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