From owner-sci-resources@net.bio.net Sun Feb 02 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 1 February 1997 Date: 3 Feb 1997 14:54:02 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 121 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5d5qaa$mmb@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 February 1, 1997. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: International Document Title: Special Scientific Report 97-02 File size (bytes): 3706 STIS Filename: int976.txt Also available: int976.doc Title: FY '96 Annual Report File size (bytes): 40035 STIS Filename: int977.txt Also available: int977.doc Document Type: Letter Title: Dear College Letter: Program Announcement File size (bytes): 14472 STIS Filename: nsf9752.txt Document Type: News Title: BACTERIA TELL TIME File size (bytes): 4959 STIS Filename: tip97128.txt Document Type: Press Release Title: Major Changes in Mineral Chemistry and Properties at High Pressures Seen File size (bytes): 4193 STIS Filename: pr975.txt Document Type: Program Guideline Title: NSF 97-30--Guide to Programs File size (bytes): 487495 STIS Filename: nsf9730.txt Title: Life in Extreme Environments (LExEn) File size (bytes): 14390 STIS Filename: nsf9745.txt Title: NSF 97-53-- Fifth Competition for Long-Term Ecological Research (LTER): Urban LTER File size (bytes): 19897 STIS Filename: nsf9753.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Letter Title: Dear College Letter: Program Announcement File size (bytes): 14472 STIS Filename: nsf9752.txt Title: REULIST -- Current List of REU Sites File size (bytes): 90288 STIS Filename: reulist.txt Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 113894 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Directory File size (bytes): 128319 STIS Filename: phnorg.txt Document Type: Program Guideline Title: NSF 97-53-- Fifth Competition for Long-Term Ecological Research (LTER): Urban LTER File size (bytes): 19897 STIS Filename: nsf9753.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 nsf9753.txt, the text of your message should be as follows: get nsf9753.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9753.txt, you would enter: ftp> get nsf9753.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 Feb 05 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-033 - V26(03) 01/31/97 Date: 6 Feb 1997 15:07:16 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 307 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ddo74$kbh@net.bio.net> NNTP-Posting-Host: net.bio.net HIV, AIDS AND RELATED ILLNESSES COLLABORATION AWARD NIH GUIDE, Volume 26, Number 3, January 31, 1997 PA NUMBER: PAR-97-033 P.T. 34; K.W. 0715008 Fogarty International Center PURPOSE The Fogarty International Center (FIC) is expanding its AIDS International Research and Training Program to provide small individual research grants for collaboration between U.S. and foreign scientists in any country, consistent with U.S. foreign policy considerations. Support is available for research on human immunodeficiency virus (HIV) infection, acquired immunodeficiency syndrome (AIDS) and for research related to AIDS. Up to $20,000 per year for a maximum of three years is available for U. S. investigators and their foreign collaborators to conduct research mainly at the foreign site. U.S. investigators holding currently active NIH grants for research related to HIV infections, AIDS and other related health problems are eligible to apply with their foreign collaborator for the AIDS Fogarty International Research Collaboration Award (AIDS-FIRCA). A similar program of Fogarty International Research Collaboration Awards (FIRCA) is available in all non-AIDS biomedical sciences research subjects for collaborative projects involving U.S. scientists and investigators in developing countries: see program announcement number PA-95- 011. AIDS-FIRCA grants will provide funds to the foreign collaborator, through the U.S. grantee institution, for supplies at the foreign institution; for expenses incurred at the U.S. institution to support the collaboration; and for research- related travel and subsistence expenses for both the U.S. and foreign investigators. If the foreign collaborator is in a developing country, applicants may also request funds for small pieces of equipment necessary to the AIDS-FIRCA project at the foreign site. For the purpose of this program, developing countries are considered to include those in the following regions: Africa, Asia (except Hong Kong, Japan, Singapore, South Korea and Taiwan), Central and Eastern Europe, Latin America, the Middle East (except Israel and the Persian Gulf states), and the Pacific Ocean Islands (except Australia and New Zealand). ELIGIBILITY REQUIREMENTS Applications may be submitted by U.S. non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. To be eligible for the AIDS-FIRCA program, the following conditions must be met: - The proposed U.S. Principal Investigator must be the Principal Investigator (Project Director) of an NIH-sponsored AIDS or AIDS-related research grant project (R, P, or U-01 series) that will be active and funded during the proposed grant award period (up to three years). Under exceptional circumstances, after consultation with program officials, some research contracts (N01 series) may be eligible "parent" funding for the AIDS-FIRCA. On submission of an application, at least 18 months of active research support must remain on the listed parent grant. Investigators may request the full three years of support in the FIRCA application in cases where less than three future years remain on the parent grant, presuming that the renewal application will be submitted and awarded. - The foreign collaborator must hold a position at an institution in a foreign country that will allow him or her adequate time and provide appropriate facilities to conduct the proposed research. - The application must demonstrate that the award will enhance the scientific contributions of both the U.S. and foreign scientists and will enhance or expand the contribution of the NIH-sponsored research project (parent grant). MECHANISM OF SUPPORT The small grants (R03) will provide up to $20,000 per year in direct costs for up to three years. Funds may be used for materials and supplies necessary to conduct the collaborative research in the foreign scientist's research laboratory or site, and for costs related to the AIDS-FIRCA project at the U.S. institution. Equipment requests are limited to items for use in the AIDS-FIRCA project at foreign institutions in developing countries. Travel and subsistence-related expenses may be requested for the U.S. Principal Investigator, the foreign collaborator, and/or their colleagues for visits directly related to the subject of the collaborative research. All proposed expenditures must be well justified and clearly related to the research objectives of the proposed project. Applicants should request support to conduct research not already being supported by the U.S. investigator's parent grant; however, the research proposal must be an extension of or related to the research project currently funded by the NIH. The awards will be made to U.S. institutions which will be responsible for the expenditures. The minimum FIRCA project period will be for one year, the maximum will be for three years. Continuation of the FIRCA project depends upon research progress, availability of funds, and continuation of appropriate NIH support of the Principal Investigator's AIDS-related research. Since the research supported under this award is mainly to occur at the foreign site, indirect costs will be calculated on the basis of the off-site rate of the U.S. sponsoring institution. RESEARCH OBJECTIVES The main objective of this AIDS-FIRCA program is to facilitate unique and highly promising collaborative basic and applied research efforts between U.S. and foreign scientists that will both expand and enhance the HIV- and AIDS-related NIH-supported research program of the U.S. Principal Investigator and benefit the scientific interests of the collaborating foreign scientist. All areas of research directly and indirectly related to HIV infection and AIDS are eligible for consideration. Examples of topics include but are not limited to: - Research related to the development of HIV/AIDS vaccines; - Research on antiviral and other interventions for HIV/AIDS; - Research on HIV and infection by the virus; - Research on other retroviruses related to HIV; - Studies of maternal/pediatric HIV infections; - Cofactors involved in HIV infection; - Studies on the spread of HIV infection and AIDS into new locales; - The natural history of HIV infection; - Research on opportunistic infections and other disorders that result from immunosuppression by the AIDS virus; - Studies of emerging/reemerging microbes and diseases linked to factors known or suspected to relate to the spread of HIV; and - Research on the social and behavioral factors that affect HIV risk and transmission. Applicants should be aware that applicable provisions for protection of human research subjects and laboratory animals must be met in both domestic and foreign settings. See Title 45 CFR, Part 46, for information concerning the Department of Health and Human Services regulations for the protection of human subjects and the PHS Policy on Humane Care and Use of Laboratory Animals. These are available from the Office for Protection from Research Risks, National Institutes of Health, 6100 Executive Blvd., MSC 7507, Suite 3B01, Rockville, MD, 20892- 7507. Information on these assurances is included in the special application instructions available from FIC (address below). INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (59 FR 14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. APPLICATION PROCEDURES - Special application instructions are required and are available from the International Research and Awards Branch, FIC (address below). - The application consists of a portion to be completed by the U.S. Principal Investigator, and a separate portion to be completed by the foreign collaborator. Both portions of this application must be submitted as a single package, by the U.S. grantee institution. - Applications must be submitted by the U.S. Principal Investigator on standard form PHS 398 (rev. 5/95), which is available from most U.S. 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. Receipt dates for completed applications are September 1, January 2 and May 1. If the deadline falls on a weekend or a holiday, it is automatically extended to the following workday. Applications received on these dates will be reviewed using the mandated AIDS-Expedited Review schedule. REVIEW CONSIDERATIONS Applications will be assigned to the Fogarty International Center. Applications will be reviewed for scientific and technical merit by the AIDS and Related Research Initial Review Group in the Division of Research Grants (DRG), NIH. Following scientific-technical review, the applications will receive a second level review by the Fogarty International Center Advisory Board. As part of the initial merit review, a process may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the program announcement. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria - likelihood that the proposed research extends or enhances the ongoing funded research of the U.S. Principal Investigator; - ability of the foreign collaborator to undertake and direct the foreign research efforts; - appropriateness of the proposed collaborative effort as a format for accomplishing the stated aims; - appropriateness of the proposed budget and duration in relation to the proposed research; - scientific, technical, or medical significance and originality of proposed research; - appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; - availability of the resources necessary to perform the research; - and conformance with 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 Fogarty International Center. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Special application instructions are necessary to apply for this program. To obtain further information write, fax or phone the Fogarty International Center. Direct inquiries regarding programmatic issues to: Dr. Jean Flagg-Newton Division of International Training and Research Fogarty International Center Building 31, Room B2C39 31 CENTER DRIVE MSC 2220 BETHESDA MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: flaggnej@ficod.fic.nih.gov For grants management and fiscal matters, contact: Ms. Susan Bettendorf Grants Management Specialist Fogarty International Center Building 31, Room B2C39 31 CENTER DRIVE MSC 2220 BETHESDA MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: bettends@ficod.fic.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.934. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed Feb 05 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-026 - V26(03) 01/31/97 Date: 6 Feb 1997 15:09:24 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 431 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ddob4$krt@net.bio.net> NNTP-Posting-Host: net.bio.net ASPERGILLOSIS, EHRLICHIOSES AND DRUG RESISTANCE NIH GUIDE, Volume 26, Number 3, January 31, 1997 PA NUMBER: PA-97-026 P.T. 34; K.W. 0715125, 0765033, 0745020, 1002008, 0765012 National Institute of Allergy and Infectious Diseases PURPOSE The purpose of this program announcement (PA) is to stimulate research on selected topics in three separate areas:aspergillosis, the ehrlichioses, and antibacterial or antifungal drug resistance. For aspergillosis, the goal is to support research on clinically relevant aspects of Aspergillus fumigatus and/or A. flavus. For the ehrlichioses, the goal is to support investigations on the diagnosis and pathogenesis of the agents of human ehrlichiosis. For drug resistance, the goal is to support research projects elucidating the molecular biology and molecular epidemiology of antibiotic resistance mechanisms in health care associated bacteria and fungi, including the molecular mechanisms of acquisition, expression, maintenance, and dissemination of resistance genes. Specific organisms of interest include but are not limited to: vancomycin-resistant enterococci, methicillin-resistant staphlyococci, drug-resistant pneumococci, Gram negative bacteria and the fungi of greatest significance in the nosocomial setting. Pathogens covered under other NIAID PAs or recent initiatives (e.g., Mycobacterium tuberculosis) will not be considered responsive to this PA. 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, Aspergillosis, Ehrlichioses and Drug Resistance, is related to the priority areas of immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). ELIGIBILITY Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Traditional research project grant (R01), FIRST award (R29), and small research grant (R03) applications may be submitted in response to this program announcement. Applications for R01 grants may request up to five years of support; applications for R29 grants must request five years of support. The NIAID uses R03 grants to support small, highly innovative or pilot projects. Applicants for R03 grants may request up to $50,000 annual direct costs for a period not to exceed three years. Funds and time requested should be appropriate for the research proposed. Applicants for R03 grants must follow the special application guidelines and Terms and Conditions of Award in the NIAID SMALL RESEARCH GRANTS brochure (September 1996); this brochure is available via the WWW at: http://www.niaid.nih.gov/newsletter/maya/tools/broch.htm Responsibility for the planning, direction, and execution of the proposed research for all applicable mechanisms of support will be solely that of the applicant. RESEARCH OBJECTIVES Background The purpose of this initiative is to advance the development of research in three specific areas: aspergillosis, ehrlichioses and drug resistance. Aspergillosis: Aspergillosis is representative of a large group of health care associated infections caused by filamentous fungi. Aspergillosis is a disease with exceptionally high health care costs, not only because of the chronic course of disease and high mortality rates, but also because of the lost investment in expensive medical procedures such as bone marrow (BMTx) and organ transplantation that place patients at risks for infection. Incidence of aspergillosis is estimated at 10 to 20 percent of all BMTx, with >10,000 new transplants each year in the U.S. Incidence is also increasing in AIDS. Major limitations exist in diagnosis and treatment of this infection as highlighted in the June 1994 NIAID mycology workshop, Molecular and Immunologic Approaches to the Diagnosis and Treatment of Systemic Mycoses. Ehrlichioses: Several new or previously unrecognized vector-borne or zoonotic human diseases, such as human the ehrlichioses, either have just been described or have been found to be on the increase in recent years. Ehrlichia chaffeensis was considered to be the sole causative agent of human ehrlichiosis (human monocytic ehrlichiosis, HME); however, a second ehrlichial species now has been documented in human disease. The ability to cultivate the agent of human granulocytic ehrlichiosis (HGE) in vitro is a major advance and now opens up new possibilities. There is potential for the development of new and more sensitive diagnostic procedures for the rapid detection of Ehrlichia species, and for definitive studies on mechanisms of pathogenesis alteration of host cells and host defense mechanisms. A recent (September 1996) NIAID workshop on the human ehrlichioses identified research opportunities in relation to the natural history, transmission, pathogenesis, and diagnosis of disease. Antibacterial/Antifungal Drug Resistance: Antimicrobial resistance is emerging in virtually all nosocomial pathogen-antimicrobial combinations. Several bacterial infections may soon be untreatable. These include: methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococci, and numerous Gram negative species. Factors leading to the emergence of resistance among nosocomial pathogens include: the use of broad-spectrum antibiotics; increasing numbers of susceptible, immunocompromised patients; technologic changes (implants, catheters, intravenous lines) leading to increased exposure to resistant microorganisms; and the breakdown in hygiene, infection control, and disease control programs that lead to increased transmission of resistant bacteria. Penicillin-resistant pneumococci have emerged as an important problem over the past decade. Clusters of isolates have been reported from five continents. In the United States, the prevalence of these resistant organisms increased from 3.6 percent to 14.5 percent between 1987 and 1994 according to reporting from 12 sentinel hospitals. Between 1989 and 1994, the percentage of reported nosocomial enterococcal infections that were due to vancomycin-resistant enterococci (VRE) increased from 0.3 percent to 9.1 percent. In intensive care units (ICUs), the increase of VRE was even larger, growing from 0.4 to 13.6 percent; however, in 1994, the reports of VRE from other care units showed a much greater proportional increase (the percentage almost doubled) compared to the increase observed from ICUs, suggesting that VRE was spreading from the ICUs to other parts of the hospitals. The development of vancomycin resistant enterococci has coincided with the emergence of high levels of enterococcal resistance to penicillin and the aminoglycosides, which further limited the options available to physicians trying to care for patients infected with these organisms. Methicillin was one of the synthetic penicillins that was developed for treating infections due to staphylococci that were resistant to penicillin. Shortly after its introduction, methicillin resistant staphylococci began to appear. Their prevalence increased dramatically during the 1980's and by 1991, approximately 40 percent of isolates from large teaching hospitals were resistant. These developments highlight the need to stimulate further research into strategies aimed at preserving the effectiveness of currently available antibacterial agents and finding new classes of antibacterial agents. Research Objectives and Experimental Approaches Aspergillosis: Efforts should be focused on clinically relevant aspects of Aspergillus fumigatus and Aspergillus flavus. Relevant projects for aspergillosis will address one or more of the following objectives: o The development of contemporary model systems for A. fumigatus or A. flavus that focus on the factors endowing these fungi with pathogenic potential. Basic biological studies should include components that hold short term potential to improve diagnosis or treatment of human disease. o The identification of fungal nucleic acids, antigens or products that can be utilized in a rapid, sensitive and specific assay to identify patients with aspergillosis. Projects should include specific aims that validate the choice of target in preliminary in vitro or animal model experiments. Ehrlichioses: Studies should be directed toward the agents of HME and HGE and could include any of the following: o Detailed and definitive studies on the mechanisms involved in the transmission and pathogenesis of the human ehrlichioses, especially those that influence intracellular growth and alter host defense functions. o Analysis of factors that influence susceptibility or resistance to infection. o Isolation and characterization of the major components or products of Ehrlichia for use in highly specific and more sensitive diagnostic procedures that will have practical (rapid, economically feasible) application, and/or their potential use in the development of vaccines to induce protective immunity. Antibacterial/Antifungal Drug Resistance: This announcement is intended to stimulate innovative research on drug resistance of health care associated pathogens with a strong emphasis on studies to develop improved means of rapid detection of resistance. Research efforts aimed at preserving the effectiveness of current antimicrobials could include: o Basic research toward understanding the molecular biology and genetics of resistance gene acquisition, maintenance, and transmission among health care associated bacterial and fungal pathogens. o Development of new diagnostic technologies to facilitate rapid detection of resistance. o Identification of new classes of antimicrobials or new targets for rational drug development and their validation in an appropriate preclinical model. o Evaluation of alternative technologies for the treatment of bacterial and fungal diseases where resistance is established. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) 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 listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applicants are strongly encouraged to contact the program staff listed under INQUIRIES early in project development with any questions regarding the proposed project(s). Applications are to be submitted on the grant application for PHS 398 (rev. 5/95) and will be accepted on the standard application deadlines as indicated on the application kit and at the beginning of this PA. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: ASKNIH@odrockm1.nih.gov. For purposes of identification and processing, the number and title of this program announcement must be typed in item 2 and the "YES" box must be marked. Applicants from institutions that have a General Clinical Research Centers (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 the GCRC Program Director must be included in the application material. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants for small research (R03) grants are to follow the application guidelines in the NIAID SMALL RESEARCH GRANTS brochure (September 1996), which is available from the program staff listed under INQUIRIES and via the WWW at: http://www.niaid.nih.gov/newsletter/maya/tools/broch.htm. R03 applications that do not conform to the instructions in the brochure will be judged non-responsive and returned to the applicant. ALL APPLICANTS REQUESTING $500,000 OR MORE IN ANNUAL DIRECT COSTS. The NIH policy update on acceptance for review of unsolicited applications that request more than $500,000 direct cost for any one year applies to applications in response to this PA. The Policy Update was published in the NIH Guide for Grants and Contracts, Vol. 25, No. 14, May 3, 1996, and became effective June 1, 1996. NIAID has (1) policies that require pre-approval by the Institute before acceptance of applications that request $500,000 or more in annual direct costs and (2) guidelines for preparation of multi-project research grant applications. Potential applicants must contact the appropriate program staff listed in INQUIRIES below to initiate clearance processes for acceptance of their applications. The completed, signed original and five legible, single-sided copies of the application must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) REVIEW CONSIDERATIONS Review Procedures Applications will be assigned on the basis of established PHS referral guidelines. Upon receipt, applications will be reviewed for completeness by the Division of Research Grants (DRG). Incomplete applications will be returned to the applicant without further consideration. R01 and R29 applications will be reviewed for scientific and technical merit by study sections of the DRG 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. R03 applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID. 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 plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications. The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance among research areas of the program announcement, and availability of funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dennis M. Dixon, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3A-06 - MSC 7640 Bethesda, MD 20892-7640 Telephone: (301) 496-7728 FAX: (301) 402-2508 Email: dd24a@nih.gov Requests for the NIAID brochure "NIAID SMALL RESEARCH GRANTS" may be directed to: Olivia T. Preble, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4C19 Bethesda, MD 20892-7610 Telephone: (301) 496-8208 FAX: (301) 402-2638 Email: op2t@nih.gov Direct inquiries regarding fiscal matters to: Todd Ball Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4B35 Bethesda, MD 20892-7610 Telephone: (301) 492-5512 FAX: (301) 480-3780 Email: tb22j@nih.gov AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301(c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citation is (No. 93.855 - Immunology, Allergy, and Transplantation Research and No. 93.856 - Microbiology and Infectious Disease Research [or] both of the preceding). Awards will be administered under PHS grants policies and Federal Regulations 24 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed Feb 05 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-97-003 - V26(03) 01/31/97 Date: 6 Feb 1997 15:09:10 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 582 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ddoam$kqo@net.bio.net> NNTP-Posting-Host: net.bio.net PEDIATRIC CARDIOVASCULAR DISEASE NIH GUIDE, Volume 26, Number 3, January 31, 1997 RFA: HL-97-003 P.T. 34; K.W. 0715040, 0770005, 0403001 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: June 30, 1997 Application Receipt Date: December 11, 1997 PURPOSE This solicitation invites grant applications to enter a single open competition for Specialized Centers of Research (SCOR) in pediatric cardiovascular disease. This program is open to all investigators, including those who are participating in the current program and those who are not. The objective of this initiative is to foster interdisciplinary studies of the etiology, pathophysiology and diagnosis of congenital and acquired cardiovascular disease in children in a context that will lead to more effective methods of treatment and prevention. To this end, investigators must present applications that encompass both basic and clinical science, and include studies of patients. Those studies must be designed to comply with NIH policies regarding gender and ethnicity unless exceptions can be scientifically justified. 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, Pediatric Cardiovascular Disease, is related to the priority areas of maternal and infant health, heart disease and stroke, diabetes and chronic disabling diseases, 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 for-profit and non-profit institutions, public and private, such as universities, colleges, hospitals, and laboratories. The principal investigator should be an established research scientist with the ability to ensure quality control and the experience to administer effectively and integrate all components of the program. A minimum time commitment of 25 percent is expected for this individual. The principal investigator must also be the project leader of one of the component research projects. If, through peer review, this project is not recommended for further consideration, the overall SCOR application will not be considered further. If this project is judged by peer review to be of low scientific merit, it will markedly reduce the overall scientific merit ranking assigned to the entire application by the review committee. Project leaders must agree to commit at least 20 percent effort to each project for which they are responsible. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) specialized center of research grant mechanism (P50). Responsibility for planning the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed five years. The anticipated date of award is January 1, 1999. Upon initiation of the program, there will be required communications between SCORs, usually in the setting of a meeting of SCOR participants. Therefore, in the preparation of the budget, applicants should request travel funds for this purpose in fiscal years 1999, 2000, 2001, and 2002 of the budget. Applicants should include a statement in their applications indicating their willingness to participate in these meetings. FUNDS AVAILABLE New applications may request up to $1,140,000 direct costs, not including indirect costs for collaborating institutions, in the first year, with a maximum increase of no more than three percent in each future year requested in the application. Competing renewal applications may request no more than 10 percent above the direct costs awarded in the final budget period or $1,140,000, whichever is greater. It is anticipated to support three SCOR grants for a five year project period at an estimated first year total cost of $3.22 million. Award of grants pursuant to this RFA is contingent upon receipt of funds for this purpose. Designated funding levels are subject to change at any time prior to final award, due to unforeseen budgetary, administrative, and/or scientific developments. Equipment is included in the budget limitation. However, requests for expensive special equipment that cause an application to exceed this limit may be permitted on a case-by-case basis following staff consultation. Such equipment requires justification. Final decisions will depend on the nature of the justification and the availability of funds. RESEARCH OBJECTIVES Background According to the recent report of the American Heart Association Task Force on Children and Youth, cardiovascular disease affects more than 600,000 infants, children and youths in the United States. This number includes patients with congenital cardiovascular malformations (CCVM), inherited progressive disorders such as Marfan's syndrome and hypertrophic cardiomyopathy, cardiac dysrhythmias and conduction disorders, and acquired diseases such as Kawasaki disease and rheumatic heart disease. Recent studies in flies, fish, frogs and mice have identified a large number of genes that are involved in cardiac and vascular morphogenesis, although for the most part the gene products and their functions have yet to be identified. In parallel with these discoveries, progress has been made in understanding the etiology of congenital heart disease with the important discovery that, contrary to earlier hypotheses, there is a relatively high incidence of inherited heart defects and many of these are single gene defects. However, as with animal studies, the gene products and their functions have yet to be elucidated. Thus, the field is now poised for fruitful collaborations between basic and clinical investigators who seek knowledge of how mutated or deleted genes perturb normal development. A goal of the SCOR program is to forge between experimental embryologists and clinical scientists a link that will rapidly increase knowledge of possible causes of CCVM and lead to new treatment and prevention strategies. For a number of different cell types, significant progress has been made in understanding the molecular control of the life and death of a cell. However, the genes involved in proliferation of cardiac myocytes, their differentiation, withdrawal from the cell cycle, and programmed cell death remain to be elucidated. Furthermore, it is not known whether manipulation of gene expression could cause cardiac myocytes to re-enter the cell cycle or avoid apoptosis. Such research could provide an important foundation toward repair and regeneration of cardiac muscle in patients with myocardial cell deficiency as in hypoplastic left heart syndrome or cell loss resulting from disease. The potential for gene therapy for cardiac muscle defects and disease would be increased by such studies. The clinical health of the myocardium is determined by genetic and environmental factors. Adverse effects of these factors could result in dysfunction of myocytes, fibroblasts and endocardial endothelium. Injury may result from toxic agents, infections, inflammatory cells and neurohormonal influences. Little is understood of the effects of such factors and the possibilities of etiology-specific prevention strategies and therapeutics have yet to be explored. Immunologic rejection is a major cause of death and morbidity in pediatric cardiac transplantation. Immunologic factors may also be crucial in the pathogenesis of coronary vascular disease following transplantation. Studies to define mechanisms of these events in pediatric patients and to alter their occurrence by therapeutic interventions will be crucial in improving outcome. Arrhythmias are a substantial cause of mortality and morbidity in pediatric patients. Recently, molecular genetic studies of familial arrhythmias have been fruitful. Several genetic loci causing the long QT syndrome have been mapped and mutations in cardiac sodium and potassium channels defined. The mechanisms by which these mutations are arrhythmogenic need to be elucidated. Other familial rhythm disorders (WPW syndrome and RV dysplasia) are being studied by similar techniques. The etiologies and treatments of sporadic and post-operative arrhythmias remain as inviting challenges for investigation. Furthermore, little is known about the genes that control the initiation of the heart beat and development of conduction system or how the products of those genes control function of the heart. Recent success in the in utero repair of lung defects, congenital diaphragmatic hernia and resection of congenital cystic adenomatoid malformations gives good reason to expect that similar results could be obtained for serious congenital cardiovascular malformations. Moreover, second trimester clinical fetal surgery has shown that tissue hypoplasia can be reversed if correction is made early. If the goal of early intervention is to be achieved, considerable effort must be placed on the detection of malformations earlier in fetal development than the current limit of 18 to 22 weeks of gestation for diagnosis of congenital heart defects by echocardiography . Early and accurate visualization of cardiac defects, for instance by ultrasound or MRI, would allow the option of in utero intervention, either by surgery or percutaneously delivered catheters, or perhaps ultimately by local delivery of constructs or genetically altered cells. Fetal somatic gene therapy with local delivery of vectors expressing essential genes or genetically altered cells may eventually prove to be the least traumatic way to alter aberrant cardiovascular development. In the meantime, refinement of current imaging techniques and miniaturization of interventional catheters for use in fetal therapy is essential. There is