAILABLE This is the ninth in a series of annual announcements. Plans are to make four awards in fiscal year 1998. The estimated funds available for the first year of support for the entire program is $4.7 million total costs. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the Institute, awards pursuant to this RFA are also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Mental Retardation Research Center Core Grants are intended to bring together in a Center scientists from a variety of disciplines to work on the common problems of mental retardation. Consequently, applications for Mental Retardation Center Core Grants (P30) should include investigators studying a range of topics in basic and clinical or applied research. Applicants are encouraged, but are not required, to include both biomedical and behavioral components among the topics addressed within their Center. Center grant applications must include among these topics at least 5 of the following that are focused specifically on mental retardation and developmental disabilities: 1. Developmental neurobiological studies relevant to MRDD: neurophysiology, neuroanatomy, neurochemistry, neuropharmacology, neuroplasticity. 2. Inborn errors of metabolism relevant to MRDD, including mitochondrial disorders: pathophysiology, recombinant DNA technology, screening, applied clinical and experimental studies, including treatment. 3. Genetic/cytogenetic disorders associated with MRDD: research on prenatal diagnosis, particularly non-invasive methods during the early stages of pregnancy on prevalent genetic causes of mental retardation such as Down syndrome or Fragile X syndrome; research on rare genetic disorders associated with mental retardation; genomic imprinting. 4. Molecular biology: gene localization, structure, function and organization; gene mapping; gene therapy; and development of animal models. 5. Toxicology and physical environmental factors in the etiology, treatment and prevention of MRDD including lead, mercury, and alcohol; developmental and behavioral teratology; subclinical levels of toxic agents and their effects on morphological and behavioral changes associated with mental retardation. 6. Effects of malnutrition (protein, calorie, micronutrients) on intellectual, behavioral, social and physical development and the intergenerational effects of malnutrition. 7. Developmental pharmacology and psychopharmacology: medication used with MRDD populations. 8. Infectious diseases in the etiology, prevention and treatment of MRDD; neurological, neuropathological, behavioral and intellectual consequences of AIDS in children. 9. Diagnosis: development and application of biomedical and behavioral methods and measures; identification of children and infants at risk for MRDD. 10. Early interventions for infants at risk to develop MRDD: research into the process of early intervention strategies. 11. Predictive and developmental studies of perinatal problems associated with MRDD: developmental studies of low birth weight, small for gestational age, preterm and neonatally sick infants; hypoxic or ischemic insults. 12. Psychobiological processes in MRDD of conditions such as autism and Rett syndrome using methods of behavioral genetics, embryology and teratology, developmental neuroscience and psychophysiology. 13. Psychological processes in MRDD: studies of cognitive and information processing; attention and perception; sensory and motor development; family, social and affective behavior; and, motivation and personality. 14. Behavioral analyses: manipulations of interaction between behavior and environments of individuals with MRDD to reduce problem behaviors, facilitate vocational training, improve social and self- help skills, and increase acquisition of adaptive behaviors. 15 . Family and community studies: parent-child and family interactions; sexual behaviors; family structure and demographic variables, including ethnic minority families with members with MRDD; family and community factors influencing developmental outcomes and adjustment; community resources; care giver behavior; and social support networks. 16. Language and communication of MRDD populations: studies on development of alternative communication systems; ontogeny of linguistic processes. 17. Learning disabilities, dyslexia, and attention deficit disorder. 18. Residential, educational, and occupational settings throughout the life- span: effects on behavior and adjustment of individuals with MRDD; learning and social behavior in educational settings; adaptation to residential environments; aberrant behavior, including stereotypies, destructive behavior, and self-injury. 19. Socioeconomic status, ethnicity, and ecological processes: interaction of MRDD individuals in multiple settings (naturalistic observation); ethnographic research; life history reporting; systematic observation of specific activities. 20. Epidemiology of MRDD: analytic and case-control studies of etiology; prevalence; follow-up of outcomes. 21. Behavior and life-styles that could affect mortality and morbidity. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Because P30 funds in general do not directly support research projects, the issue of minority/gender representation will need to be addressed at the individual project level (i.e., R01 level). However, the application will specifically need to address these issues for any New Program Development projects or core units that focus on subject recruitment. LETTER OF INTENT Prospective applicants are asked to submit, by May 16, 1997, a letter of intent that includes descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows Institute staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Felix F. de la Cruz, M.D., M.P.H. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B-09 Bethesda, MD 20892 Telephone: (301) 496-1383 FAX: (301) 496-3791 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov; and from the program administrator listed under INQUIRIES. Applicants for P30 Mental Retardation Research Center grants must propose a program with a theme relevant to the mission of the MRDD Branch as outlined above. The program should consist of at least 10 externally funded research projects grouped according to relevant topics. These projects must be of high quality, providing a multidisciplinary approach to the problem(s) being investigated. Each project is to be summarized in accordance with the NICHD P30 Center Core Grant Guidelines. SPECIAL REQUIREMENTS The MRRC Director should be a scientist or science administrator who can provide effective administrative and scientific leadership. The Director will be responsible for the organization and operation of the MRRC and for communication with the NICHD on scientific and operational matters. Scientific personnel and institutional resources capable of providing a strong research base in the fields specified must be available. In addition, the institution and pertinent departments have to show a strong commitment to the Center's support. Such commitment may be provided as dedicated space, salary support for investigators, dedicated equipment, or other financial support for the proposed Center. Each core unit proposed for funding under the MRRC grant must be utilized by a minimum of three federally funded research projects, at least one of which is funded by the MRDD Branch of NICHD, exclusive of research contracts, training grants, interagency agreements, and NIH-supplemental projects funded by other agencies. Program staff will make exceptions to this requirement in instances where research relevant to MRDD is assigned elsewhere within NICHD. Subprojects within a program project (P01) will be considered as individual projects comparable to an R01. A detailed description of each core unit proposed as part of the center must be provided with detailed budget and budget justification. A scientist must be named as responsible for each core unit proposed. The description of the core units proposed should include a rationale to show how they will support the research effort in a cost effective manner. Facilities must be available for the primary needs of the MRRC Program and require no more than modest alteration and/or renovation. Funds for new construction will not be provided. Promoting interdisciplinary collaboration among scientists working within a Center is a major goal of the MRRC Program. Each Center applicant should submit a plan, as part of the application, to assure continuing interaction among participating scientists from different disciplines. Another goal of the MRRC Program is to attract scientists to the field of mental retardation research. Therefore, where appropriate, the applicant may request "New Program Development" funds for direct research support of one or more projects, not to exceed a total of $50,000 per year or 10% of total direct cost, whichever is less. Such funds might serve to attract new investigators to the Center, to develop a new area or program of research, or to facilitate the development of newly trained investigators' research programs. New Program Development projects should be comparable to R01 research applications in their detail and development. Each such project can provide support for only two years for any one investigator. It is a major goal of the NICHD to promote active collaboration among MRRCs. To accomplish this goal, the successful applicants will be encouraged to participate in the collaborative efforts of established Centers' programs. Some consideration should be given, in planning the program, to potential collaborative studies and projects which might be proposed for the MRRCs network. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Director, Division of Scientific Review National Institute of Child Health and Human Development Building 6100, Room 5E-03 6100 Executive Boulevard, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-1485 Applications must be received by July 18, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by Institute staff. Incomplete and/or non- responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by the NICHD Mental Retardation Research Committee at its March 1998 meeting in accordance with the review criteria stated below. As part of the initial merit review, a process may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non- competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. The second-level review will be made by the National Advisory Child Health and Human Development Council at its June 1998 meeting. The anticipated date of award is August 1, 1998. Review Criteria In addition to the specific criteria listed in the NICHD P30 Guidelines, reviewers will evaluate: o scientific, technical, or medical significance and originality of proposed research; o qualifications and research experience of the Principal Investigator and scientific collaborators; o scientific and administrative leadership of the Principal Investigator; o quality of proposed core facilities; o availability and quality of resources and research environment; o quality of research projects that will be using the core facilities; o plans for interdisciplinary/multidisciplinary collaboration; o institutional commitment; o appropriateness of the proposed budget; o inclusion of women and minority subjects in research. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA In addition to the scientific and technical merit of the application, other factors will be considered in making the awards. Among these are: o centers addressing research areas of high programmatic interest to the MRDD Branch, the CRMC, and NICHD; and research areas targeted by Congress; o relevance of research projects accessing the core facilities to mental retardation and related developmental disabilities. o availability and quality of resources, especially institutional commitment and support; o access to unique populations; o potential to increase productivity and quality of research within the Center, and stimulate interdisciplinary/multidisciplinary collaborations; o providing unique resources for the use of other Centers, and the greater research community; and o cost-effectiveness of the core facilities. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Felix F. de la Cruz, M.D., M.P.H. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B-09 Bethesda, MD 20892 Telephone: (301) 496-1383 FAX: (301) 496-3791 Email: CRUZF@HD01.NICHD.NIH.GOV Direct inquiries regarding fiscal matters to: Mr. Edgar D. Shawver Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A-17 Bethesda, MD 20892 Telephone: (301) 496-1303 FAX: (301) 402-0915 E-mail: SHAWVERD@HD01.NICHD.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865 Research for Mothers and Children. Awards are made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed Mar 26 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-048 - V26(09) 03/21/97 Date: 27 Mar 1997 14:06:29 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 422 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5her15$3v7@net.bio.net> NNTP-Posting-Host: net.bio.net SELF-CARE BEHAVIORS AND AGING NIH GUIDE, Volume 26, Number 9, March 21, 1997 PA NUMBER: PA-97-048 P.T. 34; K.W. 0710010, 0730052, 0745035 National Institute on Aging National Institute of Nursing Research PURPOSE The National Institute on Aging (NIA) and National Institute of Nursing Research (NINR) invites qualified researchers to submit applications to investigate the nature, use, and outcomes of self- care activities. For the purposes of this Program Announcement, self-care is defined broadly. "Self-care" includes positive steps taken by individuals to either prevent disease or promote general health status through health promotion or lifestyle modification; medical self-care for the identification or treatment of minor symptoms of ill-health or the self-management of chronic health conditions; and steps taken by laypersons to compensate or adjust for functional limitations affecting routine activities of daily living. Research is encouraged on issues pertaining to the nature and extent of self-care practice by older adults; on stability and change of self-care behaviors over time; on the social, behavioral, and technological factors which facilitate or impede the development and maintenance of self-care; on the impact of self-care practice on health outcomes, including the potential for independent living and the relationship of self-care practice to the types and costs of formal health care utilization; and on the effectiveness of interventions to promote self-care, in response to acute conditions, and for the management of chronic illnesses and disabilities. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Self-Care Behaviors and Aging, is related to the priority area of age-related objectives for adults and older adults. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications may be submitted by single institutions or by a consortia of institutions. Women and minority investigators are encouraged to apply. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards, but may submit applications for individual research project grants (R01). MECHANISM OF SUPPORT This program announcement will use the NIH investigator-initiated research project grant (R01) and FIRST (R29) award mechanisms. Research on self-care behaviors is one of the limited numbers of topics identified in the NIA small grant program. It is anticipated that the size of an award will vary due to the nature and scope of the proposed research, with the R01 award averaging $250,000 in total (direct plus indirect) costs per year. RESEARCH OBJECTIVES In 1983, the World Health Organization (WHO) defined self-care as referring to "activities individuals, families, and communities undertake with the intention of enhancing health, preventing disease, limiting illness, and restoring health. These activities are derived from knowledge and skills from the pool of both professional and lay experience. They are undertaken by lay people on their own behalf, either separately or in participative collaboration with professionals." Rather than being viewed as a failure of the individual to use medical services, self-care is seen as a continuum of self-initiated behaviors which may enhance the health and independent functioning of individuals as they age. The contemporary notion of aging and health is one in which the later years of life are significantly determined by patterns of living established in middle and younger adulthood. Thus, one of the goals of research on self-care is to relate specific health behaviors to important health outcomes, such as reduction in morbidity and mortality, and improvements in functional status. Other important goals include understanding the nature and extent of self-care in the general population, and identifying factors which activate the use of self-care practices. Finally, research must consider factors influencing changes in self-care patterns and practices throughout the adult years. A National Invitational Conference on Research Issues Related to Self-Care and Aging was convened in 1994 to conceptualize the scope of these issues and to begin to formulate research objectives. Experts attending this conference recommended that self-care behaviors be classified as one of three broad types, as follows. Healthy lifestyle behaviors intended to promote health and prevent disease. These practices include maintenance of good dietary and sleeping habits, avoidance of smoking and inactivity, promotion of environmental and home safety, and maintenance of good personal hygiene habits. The continuity of these lifestyle practices throughout adulthood defines one's overall health regimen and most likely has a bearing on the emergence of risk factors affecting later-life morbidity and mortality. Medical self-care behaviors that occur in association with symptoms and treatment. Included here are the phases of symptom detection and recognition, and self-initiated practices aimed at reducing discomfort and alleviating pain. Additional research is needed on the limits of self-care and when it may be harmful to substitute self-care for more formal health care. Behaviors engaged in to compensate for decrements in physical or cognitive function, or to adjust to limitations imposed by chronic illness. These purposive behaviors are intended to improve quality of life and are often targeted to basic activities of daily living and other instrumental activities. These efforts are adaptive responses to functional changes which are intended to prevent further disabling limitations. It may be important to further distinguish behaviors known as "self- care" from other behaviors. Research on "self-care" practices has a strong foundation in the study of volitional behavior. That is, the individual is presumed to have a deliberate and purposeful intention to act or to avoid acting in the practice of a self-care behavior. This characteristic of the behavior under investigation distinguishes "self-care" research from survey research which attempts to establish prevalence of behaviors regardless of intention. An individual may, for example, engage in particular eating or sleeping behaviors without regard for their health outcomes. Thus, prevalence research on a self-care practice is not necessarily the same as behavioral epidemiologic surveys to establish population prevalence (regardless of intention behind the behavior). Applications appropriate to this PA are not restricted to any specific discipline, but should be focused on well-articulated theoretical approaches and methodologies in aging to elucidate issues specifically related to self-care behaviors. Research is encouraged that specifies conceptual approaches within aging research and would give the field a strong base of scientific methodologies and data. Researchers are urged to design innovative strategies for this emerging area of study that may include qualitative approaches, use of available data sets, or targeted survey strategies. Of particular value would be studies comparing older age groups because self-care may vary with the age and aging-related circumstances of the older individual. When supported by empirical data from prior research, applications that include theory-based intervention projects may be submitted. The following are offered as illustrations of appropriate topics for research. Applications need not, however, be limited to these issues. Accepted referral guidelines will be followed in assigning applications to NIA, NINR, or to other Institutes. o Nature and Extent of Self-Care Practices by Older Adults Does the range of self-care practices vary by age, gender, education, minority status or the degree to which priorities are socially or culturally embedded? Are there secular changes which may have a bearing on the healthy lifestyle and self-care practices of different cohorts as they age? What are the intra-individual patterns of self-care practice? For example, are individuals who respond effectively to minor symptom detection the same people who use effective coping strategies in response to major life threats? Are these patterns of self-care stable over the life course? How are decisions regarding self-care made? Are decisions to engage in self-care automatic or reactive, or is there an elaborate decision making process through which information is sorted while actions are planned accordingly? o Factors which Facilitate or Impede the Development and Maintenance of Self-Care Along with gender, educational level, and marital status, what other psychosocial variables affect how people view self-care and whether they are disposed to engage in it? For example, when are personality and attitudes, degree of lay medical knowledge, or history of management of illness predictive of self-care as people age? How does readiness and acceptance of self-care vary by cultural, racial, and other demographic variables? And when do contextual factors, such as availability of social supports or presence of life stresses, become important determinants of the activation and maintenance of self-care behaviors? What are the sources of information about self-care practices and how do these vary by the nature of the symptoms/illness or characteristics of the user? Are there differential factors affecting the initiation of self-care behaviors as compared to the long-term maintenance of such behaviors? o Impact of Self-Care Practice on Health Outcomes What is the relationship of self-care to other aspects of health behavior and attitudes? How does the relationship of self-care at different points in the life course affect short- and long-term health outcomes? Can it be determined which elements of self-care regimens are effective, and which might have unexpected or harmful effects for specific disease/conditions as well as for general health and well being? When is reliance on self-care harmful? Under what conditions are illness symptoms likely to be misinterpreted and potentially life- threatening practices engaged in? o Interventions to Promote Self-Care How can interventions be designed to match individuals readiness to adopt a new strategy (e.g., precontemplation, contemplation, preparation) and/or the nature of their symptoms or condition? How can intervention efforts be most effectively targeted? How do psychosocial, demographic, and cultural factors determine the most effective intervention strategy to affect self-care practices? What is the role of organizations in the effective communication of self-care information to older people and their families? o Relationship of Self-Care Practice to Formal Health Care Utilization What is the role of medical, nursing, and other professionals in the initiation and maintenance of self-care behaviors? Does the effectiveness of professionals depend upon whether the purpose of self-care is to maintain health, respond to acute symptoms, or manage chronic illness? Are there some conditions or situations in which older people rely more on medical knowledge versus lay knowledge in determining the appropriate response to symptoms? o Methodological and Conceptual Issues How can self-care indices such as delay in use of self-care or appropriateness of care-seeking behavior be best conceptualized and modeled? How are self-care practices measured? Are these methods valid and reliable? Can hypothesized causal relationships between self-care activities and health outcomes be tested using multivariate and multilevel statistical models and techniques? How can data from large national longitudinal databases be used to address issues relating to self-care practices, health, and aging? INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14512), and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The number and title of this program announcement must be typed in Section 2 on the face page of the application. Applications for the FIRST (R29) award must include at least three sealed letters of reference attached to the face page of the original application. FIRST (R29) award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The complete original and five permanent, legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) REVIEW CONSIDERATIONS Applications received under this program announcement will be assigned to an appropriate Initial Review Group (IRG) in accordance with established NIH Referral Guidelines. The IRG, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit in accordance with standard NIH review procedures. As part of the initial merit review, a process may be used by the initial review groups in which applications will be determined to be competitive or non-competitive based on their scientific merit. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Notification of the review recommendations will be sent to the applicant after the initial review. Applications recommended for further consideration and receiving sufficiently high priority will receive a second-level review by an appropriate National Advisory Council, whose review may be based on policy considerations as well as scientific merit. Applications that deal primarily with health services research, especially in the context of primary care and managed care systems, may be referred to the Agency for Health Care Policy and Research (AHCPR) for possible funding or co-funding. The requirements of AHCPR are similar to those of NIH, except applicants must be non- profit institutions. AWARD CRITERIA Applications recommended by a National Advisory Council will be considered for funding on the basis of overall scientific and technical merit of the research as determined by peer review, program needs and balance, and availability of funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Further information about NIA priorities and procedures can be found on the NIA Home Page http://www.nih.gov/nia Direct inquiries regarding programmatic issues to: Dr. Marcia G. Ory Behavioral and Social Research Program National Institute on Aging Gateway Building, Room 533 7201 Wisconsin Avenue MSC 9025 Bethesda, MD 20892-9205 Telephone: 301-402-4156 FAX: 301-402-0051 Email: Marcia_Ory@NIH.GOV Dr. Lynn M. Amende Director, Division of Extramural Activities National Institute of Nursing Research Building 45, Room 3AN12 Bethesda, MD 20892-6300 Tel: 301-594-6906 Fax: 301-480-8260 Email: LAMENDE@ep.ninr.nih.gov Email contact preferred Direct inquiries regarding fiscal matters to: Ms. Crystal Ferguson Grants Specialist Grants Management Office National Institute on Aging Gateway Building, Room 2N212 Bethesda, MD 20892 Tel: 301-496-1472 FAX: 301-402-3672 Email: Crystal_Ferguson@NIH.GOV Mr. Jeff Carow Grants Management Officer National Institute of Nursing Research Building 45, Room 3AN12 Bethesda, MD 20892-6301 Tel: 301-594-6869 Fax: 301-480-8260 Email: JCAROW@ep.ninr.nih.gov Direct inquiries regarding AHCPR programmatic issues to Ms. Linda Siegenthaler, MA, Senior Economist, Center for Primary Care Research, AHCPR, email: lsiegent@ahcpr.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed Mar 26 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-047 - V26(09) 03/21/97 Date: 27 Mar 1997 14:06:11 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 467 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5her0j$3sh@net.bio.net> NNTP-Posting-Host: net.bio.net OPPORTUNITIES IN GENETICS AND NURSING RESEARCH NIH GUIDE, Volume 26, Number 9, March 21, 1997 PA NUMBER: PA-97-047 P.T. 34; K.W. 1002019, 0785130, 1002008, 1014004 National Institute of Nursing Research BACKGROUND The National Institute of Nursing Research (NINR) is committed to answering relevant clinical questions by interfacing genetics with nursing research. These studies, which emerge from nursing questions, will move basic science from the bench to the bedside as nursing practice is validated through research. To assist NINR in identifying unique research and research training opportunities in the field of genetics, NINR convened a science workgroup in the spring of 1996, entitled, "Opportunities in Genetics Research." Participants were basic and clinical scientists from multiple disciplines. This program announcement is an outgrowth of this workgroup and is NINR's second step in linking nurse scientists with genetic research. Genetics offers many opportunities for nursing research, ranging from basic biological and behavioral investigations to clinical and population studies. In turn, nurse researchers offer a unique perspective and special expertise that is not otherwise found in genetics research. Specific topics of interest to nursing research that have immediate application to genetic studies include the role of biopsychosocial factors in health and illness, managing and diagnosing cardinal symptoms of chronic conditions, holistic and community approaches, cognitive decision making and learning styles, family education and counseling, risk behaviors and risk reduction, health promotion and disease prevention, and rehabilitation. With an emphasis in an integrated, whole-person approach, researchers can provide valuable insight across the continuum of nursing interventions, from genetic counseling and testing to the care and rehabilitation of patients with chronic illness. In these roles, nurse researchers and molecular biology/genome scientists are an essential component of multidisciplinary research teams. Genetic research can be a major force for stimulating collaboration among nurse researchers because it is related to all areas of nursing science. As a relatively new area of study for nursing research, genetics also offers scientists a special opportunity for initiating multidisciplinary efforts to develop important contributions to nursing and genetics research. Nurse researchers are encouraged to stimulate genetics research by organizing cooperative relationships with researchers in other disciplines, "piggybacking" nursing research components onto existing or new studies, and/or sharing expertise on various aspects of genetics research at collegial gatherings. Nursing research can contribute to basic studies of biological, environmental, and behavioral linkages, the genetic determination of physiological responses, and applied studies aimed at translating basic science results into health care management and delivery. Nurse researchers are especially well positioned for fostering the necessary connection between basic and applied studies through the development and implementation of improved strategies for managing illness. The multidisciplinary collaboration of basic and clinical scientists involved in genetics research is especially important in order to solve biobehavioral problems. A cadre of nurse scientists and genetic researchers is key in translating research findings from biobehavioral research to clinical practice. Participation of nurse scientists in genetics research will further reinforce the benefits of multidisciplinary research. PURPOSE The purpose of this Program Announcement (PA) is to integrate genetics and nursing research. Currently funded PHS-funded investigators with at least two years remaining on their research grants are eligible. Nurse researchers are encouraged to collaborate with an ethicist, geneticist, molecular biologist, or an equivalent professional trained in genetic research. Likewise, PHS-funded genetic researchers in fields of ethics, genetics, molecular biology, or equivalent fields are encouraged to collaborate with a nurse researcher. Collaborations and consortia promoting the cross- fertilization of ideas are welcome. In such cases, each participant's contribution should be identified and well-integrated into the overall design. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Combining Nursing with Genetics Research, is related to the priority areas of heart disease, chronic disabling conditions, and clinical prevention services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No.017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Applications from women, ethnic minorities and persons with disabilities are encouraged. MECHANISM OF SUPPORT The research mechanism that supports additional funds for an expanded scope of work is the competing supplement. The competing supplement application should be submitted to request support for a significant expansion of a currently funded research project (R01) research project's scope. Applications will be accepted only from individuals who currently hold NIH R01 grants with at least two years of support remaining at the time of submission. Policies that govern the research grants programs of the NIH will prevail. RESEARCH OBJECTIVES SUMMARY This PA emphasizes the ongoing commitment of the NINR to support cross-cutting areas of opportunity for nurse researchers. Nurse researchers can make a significant contribution to clinical practice by addressing the gaps and opportunities in genetics research. Possible areas of investigation include the gene-environment- behavioral interface, biopsychosocial and neuroimmunological markers, basic research, biopsychosocial intervention and counseling, cognitive models of patients' decision making, new approaches to health care delivery, and strategies for primary care providers. RESEARCH SCOPE Specific areas of interest include, but are not limited to the following topics: o gene-environmental-behavioral interface o interventions to delay the symptoms or onset of chronic conditions o modify an individual's genetic predisposition to illness o improve treatment and management programs for patients with chronic conditions o decision making process of patients and families to consent/decline genetic testing/therapy o biopsychosocial and neuroimmunological markers o identify/isolate disease markers and risk factors in at-risk individuals and families to decrease symptoms and treat/diagnose illness o monitoring the development and progression of conditions to assess patient's adherence to treatment and management o implement genetic, biopsychosocial or neuroimmunological markers to predict the development of chronic conditions o biopsychosocial intervention and counseling related to genetic testing o identify outcome measures for quantifying the effectiveness of interventions for individuals with chronic illness o prescribe optimum timing and methods of conveying genetic information to individuals, particularly children o approaches to predict the development of chronic conditions in susceptible individuals and families o cognitive models of patients' decision making o determine the cognitive mechanism, experiential and cultural reasons by which individuals and families make decisions o design/test interventions for assisting patients in assessing their risk reduction, satisfaction, and quality of life in relation to decisions made before and after genetic testing o determine the behaviors necessary for patients to comprehend genetic information and change health practices resulting from this information, particularly for patients with chronic illnesses RESEARCH DESIGN The introduction to the competing supplement application should provide an overall description of the nature of the supplement and how it will influence the specific aims, research design, and methods of the current grant. The applicant should be explicit in describing the interface of the chosen genetic research topic with the currently funded clinical research grant. Since the intent of this program announcement is to fund a genetic research competing supplement to an ongoing funded application by a researcher, preliminary data of the supplement's research question are not required. However, substantiation of the methodology and the research design should be appropriate to the nature of the project proposed and the disciplines involved. Interdisciplinary, collaborative projects between nurse researchers, genome scientists, mental health researchers, genetics specialists, and/or ethicists are particularly encouraged. RESEARCH PLAN The competing supplement application should be submitted to request support to significantly expand the currently funded research project's scope by incorporating a clearly articulated component of genetics or nursing research. Applications for competing supplements are not appropriate when the sole purpose is to restore the Initial Review Group (IRG)-recommended level awards that were administratively reduced by the funding agency. A competing supplement application will not be awarded until after the original application has been awarded, and may not extend beyond the term of the current grant. Any budgetary changes for the remainder of the project period of the current grant should be discussed under the budget justification. The body of the competing supplement application should contain sufficient information from the original grant application to allow evaluation of the proposed supplement in relation to the goals of the original application. If the competing supplement application relates to a specific line of investigation presented in the original application that was not recommended for approval by the IRG, then the applicant must respond to the criticisms in the prior summary statement, and substantial revisions must be clearly evident and summarized in the introduction. Preliminary Studies/Progress Report. A progress report is required for competing supplement applications. The beginning and ending dates for the period covered since the project was last reviewed competitively should be included in the competing supplement application. BUDGET CONSIDERATIONS For this PA, a ceiling of $50,000 direct costs per year may be requested. It is anticipated that a competing supplement could request $50,000 for the first-year to be used to support a geneticist, molecular biologist, ethicist, nurse researcher, or other personnel and for other project costs, such as the purchase of specialized equipment. Future year escalation of direct costs may not exceed three percent per year. Because this is a competing supplement application, the detailed requests for the initial budget period should show only those items for which additional funds are requested. The ending date of the competing supplement's first budget period should coincide with the ending date of the budget period of the currently funded grant that is to be supplemented, regardless of the competing supplement's beginning date. Amounts for first year budget periods of less than 12 months should be prorated at a rate proportional to the actual time requested. When requesting competing supplement funds for the future years of the currently funded grant, make the future years' budget periods coincide with those of the currently funded grant. Grant funds may be used for expenses clearly related and necessary to conduct the proposed research, including both direct costs and allowable indirect costs. Grant funds may not be used to create a treatment, rehabilitation or other service program. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Program staff may also provide additional relevant information concerning the policy. STUDY POPULATIONS All applications involving human subjects should describe, in detail, plans for the protection of the rights and interests of any individual and/or family involved in any clinical testing protocol. Specific plans for recruitment of subjects should be clearly summarized. Any plans for sharing of data and storage of DNA samples for other purposes must be outlined. While it is foreseeable that there may be some research situations in which it would be appropriate to involve minors as subjects, studies proposing to perform gene-based risk assessments involving minors have the potential to result in a "greater than minimal risk," and thus applicants need to explicitly address any potential benefits and risks to minor subjects, in whom such testing would be carried out. Applicants proposing to carry out clinical protocols should review the Protecting Human Research Subjects: Institutional Review Board Guidebook, Chapter 5, Section H, Human Genetic Research [1993, Office of Protection from Research Risks (OPRR), NIH]. If funded, applicants may wish to consider applying for a Certificate of Confidentiality from the Department of Health and Human Services in order to attempt to provide further protection for research subjects. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. This PA is for a competing supplement. Follow the instructions specified in the standard PHS 398 application instructions for a competing supplement. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. To identify the application as a response to this PA, check "Yes" on item 2 of page 1 of the application and enter "PA-97-047, Opportunities in Genetics and Nursing Research." Submit a signed, typewritten original of the application and five signed, exact photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. Review Criteria Competing supplement applications will be reviewed by the Division of Research Grants. The following review criteria will apply: o scientific, technical, scholarly or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental or scholarly approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o evidence that the competing supplement contains a genetic or nursing research component as an extension of currently funded research; and o appropriateness of the proposed budget and duration in relation to the proposed research. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to NINR. The following criteria will be considered in making funding decisions: o quality of the proposed project as determined by peer review; o availability of funds; o potential impact of the proposed project to provide insight into, or solutions to, critical clinical, ethical, and social issues that link nursing and genetic research; o balance among funded projects to address high priority areas. In order for the NIH to fund applications from foreign institutions, the application must meet the following three criteria: (1) The proposed project must have special relevance to the mission and objectives of the awarding organization and have the potential to advance knowledge that will benefit the United States; (2) The project must present special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries which are not readily available in the United States or which provide augmentation of existing U.S. resources; and (3) The foreign grant application must be in the upper half of the research grant priority scores. Because most of the ethical and social issues which are the focus of this announcement are intrinsically specific to the U.S. cultural and social context, it is not anticipated that applications from foreign institutions will be able to meet all three criteria cited. However, i t is anticipated that U.S. collaborations with foreign investigators and subcontracts to foreign institutions could meet all criteria. INQUIRIES Inquiries concerning this program announcement are encouraged. The opportunity to clarify any issues or questions from potential applicants are welcome. Direct inquires regarding programmatic issues to: Hilary D. Sigmon, Ph.D., R.N. National Institute of Nursing Research Building 45, Room 3AN-18, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5970 FAX: (301) 480-8260 Email: hsigmon@ep.ninr.nih.gov Direct inquiries regarding fiscal matters to: Mr. Jeff Carow Grants Management Office National Institute of Nursing Research Building 45, Room 3AN-24, MSC 63016 Bethesda, MD 20892-6300 Telephone: (301) 594-6869 FAX: (301) 480-8256 Email: jcarow@ep.ninr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361, Nursing Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR parts 52, and 45 CFR Parts 74 and 92. The program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement (April 1, 1994). The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed Mar 26 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-046 - V26(09) 03/21/97 Date: 27 Mar 1997 14:05:52 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 272 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5her00$3re@net.bio.net> NNTP-Posting-Host: net.bio.net BEHAVIORAL SCIENCE TRACK AWARDS FOR RAPID TRANSITION-NIDA NIH GUIDE, Volume 26, Number 9, March 21, 1997 PA NUMBER: PAR-97-046 P.T. 34; K.W. 0404000, 0414000, 0414014, 0404009, 0414005 National Institute on Drug Abuse PURPOSE The National Institute on Drug Abuse (NIDA) invites newly independent investigators to submit applications for small-scale, exploratory (i.e., pilot) research projects related to NIDA's behavioral sciences mission. The Behavioral Science Track Award for Rapid Transition (B/START-NIDA) will provide rapid review and funding decisions of applications. Experimentally-based research applications are encouraged across a wide variety of behavioral factors in drug abuse, including neurocognitive, cognitive and perceptual processes, psychosocial, and more broadly motivational, social and community factors in drug abuse. Given the role that drug abuse plays in HIV/AIDS transmission, studies applying basic behavioral science models and methods to address this issue are especially encouraged. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Behavioral Science Track Awards for Rapid Transition-NIDA, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. To be eligible for a B/START-NIDA award, the proposed principal investigator must be independent of a mentor at the time of award but be at the beginning stages of her/his research career. If the applicant is in the final stages of training, he/she may apply, but no B/START award will be made to individuals in training status. The proposed principal investigator may not have been designated previously as principal investigator on any Public Health Service (PHS)-supported research project. Previous receipt of National Research Service Award funds (i.e., Institutional Training Grant or Individual Fellowship) is permissible. Foreign organizations are not eligible to apply. MECHANISM OF SUPPORT The funding mechanism that will be used to support this initiative is the small grant (R03). Each award is not to exceed $50,000 in direct costs and is for a period of one year only. The award is not renewable. RESEARCH OBJECTIVES The National Institute on Drug Abuse (NIDA), through the issuance of this Program Announcement (PA) hopes to facilitate the entry of beginning investigators into the field of behavioral science research. It is well-documented that the number of investigators entering basic behavioral sciences research is declining. This is of special concern to NIDA because understanding behavioral processes is fundamental to curbing drug abuse and addiction. Because of the importance of this public health mission, the pipeline of behavioral science investigators who will make the next important discoveries in drug abuse must not run dry. Recently NIDA has pursued several initiatives to emphasize its interest in the behavioral sciences. The purpose of this PA is to underscore NIDA's commitment and interest in expanding the scope of basic behavioral sciences research in drug abuse. NIDA supports both animal and human basic research to elucidate underlying behavioral mechanisms, determinants and correlates of drug abuse (both licit and illicit), and to characterize the harmful sequelae of drug abuse and addiction. Animal and human research applications are encouraged in the following broad areas (specific research examples shown are illustrative only; research topics will not be restricted to those listed). While the proposed project is not required to use drugs of abuse or to study drug abusers in the research protocol, the application should advance our understanding of and be related to drug abuse and addiction. o Behavioral genetic approaches either in animal models (e.g., transgenic animals, development of simple high-input behavioral screens) or human subject studies (e.g., establishment of pedigrees, twin studies). o Cognitive effects and causative factors (learning and memory, information processing, perceptual processes including pain and analgesia, attention, problem solving, concept formation, spatial ability, neuropsychology and neurocognition, animal cognition). o Psychosocial, social and personality factors (psychosocial risk factors, group and interpersonal processes, risk taking and HIV/AIDS, social influence, social values, social attitudes and cognition, persuasion conformity and compliance). o Motivational bases of behavior (self-control, behavioral alternatives, craving, appetitive and ingestive behaviors, emotion). INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The title and number of the program announcement must be typed in Section 2 on the face page of the application. The application length should not exceed 10 typewritten pages. Additionally, the new NIH Just-in-Time application procedures apply for B/START-NIDA submissions such that Other Support and detailed budgetary information is not required until the application is likely to be funded. See the NIH Guide for Grants and Contracts, Volume 25, Number 10, March 29, 1996 for further information. The completed original application and three legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20897 (if using courier/express service) To permit an expedited review of the application, applicants must simultaneously send two complete copies to: Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 In FY 97, the regular receipt date of June 1 for R03 applications applies. For FY 98 and beyond, there will be two receipt dates per fiscal year: October 1 and February 1. REVIEW CONSIDERATIONS Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by appropriate peer reviewers. As part of the merit review, all applications will receive a written critique. Scientific reviews will be conducted on receipt of the application. In about five months, applicants will be notified by NIDA staff whether or not their application will be funded. No funding will occur during the months of October and November. Revised B/START- NIDA applications are not allowed. Review Criteria o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o availability of the resources necessary to perform the research; o adequacy of plans to include both genders and minorities as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The reviewers will also examine the provisions for the protection of human and animal subjects, and the safety of the research environment. AWARD CRITERIA It is anticipated that up to $500,000 for FY 1997 will be available to support projects submitted under this program announcement. Future years' support will depend upon available appropriations. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Jaylan Turrkan, Ph.D. Division of Basic Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A31 Rockville, MD 20857 Telephone: (301) 443-1263 Email: jaylan@helix.nih.gov Harold Gordon, Ph.D. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-46 Rockville, MD 20857 Telephone: (301) 443-4877 Email: hg23r@nih.gov Meyer Glantz, Ph.D. Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-55 Rockville, MD 20857 Telephone: (301) 4432974 Email: mg115g@nih.gov Direct inquiries regarding fiscal matters to: Dr. Gary Fleming Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Email: gf6s@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed Mar 26 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA NR-97-001 - V26(09) 03/21/97 Date: 27 Mar 1997 14:04:57 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 554 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5hequ9$3nd@net.bio.net> NNTP-Posting-Host: net.bio.net NINR/ORMH MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD FOR MINORITY INVESTIGATORS NIH GUIDE, Volume 26, Number 9, March 21, 1997 RFA: NR-97-001 P.T. 34; K.W. 0710030, 0785130 National Institute of Nursing Research Office of Research on Minority Health Application Receipt Date: May 22, 1997 PURPOSE The National Institute of Nursing Research (NINR) and the Office of Research on Minority Health (ORMH) invite grant applications to support the research career development of doctorally prepared minority nurse investigators in tenure-earning positions at Traditionally Minority Based Institutions (TMBIs) and at majority academic institutions in the biomedical and behavioral scientific mission areas of the NINR. The purpose of this program initiative is to: (1) foster the development of independent investigators in nursing research on the faculties of TMBIs and majority academic institutions; (2) stimulate nursing research and nursing research training at these institutions; and (3) encourage the development of qualified minority nurse investigators in academic research settings who can become effective role models for minority students. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, NINR/ORMH Mentored Research Scientist Development Award for Minority Investigators, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS For purposes of this RFA, applications may be submitted on behalf of candidates by domestic TMBIs and majority academic institutions, public and private. Applications from foreign institutions will not be accepted. Candidates who are minority individuals underrepresented in biomedical and behavioral research in nursing and who are persons with disabilities are particularly encouraged to apply as candidates. For the purpose of this announcement, underrepresented minority investigators are defined as individuals belonging to a particular ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical or behavioral research. Awards will be limited to citizens or non-citizen nationals of the United States or to individuals who have been lawfully admitted for permanent residence (i.e., in possession of an Alien Registration Receipt Card) at the time of application. In awarding grants, the NIH will give priority to projects involving Black, Hispanic, Native American, and Pacific Islander or other ethnic or racial group members who have been found to be underrepresented in biomedical or behavioral research nationally. Before submitting an application f or the Mentored Research Scientist Award, applicants are encouraged to call their program administrator at the NIH to discuss any aspects of this program that need clarification. Candidates for this award must be full-time nursing faculty members in tenure-earning positions at Historically Black Colleges and Universities or majority academic institutions who: (1) are citizens of the United States, noncitizen nationals, or have been lawfully admitted for permanent residency at the time of application; (2) have a research or health-professional doctorate (PhD or DNSc), or its equivalent; (3) have demonstrated the capacity or potential for a highly productive independent research after the doctorate; (4) has a Registered Nurse license; and (5) have secured the commitment of an appropriate research mentor actively involved in research relevant to the mission of NINR. The candidate must identify a(n) appropriate mentor(s) with extensive research experience in the research area proposed in the application. The candidate must be willing to spend a minimum of 75 percent of full-time professional effort conducting research and career development activities for the period of the award. The remaining 25 percent time should be devoted to other research-related and/or teaching or clinical pursuits consistent with the objectives of the award. Candidates who have served as principal investigators on PHS research grants or have been supported by a research career award in the past, are eligible to apply, provided the proposed research career development program is in a fundamentally new area of scientific endeavor for the candidate or there has been a significant hiatus in his/her research career because of family or other personal obligations. Current principal investigators on PHS research grants are not eligible. MECHANISM OF SUPPORT This RFA will use the National Institute of Nursing (NINR) Mentored Research Scientist Development Award (K01) mechanism. This mechanism is described in program announcement PA-95-071 (NIH Guide, Vol. 24, No. 2, June 16, 1995). Although all general guidelines of PA-95-071 will apply, this RFA is written as a stand-alone document and contains provisions that are unique to this initiative. Planning, direction, and execution of the proposed career development program are the responsibility of the candidate and his/her mentor on behalf of the applicant institution. The total project period for grants awarded under this program must be three years. These grants are not eligible for renewal. Individuals applying for the K01 award must comply with the JUST-IN- TIME procedures announced in the NIH Guide on March 29, 1996 and May 17, 1996. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the program are expected to be $300,000 in Fiscal Year 1997. NINR anticipates funding up to four awards in FY 1997 with each award being $75,000 in total costs. Salary support for each recipient will be for a maximum of $50,000 with a minimum of 50% effort committed. Each year $20,000 will be available for research development support. No financial support is available for the mentor(s) who must be a(n) accomplished investigator(s). Funding beyond the first year of the award will be contingent on the satisfactory progress of the awardee and the availability of funds. RESEARCH OBJECTIVES Background The striking underrepresentation of racial/ethnic minority groups in biomedical and behavioral research in the United States has been underscored in many studies. There are existing programs at the NIH designed to improve this situation. These include: the Minority Biomedical Research Support Program, the Minority Access to Research Careers (MARC) Program, and the Individual Predoctoral Fellowship for Minority Students Program, and the Research Supplements for Underrepresented Minorities Program. The NINR has been an active participant in the trans-NIH minority research training programs and has implemented its own minority supplement program for its institutional research training grants under the National Research Service Award program. NINR has had a long-standing interest in increasing the number of minority investigators in nursing research. Based on the recommendations from two groups of minority health experts, NINR has developed a variety of outreach strategies that assist individuals at TMBIs and other majority institutions in obtaining support for research training, career development, and research funding from NINR. Further refinement of the strategies will take place in May 1997 when NINR and ORMH will co-sponsor the Third Minority Congress with the Human Resources and Services Administration (HRSA) Division of Nursing. (The focus of the Third Minority Congress will be on the "Caring for the Emerging Majority: A Blue Print for Action.") Initiating the NINR/ORMH Research Scientist Development Award for Minority Investigators will strengthen the participation of TMBIs, where there are few schools of nursing and no nursing doctoral programs, and majority academic institutions by addressing the needs of minority nurse investigators for additional research training with financial support. NINR also recognizes that the paucity of qualified minority nurse investigators in academic research settings has created a shortage of role models for minority students. This RFA seeks to address this problem by enhancing the research capabilities of minority nurse faculty members so these individuals may establish research laboratories and research programs in nursing at their institutions. In this fashion they will serve as role models for minority undergraduate and graduate students, stimulating them to consider research career opportunities in nursing research. The purpose of the present RFA is to: o foster the development of independent investigators in nursing research on the faculties of TMBIs and majority academic institutions; o stimulate nursing research and nursing research training at these institutions; and o encourage the development of qualified minority nurse investigators in academic research settings who can become effective role models for minority students. Research Areas The research career development plan must address one of NINR's six scientific areas concerned with: maternal and child health; chronic diseases and conditions; health and risk behaviors; cardiopulmonary health; neurological conditions and brain disorders; and immune and neoplastic diseases. Minority nurse investigators are encouraged to develop their innovative research career development plans in areas relevant to underserved minority populations and in priority areas of NINR's scientific research mission. Environment The applicant TMBI or majority academic institution must demonstrate in the application a firm commitment to the development of the candidate as a productive, independent investigator in nursing research and to the pursuit of the research career development plan described in the application. The candidate should describe a career development program that will maximize the use of relevant research and educational resources available in the TMBI or the majority academic institution and in the mentor's institution. Program The award provides three consecutive 12-month appointments to pursue a mentored research experience and specialized study in nursing research that are tailored to the individual needs of the candidate. At least 75 percent of the recipient's full- time professional effort must be devoted to the program, and the remaining 25 percent devoted to other research-related and/or teaching or clinical pursuits consistent with the objectives of the award. The program must consist of both a research plan and a research career development plan that will develop knowledge and research skills relevant to his or her career goals. Mentor(s) The candidate must receive appropriate mentoring throughout the three year program. Where feasible, women and minority mentors should be involved as role models. If the mentor (and/or a co-mentor, if desired) is geographically distant from the candidate, detailed rationale must be provided to document the mentor-candidate relationship and level of commitment for the successful implementation and completion of the proposed research and career development program. Allowable Costs: 1. Salary: The NINR will provide salary for the recipient of this award up to a maximum of $50,000 per year plus commensurate fringe benefits. The institution may supplement the NINR contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose and provisions of this research career development award. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary requested must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. 2. Research Development Support: The NINR will provide up to $20,000 per year for the following expenses: (a) tuition, fees, and books related to career development; (b) research expenses, such as supplies, equipment, and technical personnel; ( c) travel to research meetings or training; (d) statistical services including personnel and computer time. These funds must be expended solely for the support of the candidate's research career development plan. 3. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed. 4. Indirect costs: Indirect costs will be reimbursed at eight percent of modified total direct costs, or at the actual indirect cost rate, whichever is less. Evaluation In carrying out its stewardship of human resource related programs, the NINR, ORMH or NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). These forms are available at most institutional offices of sponsored research as well as from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, FAX 301/480-0525, email: ASKNIH@ODROCKM1.OD.NIH.GOV. The RFA label available in the PHS 398 (rev.5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number (NINR/ORMH Mentored Research Scientist Development Award for Minority Investigators, NR-97-001) must be typed on line 2 of the face page of the application form and the YES box must be marked. Instructions for completing the application are found in the PHS 398 form. The application must address the following issues: Candidate o The candidate's commitment to a nursing career in biomedical or behavioral research. o The candidate's potential to develop into a successful independent nursing investigator. o The candidate's immediate and long-term career objectives, and how the award will contribute to their attainment. o Letters of recommendation. Three sealed letters of recommendation, including a letter from the mentor, addressing the candidate's potential for an independent nursing research career must be included as part of the application. Career Development Plan o The career development plan, incorporating consideration of the candidate's goals and prior experience. It should describe a systematic plan to obtain any necessary basic biomedical or behavioral science background and research experience to launch or reinitiate an independent nursing research career. o The candidate must describe plans to receive instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction as well as the amount and nature of faculty participation. No award will be made if an application lacks this component. Research Plan The candidate must describe the research plan and the use of a basic or clinical approach to a biomedical or behavioral problem. The candidate must describe the research plan as outlined in form PHS 398, including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. Mentor's Statement The application must include a biographical sketch and information on the mentor(s) including research qualifications and previous experience as a research supervisor. The application must also include information that describes the nature and extent of supervision that will occur during the award period. A letter of support from the mentor (and co-mentor, if appropriate) must be included in the application delineating the match with the candidate's research and development plan and willingness to provide the necessary assistance. Environment and Institutional Commitment The sponsoring TMBI or majority academic institution must provide a statement of commitment to the candidate's development into a productive, independent investigator in nursing research. This statement must indicate that the candidate will be provided with sufficient release time from other duties to accomplish the research and career development goals stated in the application. Budget The budget requests must be provided according to the instructions in form PHS 398. The request for tuition and fees, books, travel, etc., must be justified and specified by category. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier service) At the time of submission, two additional copies of the application must be sent to: Dr. Mary Stephens-Frazier Division of Extramural Activities National Institute of Nursing Research Building 45, Room 3AN-12 45 CENTER DRIVE - MSC 6300 Bethesda, MD 20892-6300 ATTN: Minority Investigator MRSDA Telephone: (301) 594-5971 FAX: (301) 480-8260 Applications must be received by May 22, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA (as judged by NINR Program Staff) will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NINR in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score. Review Criteria The following criteria will be applied: Candidate o Commitment to an independent research career in nursing research; o Potential to develop (or evidence of the capacity to develop) as an independent nurse investigator; and o Quality and breadth of prior scientific training and experience, including, where appropriate, the record of previous research support and publications. Career Development Plan o Likelihood that the plan will contribute substantially to the scientific development of the candidate and the achievement of research independence; o Appropriateness of the research plan to the career goals of the candidate; o Appropriateness of the research plan to develop new nursing knowledge; o Consistency of the career development plan with the candidate's prior research and academic experience and stated career goals; o Clarity of the goals and scope of the plan and the need for the proposed research experience; and o Quality of the proposed training in the responsible conduct of research. Research Plan All candidates for this award will have had previous research experience and in some cases will have been Principal Investigators in other scientific fields. A sound research plan that is consistent with the career development plan and the candidate's level of research development must be provided: o Usefulness of the research plan as a vehicle for enhancing existing research skills as described in the career development plan; o Scientific and technical merit of the research question, design and methodology, judged in the context of the candidate's previous training and experience; o Relevance of the proposed research to the candidate's career objectives; and o When human subjects are involved, adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. Mentor o Appropriateness of mentor's(s') research qualifications in the specific areas of the application; o Quality and commitment of the mentor(s) to supervising and guiding the candidate throughout the award period; o Previous experience in fostering the development of independent nurse investigators; and o History of research productivity and support. Institutional Environment and Commitment o Applicant institution's commitment to the scientific development of the candidate and assurances that the institution intends the candidate to be an integral part of its research program; o Adequacy of research facilities and training opportunities at the sponsoring institution; o Quality of environment for scientific and professional development; and o Applicant institution's willingness to develop an appropriate balance of research, teaching and administrative responsibilities for the candidate. Budget Justification of budget requests in relation to career development goals and research aims and plans. AWARD CRITERIA The NINR anticipates awarding up to four K01 grants in response to this RFA. The anticipated date of award is September 30, 1997. The following criteria will be considered in making funding decisions: o Responsiveness to the purpose of this request; o Quality of the proposed research career development program, as determined by peer review; and o Availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Consultation with NINR staff is strongly encouraged, especially during the planning phase of the application process, in order to ensure that the application is responsive to the scientific mission and the research training and career development goals of the NINR. Direct inquiries regarding programmatic issues to: Laura A. James, Ph.D., R.N. Division of Extramural Activities National Institute of Nursing Research Building 45, Room 3AN-12 - MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-6906 FAX: (301) 480-8260 Email: LJAMES@ep.ninr.nih.gov Direct inquiries regarding fiscal matters to: Jeff Carow Grants Management Office National Institute of Nursing Research Building 45, Room 3AN-32 - MSC 6301 Bethesda, MD 20892-6301 Telephone: (301) 594-6869 FAX: (301) 480-8260 Email: JCAROW@ep.ninr.nih.gov AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance No. 93.316. Awards are made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies and Federal Regulations at 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed Mar 26 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-97-009 - V26(09) 03/21/97 Date: 27 Mar 1997 14:05:17 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 470 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5hequt$3pj@net.bio.net> NNTP-Posting-Host: net.bio.net AIDS-ONCOLOGY CLINICAL SCIENTIST DEVELOPMENT PROGRAM NIH GUIDE, Volume 26, Number 9, March 21, 1997 RFA: CA-97-009 P.T. 34; K.W. 0715008, 0715035, 0785140 National Cancer Institute Letter of Intent Receipt Date: April 25, 1997 Application Receipt Date: July 16, 1997 PURPOSE The National Cancer Institute (NCI) invites applications for Clinical Scientist Development Program Awards to support institutional, multidisciplinary, training programs focused on the HIV/AIDS Oncology field. The goal of the program is to train a cadre of clinicians with the highly specialized skills necessary to address the clinical and research problems associated with AIDS-related malignancies. There is an important need for trained AIDS-Oncology specialists to exploit research opportunities, conduct patient-oriented research, and provide the clinical management skills necessary for advancement in this field. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Application (RFA), AIDS-Oncology Clinical Scientist Development Program, is related to the priority area of human resource development in cancer research. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-0047-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Institution: Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applicant organizations should have well-established research programs with adequate peer-reviewed grant support and highly qualified faculty in clinical and basic science departments. Minorities and women are encouraged to apply as principal investigators. Clinical Candidates: All candidates for support under this program award must currently be physicians holding the M.D. or D.O. degrees. In addition, they should have completed a minimum of one year of sub- specialty training, for example in Hematology, Gynecology, or Oncology disciplines prior to joining this training program. Appointments of clinical candidates to the program must be for a minimum of two years. The candidate must be willing to devote a minimum of 75 percent of full-time professional effort to the basic/clinical research program. The remaining 25 percent can be divided among other clinical and teaching activities only if they are consonant with the program goals, i.e. the candidate's development into an independent clinical investigator. Candidates appointed under this program award must be U.S. citizens or noncitizen nationals, or have been lawfully admitted for permanent residence and possess an Alien Registration Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Noncitizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states, but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. Candidates who are or have been former principal investigators on NIH research projects (R01), FIRST Awards (R29), sub-projects of program project grants (P01) or the equivalent, are not eligible for appointment under this program. MECHANISM OF SUPPORT Support for this program will be through the National Institutes of Health's (NIH) grant-in-aid, the Institutional Clinical Scientist Development Award (K12). Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. This RFA is a one-time solicitation. Generally, future competitive continuation applications will compete with all investigator- initiated applications. Should the NCI determine that there is a sufficient continuing program need, a request for competitive continuation and/or new applications will be announced. FUNDS AVAILABLE Total costs of $1,500,000 for the first year, $3,000,000 for years two and three, and $1,500,000 for the fourth and final year will be committed to fund applications which are submitted in response to this RFA. It is anticipated that approximately five awards will be made. This funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. The total project period for applications submitted in response to the present RFA should not exceed four years. The earliest feasible start date for the initial awards will be December 31, 1997. Although this program is provided for in the financial plans of the National Cancer Institute (NCI), the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background: Malignancies have been associated with HIV/AIDS since the beginning of the epidemic in the early 1980s. As the AIDS epidemic continues, additional AIDS-defining malignancies have been identified; larger numbers of HIV-infected individuals have been diagnosed with malignancies as improved anti-retroviral and opportunistic infection management has allowed them to live longer. The AIDS Malignancy Working Group, which includes NCI staff and extramural scientists, identified the need for interdisciplinary training programs to provide the spectrum of clinical and research skills necessary for conducting patient-oriented research in conjunction with appropriate management of patients with HIV/AIDS malignancies. At the present time, there is no specific subspecialty of Medicine in the area of HIV/AIDS, nor are there any formal, nationally recognized training programs integrating the specialized skills in Hematology, Oncology disciplines, and Infectious Diseases needed to address AIDS- related malignancies. The expanding population of patients with HIV/AIDS and malignancies have complex multi-system illnesses, requiring the expertise of physicians with considerable multidisciplinary knowledge. Most investigators pursuing research in the HIV/AIDS field have had sub-specialty training in Infectious Diseases and most Oncology programs have no formal training in AIDS Oncology. It is clear that advances in the field of HIV/AIDS Oncology will require highly specialized expertise and "cross-training" of clinicians. Interdisciplinary training is essential to developing a cadre of experts in clinical and translational research to move the field forward and to contribute to the competent management of HIV- infected individuals with malignancies. Environment: Institutions should have well-established basic and clinical research programs in the areas of oncology, hematology, and infectious diseases. Departmental/Divisional collaborations should be arranged in order to achieve the required multidisciplinary training. The program must include clinical researchers with expertise in AIDS- related malignancies and experience in postdoctoral research training. There should also be sufficient numbers of patients with AIDS and AIDS-related malignancies available to sustain a credible training program. Program: Applicants should provide details of the content and scope for a TWO YEAR interdisciplinary training program for each candidate. The proposed training program must provide didactic, research, and clinical components that will integrate knowledge and skills across disciplines relevant for clinical research and care for AIDS patients with malignancies, for example, Oncology disciplines, Hematology and Infectious Diseases The program should prepare clinicians to handle the clinical complexities of patients with HIV/AIDS and malignancies. Additionally, the program should provide laboratory/translational research training in areas directly involved in AIDS research or in related fields of immunology, virology, or molecular biology. The research component should focus on the skills necessary for translating research results into clinical experiments, procedures, and trials directly involving patients with AIDS/HIV malignancies. For example, it will not be sufficient within the scope of this initiative to use human cells and other clinical materials in an isolated basic laboratory setting as the total research experience. Applicants should clearly address the following issues: 1) arrangements for organizational interactions and collaborations necessary to achieve the objectives of this RFA; 2) the qualifications of the faculty mentors, highlighting their clinical and basic research projects and prior training experience; 3) the availability of appropriate mentors who would have responsibility for the candidate's clinical/research program and day-to-day progress; 4) the availability of sufficient numbers of patients with AIDS and AIDS-related malignancies; 5) procedures to be used to announce the program and to select appropriate candidates, mentors, and projects; and 6) the establishment of an Advisory Committee (see Special Requirement) to provide an oversight function and annual evaluation of the AIDS-Oncology Clinical Scientist Development Program as a whole. Special Requirements: The Principal Investigator must establish an Advisory Committee for this program. The various departments/divisions participating in this program should be represented on the committee. Examples of the Committee's responsibilities might include: selecting physician candidates, assigning preceptors, approving each candidate's clinical research development plan, evaluating each candidate's progress, and monitoring the overall effectiveness of the program. Each candidate should have one or more preceptor(s) who are accomplished investigator/clinicians in their field. The advisor(s) should assume responsibility for devising a career development and clinical research plan with the candidate, obtaining the concurrence of the Advisory Committee, and providing day-to-day advice. Plans for an annual evaluation of the program by the Advisory Committee should be described. The Annual Progress Report for the grant should provide a summary of this evaluation and include a description of the clinical research and career progress of each candidate describing how laboratory and clinical research and practice are being integrated. These Annual Reports will be closely monitored by NCI staff to ensure that the grant is achieving the goals of the RFA and for a final evaluation to determine the success and need for a continuation of the program beyond the initial four year period. ALLOWABLE COSTS In order to provide sufficient diversity and distribution of programs, direct costs for the (01) year should not exceed $300,000, and any increases in future year positions should be incremented gradually with appropriate justification. The budget should take into consideration that each candidate should receive a minimum of two years of training. Peer review will assess the quality of resources available to support the type of program proposed and the number of training positions requested within the above limitations. Salary: Clinical research candidates will be provided salary support of up to $50,000 each year, plus applicable fringe benefits commensurate with the applicant institution's salary structure for persons of equivalent qualifications, experience, and rank. The institution may supplement the NCI contribution; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary may not require extra duties or responsibilities that would interfere with the purpose of this award. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution salary scale. The total salary requested must be based on a full-time 12 month staff appointment. Other Expenses: $20,000 per candidate will be provided annually to partially support supplies, equipment, travel, tuition, and other costs which are essential for the individual's clinical research development program. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance , etc. is not allowed. Indirect Costs: Indirect costs will be provided at a rate not exceeding eight percent of total direct costs of each award, exclusive of tuition, fees, and expenditures for equipment. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by April 25, 1997, a letter of intent that includes a descriptive title of the proposed program, the name, address, telephone and FAX numbers, and E-mail address of the Principal Investigator, the names of other key personnel, the participating institutions and the number and title of the RFA in response to which the application is being submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NCI staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Dr. Vincent J. Cairoli Division of Cancer Treatment, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 20892-7390 Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: VC14Z@NIH.GOV APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov; and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892-7405 Rockville, MD 20852 (express/courier service) Applications must be received by July 16, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI. Incomplete or unresponsive applications will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit in accordance with the review criteria stated below by an appropriate peer review group convened by the NCI. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. All applications will receive a second level of review by the National Cancer Advisory Board. REVIEW CRITERIA Review criteria will include: o Scientific and administrative leadership qualifications and experience of the Principal Investigator. o Qualifications of faculty mentors: adequacy of peer-reviewed clinical and basic cancer research projects, publications and training experience in the context of achieving the objectives of this RFA. o Recruitment and selection plans for appointees and the availability of high quality candidates. o Appropriateness of detailed plans for a comprehensive program to provide physician appointees with the proper integration of knowledge and skills in oncology and infectious diseases necessary for clinical research and care of patients with AIDS-related malignancies. o Appropriateness of an environment to promote collaborations among clinicians and research scientists as well as departmental/division programs. o Adequacy of facilities and other resources. o Availability of sufficient AIDS and AIDS-related malignancy patient populations and clinical materials to support appropriate clinical research experiences. o Adequacy of the membership and functions of the program Advisory Committee. o Effective plans for program oversight and evaluation to be reported in the Annual Progress Report. o Adequacy of the proposed means for protecting human subjects and vertebrate animals against hazardous or unethical research procedures and for protecting the privacy of human subjects. Budget The review group will critically examine the proposed budget and recommend an appropriate budget for each approved application within the guidelines stated above. AWARD CRITERIA Applications will compete for available funds with all other scored applications submitted in response to this RFA. The following will be considered in making decisions: quality of the proposed project as determined by peer review, availability of funds and program priority. The NCI will notify the applicant of the National Cancer Advisory Board's (NCAB) action. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding Career/Training issues to: Dr. Vincent J. Cairoli Division of Cancer Treatment, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 20892-7390 Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: VC14Z@NIH.GOV Direct inquiries regarding Clinical issues to: Ellen Feigal, M.D. Division of Cancer Treatment, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 741 Bethesda, MD 20892 Telephone: (301) 496-2522 FAX: (301) 402-0557 Email: FEIGALE@CTEP.NCI.NIH.GOV Direct inquiries regarding Fiscal/Administrative matters to: Ms. Kelli Oster Office of Administrative Management National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext 261 FAX: (301) 496-8601 Email: OSTERK@GAB.NCI.NIH.GOV AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance Number 93.398, Cancer Research Manpower. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking in certain facilities (or, in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Mar 28 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 10, pt. 1of1, 28 March 1997 Date: 28 Mar 1997 20:39:33 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 678 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5hi6e5$oog@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 26, No. 10 - March 28, 1997 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** 1997 NCRR STRATEGIC PLAN SURVEY ON NCRR WEB SITE National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX N2 ********************************************************** DRAFT OF THE "COST ANALYSIS AND RATE SETTING MANUAL FOR ANIMAL RESEARCH FACILITIES" POSTED ON NCRR WEB SITE FOR COMMENT National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX N3 ********************************************************** NCI SCIENCE ENRICHMENT PROGRAM National Cancer Institute INDEX: CANCER NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** MEDICINAL CHEMISTRY-SYNTHESIS OF POTENTIAL TREATMENT AGENTS FOR COCAINE ADDICTION (RFP N01DA-7-8077) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX R2 05/23/97 ************************************************* NIDCD/ORMH MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD FOR MINORITY SCHOOL FACULTY (RFA DC-97-001) National Institute on Deafness and Other Communication Disorders Office of Research on Minority Health INDEX: DEAFNESS, OTHER COMMUNICATIONS DISORDERS; MINORITY HEALTH $$INDEX R3 05/23/97 ************************************************* NIDCD/ORMH MINORITY DISSERTATION RESEARCH GRANTS IN HUMAN COMMUNICATION (RFA DC-97-002) National Institute on Deafness and Other Communication Disorders Office of Research on Minority Health INDEX: DEAFNESS, OTHER COMMUNICATIONS DISORDERS; MINORITY HEALTH $$INDEX P1 ********************************************************** EXPLORATORY STUDIES FOR HIGH RISK/HIGH IMPACT RESEARCH (PA-97-049) National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES $$INDEX P2 ********************************************************** MANAGING THE SYMPTOMS OF COGNITIVE IMPAIRMENT (PA-97-050) National Institute of Nursing Research National Institute on Aging National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Child Health and Human Development INDEX: NURSING RESEARCH; AGING; MENTAL HEALTH; NEUROLOGICAL DISORDERS, STROKE; CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX P3 ********************************************************** DEHYDROEPIANDROSTERONE (DHEA) AND AGING: BIOLOGIC ACTIONS AND EFFECTS OF ADMINISTRATION (PA-97-051) National Institute on Aging National Institute of Diabetes and Digestive and Kidney Diseases INDEX: AGING; DIABETES, DIGESTIVE, KIDNEY DISEASES The NIH GUIDE is available electronically via LISTSERV subscription, and is also on the nih gopher (gopher.nih.gov) and the NIH web site (http://www.nih.gov). Alternative access is available through the NIH Grant Line via modem (data line 301/402-2221); contact Dr. John James at 301/435-2801 for details on the NIH Grant Line. All competing (new, renewal, amended (revised) applications for grants, cooperative agreements, and fellowships from the National Institutes of Health must be sent to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) ASKNIH is a service of the Division of Extramural Outreach & Information Resources, Office of Extramural Research, Office of the Director, NIH. ASKNIH is the point of contact for obtaining general information about NIH extramural research & research training programs, requesting publications, and learning more about obtaining the NIH GUIDE and other information on the NIH web site. ASKNIH is also the contact to which organizations should request application kits and forms. ASKNIH NATIONAL INSTITUTES OF HEALTH EMAIL: ASKNIH@odrockm1.od.nih.gov FAX: (301) 480-0525 TELEPHONE: (301) 435-0714 INQUIRIES ABOUT THE NOTICES, PAS, AND RFAS IN THIS PUBLICATION SHOULD BE DIRECTED TO THE NIH STAFF MEMBER IDENTIFIED AT THE END OF EACH ITEM. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** 1997 NCRR STRATEGIC PLAN SURVEY ON NCRR WEB SITE NIH GUIDE, Volume 26, Number 10, March 28, 1997 P.T. 34; K.W. 0404021 National Center for Research Resources On January 31, 1997, the National Center for Research Resources (NCRR) asked the scientific community to respond to its 1997 Strategic Plan Survey. Its purpose is to anticipate and fill the biomedical research community~s needs for critical research resources and technologies. The comments will help NCRR update its 1994 strategic plan entitled "NCRR: A Catalyst for Discovery." The survey form is located on the World Wide Web at . The deadline for responding is May 15, 1997. INQUIRIES Direct inquiries regarding the 1997 NCRR Strategic Plan Survey to: Ms. Barbara Perrone Office of Science Policy National Center for Research Resources 6705 Rockledge Drive, Suite 5046, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0866 FAX: (301) 480-3654 Email: NCRRPLAN@EP.NCRR.NIH.GOV $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** DRAFT OF THE "COST ANALYSIS AND RATE SETTING MANUAL FOR ANIMAL RESEARCH FACILITIES" POSTED ON NCRR WEB SITE FOR COMMENT NIH GUIDE, Volume 26, Number 10, March 28, 1997 P.T. 34; K.W. 1002002 National Center for Research Resources The purpose of this notice is to announce that a draft of the revised "Cost Analysis and Rate Setting Manual for Animal Research Facilities" is posted on the NCRR web site for comment at the following address: http://www.ncrr.nih.gov This Manual is posted for comment only and is not officially approved for use. The deadline for submitting responses is May 12, 1997. INQUIRIES Direct inquiries regarding the draft of the "Cost Analysis and Rate Setting Manual for Animal Research Facilities" to: Ms. Lori Mulligan Office of Science and Health Reports National Center for Research Resources 6705 Rockledge Drive, Suite 5140, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0888 FAX: (301) 480-3558 Email: webmaster@ep.ncrr.nih.gov $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NCI SCIENCE ENRICHMENT PROGRAM NIH GUIDE, Volume 26, Number 10, March 28, 1997 P.T. 34; K.W. 0502000, 0503016 National Cancer Institute The National Cancer Institute (NCI), Division of Cancer Prevention and Control, Cancer Control Research intends to negotiate with the University of Massachusetts, Contract No. N02-CN-25406; University of Kentucky, Contract No. N02-CN-25472, University of Southern California, Contract No. N02-CN-25473, and American Indian Science and Engineering Society, Contract No. N02-CN-25479 for a seven-month continuation of their contracts for conducting a regional, summer resident Science Enrichment Program for incoming tenth grade underrepresented minority and underserved youth who have demonstrated an interest in science and/or mathematics. The goals of this program are: 1) to encourage underrepresented minority and underserved youth to pursue professional careers in science or research; and 2) to broaden and enrich student's science research, and sociocultural backgrounds. Authority: 41 USC 253 (c)(1), as set forth in FAR 6.302-1. Inherent duplication of cost to the government and unacceptable delays in competing the project make competition unfeasible. Incumbent contractors have established curriculums, access to the required diversity of students and geographic disbursement, faculty and facilities. For Information Purposes Only. The RFP is not available. No collect calls will be accepted. Mr. Clyde Williams Research Contracts Branch National Cancer Institute 6120 Executive Boulevard, Room 635 MSC 7226 Bethesda MD 20892-7226 Telephone: (301) 435-3832 $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN N01DA-7-8077 ********************************************* MEDICINAL CHEMISTRY-SYNTHESIS OF POTENTIAL TREATMENT AGENTS FOR COCAINE ADDICTION NIH GUIDE, Volume 26, Number 10, March 28, 1997 RFP AVAILABLE: N01DA-7-8077 P.T. 34; K.W. 0404009, 0404001, 1003006, 1002012, 0760035 National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) is soliciting proposals from qualified organizations having the capability to design and synthesize compounds which affect primarily dopaminergic systems and either substitute for cocaine or antagonize its effects. The project shall involve the synthesis of any of the following: dopamine uptake inhibitors with a slower rate of onset than cocaine; compounds which affect dopaminergic systems through the inhibition of dopamine or serotonin transporters; serotonin transporter selective cocaine analogs; dopamine partial agonists, agonists, and antagonists; and dopamine sparing cocaine antagonists (compounds that bind to the dopamine transporter without inhibiting dopamine uptake); and compounds selective for D1 and D3 receptors. The project shall also provide for the scale-up production, and analog synthesis, of promising compounds. The major goal of this project is to provide NIDA with a resource of novel compounds with potential use in the treatment of cocaine abuse. It is anticipated that six cost reimbursement, term type contracts will be awarded for a period of two years, with two one-year options. This requirement is a partial set-aside for small business, i.e., three of the awards will be made to small businesses. RFP No. N01DA-7-8077 will be available electronically on or about April 14, 1997, and may be accessed through the NIH Gopher and/or the Internet by using the following electronic mail addresses and instruction: 1. NIH Home Page (via the World Wide Web): Access the NIH Home Page by using http://www.nih.gov . Once you are at the NIH Home Page, select "Grants and Contracts"; select NIH Gopher directory: listed under the "Contracts Page" section. Once at the NIH R&D Gopher, select "RFPs Available"; select "NIDA"; and select "RFP N01DA-7- 8077". (URL: gopher://gopher.nih.gov:70/11/res/rd-rfp) 2. NIH Gopher: Point your Gopher client to GOPHER.NIH.GOV Port 70 (you should now be in the NIH Gopher). Select "Grant and Research Information"; select "R&D Request for Proposals (RFP)"; select "RFPs Available"; select "NIDA"; and, select "RFP N01DA-7-8077". Please note that the RFP for this acquisition will be streamlined to include only the Work Statement, deliverable and reporting requirements, special requirements and mandatory qualifications, Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Response to this RFP will be due on or about May 29, 1997. Any responsible offeror may submit a proposal which will be considered by the Government. This advertisement does not commit the Government to award a contract. INQUIRIES Kenneth E. Goodling Contracts Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 10-49 Rockville, MD 20857 Telephone: (301) 443-6677 FAX: (301) 443-7595 Email: kg25d@nih.gov $$R1 END ************************************************************ $$R2 BEGIN DC-97-001 FULL-TEXT ************************************** NIDCD/ORMH MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD FOR MINORITY SCHOOL FACULTY NIH GUIDE, Volume 26, Number 10, March 28, 1997 RFA AVAILABLE: DC-97-001 P.T. 34; K.W. 0715050, 0715055, 0775017 National Institute on Deafness and Other Communication Disorders Office of Research on Minority Health Application Receipt Date: May 23, 1997 PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) and the Office of Research on Minority Health (ORMH) invite Mentored Research Scientist Development Award (K01) applications for grants to support the research career development of faculty investigators at minority academic institutions in the biomedical and behavioral scientific mission areas of the NIDCD, hearing, balance, smell, taste, voice, speech and language. The purpose of this program initiative is to: (1) foster the development of independent investigators in research in human communication on the faculties of minority institutions; (2) stimulate research and research training in human communication at these institutions; and (3) encourage the entry of investigators from minority groups who were trained in a variety of scientific areas and disciplines into research in human communication. It is anticipated that approximately $300,000 will be available to support up to four awards in FY 97. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, NIDCD/ORMH Mentored Research Scientist Development Award for Minority School Faculty, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Daniel A. Sklare, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C - MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 496-1804 FAX: (301) 402-6251 Email: daniel_sklare@nih.gov $$R2 END ************************************************************ $$R3 BEGIN DC-97-002 FULL-TEXT ************************************** NIDCD/ORMH MINORITY DISSERTATION RESEARCH GRANTS IN HUMAN COMMUNICATION NIH GUIDE, Volume 26, Number 10, March 28, 1997 RFA AVAILABLE: DC-97-002 P.T. 34; K.W. 0715050, 0715055, 0775017 National Institute on Deafness and Other Communication Disorders Office of Research on Minority Health Application Receipt Date: May 23, 1997 PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) and the Office of Research on Minority Health (ORMH) announce the availability of small grants (R03) to support doctoral dissertation research in human communication for minority doctoral candidates. Grant support is designed to aid the research of new minority investigators and to encourage minority individuals from a variety of academic disciplines and programs to conduct research in hearing, balance, smell, taste, voice, speech, and language. Grants may be made for up to two years. Grants to support dissertation research will provide no more than $30,000 in direct costs over the two-year period, and no more than $25,000 in direct costs in any one year. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), NIDCD/ORMH Minority Dissertation Research Grants in Human Communication, is related to several priority areas applicable to human communication. Potential candidates for the awards may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Dr. Judith A. Cooper Division of Human Communication National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C - MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 496-5061 FAX: (301) 402-6251 Email: judith_cooper@nih.gov $$R3 END ************************************************************ $$P1 BEGIN PA-97-049 FULL-TEXT ************************************** EXPLORATORY STUDIES FOR HIGH RISK/HIGH IMPACT RESEARCH NIH GUIDE, Volume 26, Number 10, March 28, 1997 PA AVAILABLE: PA-97-049 P.T. 34; K.W. 0710030, 1002004, 0710035, 1003002, 1014001 National Institute of General Medical Sciences PURPOSE The National Institute of General Medical Sciences (NIGMS) announces a new initiative. The purpose of this initiative is to broaden the base of inquiry in fundamental biomedical research by encouraging applications for research projects that involve an especially high degree of innovation and novelty and, therefore, require a preliminary test of feasibility. The research projects proposed under this program announcement may involve substantial experimental risks such that their potential for highly significant outcomes may be difficult to judge by the standard criteria used in evaluating R01 applications. The amount awarded for each of these pilot projects would be lower than that awarded for the average R01 grant. The NIGMS seeks to encourage fundamental research projects that fall into the following classes: projects to test novel and significant hypotheses for which there is scant precedent or preliminary data and which, if confirmed, would have a substantial impact on current thinking; projects to explore a new experimental organism or system in order to address particularly difficult basic biomedical questions for which the new system would be particularly advantageous; and projects to develop innovative techniques or methodologies with wide applicability to the study of basic biomedical problems. The projects must support the NIGMS mission as detailed in the publication, "Divisions and Grant Award Mechanisms," available from the NIGMS Public Information Office (301/496-7301); additional information can be found on the NIGMS home page at http://www.nih.gov/nigms/. In brief, NIGMS supports research in (a) cell biology and molecular biophysics, including basic studies of the structure and function of cells, cellular components, and the biological macromolecules that make up these components; (b) fundamental mechanisms of inheritance and development that typically utilize non-human model systems; (c) basic studies in pharmacology, physiology, biochemistry, biorelated chemistry and anesthesiology; (d) basic studies in biotechnology, including biocatalysis and metabolic engineering; (e) bioengineering, including instrumentation development and refinement and development of bioanalytical methods and biomaterials; and (f) trauma and burn injury. INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH Gopher (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and my mail and email from the contacts listed below. Dr. James C. Cassatt Division of Cell Biology and Biophysics National Institute of General Medical Sciences 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594 0828 FAX: (301) 480-2004 Email: CZJ@cu.nih.gov $$P1 END ************************************************************ $$P2 BEGIN PA-97-050 FULL-TEXT ************************************** MANAGING THE SYMPTOMS OF COGNITIVE IMPAIRMENT NIH GUIDE, Volume 26, Number 10, March 28, 1997 PA AVAILABLE: PA-97-050 P.T. 34; K.W. 0414005, 0745027 National Institute of Nursing Research National Institute on Aging National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Child Health and Human Development PURPOSE The National Institute of Nursing Research (NINR), National Institute on Aging (NIA), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), and the National Center for Medical Rehabilitation Research of the National Institute of Child Health and Human Development (NICHD) are interested in facilitating investigator-initiated research into nonpharmacological intervention strategies designed to deal with symptoms associated with cognitive impairment in adults. Several conditions can result in cognitive impairment, including Alzheimer's disease, multi-infarct dementia, AIDS-related cognitive dysfunction, traumatic brain injury, stroke, and other neurological conditions such as Parkinson=s disease. The overall goals are to deter or delay symptoms requiring costly services or institutionalization and improve health-related quality of life for patients, caregivers, and families. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Managing the Symptoms of Cognitive Impairment, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Mary D. Leveck, Ph.D., R.N. National Institute of Nursing Research Building 45, Room 3AN12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5963 FAX: (301) 480-8260 Email: mleveck@ep.ninr.nih.gov Neil Buckholtz, Ph.D. National Institute on Aging 7201 Wisconsin Avenue, Suite 3C307 - MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: BuckholN@GW.NIA.NIH.GOV Jane L. Pearson, Ph.D. National Institute of Mental Health 5600 Fishers Lane, Room 18-101 Rockville, MD 20957 Telephone: (301) 443-1185 FAX: (301) 594-6784 Email: jp36u@nih.gov Eugene J. Oliver, Ph.D. National Institute of Neurological Disorders and Stroke 7550 Wisconsin Avenue, Room 806 Bethesda, MD 20892-9150 Telephone: (301) 496-5680 FAX: (301) 480-1080 Email: EO11C@NIH.GOV Louis A. Quatrano, Ph.D. National Institute of Child Health and Human Development 6100 Executive Building, Room 2A03 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 FAX: (301) 402-0832 Email: Quatranl@hd01.nichd.nih.gov $$P2 END ************************************************************ $$P3 BEGIN PA-97-051 FULL-TEXT ************************************** DEHYDROEPIANDROSTERONE (DHEA) AND AGING: BIOLOGIC ACTIONS AND EFFECTS OF ADMINISTRATION NIH GUIDE, Volume 26, Number 10, March 28, 1997 PA AVAILABLE: PA-97-051 P.T. 34; K.W. 0710010, 0760085, 1002034 National Institute on Aging National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The National Institute on Aging (NIA)and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) are interested in receiving research project grant applications (R01 and R29 mechanisms) addressing gaps in our knowledge of the physiologic roles and effects of administration of dehydroepiandrosterone (DHEA), or its sulfated derivative, dehydroepiandrosterone sulfate (DHEA(S), in middle-aged and older people, and of the mechanism of action of DHEA(S) at the molecular, cellular and tissue levels. This program announcement updates and replaces a previous program announcement on this topic (PA-93-015, Physiological Role of the Adrenal Androgen, DHEA, in Aging, NIH Guide, Vol. 21, No. 40, November 6, 1992). HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Dehydroepiandrosterone (DHEA) and Aging: Biologic Actions and Effects of Administration, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Frank Bellino, Ph.D. Biology of Aging Program National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892-9205 Telephone: (301) 496-6402 FAX: (301) 402-0010 Email: bellinof@gw.nia.nih.gov Ronald N. Margolis, Ph.D. Endocrinology Section National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 5AN-12J Bethesda, MD 20892-6600 Telephone: (301) 594-8819 FAX: (301) 480-3503 Email: rm76f@nih.gov $$P3 END ************************************************************ From owner-sci-resources@net.bio.net Fri Mar 28 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DC-97-001 - V26(10) 03/28/97 Date: 28 Mar 1997 21:24:57 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 582 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5hi939$6k@net.bio.net> NNTP-Posting-Host: net.bio.net NIDCD/ORMH MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD FOR MINORITY SCHOOL FACULTY NIH GUIDE, Volume 26, Number 10, March 28, 1997 RFA: DC-97-001 P.T. 34; K.W. 0715050, 0715055, 0775017 National Institute on Deafness and Other Communication Disorders Office of Research on Minority Health Application Receipt Date: May 23, 1997 PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) and the Office of Research on Minority Health (ORMH) invite applications for grants to support the research career development of faculty investigators at minority academic institutions in the biomedical and behavioral scientific mission areas of the NIDCD, hearing, balance, smell, taste, voice, speech and language. The purpose of this program initiative is to: (1) foster the development of independent investigators in research in human communication on the faculties of minority institutions; (2) stimulate research and research training in human communication at these institutions; and (3) encourage the entry of investigators from minority groups who were trained in a variety of scientific areas and disciplines into research in human communication. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, NIDCD/ORMH Mentored Research Scientist Development Award for Minority School Faculty, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted on behalf of candidates by domestic non-Federal minority academic institutions, public and private. For the purposes of this RFA, a minority institution is defined as a domestic college, university, or equivalent school of higher learning in which students of minority ethnic/racial groups, which have been found to be underrepresented in biomedical and behavioral research in the United States, including African Americans, Hispanic Americans, Native Americans and Alaskan Natives, and Pacific Islanders, comprise a substantial proportion of the institution's enrollment. Ethnic/racial minority individuals underrepresented in biomedical and behavioral research, women, and persons with disabilities are particularly encouraged to apply as candidates. Applications from foreign institutions will not be accepted. Candidates for this award must be full-time faculty members of minority academic institutions who: (1) are citizens of the United States, noncitizen nationals, or have been lawfully admitted for permanent residency at the time of application; (2) have a research or health-professional doctorate, or its equivalent; (3) have demonstrated capacity or potential for productive independent research; (4) have secured the commitment of an appropriate research mentor actively involved in research in human communication and of the minority (home) institution to the proposed research career development program; and (5) agree to remain at the minority institution for at least two years after completion of the award. The candidate must identify an appropriate mentor either at the applicant institution or at another institution within geographic proximity of the home institution with extensive research experience in the research area proposed in the application. The candidate must be willing to spend a minimum of 50 percent professional effort conducting research and career development activities for the period of the award. Candidates who have served as principal investigators on PHS research grants or have been supported by a research career award in the past, are eligible to apply, provided the proposed research career development program is in a fundamentally new area of scientific endeavor for the candidate or there has been a significant hiatus in his/her research career because of family or other personal obligations. Current principal investigators on PHS research grants are not eligible. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Mentored Research Scientist Development Award (K01) mechanism. This mechanism is described in program announcement PA-95-049 (NIH Guide, Vol. 24, No. 15, April 28, 1995). Although all general guidelines of PA-96-049 will apply, this RFA is written as a stand-alone document and contains provisions that are unique to this initiative. Planning, direction, and execution of the proposed career development program are the responsibility of the candidate and his/her mentor on behalf of the applicant institution. The total project period for grants awarded under this program must be three, four or five years, and will depend on the number of years of prior research experience and the need for additional career development to achieve research independence in research in human communication. These grants are not eligible for renewal. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the program are expected to be $300,000 in Fiscal Year 1997 (FY 97). Up to four awards are anticipated to be made in FY 97. Funding beyond the first year of the award will be contingent on the satisfactory progress of the awardee and the availability of funds. RESEARCH OBJECTIVES Background The striking underrepresentation of racial/ethnic minority groups in biomedical and behavioral research in the United States has been underscored in many studies. There are existing programs at the NIH designed to improve this situation. These include: the Minority Biomedical Research Support Program, the Minority Access to Research Careers (MARC) Program, the Individual Predoctoral Fellowship for Minority Students Program, and the Research Supplements for Underrepresented Minorities Program. The NIDCD has been an active participant in trans-NIH minority research training programs and has implemented its own minority programs, including the Travel Fellowships for Underrepresented Minority Students in Communication Sciences Program, the NIDCD Partnership Program and the NIDCD/ORMH Minority Dissertation Research Grants in Human Communication Program. In the spring of 1994, NIDCD conducted a program planning workshop on research training, Training Researchers for the Next Century in the Communication Sciences. Among the recommendations of this workshop were: (1) to expand partnership programs with professional and voluntary organizations for minority research training initiatives, and (2) to promote the research training of scientists from underrepresented minority groups at the investigator level. Although the aforementioned NIH grant programs have yielded a measurable degree of success, it has been recognized that the paucity of qualified minority investigators in academic research settings has created a shortage of role models for minority students. This RFA seeks to address this problem by enhancing the research capabilities of faculty members, especially minority faculty members, at minority academic institutions so that these individuals may establish research laboratories and research programs in human communication at their institutions. In this fashion they will serve as role models for minority undergraduate and graduate students, stimulating them to consider research career opportunities in human communication. The purpose of this RFA is to: o foster the development of independent investigators in research in human communication on the faculties of minority academic institutions; o stimulate research and research training in human communication at these institutions; and o encourage the entry of investigators from underrepresented minority groups who were trained in a variety of scientific areas and disciplines into research in human communication. Research Areas The research career development plan must address a scientific area of hearing, balance, smell, taste, voice, speech or language. The NIDCD particularly encourages minority school faculty to develop their research careers in underserved and priority areas of NIDCD's scientific research mission. These research areas are enumerated in the National Strategic Research Plans published by the NIDCD. Environment The applicant minority institution must demonstrate in the application a firm commitment to the development of the candidate as a productive, independent investigator in human communication and to the pursuit of the research career development plan described in the application. The candidate should describe a career development program that will maximize the use of relevant research and educational resources available in the minority institution and in the mentor's institution. Program The award provides three, four or five consecutive 12-month appointments to pursue a mentored research experience and specialized study in the sciences applicable to human communication that are tailored to the individual needs of the candidate. At least 50 percent of the recipient's full-time professional effort over the 12-month appointment period must be devoted to the program, and the remainder devoted to other research- related and/or teaching activities consistent with the objectives of the award. The candidate must develop knowledge in the basic sciences and research skills relevant to his or her career goals, and must arrange relevant didactic and laboratory or field research experiences. Mentor(s) The candidate must identify and complete arrangements with a nearby scientist at the host institution or at another institution within approximately 100 miles who is an accomplished investigator in the research area proposed in the application and an appropriate mentor. There may be additional mentors, but the primary mentor should be in geographic proximity to the candidate. Arrangements with primary mentors at institutions greater than 100 miles from the applicant institution will be considered, but must be strongly justified and clearly outlined in the application. The candidate must receive appropriate mentoring throughout the three- to five-year program. Allowable Costs: 1. Salary: The NIDCD will provide salary for the recipient of this award, based on the institution's salary scale for faculty at an equivalent experience level, up to a maximum of $50,000 per year (plus commensurate fringe benefits). The actual amount allowable for salary will depend on the percentage of effort committed by the candidate to the program. The institution may supplement the NIDCD contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose and provisions of this research career development award. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary requested must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full- time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. 2. Research Development Support: The NIDCD will provide up to $20,000 per year for the following expenses: (a) tuition, fees, and books related to career development; (b) research expenses, such as supplies, equipment, and technical personnel; (c) travel to research meetings or training; (d) statistical services including personnel and computer time. These funds must be expended for the support of the candidate's research career development plan. The transfer of funds for this purpose to the mentor's institution by subcontract or other written agreement will be permitted only with appropriate justification. 3. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not provided. 4. Facilities and Administrative Costs: Facilities and administrative costs will be reimbursed at eight percent of modified total direct costs, or at the actual facilities and administrative cost rate, whichever is less. Evaluation In carrying out its stewardship of human resource related programs, the NIDCD, ORMH or NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508- 14513), and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). These forms are available at most institutional offices of sponsored research, from the program administrator listed under INQUIRIES, as well as from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, FAX 301/480- 0525, email: ASKNIH@ODROCKM1.OD.NIH.GOV. The PHS 398 form is also available electronically on the NIH Home Page at http://www.nih.gov/grants/phs398. The RFA label available in the PHS 398 (rev.5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number (NIDCD/ORMH Mentored Research Scientist Development Award for Minority School Faculty, DC-97-001) must be typed on line 2 of the face page of the application form and the YES box must be marked. Instructions for completing the application are found in the PHS 398 form. The application must address the following issues: Candidate o The candidate's commitment to a career in research in human communication. o The candidate's potential to develop into a successful independent investigator. o The candidate's immediate and long-term career objectives, and how the award will contribute to their attainment. o Letters of recommendation. Three sealed letters of recommendation, including a letter from the mentor, addressing the candidate's potential for an independent research career in human communication must be included as part of the application. Career Development Plan o The career development plan, incorporating consideration of the candidate's goals and prior experience. It should describe a systematic plan to obtain any necessary background and research experience to launch or reinitiate an independent research career in human communication. o Plans to receive instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction as well as the amount and nature of faculty participation. No award will be made if an application lacks this component. Research Plan o The candidate's and mentor's research plan, as outlined in form PHS 398, including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. Mentor's(s') Statement(s) o The application must include information on the mentor(s) including information on research qualifications and previous experience in research training and mentoring. The application also must include information that describes the nature and extent of mentoring that will occur during the proposed award period. Environment and Institutional Commitment o The applicant minority institution must describe the anticipated impact of the candidate's career development program to the promotion of research and research training in human communication at that institution. o The applicant minority institution must also provide a statement of commitment to the candidate's development into a productive, independent investigator in research in human communication. This must include statements from the Dean and the Departmental Chair indicating that the candidate will be provided with sufficient release time from other duties to accomplish the research and career development goals stated in the application. Budget o The budget must be prepared in accordance with the instructions in Form 398 and the Just-In-Time (JIT) procedures for FIRST and Career (K) Awards. The JIT procedures are described in two NIH Guide notices (Volume 25, Number 10, March 29, 1996; Volume 25, Number 16, May 17, 1996), available from the program administrator listed under INQUIRIES and from the NIH Home Page at http://www.nih.gov. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier service) At the time of submission, two additional copies of the application must be sent to: Chief, Scientific Review Branch Division of Extramural Activities National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard - MSC 7180 Bethesda, MD 20892-7180 ATTN: Minority Faculty MRSDA Telephone: (301) 496-8683 FAX: (301) 402-6250 Applications must be received by May 23, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA (as judged by NIDCD Program Staff) will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDCD in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score. Review Criteria The following criteria will be applied: Candidate o Commitment to an independent research career in human communication; o Potential to develop (or evidence of the capacity to develop) as an independent investigator; and o Quality and breadth of prior scientific training and experience, including, where appropriate, the record of previous research support and publications. Career Development Plan o Likelihood that the plan will contribute substantially to the scientific development of the candidate and the achievement of research independence; o Appropriateness of the research plan to the career goals of the candidate; o Appropriateness of the plan to develop new knowledge in human communication, and appropriateness of the proposed award duration; o Clarity of the goals and scope of the plan and the need for the proposed research experience; and o Quality of the proposed training in the responsible conduct of research. Research Plan All candidates for this award will have had previous research experience and in some cases will have been Principal Investigators in other scientific fields. A sound research plan that is consistent with the career development plan and the candidate's level of research development must be provided: o Usefulness of the research plan as a vehicle for enhancing existing research skills as described in the career development plan; o Scientific and technical merit of the research question, design and methodology; o Relevance of the proposed research to the candidate's career objectives; and o When human subjects are involved, adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. Mentor(s) o Appropriateness of mentor's(s') research qualifications in human communication and in the specific areas of the application; o Quality and commitment of the mentor(s) to supervising and guiding the candidate throughout the award period; o Previous experience in fostering the development of independent investigators; and o Record of research productivity and support. Institutional Environment and Commitment o Applicant institution's commitment to the scientific development of the candidate and assurances that the institution intends the candidate to be an integral part of its research program; o Quality of the environment and facilities of the mentor(s) and of the applicant institution for the candidate's scientific and professional development; and o Willingness of the applicant institution to develop an appropriate balance of research, teaching and administrative responsibilities for the candidate. Budget o Justification of budget requests in relation to career development goals and research aims and plans. AWARD CRITERIA The NIDCD anticipates awarding up to four K01 grants in response to this RFA. The anticipated date of award is September 30, 1997. The following criteria will be considered in making funding decisions: o Responsiveness to the purpose of this request; o Quality of the proposed research career development program, as determined by peer review; and o Availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Consultation with NIDCD staff is strongly encouraged, especially during the planning phase of the application process, in order to ensure that the application is responsive to the scientific mission and the research training and career development goals of the NIDCD. Direct inquiries regarding programmatic issues to: Daniel A. Sklare, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard - MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 496-1804 FAX: (301) 402-6251 Email: daniel_sklare@nih.gov Direct inquiries regarding fiscal matters to: Sharon Hunt Division of Extramural Activities National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-B 6120 Executive Boulevard - MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: sh79f@nih.gov AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance No. 93.173. Awards are made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies and Federal Regulations at 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Mar 28 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-050 - V26(10) 03/28/97 Date: 28 Mar 1997 21:26:07 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 611 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5hi95f$b5@net.bio.net> NNTP-Posting-Host: net.bio.net MANAGING THE SYMPTOMS OF COGNITIVE IMPAIRMENT NIH GUIDE, Volume 26, Number 10, March 28, 1997 PA NUMBER: PA-97-050 P.T. 34; K.W. 0414005, 0745027 National Institute of Nursing Research National Institute on Aging National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Child Health and Human Development PURPOSE The National Institute of Nursing Research (NINR), National Institute on Aging (NIA), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), and the National Center for Medical Rehabilitation Research of the National Institute of Child Health and Human Development (NICHD) are interested in facilitating investigator-initiated research into nonpharmacological intervention strategies designed to deal with symptoms associated with cognitive impairment in adults. Several conditions can result in cognitive impairment, including Alzheimer's disease, multi-infarct dementia, AIDS-related cognitive dysfunction, traumatic brain injury, stroke, and other neurological conditions such as Parkinson's disease. The overall goals are to deter or delay symptoms requiring costly services or institutionalization and improve health-related quality of life for patients, caregivers, and families. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Managing the Symptoms of Cognitive Impairment, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for- profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanisms of support will be the National Institutes of Health (NIH) research project grant (R01) and FIRST (R29) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Individuals applying for the FIRST award must comply with the 1994 NIH Guidelines for FIRST awards and the Just-in-Time procedures announced in the NIH Guide, Vol. 25, No. 10, March 29, 1996. RESEARCH OBJECTIVES Cognitive impairment associated with dementia or other brain disorders is a significant public health problem, with major implications for morbidity and mortality, quality of life, and health-care costs. The financial burden of dementia, including direct care costs and lost productivity, is estimated at 100 billion dollars annually. This estimate does not include the costs of care provided by family caregivers. This program announcement encompasses conditions which might cause cognitive impairment, such as Alzheimer's disease and related disorders (ADRD), multi-infarct dementia, AIDS-related cognitive dysfunction, traumatic brain injury, stroke, and other neurological conditions such as Parkinson's disease. Until more is known about the neurobiological mechanisms underlying these conditions and until treatments are developed to target those processes, research is needed to deal with the symptoms of cognitive impairment. Five symptoms -- wandering, aggression, agitation, incontinence, and sleep disruption -- have been proposed as the most frequent reasons for institutionalization among ADRD patients. Thus, if methods were found to deal effectively with these problems, costly and disruptive change in living situations might be delayed or prevented. Symptoms Although the pathology underlying cognitive impairment cannot be altered at the present time, interventions are showing that some behaviors can be changed, functional ability improved, quality of life increased, and institutionalization delayed. If improvements are not always possible, maintaining function or delaying a decline for a period of time may provide a valuable contribution. Symptoms that may occur during the course of the targeted conditions include: o cognitive changes: memory deficits, language impairment, visuospatial changes, decreased executive function o affective changes: irritability, lability, disinhibition, anxiety, dysphoria, delusions, hallucinations, apathy, withdrawal o dementia-related behaviors: wandering, pacing, agitation, disruptive vocalizations, repetitive behaviors o functional changes: loss of instrumental activities of daily living (telephone, financial activities); loss of activities of daily living (dressing, feeding); incontinence; immobility o other changes: sleep and circadian rhythm disturbances, sexual alterations, appetite disturbances. The physical status of persons with cognitive impairment also needs careful research attention. Factors such as the correction of hearing and vision impairment might improve physical status, and may also positively influence cognition and behavioral symptoms, functioning, and quality of life. Persons with cognitive impairment are at risk for infections, falls and injury, poor nutrition, and delirium. Delirium can be a complication or a presenting symptom of a coexisting condition and needs careful research attention. Dementia is a significant risk factor for the development of delirium during hospitalization or surgery and is associated with increased mortality in the hospitalized elderly. Research instruments exist to diagnose delirium and to distinguish the confusion from the dementia, but new strategies to decrease delirium need to be developed and tested. Additionally, drug interactions cause by the simultaneous use of multiple drugs is a common cause of cognitive decline. Thus, the effect of polypharmacy in these individuals may also be considered. Interventions Promising interventions to treat the symptoms of cognitive impairment may take one or more of several approaches, including behavioral, cognitive, psychosocial, or environmental. The goals of the interventions may vary with the specific underlying condition and stage of the disease, but can generally be classified as maximizing potential, preventing undesirable consequences, delaying the onset of symptoms, or providing palliative measures. The types of interventions proposed for testing may include, but are not limited to the following examples. o Interventions directed at cognitive function are difficult given the progressive decline in several of the types of dementia. But despite being perhaps less amenable to change, even achieving small improvements or maintaining function for a time can be perceived by patients and caregivers as worthwhile. o Interventions directed at activities of daily living are showing some promise, but need further attention. Highly targeted training in continence, dressing, and other functions have been shown to have favorable outcomes in some settings. o Behavioral interventions to deal with agitated and disturbed behaviors are showing some promise. Research is underway in both homes and long-term care facilities to determine effective techniques. Additional research is needed including methods to train staff and family in administering these treatments and strategies to sustain the treatment and outcomes over time. o Targeted interventions to influence social participation and to determine the effects of increased social involvement are needed. Particular attention should be given to individual patient preferences. o Interventions related to the patients' affective states are needed. Some research has shown that both positive and negative patient states can be measured based on nonverbal and sometimes verbal behavior. However, additional study is needed to determine how it can be assessed more accurately and how it can be used in family and formal treatment programs. o Environmental interventions dealing with the context of care are based on the assumption that the environment has an important effect on behavior. Studies, such as reducing distraction or controlling excessive stimulation in long-term care facilities, need testing in a variety of settings for their effect on the symptoms of cognitive impairment. o A variety of interventions are being tested with family caregivers, notably in the NIA/NINR cooperative agreement, Resources for Enhancing Alzheimer's Caregiver Health (REACH). Six sites across the country are testing promising home and community based interventions for enhancing family caregiving, particularly with minority families. In addition to a common core database managed by a coordinating center, data are being collected on interventions including an in-home skills training program, a telephone linked computer program, a primary care based intervention in the context of office visits, a family counseling program with a computer-phone component, a psychoeducational program with a support group component, and a home environmental skill building program. Minority groups receiving special attention include Hispanic, Cuban-Hispanic, and Black family caregivers. Additional research needs to be done with careful attention to placing the proposed studies in the context of what is already known. Consideration may be given to several variables that could influence the effectiveness of various nonpharmacologic approaches, including type and severity of cognitive impairment; noncognitive impairments such as neurological deficits; psychiatric problems, such as depression; other physical health problems and sensory impairments; as well as differences due to personality characteristics; age; gender; ethnicity and culture; and previous life experiences and lifestyle factors. There is a need for careful identification in the research literature of which particular approaches are effective given different patient factors. Both community and institutional settings and various services are appropriate for research related to symptom management. These might include long-term care facilities, homes, adult day care, hospitals, assisted living sites, home health care, special care units, respite care, and rural versus urban settings. Research on testing specific services needs to address the issue of dose-response, including clear quantification of both the treatment and the response patterns, as well as the general services provided and the outcomes to be achieved. Some studies are finding that the symptoms and effective treatment strategies may vary based on gender and ethnic issues. Continued research on these factors is encouraged. Careful attention to methodological issues is critical, including treatment integrity, masked assessment or control of rater bias, randomization, and appropriate control group(s). The theoretical basis for the planned study must be clearly explicated and linked to the intervention to be tested. In addition to ensuring that measures have adequate psychometric properties, the instruments should be carefully linked to the outcomes and should be sensitive to change. Some symptoms associated with cognitive impairment have had more research than others, therefore applicants are encouraged to ensure that the proposed studies are well-grounded in the research literature. Likewise, some interventions are ready for larger scale, multi-site studies of efficacy while other interventions need smaller scale studies to determine feasibility and effectiveness. Applications in response to this program announcement may also include animal and other basic science studies of the mechanisms underlying behavioral symptoms of dementia, and of potential clinical interventions directed at these symptoms. These might include, for example, studies of learning and memory impairment, aggression, or circadian disturbances in transgenic animal models of AD, animal models of traumatic brain injury, or models of cerebral hypoxia/ischemia. The therapeutic strategies to be tested may encompass non-behavioral, as well as behavioral, components. Outcomes Health outcomes, defined as changes in health status that can be attributed to care, are critical components of this research endeavor. Several of the following possible variables have been used successfully in prior research while others have not received adequate conceptual and psychometric attention. Investigators are cautioned to select measures that are specific to the targeted outcomes and that are sensitive to change. Multiple outcomes are generally