From owner-sci-resources@net.bio.net Sun Dec 01 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 30 November 1996 Date: 2 Dec 1996 15:58:37 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 71 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <57vqfd$rqc@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 November 30, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Program Guideline Title: NSF 97-18--Research in Learning and Intelligent Systems (LIS) File size (bytes): 38488 STIS Filename: nsf9718.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Program Guideline Title: NSF 95-111-Grant Opportunities for Academic Liaison with Industry(GOALI) File size (bytes): 23416 STIS Filename: nsf95111.txt Title: NSF 95-112-Grant Opportunities for Academic Liaison with Industry File size (bytes): 16989 STIS Filename: nsf95112.txt Title: NSF 96-119 - CISE Postdoctoral Research Associates in Computational Science and Engineering & Experimental Computer Science File size (bytes): 14406 STIS Filename: nsf96119.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 nsf96119.txt, the text of your message should be as follows: get nsf96119.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf96119.txt, you would enter: ftp> get nsf96119.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 Tue Dec 03 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-012 - V25(41) 11/29/96 Date: 4 Dec 1996 13:52:05 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 301 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <584rq5$h3l@net.bio.net> NNTP-Posting-Host: net.bio.net SMALL GRANT PROGRAM FOR THE NIDCD NIH GUIDE, Volume 25, Number 41, November 29, 1996 PA NUMBER: PAR-97-012 P.T. 34; K.W. 0715050, 0715055, 0775005, 0775017 National Institute on Deafness and Other Communication Disorders Application Receipt Date: December 20, 1996; April 22, 1997; August 22, 1997 PURPOSE This program announcement (PA) supersedes all previous program announcements of the National Institute on Deafness and Other Communication Disorders (NIDCD) Small Grant (R03) Program for support of 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. The research must be focused on one or more of the areas within the biomedical and behavioral scientific mission of the NIDCD: hearing, balance, smell, taste, voice, speech, or 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 PA, Small Grant Program for the NIDCD, is related to the priority area of clinical prevention services. 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. Institutions located in foreign countries are not eligible to apply for this program. Current and previous recipients of NIH research grants such as Research Project Grants (R01), FIRST (R29), or NIH Academic Research Enhancement Awards (R15) awards are ineligible for this Small Grant Program, as are principal investigators of research subprojects of Research Program Projects (P01) and Centers (P50 and P60). Current and previous recipients of Small Grants (R03), excluding Minority Dissertation Small Grant Awards, are also ineligible. Individuals who have served as principal investigators on other Federally-funded research grants are also ineligible. Before completion of the R03, investigators are encouraged to seek continuing support for a promising program of research through a research project grant (R01) or FIRST (R29) award. However, R01 or R29 support may not be held concurrently with an R03 until the final year of the R03 support. Guidelines addressing scientific and budgetary overlap still apply. Former recipients of Mentored Research Scientists Development Awards (K01), or Mentored Clinical Scientist Development Awards (K08) (formerly called Clinical Investigator Development Awards) are eligible for this Small Grant Program; however, an individual may not hold an R03 award concurrently with a K01 or K08 award. Former recipients of Individual (F32) or Institutional (T32) National Research Service Award training support are eligible for this Small Grant Program; however, the Small Grant award cannot be held concurrently with this support. Investigators who have questions about eligibility should contact one of the program officials listed under INQUIRIES. MECHANISM OF SUPPORT This PA will use the small grant (R03) mechanism. The small grant funds may not be used to supplement projects currently supported by Federal or non-Federal funds, or to support thesis or dissertation research. Applicants may request up to $35,000 (direct costs) per year through the R03 mechanism. The grant may not exceed three years and is not renewable. RESEARCH OBJECTIVES The Small Grant Program is designed to support basic and clinical research of scientists who are in the early stages of pursuing an independent research career. 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) 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 policy. 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 also may obtain copies of the policy >From the program staff listed under INQUIRIES. Program staff also may 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 prepared according to the directions in the application packet, with the exceptions noted below. 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. On the face page of the application: Item 2, Type "Small Grant Program NIDCD" in "Title" box. Check the "YES" box. Sections a-d: Do not exceed a total of five pages for the following sections: Specific Aims, Background and Significance, Preliminary Studies/Progress Report, and Research Design and Methods. Tables and figures are included in the five page limitation. For revised applications, an additional introduction not to exceed one-half page is allowed. This introduction should respond to the comments and concerns of the Initial Review Group delineated in the summary statement. Applications that exceed the page limitation or NIH requirements for type size and margins (refer to PHS 398 application for details) will be returned to the investigator. The five page limitation does not include Sections e-i (Human Subjects, Vertebrate Animals, Consortia, Literature Cited, etc.). Appendix materials are not allowed. Use the mailing label in the application kit to mail the original and three copies of the application to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 1040 - MSC-7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) To ensure that the application is received in sufficient time for the review, send two copies of the application to: Acting Chief, Scientific Review Branch National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard MSC 7180 Bethesda, MD 20892-7180 Rockville, MD 20852 (for express/courier service) The submission, review, and award schedule for the Small Grant Program for FY 97 (these dates likely will differ for FY 98) is: Application Receipt Dates for: Dec 20 Apr 22 Aug 22 NIDCD Committee Review: Feb/Mar Jun/Jul Oct/Nov Council Review: May Oct Jan Earliest Funding: Aug Jan May Only one Small Grant application may be submitted by a principal investigator per receipt date. Applicants may not submit an R01 or R29 application on the same topic concurrently (to be considered at the same National Advisory Council cycle) with the submission of a Small Grant application. REVIEW CONSIDERATIONS A review committee of the NIDCD will evaluate each Small Grant application in accordance with the usual NIH peer review procedures and criteria, which include: o Scientific, technical, or clinical significance and originality of the proposed research. o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. o Appropriateness of the statistical methods proposed to analyze the results. o Potential of the proposed studies to lead to more extensive research. o Qualifications and research experience of the principal investigator. o Availability of resources necessary to conduct the research, including information beyond what is requested in the submitted budget (such as support for salaries, equipment and supplies). o Appropriateness of the proposed budget, resources, and timetable in relation to the scope of the proposed research. 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 involving humans. Applications will be subsequently reviewed by the National Deafness and Other Communication Disorders Advisory Council. AWARD CRITERIA The award of grants is contingent on (1) the receipt of applications of high scientific merit; (2) responsiveness to this program announcement, including the eligibility of investigators; (3)relevance to the mission of the NIDCD; and (4) the availability of appropriated funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Hearing Dr. Chyren Hunter Telephone: (301) 402-3461 Email: Chyren_Hunter@NIH.GOV Balance/Vestibular Dr. Daniel Sklare Telephone: (301) 496-1804 Email: Daniel_Sklare@NIH.GOV Taste Dr. Jack Pearl Telephone: (301) 402-3464 Email: Jack_Pearl@NIH.GOV Smell Dr. Rochelle Small Telephone: (301) 402-3464 Email: Rochelle_Small@NIH.GOV Voice/Speech Dr. Beth Ansel Telephone: (301) 402-3461 Email: Beth_Ansel@NIH.GOV Language Dr. Judith Cooper Telephone: (301) 496-5061 Email: Judith_Cooper@NIH.GOV The address and FAX number for the above named persons are: 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 FAX: (301) 402-6251 Direct inquiries regarding fiscal matters to: Sharon Hunt Grants Management Office 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 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 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 Tue Dec 03 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AA-97-001 - V25(41) 11/29/96 Date: 4 Dec 1996 13:50:45 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 558 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <584rnl$gua@net.bio.net> NNTP-Posting-Host: net.bio.net HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS NIH GUIDE, Volume 25, Number 41, November 29, 1996 RFA: AA-97-001 P.T. 34; K.W. 0404003, 0730050 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: March 21, 1997 Application Receipt Date: April 24, 1997 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks health services research grant applications that are aimed at developing a knowledge base to improve the delivery of services for alcohol-related problems. Such a knowledge base includes both treatment and preventive interventions. This Request for Applications (RFA) invites research grant applications related to improving the availability, accessibility, delivery, quality, effectiveness, cost-effectiveness, and outcomes of alcohol-related treatment and prevention services. The research objectives include, but are not limited to, five major areas: (1) determining the effects of financing and reimbursement mechanisms on alcohol-related health care program availability, accessibility, delivery, organization, content, quality, and outcomes; (2) assessing sources of variation in access and utilization of treatment services and prevention interventions for alcohol-related problems; (3) identifying and assessing the effectiveness and outcomes of alcohol-related treatment and preventive services; and (4) evaluating the cost, cost-effectiveness, cost-benefit, and cost-utility of alcohol-related treatment and prevention services; and (5) identifying organizational and managerial factors that influence the delivery of treatment and prevention services for alcohol-related problems across regions, populations, and settings. 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, Health Services Research On Alcohol-Related Problems, is related to the priority areas of alcohol abuse reduction and alcoholism treatment. 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 Applications may be submitted by domestic and foreign, for-profit and non-profit, public and private organizations, 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 institutions are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29). Regular research project grant applications (R01) from foreign institutions are limited to three years. MECHANISM OF SUPPORT Research support may be obtained through applications for a regular research project grant (R01) or FIRST (R29) Award. Applications are also encouraged for exploratory/developmental grants (R21), which are limited to up to two years for up to $70,000 per year for direct costs. Applicants may also submit Investigator-Initiated Interactive Research Project Grants (IRPG) under this RFA. Interactive Research Project Grants require the coordinated submission of related regular research project grant applications and, to a limited extent, FIRST Award applications from investigators who wish to collaborate on research, but do not require extensive shared physical resources. Program Project Grant applications (P01) will not be accepted under this RFA. Potential applicants for FIRST (R29) Awards, or exploratory/developmental (R21) grants may obtain copies of the specific announcements from the NIAAA Home Page at HTTP://WWW.NIAAA.NIH.GOV or from the Office of Scientific Affairs, NIAAA, Willco Building, Suite 409, 6000 Executive Boulevard MSC 7003, Bethesda, MD 20892-7003, telephone: 301-443-4375 or FAX 301-443-6077. Further information on grant mechanisms and areas of research interest may be obtained from the program staff listed under INQUIRIES. FUNDS AVAILABLE It is estimated that up to $4 million will be available for approximately 16 grant awards under this RFA in FY 1997. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. The NIAAA estimates that the average grant size will be approximately $250,000 in total costs for the first year. Although the financial plans of the NIAAA provide for the support of this program, the award of grants pursuant to this RFA is contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Health services research is defined as "research endeavors that study the impact of the organization, financing and management of health services on the quality, cost, access to and outcomes of care" (PL 101-321, Section 409). Health services research also is concerned with assessing the effectiveness of health services in everyday practice. For the purposes of this RFA, health services research includes: (a) the assessment of the impact of health services and the effects of organizational and financing arrangements in "real world" clinical settings on the quality and outcomes of care provided to patients with alcohol abuse and alcoholism or with medical problems consequent to alcoholism and (b) the assessment of the effectiveness of prevention services as well as their financing, organization, management, implementation, cost, and utilization. As directed by subsequent legislation (P.L. 103-43), for the purposes of this RFA health services research does not include studies of the efficacy of specific preventive, diagnostic, and treatment modalities. Applications whose main objective is to establish and support treatment or prevention service programs are not eligible for funding under this RFA. Support for research-related treatment, rehabilitation, or prevention services and programs may be requested only for those particular costs related to the implementation of the research project and for that period of time required by the research project. These costs must be justified in terms of research objectives, methods, and designs that promise to yield important generalizable knowledge and/or to make a significant contribution to theoretical concepts. Applicants should adopt the most rigorous research designs feasible in conducting their alcohol-related treatment and prevention services research studies (see Lettieri 1992; Sechrest, Persin, and Bunker 1990; Cook and Campbell 1979). As elaborated in the "Review Criteria" section of this RFA, applications will be judged on the basis of the scientific and technical merit of the proposed research as well as on the adequacy and appropriateness of the proposed methodology. Applicants may wish to consult generic publications in health services research as well as alcohol-specific examples of prevention and treatment research. The following list of research topics is for illustrative purposes. Topics not mentioned below that fall within the research objectives of this RFA will also be accepted. The NIAAA is particularly interested in applications that address the effects of managed care on access, utilization, cost, cost-effectiveness, and outcomes of alcohol services. Financing and Reimbursement of Services o Investigating the effects of financing and reimbursement approaches on the quality, cost effectiveness, and supply of alcohol treatment and/or prevention services as well as demand for and barriers to those services. o Assessing how alternative managed care systems affect availability, quality, cost, and outcomes of treatment and prevention services. o Developing uniform ways to measure insurance benefits and payments for treatment and prevention of alcohol-related problems in order to compare performance of alternative health plans. o Identifying the impact of changes in compensation incentives on 1) the behavior of consumers, clinicians, and institutions; 2) treatment appropriateness; 3) treatment outcomes; and 4) the nature and extent of prevention services within the health care system. o Modeling and assessing the impact of health care reform legislation and other policy changes on the organization, management, financing, availability, appropriateness, and cost of alternative alcohol-related health policies and treatment/prevention services. Access and Utilization of Services o Identifying health service factors and individual characteristics influencing access to, or compliance with, treatment or preventive interventions for alcohol-related problems, particularly among underserved, uninsured, and HIV-infected populations. o Assessing how alternative managed care systems affect access and utilization of treatment and prevention services. o Identifying care-seeking behavior of people with alcohol problems, including utilization of informal resources (e.g., self-help groups) and alternative (e.g., acupuncture) health resources as well as general medical and specialty alcohol services. o Developing standardized criteria for identifying episodes of alcohol treatment to apply in longitudinal analyses of utilization data. o Determining whether prevention programs have significant effects on the utilization of treatment services. Effectiveness and Outcomes of Services o Developing and assessing criteria to classify and measure objectives, components, and processes involved in delivering major types of treatment services or prevention interventions for alcohol-related problems; examining linkages between treatment content, quality of care, and functional as well as alcohol-specific outcomes; and examining linkages (e.g., process evaluations) between prevention content, its method of delivery, and alcohol outcomes. o Examining alternative managed care systems to assess the effect of these arrangements on the effectiveness and outcomes of alcohol-related treatment and prevention interventions. o Assessing the effectiveness of brief interventions to treat or prevent problem drinking and its medical and social consequences. Health services treatment research may assess brief interventions in inpatient or outpatient acute and specialty as well as primary care settings. o Assessing adequacy and appropriateness of treatment and prevention services to meet needs and demands of different groups such as women, youth, minorities, rural residents, and the elderly. o Determining the impact of organization, financing, and management on the effectiveness of research-based treatment and prevention interventions when they are delivered to heterogeneous populations in natural rather than experimental settings. o Developing classification or measurement systems for use by clinicians to better assign patients to treatment modalities or to improve outcomes, particularly prevention and management of post-treatment relapse. o Assessing the effects of participation in Alcoholics Anonymous on treatment utilization, outcome, and cost. Cost Analyses of Services o Determining the extent to which costs of treatment or prevention services are offset by subsequent reductions in health care costs. For example, evaluating characteristics of individuals, programs, service systems, and insurance benefits associated with greater cost offsets and cost effectiveness. o Applying cost effectiveness, cost-benefit and cost-utility analyses to alcohol-related health services (including treatment and prevention) from the perspective of consumers or their families as well as from the perspectives of payers, providers, or employers. o Applying cost effectiveness, cost-benefit and cost-utility analyses to alcohol-related health services within managed health care systems. o Effects of managed care on costs of alcohol-related health services. Service System Delivery, Organization, and Management o Examining organization and management of alcohol treatment and prevention services, including social, economic, demographic, geographic, legal or health policy, and other factors that may facilitate or impede effective and efficient linkage and delivery of those services. o Evaluating the effect of different organizational models of managed care on the availability, quality, cost, and outcomes of treatment and prevention services. o Determining the impact of system-level, service integration initiatives on the coordination, comprehensiveness, and continuity of alcohol treatment and prevention services. o Identifying different organizational models needed for delivery of alcohol treatment and prevention services to different subpopulations such as the elderly, youth, women, minorities, rural residents, or HIV-positive individuals. o Developing and testing innovative management approaches to improve productivity and efficiency in implementing treatment and prevention services. Examining organizational, provider, and consumer responses to changes in the following areas: (a) financing and reimbursement policies, (b) structural aspects of managed care systems, insurance coverage characteristics of populations in the service area, (d) number and characteristics of other organizations and providers in the area, and (e) demographic factors such as population density, and/or other factors that may lead to changes in organizational and provider behavior with ultimate consequences for access to and outcomes of treatment and prevention services. Investigating factors that influence how preventive interventions or treatment services reach the appropriate target populations; are distributed to be accessible to those populations; are utilized in an effective manner; are adopted with sufficient commitment from policy makers to make them viable; and are implemented with adequate resources. 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. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by March 21, 1997, a letter ofc intent that includes a descriptive title of the proposed research, the name,c address, and telephone number of the Principal Investigator, the identities ofc 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 NIAAA staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: RFA-AA-97-001 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 409 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4375 FAX: (301) 443-6077 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 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. 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. Applications for support mechanisms other than R01 (i.e., an R29) must cite the relevant program announcement on line 2 in addition to listing the current RFA. Applications for FIRST awards (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. Page limits and limits on size of type are strictly enforced. Non-conforming applications will be returned without being reviewed. 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 Center 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 in the application material. 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 20817-7710 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to: RFA-AA-97-001 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 409 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852-7003 (for express/courier service) Applications must be received by April 24, 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 and must be prepared in the format of a revised application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, DRG staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. 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 NIAAA in accordance with the review criteria stated below. As part of the initial merit review, a review process may be used by the initial review group in which applications may or may not be discussed based on their scientific merit relative to other applications received in response to the RFA. Applications that are fully discussed will be assigned a priority score. Applications that are not discussed will be withdrawn from further considerations and the Principal Investigator and the official signing for the applicant organization will be notified. The second level of review will be provided by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria Criteria to be used in the scientific and technical merit review of alcohol-related health services research grant applications will include the following: 1. The scientific, technical, health or medical significance, and originality of the proposed research in the context of alcohol-related health services and relevance to the goals of this RFA. 2. The appropriateness and adequacy of the research design and methodology proposed to carry out the research. 3. The adequacy of the qualifications (including level of education and training) and relevant research experience of the principal investigator and key research personnel. 4. The feasibility of implementing the project (including recruitment of subjects, implementation of the intervention or innovation, cooperation of relevant organizations, and/or availability and quality of necessary data). 5. The availability of adequate facilities, general environment for the conduct of the proposed research, other resources, and collaborative arrangements necessary for the research. 6. The appropriateness of budget estimates and duration in relation to the proposed research. 7. 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 these subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment. The review criteria for FIRST Awards (R29) and Exploratory/Developmental Grants (R21) are contained in their program announcements. AWARD CRITERIA Applications recommended for approval by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for funding on the basis of the overall scientific and technical merit of the proposal as determined by peer review, NIAAA programmatic needs and balance, and the availability of funds. NIAAA is particularly interested in managed care and alcohol-related health services. Special consideration will be given to applications that focus on the effects of managed care arrangements on access, utilization, cost, cost-effectiveness, and outcomes of alcohol services. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding applications under this RFA to: Robert B. Huebner, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0786 FAX: (301) 443-8774 Email: bhuebner@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Linda Hilley Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0915 FAX: (3010 443-3891 Email: lhilley@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 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 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. References Cook, T.D. and Campbell, D.T. Quasi-Experimentation: Design and Analysis Issues for Field Settings. Boston: Houghton Mifflin, 1979. Lettieri, D.J. A Primer of Research Strategies in Alcoholism Treatment Assessment. DHHS Pub. No. (ADM) 92-1882. Rockville, MD: National Institute on Alcohol Abuse and Alcoholism, 1992. Sechrest, L.; Persin, E.; and Bunker, J., eds. Research Methodology: Strengthening Causal Interpretations of Nonexperimental Data. DHHS Pub. No. (PHS) 90-3454. Rockville, MD: Agency for Health Care Policy and Research, 1990. From owner-sci-resources@net.bio.net Tue Dec 03 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 41, pt. 1of1, 29 November 1996 Date: 4 Dec 1996 13:50:31 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 670 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <584rn7$gs0@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 25, No. 41 - November 29, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** REVISION TO THE PHS GRANTS POLICY STATEMENT AND THE PHS 398 GRANT APPLICATIONS INSTRUCTIONS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** NATIONAL RESEARCH SERVICE AWARD (NRSA) STIPEND INCREASE National Institutes of Health Agency for Health Care Policy and Research Health Resources Services Administration INDEX: NATIONAL INSTITUTES OF HEALTH; HEALTH CARE POLICY, RESEARCH; HEALTH RESOURCES $$INDEX N3 ********************************************************** MOLECULAR BIOLOGY AND GENETICS OF SLEEP AND SLEEP DISORDERS - ADDENDUM RFA HL-96-015 National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Child Health and Human Development National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: HEART, LUNG, BLOOD; MENTAL HEALTH; CHILD HEALTH, HUMAN DEVELOPMENT; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 04/24/97 ************************************************* HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS (RFA AA-97-001) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX R2 04/24/97 ************************************************* BIOMEDICAL RESEARCH ON ALCOHOL AND AIDS (RFA AA-97-002) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX R3 04/24/97 ************************************************* DEVELOPING ALCOHOL-RELATED HIV PREVENTIVE INTERVENTIONS (RFA AA-97-003) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX P1 ********************************************************** SMALL GRANT PROGRAM FOR THE NIDCD (PAR-97-012) National Institute on Deafness and Other Communication Disorders INDEX: DEAFNESS, OTHER COMMUNICATION DISORDERS $$INDEX P2 ********************************************************** INITIATIVE FOR MINORITY STUDENT DEVELOPMENT (PAR-97-013) National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** REVISION TO THE PHS GRANTS POLICY STATEMENT AND THE PHS 398 GRANT APPLICATIONS INSTRUCTIONS NIH GUIDE, Volume 25, Number 41, November 29, 1996 P.T. 34; K.W. 0404000, 0710030, 1014006 National Institutes of Health As a part of ongoing efforts to reduce the administrative costs and burden on applicants and grantees, the NIH has reviewed its policy regarding the receipt date of competing applications (PHS 398). In the past, the NIH required that grant, fellowship, and cooperative agreement applications be received on specific published "receipt dates." A consequence of this policy has been that many applicants felt compelled to submit applications via express shipping or courier service. To simplify and minimize the cost associated with application submission, the NIH is making the following policy change: Unsolicited Applications: Effective January 2, 1997, an application will be considered on time if it is received by or mailed on or before the published receipt date and a proof of mailing is provided. Proof of timely mailing consists of one of the following: a legibly dated U.S. Postal Service postmark; or a dated receipt from a commercial carrier or the U.S. Postal Service. Private metered postmarks are not acceptable. The receipt dates for unsolicited investigator-initiated applications as published in the competing application kit (PHS 398) remain unchanged. It is hoped that this will lead to delivery methods that are timely but more economical in practice. Solicited Applications and Proposals: Solicited applications and proposals continue under the previous policy. Applications must be received by the specified dates. However, an application received after the deadline may be acceptable if it carries a legible proof- of-mailing date assigned by the carrier and the proof-of-mailing is not later than one week prior to the deadline date. These include Request for Applications (RFAs); Program Announcements (PAs) with specified receipt dates, such as Academic Research Enhancement Awards (AREAs), Small Business Innovation Research applications (SBIRs), and Small Business Technology Transfer applications (STTRs); and Request for Proposals (RFPs). Noncompeting Applications: This new policy also applies to the noncompeting continuation application (PHS 2590). The receipt submission dates identified in the noncompeting continuation application remain unchanged. Grantees are reminded that noncompeting applications should be received in time for orderly processing of noncompeting awards. This is particularly critical during peak workload times at Institute or Center grants management offices This policy announcement supersedes the PHS Grants Policy Statement (rev. 5/95), section 4-14, and the competing application kit (PHS 398), page 22. INQUIRIES Questions regarding the receipt of competing applications procedures may be directed to: Referral Office Division of Research Grants Telephone: (301) 435-0715 For issues relating to noncompeting applications, Institute or Center grants management offices should be contacted. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NATIONAL RESEARCH SERVICE AWARD (NRSA)STIPEND INCREASE NIH GUIDE, Volume 25, Number 41, November 29, 1996 P.T. 22, 44; K.W. 0720005, 1014006 National Institutes of Health Agency for Health Care Policy and Research Health Resources Services Administration Effective with all awards made on or after October 1, 1996, the following annual stipend levels apply to all individuals receiving support through institutional or individual National Research Service Awards (NRSA), including the Minority Access to Research Career (MARC) and Career Opportunities in Research (COR) programs. These awards are all made under the authority of Section 487 of the Public Health Service Act. The new stipends are as follows: Career Level Stipend for FY 97 MARC/COR Honors Undergraduates Freshmen/Sophomores $6,276 Juniors/Seniors $8,796 Predoctoral $11,496 Postdoctoral Years of Experience 0 $20,292 1 $21,420 2 $25,600 3 $26,900 4 $28,200 5 $29,500 6 $30,800 7 or more $32,300 THESE STIPEND LEVELS ARE EFFECTIVE ONLY FOR AWARDS MADE WITH FY 1997 FUNDS. Retroactive adjustments or supplementation of stipends with NRSA funds for awards made prior to October 1, 1996 is not permitted. Stipend level adjustments can be made only on the award date of the fellowship or the appointment date of the trainee on awards made with FY 1997 funds. Competing and non-competing awards made during the period between October 1, 1996 and the date of this announcement will be retroactively adjusted by the awarding component. Institutions are permitted to supplement NRSA stipends from non-Federal sources according to their own formally established policies, as described in the PHS Grants Policy Statement. The new stipend levels are to be used in the preparation of future competing and non-competing NRSA institutional training grant and individual fellowship applications. They will be administratively applied to all applications now in the review process. $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** MOLECULAR BIOLOGY AND GENETICS OF SLEEP AND SLEEP DISORDERS - ADDENDUM NIH Guide, Volume 25, Number 41, November 29, 1996 RFA: HL-96-015 P.T. 34; K.W. 0715187, 1002008, 1002019 National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Child Health and Human Development National Institute of Arthritis and Musculoskeletal and Skin Diseases This is to inform the scientific community that the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is also a co-sponsor of RFA HL-96-015, which was published in NIH Guide Vol. 25, No. 29, August 30, 1996. FUNDS AVAILABLE It is anticipated that during fiscal year 1997, support will be available for total costs of approximately $2,000,000 from the NHLBI, $800,000 from NIMH, $400,000 from NICHD, and $400,000 from NIAMS for the first year of this initiative. It is anticipated that approximately 12 to 15 grants will be awarded under this program. Award of grants pursuant to this RFA is contingent upon receipt of such funds for this purpose and scientific merit. INQUIRIES Inquiries may be directed to: James P. Kiley, Ph.D. National Center on Sleep Disorders Research National Heart, Lung, Blood Institute 6701 Rockledge Drive, Suite 7024, MSC-7920 Bethesda, MD 20892-7920 Telephone: (301) 435-0199 FAX: (301) 480-3451 Email: Kileyj@nih.gov Susana A. Serrate-Sztein, M.D. Arthritis Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS19J Bethesda, MD 20892-6500 Telephone: (301) 594-5032 FAX: (301) 480-4543 Email: szteins@ep.niams.nih.gov $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN AA-97-001 FULL-TEXT ************************************** HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS NIH Guide, Volume 25, Number 41, November 29, 1996 RFA AVAILABLE: AA-97-001 P.T. 34; K.W. 0404003, 0730050 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: March 21, 1997 Application Receipt Date: April 24, 1997 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks health services research grant applications that are aimed at developing a knowledge base to improve the delivery of services for alcohol-related problems. Such a knowledge base includes both treatment and preventive interventions. This Request for Applications (RFA) invites research project grants (R01), First Independent Research Support and Transition (FIRST) (R29) awards, exploratory/developmental (R21) grants, and Interactive Research Project Grants (IRPG) related to improving the availability, accessibility, delivery, quality, effectiveness, cost-effectiveness, and outcomes of alcohol-related treatment and prevention services. The research objectives include, but are not limited to, five major areas: (1) determining the effects of financing and reimbursement mechanisms on alcohol-related health care program availability, accessibility, delivery, organization, content, quality, and outcomes; (2) assessing sources of variation in access and utilization of treatment services and prevention interventions for alcohol-related problems; (3) identifying and assessing the effectiveness and outcomes of alcohol-related treatment and preventive services; and (4) evaluating the cost, cost-effectiveness, cost-benefit, and cost-utility of alcohol-related treatment and prevention services; and (5) identifying organizational and managerial factors that influence the delivery of treatment and prevention services for alcohol-related problems across regions, populations, and settings. It is anticipated that up to $4 million will be available to support approximately 16 grants under 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, Health Services Research on Alcohol-Related Problems, is related to the priority areas of alcohol abuse reduction and alcoholism treatment. 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. Robert B. Huebner, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0786 FAX: (301) 443-8774 Email: bhuebner@willco.niaaa.nih.gov $$R1 END ************************************************************ $$R2 BEGIN AA-97-002 FULL-TEXT ************************************** BIOMEDICAL RESEARCH ON ALCOHOL AND AIDS NIH Guide, Volume 25, Number 41, November 29, 1996 RFA AVAILABLE: AA-97-002 P.T. 44; K.W. 0404003, 0715008 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: March 21, 1997 Application Receipt Date: April 24, 1997 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking applications to support human immunodeficiency virus (HIV)-related biomedical alcohol research. Investigations into the biologic determinants of HIV disease have begun to yield interventions that can transform HIV disease from a fatal condition to a chronic, manageable disease syndrome. As understanding of the pandemic progresses, and as HIV/AIDS research becomes more focused, it is becoming increasing apparent that cofactors such as alcohol consumption may play an important role in sexual transmission, susceptibility to infection, and progression of HIV disease. Alcohol has been suggested as a cofactor in HIV disease (Crum, et al.; Alcoholism Clin Exp Res 20:364-371, 1996) and recent evidence demonstrated additive effects of alcohol abuse and HIV infection on brain function (Fein, et al.; Biological Psychiatry 37:183-195, 1995). However, there is no conclusive evidence that acute or chronic alcohol consumption increases susceptibility to HIV infection or accelerates AIDS progression. Strain variations of HIV, individual differences in susceptibility, and long incubation time following seroconversion are some of the difficulties in studying disease progression. Whether alcohol consumption increases susceptibility to opportunistic infections in HIV+ patients and whether alcohol-induced immunosuppression is associated with stimulation, expansion, and perpetuation of disease are important questions to be answered. The purpose of this Request for Applications (RFA) is to solicit applications to study two of the most important questions in alcohol-AIDS research: 1. Does alcohol consumption modulate host susceptibility to HIV infection? 2. Does alcohol consumption accelerate progression of AIDS or predispose to new complications of HIV infection? It is estimated that up to $2.0 million will be available to fund approximately twelve research project grants (R01), First Independent Research Support and Transition (FIRST) (R29) awards, exploratory/developmental (R21) grants, and Interactive Research Project Grants (IRPG) under 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, Biomedical Research on Alcohol and AIDS, is related to the priority area of AIDS prevention. 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. Leslie Isaki, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4224 FAX: (301) 594-0673 Email: lisaki@willco.niaaa.nih.gov $$R2 END ************************************************************ $$R3 BEGIN AA-97-003 FULL-TEXT ************************************** DEVELOPING ALCOHOL-RELATED HIV PREVENTIVE INTERVENTIONS NIH GUIDE, Volume 25, Number 41, November 29, 1996 RFA AVAILABLE: AA-97-003 P.T. 34; K.W. 0404003, 0715008, 0745027 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: March 21, 1997 Application Receipt Date: April 24, 1997 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks to stimulate the design, development, and testing of alcohol-related HIV preventive interventions that have the potential for reducing the risk of transmission of HIV in alcohol using, abusing, and dependent populations. Alcohol consumption has been identified as an important behavioral cofactor for HIV infection and has been consistently associated with HIV-risk behaviors over time. Alcohol use has been shown to predict time to seroconversion among gay men. Significantly higher rates of HIV infection are found among clinical samples of alcoholics and nonclinical samples of individuals who meet criteria for alcohol dependence than in the general public. In addition, reduction in alcohol use is associated with reduced sexual risk taking. Alcohol-related HIV interventions are currently being tested among gay and bisexual men, Native American youth, and persons in alcoholism treatment. Initial results suggest that a wide range of HIV-risk behaviors can be reduced after intervention and at follow-up, particularly among gay men. This research suggests that substance abuse prevention and treatment programs that include HIV components are more effective in reducing alcohol consumption and risky sexual practice than programs those that do not contain these components. Similarly, it appears that HIV prevention programs that include an alcohol risk reduction component may be more effective in reducing HIV risk behaviors than those that do not. This Request for Applications (RFA) reflects "Findings and Recommendations" suggested by the "NIH AIDS Research Program Evaluation; Behavioral, Social Science, and Prevention Research Area Review Panel." The review panel recommended a substantial increase in support for preventive intervention research in a diverse range of alcohol-related settings, drinking populations, and HIV-risk populations. Investigators are encouraged to move beyond basic behavioral studies to measure the efficacy and effectiveness of substance use risk-reduction interventions in populations at risk for both alcohol problems and HIV infection. The emphasis of this RFA on prevention research in the alcohol/AIDS area continues the previous focus of the NIAAA Prevention Research Branch on primary prevention of HIV and alcohol abuse among alcohol users. In addition, this RFA addresses secondary prevention among HIV infected alcoholics who may be more likely than other HIV infected individuals to engage in high-risk sexual behavior, to use unclean needles, and to have problems adhering to therapeutic treatments for HIV and AIDS. It is estimated that up to $2.0 million will be available to fund approximately ten research project grants (R01), First Independent Research Support and Transition (FIRST) (R29) awards, exploratory/developmental (R21) grants, and Interactive Research Project Grants (IRPG) under 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, Developing Alcohol-Related HIV Preventive Interventions, is related to the priority area of AIDS prevention. 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. Kendall Bryant, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-8820 FAX: (301) 443-8774 Email: kbryant@willco.niaaa.nih.gov $$R3 END ************************************************************ $$P1 BEGIN PAR-97-012 FULL-TEXT ************************************* SMALL GRANT PROGRAM FOR THE NIDCD NIH Guide, Volume 25, Number 41, November 29, 1996 PA AVAILABLE: PAR-97-012 P.T. 34; K.W. 0715050, 0715055, 0775005, 0775017 National Institute on Deafness and Other Communication Disorders Application Receipt Date: December 20, April 22, August 22 PURPOSE This program announcement (PA) supersedes all previous announcements of the National Institute on Deafness and Other Communication Disorders (NIDCD) Small Grant (R03) Program for support of 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. The research must be focused on one or more of the areas within the biomedical and behavioral scientific mission of the NIDCD: hearing, balance, smell, taste, voice, speech, or 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 PA, Small Grant Program for the NIDCD, is related to the priority area of clinical prevention services. 