increasing evidence that a spectrum of congenital cardiovascular malformations and alterations in myocardial growth and function may be the result of maternal-fetal interactions. Important environmental influences include maternal diabetes, maternal systemic lupus erythematosus, maternal toxemia/placental insufficiency, cocaine addiction, HIV, alcoholism, and poor nutrition. Very little is known about the physiological effects of altered hemodynamics and changes in the hormonal, immune, and growth factor environment on the developing embryo and fetus. These topics are for illustrative purposes only. Applicants are expected to develop programs based on their knowledge of the field, their expertise and availability of patients. Basic and Clinical Research The overall concept of a SCOR program focuses on scientific issues related to diseases relevant to the mission of the NHLBI. It is essential, therefore, that all applications include both basic and clinical research projects. In the ideal SCOR, the basic research derives from, or is otherwise intimately linked to, the clinical research proposed by the investigators. Interactions between basic and clinical scientists are expected to strengthen the research, enhance transfer of fundamental research findings to the clinical setting, and identify new research directions. Plans for transfer of findings from basic to clinical studies should be described. Each SCOR grant application and award must include research involving human/patient subjects. Support may be provided for human biomedical studies of etiology, pathogenesis, prevention and prevention strategies, diagnostic approaches, and treatment of diseases, disorders or conditions. Small population-based studies, where the research can be completed within five years, may also be proposed. In addition, basic research projects must be included that relate to the clinical focus. A SCOR may also contain one or more core units that support the research projects. SPECIAL REQUIREMENTS Exclusions This RFA is intended to support Specialized Centers of Research grants. A SCOR provides the opportunity for investigators to engage in interdisciplinary and collaborative research which is focused on a specific disease or an area within a disease category. It is required that SCOR applications include studies of human subjects and/or human materials as well as basic studies clearly related to a disease area. The foundation of the clinical component should be strongly linked to the basic science projects; the basic science studies should be driven by the needs of the clinical projects. Thus, a SCOR has a central theme to which all research projects pertain. In addition, a SCOR may include CORE units to provide services to the various research projects and to support the organizational and administrative aspects of the program. Applications that include only basic or only clinical research will not be responsive to this RFA. In addition, clinical research projects focused on large epidemiological studies or large clinical trials will be considered unresponsive to this RFA. Awards will not be made to foreign institutions. However, under exceptional circumstances, a foreign component critical to a project may be included as a part of that project. In addition, to encourage women and underrepresented minority investigators to work within a SCOR project, to facilitate recruitment of new scientists to this area of research, and to foster cutting edge and innovative research directions, each SCOR program may support up to two investigators by utilizing up to $50,000 direct costs per year per investigator to fund pilot and feasibility projects. This will allow underrepresented minority investigators to acquire skills and data to make them more competitive in seeking independent research support (e.g. R01, R29). These funds will not be supplements, but rather specific dollars identified in the SCOR budget and restricted to be used for this purpose. The recipients would be chosen based on a proposal written by a SCOR investigator and reviewed by an internal review committee at the parent institution. Applicants should be aware that applications for supplemental funds will be accepted only under unusual and well defined circumstances. For example, the NHLBI may provide supplements to Centers to continue a project not funded for the entire project period. NHLBI staff must be consulted prior to submission of an application for supplemental funds. Supplemental grants for these purposes will not be awarded for the first 18 months or the last 12 months of a total project period. Length of SCOR Programs The National Heart, Lung, and Blood Advisory Council, at its meeting in September 1992, recommended that each NHLBI SCOR program be limited to ten years of support. Exceptions to this policy will be made only if a thorough evaluation of needs and opportunities, conducted by a committee composed of non-federal experts, determines that there are extraordinarily important reasons to continue a specific SCOR program. Thus, under this policy, a given SCOR grant is awarded for a five-year project period following an open competition. Only one five-year competing renewal is permitted, for a total of ten years of support, unless the SCOR program is recommended for extension. The NHLBI comprehensive evaluation of the SCOR program in Pediatric Cardiovascular Disease will be conducted during the second project period according to the following schedule: Project Period (Second Competition) FY 1999 to FY 2003 Letters to SCOR Directors regarding FY 2001 (mid-way through year 02 SCOR evaluation Plans of 2nd project period) SCOR Evaluation Meeting FY 2001 (Late in year Notification of SCOR Directors FY 2002 (mid-way through year 03 of NHLBI decision period 2nd project period) Number of Applications The NHLBI does not limit the number of SCOR applications in a given SCOR program from one institution provided there is a different SCOR principal investigator for each application and each application is self-contained and independent of the other(s). This does not preclude cooperation among participants of SCORs after awards are made. Scientific overlap among applications will not be accepted. If more than one application is envisioned from an institution, the institution is encouraged to discuss its plans with the NHLBI SCOR program administrator. Consortium Arrangements If a grant application includes research activities that involve institutions other than the grantee institution, the program is considered a consortium effort. Such activities may be included in a SCOR grant application, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. The published policy governing consortia is available in the business offices of institutions that are eligible to receive Federal grants-in-aid. Consult the latest published policy governing consortia before developing the application. If clarification of the policy is needed, contact Mr. William Darby, Section Chief, Grants Operation Branch, NHLBI, (301) 435-0177. Applicants should exercise great diligence in preserving the interactions of the participants and the integration of the consortium project(s) with those of the parent institution, because synergism and cohesiveness can be diminished when projects are located outside the group at the parent institution. Indirect costs paid as part of a consortium agreement are excluded from the limit on the amount of direct costs that can be requested. At least 50 percent of the projects and cores and their associated costs must be at the parent institution. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28,1994 (FR 59 14508-14513), and reprinted in the NIH Guide for Grants and Contract, Volume 23, Number 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by June 30, 1997 a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the principal investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. The letter of intent is to be sent to: Dr. James Scheirer Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7220, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0266 FAX: (301) 480-3541 Email: James_scheirer@NIH.gov Upon receipt of the letter of intent, applicants will be contacted by program staff to discuss their proposed applications and to provide guidance to applicants not familiar with the SCOR concept. APPLICATIONS PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. In addition potential applicants should contact Dr. Constance Weinstein, at the address listed under INQUIRIES, to obtain supplemental instructions for modifying the forms to accommodate a SCOR application. Applicants must follow these instructions for their application to be considered responsive. 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. 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 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, to identify the application as a response to this RFA, check "YES", enter the title, "Specialized Center of Research: Pediatric Cardiovascular Disease," and the RFA number HL-97-003 on Line 2 of the face page of the application. Send or deliver 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, SUITE 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/express service) Send two additional copies of the application to Dr. James Scheirer, 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 December 11, 1997. If an application is received after that date, it will be returned to the applicant. 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, or is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for 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 a peer group convened by the NHLBI in accordance with the review criteria stated below. As part of the initial merit review, a process may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be notified. Neither site visits nor reverse site visits are planned as a part of the review process, therefore each application must be complete on submission. Rosters of NHLBI reviewers are listed on the NHLBI Homepage at http://www.nhlbi.nih.gov/meet/sep/devlop.asc. The review criteria for this RFA are: o the scientific merit of each proposed project in the application, including originality, feasibility of the approach, and adequacy of the experimental design; o the integration of the clinical and fundamental research into a coherent enterprise with adequate plans for interaction and communication of information and concepts among the collaborating investigators; o the technical merit and justification of each core unit; o the qualifications, experience, and commitment of the SCOR Director and his/her ability to devote adequate time and effort to provide effective leadership; o the competence of the investigators to accomplish the proposed research goals, their commitment, and the time they will devote to the program; o the adequacy of facilities to perform the proposed research including the laboratory and clinical facilities, access to subjects, instrumentation, and data management systems when needed; o the scientific and administrative structure of the program, including adequate internal and external arrangements and procedures for monitoring and evaluating the proposed research and for providing ongoing quality control and scientific review; o the institutional commitment to the program and the appropriateness of the institutional resources and policies for the administration of a research program of the type proposed; and o the appropriateness of the budget for the proposed program. AWARD CRITERIA Applications must fulfill all the eligibility criteria in order to be considered for funding. 