indicated in clinical intervention research. Consideration should be given to incorporating measures such as cognitive function, specific functional status, neurological performance, and other health status indicators. The following list provides some possible outcomes for consideration: o physical status: health goals may include avoidance of complications and/or coexisting conditions of dementia, e.g., infections, malnutrition, incontinence, delirium, or in later stages, seizures or pressure ulcers. o cognitive abilities: memory, language, visuospatial skills, executive function o affect and neuropsychiatric disorders: depression, pleasure, mood, hallucinations, delusions o functional performance: such as mobility, activities of daily living including feeding, toileting, bathing, dressing and instrumental activities of daily living such as household tasks, shopping, managing money, using the telephone. o behavioral symptoms: wandering, pacing, agitation, disruptive behaviors, aggression, hostility, repetitive behaviors, sleep disruption, o psychosocial variables: communication, intimacy, sexuality, satisfaction, independent living status, vocational skills o decision making: food preferences, end of life decisions o quality of life: well-being, competence, environmental quality, meaningful time use o caregiver outcomes: stress, burden, physical and psychosocial status, productivity, commitment, satisfaction, resource use, decision making, social well-being, bereavement o costs of care, service use, institutionalization Applications from institutions that have a General Clinical Research Center (GCRC) may wish to identify these programs as a resource for conducting the proposed research. If so, a letter of agreement from the program director or Principal Investigator should be included with the application. Summary Research applications may address the issues noted in the narrative above as well as research objectives such as: o test nonpharmacological interventions to manage the behavioral, physical, and functional problems associated with cognitive impairment, such as wandering, falls, sleep disturbances, and inadequate nutrition. o evaluate interventions for the cognitive rehabilitation of people with conditions such as traumatic brain injury or stroke that are aimed at either remediating cognitive impairments or encouraging compensatory strategies for them. o investigate cognitive, behavioral, attitudinal, and physiological interventions to prevent or delay the onset of cognitive impairment. o support basic and clinical studies of neurobehavioral and cognitive effects of dementia and delirium to determine similarities and differences in these conditions and ways to assess and treat them. o test interventions for family caregivers that mitigate the deleterious effects of the caregiving role on mood, immune function, and productivity. o investigate interventions targeted to differences in patient management and family caregiving due to gender, ethnic, cultural, and socioeconomic factors. Primary Sources: 1. Conference: "Defining and Measuring Outcomes in Alzheimer's Research: Do We Agree?" Sponsored by Alzheimer's Association, Advisory Panel on Alzheimer's Disease, Agency for Health Care Policy and Research, Department of Veterans Affairs, National Institute on Aging, National Institute of Mental Health, National Institute of Nursing Research, University Hospitals of Cleveland. September 11-12, 1996, Washington, DC. To be published in a special issue in Alzheimer's Disease and Associated Disorders: An International Journal. A summary of conference discussions and findings may be obtained from The Alzheimer's Association, Washington office, phone 202-393-7737. 2. Conference: "Alzheimer's Disease Research Plan II," sponsored by National Institute on Aging and Fisher Medical Foundation, August 9-11, 1994, Washington, DC. Published in International Psychogeriatrics, Volume 8, Supplement 1, 1996. 3. NIA/NINR Cooperative Agreement, Research to Enhance Alzheimer's Caregiver Health (REACH); including investigators: L. Burgio at University of Alabama, Birmingham; R. Burns at VA, Memphis; C. Eisdorfer at University of Miami; D. Gallagher-Thompson at VA, Palo Alto; D. Mahoney at Boston Medical Center; R. Schulz at University of Pittsburgh; L. Gitlin at Thomas Jefferson University, and NIH staff: M. Ory at NIA; and M. Leveck at NINR. 4. Conference: "Outcomes Research in Medical Rehabilitation" sponsored by NCMRR on August 29-31, 1994. Fuhrer, J.J., & Richards, J.S. (1996). Medical Rehabilitation Outcomes for Persons with Traumatic Brain Injury: Some Recommended Directions for Research in B.P. Uzzell & H.H. Stonnington (Eds.), Recovery After Traumatic Brain Injury (pp. 247-255). Mahwah, NJ: Lawrence Erlbaum Associates. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators may access the policy via Internet on the NIH Website (http://www.nih/gov) or may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. Receipt dates for new research grant applications are February 1, June 1, and October 1. On page 1 of form PHS 398, check "Yes" in Item 2 and enter the number and title of this program announcement in the space provided. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The complete original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) A number of other Institutes, Centers, and Divisions (ICDs) at the NIH may be interested in the general subject of this program announcement. Applications submitted in response to this PA that propose research in scientific areas that overlap ICD interests will receive a funding component assignment in accord with existing referral guidelines and procedures established by the Division of Research Grants, NIH. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH in accordance with the standard NIH review procedures. Following scientific and technical review, the applications will receive second-level review by the appropriate national advisory council. Review Criteria o Scientific, technical, and clinical significance and originality of proposed research; o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o Qualifications and research experience of the Principal Investigator and staff; o Availability of the resources necessary to perform the research; o Appropriateness of the proposed budget and duration in relation to the proposed research; o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that institute or center. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. For general scientific and program questions, contact Mary D. Leveck, PhD, RN Scientific Program Administrator National Institute of Nursing Research Building 45, Room 3AN12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5963 Fax: (301) 480-8260 Email: mleveck@ep.ninr.nih.gov Neil Buckholtz, PhD Neuroscience and Neuropsychology of Aging Program National Institute on Aging Gateway Building, Suite 3C307 7201 Wisconsin Avenue MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 Fax: (301) 496-1494 Email: BuckholN@GW.NIA.NIH.GOV Jane L. Pearson, PhD Mental Disorders of the Aging Research Branch National Institute of Mental Health Parklawn Building, Room 18-101 5600 Fishers Lane Rockville, MD 20957 Telephone: (301) 443-1185 Fax: (301) 594-6784 Email: jp36u@nih.gov Eugene J. Oliver, PhD Division of Stroke, Trauma, and Neurodegenerative Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 806 7550 Wisconsin Avenue Bethesda, MD 20892-9150 Telephone: (301) 496-5680 Fax: (301) 480-1080 Email: EO11C@NIH.GOV Louis A. Quatrano, PhD National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development 6100 Executive Building 2A03 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 Fax: (301) 402-0832 Email: Quatranl@hd01.nichd.nih.gov Direct inquiries regarding fiscal matters to: Jeff Carow Grants Management Officer National Institute of Nursing Research Building 45, Room 3AN-12 MSC 6301 Bethesda, MD 20892-6301 Telephone: (301) 594-6869 Fax: (301) 480-8260 Email: jcarow@ep.ninr.nih.gov Joseph Ellis Grants Management Officer National Institute on Aging Gateway Building, Suite 2N212 7201 Wisconsin Avenue MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 Fax: (301) 402-3672 Email: ellisj@GW.NIA.NIH.GOV Diana S. Trunnell Assistant Chief, Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-2805 Fax: (301) 443-6885 Email: Diana_Trunnell@nih.gov Ms. Pat Driscoll Grants Management Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 7550 Wisconsin Avenue Bethesda, MD 20892-9190 Telephone: (301) 496-9231 Fax: (301) 402-0219 Email: PD23N@NIH.GOV Mary Ellen Colvin Grants Management Branch National Institute of Child Health and Human Development Building 6100, 8A17 MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 Fax: (301) 402-0915 Email: ColvinM@hd01.nichd.nih.gov An additional contact for support of research in this area is the Alzheimer's Association, Inc. This association is a private, national voluntary agency dedicated to research, service, and policy development related to ADRD. Research grant opportunities are described at www.alz.org. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361, Nursing Research and No 93.866 Aging Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards by PHS agencies will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (April 1, 1994). The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Mar 28 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-049 - V26(10) 03/28/97 Date: 28 Mar 1997 21:25:41 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 236 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5hi94l$9e@net.bio.net> NNTP-Posting-Host: net.bio.net EXPLORATORY STUDIES FOR HIGH RISK/HIGH IMPACT RESEARCH NIH Guide, Volume 26, Number 10, March 28, 1997 PA NUMBER: PA-97-049 P.T. 34; K.W. 0710030, 1002004, 0710035, 1003002, 1014001 National Institute of General Medical Sciences PURPOSE The purpose of this initiative is to broaden the base of inquiry in fundamental biomedical research by encouraging applications for research projects that involve an especially high degree of innovation and novelty and, therefore, require a preliminary test of feasibility. The research projects proposed under this program announcement may involve substantial experimental risks such that their potential for highly significant outcomes may be difficult to judge by the standard criteria used in evaluating R01 proposals. The amount awarded for each of these pilot projects will be lower than that awarded for the average research project (R01) grant. New applications will be accepted under this program announcement on the regular application receipt deadlines: February 1, June 1 and October 1. ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign, domestic, for-profit and non-profit organizations, both public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Research projects will be supported with the exploratory/developmental research grant mechanism (R21). Applicants may request up to two years of support and up to $70,000 per annum in direct costs. The award is non-renewable. If desired, the specific aims of the R21 project may be incorporated into a research project grant application (R01) submitted prior to the termination of the R21 award. RESEARCH OBJECTIVES The National Institute of General Medical Sciences (NIGMS) seeks to encourage fundamental research projects that fall into the following classes: projects to test novel and significant hypotheses for which there is scant precedent or preliminary data and which, if confirmed, would have a substantial impact on current thinking; projects to explore a new experimental organism or system in order to address particularly difficult basic biomedical questions for which the new system would be particularly advantageous; and projects to develop innovative techniques or methodologies with wide applicability to the study of basic biomedical problems. The projects must support the NIGMS mission as detailed in the publication, "Divisions and Grant Award Mechanisms," available from the NIGMS Public Information Office (301/496-7301); additional information can be found on the NIGMS World Wide Web home page at http://www.nih.gov/nigms/. In brief, NIGMS supports research in (a) cell biology and molecular biophysics, including basic studies of the structure and function of cells, cellular components, and the biological macromolecules that make up these components; (b) fundamental mechanisms of inheritance and development that typically utilize non-human model systems; (c) basic studies in pharmacology, physiology, biochemistry, biorelated chemistry and anesthesiology; (d) basic studies in biotechnology, including biocatalysis and metabolic engineering; (e) bioengineering, including instrumentation development and refinement and development of bioanalytical methods and biomaterials; and (f) trauma and burn injury. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103 43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The title and number of this program announcement must be typed in Section 2 on the face page of the application. The completed original application and five legible copies must be sent or delivered to: OFFICE OF GRANTS INFORMATION DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS: Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by an appropriate Initial Review Group of the Division of Research Grants. Following the initial scientific-technical review, the applications will receive a second-level review by the appropriate National Advisory Council. REVIEW CRITERIA o scientific, technical, or medical significance and originality of proposed research o prospects for the demonstration of feasibility, given a modest budget and term of award; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o adequacy of plans to include both genders and minorities and their subgroups for the scientific goals of the research; o availability of the resources necessary to perform the research. o appropriateness of the proposed budget and duration in relation to the proposed research; The initial review group also will examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o the quality of the proposed project as determined by peer review; o the availability of funds; o other research funding available to the applicant; The following additional factor will be considered for applications assigned to the NIGMS: o potential for ground-breaking, precedent setting significance of the proposed research, with particular emphasis on novel and innovative approaches that clearly require additional preliminary data for their value to be established. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. James C. Cassatt Division of Cell Biology and Biophysics National Institute of General Medical Sciences 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594 0828 FAX: (301) 480-2004 email: czj@cu.nih.gov Dr. Judith Greenberg Division of Genetics and Developmental Biology National Institute of General Medical Sciences 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594 0943 FAX: (301) 480-2228 email: greenbej@gm1.nigms.nih.gov Dr. Michael E. Rogers Division of Pharmacology, Physiology and Biological Chemistry National Institute of General Medical Sciences 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594 3827 FAX: (301) 480-2802 email: rogersm@gm1.nigms.nih.gov Direct inquiries regarding fiscal matters to: Ms. Carol Tippery Grants Management Office National Institute of General Medical Sciences 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-5135 FAX: (301) 480-1969 email: tipperyc@gm1.nigms.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Numbers 93.821, 93.859, and 93.862. Awards are made under authorization of the Public Health Service Act, as amended and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, and portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Mar 28 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DC-97-002 - V26(10) 03/28/97 Date: 28 Mar 1997 21:25:22 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 407 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5hi942$8m@net.bio.net> NNTP-Posting-Host: net.bio.net NIDCD/ORMH MINORITY DISSERTATION RESEARCH GRANTS IN HUMAN COMMUNICATION NIH GUIDE, Volume 26, Number 10, March 28, 1997 RFA: DC-97-002 P.T. 34; K.W. 0715050, 0715055, 0775017 National Institute on Deafness and Other Communication Disorders Office of Research on Minority Health Application Receipt Date: May 23, 1997 PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) and the Office of Research on Minority Health (ORMH) announce the availability of small grants (R03) to support doctoral dissertation research in human communication for minority doctoral candidates. Grant support is designed to aid the research of new minority investigators and to encourage minority individuals from a variety of academic disciplines and programs to conduct research in hearing, balance, smell, taste, voice, speech, and language. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), NIDCD/ORMH Minority Dissertation Research Grants in Human Communication, is related to several priority areas applicable to human communication. Potential candidates for the awards may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Minority Status. Applicants must be from ethnic/racial groups that are underrepresented in the biomedical or behavioral research sciences in the U.S. For purposes of this RFA, the NIDCD will give priority consideration to applications from African Americans, Alaskan Natives, Hispanics, Native Americans, and Pacific Islanders. Within this group, women and persons with disabilities are particularly encouraged to apply. The applicant for dissertation research grant support must be a citizen of the United States or have been lawfully admitted for permanent residence. The doctoral candidate must have a dissertation topic approved by his/her institutional committee established for that purpose. This information must be verified in a letter of certification from the thesis chairperson and submitted with the grant application (see APPLICATION PROCEDURES). Research topics must address issues in human communication, focusing on one or more of the areas described under RESEARCH OBJECTIVES. The applicant organization must be a domestic institution supporting doctoral level training, such as a university or college. The performance site may be foreign or domestic. MECHANISM OF SUPPORT The mechanism of support is the NIH small grant (R03). Grants may be made for up to two years. Grants to support dissertation research will provide no more than $30,000 in direct costs over the two-year period, and no more than $25,000 in direct costs in any one year. FUNDS AVAILABLE The NIDCD and ORMH anticipate awarding up to 10 grants. These grants are not eligible for renewal. RESEARCH OBJECTIVES This grant initiative is to provide minority students assistance to perform their dissertation research on a topic related to human communication and thereby increase the pool of minority researchers in hearing, balance, smell, taste, voice, speech and language. The research supported by NIDCD includes basic or fundamental sciences as well as clinical or applied sciences, such as molecular and cellular biology, genetics, epidemiology, and imaging. The descriptions below of the research foci of NIDCD are provided to help potential applicants determine whether a topic may be appropriate for this initiative. Questions on the relevance of a particular topic can be addressed to the program contact listed under INQUIRIES. HEARING. Diseases and disorders of the auditory system including otitis media, otosclerosis, autoimmune-mediated hearing loss, tinnitus, and genetic deafness/hearing impairment; the normal auditory system, including plasticity, development and regeneration of auditory structures, cochlear mechanics, and perception of complex auditory signals; rehabilitation devices, including but not limited to cochlear prostheses, and hearing aids. BALANCE. Human balance control, structure and function of the peripheral and central vestibular system; development and regeneration of vestibular structures; molecular bases of vestibular function; adaptive plasticity in the vestibular system; vestibulo-autonomic regulation; diseases and disorders primarily affecting balance and the vestibular system, including Meniere's disease, vestibular toxicity and age-related changes in vestibular functioning; clinical assessment of balance and the vestibular function; and therapeutics and physical rehabilitation of balance and vestibular disorders. SMELL. Normal and abnormal olfactory functions, including development and regeneration of olfactory receptor neurons; transport of substances to and from the brain via the olfactory receptor neurons, including transport of pathogens; associations between olfaction and diseases throughout life. TASTE. Normal and abnormal sense of taste, including development and regeneration of taste bud cells; central processing; gustatory determinants of food intake; and the diagnosis of gustatory disorders. VOICE. The neural basis of vocal learning and vocalization; neural mechanisms and physiology of the larynx; voice disorders, including assessment, characteristics of specific populations, and treatment of voice disorders. SPEECH. Speech perception; characterization of normal speech production; and disorders of speech production such as neurogenic speech disorders (apraxia and dysarthia), speech of deaf individuals, and stuttering. LANGUAGE. Normal language processing; brain basis of language; adult aphasia; the grammatical abilities and writing deficits associated with Alzheimer's disease; language acquisition in deaf individuals; American Sign Language; literacy in deaf individuals; and language disorders in children, including specific language impairment, early expressive language delay, and language deficits associated with autism. SPECIAL REQUIREMENTS Additional Material. In addition to the completed PHS 398 form described under APPLICATION PROCEDURES, applicants must also submit: o A letter from the faculty committee or university official directly responsible for supervising the development and progress of the dissertation research. The letter must be countersigned by a representative of the graduate school of the sponsoring institution. The letter must: (a) fully identify the members of the committee and certify their approval of the dissertation topic and, (b) certify that the author of the letter has read the application and believes that it reflects the work to be completed in the dissertation. o A tentative timeline for completion of the research, the dissertation, and the doctoral defense. o A transcript of the investigator's graduate school record o Biography of mentors, limited to 2 pages each (use the Biographical Sketch page in form PHS 398) o Statement of the investigator's career goals to be placed under "Background" (see the Research Plan instructions in PHS 398) o A signed statement from the sponsoring institution establishing the eligibility for support under this program including information on ethnicity and citizenship. (See Eligibility Requirements). Grant Conditions. The following conditions apply to dissertation grants: o The doctoral candidate must be the designated Principal Investigator on the grant and the doctoral candidate must be the only individual named in the application for whom salary support is requested. o The principal investigator's salary may not exceed $12,000 per twelve months. o Work on the funded project must be initiated within three months after the date of the award. o Investigators may request support for up to 24 months. An application that requests support beyond this time period will be returned. o Grantees who are approved for two years of support must submit a satisfactory progress report no later than 10 months after the start of the first year of the grant. This report should contain a brief summary of the work completed to date together with copies of any publications supported wholly or in part by the dissertation grant. o A copy of the dissertation must be submitted and constitutes the final report of the grant. The dissertation must be officially accepted by the faculty committee or university official responsible for the candidate's dissertation and must be signed by the responsible officials. An applicant who receives support for dissertation research under a grant from the NIDCD/ORMH may not at the same time receive salary support under a predoctoral or fellowship grant, nor be supported under any other research project grant awarded by a Federal agency. Allowable Costs. Expenses usually allowed under PHS research grants will be covered by the NIDCD/ORMH dissertation research grants, but may not exceed $30,000 for the total project. Allowable costs include the investigator's salary (not to exceed $12,000 per 12 months); direct research project expenses such as travel to one scientific meeting per year (limited to $1000 per year), data processing, supplies, and dissertation preparation costs. Any level of effort by the candidate that is less than full time must be fully justified. No tuition support is allowed. It is expected that most equipment needed for the research will be available at the site or laboratory in which the dissertation is to be performed. Therefore, any requests for equipment must be specifically justified. Facilities and administrative costs are limited to eight percent of requested direct costs, less equipment. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508- 14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research as well as from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, FAX (301) 480-0525, email ASKNIH@ODROCKM1.OD.NIH.GOV. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number (NIDCD/ORMH Minority Dissertation Research Grants in Human Communication, DC-97-002) must be typed on line 2 of the face page of the application form and the YES box must be marked. Instructions for completing the applications are found in the PHS 398 form. These instructions must be followed except that under C. Specific Instructions - Research Plan, no more than 10 pages may be used for items A to D (instead of 25 pages as stated in the standard instructions). Applications that exceed the 10 page limit for this section will be returned. Appendices are not allowed. Submit a signed original of the application (with the supporting letter and graduate school transcript), including the Checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight service) At the time of submission, two additional copies of the application (with the supporting letter and the graduate school transcript) must be sent to: Chief, Scientific Review Branch Division of Extramural Activities National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard - MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 496-8683 FAX: (301) 402-6250 ATTN: Minority Dissertation Applications must be received by May 23, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIDCD.Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDCD in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score. Review Criteria o scientific and technical merit, significance in relation to the promotion of public health, and originality of the proposed research; o appropriateness and adequacy of the literature review, experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator (the student); o qualifications, research and training experience of the mentor particularly, but not exclusively, in the proposed area of research; o quality and availability of research resources needed to complete the dissertation; o appropriateness of the proposed budget and duration in relation to the research; o Adequacy of plans to include minorities and their subgroups and both genders as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA The anticipated date of award is September 1997. Final funding decisions are based on the recommendations of the reviewers, the relevance of the project to NIDCD priorities, and the availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Interested investigators are strongly encouraged to contact the person named below who can provide clarifying information about material described in this RFA. The investigator will then be referred to the relevant program to discuss the suitability of the research topic. Dr. Judith A. Cooper Deputy Director Division of Human Communication National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard - MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 496-5061 FAX: (301) 402-6251 Email: judith_cooper@nih.gov Direct inquiries relating to fiscal matters to: Ms. Sharon Hunt Chief, Grants Management Branch National Institute on Deafness and Other Communication Disorders Executive Plaza South , Room 400-B 6120 Executive Boulevard - MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: sh79f@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.173 Awards are made under authorization of the Public Health Service Act Title IV, Part A (Public Law 79-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. The requirements of Executive Order 12372, "Intergovernmental Review of Federal Programs," are not applicable to NIDCD research grant programs. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Mar 28 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-051 - V26(10) 03/28/97 Date: 28 Mar 1997 21:26:35 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 508 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5hi96b$c9@net.bio.net> NNTP-Posting-Host: net.bio.net DEHYDROEPIANDROSTERONE (DHEA) AND AGING: BIOLOGIC ACTIONS AND EFFECTS OF ADMINISTRATION NIH GUIDE, Volume 26, Number 10, March 28, 1997 PA NUMBER: PA-97-051 P.T. 34; K.W. 0710010, 0760085, 1002034 National Institute on Aging National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The National Institute on Aging (NIA)and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is interested in receiving research project grant applications (R01 and R29 mechanisms) addressing gaps in our knowledge of the physiologic roles and effects of administration of dehydroepiandrosterone (DHEA), or its sulfated derivative, dehydroepiandrosterone sulfate (DHEA(S), in middle-aged and older people, and of the mechanism of action of DHEA(S) at the molecular, cellular and tissue levels. This program announcement updates and replaces a previous program announcement on this topic (PA-93-015, Physiological Role of the Adrenal Androgen, DHEA, in Aging, NIH Guide, v 21, no. 40, November 6, 1992). HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000,"a PHS-led national activity for setting priority areas. This PA, Dehydroepiandrosterone (DHEA) and Aging, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support for this program will be by research project grants (R01) and FIRST Awards (R29). RESEARCH OBJECTIVES Background Dehydroepiandrosterone (DHEA) is a metabolite on the steroidogenic pathway between cholesterol and the sex steroids. In the human and other primates, the adrenal is the most prolific source of DHEA, with the sulfated derivative, DHEAS, synthesized primarily in hepatic and adrenal tissues. (For the remainder of this Announcement, the abbreviation DHEA refers to DHEA and/or DHEA sulfate collectively.) In primates, DHEA is present in levels considerably higher than the other steroid metabolites of cholesterol. Many cross-sectional studies have documented that serum DHEA levels in humans and other primates is developmentally regulated, i.e., DHEA increases during pregnancy to a high level prior to birth, drops precipitously at birth, increases at adrenarche to a maximum around the early 20's, then declines gradually into old age (while other major adrenal steroids, glucocorticoids, remain relatively unchanged with age), reaching about 10-20% of its peak value around age 80. Clinical and epidemiologic studies on the relationship of DHEA levels to diseases and other health outcomes have not had consistent results. Some prospective studies have found an inverse relationship between DHEA levels and risk for cardiovascular disease risk in men, while others have found no relationship. A case-control study found low DHEA levels in Alzheimer's disease patients relative to age-matched controls, while another did not. Other cross-sectional studies have reported associations between low DHEA levels and dyspnea, depressive symptoms, impairments in activities of daily living in older women (but not men), elevated mortality risk in older men (but not women), and rheumatoid arthritis, but there have not been reports of studies to replicate these findings. On the other hand, a case-control study found higher DHEA levels in cases of ovarian cancer relative to controls, and two studies found an association between high DHEA levels and hypertension, while others found no relationship. Most of these studies had very limited power to address the potential confounding effects of covariates which could contribute to spurious associations (or lack of association) between DHEA levels and the outcomes reported. Animal studies, generally performed in species in which endogenous DHEA levels are normally relatively low and may not change substantially with age, and involving dietary DHEA at very high levels for most studies, show delayed tumor formation, prevention of atherosclerosis, weight loss in obese animals and, in general, retardation of the development of many chronic age-related pathologic changes. The conference "Dehydroepiandrosterone (DHEA) and Aging", supported in part by the NIH and sponsored by the New York Academy of Sciences, was held in Washington, DC in June, 1995 (Bellino, FL, Daynes, RA, Hornsby, PJ, Lavrin, DH and Nestler, JE, eds. Annals of the New York Academy of Sciences, vol 774, New York, 1995). The purpose of the conference was to define a future research agenda based on a review of the current status of a variety of ongoing investigations into a) mechanisms of the apparent steady decline of DHEA with age from the mid-twenties to old age, b) epidemiologic studies suggesting positive health benefits for individuals with higher levels of DHEA for their age group and clinical studies of effects in individuals supplemented with DHEA in the short-term studies, and c) health effects of supplementary DHEA in animal studies. Goals of the Program Announcement Research on the role of age-related alterations in levels of DHEA, and its metabolites, is currently hampered by a lack of information on certain key issues: 1) There is limited information available regarding the biological role of DHEA, whether produced endogenously or administered exogenously, and of its metabolites, and the molecular and cellular mechanism(s) of action of the active compound(s). This has hampered epidemiologic, clinical and animal studies on DHEA and aging. 2) Clinical intervention studies to date have rarely been repeated by other investigators, and have not systematically examined the various subgroups (e.g., of gender, age, or DHEA levels) in the older population to determine which, if any, show responses to DHEA administration. Studies to date have provided very limited dose-response and time-course information. In order to facilitate and guide further mechanistic and applied studies related to DHEA and aging, this program announcement solicits high quality research that fills these gaps in knowledge. Although the ultimate goal of this program announcement is focused on human studies, the use of appropriate animal models, and in vitro human cell and tissue culture models will also be essential to define the active form(s) and molecular and cellular mechanism(s) of action. This information will be valuable for the design of better human intervention studies. This announcement encourages research in the following areas: 1. DHEA BIOLOGIC ACTIONS AND ACTIVE SPECIES: Studies in animals and humans have demonstrated a) the requirement for large (pharmacologic) doses of dietary DHEA for effectiveness in most rodent studies, b) the presence of DHEA metabolic enzymes in various body tissues, including non-steroidogenic peripheral tissues, c) the different profile of DHEA biosynthesis, metabolism and age-dependent serum pattern in non-primates relative to primates, and d) lack of attention to DHEA metabolism on the effects and mechanism of action of DHEA in animals or humans. For these reasons, it is important to characterize the biologic effects of DHEA and its metabolites more fully, and determine the active form(s) of DHEA or its metabolites responsible for them. Once defined, more directed molecular and cellular mechanism of action studies can be accomplished. One approach, already utilized to some extent, might be to utilize non-metabolizable analogs of DHEA or specific metabolites to determine the extent of their contribution to specific biologic effects. Research questions of interest include, but are not limited to: o What are the bioactive form(s) of DHEA; are there separate active forms depending on the effect sought? o What are the roles of sulfatase and sulfotransferase in DHEA action? 2. DHEA MECHANISM OF ACTION: Potential mechanisms of action for DHEA are extensive. The range of projected actions is so wide (brain, cardiovascular and immune system effects, anti-cancer or carcinogenic (depending on dose), anti-obesity, bone protective, etc.), it raises the question of whether a single compound is responsible for all of the actions. Ongoing studies suggest several mechanisms of action: a) as a non-competitive inhibitor of glucose 6-phosphate dehydrogenase (G6PD), the rate-limiting enzyme in the pentose phosphate pathway which provides ribose 5-phosphate and NADPH, b) as a "neurosteroid" through interactions with neuronal GABA and sigma receptors, c) through regulation of enzyme activity or bioregulatory factors and their receptors (e.g., enoyl CoA hydratase, carbomylphosphate synthetase, malic enzyme, glycerol-3- phosphate dehydrogenase, T cell IgD receptor, cytokines), or d) through regulation of gene expression (e.g., various cytochrome P450s, NADPH-cytochrome P450 reductase, fatty acyl CoA oxidase). There are a small number of reports in the literature of 'receptors' for DHEA, but as yet no study has unequivocally identified these DHEA 'binding proteins' as nuclear transcription factors. Research questions of interest include, but are not limited to: o What are specific molecular mechanisms of action of the active form(s) of DHEA, i.e., interactions with receptors, nuclear transcription factors and/or signal transduction pathways? o To what extent and by what mechanisms do biologic effects in animal studies translate to human cells, tissues and the entire organism? o The Endocrinology Research Programs at NIDDK focus on the molecular endocrinology of hormones, growth factors, and cytokines. In particular, support for research on the steroid/thyroid/retinoid supergene family of hormones and their receptors is an important part of the NIDDK mission. Additional areas of concern include the hypothalamic-pituitary-adrenal axis with regard to response to stress, regulation of body composition, and interaction with the neuroendocrine and immune systems. NIDDK would welcome any submissions in response to this PA which are relevant to its mission, including: o Fundamental questions of the role of DHEA in the regulation of gene expression in target tissues o Identification and characterization of putative DHEA receptor(s) 0 Cross-talk between DHEA and other hormones, including questions related to signal transduction. 3. CLINICAL ISSUES. Background: Whether the decline in serum DHEA levels in humans with age has any relevance to the occurrence of chronic or acute health problems in older people is still an open question. Even if a strong and specific association of health problems with serum DHEA levels is demonstrated, are those health problems reversible or preventible with the active form(s) of DHEA through supplementation? DHEA has been used in controlled human studies at doses up to 1600 mg/day for four weeks, and at much lower doses (50 mg/day) for as long as six months, in subjects up to age 70. No apparent significant adverse effects have been reported. These studies have reported effects suggesting potential therapeutic benefits from DHEA: preservation of insulin sensitivity in post-menopausal women, increased muscle mass and strength, and decreased fat mass in men (but not in women) and decreased platelet aggregability. These results suggest that administration of DHEA to certain individuals might aid in preventing or treating several important age-associated conditions, disabilities, and risk factors: prevention of non insulin-dependent diabetes mellitus, maintenance of muscle function, prevention of obesity, and prevention of thrombotic events such as myocardial infarction and thrombotic stroke. However, the value of intervention trials to determine the effects of DHEA administration on these clinical outcomes will remain unclear without clarification of several issues. All the above studies involved small numbers of subjects, and (with the exception of the studies on fat mass), have not been followed by reports of replication studies from other research groups. In addition, several were confined to one gender only. Potential adverse effects of DHEA administration have not been systematically explored. For example, the potential for DHEA to be metabolized to androgens and estrogens could have both beneficial and adverse effects. If indeed DHEA has antithrombotic and fibrinolytic effects which might lessen risk for thrombotic events or their consequences, these could also increase risk for hemorrhagic events. Additional ambiguities stem from the fact that most of these intervention studies did not address the degree of metabolism of DHEA to other steroids, administration of these metabolites as additional controls, dose-response studies, analysis in relation to subjects' DHEA level and age at the beginning of treatment, and effects of different schedules of DHEA administration. Clinical Studies Solicited by this Announcement: As reviewed in the foregoing sections, a variety of epidemiologic, biologic, and clinical studies suggest that DHEA may have effects on age-related health outcomes, but do not in themselves provide a strong rationale for clinical trials to test effects of DHEA administration to these outcomes, nor provide the information to determine what the most suitable subjects, dosages and outcomes for testing would be, were such trials warranted. Thus, to determine whether there is a rationale for clinical trials of effects of DHEA administration on age-related health outcomes, and if so, the most suitable designs for such trials, this Announcement solicits clinical intervention studies to address issues such as the following. o Relationships of physiologic and functional responses to DHEA and/or DHEA analogues to: age (including very advanced age), gender, levels of DHEA and other hormones before starting administration of DHEA, and duration, dosage and scheduling of DHEA (or DHEA analog) administration. o Circulating levels of DHEA, (or the DHEA analogue administered), key active metabolites, and other relevant circulating hormones, over the course of intervention, and their relationships to observed effects. Inclusion of additional intervention arms using possible active DHEA metabolites such as gonadal steroids, or non- metabolizable DHEA derivatives, may also be useful in addressing this point. o Potential adverse effects, including those which might be anticipated from DHEA metabolites. In addition to monitoring adverse clinical events per se, measurements of risk factors or physiologic indicators which indicate risk for such events are important. o Effects ascribed to DHEA in other studies, to test the replicability of these findings. (It is not required that each application submitted in response to this Announcement must address ALL the variables outlined in the above topics. The range and selection of variables to be studied is at the discretion of the applicant.) Additional research questions of interest include, but are not limited to: o If circulating DHEA is not the primary active form in humans, does the decline of circulating DHEA with age in humans reflect a decline in the true active form(s)? If not, what, if anything, is a valid marker of "DHEA" status? o Since longitudinal studies suggest that the age-related decline of serum DHEA in humans is not universal, does maintenance of endogenous circulating DHEA levels through old age contribute to maintenance of health or functional status? Related to this, is there a DHEA deficiency state or syndrome that would help in sorting out biologic effects in humans? o What accounts for the gender effects in epidemiologic and clinical DHEA research? In addition to the award mechanisms listed above under "Mechanisms of Support", prospective applicants with research interests in the topics listed above under "Clinical Studies Solicited by this Announcement" may wish to consider two additional funding mechanisms: Up to $50,000 (direct costs) for pilot studies on these topics may be requested through NIA Pilot Grants (R03) in Geriatrics (PAR-97-041, NIH Guide to Grants and Contracts, Vol. 26, No. 7, March 7, 1997. Up to $100,000 (direct costs) in support for planning efforts to develop research projects on these topics may be requested through NIA Planning Grants for Biomedical Epidemiologic and Intervention Studies (PAR-97-011, NIH Guide to Grants and Contracts, Vol. 25, #39, November 15, 1996). Announcements describing these two award mechanisms are available on the NIA Home Page (http://www.nih.gov/nia/) or from the NIA Geriatrics Program (FAX 301-402-1784, or E-mail: solomonw@gw.nia.nih.gov). INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714; email: asknih@odrockm1.od.nih.gov. The title and number of the program announcement must be typed in Section 2 on the face page of the application. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for courier/overnight mail service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. Review Criteria o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the NIA. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Frank Bellino, PhD Biology of Aging Program National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892-9205 Telephone: (301) 496-6402 FAX: (301) 402-0010 Email: bellinof@gw.nia.nih.gov Evan Hadley, MD Geriatrics Program National Institute on Aging Gateway Building, Suite 3E327 Bethesda, MD 20892-9205 Telephone: (301) 435-3044 FAX: (301) 402-1784 Email: hadleye@gw.nia.nih.gov For inquiries related to the mission of the NIDDK: Ronald N. Margolis, PhD Chief, Endocrinology Section NIDDK Building 45, Room 5AN-12J 45 Center Dr. Bethesda, MD 20892-6600 Telephone: (301) 594-8819 FAX: (301) 480-3503 Email: rm76f@nih.gov Direct inquiries regarding fiscal matters to: Robert Pike Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 FAX: (301) 402-3672 email: pikeb@gw.nia.nih.gov Kim Law Grants Management Specialist Building 45, Room 6AS-49A NIDDK 45 Center Dr. Bethesda, MD 20892-6600 Telephone: (301) 594-8869 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866, Aging Research, and 93.847, Diabetes and Digestive and Kidney Disease Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.