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. Beth Ansel Division of Human Communications National Institute of Deafness and Other Communication Disorders Executive Plaza South, Room 400-C - MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3461 FAX: (301) 402-6251 Email: Beth_Ansel@NIH.GOV $$P1 END ************************************************************ $$P2 BEGIN PAR-97-013 FULL-TEXT ************************************* INITIATIVE FOR MINORITY STUDENT DEVELOPMENT NIH GUIDE, Volume 25, Number 41, November 29, 1996 PA AVAILABLE: PAR-97-013 P.T. 34; K.W. 0710030, 0720005 National Institute of General Medical Sciences Application Receipt Date: February 1 PURPOSE The National Institute of General Medical Sciences (NIGMS) reannounces an initiative directed toward increasing the number of underrepresented minorities entering careers in biomedical research. This initiative seeks to encourage the development and/or expansion of innovative programs to improve the academic and research competitiveness of underrepresented minority students at the undergraduate, graduate, and postdoctoral levels and to facilitate their progress toward careers in biomedical research. Programs developed under this initiative must be specifically designed to target underrepresented minority students majoring in the biomedical sciences or in medical, dental, or veterinary training who are interested in pursuing research careers. The term "science" is used in this program announcement to mean the natural, physical, and behavioral sciences and mathematics relevant to biomedical research. Awards under this program will use the institutional education program (R25) grant. INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Ernest D. Marquez, Ph.D. Division of Minority Opportunities in Research National Institute of General Medical Sciences 45 Center Drive, Room 2AS.37 MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-3900 FAX: (301) 480-2753 Email: marqueze@gm1.nigms.nih.gov $$P2 END ************************************************************ From owner-sci-resources@net.bio.net Tue Dec 03 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AA-97-003 - V25(41) 11/29/96 Date: 4 Dec 1996 13:51:24 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 475 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <584ros$h00@net.bio.net> NNTP-Posting-Host: net.bio.net DEVELOPING ALCOHOL-RELATED HIV PREVENTIVE INTERVENTIONS NIH GUIDE, Volume 25, Number 41, November 29, 1996 RFA: AA-97-003 P.T. 34; K.W. 0404003, 0715008, 0745027 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: March 21, 1997 Application Receipt Date: April 24, 1997 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks to stimulate the design, development, and testing of alcohol-related HIV preventive interventions that have the potential for reducing the risk of transmission of HIV in alcohol using, abusing, and dependent populations. Alcohol consumption has been identified as an important behavioral cofactor for HIV infection and has been consistently associated with HIV-risk behaviors over time. Alcohol use has been shown to predict time to seroconversion among gay men. Significantly higher rates of HIV infection are found among clinical samples of alcoholics and nonclinical samples of individuals who meet criteria for alcohol dependence than in the general public. In addition, reduction in alcohol use is associated with reduced sexual risk taking. Alcohol-related HIV interventions are currently being tested among gay and bisexual men, Native American youth, and persons in alcoholism treatment. Initial results suggest that a wide range of HIV-risk behaviors can be reduced after intervention and at follow-up, particularly among gay men. This research suggests that substance abuse prevention and treatment programs that include HIV components are more effective in reducing alcohol consumption and risky sexual practice than programs those that do not contain these components. Similarly, it appears that HIV prevention programs that include an alcohol risk reduction component may be more effective in reducing HIV risk behaviors than those that do not. This Request for Applications (RFA) reflects "Findings and Recommendations" suggested by the "NIH AIDS Research Program Evaluation; Behavioral, Social Science, and Prevention Research Area Review Panel." The review panel recommended a substantial increase in support for preventive intervention research in a diverse range of alcohol-related settings, drinking populations, and HIV-risk populations. Investigators are encouraged to move beyond basic behavioral studies to measure the efficacy and effectiveness of substance use risk-reduction interventions in populations at risk for both alcohol problems and HIV infection. The emphasis of this RFA on prevention research in the alcohol/AIDS area continues the previous focus of the NIAAA Prevention Research Branch on primary prevention of HIV and alcohol abuse among alcohol users. In addition, this RFA addresses secondary prevention among HIV infected alcoholics who may be more likely than other HIV infected individuals to engage in high-risk sexual behavior, to use unclean needles, and to have problems adhering to therapeutic treatments for HIV and AIDS. 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 is related to the priority area of AIDS prevention. 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 Applications may be submitted by domestic and foreign, for-profit and non-profit, public and private organizations, 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 institutions are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29). Research project grant applications (R01) from foreign institutions are limited to three years. MECHANISM OF SUPPORT Research support may be obtained through an application for a regular research project grant (R01) or FIRST (R29) award. Applications are also encouraged for exploratory/developmental Grants (R21), which are limited to two years for up to $70,000 per year for direct costs. Exploratory/Developmental grants are also available for the secondary analysis of existing alcohol abuse prevention research data. Applicants may submit applications for Investigator-Initiated Interactive Research Project Grants (IRPGs). Interactive Research Project Grants require the coordinated submission of related research project grant (R01) and, to a limited extent FIRST Award (R29) applications from investigators who wish to collaborate on research, but do not require extensive shared physical resources. These applications must share a common theme and describe the objectives and scientific importance of the interchange of, for example, ideas, data, and materials among the collaborating investigators. A minimum of two independent investigators with related research objectives may submit concurrent, collaborative, cross-referenced individual R01 and R29 applications. Applicants may be from one or several institutions. Further information on these and other grant mechanisms may be obtained from the program staff listed under INQUIRIES. Further information on the IRPG mechanism is available in program announcement PA-96-001, NIH Guide for Grants and Contracts, Vol. 24, No. 35, October 6, 1995. Potential applicants for FIRST Awards or Exploratory/Developmental Grants may obtain copies of the specific announcements for these programs from the NIAAA Home Page at HTTP://WWW.NIAAA.NIH.GOV or from the Office of Scientific Affairs, NIAAA, Willco Building, Suite 409, 6000 Executive Boulevard MSC 7003, Bethesda, Maryland 20892-7003, telephone: 301-443-4375 or FAX 301-443-6077. Further information on these and other grant mechanisms may be obtained from the program staff listed under INQUIRIES. FUNDS AVAILABLE It is estimated that up to $2.0 million will be available to fund approximately ten grants under this RFA. This level of support is dependent on the receipt of sufficient number of applications of high scientific merit. Although this program is provided for in the financial plan of the NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. The earliest possible award date is September 30, 1997. RESEARCH OBJECTIVES Preventive interventions may be initiated and implemented by the investigators themselves for the specific purpose of testing effects of the strategies; or the interventions may occur naturally through the actions of public and private organizations (e.g., reduction in availability and accessibility of alcohol, increased distribution of condoms at bars, health promotion campaigns that highlight linkages between alcohol use and AIDS). Investigator-initiated alcohol-focused interventions may also be nested within the context of naturally occurring HIV interventions, such as vaccine trials, permitting the effects of both types of interventions to be studied simultaneously. These alcohol-focused interventions can be aimed at individuals, social networks, institutions, and specific alcohol settings such as bars and clubs, to change alcohol-related sexual expectancies, behavioral norms, and HIV risk-taking behaviors. Populations at risk for HIV who also abuse or are dependent on alcohol are most in need of study. These special subgroups include gay or bisexual men, alcoholics in treatment, alcohol abusing women and minorities, and adolescents initiating sexual behavior in the context of drinking. Other groups of interest that may be indirectly affected by alcohol use include partners and families of HIV-infected alcoholics. In addition to developing and testing new investigator-initiated interventions or naturally-occurring preventive programs, timely and cost-effective approaches may include: a) developing "augmenting" HIV interventions within the context of clinical or epidemiological studies to address alcohol-related problems (e.g., improving adherence of alcohol abusers to therapeutic regimes involving protease inhibitors). b) supplementing ongoing alcohol-problem intervention studies to include HIV infected or at-risk populations and adapting the intervention to address HIV issues in this subgroup (e.g., including HIV-risk populations in comparisons of brief motivational counseling and cognitive-behavioral interventions.) A wide range of contexts may be appropriate for intervention studies. These include but are not limited to: o Hard-to-reach populations: Alcohol abusers often delay entering medical settings where they could be identified as needing appropriate interventions and are often difficult to retain in controlled clinical trials. Such difficulties in attracting and retaining alcohol-abusing individuals may have particular significance for the testing and evaluation of HIV vaccines and therapeutics. New interventions need to be developed to attract and retain individuals at extremely high-risk for alcohol abuse and HIV infection, and new research designs and analytic strategies need to be developed to adequately evaluate these interventions in settings in which high rates of attrition may occur. Intervention strategies might, for example, include more informal and culturally relevant drop-in clinics, and different analytic procedures, such as case-control or case-based designs, may be necessary to test the effects of these interventions on such variables as HIV exposure, alcohol abuse, and retention in trials. o Health-Care Systems: Increasing attention is being paid to the role of health-care systems and professionals in preventing alcohol-related problems before they occur, in facilitating early detection of alcohol-related high-risk behaviors, and in providing appropriate treatment. Experimental and quasi-experimental designs may be used within health-care settings to test the efficacy of preventive strategies. These strategies may include risk assessment, brief and more extensive advice, case monitoring, and improved linkage to services for alcoholics in treatment or for HIV-infected individuals with alcohol problems. o Application of Basic Behavioral Research to Interventions: A wide range of preintervention studies have addressed the relationship of cognitive and physiological effects of alcohol use on high-risk sexual behavior. These studies have measured the effects of alcohol-related sexual expectancies, physiological disinhibition, decision making while intoxicated, and affect regulation. Interventions need to be developed that take into account these recent findings concerning high-risk behavior under conditions of intoxication. o Media/Communications: Ongoing research is needed to assess the efficacy of media strategies, alone or combined with other strategies, to prevent alcohol-related risky sexual behavior. Applicants are encouraged to develop and test promising media messages, new communications technologies, and special media for cultural subgroups to determine the most effective media/communications approaches for varied target audiences. Of particular interest are communication strategies that reach audiences at highest risk for alcohol abuse and HIV-infection, which include youth, selected ethnic minorities, gay and bisexual men, and male and female partners of HIV-infected individuals. o Family Studies: Research suggests that family involvement, broadly defined, can enhance the effectiveness of school-based and clinic-based alcohol prevention programs among youth at-risk for alcohol problems. Research on homeless and runaway youth indicates a high rate of co-occurring alcohol abuse and unsafe sexual behavior, often resulting in the spread of sexually transmitted diseases. Research needs to be expanded in this area to develop effective interventions among family members to reduce the risk for HIV infection. o College and School-Based Studies: Interventions are needed in school and college environments to alter drinking practices that contribute to unprotected sex, sexual assaults, and spread of sexually transmitted diseases. Late adolescence and the transition >From high-school to college is when many young people are initially freed from parental controls, increase their levels of alcohol consumption, and increase sexual activity. Often high rates of drinking and binge drinking are encountered on college campuses. Studies of alcohol-focused interventions that are currently being carried out in school or college contexts could be usefully expanded to evaluate effects of these interventions on high-risk sexual behavior. 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. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by March 21, 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 of 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 NIAAA staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: RFA-AA-97-003 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 409 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 FAX: (301) 443-6077 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 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. 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. Applications for support mechanisms other than R01 (i.e., an R29) must cite the relevant program announcement on line 2 in addition to listing the current RFA. Applications for FIRST awards (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. Page limits and limits on size of type are strictly enforced. Non-conforming applications will be returned without being reviewed. 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 also be sent to: RFA AA-97-003 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 409 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) Failure to forward the above two applications to NIAAA at the above address may delay consideration of an application such that it may not be received in time for FY 1997 funding consideration. Applications must be received by April 24, 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 and must be prepared in the format of a revised application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and for responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, the DRG staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. 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 Institute in accordance with the review criteria stated below. As part of the initial merit review, a streamlined review process may be used by the initial review group in which applications may or may not be discussed based on their scientific merit relative to other applications received in response to the RFA. Applications which are fully discussed will be assigned a priority score. Applications which are not discussed will be withdrawn from further considerations and the Principal Investigator and the official signing for the applicant organization will be notified. The second level of review will be provided by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria Criteria to be used in the scientific and technical merit review of the research grant applications will include the following: 1. The scientific, technical, or medical significance and originality of the proposed research and its relevance to the goals of this RFA: 2. The appropriateness and adequacy of the experimental approach and methodology, including adequacy of quality control methods, proposed to carry out the research such as adequacy of plans to measure biological markers relevant to AIDS behavioral research e.g., seroconversion. 3. The adequacy of the qualifications (including level of education and training) and relevant research experience of the principal investigator and key research personnel. 4. The availability of adequate facilities, general environment for the conduct of the proposed research, other resources, and collaborative arrangements necessary for the research. 5. The reasonableness of budget estimates and duration for the proposed research. 6. When applicable, 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 these subjects will also be evaluated. When applicable, the initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. The review criteria for Exploratory/Developmental Grants (R21) and FIRST Awards (R29) are contained in their program announcements. AWARD CRITERIA Applications recommended for approval by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for funding on the basis of the overall scientific and technical merit of the application as determined by peer review, NIAAA programmatic needs and balance, 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. Direct inquiries regarding programmatic issues to: Kendall Bryant, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-8820 FAX: (301) 443-8774 Email: kbryant@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Linda Hilley Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4703 FAX: (301) 443-3891 Email: lhilley@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects;" Title 45 CFR Parts 74 and 92, "Administration of Grants;" and 45 CFR Part 46, "Protections of Human Subjects." 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 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 Tue Dec 03 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AA-97-002 - V25(41) 11/29/96 Date: 4 Dec 1996 13:51:06 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 429 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <584roa$gv3@net.bio.net> NNTP-Posting-Host: net.bio.net BIOMEDICAL RESEARCH ON ALCOHOL AND AIDS NIH GUIDE, Volume 25, Number 41, November 29, 1996 RFA: AA-97-002 P.T. 44; K.W. 0404003, 0715008 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: March 21, 1997 Application Receipt Date: April 24, 1997 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking applications to support human immunodeficiency virus (HIV)-related biomedical alcohol research. Investigations into the biologic determinants of HIV disease have begun to yield interventions that can transform HIV disease from a fatal condition to a chronic, manageable disease syndrome. As understanding of the pandemic progresses, and as HIV/AIDS research becomes more focused, it is becoming increasing apparent that cofactors such as alcohol consumption may play an important role in sexual transmission, susceptibility to infection, and progression of HIV disease. Alcohol has been suggested as a cofactor in HIV disease (Crum, et al.; Alcoholism Clin Exp Res 20:364-371, 1996) and recent evidence demonstrated additive effects of alcohol abuse and HIV infection on brain function (Fein, et al.; Biological Psychiatry 37:183-195, 1995). However, there is no conclusive evidence that acute or chronic alcohol consumption increases susceptibility to HIV infection or accelerates AIDS progression. Strain variations of HIV, individual differences in susceptibility, and long incubation time following seroconversion are some of the difficulties in studying disease progression. Whether alcohol consumption increases susceptibility to opportunistic infections in HIV+ patients and whether alcohol-induced immunosuppression is associated with stimulation, expansion, and perpetuation of disease are important questions to be answered. The purpose of this Request for Applications (RFA) is to solicit applications to study two of the most important questions in alcohol-AIDS research: 1. Does alcohol consumption modulate host susceptibility to HIV infection? 2. Does alcohol consumption accelerate progression of AIDS or predispose to new complications of HIV infection? 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, Biomedical Research on Alcohol and AIDS, is related to the priority area of AIDS prevention. 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 Applications may be submitted by domestic and foreign, for-profit and non-profit, public and private organizations, 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 institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Research project grant applications (R01) from foreign institutions are limited to three years. MECHANISM OF SUPPORT Research support may be obtained through applications for a regular research project grant (R01) or FIRST (R29) award. Applications are also encouraged for exploratory/developmental grants (R21), which are limited to two years for up to $70,000 per year for direct costs. Applicants may also submit applications for Investigator-Initiated Interactive Research Project Grants (IRPGs). Interactive Research Project Grants require the coordinated submission of related research project grant (R01) and, to a limited extent FIRST Award (R29) applications from investigators who wish to collaborate on research, but do not require extensive shared physical resources. These applications must share a common theme and describe the objectives and scientific importance of the interchange of, for example, ideas, data, and materials among the collaborating investigators. A minimum of two independent investigators with related research objectives may submit concurrent, collaborative, cross-referenced individual R01 and R29 applications. Applicants may be from one or several institutions. Further information on the IRPG mechanism is available in program announcement PA-96-001, NIH Guide for Grants and Contracts, Vol. 24, No. 35, October 6, 1995. Potential applicants for FIRST Awards and Exploratory/Developmental Grants may obtain copies of the specific announcements for these programs from the NIAAA Home Page at HTTP://WWW.NIAAA.NIH.GOV or from the Office of Scientific Affairs, NIAAA, Willco Building, Suite 409, 6000 Executive Boulevard MSC 7003, Bethesda, Maryland 20892-7003, telephone: 301-443-4375 or FAX 301-443-6077. Further information on these and other grant mechanisms may be obtained from the program staff listed under INQUIRIES. FUNDS AVAILABLE It is estimated that up to $2.0 million will be available to fund approximately twelve grants under this RFA. This level of support is dependent on the receipt of sufficient number of applications of high scientific merit. Although this program is provided for in the financial plan of the NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. The earliest possible award date is September 30, 1997. RESEARCH OBJECTIVES Chronic and acute alcohol consumption has been demonstrated to be immunosuppressive, to decrease host defense against infection, and to increase viral replication. Given the frequency of alcohol consumption (to moderate and excessive extents), alcohol drinking has the potential to influence the severity and course of disease. Sophisticated molecular and cellular biology methodologies are revealing the detailed cellular processes responsible for virus growth and escape from host defense systems, and alcohol/AIDS researchers are beginning to define mechanisms of ethanol-induced immune impairments. However, basic questions such as whether alcohol consumption can modulate susceptibility to HIV infection remain unanswered. Although alcoholics have been reported to be at higher risk for HIV infection because of associated intravenous drug use, recent studies on HIV seropositivity rates in alcoholics without a history of intravenous drug use reported significant rates of HIV infection ranging from 4.5 percent (Schleiffer, et al.; Alcohol Clin Exp Res 20:75-80, 1996) to 11.4 percent (Lee, et al.; Am J Addiction 1:85-88, 1992 ). Behavioral studies in adolescents, gay men, and alcoholics in treatment settings indicate a substantial correlation between alcohol consumption and risky sexual behavior which can result in increased frequency of exposure to HIV. However, regardless of the route of primary HIV infection, once infected, whether alcohol consumption can accelerate the clinical course of the disease is a second critical question that remains unanswered. Although progress in alcohol/AIDS research has been significant, many areas require further investigation. Strategies to study the effects of alcohol consumption on modulating host susceptibility to primary HIV infection may include investigations on: o HIV infectivity on host immune function including studies on immune activation, suppression, and differentiation, and alteration of cytokine production by lymphocytes, monocytes/ macrophages, dendritic cells, and neural cells; o HIV factors including studies on early replication events such as attachment, uncoating and reverse transcription; o Host organ systems that may alter HIV infectivity and/or replication characteristics including studies on mucosal integrity, mucosal immunity, inflammation, microflora, and viral uptake; and o Other host factors that may alter HIV infectivity including studies on nutritional consequences, changes in regional immunity, and interactions with underlying disease, e.g., alcoholic liver disease and alcoholic neurologic disease, and other sexually transmitted diseases. Strategies to elucidate the effects of alcohol consumption on acceleration of progression of HIV disease or on predisposition to new complications of HIV infection may include studies on: o HIV-infected cells including studies on upregulation of HIV gene expression and replication in permissive cells, and in activated versus resting CD4+ cells; cytopathogenic effects; cell-to-cell transmission; and differences in HIV phenotype; o Host immune mechanisms directed against HIV including studies on whether ethanol enhances the acquisition of Th2-like state by T cells >From HIV+ patients or enhances the immunodeficient state in animal models of ethanol consumption and AIDS; o Host immunosuppression as a consequence of HIV infection including studies on localized and systemic opportunistic infections; cancer development, progression, and metastasis; and o HIV-specific complications including studies on the neuropathogenesis and pathogenic processes involved in HIV wasting, neuropathy, encephalopathy, and enteropathy; studies that evaluate whether ethanol alters efficacy of AIDS treatment strategies, especially by interfering with drug absorption and altered hepatic drug metabolism; and whether ethanol increases toxicity of AIDS therapeutics. 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. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by March 21, 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 of 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 NIAAA staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: RFA-AA-97-002 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 409 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 FAX: (301) 443-6077 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 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. 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. Applications for support mechanisms other than R01 (i.e., an R29) must cite the relevant program announcement on line 2 in addition to listing the current RFA. Applications for FIRST awards (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. Page limits and limits on size of type are strictly enforced. Non-conforming applications will be returned without being reviewed. 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 also be sent to: RFA AA-97-002 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 409 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) Failure to forward the above two applications to the NIAAA at the above address may delay consideration of an application such that it may not be received in time for FY 1997 funding consideration. Applications must be received by April 24, 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 and must be prepared in the format of a revised application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and for responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, the DRG staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. 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 Institute in accordance with the review criteria stated below. As part of the initial merit review, a streamlined review process may be used by the initial review group in which applications may or may not be discussed based on their scientific merit relative to other applications received in response to the RFA. Applications that are fully discussed will be assigned a priority score. Applications that are not discussed will be withdrawn from further considerations and the Principal Investigator and the official signing for the applicant organization will be notified. The second level of review will be provided by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria Criteria to be used in the scientific and technical merit review of the research grant applications will include the following: 1. The scientific, technical, or medical significance and originality of the proposed research and its relevance to the goals of this RFA. 2. The appropriateness and adequacy of the experimental approach and methodology, including adequacy of quality control methods, proposed to carry out the research. 3. The adequacy of the qualifications (including level of education and training) and relevant research experience of the principal investigator and key research personnel. 4. The availability of adequate facilities, general environment for the conduct of the proposed research, other resources, and collaborative arrangements necessary for the research. 5. The reasonableness of budget estimates and duration for the proposed research. 6. When applicable, 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 these subjects will also be evaluated. When applicable, the initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. The review criteria for Exploratory/Developmental Grants (R21) and FIRST Awards (R29) are contained in their program announcements. AWARD CRITERIA Applications recommended for approval by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for funding on the basis of the overall scientific and technical merit of the application as determined by peer review, NIAAA programmatic needs and balance, 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. Direct inquiries regarding programmatic issues to: Leslie Isaki, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4224 FAX: (301) 594-0673 Email: lisaki@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Linda Hilley Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4703 FAX: (301) 443-3891 Email: lhilley@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects;" Title 45 CFR Parts 74 and 92, "Administration of Grants;" and 45 CFR Part 46, "Protections of Human Subjects." 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 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 Tue Dec 03 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-013 - V25(41) 11/29/96 Date: 4 Dec 1996 14:33:58 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 411 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <584u8m$mho@net.bio.net> NNTP-Posting-Host: net.bio.net INITIATIVE FOR MINORITY STUDENT DEVELOPMENT NIH GUIDE, Volume 25, Number 41, November 29, 1996 PA NUMBER: PAR-97-013 P.T. 34; K.W. 0710030, 0720005 National Institute of General Medical Sciences Application Receipt Date: February 1 PURPOSE The National Institute of General Medical Sciences (NIGMS) reannounces an initiative directed toward increasing the number of underrepresented minorities entering careers in biomedical research. This initiative seeks to encourage the development and/or expansion of innovative programs to improve the academic and research competitiveness of underrepresented minority students at the undergraduate, graduate, and postdoctoral levels and to facilitate their progress toward careers in biomedical research. Programs developed under this initiative must be specifically designed to target underrepresented minority students majoring in the biomedical sciences or in medical, dental, or veterinary training who are interested in pursuing research careers. For the purposes of this program announcement, underrepresented minority students are 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. Nationally, individuals who have been found to be underrepresented in biomedical or behavioral research include, but are not limited to, United States citizens who are African Americans, Hispanic Americans, Native Americans and Natives of the U.S. Pacific Islands. The term "science" is used in this program announcement to mean the natural, physical, and behavioral sciences and mathematics relevant to biomedical research. ELIGIBILITY Applications may be submitted by domestic private and public, educational institutions. The application may be directed toward the development of underrepresented minority scientists who are in any phase of their career development, from the undergraduate level through the Ph.D. Applications proposing to develop the competitive research skills of recent clinical doctorates are also eligible. An applicant institution may submit only one application for this program announcement. This initiative expands on and replaces the MBRS Associate Investigator (AI) Institution category of support. Currently funded AI institutions are encouraged to apply for the present initiative with a start date to coincide with the end of their current project period. Institutions holding active MBRS regular research (S06) or undergraduate (S14) awards are not eligible. MECHANISM OF SUPPORT Awards under this program will use the institutional education project (R25) grant. Responsibility for the planning, direction, execution, and tracking for evaluation of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this program announcement may not exceed four years and is renewable. Requested direct costs are not to exceed $500,000 a year for the four-year period. Indirect costs will be paid at 8% of the direct costs, minus appropriate exclusions. A budget for each year must be provided. Allowable Costs The budget request may include the reasonable costs of administering, coordinating, and evaluating the program. Requests for equipment, supplies, travel, and other expenses for program operation should be carefully and specifically justified. Student remuneration through salary/wages and/or other forms of compensation paid in lieu of wages for participation in research experiences may be requested, provided the following conditions are met: o the student is performing necessary work, o there is an employer-employee relationship between the student and the institution, o the total compensation is reasonable for the work performed, and o it is the institution's practice to provide compensation for all students in similar circumstances, regardless of the source of support for the activity. Tuition remission is allowable for graduate students only and is limited to the current NIH guidelines for graduate student remuneration. It is an expectation of NIGMS that students who are enrolled in a Ph.D. program as a result of this program announcement will not be excluded from support from other non-federal sources, if needed, while making satisfactory progress toward the Ph.D degree. The student may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill), or may receive funds from a Pell Grant, based on financial need. Such funds are not considered supplementation or compensation. In summary, allowable costs include, but are not limited to: graduate student tuition remission, supplies, equipment, travel, other expenses, as well as salary/wages and fringe benefits for students and faculty. Unallowable Costs Undergraduate tuition, housing, food, or recruitment expenses of any kind are not allowable costs under this program. Release time solely for faculty mentoring is not allowable. Support for faculty research is not allowable, since faculty mentors in competitive programs are expected to have their own research support and an active research program capable of supporting the research of MBRS students. RESEARCH OBJECTIVES Background As of 1992, underrepresented minorities constituted only 4.5 percent of the postdoctoral fellows in the life sciences and less than 2.7 percent of the principal investigators of NIH research grants. In addition, the number of underrepresented minority applicants for research grants and training positions is very low. In the NIH Revitalization Act of 1993, NIH was encouraged to increase the number of underrepresented minorities participating in biomedical and behavioral research. In response to the Act, this program announcement will establish an opportunity for universities and other eligible institutions that are involved in biomedical research and training to target qualified underrepresented minorities at various stages in their education and move them along the path to competitive research careers. The objective of this program announcement is to significantly increase the number of underrepresented minority students entering competitive careers in biomedical research by promoting the initiation and development of new programs, as well as the expansion and enhancement of existing programs, to motivate and foster the development of underrepresented minority students in biomedical research careers. NIGMS recognizes the heterogeneity in institutional settings and institutional missions. Therefore, the emphasis of this initiative will be on the institution's program, as defined by its own goals and specific measurable objectives, to make a substantial contribution to ameliorating the underrepresentation of minority groups in biomedical research. Some institutions may have the greatest opportunity for impact by motivating undergraduate students. Other institutions may be poised for success in developing graduate students. Still others may wish to motivate and develop the research skills of students in, or recently graduated from, medical schools or other biomedically relevant professional schools. Additional Information Institutional programs must be designed with special attention to the needs and special requirements of underrepresented minority students who are pursuing biomedical research careers. For example, they may include, but are not limited to, the following: o providing research opportunities for undergraduate, graduate, medical, or post-clinical doctoral students at the institution (students may receive compensation for these activities); o while routine research support is not allowable, funds may be provided for strengthening the research capabilities of faculty who are uniquely successful in the development of underrepresented minority students or who are critical to the development of an environment supportive of minority students; o research-oriented technical training courses or workshops for students; o activities to improve technical skills of students such as writing; o student travel for presentation of research at scientific meetings; and o mentoring activities. Professional degree-granting institutions need to describe new programs or modifications and/or additions to their existing programs that would encourage and facilitate minority students to enter research careers. Request for support of existing efforts and programs related to the objectives of this announcement must be well justified. 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 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; and from the NIGMS program director listed under INQUIRIES. The title and number of the program announcement must be typed in Section 2 on the face page of the application. Submit a signed, typewritten original of the application, including the Checklist, and three legible copies of the signed application in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20872-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to Dr. Marquez at the address listed under INQUIRIES. Application receipt date is February 1. SPECIAL REQUIREMENTS Applicants should describe their proposed program in detail. They should explain how the program will meet their institutional goals and specific measurable objectives and how meeting these institutional goals will fulfill the objectives of this program announcement. Applicants should describe: o the criteria to be used in the selection of, and steps taken to ensure the retention of, the student participants for this program; o the criteria for selecting participating faculty; o the methods and facilities available for tracking student participants and their career outcomes; and o the criteria to be used for program evaluation. In this context, the applicant should provide institutional data for the previous five years on underrepresented minority student training or participation in biomedical research. This will serve as a baseline for the specific measurable objectives proposed (See Student Population and Career Tracking section below). Other Training Programs Applicants should describe the type(s) of support available to underrepresented minority students at their institutions. Applications from academic institutions with funding for student development programs such as, but not limited to, National Research Service Award (NRSA) training grants (e.g., NIH pre- and post-doctoral T32 grants or MARC T34 grants), NIH minority supplements, National Science Foundation grants or Howard Hughes Medical Institute grants, should define the relationship between those programs and a program responding to this program announcement. Reporting Requirements An annual progress report will be required. A final report will be required 90 days after the termination date of the award and must include information for each student participant and the benefits derived from the program. Student Population and Career Tracking The nature and extent of underrepresented minority student participation must be thoroughly delineated. The applicant should describe the institution's success in training its students from underrepresented minority groups in the sciences, including information on the number of minority students enrolled and receiving baccalaureate, master's, or Ph.D. degrees and data on the subsequent careers or education of the institutions underrepresented minority graduates. In order to evaluate the success of the program, applicants should describe the systems by which they would monitor and track the student participants in their programs, including the careers students choose after graduation. Applicants should maintain data to be able to demonstrate the benefits of their programs on matriculation, retention and graduation rates. These data should be compared to those of non-minority students and to those of minority students at their institutions from the previous five years. Key Personnel The program director is the individual designated on the application as the principal investigator and is responsible for the overall execution of the program. Unless otherwise stated in the application, the program director will have direct responsibility for all projects/activities (e.g., mentoring activities, individual research or pilot projects, curriculum development), including the Student Population and Career Tracking project. The names and qualifications of the program director, the directors of individual projects within the program (where appropriate), and any other key personnel, shall be listed in the application under Key Personnel and in the Biographical Sketch. REVIEW CONSIDERATIONS Upon receipt, applications will be administratively reviewed by NIH staff. Incomplete and/or unresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive will be evaluated by the NIGMS in accordance with the criteria stated below for scientific and technical merit by appropriate peer review groups. The second level of review will be provided by the National Advisory General Medical Sciences Council. Review criteria Proposed Education Plans: o the difference the program will make as defined by the stated goals and specific measurable objectives relative to the current status quo (previous five years); o the degree to which the program's plan may be expected to meet the goals of this solicitation, as well as the goals and specific measurable objectives of the applicant institution; o the budget and cost-effectiveness of the program, including its appropriateness to the scope of the program, benefit to the students, number of students involved, and responsible and prudent senior personnel costs; o evidence of a programmatic quality of the projects/activities proposed as distinct from a potential collection of minority supplements to existing research grants; and o the appropriateness of the applicant's plan for the evaluation of the impact of the program, including a system to track the future course of program participants. Institutional Setting and Personnel: o the availability of significant numbers of underrepresented minority students in the participating science department(s) who are interested in developing their research careers in biomedical and health-related fields; o the qualifications and experience of the Principal Investigator, faculty and staff to carry out the proposed program; o evidence of institutional commitment, and strength of the efforts of the institution, to foster the professional development of underrepresented minority faculty; o evidence of institutional commitment, and strength of the efforts of the institution, to foster the training of underrepresented minority students in the biomedical sciences; o the past training record of both program and designated preceptors, as determined by the success of former trainees in establishing independent and productive research careers, which may include non-underrepresented minority students; o the caliber of the proposed preceptors as researchers, including their successful competition for research support. AWARD CRITERIA Award decisions will be based on the technical merit of the applications, the diversity of the underrepresented minority student participants within the grant portfolio of NIGMS, and the geographical distribution of the awardee institutions. Awards can be made only to institutions with financial management systems and management capabilities that are acceptable under PHS policy. Awards will be administered under the PHS Grants Policy Statement. INQUIRIES Written and telephone inquiries concerning this announcement are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to the program director: Ernest D. Marquez, Ph.D. Division of Minority Opportunities in Research National Institute of General Medical Sciences 45 Center Drive, Room 2AS.37 MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-3900 FAX: (301) 480-2753 Email: marqueze@gm1.nigms.nih.gov Direct inquiries regarding fiscal matters to: Ms. Antoinette Holland National Institute of General Medical Sciences 45 Center Drive, Room 2AN.50B MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-5132 FAX: (301) 480-3423 Email: hollanda@gm1.nigms.nih.gov AUTHORITY AND REGULATIONS Awards are authorized by Sections 301 and 405 of the Public Health Service Act, as amended, and administered under PHS grants policies and the code of Federal Regulations 45 CFR Part 74, 45 CFR Part 92 and 42 CFR Part 52. 