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. The most important criterion in selecting awardees will be the scientific merit as reflected in the priority score. However, factors such as program balance and available funds may enter into selection from among meritorious applications. Schedule Letter of Intent Receipt Date: June 30, 1997 Application Receipt Date: December 11, 1997 Review by NHLBAC: September 3-4, 1998 Anticipated Award Date: January 1, 1999 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: Dr. Constance Weinstein Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 9144 - MSC 7940 Bethesda, MD 20892-7940 Telephone: (301) 435-0510 FAX: (301) 480-1335 Email: weinstec@gwgate.nhlbi.nih.gov Inquiries regarding fiscal and administrative matters may be directed to: Mr. William Darby Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7128 - MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0177 FAX: (301) 435-3310 Email: William_darby@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.837, Heart and Vascular Diseases. Awards will be made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirement of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed Feb 05 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-97-003 - V26(03) 01/31/97 Date: 6 Feb 1997 15:08:51 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 472 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ddoa3$kl7@net.bio.net> NNTP-Posting-Host: net.bio.net MENTORED CAREER DEVELOPMENT AWARD NIH GUIDE, Volume 26, Number 3, January 31, 1997 RFA: CA-97-003 P.T. 34, FF; K.W. 0715035 National Cancer Institute Letter of Intent Receipt Date: March 06, 1997 Application Receipt Date: May 08, 1997 PURPOSE The Comprehensive Minority Biomedical Program, Division of Extramural Activities, National Cancer Institute (NCI), invites underrepresented minority research scientists who have been the recipient of an NIH Research Supplement for Underrepresented Minority Individuals in Postdoctoral Training (MIPT) or a Minority Investigator Supplement (MIS), funded by the NCI, who need an extended period of sponsored research as a way to gain scientific expertise while bridging the transition from a mentored research environment to an independent research/academic career to submit applications. This award offers opportunities for a mentored peer review experience in cancer research which will enhance the candidates knowledge and understanding of the peer review process with the intended purpose of developing skills with the expectation that the candidate will submit a grant application for nontargeted mechanisms (R29, R01). This award is aimed at fostering the cancer research careers of outstanding, junior minority scientists who: o have been the recipient of an NIH Research Supplements for Underrepresented Minorities award, funded by the NCI; o are located at a majority institution; and o are committed to developing and sustaining academic research programs. This award is a novel mechanism which is intended to support underrepresented minority scientists and enhance the likelihood of success for junior underrepesented minority investigators who have committed to basic and clinical research careers in cancer. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS-led national activity for setting priority areas. This Request for Application (RFA), Career Development Award, is related to the priority area of human resource development in cancer research. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS This award is designed to provide an intensive, supervised research experience for underrepresented minority investigators. For the purpose of this award, underrepresented minorities are defined as individuals belonging to a particular ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical and behavioral research. In making these awards, NCI will give priority to projects involving African American (Black), Latinos (Mexican American, Cuban, Puerto Rican, Central American), Native Americans, and non-Asian Pacific Islanders or other ethnic or racial group members who have been found to be underrepresented in biomedical or behavioral research nationally. All applicants must submit three letters of recommendation from established investigators and are encouraged to contact the NCI regarding their eligibility for this award (see Inquiries Section). In general, the candidate must have: o a research or a health professional doctorate or its equivalent and must have demonstrated productive research activity; o been the recipient of a minority supplement award at the postdoctoral (MIPT) or junior faculty (MIS) level, funded by the NCI; and o the potential for establishing an independent research program highly relevant to the understanding of human biology and human disease as it relates to the etiology, pathogenesis, prevention, diagnosis, and treatment of cancer. Applications may be submitted on behalf of candidates by domestic, non-profit and for profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local government, and eligible agencies of the Federal government or comparable institutions. Awards will be limited to individuals who are citizens or non-citizen alien nationals, and permanent residents of the United States. Individuals on temporary or student visas are not eligible. MECHANISM OF SUPPORT Support for this program will be through the NIH grant-in-aid Mentored Research Scientist Development Award (K01). Planning, direction, and execution of the program will be the responsibility of the candidate and her/his mentor on behalf of the applicant institution. The project period for an application responding to the RFA will be for up to five years of support depending upon the number of years of prior research experience and the need for additional experiences to achieve independence. Awards are not renewable and are not transferable from one Principal Investigator to another. Funding beyond the first year is contingent upon satisfactory progress during the preceding year, as documented in the required Progress Report. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1,1990. FUNDS AVAILABLE Up to $500,000 in direct costs the first year and up to $1,500,000 in future years will be committed specifically to fund applications submitted in response to this RFA. It is anticipated that approximately 5 awards will be made from the initial competition for this K01 solicitation at a direct cost level of $100,000 for the first year and $150,000 per year thereafter. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the continuing availability of funds for this purpose. This RFA will be reissued in FY 1998 and the terms of award will remain the same. RESEARCH OBJECTIVES Environment: The majority institution must have well-established basic biomedical or behavioral and/or clinical cancer research programs and must have received an NIH Research Supplements for Underrepresented Minorities award funded by the NCI. Either the Principal Investigator of the NIH Research Supplements for Underrepresented Minorities award or other established investigator will serve as the mentor to the minority candidate. The candidate, mentor and institution must be able to describe a cancer research/career development program that will maximize the use of relevant cancer research and educational resources. Program: The award provides up to five consecutive 12 month appointments. The minority candidate must devote at least 75 % of the professional effort to cancer research-related and/or peer review pursuits consistent with the objectives of this award. The candidate must develop knowledge in the basic biomedical, clinical or population-based sciences and research skills relevant to his/her cancer research fields. Where appropriate, research areas in cancer which disproportionately affect minority populations should be incorporated. During the second year if funding, the candidate must plan to attend NCI-approved peer review activities, such as NCI-sponsored peer review workshops, and/or NIH review committees as an observer or a temporary member. This activities must be reflected in the career development plan. The candidate must agree to report annually on the status of the program and to meet annually to exchange information with NCI staff and other awardees. It is expected that the candidate will prepare and submit a research grant application for traditional research support during Phase II of the award (year 4/5). Mentor: The recipient must receive appropriate mentoring during both phases of the award. These activities are crucial during the mentoring peer review phase as well as during the development and preparation of the traditional investigator initiated grant application (R29, R01). The mentor must be a senior or mid-level faculty member with research competence and a major interest in the training of underrepresented minority investigators in cancer research. Where feasible, women and minority mentors should be involved as role models. ALLOWABLE COSTS Salary: This award will provide salary up to $75,000 plus related fringe benefits. The institution may supplement the NCI contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case, may PHS funds be used for salary supplementation. Institutional supplementation of salary may not require extra duties or responsibilities that would interfere with the purpose of this award. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institutions salary scale. The total salary requested must be based on a full-time, 12 month staff appointment. Research Development Support: During Phase I of the award, $25,000 per year will be provided for the following types of expenses: a) research expenses; b) statistical services including personnel and computer time; c) tuition, fees, and books related to career development; d) travel to research meetings, and e) travel to an annual two-day NCI awardee meeting and for peer review related and training expenses. The amount of this support will increase to $75,000 in Phase II when the Principal Investigator moves to a new research environment, as opposed to the environment provided by a mentor, which includes an independent research position either at the same institution or at a different institution. During Phase II of the award funds may be requested for the purchase of equipment. Ancillary Personnel Support: Salary support for technicians is allowed in Phase II. Support for mentors, secretarial and administrative assistance, etc., is not allowed. Indirect Costs: Indirect costs will be reimbursed at eight percent of modified total direct costs. Categorical amounts cited above, notwithstanding, the total award may not exceed $100,000 in direct costs for the first year and $150,000 for subsequent years. TERMINATION OR CHANGE OF INSTITUTION When a grantee institution plans to terminate an award, the NCI must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination (see INQUIRIES section for contacts). If the individual is moving to another eligible institution, career award support may be continued provided: o A formal request for transfer of award is submitted by the new organization. o The period of support requested is no more than the time remaining within the existing award period. o A final progress report, invention statement, and Financial Status Report are submitted upon either termination of an award or relinquishment of an award in a change of institutional situation. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28,1994 (FR 59 14508-14513), and reprinted in the NIH Guide for Grants and Contract, Volume 23, Number 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by March 6, 1997, a letter of intent that includes a descriptive title of the proposed career plan, the name, address, telephone, FAX, and E-mail numbers of the Principal Investigator and mentor, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which this 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. The letter of intent is to be sent to: Sanya A. Springfield, Ph.D. Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 620 Bethesda, MD 20892-7405 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-7344 FAX: (301) 402-4551 Email: springfs@dea.nci.nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for this grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. 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. Three sealed letters of recommendation addressing the candidate's potential for the research career must be included as part of the application. Submit a signed, typewritten original of the application, reference letters, current curriculum vitae with complete bibliography, including the Checklist, and the 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 (express/courier service) At time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636 Bethesda, MD 20892-7405 Rockville, MD 20852 (express/courier service) Applications must be received by May 08, 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 an application already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness. Incomplete or unresponsive applications will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below. Review Criteria Candidate (Principal Investigator) o Evidence of Research Supplements for Underrepresented Minorities award funded by the NCI. o Commitment to an independent cancer research career in terms of effort and future plans. o Quality and breadth of prior scientific training and experience. o Recommendations of three well-established scientists attesting to the special potential of the individual to pursue an independent career in cancer research. Career Development Plan o Likelihood that the plan will contribute substantially to the scientific development of the candidate and the achievement of scientific independence. o Appropriateness of the career development plan in terms of the candidate's prior research and academic experience; and the stated career goals. o Clarity of the goals and scope of the plan and the need for the proposed research experience. o Quality of the proposed training in the peer review process. o Likelihood of successful planning, writing and submitting of traditional grant applications. Research Plan All applicants for this award will have had previous postdoctoral research experience and have been the recipient of an NIH Research Supplements for Underrepresented Minorities award funded by the NCI. A sound research project that is consistent with the development plan for an independent career in cancer research and the candidate's level of research development must be provided. o Usefulness of the research plan as a vehicle for enhancing existing research skills as described in the career development plan. o The originality and quality of the research hypothesis/question, design and methodology, judged in the context of the candidate's previous training and experience. o Appropriateness of the mentor's research qualifications in the area of the proposed research. o Quality and time commitment of the mentor to supervising and guiding the candidate during the entire phase of the award. o Previous experience of the mentor in fostering and developing minority cancer researchers. o History of research productivity. o Applicant institution's commitment to the scientific development of the investigator according to the terms of this award. o Applicant institution's assurance that the investigator will spend a minimum of 75 percent effort on the career development project. o Adequacy of research facilities and training opportunities. Budget The appropriateness of the budget in relation to career development goals and research aims and plans. AWARD CRITERIA Applications will compete for available funds with all other scored applications submitted in response to this RFA. The following will be considered in making decisions: quality of the proposed project as determined by peer review, availability of funds and program priority. The NCI will notify the applicant of the National Cancer Advisory Board's (NCAB) action. INQUIRIES Inquiries concerning this RFA are encouraged, especially during the planning phase of the application. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Sanya A. Springfield, Ph.D. Comprehensive Minority Biomedical Program National Cancer Institute 6130 Executive Boulevard, Room 620 Bethesda, MD 20892-7405 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-7344 FAX: (301) 402-4551 Email: springfs@dea.nci.nih.gov Direct inquiries regarding fiscal matters to: Ms. Joan Metcalfe Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892-7150 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-7800 ext 228 FAX: (301) 496-8601 Email: metcalfj@gab.nci.nih.gov AUTHORITY AND REGULATION This program is described in the catalog of Federal Domestic Assistance No. 93.398. 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 52,45 CFR 92, 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. From owner-sci-resources@net.bio.net Wed Feb 05 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-97-008 - V26(03) 01/31/97 Date: 6 Feb 1997 15:08:28 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 521 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ddo9c$kgc@net.bio.net> NNTP-Posting-Host: net.bio.net CLINICAL ONCOLOGY RESEARCH CAREER DEVELOPMENT PROGRAM NIH GUIDE, Volume 26, Number 3, January 31, 1997 RFA: CA-97-008 P.T. 34; K.W. 0785140, 0755015 National Cancer Institute Letter of Intent Receipt Date: March 5, 1997 Application Receipt Date: April 29, 1997 PURPOSE The National Cancer Institute (NCI), through its Cancer Training Branch, invites applications for Institutional Physician Scientist program grants that will prepare medical doctors for clinical research careers in medical oncology, surgical oncology, radiation oncology and other clinical specialties with a focus on cancer. The high level of support and intense activity in basic cancer research over the past decades have resulted in the rapid growth and constantly increasing body of knowledge about the molecular biology, immunology, genetics, and cell biology of cancer. However, the clinical application of this knowledge to improve procedures that benefit cancer patients has not kept pace with the accumulation of research results. This RFA is intended to stimulate the recruitment and research career development of clinicians who will be oriented and skilled in the translation of basic research results into new clinical procedures and approaches that are of direct benefit to cancer patients. 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, Clinical Oncology Research Career Development Program, 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 Institution: 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. Applicant organizations should have well established research programs with adequate peer-reviewed grant support and highly qualified faculty in clinical and basic science departments. Clinical Candidates: All candidates must be U.S. citizens, nationals or lawfully admitted permanent residents of the U.S. All candidates must currently be physicians holding the M.D. or D.O. degrees. Appointments of clinical candidates to the program should be for a minimum of two years. A minimum 75 percent effort must be devoted to the basic/clinical research program. The remaining 25 percent can be divided among other clinical and teaching activities only if they are consonant with the program goals, i.e. the candidate's development into an independent clinical investigator. Programs: Proposed programs must demonstrate the potential to provide research career development opportunities in more than one clinical oncology research discipline (e.g., medical oncology, surgical oncology, radiation oncology, etc.) i.e., not be limited to a single discipline. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) mentored clinical scientist development program (K12). Applicants will be responsible for the planning, direction, and execution of the proposed project. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. If there is a current institutional (T32) National Research Service Award (NRSA) supporting a clinical or surgical oncology training program within the same milieu of this proposed institutional clinical oncology research development program (Kl2), the relationship between the existing and proposed program must be addressed (see Special Requirements). This RFA is a one-time solicitation. Generally, future competitive continuation applications will compete with all investigator-initiated applications. Should the NCI determine that there is a sufficient continuing program need, a request for competitive continuation and/or new applications will be announced. FUNDS AVAILABLE Total costs of $3.6 million will be committed to fund applications submitted in response to this RFA. It is anticipated that approximately ten awards will be made. This funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. The total project period for an application submitted in response to this RFA may not exceed five years. The earliest feasible start date for the initial awards will be September 1997. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Information: A workshop on "Training in Clinical Research in Oncology" was held on September 12, 1990 to identify the concerns and problems facing the clinical oncology community, and to examine the adequacy of NCI training and career grant mechanisms as well as institutional research environments for attracting and retaining physicians in clinical oncology research. A summary of the workshop was published in Cancer Research 51: 753-756, 1991. Participants included 20 clinicians representing a wide geographic distribution of oncology programs and cancer centers as well as NCI staff. There was unanimous agreement on the decline in the number of clinical oncologists pursuing careers in innovative clinical research, resulting in a shortage of properly trained research clinicians to translate salient basic research findings to patient populations. Conversely, interesting clinical observations and problems also need to be communicated to the basic research laboratory. In order to address this deficit in clinical oncology research, NCI initiated a new program career grant (Kl2) mechanism, and on the basis of peer-review made a number of awards to excellent clinical departments and cancer centers to provide greater flexibility in selecting and sustaining young physicians for the critical three to five year period during which these physician scientists will learn the skills needed for the successful transition to their own independently supported research program. Because progress has been sufficiently successful during the initial phase of this project, NCI is reannouncing this award for competitive peer-review of continuation and new applications. Goals and Scope: The objectives of this RFA are to increase the number of clinical oncologists who are motivated and properly prepared to: (1) interact and coordinate clinical research activities with basic research scientists in order to expedite the translation of basic research information into patient-oriented research; (2) perform independent clinical research that develops and tests rational scientific hypotheses based on fundamental and clinical research findings for improving the medical care of cancer patients; and (3) design and test innovative clinical protocols and manage all phases of clinical trial research. These clinical oncology research career development programs should involve staff and clinical candidates representing at least two clinical oncology disciplines such as medical, surgical, radiation, pediatric, and gynecologic oncology. Programs limited to one clinical oncology discipline are not responsive to the objectives of this initiative. Interaction during these early years of training might serve to enhance the kinds of coordination and team approach necessary for optimum cancer patient care. Applicants must propose a program designed to provide clinician candidates with the research skills that deal directly with aspects of cancer detection, diagnosis, prognosis, or treatment of cancer patients. It is expected that these clinical oncology career development programs will include both a didactic component (e.g. formal courses, lecture series, seminars, and journal clubs) and a research component that focuses on the skills necessary for translating basic cancer research results into clinical experiments, procedures, and trials directly involving cancer patients in a clinical environment. For example, it will not be sufficient within the scope of this initiative to use human cells and other clinical materials in an isolated basic laboratory setting as the total research development program. Basic laboratory research experience is essential but it must be properly integrated with clinical research, thereby affording the candidate