From owner-sci-resources@net.bio.net Mon Jun 05 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 4 June 1995 Date: 5 Jun 1995 20:13:03 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 96 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3r0h3v$3cj@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Dir of Awards Title: NSF 95-94 AWARDS FOR CALCULUS AND BRIDGE TO CALCULUS CURRICULUM DEVELOPMENT FY 1994 File size (bytes): STIS Filename: nsf9594.txt Also available: nsf9594.doc Title: NSF 95-96 ARCTIC SCIENCE, ENGINEERING, AND EDUCATION Directory of Awards Fiscal Year 1994 File size (bytes): STIS Filename: nsf9596.txt Document Type: Press Release Title: NSF PA 95-1 LAWRENCE RUDOLPH APPOINTED TO SERVE AS GENERAL COUNSEL File size (bytes): STIS Filename: pa951.txt Title: NATIONAL SCIENCE FOUNDATION FUNDS NEW ECOLOGY CENTER File size (bytes): STIS Filename: pr9539.txt Document Type: Program Guideline Title: NSF 94-119 Mathematical Sciences Postdoctoral Research Fellowships File size (bytes): STIS Filename: nsf94119.txt Title: NSF 95-99 - Transformations to Quality Organizations File size (bytes): STIS Filename: nsf9599.txt Document Type: Recruit Title: Staff Scientist for Oversight File size (bytes): STIS Filename: vex9525.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: News Title: MPSLECT -- Intelligent Gels and Molecular Recognition File size (bytes): 2066 STIS Filename: mpslect.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve mpslect.txt, the text of your message should be as follows: get mpslect.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve mpslect.txt, you would enter: ftp> get mpslect.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. 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" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Thu Jun 08 23:00:00 1995 Path: biosci!biosci!not-for-mail From: kcowing@aibs.org (Keith L. Cowing) Newsgroups: bionet.sci-resources Subject: Army 1995 Breast Cancer Research BAA Release 6.1.95 Date: 9 Jun 1995 15:55:13 -0700 Organization: American Institute of Biological Sciences Lines: 73 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: NNTP-Posting-Host: net.bio.net Provided as a public service by the American Institute of Biological Sciences (AIBS). Contact the US Army at the address below for further information. ____________________________ United States Army Medical Research and Materiel Command (USAMRMC) Broad Agency Announcement (BAA) for Breast Cancer Research 1 June 1995 ____________________________ To request copies of this BAA contact: COMMANDER, USAMRMC MCMR-RMA-BCR-BAA-95 Fort Detrick, Maryland 21702-5012 Phone: 301-619-7786 Fax: 301-619-7792 ____________________________ Proposal Submission Dates: 8 September 1995 Training and Recruitment 13 September 1995 Research Projects; Mammography/Breast Imaging Projects 15 September 1995 Cancer Centers ____________________________ Overview (quoted directly from the BAA): "The U. S. Army Medical Research and Materiel Command (USAMRMC), through this Broad Agency Announcement (BAA), is soliciting applications on breast cancer research. Proposals will be sought across all areas of basic, clinical and epidemiologic research including all disciplines within the basic sciences, basic health sciences, the clinical sciences, as well as public health, economics, social sciences, psychosocial, quality care, non conventional therapies, occupational health, nursing research, environmental concerns, and conventional therapies. The overall objective of this funding effort is to promote research directed toward reducing the incidence of breast cancer, increasing survival rates, and improving the quality of life for those diagnosed with this disease. This effort is intended to invigorate research in breast cancer by fostering new directions, addressing neglected issues, and bringing new investigators into the field. Interdisciplinary research and communication is encouraged, as are military/private collaborations. Proposals addressing the needs of minority, elderly, lowincome, rural, and other underrepresented populations are encouraged, as are proposals to reduce the obstacles to widespread dissemination of proven detection, diagnostic, and therapeutic methods. However, while programmatic goals are important, scientific merit is the principal criterion by which proposals will be evaluated. The BAA reflects the intent of the Institute of Medicine (IOM) report, Strategies for Managing the Breast Cancer Research Program (1993), a report commissioned specifically for this program. The report has not been incorporated into the BAA; the provisions of the BAA are controlling. Proposals are solicited in four major areas: research projects, training & recruitment projects, cancer center projects, and special mammography projects. These areas and their various component award categories are described in this section, followed by a description of who may apply for awards." -- Keith L. Cowing - Manager of Planning and Operations American Institute of Biological Sciences 10700 Parkridge Blvd Suite 380 - Reston, VA, USA 22091 703-758-1212 voice - 703-758-1222 fax kcowing@aibs.org - gopher://aibs.org From owner-sci-resources@net.bio.net Thu Jun 08 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 21, pt. 1of1, 9 June 1995 Date: 9 Jun 1995 16:38:09 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 582 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ram11$ih3@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 24, No. 21 - June 9, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** ADMINISTRATIVE AND COMPETING SUPPLEMENTS TO STUDY ISSUES RELATED TO MARIJUANA National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX N2 ********************************************************** HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG ABUSE National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX N3 ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 08/29/95 ************************************************* COMMUNITY CLINICAL ONCOLOGY PROGRAM (RFA CA-95-015) National Cancer Institute INDEX: CANCER $$INDEX R2 10/20/95 ************************************************* POPULATION RESEARCH CENTERS (RFA HD-95-013) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R3 10/20/95 ************************************************* NONHUMAN IN VITRO FERTILIZATION AND PREIMPLANTATION DEVELOPMENT (RFA HD-95-014) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R4 11/10/95 ************************************************* CHILD HEALTH RESEARCH CENTERS (RFA HD-95-016) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT THIS PUBLICATION IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE USING A PERSONAL COMPUTER (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435- 0692 FOR DETAILS. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTING EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. THE DIVISION OF RESEARCH GRANTS (DRG) HAS MOVED TO A NEW LOCATION. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** ADMINISTRATIVE AND COMPETING SUPPLEMENTS TO STUDY ISSUES RELATED TO MARIJUANA NIH GUIDE, Volume 24, Number 21, June 9, 1995 P.T. 34; K.W. 0404009, 0715129, 0785055 National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) announces the availability of funds to supplement existing NIH-supported individual research project grants (R01) to study issues related to marijuana, including issues in the context of polysubstance abuse and/or comorbid mental disorders and other diseases, e.g., HIV infection. Research is requested in the following areas: etiology to determine the interaction of multiple biological, genetic, social, psychological, cultural, and environmental factors and processes associated with the initiation and progression of marijuana use and abuse; epidemiology to understand the factors associated with the trends in incidence and prevalence and patterns of marijuana use among various subpopulations including ethnic groups, rural youth, preadolescents, school dropouts; social, psychological, physiological, and health sequelae and consequences of marijuana use; and, assessment of interventions to prevent the initiation and progression of marijuana use and its consequences. Within the area of prevention and treatment, issues that may be addressed included client evaluation, engagement, retention, cost/effectiveness, and family and couples factors. Studies using animal models as well as human subjects both in clinical settings as well as the community are encouraged. Cross-cutting issues that impact marijuana use are strongly recommended to include comparative studies across gender, ethnic groups, and age cohorts. For FY 1995, $250,000 will be available for administrative supplements to existing R01 grants only. These supplements must be within the scope of the parent grant. Administrative supplements will undergo a program, grants management, and budget review within the NIDA. Administrative supplements may be submitted at any time for the remainder of FY 1995, but no later than August 1, 1995; any one award should not be more than 25 percent of the Council-approved direct cost budget for FY 1995 or $100,000, whichever is less. For FY 1996, it is anticipated that approximately $500,000 will be available for both administrative and competing renewal supplements. The competing renewal supplements will be reviewed in accordance with NIH standard review procedures, i.e., peer review/council review. Competing renewal supplement requests must be submitted utilizing the following receipt dates: March 1, July 1 and November 1. Administrative supplements may be submitted any time during the fiscal year, but no later than August 1, 1996. INQUIRIES Zili Sloboda, Ph.D. Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-6504 Email: zsloboda@aoada@ssw.dhhs.gov $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG ABUSE NIH GUIDE, Volume 24, Number 21, June 9, 1995 P.T. 34; K.W. 0715008, 0745007, 0502017 National Institute on Drug Abuse Purpose Drug abuse and behaviors that transmit HIV are linked, and HIV risk reduction interventions have been demonstrated to effectively reduce these behaviors. Therefore, the National Institute on Drug Abuse (NIDA is establishing a policy intended to reduce drug abuse-related transmission of HIV infection in its study populations. The policy strongly encourages NIDA-funded researchers to make HIV risk reduction counseling and HIV testing available to research subjects at high risk for acquiring or transmitting HIV. AIDS is a major health problem among injection and other illicit drug users in the United States. In addition, the sexual partners of drug users are at high risk of being exposed to HIV. The majority of children with AIDS are offspring of mothers who injected drugs or were the sexual partners of drug users. Given the tremendous impact of the AIDS epidemic and the significant role of drug abuse in the transmission of HIV, the NIDA has developed this policy intended to help reduce HIV risk behaviors and infection in drug using populations, their sexual partners, and their children. As a public health research institute, NIDA believes that every reasonable opportunity should be taken to prevent HIV transmission by offering HIV education and counseling, including testing, to our clientele. Researchers funded by NIDA, who are conducting research in community outreach settings, clinics, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing services. Persons at risk for HIV infection include injection drug users, crack cocaine users, and sexually active drug users and their sexual partners. In general, the opportunity to offer education and counseling will occur in any clinical or laboratory study that provides diagnostic, treatment, or other health or social services to participants over a period of time. NIDA recognizes that this policy may be difficult to implement in some research settings, such as surveys and studies where investigator-subject contacts occur only once and are brief. However, researchers are strongly encouraged to make available HIV risk reduction materials and counseling to participants. For current grantees and contractors, NIDA will consider requests for administrative supplemental funding to implement this recommendation for ongoing studies. INQUIRIES Counseling materials developed by the NIDA AIDS Demonstration Research project and materials developed by the Centers for Disease Control and Prevention are available through NIDA for use as models by grantees and contractors. Public Health Service approved educational materials (manuals, brochures, and posters) may also be obtained by calling or writing the National Clearinghouse for Alcohol and Drug Information (1-800-729-6686) and the National AIDS Information Clearinghouse (1-800-458-5231). For additional information on this policy, contact Dr. Harry W. Haverkos Director, Office on AIDS National Institute on Drug Abuse 5600 Fishers Lane, Room 9A30 Rockville, MD 20857 Telephone: (301) 443-6046 Email: hhaverko.aoada.ssw.dhhs.gov $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS NIH GUIDE, Volume 24, Number 21, June 9, 1995 P.T. 42; K.W. 0201011, 1014003 National Institutes of Health The National Institutes of Health, Office of Extramural Research (OER), Office for Protection from Research Risks (OPRR) is continuing to cosponsor workshops on implementing the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Each of the workshops scheduled for Fiscal Year 1995 will focus on a specific theme. The workshops are open to institutional administrators, members of Institutional Animal Care and Use Committees, laboratory animal veterinarians, investigators and other institutional staff who have responsibility for high-quality management of sound institutional animal care and use programs. Ample opportunities will be provided to exchange ideas and interests through question and answer sessions and information discussions. DATES: September 14-15, 1995 TOPIC: Internal Audits of the Animal Care and Use Program LOCATION Radisson Riverfront Hotel Two Tenth Street Augusta, GA 30910 Telephone: (706) 721-3967 FAX: (706) 721-4642 SPONSORS National Institutes of Health; Medical College of Georgia; Albany State College REGISTRATION Ms. Katrinka Akeson Department of Continuing Education HM100 Medical College of Georgia Augusta, GA 300912 Telephone: (706) 721-3967 FAX: (706) 721-4642 FEE: $150.00 DESCRIPTION: The Workshop will address processes whereby Institutional Animal Care and Use Committees (IACUC) can effectively evaluate their institution's animal care and use program. The PHS Animal Welfare Policy and USDA Regulations state that at least once every six months the institution's program for humane care and use of animals is to be evaluated by the IACUC using the Guide and USDA Regulations (Title 9, Chapter 1, subchapter A-Animal Welfare) as a basis. Topics to be included in the Workshop include: A review of the program as described in the Guide; institutional policy issues such as the occupational health and safety program, personnel training, and the activities of the IACUC and how effectively does it meet its mandates. Other program issues to be included are veterinary care, the animal environment, and record reviews. Reports of the IACUC semiannual program and facility reviews will also be discussed. Approaches useful to IACUC's serving both small and large institutions will be included. INQUIRIES For further information concerning these workshops and future NIH/OER/OPRR Animal Welfare Education Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, Suite 3B01 Rockville, MD 20892-7507 Telephone: (301) 496-8101 ext. 233 FAX: (301) 402-0527 $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN CA-95-015 FULL-TEXT ************************************** COMMUNITY CLINICAL ONCOLOGY PROGRAM NIH GUIDE, Volume 24, Number 21, June 9, 1995 RFA AVAILABLE: CA-95-015 P.T. 34; K.W. 0715035, 0403004, 0795003 National Cancer Institute Letter of Intent Receipt Date: July 10, 1995 Application Receipt Date: August 29, 1995 PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), invites applications from domestic institutions for cooperative agreements (U10) to the Community Clinical Oncology Program (CCOP). New community and research base applicants and currently funded programs are invited to respond to this RFA as described below. This issuance of the CCOP RFA seeks to build on the strength and demonstrated success of the CCOP over the past eleven years by continuing the program to support community participation in cancer treatment and cancer prevention and control clinical trials through research bases (clinical cooperative groups and cancer centers supported by NCI) and utilizing the CCOP network for conducting NCI-assisted cancer prevention and control research. It is anticipated that seven research base awards and eight CCOP awards will be made. Up to $4.0 million in total costs per year will be set aside to fund applications submitted in response to this RFA. An additional $13.0 million in total costs per year will be committed to specifically fund several large chemoprevention trials implemented through the CCOP network. 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, Community Clinical Oncology 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 202-783-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail from the program contact listed below. Dr. Leslie G. Ford, M.D. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 300-D 6130 Executive Boulevard, MSC-7340 Bethesda, MD 20892-7340 Telephone: (301) 496-8541 FAX: (301) 496-8667 $$R1 END ************************************************************ $$R2 BEGIN HD-95-013 FULL-TEXT ************************************** POPULATION RESEARCH CENTERS NIH GUIDE, Volume 24, Number 21, June 9, 1995 RFA AVAILABLE: HD-95-013 P.T. 04; K.W. 0413000, 0404000, 0417000 National Institute of Child Health and Human Development Letter of Intent Receipt Date: July 1, 1995 Application Receipt Date: October 20, 1995 PURPOSE The Demographic and Behavioral Sciences Branch (DBSB), Center for Population Research (CPR), National Institute of Child Health and Human Development (NICHD), announces the availability of a Request for Applications (RFA) for Population Research Centers. The DBSB supports a fixed number of Population Research Centers which are designed to provide either integrated groups of research projects and supporting core services (P50) or core services and facilities in support of a large number of active research projects that are supported by a variety of NIH and outside funding sources (P30). Three existing center grants are due for competitive renewal in FY 95. This RFA is a solicitation for competition for center grants in this program. Depending on quality of applications and resources available, DBSB anticipates making three awards. $1,620,000 has been set-aside for first year total costs. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Population Research Centers, is related to the priority areas of family planning, educational and community based programs, maternal and infant health, HIV infection, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00494-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail and e-mail from the program contact listed below. V. Jeffery Evans, Ph.D, J.D. Center for Population Research National Institute of Child Health and Human Development Executive Building, Room 8B13 6100 Executive Boulevard, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express mail) Telephone: (301) 496-1174 FAX: (301) 496-0962 Email: evansj@hd01.nichd.nih.gov $$R2 END ************************************************************ $$R3 BEGIN HD-95-014 FULL-TEXT ************************************** NONHUMAN IN VITRO FERTILIZATION AND PREIMPLANTATION DEVELOPMENT NIH GUIDE, Volume 24, Number 21, June 9, 1995 RFA AVAILABLE: HD-95-014 P.T. 34; K.W. 0413002, 1002017 National Institute of Child Health and Human Development Letter of Intent Receipt Date: August 11, 1995 Application Receipt Date: November 10, 1995 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate in the ongoing multisite National Cooperative Program on Culture Conditions for Nonhuman In Vitro Fertilization and Preimplantation Development with the assistance of the NICHD through cooperative agreements (U01). The principal goal of this Program is to improve the culture conditions for mammalian oocyte and preimplantation development. In order to achieve this goal, it is expected that methods for evaluation of the quality of mammalian oocytes, eggs, and preimplantation embryos in culture will continue to be an important feature of the Program. It is anticipated that a multispecies approach will also continue to characterize the Program. The ultimate beneficiaries of this Program may be people who seek medical treatment, advice, or assistance with problems of infertility, contraception, or preimplantation genetic diagnosis. It is anticipated that an estimated total of $1,900,000 (including direct and indirect costs) will be available for the entire Program for the first year. It is also anticipated that up to six awards (either new and/or competing continuation) will be made with an award period of four years. 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), Nonhuman In Vitro Fertilization and Preimplantation Development, is related to the priority area of family planning. 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 202-783-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Richard J. Tasca, Ph.D. Center for Population Research National Institue of Child Health and Human Development Building 61E, Room 8B01 Bethesda, MD 20892 Telephone: (301) 496-6515 FAX: (301) 496-0962 Email: tascar@hd01.nichd.nih.gov $$R3 END ************************************************************ $$R4 BEGIN HD-95-016 FULL-TEXT ************************************** CHILD HEALTH RESEARCH CENTERS NIH GUIDE, Volume 24, Number 21, June 9, 1995 RFA AVAILABLE: HD-95-016 P.T. 04, AA; K.W. 0403001, 0770005, 0785170, 0785035 National Institute of Child Health and Human Development Letter of Intent Receipt Date: August 15, 1995 Application Receipt Date: November 22, 1995 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites Center Core (P30) grant applications for a program of Child Health Research Centers (CHRC). These Centers are intended to provide resources to speed the transfer of knowledge gained through studies in basic science to clinical applications that will benefit the health of children. This will be accomplished by increasing the number of pediatric medical centers that can stimulate and facilitate the application of research findings to pressing pediatric problems, as well as by increasing the number and effectiveness of pediatric investigators who have a grounding in basic science and research skills that can be applied to the clinical problems of children. The estimated total costs awarded will be $2.4 million for the first year of support. It is anticipated that six or more awards (new and competing continuations) will be made. 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, Child Health Research Centers, is related to several priority areas, such as nutrition, maternal and infant health, diabetes and chronic disabling conditions, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail and email from the program contact listed below. Ephraim Y. Levin, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B11 MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5593 FAX: (301) 402-2085 Email: FJT@CU.NIH.GOV $$R4 END ************************************************************ From owner-sci-resources@net.bio.net Thu Jun 08 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-95-015 - V24(21) 06/09/95 - P1/2 Date: 9 Jun 1995 16:38:39 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1499 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ram1v$iif@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA95015 CA-95-015 P1O2 *************************************** COMMUNITY CLINICAL ONCOLOGY PROGRAM NIH GUIDE, Volume 24, Number 21, June 9, 1995 RFA: CA-95-015 P.T. 34; K.W. 0715035, 0403004, 0795003 National Cancer Institute Letter of Intent Receipt Date: July 10, 1995 Application Receipt Date: August 29, 1995 PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), invites applications from domestic institutions for cooperative agreements to the Community Clinical Oncology Program (CCOP). Applicants for new and currently funded Community Clinical Oncology Programs (CCOP) and research bases are invited to respond to this Request For Applications (RFA). Using the national resource of highly trained oncologists in community practice, the CCOP: (1) provides support for expanding the clinical research effort in the community setting; (2) stimulates quality care in the community through participation in protocol studies; (3) fosters the growth and development of a scientifically viable community cancer network able to work closely with NCI-supported clinical cooperative groups and cancer centers; (4) supports development of and community participation in cancer prevention and control intervention research, which includes chemoprevention, biomarkers and early detection, patient management, rehabilitation, and continuing care research; (5) involves primary care providers and other specialists in cancer prevention and control clinical trials; and (6) increases the involvement of minority and underserved populations in clinical research. Combining the expertise of community physicians and other health care professionals with NCI-approved cancer treatment and prevention and control clinical trials provides the opportunity for the transfer of the latest research findings to the community level. This issuance of the CCOP RFA seeks to build on the strength and demonstrated success of the CCOP over the past twelve years by: (1) continuing the program as a vehicle for supporting community participation in cancer treatment and prevention and control clinical trials through research bases (clinical cooperative groups and cancer centers supported by NCI); (2) expanding and strengthening the cancer prevention and control research effort; (3) utilizing the CCOP network for conducting NCI-assisted cancer prevention and control research; and (4) evaluating on a continuing basis CCOP performance and its impact in the community. 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, Community Clinical Oncology 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted from domestic institutions for cooperative agreements to continue the Community Clinical Oncology Program (CCOP). New applicants and currently funded programs are eligible as described below. A. CCOP Applicants 1. An applicant may be a hospital, a clinic, a group of practicing physicians, a health maintenance organization (HMO), or a consortium of hospitals and/or clinics and/or physicians and/or HMOs that agree to work together with a principal investigator and a single administrative focus. 2. A university, military, or Veterans Administration hospital may be included in an application as a member of a consortium led by a community institution, but may not be the applicant organization or the major contributor to accrual. An unfunded, non-university clinical trials cooperative group member is eligible to apply. 3. Funded Cooperative Group Outreach Program (CGOP) participants are eligible to apply, but should state in the application that CGOP support will be relinquished if a CCOP award is received. 4. Institutions not eligible to apply as the CCOP applicant organization include: a. A comprehensive, consortial, or clinical cancer center holding an NCI Cancer Center Support (CORE) grant; b. A university hospital that is the major teaching institution for that university; or c. A university hospital clinical trials cooperative group member funded by DCT, NCI. B. Research Base Applicants An applicant may be: 1. An NCI-funded clinical trials cooperative group; 2. An NCI-funded clinical, consortia, or comprehensive cancer center. Cooperative groups must participate in both cancer treatment and prevention and control clinical trials; cancer centers as CCOP research bases may participate in both cancer treatment and prevention and control studies or cancer prevention and control research only. MECHANISM OF SUPPORT Support of this program will be through the Cooperative Agreement (U10). The Cooperative Agreement is an assistance mechanism in which substantial NCI programmatic involvement with the recipient during performance of the planned activity is anticipated to assist awardees in the planning, direction, and execution of the proposed project. The total project period for an application submitted in response to this RFA may not exceed three years for new applicants, and five years for applicants currently supported under this program. Currently supported applicants will be funded for three, four, or five years depending upon priority score/percentile, review committee recommendations, and programmatic considerations. FUNDS AVAILABLE The NCI has determined that there is a continuing program need for community participation in cancer clinical research trials, both cancer treatment and prevention and control. Although this RFA is a one-time issuance, it is expected that a CCOP RFA will be published in the NIH Guide for Grants and Contracts annually, if funds are available. It is anticipated that up to $4.0 million in total costs per year for five years will be committed to specifically fund applications that are submitted in response to this RFA. An additional $13.0 million in total costs per year for five years will be committed to specifically fund several large chemoprevention trials that have been implemented through the CCOP network. Approximately seven research base awards and eight CCOP awards will be made. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES A. Background The CCOP was initiated in 1983 to bring the benefits of clinical research to cancer patients in their own communities by providing support for physicians to enter patients onto treatment research protocols. In the first three years of the CCOP, 62 community programs in 34 states were funded and accrued 14,000 patients to NCI approved treatment clinical trials. The CCOPs were clearly effective in accruing patients to treatment clinical trials. The second CCOP RFA, issued in 1986, expanded the focus to include cancer prevention and control research based on the rationale that the multi-institutional clinical trials model essential for testing new treatment regimens is also required for conducting large-scale cancer prevention and control trials. In 1994, there were 50 programs in 29 states involving over 300 hospitals and over 3,000 physicians. Approximately 3,800 patients were entered onto treatment trials and 5,000 subjects on cancer prevention and control trials in 1994. Cancer prevention and control research in the CCOPs is aimed at reducing cancer incidence, morbidity, and mortality through the identification, testing, and evaluation of interventions in controlled clinical trials. The development of cancer prevention and control research in the CCOP network has been increasing steadily since funding started in 1987. Protocols cover the full spectrum of cancer prevention and control research, from chemoprevention and the validation of biomarkers screening and early detection, pain control and symptom management, and other rehabilitation and continuing care interventions. Several large chemoprevention trials have been implemented through the CCOP network, including the breast cancer prevention trial with tamoxifen, the head and neck chemoprevention trial with 13-cis retinoic acid (13-cRA), and the prostate cancer prevention trial with finasteride. The CCOPs are a vital resource for conducting NCI cancer prevention and control research because they provide access to: (1) a national network for cancer prevention and control trials that require large sample sizes for completion; (2) geographic areas that include cross sections of the population, providing mixes of patients/subjects not always available in university or urban settings; (3) large populations of cancer patients free of disease which provide a unique resource for chemoprevention clinical trials; and (4) cancer patients' family members and others who may be at increased risk of developing cancer and thus be candidates for prevention and detection studies. Participation in cancer prevention and control research by CCOPs also further expands the network of community physicians, increasing the potential for diffusion of state-of-the-art cancer prevention and control practices. B. Goals and Scope The CCOP initiative is designed to: o Bring the advantages of state-of-the-art cancer treatment and prevention and control research to individuals in their own communities by having practicing physicians and their patients/subjects participate in NCI-approved cancer treatment and prevention and control clinical trials; o Provide a basis for involving a wider segment of the community in cancer prevention and control research and investigate the impact of cancer therapy and control advances in community medical practices; o Increase the involvement of primary health care providers and other specialists (e.g., surgeons, family practitioners, urologists, gynecologists) with the CCOP investigators in cancer treatment and prevention and control research, providing an opportunity for education and exchange of information; o Facilitate wider community participation, including minorities, women, and other underserved populations, in cancer treatment and prevention and control research approved by NCI; and o Reduce cancer incidence, morbidity, and mortality by accelerating the transfer of newly developed cancer prevention, early detection, treatment, patient management, rehabilitation, and continuing care technology to widespread community application. Participating community programs (CCOPs) will be required to enter patients onto NCI-approved cancer treatment and prevention and control clinical trials through the research base(s) with which each CCOP is affiliated. CCOPs may relate directly to NCI for assistance and participation in selected cancer prevention and control protocols. CCOP performance will be evaluated on a continuing basis by the NCI program director. Participating research bases will be required to continue providing clinical research treatment and/or cancer prevention and control protocols, as applicable, and as studies progress and findings indicate, to develop new protocols. Cancer prevention and control research should be intervention-oriented and may include such areas as cancer prevention, early detection, patient management, rehabilitation, and continuing care. Research bases will be expected to monitor the quality of protocol conduct, follow CCOP accrual, and participate on a continuing basis in program evaluation. SPECIAL REQUIREMENTS A. Terms and Conditions of Award The administrative and funding instrument used for this program is a cooperative agreement (U10), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NCI Program Staff. The following terms and conditions pertaining to the scope and nature of the interaction between NCI and the investigators will be incorporated in the Notice of Award. These terms will be in addition to the customary programmatic and financial negotiations which occur in the administration of grants. The "Terms and Conditions of Award: Nature of NCI Staff Involvement" and "Terms and Conditions: Responsibilities of Awardees" described in this section are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines; DHHS grant administration regulations 45 CFR 74; other DHHS, PHS, and NIH grant administration policy statements; and other NCI administrative terms of award. 1. Community (CCOP) Awardees 1.a. Responsibilities of Awardees The awardee's programmatic responsibilities for the conduct of the research supported by this cooperative agreement are described in the INVESTIGATOR'S HANDBOOK, a Manual for Participants in Clinical Trials of Investigational Agents Sponsored by the Division of Cancer Treatment, National Cancer Institute, the CANCER PREVENTION AND CONTROL HANDBOOK, and the NCI-CTMB GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS AND CCOP RESEARCH BASES and any subsequent modifications of these documents. These documents are hereby incorporated by reference as term of award and are available on request from the Cancer Therapy Evaluation Program (CTEP) or the CORB/DCPC. 1.a.(1) Protocols All protocols used by the CCOPs must be reviewed and approved for CCOP use by the Cancer Control Protocol Review Committee (CCPRC), Division of Cancer Prevention and Control (DCPC), and/or the Protocol Review Committee (PRC), Division of Cancer Treatment (DCT), NCI, prior to implementation. To be eligible to receive credit for accrual to a research base protocol, the CCOP must have an affiliation agreement with the research base responsible to NCI for that protocol. The research base is responsible for the development and implementation of high quality cancer treatment and prevention and control clinical trials, and for evaluation of the results of such studies. 1.a.(2) Research Base Affiliation(s) Each CCOP must affiliate with a national multi-specialty cooperative group having a spectrum of cancer treatment and prevention and control clinical trials. Each CCOP can affiliate with a maximum of four additional research bases. Note: A list of currently eligible research bases may be obtained >From the program official listed in the Letter of Intent Section. If participation in the protocols of one group competes with that of another group with which the CCOP is affiliated, the CCOP must prioritize the protocols in order to avoid bias in the allocation of patients to competing protocols. Initial affiliations should be maintained for the duration of the funding cycle. When circumstances require changes in research base affiliations, prior written approval from the DCPC Program Director is required. 1.a.(3) Accrual Each CCOP is required to accrue a minimum of 50 credits* per year to treatment clinical trials that have been approved by the PRC, DCT, NCI. (For applicants whose specialty is pediatrics, the 50 credit minimum requirement may be waived for those applicants who are able to place a majority of their eligible patients on protocols.) As one measure of performance, it is expected that at least 10 percent of patients for whom protocols are available will be placed on clinical trials by CCOP physicians. Each CCOP is required to accrue a minimum of 50 credits* per year to cancer prevention and control clinical trials that have been approved by the CCPRC, DCPC. The CCOPs ability to meet projected accrual goals to both cancer treatment and prevention and control clinical trials will also be assessed. * Each protocol approved for CCOP use will be assigned a credit value. Credits will be based on the complexity of the intervention, the amount of data management required, and the duration of follow-up. For example, each patient accrued to an average Phase II or Phase III treatment protocol will count 1 credit; an NCI-designated high-priority treatment protocol 1.5 credits; and a childhood acute lymphocytic leukemia protocol 2 credits. Cancer prevention and control protocols will be assessed for credit using a similar approach. For example, a randomized Phase III chemoprevention protocol will be assigned a value of 1 credit per subject entered. Cancer control protocols involving limited interventions will receive credit that is commensurate with the amount of data management effort required, usually an assignment of 0.3 or 0.5 credit per subject entered. 