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 Dec 05 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 42, pt. 1of1, 6 December 1996 Date: 6 Dec 1996 12:45:47 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 357 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <58a0lr$hbl@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 25, No. 42 - December 6, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N2 ********************************************************** NCRR SMALL GRANTS FOR INNOVATIVE TECHNOLOGY National Center for Research Resources INDEX: RESEARCH RESOURCES NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** IN VITRO BIOGENIC AMINE TRANSPORTER TESTING FOR POTENTIAL COCAINE TREATMENT MEDICATIONS (RFP N01DA-7-8071) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P1 ********************************************************** INNOVATIVE APPROACHES TO DEVELOPING NEW TECHNOLOGIES (PAR-97-014) National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX P2 ********************************************************** NIMH SMALL GRANTS PROGRAM (PAR-97-015) National Institute of Mental Health INDEX: MENTAL HEALTH THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS 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. 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. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO 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) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & 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 $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 25, Number 42, December 6, 1996 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: Eric Whitters, Ph.D., University of Oregon: Based upon an investigation conducted by the University of Oregon as well as Dr. Whitters' own admission, ORI found that Eric Whitters, Ph.D., former postdoctoral fellow, Institute of Molecular Biology at the University of Oregon, engaged in scientific misconduct by fabricating experimental results that involved the selective growth of yeast strains that he represented as having temperature-sensitive phenotypes. The research was supported in part by a grant from the National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH). Dr. Whitters 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 November 6, 1996, to exclude himself from: (1) any contracting or subcontracting with any agency of the United States Government and from eligibility for, or involvement in, nonprocurement transactions (e.g., grants and cooperative agreements) of the United States Government as defined in 45 C.F.R. Part 76 (Debarment Regulations), and (2) 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. The research at issue did not affect any published research and was not included in any grant application. INQUIRIES 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 ********************************************************** NCRR SMALL GRANTS FOR INNOVATIVE TECHNOLOGY NIH GUIDE, Volume 25, Number 42, December 6, 1996 P.T. 34; K.W. 0706000, 1014006, 0735000 National Center for Research Resources This notice is to inform the research community that Biomedical Technology, National Center for Research Resources (NCRR), is discontinuing its current Small Grant Program Announcement number PA- 90-28 that supported one-year grants with a maximum direct cost award of $35,000. This PA was published in the NIH Guide, Vol. 19, No. 31, August 24, 1990, and Vol. 20, No. 31, August 16, 1991. In its place, NCRR is announcing a new Biomedical Technology Exploratory Grant Program that will encourage applications for up to $75,000 direct costs per year for up to two years. The program announcement for this replacement activity appears elsewhere in this issue of the NIH Guide. INQUIRIES For further information regarding this notice contact: Dr. Dov Jaron Biomedical Technology National Center for Research Resources 6705 Rockledge Drive, Suite 6160, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0755 Email: dov.jaron@nih.gov $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN N01DA-7-8071 ********************************************* IN VITRO BIOGENIC AMINE TRANSPORTER TESTING FOR POTENTIAL COCAINE TREATMENT MEDICATIONS NIH GUIDE, Volume 25, Number 42, December 6, 1996 RFP AVAILABLE: N01DA-7-8071 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 perform screening of in vitro transporter binding and uptake assays utilizing cells transfected with human dopamine, serotonin and norepinephrine transporters. Proprietary test compounds will be evaluated in established assays, 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 have applied for Schedule I registration at the time of award. It is anticipated that one cost reimbursement, completion type contract will be awarded for a period of three years, with two options each for an additional year, as well as additional quantity options. Request for Proposals (RFP) No. N01DA-7-8071 will be available electronically on or about December 4, 1996, 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-7-8071. 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-7-8071. Please note that the RFP for this acquisition is streamlined and includes only the Work Statement, deliverable and reporting requirements, special requirements and mandatory qualification, if any, the Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Following proposal submission and the initial review process, offerors comprising the competitive range will be requested to provide additional documentation to the Contracting Officer. INQUIRIES Responses to this RFP will be due on January 21, 1997. Any responsible offeror may submit a proposal that will be considered by the Government. This advertisement does not commit the Government to award a contract. 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 $$R1 END ************************************************************ $$P1 BEGIN PAR-97-014 FULL-TEXT ************************************* INNOVATIVE APPROACHES TO DEVELOPING NEW TECHNOLOGIES NIH GUIDE, Volume 25, Number 42, December 6, 1996 PA AVAILABLE: PAR-97-014 P.T. 34; K.W. 0706000, 0735000 National Center for Research Resources Application Receipt Date: February 13, 1997 PURPOSE The mission of the Biomedical Technology area of the NCRR is to support research to identify, create and develop innovative technologies and to provide these technologies for biomedical research. Areas of emphasis are biomedical engineering, biomedical computing, and technologies for the study of structure and function at all levels of living systems. The purpose of this PA is to encourage submission of new exploratory/developmental grant (R21) applications to explore new research paradigms in engineering, instrumentation, physics, mathematics or computer science as applied to biomedical research. The projects should provide the opportunity to develop new technologies, methods, devices, and materials that provide greater understanding of fundamental elements of biological phenomena. These efforts should lead to new approaches to the solution of basic research questions in order to prevent, diagnose, and treat disease and disability and ultimately to improve human health. HEALTHY PEOPLE 2000 The 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 is related to several of the priority areas. 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. Dr. Dov Jaron Biomedical Technology National Center for Research Resources 6705 Rockledge Drive Room 6160, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301)-435-0755 Email: dov.jaron@nih.gov $$P1 END ************************************************************ $$P2 BEGIN PAR-97-015 FULL-TEXT ************************************* NIMH SMALL GRANTS PROGRAM NIH GUIDE, Volume 25, Number 42, December 6, 1996 PA AVAILABLE: PAR-97-015 P.T. 34; K.W. 1014006, 0715095, 0715129 National Institute of Mental Health PURPOSE The National Institute of Mental Health (NIMH) small grants (R03) program provides research support of up to $50,000 per year (direct costs) for up to two years for new research projects relevant to the mission of the NIMH. This award is not renewable. This Program Announcement replaces and supersedes the NIMH portion of PA-91-08. 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, NIMH Small Grants Program, is related to the priority areas of mental health and mental disorders. 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. Carolyn Strete, Ph.D. Division of Extramural Activities National Institute of Mental Health Parklawn Building, Room 9-101 Rockville, MD 20892 Telephone: (301) 443-3373 Email: cstrete@ngmsmtp.nimh.nih.gov $$P2 END ************************************************************ From owner-sci-resources@net.bio.net Thu Dec 05 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-014 - V25(42) 12/06/96 Date: 6 Dec 1996 12:46:02 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 306 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <58a0ma$hda@net.bio.net> NNTP-Posting-Host: net.bio.net INNOVATIVE APPROACHES TO DEVELOPING NEW TECHNOLOGIES NIH GUIDE, Volume 25, Number 42, December 6, 1996 PA NUMBER: PAR-97-014 P.T. 34; K.W. 0706000, 0735000 National Center for Research Resources Application Receipt Date: February 13, 1997 PURPOSE The mission of the Biomedical Technology area of the NCRR is to support research to identify, create and develop innovative technologies and to provide these technologies for biomedical research. Areas of emphasis are biomedical engineering, biomedical computing, and technologies for the study of structure and function at all levels of living systems. The purpose of this program announcement (PA) is to encourage submission of new Exploratory/Developmental Grant (R21) applications to explore new research paradigms in engineering, instrumentation, physics, mathematics or computer science as applied to biomedical research. The projects should provide the opportunity to develop new technologies, methods, devices, and materials that provide greater understanding of fundamental elements of biological phenomena. These efforts should lead to new approaches to the solution of basic research questions in order to prevent, diagnose, and treat disease and disability and ultimately to improve human health. 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 is related to several of the priority areas. 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, D.C. 20402-9325 (telephone 202/512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic nonprofit and for-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. MECHANISM OF SUPPORT Support of this activity will be through the National Institutes of Health (NIH) exploratory grants (R21) mechanism, with direct costs limited to $75,000 per year for up to two years. Indirect costs will be provided. Although these grants are not renewable, they are expected to provide the opportunity to collect sufficient preliminary data to apply for future support from either the NCRR or other NIH Institutes and Centers. These funds may not be used to supplement projects currently supported by Federal or non-Federal funds, nor to provide interim support for projects under review by the Public Health Service, nor to support thesis or dissertation research. Following completion of the exploratory (R21) grant, investigators are encouraged to seek continuing support for research through other NIH grant mechanisms. RESEARCH OBJECTIVES The purpose of this PA is to provide the opportunity to: o explore new approaches, test imaginative new ideas or to challenge existing paradigms in technologies related to biomedical research; o develop significant changes in an existing high technology important to biomedical research; or o translate a scientific concept into the basis for a future technology that leads to the solution of important biomedical research problems. The research must be unusually imaginative or drastically different >From past paradigms with the potential to lead to a significant expansion of biomedical research horizons. The proposal should contain an element of risk as it must encompass work at the frontiers or the limits of understanding of a problem. 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 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 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff also may 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 prepared according to the instructions provided except for the following related to "C. SPECIFIC INSTRUCTIONS." Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: asknih@odrockm1.od.nih.gov. C. SPECIFIC INSTRUCTIONS 1. Face Page of the application: Item 2. Check the box marked "YES" and type the number and title of this program announcement. Item 7a and 8a, DIRECT COSTS REQUESTED FOR INITIAL BUDGET PERIOD; and DIRECT COSTS REQUESTED FOR PROPOSED PERIOD OF SUPPORT: Direct costs are limited to a maximum of $75,000 per year for a maximum of two years. The award may not be used to supplement an ongoing project, and, because of the feasibility-testing nature of the work, the support of salaries for student employees conducting dissertation-related research is discouraged. 9. Research Plan: Item a., Specific Aims. The instructions for this section suggest that the applicant state "the hypotheses to be tested." Since the goal of this program announcement is to develop innovative technologies, hypothesis testing per se may not be the driving force in developing such a proposal and, therefore, may not be applicable. Importantly, however, research that develops new technologies does require the application of principles of the fields such as engineering, materials science, physics, mathematics and computer science. Clear statements of these underlying principles within this section are essential. Items a-d: Do not exceed a total of ten pages for items a-d in the Research Plan. Tables and figures are included in the ten page limitation. Applications that exceed the page limitation or NIH requirements for type size and margins (refer to PHS 398 application for details) will be returned to the applicant without further consideration. The ten page limitation does not include items (e)-(i) (Human Subjects, Vertebrate Animals, Literature Cited, Consortia, Consultants). 10, Appendix: Appendix materials are not allowed. Applications not following the above instructions will be returned to the applicant without review. Use the mailing label in the application kit to mail the original and three copies of the application to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission send two additional copies of the application to: Office of Review National Center for Research Resources 6705 Rockledge Drive, Room 6018 - MSC 7965 Bethesda, MD 20892-7965 Bethesda, MD 20817 (for express/courier service) The submission, review, and award schedule for this Program Announcement for FY 1997 is: The single application receipt date is February 13, 1997. NCRR Committee Review: June/July 1997 Council Review: September 1997 Earliest Funding: September 1997 Only one grant application may be submitted by a principal investigator for this receipt date. Applicants may not submit R01 or R29 applications on the same topic concurrently with the submission of this exploratory grant application. REVIEW CONSIDERATIONS Applications not adhering to application instructions described above and those applications that are incomplete or nonresponsive to this program announcement will be returned to the applicant without review. Applications that are responsive to the program announcement will be evaluated for scientific and technical merit by a review committee convened by the NCRR in accordance with 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 the applications, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Research Resources Council, NCRR. Review Criteria o degree of innovation of the proposed research; o presence of an element of risk because no historical basis exists for the proposed approach; o potential of the investigation to lead to significant expansion of biomedical research horizons. o appropriateness and adequacy of the approach, and methodology proposed to carry out the research; o adequacy of proposed experimental equipment or materials; o adequacy of the investigator's background and training; o adequacy of the available and requested facilities; In addition to review of the merit of the application, the review committee will also examine the appropriateness of the requested budget. Investigators should be aware that NIH urges applicants to give added attention, where feasible and appropriate, to the inclusion of minorities and women in study populations. If minorities and/or women are not included in a given study involving human subjects, a clear rationale for their exclusion should be provided. The initial review group will also examine the adequacy of the proposed means for protecting against or minimizing potential adverse effects upon humans, animals or the environment. AWARD CRITERIA The award of grants is contingent on the receipt of applications of high scientific merit; relevance to the mission of the Biomedical Technology area of the NCRR; and the availability of appropriated funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Dov Jaron Biomedical Technology National Center for Research Resources 6705 Rockledge Drive Room 6160, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0755 FAX: (301) 480-3659 Email: dov.jaron@nih.gov Direct inquiries regarding fiscal matters to: Mr. Paul Karadbil Office of Grants and Contracts Management National Center for Research Resources 6705 Rockledge Drive, Room 6205, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0844 Email: Paulk@ep.ncrr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.371. Awards are made under authorization of the Public Health Service Act, Title III, 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. 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 Dec 05 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-015 - V25(42) 12/06/96 Date: 6 Dec 1996 12:46:29 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 343 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <58a0n5$hf2@net.bio.net> NNTP-Posting-Host: net.bio.net NIMH SMALL GRANTS PROGRAM NIH GUIDE, Volume 25, Number 42, December 6, 1996 PA NUMBER: PAR-97-015 P.T. 34; K.W. 1014006, 0715095, 0715129 National Institute of Mental Health PURPOSE The National Institute of Mental Health (NIMH) Small Grants Program provides research support of up to $50,000 per year (direct costs) for up to two years for new research projects relevant to the mission of the NIMH. This award is not renewable. This Program Announcement replaces and supersedes the NIMH portion of PA-91-08. 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, NIMH Small Grants Program, is related to the priority areas of mental health and mental disorders. 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 for small research grants may be submitted by any public or private, for profit or nonprofit institution such as: a university, college, hospital, or laboratory; units of State or local government; and authorized units of Federal government. Foreign institutions are not eligible for this program announcement. Small grant support may not be used to supplement research projects already being supported or to provide interim support of projects under review by the Public Health Service. Simultaneous submissions of both a small and regular research grant application on the same topic will not be accepted. Small grant support may not be requested for thesis or dissertation research. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This program will use the small grant (R03) mechanism. Support may be requested for up to two years at $50,000 per year in direct costs, plus allowable indirect costs, and an award is not renewable. A no- cost extension of up to 1 year may be granted to the grantee institution prior to expiration of the project period. Support for subsequent years may be requested through regular research grant programs. RESEARCH OBJECTIVES The small grant program provides limited and relatively rapid financial support for research within the program interests of the NIMH. Funding decisions will be based on scientific merit as determined by peer review, with priority given to applications in any of the following four categories: 1. Newer, less experienced investigators. 2. Investigators at institutions without well developed research traditions and resources. 3. More experienced investigators, for exploratory studies that represent significant change in research direction for them. 4. More experienced investigators, for testing new methods or techniques. Applications must include an introductory paragraph in the research plan section of the application identifying which priority category (1 through 4 above) is relevant and providing explicit justification for its applicability. If the application does not fall into any of the priority categories, this should be stated. Applications may be made for support of research in any scientific area relevant to mental health. While applications may involve a wide variety of biomedical, behavioral, or clinical disciplines, relevance to the mission of the NIMH must be clear. Applications for studies outside these areas will be returned without review. Potential applicants with questions concerning acceptability of their proposed work may contact the program staff listed under INQUIRIES. Division of Epidemiology and Services Research The Division of Epidemiology and Services Research directs, plans, supports, and conducts programs of research, research demonstrations, research training, and resource development in prevention, clinical services and service systems research, epidemiology, psychopathology, assessment, classification, violence and traumatic stress, law and mental health, and health and behavior. Division of Neuroscience and Behavioral Science The Division of Neuroscience and Behavioral Science directs, plans, supports, and conducts programs of research, research demonstrations, research training, and resource development to further understand the etiology, and pathophysiology of mental disorders with a focus on: behavioral and social sciences, cognitive sciences, and neurosciences, including neuroimaging, neurophysiology, neuropsychopharmacology, and cellular and molecular neurobiology. Division of Clinical and Treatment Research The Division of Clinical Research directs, plans, supports, and conducts programs of research, research demonstrations, research training, and resource development in psychopathology, classification, assessment, etiology, genetics, clinical course, outcome, and treatment of mental disorders with emphasis on schizophrenic disorders, affective and anxiety disorders, and mental disorders of children and adolescents, the elderly, minorities, and other special populations. The Division also coordinates the Institute's medications development program. Office on AIDS The Office of AIDS supports programs of research that focus on the mental health issues of persons with AIDS, persons who are HIV positive, or persons who are at risk of contracting the virus. Office on Rural Mental Health Research The Office on Rural Mental Health Research supports programs of research that focus on the mental health issues of persons who live in rural areas. 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 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also 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 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 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 title and number of the program announcement must be typed in Section 2 on the face page of the application. The application must be completed according to the instructions accompanying the PHS 398, with two exceptions: 1. The narrative portion of the small grant application that describes the research plan (items a-d) may not exceed 10 pages of text. Applications exceeding this length will be returned without review. Appendices may not be used to exceed the page limitation. 2. An introductory paragraph to the research plan must identify which of the four priority categories listed under RESEARCH OBJECTIVES applies and provide an explanation of how that priority category applies. If the application does not fall into any of the priority areas, this should be stated. 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 service) REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. 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 and assigned a priority score. Review Criteria When reviewing applications for scientific merit, the review committee will consider the following criteria: o Innovativeness/significance of the research idea; creativity of the approach o Qualifications of the Principal Investigator and other relevant staff o For pilot studies, the potential of the proposed study to be a building block in the development of future research o Appropriateness of the proposed approach; i.e. the research design, methods, and analyses o Availability and quality of the proposed resources. Appropriateness of the budget for the tasks proposed. 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, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. In applying the above criteria, reviewers take into consideration the stage of scientific career development of the principal investigator. After their review for scientific merit and the assignment of a priority score, reviewers will evaluate the justification provided for the priority category listed for this program. An administrative note in the summary statement documenting the review will reflect their evaluation. AWARD CRITERIA Criteria for funding of applications include the scientific merit of the application, relevance to areas of interest described in the institute research program announcements, and availability of funds. In addition, NIMH staff will consider the IRG evaluation of the justification for the small grant priority category. While this program announcement does not specifically exclude applications that do not fall into one of the priority categories, applications that are in these areas will be given priority in funding. Accordingly, other applicants are advised to consider applying for regular research grants even if they are requesting support that is within the small grant program dollar and time limits. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Kenneth G. Lutterman, Ph.D. Division of Epidemiology and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10-95 Rockville, MD 20857 Telephone: (301) 443-3373 FAX: (301) 443-4045 Email: klutterm@.nih.gov Henry Khachaturian, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health 5600 Fishers Lane, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-8033 FAX: (301) 443-1731 Email: hk11b@nih.gov David Stoff, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 10C-16 Rockville, MD 20857 Telephone: (301) 443-1636 FAX: (301) 480-8976 Email: dstoff@nih.gov Lauretta Grau, Ph.D. Office on AIDS National Institute of Mental Health 5600 Fishers Lane, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: LGrau@nih.gov Anthony Pollitt, Ph.D. Office of Rural Mental Health Research National Institute of Mental Health 5600 Fishers Lane, Room 10-104 Rockville, MD 20857 Telephone: (301) 443-9001 FAX: (301) 443-6893 Email: apollitt@nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. 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. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (April 1, 1994). PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the nonuse 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 Sun Dec 08 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 7 December 1996 Date: 8 Dec 1996 21:22:58 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 43 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <58g7ni$5de@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 December 7, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ There were no new documents on STIS this week. ------------------------------------------------------------------------ ** 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 nsf9564.txt, the text of your message should be as follows: get nsf9564.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9564.txt, you would enter: ftp> get nsf9564.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 Fri Dec 13 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 43, pt. 1of1, 13 December 1996 Date: 13 Dec 1996 21:33:11 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 259 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <58te6n$242@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 25, No. 43 - December 13, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 04/18/97 ************************************************* HUMAN ANTI-HIV MONOCLONAL ANTIBODIES IN IMMUNOTHERAPY OF HIV (RFA HL-97-002) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX P1 ********************************************************** NATIONAL INSTITUTE OF NURSING RESEARCH NATIONAL RESEARCH SERVICE AWARD INDIVIDUAL PREDOCTORAL FELLOWSHIPS (PAR-97-016) National Institute of Nursing Research INDEX: NURSING 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 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 25, Number 43, December 13, 1996 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: Yi Li, University of Illinois, Urbana-Champaign: Based upon an investigation conducted by the University of Illinois, Urbana- Champaign, information obtained by the Office of Research Integrity (ORI) during its oversight review, and Mr. Li's own admission, ORI found that Yi Li, while a candidate for a Ph.D. degree in the Neuroscience Program at the University of Illinois, Urbana-Champaign, engaged in scientific misconduct by fabricating an experimental study and results for research represented in an abstract prepared for submission for presentation at a national meeting. The research was supported by a grant from the National Institute on Aging (NIA), National Institutes of Health (NIH). The fabricated abstract and results addressed an electrophysiological study of the behavioral correlates for long-term potentiation in the motor cortex of the central nervous system of freely moving rats. Mr. Li 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 November 18, 1996: (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. The fabricated abstract was not submitted and has not been published or used in any grant applications. INQUIRIES 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 ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN HL-97-002 FULL-TEXT ************************************** HUMAN ANTI-HIV MONOCLONAL ANTIBODIES IN IMMUNOTHERAPY OF HIV NIH GUIDE, Volume 25, Number 43, December 13, 1996 RFA AVAILABLE: HL-97-002 National Heart, Lung, and Blood Institute P.T. 34; K.W. 0760045, 0745045, 0715008 Letter of Intent Receipt Date: March 17, 1997 Application Receipt Date: April 18, 1997 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THE RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING RESPONSES TO THIS RFA. PURPOSE The Transfusion Medicine Scientific Research Group, Division of Blood Diseases and Resources, National Heart, Lung, and Blood Institute (NHLBI), invites research project grant (R01) applications to conduct basic and applied research on the development of human anti-HIV monoclonal antibodies (mAb), establishing effective in vitro neutralization test system or other assay systems for the evaluation of candidate mAb preparations prior to their use in in vivo studies, and creating animal model systems to evaluate their effectiveness as passive immunotherapy for prevention and treatment of HIV infection. The goal of this program is to produce sufficient quantities of mAb preparations, perhaps formulated as mixtures of mAbs or in combination with other products for evaluation of their safety and efficacy in clinical trials. 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, Human anti-HIV Monoclonal Antibodies in Immunotherapy of HIV, 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. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, special 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 the NIH Website (http://www.nih.gov), and by mail and e-mail from the program contact listed below. Dr. Luiz H. Barbosa Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 10146 Bethesda, MD 20892-7950 Telephone: (301) 435-0050 FAX: (301) 480-0868 Email: lb30o@nih.gov $$R1 END ************************************************************ $$P1 BEGIN PAR-97-016 FULL-TEXT ************************************* NATIONAL INSTITUTE OF NURSING RESEARCH NATIONAL RESEARCH SERVICE AWARD INDIVIDUAL PREDOCTORAL FELLOWSHIPS NIH GUIDE, Volume 25, Number 43, December 13, 1996 PA AVAILABLE: PAR-97-016 P.T. 22; K.W. 0720005, 0785130 National Institute of Nursing Research Purpose The National Institute of Nursing Research (NINR) awards NRSA Individual Predoctoral Fellowships (F31) to the most promising applicants. Up to five years of aggregate NRSA support may be provided. Applicants must be registered nurses enrolled in doctoral programs or have been accepted by and agreed to enroll in such a graduate program in the academic year in which funds are awarded. Individuals are required to pursue their research training on a full-time basis, devoting at least 40 hours per week to the training program. This individual predoctoral fellowship program announcement is issued under the auspices of the NRSA. Awards will be administered under the Public Health Service (PHS) Grants Policy Statement and the NRSA Guidelines for Individual Awards. An applicant must work with her/his research advisor or graduate program director in preparing the application. INQUIRIES The PA, which describes the research training objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), the NIH Website (http://www/nih.gov), the NINR Website (http://www/nih.gov/ninr), and by mail or email from the program contact listed below. Lynn M. Amende, Ph.D. Division of Extramural Activities National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-5968 FAX: (301) 480-8260 Email: lamende@ep.ninr.nih.gov $$P1 END ************************************************************ From owner-sci-resources@net.bio.net Fri Dec 13 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-97-002 - V25(43) 12/13/96 Date: 13 Dec 1996 21:33:30 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 571 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <58te7a$24j@net.bio.net> NNTP-Posting-Host: net.bio.net HUMAN ANTI-HIV MONOCLONAL ANTIBODIES IN IMMUNOTHERAPY OF HIV NIH GUIDE, Volume 25, Number 43, December 13, 1996 RFA: HL-97-002 National Heart, Lung, and Blood Institute P.T. 34; K.W. 0760045, 0745045, 0715008 Letter of Intent Receipt Date: March 17, 1997 Application Receipt Date: April 18, 1997 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA. PURPOSE The Transfusion Medicine Scientific Research Group, Division of Blood Diseases and Resources, National Heart, Lung, and Blood Institute (NHLBI), announces the availability of a Request for Applications (RFA) on the above subject. The purpose of this initiative is to encourage the conduct of basic and applied research on the development of human anti-HIV monoclonal antibodies (mAb), the establishment of effective in vitro neutralization test systems or other assay systems for the evaluation of candidate mAb preparations prior to their use in in vivo studies, and the creation of animal model systems to evaluate their effectiveness as passive immunotherapy for prevention and treatment of HIV infection. The goal of this program is to produce sufficient quantities of mAb preparations, perhaps formulated as mixtures of mAbs or in combination with other products, for evaluation of their safety and efficacy in clinical trials. 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, Human anti-HIV Monoclonal Antibodies in Immunotherapy of HIV, 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. 017-001-00473-1) 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. Awards in response to this RFA will be made to foreign institutions only for research of very unusual merit, need, and promise, and in accordance with PHS policy governing such awards. Minority individuals, women, and persons with disabiities are encouraged to apply. Newly independent investigators, who may wish to consult with a program representative, (see "INQUIRIES" section) are encouraged to apply. MECHANISM OF SUPPORT This RFA will use the NIH individual research project grant (R01) mechanism of support. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. The MODULAR GRANT concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The JUST-IN-TIME concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and Institute staff. For this RFA, funds must be requested in $25,000 direct cost modules. A maximum of eight modules ($200,000 direct costs) per year may be requested. Any necessary escalation must be included within the number of modules being requested. Only limited budget information will be required and any budget adjustments made by the Initial Review Group will be in modules of $25,000. Instructions for completing the Biographical Sketch have also been modified. In addition, Other Support information and the application Checklist page are not required as part of the initial application. If there is a possibility for an award, necessary budget, Other Support and Checklist information will be requested by NHLBI staff following the initial review. The APPLICATION PROCEDURES section of this RFA provides specific details of modifications to standard PHS 398 application kit instructions. Applicants, who will plan and execute their own research programs, are requested to furnish their own estimates of the time required to achieve the objectives of the proposed research project. Up to 5 years of support may be requested. At the end of the official award period, renewal applications may be submitted for peer review and competition for support through the regular grant program of the NHLBI. It is anticipated that support for this program will begin in September 1997. Administrative adjustments in project period or amount of support may be required at the time of the award. Since a variety of approaches would represent valid responses to this RFA, it is anticipated that there will be a range of costs among individual grants awarded. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded in connection with this RFA. FUNDS AVAILABLE It is anticipated that for fiscal year 1997, the first year of support for this initiative, $3,000,000 total costs will be available. The award of grants pursuant to this RFA is contingent upon receipt of such funds for this purpose. It is anticipated that approximately ten to twelve new grants will be awarded under this program. Applicants may request up to five years of support. The specific number to be funded will, however, depend on the merit and scope of the applications received and on the availability of funds. Direct costs will be awarded in modules of $25,000, less any overlap or other necessary administrative adjustments. Facilities and Administrative costs (indirect costs) will be awarded based on the negotiated rates. If collaborative arrangements involve subcontracts with other institutions, Ms. Jane R. Davis of the NHLBI Grants Operations Branch (telephone: (301) 435-0166), should be consulted regarding procedures to be followed. RESEARCH OBJECTIVES Background Passive immunotherapy in the prevention of viral diseases prior to or shortly after exposure is a well-accepted procedure and is utilized in preventing infection with hepatitis B, measles, and varicella-zoster, among other viruses. Passive immunity may also play an important role in the treatment or prevention of human immunodeficiency virus (HIV) infection as suggested by a number of clinical trials utilizing antibody preparations derived from HIV-infected plasma donors. The reagents thus far utilized in animal as well as in human studies fall into one of the following categories: 1. Polyclonal antibodies: These antibody products are obtained by plasmapheresing clinically healthy asymptomatic donors who have been found to have high titer anti-p24 antibody and who are p24 antigen negative. Plasma pools are inactivated by a solvent-detergent procedure before fractionation with the cold alcohol Cohn-Oncley process. The final product is a monomeric, unfragmented, and undenatured IgG. Currently, the NHLBI is supporting the preparation of an immunoglobulin with high titers of anti-HIV antibodies, which is under evaluation in Phase III clinical trials. One trial involves the use of this HIV-specific immunoglobulin (HIVIG) to prevent the vertical transmission of the virus from HIV-infected pregnant women to their offspring. In a pilot study, the clinical usefulness of HIVIG is being evaluated in children already infected with HIV. It is unknown whether or not HIVIG or other products of this type contain adequate levels of protective antibodies to be effective either prophylactically or therapeutically. One of the drawbacks in the use of HIVIG is that large quantities of the product are needed for adult patients and the supply is quite limited. 2. Monoclonal antibodies: With the development of human mAb, the potential for passive immunization has been enhanced, as antibodies with negligible antigenicity and defined specificity can be administered in relatively small amounts to individuals infected with or at high risk for a particular infectious agent. Several anti-HIV mAbs have been produced but few have been shown to neutralize primary HIV isolates. Human mAbs offer the advantages that they can be produced in large quantities without need for plasma donors and the viral inactivation procedures currently used to treat plasma obtained from such donors. A potential problem with mAb preparations is that they possess very specific neutralization properties, and may only bind to a specific epitope of the HIV surface protein failing to neutralize viral infectivity. Thus, mixtures of several mAbs may be required in order to achieve the broad neutralizing effect needed to be clinically effective. Such a cocktail would offer the advantages of a greater range of activity against variants of HIV, and the use of appropriately selected mAbs might lead to more effective neutralization due to synergistic interaction between antibodies. 