actual experience in the application of their own basic research to clinical research. The proposed program should have the flexibility to accommodate clinician candidates with different levels of research competence. While the end goal of this program is specifically to prepare physicians for dedicated careers in clinical oncology research and not basic research, candidates must be or become competent in the fundamentals of the scientific method, particularly hypothesis development, experimental design, and biostatistical methods that are usually gained through a significant hands-on basic research experience. The research environment will be a critical factor. It should be one where there are active basic/clinical research collaborations that exemplify a dynamic two-way exchange of information and ideas between laboratory and clinical scientists. The research environment should also promote rapid translation of basic research into clinical testing as well as stimulate new ideas and laboratory experiments, based on clinical observations and testing results. In most cases, candidates would acquire both basic and clinical research skills that will prepare them to become dedicated clinical researchers able to interact and communicate effectively with basic research scientists in the design and implementation of collaborative research involving patients. In this context, it might also be appropriate for the basic scientists to be involved in the clinical seminars, protocol planning sessions, and grand rounds. However, applicants may address these issues in other creative ways. Applicants should provide a detailed outline of the content and scope of the program for the career development of clinicians in innovative clinical oncology research and how it will provide the skills and experience necessary for the development and testing of new clinical procedures that will be of direct benefit to cancer patients. Additionally, applicants should clearly address the following issues: 1) the availability of a research environment that promotes the interactions and collaborations of clinical researchers and basic researchers which are necessary for the translation of basic research results into the clinical arena; 2) the qualifications of the faculty mentors, highlighting their clinical and basic research projects and how this research will promote the integration of basic and clinical research experiences to achieve the overall objectives of this RFA; 3) the availability of an appropriate mentor for each candidate who would have responsibility for his/her research program and day-to-day progress; 4) the procedures to be used to announce the program and to select appropriate candidates, mentors, and research projects; 5) the efforts that will be made to evaluate each candidate's level of research experience and needs and to report on the progress of each candidate in the program; and 6) the establishment of an Advisory Committee (see Special Requirements) to provide an oversight function and annual evaluation of the clinical research development program as a whole. SPECIAL REQUIREMENTS The principal investigator must establish an Advisory Committee for this program. Clinical and basic science departments participating in this program should be represented on the committee by clinical investigators from the various oncology disciplines such as medical oncology, surgical oncology, radiation oncology and other oncology specialties as well as by basic research investigators. The committee's responsibilities might include: selecting physician candidates, assigning preceptors, approving each candidate's clinical research development plan, evaluating each candidate's progress, and monitoring the overall effectiveness of the program. A detailed description should be provided of the committee's composition, function, and frequency of meetings. A detailed report of the actions of the committee meetings should be provided in the annual progress report of the grant. Each clinical research candidate should have one or more preceptor/mentor(s) who are accomplished investigators in their field. The advisor(s) should assume responsibility for devising a career development and research plan with the candidate, obtaining the concurrence of the program Advisory Committee, and providing day-to- day advice. Plans for an annual evaluation of the program by the Advisory Committee should be described. The Annual Progress Report for the grant should provide a summary of this evaluation and include a description of the research and career progress of each candidate, describing how laboratory and clinical research and practice are being integrated. These Annual Reports will be closely monitored by NCI staff to ensure that the grant is achieving the goals of this Clinical Oncology Research Career Development Program. Where there already exists an active institutional (T32) National Research Service Award (NRSA) supporting a surgical or other clinical oncology research training program, the applicant must address the relationship between the existing T32 and proposed K12 programs. If there is significant overlap in the programs, the T32 award can be merged into the K12 program or modified to remove areas of substantial overlap. ALLOWABLE COSTS In order to provide sufficient diversity and distribution of programs, direct costs for the (01) year should not exceed $350,000, and any increases in future year positions should be incremented gradually over the five year program with appropriate justification. Peer review will assess the quality of resources available to support the type of program proposed and the number of positions requested within the above limitations. Salary: Clinical research candidates will be provided salary support of up to $50,000 each year, plus fringe benefits commensurate with the applicant institution's salary structure for persons of equivalent qualifications, experience, and rank. The institution may supplement the NCI contribution; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case, may PHS funds be used for salary supplementation. Institutional supplementation of salary may not require extra duties or responsibilities that would interfere with the purpose of this award. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution salary scale. The total salary requested must be based on a full-time, 12 month staff appointment. Other Expenses: $20,000 per candidate will be provided annually to partially support supplies, equipment, travel, tuition and other costs which are essential for the individual's clinical research development program. Indirect Costs: Indirect costs will be provided at a rate not exceeding eight percent of total direct costs of each award, exclusive of tuition, fees, and expenditures for equipment. Categorical amounts cited above, notwithstanding, the total award may not exceed $350,000 in direct costs for the first year. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research" which have been published in the Federal register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by March 5, 1997, a letter of intent that includes a descriptive title of the proposed program, the name, address, telephone, FAX, and E-mail numbers of the Principal Investigator, the names of other key personnel, the participating institutions and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NCI staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Dr. Vincent J. Cairoli Division of Cancer Treatment, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 20892 Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: VC14Z@NIH.GOV APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The completed original application and three legible copies must be sent to or delivered to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040-msc 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (For express/courier service) At the time of submission, two additional copies must also be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636 Bethesda, MD 20892-7405 Rockville, MD 20852 (express/courier service) Applications must be received by April 29, 1997. If an application is received after that date, it will be returned to the applicant without review. If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. An application, therefore, cannot be submitted in response to this RFA which is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI. 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 NCI 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 National Cancer Advisory Board. Review Criteria The review criteria set forth below are neither exhaustive nor prescriptive. Applicants are asked at a minimum, to address each criterion. Members of the peer review group convened by the NCI Division of Extramural Activities (DEA) will be requested to use their best professional judgment in evaluating the educational and scientific merit of any application under review. The review criteria, therefore, are more than a guide but less than an absolute requirement. o Scientific and administrative leadership qualifications and experience of the principal investigator. o Qualifications of faculty mentors: adequacy of peer-reviewed clinical and basic cancer research projects, publications and training experience in the context of achieving the objectives of this RFA. o Recruitment and selection plans for appointees and the availability of high quality candidates. o Appropriateness of detailed plans for a comprehensive program to provide physicians with the proper integration of basic and clinical research skills and experiences necessary for careers in clinical oncology research. o Adequacy of procedures for assessing each candidate's level of scientific research experience, ability and needs in order to optimize his/her research career development and as a prerequisite for clinical research. o Appropriateness of a research environment that provides collaborations among clinical and basic research scientists or of plans to establish and promote such collaborations. o Adequacy of facilities and other resources. o Availability of sufficient cancer patient populations and clinical materials to support appropriate clinical research experiences. o Adequacy of the membership and functions of the program Advisory Committee. o Effective plans for program oversight and evaluation to be reported in the Annual Progress Report. o Renewal applications: a detailed Progress Report summarizing the duration of training, accomplishments, and current status of candidates supported by this program. o Adequacy of the proposed means for protecting human subjects and vertebrate animals against hazardous or unethical research procedures and for protecting the privacy of human subjects. Budget The review group will critically examine the proposed budget and recommend an appropriate budget for each approved application within the guidelines stated above. AWARD CRITERIA Applications will compete for available funds with all other scored applications submitted in response to this RFA. The following will be considered in making decisions: quality of the proposed project as determined by peer review, availability of funds and program priority. The NCI will notify the applicant of the National Cancer Advisory Board's (NCAB) action. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Vincent Cairoli Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute Executive Plaza North, Room 520 Bethesda, MD 20892-7390 Telephone: (301)-496-8580 FAX: (301) 402-4472 Email: VC14Z@NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Sara Stone Office of Administrative Management National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301)-496-7800, ext. 266 FAX: (301)-496-8601 Email: STONES@GAB.NCI.NIH.GOV AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance Number 93.398, Cancer Research Manpower. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A ~(Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public law 103- 227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or, in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed Feb 05 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AG-97-003 - V26(03) 01/31/97 Date: 6 Feb 1997 15:08:10 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 383 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5ddo8q$keq@net.bio.net> NNTP-Posting-Host: net.bio.net MINORITY DISSERTATION RESEARCH GRANTS IN AGING NIH GUIDE, Volume 26, Number 3, January 31, 1997 RFA: AG-97-003 P.T. 34, FF; K.W. 0710010 National Institute on Aging Application Receipt Date: April 18, 1997 PURPOSE Small grants to support doctoral dissertation research will be available for minority doctoral candidates. Grant support is designed to aid the research of new minority investigators and to encourage minority individuals from a variety of academic disciplines and programs to study topics relevant to aging. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000,"a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Minority Dissertation Research Grants in Aging, is related to several priority areas applicable to aging. Potential candidates for the awards may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS For the purpose of this RFA, underrepresented minority students and investigators are defined as individuals belonging to a particular ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical or behavioral research. Awards will be limited to citizens or non-citizen nationals of the United States or to individuals who have been lawfully admitted for permanent residence (i.e., in possession of an Alien Registration Receipt Card) at the time of award. In awarding grants for dissertation support, the NIA will give priority to dissertation candidates who are African American (Black), Hispanic American, Native American or Alaskan Natives, or Pacific Islanders, or other ethnic or racial group members who have been found to be underrepresented in biomedical or behavioral research nationally. The doctoral candidate must have a dissertation topic approved by the named committee. This information must be verified in a letter of certification from the thesis chairperson and submitted with the grant application (see APPLICATION PROCEDURES). Research topics must be on aging-related issues and fit within one or more of the areas described below for each individual program (see RESEARCH OBJECTIVES). The applicant organization must be a domestic institution supporting doctoral level training, such as a university or college. The performance site may be foreign or domestic. MECHANISM OF SUPPORT The mechanism of support is the NIH small grant (R03). Grants may be made for up to two years. Grants to support dissertation research will provide no more than $30,000 in total direct costs, and no more than $25,000 in direct costs in any one year. FUNDS AVAILABLE The NIA anticipates funding between 10 and 12 grants with a total cost of up to $300,000. These grants are not eligible for competitive renewal. RESEARCH OBJECTIVES This research initiative is to provide minority students assistance to complete their dissertation research on an aging-related topic and thereby increase the pool of minority researchers in aging. The descriptions of the four extramural programs below are provided to help potential applicants determine whether or not their topic may be appropriate for this initiative. Questions on the relevance of a particular topic may be addressed to the program contact listed under INQUIRIES. Information on other initiatives supported by NIA may be found at the following internet address: http://www.nih.gov/nia . Biology of Aging Program This program supports studies that focus on diseases associated with increasing age and the basic mechanisms involved in aging processes. The overall objectives of the program are related to understanding normal functions and alterations in them that can be induced by interaction with the environment and disease processes as aging proceeds. The program interests are in molecular and cellular biology, genetics, immunology, basic nutrition, and endocrinology. Behavioral and Social Research Program This program supports research on social and psychological aging processes and the place of older people in society and its social institutions. The emphasis is on promoting health, effective functioning, productivity, and independence throughout the middle and later years. Areas of special interest include health and behavior; cognitive functioning; health care and long term care; work, retirement and productivity; family and intergenerational relationships; the demography of population aging; biodemography; aging among minorities, women, oldest old, and rural populations; and the aging of adults who are retarded. Neuroscience and Neuropsychology of Aging Program This program supports research on the structure and function of the aging nervous system and the behavioral manifestations of the aging brain. Areas of special interest include age-related changes in the nervous system, especially as these affect sensory processes, learning, cognition, memory and sleep. The study of Alzheimer's disease and other disorders associated with the aging nervous system, including the causes, diagnosis, epidemiology, treatment and management of such disorders is of special interest. Geriatrics Program This program supports research on clinical issues and problems that occur predominantly among middle-aged and older persons or that are associated with increased morbidity and mortality in older people. Areas of interest include cardiovascular and pulmonary diseases, infectious diseases, osteoporosis, digestive diseases, rehabilitation, menopause, and physical function and performance in older persons. SPECIAL REQUIREMENTS Additional Material. In addition to the completed PHS 398 form described under APPLICATION PROCEDURES, applicants must also submit: o A letter from the faculty committee or university official directly responsible for supervising the development and progress of the dissertation research. The letter must be countersigned by a representative of the graduate school of the sponsoring institution. The letter must: (a) fully identify the members of the committee and certify their approval of the dissertation topic, (b) certify that the candidate is a member of an ethnic minority group underrepresented in biomedical or behavioral science (see ELIGIBILITY REQUIREMENTS) (c) certify that the author of the letter has read the application and that it reflects the work to be completed in the dissertation, and (d) note that the university official or faculty committee expects the doctoral candidate to proceed with the approved project proposal with or without NIA support. o A transcript of the investigator's graduate school record o Biography of mentor, limited to 2 pages (use the Biographical Sketch page in form PHS 398) o Statement of the investigator's career goals to be placed under "Background" (see the Research Plan instructions in PHS 398) Although not required, identification of the investigator's particular minority group would be helpful so that NIA may continue to monitor and improve the effectiveness of this program. Grant Conditions. The following conditions apply to dissertation grants: o The doctoral candidate must be the designated principal investigator on the grant and the doctoral candidate must be the only individual on the grant for whom salary support is requested. o The principal investigator's salary may not exceed $12,000 per twelve months. o Work on the funded project must be initiated within three months after the date of the award. o An awardee may be invited to participate in a meeting or presentation with other NIA dissertation awardees. o The dissertation constitutes the final report of the grant. Two copies of the dissertation must be submitted. The dissertation must be officially accepted by the faculty committee or university official responsible for the candidate's dissertation and must be signed by the responsible officials. o Investigators may request support for up to 24 months. An application that requests support beyond this time will be returned. o Grantees who are approved for two years of support must submit a satisfactory progress report no later than 10 months after the start of the first year of the grant. This report should contain a brief summary of the work completed to date together with copies of any publications supported wholly or in part by the dissertation grant. An applicant who receives support for dissertation research under a grant from the NIA may not at the same time receive support under a predoctoral or fellowship grant awarded by any Federal agency, nor be supported under any other research project grant. Allowable Costs. Expenses usually allowed under PHS research grants will be covered by the NIA dissertation research grants, but may not exceed $30,000 for the project. Allowable costs include the investigator's salary (not to exceed $12,000 per 12 months); direct expenses such as travel to one scientific meeting per year (limited to $1000 per year), data processing, supplies, and dissertation costs. Any level of effort that is less than full time for the candidate must be fully justified. No tuition is allowed. It is expected that most equipment needed for the research will be available at the site or laboratory in which the dissertation is to be performed. Therefore, any requests for equipment must be specially justified. Indirect costs are limited to eight percent of requested direct costs, less equipment. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The RFA label available in 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 (Minority Dissertation Research Grants in Aging, AG-97-003) must be typed on line 2 of the face page of the application form and the YES box must be marked. Instructions for completing the applications are found in the PHS 398 form. These instructions must be followed except that under C. Specific Instructions - Research Plan, no more than 10 pages may be used for items 1 to 4 (instead of 25 pages as stated in the standard instructions). Applications that exceed the 10 page limit for this section will be returned. Submit a signed original of the application (with the supporting letter and graduate school transcript), including the Checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight service) At the time of submission, two additional copies of the application (with the supporting letter and the graduate school transcript) must be sent to: Chief, Scientific Review Office National Institute on Aging Gateway Building, Suite 2C212 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 ATTN: Minority Dissertation Complete 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 an application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIA 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 and assigned a priority score. Review Criteria o scientific, technical, or medical significance and originality of the proposed research; o appropriateness and adequacy of the literature review, experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the principal investigator (the student); o qualifications, research and training experience of the mentor, particularly, but not exclusively, in the proposed area of research; o quality and availability of research resources needed to complete the dissertation; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA The anticipated date of award is September 1997. Final funding decisions are based on the recommendations of the reviewers, the relevance of the project to NIA priorities, and the availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. Interested investigators are strongly encouraged to contact the person named below who can provide clarifying information about material described in this RFA. The investigator will then be referred to the relevant program to discuss the suitability of the research topic. Dr. 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 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: je14j@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866. Awards are made under authorization of the Public Health Service Act Title IV, Part A (Public Law 79-410, as amended by Public Law 99-158, 42 DSC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52