1.a.(4) Quality Control The CCOP must establish and follow procedures for the assurance of data quality and quality control in accordance with research base guidelines and NCI policies. The CCOP must follow NCI- approved procedures developed by the research base for the prevention and/or identification of false or otherwise unreliable data and for quality assurance of data collected by the research base. The CCOP must follow policies developed by the research base and approved by the NCI for auditing the accuracy of scientific data submitted to them by the research base participants. 1.a.(5) Data Management The CCOP must provide the DCPC Program Director with access to all data generated under this award for periodic review of data management procedures of the CCOP. Data must also be available for external monitoring if required by NCI's agreement with other federal agencies, such as the FDA and with NCI's agreements with pharmaceutical companies for the co-development of investigational agents. The awardees will retain custody of and primary rights to their data. 1.a.(6) Investigational Drug Management Investigators performing trials under cooperative agreements will be expected, in cooperation with NCI, to comply with all FDA monitoring and reporting requirements for investigational agents. 1.a.(7) Organizational Changes Certain CCOP organizational changes must have the prior written approval of the DCPC Program Director. These include the addition/deletion of a participating physician, a health professional other than a physician (who actively enters patients to cancer prevention and control trials), an affiliate, component, or research base. 1.a.(8) Radiotherapy Equipment Radiotherapy equipment must have its calibration verified according to standards set by the Radiologic Physics Center (RPC) in order for institutions to participate in protocols requiring radiation therapy, as required by the affiliated research base(s). 1.a.(9) Monitoring Each CCOP must agree to periodic on-site audits by representatives of its research base(s), NCI, or an NCI-designee. Such on-site audits may include review of the following: use of investigational drugs; compliance with regulations for Institutional Review Board (IRB) approval and informed consent (compliance with 45 CFR 46); compliance with protocol specifications; quality control and accuracy of data recording; and completeness of reporting adverse drug reactions. Reports of such on-site audits will be reviewed by the Clinical Trials Monitoring Branch (CTMB), Cancer Therapy Evaluation Program (CTEP), DCT, and by the DCPC Program Director. In addition, NCI program and grants management staff will review protocol accrual, fiscal and administrative procedures. CCOP members/affiliate performance sites and/or participating and/or individual investigators participating or collaborating on NCI funded and unfunded, who are participating or collaborating in the CCOPs on NCI-supported multi-institutional clinical trials must be in compliance with the monitoring standards established by the research base. They should include the following standards o Medical records submitted in support of NCI multi- institutional trials must conform to usual standard for the maintenance of clear, accurate, and unambiguous medical records. White-outs on medical records are unacceptable. o If it is the usual and customary practice of a department, laboratory, clinic or office to prepare or issue official reports, then only that department, laboratory, clinic or office can change the report, and alterations of the medical record must be initialed and dated by the person making such alterations. For clinical progress notes, the change must be dated and initialled by the person making the change. Only one line should be placed through the initial entry, so that both the original entry and the change are legible. o The improper modification of important patient records will result in additional investigations by the NCI Clinical Trials Monitoring Branch (CTMB) and may lead to suspension of accrual and funding. 1.a.(10) Reporting Requirements Annual progress reports must be submitted to DCPC. A suggested format developed by the DCPC Program Director for this purpose will be provided. The inability of a CCOP to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. 1.a.(11) Network Participation CCOPs are part of a national network for conducting cancer treatment and prevention and control clinical trials. As such, each CCOP may be asked to participate in strategy sessions or workshops and in the continuing evaluation of the program and its impact in the community. 1.a.(12) Patient/Subject Log Each CCOP may be asked to periodically maintain a new patient/subject log or minimal registry to include as applicable age, sex, race, insurance status, risk factors, primary site of cancer, stage of disease, and disposition for the potentially eligible patient/subject pool seen by the CCOP investigators. 1.a.(13) Federally Mandated Regulatory Requirements Each CCOP must establish mechanisms to meet DHHS/PHS regulations for the protection of human subjects. At a minimum, these include: o methods for assuring that each facility at which CCOP investigators are conducting clinical trials has a current, approved assurance on file with the Office for Protection from Research Risks (OPRR); that each protocol is reviewed by the responsible IRB prior to patient entry; and that each protocol is reviewed annually by the IRB so long as the protocol is active; o methods for assuring or documenting that each patient (or patient's parent/legal guardian) gives fully informed written consent to participation in a research protocol prior to the initiation of the experimental intervention; o a system for assuring timely reporting of all serious and unexpected toxicities to the Investigational Drug Branch, CTEP, DCT, according to DCT guidelines and/or to DCPC according to DCPC guidelines; and o implementation of DCPC/DCT requirements for storage and accounting for investigational agents provided under DCPC/DCT sponsorship. 1.a.(14) Publications Timely publication of major findings is encouraged. Publication or oral presentation of work done under this agreement requires acknowledgement of NCI support. 1. Community (CCOP) Awardees 1.b. Nature of NCI Staff Involvement 1.b.(1) Protocol Review All protocols used by the CCOPs must be reviewed and approved for CCOP use by the Cancer Control Protocol Review Committee Protocol Review Committee (CCPRC), (DCPC), and/or the Protocol Review Committee (PRC), DCT, NCI, prior to implementation. NCI will not provide investigational drugs, permit expenditure of NCI funds, or allow accrual credit for a protocol that has not been approved, or that has been closed (except for patients already on study). 1.b.(2) Monitoring There will be periodic on-site audits of each CCOP by representatives of its research base(s), NCI, or an NCI-designee, such as DCT's current Clinical Trials Monitoring Service contractor. The DCPC and CTMB/CTEP will review and provide advice regarding mechanisms established for study monitoring including the on-site auditing program. DCPC/CTEP and/or its contractor staff may attend, the on-site audits conducted by the Research Base or its NCI designee as observers. 1.b.(3) Data Management The DCPC Program Director will have access to all data generated under this award and will periodically review the data management procedures of the CCOP. Data must also be available for external monitoring if required by NCI's agreement with other federal agencies, such as the Food and Drug Administration (FDA). 1.b.(4) Investigational Drug Management The Regulatory Affairs Branch (RAB), PMB, CTEP, DCT, and Chemoprevention Investigational Studies Branch (CISB), Chemoprevention Research Program (CPRP), and DCPC staff will advise investigators of specific requirements and changes in requirements about investigational drug management that the FDA and NCI may mandate. 1.b.(5) Organizational Changes The DCPC program director will review requests for certain organizational changes and provide written approval. These changes include the addition/deletion of a participating physician or other health professional entering patients/subjects in cancer prevention and control research in the CCOP, an affiliate, component, or research base. 1.b.(6) Program Review The DCPC program director will review the annual progress report submitted by each CCOP. A suggested format will be developed by the DCPC Program Director for this purpose. The DCPC Program Director will review the progress of each CCOP through consideration of the CCOP annual report, program site visits, and reports from affiliated research bases. This review may include, but not be limited to, overall accrual credits, percent of available patients/subjects placed on study, eligibility and evaluability of individuals entered on study, and timeliness and quality of data reporting. The inability of a CCOP to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. 1.b.(7) Strategy Sessions The DCPC Program Director or designee will sponsor strategy sessions when indicated, attended by principal investigators from the CCOPs and appropriate DCPC/DCT staff. At these meetings, information relevant to the CCOPs will be reviewed and discussed, including such issues as overall CCOP performance and the science of current or proposed clinical trials. Data will be analyzed and the outstanding research questions established and prioritized into national research goals by CCOP investigators and the DCPC/DCT attendees. The principal investigators will have the primary responsibility for analyzing and prioritizing the research questions to be developed into clinical trials. The DCPC Program Director will also assist the CCOP investigators in exploring mutual interests in cancer prevention and control research. 1.b.(8) Federally Mandated Regulatory Requirements The DCPC Program Director or designee and DCT staff will review mechanisms established by each CCOP to meet the Department of Health and Human Services (DHHS)/Public Health Service (PHS) regulations for the protection of human subjects and FDA requirements for the conduct of research using investigational agents. 1.b.(9) Arbitration Process The Terms and Conditions of Award require that the DCPC Program Director make post-award administrative decisions related to program performance, programmatic decisions on scientific- technical matters, and funding adjustments. NCI will establish an arbitration process when a mutually acceptable agreement cannot be obtained between the awardee and the DCPC Program Director. An arbitration panel (with appropriate expertise) composed of one member of the recipient group, one NCI nominee, and a third member chosen by the other two will be formed to review the NCI decision and recommend a course of action to the Director, DCPC. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS regulations 45 CFR Part 16. B. Terms and Conditions of Award 2. Research Base Awardees 2.a. Responsibilities of Awardees It is the responsibility of the Research Base in accordance with its constitution, bylaws, policies and procedures to develop the details of the research design, including definition of objectives and approaches, planning, implementation, analysis, and publication of results, interpretations and conclusions of studies. The research base shall designate research base investigators to serve as Protocol Chairpersons for each proposed study. Protocols will be developed in accordance with the instructions in the GUIDELINES CLINICAL TRIALS COOPERATIVE GROUP PROGRAM and the INVESTIGATOR'S HANDBOOK, and CANCER PREVENTION AND CONTROL HANDBOOK. 2.a.(1) Protocol Development The research base is responsible for the development and implementation of high quality cancer treatment and prevention and control clinical trials, and for evaluation of the results of such clinical trials. The protocol should be a document mutually acceptable to the research base and to DCPC/DCT. Communication at the various stages of development is encouraged. 2.a.(2) Concept/Protocol Submission All research base protocols utilized by the CCOPs must have been reviewed and approved for CCOP use by the Cancer Control Protocol Review Committee (CCPRC), DCPC, and/or the Protocol Review Committee (PRC), DCT, NCI, prior to implementation. Treatment and cancer prevention and control protocols should be submitted to the protocol Information Office (PIO), CTEP, DCT for review by the appropriate committee. All cancer prevention and control protocols must be preceded by the submission of a concept proposal for review by the DCPC Cancer Control Concept Review Committee (CCCRC). The CCCRC considers scientific merit and the feasibility of implementing prospective cancer control protocols in the CCOP research network. Similarly, concept proposals for cancer treatment protocols must precede protocol development. Cancer treatment concepts are reviewed by the CTEP Protocol Review Committee (PRC) in the Division of Cancer Treatment. All concept and protocol documents should be submitted to the PIO, CTEP, DCT. DCT may also require a letter of intent for new cancer treatment trials. 2.a.(3) Accrual A research base for treatment research is required to accrue a minimum of 50 credits* per year from affiliated CCOPs to treatment clinical trials that have been approved by the PRC, DCT, NCI. A research base for cancer prevention and control research is required to accrue a minimum of 50 credits* per year from affiliated CCOPs to cancer prevention and control clinical trials that have been approved by the CCPRC, DCPC. * Each protocol approved for CCOP use will be assigned a credit value. Credits will be based on the complexity of the intervention, the amount of data management required, and the duration of follow-up. For example, each patient accrued to an average Phase II or Phase III treatment protocol will count 1 credit; an NCI-designated high-priority treatment protocol 1.5 credits; and a childhood acute lymphocytic leukemia protocol 2 credits. Cancer prevention and control protocols will be assessed for credit using a similar approach. For example, a randomized Phase III chemoprevention protocol will be assigned a value of 1 credit per subject entered. Cancer control protocols involving limited interventions will receive credit that is commensurate with the amount of data management effort required, usually an assignment of 0.3 or 0.5 credit per subject. 2.a.(4) Data Management and Analysis The research base shall establish and implement mechanisms for data management and analysis that ensure that data collection and management procedures are: (a) adequate for quality control and analysis; (b) as simple as appropriate in order to encourage maximum participation of physicians entering patients and to avoid unnecessary expense; and (c) sufficiently uniform across research bases. CCOP members/affiliate performance sites are required to follow procedures for data management and analysis. Data generated is the property of the awardee; however, the research base must provide DCPC/DCT with access to all data generated under this award. Data must also be available for external monitoring if required by NCI's agreement with other Federal agencies, such as the FDA and by NCI's agreements with pharmaceutical companies for the co- development of investigational agents. 2.a.(5) Quality Control A DCPC/DCT-funded research base must follow all the policies and procedures for quality control established by NCI. Similar policies and procedures for quality control will be expected from cancer centers. The research bases shall establish mechanisms for quality control of all procedures and modalities employed in its trials. CCOP member/affiliates are required to follow research base procedures for quality control. The research base shall establish mechanisms for study monitoring. CCOP Members/Affiliates are required to follow the awardee procedures for study monitoring. The research base is responsible for assuring accurate and timely knowledge of the progress of each study through: o tracking and reporting of patient accrual and adherence to defined accrual goals; o ongoing assessment of case eligibility and evaluability; o timely medical review and assessment of patient data; o rapid reporting of treatment-related morbidity and measures to ensure communication of this information to all parties; o interim evaluation and consideration of measures of outcome as consistent with patient safety and good clinical trials practice; o timely communication of results of studies; and o an on-site monitoring program. The research base is responsible for ensuring that all performance sites have routine audits which are reported to the NCI in accordance with the NCI/CTMB GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS AND CCOP RESEARCH BASES. In the event that the NCI determines that the awardee failed to comply with these guidelines, the accrual of new patients/subjects to the research base's protocols at the affected performance site shall be suspended immediately upon notice of the NCI determination. The suspension will remain in effect until the awardee conducts the required audit and the audit report is accepted by the NCI. The research base will be responsible for notifying any affected performance site of the suspension. During the suspension period, no funds from this award may be provided to the performance site for new accruals, and no changes to the award for new accruals will be permitted. The NCI will also notify an institution that is the direct recipient of a cooperative agreement from the NCI if it is necessary to suspend accrual at that institution. 2.a.(6) Quality Assurance of Data The research base must develop and follow procedures for the assurance of data quality and quality control in accordance with research base guidelines and NCI policies. The research base must follow NCI-approved procedures for the prevention and/or identification of false or otherwise unreliable data and for quality assurance of data collected. The research base must develop and implement NCI-approved policies for auditing the accuracy of scientific data submitted to them. In the event that there is a finding through the quality assurance and/or quality control programs of any indication of a pattern of non-compliance with protocol or regulatory requirements or a finding of possible alteration of data, these findings must be reported in accordance with the NCI-CTMB GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS AND CCOP RESEARCH BASES. 2.a.(7) Data and Safety Monitoring Committees The research base must establish and maintain Data and Safety Monitoring Committees (DSMCs) for Phase III prevention and control clinical trials. The policies and procedures of the DSMC must be approved by the NCI. The research base must comply with the approved policies and procedures of the DSMC. 2.a.(8) Protocol Closure The research base shall establish a mechanism for interim monitoring of results and monitoring protocol progress. If the research base wishes to close accrual to a study prior to meeting the initially established accrual goal, the interim results and other documentation should be made available to NCI staff for review and concurrence prior to closure. It is recommended that statistical guidelines for early closure be presented as explicitly as possible in the protocol in order to facilitate these decisions. In the event that the DMSC has recommended early closure, DSMC procedures regarding notification of DCPC must be followed. 2.a.(9) Protocol Reporting Requirements Reporting requirements will be in agreement with FDA regulations and NCI procedures. Interim reports of each activated and ongoing study shall appear in the minutes of each research base meeting and shall include specific data on patient/subject accrual as well as, when appropriate, detailed reports of treatment-associated morbidity. Quarterly accrual reports must be provided as appropriate to CTEP for all active studies. A system for providing such information in a timely manner should be in place. 2.a.(10) Annual Progress Report Annual progress reports, including an annual performance report on each affiliated CCOP, must be submitted to DCPC. A suggested format developed by the DCPC Program Director for this purpose will be provided. The DCPC Program Director will review the performance of each research base. The annual report will include, at a minimum, information on: overall case accrual credits; cancer prevention and control research, existing or planned; eligibility and evaluability of patients/subjects entered on study; timeliness and quality of data reporting; and results of quality control review and audits if performed during that year. Research base funding is contingent on accrual from affiliated CCOPs/Minority-Based CCOPs and annual adjustments may be made. The inability of a research base to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. 2.a.(11) Adverse Event Procedures In order to be in compliance with FDA regulations, all recipients of NCI support for clinical trials, including research bases responsible for coordinating and monitoring such trials, must promptly report adverse events (including adverse drug reactions) to the NCI and any other trial sponsors according to directions provided in the adverse event reporting section of the protocol. The awardee will notify all institutions/investigators participating in this project, funded or unfunded, about the above requirement and about the institutions'/investigators' responsibility to report adverse events as specified in the protocol. The awardee will also notify the Investigational Drug Branch (IDB), Drug Monitor for DCT-sponsored investigational agents and the Program Director for other agents, of serious or life-threatening events, as specified in the protocol. 2.a.(12) Performance Review The research base shall establish policies and procedures for credentialing participating CCOPS and conducting periodic review of the performance and membership status of each performance site conducting prevention and control clinical trials. This review should examine scientific contributions, patient accrual, data accuracy and timeliness, protocol compliance, and audit results. 2.a.(13) Data Files Available to NCI Upon Request Upon the request of the Grants Management Officer, NCI, true copies of data files and supporting documentation for all NCI- supported protocols that have a major impact on patterns of care, as determined by the NCI, shall be made available to the NCI in a timely manner. 2.a.(14) Investigational Drug Management Investigators performing trials under cooperative agreements will be expected, in cooperation with DCPC/DCT to comply with all FDA distribution, monitoring, and reporting requirements for investigational agents. 2.a.(15) Network Participation Research bases are part of a national network for conducting cancer treatment and prevention and control clinical trials. As such, each research base may be asked to participate in strategy sessions or workshops and the continuing evaluation of the program and its impact in the community. 2.a.(16) Federally Mandated Regulatory Requirements Each research base must establish mechanisms to meet FDA regulatory requirements for clinical trials involving DCPC/DCT- sponsored investigational agents and DHHS/PHS regulations for the protection of human subjects. These regulations include, but are not limited to, Title 21 CFR 50, 56 and 312 and Title 45 CFR 46. At a minimum the research base must be able to: o demonstrate that each participant has a current approved assurance number on file with the NIH Office for Protection from Research Risks (OPRR). o demonstrate that each protocol and informed consent is approved by the responsible Institutional Review Board (IRB) prior to patient entry, that each investigator has a current FDA Form 1572 and curriculum vitae on file with the Pharmaceutical Management Branch, (PMB), CTEP. o demonstrate that each patient (or legal representative) gives written informed consent prior to entry on study. o implement the CTEP requirement for storage and accounting for investigational agents provided under DCPC/DCT sponsorship. o establish an on-site audit program for periodic data verification and review of regulatory responsibilities at each CCOP, cooperative group member, and Cooperative Group Outreach/cancer center affiliate institution. o provide a method, upon DCPC/DCT request, of summarizing efficacy and toxicity data to be included in DCPC/DCT's annual reports to the FDA for each investigational agent. o a method for the timely reporting of all serious and unexpected toxicities. 2.a.(17) CCOPS/Minority-Based CCOPs Research bases must agree to affiliate with CCOPs/Minority-Based CCOPs when they are funded, according to guidelines established by each research base for its affiliates, and as appropriate. 2.a.(18) Publications Timely publication of major findings is encouraged. Publication or oral presentation of work done under this agreement requires acknowledgement of NCI support. 2.a.(19) Procedures in the Event of Scientific Misconduct If a duly authorized governmental or institutional body issues a final determination that scientific misconduct has occurred or if the awardee determines that other events have occurred which have significantly affected the quality or integrity of the Group data or patient safety, the awardee is responsible for notifying the Group Data and Safety Monitoring Committee (DSMC), the CTMB, the collaborating investigators, the appropriate Institutional Review Boards (IRBs), and other sponsors of the affected work. The awardee is also responsible, if the events describe above have occurred, for ensuring that submitted but unpublished abstracts and manuscripts are corrected, if possible. If publication deadlines have passed or if abstracts and/or manuscripts containing the affected data have already been published, the awardee is responsible, within 90 days after learning of the event(s) significantly affecting the quality of the Group data or patient safety, for submitting to NCI a re-analysis of the results deleting the false or otherwise unreliable data, and disclosing within the text the reason(s) for the reanalysis. The awardee must submit the reanalysis for publication. The NCI may disseminate information about the reanalysis as broadly as it deems necessary. The awardee must use its best efforts to notify all scientists, research laboratories, and other organizations to which the awardee has sent research materials affected by false or otherwise unreliable data. True copies of data files and other supporting documentation from studies affected by scientific misconduct or other findings affecting the quality or integrity of data or patient safety shall be made available to the NCI in a timely manner upon the request of the Grants Management Officer, NCI. The NCI reserves the right to reanalyze, to publish, or to distribute its analyses of these data when it is in the interest of public health. Prior to release, publication or distribution of such analyses, the NCI will provide such analyses to the awardee. 2.a.(20) Data Files Available to NCI Upon Request Upon the request of the Grants Management Officer, NCI, true copies of data files and supporting documentation for all NCI-supported protocols that have a major impact of patterns of care, as determined by the NCI, shall be made available to the NCI in a timely manner. 2.a.(21) Notification of Patients by the Awardee During Patient's Lifetime In order for there to be an appropriate response in the event the NCI determines, either while a protocol is active or (if relevant) during the lifetime of the subjects following protocol closure, that a medically important toxicity or side effect is associated with protocol-directed treatment or that the medical care of one or more subjects may have been compromised by scientific misconduct or other finding affecting the integrity of the data or patient safety at the awardee institution or at a third-party institution, funded or unfunded, the awardee shall assure that the institution(s) responsible for these subject(s') accrual, whether funded or unfunded, will have procedures in place to; (a) contact each subject individually at his or her last known address on file with the institution and which give each subject contacted appropriate information and the right to communicate with an appropriate institutional representative and, in the event of misconduct, to meet with a physician not connected with the clinical trial or study in which the subject has participated; and (b) encourage subjects to notify the institution of any changes of address. The procedure must provide for informing the subjects fully of; the consequences of the toxicity or misconduct for their care and well-being, if any, and the availability of follow-up; and their opportunity to examine any portion of their medical records relevant to the potential effect of the toxicity or side effect upon them or that may be affected by scientific misconduct or other findings affecting the quality or integrity of the data or patient safety. It is understood that under regulations at 45 CFR Section 74.53, NCI has a right of access to research records pertinent to the NCI funding. In exceptional circumstances, such as a public health emergency, the institutions will be required to provide subject names and treatments to the NCI in a format that allows direct notification of the patient by the NCI. 2. Research Base Awardees 2.b. Nature of NCI Staff Involvement 2.b.(1) Scientific Resource The Division of Cancer Prevention and Control (DCPC) and Division of Cancer Treatment (DCT) staff will serve as a resource for specific scientific information on cancer prevention and control clinical trials, treatment regimens, and clinical trial design. The DCPC Program Director will assist the research base as appropriate in developing information concerning the scientific basis for specific trials and will also be responsible for advising the research base of the nature and results of relevant trials being carried out nationally or internationally. The DCPC Program Director will sponsor strategy sessions when indicated, attended by leading investigators from the research bases, other extramural scientists, and appropriate experts to discuss specific research initiatives. The Investigational Drug Branch (IDB), Cancer Therapy Evaluation Program (CTEP), DCT, Chemoprevention Investigational Studies Branch (CISB), DCPC, staff, through the DCPC Program Director, will provide updated information on the efficacy, toxicity and availability of all Investigational New Drugs (INDs) supplied by NCI to the research base. 2.b.(2) Protocol Development The protocol should be a document mutually acceptable to the research base and to DCPC/DCT. Communication at the various stages of development is encouraged. DCPC/DCT will assist the research base in protocol design as appropriate by providing information regarding: a) the existence and nature of concurrent clinical trials in the area of research, with an emphasis on preventing duplication of effort; b) relevant pharmacokinetic and pharmacodynamic data on investigational agents; c) availability of investigational agents, including biologic response modifiers; d) feasibility and appropriateness of the research for use by the CCOPs and/or in a community setting; and e) basic research in cancer centers and other NCI-funded programs which may be ready for clinical trials. DCPC/DCT will also comment on the scientific rationale, programmatic relevance, priority, design, statistical requirements, and implementation of the proposed study. 2.b.(3) Concept/Protocol Review All research base protocols utilized by the CCOPs must be reviewed and approved for CCOP use by the (CCPRC), DCPC, and/or the (PRC), DCT, NCI, prior to implementation. The major considerations in protocol review by DCPC/DCT include; a) strength of the scientific rationale supporting the study; b) importance of the question being proposed; c) avoidance of undesirable duplication with ongoing clinical trials; d) appropriateness and feasibility of study design; e) satisfactory projected accrual rate and follow-up period; f) patient/subject safety; g) compliance with NIH and the federal regulatory requirements; H) adequacy of data management; and i) appropriateness of patient/subject selection, evaluation, assessment of toxicity, response to intervention, and follow-up. The DCPC/DCT review committee chairperson will provide the research base with a consensus review that describes recommended modifications and other suggestions as appropriate. If a protocol is disapproved, reasons will be communicated to the research base principal investigator as a consensus review within a reasonable time. The DCPC Program Director will work with the research base, where appropriate, to develop a mutually acceptable protocol compatible with the research interests, abilities, and needs of the base, its affiliates, and NCI. Credit will be assigned following final approval of the protocol. NCI will not provide investigational drugs, permit expenditure of NCI funds, or allow accrual credit for a protocol that has not been approved. 2.b.(4) Data Management and Analysis The awardees will retain custody of and primary rights to their data; however, DCPC/DCT will have access to all data generated under this award. The DCPC Program Director or a DCT representative may review data management and analysis procedures of the research base, under mutually agreeable circumstances, for consistency with policies and procedures established by DCPC/DCT for awardees conducting cancer treatment and prevention and control clinical trials. Data must also be available for external monitoring if required by NCI's agreement with other federal agencies, such as the Food and Drug Administration (FDA) and by NCI's agreements with pharmaceutical companies for the co-development of investigational agents. 2.b.(5) Quality Control and Monitoring The Clinical Trials Monitoring Branch (CTMB), CTEP, DCT/DCPC Program Director may review quality control and monitoring procedures of the research base including the on-site auditing program for consistency with policies and procedures established by DCT/DCPC for awardees conducting cancer treatment and prevention and control clinical trials. 2.b.(6) Review of Quality Control and Study Monitoring The DCPC and CTMB/CTEP will review and provide advice regarding mechanisms established for study monitoring including the on-site auditing program. DCPC/CTEP and/or its contractor staff may attend as observers, the on-site audits conducted by the Research Base or its NCI designee. The frequency of participation by an NCI representative as observer will be determined by the NCI. 2.b.(7) Data and Safety Monitoring Committees The NCI Staff will assess the research base compliance with NCI established policies on Data and Safety Monitoring Committees for Phase III trials. One or more DCPC/CTEP staff will serve as non- voting members on the DSMC. 2.b.(8) Investigational Drug Management The Regulatory Affairs Branch, CTEP, DCT, and CISB, CPRP, DCPC, staff will advise investigators of specific requirements and changes in requirements concerning investigational drug management that the FDA may mandate. 2.b.(9) Program Review Annual progress reports, including an annual performance report on each affiliated CCOP, must be submitted to DCPC. DCPC staff will provide a suggested format for this purpose. The DCPC Program Director will review the progress of each research base through consideration of the research base quarterly accrual reports, annual report and program site visits. The DCPC program director will make funding recommendations based on accrual from affiliated CCOPs/Minority-Based CCOPs and annual adjustments in funding may be made. The inability of a research base to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. 2.b.(10) Protocol Closure DCPC/DCT will review research base mechanisms for interim monitoring of results and will monitor protocol progress. DCPC/DCT may request that a protocol study be closed for reasons including: a) insufficient accrual rate; b) accrual goal met; c) poor protocol performance; d) patient/subject safety; e) already conclusive study results; and f) emergence of new information which diminishes the scientific importance of the study question. NCI will not provide investigational drugs, permit expenditure of NCI funds, or allow accrual credit for a study after requesting closure (except for patients already on study). 2.b.(11) Federally Mandated Regulatory Requirements The DCPC Program Director and a DCT representative will review mechanisms established by each research base to meet Department of Health and Human Services (DHHS)/Public Health Service (PHS) regulations for the protection of human subjects and FDA requirements for the conduct of research using investigational agents. 2.b.(12) CCOPs/Minority-Based CCOPs The DCPC Program Director will notify research bases when CCOPs/Minority-Based CCOPs are funded. 2.b.(13) Arbitration Process The Terms and Conditions of Award require that the DCPC Program Director make post-award decisions related to protocol review, program performance and adjustments in funding. NCI will establish an arbitration process when a mutually acceptable agreement cannot be obtained between the awardee and NCI staff. An arbitration panel (with appropriate expertise) composed of one member of the recipient group, one NCI nominee, and a third member chosen by the other two will be formed to review the NCI decision and recommend an appropriate course of action to the Director, DCPC. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS regulations 45 CFR Part 16. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and superseded 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 on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 29, 1994 (59 FR 14508-14513) to correct type setting errors, and reprinted in the Federal Register of March 28, 1994 (59 FR 14508-14513) and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by July 10, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the principal investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Leslie G. Ford, M.D. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 300-D 6130 Executive Boulevard, MSC-7340 Bethesda, MD 20892-7340 Telephone: (301) 496-8541 APPLICATION PROCEDURES A. Preparation of Application General instructions for the preparation of the cooperative agreement application are contained in the grant application form PHS 398 (rev. 9/91). Responses to the instructions concerning "Human Subjects" verification must be provided when the application is initially submitted. 1. CCOP Applicants Because the Terms and Conditions of Award (discussed in the SPECIAL REQUIREMENTS Section above) will be included in all awards issued as a result of this RFA, it is critical that each applicant include specific plans for responding to these terms. Plans must describe how the applicant will comply with NCI staff involvement as well as how all the responsibilities of awardees will be fulfilled. An application from a currently funded program will be a competitive continuation and must include a progress report, which at a minimum consists of: (1) a summary of prior CCOP activities/accomplishments, including a clear presentation of annual accrual over the funding period. Accrual tables from previous annual progress reports should be included. A summary of accrual to all cancer treatment and a summary of accrual to all cancer prevention and control protocols by gender and ethnicity must be provided; progress in meeting DCPC's established accrual goals must be presented; (2) a plan for continuing to meet prevention and control accrual requirements including plans for follow-up of subjects from the large prevention trials as well as plans for implementation of additional cancer control protocols; (3) tables of the current budget and FTEs with a justification for any request for additional resources; (4) an evaluation of CCOP performance by affiliated research base(s); and (5) a complete description of how the applicant has met the special cooperative agreement terms and conditions of the award. ALL Applications 1.a. Each applicant must delineate its catchment area. A map of the service area, designating counties or zip codes from which approximately 80 percent of the patients will be drawn, should be provided. A description of other cancer care resources in the catchment area (i.e., hospitals, clinics, physicians, cancer centers) which are not part of the application should be included. In describing the study population, a breakdown by percentage of the gender and minority composition of the study population should be provided. This information may be based on the institutional records and/or prior experience. 1.b. Each applicant must demonstrate the potential and stated commitment to accrue a minimum of 50 credits per year to treatment clinical trials (except if waived for applicants whose specialty is pediatrics). Documentation must include any prior participation in treatment research clinical trials with a clear presentation of the total number of patients and credits accrued to NCI-approved treatment clinical trials. A list of the NCI approved treatment protocols in which the applicant expects to participate and the projected accrual to each must be provided. Plans for recruiting women and minority participants must be included. 1.c. Each applicant must demonstrate the potential and plans for accrual of a minimum of 50 credits per year to cancer prevention and control protocols. Documentation must include any prior participation in cancer prevention and control research clinical trials with a clear presentation of the total number of patients and credits accrued to NCI approved cancer prevention and control clinical trials. A list of the NCI approved prevention and control protocols in which the applicant expects to participate and the projected accrual must be provided. Plans for recruiting women and minority subjects must be included. New applicants must provide at least two examples of NCI-approved intervention cancer prevention and control protocols appropriate for the CCOP's participation. The applicant should describe their implementation, including specifics on patient/subject recruitment, compliance and follow-up. These studies must come from research base's that they propose to affiliate. The CCOP applicant must document the ability to access the appropriate physicians and patient/subject populations, and adequate facilities to participate in the proposed clinical trials. 1.d. A designated Principal Investigator is required. An associate principal investigator should also be named to assure continuity in the event of resignation of the principal investigator. The qualifications and experience of both, in terms of ability to organize and manage a community oncology program that includes cancer treatment and prevention and control research and related activities, must be described. 1.e. Each applicant is expected to have a committed multidisciplinary professional group appropriate for its expected protocol participation. This team may include medical oncologists, surgeons, radiation oncologists, pathologists, oncology nurses, data managers, health educators, and other disciplines (e.g., gynecology, urology, pediatrics, internal medicine, family practice) as appropriate. The training and experience of participating physicians must be provided, along with a description of working relationships. Any experience working together as a group, particularly in implementing clinical cancer treatment and prevention and control research and related activities, should be included. An organizational chart showing how the group will function must also be included. 1.f. Each applicant must provide the qualifications and experience of all proposed support personnel as well as a description of the proposed duties for each position. 1.g. Through formal affiliations with a maximum of five research bases, only one of which may be a national multi-specialty cooperative group, each applicant must demonstrate access to both cancer treatment and prevention and control research protocols. Evidence must be provided that an affiliation has been established with at least one NCI-approved research base that has the capacity to provide both clinical cancer treatment and prevention and control protocols. In addition, affiliations with research bases offering only cancer prevention and control protocols are appropriate. The conditions of affiliation must be provided in the CCOP-research base affiliation agreement(s). Initial affiliations should be maintained during the funding cycle. Multiple research base affiliations are permitted provided they are not conflicting. The affiliation agreements must state specifically how the problem of competing protocols will be resolved. Note: A list of currently eligible research bases may be obtained >From the program official listed in the Letter of Intent Section. 1.h. Quality control procedures must be described in detail. Assurance of quality is the joint responsibility of the CCOP and its research base(s). Quality control procedures of the research base will be applied to the CCOPs and should be specified in the CCOP-research base affiliation agreement. Procedures for investigational drug monitoring and data management must also be described. 1.i. The availability of facilities, including laboratories, inpatient and outpatient resources, cancer registries, etc., must be described. A statement of commitment from each participating institution or organization and/or documentation of consortium arrangements must be provided. Evidence of involvement with community-based voluntary organizations may be submitted. In addition, each applicant must have a defined space for administrative activities and administrative personnel, which will serve as a focus for data management, quality control, and communication. 1.j. Allocation of funds to support community costs for receipt, handling, and quality control of patient data must be specified. Allowable items in the budget are requests for full or part-time administrative personnel, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); and appropriate travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/workshops, local travel). Funding is not allowed for clinical care provided to patients (e.g., reimbursement of patient care expenses; transportation costs). Funding is not allowed for clinical support personnel (e.g. pharmacist, physicist, clinical psychologist, dosimetrist). Physician compensation is only an allowable cost for the Principal Investigator (PI) and Co-PI, specifically for time spent on CCOP organizational/administrative tasks. Justification must be provided for personnel time, effort and funds requested. 2. Research Base Applicants Because the Terms and Conditions of Award (discussed in the Special Requirements Section above) will be included in all awards issued as a result of this RFA, it is critical that each applicant include specific plans for responding to these terms. Plans must describe how the applicant will comply with NCI staff involvement as well as how all the responsibilities of awardees will be fulfilled. An application from a currently funded research base will be a competitive continuation and must include a progress report, which at a minimum consists of: 1) a summary of prior research base activities/accomplishments, including a clear presentation of annual accrual to cancer treatment and annual accrual to cancer prevention and control protocols (gender and racial/ethnic minority composition) >From affiliated CCOPs over the funding period; 2) progress in developing and implementing a cancer prevention and control research program. Include the process and organizational structure for protocol development and implementation, selection and evaluation (auditing) of performance sites, data management, quality control, statistical analysis, and study safety monitoring; 3) a clear presentation of annual accrual to each NCI-approved prevention and control clinical trial for CCOPs, and research base members and affiliates; (4) status of concepts and protocols under development; (5) a description of how the applicant has met the special cooperative agreement terms and conditions of the award. Cooperative groups must participate in both cancer treatment and prevention and control clinical trials; cancer centers may participate in cancer treatment and prevention and control clinical trials or cancer prevention and control research only. In describing the study population, it is required that a description of the gender and minority population and subpopulation served be provided, as well as an outreach plan. This information may be based on the institutional records and/or prior experience. 2.a. Each applicant must demonstrate the ability to design and implement multi-institutional treatment clinical trials (if applicable). A list of treatment protocols available for CCOP participation must be provided. 2.b. Each applicant must demonstrate the ability to design and implement multi-institutional cancer prevention and control clinical trials. A list of cancer prevention and control protocols available for CCOP participation must be provided. New research base applicants must also provide a least two examples of active or proposed cancer prevention and control intervention clinical trial and describe plans for study design, intervention(s), and statistical considerations; access to potential patients/subjects to be studied; and procedures for data management, quality control, and follow-up. The availability of appropriate expertise to design, implement, and analyze the results of the proposed clinical trials must be documented. 2.c. Each applicant must have an organizational structure for involving appropriate personnel in the design and implementation of treatment and/or cancer prevention and control research. An organizational chart and a description of the research base From owner-sci-resources@net.bio.net Thu Jun 08 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-95-013 - V24(21) 06/09/95 Date: 9 Jun 1995 16:38:31 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 381 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ram1n$ihv@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HD95013 HD-95-013 P1O1 *************************************** POPULATION RESEARCH CENTERS NIH GUIDE, Volume 24, Number 21, June 9, 1995 RFA: HD-95-013 P.T. 04; K.W. 0413000, 0404000, 0417000 National Institute of Child Health and Human Development Letter of Intent Receipt Date: July 1, 1995 Application Receipt Date: October 20, 1995 PURPOSE The Demographic and Behavioral Sciences Branch (DBSB), Center for Population Research (CPR), National Institute of Child Health and Human Development (NICHD), supports population research that uses many of the approaches found in the social and behavioral sciences. The DBSB supports a fixed number of Population Research Centers, which support integrated groups of research projects and supporting core services (P50) or core services and facilities that serve a large number of active research projects that are supported by NIH and outside funding sources (P30). Three existing center grants are due for competitive renewal in FY 96. This Request for Applications (RFA) is a solicitation for applications for center grants (P30, P50) in this program. HEALTHY PEOPLE 2000 The Public Health Service 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, Population Research Centers, is related to the priority areas of family planning, educational and community based programs, maternal and infant health, HIV infection, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock Number 017-001-00494-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state or local governments, and eligible agencies of the federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The support mechanisms for this program are the specialized research center grant (P50) and the center core grant (P30). Applications should be consistent with the guidelines, which are available from DBSB. Each center is given a commitment of five years of support and are renewable at five year intervals. Renewals must be invited by a specific RFA that also will give interested organizations a chance to compete with the incumbent for the award. Because population research center grants are complex entities, it is strongly recommended that interested applicants contact the DBSB staff for a personal consultation regarding the centers program. The current policies and requirements that govern the research grant programs of NIH will prevail. The total project period for an application submitted in response to this RFA is five years. The anticipated award date will be July 1, 1996. FUNDS AVAILABLE The DBSB anticipates funding three centers in FY 96. $1,620,000 has been set aside for first year total cost. This is contingent on the approval of funds in the FY 96 appropriations. RESEARCH OBJECTIVES Background The DBSB supports a national network of population research centers that provide both infrastructure and direct support of a wide range of topics relevant to the causes and consequences of population change. These centers are each given a commitment for five years of support, after which they may submit an application for a renewal in competition with other institutions in the field for an additional five years of support. It is anticipated that three centers will submit renewal applications in FY 96. The FY 96 competition will allow other institutions to compete for new awards. Depending on quality of applications and resources available, DBSB anticipates making three awards. Other This RFA is specifically designed to stimulate the research community to organize or to maintain population research centers of high quality that will serve as a national research network that fosters communication, innovation, and high quality research. Examples of desired population research topics are listed below, and centers may concentrate on any combination of these topics: 1. Fertility and Family Planning 2. Social acceptability of measures for the biological regulation of human fertility 3. Sexual behavior, sexually transmitted diseases, AIDS, and contraception 4. Family and household dynamics 5. Age at marriage and first birth, child spacing, family size and fertility 6. Status and roles of women in relation to fertility, with special emphasis on implications for the U.S. 7. Relation of economic development to population growth and decline 8. Antecedents and consequences of stability or change in the size of the U.S. population 9. Population modelling for the projection and/or prediction of human population change in the U.S. 10. Migration of human population groups 11. Population redistribution 12. Population composition and structure 13. Mortality of human population groups 14. Population and physical environment 15. Status of children 16. Demographic aspects of health, morbidity, and disability in pre-retirement populations SPECIAL REQUIREMENTS A center core grant (P30) must be predicated on the existence of a substantial number of research grants that will be active on July 1, 1996, and that includes at least one NIH and two other federally funded grants. A minimum of three cores is required for each year of a funded P30 grant. Each core unit must provide essential facilities and services for at least three federally funded research projects at all times, at least one of which is NIH funded. These grants must be active users of the core facilities and services proposed in the center grant application. The applications should be consistent with the guidelines contained in the NICHD P30 CENTER CORE GRANT GUIDELINES, which are available from the program contact listed under INQUIRIES. Cooperation between independent institutions is allowed in some circumstances. In these instances, core facilities may be located in both institutions if they are cost effective and promote the overall goals of the center program. Consult the statement of clarification about center program principles that is available from DBSB. A specialized research center (P50) must have three or more related, integrated, and high quality research projects that provide a multidisciplinary, yet thematically related, approach to the problems to be investigated. These research projects may be accompanied by an appropriate number and type of core facilities providing cost-effective technical support. The projects and theme of the center must be relevant to the DBSB funding mission. The applications should be consistent with the guidelines contained in the NICHD P50 SPECIALIZED RESEARCH CENTER GRANT GUIDELINES, which are available from the program contact listed under INQUIRIES. Applicants must request travel funds to attend an annual meeting of the directors of P50s and P30s in Bethesda, MD. New P50 applications may not request more than $600,000 for first year direct costs. New P30 applications may not request more than $500,000 for first year direct cost support. Previously funded centers may not request more than 120 percent of the National Advisory Child Health and Human Development Council recommended direct costs for the final year of the preceding project period. Applications exceeding these budget guidelines will be returned to the applicant, unless they have received written permission from NICHD to exceed them. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Population, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by July 1, 1995, a letter of intent that includes a descriptive title of the proposed center, the name, address, and telephone number of the Principal Investigator, the identities of key personnel and participating institutions and the number and title of the RFA in response to which the application may be submitted. Although the letter of intent is not required, not binding, and will not be considered in the review of a subsequent application, the information that it contains allows NICHD staff to estimate review workload and avoid potential conflicts of interest in the review. The letter of intent is to be sent to Dr. V. Jeffery Evans at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3032, MSC 7762, Bethesda, MD 20892, telephone 301/435-0714. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page. 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 the review. In addition, the RFA Title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed, photocopies in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/express service) At the time of submission, two additional copies of the application must be sent to: Susan Streufert, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E01 Bethesda, MD 20892 Rockville, MD 20852 (for courier/express service) Applications must be received at the Division of Research Grants (DRG) by October 20, 1995. If an application is received after that date, it will be returned to the applicant without review. The DRG will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NICHD. Incomplete applications or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be reviewed by the Population Research Committee or a Special Review Committee of the NICHD for scientific merit and by the NICHD's Advisory Council for program relevance and policy issues before awards for meritorious applications are made. Review procedures and criteria are detailed in the NICHD P30 CORE CENTER GRANT GUIDELINES or the NICHD P50 CENTER GRANT GUIDELINES which are available from DBSB staff. As part of the initial merit review, a process (triage) 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 judged 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 o scientific, technical or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research o appropriateness of the proposed budget and duration in relation to the proposed research; o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA The anticipated date of award is July 1, 1996. Funding decisions will be based on scientific and technical merit as determined by the initial review committee, NACHHD Council recommendations, program relevance, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: V. Jeffery Evans, Ph.D, J.D. Center for Population Research National Institute of Child Health and Human Development Executive Building, Room 8B13 6100 Executive Boulevard, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express mail) Telephone: (301) 496-1174 FAX: (301) 496-0962 Email: evansj@hd01.nichd.nih.gov Direct inquiries regarding fiscal matters to: Ms. Melinda Nelson Office of Grants and Contracts National Institute of Child Health and Human Development Executive Building, Room 8A17 6100 Executive Boulevard, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express mail) Telephone: (301) 496-5481 FAX: (301) 402-0915 Email: nelsonm@hd01.nichd.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.864 (Population Research). Awards made are 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 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 to Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Thu Jun 08 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-95-016 - V24(21) 06/09/95 Date: 9 Jun 1995 16:39:05 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 711 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ram2q$ik1@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HD95016 HD-95-016 P1O1 *************************************** CHILD HEALTH RESEARCH CENTERS NIH GUIDE, Volume 24, Number 21, June 9, 1995 RFA: HD-95-016 P.T. 04, AA; K.W. 0403001, 0770005, 0785170, 0785035 National Institute of Child Health and Human Development Letter of Intent Receipt Date: August 15, 1995 Application Receipt Date: November 22, 1995 PURPOSE The National Institute of Child Health and Human Development (NICHD) supports a program of Child Health Research Centers (CHRC), intended to provide resources to speed the transfer of knowledge gained through studies in basic science to clinical applications that will benefit the health of children. This will be accomplished by increasing the number of pediatric medical centers that can stimulate and facilitate the application of research findings to pressing pediatric problems, as well as by increasing the number and effectiveness of pediatric investigators who have a grounding in basic science and research skills that can be applied to the health problems of children. 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), Child Health Research Centers, is related to the priority areas of nutrition, maternal and infant health, diabetes and chronic disabling conditions, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. A CHRC grant is awarded to a children's hospital or a department of pediatrics of an approved medical school in the United States of America that has as a primary teaching site, either a general children's hospital or a children's program, with an identifiable organizational structure that is part of a larger medical institution. Recipient institutions must have the clinical pediatric specialties and subspecialties and the discrete clinical and research facilities sufficient to ensure the linkage of basic research and clinical applications that will meet the purposes of the CHRC program. The CHRC must have a strong, well-established research base, resting on the interests of established investigators who make their expertise available to the junior investigators and act as mentors or senior collaborators for them. The research at the Institution must be relevant to the current areas of interest of the research and programmatic needs of the NICHD. Research should be broadly-based, not defined by a specific disease category or organ system. There should be an adequate pool of junior investigators likely to benefit >From career development under the guidance of established investigators. In addition, each Center must have a scientifically sound and equitable system for choosing which junior investigators and which projects are to be supported. Finally, there should be evidence of an institutional commitment to support the Center resources and to the development and retention of pediatric investigators. MECHANISM OF SUPPORT Support for this program will be through National Institutes of Health (NIH) Center Core Grant (P30) awards, which provide core support for laboratories and administrative resources applicable to a number of different research projects. Policies that govern the grants award programs of the PHS will prevail. The support of grants pursuant to the RFA is contingent upon receipt of appropriated funds for this purpose. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. The maximum will be $400,000 for direct and indirect costs (total) in the first year, with no increases for inflation in subsequent years. The number of awards will be influenced by the amount of funds available to the NICHD, by the overall merit of applications, and by their relevance to program goals. It is not a requirement that any CHRC grant be funded at the allowable budgetary maximum in any particular year. Small size is not a disadvantage for Center funding, if the support requested for core resources (administration, shared core laboratory) is in proportion to the activity in new investigator development, which is the Center's primary purpose. Applications from institutions not previously funded for Child Health Research Centers will compete on an equal basis with competing continuation applications. It is expected an RFA similar to this one will be issued in FY 1996. FUNDS AVAILABLE The estimated total costs awarded will be $2.4 million for the first year of support. It is anticipated that six or more awards (new and competing continuations) will be made. RESEARCH OBJECTIVES A CHRC grant provides pediatric research institutions, both developing and established, an opportunity to build a greater capacity for nurturing pediatric investigators. Established investigators whose research is already funded by NIH or other sources through competitively reviewed grants or contracts combine to establish in their institution a center of research excellence. Individuals with a wide range of scientific backgrounds, especially those with basic science orientation, are encouraged to interact with each other and with newly trained pediatricians just embarking on their research careers. A shared core laboratory, which provides services to complement and extend the capabilities of the established investigators to facilitate the career development of new investigators, may be a major part of the Center. The established investigators make available their expertise, guidance, and laboratory facilities, which with the shared core laboratory, comprise the laboratory resources of the Center, to be utilized by junior investigators for research projects that will enhance their basic science knowledge and skills. Support for conducting these projects is provided by the Center grant. The CHRC grant may provide funds for three purposes: A. Administration of the Center. B. Improvements in the child health-related research program of an institution in an area of scientific excellence through the establishment and maintenance of a shared core laboratory. C. Support for new projects, conducted by junior investigators, designed to enhance their research skills and produce preliminary data which could lead to successful competitive grant applications to the NIH or other agencies (New Program Development Funds), thereby providing a bridge between formal research training and the receipt of independent research grants. The novel feature of these grants is the flexibility in the use of the funds awarded for research support, so that decisions about which new projects and which junior investigators are to be supported are made by the grantee institution. Both competing (renewal) and noncompeting continuations of a CHRC grant are contingent on demonstration of good judgment in these decisions, as indicated by scientific progress, success in the initiation of new competitively-supported research grants and contracts, and the development of new pediatric investigators. Components of a CHRC A. Principal Investigator The principal investigator of the CHRC must be the chairperson of the department of pediatrics or the chief of the pediatric service. He or she is responsible for development and maintenance of the Center as an institutional resource and for its general oversight, appointing the program director and members of the advisory committee (see below). He or she makes the decisions regarding appropriate recipients of the Center funds for research and career development, taking into consideration recommendations from the Center advisory committee. The principal investigator does not receive salary or fringe benefit support from the CHRC for this responsibility. B. Administrative Staff The day-to-day administration of the Center grant may be made the responsibility of a senior faculty member, called the program director, supported for up to 10 percent time and effort for this activity. The program director must be a physician who is knowledgeable about pediatric research and has a record of success at laboratory or clinical investigation and preferably a demonstrated skill in career development. The principal investigator may also serve as program director, with appropriate support. The program director may be assisted by a part-time Center-supported secretary. Administrative staff funds may also be used for a well-qualified recruitment officer, supported up to 20 percent time and effort, to enhance participation in the program by women and members of minority groups that are underrepresented in pediatric research (see below). C. Advisory Committee The advisory committee is a group of Center scientists, selected from the pediatric department and other departments or institutions as appropriate, who have interests and expertise relevant to modern pediatric research. The advisory committee is to be chaired by the principal investigator and must include the program director, the core laboratory director, and some or all of the established investigators. It may also include the recruitment officer and any other persons considered potentially contributory by the principal investigator. It is the function of the advisory committee to evaluate applications for the use of the Center's New Program Development Funds and make recommendations to the principal investigator about appropriate awardees. It evaluates ongoing activities annually, makes recommendations about their continuation, and recommends to the principal investigator priorities for use of the resources of the core laboratory. For these functions, the committee may utilize institutional or outside consultants as necessary. The advisory committee provides expert counsel essential to the principal investigator for his or her administration of the Center. Its should meet regularly and its evaluation activities formalized. Minutes of the advisory committee meetings may be reviewed as part of a competing or non-competing continuation application. D. Established Investigators At least six established investigators, supported by NIH or other competitively-awarded grants, are required for a CHRC. They should be expert in the application of new advances in basic science methodology to problems of human development and pediatric disease that are relevant to the mission of the NICHD and within its authority to support. Their research interests must contribute to areas that justify their collective designation as a Child Health Research Center, making the CHRC attractive to recently-trained pediatricians as a place to develop their investigative careers. The established investigators need not be pediatric department members; linkage to other departments can enhance the power of the CHRC, and is expected to be a key feature of each Center. When a junior investigator is to be supported by the Center through New Program Development Funds, at least one of the established investigators must agree to provide his or her expertise as a mentor and collaborator and allow the junior investigator access to his or her laboratories. The established investigators do not receive support for their salaries or fringe benefits from the Center grant. Established investigators may be added as appropriate to the roster of an ongoing funded Center. E. Laboratory Resources The laboratory resources of the CHRC comprise the research laboratories of the established investigators, as well as a shared core laboratory to be utilized by the established investigators and the Center-supported junior investigators whose activities they will supervise. The justification for the shared core laboratory is its provision of a cost-effective expansion or centralization of the research resources that make the Center a magnet for beginning investigators. The CHRC grant may support professional supervision of the shared core laboratory (core laboratory director, maximum 50 percent time and effort), as well as technical assistance, supplies, and equipment purchase and maintenance. The principal investigator, program director, and core laboratory director are responsible for efficient and equitable utilization of the core laboratory on the basis of recommendations from the advisory committee. Core laboratory log books are subject to review by NICHD staff and outside consultants upon request of the former. There must be an institutional commitment to this shared core laboratory, which may take the form of alterations and renovations to establish it, the purchase of research equipment, the assignment of research space, and/or the support of personnel. Creative approaches to stimulating interactions between diverse investigators who can contribute to Center goals are particularly desirable. The laboratories of the established investigators are not supported directly by the Center grant. Funds for supplies, small equipment, and technical assistance needed for the conduct of Center-supported research projects in these laboratories are provided through New Program Development Funds. Support for projects conducted in the core laboratory by recipients of New Program Development Funds may come either from those funds, the core laboratory budget, or both. F. New Program Development Funds The principal investigator, after considering recommendations from the advisory committee, is to use Center funds to make annual awards to junior faculty members for the pursuit of research projects that will utilize the Center laboratory resources and established investigator expertise. The projects may be clinical or non-clinical, as long as they relate to the goal of the Center. Each junior investigator must be under the mentorship of an established investigator who will provide supervision of the research to be undertaken. The maximum award to any individual for a project in this category is $50,000 per year. These funds may be used to defray the costs of materials, supplies, technical assistance, and miscellaneous expenses generated by these projects in the laboratories of the established investigators who serve as preceptors and collaborators of the awardees; for supplies needed for work in the core laboratory that are beyond the capacity of that laboratory's budget; for small items of equipment; for travel; and for a portion of the salaries and fringe benefits of the junior investigators. These funds may not be used for patient care costs such as inpatient bed days or outpatient visits, except for clinical laboratory analyses essential for the research. The recipient of New Program Development Funds should be a physician who has completed pediatric training, who has not previously been the principal investigator of a competitively awarded NIH research grant or contract* (except for an NICHD-supported R03 grant), and who is no more than three years beyond fellowship training at the time the first New Program Development Fund award is made. The awards are renewable at the discretion of the principal investigator, contingent upon presentation of evidence of satisfactory progress to the advisory committee and the NICHD in the Center annual progress report. Each recipient should make a commitment of time and effort to research that is appropriate for the magnitude of the award. Institutions with CHRC grants are encouraged to develop novel mechanisms for recruiting qualified pediatricians to become grant-supported investigators in the Center. Such mechanisms could include, for example, part-time appointments for persons with families and special efforts to recruit members of minority groups. *Note: This restriction does not apply to NIH CIDA (K08) awards or any of its precursors (CIA, PSA), which are career development awards and not research grants. Recipients of New Program Development Funds are especially encouraged to apply for CIDA awards, which may be held prior to or concurrently with (subject to the relevant CIDA salary restriction) New Program Development Funds. Allowable Budgetary Items and Supportable Activities Allowable costs in NIH grants are governed by the Public Health Service Grants Policy Statement and the NIH Guide for Grants and Contracts. Under these rules the principal investigator may exercise flexibility in meeting unexpected Center requirements by rebudgeting or requesting approval to rebudget among categories within the total direct cost budget of the Center (as shown on the Notice of Grant Award), within the ceilings set in these guidelines. CHRC grants are for five years, at a maximum level of $400,000 (direct plus indirect cost) annually, and are renewable. Competing continuation (renewals) are limited by Congressional action to one five-year period. No institution will be funded for a CHRC for more than ten years in any twelve-year period. That is, institutions that have been funded for a new CHRC and one competing continuation may not reapply until after a lapse of two years. An institution not funded for a competing continuation application may make a new application when a new RFA is issued. Items fundable under a CHRC grant include: A. Administration 1. Salaries and support for a Center program director (maximum 10 percent time and effort), a part-time secretary, and a recruiting officer (maximum 20 percent time and effort). 