3. Immunoadhesin (CD4-IgG): This is a genetically engineered molecule containing two to four CD4 moieties associated with the heavy and/or light chains of IgG replacing the immunoglobulin variable domains. One of the advantages that a preparation of this type offers is its broad neutralizing capacity for both laboratory and primary isolates of HIV. Its half-life is significantly shorter than that of IgG, but a half-life of a few days may be adequate in a prophylactic setting. Moreover, CD4-IgG can act in synergy with human anti-HIV mAbs. Ongoing studies and the availability of this product will determine the utility of this immunoadhesin. Most of the clinical studies conducted thus far involving the use of immune plasma or HIVIG, have shown that both products are well tolerated. However, the number of patients in the studies who received these products is generally small, and are primarily adult males. Furthermore, most of the studies have been open label and the definition of clinical response to therapy differed among studies. Nevertheless, most studies have suggested some clinical benefit, either in terms of time to development of opportunistic infections or a decrease in their number as well as a trend towards increased survival. A number of the studies have shown a decrease in plasma HIV; some showed a decline in p24 antigen; some demonstrated a reduction in plasma HIV RNA; and in some studies , CD4 cell count rose. A serious obstacle to the development of these reagents for passive immunization is the lack of a reliable in vitro assay to evaluate their effectiveness. Most assays depend on the infection of mitogen-stimulated peripheral blood mononuclear cells (PBMC) and the ability of mAbs, HIVIG, etc, to inhibit infection. Results, however, are difficult to interpret due to variations in both methods among laboratories and between experiments within the same laboratory. It is as yet unclear why there is so much variation in sensitivity to neutralization. These variations are at least partially due to the use of different PBMC donors, different sensitivity of primary isolates, and differences in assay conditions. Additionally, the criteria for determining an acceptable antiviral activity or antibody level are problematic because it is not currently known what level of antibody titer or neutralizing antibody activity is likely to prevent transmission of HIV. It is postulated, however, that the infusion of a candidate antibody product should result in antibody levels and neutralizing activity that are at least as high as those found in HIV-infected individuals. Ultimately, the in vitro criteria for such products will have to be determined from the correlation between the in vitro antiviral characteristics of these preparations and their efficacy in clinical trials. Perhaps the best method for evaluating the effects of passive immunotherapy is the severe combined immune deficiency (SCID) mouse model. This model has been successfully used in the evaluation of HIVIG for pre- and post-exposure to HIV. The SCID mouse model has the potential of becoming the "gold standard" for the evaluation of candidate antibody preparations. Correlation between this in vivo system and a reliable, standardized in vitro antiviral activity would then form the basis for a product advancing to clinical trials. In summary, this initiative would support research leading to the development and evaluation of mAbs that can be used for passive immunization in the prevention and/or treatment of HIV infection in man. Research areas that are encouraged by this solicitation include assessments of in vitro assays for evaluating candidate mAbs and validating in vivo studies, characterization of the protective effect of the candidate mAbs, evaluation of the SCID mouse model, and preparation of sufficient amounts of the product to determine its safety in Phase I clinical trials. The candidate products could be mixtures of mAbs, or mixtures of mAbs with polyclonal antibodies, immunoadhesins, or other potentially effective products for passive immunotherapy. SPECIAL REQUIREMENTS Upon initiation of the program, the NHLBI will sponsor annual meetings to encourage the exchange of information among investigators who participate in this program. Travel funds for a one day meeting each year, most likely to be held in Bethesda, Maryland, should be included in the modules. Applicants should also include a statement in the applications indicating their willingness to participate in such meetings. 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 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 person listed below. Program staff may also provide additional relevant information concerning the policy. 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. Such letters are requested only for the purpose of providing an indication of the number and scope of applications to be received; therefore, their receipt is usually not acknowledged. A letter of intent is not binding, and it will not enter into the review of any application subsequently submitted, nor is it a necessary requirement for the application. A faxed letter of intent may be used in place of a posted one. This letter of intent is to be mailed or FAXed to: Dr. C. James Scheirer Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0266 FAX: (301) 480-3541 Email: james_scheirer@nih.gov APPLICATION PROCEDURES Applications are to be submitted on the research 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 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. Use the conventional format for research grant applications and ensure that the points identified in the section on REVIEW CONSIDERATIONS are fulfilled. BUDGET INSTRUCTIONS The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: DETAILED BUDGET FOR THE 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. BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT Do not complete the categorical budget tables on Form page 5 of the PHS 398 (rev. 5/95). Only the requested total direct costs line for each year must be completed based on the number of $25,000 modules being requested. Applicants may not request a change in the amount of each module. A maximum of eight modules ($200,000) direct costs per year may be requested and each applicant may request up to five years of support for this RFA. Direct cost budgets will usually remain constant throughout the life of the project (i.e., the same number of modules requested for all budget periods). Any necessary escalation should be considered when determining the number of modules to be requested. However, in the event that the number of modules requested must change in any future year due to the nature of the research proposed, appropriate justification must be provided. Total Direct Costs for the entire Proposed Project Period should be shown in the box provided. BUDGET JUSTIFICATION - Budget justifications should be provided under "Justifications" on Form Page 5 of the PHS 398. - List the names, role on the project and proposed 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. - Identify all consultants by name and organizational affiliation and describe the services to be performed. - Provide a general narrative justification for individual categories (equipment, supplies, etc.) required to complete the work proposed. More detailed justifications should be provided for high cost items. Any large one-time purchases, such as large equipment requests, must be accommodated within these limits. CONSORTIUM/CONTRACTUAL COSTS - If collaborations or subcontracts are involved that require transfer of funds from the grantee to other institutions, it is necessary to establish formal subcontract agreements with each collaborating institution. A letter of intent from each collaborating institution should be submitted with the application. Only the percentage of the consortium/contractual TOTAL COSTS (direct and indirect) relative to the total DIRECT COSTS of the overall project needs to be stated at this time. The following example should be used to indicate the percentage cost of the consortium, "The consortium agreement represents 27 percent of overall $200,000 direct costs requested in the first year." A budget justification for the consortium should be provided as described in the "Budget Justification" section above (no Form Page 5 required for the consortium). Indicate whether the consortium will be in place for the entire project period and identify any future year changes in the percentage relative to the parent grant. If there is a possibility for an award, the applicant will be requested to identify actual direct and indirect costs for all years of the consortium. Total subcontract costs need not be calculated in $25,000 modules. However, when subcontract funds are added to the parent grant budget, the total direct cost amount must be included in the number of $25,000 modules requested. 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. - Complete the educational block at the top of the form page; - List current position(s) and those previous positions directly relevant to the application; - List selected peer-reviewed publications directly relevant to the proposed project, with full citation; - The applicant has the option to provide information on research projects completed and/or research grants participated in during the last five years that are relevant to the proposed project. OTHER SUPPORT - Do not complete the "Other Support" pages (Form Page 7). Selected other support information relevant to the proposed research may be included in the Biographical Sketch as indicated above. Complete Other Support information will be requested by NHLBI staff if there is a possibility for an award. CHECKLIST - No "Checklist" page is required as part of the initial application. A completed Checklist will be requested by NHLBI staff if there is a possibility for an award. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Sample budgets and justification page will be provided upon request or following the submission of a letter of intent. Applications not conforming to these instructions will be considered unresponsive to this RFA and will be returned without further review. 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. The RFA label available in the PHS 398 application kit must be affixed to the bottom of the face page of the original copy 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 (HUMAN ANTI-HIV MONOCLONAL ANTIBODIES IN IMMUNOTHERAPY OF HIV) and number (HL-97-002) must be typed on line 2 of the face page of the application form and the YES box must be marked. Send or deliver the completed application and three signed, exact photocopies of it to the following, making sure that the original application with the RFA label attached is on top: 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) Send an additional two copies of the application to the Chief, Review Branch, at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants. Otherwise the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by April 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. Although this is a National Heart, Lung, and Blood Institute Request for Grant Applications, the National Institute of Allergy and Infectious Diseases (NIAID) also has an interest in the subject matter of this RFA. Therefore, the NIAID may be given a secondary institute assignment, if appropriate. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness by the NHLBI. 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 an view, 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/program director and the official signing for the applicant organization will be notified. The criteria used in the evaluation of scientific merit of each application will be similar to those used in the review of traditional research-project grant applications, including novelty, originality, and feasibility of the approach; the training experience and research competence of the investigator(s); the adequacy of the experimental design; the suitability of the facilities; and the appropriateness of the requested budget to the work proposed. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. The personnel category will be reviewed for appropriate staffing based on the requested percent effort. The direct costs budget request will be reviewed for consistency with the proposed methods and specific aims. Any budgetary adjustments recommended by the reviewers will be in $25,000 modules. The duration of support will be reviewed to determine if it is appropriate to ensure successful completion of the requested scope of the project. AWARD CRITERIA The anticipated date of award is September 1997. Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs and balance, and the availability of funds. Awards in response to this RFA will be made to foreign institutions only for research of very unusual merit, need, and promise, and in accordance with PHS policy governing such awards. Designated funding levels are subject to change at any time prior to award, due to unforeseen budgetary, administrative and/or scientific developments. INQUIRIES Inquiries concerning this RFA are encouraged. Potential applicants may request a copy of sample budget pages. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Dr. Luiz H. Barbosa Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 10146 Bethesda, MD 20892-7950 Telephone: (301) 435-0075 FAX: (301) 480-0868 Email: lb30o@nih.gov Direct inquiries regarding fiscal matters to: Ms. Jane R. Davis Section Grants Management Officer 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 AUTHORITY AND REGULATIONS The programs of the Division of Blood Diseases and Resources, NHLBI, are described in the Catalog of Federal Domestic Assistance No. 93.839. Awards will be made under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grant policies and Federal regulations, most specifically 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 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 Dec 13 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-016 - V25(43) 12/13/96 Date: 13 Dec 1996 21:33:55 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 469 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <58te83$256@net.bio.net> NNTP-Posting-Host: net.bio.net NATIONAL INSTITUTE OF NURSING RESEARCH NATIONAL RESEARCH SERVICE AWARD INDIVIDUAL PREDOCTORAL FELLOWSHIPS NIH GUIDE, Volume 25, Number 43, December 13, 1996 PA NUMBER: PAR-97-016 P.T. 22; K.W. 0720005, 0785130 National Institute of Nursing Research PURPOSE The Congress of the United States enacted the National Research Service Act (NRSA) Program in 1974 to help ensure that highly trained scientists would be available in adequate numbers and in appropriate research areas to carry out the Nation's biomedical and behavioral research agenda. Under this congressional authority, the National Institute of Nursing Research (NINR) awards NRSA Individual Predoctoral Fellowships (F31) to the most promising applicants. Up to five years of aggregate NRSA support may be provided. The proposed NRSA training must be within the scope of biomedical or behavioral research relevant to the NINR mission and must offer an opportunity for research training. Individuals are required to pursue their research training on a full-time basis, devoting at least 40 hours per week to the training program. Research clinicians must devote full-time to their proposed research training and must restrict clinical duties within their full-time research training experience to those that are part of the research training experience. NIH recognizes the critical importance of training clinicians to become researchers and encourages them to apply. Women, minorities, and individuals with disabilities are also encouraged to apply. An NRSA Award may not be used to support studies leading to the M.D., D.O., D.D.S., D.V.M., or other similar health-professional degrees. Neither may this award be used to support the clinical years of residency training. ELIGIBILITY REQUIREMENTS Citizenship. By the earliest possible start date of the individual predoctoral fellowship award, individuals must be citizens or noncitizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence (i.e., possess a currently valid Alien Registration Receipt Card I-551, or other legal verification of such status). Noncitizen nationals are persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. Degree Requirements. Applicants must be registered nurses (R.N.) enrolled in doctoral programs or have been accepted by and agreed to enroll in such a graduate program in the academic year in which funds are awarded. Sponsorship. As part of the fellowship application process, certification by an authorized official of the degree-granting institution that the R.N. applicant is enrolled in the sponsoring institution's doctoral program is required. The applicant must identify an individual who will serve as a sponsor and will supervise the training and research experience. The sponsoring institution may be private (profit or nonprofit) or public. The applicant's sponsor should be an active investigator in the area of the proposed research who will directly supervise the candidate's research. The sponsor must document, in the application, the availability of staff, research support, and facilities for high-quality research training. MECHANISM OF SUPPORT This individual predoctoral fellowship (F31) program announcement is issued under the auspices of the NRSA Act(see Authority and Regulations). Awards will be administered under the Public Health Service (PHS) Grants Policy Statement and the NRSA Guidelines for Individual Awards. An applicant must work with her/his research advisor or graduate program director in preparing the application. Period of Support Individuals may receive up to five years of aggregate NRSA support at the predoctoral level, including any combination of support from institutional training grants and individual fellowship awards. Exceptions to the five-year limit require a waiver from NINR. Individuals interested in a waiver should consult with NINR staff. Award Provisions The fellowship award provides an annual stipend of $11,496 as a subsistence allowance to help defray living expenses during the research training program, a tuition and fee allowance in accordance with NIH policy, and an annual institutional allowance of $2,000. The award is not provided as a condition of employment with either the Federal Government or the sponsoring institution. Stipends For fellows sponsored by domestic non-Federal institutions, the stipend will be paid through the sponsoring institution. Stipend Supplementation. Supplementation or additional support to offset the cost of living may be provided by the awardee institution, but must not require any additional obligation from the fellow. Federal funds may not be used for supplementation unless specifically authorized under the terms of both the program from which such supplemental funds are to be received and the program whose funds are to be supplemented. Under no circumstances may PHS funds be used for supplementation. Compensation. An institution may provide additional funds to a fellow in the form of compensation (such as salary and/or tuition remission) for services, such as teaching or laboratory assistantships. A fellow may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a PHS research grant. However, compensated services must occur on a limited, part-time basis apart from the normal research training activities, which require a minimum of 40 hours per week. In addition, compensation may not be paid from a research grant supporting research that is part of the research training experience. Under no circumstances may the services provided for compensation interfere with, detract from, or prolong the fellow's approved NRSA training program. Additionally, compensation must be in accordance with institutional policies applied consistently to both Federally and non-Federally supported activities and supported by acceptable accounting records determined by the employer-employee relationship agreement. Educational Loans or G.I. Bill. An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation. Concurrent Awards. An NRSA fellowship may not be held concurrently with another Federally sponsored fellowship or similar award that provides a stipend or otherwise duplicates provisions of the NRSA. Leave Fellows may continue to receive stipends during periods of vacation and holidays available to individuals in comparable training positions at the sponsoring institution. Also, fellows may continue to receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth pursuant to the Pregnancy Discrimination Act (42 USC 2000 e(k)). Fellows may continue to receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee or sponsoring institution have access to paid leave for this purpose and the use of parental leave is approved by the sponsor. A period of terminal leave is not permitted and payment may not be made from grant funds for leave not taken. Individuals requiring extended periods of time away from their research training experience must seek approval from NINR for an unpaid leave of absence. Tax Liability The Internal Revenue Code, Section 117, applies to the tax treatment of all scholarships and fellowships. Degree candidates may exclude from gross income reported for tax purposes any amount used for tuition and related expenses, such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization. The taxability of stipends, however, in no way alters the relationship between NRSA fellows and institutions. NRSA stipends are not considered salaries. NRSA fellows are not considered to be in an employee-employer relationship with NIH or with the institution in which they are pursuing research training. The interpretation and implementation of the tax laws are the domain of the Internal Revenue Service (IRS) and the courts. NIH takes no position on the status of a particular taxpayer, and it does not have the authority to dispense tax advice. Individuals should consult their local IRS office about the applicability of the law to their situations and for information on the proper steps to be taken regarding their tax obligations. The business office of the sponsoring institution is responsible for the annual preparation and issuance of the IRS form 1099 (Statement of Miscellaneous Income) for fellows paid through the institution (fellows at domestic non-Federal institutions). Other Training Costs NINR will provide an institutional allowance of $2,000 per 12-month period to non-Federal, nonprofit sponsoring institutions to help defray such awardee expenses as research supplies, equipment, and travel to scientific meetings. This allowance is intended to cover training-related expenses for the individual awardee. The allowance is not available until the fellow officially activates the award. If an individual fellow is not enrolled or engaged in training for more than 6 months of the award year, only one-half of that year's allowance may be charged to the grant. The Notice of Research Fellowship Award will be revised and the balance must be refunded to NINR. Tuition and Fees. The NINR will offset the combined cost of tuition, fees, and self-only health insurance at the following rate: 100 percent of all costs up to $2,000 and 60 percent of costs above $2,000. Costs associated with tuition and fees are allowable for course work required under the research training program supported by the fellowship. Family medical insurance is not allowable under an NRSA fellowship. A description of this policy change appeared in the NIH Guide for Grants and Contracts, Volume 25, No. 2, February 2, 1996. Funds are not provided to cover the cost of travel between the fellow's place of residence and a domestic training institution. However, in cases of extreme need or hardship, a one-way travel allowance may be authorized by NINR. Such travel must be paid from the institutional allowance. Indirect costs are not allowed on individual fellowship awards. APPLICATION PROCEDURES Individuals must submit the application form, PHS Individual National Research Service Award (PHS 416-1, rev. 8/95). The applicant must follow ALL general instructions in the application kit AND the specific instructions included in the Appendix to this program announcement, which is available from the program contact listed under INQUIRIES. Application kits are available at most institutional offices of sponsored research. Application forms and the brochure "Helpful Hints on Preparing a Fellowship Application to the National Institutes of Health" are available 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, Email: asknih@odrockm1.od.nih.gov. Potential applicants are strongly encouraged to consult with one of the NINR program staff listed under INQUIRIES prior to submitting an application. If the applicant has been lawfully admitted to the United States for permanent residence, the appropriate item should be checked on the Face Page of the application. A notarized statement documenting legal admission for permanent residence must be submitted prior to the issuance of an award. Applicants and sponsoring institutions must comply with policies and procedures governing the protection of human subjects, the humane care and use of live vertebrate animals, and the inclusion of women and minorities in study populations. Applicants should indicate in Item 3 on the face page of the application the initials NR to represent that the National Institute of Nursing Research is appropriate to the research area of the application. Also in Item 3, cite the number of this program announcement (PAR-97-016) to assist in the assignment process. Submission Submit a signed, typewritten original of the application (including the Checklist, Personal Data Form, at least three sealed reference letters, a clear and legible copy of the applicant's transcript(s) from all undergraduate and graduate institutions in which the applicant is/has been enrolled, and all other required materials) and two exact and clear, single-sided photocopies of the signed application. Appendices should contain three collated sets of materials with items stapled where appropriate and each marked with the name of the fellow. Include a summary sheet listing all of the items included in the appendix. Mail all items 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 (express/courier service) Application Receipt Dates and Review Schedule The Individual (F31) NRSA Fellowship application undergoes a review process that takes between 5 and 8 months. The three annual review cycles are as follows: Application Receipt Date: Apr 5 Aug 5 Dec 5 Initial Review Date: Jun/Jul Oct/Nov Feb/Mar Secondary Review Date: Aug/Sep Dec/Jan Apr/May Anticipated Date of Award: Sept 1/Dec1 Jan 1/Mar 1 May 1/Jul 1 REVIEW CONSIDERATIONS Applications receive two sequential levels of review. The initial review group (IRG), composed primarily of nongovernment scientists who have been selected for their competence in particular scientific areas, evaluate applications for merit. A scientific review administrator (SRA), a designated Federal official, coordinates the review of applications for the IRG. After the initial review meeting, the SRA prepares the summary statement for each application and forwards it to the Division of Extramural Activities in NINR. There, a second level of review is provided by the NINR program staff members before a funding decision is made. Review Criteria The review criteria include the quality of the academic record and the prior research experience of the applicant, the quality of the graduate program in which the applicant is already enrolled or plans to enroll, the qualifications and the research/research training experience of the applicant's sponsor or research advisor, the match between the research interests of the student and the research advisor/sponsor; and for advanced graduate students, scientific significance, originality, and feasibility of the proposed research; for beginning students, quality and clarity of stated research interests. This grant mechanism is used to provide predoctoral individuals with supervised research training in specified health and health-related areas leading toward the research degree. Applicants for nursing individual predoctoral fellowship applications fall into one of three categories: Level 1, Level 2, and Level 3 candidates. Because fellowship applications are submitted by applicants in various stages of all three of these categories, the information in each application and the items that need to be evaluated will vary. All of the review criteria will, therefore, not be applicable in all cases. or is in the first quarter/semester of graduate study. The applicant may or may not have a postmaster's research experience. The review criteria will be based on an evaluation of the most recent academic performance, past experiences, references supportive of a research career, and evidence of scholarship and analytical ability. Courses should support the research area, in addition to the required courses. There should be an adequate description on a problem area in which a proposal can be developed and several potential research questions. The literature review should include interpretation and identification of the critical concepts related to the problem area. There should also be evidence of a critical analysis and synthesis of key studies in the problem area. The sponsor should have expertise in the proposed research area. If the sponsor is an academic advisor there should be a faculty mentor with research expertise in the applicant's research area. be the degree of course completion at the time the application was written. There should be a short description sufficient to indicate the content of courses taken or planned relating to the research area. There should be a clearly defined problem area and statement of purpose. The review of the literature should include analyses and synthesis related to concepts important to the research topic proposed. The project's research design and methods and its significance and originality should be defined. The sponsor should have expertise in the content and methodology in the proposed research. The sponsor's statement should show knowledge of the applicant's plan as well as a description of resources available. If the sponsor does not have total expertise, a cosponsorship should be included with expertise in the content and/or methodology proposed. The specific review criteria will be the same as for Level 2 applicants except for: 1) the research project should be defined and detailed with a well-developed research design and methods section and 2) the inclusion of dissertation committee members and their areas of expertise, as well as the university's resources in the sponsor's statement. It is important to remember that the individual predoctoral fellowship (F31) program is a training award and not a research award. Major considerations in the review are the potential for a productive scientific career, the need for the proposed training, and the degree to which the research training proposal, the sponsor, and the environment will satisfy these needs. For more details, see the section on Peer Review Process in the PHS 416-1 application instructions. Award Criteria NINR staff use the following criteria in making awards: priorities and program balance, and Activation. An awardee has up to 6 months from the issue date on the award notice to activate the award. Under unusual circumstances, NINR may grant an extension of the activation period upon receipt of a specific request from the fellow. In general, no awards may be activated between October 1 and November 15. Terms and Conditions of Support Fellowships must be administered in accordance with the current National Research Service Award Guidelines for Individual Awards and Institutional Grants, the current award, the recipient is free to arrange for copyright without approval when publications, data, or other copyrightable works are developed in the course of work under a PHS grant-supported project or activity. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes. Nondiscrimination. NINR research training and career development programs are conducted in compliance with applicable laws that provide that no person shall, on the grounds of race, color, national origin, handicap, or age, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity (or, on the basis of sex, with respect to any education program or activity) receiving Federal assistance. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Lynn Amende - diabetes, and urinary incontinence; and in long-term care and caregiving. Dr. J. Taylor Harden - women's health; developmental transitions, such as adolescence and menopause; and health and behavior research, such as studies of smoking cessation. Dr. Hilary Sigmon - care of individuals with cardiac or respiratory conditions. This area also includes research in critical care, trauma, wound healing, and organ transplantation. Dr. Mary Leveck - pain management, sleep disorders, symptom management in persons with brain disorders such as Alzheimer's disease, and rehabilitation following brain and spinal cord injury. This area also includes research on patient care in acute care settings. Dr. Laura James - factors during pregnancy, delivery of prenatal care, care of neonates, infant growth and development, and fertility issues. The address, telephone, FAX & email for the above listed staff members are: Building 45, Room 3AN-12 45 Center Drive, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-6906 FAX: (301) 480-8260 Email: Firstname_Lastname@nih.gov For inquiries regarding fiscal matters, contact: Mr. Jeff Carow Grants Management Office National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6301 Telephone: (301) 594-5974 FAX: (301) 480-8256 Email: JCarow@ep.ninr.nih.gov AUTHORITY AND REGULATIONS NRSA awards are made under the authority of Section 487 of the Public Health Service Act as amended (42 USC 288), and Title 42 of the Code of Federal Regulations, Part 66. The following Catalog of Federal Domestic Assistance number 93.361 applies to NINR supported predoctoral awards. 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 Mon Dec 16 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 14 December 1996 Date: 16 Dec 1996 16:52:05 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 135 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <594qrl$62b@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 December 14, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: December Bulletin-Vol. 24, No. 4 File size (bytes): 46331 STIS Filename: bul9612.txt Document Type: Grant Conditions Title: fdparmya -- DEPARTMENT OF ARMY - Agency Specific Requirements - Mod[4 File size (bytes): STIS Filename: fdparmya.txt (NSF) Document Type: International Document Title: INT 96-39-SSR 96-11 Pressurized Gas Transport for Intravascular Oxygenation File size (bytes): 4458 STIS Filename: int9639.txt Title: INT 96-40-SSR 96-14 Studies of the Solar Corona Using Simultaneous X-ray and Radio Observations File size (bytes): 6299 STIS Filename: int9640.txt Title: INT 96-41 -- SSR 96-15 Theoretical and Numerical Investigations of Relaxation in Metastable System File size (bytes): 11396 STIS Filename: int9641.txt Document Type: Letter Title: nsf9731.txt - Dear Colleague Letter - Biosystems Analysis and Contr File size (bytes): 8251 STIS Filename: nsf9731.txt Document Type: Program Guideline Title: NSF 97-21 -- Special Competition in Systematic Biology File size (bytes): Partnerships STIS Filename: nsf9721.txt (NSF) Title: NSF 97-22--TRANSFORMATIONS TO QUALITY ORGANIZATIONS PROGRAM File size (bytes): 32267 STIS Filename: nsf9722.txt Title: The Northeast Pacific Study File size (bytes): Co-ordinated Coastal Research Phase I STIS Filename: nsf9725.txt (NSF) Document Type: Recruit Title: Program Director File size (bytes): 7108 STIS Filename: vex973.txt Title: Program Director File size (bytes): 6496 STIS Filename: vex974.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 6957 STIS Filename: cmmtg.txt Document Type: Letter Title: nsf9731.txt - Dear Colleague Letter - Biosystems Analysis and Contr File size (bytes): 8251 STIS Filename: nsf9731.txt Document Type: Recruit Title: Program Director File size (bytes): 7108 STIS Filename: vex973.txt Title: Program Director File size (bytes): 7108 STIS Filename: vex973.txt Title: Program Director File size (bytes): 6496 STIS Filename: vex974.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 vex974.txt, the text of your message should be as follows: get vex974.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve vex974.txt, you would enter: ftp> get vex974.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 Dec 18 22:00:00 1996 Path: biosci!biosci!not-for-mail From: Jiang Yan Newsgroups: bionet.sci-resources Subject: Australia-China Institutional Links Program Seeking for Collaborative Australia Institutions Date: 18 Dec 1996 20:44:35 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 142 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <32B90320.1250@cdisn2.cdisn.cd.sc.cn> NNTP-Posting-Host: net.bio.net According to the agreement between Chinese Government and Australia Government, Australian Agency for International Development(AusAID)will provide $A4,000,000 for 20 Chinese-Australia research project. Now the ministry of Foreign Trade and Economic Cooperation and State Education Commission of China listed my Institution as an application unit. As the rule of the program I must find a collaborative Institution in Australia. My institution named the National Lab for Grassland Biological Control in Sichuan University. The following is a brief introduction of my institution. "National Lab for Grassland Biological Control " in Sichuan University,is one of the World Bank Loan important science developing projects.In 1990,with the comment of relation experts and the ratification of the government, it cost 430,000SDR from W.B. loan,and 1,800,000RMP from the government. From 1991 to now,according to the feasibility report and implement plan,this project had been successfully finished.This not only laid good foundation for our research and education work,but also developed our research and education work and academic interchange.With the advanced equipments parchased from the W.B.loan,the research terms of our Lab.was ameliorated, in addition academic interchange and technical assistance, developed the research and education level,apply important subjects. Now let's get brief summary: First.The research had made noticeable improvement,both in range and depth,and have setup the distinguishing feature science system of "grass biotechnology".The foundation of this project made us powerful to strive for,accept and undertake more subjects,get more funds, and obtain more research achievement(See table 1).The number of subjects,funds,and achievements in 1991-1995 are twice than that in 1986-1990. Table 1.The research in recent 10 years Items 1991--1995 1986--1990 Research subjects and funds National science and technology subject 5 1 National science fund 14 5 Important subject form province and ministry 17 9 International co-operation subject 2 / The other subject 5 2 Total of subjects 43 17 Total of funds(not includ international co-operation 600 120 subjects) (10 thousand yuan) research achievements Appraisal 15 5 Prize 7 4 research papers 300 100 Treaties 5 2 There are very great develop in the research contain.In the past, we did work in the biocontrol ofgrassland rodden, disease and insect pests, and grassland protect.Now we can research the crux of grassland especially the protecting,building and developing of qing-zhang plateau from different level: from molecular, cellar,individual and population. Second.With the precision equipments,stable research direction and experienced teachers,we have get marked progress in education,consummated the education manage system,trained lot of graduate students for Dr.and Ms. degree and foreign students(See table 2). Table 2. The education in recent 10 years Items 1991-1995 1986-1990 Number of graduate students Accepted graduate students for Dr.degree 22(female 5) 8 Graduate Student for Dr.dgree in school(Sept.1995) 16 / Accept G.S.for MS.degree 52(female 23) 36 G.S.for MS.degree in school (Sept.1995) 31 / Accepted foreign students 7 / G.S.for Dr.degree from other school work in the Lab. 7 / Education system Tutors for G.S.for Dr.degree 3 1 Majors for G.S.for Dr.degree 3 1 Tutors for G.S.for Ms.degree 8 4 Majors for G.S.for MS.degree 3 3 1.Teachers group:There are 25 fellow in this Lab,4 professors,8 associate professors. 2 professors and 8 associate professors were admitted during this project going.There are 3 majors for graduate students for Dr.degree, they are plant genetics and grassland ,3 tutors for graduate students for Dr.degree,8 tutors for Ms.degree.part of the majors and tutors were admitted during this project. 2.The number of accepted graduated students exceeded the guota.From 1991-1995, we accepted 22(female 5) students for Dr.degree,52(female 23) for MS.degree, far exceeded the number of 1986-1990.we have accepted 7 foreign students from Germany, Korea, Pakistan, Thailand and Nepal.In addition,we also accepted some students for Dr.degree form other Lab. working in this Lab to finish their research paper. The third.The academic interchange and technical co-operation got forward(See table 3). Items 1991-1995 1986-1990 1.We get in touch with universities and institutes for academic interchange, technical co-operation and teacher train from many countries USA, England, Germany, Australian, New Zealand,Italy and our country.From 1991,we took part in international congresses 3-4 times very year,sent 1-2 person to get training or visit in other countries. Now there are still 8 young experts study and work in other countrsies. Invited 10 foreign experts coming to get open lectures in our Lab. The aim: 1.For this Lab. has just been setup,we should develop research,educate manage and instrument manage in order to make perfect use of the invisible function and make more progress in work. 2.Enhance the touch with national and international institutes inacademic interchange and other aspects,in order to make it to be an openning Lab. recently. 3.Prefectly make use of the research condition,set up the research in subjects of high-level technology.In the meantime,enhance the contact with high-level technology products factories,in order to make the research achievements become to products.Make the Lab. to be "National Biopesticide recearch centre". 4.Geting the person training,include researchers and managers,enhance the group's ability,and accept new experts. The project we are interested in is the environmental biological control and development. Now we want to study several subtitles especially in the construction of a transgenomic plant from the GPD gene in a kind of alga-Dunaliella salina, key technology in anti Taenia Sodium which wide spread in human and animal range from 30% to 80% in more than ten provinces in Chines countryside and the development of the biological pesticide for harmful insects and rodden in the grassland. All the above projects are also aided by the National Science Foundation in China. If anyone who may concern with the collaboration, please contact me for more details and we may do more discussion. And if someone wants to know more about the Australia-China Institutional Links Program, please contact Australian Agency for International Development. Jiang Yan National Lab for Grassland Biological Control Bioengineering Department Sichuan University Chengdu, Sichuan 610064 P.R.C. From owner-sci-resources@net.bio.net Fri Dec 20 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: BIOSCI/bionet miniFAQ & Fundraiser Date: 21 Dec 1996 13:56:03 -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: <199612201000.CAA05202@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 Dec 23 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 44, pt. 1of1, 20 December 1996 Date: 24 Dec 1996 15:08:25 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 858 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <59pnp9$ph@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 25, No. 44 - December 20, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIH GUIDE PUBLICATION DATES $$INDEX N2 ********************************************************** CHANGE IN PROVISION OF COSTS ON NIA-SUPPORTED CAREER AWARDS National Institute on Aging INDEX: AGING NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 03/19/97 ************************************************ SUPPORT OF MINORITIES IN DIABETES, DIGESTIVE AND KIDNEY DISEASE (RFA DK-97-009) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX R2 04/03/97 ************************************************ COOPERATIVE COMMUNITY BASED PERINATAL STUDIES AND INTERVENTIONS IN MINORITY POPULATIONS IN THE DISTRICT OF COLUMBIA (RFA HD-96-005) National Institute of Child Health and Human Development Office of Research on Minority Health INDEX: CHILD HEALTH, HUMAN DEVELOPMENT; MINORITY HEALTH $$INDEX P1 ********************************************************** HIV-1 INFECTION OF THE CENTRAL NERVOUS SYSTEM (PA-97-017) National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute on Drug Abuse National Institute of Child Health and Human Development INDEX: MENTAL HEALTH; NEUROLOGICAL DISORDERS, STROKE; DRUG ABUSE; CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX P2 ********************************************************** CARDIOVASCULAR AGING RESEARCH (PA-97-018) National Institute on Aging National Heart, Lung, and Blood Institute National Institute of Nursing Research INDEX: AGING; HEART, LUNG, BLOOD; NURSING $$INDEX P3 ********************************************************** AGING, RACE, AND ETHNICITY IN PROSTATE CANCER (PA-97-019) National Institute on Aging National Cancer Institute National Institute of Environmental Health Sciences INDEX: AGING; CANCER, ENVIRONMENTAL HEALTH SCIENCES $$INDEX P4 ********************************************************** NCRR SHARED INSTRUMENTATION GRANT PAR-97-020) National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX P5 ********************************************************** HIGH-THROUGHPUT TECHNOLOGIES TO DETECT ALTERATIONS IN TUMORS (PAR-97-021) National Cancer Institute INDEX: CANCER ERRATA $$INDEX E1 PAR-97-016 *********************************************** NINR NATIONAL RESEARCH SERVICE AWARD INDIVIDUAL PREDOCTORAL FELLOWSHIPS (PAR-97-016) National Institute of Nursing Research INDEX: NURSING 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 $$N1 BEGIN ********************************************************** THE NIH GUIDE FOR GRANTS AND CONTRACTS WILL NOT BE PUBLISHED ON DECEMBER 27, 1996 AND JANUARY 3, 1997. THE NEXT ISSUE OF THE NIH GUIDE WILL BE ON JANUARY 10, 1997. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** CHANGE IN PROVISION OF COSTS ON NIA-SUPPORTED CAREER AWARDS NIH GUIDE, Volume 25, Number 44, December 20, 1996 P.T. 34 National Institute on Aging The National Institute on Aging (NIA) announces a change in the provision of costs on certain career awards supported by the Institute. This change is effective for new and continuing awards to be issued in fiscal year 1997 (FY 97) and subsequent years. Where applicants have already applied for an award under the former guidelines, if they are to be issued an award, they will be contacted by Institute staff and asked whether they wish to submit a budget that is revised to match the revised allowable costs. Prospective applicants are also reminded that all career award applications must be submitted following just-in-time procedures. These procedures are described in the NIH Guide (NIH GUIDE, Vol. 25, No. 10, March 29, 1996; NIH GUIDE, Vol. 25, No. 16, May 17, 1996). Affected mechanisms: This change in allowable costs applies to new and continuing K01 (Mentored Research Scientist Development awards, Special Emphasis Research Career awards), K02 (Independent Scientist awards), K04 (Research Career Development awards), K08 (Mentored Clinical Scientist Development awards, Clinical Investigator awards), K11 (Physician Scientist awards) and K12 (Mentored Clinical Scientist Development Program awards, Geriatric Academic Program awards.) The change does not apply to K07 (Academic Career - Leadership awards). NIA does not support K05 (Senior Scientist awards) and K07 (Academic Career - Development awards). Allowable Costs: New Awards and Competing Continuations 1. Salary: Beginning in FY 97 the NIA is providing salary and fringe benefits for K award recipients, based on the institution's salary scale for faculty at an equivalent experience level. The amount allowed varies by the length of the award. Up to $60,000 per year (plus commensurate fringe benefits) is allowed for three year awards. For longer awards, up to $60,000 is allowed on any three years of the award, and $50,000 is allowed on the remaining year or years. For K12 program awards amounts are limited per slot. The $60,000 per year limit is allowed for no more than 60 per cent of authorized slots in any one year, and no more than 5 total slots. The $50,000 limit will apply to remaining slots. The institution may supplement the NIA 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 Public Health Service (PHS) funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the career 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: 1. K01 and K08 awards. The NIA is providing 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. 2. K12 awards. The NIA is providing $20,000 per year for up to five slots and no more than $10,000 per year for remaining slots. For K02 awards NIA will provide up to $5,000 annually to offset the cost of tuition, fees, books, and similar educational materials related to career development. 3. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed. Continuing Awards (Type 5) Beginning with the FY 97 renewal of Type 5 noncompeting continuing K01, K02, K04, K08 and K11 awards, the NIA is permitting increases to these awards up to the revised limits for new and competing awards for salary and for research development expenses. However, no continuing award may be increased by more than $15,000 in direct costs in any single fiscal year. For Type 5 noncompeting continuing K12 awards, NIA is also permitting increases to these awards up to the revised limits for new and competing K12 awards. However, no K12 award may be increased by more than $7,500 in direct costs per awarded slot in any single fiscal year. Direct inquiries concerning programmatic issues to: Dr. Robin A. Barr Office of Extramural Affairs National Institute on Aging 7201 Wisconsin Avenue, Suite 2C218, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9322 FAX: (301) 402-2945 Email: rb42h@nih.gov Direct inquiries relating to fiscal matters to: Mr. Joseph Ellis Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: EllisJ@gw.nia.nih.gov $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN DK-97-009 FULL-TEXT ************************************** SUPPORT OF MINORITIES IN DIABETES, DIGESTIVE AND KIDNEY DISEASE NIH GUIDE, Volume 25, Number 44, December 20, 1996 RFA AVAILABLE: DK-97-009 P.T. 34; FF; K.W. 0715075, 0715085 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 19, 1997 Application Receipt Date: March 19, 1997 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) recognizes the need to increase the number of under represented minority individuals committed to scientific careers in research areas served by the NIDDK. This program is aimed primarily at recently trained M.D. and/or Ph.D. minority investigators. The program will enable the minority applicant to accept a tenure-earning position, gain additional research experience and obtain preliminary data on which to base a subsequent research grant application (R01 or R29) in an area of diabetes, endocrinology, metabolic diseases, digestive diseases, nutrition, kidney diseases, urologic diseases, or hematologic diseases. For FY 1997, it is anticipated that approximately @250,000 will be available to award approximately five small grants (R03) under this Request for Applications (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, Support of Minorities in Diabetes, Digestive and Kidney Disease, is related to the priority area of increasing under represented minority health scientists. 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. Charles H. Rodgers, Ph.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS 19J, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 Email: rodgersc@ep.niddk.nih.gov $$R1 END ************************************************************ $$R2 BEGIN HD-96-005 FULL-TEXT ************************************** COOPERATIVE COMMUNITY BASED PERINATAL STUDIES AND INTERVENTIONS IN MINORITY POPULATIONS IN THE DISTRICT OF COLUMBIA NIH GUIDE, Volume 25, Number 44, December 20, 1996 RFA AVAILABLE: HD-96-005 P.T. 34, FF; K.W. 0775013, 0775025, 0775020, 0403004 National Institute of Child Health and Human Development Office of Research on Minority Health Letter of Intent Receipt Date: January 31, 1997 Application Receipt Date: April 3, 1997 PURPOSE The National Institute of Child Health and Human Development (NICHD) and the Office of Research on Minority Health (ORMH), invite new and renewal applications from institutions desiring to participate with the NICHD under a cooperative agreement (U18) in an ongoing multi-center research program designed to investigate topics related to the high infant mortality among minority populations in Washington, DC. It is the objective of this initiative to expedite the development of answers to these problems through a cooperative research network of participating centers in Washington, DC in cooperation with the NICHD. Research topics to be addressed include studies and interventions in women during pregnancy, infants and young children, as well as non-pregnant women during the preconception or interconception phase. Applicants must be able to propose research projects and to demonstrate relevant research experience pertinent to the objectives delineated in this RFA, qualifications of key personnel, and proven capacity to recruit community, clinic or hospital based populations for the planned interventions. The applicants must be willing and able to participate in a cooperative program of research and evaluation with other successful applicants. Peer reviewers convened by the NICHD will evaluate the qualifications and relevant research experience of the principal investigator and staff to do the proposed research; and the availability of resources necessary to conduct the research. It is anticipated that between six and eight organizations will be involved in this initiative. 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-lead national activity for setting priority areas. This Request for Applications (RFA), Cooperative Community Based perinatal studies and interventions in minority populations, is related to the priority areas of infant mortality, fetal deaths, low birth weight, high risk pregnancies and prenatal care. 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. Barbara Wingrove, M.P.H. Division of Epidemiology, Statistics and Prevention Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 7B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 594-1302 FAX: (301) 480-0649 Email: Barbara_Wingrove@NIH.GOV $$R2 END ************************************************************ $$P1 BEGIN PA-97-017 FULL-TEXT ************************************** HIV-1 INFECTION OF THE CENTRAL NERVOUS SYSTEM NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA AVAILABLE: PA-97-017 P.T. 34; K.W. 0705055, 0715008, 0765033, 0745070 National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute on Drug Abuse National Institute of Child Health and Human Development PURPOSE The National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Drug Abuse (NIDA) and National Institute of Child Health and Human Development (NICHD) invite research grant applications through this Program Announcement (PA) to support research focused on determining the pathogenic mechanisms involved in HIV-1 associated neurobehavioral and neurological dysfunction in adults and children. The objective of this cooperative effort is to foster investigations that will provide the foundation for the rapid development of therapeutic interventions to prevent and treat the effects of HIV-1 on the central nervous system (CNS). Applications ranging from basic research to clinical diagnosis and treatment studies are being solicited. Multidisciplinary research teams and collaborative alliances are encouraged but not required. This PA will use the investigator-initiated research project grant (R01), First Independent Research Support and Transition (FIRST) (R29) award, program project grant (P01), individual postdoctoral fellowship program (F32), and small research grant (R03) mechanisms. 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, HIV-1 Infection of the Central Nervous System, is related to the priority area of HIV infection. 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. Walter L. Goldschmidts, Ph.D. Office on AIDS National Institute of Mental Health Parklawn Building, Room 10-75 Bethesda, MD 20857 Telephone: (301) 443-7281 FAX: (301) 443-9719 Email: wgoldsch@nih.gov A. P. Kerza-Kwiatecki, Ph.D. Division of Convulsive, Infectious and Immune Disorders National Institute of Neurological Disorders and Stroke 7550 Wisconsin Avenue, Room 804 Bethesda, MD 20892 Telephone: (301) 496-1431 FAX: (301) 402-2060 Email: ak45w@nih.gov Lynda Erinoff, Ph.D. Office on AIDS National Institute on Drug Abuse Parklawn Building, Room 9A30 Bethesda, MD 20857 Telephone: (301) 443-6046 FAX: (301) 443-4100 Email: le30q@nih.gov Anne Willoughby, M.D., MPH Pediatric, Adolescent and Maternal AIDS Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B11H Bethesda, MD 20892 Telephone: (301) 496-7339 FAX: (301) 496-8678 Email: willouga@hd01.nichd.nih.gov $$P1 END ************************************************************ $$P2 BEGIN PA-97-018 FULL-TEXT ************************************** CARDIOVASCULAR AGING RESEARCH NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA AVAILABLE: PA-97-018 P.T. 34; K.W. 0710010, 0715040 National Institute on Aging National Heart, Lung, and Blood Institute National Institute of Nursing Research PURPOSE The goal of this program announcement (PA) is to foster research that will enhance our understanding of age-associated changes in the cardiovascular system and, moreover, how these normal changes increase susceptibility to cardiovascular disease. The PA documents eight areas of research opportunities highlighted by the National Institute on Aging (NIA) Cardiovascular Aging Advisory Panel. Another goal of this PA is to promote cardiovascular health during the aging process. This program will use the NIH investigator-initiated research project grant (R01) and the First Independent Research Support and Transition (FIRST) (R29) award mechanisms. 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, Cardiovascular Aging Research, is related to the priority area of heart disease and stroke. 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 program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221), the NIH GOPHER (gopher.nih.gov), the NIH Website (http://www.nih.gov), and the NIA Home Page (http://www.nih.gov/nia/) and by mail and Email from the program contact listed below. Andre J. Premen, Ph.D. Geriatrics Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3E327, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-6761 FAX: (301) 402-1784 Email: PremenA@gw.nia.nih.gov $$P2 END ************************************************************ $$P3 BEGIN PA-97-019 FULL-TEXT ************************************** AGING, RACE, AND ETHNICITY IN PROSTATE CANCER NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA AVAILABLE: PA-97-019 P.T. National Institute on Aging National Cancer Institute National Institute of Environmental Health Sciences PURPOSE The National Institute on Aging (NIA), National Cancer Institute (NCI), and National Institute of Environmental Health Sciences (NIEHS) invite research project grant (R01) and First Independent Research Support and Transition (FIRST) (R29) award applications to expand the understanding of biological and clinical factors leading to the development, progression, and treatment of prostate cancer in aging men. The increased risk of prostate cancer with advancing age and its prominence in older-aged men are well known characteristics of this tumor. The unusually high incidence and mortality rates of prostate cancer for older white and black American men and, by contrast, the much lower rates in men of Hispanic and Asian descent, provide the need for research that emphasizes the role of race and ethnic factors, as well as age, in early diagnosis, management, and etiology of this tumor. This Program Announcement is intended to stimulate research that applies the expanding scientific knowledge gained on prostate cancer to older men and to extend the knowledge base on age-related aspects of the etiology of this malignancy. 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, Aging, Race, and Ethnicity in Prostate Cancer, 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 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. Rosemary Yancik, Ph.D. Cancer Section, Geriatrics Program National Institute on Aging Building 31, Room 5C05 Bethesda, MD 20892 Telephone: (301) 496-5278 FAX: (301) 496-2793 Email: YancikR@31.nia.nih.gov Andrew Chiarodo, Ph.D. Organs System Coordinating Branch National Cancer Institute Executive Plaza North, Room 512 Bethesda, MD 20892 Telephone: (301) 496-8528 FAX: (301) 402-0181 Email: ac53a@nih.gov Gwen Collman, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-4980 FAX: (919) 541-4937 Email: collman@niehs.nih.gov $$P3 END ************************************************************ $$P4 BEGIN PAR-97-020 FULL-TEXT ************************************* NCRR SHARED INSTRUMENTATION GRANT NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA AVAILABLE: PAR-97-020 P.T. 34; K.W. 0735015, 1014001 National Center for Research Resources Application Receipt Date: March 26, 1997 PURPOSE The National Center for Research Resources (NCRR) announces the availability of a Program Announcement (PA), to continue the competitive NCRR Shared Instrumentation Grant (SIG) Program initiated in Fiscal Year 1982. The (1996) National Report on Academic Research Equipment and Equipment Needs for Biological Sciences, co-sponsored by the National Institutes of Health (NIH) and the National Science Foundation (NSF), identified research equipment of the type provided through this program as top-priority. The objective of the program is to make available to institutions with a high concentration of NIH-supported biomedical investigators expensive research instruments which can only be justified on a shared-use basis and for which meritorious research projects are described. Awards under this PA will use the Shared Instrumentation Grant mechanism (S10). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Marjorie A. Tingle, Ph.D. Shared Instrumentation Grant Program National Center for Research Resources 6705 Rockledge Drive, Room 6154, MSC 7965 Bethesda, MD 20892- 7965 Telephone: (301) 435-0772 FAX: (301) 480-3659 Email: SIG@EP.NCRR.NIH.GOV $$P4 END ************************************************************ $$P5 BEGIN PAR-97-021 FULL-TEXT ************************************* HIGH-THROUGHPUT TECHNOLOGIES TO DETECT ALTERATIONS IN TUMORS NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA AVAILABLE: PAR-97-021 P.T. 34; K.W. 0715035, 0745020, 0785140 National Cancer Institute PURPOSE The Technology Development Branch of the Cancer Diagnosis Program, Division of Cancer Treatment, Diagnosis and Centers (DCTDC), National Cancer Institute (NCI) invites Program Project grant applications (P01s) proposing the development of high-throughput technologies for the evaluation of the spectrum of molecular alterations in primary tumor tissue. To take full advantage of the advances made in sequencing of the human genome and in our understanding of the alterations underlying cancer, it will be necessary to develop new and improved technologies to scan the entire genome of a cancer cell or of tumor tissue for constellations of gene mutations and to identify changes in gene expression at the level of both RNA and protein. Assessing the potential utility of these new techniques for doing genome-wide genetic analyses or for analyzing patterns of protein expression will require the coordination of technology development efforts with the application of the technologies to appropriate clinical specimens. The P01 funding mechanism is being used to facilitate collaborations between researchers developing novel technologies and clinical investigators with the appropriate expertise and resources to assess the application of the technologies to tumor specimens. The Advanced Technology Program (ATP) of the National Institute of Standards and Technology (NIST) is supporting commercial organizations to develop DNA-based technologies for a wide variety of diagnostic applications. The current Program Announcement will complement this important effort by supporting application of these and other technologies to the analysis of tumor tissue and by supporting the modification of technologies to optimize their utility in the clinical setting. 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), High-Throughput Technologies to Detect Alterations in Tumor Specimens, 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 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. James W. Jacobson, Ph.D. Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute 6130 Executive Boulevard, Room 513, MSC 7388 Bethesda, MD 20892-7388 Telephone: (301) 496-1591 FAX: (301) 402-1037 Email: JJ37D@NIH.GOV $$P5 END ************************************************************ ERRATA $$E1 BEGIN P1 19961213 APPEND PAR-97-016 BOTH ************************** NINR NATIONAL RESEARCH SERVICE AWARD INDIVIDUAL PREDOCTORAL FELLOWSHIPS NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA NUMBER: PAR-97-016 P.T. 22; K.W. 0720005, 0785130 National Institute of Nursing Research The following erratum is issued for PAR-97-016, which appeared in the NIH Guide, Vol. 25, No. 43, December 13, 1996. Under the heading "Review Criteria", paragraph 3 should read: Level 1 - The applicant has not formally started course work or is in the first quarter/semester of graduate study. The applicant may or may not have a postmaster's research experience. Paragraphs 5 and 6 should read: Level 2 - The applicant has completed one semester of course work, has not completed candidacy examinations or has not had a research proposal approved by the dissertation committee. The specific review criteria will be based on progress toward completion of the research training program requirements. The critical determinant will be the degree of course completion at the time the application was written. There should be a short description sufficient to indicate the content of courses taken or planned relating to the research area. There should be a clearly defined problem area and statement of purpose. The review of the literature should include analyses and synthesis related to concepts important to the research topic proposed. The project's research design and methods and its significance and originality should be defined. The sponsor should have expertise in the content and methodology in the proposed research. The sponsor's statement should show knowledge of the applicant's plan as well as a description of resources available. If the sponsor does not have total expertise, a cosponsorship should be included with expertise in the content and/or methodology proposed. Paragraph 7 and 8 should read: Level 3 - The applicant has completed course work. The specific review criteria will be the same as for Level 2 applicants except for: 1) the research project should be defined and detailed with a well-developed research design and methods section and 2) the inclusion of dissertation committee members and their areas of expertise, as well as the university's resources in the sponsor's statement. Under the heading "Award Criteria", paragraph 1 should read: NINR staff use the following criteria in making awards: - IRG recommendation of the overall merit of the application - relevance of the application to Institute research priorities and program balance, and - availability of funds. INQUIRIES Inquiries regarding this PA may be directed to: Lynn M. Amende, Ph.D. Division of Extramural Activities National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-5968 FAX: (301) 480-8260 Email: lamende@ep.ninr.nih.gov $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Mon Dec 23 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-019 - V25(44) 12/20/96 Date: 24 Dec 1996 15:09:02 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 495 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <59pnqe$1a1@net.bio.net> NNTP-Posting-Host: net.bio.net AGING, RACE, AND ETHNICITY IN PROSTATE CANCER NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA NUMBER: PA-97-019 P.T. National Institute on Aging National Cancer Institute National Institute of Environmental Health Sciences PURPOSE The National Institute on Aging (NIA), the National Cancer Institute (NCI) and the National Institute of Environmental Health Sciences (NIEHS) invite research grant applications to expand the understanding of biological and clinical factors leading to the development, progression, and treatment of prostate cancer in aging men. The increased risk of prostate cancer with advancing age and its prominence in older-aged men are well known characteristics of this tumor. The unusually high incidence and mortality rates of prostate cancer for older white and black American men and, by contrast, the much lower rates in men of Hispanic and Asian descent, provide the need for research that emphasizes the role of race and ethnic factors, as well as age, in early diagnosis, management, and etiology of this tumor. This Program Announcement is intended to stimulate research that applies the expanding scientific knowledge gained on prostate cancer to older men and to extend the knowledge base on age-related aspects of the etiology of this malignancy. 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, Aging, Race, and Ethnicity in Prostate Cancer, 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 foreign and 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. Foreign institutions are not eligible for the research program project or First Independent Research Support and Transition (FIRST) awards (R29). 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 investigator-initiated research project grant (R01) and FIRST award (R29). RESEARCH OBJECTIVES Background Though investigators acknowledge aging as a high risk factor for prostate cancer, current studies are limited by a lack of attention to the aging process and/or old age in combination with race, and ethnic factors. Further, it is also recognized that black Americans are affected by this tumor to an even greater extent than white Americans and that men of other race or ethnic origin are affected far less. Despite these striking age, race, and ethnic differences, no extensive research focus has been directed toward the role of aging, race, and ethnicity in prostate cancer. The magnitude of the prostate cancer problem for aging men, recent scientific and technologic advancements made relevant to prostate cancer detection and management, and the projected expansion of the aged male population combine to provide the impetus for this research solicitation. Summary Data -- Prostate cancer has the highest incidence of any tumor affecting men in the United States. In 1996, 317,000 new prostate cancer cases will be diagnosed according to estimates made by the American Cancer Society (ACS). Population-based data from the NCI Surveillance, Epidemiology, and End Results (SEER) Program show that the majority (81 percent) of persons affected by prostate cancer are 65 years and older. The median age for this malignancy is 72 years (SEER). Race and ethnic disparities in prostate cancer are portrayed with data collected on newly diagnosed cancers between 1988 and 1992 by the NCI SEER Program showing age-adjusted incidence rates for cancer for men of all ages. The summary incidence rate among black men is 180.6 per 100,000 population as compared to a rate of 134.7 for white men. Rates for men of other race and ethnic backgrounds are much lower: Hispanics, 89.0; Japanese, 88.0; American Indian, 52.5; Alaskan Native, 45.1; Chinese, 46.0; Filipino, 69.8; Hawaiian, 57.2; Vietnamese, 40.0; and Korean, 24.2 (SEER Racial/Ethnic Patterns Monograph). Using age 65 years as a breakpoint, age-adjusted rates per 100,000 population for 1988-1992, show that white men under 65 years have a rate of 32.0 as compared to 48.3 for blacks. For men 65 years and older, the rates are 1120.3 for whites as compared to 1458.9 for blacks. Age-adjusted mortality rates are more than twice as high for blacks as compared to whites for both younger and older age groups. For men under 65 years, the mortality rate for whites is 2.6 as compared to 7.3 for blacks. For men 65 years and older, the rates are 219.7 for whites as compared to 475.6 for blacks (SEER). The overall incidence and mortality rates for black Americans are not only the highest in the United States, they are the highest in the world. Cross-national comparisons with selected industrial nations show that only Sweden has prostate cancer incidence and mortality rates comparable to U.S. whites. Netherlands and Italy follow with rates about half as high as American blacks and whites, respectively. Japan has the lowest prostate cancer incidence and mortality rates of all these countries. Knowledge Development -- Much work has been done to increase the understanding of prostate cancer and great strides have been made in recent years to develop information on effective modalities in early detection and diagnosis of this malignancy. Investigations have explored the relationship between prostatic intraepithelial neoplasia (PIN), a putative precursor lesion to prostate cancer, and the serum marker for prostate cancer known as prostate-specific-antigen (PSA), a screening technique used in combination with other modalities in evaluating men for prostate cancer. Transrectal ultrasound development is another important advancement made in urology techniques that allows characterization of the prostate's normal and abnormal tissue, which when complemented by digital rectal examination (DRE) and PSA, provides valuable information for the detection and study of prostate cancer. Though benefits of different forms of therapy for prostate cancer have not been definitively determined, many investigators continue to address different treatment options that include radical prostatectomy, radiation, and expectant management as the most common therapies. The impact of how aging and concurrent comorbid conditions of the patient with prostate cancer affect treatment decisions and outcomes remain an under investigated area. Demographic Transition -- Unparalleled increases in the aging of the U.S. population impose a considerable public health challenge. The numerical growth of the older-aged male population will increase. Thus, in the future there will be even more older men vulnerable to prostate cancer. The proportion of males in the age segment 65 years and older in the U.S. population currently constitutes 13.9 million. At the beginning of the 21st century (2000), that number is expected to increase to 14.6 million. Fifteen years later, in 2015, 20.0 million of the male population will be in this age group. By 2030, 31.8 million men will be 65 years and older (reflecting the total effects of the "baby boom" phenomenon). Because of population growth alone, there will be even greater numbers of males likely to be affected by prostate cancer. An organized focus to ascertain what transpires at the aging/prostate cancer interface is needed to deal with the current and future problems caused by this malignancy. Research Goals and Scope This PA encourages the extramural research community to take advantage of recently acquired scientific knowledge and expertise developed in biology, gerontology, oncology, urology, and other disciplines and professions and apply these resources to aging relevant research questions on prostate cancer for aging males of different races and minority backgrounds. Major questions on prostate cancer in the context of an aging host invite multidisciplinary research in the areas of early diagnosis, management, and etiology of prostate cancer. Research efforts, single or in combination, focusing on diagnosis, management, and etiology, may be addressed as these areas pertain to aging, race, and/or ethnic groups. The targeted areas of research relevant to this PA are identified below. These are not exclusive and related issues designated by the applicant will be considered. Etiology and Risk Factors o Studies on factors that affect the rate of increase with age in risk for prostate cancer, and/or the rate of development and progression of premalignant changes in prostate tissue, as well as their interaction with familial factors, race, and/or ethnicity; o Epidemiologic studies of age-related familial, genetic, and environmental factors that may affect the age of onset, rate of progression, and duration of survival for prostate cancer; o Interactions of aging and age with prostate cancer risk factors (e.g., relative prominence of various risk factors for onset of prostate cancer at different ages; o Risk factors for occurrence of multiple primary prostate tumors. Disease Progression o Extent to which, and mechanism by which, age-related prostate growth leads to increased incidence of prostate cancer; o Role of other age-related biological factors that lead to the development and affect the progression rate of prostate cancer; o Assessment of protective factors that mitigate against prostate cancer (allow aging without development of premalignant changes); o Metastatic potential of various precursor lesions for prostate cancer in aging men. Diagnosis o Testing of improved methods to identify high risk older white and black men and low risk men of different race and ethnic origin through development of new techniques to distinguish premalignant changes from nonmalignant age-associated changes in prostate tissue; o Validation of new and/or current methodologies or application of current biological, physiological, and clinical techniques to identify high-risk older white and black men [e.g., prostatic intraepithelial neoplasia (PIN) and prostate-specific antigen (PSA)]; o Methods to distinguish older men with "clinically significant" cancer preoperatively; o Verification of diagnostic specificity and predictive value of PSA parameters for older men; o Studies of the causes of racial/ethnic disparities in disease stage at diagnosis (black men present with advanced disease stage more frequently); o Effects of age-associated changes on sensitivity, specificity, prognostic value of diagnostic techniques and their predictive value for response to treatment. Testing new methods and technologies to reduce age-associated problems in diagnosis and prognosis. Management o Testing new interventions or treatment strategies in older men with comorbid conditions to reduce age-associated complications or lessen age-associated reduction in treatment efficacy (as measured by treatment outcomes such as quality of life, functional status, and/or survival experience); o Clinical determinants of age- and ethnicity-associated differences in prostate cancer treatment efficacy and effectiveness for such outcomes as survival, treatment complications, side effects of treatment, and functional status; o Factors responsible for differences among age and ethnic groups in treatment received and clinical outcomes (e.g., stage at diagnosis, presence of comorbid conditions, age selection bias by physicians) and the effects of interactions among such factors. These may address: -- Special features of aging and/or symptoms of illness in old age that influence the treatment and care of older-aged prostate cancer patients and relate to treatment differences or modifications made because of old age; -- Assessment of the effectiveness of different treatments relative to the stage of disease and characteristics of old age (e.g., poor repair mechanisms, functional loss, greater susceptibility to toxicity of treatment); -- Evaluation of tolerance and response to standard or experimental adjuvant radiotherapy regimens or multimodality prostate cancer treatment interventions, controlling for physiologic parameters and other factors; -- Effects of age-associated, cultural, and life-style changes on sensitivity, specificity, prognostic value, and predictive value for treatment responsiveness and diagnostic techniques; -- Effects of previous and/or concurrent illnesses on prostate cancer treatment recommendations. Ancillary Studies/Existing Databases o Ancillary studies conducted with the NCI Clinical Trials Research Cooperative Groups, SEER Special Studies, and population-based tumor registry studies related to aging, race, and ethnicity in prostate cancer are welcome for this research solicitation. These may include studies on barriers to recruitment of older white and black males to prostate cancer clinical trials (e.g., comorbid conditions, physical frailty, lack of transportation), quality of life parameters for cancer patient survival follow-up; o Analyses of existing databases applicable and relevant to addressing treatment of older prostate cancer patients. Emphasis on older ethnic populations that may be compared with white and black populations is encouraged (e.g., longitudinal studies such as the Baltimore Longitudinal Study on Aging; Normative Aging Study; Framingham Study; as well as clinical studies). Research applications require a thorough and detailed explanation of the data elements in the studies identified as candidates for this research solicitation. Special attention should be given to ascertaining biases in the databases. Definitions This PA focuses in particular on men aged 65 years and older because the highest cancer incidence and mortality rates are found in this age group. Also, men in their mid-seventies and older are generally those most severely affected by prostate cancer. These men are also already quite likely to have preexisting chronic conditions which may be problematic in the diagnosis and management of cancer. The definition of "old age" or "elderly," however, is flexible and dependent on investigator-defined parameters. Applicants are expected to identify what is meant by "old" in the context of their research. Age comparisons with younger men are appropriate and may be included. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that 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 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 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also 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 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 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. 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 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 20892-7762 BETHESDA, MD 20817 (for express/courier service) Receipt dates for new Research Project Grants and FIRST Awards applications are February 1, June 1, and October 1 of each year. 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 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 vertebrate 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 IC. 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: Rosemary Yancik, Ph.D. Geriatrics Program National Institute on Aging Building 31, Room 5C05 Bethesda, MD 20892 Telephone: (301) 496-5278 FAX: (301) 496-2793 Email: YancikR@31.nia.nih.gov Andrew Chiarodo, Ph.D. Organs System Coordinating Branch National Cancer Institute Executive Plaza North, Room 512 Bethesda, MD 20892 Telephone: (301) 496-8528 FAX: (301) 402-0181 Email: ac53a@nih.gov Gwen Collman, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-4980 FAX: (919) 541-4937 Email: collman@niehs.nih.gov Direct inquiries regarding fiscal matters to: Joseph Ellis Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: EllisJ@gw.nia.nih.gov Robert E. Hawkins, Jr. Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800 Ext. 213 FAX: (301) 496-8601 Email: HawkinsR@gab.nci.nih.gov David L. Mineo Grants Management Branch National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-1373 FAX: (919) 541-2860 Email: mineo@niehs.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866, Aging Research; No. 93.394, Cancer Detection and Diagnosis Research; No. 93.395, Cancer Treatment Research; No. 93.396, Cancer Biology Research; No. 93.399, Cancer Control Research; and No. 93.113, Biological Response to Environmental Health Hazards. 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 Mon Dec 23 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DK-97-009 - V25(44) 12/20/96 Date: 24 Dec 1996 15:09:40 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 367 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <59pnrk$1kc@net.bio.net> NNTP-Posting-Host: net.bio.net SUPPORT OF MINORITIES IN DIABETES, DIGESTIVE AND KIDNEY DISEASE NIH GUIDE, Volume 25, Number 44, December 20, 1996 RFA: DK-97-009 P.T. 34, FF; K.W. 0715075, 0715085 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 19, 1997 Application Receipt Date: March 19, 1997 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) recognizes the need to increase the number of under represented minority individuals committed to scientific careers in research areas served by the NIDDK. This program is aimed primarily at recently trained M.D. and/or Ph.D. minority investigators. The program will enable the minority applicant to accept a tenure-earning position, gain additional research experience and obtain preliminary data on which to base a subsequent research grant application (R01 or R29) in an area of diabetes, endocrinology, metabolic diseases, digestive diseases, nutrition, kidney diseases, urologic diseases, or hematologic diseases. 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, Support of Minorities in Diabetes, Digestive and Kidney Disease, is related to the priority area of increasing under represented minority health scientists. 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 or local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Applicant must be African-American, Hispanic, Native American, Pacific Islander, or other ethnic or racial group members under represented in biomedical or behavioral research. To apply, an applicant must be a citizen of, or have been lawfully admitted to, the United States for permanent residence. An applicant must have a doctoral degree (M.D., Ph.D., D.O., D.D.S., D.V.M.). He or she should have received at least two years of postgraduate research training in an area of research applicable to research supported by the NIDDK, and have direct access to an expert in the area of the proposed research. Applicants may not hold, nor apply concurrently for any other PHS research project grant at the time of this application. Priority will be given to those applicants who have not previously been a Principal Investigator on a major research grant. Applicants are encouraged to apply for other research project grants (R01, R29) during the course of, or following, this award. MECHANISM OF SUPPORT Support will be provided through the Small Research Grant (R03) program administered by the Division of Diabetes, Endocrinology and Metabolism, the Division of Digestive Diseases and Nutrition, and the Division of Kidney, Urologic and Hematologic Diseases in the NIDDK. Responsibility for the planning, direction, and execution of the proposed project will be 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. If the NIDDK determines that there is a sufficient continuing program need, a new request for applications will be announced. The total project period for an application submitted in response to this RFA may be for one year, but may not exceed two years. Direct costs requested must not exceed $50,000 per year. These grants cannot be renewed. The anticipated award date is September 30, 1997. FUNDS AVAILABLE For FY 1997, $250,000 in total direct costs will be committed in each of the three research divisions in the NIDDK. It is anticipated that a total of five awards will be made in each of the three divisions in FY 1997. This level of support depends 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 NIDDK, the award of grants pursuant to this RFA is contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The primary purpose of this RFA is to increase the number of under represented minority Principal Investigators conducting research in areas supported by the NIDDK. Surveys of research and training programs administered by the NIDDK disclose the need to increase the access to NIDDK support of recently-trained minority scientists who are U.S. citizens or permanent residents. Those who receive several years of training via an individual postdoctoral fellowship or an institutional training grant funded by a National Research Service Award still require research experience and preliminary data to support an independent research career at this stage of development. An additional period of training may not be feasible for minority individuals with pressing economic burdens. Such individuals may be lost to academic research through a lack of opportunity to obtain an additional one or two years of support essential for establishing a research career. This program was designed to help alleviate some of the problems experienced by under represented minorities who may wish to pursue a career in academic research. The program will allow the minority investigator to hold a tenure-earning position, gain additional research experience and obtain preliminary data on which to base a subsequent research grant application. Special Requirements Applicants are required to have available a recognized expert in the area of proposed research for guidance and consultation. It is expected that this expert will assist the applicant in the design and conduct of his/her research. It is not necessary that the expert be at the same institution as the applicant, but he/she should be within a reasonable proximity to be available for guidance and consultation. Following the research plan, the applicant is required to provide a brief summary of his/her long-term career plans and objectives. The application should state how this award would make a difference in and enhance the applicant's development as a scientist. The department chairman/head should provide a brief paragraph indicating his/her plans for the applicant. This official should indicate the extent to which time, space and other necessary support will be provided to the applicant to conduct the proposed investigation(s). A letter from a recognized expert in the area of the proposed research should accompany the application packet. The letter should attest to his/her willingness to provide counsel and advice to the applicant, and an initial plan for ongoing contacts with the applicant. 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) 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 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 also obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by February 19, 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 a subsequent application, the information that it contains allows NIDDK staff to estimate the potential review workload and 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 37-F, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. The form is available at most institutional offices of 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) 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, 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) At the time of submission, two additional copies of the application, and five copies of any appendix material, 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 37-F, MSC 6600 Bethesda, MD 20892-6600 Applications must be received by March 19, 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 previously reviewed, but such applications must include an introduction addressing the previous critique. 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 NIDDK program division to which the application has been assigned. Review Criteria o the applicants previous research training, experience and publications; o his/her ability to complete the proposed research plan; o the overall scientific merit of the research plan; o whether the aims and scope of the research plan can provide definitive data within a one or two year period; o the potential of the proposed research to provide the bases for future studies; o the institutions willingness to commit facilities and departmental support to the applicant; o the applicants plans and career goals; o the availability of a recognized expert in the area of the proposed research for council and advice as attested to by a letter of agreement. AWARD CRITERIA The anticipated date of award is September 30, 1997. Applications will compete for available funds with all other applications submitted in response to this RFA and recommended by the initial review group. 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 balance among research areas of the RFA. o History of research support Schedule Letter of Intent Receipt Date: February 19, 1997 Application Receipt Date: March 19, 1997 Technical/Scientific Review: June/July 1997 Review by Divisions/NIDDK: September 1997 Anticipated Award Date: September 30, 1997 INQUIRIES Written and telephone 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: Charles H. Rodgers, Ph.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS 19J, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 Email: rodgersc@ep.niddk.nih.gov Judith M. Podskalny, Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN 12E, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8876 Email: podskalnyj@ep.niddk.nih.gov Ronald Margolis, Ph.D. Division of Diabetes, Endocrinology and Metabolism National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 5AN 12J, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8819 Email: margolisr@ep.niddk.nih.gov Direct inquiries regarding fiscal matters to: Ms Nancy C. Dixon Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN 44C, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8854 Email: dixonn@ep.niddk.