2. Administrative support services, including supplies, duplicating equipment, telephone, or maintenance contracts for equipment if not covered by institutional overhead charges. 3. Travel of principal investigator and Center program director to an annual scientific meeting of Centers. B. Shared Core Laboratory (maximum $200,000 annually) 1. Salaries and support for shared core laboratory staff. 2. Supplies and animals. 3. Scientific equipment (purchase and maintenance). 4. Computer facilities. C. New Program Development Funds (maximum $250,000 annually) Up to $50,000 annually can be used to provide support for projects of individual junior investigators that are pursued in their own laboratories, in the shared core laboratory, and/or in the laboratories of the established investigators. For each person supported in this category, the maximum expenditure for equipment is $7,000 annually and for travel $2,000 annually. The grant application should indicate the number of awards proposed for each year, and provide evidence that this number of worthwhile projects is likely to be forthcoming. No investigator may receive more than one such award per year. The number of New Program Development Awards to be supported must be commensurate with the institution's capacity to develop and recruit appropriate candidates. To encourage use of these funds only for the most deserving candidates, requests will be considered for the carry-over of unexpended New Program Development Funds into subsequent budget periods. Items not fundable under a CHRC grant include: 1. Direct support of the laboratories, salaries, fringe benefits, travel, and research projects of the established investigators, except for reimbursement for costs from New Program Development Funds within the Center. 2. Salary and support for central institutional administrative personnel usually paid from institutional overhead charges, such as budget officers, grant assistants, and building maintenance personnel. 3. Salary and support for administrative activities such as public relations or health and educational services. 4. Travel of principal investigator, program director, core laboratory director, or established investigators to scientific meetings. 5. Costs of clinical care, such as patient bed days or outpatient visit charges. 6. Alterations and renovations. Application Format A. Text Applicants should follow the instructions for applications included in the "National Institute of Child Health and Human Development Research Center Programs P30 Center Core Grant Guidelines," except where these are at variance with these specific guidelines for CHRC grants. Since P30 Guidelines were not designed prospectively to be used for CHRC-type applications, considerable flexibility in format will be permitted. Applicants should take care, however, that adequate information is provided for evaluation with respect to the eleven review criteria described below. Prospective applicants are urged to discuss their plans with Institute staff. Specific research projects proposed for support need not be described in the application. However, a brief description of examples of junior investigators who might be supported through this award, their training background, research areas in which they are interested, and established investigators who might supervise them is desirable, since it might provide evidence that enough worthy projects will be available to justify the requested budget. B. Budget Each application submitted in response to this RFA should include the following separate budget pages (plus any budget justification pages): 1. A composite budget, the sum of the other budgets, in categories, for the first year. New program development funds should be listed under Other Expenses. 2. A budget for the administrative core, including personnel or supplies, travel for the principal investigator and program director to the Centers' meeting, and any other expenses requested, for the first year. 3. A budget for the shared core laboratory (unless no funds are requested for this laboratory), including personnel, equipment, supplies, and other expenses. 4. A budget for New Program Development Funds, providing under Other Expenses the total dollars and minimum number of positions requested, according to the following format: (Examples) New Program Development Awards: 3 @$ 50,000 or 5 @$ 30,000 etc. The New Program Development Funds budget need not be allocated into categories, since these will vary with the situations of the recipients. However, it should be specified to what extent these funds will be used for salaries. The number of such awards planned should be appropriate for the size of the institution, the number and skills of the established investigators, and the magnitude of the request for Center administration and core laboratory resources. 5. The usual future-year continuation page, listing New Program Development Awards under Other Expenses. SPECIAL REQUIREMENTS Non-competing continuations Annual progress reports of a CHRC grant will be reviewed by NICHD staff and outside consultants in order to confirm that the Center is continuing to meet its goal of recruiting promising new pediatric investigators and stimulating and facilitating their career development. In addition, each Center will be asked to send some of its recent recipients of research support as well as the principal investigator and/or program director to an annual meeting. One purpose of this meeting will be to allow these junior investigators to present their Center-supported research to their peers as well as to other critics. Center principal investigators and program directors are expected to make a special effort to attend these meetings to demonstrate their support of the program and the junior investigators. In addition, they will have an opportunity at these meetings to exchange ideas about common problems and make suggestions to NICHD staff about possible modifications in the program. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by August 15, 1995, a letter of intent that includes the descriptive title of the proposed Center, 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 this RFA. 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 NICHD staff to estimate the potential review workload, and to avoid possible conflicts of interest in the review. The letter of intent is to be sent to Dr. Ephraim Levin at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3032, MSC 7762, Bethesda, MD 20892-7762, telephone 301-435-0714. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. 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 (CHILD HEALTH RESEARCH CENTER) and number (HD-95-016) must be typed on line 2a of the face page of the application. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E01 - MSC 7510 Bethesda, MD 20892-7510 Applications prepared in response to this RFA must be received by November 22, 1995. 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 already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NICHD. Incomplete or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, a triage process may be used 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 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 A. The review criteria for the evaluation of new and competing continuation CHRC applications are the following: 1. Probable impact of the Center on enhancing the capacity of the grantee institution to develop well-qualified new pediatric investigators, thereby advancing pediatric research at the grantee institution, in the local medical environment, and in the nation, especially with regard to the application of basic research developments to clinical problems in pediatrics. 2. Quality and productivity of the research activities of the participating established investigators and the relevance of their programs to the NICHD mission. 3. Nature and quality of the shared core laboratory: technical merit, scientific justification, evidence of cost-effectiveness, procedures for quality control and allocation of resources, qualifications of the core laboratory director and technical staff, and probable utility to the investigators. 4. Institutional commitment to the requirements of the program, such as recruitment efforts, salaries, equipment, or other forms of cost sharing. 5. Evidence for a pool of prospective investigators, trained locally or recruited from elsewhere, who could benefit from receiving support >From the Center. 6. Opportunities for recipients of New Program Development Funds for faculty positions at the applicant institution or elsewhere that emphasize research. 7. Previous success of the institution in developing new pediatric investigators. 8. For renewal (competing continuation) applications, or subsequent new applications from an institution with a previously-funded Center, success of the Center-funded junior investigators in producing research publications and in obtaining independent, competitively-funded support for pediatric research. 9. Efforts to develop novel mechanisms for recruiting candidates for New Program Development Awards from groups under-represented in pediatric research. 10. Procedures established for evaluating candidates for New Program Development Funds and providing internal quality control of ongoing research. AWARD CRITERIA Scientific merit and technical proficiency, based on the demonstrated and projected capabilities described in the application will be the predominant criteria for determining funding priorities. Schedule Letter of Intent Receipt Date: August 15, 1995 Application Receipt Date: November 22, 1995 Review by Advisory Council: June 1996 Anticipated Date of Award: September 1, 1996 INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions for potential applicants is welcome. Direct inquiries regarding programmatic issues and address the letter of intent to: Ephraim Y. Levin, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B11 - MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5593 FAX: (301) 402-2085 Email: FJT@CU.NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Mary Ellen Colvin Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17- MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (301) 402-0915 Email: COLVIN@HD01.NICHD.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865, Research for Mothers and Children. Awards are made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 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 routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Thu Jun 08 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-95-014 - V24(21) 06/09/95 Date: 9 Jun 1995 16:38:56 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 703 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ram2g$ij9@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HD95014 HD-95-014 P1O1 *************************************** NONHUMAN IN VITRO FERTILIZATION AND PREIMPLANTATION DEVELOPMENT NIH GUIDE, Volume 24, Number 21, June 9, 1995 RFA: HD-95-014 P.T. 34; K.W. 0413002, 1002017 National Institute of Child Health and Human Development Letter of Intent Receipt Date: August 11, 1995 Application Receipt Date: November 10, 1995 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate in the ongoing multisite National Cooperative Program on Culture Conditions for Nonhuman In Vitro Fertilization and Preimplantation Development with the assistance of the NICHD through cooperative agreements (U01). The principal goal of this Program is to improve the culture conditions for mammalian oocyte and preimplantation development. In order to achieve this goal, it is expected that methods for evaluation of the quality of mammalian oocytes, eggs and preimplantation embryos in culture will continue to be an important feature of the Program. It is anticipated that a multispecies approach will also continue to characterize the Program. The ultimate beneficiaries of this Program may be people who seek medical treatment, advice, or assistance with problems of infertility, contraception, or preimplantation genetic diagnosis. 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), Nonhuman In Vitro Fertilization and Preimplantation Development, is related to the priority area of family planning. 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, persons with disabilities, and women are encouraged to apply. The need for continuous and active communications and interactions among sites dictates that only institutions in the continental United States will be eligible for participation. MECHANISM OF SUPPORT Funding to assist the scientific community in undertaking this Program of basic and applied science will be through the use of cooperative agreements (U01) between participating sites and the NICHD. The major difference between a cooperative agreement and a research grant is that there will be substantial programmatic/scientific involvement of the NICHD staff Research Coordinator above and beyond the levels required by the traditional program management of grants. Specifically, an NICHD staff member will cooperate with the Principal Investigators as a partner in the research and serve as Research Coordinator. The Research Coordinator will assist the recipient(s) in a cooperative way but without assuming direction, prime responsibility or a dominant role in the activity. In a cooperative agreement, which is an assistance mechanism and not an acquisition mechanism, the NIH purpose is to support, stimulate and expedite the recipient's activities through a partnership role. All recipients in this Program will agree to accept the participatory and cooperative nature of the group process. Details of the responsibilities, relationships and governance of the activities to be funded under the cooperative agreements to be awarded for this Program are discussed later in this document under Direction and Management: The Steering Committee and in Terms and Conditions of the Award. The anticipated award date is September 1, 1996. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of the awards will also vary. Awards and levels of support depend on the receipt of a sufficient number of applications of high scientific merit. Although the Program is provided for in the financial plans of the NICHD, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. This RFA is a one-time solicitation for the purpose of the present competition. At this time, the NICHD has not determined whether or how this Program will be continued beyond the present solicitation. Any future determination in this regard will be publicly announced. FUNDS AVAILABLE It is anticipated that an estimated total of $1,900,000 (including direct and indirect costs) will be available for the entire Program for the first year. It is also anticipated that up to six awards (either new and/or competing continuation) will be made with an award period of four years. RESEARCH OBJECTIVES Background The goal of this Cooperative Program is to improve the culture conditions for nonhuman in vitro fertilization and preimplantation development that are necessary for basic and applied reproductive research on mammalian gametes and preimplantation development. Indeed, nearly our entire knowledge of mammalian oocytes and preimplantation embryos depends upon our ability to culture and manipulate them in vitro. The basic and applied studies that will benefit from this Program are at the very center of mammalian, including human, reproductive biology. Some of these research topics are: 1. The mechanisms of oocyte development in vitro, fertilization, activation of development and implantation, the prevention of polyspermy, the causes and alleviation of infertility, new contraceptive leads and genetic assessment of individual oocytes, eggs or embryos; 2. the genetic and epigenetic regulation of the program of preimplantation development that is crucial for the initiation of placenta formation (i.e., trophectoderm formation) that is, in turn, the key prerequisite for successful embryo transfer, implantation and the establishment of pregnancy; and 3. the initiation and maintenance of normal mammalian embryo development into blastocysts, as well as the production and culture of healthy oocytes and eggs that are capable of fertilization and full development. Owing to new technology and broad interest, there exists an opportunity for rapid progress on these critical problems of mammalian reproductive biology. This progress will depend upon the use of more efficient in vitro techniques for the study of mammalian gametes and preimplantation embryos. This is the case for many gene transfer experiments, twinning experiments, and a multitude of experiments on the genetic assessment, morphology, physiology, biochemistry and molecular biology of oocytes and eggs and on embryo development from fertilization through implantation. In applied science, in vitro procedures are widely used in commercial endeavors, such as producing twins of valuable animals and improving the commercial qualities of livestock for food production. Knowledge gained from the animal studies is considered to be a vital step in making improvements in human in vitro fertilization, preimplantation development, and embryo transfer. Those who use in vitro fertilization, oocyte and preimplantation development and implantation as model systems for reproductive toxicology studies also need in vitro systems that produce high quality oocytes, eggs and embryos. Sensitivity of these systems to drugs and radiation may be much different in culture media that support growth better than the previously and currently used media. A far-reaching benefit of this Cooperative Program will be the improvement of conditions for the production and genetic assessment of genetically engineered embryos leading to the establishment of animals that could be used in many biomedical experiments, including models for human diseases. It is also expected that the results of the Cooperative Program will provide a better understanding of the general principles of nutrition with regard to the interaction of the preimplantation embryo with the maternal environment. Unfortunately, the culture conditions in current use bear little resemblance to in vivo conditions, our understanding of nutritional requirements and basic principles of oocyte and embryonic metabolism and nutrition are practically nonexistent, and oocytes, eggs and embryos raised under these conditions are inferior. This inferior development may be responsible for defects in fertilization, in the implantation process or during postimplantation development, resulting in limited success of embryo transfer experiments. Despite the fact that numerous successful pregnancies have followed >From in vitro procedures, the efficiency and therefore the cost-effectiveness could be greatly improved by increased basic knowledge expected from the results of this Cooperative Program. This would be especially true in the case of in vitro fertilization and embryo transfer for humans, domestic livestock and of nonhuman primates, but also for small laboratory animals. Thus, there are both basic and applied science needs for improvement of culture conditions for successful in vitro reproductive procedures for a variety of mammalian species. The ongoing Cooperative Program was established by NICHD more than eight years ago. During that time, significant improvements have been made in the culture conditions for the production of higher quality mammalian oocytes and eggs that are capable of fertilization and subsequent development. Significant progress has also been made in solving the problem of in vitro "blocks" for preimplantation development for several mammalian species. We are just beginning to make correlations between superior culture media, improved development and the regulation of specific gene expression that may be used as one of the criteria for embryo quality. It is clear that there is a continuing need for major improvements in the quality of in vitro-raised oocytes and embryos for mammals and that these improvements will be critical for successful, cost-effective in vitro fertilization and subsequent development in vitro and in vivo. This Program has been enriched by the multispecies approach that has been a consistent feature. This is important since the potential beneficiaries include not only human reproductive technology and other biomedical applications, but also reproduction in agricultural species, endangered species and others. Objectives The objectives of this ongoing Program continue to be to improve the culture conditions for mammalian oocytes and preimplantation embryos. Implicit in making improvements in culture conditions is to know when improvements have been made by demonstrating that higher quality oocytes or embryos have been produced. For this Program, then, it is essential to be able to evaluate the quality of individual mammalian oocytes and preimplantation embryos by a number of parameters during and after in vitro development. The need for these assessments has always been a part of this Program and may include morphological assessments, biochemical assessments, metabolic assessments, genetic assessments and molecular assessments. Of course, these should also include the generation of live offspring after in vitro development that would prove that an oocyte or embryo has full developmental potential. Scope The scope of the Program will include research on improved culture conditions and assessment of quality for: o mammalian oocytes developing in vitro; o fertilization in vitro; and o preimplantation embryos developing in vitro. Studies on fertilization may be included in proposals only if that is part of a project in which the primary emphasis is upon oocyte development and/or preimplantation development in vitro. Of particular interest will be studies with continuum capabilities, i.e., those in which oocytes are raised in vitro, fertilized in vitro, resultant embryos developed in vitro and transferred to the female reproductive tract for further development. This enables one to study the quality or the results of oocyte manipulation of an individual oocyte in the context of future developmental potentialities of that oocyte. It is recognized that most applicants will not have that full capability, but it is anticipated that capability will exist within the Program. For oocyte and preimplantation embryo studies, it is desirable to have the capability to conduct comparisons between in vivo and in vitro-raised oocytes and embryos. The protocols will be approved, developed and/or modified by the Steering Committee (see Direction and Management, below) through a consensus process. The Program is expected to have the following features: o Different sites that emphasize the study of different aspects of the culture environment and utilize different species; some sites may study micronutrients, some may emphasize macronutrients, and some will study other aspects of the environment. This underscores the need for coordination and communication. o Some investigators may focus strongly on the establishment of endpoints, that is the evaluation of the quality of individual oocytes or embryos raised in vitro, using various possible assays, including morphological, biochemical, metabolic, genetic or molecular assays and that may include spatial and temporal displays of gene expression. o Principles obtained from research on one species can be rapidly tested in other species. o Approaches will be determined and prioritized. o Some sites will place more emphasis on oocyte development, others on preimplantation development, but the goals of improved quality of oocytes and embryos and the production of live offspring will be an important feature. o Detailed experimental designs will be established in order to maximize chances of success and to facilitate statistical analysis. o Progress reports will be transmitted to the cooperating sites and NICHD. o Results will be analyzed and disseminated. o Meetings will be held at least three times each year to discuss progress and future plans. Direction and Management: The Steering Committee Planning and implementation of the study will be done by a Steering Committee consisting of the Principal Investigators from each of the participating sites, one NICHD staff member from the Reproductive Sciences Branch who will serve as Research Coordinator, and an independent chairperson. To ensure impartiality, the independent chairperson will be a scientist of national stature who is not participating as a Principal Investigator and who is mutually acceptable to the participants. The Steering Committee will meet at least three times per year. The purpose of these meetings will be to share scientific information, assess scientific progress, identify new research opportunities, exploit opportunities for collaboration within the Program and with outside scientists when appropriate, establish priorities that will facilitate the translation of basic research findings to the many beneficiaries of this work, and to conduct other business of the Program. SPECIAL REQUIREMENTS The NICHD invites applications both from current members of the Cooperative Program (competing continuation applications), and from prospective members (new applications). The minimal requirements for applicants are as follows (See also REVIEW CONSIDERATIONS below): o Competent, experienced principal investigators who are committed to this problem and who are willing to cooperate with the other Principal Investigators and the NICHD Research Coordinator; o access to properly managed animal colonies with breeding capabilities; o demonstration of the capability of producing and evaluating sufficient numbers of oocytes, eggs or embryos for sound statistical analysis; o experience with in vitro oocyte development, in vitro fertilization and/or preimplantation development followed by embryo transfer; o excellent technical resources necessary for conduct of the experiments; and o evidence of departmental and institutional support and commitment. Terms and Conditions of Award Cooperative agreements are assistance mechanisms subject to the same administrative requirements as grants. The special Terms and Conditions of Award are in addition to, not in lieu of, otherwise applicable OMB administrative guidelines, HHS, PHS, and NIH grant regulations, policies and procedures, with particular emphasis on HHS regulations at 42 CFR Part 74 and 92. The NIH Information for Management and Planning Analysis and Coordination (IMPAC) system and indirect cost award procedures will apply to cooperative agreement awards in the same manner as for grants. Business management aspects of these awards will be administered by the NICHD Grants Management Office in accordance with HHS, PHS, and NIH grant administration requirements. The following terms and conditions of the cooperative agreement award, and details of the arbitration procedures pertaining to the scope and nature of the interaction between the NICHD and the participating awardees will be incorporated into the Notice of Grant Award and provided to the Principal Investigator as well as to the institutional official at the time of award. These procedures will be in addition to the customary programmatic and financial negotiations which occur in the administration of grants. 1. The Steering Committee The planning and implementation of the study will be done by a Steering Committee consisting of the Principal Investigators from each of the participating sites, one NICHD staff member from the Reproductive Sciences Branch who will serve as Research Coordinator, and a nonvoting, independent chairperson who is acceptable to the participants and who is a nongovernment employee. The Steering Committee will meet at least three times a year. The purpose of these meetings is to share scientific information, assess scientific progress, identify new research opportunities, exploit opportunities for collaboration within the Program and with outside scientists when appropriate, ensure the rapid dissemination of the findings, establish priorities that will facilitate the translation of basic research findings to the many beneficiaries of this work, and to conduct other business of the Program. 2. Awardee Responsibilities and Rights The primary responsibilities of the awardees are: o Determine experimental approaches o Design protocols o Conduct experiments o Analyze and interpret the results o Present results and plans at Steering Committee meetings o Publication of results o Modify, delete or add protocols o Accept and participate in the cooperative nature of the group process. Awardees will retain custody of and primary rights to their data developed under the award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. 3. The degree of programmatic/scientific assistance by the NICHD staff Research Coordinator includes: o Participation in the development of optimal approaches and protocol designs (and adjustments of protocols and approaches when needed). The Research Coordinator will assist and facilitate the process, rather than directing it. o Assistance and review of all phases of the study to assure consistency of protocol compliance, to improve and strengthen cooperation between the sites, and to help redirect efforts, if necessary. In the event of disagreement among participants, the Research Coordinator will assist in forming an arbitration panel acceptable to participants (see below). o Participation in data analyses, interpretation and publication of study results. o Identification, jointly with awardees, the need to modify or terminate a site when technical performance requirements are not met. 4. Arbitration When agreement between an awardee and NIH staff cannot be reached on scientific/programmatic issues that may arise after the award, an arbitration panel will be formed. The panel will consist of one person selected by the Principal Investigators, one person selected by NICHD staff, and a third person selected by these two members. The decision of the arbitration panel, by majority vote, will be binding. This special arbitration procedure in no way affects the right of an awardee to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which has been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Program staff may also provide additional relevant information concerning the policy (see INQUIRIES). LETTER OF INTENT Prospective applicants are asked to submit, by August 11, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NICHD staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Richard J. Tasca, Ph.D. Center for Population Research National Institute of Child Health and Human Development Building 61E, Room 8B01 Bethesda, MD 20892 Telephone: (301) 496-6515 FAX: (301) 496-0962 Email: TASCAR@HD01.NICHD.NIH.GOV APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these cooperative agreements. These forms are available at most institutional offices of sponsored research and >From the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3032, MSC 7762, Bethesda, MD 20892-7762, telephone 301/435-0714. Content of Applications Applications in response to this RFA should include: o A description of the capabilities of the site to meet or exceed the minimal requirements (see SPECIAL REQUIREMENTS above). o A proposed four-year research plan that should be the applicant's perception of the study and of his/her cooperative role. This plan should demonstrate the applicant's knowledge, ingenuity, practicality, and commitment to improve the culture conditions for nonhuman in vitro oocyte development, fertilization and/or in vitro preimplantation development followed by embryo transfer. o All essential information in the body of the application rather than in the Appendix. o Current members who wish to submit competing continuation applications should prepare a renewal proposal, and are required to list significant progress they have made in this Program and indicate how they have met any special cooperative agreement terms and conditions of their awards including their interaction with other investigators and the Research Coordinator, if appropriate. In order to respond to these requirements, current members may use up to five additional pages in the Progress Report section of their application. Budget Since the final protocol(s) for this study will not be exactly known at the time of submission of the application, the budget request should be based on the plan proposed by the applicant and should reflect the scope of the project. The requested budget should not be in excess of the amount generally requested for a regular research grant. Include estimates for staffing needs, although it is expected that some modification will be needed once the final research protocol(s) have been developed. The budget must also include estimates of travel expenses for three meetings of two days each of the Steering Committee per year. The first meeting will be a planning meeting held in Bethesda, Maryland in September 1996. Applications must be identified by typing in the RFA number, HD-95-014, and the RFA Title, NONHUMAN IN VITRO FERTILIZATION AND PREIMPLANTATION DEVELOPMENT, on line 2a of the face page of the application form and the YES box must be checked. Type U01 in Item Number 2b. In addition, the RFA label available in the PHS 398 must be affixed to the bottom of the face page. 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. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development Building 61E, Room 5E03 Bethesda, MD 20892 Applications must be received by November 10, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Schedule Letter of Intent Receipt Date: August 11, 1995 Application Receipt Date: November 10, 1995 NACHHD Council Review: June 4, 1996 Earliest Award Date: September 1, 1996 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and for responsiveness by NICHD staff. Incomplete applications will be returned to the applicant without further consideration. Any application that does not meet the minimum requirements (see SPECIAL REQUIREMENTS above) of this RFA will be judged to be unresponsive to this RFA and will be returned to the applicant. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD, in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or noncompetitive based on their scientific merit relative to other applications received in response to this RFA. Applications judged to be competitive will be discussed and assigned a priority score. Applications determined to be noncompetitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria In addition to the usual NIH criteria for scientific merit, evaluation of the applications will be based upon the following: 1. Qualifications, experience and commitment of key personnel o Scientific and administrative abilities of the Principal Investigator and other team members, as evidenced by pertinent publications. o Knowledge and experience in areas relevant to the conduct of the experiments proposed. o Commitment of time for the proposed study and stated willingness to work and collaborate with other sites and the NIH in the manner summarized in this RFA. 2. Protocols and Procedures o Appropriateness of the application to the objectives of the study as outlined in this RFA. o Scientific merit of the proposal. o Demonstration of cost-effectiveness through improved oocyte and/or embryo quality. 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. 3. Facilities and Management o Adequacy of administrative and technical capabilities. o Adequacy of animal facilities and appropriateness of animal care management. o Institutional assurance to provide support to the study in such areas as fiscal administration, personnel management, space allocation, procurement, planning and budgeting. 4. Budgeting o Appropriateness of budget. 5. Human Subjects, Animal Welfare, Biohazards, Gender and Minorities o 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 1, 1996. Applications recommended by the NACHHD Council will be considered for award based upon scientific and technical merit as determined by peer review; program balance, including in this instance, sufficient compatibility of features to enhance the likelihood of a successful collaborative Program; and availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding scientific program issues to: Richard J. Tasca, Ph.D. Center for Population Research National Institute of Child Health and Human Development Building 61E, Room 8B01 Bethesda, MD 20892 Telephone: (301) 496-6515 FAX: (301) 496-0962 Email: TASCAR@HD01.NICHD.NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Melinda Nelson Office of Grants and Contracts National Institute of Child Health and Human Development Building 61E, Room 8B17 Bethesda, MD 20892 Telephone: (301) 496-5481 FAX: (301) 402-0915 Email: NELSONM@HD01.NICHD.NIH.GOV AUTHORITY AND REGULATIONS This Program is described in the Catalog of Federal Domestic Assistance No. 93.864, Population Research. Awards are made under authorization of the Public Health Service Act, Title IV,Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Thu Jun 08 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-95-015 - V24(21) 06/09/95 - P2/2 Date: 9 Jun 1995 16:38:20 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 432 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ram1c$ihf@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA95015 CA-95-015 P2O2 *************************************** operations showing the relationship(s) between the scientific and administrative functional units of the research base, vis-a-vis the conduct of treatment and/or cancer prevention and control clinical trials, must be provided. The organizational focus within the research base for cancer prevention and control research must be described, including the composition and activities of the research base cancer prevention and control committee, or equivalent, and its relationship to other clinical trial committees and activities. 2.d. Collaboration with affiliated CCOPs/Minority-Based CCOPs in treatment and/or cancer prevention and control research, as applicable, is required. CCOP-research base affiliation agreements must be included in the application. For treatment research, each applicant must demonstrate the ability to accrue a minimum of 50 credits per year from affiliated CCOPs/Minority-Based CCOPs to treatment clinical trials. For cancer prevention and control research, each applicant must demonstrate the ability to accrue a minimum of 50 credits per year >From affiliated CCOPs/Minority-Based CCOPs to cancer prevention and control clinical trials. It is expected that selected cooperative group members and/or Cooperative Group Outreach/cancer center affiliates other than the CCOPs will participate in cancer prevention and control research. The applicant must indicate the participants and their expected level of participation, and describe their ability to participate. 2.e. A designated Principal Investigator is required and his/her qualifications and experience must be described. An individual must be designated to coordinate cancer prevention and control research. His or her qualifications and experience within the research base structure should also be described. Each applicant must also demonstrate the ability to access professionals with the appropriate expertise to design and implement the proposed treatment and/or cancer prevention and control clinical trials. Basic scientists, medical, surgical, radiation and other oncology specialists, nurse oncologists, epidemiologists, health educators and/or other public health professionals may be included. 2.f. Each applicant's ability to manage the data from multi- institutional treatment and/or cancer prevention and control clinical trials must be described. Data management includes development of data collection forms, procedures for data transmittal, procedures for data entry, data editing, compilation, and analysis, as well as procedures for quality control and verification of submitted data. Standards should exist for determining eligibility and evaluability of patients/subjects entered on protocols. Statistical capability must exist to develop protocol statistical parameters, analyze the data, and report results. 2.g. Each applicant must demonstrate the ability to initiate procedures for training and maintaining the proficiency of personnel >From affiliated CCOPs/Minority-Based CCOPs on techniques for successful management of treatment and/or cancer prevention and control clinical trials research. Depending on the clinical trials initiated and the interventions involved, this will include training for data managers/nurses and any other individuals responsible for data collection, monitoring, or carrying out the intervention(s). 2.h. Each applicant's ability to provide mechanisms for periodic review of the performance of affiliated CCOPs/Minority-Based CCOPs, including on-site monitoring (auditing) and written procedures and criteria for continued affiliations, must be described. Similar measures must be described for other member/affiliates participating in cancer prevention and control research. 2.i. Each applicant must describe their plans for independent data and safety monitoring for all phase III prevention and control clinical trials. 2.j. Requests for funds must reflect operations/statistical costs for quality control and data management costs for CCOP participation in protocols. This estimate is based on the expected accrual credits of affiliated CCOPs/Minority-Based CCOPs and for member/affiliate accrual credits in cancer prevention and control. CCOP-research base affiliation agreements must be included. Each applicant should include a budget for monitoring and auditing activities. Funding can be requested for scientific development and pilot testing of new cancer prevention and control research initiatives (including support of a cancer prevention and control committee for the research base), and funds can also be requested for appropriate travel to meetings directly related to study activities (such as NCI-sponsored strategy sessions/workshops). Specific justification must be provided. B. Method of Applying The research grant application form PHS 398 (rev. 9/91) is to be used in applying for cooperative agreements. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3032, MSC 7762, Bethesda, MD 20892-7762; and from the NCI program official listed under INQUIRIES. A suggested format will be sent to all applicants requesting an RFA or submitting a letter of intent. All applicants are encouraged to obtain and use the suggested format instructions for organizing the specific information concerning the RFA programmatic requirements in the PHS 398. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to DRG at the address below. The photocopies must be clear and single sided. DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North - Room 636 6130 Executive Boulevard Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) It is important to send these copies at the same time that the original and three copies are sent to DRG; otherwise, the NCI cannot guarantee that the applications will be reviewed in competition with other applications received on or before the designated receipt date. Applications must be received by August 29, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS A. Review Procedures Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI staff will return it. 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. As part of the initial merit review, all applicants will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and received a second level review by the appropriate National Cancer Advisory Board. B. Review Criteria 1. CCOP Applicants 1.a. In describing the study population, it is required that a description of the gender and minority population and subpopulation served be provided, as well as an outreach plan. This information may be based on the institutional records and/or prior experience. 1.b. Each applicant should demonstrate the ability to accrue a minimum of 50 credits per year to treatment clinical trials and a minimum of 50 credits per year to cancer prevention and control clinical trials. Established CCOPs will be funded at a yearly accrual goal that may be higher than 50 credits for treatment clinical trials and 50 credits for cancer prevention and control clinical trials. These established CCOPs will be evaluated for their past performance in meeting these accrual goals. The minimum accrual requirement may be waived for applicants whose specialty is pediatrics. Each applicant's ability to access the appropriate populations, professional disciplines, and facilities to participate with affiliated research bases in NCI-approved cancer prevention and control intervention protocols will be appraised. Any prior participation in cancer treatment and prevention and control research will be considered. 1.c. Qualifications and experience of the principal investigator/associate principal investigator, in terms of ability to organize and manage a community oncology program that includes both cancer treatment and prevention and control research and related activities. 1.d. Training, experience, and commitment of participating physicians for accruing individuals to protocols in which the applicant has agreed to participate. The experience of proposed investigators in the entry and treatment of cancer patients on research trials (gained from residency, fellowships, postdoctoral training and/or subsequent practice) will be appraised. For multidisciplinary studies, evidence of the availability of appropriate professional resources (e.g., radiotherapy, pediatrics, surgery, gynecology, urology, pathology, internal medicine, family practice, nursing, and nutrition) will be required. Experience or special skills in cancer prevention and control research and related activities will be considered, together with availability of other community resources and personnel for such clinical trials. 1.e. Stability of the functional unit or group applying to become a CCOP. Preexisting organizational affiliations of at least a core of the group applying, and evidence of stable working relationships, will be appraised. Examples of established consortium arrangements, and committee structure which demonstrates the participation of appropriate physicians and administrators, may be submitted. Evidence of previous success as a group in implementing clinical cancer treatment and prevention and control research and related activities will be considered. 1.f. Qualifications and experience of all proposed support personnel relative to their position descriptions. The relevant credentials and expected contributions to the program of personnel resources not fiscally supported by the award will be considered. 1.g. Adequacy of quality assurance mechanisms for both cancer treatment and prevention and control interventions, and adequacy of procedures for investigational drug monitoring and data management and identification of false or otherwise unreliable data. 1.h. Adequacy of available facilities, including laboratories, in-patient and outpatient resources, cancer registries, etc., and adequacy of space for administrative activities and personnel. 1.i. Appropriateness of research base affiliations and of the cancer treatment and prevention and control research protocols chosen. Affiliation agreements must be provided in the application. 1.j. For competitive continuations, adequacy of progress during the funding period, including ability to meet the accrual goals in cancer treatment and prevention and control, progress made as a CCOP, and evaluation of CCOP performance by affiliated research bases(s). Consideration will be given to previous accrual and the ability to meet the previous accrual projections for which the CCOP was funded. The research base evaluation report(s) must be provided in the application. Plans for continued accrual and follow-up of subjects on protocols will be evaluated. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each favorably recommended application. Allowable items in the budget are requests for full or part-time administrative personnel, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); and appropriate travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/workshops, local travel). Funding is not allowed for clinical care provided to patients (e.g., patient care reimbursement, transportation costs). Funding is not allowed for clinical support personnel (e.g., pharmacist, physicist, clinical psychologist, dosimetrist). Physician compensation is only an allowable cost for the Principal Investigator (PI) and Co-PI, specifically for time spent on CCOP organizational/administrative tasks. Justification must be provided for personnel time and effort and funds requested. The initial review group will also examine the provisions for the protection of human subjects, recruitment plans for the inclusion of women, minorities and sub-populations to clinical trials, and the safety of the research environment. 2. Research Base Applicants All research base applicants will be evaluated on the following criteria: 2.a. In describing the study population, it is required that a description of the gender and minority population and subpopulation served be provided, as well as an outreach plan. This information may be based on the institutional records and/or prior experience. 2.b. Experience in conducting multi-institutional clinical trials; demonstrated ability to develop such studies and act as a coordinating and statistical center; adequate facilities to conduct the clinical trials; adequate procedures to collect, monitor, and analyze the data and assure the safety of patients/subjects. 2.c. Quality and availability of cancer treatment and/or prevention and control protocols, as applicable, which are appropriate for CCOP participation, or the potential for developing such clinical trials. For new applications, a detailed description of at least two examples of actual or planned cancer prevention and control protocols, with professional expertise to assure the quality of the proposed intervention clinical trial will be evaluated. 2.d. The ability to accrue a minimum of 50 credits per year from affiliated CCOPs/Minority-Based CCOPs to treatment clinical trials. The ability to accrue a minimum of 50 credits per year from affiliated CCOPs/Minority-Based CCOPs to cancer prevention and control clinical trials. Experience as well as the potential for developing future clinical trials will be considered. Documentation must include CCOP-research base affiliation agreements. 2.e. Organizational structure for involving appropriate personnel in the design and implementation of treatment and/or cancer prevention and control research. The organizational focus within the research base for cancer prevention and control research, including the composition and activities of the cancer prevention and control committee, and the designation of protocol chairpersons and its relationship to other clinical trial committees and activities will be assessed. 2.f. Qualifications and experience of the principal investigator and/or the individual responsible for directly relating to the CCOPs. The availability and experience of multidisciplinary health professionals and allied professionals with skills needed to develop, utilize, and analyze treatment and/or cancer prevention and control clinical trials will also be evaluated. 2.g. Experience in working with community oncologists, orienting community data management personnel to protocol requirements, organizing scientific and educational meetings for those participating in the clinical trials, and participating in intergroup clinical trials. 2.h. Ability to establish quality control, quality assurance, and data management procedures. Experience in data management and analysis of multi-institutional clinical trials and adequacy of data management staff will be appraised. The use of mechanisms for periodic review of quality control, quality assurance, and data management procedures, safety monitoring, including procedures for data safety and monitoring committee and on-site auditing program will be assessed. 2.i. For competitive continuations, adequacy of progress in implementing a prevention and control clinical trials program including; cancer prevention and control protocol development and implementation, accrual, data management, evaluation of performance sites; current status of each protocol and progress towards meeting planned accrual goals from CCOPs and members/affiliates; summary of prior activities with a clear presentation of annual accrual; completion of clinical trials, interim analyses, publication of findings, or other dissemination of trial findings throughout the research base; and other progress in meeting the requirements for a CCOP research base. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each favorably recommended application. Requests for funds must reflect operations/statistical costs for quality control and data management costs for CCOP participation in protocols. This estimate is based on the expected accrual credits of affiliated CCOPs/Minority-Based CCOPs and for member/affiliate accrual credits in cancer prevention and control. Research bases should include a budget for monitoring and auditing costs. Funding may be requested for scientific development and pilot testing of new cancer prevention and control research initiatives, other costs related to implementation of specific cancer prevention and control protocols (include support of cancer prevention and control committee for the research base), or for appropriate travel to meetings directly related to study activities (such as NCI- sponsored strategy sessions/workshops). Specific justification must be provided. The initial review group will also examine the provisions for the protection of human subjects, the plans for the accrual of women, minorities and sub-populations to clinical trials, and the safety of the research environment. AWARD CRITERIA The anticipated date of award is June 1, 1996. NCI program staff will take into account demographic and geographic distribution of applicants in the final funding selection process to assure inclusion of minority and underserved populations. Multiple CCOP applicants for funding who are competing for the same patient population will be considered, but all may not be awarded unless warranted by the population density. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Leslie G. Ford, M.D. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 300-D 6130 Executive Boulevard, MSC-7340 Bethesda, MD 20892-7340 Telephone: (301) 496-8541 Direct inquiries regarding fiscal matters to: Ms. Crystal Wolfrey Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7800, Ext. 282 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 13.399, Cancer Control. 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 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 routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Mon Jun 12 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 11 June 1995 Date: 12 Jun 1995 18:59:41 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 99 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3rired$i8r@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Letter Title: NSF 95-95 Dear Colleague Letter File size (bytes): STIS Filename: nsf9595.txt Document Type: Press Release Title: NEW REPORT IDENTIFIES RESEARCH FRONTIERS IN INLAND WATER ECOLOGY File size (bytes): STIS Filename: pr9540.txt Title: EARLY SIGNALS FROM MICROSATELLITE GPS/MET LOOKING GOOD File size (bytes): STIS Filename: pr9541.txt Title: NSF-FUNDED SCIENTISTS TAKE CLEAREST LOOK YET DEEP INSIDE LIVING CELLS File size (bytes): STIS Filename: pr9542.txt Document Type: Program Guideline Title: NSF 95-101 Inter-American Institute for Global Change Research - IAI Start-Up Grants File size (bytes): STIS Filename: nsf95101.txt Document Type: Recruit Title: Secretary (Office Automation) File size (bytes): STIS Filename: vgs95100.txt Title: Information Management Supervisor (Section Head) File size (bytes): STIS Filename: vgs9597.txt Title: Secretary (Office Automation) File size (bytes): STIS Filename: vgs9599.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 109564 STIS Filename: phnalpha.txt Also available: phnalpha.dlm ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnalpha.txt, the text of your message should be as follows: get phnalpha.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnalpha.txt, you would enter: ftp> get phnalpha.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. 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" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Sun Jun 18 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 22, pt. 1of1, 16 June 1995 Date: 19 Jun 1995 15:54:29 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1235 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3s4v75$e1@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950616 V24N22 P1O1 ************************************ X-comment: RFAS described: HL-95-015, HL-95-016, HL-95-017, HL-95-018, PA-95- X-URL: gopher://gopher.nih.gov/11/res/nih-guide/guide-files/95.06.16 NIH GUIDE - Vol. 24, No. 22 - June 16, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** HISTORICALLY BLACK COLLEGES AND UNIVERSITIES INITIATIVE GENERAL PROVISIONS FOR ADMINISTRATIVE SUPPLEMENTS National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX N2 ********************************************************** SMALL BUSINESS TECHNOLOGY TRANSFER PROGRAM National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** CLINICAL STUDIES OF CHRONIC LYME DISEASE (RFP NIH-NIAID-DMID-96-09) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R2 ********************************************************** CLINICAL STUDIES OF THERAPIES FOR VIRUS INFECTIONS (RFP NIH-NIAID- DMID-96-10) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R3 08/23/95 ************************************************* NHLBI MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD FOR MINORITY FACULTY (RFA HL-95-015) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R4 08/23/95 ************************************************* NHLBI MINORITY INSTITUTIONAL RESEARCH TRAINING PROGRAM (RFA HL-95-016) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R5 08/23/95 ************************************************* NHLBI MINORITY INSTITUTION FACULTY MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD (RFA HL-95-017) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R6 08/23/95 ************************************************* NHLBI SHORT-TERM RESEARCH TRAINING FOR MINORITY STUDENTS PROGRAM (RFA HL-95-018) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX P1 ********************************************************** BRIEF INTERVENTIONS TO PREVENT THE SPREAD OF AIDS (PA-95-070) National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX P2 ********************************************************** MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD-NURSING (PAR-95-071) National Institute of Nursing Research INDEX: NURSING RESEARCH $$INDEX P3 ********************************************************** INTERNATIONAL RESEARCH ON THE EPIDEMIOLOGY OF DRUG ABUSE (PA-95-072) National Institute on Drug Abuse INDEX: DRUG ABUSE THIS PUBLICATION IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE USING A PERSONAL COMPUTER (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435- 0692 FOR DETAILS. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTING EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. THE DIVISION OF RESEARCH GRANTS (DRG) HAS MOVED TO A NEW LOCATION. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** HISTORICALLY BLACK COLLEGES AND UNIVERSITIES INITIATIVE GENERAL PROVISIONS FOR ADMINISTRATIVE SUPPLEMENTS NIH GUIDE, Volume 24, Number 2, June 16, 1995 P.T. 34, FC; K.W. 0404009, 0715008, 1014006, 0755020, 0745027 National Institute on Drug Abuse PURPOSE Research Goals and Scope The Special Populations Office (SPO), Office of the Director, National Institute on Drug Abuse (NIDA) will offer to current NIDA grantees supplemental awards of up to $50,000 (direct costs) for a one year project in support of efforts to increase opportunities for students and investigators at Historically Black Colleges and Universities (HBCUs) to become involved in drug abuse research. It is anticipated that research experiences will be provided that will enable participants to develop knowledge, skills, and linkages needed to conduct rigorous drug abuse research. Opportunities to develop linkages and collaborations for joint projects and research experiences that increase the parent grant's knowledge base about cultural and ethnic issues in drug abuse research are also encouraged. The research experiences can be provided at either the applicant or participant's institution. Examples of research experiences that have been identified as being particularly needed include, but are not limited to, the following: o Analytical design and analysis especially with longitudinal data and other large data sets o Laboratory techniques (e.g., advanced lab equipment and methods) o Drug abuse issues in AIDS o Prevention and intervention implementation o Materials development o Model development, research conceptualization o Cultural issues in drug abuse research o Ethnographic methods o HIV/AIDS prevention and treatment o Treatment protocols o Medications development process o Clinical trials Examples of specific experiences that could be proposed include providing a summer internship for faculty in advanced laboratory techniques, participating in the design of data collection instruments for minority groups, and expanding a study to include an additional sample/site with an HBCU investigator as a collaborator. All experiences must be within the scope of the approved aims of the parent project. Experiences may be short- or long-term (i.e., no longer than one year). Participants are to be identified by the applicant. The SPO is willing to assist in identifying potential participants. ELIGIBILITY Ongoing NIDA projects, or those to be funded by July 1, 1995, with at least one year remaining on the active grant are eligible for HBCU supplements. Most research grants are eligible; however, the following mechanisms are not eligible: contracts, R13, R15, and R55. NIDA grantees at HBCUs are eligible for participation under this announcement. A list of HBCU may be obtained from the program person listed under INQUIRIES. PROCEDURES Program staff are asked to encourage all eligible grantees to consider participating, but special encouragement is requested of those grantees who have ongoing research that would be of unusual or unique value to underrepresented minority students and investigators. Interested Principal Investigators should formally request supplemental funds for the proposed research experiences, describe the specific experience and its value to the student or investigator, provide qualifications of the HBCU participant with a statement of intent to participate (for those applications identifying a specific person), and propose a time-frame and budget. A PHS face page and budget page must be included and signed by the appropriate officials. This submission should not exceed seven pages plus the budget information and face page. APPLICATION PROCEDURES Applications are to be submitted to Lula Beatty at the address listed under INQUIRIES. Five copies of each application must be received by July 31, 1995. INQUIRIES Inquiries regarding this announcement may be directed to: Lula Beatty Special Populations Office National Institute on Drug Abuse 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-0441 FAX: (301) 443-9127 Email: lbeatty@aoada2.ssw.dhhs.gov $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** SMALL BUSINESS TECHNOLOGY TRANSFER PROGRAM NIH GUIDE, Volume 24, Number 22, June 16, 1995 P.T. 34; K.W. 1016004 National Institutes of Health Application Receipt Dates: August 1, 1995; December 1, 1995; April 1, 1996; August 1, 1996; and December 1, 1996 Innovative technologies and methodologies fuel progress in biomedical and behavioral research and represent an increasingly important area of the economy. The Small Business Technology Transfer (STTR) program provides support to small business concerns -- in collaboration with U.S. research institutions -- for research or research or development (R&D) of new technologies and methodologies that have the potential to succeed as commercial products. The purpose of this notice is to inform the public about the opportunities that the STTR program offers to small business concerns as well as to scientists at research institutions, INCLUDING COLLEGES AND UNIVERSITIES. The applicant organization must be the small business concern. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent of the project is to be performed by the research institution. The STTR program consists of the following three phases: Phase I: The objective of this phase is to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort and the quality of performance of the small business concern, prior to providing further Federal support in Phase II. Phase II: The objective of this phase is to continue the research or R&D efforts initiated in Phase I. Funding shall be based on the results of Phase I and the scientific and technical merit and commercial potential of the Phase II application. Phase III: The objective of this phase, where appropriate, is to pursue with non-STTR funds the commercialization of the results of the research or R&D funded in Phases I and II. The amount and period of support for STTR awards are as follows: Phase I: Awards may not exceed $100,000 for direct costs, indirect costs, and fixed fee for a period normally not to exceed one year. Phase II: Awards may not exceed $500,000 for direct costs, indirect costs, and fixed fee for a period normally not to exceed two years, that is, generally, a two-year Phase II project may not cost more than $500,000 for that project. A Phase I award must have issued in order to be eligible to apply for a Phase II award. Both Phase I and Phase II applications will be accepted on the application receipt dates identified above. It is estimated that fiscal year 1996 funds of about $12 million will be set aside by the National Institutes of Health (NIH) to make grant awards under the STTR program. INQUIRIES Eligibility requirements, definitions, application procedures, review considerations, application forms and instructions, and other pertinent information are contained in the Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR) Grant Applications. Hard copies of the NIH STTR Solicitation are available directly from the following office ONLY: SBIR/STTR Solicitation Office 13687 Baltimore Avenue Laurel, MD 20707-5096 Telephone: (301) 206-9385 FAX: (301) 206-9722 Email: a2y@cu.nih.gov In addition, the Solicitation is available electronically using Business Gold, the National Technology Transfer Center's bulletin board system. (The electronic version of the Solicitation does NOT include STTR application forms, which must be obtained from the SBIR/STTR Solicitation Office above.) Connect via Internet by telneting to 'iron.nttc.edu' or by dialing (304) 243-2560 for high speed modems (9600+) or (304) 243-2561 for 1200-2400 baud modems and logging in as 'guest.' For more information about their electronic bulletin board system, contact: National Technology Transfer Center Wheeling Jesuit College 316 Washington Avenue Wheeling, WV 26003-6295 Telephone: (800) 678-6882 (toll-free within U.S.) Following are contact points for discussion of program interests pertaining to the NIH awarding components participating in the STTR grant program: Dr. Miriam F. Kelty Office of Extramural Affairs National Institute on Aging 7201 Wisconsin Avenue, Suite 2C218 Bethesda, MD 20892 Telephone: (301) 496-9322 FAX: (301) 402-2945 Email: mk46u@nih.gov Dr. Laurie Foudin National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 Bethesda, MD 20892-7003 Telephone: (301) 443-4224 FAX: (301) 594-0673 Email: lf29z@nih.gov Mr. Allan Czarra National Institute of Allergy and Infectious Diseases Solar Building, Room 3C28 Bethesda, MD 20892 Telephone: (301) 496-7291 FAX: (301) 402-0369 Email: ac20a@nih.gov Dr. Michael Lockshin National Institute of Arthritis and Musculoskeletal and Skin Diseases Building 45, Room 5AS-13F Bethesda, MD 20892 Telephone: (301) 594-2463 FAX: (301) 480-6069 Email: ml47h@nih.gov Ms. Joanne Goodnight Division of Cancer Biology and Diagnosis National Cancer Institute Executive Plaza North, Room 500 Bethesda, MD 20892 Telephone: (301) 496-5307 FAX: (301) 496-8656 Email: jg128w@nih.gov Dr. Jack Gruber Division of Cancer Etiology National Cancer Institute Executive Plaza North, Room 540 Bethesda, MD 20892 Telephone: (301) 496-9740 FAX: (301) 496-2025 Email: jg65y@nih.gov Dr. Ruthann M. Giusti Division of Cancer Treatment National Cancer Institute Building 31, Room 3A49 Bethesda, MD 20892 Telephone: (301) 496-6404 FAX: (301) 496-0826 Email: rg39r@nih.gov Dr. Barry Portnoy Division of Cancer Prevention and Control National Cancer Institute Building 31, Room 10A49 Bethesda, MD 20892 Telephone: (301) 496-1071 FAX: (301) 496-9931 Email: bp22z@nih.gov Ms. Connie Dresser Interactive Multimedia Technologies for Cancer Prevention National Cancer Institute Executive Plaza North, Room 241 Bethesda, MD 20892 Telephone: (301) 496-0273 FAX: (301) 496-8675 Email: cd34b@nih.gov Ms. Hildegard Topper National Institute of Child Health and Human Development Building 31, Room 2A03 Bethesda, MD 20892-2425 Telephone: (301) 496-0104 FAX: (301) 402-1104 Email: ht20t@nih.gov Ms. Jamie Friedman National Institute on Drug Abuse Parklawn Building, Room 10A-55 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-1056 FAX: (301) 443-6277 Email: jf78i@nih.gov Dr. Lynn E. Huerta National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C Bethesda, MD 20892-7180 Telephone: (301) 402-3458 Dr. Norman S. Braveman National Institute of Dental Research Building 45, Room 4AN-24B Bethesda, MD 20892-6402 Telephone: (301) 594-2089 FAX: (301) 480-8318 Email: nb10u@nih.gov Dr. Judith Fradkin Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 5AN-12E Bethesda, MD 20892 Telephone: (301) 594-8814 FAX: (301) 480-3503 Email: jf58s@nih.gov Dr. Judith Podskalny Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 6AN-12E Bethesda, MD 20892 Telephone: (301) 594-8876 FAX: (301) 480-8300 Email: jp53s@nih.gov Dr. Charles H. Rodgers Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 6AS-19J Bethesda, MD 20892 Telephone: (301) 594-7726 FAX: (301) 480-3510 Email: cr36d@nih.gov Dr. Allen Dearry National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 Research Triangle Park, NC 27709 Telephone: (919) 541-4943 FAX: (919) 541-2843 Email: ad29x@nih.gov Dr. Ralph Helmsen National Eye Institute Executive Plaza South, Suite 350 Bethesda, MD 20892-7164 Telephone: (301) 496-5301 FAX: (301) 402-0528 Email: rh27v@nih.gov Dr. Michael R. Martin National Institute of General Medical Sciences Building 45, Room 2AN-32K Bethesda, MD 20892-6200 Telephone: (301) 594-3910 FAX: (301) 480-1852 Email: mm72k@nih.gov Dr. Rosalie Dunn Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Two Rockledge Center, Room 9196 Bethesda, MD 20892-7940 Telephone: (301) 435-0505 FAX: (301) 480-1454 Email: rd39w@nih.gov Dr. Thomas Blaszkowski Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute Two Rockledge Center, Room 8106 Bethesda, MD 20892-7938 Telephone: (301) 435-0417 FAX: (301) 480-1455 Email: tb33i@nih.gov Dr. J. Sri Ram Division of Lung Diseases National Heart, Lung, and Blood Institute Two Rockledge Center, Room 10018 Bethesda, MD 20892-7952 Telephone: (301) 435-0202 FAX: (301) 480-3557 Email: sr32p@nih.gov Dr. George Nemo Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute Two Rockledge Center, Room 10042 Bethesda, MD 20892-7950 Telephone: (301) 435-0075 FAX: (301) 480-0868 Email: gn6y@nih.gov Dr. Michael Huerta National Institute of Mental Health Parklawn Building, Room 11-103 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4885 FAX: (301) 443-1731 Email: mh38f@nih.gov Mr. Edward Donohue National Institute of Neurological Disorders and Stroke Federal Building, Room 1016 Bethesda, MD 20892 Telephone: (301) 496-4188 FAX: (301) 402-4370 Email: ed25b@nih.gov Dr. Patricia Moritz National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-5956 FAX: (301) 480-8260 Email: pm61c@nih.gov Dr. Louise E. Ramm National Center for Research Resources Building 12A, Room 4009 Bethesda, MD 20892-5662 Telephone: (301) 496-6023 FAX: (301) 402-0006 Email: lr34m@nih.gov Dr. Bettie Graham National Center for Human Genome Research Building 38A, Room 610 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: bg30t@nih.gov $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NIH-NIAID-DMID-96-09 ************************************* CLINICAL STUDIES OF CHRONIC LYME DISEASE NIH GUIDE, Volume 24, Number 22, June 16, 1995 RFP AVAILABLE: NIH-NIAID-DMID-96-09 P.T. 34; K.W. 0715125, 0785035 National Institute of Allergy and Infectious Diseases The Bacteriology and Mycology Branch of the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), has a requirement for establishing the capability to perform clinical studies in patients with chronic Lyme disease. One contract is intended to result from this Request for Proposals (RFP). The emphasis of this solicitation will be on conducting studies to evaluate the effectiveness of curative therapies for patients with documented cases of chronic Lyme disease borreliosis. These studies may be multicenter in design. It is anticipated that one cost-reimbursement, level of effort type contract will be awarded for a period of five years. RFP No. NIH- NIAID-DMID-96-09 will be available on or about June 15, 1995 electronically through the NIH GOPHER and Internet using the following electronic mail addresses and instructions: 1. To access the NIH Gopher: Point your gopher client to GOPHER.NIH.GOV PORT 70 (you should now be in the NIH Gopher). Select "Grant and Research Information", then select "R&D Request for Proposals (RFP)". 2. To access the NIH Grant Line (Internet): Configure your terminal emulator as: 1200 or 2400 baud, even parity, 7 data bits, 1 stop bit, Half Duplex. Using the procedure specified in your communication software, dial 301-402-2221. When you get a response indicating that you have been connected, then type ,GEN1 (the comma is mandatory) and press ENTER; you will be prompted by the NIH system for "INITIALS?". Type BB5 and press ENTER. You will then be prompted for "Account?". Type CCS2 and press ENTER. Read the 12/22/94 News Flash for additional instructions. NOTE: Offerors who intend to submit a proposal in response to this RFP must notify Carl Henn at the Address/Phone listed below. If an offeror does not notify the RFP's contact person, they will not receive amendments to the RFP, which could impact proposal Preparation. INQUIRIES Please note that the RFP for this procurement has been re-engineered to include only the Work Statement, deliverable and reporting requirements, special requirements and mandatory qualification, if any, the Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the re-engineered RFP package. Following proposal submission and the initial review process, offerors comprising the competitive range will be requested to provide additional documentation (e.g., Representations and Certifications) to the Contracting Officer. Responses to this RFP will be due on October 15, 1995. Any responsible offeror may submit a proposal that will be considered by the Government. This advertisement does not commit the Government to award a contract. $$R1 END ************************************************************ $$R2 BEGIN NIH-NIAID-DMID-96-10 ************************************* CLINICAL STUDIES OF THERAPIES FOR VIRUS INFECTIONS NIH GUIDE, Volume 24, Number 22, June 16, 1995 RFP AVAILABLE: NIH-NIAID-DMID-96-10 P.T. 34; K.W. 0715125, 0785035 National Institute of Allergy and Infectious Diseases The Virology Branch, Division of Microbiology and Infectious Diseases Program of the National Institute of Allergies and Infectious Diseases (NIAID) is seeking a multicenter collaborative group to continue ongoing clinical trials and conduct new trials to evaluate new therapies for severe virus infections (including : herpes simplex encephalitis, neonatal herpes, varicella zoster virus infections, cytomegalovirus infections, parainfluenza virus infections, respiratory syncytial virus infections, and Epstein Barr virus- mediated diseases). This solicitation does not include studies of therapies for Human Immunodeficiency Virus (HIV), but does include therapies for the above stated virus infections in HIV-infected and other immunocompromised subjects. The NIAID solicits proposals from medical institutions qualified to serve as the sole Contracting Unit or as the Central Unit of a collaborative trial. The Contractor must have demonstrated experience in the clinical evaluation of antivirals and the demonstrated capacity to organize and administer a collaborative clinical study. This announcement is a new solicitation. The issuance of the Request for Proposals (RFP) will be on June 19, 1995 and proposals will be due by COB on September 15, 1995. It is anticipated that one contract may be awarded as a result of this solicitation. It is expected that the contract will have a seven year period of performance. RFP No. NIH-NIAID-DMID-96-10 will be available electronically through the NIH Gopher and via modem using the following electronic mail addresses and instructions: 1. To access the NIH Gopher: Point your gopher client to GOPHER.NIH.GOV PORT 70 (you should now be in the NIH Gopher). Select "Grant and Research Information", then select "R&D Request for Proposals (RFP)". 