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.847, 93.848, and 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 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 Dec 26 22:00:00 1996 Path: biosci!ihnp4.ucsd.edu!biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 44, pt. 1of1, 20 December 1996 Date: 26 Dec 1996 16:07:34 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 859 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <59v406$9c7@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 25, No. 44 - December 20, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIH GUIDE PUBLICATION DATES $$INDEX N2 ********************************************************** CHANGE IN PROVISION OF COSTS ON NIA-SUPPORTED CAREER AWARDS National Institute on Aging INDEX: AGING NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 03/19/97 ************************************************ SUPPORT OF MINORITIES IN DIABETES, DIGESTIVE AND KIDNEY DISEASE (RFA DK-97-009) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX R2 04/03/97 ************************************************ COOPERATIVE COMMUNITY BASED PERINATAL STUDIES AND INTERVENTIONS IN MINORITY POPULATIONS IN THE DISTRICT OF COLUMBIA (RFA HD-96-005) National Institute of Child Health and Human Development Office of Research on Minority Health INDEX: CHILD HEALTH, HUMAN DEVELOPMENT; MINORITY HEALTH $$INDEX P1 ********************************************************** HIV-1 INFECTION OF THE CENTRAL NERVOUS SYSTEM (PA-97-017) National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute on Drug Abuse National Institute of Child Health and Human Development INDEX: MENTAL HEALTH; NEUROLOGICAL DISORDERS, STROKE; DRUG ABUSE; CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX P2 ********************************************************** CARDIOVASCULAR AGING RESEARCH (PA-97-018) National Institute on Aging National Heart, Lung, and Blood Institute National Institute of Nursing Research INDEX: AGING; HEART, LUNG, BLOOD; NURSING $$INDEX P3 ********************************************************** AGING, RACE, AND ETHNICITY IN PROSTATE CANCER (PA-97-019) National Institute on Aging National Cancer Institute National Institute of Environmental Health Sciences INDEX: AGING; CANCER, ENVIRONMENTAL HEALTH SCIENCES $$INDEX P4 ********************************************************** NCRR SHARED INSTRUMENTATION GRANT PAR-97-020) National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX P5 ********************************************************** HIGH-THROUGHPUT TECHNOLOGIES TO DETECT ALTERATIONS IN TUMORS (PAR-97-021) National Cancer Institute INDEX: CANCER ERRATA $$INDEX E1 PAR-97-016 *********************************************** NINR NATIONAL RESEARCH SERVICE AWARD INDIVIDUAL PREDOCTORAL FELLOWSHIPS (PAR-97-016) National Institute of Nursing Research INDEX: NURSING 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 $$N1 BEGIN ********************************************************** THE NIH GUIDE FOR GRANTS AND CONTRACTS WILL NOT BE PUBLISHED ON DECEMBER 27, 1996 AND JANUARY 3, 1997. THE NEXT ISSUE OF THE NIH GUIDE WILL BE ON JANUARY 10, 1997. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** CHANGE IN PROVISION OF COSTS ON NIA-SUPPORTED CAREER AWARDS NIH GUIDE, Volume 25, Number 44, December 20, 1996 P.T. 34 National Institute on Aging The National Institute on Aging (NIA) announces a change in the provision of costs on certain career awards supported by the Institute. This change is effective for new and continuing awards to be issued in fiscal year 1997 (FY 97) and subsequent years. Where applicants have already applied for an award under the former guidelines, if they are to be issued an award, they will be contacted by Institute staff and asked whether they wish to submit a budget that is revised to match the revised allowable costs. Prospective applicants are also reminded that all career award applications must be submitted following just-in-time procedures. These procedures are described in the NIH Guide (NIH GUIDE, Vol. 25, No. 10, March 29, 1996; NIH GUIDE, Vol. 25, No. 16, May 17, 1996). Affected mechanisms: This change in allowable costs applies to new and continuing K01 (Mentored Research Scientist Development awards, Special Emphasis Research Career awards), K02 (Independent Scientist awards), K04 (Research Career Development awards), K08 (Mentored Clinical Scientist Development awards, Clinical Investigator awards), K11 (Physician Scientist awards) and K12 (Mentored Clinical Scientist Development Program awards, Geriatric Academic Program awards.) The change does not apply to K07 (Academic Career - Leadership awards). NIA does not support K05 (Senior Scientist awards) and K07 (Academic Career - Development awards). Allowable Costs: New Awards and Competing Continuations 1. Salary: Beginning in FY 97 the NIA is providing salary and fringe benefits for K award recipients, based on the institution's salary scale for faculty at an equivalent experience level. The amount allowed varies by the length of the award. Up to $60,000 per year (plus commensurate fringe benefits) is allowed for three year awards. For longer awards, up to $60,000 is allowed on any three years of the award, and $50,000 is allowed on the remaining year or years. For K12 program awards amounts are limited per slot. The $60,000 per year limit is allowed for no more than 60 per cent of authorized slots in any one year, and no more than 5 total slots. The $50,000 limit will apply to remaining slots. The institution may supplement the NIA 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 Public Health Service (PHS) funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the career 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: 1. K01 and K08 awards. The NIA is providing 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. 2. K12 awards. The NIA is providing $20,000 per year for up to five slots and no more than $10,000 per year for remaining slots. For K02 awards NIA will provide up to $5,000 annually to offset the cost of tuition, fees, books, and similar educational materials related to career development. 3. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed. Continuing Awards (Type 5) Beginning with the FY 97 renewal of Type 5 noncompeting continuing K01, K02, K04, K08 and K11 awards, the NIA is permitting increases to these awards up to the revised limits for new and competing awards for salary and for research development expenses. However, no continuing award may be increased by more than $15,000 in direct costs in any single fiscal year. For Type 5 noncompeting continuing K12 awards, NIA is also permitting increases to these awards up to the revised limits for new and competing K12 awards. However, no K12 award may be increased by more than $7,500 in direct costs per awarded slot in any single fiscal year. Direct inquiries concerning programmatic issues to: Dr. Robin A. Barr Office of Extramural Affairs National Institute on Aging 7201 Wisconsin Avenue, Suite 2C218, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9322 FAX: (301) 402-2945 Email: rb42h@nih.gov Direct inquiries relating to fiscal matters to: Mr. Joseph Ellis Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: EllisJ@gw.nia.nih.gov $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN DK-97-009 FULL-TEXT ************************************** SUPPORT OF MINORITIES IN DIABETES, DIGESTIVE AND KIDNEY DISEASE NIH GUIDE, Volume 25, Number 44, December 20, 1996 RFA AVAILABLE: DK-97-009 P.T. 34; FF; K.W. 0715075, 0715085 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 19, 1997 Application Receipt Date: March 19, 1997 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) recognizes the need to increase the number of under represented minority individuals committed to scientific careers in research areas served by the NIDDK. This program is aimed primarily at recently trained M.D. and/or Ph.D. minority investigators. The program will enable the minority applicant to accept a tenure-earning position, gain additional research experience and obtain preliminary data on which to base a subsequent research grant application (R01 or R29) in an area of diabetes, endocrinology, metabolic diseases, digestive diseases, nutrition, kidney diseases, urologic diseases, or hematologic diseases. For FY 1997, it is anticipated that approximately @250,000 will be available to award approximately five small grants (R03) under this Request for Applications (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, Support of Minorities in Diabetes, Digestive and Kidney Disease, is related to the priority area of increasing under represented minority health scientists. 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. Charles H. Rodgers, Ph.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS 19J, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 Email: rodgersc@ep.niddk.nih.gov $$R1 END ************************************************************ $$R2 BEGIN HD-96-005 FULL-TEXT ************************************** COOPERATIVE COMMUNITY BASED PERINATAL STUDIES AND INTERVENTIONS IN MINORITY POPULATIONS IN THE DISTRICT OF COLUMBIA NIH GUIDE, Volume 25, Number 44, December 20, 1996 RFA AVAILABLE: HD-96-005 P.T. 34, FF; K.W. 0775013, 0775025, 0775020, 0403004 National Institute of Child Health and Human Development Office of Research on Minority Health Letter of Intent Receipt Date: January 31, 1997 Application Receipt Date: April 3, 1997 PURPOSE The National Institute of Child Health and Human Development (NICHD) and the Office of Research on Minority Health (ORMH), invite new and renewal applications from institutions desiring to participate with the NICHD under a cooperative agreement (U18) in an ongoing multi-center research program designed to investigate topics related to the high infant mortality among minority populations in Washington, DC. It is the objective of this initiative to expedite the development of answers to these problems through a cooperative research network of participating centers in Washington, DC in cooperation with the NICHD. Research topics to be addressed include studies and interventions in women during pregnancy, infants and young children, as well as non-pregnant women during the preconception or interconception phase. Applicants must be able to propose research projects and to demonstrate relevant research experience pertinent to the objectives delineated in this RFA, qualifications of key personnel, and proven capacity to recruit community, clinic or hospital based populations for the planned interventions. The applicants must be willing and able to participate in a cooperative program of research and evaluation with other successful applicants. Peer reviewers convened by the NICHD will evaluate the qualifications and relevant research experience of the principal investigator and staff to do the proposed research; and the availability of resources necessary to conduct the research. It is anticipated that between six and eight organizations will be involved in this initiative. 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-lead national activity for setting priority areas. This Request for Applications (RFA), Cooperative Community Based perinatal studies and interventions in minority populations, is related to the priority areas of infant mortality, fetal deaths, low birth weight, high risk pregnancies and prenatal care. 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. Barbara Wingrove, M.P.H. Division of Epidemiology, Statistics and Prevention Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 7B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 594-1302 FAX: (301) 480-0649 Email: Barbara_Wingrove@NIH.GOV $$R2 END ************************************************************ $$P1 BEGIN PA-97-017 FULL-TEXT ************************************** HIV-1 INFECTION OF THE CENTRAL NERVOUS SYSTEM NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA AVAILABLE: PA-97-017 P.T. 34; K.W. 0705055, 0715008, 0765033, 0745070 National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute on Drug Abuse National Institute of Child Health and Human Development PURPOSE The National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Drug Abuse (NIDA) and National Institute of Child Health and Human Development (NICHD) invite research grant applications through this Program Announcement (PA) to support research focused on determining the pathogenic mechanisms involved in HIV-1 associated neurobehavioral and neurological dysfunction in adults and children. The objective of this cooperative effort is to foster investigations that will provide the foundation for the rapid development of therapeutic interventions to prevent and treat the effects of HIV-1 on the central nervous system (CNS). Applications ranging from basic research to clinical diagnosis and treatment studies are being solicited. Multidisciplinary research teams and collaborative alliances are encouraged but not required. This PA will use the investigator-initiated research project grant (R01), First Independent Research Support and Transition (FIRST) (R29) award, program project grant (P01), individual postdoctoral fellowship program (F32), and small research grant (R03) mechanisms. 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, HIV-1 Infection of the Central Nervous System, is related to the priority area of HIV infection. 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. Walter L. Goldschmidts, Ph.D. Office on AIDS National Institute of Mental Health Parklawn Building, Room 10-75 Bethesda, MD 20857 Telephone: (301) 443-7281 FAX: (301) 443-9719 Email: wgoldsch@nih.gov A. P. Kerza-Kwiatecki, Ph.D. Division of Convulsive, Infectious and Immune Disorders National Institute of Neurological Disorders and Stroke 7550 Wisconsin Avenue, Room 804 Bethesda, MD 20892 Telephone: (301) 496-1431 FAX: (301) 402-2060 Email: ak45w@nih.gov Lynda Erinoff, Ph.D. Office on AIDS National Institute on Drug Abuse Parklawn Building, Room 9A30 Bethesda, MD 20857 Telephone: (301) 443-6046 FAX: (301) 443-4100 Email: le30q@nih.gov Anne Willoughby, M.D., MPH Pediatric, Adolescent and Maternal AIDS Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B11H Bethesda, MD 20892 Telephone: (301) 496-7339 FAX: (301) 496-8678 Email: willouga@hd01.nichd.nih.gov $$P1 END ************************************************************ $$P2 BEGIN PA-97-018 FULL-TEXT ************************************** CARDIOVASCULAR AGING RESEARCH NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA AVAILABLE: PA-97-018 P.T. 34; K.W. 0710010, 0715040 National Institute on Aging National Heart, Lung, and Blood Institute National Institute of Nursing Research PURPOSE The goal of this program announcement (PA) is to foster research that will enhance our understanding of age-associated changes in the cardiovascular system and, moreover, how these normal changes increase susceptibility to cardiovascular disease. The PA documents eight areas of research opportunities highlighted by the National Institute on Aging (NIA) Cardiovascular Aging Advisory Panel. Another goal of this PA is to promote cardiovascular health during the aging process. This program will use the NIH investigator-initiated research project grant (R01) and the First Independent Research Support and Transition (FIRST) (R29) award mechanisms. 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, Cardiovascular Aging Research, is related to the priority area of heart disease and stroke. 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 program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221), the NIH GOPHER (gopher.nih.gov), the NIH Website (http://www.nih.gov), and the NIA Home Page (http://www.nih.gov/nia/) and by mail and Email from the program contact listed below. Andre J. Premen, Ph.D. Geriatrics Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3E327, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-6761 FAX: (301) 402-1784 Email: PremenA@gw.nia.nih.gov $$P2 END ************************************************************ $$P3 BEGIN PA-97-019 FULL-TEXT ************************************** AGING, RACE, AND ETHNICITY IN PROSTATE CANCER NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA AVAILABLE: PA-97-019 P.T. National Institute on Aging National Cancer Institute National Institute of Environmental Health Sciences PURPOSE The National Institute on Aging (NIA), National Cancer Institute (NCI), and National Institute of Environmental Health Sciences (NIEHS) invite research project grant (R01) and First Independent Research Support and Transition (FIRST) (R29) award applications to expand the understanding of biological and clinical factors leading to the development, progression, and treatment of prostate cancer in aging men. The increased risk of prostate cancer with advancing age and its prominence in older-aged men are well known characteristics of this tumor. The unusually high incidence and mortality rates of prostate cancer for older white and black American men and, by contrast, the much lower rates in men of Hispanic and Asian descent, provide the need for research that emphasizes the role of race and ethnic factors, as well as age, in early diagnosis, management, and etiology of this tumor. This Program Announcement is intended to stimulate research that applies the expanding scientific knowledge gained on prostate cancer to older men and to extend the knowledge base on age-related aspects of the etiology of this malignancy. 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, Aging, Race, and Ethnicity in Prostate Cancer, 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 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. Rosemary Yancik, Ph.D. Cancer Section, Geriatrics Program National Institute on Aging Building 31, Room 5C05 Bethesda, MD 20892 Telephone: (301) 496-5278 FAX: (301) 496-2793 Email: YancikR@31.nia.nih.gov Andrew Chiarodo, Ph.D. Organs System Coordinating Branch National Cancer Institute Executive Plaza North, Room 512 Bethesda, MD 20892 Telephone: (301) 496-8528 FAX: (301) 402-0181 Email: ac53a@nih.gov Gwen Collman, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-4980 FAX: (919) 541-4937 Email: collman@niehs.nih.gov $$P3 END ************************************************************ $$P4 BEGIN PAR-97-020 FULL-TEXT ************************************* NCRR SHARED INSTRUMENTATION GRANT NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA AVAILABLE: PAR-97-020 P.T. 34; K.W. 0735015, 1014001 National Center for Research Resources Application Receipt Date: March 26, 1997 PURPOSE The National Center for Research Resources (NCRR) announces the availability of a Program Announcement (PA), to continue the competitive NCRR Shared Instrumentation Grant (SIG) Program initiated in Fiscal Year 1982. The (1996) National Report on Academic Research Equipment and Equipment Needs for Biological Sciences, co-sponsored by the National Institutes of Health (NIH) and the National Science Foundation (NSF), identified research equipment of the type provided through this program as top-priority. The objective of the program is to make available to institutions with a high concentration of NIH-supported biomedical investigators expensive research instruments which can only be justified on a shared-use basis and for which meritorious research projects are described. Awards under this PA will use the Shared Instrumentation Grant mechanism (S10). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Marjorie A. Tingle, Ph.D. Shared Instrumentation Grant Program National Center for Research Resources 6705 Rockledge Drive, Room 6154, MSC 7965 Bethesda, MD 20892- 7965 Telephone: (301) 435-0772 FAX: (301) 480-3659 Email: SIG@EP.NCRR.NIH.GOV $$P4 END ************************************************************ $$P5 BEGIN PAR-97-021 FULL-TEXT ************************************* HIGH-THROUGHPUT TECHNOLOGIES TO DETECT ALTERATIONS IN TUMORS NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA AVAILABLE: PAR-97-021 P.T. 34; K.W. 0715035, 0745020, 0785140 National Cancer Institute PURPOSE The Technology Development Branch of the Cancer Diagnosis Program, Division of Cancer Treatment, Diagnosis and Centers (DCTDC), National Cancer Institute (NCI) invites Program Project grant applications (P01s) proposing the development of high-throughput technologies for the evaluation of the spectrum of molecular alterations in primary tumor tissue. To take full advantage of the advances made in sequencing of the human genome and in our understanding of the alterations underlying cancer, it will be necessary to develop new and improved technologies to scan the entire genome of a cancer cell or of tumor tissue for constellations of gene mutations and to identify changes in gene expression at the level of both RNA and protein. Assessing the potential utility of these new techniques for doing genome-wide genetic analyses or for analyzing patterns of protein expression will require the coordination of technology development efforts with the application of the technologies to appropriate clinical specimens. The P01 funding mechanism is being used to facilitate collaborations between researchers developing novel technologies and clinical investigators with the appropriate expertise and resources to assess the application of the technologies to tumor specimens. The Advanced Technology Program (ATP) of the National Institute of Standards and Technology (NIST) is supporting commercial organizations to develop DNA-based technologies for a wide variety of diagnostic applications. The current Program Announcement will complement this important effort by supporting application of these and other technologies to the analysis of tumor tissue and by supporting the modification of technologies to optimize their utility in the clinical setting. 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), High-Throughput Technologies to Detect Alterations in Tumor Specimens, 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 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. James W. Jacobson, Ph.D. Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute 6130 Executive Boulevard, Room 513, MSC 7388 Bethesda, MD 20892-7388 Telephone: (301) 496-1591 FAX: (301) 402-1037 Email: JJ37D@NIH.GOV $$P5 END ************************************************************ ERRATA $$E1 BEGIN P1 19961213 APPEND PAR-97-016 BOTH ************************** NINR NATIONAL RESEARCH SERVICE AWARD INDIVIDUAL PREDOCTORAL FELLOWSHIPS NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA NUMBER: PAR-97-016 P.T. 22; K.W. 0720005, 0785130 National Institute of Nursing Research The following erratum is issued for PAR-97-016, which appeared in the NIH Guide, Vol. 25, No. 43, December 13, 1996. Under the heading "Review Criteria", paragraph 3 should read: Level 1 - The applicant has not formally started course work or is in the first quarter/semester of graduate study. The applicant may or may not have a postmaster's research experience. Paragraphs 5 and 6 should read: Level 2 - The applicant has completed one semester of course work, has not completed candidacy examinations or has not had a research proposal approved by the dissertation committee. The specific review criteria will be based on progress toward completion of the research training program requirements. The critical determinant will be the degree of course completion at the time the application was written. There should be a short description sufficient to indicate the content of courses taken or planned relating to the research area. There should be a clearly defined problem area and statement of purpose. The review of the literature should include analyses and synthesis related to concepts important to the research topic proposed. The project's research design and methods and its significance and originality should be defined. The sponsor should have expertise in the content and methodology in the proposed research. The sponsor's statement should show knowledge of the applicant's plan as well as a description of resources available. If the sponsor does not have total expertise, a cosponsorship should be included with expertise in the content and/or methodology proposed. Paragraph 7 and 8 should read: Level 3 - The applicant has completed course work. The specific review criteria will be the same as for Level 2 applicants except for: 1) the research project should be defined and detailed with a well-developed research design and methods section and 2) the inclusion of dissertation committee members and their areas of expertise, as well as the university's resources in the sponsor's statement. Under the heading "Award Criteria", paragraph 1 should read: NINR staff use the following criteria in making awards: - IRG recommendation of the overall merit of the application - relevance of the application to Institute research priorities and program balance, and - availability of funds. INQUIRIES Inquiries regarding this PA may be directed to: Lynn M. Amende, Ph.D. Division of Extramural Activities National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-5968 FAX: (301) 480-8260 Email: lamende@ep.ninr.nih.gov $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Thu Dec 26 22:00:00 1996 Path: biosci!ihnp4.ucsd.edu!biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-021 - V25(44) 12/20/96 Date: 26 Dec 1996 16:06:33 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 302 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <59v3u9$99q@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA NUMBER: PAR-97-021 P.T. 34; K.W. 0715035, 0745020, 0785140 National Cancer Institute PURPOSE The Technology Development Branch of the Cancer Diagnosis Program, Division of Cancer Treatment, Diagnosis and Centers (DCTDC), National Cancer Institute (NCI) invites Program Project grant applications (P01s) proposing the development of high-throughput technologies for the evaluation of the spectrum of molecular alterations in primary tumor tissue. To take full advantage of the advances made in sequencing of the human genome and in our understanding of the alterations underlying cancer, it will be necessary to develop new and improved technologies to scan the entire genome of a cancer cell or of tumor tissue for constellations of gene mutations and to identify changes in gene expression at the level of both RNA and protein. Assessing the potential utility of these new techniques for doing genome-wide genetic analyses or for analyzing patterns of protein expression will require the coordination of technology development efforts with the application of the technologies to appropriate clinical specimens. The P01 funding mechanism is being used to facilitate collaborations between researchers developing novel technologies and clinical investigators with the appropriate expertise and resources to assess the application of the technologies to tumor specimens. The Advanced Technology Program (ATP) of the National Institute of Standards and Technology (NIST) is supporting commercial organizations to develop DNA-based technologies for a wide variety of diagnostic applications. The current Program Announcement will complement this important effort by supporting application of these and other technologies to the analysis of tumor tissue and by supporting the modification of technologies to optimize their utility in the clinical setting. 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), High-Throughput Technologies to Detect Alterations in Tumor Specimens, 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 nonprofit 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 >From single institutions but collaborative studies between companies developing technologies and institutions with clinical resources and expertise are also encouraged. 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 National Institutes of Health (NIH) program project grant (P01) mechanism. The applications should be constructed using the P01 application guidelines of the NCI. The P01 mechanism is designed to support multiple, interacting projects focused on a central theme. P01s may support projects that are performed at multiple sites but coordinated by a single principal investigator at the grantee institution. PIs will be responsible for the planning, direction and execution of the proposed project. Applicants may request up to $750,000 per year direct cost, however, each budget item must be carefully justified (See Letter of Intent). The period of support for applications submitted in response to this PA may be for up to five years. This PA will be in effect for two years, up to and including the October 1, 1998 P01 receipt. RESEARCH OBJECTIVES Background The impressive advances in our understanding of the molecular alterations underlying tumor initiation and progression coupled with the sequencing of the entire human genome will provide the intellectual basis for dramatic changes in the way cancer patients are managed. Previous studies to correlate alterations in tumors to clinical parameters have suggested the potential importance of measuring these changes as a part of clinical decision-making. The sequencing of the human genome and ongoing development of technologies to analyze genetic alterations on a genome-wide scale may soon make it feasible to simultaneously look at all or a subset of the alterations in tumor tissue. Similar technologies to detect patterns of protein expression or to detect changes in proteins functioning in pathways of cellular regulation are also needed. The development of these new technologies will facilitate the discovery of new alterations in tumor cells and, ultimately, the rapid collection of diagnostic and prognostic information that may be useful in cancer patient management. Research Goals and Scope This initiative invites grant applications to support development of high-throughput technologies for analysis of the spectrum of molecular alterations in primary tumor tissues. The applications should propose development of appropriate technologies and studies to assess their use in analysis of primary tumor specimens. Modification of these technologies to optimize their utility in the clinical setting may also be proposed. Technologies may be designed to analyze a variety of alterations including genome-wide cytogenetic changes; mutations in constellations of genes known to be important in tumor initiation and progression, including genes that are members of pathways of cellular regulation; analysis of all possible mutations in a single gene; changes in patterns of gene expression at the level of both RNA and protein; or changes in protein function. The applications must document access to appropriate tumor tissue resources to facilitate evaluation of the technologies in clinical specimens. Development of informatics systems to support collection and evaluation of research data may also be proposed. This program encourages interactions among academic scientists and clinicians, basic scientists involved in the development of new technologies and informatics specialists. The initiative envisions collaborations among commercial or academic organizations with appropriate programs in technology development and academic institutions with expertise and ongoing programs in cancer biology and genetics with the necessary clinical resources. These collaborations will ensure that the technologies developed are appropriate steps toward meeting the clinical needs of the cancer community. 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. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research and a list of titles for the anticipated components of the P01, 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 PA 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 NCI staff to estimate the potential review workload and avoid conflict of interest in the review. Applicants requesting budgets greater than $500,000 are required to contact NCI program staff prior to submitting their applications (NIH GUIDE, Vol. 25, No. 14, May 3, 1996). Applications with budgets of more than $500,000 received without prior communication with the NCI program staff listed under INQUIRIES will not be accepted for review. The letter of intent is to be sent to the Referral Officer, National Cancer Institute at the address listed under APPLICATION PROCEDURES. APPLICATION PROCEDURES Applications are to be submitted on the research grant application form PHS 398 (rev. 5/95) and will be accepted at the standard deadlines for P01 applications as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained 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, e-mail: ASKNIH@odrockm1.od.nih.gov. The title and number of the program announcement must be typed in line 2 of the face page of the application and the YES box must be marked. 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, SUITE 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) In addition send two complete copies under separate cover to: REFERRAL OFFICER NATIONAL CANCER INSTITUTE EXECUTIVE PLAZA NORTH, ROOM 636A 6130 EXECUTIVE BOULEVARD, MSC 7405 BETHESDA, MD 20892-7405 ROCKVILLE, MD 20852 (for express/courier service) Telephone: (301) 496-3428 FAX: (301) 402-0275 REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Services referral guidelines. Applications will be reviewed for scientific and technical merit by an appropriate peer review group convened by the Grants Review Branch of the Division of Extramural Activities of NCI. The second level of review will be provided by the National Cancer Advisory Board. Review criteria that will be used to assess the scientific merit of an application are: o scientific and technical merit and originality of the proposed research; o appropriateness and adequacy of the experimental approach 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; The initial review group will also 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 the NCI. 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 Responsiveness to the goals and objectives of the PA INQUIRIES Inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: James W. Jacobson, Ph.D. Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute 6130 Executive Boulevard, Room 513, MSC 7388 Bethesda, MD 20892-7388 Telephone: (301) 496-1591 FAX: (301) 402-1037 Email: JJ37D@NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Teresa Mercogliano Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243, MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, ext. 243 FAX: (301) 496-8601 Email: MERCOGLT@GAB.NCI.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.394, Cancer Detection and Diagnostic 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 Part 92. 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 recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. 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. From owner-sci-resources@net.bio.net Thu Dec 26 22:00:00 1996 Path: biosci!ihnp4.ucsd.edu!biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-020 - V25(44) 12/20/96 Date: 26 Dec 1996 16:04:20 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 426 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <59v3q4$94j@net.bio.net> NNTP-Posting-Host: net.bio.net NCRR SHARED INSTRUMENTATION GRANT NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA NUMBER: PAR-97-020 P.T. 34; K.W. 0735015, 1014001 National Center for Research Resources Application Receipt Date: March 26, 1997 PURPOSE The National Center for Research Resources (NCRR) is continuing its competitive Shared Instrumentation Grant (SIG) Program initiated in Fiscal Year 1982. The (1996) National Report on Academic Research Equipment and Equipment Needs for Biological Sciences, co-sponsored by the National Institutes of Health (NIH) and the National Science Foundation (NSF), identified research equipment of the type provided through this program as top-priority. The objective of the program is to make available to institutions with a high concentration of NIH-supported biomedical investigators expensive research instruments which can only be justified on a shared-use basis and for which meritorious research projects are described. Awards under this Program Announcement (PA) will use the Shared Instrumentation Grant mechanism (S10). ELIGIBILITY REQUIREMENTS Under the general research support authority of Section 301 (a)(3) of the Public Health Service Act, Shared Instrumentation Grant awards are made to public and non-profit institutions only. For purposes of these guidelines, an "institution" is defined as the organizational component identified on page 1, item 11 of the PHS 398 (rev. 5/95), for which descriptive information is provided on page 9-10 in the PHS 398 kit. These institutions include health professional schools, other academic institutions, hospitals, health departments, and research organizations. Federal institutions, foreign institutions, and for-profit institutions are not eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. An eligible institution may submit more than one application for different instrumentation for the March 26, 1997, deadline. However, if several applications are submitted for similar instrumentation >From one or more eligible institutions on the same campus of a university, documentation from a high administrative official must be provided stating that this is not an unintended duplication but part of a campus- wide institutional plan. MECHANISM OF SUPPORT Shared Instrumentation Grants (S10) provide support for expensive state-of-the-art instruments utilized in both basic and clinical research. Applications are limited to instruments that cost at least $100,000 per instrument or system. The maximum award is $400,000. Because the nature and scope of the instruments that may be requested will vary, it is anticipated that the size of an award will vary also. RESEARCH OBJECTIVES This program is designed to meet the special problems of acquisition and updating of expensive shared-use instruments which are not generally available through other NIH mechanisms, such as the regular research project, program project, or center grant programs. Proposals for research on advancing the design or for the development of new instrumentation will not be considered. Types of instrumentation supported include, but are not limited to, nuclear magnetic resonance systems, electron microscopes, mass spectrometers, protein sequencer / amino acid analyzers, x-ray diffractometers, and cell sorters. Support will not be provided for general purpose equipment or purely instructional equipment, personal computers, personal work stations, printers, and Ethernet interfaces. Proposals for "stand alone" computer systems will only be considered if the instrument is solely dedicated to the research needs of a broad community of NIH-supported investigators. Awards will be made for the direct costs of the acquisition of new, or the updating of existing, research instruments. The institution must meet those costs (not covered in the normal purchase price) required to place the instrumentation in operational order as well as the maintenance, support personnel, and service costs associated with maximum utilization of the instrument. There is no upper limit on the cost of the instrument, but the maximum award is $400,000. Grants will be awarded for a period of one year and are not renewable. Supplemental applications will not be accepted. The program does not provide indirect costs or support for construction or alterations and renovations. Cost sharing is not required. If the amount of funds requested does not cover the total cost of the instrument, the application should describe the proposed sources(s) of funding for the balance of the cost of the instrument. Documentation of the availability of the remainder of the funding, signed by an appropriate institutional official, must be presented to NCRR prior to the issuance of an award. Requests for a multiple instrument purchase totaling over $400,000 must specify and justify which instrument(s) should be supported within the $400,000 ceiling. Applicants proposing the direct purchase of an instrument that the institution has secured or is planning to secure via a leasing agreement are strongly encouraged to consult with their institutional sponsored projects office regarding applicable PHS policy prior to executing the leasing agreement. If the leasing agreement was executed more than one year prior to submission of the SIG application, the applicant must provide strong justification for the requested Federal funds. Further, the instrument must be considered state-of-the-art at the time of submission of the SIG application. Since the intent of the program is to promote sharing, a major user group of three or more investigators must be identified. A minimum of three major users must be Principal Investigators on NIH peer reviewed research grants at the time of the application and award. For purposes of this program research grants are defined as those grants awarded with the following activity codes: P01, R01, U01, R29, R35, and R37. The application must show a clear need for the instrumentation by projects supported by multiple NIH research awards and demonstrate that these projects will require at least 75 percent of the total usage of the instrument. Major users can be individual researchers, or a group of investigators within the same department or from several departments at the applicant institution. NIH extramural awardees from other nearby institutions may also be included. If the major user group does not require total usage of the instrument, access to the instrument should be made available to other users upon the advice of the internal advisory committee. These users need not be NIH awardees, but priority should be given to NIH-supported scientists engaged in biomedical/behavioral research. To encourage optimal sharing among individual investigators, research groups, and departments, and to foster a collaborative multidisciplinary environment, instruments should be integrated into central core facilities, whenever possible. Each applicant institution must propose a Principal Investigator who can assume administrative/scientific oversight responsibility for the instrumentation requested. An internal advisory committee to assist in this responsibility should also be utilized. The Principal Investigator and the advisory group are responsible for the development of guidelines for shared use of the instrument, for preparation of all reports required by the NIH, for relocation of the instrument within the grantee institution if the major user group is significantly altered, and for continued support for the maximum utilization and maintenance of the instrument in the post-award period. A plan should be proposed for the day-to-day management of the instrument including designation of a qualified individual to supervise the operation of the instrument and to provide technical expertise to the users. Specific plans for sharing arrangements and for monitoring the use of the instrument should be described. If a grant award is made, a final progress report is required that describes the use of the instrument, listing all users and indicating the value of the instrumentation to the research of the major users and to the institution as a whole. This report is due within 90 days following the end of the project period. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: asknih@odrockm1.od.nih.gov. 1. Form page 1 (Face page of the application) - Item 1. Name the type of instrument requested. (Note in bold type at the bottom of the face page if a duplicate application has been sent to NSF or to another organization or agency.) Item 2. Check the box marked "YES" and enter the title and number of this program announcement. Item 4. If human subjects are involved in the research, follow the instructions for completing Item 4 on the Face Page of Form PHS 398, certifying that an Institutional Review Board (IRB) approved by PHS has reviewed and approved the protocols involving human subjects. If the protocols are ongoing and have already received prior IRB review and approval within one year of the submission date of this application, then additional IRB review is not necessary. However, this fact must be noted in Item 4 on the Face Page, and, if space is insufficient, the date(s) of prior IRB review and approval of each protocol involving human subjects should be listed in the "Research Plans." Item 5. If live vertebrate animals are involved in the research, follow the instructions for completing Item 5 on the Face Page of Form PHS 398, verifying that an Institutional Animal Care and Use Committee (IACUC) approved by PHS (OPRR) has reviewed and approved the protocols involving animals. If the protocols are ongoing and have already received prior IACUC review and approval within three years of the submission date of this application, then additional IACUC review is not necessary. However, this fact must be noted in Item 5 on the Face Page and, if space is insufficient, the date(s) of prior IACUC review and approval of each protocol involving animals should be listed in the "Research Plan." Item 6. Write in 04/01/98 through 03/31/99. Item 8A. Use this block to give the total amount requested from NCRR for this instrument or system. Item 11. Insert the appropriate code identification. 2. Form page 2. Complete the abstract as directed. Under "Key Personnel," give data on the Principal Investigator and the major user group as required. 3. Form page 4. Describe the instrument requested including manufacturer and model number. The model chosen should be justified by comparing its performance with other available instruments. Provide a detailed budget breakdown of the main equipment and accessories requested including tax and import duties, if applicable. An itemized quote from a vendor should be included. If a project involves a potential biohazard, funds for accessory containment equipment for the instrument or instrument system may be included in the requested budget. 4. Form page 5. Budget Estimates for All Years. Not applicable; do not complete. 5. Form page 6 - Biographical Sketch. In addition to the personnel listed on page 2, include a biographical sketch of the person(s) who will be in charge of maintenance and operation of the instrument and a brief statement of the qualifications of the individual(s). Biographical sketches should not exceed 2 pages for each individual. 6. Form page 7 - Other Support. Provide the requested information for each major user and for each application for the same instrumentation sent to NSF or another organization or agency. 7. Form page 8 - Resources. Not applicable; do not complete. 8. Research Plan section of the application. (If this is a revised application, note the special instructions on page 15 in the PHS 398 kit regarding completion of this section of the application.) Provide information relative to the points identified under criteria for review including: a. Inventory similar instruments existing at the institution or otherwise accessible; describe why they are unavailable or inappropriate for the proposed research and provide a clear justification why new or updated equipment is needed, including accessories. Include specific documentation on the current usage of existing instruments and a realistic estimate of the projected usage for the requested instrument. b. Since the projects of the major users have been previously peer reviewed, the project descriptions should be brief and focused on a clear explanation of how the requested instrument would be utilized to enhance the progress or expand the scope of the ongoing funded research. Descriptions should not exceed two pages per user. Sufficient technical detail (preliminary data and/or supplemental information) should be included to evaluate whether the instrument is appropriate, would be effectively employed, and would provide advantages over other methods. The needs of the research projects should be clearly tied to the requested instrument and should indicate the benefit of the instrument to the research objectives of each major user. Use a table to list the names of the users, brief titles of the projects, the NIH grant numbers and the estimated percentage of use. List the page number of this table under "Table of Contents" (Form page 3) after "Resources". Make a separate table to indicate the major users' needs for requested accessories. If possible, each user should highlight those publications that demonstrate the user's expertise in using the requested instrumentation. c. Describe the organizational plan to administer the grant. Include membership of the advisory committee, policies and procedures for assuring use and equitable sharing of the instrument and plans for including minor or outside users. d. Submit a specific plan for long-term operation and maintenance of the instrument. Provide documentation (e.g., separate letters signed by appropriate institutional officials) describing the required institutional commitment in support of the proposed plan. Applications must be received by March 26, 1997. Applications received after this date will not be accepted for review in this competition and will be returned to the applicant. The completed, signed original and four exact photocopies of the signed application and any appendix material* 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) One copy of the application and appendix material must be addressed to: Shared Instrumentation Program Biomedical Technology National Center for Research Resources 6705 Rockledge Drive, Room 6154 - MSC 7965 Bethesda, MD 20892-7965 REVIEW CONSIDERATIONS Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with 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, assigned a priority score, and receive a second level review by the National Advisory Research Resources Council, NCRR. Applications are reviewed by specially convened initial review groups of the Division of Research Grants (DRG) for scientific and technical merit and for program considerations by the National Advisory Research Resources Council (NARRC) of the NCRR. Approximately half of the applications will be reviewed at the September 1997 NARRC meeting and the remainder at the NARRC meeting in February 1998. Funding decisions on all applications received for the March 26, 1997, deadline will not be made until the program receives an appropriation for FY 1998. The Council date will not affect funding decisions. JOINT NIH/NSF SUBMISSION A recent NIH/NSF Memorandum of Understanding permits the joint agency review and funding of requests for a single instrument costing more than $500,000 which would normally be eligible for submission to both NIH and NSF. Such a request may be submitted to NIH for the March 26 (SIG) deadline for review by NIH with NSF participation, thus avoiding separate agency peer review. Under this arrangement, the agencies may offer joint funding in excess of their current award limits of $400,000. Applicants contemplating joint NIH-NSF submission are strongly urged to contact both the NSF Division of Biological Infrastructure [NSF contact: Dr. Karl A. Koehler 703-306-1472; kkoehler@NSF.gov] and the NCRR SIG Program [Dr. Marjorie A. Tingle 301-435-0772; SIG@EP.NCRR.NIH.GOV] for information concerning eligibility and required documentation. Review Criteria o The Scientific Need The extent to which an award for the specific instrument would meet the scientific needs and enhance the planned research endeavors of the major users by providing an instrument that is unavailable or to which availability is highly limited. o Technical Expertise The availability and commitment of the appropriate technical expertise within the major user group or the institution for use of the instrumentation. o Management Plan The adequacy of the organizational plan for use of the instrument and the internal advisory committee for oversight of the instrument including sharing arrangements. o Institutional Commitment The institution's commitment for continued support of the utilization and maintenance of the instrument. o Overall Benefit The benefit of the proposed instrument to the overall research community it will serve. AWARD CRITERIA In making funding decisions, the NCRR will give consideration to ensure program balance among various types of instruments supported and/or geographic distribution of awards. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic or scientific issues to: Marjorie A. Tingle, Ph.D. Shared Instrumentation Grant Program National Center for Research Resources 6705 Rockledge Drive, Room 6154, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0772 FAX: (301) 480-3659 Email: SIG@EP.NCRR.NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Carmen Herbert Office of Grants and Contracts Management National Center for Research Resources 6705 Rockledge Drive, Room 6205, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0837 Email: CarmenH@ep.ncrr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.371, Biomedical Technology. Awards will be made under authorization of the Public Health Service Act, Titles III and IV, (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 287) and 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 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 Dec 26 22:00:00 1996 Path: biosci!ihnp4.ucsd.edu!biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DK-97-009 - V25(44) 12/20/96 Date: 26 Dec 1996 16:08:13 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 368 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <59v41d$9eb@net.bio.net> NNTP-Posting-Host: net.bio.net SUPPORT OF MINORITIES IN DIABETES, DIGESTIVE AND KIDNEY DISEASE NIH GUIDE, Volume 25, Number 44, December 20, 1996 RFA: DK-97-009 P.T. 34, FF; K.W. 0715075, 0715085 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 19, 1997 Application Receipt Date: March 19, 1997 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) recognizes the need to increase the number of under represented minority individuals committed to scientific careers in research areas served by the NIDDK. This program is aimed primarily at recently trained M.D. and/or Ph.D. minority investigators. The program will enable the minority applicant to accept a tenure-earning position, gain additional research experience and obtain preliminary data on which to base a subsequent research grant application (R01 or R29) in an area of diabetes, endocrinology, metabolic diseases, digestive diseases, nutrition, kidney diseases, urologic diseases, or hematologic diseases. 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, Support of Minorities in Diabetes, Digestive and Kidney Disease, is related to the priority area of increasing under represented minority health scientists. 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 or local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Applicant must be African-American, Hispanic, Native American, Pacific Islander, or other ethnic or racial group members under represented in biomedical or behavioral research. To apply, an applicant must be a citizen of, or have been lawfully admitted to, the United States for permanent residence. An applicant must have a doctoral degree (M.D., Ph.D., D.O., D.D.S., D.V.M.). He or she should have received at least two years of postgraduate research training in an area of research applicable to research supported by the NIDDK, and have direct access to an expert in the area of the proposed research. Applicants may not hold, nor apply concurrently for any other PHS research project grant at the time of this application. Priority will be given to those applicants who have not previously been a Principal Investigator on a major research grant. Applicants are encouraged to apply for other research project grants (R01, R29) during the course of, or following, this award. MECHANISM OF SUPPORT Support will be provided through the Small Research Grant (R03) program administered by the Division of Diabetes, Endocrinology and Metabolism, the Division of Digestive Diseases and Nutrition, and the Division of Kidney, Urologic and Hematologic Diseases in the NIDDK. Responsibility for the planning, direction, and execution of the proposed project will be 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. If the NIDDK determines that there is a sufficient continuing program need, a new request for applications will be announced. The total project period for an application submitted in response to this RFA may be for one year, but may not exceed two years. Direct costs requested must not exceed $50,000 per year. These grants cannot be renewed. The anticipated award date is September 30, 1997. FUNDS AVAILABLE For FY 1997, $250,000 in total direct costs will be committed in each of the three research divisions in the NIDDK. It is anticipated that a total of five awards will be made in each of the three divisions in FY 1997. This level of support depends 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 NIDDK, the award of grants pursuant to this RFA is contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The primary purpose of this RFA is to increase the number of under represented minority Principal Investigators conducting research in areas supported by the NIDDK. Surveys of research and training programs administered by the NIDDK disclose the need to increase the access to NIDDK support of recently-trained minority scientists who are U.S. citizens or permanent residents. Those who receive several years of training via an individual postdoctoral fellowship or an institutional training grant funded by a National Research Service Award still require research experience and preliminary data to support an independent research career at this stage of development. An additional period of training may not be feasible for minority individuals with pressing economic burdens. Such individuals may be lost to academic research through a lack of opportunity to obtain an additional one or two years of support essential for establishing a research career. This program was designed to help alleviate some of the problems experienced by under represented minorities who may wish to pursue a career in academic research. The program will allow the minority investigator to hold a tenure-earning position, gain additional research experience and obtain preliminary data on which to base a subsequent research grant application. Special Requirements Applicants are required to have available a recognized expert in the area of proposed research for guidance and consultation. It is expected that this expert will assist the applicant in the design and conduct of his/her research. It is not necessary that the expert be at the same institution as the applicant, but he/she should be within a reasonable proximity to be available for guidance and consultation. Following the research plan, the applicant is required to provide a brief summary of his/her long-term career plans and objectives. The application should state how this award would make a difference in and enhance the applicant's development as a scientist. The department chairman/head should provide a brief paragraph indicating his/her plans for the applicant. This official should indicate the extent to which time, space and other necessary support will be provided to the applicant to conduct the proposed investigation(s). A letter from a recognized expert in the area of the proposed research should accompany the application packet. The letter should attest to his/her willingness to provide counsel and advice to the applicant, and an initial plan for ongoing contacts with the applicant. 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) 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 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 also obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by February 19, 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 a subsequent application, the information that it contains allows NIDDK staff to estimate the potential review workload and 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 37-F, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. The form is available at most institutional offices of 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) 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, 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) At the time of submission, two additional copies of the application, and five copies of any appendix material, 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 37-F, MSC 6600 Bethesda, MD 20892-6600 Applications must be received by March 19, 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 previously reviewed, but such applications must include an introduction addressing the previous critique. 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 NIDDK program division to which the application has been assigned. Review Criteria o the applicants previous research training, experience and publications; o his/her ability to complete the proposed research plan; o the overall scientific merit of the research plan; o whether the aims and scope of the research plan can provide definitive data within a one or two year period; o the potential of the proposed research to provide the bases for future studies; o the institutions willingness to commit facilities and departmental support to the applicant; o the applicants plans and career goals; o the availability of a recognized expert in the area of the proposed research for council and advice as attested to by a letter of agreement. AWARD CRITERIA The anticipated date of award is September 30, 1997. Applications will compete for available funds with all other applications submitted in response to this RFA and recommended by the initial review group. 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 balance among research areas of the RFA. o History of research support Schedule Letter of Intent Receipt Date: February 19, 1997 Application Receipt Date: March 19, 1997 Technical/Scientific Review: June/July 1997 Review by Divisions/NIDDK: September 1997 Anticipated Award Date: September 30, 1997 INQUIRIES Written and telephone 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: Charles H. Rodgers, Ph.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS 19J, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 Email: rodgersc@ep.niddk.nih.gov Judith M. Podskalny, Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN 12E, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8876 Email: podskalnyj@ep.niddk.nih.gov Ronald Margolis, Ph.D. Division of Diabetes, Endocrinology and Metabolism National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 5AN 12J, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8819 Email: margolisr@ep.niddk.nih.gov Direct inquiries regarding fiscal matters to: Ms Nancy C. Dixon Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN 44C, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8854 Email: dixonn@ep.niddk.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.847, 93.848, and 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 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 Dec 26 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-020 - V25(44) 12/20/96 Date: 26 Dec 1996 16:04:20 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 426 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <59v3q4$94j@net.bio.net> NNTP-Posting-Host: net.bio.net NCRR SHARED INSTRUMENTATION GRANT NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA NUMBER: PAR-97-020 P.T. 34; K.W. 0735015, 1014001 National Center for Research Resources Application Receipt Date: March 26, 1997 PURPOSE The National Center for Research Resources (NCRR) is continuing its competitive Shared Instrumentation Grant (SIG) Program initiated in Fiscal Year 1982. The (1996) National Report on Academic Research Equipment and Equipment Needs for Biological Sciences, co-sponsored by the National Institutes of Health (NIH) and the National Science Foundation (NSF), identified research equipment of the type provided through this program as top-priority. The objective of the program is to make available to institutions with a high concentration of NIH-supported biomedical investigators expensive research instruments which can only be justified on a shared-use basis and for which meritorious research projects are described. Awards under this Program Announcement (PA) will use the Shared Instrumentation Grant mechanism (S10). ELIGIBILITY REQUIREMENTS Under the general research support authority of Section 301 (a)(3) of the Public Health Service Act, Shared Instrumentation Grant awards are made to public and non-profit institutions only. For purposes of these guidelines, an "institution" is defined as the organizational component identified on page 1, item 11 of the PHS 398 (rev. 5/95), for which descriptive information is provided on page 9-10 in the PHS 398 kit. These institutions include health professional schools, other academic institutions, hospitals, health departments, and research organizations. Federal institutions, foreign institutions, and for-profit institutions are not eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. An eligible institution may submit more than one application for different instrumentation for the March 26, 1997, deadline. However, if several applications are submitted for similar instrumentation >From one or more eligible institutions on the same campus of a university, documentation from a high administrative official must be provided stating that this is not an unintended duplication but part of a campus- wide institutional plan. MECHANISM OF SUPPORT Shared Instrumentation Grants (S10) provide support for expensive state-of-the-art instruments utilized in both basic and clinical research. Applications are limited to instruments that cost at least $100,000 per instrument or system. The maximum award is $400,000. Because the nature and scope of the instruments that may be requested will vary, it is anticipated that the size of an award will vary also. RESEARCH OBJECTIVES This program is designed to meet the special problems of acquisition and updating of expensive shared-use instruments which are not generally available through other NIH mechanisms, such as the regular research project, program project, or center grant programs. Proposals for research on advancing the design or for the development of new instrumentation will not be considered. Types of instrumentation supported include, but are not limited to, nuclear magnetic resonance systems, electron microscopes, mass spectrometers, protein sequencer / amino acid analyzers, x-ray diffractometers, and cell sorters. Support will not be provided for general purpose equipment or purely instructional equipment, personal computers, personal work stations, printers, and Ethernet interfaces. Proposals for "stand alone" computer systems will only be considered if the instrument is solely dedicated to the research needs of a broad community of NIH-supported investigators. Awards will be made for the direct costs of the acquisition of new, or the updating of existing, research instruments. The institution must meet those costs (not covered in the normal purchase price) required to place the instrumentation in operational order as well as the maintenance, support personnel, and service costs associated with maximum utilization of the instrument. There is no upper limit on the cost of the instrument, but the maximum award is $400,000. Grants will be awarded for a period of one year and are not renewable. Supplemental applications will not be accepted. The program does not provide indirect costs or support for construction or alterations and renovations. Cost sharing is not required. If the amount of funds requested does not cover the total cost of the instrument, the application should describe the proposed sources(s) of funding for the balance of the cost of the instrument. Documentation of the availability of the remainder of the funding, signed by an appropriate institutional official, must be presented to NCRR prior to the issuance of an award. Requests for a multiple instrument purchase totaling over $400,000 must specify and justify which instrument(s) should be supported within the $400,000 ceiling. Applicants proposing the direct purchase of an instrument that the institution has secured or is planning to secure via a leasing agreement are strongly encouraged to consult with their institutional sponsored projects office regarding applicable PHS policy prior to executing the leasing agreement. If the leasing agreement was executed more than one year prior to submission of the SIG application, the applicant must provide strong justification for the requested Federal funds. Further, the instrument must be considered state-of-the-art at the time of submission of the SIG application. Since the intent of the program is to promote sharing, a major user group of three or more investigators must be identified. A minimum of three major users must be Principal Investigators on NIH peer reviewed research grants at the time of the application and award. For purposes of this program research grants are defined as those grants awarded with the following activity codes: P01, R01, U01, R29, R35, and R37. The application must show a clear need for the instrumentation by projects supported by multiple NIH research awards and demonstrate that these projects will require at least 75 percent of the total usage of the instrument. Major users can be individual researchers, or a group of investigators within the same department or from several departments at the applicant institution. NIH extramural awardees from other nearby institutions may also be included. If the major user group does not require total usage of the instrument, access to the instrument should be made available to other users upon the advice of the internal advisory committee. These users need not be NIH awardees, but priority should be given to NIH-supported scientists engaged in biomedical/behavioral research. To encourage optimal sharing among individual investigators, research groups, and departments, and to foster a collaborative multidisciplinary environment, instruments should be integrated into central core facilities, whenever possible. Each applicant institution must propose a Principal Investigator who can assume administrative/scientific oversight responsibility for the instrumentation requested. An internal advisory committee to assist in this responsibility should also be utilized. The Principal Investigator and the advisory group are responsible for the development of guidelines for shared use of the instrument, for preparation of all reports required by the NIH, for relocation of the instrument within the grantee institution if the major user group is significantly altered, and for continued support for the maximum utilization and maintenance of the instrument in the post-award period. A plan should be proposed for the day-to-day management of the instrument including designation of a qualified individual to supervise the operation of the instrument and to provide technical expertise to the users. Specific plans for sharing arrangements and for monitoring the use of the instrument should be described. If a grant award is made, a final progress report is required that describes the use of the instrument, listing all users and indicating the value of the instrumentation to the research of the major users and to the institution as a whole. This report is due within 90 days following the end of the project period. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: asknih@odrockm1.od.nih.gov. 1. Form page 1 (Face page of the application) - Item 1. Name the type of instrument requested. (Note in bold type at the bottom of the face page if a duplicate application has been sent to NSF or to another organization or agency.) Item 2. Check the box marked "YES" and enter the title and number of this program announcement. Item 4. If human subjects are involved in the research, follow the instructions for completing Item 4 on the Face Page of Form PHS 398, certifying that an Institutional Review Board (IRB) approved by PHS has reviewed and approved the protocols involving human subjects. If the protocols are ongoing and have already received prior IRB review and approval within one year of the submission date of this application, then additional IRB review is not necessary. However, this fact must be noted in Item 4 on the Face Page, and, if space is insufficient, the date(s) of prior IRB review and approval of each protocol involving human subjects should be listed in the "Research Plans." Item 5. If live vertebrate animals are involved in the research, follow the instructions for completing Item 5 on the Face Page of Form PHS 398, verifying that an Institutional Animal Care and Use Committee (IACUC) approved by PHS (OPRR) has reviewed and approved the protocols involving animals. If the protocols are ongoing and have already received prior IACUC review and approval within three years of the submission date of this application, then additional IACUC review is not necessary. However, this fact must be noted in Item 5 on the Face Page and, if space is insufficient, the date(s) of prior IACUC review and approval of each protocol involving animals should be listed in the "Research Plan." Item 6. Write in 04/01/98 through 03/31/99. Item 8A. Use this block to give the total amount requested from NCRR for this instrument or system. Item 11. Insert the appropriate code identification. 2. Form page 2. Complete the abstract as directed. Under "Key Personnel," give data on the Principal Investigator and the major user group as required. 3. Form page 4. Describe the instrument requested including manufacturer and model number. The model chosen should be justified by comparing its performance with other available instruments. Provide a detailed budget breakdown of the main equipment and accessories requested including tax and import duties, if applicable. An itemized quote from a vendor should be included. If a project involves a potential biohazard, funds for accessory containment equipment for the instrument or instrument system may be included in the requested budget. 4. Form page 5. Budget Estimates for All Years. Not applicable; do not complete. 5. Form page 6 - Biographical Sketch. In addition to the personnel listed on page 2, include a biographical sketch of the person(s) who will be in charge of maintenance and operation of the instrument and a brief statement of the qualifications of the individual(s). Biographical sketches should not exceed 2 pages for each individual. 6. Form page 7 - Other Support. Provide the requested information for each major user and for each application for the same instrumentation sent to NSF or another organization or agency. 7. Form page 8 - Resources. Not applicable; do not complete. 8. Research Plan section of the application. (If this is a revised application, note the special instructions on page 15 in the PHS 398 kit regarding completion of this section of the application.) Provide information relative to the points identified under criteria for review including: a. Inventory similar instruments existing at the institution or otherwise accessible; describe why they are unavailable or inappropriate for the proposed research and provide a clear justification why new or updated equipment is needed, including accessories. Include specific documentation on the current usage of existing instruments and a realistic estimate of the projected usage for the requested instrument. b. Since the projects of the major users have been previously peer reviewed, the project descriptions should be brief and focused on a clear explanation of how the requested instrument would be utilized to enhance the progress or expand the scope of the ongoing funded research. Descriptions should not exceed two pages per user. Sufficient technical detail (preliminary data and/or supplemental information) should be included to evaluate whether the instrument is appropriate, would be effectively employed, and would provide advantages over other methods. The needs of the research projects should be clearly tied to the requested instrument and should indicate the benefit of the instrument to the research objectives of each major user. Use a table to list the names of the users, brief titles of the projects, the NIH grant numbers and the estimated percentage of use. List the page number of this table under "Table of Contents" (Form page 3) after "Resources". Make a separate table to indicate the major users' needs for requested accessories. If possible, each user should highlight those publications that demonstrate the user's expertise in using the requested instrumentation. c. Describe the organizational plan to administer the grant. Include membership of the advisory committee, policies and procedures for assuring use and equitable sharing of the instrument and plans for including minor or outside users. d. Submit a specific plan for long-term operation and maintenance of the instrument. Provide documentation (e.g., separate letters signed by appropriate institutional officials) describing the required institutional commitment in support of the proposed plan. Applications must be received by March 26, 1997. Applications received after this date will not be accepted for review in this competition and will be returned to the applicant. The completed, signed original and four exact photocopies of the signed application and any appendix material* 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) One copy of the application and appendix material must be addressed to: Shared Instrumentation Program Biomedical Technology National Center for Research Resources 6705 Rockledge Drive, Room 6154 - MSC 7965 Bethesda, MD 20892-7965 REVIEW CONSIDERATIONS Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with 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, assigned a priority score, and receive a second level review by the National Advisory Research Resources Council, NCRR. Applications are reviewed by specially convened initial review groups of the Division of Research Grants (DRG) for scientific and technical merit and for program considerations by the National Advisory Research Resources Council (NARRC) of the NCRR. Approximately half of the applications will be reviewed at the September 1997 NARRC meeting and the remainder at the NARRC meeting in February 1998. Funding decisions on all applications received for the March 26, 1997, deadline will not be made until the program receives an appropriation for FY 1998. The Council date will not affect funding decisions. JOINT NIH/NSF SUBMISSION A recent NIH/NSF Memorandum of Understanding permits the joint agency review and funding of requests for a single instrument costing more than $500,000 which would normally be eligible for submission to both NIH and NSF. Such a request may be submitted to NIH for the March 26 (SIG) deadline for review by NIH with NSF participation, thus avoiding separate agency peer review. Under this arrangement, the agencies may offer joint funding in excess of their current award limits of $400,000. Applicants contemplating joint NIH-NSF submission are strongly urged to contact both the NSF Division of Biological Infrastructure [NSF contact: Dr. Karl A. Koehler 703-306-1472; kkoehler@NSF.gov] and the NCRR SIG Program [Dr. Marjorie A. Tingle 301-435-0772; SIG@EP.NCRR.NIH.GOV] for information concerning eligibility and required documentation. Review Criteria o The Scientific Need The extent to which an award for the specific instrument would meet the scientific needs and enhance the planned research endeavors of the major users by providing an instrument that is unavailable or to which availability is highly limited. o Technical Expertise The availability and commitment of the appropriate technical expertise within the major user group or the institution for use of the instrumentation. o Management Plan The adequacy of the organizational plan for use of the instrument and the internal advisory committee for oversight of the instrument including sharing arrangements. o Institutional Commitment The institution's commitment for continued support of the utilization and maintenance of the instrument. o Overall Benefit The benefit of the proposed instrument to the overall research community it will serve. AWARD CRITERIA In making funding decisions, the NCRR will give consideration to ensure program balance among various types of instruments supported and/or geographic distribution of awards. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic or scientific issues to: Marjorie A. Tingle, Ph.D. Shared Instrumentation Grant Program National Center for Research Resources 6705 Rockledge Drive, Room 6154, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0772 FAX: (301) 480-3659 Email: SIG@EP.NCRR.NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Carmen Herbert Office of Grants and Contracts Management National Center for Research Resources 6705 Rockledge Drive, Room 6205, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0837 Email: CarmenH@ep.ncrr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.371, Biomedical Technology. Awards will be made under authorization of the Public Health Service Act, Titles III and IV, (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 287) and 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 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 Dec 26 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-018 - V25(44) 12/20/96 Date: 26 Dec 1996 16:03:41 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 449 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <59v3ot$931@net.bio.net> NNTP-Posting-Host: net.bio.net CARDIOVASCULAR AGING RESEARCH NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA NUMBER: PA-97-018 P.T. 34; K.W. 0710010, 0715040 National Institute on Aging National Heart, Lung, and Blood Institute National Institute of Nursing Research PURPOSE The goal of this program announcement (PA) is to foster research that will enhance our understanding of age-associated changes in the cardiovascular system and, moreover, how these normal changes increase susceptibility to cardiovascular disease. The PA documents eight areas of research opportunities highlighted by the National Institute on Aging (NIA) Cardiovascular Aging Advisory Panel. Another goal of this PA is to promote cardiovascular health during the aging process. The National Institute on Aging (NIA), National Heart, Lung, and Blood Institute (NHLBI), and the National Institute of Nursing Research (NINR) encourage submission of investigator-initiated research project grant (R01) and First Independent Research Support and Transition (FIRST) (R29) award 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 PA, Cardiovascular Aging Research, is related to the priority area of heart disease and stroke. 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 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. Awards under this program to foreign institutions will be made only for studies of very unusual scientific merit, need, and opportunity. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. 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. MECHANISM OF SUPPORT This program will use the traditional NIH investigator-initiated research project grant (R01) and FIRST (R29) award mechanisms. Investigators interested in career development (K-series) in the cardiovascular aging field are encouraged to respond to NIA's Mentored Research Scientist Development Award in Aging program. This program was announced in the NIH Guide for Grants and Contracts, Vol. 25, No. 12, April 19, 1996. The Nursing Mentored Research Scientist Development Award (K01) was published in the NIH Guide for Grants and Contracts, Vol. 24, No. 2, June 16, 1995. Investigators seeking career development in the area of nursing and cardiovascular aging research are encouraged to respond to this mechanism. The total project period for an application submitted in response to this solicitation may not exceed five years. Because the nature and scope of the research proposed may vary, it is anticipated that the size of awards will vary as well. An investigator planning to submit an application requesting $500,000 or more in direct costs for any year is advised that he or she must contact the Institute program staff listed under INQUIRIES before submitting the application, i.e., as plans for the research are being developed, to obtain agreement >From program staff that the Institute or Center will accept the application for consideration of award. An application of such a size received without indication of prior staff concurrence and identification of that contact will be returned to the applicant without review. Investigators planning to request $500,000 or more in direct costs are referred to the policy update notice in the NIH Guide for Grants and Contracts, Volume 25, Number 14, May 3, 1996. Applicants proposing human intervention studies are referred to the NIA policy notice in the NIH Guide for Grants and Contracts, Volume 25, Number 33, October 4, 1996. This program will not support large, multi-center, clinical trials. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000 (rev. 4/1/94). RESEARCH OBJECTIVES Age is a major risk factor for cardiovascular disease. Deaths from cardiovascular disease rise significantly with advancing age as does the number of older individuals suffering from this disease. Cardiovascular disease remains a main cause of disability and the leading cause of death of older Americans, killing approximately 50 percent of individuals 65 years of age or older. Disability due to cardiovascular disease limits the activity and significantly erodes the quality of life of millions of older Americans each year. It is estimated that there are 33 million people in the United States (about 13 percent of the total population) 65 years of age or older. Individuals aged 85 and older, known as the "oldest old," are the fastest growing segment of the older population. According to the Bureau of the Census, by the year 2030, there will be approximately 70 million people in the United States over 65 years of age (about 20 percent of the total population). The increasing number of older persons may lead to increased susceptibility to age-associated cardiovascular disease (e.g., atrial fibrillation and congestive heart failure) and its related morbidity, infirmity, and dependency. New research may hold promise in addressing this upcoming burden. Although age is a major risk factor for cardiovascular disease, the reasons remain to be determined. To better appreciate the link between aging and development of disease, we need to better understand normal aging, i.e., aging in the absence of disease, and also how aging increases cardiovascular morbidity. Age-associated changes in cardiac function, circulatory hemodynamics, blood pressure regulation, and lipid metabolism all contribute to the development of cardiovascular disease in older persons. Ongoing research supported by the NIA is defining important age-related changes in the cardiovascular system. Yet, to ensure continued success and productivity in this important area, new research is needed to expand, and to integrate, the wealth of knowledge already accumulated at the basic and systems physiology levels. To address this issue, a scientific panel composed of non-federal scientists was recently convened by the Geriatrics Program, NIA. The panel's charge was to identify promising new areas for research opportunities in the cardiovascular aging field. The following eight research areas highlighted by the NIA Cardiovascular Aging Advisory Panel are neither prioritized nor meant to be restrictive. They represent a synthesis of ideas generated by the panel and later augmented by NIA staff. A more detailed description of the research recommendations has been published in the September 1996 issue (Vol. 44, No. 9, pp.1114-1117) of the Journal of the American Geriatrics Society. Potential applicants are encouraged to read the article: "Report from the NIA. Research Recommendations for Cardiovascular Aging Research." Recommendation 1. Foster clinically related research, focused on an integrative approach, in continuing to define important age-associated changes in the cardiovascular system and how these normal changes may contribute to cardiovascular morbidity. The goal is to stimulate new research that incorporates the advances made in cellular, structural, and molecular biology in the study of function in whole animals and humans. Fostering integrative biomedical research, by using the tools of molecular biology for the study of function, will lead to a better understanding of human health, aging processes, and susceptibility to cardiovascular disease. Recommendation 2. Expand research on cardiovascular-renal interactions in aging including the importance of gender and racial differences; changes in arterial blood pressure control and fluid and electrolyte balance; neurohumoral influences (e.g., changes in renal responsiveness to aldosterone and vasopressin); autonomic function and reflex mechanisms; and drug metabolism and clearance. An additional area includes the role of the aging kidney in age-associated cardiovascular diseases including hypertension, coronary heart disease, and congestive heart failure. This systems physiology approach to aging research is not restricted to cardiovascular-renal interactions and may include other relevant systems. Recommendation 3. Develop new methodologies to measure blood vessel wall stiffening and support new studies which will enhance our understanding of vascular stiffening in aging and its link (if any) in promoting atherosclerosis. Once thought to be a part of normal aging without consequence, stiffening of the large elastic arteries, such as the aorta, may lead to increased susceptibility to cardiovascular disease. The NIA has released a program announcement on "Aging, Vascular Stiffness, and Cardiovascular Function" in the NIH Guide for Grants and Contracts, Vol. 24, No. 24, June 30, 1995. Applicants interested in this area of research should respond to the June 1995 NIH Guide announcement. Recommendation 4. Examine the effects of aging on cardiac diastolic function including the relationship between systolic and diastolic function; e.g., adaptation, remodeling, and/or dysfunction during aging. Studies are needed to better understand diastolic performance in aging, including defining an easily measured and reproducible marker for diastolic dysfunction. This area of research is important because about 40 percent of older heart failure patients have diastolic dysfunction (with normal systolic function) as the etiology of their condition. Research on the importance of age-associated changes in the atria (e.g., development of fibrosis) in increasing susceptibility to atrial fibrillation, and stroke, is also needed. Recommendation 5. Studies are needed to examine the importance of gender differences in the aging cardiovascular system. Examples include the effects of sex steroids on the structure and function of the aging heart and blood vessels, regulation of lipoprotein metabolism, and body composition. Research on gender differences in renin-angiotensin-aldosterone reactivity and drug metabolism/clearance are needed. Research is also needed on ascertaining the mechanisms of action for estrogen-mediated cardioprotection in older, postmenopausal, women. This area is important because one in five women over 65 years of age has some form of heart disease. Recommendation 6. Examine the role of social and behavioral factors in promoting cardiovascular health. This includes the development of new approaches to enhance participation of older persons in exercise programs, or other forms of physical activity, as a means to foster health promotion and disease prevention. The importance of physical activity was the topic of discussion at the recent NIH Consensus Development Conference on "Physical Activity and Cardiovascular Health." Potential applicants are encouraged to read the NIH Consensus Statement in The Journal of the American Medical Association 276(3): 241-246, 1996. Investigators interested in this area of research are referred to NIA's program announcement on "Psychosocial Geriatrics Research: Health Behaviors and Aging," NIH Guide for Grants and Contracts, Volume 22, Number 11, March 19, 1993. Recommendation 7. Support research on the clinical pharmacology of cardiovascular drugs in older individuals, including pharmacodynamic and pharmacokinetic studies. Cardiovascular drugs comprise one of the most widely prescribed classes of medications in older persons. Yet, few studies focus on the special needs of older individuals (including gender and racial differences in drug action) and also may not take into account important age-associated physiologic changes that may alter drug absorption, distribution, metabolism, and clearance. Development of new drugs to treat age-associated cardiovascular disorders would benefit from more basic clinical investigations. Recommendation 8. Develop appropriate large animal models for clinically related cardiovascular aging research (in vivo) which mimic human age-related changes and conditions. Well defined large animal models are needed which both mimic the human condition and clearly separate the study of normal aging from disease development in old age. Model development for the study of diastolic dysfunction is a continuing need. Development of transgenic large animal models for the study of cardiovascular function in old age is an attractive possibility. Expanding research in the cardiovascular aging field will significantly augment our understanding of human health, aging processes, and susceptibility to cardiovascular disease. This new understanding will lead to the development of interventions to prevent and/or treat age-associated cardiovascular disease. The potential public health benefit, in terms of both health care cost savings and improving the quality of life of older persons, i.e., adding "life" to years, may be considerable. NIA, NHLBI, and NINR encourage submission of investigator-initiated research on the topics listed and also on any other relevant cardiovascular aging issues that are responsive to the general research objectives of this 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 has 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 also 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 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 and 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. 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 reference letters will be considered incomplete and will be returned without review. FIRST (R29) award applications must also be prepared according to the requirements of Just-In-Time procedures, as announced in the NIH Guide for Grants and Contracts, Vol. 25, No. 10, March 29, 1996. There may be a significant delay in the processing and review of a FIRST (R29) award application that has not been prepared according to the instructions in the NIH Guide notice. In addition, for all applications, the title and number of the PA must be typed on line 2 of the face page of the application form and the YES box must be marked. 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 20817-7710 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened 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. Review Criteria o Scientific, technical, or medical significance and originality of the 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 the provisions for the protection of human and animal subjects and safety of the research environment; and 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. AWARD CRITERIA Scored applications will compete for available funds with all other scored applications assigned to an 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 balance among research areas of the program announcement. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Andre J. Premen Geriatrics Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3E327, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-6761 FAX: (301) 402-1784 Email: PREMENA@GW.NIA.NIH.GOV Dr. David Robinson Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 10193, MSC 7956 Bethesda, MD 20892-7956 Telephone: (301) 435-0545 FAX: (301) 480-2849 Email: DRW@CU.NIH.GOV Dr. Hilary D. Sigmon Program Science Administrator National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-5970 FAX: (301) 480-8260 Email: HSIGMON@EP.NINR.NIH.GOV Direct inquires regarding fiscal matters to: Mr. Joseph Ellis Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: ELLISJ@GW.NIA.NIH.GOV Mr. William W. Darby Grants Management Office National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7128, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0177 FAX: (301) 480-3310 Email: WILLIAM_DARBY@NIH.GOV Mr. Jeff Carow Grants Management Office National Institute of Nursing Research Building 45, Room 3AN-18 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 Nos. 93.866, 93.837, and 93.361. 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, 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 Dec 26 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-017 - V25(44) 12/20/96 Date: 26 Dec 1996 16:03:20 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 415 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <59v3o8$91m@net.bio.net> NNTP-Posting-Host: net.bio.net HIV-1 INFECTION OF THE CENTRAL NERVOUS SYSTEM NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA NUMBER: PA-97-017 P.T. 34; K.W. 0705055, 0715008, 0765033, 0745070 National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute on Drug Abuse National Institute of Child Health and Human Development PURPOSE The National Institute of Mental Health (NIMH), the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute on Drug Abuse (NIDA), and the National Institute of Child Health and Human Development (NICHD) invite research grant applications through this Program Announcement (PA) to support research focused on determining the pathogenic mechanisms involved in HIV-1 associated neurobehavioral and neurological dysfunction in adults and children. The objective of this cooperative effort is to foster investigations that will provide the foundation for the rapid development of therapeutic interventions to prevent and treat the effects of HIV-1 on the central nervous system (CNS). Applications ranging from basic research to clinical diagnosis and treatment studies are being solicited. Multidisciplinary research teams and collaborative alliances are encouraged but not required. 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, HIV-1 Infection of the Central Nervous System, is related to the priority area of HIV infection. 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 Eligibility and requirements for different funding mechanisms vary. Applicants are advised to contact the relevant program staff listed under INQUIRIES for additional information and specific application procedures. 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 and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for small grants (R03), First Independent Research Support and Transition (FIRST) (R29) awards, program projects (P01), or fellowships (F32). Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Grant funds may be used for expenses clearly related and necessary to conduct the proposed research, including both direct and allowable indirect costs. Grant funds may not be used to operate a treatment, rehabilitation, or other service program. Prospective applicants should contact NIH staff to ascertain the dollar and time limitations associated with each program mechanism. Information specific to the Individual Postdoctoral Training Awards (F32): Individuals must be, at time of application, citizens or noncitizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence and have in their possession an Alien Registration Receipt Card (I-151 or I-551). Noncitizen nationals are persons who, although not citizens of the United States, owe permanent allegiance to the United States. They are generally persons born in lands that are not States, but are under United States sovereignty, jurisdiction, or administration (e.g., American Samoa). Individuals on temporary or student visas are not eligible. Individuals must have received, as of the beginning date of the National Research Service Award (NRSA) appointment, a Ph.D., M.D., D.O., D.D.S., D.V.M., O.D., D.P.M., Sc.D., Eng. D., Dr.P.H., or D.N.S., or equivalent degree from an accredited domestic or foreign institution. Certification by an authorized official of the degree granting institution that all degree requirements have been met is also acceptable. Individuals may receive up to three years of aggregate NRSA support at the postdoctoral level including any combination of support from institutional training grants and individual fellowship awards. For additional eligibility criteria, see the NIH Guide, Vol. 25, No. 31, September 20, 1996. MECHANISM OF SUPPORT The mechanisms for support by the in this program announcement are: investigator initiated research project grants (R01), FIRST awards (R29), program project grants (P01), individual postdoctoral fellowship programs (F32) and small research grants (R03). NINDS does not accept applications for the R03 award. Because certain grants have special eligibility requirements (e.g., small grants, program project grants and FIRST awards), application formats, and review criteria; applicants are strongly encouraged to consult with program staff listed under INQUIRIES and obtain the appropriate additional announcements for those grant mechanisms. An applicant planning to submit a new (Type 1) investigator-initiated grant application requesting $500,000 or more in direct costs for any year is advised that he or she must contact Institute program staff before submitting the application, i.e, as plans for the study are being developed. Furthermore, the applicant must obtain agreement >From the staff that the Institute will accept the application for consideration for award. Finally, the applicant must identify, in the cover letter that is sent with the application, the staff member and Institute who agreed to accept assignment of the application. Any application subject to this policy that does not contain the required information in the cover letter sent with the application will be returned to the applicant without review. For additional information concerning large grant applications, see the NIH Guide, Vol. 25, No. 14 (May 3, 1996). For FIRST (R29) awards, Just-in-Time procedures will be used. These modified procedures are described in full in the NIH Guide, Volume 25, Number 10, March 29,1996. RESEARCH OBJECTIVES Studies of the neuropathogenesis of HIV-1 infection have enhanced our understanding of the profound impact of HIV disease on both the central and peripheral nervous systems. These effects are common and can result in considerable morbidity and mortality. The recent Report of the NIH AIDS Research Program Evaluation Task Force described neuro-AIDS as "one of the most prominent and dreaded manifestations of HIV infection." Steady progress in the field of neuro-AIDS research has been made. However, answers to critical questions that can be translated into clinical applications are needed. This program announcement is intended to encourage and foster investigations that will address research questions that will provide the foundation for the rapid development of therapeutic interventions to prevent and treat the effects of HIV-1 on the central and peripheral nervous systems. In an effort to intensify the depth, focus and coordination of efforts to address key neuro-AIDS issues, the NIMH, NINDS, NIDA, and NICHD are jointly issuing this Program Announcement. Applicants are encouraged to contact program staff of the appropriate Institute regarding programmatic specific issues. The following are research topics identified by the Institutes, the Office of AIDS Research (OAR), as well as experts in the field to be the most pressing scientific priorities and are provided as examples of research topics pertinent to this Program Announcement. o Research that will determine the pathogenic mechanisms involved in HIV-1 associated neurobehavioral and neurological dysfunction such as: - Determining how HIV enters, establishes infection and persists in the CNS - Determining the molecular and cellular changes underlying HIV-associated CNS dysfunction and their role in CNS dysfunction - Determining the mechanisms and consequences of cellular trafficking between the CNS, CSF and blood in the context of HIV-1 infection - Determining the consequences of the biological activity of cytokines, chemokines and neurotrophins on neurobehavioral and neurological dysfunction associated with HIV-1 infection o Research that will determine the impact of HIV-1/CNS infection on systemic disease progression; and the role of the CNS as a reservoir for HIV infection o Research leading to the development and expansion of methods to diagnose and monitor HIV-1 associated cognitive and motor dysfunction o Research to develop HIV-1 therapeutic agents capable of penetrating the blood-brain-barrier or delivery systems that enhance uptake across the blood-brain-barrier o Research that will determine the mechanisms and consequences of HIV-1 infection that influence the developing nervous system o Research which employs appropriate animal models of HIV-1/CNS disease to test hypotheses regarding the neuropathogenesis of HIV-1 infection and/or test therapeutic interventions o Research to determine the impact of anti-HIV-1 treatments on neurobehavioral and neurological complications of HIV-1 infection o Research to determine the role of opportunistic infections in neurobehavioral and neurologic complications of HIV-1 infection o Research investigating biological, environmental and nutritional factors that impact nervous system function in the context of HIV-1 infection 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 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also 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 (with the exception of F32) are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at standard deadlines for AIDS applications as indicated on page 21 of the application kit. Applications for fellowships (F32) are to be submitted on form PHS 416-1 (rev. 8/95); the standard receipt dates for these applications are April 5, August 5, and December 5. Both application kits are available at most institutional offices of sponsored research and may be obtained from Office of Extramural Outreach and Information Resources, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910; telephone 301/435-0714; fax 301/480-0525; Email: ASKNIH@ODROCKM1.OD.NIH.GOV. The title, "HIV-1 Infection of the Central Nervous System," and number of the program announcement must be typed on the face page of the application. Applications for the FIRST award (R29) must include at least three sealed reference letters 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. Applications for individual postdoctoral NRSAs (F32) must submit at least three completed reference forms. These forms are enclosed in the PHS 416-1 (rev. 8/95) kit used for individual NRSA applications. The completed original application and five legible copies of the PHS 398 or the original and two copies of the PHS 416-1 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 PHS referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, applications may 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 or board, when applicable. Review Criteria for R01 and R29: 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, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. For foreign applications, availability of special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions not readily available in the United States, or that provide enhancement of existing U.S. resources, must be addressed. 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, potential impact and relevance to the field, availability of funds and program priority. INQUIRIES Inquiries regarding this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Walter L. Goldschmidts, Ph.D. Office on AIDS National Institute of Mental Health Parklawn Building, Room 10-75 Bethesda, MD 20857 Telephone: (301) 443-7281 FAX: (301) 443-9719 Email: wgoldsch@nih.gov A. P. Kerza-Kwiatecki, Ph.D. Division of Convulsive, Infectious and Immune Disorders National Institute of Neurological Disorders and Stroke 7550 Wisconsin Avenue, Room 804 Bethesda, MD 20892 Telephone: (301) 496-1431 FAX: (301) 402-2060 Email: ak45w@nih.gov Lynda Erinoff, Ph.D. Office on AIDS National Institute on Drug Abuse Parklawn Building, Room 9A30 Bethesda, MD 20857 Telephone: (301) 443-6046 FAX: (301) 443-4100 Email: le30q@nih.gov Anne Willoughby, M.D., MPH Pediatric, Adolescent and Maternal AIDS Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B11H Bethesda, MD 20892 Telephone: (301) 496-7339 FAX: (301) 496-8678 Email: willouga@hd01.nichd.nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-08 Bethesda, MD 20857 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov Dianna Jessee Division of Extramural Activities National Institute of Neurological Disorders and Stroke 7550 Wisconsin Avenue, Room 1004 Bethesda, MD 20892 Telephone: (301) 496-9231 FAX: (301) 402-0219 Email: dj35j@nih.gov Gary P. Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse Parklawn Building, Room 8A54 Bethesda, MD 20857 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gf6s@nih.gov Edgar D. Shawver Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17 Bethesda, MD 20892 Telephone: (301) 496-1303 FAX: (301) 402-0915 Email: shawverd@hd01.nichd.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.242, 93.281, and 93.282 for NIMH, Nos. 93.853 and 93.854 for NINDS,. No. 93.279 for NIDA and 93.865 for NICHD. 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 66, and 45 CFR Part 74. This 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 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 nonuse 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 Dec 26 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-96-005 - V25(44) 12/20/96 Date: 26 Dec 1996 16:02:50 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 799 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <59v3na$8vr@net.bio.net> NNTP-Posting-Host: net.bio.net COOPERATIVE COMMUNITY BASED PERINATAL STUDIES AND INTERVENTIONS IN MINORITY POPULATIONS IN THE DISTRICT OF COLUMBIA NIH GUIDE, Volume 25, Number 44, December 20, 1996 RFA: HD-96-005 P.T. 34, FF; K.W. 0775013, 0775020, 0403004 National Institute of Child Health and Human Development Office of Research on Minority Health Letter of Intent Receipt Date: January 31, 1997 Application Receipt Date: April 3, 1997 PURPOSE The National Institute of Child Health and Human Development (NICHD), in cooperation with the National Institutes of Health (NIH), Office of Research on Minority Health (ORMH), invites new and renewal applications from institutions desiring to participate with the NICHD under a cooperative agreement in an ongoing multi-center research program designed to investigate topics related to the high infant mortality among minority populations in Washington, DC. It is the objective of this initiative to expedite the development of answers to these problems through a cooperative research network of participating centers in Washington, DC in cooperation with the NICHD. Research topics to be addressed include studies and interventions in women during pregnancy, infants and young children, as well as non-pregnant women during the preconception or interconception phase. Funding will be provided by ORMH and NICHD. Applicants must be able to propose research projects and to demonstrate relevant research experience pertinent to the objectives delineated in this RFA, qualifications of key personnel, and proven capacity to recruit community, clinic or hospital based populations for the planned interventions. The applicants must be willing and able to participate in a cooperative program of research and evaluation with other successful applicants. Peer reviewers convened by the NICHD will evaluate the qualifications and relevant research experience of the principal investigator and staff to do the proposed research; and the availability of resources necessary to conduct the research. It is anticipated that between six and eight organizations will be involved in this initiative. 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-lead national activity for setting priority areas. This Request for Applications (RFA), Cooperative Community Based Perinatal Studies and Interventions in Minority Populations, is related to the priority areas of infant mortality, fetal deaths, low birth weight, high risk pregnancies and prenatal care. 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 profit or non-profit organizations within the District of Columbia whether public or private, such as medical schools, universities, colleges, hospitals, laboratories, community based organizations, or units of local government. For-profit organizations interested in applying under this RFA should note that no profit or fees may be requested under this kind of assistance award. In addition, since there are no cost principles applicable to for-profit organizations receiving financial assistance awards, those set forth in Federal Acquisition Regulations in 48 CFR Part 31.2 will generally be used. Institutions may submit singly or in partnerships with two or more organizations or groups. Evidence of existing or proposed community affiliations and research capabilities must be represented regardless of which organization is submitting as the applicant entity. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program to assist the community in undertaking this coordinated population-based research effort will be a cooperative agreement mechanism, the research demonstration cooperative agreement (U18). This cooperative agreement provides "support for testing, by means of a research design, the effectiveness of the transfer and application of techniques or interventions derived from a research base for the control of diseases or disorders, or for the promotion of health. The project should be capable of making conclusions which are generally applicable to other sites." The major difference between a cooperative agreement and a research project grant is that there will be substantial NIH scientific and/or programmatic involvement with the awardees above and beyond the levels required for traditional program management of grants (Grants Policy Statement, DHHS Publication (OASH) 94-50, 000 (rev. April 1, 1994). Details of the responsibility, relationship and governance of the study to be funded under a cooperative agreement are discussed later in this document under the Section "Terms of Agreement." The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated award date is February 1998. At this time the NICHD has not determined whether or how the solicitation will be continued beyond the present RFA. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the sizes of the 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 NICHD and the ORMH, the award of a grant pursuant to this RFA is also contingent on the availability of funds for this purpose. FUNDS AVAILABLE It is anticipated that between 6 and 8 awards for participating centers will be made with an estimated total cost of $3,000,000 (including direct, facilities, and administrative cost) for the entire program for the first year ($1.5 million from NICHD and $1.5 million from ORMH). These funds will be allocated to Phase I: protocol design and implementation planning and Phase II: protocol implementation and participant recruitment. The actual cost of each approved protocol will be determined in Phase I. (See budget section for allowable costs) RESEARCH OBJECTIVES A. Background Infant mortality among blacks continues to be twice as high as among whites. In 1992, the infant mortality rate among whites in the U.S. was 6.9 per 1000 births and for blacks 16.8 per 1000 births, and the black-white ratio was 2.4:1. The overall infant mortality rate (provisional data) for the U.S. in 1994 was the lowest ever at 7.9 per 1000 births, but in Washington, DC, it was 20.1 per 1000 births. Similar disparities among blacks and whites exist for other birth outcomes related to infant mortality such as low birth weight and preterm delivery. Known risk factors of poor perinatal outcome include young maternal age, low level of maternal education, poverty, inadequate housing, lack of social support, being unmarried, late or no prenatal care, unintended childbearing, adverse health behaviors during pregnancy like smoking, drinking and drug abuse, as well as a number of medical risk factors, including preeclampsia, premature rupture of the membranes, urinary tract and vaginal infections. Certain causes of infant deaths occurring post-neonatally, such as infections, injuries and sudden infant death syndrome, are more common among black infants. B. Objectives and Scope To address these issues among minority populations in Washington, DC, the NICHD and the ORMH established a cooperative research network among six institutions in Washington, DC and the NICHD, as well as a Data Coordinating Center. The Steering Committee for this initiative identified a number of areas of research interest and coordinated the development of protocols which have been implemented. Studies currently in the field include an intervention to improve parenting skills among high risk mothers leading to better utilization of preventive health services for their infants, an adolescent pregnancy prevention school-based program, a study of barriers, motivators and facilitators to early entry and maintenance of prenatal care, a baseline study of injuries among infants and young children leading to emergency room visits in Washington, DC, a study of the determinants of lack of age-appropriate immunization coverage, and a study of characteristics of health services in neonatal intensive care units among most hospitals in Washington, DC. Information about these studies can be obtained from the NICHD as listed in the INQUIRIES section of this RFA. For this RFA, applicants should describe one or more research hypotheses for consideration by the group of awardees. We encourage collaborative efforts by groups, and research topics will be evaluated independently of resources required for network wide participation. Applicants should briefly describe research topics which: directly or indirectly address the problem of infant mortality and morbidity in the District of Columbia; clarify the relationship between the defined biological or sociological risk factors and infant mortality and morbidity; could be designed to address the question being asked; and which clarify the primary sources of individuals to be studied, accounting for possible co-interventions and reasonable accrual rates within the time limits of the initiative and the boundaries of the District of Columbia. This initiative calls for innovative investigations leading to a better understanding of the determinants and risk factors of the high rates of infant mortality and low birth weight among minorities in Washington, DC and development of interventions leading toward a reduction of those risk factors. Projects may be population-, clinic- or hospital-based or may deal with selected population groups. Study populations may be pregnant women, women of childbearing age, adolescents, or young infants, who reside in Washington, DC at the time of the investigation. Potential research topics may cover the development and testing of health education/health promotion interventions to effect a reduction in smoking, drinking, drug abuse or other adverse health behaviors during pregnancy. Other studies may deal with interventions during the preconceptual and interconceptional period to increase family planning service utilization and to reduce the risk of adverse birth outcome among high-risk women. Examples of types of research that could be conducted under this Cooperative Agreement include: o The development of effective outreach strategies to enhance participation in prenatal care. o The development of health education/health promotion interventions which are shown to be effective in this population, directed toward smoking, drinking and drug abuse, or other behaviors o Investigations and interventions aimed at preventing preterm delivery or intrauterine growth retardation. Because of the complex nature of the problem of the high infant mortality rate in Washington, DC involving social, demographic, health care delivery, access and utilization of health and social services and barriers to them, as well as medical and clinical problems impinging upon infant survival, the research approaches to address these problems involve contributions from many different disciplines, including sociology, behavioral sciences, health education, health service delivery, clinical obstetrics and pediatrics, nursing, epidemiology and statistics, and possibly some others. Examples of possible specific investigations (listed mainly for illustrative purposes) include: o There is an extensive research literature on smoking interventions in women before and during pregnancy, some of which have been tested in high risk inner city populations. Based on the currently available knowledge, a smoking intervention might be developed and tested in this population. o Findings from clinical trials which address the prevention of various obstetrical complications, including preeclampsia, if proven to be beneficial could be incorporated on a population basis into the content of prenatal care to test their overall efficacy in an inner city population. o The previous cooperative agreement included surveys and observational studies of barriers, motivators and facilitators of prenatal care, childhood injuries, and age-appropriate immunizations. Interventions could be developed to increase early entry and adherence to prenatal care schedules, reduce injuries in young children or increase immunization rates in children under the age of two building on the results of these Phase I studies. Although the studies funded under this RFA will differ in terms of their focus or disciplinary perspective, it is expected that investigators, through the Steering Committee, will develop common protocols and quality control procedures and will share the data generated by it. The selected protocol(s) will be subject to external scientific review by an uninvolved expert group, the Scientific Advisory Board and external community review by representatives of the community, the Community Advisory Board. The study will proceed into the implementation phase only with the concurrence of both the awardees and the NICHD. Recognition that it will not be possible to implement all the research projects proposed for technical review is essential. Other limiting considerations will include: (1) studies that are feasible to undertake in the proposed research population; (2) the financial resources available to the network; and (3) strategies that are likely to be the most productive and cost-effective in addressing the research priorities of the network. The data coordinating center (DCC), which will be chosen through a separate RFA, will provide management support and consultation in the design, execution, and analysis for multi-institutional studies in the field of infant mortality, and will ensure that the studies are of the highest scientific integrity and meet rigorous statistical standards. It will also assume responsibility for any protocol-related training, monitoring of sites for accurate and complete data collection, regulatory compliance, and research subject safeguards. The DCC will be responsible for the integrity of the scientific databases by editing and entering data, as well as designing and maintaining the study database(s). The DCC will be functionally independent of all research sites, although it could be physically located at one of them. GUIDANCE AND MANAGEMENT STRUCTURES It is expected that the first year of this initiative will be devoted to the prioritization of research projects approved during initial peer review; the detailed development of common protocols, manuals of operation, training manuals, etc.; the finalization of implementation plans and time lines; and budget development. Protocols will be implemented and evaluated in the following years of the initiative. The management of the NIH-DC Infant Mortality Initiative includes four committees: (1) A Steering Committee, (2) A Scientific Advisory Board, (3) The Community Advisory Board, and (4) Data and Safety Monitoring Board. The roles of these committees are defined in the section on Terms and Conditions of this RFA. SPECIAL REQUIREMENTS The NICHD invites applications both from current members of the NIH-DC Initiative to Reduce Infant Mortality in Minority Populations in the District of Columbia (competing renewal applications) and from new applicants. Applicants must be able to propose research projects and to demonstrate relevant research experience pertinent to the objectives delineated in this RFA, qualifications of key personnel, and proven capacity to recruit community, clinic or hospital based populations for the interventions being considered. Applicants must also demonstrate a willingness and ability to participate in a cooperative program of research and evaluation with other successful applicants. The following terms and conditions will be incorporated into the award statement and provided to the principal investigator(s) as well as the institutional officials at the time of award. Minimum requirements for applications are described below (See Application Procedures, also see review criteria). Terms and Conditions of Award These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used to assist the scientific community in conducting studies and interventions as part of the NIH-DC Infant Mortality Initiative will be a cooperative agreement (U18), an 'assistance' mechanism (rather than an 'acquisition' mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the 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. Consistent with this concept, the dominant role and prime responsibility for the activity resides 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 NICHD staff designated below. A. Awardees Rights and Responsibilities The tasks or activities in which awardees have primary substantial responsibilities include: identification of priority issues for research; research design and protocol development; participant recruitment and follow- up; collection, quality control, and transmission of accurate data in a timely manner; analysis and interpretation of data; preparation of publication of results of studies, interventions and trials done under this initiative; and collaboration with other awardees and NICHD scientists. Awardees will retain custody of and have primary right to their site's data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. The data developed under these awards will not be disseminated publicly prior to publication or presentation of study results in a peer reviewed forum. The awardees will establish policies and procedures which direct their collaborative operations, including a publication policy. These documents may be amended and supplemented as approved by the Steering Committee. Awardees will be required to accept and implement the common protocol and procedures approved by the Steering Committee B. NICHD Staff Responsibilities Responsibility for review and oversight of these cooperative agreements will reside with the NICHD Program Officer. This role will include the following: oversight to assure the scientific merit of studies, interventions and trials done under this initiative; assistance in the efficient conduct of studies, interventions and trials, including ongoing review of progress, possible redirection of activities to improve performance, and frequent communication with other members of the Steering Committee; and initiation of a decision to modify or terminate a study based on the advice of the Data Coordinating Center, the Data Safety and Monitoring Board, the Community Advisory Board , the Scientific Advisory Board, and/or the Steering Committee. The NICHD Program Officer will have voting membership on the Steering Committee, and its subcommittees. The NICHD Program Coordinator will provide traditional extramural program management. In addition, the Program Coordinator will assist in coordination across institutions and will serve as Executive Secretary for the Scientific Advisory Board, reporting findings to the Steering Committee and protocol investigators. Other NICHD intramural scientific staff may collaborate with awardees in the studies. The NICHD Scientific Consultant, a staff member of the Epidemiology Branch of the Division of Epidemiology, Statistics and Prevention Research (DESPR) will provide scientific and technical assistance to the awardee investigators. This assistance includes, assistance in refining methodological issues of protocols, definition of study populations, analysis plans, and evaluation of study results. Grants Management responsibility: A grants management specialist in the Grants Management Branch, NICHD will administer the business and financial management aspects of the award. The NICHD reserves the right to terminate or curtail a study (or an individual award) in the event of substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of a protocol; a study reaches a major study endpoint substantially before schedule with persuasive statistical significance; qualified scientific investigators are not available to participate in the study; an awardee's nonparticipation in the committee/group activities; or human subject ethical issues that may dictate a premature termination. C. Collaborative Responsibilities The management of the NIH-DC Infant Mortality Initiative includes four committees: (1) A Steering Committee will be responsible for the overall coordination of the study including: protocol prioritization, finalization, implementation and conduct of studies, and the preparation of publications. The Steering Committee will be composed of the awardee Principal Investigators, the Principal Investigator >From the Data Coordinating Center and the NICHD Program Officer, each having one vote. The chairperson of the Steering Committee will be an outside consultant chosen by the NICHD in consultation with the Steering Committee. The program coordinator, scientific consultant, and a staff member from the Grants Management Branch will attend Steering Committee meetings. The Steering Committee chairperson will chair all meetings of this committee. The Steering Committee will meet three to four times per year. (2) A Scientific Advisory Board will advise the NICHD and the Steering Committee on the scientific merit and technical soundness of protocols which have been developed before their implementation. This advisory board will have expertise in areas relevant to the research topics of this initiative and will be chosen by the NICHD in consultation with the Steering Committee. The NICHD Program Coordinator will act as executive secretary of this Board and report the findings to the Steering Committee and Protocol investigators. (3) The Community Advisory Board will advise the NICHD and the Steering Committee on issues related to community acceptance and sensitivities, as well as appropriateness of a given research protocol. This advisory board will consist of individuals with a demonstrated knowledge of, and a history of involvement with, the community and will be chosen by the NICHD in consultation with the Steering Committee. (4) Data and Safety Monitoring Board will be established as needed to monitor the safety of ongoing interventions or clinical trials and advise on their conduct. Members of the Board will represent expertise in ethics, clinical trial design, and other disciplines relevant to the intervention or trial for which they are constituted. The members of the Board will be chosen by the NICHD. Subcommittees will be established by the Steering Committee, as it deems appropriate; the NICHD Program Officer will serve on the subcommittees as appropriate. The collaborative protocols will be approved by the Steering Committee. Data will be submitted centrally to the Data Coordinating Center. The Steering Committee will define rules regarding access to data and publications. An independent Data and Safety Monitoring Board will review progress of clinic trials at least annually and report to the NICHD. Awardees will be required to accept and implement the common protocol(s) and procedures approved by the Steering Committee. D. Arbitration Any disagreement that may arise on scientific matters (within the scope of the award), between award recipients and the NICHD may be brought to arbitration. An arbitration panel will be composed of three members -- one person selected by the principal investigator, one person selected by the NICHD, and a third person selected by the two prior selected members. The decision of the arbitration panel, by majority vote, will be binding. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. These special arbitration procedures described above in no way affect the right of a recipient of a cooperative agreement assistance grant to appeal an adverse determination 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 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 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. The usual NIH policies concerning research on human subjects also apply. All applications for clinical research submitted to the NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. Investigators may also obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit by January 31, 1997, a letter of intent that includes a descriptive title of the 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 and the 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 the NICHD staff to estimate the potential review workload and avoid conflict of interest in the review. A letter of intent should be sent to: Barbara K. Wingrove Division of Epidemiology, Statistics and Prevention Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 7B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 594-1302 FAX: (301) 480-0649 Email: Barbara_Wingrove@NIH.GOV 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 business offices and from the Extramural Outreach and Information Resources Office, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: asknih@odrockm1.od.nih.gov. Budget Facilities and administrative costs will be awarded in the same manner as for research project grants (R01). Allowable costs and policies governing the research grant programs of the NIH will prevail. In planning the budget section of the application, each applicant should submit budget estimates for all years. The first year's budget for Phase I: Protocol design and implementation planning will be limited to the following maximum allowances: Principal Investigator: 10 percent effort Co-principal Investigator: 5 percent effort Site Coordinator: 50 percent effort Secretary: 50 percent effort Supplies and small equipment (itemize and justify) Not to exceed $4500 Travel to Steering Committees based upon four meetings a year lasting one day each attended by no more than three individuals per institution Other costs (itemize and individually justified) Not to exceed $2500 Budgets for implementation of protocols must include estimated research project costs for years 2 through 5 at the applicant's institution. Actual annual budgets for subsequent years of the Initiative of the member institutions of the NIH-DC Initiative to Reduce Infant Mortality in Minority Populations in the District of Columbia will be based on individual protocols in which these member institutions are participating. Budgets for protocols will be based on specific protocol requirements and availability of funds.Determination of actual cost allocations will be those requested by the individual protocol group(s) based on the requirements of the approved protocols and approved by the Steering Committee. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to do this 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 checked. The signed, typewritten original of the application, including the checklist, and three exact photocopies 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) At the time of submission, two additional copies of the application must be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03A, MSC 7510 Bethesda, MD 20892-7510 Bethesda, MD 20852 (for express/courier service) Applications must be received by April 3, 1997. If an application is received after that date, it will be returned to the applicant without review. The 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 also not accept an application that is essentially the same as one already reviewed. Letter of Intent Receipt Date: January 31, 1997 Application Receipt Date: April 3, 1997 NICHD Council review: September 1997 Anticipated Award Date: February 1998 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness by the NICHD. Incomplete 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 an appropriate scientific peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, a triage process may be used in which applications will be determined to be competitive or noncompetitive based on their scientific merit relative to other applications received in response to this RFA. Applications determined to be noncompetitive by the scientific review committee will be withdrawn from further consideration, and the Principal Investigator will receive a summary statement reflecting the reviewers' evaluation. Applications judged to be competitive will be further discussed and assigned a priority score. They will then receive a second level review by the National Advisory Child Health and Human Development Council (NACHHD). General Considerations All applications will be judged on the basis of their scientific merit and the documented ability of the investigators to meet the RESEARCH OBJECTIVES of the RFA. Although the technical merit of the application is important, it will not be the sole criterion for evaluation of the application. Other considerations, such as access to populations and qualifications of the project staff, will be part of the evaluation criteria. Review Criteria A. Experience with community-based perinatal studies or clinical trials and protocol development. Quality of the unit's participation in either an intervention, clinical trial or study of a cooperative nature in the recent past (new applicants) or in ongoing protocols during the current grant support period (current members in the initiative). B. Qualifications of Applicant Interdisciplinary nature of potentially available scientific collaborators reflecting several of the disciplines required for these studies. Knowledge and experience in areas relevant to the conduct of research relevant to the area of infant mortality and low birth weight in minority populations, including interventions and clinical trials, and experience in research design. Commitment of staff for the satisfactory conduct of the study. Willingness to work as part of a cooperative study with other participating members in the NICHD as outlined in the RFA. C. Qualifications of Personnel Qualifications, research experience and commitment of the principal investigator and key personnel, particularly, but not exclusively, in the area of the proposed research. Scientific, clinical and administrative abilities and academic productivity of Principal Investigator and other team members. Willingness to work as part of a cooperative study with other participating members in the NICHD as outlined in the RFA. D. Available Population Access to populations which may be the target of both research projects or collaborative relationships in the community addressing concerns in maternal- child health. Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the research. Plans for the recruitment and retention of subjects will be evaluated. The scientific peer review group will also examine the provisions for the protection of human subjects and the safety of the research environment. E. Evidence of Collaboration Evidence of collaboration with other institutions, agencies, or community- based organizations for outreach, case identification, and participation in clinical trials. Every collaborative initiative cited should be accompanied by a letter of commitment specific to the activity of this RFA. F. Facilities and management. Availability of the resources necessary to perform the research, Institutional assurance to provide support to this study in such areas as fiscal administration, personnel management, space allocation. Facilities in