2. To access the NIH Grant Line via modem: Configure your terminal emulator as: 1200 or 2400 baud, even parity, 7 data bits, 1 stop bit, Half Duplex. Using the procedure specified in your communication software, dial 301-402-2221. When you get a response indicating that you have been connected, then type ,GEN1 (the comma is mandatory) and press ENTER; you will be prompted by the NIH system for "INITIALS?". Type BB5 and press ENTER. You will then be prompted for "Account?". Type CCS2 and press ENTER. Read the 12/22/94 News Flash for additional instructions. INQUIRIES Please note that the RFP for this procurement has been revised to include only the Work Statement, deliverable and reporting requirements, special requirements and mandatory qualification, if any, the Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the re-engineered RFP package. Following proposal submission and the initial review process, offerors comprising the competitive range will be requested to provide additional documentation (e.g., Representations and Certifications) to the Contracting Officer. Frank Murphy Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C07 6003 Executive Boulevard Rockville, MD 20852 Telephone: (301) 496-2509 This advertisement does not commit the Government to award a contract. $$R2 END ************************************************************ $$R3 BEGIN HL-95-015 FULL-TEXT ************************************** NHLBI MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD FOR MINORITY FACULTY NIH GUIDE, Volume 24, Number 2, June 16, 1995 RFA AVAILABLE: HL-95-015 P.T. 34, FF; K.W. 0715032, 0715040, 0715165 National Heart, Lung, and Blood Institute Application Receipt Date: August 23, 1995 The National Heart, Lung, and Blood Institute (NHLBI) invites grant applications for the Mentored Research Scientist Development Award (K01) for Minority Faculty program. The purpose of the award is to encourage the enhancement of the research skills of minority faculty members at non-minority and minority institutions in the areas of interest to the NHLBI and to increase the number of minority individuals involved in research endeavors. Individuals applying for this program must have been awarded a doctoral degree (Ph.D., M.D., D.V.M., D.O. degree or its equivalent), have a faculty appointment at an accredited college or university at the time of award, and be members of an underrepresented minority group. For the purpose of this program, underrepresented minority faculty members are defined as individuals belonging to a particular ethnic or racial group that has been determined to be underrepresented in biomedical or behavioral research. In making grant awards under this program, the NHLBI will give priority to projects involving Black, Hispanic, Native American, Pacific Islander, and/or other ethnic or racial group members who have been found to be underrepresented in biomedical or behavioral research nationally. Candidates must be nominated by an institution on the basis of qualifications, interests, accomplishments, motivation, and potential for performing quality research. The candidate's academic background, previous experience, and career goals should determine both the necessary length and the kind of program that is appropriate. Each candidate must identify a sponsor(s) who is an accomplished investigator in the research area proposed, who is engaged in research in areas related to heart, lung, blood, or sleep disorders, and has experience in developing independent investigators. Awardees, under this program, may receive salary support up to a maximum of $50,000 plus fringe benefits per year for five years. A minimum of 80 percent effort must be devoted to the research program. In addition to the salary request for the candidate, support for up to five percent of the sponsor's salary and $30,000 per year for research support may be requested. The estimated funds (total costs) available for the first year of support for this program are expected to be $1 million in fiscal year 1996. The number of awards is estimated to be 10 awards for the Mentored Research Scientist Development Award for Minority Faculty program. The actual amount may vary, depending on the response to the RFA and availability of funds. 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, NHLBI Mentored Research Scientist Development Award for Minority Faculty, is related to the priority areas of heart disease and stroke, maternal and infant health, environment health, and educational and community-based programs. 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 202-783-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH Gopher (gopher.nih.gov), and by mail and email from the program contact listed below. Joyce Hunter, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7956 Bethesda, MD 20892-7956 Telephone: (301) 435-0535 FAX: (301) 480-1454 Email: joyce_hunter@nih.gov $$R3 END ************************************************************ $$R4 BEGIN HL-95-016 FULL-TEXT ************************************** NHLBI MINORITY INSTITUTIONAL RESEARCH TRAINING PROGRAM NIH GUIDE, Volume 24, Number 2, June 16, 1995 RFA AVAILABLE: HL-95-016 P.T. 44, FF; K.W. 0720005, 0715032, 0715040, 0715165, 0715187 National Heart, Lung, and Blood Institute Application Receipt Date: August 23, 1995 The National Heart, Lung, and Blood Institute (NHLBI) invites applications for the Minority Institutional Research Training program directed at developing the research capabilities of minority individuals in areas relevant to cardiovascular, pulmonary, and hematologic diseases, and sleep disorders. The purpose of this program is to encourage the enhancement of research skills by minority individuals and to increase the number of minority individuals involved in research endeavors in the areas of interest to the NHLBI. Awards in this program will be made to domestic minority institutions (institutions in which a majority of the students are minority) engaged in health related-research. These grants will are intended to support the research training of predoctoral students, health-professional students, and/or postdoctoral trainees at the minority institution. Training will be provided in conjunction with a collaborating research center (university, medical school, or comparable institution) that has strong, well-established research and research training programs in areas relevant to heart, lung, and blood diseases. Trainees appointed to the program by the minority institution will be placed with a mentor at the cooperating research center who is an accomplished investigator and who will assist the advisor at the minority institution in the trainee's development and research plan. The mechanism of support will be the National Institutes of Health (NIH) Institutional National Research Service Award (T32). The total project period for an application in response to this RFA may not exceed five years. The anticipated award date is May 1, 1996. The estimated funds (total costs) available for the first year of support for the entire program is expected to be $300,000 in fiscal year 1996. Two new awards for Minority Institutional Research Training Program are anticipated. The actual amounts awarded for this specific program may vary, depending on the response to the RFA and availability of funds. 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, NHLBI Minority Institutional Research Training Program, is related to the priority areas of heart disease and stroke, educational and community-based programs, maternal and infant health, and environmental health. 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 202-783-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH Gopher (gopher.nih.gov), and by mail and email from the program contact listed below. Michael Commarato, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7940 Bethesda, MD 20892-7940 Telephone: (301) 435-0530 FAX: (301) 480-1454 Email: michael_commarato@nih.gov $$R4 END ************************************************************ $$R5 BEGIN HL-95-017 FULL-TEXT ************************************** NHLBI MINORITY INSTITUTION FACULTY MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD NIH GUIDE, Volume 24, Number 2, June 16, 1995 RFA AVAILABLE: HL-95-017 P.T. 44, FF; K.W. 0720005, 0715032, 0715040, 0715165, 0715187 National Heart, Lung, and Blood Institute Application Receipt Date: August 23, 1995 The National Heart, Lung, and Blood Institute (NHLBI) invites applications for the Minority Institution Faculty Mentored Research Scientist Development Award. The purpose of this program is to encourage the development of faculty investigators at minority institutions in areas relevant to cardiovascular, pulmonary, and hematologic diseases and sleep disorders research and stimulate cardiovascular, pulmonary, and hematologic disease and sleep disorder research, prevention, control and education by offering faculty members of minority institutions the opportunity to enhance their research capabilities in these areas. Awards in this program will be made to domestic minority institutions on behalf of the applicant. Candidates for this award are faculty members of minority institutions who are citizens of the United States, non-citizen nationals, or permanent residents at the time of application and have a doctoral degree or equivalent in a biomedical or behavioral science. Applicants should propose a research development program that includes arrangements to work with a mentor at a nearby (within 100 miles) research center. The mentor should be recognized as an accomplished investigator in the area proposed and should provide guidance for the awardee's development and research plan in research areas related to heart, lung, or blood disorders. The mechanism of support will be the National Institutes of Health (NIH) Mentored Research Scientist Development Award (K01). The total project period for an application submitted in response to this RFA may not exceed five years. The anticipated award date is May 1, 1996. The estimated funds (total costs) available for the first year of support for the entire program is expected to be $250,000 in fiscal year 1996. Three new awards for the NHLBI Minority Institution Faculty Mentored Research Scientist Development Award are anticipated. 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, NHLBI Minority Institution Faculty Mentored Research Scientist Development Award, is related to the priority areas of heart disease and stroke, maternal and child health, environment health, and educational and community-based programs. 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 202-783-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH Gopher (gopher.nih.gov), and by mail and email from the program contact listed below. LeeAnn Jensen, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7950 Bethesda, MD 20892-7950 Telephone: (301) 435-0065 FAX: (301) 480-1060 Email: leeann_jensen@nih.gov $$R5 END ************************************************************ $$R6 BEGIN HL-95-018 FULL-TEXT ************************************** NHLBI SHORT-TERM RESEARCH TRAINING FOR MINORITY STUDENTS PROGRAM NIH GUIDE, Volume 24, Number 2, June 16, 1995 RFA AVAILABLE: HL-95-018 P.T. 44, FF; K.W. 0715032, 0715040, 0715165 National Heart, Lung, and Blood Institute Application Receipt Date: August 23, 1995 The National Heart, Lung, and Blood Institute (NHLBI) invites grant applications for the Short-Term Research Training for Minority Students Program. The purpose of the award is to encourage institutions to provide opportunities for underrepresented minority students at the undergraduate and graduate level to become exposed to biomedical research in areas relevant to cardiovascular, pulmonary, and hematologic diseases through a short-term research experience. Awards in this program will be made to domestic institutions or organizations, including minority institutions, engaged in research in areas related to heart, lung, or blood disorders. These grants will support short-term research training experiences of two to three months duration for minority students at the undergraduate or graduate level, including health professional students. Students appointed to the program must be U.S. citizens, noncitizen nationals, or permanent residents of the U.S. Individuals holding Ph.D., M.D., D.V.M., or equivalent doctoral degrees in the health sciences are not eligible. The grantee institution will be responsible for the selection and appointment of trainees. The program is intended to introduce students to research that would not otherwise be available through their regular course of studies. The mechanism of support will be the National Institutes of Health (NIH) Short-Term Training grant (T35). The total project period for an application submitted in response to this RFA may not exceed five years. The anticipated award date is May 1, 1996. The estimated funds (total costs) available for the first year of support for the entire program is expected to be $300,000 in fiscal year 1996. The number of awards is estimated to be 10 awards for the Short-Term Research Training for Minority Students Program. The actual amounts may vary, depending on the response to the RFA and availability of funds. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. 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, NHLBI Short-Term Research Training for Minority Students Program, is related to the priority areas of heart disease and stroke, maternal and infant health, environmental health, and educational and community-based programs. 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 202-783-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH Gopher (gopher.nih.gov), and by mail and email from the program contact listed below. Mary Reilly Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: mary_reilly@nih.gov $$R6 END ************************************************************ $$P1 BEGIN PA-95-070 FULL-TEXT ************************************** BRIEF INTERVENTIONS TO PREVENT THE SPREAD OF AIDS NIH GUIDE, Volume 24, Number 2, June 16, 1995 PA AVAILABLE: PA-95-070 P.T. 34; K.W. 0715008, 0745027, 0404000 National Institute of Mental Health PURPOSE The National Institute of Mental Health (NIMH) is encouraging applications for the support of research on brief preventive interventions that can be implemented in public health clinics and community-based organizations to prevent the further spread of HIV. This program announcement (PA) is critical, because prevention efforts must be developed to reach individuals who may not proactively seek HIV prevention programs to change high-risk behavior. The urgency of the AIDS crisis demands that top priority be given to research with implications for preventive interventions that access hard-to-reach populations who are at high risk for HIV infection. Even if an AIDS vaccine were to be identified in the next few years, prevention efforts would continue to be the primary way to stop further spread of HIV infection. Research is needed to develop methods and techniques to motivate people to assess their risk for HIV and to seek help in changing high-risk, HIV-related behaviors and to seek additional behavior-change help. Some people may not actively seek long-term HIV prevention programs, but might be reached at clinics where they are being treated for other medical problems. Therefore, brief interventions that could be used in Sexually Transmitted Disease (STD) clinics, health care facilities, and alternative (non-health care) sites are urgently needed. This PA solicits theoretically grounded research applications focusing on developing models of brief HIV prevention programs. No definition is provided for "brief intervention" so that investigators can develop and test a range of single and short-term interventions. 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, Brief Interventions to Prevent the Spread of AIDS, is related to the priority areas of mental health and mental disorders and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), Mental Health FAX4U (301/443-5168), and by mail and email from the contact listed below. Willo Pequegnat, Ph.D. Office on AIDS National Institute of Mental Health 5600 Fishers Lane, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: WPEQUEGN@A0AMH2.SSW.DHHS.GOV $$P1 END ************************************************************ $$P2 BEGIN PAR-95-071 FULL-TEXT ************************************* MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD-NURSING NIH GUIDE, Volume 24, Number 2, June 16, 1995 PA AVAILABLE: PAR-95-071 P.T. 34; K.W. 0785130, 0710030 National Institute of Nursing Research Application Receipt Dates: February 1, June 1, and October 1 PURPOSE The Mentored Research Scientist Development Award- Nursing (MRSDA-N) is for research scientists who need a period of sponsored research experience as a way to gain expertise in a research area new to the candidate or in an area that would demonstrably enhance the candidate's scientific career. It is expected that following this experience, the candidate will be able to pursue an independent and productive research career. The MRSDA-N (K01) replaces the K07 Academic Investigator Award - Nursing (PA-91-57) and the K08 Clinical Investigator Award - Nursing (PA-91-56). 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, Mentored Research Scientist Development Award-Nursing, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Dr. Mary Lucas Leveck National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-5963 FAX: (301) 480-8260 Email: mleveck@ep.ninr.nih.gov $$P2 END ************************************************************ $$P3 BEGIN PA-95-072 FULL-TEXT ************************************** INTERNATIONAL RESEARCH ON THE EPIDEMIOLOGY OF DRUG ABUSE NIH GUIDE, Volume 24, Number 2, June 16, 1995 PA AVAILABLE: PA-95-072 P.T. 34; K.W. 0404009, 0715008, 0785055 National Institute on Drug Abuse PURPOSE The purpose of this program announcement is to stimulate international research on similarities and variations in drug abuse behaviors, factors influencing the initiation, progression, and cessation of drug abuse, and social and health consequences of drug abuse including HIV transmission. This program initiative expands and advances the study of the interrelationship of the agent, host, and environment to include environments across and within different countries. Increased understanding of the role of social, cultural, political, and economic factors on drug abuse behaviors, obtained by examining configurations of these factors in varying national and regional environments, is sought. Comparative studies with U.S. populations are encouraged. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, International Research on the Epidemiology of Drug Abuse, is primarily related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Moira O'Brien Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-53 Rockville, MD 20857 Telephone: (301) 443-6637 Email: mobrien@aoada2.ssw.dhhs.gov $$P3 END ************************************************************ From owner-sci-resources@net.bio.net Sun Jun 18 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-95-015 - V24(22) 06/16/95 Date: 19 Jun 1995 15:54:32 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 353 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3s4v78$e6@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL95015 HL-95-015 P1O1 *************************************** NHLBI MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD FOR MINORITY FACULTY NIH GUIDE, Volume 24, Number 2, June 16, 1995 RFA: HL-95-015 P.T. 34, FF; K.W. 0715032, 0715040, 0715165 National Heart, Lung, and Blood Institute Application Receipt Date: August 23, 1995 PURPOSE The National Heart, Lung, and Blood Institute (NHLBI) invites grant applications for the Mentored Research Scientist Development Award for Minority Faculty Program. The purpose of the award is to encourage the enhancement of research skills in the areas of interest to the National Heart, Lung, and Blood Institute by minority faculty members at domestic institutions and to increase the number of minority individuals involved in research endeavors. 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, NHLBI Mentored Research Scientist Development Award for Minority Faculty, is related to the priority areas of heart disease and stroke, maternal and infant health, environmental health, and educational and community-based programs. 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, and units of state and local government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Individuals applying for this program must have been awarded a doctoral degree (Ph.D., M.D., D.V.M., D.O. degree or its equivalent), have a faculty appointment at an accredited college or university at the time of award, and be members of an underrepresented minority group. For the purpose of this program, underrepresented minority faculty members are defined as individuals belonging to a particular ethnic or racial group that has been determined to be underrepresented in biomedical or behavioral research. In making grant awards under this program, the NHLBI will give priority to projects involving Black, Hispanic, Native American, Pacific Islander, and/or other ethnic or racial group members who have been found to be underrepresented in biomedical or behavioral research nationally. Candidates must be nominated by an institution on the basis of qualifications, interests, accomplishments, motivation, and potential for performing quality research. The candidate's academic background, previous experience, and career goals should determine both the necessary length and the kind of research development program that is appropriate. Each candidate must identify a sponsor(s) who is an accomplished investigator in the research area proposed and has experience in developing independent investigators. The sponsor is not required to be affiliated with the applicant institution. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Mentored Research Scientist Development Award grant (K01). Responsibility for the planning, direction, and execution of the proposed career development program will be solely that of the applicant. The awardee may receive salary support up to a maximum of $50,000 plus fringe benefits per year for the five year period. All funds must be used to support the awardee. A minimum of 75 percent effort must be devoted to the research program. In addition to the salary request for the candidate, support for up to five percent of the sponsor's salary may be requested. Up to $30,000 per year will be provided for research support. Substitution of another sponsor and/or a change of institution may be permitted with the prior approval of the NHLBI. The total project period for an application submitted in response to this RFA may not exceed five years. Funding beyond the first year of the grant is contingent upon satisfactory progress during the preceding year and the availability of funds. Indirect costs will be awarded based on eight percent of total direct costs exclusive of equipment and tuition and fees. The anticipated award date is May 1, 1995. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for this program are expected to be $1 million in fiscal year 1996. The actual amount may vary, depending on the response to the RFA and availability of funds, but the number of new awards is anticipated to be 10 awards. RESEARCH OBJECTIVES Background Many studies have emphasized the need for minority individuals to participate in modern research activities to develop their investigative talents. Whereas approximately 12 percent of the U.S. population is Black, less than 0.25 percent of individuals holding a Ph.D. degree in biomedical science are Black. There are existing programs at the NIH that are designed to answer this need. These include the Minority Biomedical Research Support Program, the Minority Access to Research Careers Program, and the Research Supplements for Underrepresented Minorities Program. Even though these programs appear successful in meeting their specific objectives and career development goals, minority students and faculty need additional opportunities to develop biomedical and behavioral research skills and become productive investigators. One method of addressing this problem is by attracting minority students to research opportunities and by providing them with research training to develop their research capabilities in cardiovascular, pulmonary, and hematologic disease areas. In addition, by increasing the research capabilities of minority faculty members and faculty members at minority institutions, these individuals may serve as role models for minority undergraduate and graduate students, and stimulate these students to become more cognizant of research opportunities in cardiovascular, pulmonary, and hematologic disease areas. Other The present RFA is designed to offer career development opportunities for minority faculty members to encourage their participation in cardiovascular, pulmonary, and hematologic research. The Mentored Research Scientist Development Award for Minority Faculty is intended to: o Encourage research-oriented minority faculty to develop independent research skills and gain experience in advanced methods and experimental approaches in the basic and applied sciences relevant to heart, blood vessel, lung, and blood diseases and transfusion medicine. o Increase the pool of highly trained minority investigators who can use advanced technologies to address the major problems in heart, blood vessel, lung, blood diseases, and transfusion medicine. * Within NHLBI, the term "hematologic" covers research on thrombosis and hemostasis, immunohematology, blood cell disorders, hematopoiesis, thalassemia, sickle cell disease, transfusion medicine, blood resources including blood component and derivative therapy, blood substitutes and blood resource management, aspects of AIDS-products in AIDS prevention and treatment, and AIDS-related bone marrow and hematologic disorders. Other Institutes of the NIH are responsible for research on disorders of white cells, including the leukemias and other blood malignancies, and basic immunology related to the lymphoid system. Therefore, NHLBI cannot provide support for such studies. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Application kits are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive MSC 7762, Bethesda, MD 20892-7762, telephone 301-435-0714; and from the program administrator listed under INQUIRIES. Guidelines and supplemental instructions for the Mentored Research Scientist Development Award for Minority Faculty may be obtained from NHLBI staff listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 9/91) 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 (NHLBI Research Development Award for Minority Faculty) and number (HL-95-015) must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE ROOM 1040 MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier service) Two additional copies of the application must also be sent to: Scientific Review Administrator Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0288 FAX: (301) 480-3541 Applications must be received by August 23, 1995. 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 to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by 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 the Research Training Review Committee of the Division of Extramural Affairs, NHLBI, in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) 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 assigned a priority score. Application determined to be non-competitive will be withdrawn from further consideration and the applicant and the official signing for the applicant organization will be notified. Review Criteria The following criteria will be considered when assessing the merit of career development applications, including the Mentored Research Scientist Development Award for Minority Faculty. o Candidate -- The candidate's overall competence as demonstrated by academic record and performance, potential for a career in independent research, and commitment or interest in pursuing an academic research career. o Sponsor(s) -- The sponsor's accomplishments in the scientific research area(s) proposed, experience and track record in training investigators, and commitment for the duration of a candidate's research development. o Environment -- The applicant institution's ability to provide adequate facilities, resources, and opportunities necessary for the candidate's training, and the institutional commitment to the candidate. If different from the applicant institution, the quality and extent of interaction of the faculty in the basic and clinical sciences, and the quality of the research and research training programs at the sponsor's institution. o Career Development Plan -- The adequacy of the research career development plan, based on the candidate's past research experience, training, and career goals. o Research Project -- Scientific merit of the proposed research project and its appropriateness as a vehicle for developing the candidate's research skills. o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA The following will be considered in making funding decisions: o Technical merit of the application as determined by peer review o Availability of funds o Program balance among the research areas of the announcement INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding program guidelines, supplemental instructions, or programmatic issues to: Joyce Hunter, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7956 Bethesda, MD 20892-7956 Telephone: (301) 435-0535 FAX: (301) 480-1454 Email: joyce_hunter@nih.gov Direct inquiries regarding fiscal matters to: Jane Davis Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0166 FAX: (301) 480-3310 Email: jane_davis@nih.gov AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance numbers 93.837, 93.838, and 93.839. Awards are made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies and Federal Regulations at 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Sun Jun 18 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-95-071 - V24(22) 06/16/95 Date: 19 Jun 1995 15:54:34 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 550 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3s4v7a$e9@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PAR95071 PAR-95-071 P1O1 ************************************* MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD-NURSING NIH GUIDE, Volume 24, Number 2, June 16, 1995 PA NUMBER: PAR-95-071 P.T. 34; K.W. 0785130, 0710030 National Institute of Nursing Research Application Receipt Dates: February 1, June 1, and October 1 PURPOSE The Mentored Research Scientist Development Award- Nursing (MRSDA-N) is for research scientists who need a period of sponsored research experience as a way to gain expertise in a research area new to the candidate or in an area that would demonstrably enhance the candidate's scientific career. It is expected that following this experience, the candidate will be able to pursue an independent and productive research career. The MRSDA-N (K01) replaces the K07 Academic Investigator Award - Nursing (PA-91-57) and the K08 Clinical Investigator Award - Nursing (PA-91-56). 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, Mentored Research Scientist Development Award-Nursing, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS The candidate must have a research or a health-professional doctorate or its equivalent, and must have demonstrated the capacity or potential for highly productive independent research in the period after the doctorate. The National Institute of Nursing Research (NINR) is primarily interested in receiving applications from Registered Nurses for this mechanism. The candidate must identify a mentor with extensive research experience, and must be willing to spend a minimum of 75 percent of full-time professional effort conducting research and research career development activities for the period of the award. The remaining 25 percent time should be devoted to other research-related and/or teaching or clinical pursuits consistent with the objectives of the award. Applications may be submitted on behalf of candidates by domestic, non-Federal organizations, public or private, such as universities, colleges, hospitals, and laboratories. Minorities and women are encouraged to apply. Candidates must be U.S. citizens or noncitizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-551) or some other verification of legal admission as a permanent resident. Noncitizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states, but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. Candidates may have been principal investigators on PHS research grants and may have been supported by a research career award in the past, provided the proposed research experience is a fundamentally new field of study or there has been a significant hiatus in their research career because of family or other personal obligations. Current principal investigators on PHS research grants are not eligible. MECHANISM OF SUPPORT Awards in response to this PA will use the K01 mechanism. 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 will be for three years and is not renewable. RESEARCH OBJECTIVES The Nursing Mentored Research Scientist Development Award (K01) provides an intensive, supervised career development experience in one of the biomedical, behavioral, or clinical sciences. The proposed experience should be in a research area new to the applicant and/or one in which a supervised research experience will demonstrably enhance the candidate's scientific career. The experiences should permit the application of novel or highly promising interdisciplinary approaches to particular research problems. Candidates must be able to provide a convincing case that the proposed period of support will substantially enhance his/her career and/or will allow the pursuit of a novel or promising approach to a particular research problem. Candidates who have interrupted their careers because of illness or pressing family care commitments may apply if they can clearly demonstrate the potential for productive independent research and the need for an additional period of mentored research experience in order to accomplish an effective scientific reentry. Similarly, faculty members at institutions with a substantial minority enrollment, who wish to enhance their research skills through a supervised research experience at a nearby research center, may also apply, if they agree to remain at their parent institution after completion of the award. A. Environment: The institution must have a well- established research and/or clinical research career development program(s) and qualified faculty to serve as mentors unless a geographically distant mentor is proposed. The institution must be able to demonstrate a commitment to the development of the candidate as a productive, independent investigator. And, the candidate, mentor, and institution must be able to describe a multi- disciplinary research career development program that will maximize the use of relevant research and educational resources. B. Program: The award provides three consecutive 12 month appointments. At least 75 percent of the recipient's full-time professional effort must be devoted to the program and the remainder devoted to other research-related and/or teaching or clinical pursuits consistent with the objectives of the award. The program consists of both a research plan and a research career development plan that will develop knowledge and research skills in scientific areas relevant to the career development goals of the applicant. C. Mentor(s): The recipient must receive appropriate mentoring throughout the three year program. Where feasible, women and minority mentors should be involved as role models. If the mentor (and/or a co-mentor, if desired) is geographically distant from the candidate, detailed rationale must be provided to document the mentor-candidate relationship and level of commitment for the successful implementation and completion of the proposed research and career development program. D. Allowable Costs: 1. Salary: The NINR will provide up to $50,000 salary plus fringe benefits for the K01 award recipient. The institution may supplement the NIH contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case, may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the MRSDA. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary requested must be based on a full-time, 12- month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. 2. Research Development Support: Up to $20,000 per year will be allowed for the following expenses: (a) tuition, fees, and books related to career development; (b) research expenses, such as supplies, equipment, and technical personnel; (c) travel to research meetings or training; (d) statistical services including personnel and computer time. 3. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed. 4. Indirect costs: Indirect costs will be reimbursed at eight percent of modified total direct costs, or at the actual indirect cost rate, whichever is less. F. Evaluation: In carrying out its stewardship of human resource related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. G. Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution. The funds may be used for health-related research purposes. The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks must be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment. Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component. H. Special Leave: Leave to another institution, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval of the NIH funding component is required. To obtain prior approval, the award recipient must submit a letter to the NIH describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH funding component and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Parental leave will be granted consistent with the policies of the NIH and the grantee institution. I. Termination or Change of Institution: When a grantee institution plans to terminate an award, the NIH funding component must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. If the individual is moving to another eligible institution, career award support may be continued provided: A new career award application is submitted by the new institution; The period of support requested is no more than the time remaining within the existing award period; and The new application is submitted far enough in advance of the requested effective date to allow the necessary time for review. The funding component may require a review by an initial review group and/or the appropriate National Advisory Council or Board. Alternatively, review may be carried out by staff within the NIH funding component, depending upon the circumstances. The Director of the NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution and career award recipient in writing of this determination, the reasons therefor, the effective date, and the right to appeal the decision. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution 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 new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91) and will be accepted on the receipt dates indicated in the application kit (February 1, June 1, and October 1). Forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3032 MSC 7762, Bethesda, MD 20892-7762, telephone 301/435-0714. The application must address the following issues: Candidate o Establish the candidate's commitment to a career in biomedical or behavioral research. o Establish the candidate's potential to develop into a successful independent investigator. o Summarize the candidate's immediate and long-term career objectives, explaining how the award will contribute to their attainment. o Letters of recommendation. Three sealed letters of recommendation addressing the candidate's potential for a research career must be included as part of the application. Career Development Plan o Describe the career development plan, incorporating consideration of the candidate's goals and prior experience. It should describe a systematic plan to obtain the necessary basic biomedical or behavioral science background and research experience to launch or reinitiate an independent research career. o The application must include a biographical sketch and information on the mentor(s) including research qualifications and previous experience as a research supervisor. The application must also include information that describes the nature and extent of supervision that will occur during the proposed award period. A letter of support from the mentor (and co-mentor, if appropriate) must be included in the applicaton delineating the match with the applicant's research and development plan and willingness to provide the necessary assistance. o Candidates must describe plans to receive instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction as well as the amount and nature of faculty participation. No award will be made if an application lacks this component. Research Plan o Describe the research plan and the use of a basic or clinical approach to a biomedical or behavioral problem. The candidate must describe the research plan as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. Environment and Institutional Commitment o The sponsoring institution must document a strong, well-established research program related to the candidate's area of interest including a high-quality research environment with staff capable of productive collaboration with the candidate. The sponsoring institution also must provide a statement of commitment to the candidate's development into a productive, independent investigator. Budget o Budget requests must be provided according to the instructions in form PHS 398. The request for tuition and fees, books, travel, etc., must be justified and specified by category. To identify the application as a response to this PA, check "YES" on item 2a of page 1 of the application and enter "PAR-95-071, Mentored Research Scientist Development Award-Nursing." Utilize the Research Career Development Award (RCDA) Table of Contents, but relabel the page, "Mentored Resarch Scientist Development Award." This substitute page is included in the Form 398 packet and will facilitate organizing the research and career development components of the application. Submit a signed, typewritten original of the application with Checklist, and five signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be reviewed for completeness by the Division of Research Grants and responsiveness to the PA by the appropriate institute staff. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. The following review criteria will be applied: Candidate o Commitment to an independent research career; o Potential to develop (or evidence of the capacity to develop) as an independent investigator; o Quality and breadth of prior scientific training and experience, including, where appropriate, the record of previous research support and publications. Career Development Plan o Likelihood that the plan will contribute substantially to the scientific development of the candidate and the achievement of scientific independence; o Appropriateness of the research plan to the career goals of the candidate; o Appropriateness of the plan to update conceptual and theoretical knowledge; o Consistency of the career development plan with 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; and o Quality of the proposed training in the responsible conduct of research. Research Plan All candidates for this award will have had previous research experience and in some cases will have been Principal Investigators in other scientific fields. A sound research plan that is consistent with the career development plan and the candidate's level of research development must be provided. o Usefulness of the research plan as a vehicle for enhancing existing research skills as described in the career development plan; o Scientific and technical merit of the research question, design and methodology, judged in the context of the candidate's previous training and experience; o Relevance of the proposed research to the candidate's career objectives; and o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. Mentor o Appropriateness of mentor's research qualifications in the area of this application; o Quality and commitment of the mentor to supervising and guiding the candidate throughout the award period; o Previous experience in fostering the development of researchers; and o History of research productivity and support. Institutional Environment and Commitment o Applicant institution's commitment to the scientific development of the candidate and assurances that the institution intends the candidate to be an integral part of its research program; o Adequacy of research facilities and training opportunities; o Quality of environment for scientific and professional development; and o Applicant institution's willingness to develop an appropriate mix of research, teaching and administrative responsibilities for the candidate. Budget o Justification of budget requests in relation to career development goals and research aims and plans. AWARD CRITERIA Funding decisions will be made based on the recommendations of the initial review group and advisory council, the need for research personnel in specific program areas, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this PA are encouraged, especially during the planning phase of the application. Direct inquiries regarding programmatic issues to one of the following program staff: Dr. Mary Lucas Leveck National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-5963 Email: mleveck@ep.ninr.nih.gov Direct inquiries regarding fiscal matters to: Sally A. Nichols Grants Management Officer National Institute of Nursing Research Building 45, Room 3AN-32 Bethesda, MD 20892-6301 Telephone: (301) 594-6869 Email: SNichols@ep.ninr.nih.gov AUTHORITY AND REGULATIONS The Mentored Research Scientist Development Awards are made under the authority of Title III, Section 301 of the Public Health Service (PHS) Act as amended (Public Law 78-410, as amended, 42 USC 241). The Code of Federal Regulations, Title 42 Part 52, and Title 45 part 74, are applicable to this program. This program is described in the Catalog of Federal Domestic Assistance No. 93.361, Nursing Research. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun Jun 18 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-95-017 - V24(22) 06/16/95 Date: 19 Jun 1995 15:54:42 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 367 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3s4v7i$f8@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL95017 HL-95-017 P1O1 *************************************** NHLBI MINORITY INSTITUTION FACULTY MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD NIH GUIDE, Volume 24, Number 2, June 16, 1995 RFA: HL-95-017 P.T. 44, FF; K.W. 0720005, 0715032, 0715040, 0715165, 0715187 National Heart, Lung, and Blood Institute Application Receipt Date: August 23, 1995 PURPOSE The National Heart, Lung, and Blood Institute (NHLBI) invites grant applications for the Minority Institution Faculty Mentored Research Scientist Development Award program. The purpose of this program is to encourage the enhancement of research skills by faculty members at minority institutions in areas relevant to cardiovascular, pulmonary and hematologic diseases and transfusion medicine and stimulate cardiovascular, pulmonary, and hematologic disease research, prevention, control and education at minority institutions by offering faculty members the opportunity to enhance their research capabilities in these areas. 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, NHLBI Minority Institution Faculty Mentored Research Scientist Development Award, is related to the priority areas of heart disease and stroke, maternal and infant health, environmental health, and educational and community-based programs. 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, and units of state and local government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Applications from foreign institutions will not be accepted. Awards in this program will be made to a domestic minority institution on behalf of a principal investigator. A minority institution is defined as a domestic medical or non-medical college, university, or equivalent school in which students of minority ethnic groups, including Blacks, Hispanics, American Indians, Asians, or Pacific Islanders, comprise a majority of the institution's enrollment. Candidates for this award are faculty members of minority institutions who: (1) are citizens of the United States, non-citizen nationals, or permanent residents at the time of application, (2) have a doctoral degree or equivalent in a biomedical or behavioral science, (3) wish to receive specialized training in cardiovascular, pulmonary, or hematologic research, and (4) have the background and potential to benefit from the training. Each candidate must propose a research development program that includes intensive, full-time, training during the summer period (two to three months) and part-time training during the academic year. In proposing a research development program, the candidate must identify and complete arrangements with a nearby investigator (within approximately 100 miles) who can act as a mentor for the research development program. The mentor must be an accomplished investigator in the research area proposed in the application and will provide guidance for the principal investigator's development and research plan related to heart, lung, or blood disorders. Plans for the research development must be developed with the mentor. The commitment of the minority institution to the faculty candidate's research and development must clearly be presented in the application. This must include statement(s) from the Dean and departmental chair indicating that the candidate will be provided with sufficient release time from other duties to accomplish the research goals stated in the application. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Mentored Research Scientist Development Award grant (K01). Responsibility for the planning, direction, and execution of the proposed career development program 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. Funding beyond the first year of the grant is contingent upon satisfactory progress during the preceding year and the availability of funds. Indirect costs will be awarded based on eight percent of total direct costs exclusive of equipment. The anticipated award date is May 1, 1996. The awardee may receive salary support up to a maximum of $50,000 per year plus fringe benefits for five years. The actual amount allowable for salary will be dependent upon the actual percent effort committed to the project. All funds must be used to support the awardee. Awardees must commit 100 percent effort during the summer and/or off quarter periods and at least 25 percent effort during the academic year. Up to $20,000 per year will be provided for research support. Details regarding the apportionment of these funds between the minority institution and the research center must be worked out with the mentor at the research center and agreed to by representatives of both institutions. If funds are to be transferred to the mentor's institution for any purpose, arrangements for the transfer or conduct of activities should be formalized in a contract or written agreement with the mentor's institution and submitted as part of the application. The award is non-renewable and may not be transferred to another institution or another faculty member. The indirect cost rate on subcontract costs for the mentor's institution may not exceed 8 percent of total costs. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the program are expected to be $250,000 in fiscal year 1996. The actual amount may vary, depending on the response to the RFA and availability of funds, but the anticipated number of awards for the Minority Institution Faculty Mentored Research Scientist Development Award Program is three new awards. RESEARCH OBJECTIVES Background Many studies have emphasized the need for minority individuals to participate in modern research activities to develop their investigative talents. Whereas approximately 12 percent of the U.S. population is Black, less than 0.25 percent of individuals holding a Ph.D. degree in biomedical science are Black. There are existing programs at the National Institutes of Health that are designed to answer this need. These include the Minority Biomedical Research Support Program, the Minority Access to Research Careers Program, and the Research Supplements for Underrepresented Minorities Program. Even though these programs appear successful in meeting their specific objectives and career development goals, students and faculty at minority schools need additional opportunities to develop biomedical and behavioral research skills and become productive investigators. While there is strong interest in the scientific community in attracting minority students into research careers, few minority students opt for science degrees and research careers, and few minority graduates of health professional schools go on to investigative careers. The shortage of qualified minority investigators in academic research positions may even exacerbate the situation due to a lack of visible role models for students. One method of addressing this problem is by increasing the research capabilities of minority faculty members and faculty members at minority institutions, so that these individuals may serve as role models for minority undergraduate and graduate students, and stimulate students to become more cognizant of research opportunities in cardiovascular, pulmonary, and hematologic disease areas. Other The present RFA is designed to offer career development opportunities for faculty at minority institutions. The Minority Institution Faculty Mentored Research Scientist Development Award is intended to: o Encourage the development of faculty investigators at minority schools in areas relevant to cardiovascular, pulmonary, and hematologic* diseases and transfusion medicine. o Stimulate cardiovascular, pulmonary, and hematologic disease research, prevention, control, and education by offering minority school faculty members the opportunity to enhance their research capabilities in these areas. * Within NHLBI, the term "hematologic" covers research on thrombosis and hemostasis, immunohematology, blood cell disorders, hematopoiesis, thalassemia, sickle cell disease, transfusion medicine, blood resources including blood component and derivative therapy, blood substitutes and blood resource management, aspects of AIDS-products in AIDS prevention and treatment, and AIDS-related bone marrow and hematologic disorders. Other Institutes of the NIH are responsible for research on disorders of white cells, including the leukemias and other blood malignancies, and basic immunology related to the lymphoid system. Therefore, NHLBI cannot provide support for such studies. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Application kits are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3032, MSC 7762, Bethesda, MD 20892-7762, telephone 301-435-0714; and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 9/91) 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 (NHLBI Minority School Faculty Development Award) and number (HL-95-017) must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier service) One additional copy of the application must also be sent to: Kathryn Ballard Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0288 FAX: (301) 480-3541 Email: kathryn_ballard@nih.gov Applications must be received by August 23, 1995. 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 to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by 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 the Research Training Review Committee of the Division of Extramural Affairs, NHLBI, in accordance with the review criteria stated below. The following criteria will be considered when assessing the merit of career development applications, including the Minority Institution Faculty Mentored Research Scientist Development Award. o Candidate -- The candidate's overall competence as demonstrated by academic record and performance, potential for a career in independent research, and commitment or interest in pursuing an academic research career. o Mentor(s) -- The mentor's accomplishments in the scientific research area(s) proposed, experience and track record in training investigators, and commitment for the duration of a candidate's research development. o Environment -- The applicant institution's ability to provide adequate facilities, resources, and opportunities necessary for the candidate's training, and the institutional commitment to the candidate. The quality of the research and research training programs at the mentor's institution. o Acceptability of plan to provide instruction on the responsible conduct of research. o Career Development Plan -- The adequacy of the research career development plan, based on the detailed description of the candidate's past research experience, training, and career goals. o Research Project -- Scientific merit of the proposed research project and its appropriateness as a vehicle for developing the candidate's research skills. o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA Applications will compete for funds with all other approved applications assigned to the NHLBI. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among the research areas of the National Heart, Lung, and Blood Institute INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding program guidelines, supplemental instructions, or programmatic issues may be directed to: LeeAnn Jensen, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7950 Bethesda, MD 20892-7950 Telephone: (301) 435-0065 FAX: (301) 480-1060 Email: leeann_jensen@nih.gov Direct inquiries regarding fiscal matters to: Jane Davis Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0166 FAX: (301) 480-3310 Email: jane_davis@nih.gov AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance numbers 93.837, 93.838, and 93.839. Awards are made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies and Federal Regulations at 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Sun Jun 18 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-070 - V24(22) 06/16/95 Date: 19 Jun 1995 15:54:40 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 320 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3s4v7g$ev@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95070 PA-95-070 P1O1 *************************************** BRIEF INTERVENTIONS TO PREVENT THE SPREAD OF AIDS NIH GUIDE, Volume 24, Number 2, June 16, 1995 PA NUMBER: PA-95-070 P.T. 34; K.W. 0715008, 0745027, 0404000 National Institute of Mental Health PURPOSE The National Institute of Mental Health (NIMH) is encouraging applications for the suppor tof research on brief preventive interventions that can be implemented in public health clinics and community-based organizations to prevent the further spread of HIV. This program announcement (PA) is critical because prevention efforts must be developed to reach individuals who may not proactively seek HIV prevention programs to change high-risk behavior. The urgency of the AIDS crisis demands that top priority be given to research with implications for preventive interventions that access hard-to-reach populations who are at high risk for HIV infection. Even if an AIDS vaccine were to be identified in the next few years, prevention efforts would continue to be the primary way to stop further spread of HIV infection. Research is needed to develop methods and techniques to motivate people to assess their risk for HIV and to seek help in changing high-risk, HIV-related behaviors, and to seek additional behavior-change help. Some people may not actively seek long-term HIV prevention programs, but might be reached at clinics where they are being treated for other medical problems. Therefore, brief interventions that could be used in Sexually Transmitted Disease (STD) clinics, health care facilities, and alternative (non-health care) sites are urgently needed. This program announcement solicits theoretically grounded research applications focusing on developing models of brief HIV prevention programs. No definition is provided for "brief intervention" so that investigators can develop and test a range of single and short-term interventions. 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, Brief Interventions to Prevent the Spread of AIDS, is related to the priority areas of mental health and mental disorders and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29s) awards or program project grants (PO1s). Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support for applications submitted in response to this program announcement will be through individual research projects (R01s), FIRST awards (R29s), and program project grants (P01s). RESEARCH OBJECTIVES Background The major objective of research supported under this PA is to identify effective brief interventions that can be implemented in clinics and other primary health care facilities. Current research indicates that HIV education campaigns that primarily provide information about the HIV virus, modes of infection, and methods of prevention do not produce sustained behavior change. In addition, models of brief interventions that access hard-to-reach populations who may not otherwise be exposed to HIV prevention programs are urgently needed. Areas of Interest The following section suggests areas of research to meet the health promotion and disease prevention objectives of this PA. However, researchers responding to this PA need not limit themselves to these topics. o Which modality of intervention (e.g., counseling, psychotherapy, health information, health education, community-level intervention) and modality of delivery (e.g., individual, group, written, interactive video, etc.), provide the most effective, parsimonious intervention in different settings? o What are the best settings for implementing brief HIV prevention interventions, and who is the best intervenor (e.g., physician, nurse, counselor, peer)? o What are the critical components in a brief intervention that will motivate individuals to assess HIV risk and seek help? o Are there brief counseling models that are generalizable and effective with different populations? o Which brief interventions are most effective in producing sustained behavior change? o What are possible barriers to conducting brief interventions in various settings (e.g., barriers to having health-care providers discuss specific sexual behaviors, lack of referrals for seropositives and for seronegatives, barriers to adopting preventive health behaviors for individuals who have been serotested and learn that they are seronegative) and how can they be overcome? o What is the appropriate means of defining, operationalizing, and measuring the effectiveness of a given brief intervention? o What types of outcomes might be expected from brief interventions (e.g., changes in sexual behavior, help-seeking behavior, increased readiness to change, changed attitudes and beliefs, etc.)? o What are realistic behavioral outcome goals for different individuals and groups as a result of brief interventions? o What factors mediate test-seeking behavior (e.g., demographic and motivating factors)? What is the emotional/ behavioral impact of deciding to be tested or planning to be tested? What factors predict which individuals will return for test results? What factors predict an individual's ability to cope with test results? o Is it possible to set standards for the content and process of prevention interventions delivered in various settings? How can the content of counseling sessions be evaluated? How can quality assurance be conducted? INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Aplications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted under the receipt deadlines for AIDS applications. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 1040, Bethesda, MD 20892; telephone 301/594-7248. The title, "Brief Interventions to Prevent the Spread of HIV," and number of the program announcement must be typed in Section 2a on the face page of the application. Applications for the FIRST award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight mail service) REVIEW CONSIDERATIONS Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with 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 an appropriate National Advisory Council. Several other Institutes have an interest in research in this research area. Most notably, the National Institute of Nursing Research, the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Aging, and the National Institute on Child Health and Human Development. Applications submitted in response to this Program Announcement will be referred to initial review groups in accordance with PHS referral guidelines. Review Criteria o significance and originality from a scientific or technical standpoint of the goals of the proposed research o qualifications and experience of the Principal Investigator and demonstrated staff expertise in prevention research, AIDS, multicultural assessment of diverse populations, statistics, AIDS, and other areas specific to the questions under investigation o adequacy of the conceptual and theoretical framework for the research and evidence of familiarity with relevant research literature o scientific merit of the research design, approaches, intervention, and methodology o access to target population(s) o sample selection and retention methods and efforts to determine factors that influence refusal rate o adequacy of the data analysis plan o adequacy of the existing and proposed facilities and resources o appropriateness of the budget, staffing plan, and time frame to complete the project 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 subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that Institute. For those applications assigned to the NIMH, the following will be considered in making funding decision: o scientific merit as determined during the peer review process o availability of funds o balance among target populations, with priority given to understudied populations o balance among theoretical and multicultural approaches o balance among geographic areas INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Willo Pequegnat, Ph.D. Office on AIDS National Institute of Mental Health Parklawn Building, Room 10-75 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: WPEQUEGN@A0AMH2.SSW.DHHS.GOV Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-08 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-3065 FAX: (301) 443-6885 Email: DT21a@NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance 93.242, Mental Health Research Grants. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (April 1, 1994). The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Sun Jun 18 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-072 - V24(22) 06/16/95 Date: 19 Jun 1995 15:54:48 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 409 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3s4v7o$fq@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95072 PA-95-072 P1O1 *************************************** INTERNATIONAL RESEARCH ON THE EPIDEMIOLOGY OF DRUG ABUSE NIH GUIDE, Volume 24, Number 2, June 16, 1995 PA NUMBER: PA-95-072 P.T. 34; K.W. 0404009, 0715008, 0785055 National Institute on Drug Abuse PURPOSE The purpose of this program announcement is to stimulate international research on similarities and variations in drug abuse behaviors, factors influencing the initiation, progression, and cessation of drug abuse, and social and health consequences of drug abuse including HIV transmission. This program initiative expands and advances the study of the interrelationship of the agent, host, and environment to include environments across and within different countries. Increased understanding of the role of social, cultural, political and economic factors on drug abuse behaviors, obtained by examining configurations of these factors in varying national and regional environments, is sought. Comparative studies with U.S. populations are encouraged. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, International Research on the Epidemiology of Drug Abuse, is primarily related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) award. MECHANISM OF SUPPORT The mechanisms available for support of this program announcement are the research project grant (R01), small grant (R03), and FIRST (R29) award. There are special requirements for the R03 and FIRST mechanisms. Applicants intending to apply for either of these mechanisms should contact the program person listed under INQUIRIES for further information. Because the nature and scope of the research proposed in response to this program announcement may vary, it is anticipated that the size of an award will vary also. Potential applicants should contact the program staff listed under INQUIRIES for further information. Research project grants (R01) provide support for up to five years for domestic grants and for domestic grants with foreign components; for research project grants to foreign institutions, the initial project period and each competitive segment thereafter may be awarded for up to three years. Small grants (R03) provide research support of up to $50,000 per year in direct costs plus appropriate indirect costs for up to two years. FIRST awards (R29) provide support for five years and up to $350,000 in direct costs for the entire project period. RESEARCH OBJECTIVES Background and Significance Once considered an "American Disease," drug abuse is now recognized as a global problem that is having an increasingly negative impact on emerging as well as developing countries. The political and economic changes that have been taking place over the past 10 years have resulted in increases in cross-border and cross-national communication and commerce. These changes, in turn, have had a major impact on drug abuse, including manufacture and production, trafficking patterns, drug use patterns, and consequences. Political and economic conditions and events in other countries/regions often directly impact the U.S. population through large influxes of new populations. U.S. border populations are directly affected by public health issues, as well as economic and political conditions, in Mexico and Canada. Furthermore, there is increasing evidence that the U.S., once the trend-setter in emerging new drug abuse patterns, is becoming the recipient of such behaviors (e.g., the use of flunitrazepam (Rohypnol or "rophies") and drug use at "rave" scenes). These changing conditions, as well as the expanded knowledge base for understanding the dynamic nature of drug abuse and the increased sophistication of the methodological tools for conducting epidemiologic research, make this an opportune time for an international epidemiologic research initiative. Finally, cross-national studies offer opportunities to examine the direction and strength of interrelationships between agent, host, and environment in different cultural and political settings. The following definitions and examples may be used in conceptualizing research questions. "Nation" or "national" refers to a political state or country. "Cross-national" refers to two or more countries, not necessarily geographically proximate. "International" refers to that which transcends national limits; with regard to this program announcement, "international" studies could include single country projects focussed on research concepts of relevance to more than one country such as, for example, the impact of childhood traumatic experience on subsequent drug use, or could include projects examining research questions in two or more countries. "Border" refers to the geopolitical boundary between countries. Residents of border areas may constitute unique populations while having different national identities. For example, research in the area of the U.S. Mexico Border suggests that drug use patterns among populations on each side of the border are more similar to each other than either is to the U.S. or Mexican general populations. "Region" refers to a geographically circumscribed area including two or more proximate countries. Drug abuse patterns in a country may be influenced by factors such as drug production, trafficking, laws, enforcement, and political and economic instability in neighboring countries. Program Objectives The primary goal of this program announcement is to improve the knowledge base on the similarities and variations in drug using behaviors in different national and regional environments with the goal of gaining a better understanding of the influence of environmental factors including social, cultural, political, and economic variables on the initiation, progression, and cessation of drug using behavior and on the social and health consequences of the behaviors including HIV transmission. Very little drug abuse epidemiologic research has been conducted outside the U.S.; theoretical models and related epidemiologic research instruments pertaining to vulnerability, resiliency, drug use progression, and health and social consequences have primarily been based on research conducted in U.S. populations. Research on minority populations within the U.S. has revealed wide variation in patterns of drug use among different ethnic/racial sub-groups and has highlighted the influence of social, economic, and cultural variables on drug using behaviors. This program announcement encourages the use of international research to provide a broader context for the examination of social and cultural variables as well as the opportunity for assessing these variables in differing political and economic environments. Comparative studies with U.S. populations and the assessment of the cross-cultural applicability of theoretical models and epidemiologic instruments are encouraged. Studies are also sought that investigate mediating and protective factors and processes in populations with very low drug use where results could be used to help in the development of effective prevention methods that could be transferred or adapted to populations where drug abuse is more prevalent. Methodological studies assessing the impact of social, cultural, political, and economic factors on the accuracy, collection, and reporting of epidemiologic data are also encouraged under this program announcement. Studies should focus on hypothesis generation and testing. Quantitative and/or systematic qualitative methodological approaches may be used, as appropriate. All applications should address project feasibility, collaborative arrangements, study design, sampling procedures, instrumentation, measurement, data collection, quality control, follow-up, and data analysis, as appropriate. If research is to be conducted in two or more countries, applicants must address project implementation for each site and describe procedures to ensure data comparability across sites. Applications should also describe how the project presents special opportunities for furthering the field of drug abuse epidemiology through the use of unique resources, populations, or environmental conditions in other countries and explain how the project has the potential to advance knowledge in the field of drug abuse that will benefit the United States. Examples of areas of research interest include, but are not limited to, the following: o The influence of socioeconomic and political factors on the availability of illicit drugs, on patterns of drug use, and differences by gender. This includes the effect of cross-border free trade on illicit drug availability, perception of availability, and drug use patterns. Studies of drug use patterns and determinants along the U.S./Mexico and U.S./Canada borders are encouraged; o The impact of drug production and drug trafficking patterns and mechanisms on the spread of drugs between countries or regions and on the initiation of drug use in specific populations; o The extent to which cultural factors such as attitudes, beliefs, perceptions, norms, and religion determine or influence drug use patterns, description of the nature of these relationships, and assessment of differences by gender; o In countries where there is a tradition of a particular pattern of drug use (such as opium smoking among older men in Thailand or Laos), identification of factors that alter the nature and extent of such use (i.e., use documented among young men or women), and/or introduce new forms or types of drug use (e.g., heroin intravenous use); o For countries with several ethnic groups, description of the patterns of drug use among these groups and identification of the determinants of the behaviors; o Drug use patterns within special populations such as (1) refugee populations displaced by political instability, unrest, persecution, or war, (2) seasonal cross-national migrant workers, (3) homeless children, or (4) children working in the streets; o The impact of migration (rural to urban and cross-national) on drug use including the extent to which migration history (1st, 2nd and 3rd generation) or acculturation play a role in drug using patterns. With cross-national migration, comparison of patterns of drug use in country of origin with populations that migrated out of the country. Studies comparing drug use patterns, determinants, and consequences in U.S. ethnic minority populations with drug use patterns, determinants, and consequences in the country of origin are encouraged. Studies of mediating and protective factors in these populations are also encouraged; o Similarities and differences in the pathways and distal and proximal determinants for the initiation, progression and maintenance of comparable drug using behaviors across countries; o The impact of traumatic (political/economic/familial) childhood experiences on subsequent drug abuse and, among vulnerable populations, mediating factors that protect against initiation or progression of drug abuse; o The extent to which variations in modes of administration of drugs of abuse, such as heroin and cocaine, have differential physical, health, social and psychological consequences in different national environments; o The influence of social, cultural, political, and economic factors on the relationship between drug use and HIV transmission. How injecting practices and needle sharing behaviors differ among subgroups of drug users in different national environments; o How abusers with similar patterns of drug use and similar characteristics in different countries seek treatment for drug abuse and drug abuse consequences; o Cross-cultural validity of epidemiologic instruments; The impact of social, cultural, political, and economic factors on the accuracy, collection, and reporting of drug abuse epidemiologic data. Examples of possible variables include trust in government or authority, legal sanctions on behaviors, religious proscriptions pertaining to substance use, and social or religious barriers to accessing specific populations such as women or ethnic minorities. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508- 14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted, in English, on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional business offices or from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Suite 3032 - MSC 7762, Bethesda, MD 20892-7762, telephone 301/435-0714. The title and number of the program announcement must be typed in Item 2a of face page of the application. FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with established NIH referral guidelines. 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 and assigned a priority score and will receive a second level of review by the appropriate national advisory council or board. Review Criteria o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provision of the protection of human and animal subjects, and safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: quality of the proposed project as determined by the peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding the programmatic issues to: Moira O'Brien Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-53 Rockville, MD 20857 Telephone: (301) 443-6637 Email: mobrien@aoada2.ssw.dhhs.gov Direct inquires regarding fiscal issues to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Email: gfleming@aoada.ssw.dhhs.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of Section 301 of the Public Health Service Act (42 USC 241) and administered under PHS policies and Federal Regulations at Title 42 CFR 52 "Grants for Research Projects," Title 45 CFR Part 74 and 92, "Administration of Grants" and 45 CFR Part 46, "Protection of Human Subjects". This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Sections of the Code of Federal Regulations are available in booklet form from the U.S. Government Printing Office. Grants must be administered in accordance with the PHS Grants Policy Statement, (rev. 4/94), which may be available from your office of sponsored research. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care of early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun Jun 18 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-95-016 - V24(22) 06/16/95 Date: 19 Jun 1995 15:54:45 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 319 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3s4v7l$fh@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL95016 HL-95-016 P1O1 *************************************** NHLBI MINORITY INSTITUTIONAL RESEARCH TRAINING PROGRAM NIH GUIDE, Volume 24, Number 2, June 16, 1995 RFA: HL-95-016 P.T. 44, FF; K.W. 0720005, 0715032, 0715040, 0715165, 0715187 National Heart, Lung, and Blood Institute Application Receipt Date: August 23, 1995 PURPOSE The National Heart, Lung, and Blood Institute (NHLBI) invites applications for the Minority Institutional Research Training program. The Minority Institutional Research Training Program is designed to offer research training grant awards in cardiovascular, pulmonary, and hematologic* research, including sleep disorders, to minority schools and institutions to enable qualified graduate students, health professional students, and postdoctoral students to participate in research programs. It is expected to attract students in their developmental stages, increase their awareness of these diseases, and to acquaint them with career opportunities in research. The purpose of this program is to encourage the enhancement of research skills by individuals at minority educational institutions and to increase the number of minority individuals involved in research endeavors in the areas of interest to the NHLBI. * Within NHLBI, the term "hematologic" covers research on thrombosis and hemostasis, immunohematology, blood cell disorders, hematopoiesis, thalassemia, sickle cell disease, transfusion medicine, blood resources including blood component and derivative therapy, blood substitutes and blood resource management, aspects of AIDS-products in AIDS prevention and treatment, and AIDS-related bone marrow and hematologic disorders. Other Institutes of the NIH are responsible for research on disorders of white cells, including the leukemias and other blood malignancies, and basic immunology related to the lymphoid system. Therefore, NHLBI cannot provide support for such studies. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), NHLBI Minority Institutional Research Training Program, is related to the priority areas of heart disease and stroke, educational and community-based programs, maternal and infant health, and environmental health. 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, medical schools, and units of state and local government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as program directors. Applications will not be accepted from foreign institutions, with the exception of institutions located in United States possessions, such as Puerto Rico. A minority school is defined as a domestic medical or non-medical college, university or equivalent school in which students of minority ethnic groups, including Blacks, Hispanics, American Indians, Asians, or Pacific Islanders, comprise a majority of the school's enrollment. The program director at the minority school will be responsible for the selection and appointment of trainees and the overall direction of the training program. The minority institution is expected to collaborate with a research center that has well-established cardiovascular, pulmonary, or hematologic research and research training programs in order to provide training in the program. The collaborating research center should be a university, medical school, or comparable institution that has strong, well-established research and research training programs in areas relevant to heart, lung, and blood diseases, including areas related to sleep disorders. Cooperation between institutions is needed to provide each trainee with a mentor at a research intensive institution who is recognized as an accomplished investigator in cardiovascular, pulmonary, or hematologic research and who will assist the advisor at the minority institution in the trainee's development and research plan. Trainees must be training at (1) the post-baccalaureate level (i.e., predoctoral level) in a relevant biomedical or behavioral science and have made a strong commitment to completing a doctoral degree, (2) be enrolled in a minority health professional school, or (3) have a doctoral degree or equivalent in a biomedical or behavioral science (i.e. postdoctoral level). MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Institutional National Research Service Award (NRSA) grant (T32). Responsibility for the planning, direction, and execution of the proposed training program 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. Funding beyond the first year of the grant is contingent upon satisfactory progress during the preceding year and the availability of funds. Indirect costs will be awarded based on eight percent of total direct costs exclusive of equipment, tuition, and fees. The anticipated award date is May 1, 1996. The Minority Institutional Research Training program may support predoctoral students, postdoctoral trainees, and short-term trainees in health professional schools. Stipend levels for predoctoral and short-term trainees are $10,008 per year and stipend levels for postdoctoral trainees range from $19,608 to $32,300 per year. Stipends may be supplemented from non-Federal sources. Training related expenses ($1,500 annually for predoctoral trainees and $2,500 annually for postdoctoral trainees), tuition and fees, and travel expenses ($800 per trip) may also be requested for trainees, although the levels may vary depending on the type of training to be supported. The trainees may be appointed to the training program for 9-12 months periods (for short-term trainees, the period of appointment may be of two to three months duration) at any time during the course of the year after acceptance as a full-time student. A strong interest in a cardiovascular, pulmonary, or hematologic research career must be evident. Trainees are encouraged to be appointed to the training for at least two years, in order to obtain adequate training. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the entire program is expected to be $300,000 in fiscal year 1996. Two new awards for the Minority Institutional Research Training Program are anticipated. The actual amounts to be awarded may vary, depending on the response to the RFA and availability of funds. RESEARCH OBJECTIVES Many studies have emphasized the need for minority individuals to participate in modern research activities to develop their investigative talents. Whereas approximately 12 percent of the U.S. population is Black, less than 0.25 percent of individuals holding a Ph.D. degree in biomedical science are Black. There are existing programs at the National Institutes of Health that are designed to answer this need. These include the Minority Biomedical Research Support Program, the Minority Access to Research Careers Program, and Research Supplements for Underrepresented Minorities. Even though these programs appear successful in meeting their specific objectives and career development goals, minority graduate students, health professional students, and postdoctoral students in minority schools need additional opportunities to develop biomedical and behavioral research skills and become productive investigators. The present RFA is designed to offer research training opportunities for individuals at minority institutions and encourage their participation in cardiovascular, pulmonary, and hematologic research, including research into sleep disorders. The Minority Institutional Research Training program is intended to: o Train graduate students, health professional students, and postdoctoral students at minority schools that have the potential to develop a meritorious program in cardiovascular, pulmonary, or hematologic research for research careers in areas relevant to these diseases. o Stimulate cardiovascular, pulmonary, and hematologic diseases, hematologic resources and sleep disorders research, prevention, control, and education by offering minority school graduate students, health professional students, and postdoctoral students the opportunity to enhance their research capabilities in these areas. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3032, MSC 7762, Bethesda, MD 20892-7762, telephone 301/435-0714. Guidelines and supplemental instructions for the Minority Institutional Research Training program may be obtained from NHLBI staff listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. The completed original application and four legible copies, must be delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier service) In addition one copy of the application must also be sent to: Research Training Review Committee Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0288 FAX: (301) 480-3541 Email: kathryn_ballard@nih.gov Applications must be received by August 23, 1995. 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 to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. All applications will be reviewed for scientific and technical merit by the Research Training Review Committee of the Division of Extramural Affairs, NHLBI, in accordance with the standard NIH peer review procedures. Following scientific-technical review, applications will receive a second level review by the National Heart, Lung, and Blood Advisory Council. The following criteria will be considered when assessing the merit of a Minority Institutional Research Training program application. o Adequacy of faculty, facilities, and resources for the proposed research training, both at the minority institution and the established research center, including the expertise of preceptors as researchers who have successfully competed for research support; o Commitment of the relevant faculty and the two institutions to the goals of the training program; o Adequacy of the cooperative arrangements between the minority institution and the established research program; o Past research training record for the program director and designated preceptors in terms of the success of trainees pursuing research activities and procedures for evaluation of the impact of the program on the trainees involved; o Objectives, design, and direction of the research training program. o Acceptability of plan to provide instruction on the responsible conduct of research. AWARD CRITERIA Applications will compete for funds with all other approved applications assigned to the NHLBI. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among the research areas of the National Heart, Lung, and Blood Institute. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding program guidelines, supplemental instructions, or programmatic issues to: Michael Commarato, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7940 Bethesda, MD 20892-7940 Telephone: (301) 435-0530 FAX: (301) 480-1454 Email: michael_commarato@nih.gov Direct inquiries regarding fiscal matters to: Jane Davis Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0166 FAX: (301) 480-3310 Email: jane_davis@nih.gov AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance numbers 93.837, 93.838, and 93.839. Awards are made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies and Federal Regulations at 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Sun Jun 18 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-95-018 - V24(22) 06/16/95 Date: 19 Jun 1995 15:54:37 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 320 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3s4v7d$em@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL95018 HL-95-018 P1O1 *************************************** NHLBI SHORT-TERM RESEARCH TRAINING FOR MINORITY STUDENTS PROGRAM NIH GUIDE, Volume 24, Number 2, June 16, 1995 RFA: HL-95-018 P.T. 44, FF; K.W. 0715032, 0715040, 0715165 National Heart, Lung, and Blood Institute Application Receipt Date: August 23, 1995 PURPOSE The National Heart, Lung, and Blood Institute (NHLBI) invites grant applications for the Short-Term Research Training for Minority Students Program. The purpose of the award is to encourage institutions to provide opportunities for underrepresented minority students at the undergraduate and graduate level to become exposed to biomedical research in areas relevant to cardiovascular, pulmonary, and hematologic diseases through a short-term research experience. 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, NHLBI Short-Term Research Training for Minority Students Program, is related to the priority areas of heart disease and stroke, maternal and infant health, environmental health, and educational and community-based programs. 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, medical schools, and units of state and local government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as program directors. Applications from foreign institutions will not be accepted. These grants will support short-term research training experiences of two to three months duration for minority undergraduate students, minority students in health professional schools, and minority graduate students. The grantee institution will be responsible for the selection and appointment of trainees. Special attention should be given to the recruitment of individuals from minority groups that are underrepresented nationally in the biomedical and behavioral sciences, i.e., Blacks, Hispanics, Native Americans, Alaska Natives, and Pacific Islanders. Trainees must have successfully completed at least one undergraduate year at an accredited school or university or have successfully completed one semester at a school of medicine, optometry, osteopathy, dentistry, veterinary medicine, pharmacy or public health, or an institution with an accredited graduate program, prior to participating in the program. Trainees appointed to the program need not be from the grantee institution, but may include a number of minority students from other institutions, schools, colleges, or universities. These grants are intended to introduce students to research that would not otherwise be available through their regular course of studies. For graduate students, this may include graduate students in programs, such as mathematics, where they would not normally be exposed to biomedical research or minority graduate students who may need a specialized research experience to supplement their normal graduate education. Students appointed to this program must be citizens or noncitizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence. Noncitizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary or student visas and individuals holding Ph.D., M.D., D.V.M., or equivalent doctoral degrees in the health sciences are not eligible. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Short-Term Research Training grant (T35). Responsibility for the planning, direction, and execution of the proposed training program 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. Funding beyond the first year of the grant is contingent upon satisfactory progress during the preceding year and the availability of funds. Indirect costs will be awarded based on eight percent of total direct costs exclusive of equipment and tuition and fees. The anticipated award date is May 1, 1996. Institutions may request support for at least four but not more than 24, short-term trainees per year. The requested number of short-term trainees must be justified in the application. Trainees may be minority undergraduate, graduate, or health professional students. The stipend level for trainees is $834 per month. Stipends may be supplemented from non-federal funds. Training-related expenses up to $125 per month per trainee may be requested. In addition, up to $500 per trainee may be requested to cover domestic travel to and from the training site and up to $250 per month per trainee may be requested to cover the cost of housing at the training site. Trainee tuition and fees, where necessary to the research training, must be covered by the Training Related Expenses. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the entire program is expected to be $300,000 in fiscal year 1996. The actual amount may vary, depending on the response to the RFA and availability of funds, but the anticipated number of awards for the Short-Term Training Program for Minority Students is anticipated to be 10 new awards. RESEARCH OBJECTIVES Background Many studies have emphasized the need for minority individuals to participate in modern research activities to develop their investigative talents. Whereas approximately 12 percent of the U.S. population is Black, less than 0.25 percent of individuals holding a Ph.D. degree in biomedical science are Black. There are existing programs at the National Institutes of Health that are designed to answer this need. These include the Minority Biomedical Research Support Program, the Minority Access to Research Careers Program, and the Research Supplements for Underrepresented Minorities Program. Even though these programs appear successful in meeting their specific objectives and career development goals, minority graduate students, health professional students, and postdoctoral students in minority schools need additional opportunities to develop biomedical and behavioral research skills and become productive investigators. While there is strong interest in the scientific community in attracting minority students into research careers, few minority students opt for science degrees and research careers, and few minority graduates of health professional schools go on to investigative careers. The shortage of qualified minority investigators in academic research positions may even exacerbate the situation due to a lack of visible role models for students. One method of addressing this problem is by attracting minority students to research opportunities and by providing them with research training to develop their research capabilities in cardiovascular, pulmonary, and hematologic disease areas. Other The present RFA is designed to offer research training opportunities for minority students in an effort to encourage their participation in cardiovascular, pulmonary, and hematologic research. The Short-Term Research Training for Minority Students program is intended to: o Provide minority undergraduate students, graduate students, and students in health professional schools exposure to opportunities inherent in research careers in areas relevant to cardiovascular, pulmonary, and hematologic diseases. o Attract highly qualified minority students into biomedical and behavioral research careers and increase the supply of minority investigators. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3032, MSC 7762, Bethesda, MD 20892-7762, telephone 301-435-0714. Guidelines and supplemental instructions for the Short-Term Training for Minority Students program may be obtained from NHLBI staff listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 9/91) 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 (NHLBI Short-Term Training for Minority Students Program) and number (HL-95-018) must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier service) One additional copy of the application must also be sent to: Scientific Review Administrator Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0288 Applications must be received by August 23, 1995. 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 to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by 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 the Research Training Review Committee of the Division of Extramural Affairs, NHLBI, in accordance with the review criteria stated below. Following scientific-technical review, applications will receive a second level review by the National Heart, Lung, and Blood Advisory Council. As part of the initial merit review, a process (triage) 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 assigned a priority score. Application determined to be non-competitive will be withdrawn from further consideration and the applicant and the official signing for the applicant organization will be notified. The following criteria will be considered when assessing the merits of a research training grant application, including the Short-Term Training for Minority Students program. o Design of the proposed training program; o Qualifications and previous training record of the program director and participating faculty, particularly with regard to prior experience with similar programs; o Adequacy of facilities, environment, and resources for the proposed research training; o Methods of recruiting, selecting and assigning minority students; o Methods for retaining promising students in the program and methods for tracking students. o Commitment of the institution and participating faculty to the goals of the training program; o Procedures for evaluation of the effectiveness of the program and the impact of the program on the students involved. AWARD CRITERIA The following will be considered in making funding decisions: o Technical merit of the application as determined by peer review o Availability of funds o Program balance among the research areas of the announcement INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding program guidelines, supplemental instructions, or programmatic issues to: Mary Reilly Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: mary_reilly@nih.gov Direct inquiries regarding fiscal matters to: Jane Davis Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0166 FAX: (301) 480-3310 Email: jane_davis@nih.gov AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance numbers 93.837, 93.838, and 93.839. Awards are made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies and Federal Regulations at 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Wed Jun 21 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 18 June 1995 Date: 21 Jun 1995 22:19:11 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 86 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3saugf$n4u@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Letter Title: LEHR9502 Volume 1, No. 2 EPSCoR Newsletter April - June 1995 File size (bytes): STIS Filename: lehr9502.txt Document Type: Press Release Title: ATMOSPHERIC PHYSICS ENTERING THE 21ST CENTURY File size (bytes): STIS Filename: pr9538.txt Document Type: Report Title: OIG-11 Number 11--NSF OIG Semiannual Report to the Congress File size (bytes): STIS Filename: oig11.txt Title: OIG-11 Number 11--NSF OIG Semiannual Report to the Congress File size (bytes): STIS Filename: oig11.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Bulletin Title: BUL 95-06 June/July/August Bulletin Vol. 22; No. 10 File size (bytes): 43636 STIS Filename: bul9506.txt Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 6649 STIS Filename: cmmtg.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve cmmtg.txt, the text of your message should be as follows: get cmmtg.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve cmmtg.txt, you would enter: ftp> get cmmtg.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. 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" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Mon Jun 26 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: UNSUBSCRIBING, BIOSCI ARCHIVES, ADDRESS DATABASE & BIOSCI FAQ Date: 26 Jun 1995 18:38:23 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 347 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3snnef$oa8@net.bio.net> NNTP-Posting-Host: net.bio.net Four important items follow: How to cancel e-mail subscriptions to BIOSCI newsgroups, BIOSCI archive searching, the BIOSCI FAQ, and the BIOSCI User Address Directory form. If you have not yet listed yourself in our BIOSCI user directory, please take a few minutes to complete and return the form below. If your personal information has changed since you listed yourself, please send us a complete new updated form. We can not make manual revisions to existing entries. Sincerely, Dave Kristofferson BIOSCI/bionet Manager biosci-help@net.bio.net **** How to cancel a BIOSCI e-mail subscription **** If you want to cancel your e-mail subscription to this group, PLEASE DO NOT POST YOUR UNSUBSCRIBE REQUEST TO THE NEWSGROUP ADDRESS (NOR REPLY TO A MESSAGE POSTED TO THE NEWSGROUP)!!! This would send your request to all of the readers of the newsgroup, but it might still not be seen by the BIOSCI staff - thus you would annoy many people and possibly not accomplish your goal anyway. IF YOU ARE LOCATED IN THE AMERICAS OR PACIFIC RIM COUNTRIES, please send a message to biosci@net.bio.net Instructions on how to subscribe/unsubscribe will be returned automatically, so the contents of your message do not matter. IF YOU ARE LOCATED IN EUROPE, AFRICA OR CENTRAL ASIA, please send a message to MXT@dl.ac.uk containing the word help in the body of the message to retrieve e-mail server instructions. Any text placed on the Subject: line of your message will be ignored, so be sure to put the "help" command in the body of the message. If you need personal assistance, a BIOSCI staff member can be contacted at either of the following addresses. Please contact the address designated for your location. Support Address Location --------------- -------- biosci@daresbury.ac.uk Europe, Africa, and Central Asia biosci-help@net.bio.net Americas and the Pacific Rim **** SEARCHING BIOSCI ARCHIVES **** The easiest way to search the BIOSCI archives is to use Mosaic or another World Wide Web browser and connect to the BIOSCI WWW home page at URL http://www.bio.net/. Select the hypertext link to the BIOSCI archives. This gives you read access to all newsgroup messages and the ability to search the indexes described below. You can also use gopher software and connect over the Internet to net.bio.net, the U.S. BIOSCI computer. We maintain three indexes which are searchable from the main gopher menu on net.bio.net: (1) an index of all BIOSCI postings; (2) an index of individual journal article references from the Table of Contents postings on the BIO-JOURNALS newsgroup; and (3) an index of BIOSCI users including regular mail and e-mail addresses, phone/FAX numbers, research interests, and newsgroup participation. E-mail users can search the BIOSCI archives by using our waismail e-mail server. For instructions send the message help to waismail@net.bio.net. Leave the Subject: line blank (anything entered on the Subject: line is ignored). WAIS software can also be used to search the archives as described in the BIOSCI FAQ (see below). Finally, the BIOSCI archive files are accessible by anonymous FTP to net.bio.net [134.172.2.69] in the directory pub/BIOSCI. **** BIOSCI FREQUENTLY ASKED QUESTIONS (FAQ) SHEET **** New users of BIOSCI/bionet may want to read the "Frequently Asked Questions" or "FAQ" sheet for BIOSCI. The FAQ provides details on how to participate in these forums and fix problems that you might encounter in using the newsgroups. The FAQ and other BIOSCI documentation is available through our WWW home page at URL http://www.bio.net/. It is also available for anonymous FTP from net.bio.net [134.172.2.69] in pub/BIOSCI/doc/biosci.FAQ or for retrieval by gopher to net.bio.net, port 70. It may also be requested by sending the command info faq in the body of an e-mail message to the Internet address biosci-server@net.bio.net. Please do not enter the info faq command on the Subject: line of your message since the e-mail server ignores text on the Subject: line. The FAQ is also posted on the first of each month to the newsgroup BIONEWS/bionet.announce immediately following the posting of the BIOSCI information sheet. **** BIOSCI USER ADDRESS DIRECTORY **** Please take this opportunity to add your name and address information to the BIOSCI User Address Database if you have not already done so. Below is the address form that we would like each reader of the BIOSCI/bionet newsgroups to complete and return if you would like to be listed in our database. The database serves as a directory that enables biologists, who are currently using (or even just reading) the BIOSCI newsgroups, to look up e-mail addresses and other information about our users. The address database is reindexed nightly for WAIS, waismail, gopher, and WWW access (the URL is http://www.bio.net). If you have access to gopher, connect to net.bio.net to search the database. If you have access to WAIS, please use our WAIS source biologists-addresses.src. If you are not on the Internet, please use our waismail server (send the word "help" to waismail@net.bio.net to get instructions; any text on the Subject: line of your message will be ignored, so put the help command in the body of the mail message.). Please carefully follow the instructions for completing the form below and return it to either of the following two addresses (whichever is more convenient for you). Thanks in advance for taking the time to complete and return the form. Addresses for returning forms Location Network ----------------------------- -------- ------- biovote@net.bio.net U.S.A. Internet/BITNET biovote@daresbury.ac.uk U.K. JANET MAKING SURE THAT YOUR INFORMATION IS CURRENT This notice will be mailed bimonthly to each newsgroup. You should check your database entry from time-to-time to see if your address information is still up-to-date. Using Gopher to complete the form --------------------------------- If you don't want to use a text editor, you can also use Dan Jacobson's gopher site to fill out the address database form as follows. Otherwise skip this section on gopher and proceed to the instructions for filling out the form below. > To add yourself to the database just point your > gopher client at merlot.gdb.org and select the following: > > --> 14. Searching For Biologists/ > > --> 9. E-mail Addresses of Biosci-Bionet Users/ > > --> 1. Add (or Correct) Your Address to the BIOSCI User Address > Data.. > > > And fill out the form. or Rob Harper's gopher site in Europe as follows: > Europeans can point their gopher client at gopher.csc.fi and add their > information to the database. All entries will be mailed directly to > Dave for incorporation in a wais source. > > The path to the questionare is as follows. > > > 6. Information in English/ > > 5. Scientific and other topics/ > > 1. Finnish EMBnet BioBox/ > > 9. FAQ Files/ > > 5. Bionauts Address Database (questionaire) > IMPORTANT INSTRUCTIONS - PLEASE READ CAREFULLY Please enter all responses after the : on each line, leaving one (1) blank space after the : (i.e., before the start of your text). Please do NOT extend your responses past the end of each line (80 characters). PLEASE DO NOT alter any of the field identifiers such as "first name: ". If you have nothing to enter after a field identifier, PLEASE LEAVE IT - do not delete it even if there is no data on the line in question. Several lines are provided at the end of the form for comments, but, please adhere to the line length restriction. On the date: line, please enter the date in the DD-MM-YY format, e.g., 15-05-93 for 15 May 1993. This line will tell others when the information was last updated. Please be sure to include the 0's for single digit days or months, e.g., 15-05-93, not 15-5-93. Note that the "e-mail network: " line below is for specifying, e.g., "Internet," "BITNET," "EARN," "JANET," or whatever other network that your computer may be on. If you are uncertain about any field, please feel free to leave it blank, but please DO NOT DELETE the field identifier from the form! In the first field below, "New information or Update ...", please enter "N" if this is the first time that you have registered in the directory or "U" if you are correcting a listing that you sent to us previously. The comment: lines may be used for anything that you like but PLEASE DO NOT DELETE THEM FROM THE FORM OR ALTER THEM. One suggested use is to list the names of the newsgroups in which you participate. Please use the MAILING LIST name (see below - the latest version of the list can be requested from biosci@net.bio.net) instead of the USENET name even if you don't participate by e-mail. WAIS might get confused by the periods in the USENET names. This allows one to retrieve via WAIS or waismail the list of participants in a particular group. For example: comment: ARABIDOPSIS PLANT-BIOLOGY BIONEWS On the comment: lines use these names below ---- NOT the USENET names below MAILING LIST NAME USENET Newsgroup Name ----------------- --------------------- ACEDB-SOFT bionet.software.acedb AGEING bionet.molbio.ageing AGROFORESTRY bionet.agroforestry ARABIDOPSIS bionet.genome.arabidopsis ASCB bionet.prof-society.ascb BIOCAN bionet.prof-society.cfbs BIOFORUM bionet.general BIO-INFORMATION-THEORY bionet.info-theory BIONAUTS bionet.users.addresses BIONEWS bionet.announce BIO-JOURNALS bionet.journals.contents BIO-MATRIX bionet.molbio.bio-matrix BIOPHYSICAL-SOCIETY bionet.prof-society.biophysics BIOPHYSICS bionet.biophysics BIO-SOFTWARE bionet.software BIOTHERMOKINETICS bionet.metabolic-reg BIO-WWW bionet.software.www CARDIOVASCULAR-RESEARCH bionet.biology.cardiovascular CELEGANS bionet.celegans CELL-BIOLOGY bionet.cellbiol CHLAMYDOMONAS bionet.chlamydomonas CHROMOSOMES bionet.genome.chromosomes COMPUTATIONAL-BIOLOGY bionet.biology.computational CSM bionet.prof-society.csm CYTONET bionet.cellbiol.cytonet DROSOPHILA bionet.drosophila EMBL-DATABANK bionet.molbio.embldatabank EMF-BIO bionet.emf-bio EMPLOYMENT bionet.jobs EMPLOYMENT-WANTED bionet.jobs.wanted FASEB bionet.prof-society.faseb GDB bionet.molbio.gdb GENBANK-BB bionet.molbio.genbank GENETIC-LINKAGE bionet.molbio.gene-linkage GRASSES-SCIENCE bionet.biology.grasses HIV-MOLECULAR-BIOLOGY bionet.molbio.hiv HUMAN-GENOME-PROGRAM bionet.molbio.genome-program IMMUNOLOGY bionet.immunology INFO-GCG bionet.software.gcg JOURNAL-NOTES bionet.journals.note METHODS-AND-REAGENTS bionet.molbio.methds-reagnts MICROBIOLOGY bionet.microbiology MOLECULAR-EVOLUTION bionet.molbio.evolution MOLECULAR-MODELLING bionet.molec-model MOLLUSC-MOLECULAR-NEWS bionet.molbio.molluscs MYCOLOGY bionet.mycology NEUROSCIENCE bionet.neuroscience N2-FIXATION bionet.biology.n2-fixation PARASITOLOGY bionet.parasitology PHOTOSYNTHESIS bionet.photosynthesis PLANT-BIOLOGY bionet.plants POPULATION-BIOLOGY bionet.population-bio PROTEIN-ANALYSIS bionet.molbio.proteins PROTEIN-CRYSTALLOGRAPHY bionet.xtallography PROTISTA bionet.protista RAPD bionet.molbio.rapd SCIENCE-RESOURCES bionet.sci-resources STADEN bionet.software.staden STRUCTURAL-NMR bionet.structural-nmr TROPICAL-BIOLOGY bionet.biology.tropical URODELES bionet.organisms.urodeles VIROLOGY bionet.virology WOMEN-IN-BIOLOGY bionet.women-in-bio YEAST bionet.molbio.yeast ZBRAFISH bionet.organisms.zebrafish Listing newsgroups on the comment: line is optional, of course. Thanks again for your cooperation! --------------- please cut here and return portion below --------------- New information or Update to old record (enter N or U): date (DD-MM-YY): first name: middle initial: family name: job title: e-mail address: e-mail network: phone number: FAX number: institution: address1: address2: address3: city: state/province: country: postal code: research interest: research interest: comment: comment: comment: comment: comment: