From owner-sci-resources@net.bio.net Wed May 01 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 14, pt. 1of1, 3 May 1996 Date: 2 May 1996 06:45:10 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1052 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4mae96$fs6@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19960503 V25N14 P1O1 ************************************ X-comment: RFAS described: CA-96-013, HD-96-004, AI-96-003, AR-96-003, PAR-96 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.05.03 NIH GUIDE - Vol. 25, No. 14 - May 3, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** SYMPOSIUM ON THE PAST, PRESENT AND FUTURE OF PEER REVIEW National Institutes of Health Division of Research Grants INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** ACCEPTANCE FOR REVIEW OF UNSOLICITED APPLICATIONS THAT REQUEST MORE THAN $500,000 DIRECT COSTS FOR ANY ONE YEAR --- POLICY UPDATE National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** COLLECTION AND TAXONOMY OF SHALLOW WATER MARINE ORGANISMS (RFP NCI-CM-77249-30) National Cancer Institute INDEX: CANCER $$INDEX R2 08/08/96 ************************************************* TRANSLATIONAL INVESTIGATOR GRANTS FOR CANCER PREVENTION AND CONTROL (RFA CA-96-013) National Cancer Institute INDEX: CANCER $$INDEX R3 10/08/96 ************************************************* NEUROBIOLOGY AND GENETICS OF AUTISM (RFA HD-96-004) National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders INDEX: CHILD HEALTH, HUMAN DEVELOPMENT; DEAFNESS, OTHER COMMUNICATION DISORDERS $$INDEX R4 10/08/96 ************************************************* TRANSPLANTATION TOLERANCE (RFA AI-96-003) National Institute of Allergy and Infectious Diseases Juvenile Diabetes Foundation International INDEX: ALLERGY, INFECTIOUS DISEASES; JUVENILE DIABETES FOUNDATION INTERNATIONAL $$INDEX R5 06/12/97 ************************************************* SPECIALIZED CENTERS OF RESEARCH IN OSTEOARTHRITIS AND SYSTEMIC LUPUS ERYTHEMATOSUS (RFA AR-96-003) National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES $$INDEX P1 ********************************************************** MENTAL HEALTH EDUCATION GRANTS (PAR-96-047) National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX P2 ********************************************************** EXPANDED RESEARCH ON EMERGING DISEASES (PA-96-048) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX P3 ********************************************************** BIOIRON RESEARCH: ROLE OF MRNA AND PROTEIN STRUCTURE IN IRON NUTRITION AND METABOLISM (PA-96-049) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX P4 ********************************************************** GENETICS OF PARKINSON'S DISEASE (PA-96-050) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** SYMPOSIUM ON THE PAST, PRESENT AND FUTURE OF PEER REVIEW NIH GUIDE, Volume 25, Number 14, May 3, 1996 P.T. 42; K.W. 1014006, 1014004 National Institutes of Health Division of Research Grants 1996 marks the 50th anniversary of the founding of the Division of Research Grants. The National Institutes of Health and the Division of Research Grants are marking this occasion with a symposium on the Past, Present, and Future of Peer Review. This symposium will be held Thursday, June 20 at the Natcher Conference Center on the Bethesda campus of NIH. The symposium will start at 8:00 a.m. and conclude with a reception at the Natcher Center in the late afternoon. This is an opportunity for colleagues, friends, and others to discuss fifty years of excellence in peer review and its impact on biomedical research. There is no fee for the symposium, but advance registration is required. The registration deadline is May 31, 1996. The Natcher facility is fully accessible in compliance with the Americans with Disabilities Act. INQUIRIES Information is available on the DRG home page - http://www.drg.nih.gov or can be requested from: Administrative Office Division of Research Grants 6701 Rockledge Drive MSC 7760 Bethesda, MD 20892-7760 Telephone: (301) 435-1099 FAX: (301) 480-3963 Questions about the symposium may be addressed to: Suzanne E. Fisher, Ph.D. Division of Research Grants National Institutes of Health Rockledge Building, Room 2030 - MSC 7720 Bethesda, MD 20892-7720 Telephone: (301) 435-0715 FAX: (301) 480-1987 Email: fys@drgpo.drg.nih.gov $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** ACCEPTANCE FOR REVIEW OF UNSOLICITED APPLICATIONS THAT REQUEST MORE THAN $500,000 DIRECT COSTS FOR ANY ONE YEAR --- POLICY UPDATE NIH GUIDE, Volume 25, Number 14, May 3, 1996 P.T. 34; K.W. 1014006 National Institutes of Health Effective Date: June 1, 1996 The NIH is updating the policy about the acceptance of applications requesting direct costs of $500,000 or more for any one year. BACKGROUND Unanticipated requests for unusually high amounts of direct costs, despite the merit of the application and the justification of the budget, are difficult to manage by NIH staff. It is in the best interest of all parties for anyone planning an application that requests unusually high direct costs to contact the appropriate NIH program staff as early as possible to ensure that an IC would be willing and able to accept the application. The NIH will continue to support research projects with large budgets, but needs to consider the possibility of such awards as early as possible in the budget and program planning process. This notice clarifies and revises the policy published in the NIH Guide, Vol. 22, No. 45, December 17, 1993. NEW POLICY. An applicant planning to submit a new (Type 1) investigator - initiated grant application requesting $500,000 or more in direct costs for any year (see Applicability below) is advised that he or she must contact Institute or Center program staff before submitting the application, i.e, as plans for the study are being developed. Furthermore, the applicant must obtain agreement >From Institute/Center staff that the Institute or Center will accept the application for consideration for award. Finally, the applicant must identify, in the cover letter that is sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. Any application subject to this policy that does not contain the required information in the cover letter sent with the application will be returned to the applicant without review. Applicants who are uncertain regarding which Institute or Center to contact should call the Referral Office, Division of Research Grants (see INQUIRIES). APPLICABILITY. This policy applies to any unsolicited new (Type 1)research or research training grant application for any mechanism (e.g., R01, P01, R18, T32) that requests $500,000 or more in direct costs for any one year. This policy applies also to any group of unsolicited applications (e.g., clinical trial networks, epidemiologic studies) that requests $500,000 or more direct costs for any one year, even if none of the individual applications request that much. This policy does not apply to applications submitted in response to RFAs. However, an application submitted in response to an RFA must be responsive to any budgetary limits specified in the RFA or will be returned to the applicant without review. This policy does not apply to competing renewal (Type 2) applications. However, a Type 2 application must still comply to the budgetary limitations set by the awarding Institute or Center. This policy does not apply to amended (revised, e.g., -01A1, -01A2) applications. PROCEDURES. An applicant planning to submit a grant application to which this policy applies is required to contact, in writing or by telephone, Institute or Center program staff when the application development process begins. If the Institute or Center is willing to accept assignment of the application for consideration of funding, the staff will notify the Division of Research Grants before the application is submitted. The applicant Principal Investigator must identify, in the cover letter sent with the application, the program staff member and Institute or Center who have agreed to accept assignment of the application. An application received without indication of prior staff concurrence and identification of that contact will be returned to the applicant without review. EFFECTIVE DATE. This policy becomes effective on June 1, 1996. Applicants are encouraged, however, to contact Institute or Center staff at any time about the preparation of applications to which this policy will apply. INQUIRIES For additional information about the policy, the program staff at any IC may be contacted. Applicants who are uncertain about which IC may have the greatest interest in the research for which support may be sought, should contact: Referral Office Division of Research Grants National Institutes of Health Telephone: (301) 435-0715 FAX: (301) 480-1987 $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 25, Number 14, May 3, 1996 P.T. 42; K.W. 0783005 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human subjects. The meetings should be of special interest to those persons currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all other Public Health Service agencies. The current schedule includes the following: DATES: June 3-5, 1996 TITLE: Basic Training for IRB Members - June 3, 1996; Cultural Diversity and Other Human Research Issues with Emphasis on Native Americans -June 4-5, 1996 LOCATION: Marriott Hotel; Oklahoma City, OK SPONSORS: University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City, OK; Cherokee Nation of Oklahoma, Tahlequal, OK; Langston University, Langston, OK; Indian Health Affairs, Office of Health Program Research and Development, Albuquerque, NM REGISTRATION: Kay Holladay, M.P.H. Conference Coordinator, Dean's Office University of Oklahoma Health Sciences Center College of Public Health P.O. Box 26901 Oklahoma City, OK 73190 Telephone: (405) 271-2342 FAX: (405) 271-3039 REGISTRATION FEE: $150 ($165 on-site registration) DESCRIPTION: This conference will provide a forum for participants to explore issues in human subjects protection in the conduct of research, including regulations and assurances, research protocols, uses of special populations, ethical/legal issues in human subjects research, and conflict of interest. Participants will learn the function, responsibilities, and process of an Institutional Review Board (IRB); how Federal regulations and community participation can protect human subjects in research; how to maximize the benefits and minimize the risks from research for individuals and communities; and how to protect individual rights as well as the rights of communities, especially those of cultural diversity. Basic training concerning IRB procedures and protocol review will take place on the afternoon of the first day and conclude on the second day at noon. At 1:00 p.m., on the second day, the conference will re-convene. Individual presentations, panels, and workshop sessions will provide maximum opportunity for participants to gain information and engage in discussions on a wide range of issues concerning human subjects research. Experts from research, regulatory, pharmaceutical, medical, legislative, and ethical backgrounds have been assembled to share their knowledge of the relevant issues. This conference should be of interest to researchers in clinical medicine and the behavioral and social sciences, IRB members and coordinators, tribal leaders and other Native Americans, university and hospital administrators, agency personnel, lawyers, ethicists, health care practitioners, health care insurers, graduate students, and others interested in human subject protection issues. INQUIRIES For further information regarding these workshops or future NIH/FDA National Human Subject Protections Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, Suite 3B01 Rockville, MD 20892-7507 Telephone: (301) 496-8101 x233 FAX: (301) 402-0527 Email: RossD@od6100m1.od.nih.gov $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NCI-CM-77249-30 ****************************************** COLLECTION AND TAXONOMY OF SHALLOW WATER MARINE ORGANISMS NIH GUIDE, Volume 25, Number 14, May 3, 1996 RFP AVAILABLE: NCI-CM-77249-30 P.T. 34; K.W. 0780005 National Cancer Institute The National Cancer Institute (NCI), Division of Cancer Treatment, Diagnosis and Centers (DCTDC), Developmental Therapeutics Program (DTP) anticipates the award of one cost-reimbursement contract, for a base period of three years, with two one-year option years, beginning on or about February 1, 1997. The objective of this project is to continue the exploration of marine organisms from the geographic areas of the globe in which biodiversity is thought to be the greatest; and to use these organisms as a source of pharmacophores that can be developed for the selective treatment of cancer and AIDS in humans. The successful offeror will be expected to provide qualified personnel, materials, and equipment for the collection, identification, storage and shipping of 700 frozen marine samples per year to an NCI designated extraction facility in the United States. Collections will comprise approximately 1000 grams frozen, wet weight of each sample, collected by SCUBA divers at depths to 50 to 55 meters using suitable safeguards. Each sample will be identified as far as possible at the time of collection, and will subsequently be identified to species level. Properly prepared voucher specimens will be prepared at the time of collection for the purposes of later unambiguous identification, and for deposition at a minimum of two repositories identified by the NCI, together with complete documentation. The collection team should include qualified taxonomists, personnel experienced in scientific diving and collection by SCUBA techniques (to at least 40 meters, but to 50-55 meters if experienced personnel are available). The Principal Investigator should be trained in marine biology or a related field and at least five years experience in marine organism collection and identification. It is anticipated that recollection of up to 50 marine samples per year in quantities to 50 kg may be required in the second and subsequent years. The number of smaller scale collections would be reduced in a suitable proportion. Collections will include examples from as wide a variety of phyla and families as possible. The collection will be heavily weighted towards invertebrates with allowance for a small percentage of marine plants, and with specific exclusion of vertebrates. A list of genera and species previously screened by NCI will be provided with the RFP, in order to aid in the determination of priorities by the successful contractor. The contractor will be responsible for obtaining all necessary permits, (including visas, shipping and export permits) from foreign governments and agencies, for deliver of samples and voucher specimens to the United States. All collections will be conducted under the conditions of the NCI's Letter of Collection, which is provided with the RFP. Where necessary, the Government will provide letters of support. This is a recompetition of a contract with Coral Reef Research Foundation. INQUIRIES The Request for Proposal (RFP) will be available on or about May 22, 1996. A copy of the RFP can be obtained by written request to: Elsa B. Carlton Research Contract Branch National Cancer Institute Executive Plaza South, Room 603 6120 Executive Boulevard - MSC 7220 Bethesda, MD 20892-7220 $$R1 END ************************************************************ $$R2 BEGIN CA-96-013 FULL-TEXT ************************************** TRANSLATIONAL INVESTIGATOR GRANTS FOR CANCER PREVENTION AND CONTROL NIH GUIDE, Volume 25, Number 14, May 3, 1996 RFA AVAILABLE: CA-96-013 P.T. 34; K.W. 0715035, 0745027, 0795003 National Cancer Institute Letter of Intent Receipt Date: June 11, 1996 Application Receipt Date: August 8, 1996 PURPOSE The Division of Cancer Prevention and Control (DCPC) of the National Cancer Institute (NCI), invites research project grant (R01) applications from new prevention and control investigators for the conduct of studies translating phase I (hypothesis development) and II (methods development) basic, epidemiological, and clinical research into new approaches for the prevention and control of cancer. Approximately $1.5 million, per year, in total costs for four years will be committed to fund new applications that are submitted in response to this Request for Applications (RFA). It is anticipated that eight new individual awards 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, Translational Investigator Grants for Cancer Prevention and Control, is related to the priority area of cancer. Potential applicants may obtain a copy of "Health People 2000" (Full Report: Stock No. 017-001-00474-01 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Helen Meissner, Sc.M. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 232D Rockville, MD 20852 Telephone: (301) 496-8520 Email: meissneh@dcpceps.nci.nih.gov $$R2 END ************************************************************ $$R3 BEGIN HD-96-004 FULL-TEXT ************************************** NEUROBIOLOGY AND GENETICS OF AUTISM NIH GUIDE, Volume 25, Number 14, May 3, 1996 RFA AVAILABLE: HD-96-004 P.T. 34; K.W. 1002030, 1002019, 0715162 National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders Letter of Intent Receipt Date: July 1, 1996 Application Receipt Date: September 20, 1996 PURPOSE The National Institute of Child Health and Human Development (NICHD) and the National Institute on Deafness and Other Communication Disorders (NIDCD) invite program project (P01) grant applications for research that will elucidate the biological (neurobiologic and genetic) basis of autism and contribute to the discovery of a biological and/or diagnostic marker(s) for autism. The purpose of this RFA is to provide support for collaborative, multidisciplinary, methodologically rigorous programs of research that will use advanced techniques in the biological and behavioral sciences to study the diagnosis, biological etiology (including genetics), pathophysiology, and developmental course of autism. It is anticipated that up to three program projects will be supported by NICHD and NIDCD in response to this Request for Application (RFA). The following amounts have been set aside for the first year of support under this RFA: NICHD, $1,875,000 (total costs) and NIDCD, $400,000 (total costs). It is anticipated that up to three awards 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, Neurobiology and Genetics of Autism, is related to the priority areas of developmental and learning problems in children and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402/2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and e-mail from the program contacts listed below. Marie M. Bristol, Ph.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development Executive Building, Room 4B09 - MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1383 FAX: (301) 496-3791 Email: BRISTOLM@HD01.NICHD.NIH.GOV Judith Cooper, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400C-11 - MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 496-5061 FAX: (301) 402-6251 Email: JUDITH_COOPER2NIH.GOV $$R3 END ************************************************************ $$R4 BEGIN AI-96-003 FULL-TEXT ************************************** TRANSPLANTATION TOLERANCE NIH GUIDE, Volume 25, Number 14, May 3, 1996 RFA AVAILABLE: AI-96-003 P.T. 34; K.W. 0745065, 0710070 National Institute of Allergy and Infectious Diseases Juvenile Diabetes Foundation International Letter of Intent Receipt Date: August 10, 1996 Application Receipt Date: October 8, 1996 APPLICATIONS IN RESPONSE TO THIS REQUEST FOR APPLICATIONS (RFA) MUST BE PREPARED USING A MODIFIED (ABBREVIATED) GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS FOR COMPLETING THE APPLICATION ARE IN THE NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR ABBREVIATED APPLICATIONS FOR MULTI-PROJECT AWARDS"; AVAILABLE FROM THE PROGRAM STAFF LISTED UNDER INQUIRIES. PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) and the Juvenile Diabetes Foundation, International (JDFI) invite program project (P01) grant applications for basic, pre-clinical and clinical studies to determine the mechanisms of immunologic tolerance that will enhance solid organ and tissue graft survival. This Request for Applications (RFA) is intended to stimulate collaboration between clinicians and basic immunologists to identify and characterize the immune mechanisms responsible for enhancing graft survival by inducing tolerance to the donor organ or tissue. The investigation of tolerance induction for the prevention or treatment of autoimmune disease could advance understanding of tolerance induction in the transplant setting. Thus, applications incorporating investigations of tolerance induction for autoimmune disease in the transplant setting are encouraged. Applications are to be submitted to and will be reviewed according to usual NIH peer review procedures. Funds for each Program Project to be awarded under this RFA will be provided by the NIAID and the JDFI. To have an application reviewed and considered for funding, applicants must authorize the NIAID, in writing, to provide to the JDFI a copy of their letter of intent, application, and NIH prepared summary statement of the initial review. The estimated total funds (direct and indirect costs) available for the first year of support for this RFA will be $3.0 million: $2.0 million from NIAID and $1.0 million from JDFI. In fiscal year 1997, the NIAID and the JDFI anticipate jointly funding approximately four to five program projects related to this RFA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Transplantation Tolerance, is related to the priority area of diabetes and chronic disabling 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 20402-0325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) or the NIH HOME PAGE on the World Wide WEB (http://www.nih.gov) and by mail and e-mail from the program contact listed below. Written and telephone inquiries concerning this RFA, including requests for the NIAID brochure "INSTRUCTIONS FOR ABBREVIATED APPLICATIONS FOR MULTI- PROJECT AWARDS" and the opportunity to clarify any issues or questions from potential applicants are welcome. Stephen M. Rose, Ph.D. Division of Allergy, Immunology, and Transplantation National Institute of Allergy and Infectious Disease Solar Building, Room 4A14 Bethesda, MD 20892-7640 Telephone: (301) 496-5598 FAX: (301) 402-2571 Email: sr8j@nih.gov $$R4 END ************************************************************ $$R5 BEGIN AR-96-003 FULL-TEXT ************************************** SPECIALIZED CENTERS OF RESEARCH IN OSTEOARTHRITIS AND SYSTEMIC LUPUS ERYTHEMATOSUS NIH GUIDE, Volume 25, Number 14, May 3, 1996 RFA AVAILABLE: AR-96-003 P.T. 04; K.W. 0715010, 0715015 National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: March 1, 1997 Application Receipt Date: June 12, 1997 PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invites applications for Specialized Centers of Research (SCORs) (P50) in the following disease areas: osteoarthritis and systemic lupus erythematosus. A SCOR should foster a coordinated research effort that strongly emphasizes basic disciplines, but also involves significant interaction between basic research and clinical investigations. A SCOR is envisioned as a national resource associated with one or more major medical complexes and dedicated to working with the NIAMS in furthering the research effort to translate basic research to clinical application. The NIAMS intends to fund up to nine SCORs in FY 1997 and 1998 in the scientific areas covered by this RFA and RFA AR-96-002. Funding is subject to the availability of resources and receipt of sufficiently meritorious applications. Nine competing continuation applications are anticipated in response to these RFAs. The anticipated awards are for four years and are subject to the availability of appropriated funds. The estimated funds (total costs) available for the first year of support of these centers are $10 million per year. The direct costs requested cannot exceed $750,000 (excluding indirect costs of subcontracts) each year. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Specialized Center of Research (SCOR), is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nigh.gov), and the NIH Website (http:/www.nih.gov), and by mail and email from the program contact listed below. Dr. Julia B. Freeman Centers Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS.19F - MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-5052 FAX: (301) 480-4543 Email: freemanj@ep.niams.nih.gov Copies of the guidelines for the SCOR program may be obtained from: NIAMS Clearinghouse 1 AMS Circle Bethesda, MD 20892-3675 Telephone: (301) 495-4484 FAX: (301) 587-4352 $$R5 END ************************************************************ $$P1 BEGIN PAR-96-047 FULL-TEXT ************************************* MENTAL HEALTH EDUCATION GRANTS NIH GUIDE, Volume 25, Number 14, May 3, 1996 PA AVAILABLE: PAR-96-047 P.T. 34; K.W. 0715095, 0720005 National Institute of Mental Health Letter of Intent Receipt Date: August 1 Application Receipt Date: October 1 PURPOSE The National Institute of Mental Health (NIMH) announces the availability of the Mental Health Education Grant Program (R25) to provide a flexible mechanism for developing innovative educational programs to encourage individuals to pursue mental health research or to enhance research and career skills in critical areas of need. To meet its programmatic needs, the NIMH will accept grant applications in response to this program announcement that propose one or more of the following educational objectives: o Providing experiences to motivate high school, college, graduate, postgraduate students, and scientists to pursue careers in mental health research o Teaching research and other related skills that can aid in enhancing the participants' research and career success, and aid the advancement of mental health research o Developing and evaluating new curricula or approaches to advance either of the above goals HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Mental Health Education Grants, is related to the priority area of mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Henry Khachaturian, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health 5600 Fishers Lane, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-8033 FAX: (301) 443-1731 Email: hkhach@helix.nih.gov $$P1 END ************************************************************ $$P2 BEGIN PA-96-048 FULL-TEXT ************************************** EXPANDED RESEARCH ON EMERGING DISEASES NIH GUIDE, Volume 25, Number 14, May 3, 1996 PA AVAILABLE: PA-96-048 P.T. 34; K.W. 0715125, 1002027 National Institute of Allergy and Infectious Diseases PURPOSE The Division of Microbiology and Infectious Diseases of the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for research on emerging and re-emerging human pathogens. The purpose of this PA is to encourage basic and applied research projects yielding new data that will enhance prediction, prevention, treatment, and control of emerging and re-emerging infectious diseases threatening the U.S. Projects dealing with those bacterial, viral, fungal and parasitic pathogens of humans which have been newly recognized, or whose prevalence has markedly increased, within the last two decades are of interest. These include, but are not limited to, Hantaan and Sin nombre viruses, hepatitis C and E, dengue virus, Group A Streptococcus, Pneumococcus, Bartonella, Vibrio cholerae, Plasmodium, Cryptosporidium, the microsporida, Coccidioides and Aspergillus. Applications dealing with additional new infectious disease problems that may emerge during the course of this PA are also encouraged. Relevant projects will address one or more of the following objectives: (1) basic and applied research on changes and adaptations of the organism which might influence emergence or re-emergence; (2) basic and applied research on ecologic and environmental factors influencing disease emergence and distribution; and (3) research aimed at improved detection of emerging diseases. Field-oriented studies, to complement laboratory based research, are particularly encouraged. Since other NIAID initiatives have recently been available to support research on other high priority areas such as HIV, opportunistic infections in AIDS patients, Lyme disease, and tuberculosis, projects on these topics will not be considered responsive to this PA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Expanded Research on Emerging Diseases, is related to the priority area of immunization-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 20402-0325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Stephanie L. James, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A-10 - MSC 7630 Bethesda, MD 20892-7630 Telephone: (301) 496-2544 FAX: (301) 402-0659 Email: sj13y@nih.gov $$P2 END ************************************************************ $$P3 BEGIN PA-96-049 FULL-TEXT ************************************** BIOIRON RESEARCH: ROLE OF MRNA AND PROTEIN STRUCTURE IN IRON NUTRITION AND METABOLISM NIH GUIDE, Volume 25, Number 14, May 3, 1996 PA AVAILABLE: PA-96-049 P.T. 34; K.W. 0765030, 0710095, 0790010, 0760070 National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The purpose of this program announcement is to stimulate research on iron absorption and metabolism. Iron is central to the health of humans, the production of animals and plants for human food. Iron deficiency affects 30 percent of the world's population. The negative impact of iron deficiency on learning adds a new dimension to the importance of adequate management of iron metabolism. In addition to nutritional iron deficiency, pathological conditions associated with altered iron metabolism include iron overload, anemia of chronic disease and inflammation, and renal failure requiring hemodialysis. The objectives of the initiative address three of the current trends in bioiron research: (l) mRNA structure/function and regulation; (2) High resolution analysis of protein structure/function; and (3) Novel approaches to iron nutrition and metabolism. Markers of current interest include ferritin mRNA and protein (iron concentration/storage), mRNA and protein for iron uptake (transferrin receptor) and the protein for iron transport (transferrin), as well as other iron-binding entities including mucins, integrins, and mobilferrin. This PA will use the National Institutes of Health (NIH) individual research project grant (R01) and First Independent Research Support and Transition (FIRST) (R29) award mechanisms. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No.017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), the NIH Website (http://www.nih.gov), the NIDDK Website (http://www.niddk.nih.gov), and by mail or email from the program official listed below. David G. Badman, Ph.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-13C MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: David_Badman@nih.gov $$P3 END ************************************************************ $$P4 BEGIN PA-96-050 FULL-TEXT ************************************** GENETICS OF PARKINSON'S DISEASE NIH GUIDE, Volume 25, Number 14, May 3, 1996 PA AVAILABLE: PA-96-050 P.T. 34; K.2. 1002019, 0715140 National Institute of Neurological Disorders and Stroke PURPOSE The National Institute of Neurological Disorders and Stroke invites investigators-initiated research grant applications for the support of a board range of studies on possible genetic factors in the causation of Parkinson's disease. Through linkage and allele sharing analysis of special populations of Parkinson's disease families, it may be possible to identify the gene or genes that increase the risk for the disorder. Findings that would be of considerable importance in this search would be the location of a genetic marker, determination of the probability of penetrance, determination of possible genetic heterogeneity, and evidence of multifactorial inheritance with environmental interaction. Finding genetic factors determining susceptibility to Parkinson's disease will enhance epidemiological studies and possibly lead to identification of susceptible groups and of significant risk factors. Applications may be submitted by domestic and foreign, for-profit and non-profit, public and private organizations, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the federal government. Applications will compete for all available extramural grant funds on the basis of scientific merit as judged by peer review. 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 initiated national activity for setting priority areas. This Program Announcement, Genetics of Parkinson's Disease, is related to the priority area of chronic debilitating diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone (202) 512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Eugene J. Oliver, Ph.D. Division of Demyelinating, Atrophic, and Dementing Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 806 Bethesda, MD 20892-9150 Telephone: (301) 496-1431 FAX: (301) 402-2060 Email: eo11c@nih.gov $$P4 END ************************************************************ From owner-sci-resources@net.bio.net Wed May 01 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-96-013 - V25(14) 05/03/96 Date: 2 May 1996 06:45:36 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 462 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4maea0$g0l@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA96013 CA-96-013 P1O1 *************************************** TRANSLATIONAL INVESTIGATOR GRANTS FOR CANCER PREVENTION AND CONTROL NIH GUIDE, Volume 25, Number 14, May 3, 1996 RFA: CA-96-013 P.T. 34; K.W. 0715035, 0745027, 0795003 National Cancer Institute Letter of Intent Receipt Date: June 11, 1996 Application Receipt Date: August 8, 1996 PURPOSE The Division of Cancer Prevention and Control (DCPC) of the National Cancer Institute (NCI), invites research project grant (R01) applications from new prevention and control investigators for the conduct of studies translating phase I (hypothesis development) and II (methods development) basic, epidemiological, and clinical research into new approaches for the prevention and control of cancer. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Translational Investigator Grants for Cancer Prevention and Control, is related to the priority area of cancer. Potential applicants may obtain a copy of "Health People 2000" (Full Report: Stock No. 017-001-00474-01 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, non-profit and for-profit organizations, public amd private entities such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Foreign institutions are ineligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. The principal investigator (PI) must have a doctoral degree and be working independently, but at the beginning stages of his or her research career in the areas of translational prevention and control research. An important principle to remember is that the more extensive the prior independent research experience, regardless of funding source, the greater likelihood there will be diminished priority for award. Applicants also must identify a senior collaborator from whom they will receive guidance regarding the proposed research. Senior collaborators are encouraged to provide sufficient input into the research proposed prior to grant submission. The investigator's senior collaborator will be required to outline specific plans for providing guidance to the candidate with respect to development and execution of the research plan. The collaborator should be an experienced investigator in cancer prevention and control who is willing to devote time and effort to ensure that acceptable standards for the research are met. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research project grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this RFA may not exceed four years. The total direct cost for the four year period may not exceed $500,000. The direct cost in any budget period may not exceed $150,000. The anticipated award date is April 1997. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is contingent upon the continuing availability of funds for this purpose. This RFA is a one-time solicitation for FY 97. Future unsolicited competing applications will compete with all investigator-initiated applications and be reviewed according to customary peer review procedures unless additional re-issuances are required. FUNDS AVAILABLE Approximately $1.5 million, per year, in total costs for four years will be committed to fund applications that are submitted in response to this RFA. It is anticipated that eight new individual awards will be made. RESEARCH OBJECTIVES Background and Rationale The DCPC supports research with an emphasis on studies to identify, evaluate, and implement techniques and approaches for the primary, secondary, and tertiary prevention of cancer. Those studies may focus on specific cancers, such as breast or prostate, or more general areas of prevention research such as studies to change current behaviors and/or develop new behaviors effective in reducing incidence, morbidity or mortality from cancer (e.g., smoking, diet, early detection), or studies to improve application of patient management, pain, or symptom management and rehabilitation principles. There is, however, ongoing concern over the declining number of investigators entering and remaining in academic research related to cancer prevention and control. These investigators are a critical component in translating phase I and phase II prevention and control research from epidemiological studies, the laboratory, and the clinic to broader venues such as physician practices, HMOs, and communities. These investigators must maintain a broad perspective and knowledge concerning epidemiology and clinical and basic sciences, while developing new delivery and intervention approaches that are hypothesis driven. They are highly interactive with basic, clinical, and epidemiological researchers in related disciplines. This translational investigator is considered distinct from the investigator who has a Ph.D. or equivalent training and concentrates on basic or epidemiological research, or the M.D. clinician who participates in cancer research by entering patients on clinical trials. Investigators who do not have the publication or research track record in cancer prevention and control translational research are usually not competitive for R01 grant support. Thus, very few prevention and control research applications are submitted by these investigators. DCPC would like to reverse this trend and encourage new prevention and control investigators in the conduct of translational research. Objectives The objective of this initiative is to support new cancer prevention and control investigators in the conduct of interventions and trials which translate phase I and II research into new means of preventing particular cancers or improving survival from cancers. Investigators are urged especially to address the more difficult prevention and control challenges, including the most common malignancies in adults (e.g., breast, lung, colon, prostate) and risk factors (e.g., tobacco use, diet and nutrition, early detection, environmental exposures). Investigators must clearly demonstrate that the research is translational. The term RtranslationalS used here refers to the science of implementing or applying the results of basic, clinical or epidemiological research into prevention and control clinical and public health practice. Project Description DCPC encourages qualified prevention and control investigators to develop R01 grant applications for the conduct of intervention studies translating phase I and II epidemiological, basic, and clinical research into new approaches for the prevention and control of cancer. Examples of translational research include controlled interventions to increase and improve smoking cessation counseling by physicians, or maximize utilization of breast, cervical and colorectal screening; trials addressing behavioral and psychosocial consequences of genetic screening for cancer; studies to determine the relative effectiveness of behavioral interventions to reduce side effects of cancer treatments, such as anxiety or nausea; controlled feeding studies to improve understanding of the bioavailability of vitamins and minerals administered in different forms (e.g., tablets, fruits). Grant applications must include trials and interventions involving human subjects and be designed to ultimately reduce the incidence of particular cancers or improve cancer survival. The trials and interventions must have a strong rationale and be based upon phase I and II research which support the underlying hypotheses. New intervention trials employing such channels as appropriate dietary regimens, pharmacologic agents, or behavioral or psychosocial change mechanisms, whether used as a single agent/modality or in combination, are appropriate. The research plan should be focused on the trial or intervention proposed. It is expected that at least 30 percent effort will be committed to the research project by the Principal Investigator. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508- 14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by June 11, 1996, 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 allows NCI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Helen Meissner, Sc.M. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 232D MSC 7330 6130 Executive Boulevard Bethesda, MD 20892-7330 Rockville, MD 20852 (for exprexx/courier service) Telephone: (301) 496-8520 FAX: (301) 496-8675 Email: meissneh@dcpceps.nci.nih.gov APPLICATION PROCEDURES A. Method of Applying Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). These forms are available at most institutional offices of sponsored research; from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive MSC 7910, Bethesda, MD 20892-7910 telephone 301/435-0714, email: asknih@odrockm1.od.nih.gov; and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed in Section 2 of the face page of the application form and the YES box must be marked. All requirements with regard to type, size, page limitations, appendix material, etc. must be followed or applications will be returned without review. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier services) At the time of submission, two additional copies of the application must also be sent to: Mrs. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Applications must be received by August 8, 1996. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. B. Application Requirements The application must include the following documentation to be considered for review: o A letter of support from the PI's senior collaborator outlining specific plans for providing guidance to the candidate with respect to development and execution of the research plan. A description of intended commitment of the institution to the project for the four year period also should be included. o A draft of any protocols involved must be included in the Appendix. Documentation of the status of Human Subjects and IRB approval should also be included. o Documentation for the composition of the proposed study population in terms of gender and racial/ethnic group, together with a rationale for its choice, must be included in the Human Subjects section. o Applications responding to this RFA should include one round trip, 2 day meeting to Bethesda in each year's budget. C. Pre-application Conference The National Cancer Institute intends to sponsor a pre-application conference for anyone interested in responding to this RFA, Translational Investigator Grants for Cancer Prevention and Control. Issues to be addressed during the conference will include application and review procedures, program goals and objectives, and award criteria. Time will be allotted for questions and answers. Participation in the conference is optional and is not a requirement of this RFA. The pre-application conference will be held Wednesday, May 29, 1996 >From 9:00 a.m to 4:00 p.m., at the Natcher Conference Center located on the National Institutes of Health (NIH) campus in Bethesda, Maryland (9000 Rockville Pike, Building 45, LL Room D). Parking is very limited and all visitors must park in areas marked for visitors only. As these spaces go very quickly, we urge anyone planning to drive to the conference to arrive by 8:00 a.m. A Metro stop, Medical Center, is conveniently located on the NIH campus and is about a 7 to 10 minute walk from the Natcher Conference Center. All travel costs and arrangements are the responsibility of the investigator. Contact Veronica Chollett at (301) 435-2837, if you are planning to attend the pre-application conference. Conference material and information will be made available to anyone interested, including those who cannot attend. If you cannot attend, but would like to receive copies of information & transcripts from the conference, contact Ms. Chollett. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the National Cancer Institute. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. As part of the initial review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score and receive a second level of review by the National Cancer Advisory Board. Review Criteria include, but are not limited to: o scientific and technical significance and originality of proposed research; o extent to which proposed research clearly translates basic, epidemiological and clinical research into cancer prevention and control applications; o evidence of familiarity with and understanding of relevant research literature as it relates to cancer prevention and control; o appropriateness and adequacy of the experimental design and methodology, including appropriateness of control and comparison groups, reliability and validity of instruments to assess key variables, methods to identify and minimize biases and threats to validity, and specification of statistical power and sample sizes; o qualifications and relevant research experience of the Principal Investigator and collaborating scientists, including the senior collaborator, particularly in the area of the proposed research; o potential contribution of the project to diffuse cancer prevention and control research into clinical and public health practice; o availability of the resources necessary to perform the research; o evidence that appropriate steps have been taken to insure the protection of human subjects; and o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each approved application. AWARD CRITERIA Applications found to have significant and substantial merit will be considered for funding by the following: o priority score o availability of funds o programmatic priorities Preference will also be given to clinical investigators who are new to cancer prevention and control translational research. 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: Helen Meissner, Sc.M. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 232D MSC 7330 6130 Executive Boulevard Bethesda, MD 20892-7330 Rockville, MD 20852 (for exprexx/courier service) Telephone: (301) 496-8520 FAX: (301) 496-8675 Email: meissneh@dcpceps.nci.nih.gov Direct inquiries regarding fiscal matters to: Tanya Terrell Collier Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7800, 247. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control. Awards are made under authorization of the Public Health Services Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and Part 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103- 227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed May 01 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-96-047 - V25(14) 05/03/96 Date: 2 May 1996 06:52:48 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 465 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4maeng$i3g@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PAR96047 PAR-96-047 P1O1 ************************************* MENTAL HEALTH EDUCATION GRANTS NIH GUIDE, Volume 25, Number 14, May 3, 1996 PA NUMBER: PAR-96-047 P.T. 34; K.W. 0715095, 0720005 National Institute of Mental Health Letter of Intent Receipt Date: August 1 Application Receipt Date: October 1 PURPOSE National Institute of Mental Health (NIMH) Education Grants provide a flexible mechanism for developing innovative educational programs to encourage individuals to pursue mental health research or to enhance research and career skills in critical areas of need. To meet its programmatic needs, the NIMH will accept grant applications in response to this announcement that propose one or more of the following educational objectives: o Providing experiences to motivate high school, college, graduate, postgraduate students, and scientists to pursue careers in mental health research o Teaching research and other related skills that can aid in enhancing the participants' research and career success, and aid the advancement of mental health research o Developing and evaluating new curricula or approaches to advance either of the above goals HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Mental Health Education Grants (R25), is related to the priority area of mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Any not-for-profit or for-profit organization engaged in health-related education or research and located in the United States, its possessions, or territories may apply for a Mental Health Education Grant. Since this is a short-term educational program, citizenship requirements do not apply to participants. MECHANISM OF SUPPORT The mechanism of support for this program announcement is the education project grant (R25). FUNDS AVAILABLE Funds requested under this mechanism are limited to $100,000 per year in direct costs. Requests for lower direct costs, as well as matching funds from the applicant institution, are encouraged. Indirect costs are payable at the rate of eight percent of total direct costs. The NIMH anticipates making approximately three to five R25 awards each year. Education Grants may be made for one to five years; the length of the grant period should be consistent with the objectives of the program. In some cases, these awards will be made to develop new educational approaches for which the institution will subsequently assume support. In other cases, the awards will strengthen ongoing activities that the NIMH will support over periods of one to five years. Applications for shorter project periods (i.e., for or one or two years of support) are encouraged, but programs proposed for three to five years may also be considered. Mental Health Education Grants are renewable (see "additional considerations for competitive renewals"). RESEARCH OBJECTIVES The activities supported by Mental Health Education Grants typically involve educational experiences shorter in duration than those funded under training grants such as National Research Service Awards (NRSA) or NIH career development (K) awards, which cover several months to a number of years. However, no use of this mechanism to circumvent or supplement existing training mechanisms will be allowed. Mental Health Education Grants support only educational activities focused on mental health research, and may not be used for support of clinical training or clinically oriented continuing education programs in the mental health professions. Potential applicants are strongly encouraged to contact appropriate NIMH staff (listed under INQUIRIES) to ascertain whether their application meets the program priorities of the particular Institute funding component. If applications do not address an identified educational need of the NIMH, as stated above, applications may be returned without review. Mental Health Education Grants may support a variety of educational activities, including: o Short courses, workshops, or seminars o Structured short-term (less than three months duration) research experiences o Projects designed for curriculum development or the design, implementation, and evaluation of educational programs Examples of educational programs that would be desirable include, but are not limited to, the following: o Seminars, workshops, or short-term courses about research career opportunities designed specifically for students enrolled in graduate school degree programs and/or postdoctoral fellows o Structured short-term research experiences for promising predoctoral students interested in research involving any of the areas covered within the mission of the NIMH, such as neuroscience and behavioral science, clinical and treatment studies, epidemiology and mental health services research, and AIDS (see "INQUIRIES") o Summer courses or workshops designed to facilitate careers in mental health research for young scientists at the intersection of basic and clinical research o Short-term courses or seminars designed to increase awareness about ethical issues surrounding scientific research o Short-term courses or seminars to address issues of relevance to women, minorities, and persons with disabilities in scientific careers o Structured summer research experiences, workshops, or seminars for undergraduate or high school students interested in pursuing research careers in neuroscience or behavioral science o Seminars designed to facilitate research experiences among child clinical psychology interns or child psychiatry fellows o Workshops focusing on designing improved or "model" training programs in clinical child psychology o Workshops to identify areas of need in mental health services and/or prevention research and research training, including areas such as managed care, cost-effectiveness, social work, and public-academic liaison issues INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by August 1, 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 this program announcement. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIMH staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent may be sent to either of the program staff listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. Applicants must use the forms for regular research grants and follow the specific instructions on pages 6-20 in the PHS 398 application kit, with the exceptions listed below. As in the standard PHS 398 instructions, sections "a-d" of the Research Plan in R25 applications are limited to 25 pages. Specific Instructions for R25 Applications: 1. Application face page: item number two on this page must include the program announcement number and the title, Mental Health Education Grants (R25). 2. Resources (Form page 8): describe the educational environment; include a description of the facilities, laboratories, participating departments, computer services, and any other resources to be used in the conduct of the proposed program. Use continuation pages, as necessary. 3. Research Plan: part "c" of this section should be retitled "Preliminary Data and Activities" and included if applicable. This section should contain information on steps that have led to the proposed Education project. A section entitled "Progress Report" is required for competing continuation and supplemental applications. 4. Research Plan: part "d" of this section should be retitled "Education Program Plan" and should contain material organized under the following subheadings, as appropriate to the specific project: a) Program Direction - describe arrangements for administration of the program; provide evidence that the Program Director is actively engaged in research and/or teaching in an area related to mental health, and can organize and administer the education program, as well as evidence of institutional commitment and support for the proposed program. b) Program Faculty/Staff - describe the characteristics and responsibilities of the faculty; provide evidence that participating faculty and preceptors are actively engaged in research or other scholarly activities related to mental health. c) Proposed Education Program - provide programmatic detail on the special activities proposed (e.g., courses, curricula), including description of plans to provide education to participants regarding the responsible conduct of research. d) Program Participants - provide detail about the proposed participants; include a description of plans for recruiting as participants individuals from underrepresented racial/ethnic groups. e) Education Evaluation Plan - include evaluation plans for determining success of the program in achieving its goals and objectives. 5. Research Plan: if applicable, under part ~h~ of this section, "Consortium/Contractual Arrangements," include a description of plans for collaborating with other institutions for purposes of exchange and sharing of resources, including faculty, equipment, and facilities. Allowable Costs Allowable costs must be consistent with PHS policy and be reasonable, allocable, and well documented and justified for the education program. Specifically, funds may be requested for: Personnel costs - faculty members participating in the design and implementation of the education program may request salary and fringe benefits appropriate for the percent of time devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions. (Mentoring interactions and activities with students are considered a regular part of a faculty member's academic duties and are non-reimbursable). Administrative and clerical salary costs associated with the program may be direct charges to the grant only when specifically identified and justified as reflecting significantly greater effort than the level of such services routinely provided by academic departments. Requests for consultant costs, equipment, supplies, necessary travel, and other project related expenses must be justified as specifically required by the program proposed and not duplicate items generally available at the institution for educational programs. Participants in the education program may receive only per diem living (necessary lodging and meals) and domestic travel expenses associated with attendance at the education programs. Unallowable costs: Tuition costs are not allowed under this program nor can the participants receive any payments or remuneration for attendance. Funds from this program may not be used to supplement stipends or provide other individual compensation to trainees supported by PHS training grants. An original and five legible copies of the completed and signed application are to be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIMH in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board, when applicable. The review committee will assess the educational, scientific, and technical merit of any application assigned to and accepted by the NIMH. These applications should be of high quality and responsive to the stated purpose of this program announcement. Grant applications to the Mental Health Education Program should be characterized by innovation, scholarship, and responsiveness to the special and/or changing needs of mental health research. To ensure that these objectives are met, applications will be evaluated by the following criteria, depending upon the nature and complexity of the proposed program. Review Criteria o Novelty and significance of the education program to mental health research o Quality of the program leadership, including the participating faculty, both in terms of past records of achievement and qualifications to implement future plans as proposed o The overall quality and adequacy of the design of the program to achieve its short-term objectives and long-term goals o Adequacy of the specialized curriculum to augment the research education o Evidence of the institution's commitment to the program o Adequacy of the program's plan to evaluate its effectiveness in achieving the proposed objectives o When appropriate, adequacy of plans to disseminate knowledge learned from the program to the mental health research community through a variety of routes including appropriate publication in professional periodicals and journals, and presentations at national meetings o Appropriateness of the budget and the duration of the support needed to achieve the stated goals and objectives o In addition to the criteria stated above, applications seeking a continuation of support will be evaluated by peer reviewers in terms of the progress reported from prior support, the viability of the proposed program extension, and continuing curriculum needs in the particular area of specialization in which the grant application is focused. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to NIMH. The following will be considered in making funding decisions: Quality of the application as determined by peer review, availability of funds, program priority, and balance among types of grants supported by NIMH. Schedule Applications for Mental Health Education Grants will be accepted and reviewed once a year only according to the following schedule: Letter of Receipt Date: August 1 Application Receipt Date: October 1 Review Meeting: February/March NIMH Council Meeting: May Earliest Possible Start Date: July 1 INQUIRIES Applicants are strongly encouraged to contact NIMH staff for technical assistance and information concerning current program priorities before applying for an award. Requests for program information about Mental Health Education Grants may be addressed to: Henry Khachaturian, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health 5600 Fishers Lane, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-8033 FAX: (301) 443-1731 Email: hkhach@helix.nih.gov Kenneth G. Lutterman, Ph.D. Division of Epidemiology and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10-95 Rockville, MD 20857 Telephone: (301) 443-3373 FAX: (301) 443-4045 Email: klutterm@nih.gov Leonard Mitnick, Ph.D. Office of AIDS Programs National Institute of Mental Health 5600 Fishers Lane, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-9719 FAX: (301) 443-9719 Email: lmitnick@nih.gov George Niederehe, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-101 Rockville, MD 20857 Telephone: (301) 443-3264 FAX: (301) 594-6784 Email: gniedere@nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-08 Bethesda, MD 20857 Telephone: (301) 443-3065 FAX: (301) 443-6885 Email: diana_trunnell@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99- 158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (April 1, 1994). PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the nonuse of all tobacco products. In addition, Public Law 103- 227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed May 01 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-048 - V25(14) 05/03/96 Date: 2 May 1996 06:52:16 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 404 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4maemg$hvk@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA96048 PA-96-048 P1O1 *************************************** EXPANDED RESEARCH ON EMERGING DISEASES NIH GUIDE, Volume 25, Number 14, May 3, 1996 PA NUMBER: PA-96-048 P.T. 34; K.W. 0715125, 1002027 National Institute of Allergy and Infectious Diseases PURPOSE The National Institute of Allergy and Infectious Diseases gives special consideration for funding to scientifically meritorious applications in response to Program Announcements. Program Announcements identify areas of ongoing research emphasis for the NIAID. The Division of Microbiology and Infectious Diseases of the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for research on emerging and re-emerging human pathogens. The purpose of this PA is to encourage basic and applied research projects yielding new data that will enhance prediction, prevention, treatment, and control of emerging and re- emerging infectious diseases threatening the U.S. Projects dealing with those bacterial, viral, fungal and parasitic pathogens of humans which have been newly recognized, and whose prevalence has markedly increased within the last two decades, are of interest. Applications dealing with additional new infectious disease problems that may emerge during the course of this PA are also encouraged. Since other NIAID initiatives have recently been available to support research on other high priority areas such as HIV, opportunistic infections in AIDS patients, Lyme disease, and tuberculosis, projects on these topics will not be considered responsive to this PA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Expanded Research on Emerging Diseases, is related to the priority area of immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) award (R29). MECHANISM(S) OF SUPPORT Investigator-initiated research project grant (R01) ,FIRST award (R29), and small grant (R03) applications may be submitted in response to this program announcement. NIAID uses R03 grants to support small highly innovative or pilot projects. Applicants for R03 grants may request up to $50,000 annual direct costs for a period not to exceed three years. Funds and time requested should be appropriate for the research proposed. Applicants for R03 grants must follow the special application guidelines and Terms and Conditions of Award for NIAID SMALL RESEARCH GRANTS, which appeared in the NIH Guide for Grants and Contracts, Vol. 25, No. 9, March 22, 1996. RESEARCH OBJECTIVES Background The emergence of the AIDS epidemic, the appearance of hantavirus in the Southwest, and the emergence of Lyme disease in the Northeast have demonstrated the vulnerability of the U.S. to emerging diseases. The NIAID recently co-funded two studies by the Institute of Medicine dealing with emerging diseases (see: Institute of Medicine: Emerging Infections- -Microbial Threats to Health in the United States, National Academy Press; and The U.S. Capacity to Address Tropical Infectious Disease Problems, National Academy Press). These studies warned that the threat posed by disease-causing microbes may be expected to continue and intensify in coming years. Factors influencing the pattern of emergence and distribution of infectious diseases in general include those associated with the microbial agent itself, the agent's hosts and vectors, and the environment in which agent and host interact. However, for many infectious agents, the specific factors contributing to emergence are poorly understood. Nonetheless, knowledge of these principles is essential in planning strategies to prevent, treat, and control such diseases. The natural life cycle of many infectious agents is multi-faceted and in addition to the organism, may include one or several reservoir or amplifying hosts, and often an arthropod vector. A change affecting the interaction of any of these fundamental elements might lead to the emergence or re-emergence of a disease. Natural or man-made changes to the environment typically impact on vectors or hosts. There are multiple recent examples of natural environmental changes influencing disease emergence in the U.S. The heavy rainfall and seasonal winds following an extended period of drought are believed to have contributed to the current epidemic of the fungal disease coccidioidomycosis in the Western U.S. Another recent example is the 1993 emergence of hantavirus in the Southwestern U.S. It is now thought that the virus in part emerged as a result of climatic and environmental conditions favorable for an increase in infected rodent populations. Nonetheless, man-made changes to the environment also lead to the emergence of disease. There have been several accounts of endemic diseases emerging and spreading as the result of man-made changes such as: (a) development of dams and water projects resulting in altered water distribution patterns, (b) deforestation and changing land-use associated with the development of new communities, and (c) the introduction of new hosts or the expansion of new vectors as the result of changing commercial practices. One example is the emergence in Lyme disease in reforested suburban communities. It is now believed that changes in agricultural practices as well as residential encroachments into previously unpopulated lands enhance the risk of human contact with increasing populations of infected ticks. Historically, commerce has often brought new microbes, vectors, or hosts into an area. Impending expansion of worldwide commercial trade may facilitate the emergence of new diseases, or increase the spread of previously known diseases to a more receptive environment. An example is the 1986 introduction of the Asian mosquito Aedes albopictus into the U.S. in a shipment of tires. This mosquito adapts well to woodland or urban settings, and it has established itself in over 18 states. It is capable of transmitting a number of diseases, and there is concern that this new vector might change the historical distribution of disease. Emerging and re-emerging disease problems may also relate to the effectiveness of existing public health measures. The recent outbreaks of diarrheal disease caused by the protozoan parasite cryptosporidium reflect increased demands on existing water treatment facilities. Furthermore, complacency with regard to implementation of standard public health precautions may lead to re-emergence of disease threats. Recent examples are outbreaks of food-borne enteric disease due to inadequate quality control in food handling and preparation. In some instances, infectious agents might emerge as the result of selection of new genetic strains and variants with increased infectiousness, virulence, or transmissibility This is most often seen as the cause of emergence of diseases that had previously been controlled by antibiotics and other drugs (e.g., multiple drug-resistant TB, antibiotic resistant bacteria, etc.). This has also been well-established as a cause for the emergence of new influenza outbreaks, and, in an analogous fashion, probably contributes to the emergence of other viruses particularly, the bunyaviruses. Major impediments in meeting these emerging disease threats are the formidable research problems posed by the need for input from multiple disciplines, and the relative scarcity of researchers working in field-oriented disciplines. Research Objectives and Experimental Approaches The overall objective of this PA is to expand research on emerging diseases, and help build a critical mass of investigators with expertise in the varied laboratory, field-, and clinically-based disciplines needed for the comprehensive study of emerging diseases. Specifically, this PA is intended to stimulate basic and applied research which will help formulate coordinated strategies for predicting, detecting, controlling, and preventing emergence or re- emergence of infectious diseases of humans. Projects concerning those bacterial, viral, fungal and parasitic pathogens of humans which have been newly recognized, or whose incidence has markedly increased, within the last two decades are of particular interest. These include, but are not limited to, Hantaan and Sin nombre viruses, hepatitis C and E, dengue virus, Group A Streptococcus, Pneumococcus, Bartonella, Vibrio cholerae, Plasmodium, Cryptosporidium, the microsporida, Coccidioides and Aspergillus. Applications dealing with additional new infectious disease problems that may emerge during the course of this PA are also encouraged. Research responsive to this PA would include: o Basic and applied research on changes and adaptations of the organism which might influence emergence or re-emergence. Studies might address mechanisms leading to appearance in the natural population of new or altered human pathogens with enhanced virulence or drug resistance, or modified transmissibility or infectivity. o Basic and applied research on ecologic and environmental factors influencing disease emergence and distribution. Studies might include evaluation of: the influence of natural, man-made, or climate-induced environmental change on emerging diseases; the effects of alterations in host or vector population density and distribution on diseases; and the influence of public health practices or modern technological developments on disease distribution. Field-oriented studies, to complement laboratory based research, are particularly encouraged. o Research aimed at improved detection of emerging diseases. The primary aim should not be surveillance per se, but the related research objectives, such as the development of improved diagnostic reagents and assays, or of new predictive strategies that might aid in the targeting of control efforts. For example, recent advances in satellite remote sensing technology and in computerized geographic information systems (GIS) have been applied to the study of infectious diseases and their distribution. These tools have provided predictive data for such purposes as identifying geographic areas where there is an increased risk of vector-borne disease transmission. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applicants for Small Research (R03) grants are to follow the application guidelines, NIAID SMALL RESEARCH GRANTS, which are available from program staff listed under INQUIRIES. Applicants are strongly encouraged to contact NIAID program staff with any questions regarding the responsiveness of their proposed project to the goals of this PA. Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted on the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. Each application must be identified by checking "YES" on line 2 of the PHS face page, and the number and title of this program announcement must be typed in section 2a. The completed original and five legible, single-sided copies of the application must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) FIRST (R29) applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit in accordance with the standard NIH peer review procedures. Following scientific/technical review, the applications will receive secondary review by the appropriate national advisory council. As part of the initial merit review, a process may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria o scientific, technical, or medical significance and originality of the proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications. The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance among research areas of the program announcement, availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic (eligibility and responsiveness) issues to: Stephanie L. James, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A-10 6003 Executive Boulevard MSC 7630 Bethesda, MD 20892-7630 Telephone: (301) 496-2544 FAX: (301) 402-0659 Email: sj13y@nih.gov Direct inquiries regarding fiscal matters to: Todd Ball Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B-35 6003 Executive Boulevard MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: tb22j@nih.gov RO3 APPLICANTS ONLY: Inquiries regarding review issues, requests for the special instructions for application preparation, two copies of the application and all five sets of any appendices may be directed to: Olivia Preble, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C-19 6003 Executive Boulevard MSC 7610 Bethesda, MD 20892 Telephone: (301) 496-8208 FAX: (301) 402-2638 Email: op2t@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.856, Microbiology and Infectious Disease Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed May 01 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AR-96-003 - V25(14) 05/03/96 Date: 2 May 1996 06:51:40 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 369 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4maelc$hu1@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AR96003 AR-96-003 P1O1 *************************************** SPECIALIZED CENTERS OF RESEARCH IN OSTEOARTHRITIS AND SYSTEMIC LUPUS ERYTHEMATOSUS NIH GUIDE, Volume 25, Number 14, May 3, 1996 RFA: AR-96-003 P.T. 04; K.W. 0715010, 0715015 National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: March 1, 1997 Application Receipt Date: June 12, 1997 PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invites applications for Specialized Centers of Research (SCORs) in the following disease areas: osteoarthritis and systemic lupus erythematosus. A SCOR should foster a coordinated research effort that strongly emphasizes basic disciplines, but also involves significant interaction between basic research and clinical investigations. A SCOR is envisioned as a national resource associated with one or more major medical complexes and dedicated to working with the NIAMS in furthering the research effort to translate basic research to clinical application. 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), Specialized Center of Research (SCOR), is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. An established clinical and research program in the disease area should be present. Foreign organizations are not eligible. International collaborations in domestic applications will only be accepted if the resources are clearly shown to be unavailable in the United States. Applications >From racial/ethnic minority individuals and women and persons with disabilities are encouraged. MECHANISM OF SUPPORT Support of this program will be through the NIH specialized center (P50) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. This RFA is a one-time solicitation for these disease areas. A separate RFA (AR-96-002) is directed to osteoporosis, rheumatoid arthritis and scleroderma. The total requested project period for an application submitted in response to this RFA may not exceed four years. The anticipated award date is April 1, 1998. FUNDS AVAILABLE The NIAMS intends to fund up to nine SCORs in FY 1997 and 1998 in the scientific areas covered by this RFA and RFA AR-96-002. Funding is subject to the availability of resources and receipt of sufficiently meritorious applications. Nine competing continuation applications are anticipated in response to these RFAs. The anticipated awards are for four (4) years and are subject to the availability of appropriated funds. The estimated funds (total costs) available for the first year of support of these centers are $10 million per year. The direct costs requested cannot exceed $750,000 (excluding indirect costs of subcontracts) each year. RESEARCH OBJECTIVES The objective of the SCOR program is to expedite development and application of new knowledge to a disease area, to learn more about the etiology of these diseases, and to foster improved approaches to treatment and/or prevention. A SCOR consists of at least three individual, but interrelated, research projects, each with high scientific merit and clear research objectives and, in the aggregate, devoted to a specific major health area. Each SCOR should provide a multidisciplinary approach utilizing both laboratory and clinical research to focus on a particular health problem and provide for a mutually supportive interaction between basic scientists and clinical investigators. Clinical research is defined as patient oriented clinical research conducted with human subjects, or on material of human origin (such as tissue specimens and cognitive phenomena) for which an investigator or colleague directly interacts with human subjects in an outpatient or inpatient setting to clarify a problem in human physiology, pathophysiology, or disease. Although research programs will vary at each institution according to local expertise, interests, and resources, each SCOR should have a central theme related to the disease area to which individual projects relate and which serves as an integrating force. Emphasis in proposed projects should be on development of innovative approaches, elaboration of new and significant hypotheses, and generation of improved strategies for approaching current issues relating to the disease area addressed. Funding may also be requested for one or more core resources. A core is defined as a resource shared by multiple investigators that enhances research productivity and increases the functional capacity of the SCOR. Ongoing projects may be absorbed into the SCOR if their original funding source is relinquished. Support for large clinical trials or for applications that contain exclusively clinical or exclusively basic studies will not be provided within this SCOR program. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. Details of the interactions of the SCOR staff with the GCRC staff and research personnel may be provided in a statement describing the collaborative linkages being developed. A letter of agreement from the GCRC Program Director must be included with the application. SPECIAL REQUIREMENTS The director and co-director should budget for an annual one-day meeting in Bethesda, MD with NIAMS staff. The director should be prepared to devote at least 15 percent effort as the director and 20 percent effort as a project PI. Each project and core PI should be prepared to devote at least 20 percent effort. To be funded, a SCOR must include at least three highly meritorious projects approved for four years. One of these must have the SCOR director as the principal investigator, and the highly meritorious projects must include both basic and clinical research. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by March 1, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIAMS staff to estimate the potential review workload and to avoid conflict of interest in the selection of reviewers. The letter of intent is to be sent to Dr. Julia B. Freeman at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. Special guidelines have been developed for the SCOR program in NIAMS. These guidelines should be used in assembling the application. See INQUIRIES for obtaining a copy of these guidelines. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title, "Specialized Center of Research (SCOR) in Osteoarthritis and Systemic Lupus Erythematosus," and number, "AR-96-003" must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies of the application in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, send two additional copies of the application to: Review Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS.25U - MSC 6500 Bethesda, MD 20892-6500 Bethesda, MD 20814 (for express/courier service) Applications must be received by June 12, 1997. If an application is received after the specified date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications for SCORs will be first screened for completeness by DRG and responsiveness by NIAMS program staff. Incomplete applications will be returned to the application without further consideration. In addition, if program staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAMS in accordance with the NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those application deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council for NIAMS. If the project from the SCOR director is not recommended for further consideration during the review for scientific merit, the entire SCOR application will not be reviewed further. If all the clinical research projects in a SCOR application are not recommended for further consideration, the SCOR application will not be further reviewed. Major factors to be considered in evaluation of applications will include: 1. How the proposed SCOR combines basic and clinical research into the scientific goals and research theme; 2. If a competing continuation application, the quality and significance of the progress made in the previous funding period; 3. Scientific merit of each proposed project, including originality and feasibility of the project and adequacy of the experimental design; 4. Scientific merit of combining the component parts into a SCOR; 5. Technical merit and justification of each core unit; 6. Competence of the investigators to accomplish the proposed research goals, their commitment, and the time they will devote to the research program; 7. Adequacy of facilities to perform the proposed research, including laboratory and clinical facilities, instrumentation, and data management systems, when needed; 8. Adequacy of plans for interaction among investigators, and the integration of the various projects and core units; 9. Qualifications, experience and commitment of the SCOR Director and his/her ability to devote time and effort to provide effective leadership; 10. Scientific and administrative structure, including internal and external procedures for monitoring and evaluating the proposed research and for providing ongoing quality control and scientific review; 11. Institutional commitment to the program, and the appropriateness of resources and policies for the administration of a SCOR; 12. 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 appropriateness of the budget for the proposed program and its individual components will be considered independently of the factors indicated above. AWARD CRITERIA The anticipated award date is April 1, 1998. The primary factors determining the award will be the priority score, the overall balance of meritorious projects (clinical and basic research) within the application relative to the disease area, and the availability of funds. Since the NIAMS is interested in funding only the best research, individual projects or cores of lesser quality may not be funded, even if approved, under the "umbrella" of the SCOR mechanism. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues and letters of intent may be directed to: Dr. Julia B. Freeman Centers Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS.19F - MSC 6500 Bethesda, MD 20892-6500 Bethesda, MD 20814 (for express/courier service) Telephone: (301) 594-5052 FAX: (301) 480-4543 Email: freemanj@ep.niams.nih.gov Copies of the guidelines for the SCOR program may be obtained from: NIAMS Clearinghouse 1 AMS Circle Bethesda, MD 20892-3675 Telephone: (301) 495-4484 FAX: (301) 587-4352 Direct inquiries regarding fiscal matters to: Sally A. Nichols Grants Management Officer National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building Room 5AS.49F - MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-3535 FAX: (301) 480-5450 Email: nicholss@ep.niams.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 410, 78th Congress, as amended, 42 USC 241) and administered under PHS grant policies and Federal regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed May 01 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-050 - V25(14) 05/03/96 Date: 2 May 1996 06:49:21 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 300 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4maeh1$hjs@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA96050 PA-96-050 P1O1 *************************************** GENETICS OF PARKINSON'S DISEASE NIH GUIDE, Volume 25, Number 14, May 3, 1996 PA NUMBER: PA-96-050 P.T. 34; K.2. 1002019, 0715140 PURPOSE In response to new basic and clinical developments in Parkinson's disease research and the interest of related voluntary organizations, the Senate Appropriations Subcommittee on Health in 1995 asked the National Institute of Neurological Disorders and Stroke (NINDS) to organize a conference to assess the progress made in Parkinson's disease research, to identify new opportunities and goals, and to plan a research agenda to coordinate and strengthen the cooperative activities of the several NIH institutes supporting research relevant to this disorder. This meeting was held in August 1995 and, with NINDS, was jointly sponsored by the National Institute on Aging, the National Institute of Environmental Health Sciences, and the National Institute of Mental Health. For fiscal year 1996 the Senate Appropriations Committee urged the NINDS to expand its initiatives in areas of promise identified at the August Parkinson's research conference. This Program Announcement (PA) is one of several responses to Congressional interest in this subject. The principal objective of this PA is to stimulate research into possible genetic factors in the causation of Parkinson's disease. It is hoped that the results of these investigations will help to elucidate the causes and pathogenesis of Parkinson's disease. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS initiated national activity for setting priority areas. This PA, Genetics of Parkinson's Disease, is related to the priority area of chronic debilitating 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 and foreign, for-profit and non-profit, public and private organizations, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the federal government. Foreign institutions are not eligible for program project grants (P01) or First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The mechanisms available for support of this PA are the National Institutes of Health (NIH) research project (R01), program project (P01), and the FIRST (R29) award. Responsibility for the planning, direction and execution of the proposed research project will be solely that of the applicant. Because the nature and scope of the research proposed in response to this PA may vary, it is anticipated that the size of an award will also vary. Applications submitted in response to this announcement will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. All applications will receive an assignment to the appropriate institute in accordance with the extant Referral Guidelines. FUNDS AVAILABLE Applications will compete for all available extramural grant funds on the basis of scientific merit as judged by peer review. RESEARCH OBJECTIVES Background Parkinson's disease (PD) is a common and disabling progressive neurodegenerative disorder characterized by tremor, rigidity, bradykinesia, and loss of postural reflexes. It affects some half million Americans. The pathology is a rather specific pattern of neuronal degeneration associated with Lewy-body formation in the substantia nigra and other regions of the brain. PD responds for a time to medication but is a progressive disorder. There is no specific biological test for the diagnosis of PD. Twin studies have shown variable results and suggest that the genetics of this disorder will prove to be complex. Despite the importance and severity of PD and despite many years of research, a cause has not been identified and there is no means of preventing the disease and no proven permanent cure. Familial parkinsonism has been recognized recently to be more frequent than was thought previously. Some physicians state that it is more prevalent in clinical practice than familial Alzheimer's disease or familial amyotrophic lateral sclerosis (ALS). The signs and symptoms in familial cases of pure Parkinson's disease do not seem to differ from sporadic cases. Familial parkinsonism is heterogeneous in onset and course, and wide variations of expression may occur within families. Most cases of PD are apparently sporadic, as with ALS and Alzheimer's disease where multiple gene loci have been found. There have been reported a growing list of small multicase PD families and a few large possibly autosomal dominant PD pedigrees. Several families in which Parkinson's disease seems to be inherited have been followed over successive generations. Sharing information on these families and subjecting the data to sophisticated computer analysis could hasten the identification of a genetic basis or predisposition in this disorder. Through linkage and allele sharing analysis of special populations of Parkinson's disease families, it may be possible to identify the gene or genes that increase the risk for the disorder. Special populations would include families with many affected members, families that are geographically restricted, those in which the origin of the disorder in that family may be traced back to a single individual, or those that have an early age of onset or unusual severity. Restricting the phenotype to be studied by eliminating from analysis those members of a family who do not have typical Parkinson's disease may enhance the opportunity to localize the gene. Some large families show apparent autosomal dominant inheritance with high penetrance. In small multicase families, the inheritance pattern is compatible with either autosomal dominance with reduced penetrance or multifactorial inheritance. The apparent paucity of parental consanguinity indicates no recessive inheritance. Anticipation and X-linked inheritance are not thought to be involved in PD. Findings which would be of considerable importance in this search would be the location of a genetic marker, determination of the probability of penetrance, determination of possible genetic heterogeneity, and evidence of multifactorial inheritance with environmental interaction. Finding genetic factors determining susceptibility to PD will enhance epidemiological studies and possibly lead to identification of susceptible groups and of significant risk factors. The areas of genetic research discussed in this section , however, are not intended to be comprehensive or exclusionary. Researchers responding to this PA are encouraged to consider novel approaches of the broadest nature in approaching the pathogenesis of this disease. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (concerning the inclusion of women in study population, and concerning the inclusion of minorities in study populations), which have been in effect since 1990. The current policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under inquiries. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES The research grant application form PHS 398 (REV. 05/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. In addition, the PA title, ("Genetics of Parkinson's Disease" NS-96 ) should be typed on line 2 of the face page of the application form and the yes box should 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 or express service) REVIEW CONSIDERATIONS Applications that are complete and responsive to the PA will be evaluated for scientific and technical merit in accordance with the review criteria stated below, by an appropriate peer review group. As part of the initial merit review, all applications will receive a written critique and undergo a streamlined (triage) review process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second review by the National Advisory Council, where applicable. REVIEW CRITERIA Criteria for scientific/technical merit review of applications are the following: o Significance and originality of proposed research from a scientific or technical standpoint; o Qualifications and experience of the principal investigator and the staff in areas specifically related to the questions under investigation; o Adequacy of the conceptual and technical framework for the research, including evidence of familiarity with relevant research literature and proposed techniques; o Access to appropriate study population (s), specimens, and equipment; o Adequacy of plan to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plan for the recruitment and retention of subjects will also be evaluated; o Adequacy of the existing and proposed facilities and resources; o Adequacy of the data analysis plan; o Appropriateness of the proposed budget, staffing plan, and the time frame in relation to the proposed project. The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment. AWARD CRITERIA The following criteria will be considered in making a funding decision: o Scientific merit as determined during the peer review process and availability of funds. INQUIRIES Inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Eugene J. Oliver, Ph.D. Division of Demyelinating, Atrophic, and Dementing Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 806 7550 Wisconsin Avenue Bethesda, MD 20892-9150 Telephone: (301) 496-1431 FAX: (301) 402-2060 Email: eo11c@nih.gov Direct inquiries regarding fiscal matters to: Ms. Pat Driscoll Grants Management Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 7550 Wisconsin Avenue Bethesda, MD 20892-9190 Telephone: (301) 496-9231 FAX: (301) 402-0219 Email: pd23n@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, 93.853 and 93.854 for Neurological Disorders and Stroke Grants. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or health systems agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and to promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed May 01 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-049 - V25(14) 05/03/96 Date: 2 May 1996 06:48:43 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 321 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4maefr$hf4@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA96049 PA-96-049 P1O1 *************************************** BIOIRON RESEARCH: ROLE OF MRNA AND PROTEIN STRUCTURE IN IRON NUTRITION AND METABOLISM NIH GUIDE, Volume 25, Number 14, May 3, 1996 PA NUMBER: PA-96-049 P.T. 34; K.W. 0765030, 0710095, 0790010, 0760070 National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The purpose of this program announcement is to stimulate research on iron absorption and metabolism. Iron is central to the health of humans, the production of animals and plants for human food. Iron deficiency affects 30 percent of the world's population. The negative impact of iron deficiency on learning adds a new dimension to the importance of adequate management of iron metabolism. In addition to nutritional iron deficiency, pathological conditions associated with altered iron metabolism include iron overload, anemia of chronic disease and inflammation, and renal failure requiring hemodialysis. The objectives of the initiative address three of the current trends in bioiron research: (l) mRNA structure/function and regulation; (2) High resolution analysis of protein structure/function; and (3) Novel approaches to iron nutrition and metabolism. Markers of current interest include ferritin mRNA and protein (iron concentration/storage), mRNA and protein for iron uptake (transferrin receptor) and the protein for iron transport (transferrin), as well as other iron-binding entities including mucins, integrins, and mobilferrin. 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. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No.017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) individual research project grant (R01) and FIRST (R29) award mechanisms. Responsibility for planning, direction, and execution of the proposed project will be solely that of the applicant. Because the nature and scope of the research proposed in response to this PA may vary, it is anticipated that the size of an award will vary also; however, the support of requests exceeding the NIDDK average grant size of $160,000 direct cost for R01 grants would be unusual and require ample justification. FIRST (R29) awards are limited to $350,000 direct cost over the five year period. RESEARCH OBJECTIVES Investigations are needed that will lead to a better understanding of the biochemistry and molecular biology of the proteins of iron absorption and metabolism including ferritin, the transferrin receptor, and aminolevulinate synthase in erythroid heme synthesis. The iron regulatory elements (IREs) are encoded in mRNAs with related regulatory sequences and coordinate protein synthesis in response to iron. At least two related proteins, IRPs, interact with the IREs, as well as initiation factors and, possibly, nucleases, to control either ribosome binding or mRNA turnover. The fundamental properties of IRE/protein interactions provide a unique model for regulation of eukaryotic mRNA translation and turnover. The three dimensional structure of the IRE, the IRPs, and the IRE/IRP complex need to be determined. Existing or new modeling systems should be employed in an attempt to predict their specific structure(s). The effect on IRP or FeS binding on phosphorylation needs to be studied, and the differences between IRP-1 and IRP-2 should be examined. The mechanism for iron-dependent mRNA turnover of the transferrin receptor mRNA is unknown, as is the manner in which iron and the IRP affect initiation factor and/or ribosome binding to the ferritin or erythroid aminolevulinate synthase IREs. Developing probes specific for the IRE can lead to rational design of drugs to regulate iron absorption and metabolism, to enhance ferritin synthesis in iron overload, and to target any mRNA with a specific structure that is involved in a pathogenic process. It is not known whether or not iron absorption and metabolism can be regulated by chemicals that have potential activity as drugs targeted to the IRE. Mutation analysis reveals regions in the cell membrane transferrin receptor required for iron uptake. High resolution x-ray crystallography reveals the sites of bound solvent/water important for reversibly concentrating iron in the interior of ferritin. Conformational flexibility also has been observed. Mutations that change receptor function could affect the structure of the transferrin receptor or of ferritin in an as yet unknown manner. Formal analogies can be drawn between ferritin structure and function and the channel proteins that transfer sodium, potassium and calcium across cell membranes. Thus, ideas gained from studying ferritin can illuminate problems important in membrane function. It is not known how protons enter and leave ferritin, nor is the manner in which the channels operate. The path of iron ions entering and leaving ferritin also is unknown. Since the iron in the center of ferritin is a solid phase mineral, understanding the reversible transfer of Fe ions across the ferritin protein has implications for the reversible transfer of Ca and phosphate from serum to hydroxyapatite mineral. Thus, study of proteins of iron metabolism can extend to the physiology of other heavy metals. Iron release from or solution in the mineral is little understood, as is the importance of phosphate in forming and dissolving the mineral in animal ferritin. Cell specific mRNAs are prime candidates for development of specific targeted drugs. These mRNAs also have wide shape specificity, in contrast to DNA, and a relatively small target size, in contrast to proteins. The mRNAs important in iron metabolism contain regions of distinctive shape, which bind regulatory proteins to increase iron uptake and decrease ferritin synthesis (iron storage) when iron levels are low. The reverse occurs when iron is high. Studies in progress are planned to determine the actual RNA and protein shapes involved. Their reactivity with shape-recognizing chemicals could help to explain the novel basis of controlling bioiron in cells. They also could contribute to development of strategies for managing abnormal iron metabolism, and for rational drug design for specific mRNA targets, such as those encoding oncogenes and viral proteins. Shape-recognizing chemicals could be used to target mRNAs such as ferritin or transferrin receptor in the development of strategies for managing abnormal iron absorption and metabolism. Other potential targets include mRNAs encoding viral or oncogene proteins. Other newly identified iron binding proteins and their manner of action are of interest. These include aspects of the pathway leading to iron absorption, such as mucins, integrins and mobilferrin, known to be involved with enterocyte function. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. ANIMAL WELFARE CONSIDERATIONS Investigators are encouraged to consider alternative methods and approaches in their research grant applications that do not require the use of whole animals, use alternative species such as nonmammals or invertebrates, reduce the number of animals required, and incorporate refinements to procedures that will result in the elimination or further minimization of pain and distress in animals. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research, or may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: asknih@odrockm1.od.nih.gov. The program announcement title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Potential R29 applicants should refer to the announcement on Just-in-Time Procedures for FIRST and Career Awards (NIH Guide for Grants and Contracts, Vol. 25, No. 10, March 29, 1996)) for information on recent changes in guidelines for FIRST award format. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, and the safety of the research environment. For Applications from Foreign Organizations: o availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries that are not readily available in the United States or that provide augmentation of existing U.S. resources. AWARD CRITERIA Applications will compete for available funds with other approved applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review; o Availability of funds; o Program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: David G. Badman, Ph.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-13C MSC 6600 BETHESDA, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: David_Badman@nih.gov Inquiries regarding fiscal matters may be directed to: Aretina Perry Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN-38B, MSC 6600 BETHESDA, MD 20892-6600 Telephone: (301) 594-8862 Email: PerryA@ep.niddk.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed May 01 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-96-003 - V25(14) 05/03/96 Date: 2 May 1996 06:47:02 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 586 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4maecm$gmb@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AI96003 AI-96-003 P1O1 *************************************** TRANSPLANTATION TOLERANCE NIH GUIDE, Volume 25, Number 14, May 3, 1996 RFA: AI-96-003 P.T. 34; K.W. 0745065, 0710070 National Institute of Allergy and Infectious Diseases Juvenile Diabetes Foundation, International Letter of Intent Receipt Date: August 10, 1996 Application Receipt Date: October 8, 1996 APPLICATIONS IN RESPONSE TO THIS REQUEST FOR APPLICATIONS (RFA) MUST BE PREPARED USING A MODIFIED (ABBREVIATED) GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS FOR COMPLETING THE APPLICATION ARE IN AN NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR ABBREVIATED APPLICATIONS FOR MULTI-PROJECT AWARDS" (February 1996). PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) and the Juvenile Diabetes Foundation, International (JDFI) invite applications for basic, pre- clinical and clinical studies to determine the mechanisms of immunologic tolerance that will enhance solid organ and tissue graft survival. This Request for Applications (RFA) for Program Project Grants is intended to stimulate collaboration between clinicians and basic immunologists to identify and characterize the immune mechanisms responsible for enhancing graft survival by inducing tolerance to the donor organ or tissue. The investigation of tolerance induction for the prevention or treatment of autoimmune disease could advance understanding of tolerance induction in the transplant setting. Thus, applications incorporating investigations of tolerance induction for autoimmune disease in the transplant setting are encouraged. Applications should be submitted to and will be reviewed according to usual NIH peer review procedures. Funds for each Program Project to be awarded under this RFA will be provided by the NIAID and the JDFI. To have an application reviewed and considered for funding, applicants must authorize the NIAID, in writing, to provide to the JDFI a copy of their letter of intent, application and NIH prepared summary statement of the initial review 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, Transplantation Tolerance, is related to the priority area of diabetes and chronic disabling 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 20402-0325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply to the NIH. However, the JDFI will separately consider non-U.S. applications (contact Sara King of the JDFI at 212-479-7524 for more information). Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanism of support will be the program project (P01) grant. This mechanism supports broadly based multi-disciplinary research programs that have a well-defined central research focus, theme, or objective. An important feature of the program project is that the interrelationships of the individual scientifically meritorious projects will result in a greater contribution to the overall program goals than if each project were pursued individually. The program project grant consists of a minimum of three interrelated individual research projects that contribute to the program objective. The program project grant also can provide support for certain common resources termed cores. Such resources should be utilized by two or more projects within the program project. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years. At this time, the NIAID is administratively limiting the duration of P01 grants to four years; this administrative limitation may change in the future. The earliest anticipated award date is July 1997. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for this RFA will be $3.0 million: $2.0 million from NIAID and $1.0 million from JDFI. In fiscal year 1997, the NIAID and the JDFI anticipate jointly funding approximately four to five program projects related to this RFA. Approximately 65 percent of the total costs of each grant will be funded by the NIAID and approximately 35 percent by the JDFI. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Applications may not request budgets in excess of $750,000 Total Costs (direct and indirect) in the first year. NIH is currently limiting annual inflationary increases to no more than four percent for future years. Funding rules and policies, including the determination of allowable indirect costs, of each funding organization will be applicable. Post award administration will conform to current policies and requirements that govern the research grant programs of the NIH and the JDFI as appropriate. Although this program is provided for in the financial plans of the NIAID and the JDFI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. At this time, it has not determined whether or how this solicitation will be continued beyond the present RFA. Administrative adjustments in the project period and/or amount of support may be required at the time of award. RESEARCH OBJECTIVES Background In 1994, more than 19,000 solid organ transplants were performed in the United States. Advances in surgical methods and current immunosuppressive therapies have improved short-term survival; however, long-term survival rates remain poor. For example, kidney transplantation has a one-year graft survival rate of 85 to 95 percent; however, the survival rate at five years is about 50 percent. These short graft survival rates demonstrate the inadequacy of the current clinical regimens to ensure long-term graft survival. In addition, if organ failure is due to an autoimmune disease, survival rates are significantly decreased. For example, diabetes, which can cause end-stage diabetic nephropathy or systemic lupus erythematosus, which can result in glomerulonephritis, can lead to significantly decreased kidney graft survival rates at five years post transplant. The ability to induce donor-specific tolerance could significantly improve long-term graft survival, reduce or eliminate the continuing need for expensive, toxic and non-specific immunosuppressive therapy and enhance the quality of life. Recent investigations have provided insights into how transplant tolerance may be accomplished. Studies have demonstrated that "passenger lymphocytes" carried within a transplanted organ may affect graft survival. This is particularly noticeable in liver transplantation. The liver, which contains a very large number of lymphoid cells, does not induce an immune response leading to rejection. Instead, it appears to induce tolerance. One possible mechanism leading to this tolerance may be that the donor lymphoid cells emigrate from the liver and take up residence in the recipient's immune organs, such as the lymph nodes. This cohabitation of large numbers of donor lymphocytes with recipient immune cells might "re-educate" the recipient immune system so that the donor organ is not recognized as foreign. In an attempt to mimic this process, transfusions of donor blood or bone marrow have been used to enhance solid organ graft survival in animal models and in clinical trials. These studies and trials have not yet provided definitive results and the mechanisms whereby the introduction of donor cells might lead to tolerance are still not understood. Therefore, further pre-clinical studies are needed to help establish the basis for clinical use of tolerance induction. Basic research has shed light on some of the mechanisms involved in tolerance induction. An example is how co-stimulation can be modulated to affect T-cell responses. Blockade of this "second signal" during delivery of the antigen specific T-cell receptor mediated "first signal" can result in antigen specific tolerance in some animal transplant models. In addition, experiments examining the role of cytokines in modulating the immune response have shown that the balance of cytokines can direct the immune response to either the TH1 type of inflammatory response and graft rejection, or to the TH2 type of suppressor/regulator response that might lead to improved graft survival. Although considerable progress has been made in the past few years, it is clear that a better understanding of how to manipulate the immune response to allow routine donor-specific tolerance induction is required. While these examples are illustrative of advances that have been made already, the purpose of this RFA is to extend and expand research to further the understanding of the processes and mechanisms leading to transplant tolerance. Research Objectives and Scope The objectives of this RFA are to identify and characterize the cellular and molecular mechanisms responsible for donor-specific tolerance and to identify and examine approaches for modulating the immune response to tolerize the transplant recipient. The scope of research to be supported under this RFA includes, but are is not limited to, the following broad areas of interest and examples of possible specific investigations. The examples are not meant to be directive, but illustrative of areas that remain to be investigated further. Investigators are encouraged to develop novel approaches to understanding the mechanisms responsible for the induction and maintenance of donor-specific tolerance. o EVALUATIONS OF THE IMMUNE RESPONSE TO ORGAN ALLOGRAFTS AND DEVELOPMENT OF WAYS TO MANIPULATE THE RESPONSE Studies to determine the mechanism of action of HLA- derived peptides and test the utility of these peptides in animal models and transplant recipients. The identification, assessment and investigation of the mechanisms of therapies that modulate underlying autoimmune diseases, such as insulin dependent diabetes mellitus (IDDM), to prevent damage to a transplanted organ. o ELUCIDATION OF THE IMPORTANT CELLULAR AND MOLECULAR EVENTS OF BOTH THE INDUCTION AND EFFECTOR PHASES OF THE IMMUNE RESPONSE Investigations to determine the indicators of immune reactions that are predictive of post-transplant graft survival and to develop clinically useful post-transplant monitoring protocols capable of predicting durable transplant tolerance. Studies to determine the relative roles and mechanisms involved of indirect vs. direct antigen presentation in the ability to induce transplant tolerance and to design approaches to manipulate the system to favor tolerance vs. destructive immune response. Definition and characterization of the role of Major and Minor Histocompatibility Antigens in both acute and chronic graft rejection and development of regimens to ensure tolerance to these antigens to promote long-term graft survival. o INVESTIGATIONS OF APPROACHES TO THE DEVELOPMENT OF THERAPEUTIC STRATEGIES TO IMPROVE LONG-TERM GRAFT SURVIVAL. Evaluations of the efficacy and mechanisms of action of multiple agent interventional therapies in vivo in animal models of tolerance induction in the presence or absence of current immunosuppressive drug regimens. Studies to delineate the mechanisms of action of immunomodulatory molecules in transplant rejection and tolerance using appropriate animal models, e.g., manipulating the immune system to affect the balance of inflammatory vs. suppressive reactions by the use of cytokines, receptors, competitors, inhibitors and mimicry molecules delivered in vivo. Development of approaches to promote transplant tolerance by treating either the donor organs or recipients using gene therapy. Proposed projects and the knowledge generated by this research must be applicable to human disease and human transplantation. Studies of human transplantation in the setting of autoimmune diseases, such as IDDM, are particularly sought. While animal models may be proposed, any such model must be an acceptable approximation of the human condition. In addition, any proposed animal or human studies must demonstrate the efficacy of the treatment under conditions of generally accepted standard immunosuppressive therapy in humans. Therefore, although studies focusing exclusively on infusion of donor immune system cells will be considered, this type of study must be focused on understanding the basic mechanisms of transplant tolerance induction and maintenance. SPECIAL REQUIREMENT The NIAID and the JDFI plan to sponsor an annual meeting to encourage the exchange of information among investigators supported under this RFA, as well as to foster collaborative efforts and identify resources that would enhance the productivity of this research program. Applications should include a statement indicating the willingness of the applicant institution to participate in such annual meetings. For this purpose, travel funds for an annual two-day meeting, to be held in the Washington, DC area, should be included in the budget request. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF AUTHORIZATION Applicants must submit a brief letter to the NIAID, co-signed by the Principal Investigator and the official signing for the applicant institution, indicating that they will allow their applications to be considered for funding by the JDFI. This letter may be combined with the Letter of Intent or may be submitted directly to Dr. Stephen Rose at the address shown in "INQUIRIES" below. If a Letter of Authorization is not submitted and signed by the appropriate institutional officials, the application will be considered incomplete and will be returned to the applicant without review. All materials relating to the application will be promptly forwarded to the JDFI by the NIAID. The summary statements for such applications will be shared with the JDFI at the time of their availability. LETTER OF INTENT Prospective applicants are asked to submit, by August 10, 1996, a letter of intent that includes a descriptive title of the overall proposed research, the name, address, and telephone number of the Principal Investigator, a list of the key investigators and their institution(s), and the number and title of this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Stephen Rose, Ph.D. at the address listed under INQUIRIES. APPLICATION PROCEDURES APPLICATIONS IN RESPONSE TO THIS REQUEST FOR APPLICATIONS (RFA) MUST BE PREPARED USING A MODIFIED (ABBREVIATED) GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS FOR COMPLETING THE APPLICATION ARE IN AN NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR ABBREVIATED APPLICATIONS FOR MULTI-PROJECT AWARDS" (February 1996). Applications are to be submitted on the standard research grant application form PHS 398 (rev. 5/95). Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. For purposes of identification and processing, item 2 on the face page of the application must be marked "YES" and the RFA number "AI-96-003" and the words "Transplantation Tolerance" must be typed in. Applications must be received by October 8, 1996. Applications that are not received as a single package on the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 5/95) Application Kit (as modified in, and superseded by, the NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR ABBREVIATED APPLICATIONS FOR MULTI-PROJECT AWARDS"), will be judged non-responsive and will be returned to the applicant. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. It is highly recommended that the appropriate NIAID program contact be consulted before submitting the letter of intent (See program contact under INQUIRIES). Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional exact copies of the grant application and all five sets of any appendix material must be sent to Dr. Olivia Preble at the address listed under INQUIRIES. Concurrent submission of an R01 and a Component Project of a Multi-project Application: Current NIH policy permits a component research project of a multi-project grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multi-project application and the R01 application are found to be in the fundable range, the investigator must relinquish the R01 and will not have the option to withdraw from the multi-project grant. This is an NIH policy intended to preserve the scientific integrity of a multi-project grant, which may be seriously compromised if a strong component project(s) is removed from the program. Investigators wishing to participate in a multi-project grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution. SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA A status report on NIH reinvention activities was presented in the NIH GUIDE (Vol. 24, No. 40, November 24, 1995. Two of these activities are: (1) the use of "Just-in-Time" grant applications; and (2) modular budget requests and funding. Both "Just-in-Time" and "Modular Budgeting" together with special page limits on the research plan are used for applications for this RFA. JUST-IN-TIME GRANT APPLICATIONS. The basic principle of "Just-in-Time" is to simplify and reduce the administrative and paperwork burdens of preparing an NIH grant application without compromising the initial review group determination of scientific merit or reasonableness of the proposed budget. To that end, both less and less detailed information is required in "Just-in-Time" applications. Applications in response to this RFA are to use the "Just-in-Time" format. MODULAR GRANTS. Applications are submitted and/or awards made with direct costs in modules (multiples) of a given amount ($25,000 for this RFA), with work proposed within these incremental categories. The model involves using pre-established funding levels for awards and acknowledging that grantees can and do rebudget post-award. This process eliminates the need for many budget details, thereby relieving administrative burdens on both NIH staff and grantee organizations and simplifying cost management by NIH program staff. RESEARCH PLAN PAGE LIMIT. Sections A - D of the research plan are limited to 20 pages for: (1) the overview of the proposed program; (2) each research project; and (3) each core. The NIAID brochure, "INSTRUCTIONS FOR ABBREVIATED APPLICATIONS FOR MULTI-PROJECT AWARDS", presents specific instructions for sections of the PHS 398 (rev. 5/95) application form that should be completed differently than usual. Some sections in the application are modified and others should not be completed for submission of the application, but will be requested if the application receives a score in the fundable range. For all other items in the application, follow the usual instructions on pages 5-20 of the PHS 398 booklet. REVIEW CONSIDERATIONS Review Procedures Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants (DRG) and for responsiveness by NIAID staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. In addition, the JDFI Lay Review Committee and Board will review all applications. Review Criteria The general criteria for P01 grant applications are presented in the NIAID BROCHURE. Additional review criteria specific to this RFA are: o A well-defined, unifying goal or problem area of research to which each project relates and contributes, thereby producing a research environment that allows each research effort to share the creative strengths of others. o A program director who possesses recognized scientific and administrative competence. He/she must demonstrate a substantial commitment to the program in time and effort, thereby exercising leadership in providing overall direction and in upholding rigorous scientific conduct. o Each research project must, as assessed by peer review, stand on its own independent scientific merit, as well as complement other projects whenever feasible. o The projects require the participation of established investigators in several disciplines or investigators with special expertise in several areas of one discipline. All investigators must contribute to and share the responsibilities of fulfilling the program objective. o In applications studying transplantation in an autoimmune setting, the ability of the proposed research to provide knowledge of basic, molecular and genetic mechanisms in the pathogenesis of the underlying autoimmune disorder and the development of innovative therapies for treating the human autoimmune disease to prevent subsequent graft loss due to the autoimmune disease. The appropriateness of the proposed experimental plan to validate the utility of the chosen strategy will be considered in this regard. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program priorities, 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. Requests for the NIAID brochure "INSTRUCTIONS FOR ABBREVIATED APPLICATIONS FOR MULTI-PROJECT AWARDS" as well as inquiries regarding programmatic issues, may be directed to: Stephen M. Rose, Ph.D. Division of Allergy, Immunology, and Transplantation National Institute of Allergy and Infectious Disease Solar Building, Room 4A14 6003 Executive Boulevard Bethesda, MD 20892-7640 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-5598 FAX: (301) 402-2571 Email: sr8j@nih.gov Direct inquiries regarding application preparation and review issues; address the letter of intent, and mail two copies of the application and all five sets of appendices to: Oliva Preble, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C-19 6003 Executive Boulevard Bethesda, MD 20892-7610 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8208 FAX: (301) 402-2638 Email: op2t@NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Victoria Putprush Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C-25 6003 Executive Boulevard Bethesda, MD 20892-7610 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: vp8g@NIH.GOV Schedule Letter of Intent Receipt Date: August 10, 1996 Application Receipt Date: October 8, 1996 Scientific Review Date: February 1997 Advisory Council Date: May 1997 Earliest Award Date: July 1997 AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301 (c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citation is No. 93.855 - Immunology, Allergy, and Transplantation Research as appropriate. Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed May 01 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-96-004 - V25(14) 05/03/96 Date: 2 May 1996 06:46:02 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 894 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4maeaq$g57@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HD96004 HD-96-004 P1O1 *************************************** NEUROBIOLOGY AND GENETICS OF AUTISM NIH GUIDE, Volume 25, Number 14, May 3, 1996 RFA: HD-96-004 P.T. 34; K.W. 1002030, 1002019, 0715162 National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders Letter of Intent Receipt Date: July 1, 1996 Application Receipt Date: September 20, 1996 PURPOSE The National Institute of Child Health and Human Development (NICHD) and the National Institute on Deafness and Other Communication Disorders (NIDCD) invite program project (PO1) grant applications for research that will elucidate the biological (neurobiologic and genetic) basis of autism and contribute to the discovery of a biological and/or diagnostic marker(s) for autism. Although the National Institute of Mental Health (NIMH) and the National Institute of Neurological Disorders and Stroke (NINDS) are not participating in this Request for Applications (RFA) for Program Projects, NIMH and NINDS have a long-standing, continuing interest in and financial commitment to autism research, including focused studies on the neurobiologic and genetic underpinnings of autistic spectrum disorders. NICHD, NIDCD, NIMH, and NINDS autism research programs support studies using the entire range of available funding mechanisms. The purpose of this RFA is to provide support for collaborative, multidisciplinary, methodologically-rigorous programs of research that will use advanced techniques in biological and behavioral sciences to study the diagnosis; biological etiology, including genetics; pathophysiology; and developmental course of autism. It is anticipated that up to three program projects will be supported by NICHD and NIDCD in response to this announcement. Autism, one of the most common of the developmental disorders, is a complex disorder of lifelong duration that affects most aspects of development, learning, and adaptation in the community. Genetic, infectious, metabolic, immunologic, neurophysiological, and environmental causes may lead to similar patterns of altered development, which result in autism. Such a complex problem requires integrated, multidisciplinary, even multisite approaches involving expertise in a number of disciplines and access to a sufficient number of well-characterized persons with autism. Program projects must have a minimum of three scientifically meritorious, related research projects. In response to this RFA, applications should propose an integrated and synergistic program of research on autism that includes at least one clinical component. Preference will be given to applications that include all of the following: (1) studies of basic biological (neurobiologic and/or genetic) factors relevant to the etiology, pathophysiology, developmental course, and/or treatment outcomes of autism; (2) specific studies of brain function (e.g., cognitive, information processing, neuropsychological, electrophysiological, and/or structural and/or functional imaging) in autism; and (3) studies of changes in phenotypic expression of autism over time. Multisite, collaborative projects are encouraged as are studies that specifically address the genetics of autism. The focus of all program projects funded under this solicitation must be autism per se. Other disorders including other autism spectrum disorders such as Asperger Syndrome (AS), Rett Syndrome (RS), Childhood Disintegrative Disorder (CDD), and Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) may also be included, but only if their inclusion clarifies distinctions between autism and these related disorders. Other well-defined disorders, which typically co-occur with autism, e.g., Fragile X, Tuberous Sclerosis, Attention Deficit Disorder (ADD), may also be included, but only if they elucidate the nature of autism. (Also see Special Requirements below.) 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, Neurobiology and Genetics of Autism, is related to the Healthy People 2000 priority areas that are concerned with developmental and learning problems in children and chronic, disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by any domestic for-profit and non-profit organization, public and private, such as a university, college, hospital, or laboratory, a unit of State and local government, and eligible agencies of the Federal government. Applicants may collaborate, through consultation or contractual arrangements, with domestic and/or international investigators. Applications from racial and ethnic minority individuals, women, and persons with disabilities are encouraged. MECHANISM OF SUPPORT This RFA will use the NIH program project grant (P01) mechanism. The purpose of the P01 mechanism is to encourage multidisciplinary approaches to the investigation of complex problems like autism and to facilitate economy of effort, space, and resources. Applications should be prepared in a manner consistent with the information presented in the NICHD PO1 PROGRAM PROJECT GUIDELINES (rev. Nov 1993), which are available from the NICHD/MRDD office listed under INQUIRIES. Responsibility for the planning, direction, and execution of the proposed program will be solely that of the applicant. The total project period for applications submitted in response to this RFA may not exceed five years. Anticipated date of award is March 1, 1997. 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. This RFA is a one-time solicitation. Future competing continuation applications will compete with all investigator-initiated program project applications and will be reviewed according to the customary NICHD peer review procedures. FUNDS AVAILABLE The following amounts have been set aside for the first year of support under this RFA: NICHD, $1,875,000 (total costs) and NIDCD, $400,000 (total costs). It is anticipated that up to three awards will be made. The 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 plan of the respective institutes, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Autism is a developmental disorder that probably originates during an early period of brain development. Most, but not all, children with autism also have mental retardation. Autism affects an estimated 400,000 Americans with staggering social and public health costs. The National Institutes of Health (NIH) has been committed to biological and behavioral research on autism since autism became a diagnostic entity. Impressive strides have been made in diagnosis and assessment, in documenting brain differences in autism, in developing behavioral techniques for intervention, and in assessing the use of medications to treat some of the learning and behavioral symptoms of autism. However, at the present time, there is no specific biological marker for autism, no cure, and no psychopharmacologic treatment for the core symptoms of the disorder. In April 1995, the National Institutes of Health (NIH) held an Autism State- of-the-Science Conference on the NIH campus. A working group of distinguished scientists in autism and related areas, and parent representatives met to assess the state of the science in autism, identify gaps in knowledge, and make recommendations to the NIH regarding promising areas for future research. The National Institute of Child Health and Human Development (NICHD) served as the lead agency for this conference which was cosponsored by the National Institute on Deafness and Other Communication Disorders (NIDCD), the National Institute of Mental Health (NIMH), and the National Institute of Neurological Disorders and Stroke (NINDS). The report >From that conference (Preliminary Report to the National Institutes of Health from the Autism Working Group) contained recommendations regarding research needs in diagnosis/ classification, epidemiology, pathophysiology including etiology and brain mechanisms, communication and social development, and medical and social/behavioral intervention. In addition, the conference attendees repeatedly cited the need for methodological refinements and multidisciplinary research strategies to identify a biological and/or diagnostic marker(s) for autism. More than 700 copies of the preliminary report were distributed to scientists and others for comment. Those comments were incorporated into the final report (Report to the National Institutes of Health on the State-of-the- Science in Autism, in press. For a copy, contact NICHD, MRDD office listed under INQUIRIES below). Particularly clear from the report and from comments from the field is the need for multi-site, collaborative studies that draw on expertise from many disciplines. This RFA represents the NIH's long-standing commitment to autism as well as NICHD's and NIDCD's specific response to the research recommendations and concerns raised in the final report from the NIH Autism State-of-the-Science conference. Research Focus This RFA invites investigators to apply advanced techniques of diagnosis and assessment, population genetics and molecular biology, structural and functional brain imaging, animal models, behavioral and cognitive neuroscience, and focused interventions, to elucidate the neurobiology of autism, with the long term goal of effective diagnosis, treatment, and prevention. Of particular interest are studies of persons with autism who are well-defined in terms of age, age of onset, gender, ethnicity, socioeconomic status (SES), severity of autism, comorbid conditions, intellectual status, cognitive-linguistic status, neuropsychological and neurophysiological status, educational status, and social/behavioral competencies. The following research priorities are offered as examples of areas of particular interest to the participating institutes. Preference in funding will be given to integrated, synergistic, multidisciplinary program projects that include all of the following: (1) studies of basic biological (neurobiological and/or genetic) factors relevant to the etiology, pathophysiology, and/or developmental course of autism; (2) specific studies of brain structure and/or function (e.g., cognitive, information processing, neuropsychological, electrophysiological, or structural and/or functional imaging) in autism; and, (3) studies of changes in phenotypic expression over time. (Also see Special Requirements below.) Genetics Available evidence indicates that the initial brain abnormalities in autism may occur during the early period of brain development. Various possible causes (e.g., infectious, metabolic, immunological, neurophysiological, environmental) may lead to similar patterns of development that result in autism. There is increasing evidence, however, that autism may be one of the most strongly genetically based of the complex developmental disorders. This genetic susceptibility probably involves more than one gene and may differ across families. Research is needed to elucidate the genetic basis for and/or contributions to the etiology of autism. Research is encouraged in, but not limited to, the following genetic priorities: o Gene mapping studies to identify the specific genetic loci that contribute directly to autism; o Development of useful animal models based on mutations of candidate genes, particularly genes regulating neurotransmitter pathways; o Studies of genomic control and regulation of neural development particularly relevant to autism; o Studies that elucidate gene-environment interactions; Brain Structure and Function Contemporary electrophysiological and imaging research, coupled with sophisticated neuropsychologic tools, offer exciting research possibilities for noninvasive study of brain structure and function in vivo, particularly as new technology in both image acquisition and image analysis is developed. Taken together, the available evidence in autism suggests that, although certain aspects of brain functioning are often spared in autism, the disorder involves multiple structures at multiple levels of the neuraxis. As with all research in autism, standardized diagnosis and control for age, age of onset (congenital vs regression), gender, degree of mental retardation, language and co-morbid conditions are essential in interpreting these findings. The identification of reliably occurring subtypes and subgroups will be absolutely critical with all methodologies, as a variety of brain structures and mechanisms may exist for subtypes with different etiologies. Applications are encouraged in, but not limited to, the following areas: o Hypothesis-driven studies combining imaging and neuropsychologic methods that demonstrate specific and predictable changes in the relationships between measurements of structure and function in different regions of the brain over the course of development, especially as they relate to executive function, attention, and memory in autism; o Systematic investigations that use in vivo and in vitro methodologies to elucidate the pathophysiology of autism; o Research on brain mechanisms (e.g., structural, functional, electrophysiological and/or neurochemical) underlying the development, regulation, and modulation of behaviors characteristic of autism, particularly those involving communication, social interaction, sensory problems, and/or movement in autism; o Studies that elucidate structural and/or functional differences: a) between children with congenital and later-onset autism, and/or b) that have the potential to explain or predict loss of language or seizure-prone or seizure-free patients; o Longitudinal studies of nerve growth and nerve growth migratory substances important for the modeling and remodeling of basic architectonics of the human brain, which have particular relevance to autism; o Research on the neurobiologic basis for reported abnormalities in motor and sensory abilities, particularly as they relate to comprehension and communicative expression, and/or to related research in movement and synchrony; o Studies of the role of immune factors in autism; o Hypothesis-driven studies of the role of neurotransmitters in autism; o Neurochemical markers for autism. Diagnosis and Classification For the first time, there are consistent criteria for the diagnosis of autism spectrum disorders in both the American (DSM-IV, 1994) and international (ICD- 10, 1993) diagnostic systems. The precision of these definitions will continue to evolve as new research clarifies the phenotype of autism. Autism remains one of the most reliable diagnoses in developmental and psychiatric research, although the validity of the definitions in terms of onset, course, or response to treatment remains to be established. Definitions of Asperger Syndrome (AS), Rett syndrome (RS), Childhood Disintegrative Disorder (CDD), and Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) yielded clear distinctions from autism in the DSM-IV field trials and other studies. Standard measures that yield these diagnoses across the age span from three years to adulthood are now available and widely used in research in North America and Europe. Subject Selection criteria outlined below are applicable for research in this area. Age of onset (congenital vs regression) has particular relevance for early identification. Recommended areas of investigation include, but are not limited to the following: o Longitudinal, developmental studies of diagnosis and classification, combined with biological and behavioral studies that establish the validity of the similarities and distinctions across two or more of the autism spectrum disorders with respect to such characteristics as onset, developmental course, response to treatment, and/or outcome. Autism can be distinguished reliably from Rett syndrome, and Childhood Disintegrative Disorder (CDD), but are these simply different expressions of the same disorder or of different disorders with different etiologies, course, and/or treatment response? The search for a biological/diagnostic marker(s) is critical here. o Studies of other subgroups within autism that have been replicated across independent centers and across time and that address significant aspects of diagnosis such as course, response to treatment, and/or well-defined differences in etiology, pathophysiology, and behavioral repertoire; o Research on additional behavioral or developmental features often observed in autism, e.g., sensory hypersensitivity or repetitive or stereotyped behaviors, as well as features that may represent separate, but co- occurring (comorbid) disorders, e.g., obsessive-compulsive disorder or epilepsy as these occur in autism; o Research on the reliability and validity of current diagnosis and assessment systems for children with autism who are from racially and/or ethnically diverse backgrounds; o Studies that establish screening and/or diagnostic criteria for very young (under three years) children with autism. Early identification and prescription of specialized services is hampered by the lack of reliable and valid screening as well as diagnostic instruments; o Studies that allow more accurate description of adults with autism, particularly those that address issues in the transition from school to work and/or follow up of higher functioning individuals into adulthood. Communication/Social/Emotional Development Autism is a disorder characterized by significant impairment in both verbal and nonverbal communication, deficits in emotional expression and understanding, difficulties in initiating and maintaining social interaction, and a limited behavioral repertoire with restricted interests and activities. There are few longitudinal data so the course of communicative, social, and emotional development in children with autism is poorly understood. If longitudinal studies in communication, social, and/or emotional development are combined with biological studies, such research can elucidate the interplay over time between biological and environmental factors that influence the onset and course of lifespan communicative and social competence. Areas of research may include, but are not limited to the following: o Longitudinal, developmental studies of behaviors that are precursors to later communicative, social, and emotional behaviors, e.g., imitation, joint attention and joint referencing, vocalization, gaze, attachment, play, compliance, and self-awareness, particularly if studied in tandem with possible underlying neurobiological mechanisms; o Subtle sensory and motor impairments in autism that impact on social interaction and communication; o Predictors of which children will ultimately develop expressive language and of which will lose expressive language (which occurs in up to one third of children who develop autism after apparently normal early development); o Development, functions, and treatment of unconventional verbal behaviors such as echolalia, perseverative language, and incessant questions, particularly in the context of underlying neurobiology; Medical and Psychosocial Intervention Although both behavioral and medical interventions are available to improve learning and behavior in autism, there is no evidence of a cure for autism, nor any psychopharmacological treatments for the core symptoms of autism. Both basic research and clinical studies suggest the importance of intensive, structured, and highly individualized treatment for autism. Interventions early in life may be particularly effective, presumably because of the plasticity of the brain at that time. People of all ages, however, can profit from individualized treatment, although it is unclear at this time what specific components of treatment "packages" are responsible for gains noted. Further, the majority of intervention research has been conducted by the originator of the methods, or by someone with vested interests in the methods under study. Focused, single subject or group design studies are needed to advance understanding of the opportunities for and limits to which developmental neuroplasticity allows for recovery with intervention. This RFA is seeking focused, theory-driven, experimental interventions targeted at abilities or deficits specifically deficient in autism and/or predictive of later language and social skills. Baseline and outcome biological, cognitive, and social/communicative functioning can be assessed and progress monitored. Interventions should be consistent with one or more of the biological hypotheses being tested in other subprojects of the RFA. Such research may include, but is not limited to: o New approaches to treatment utilizing advances in neuroscience, genetics, immunology, or other neurobiologic, electrophysiological, behavioral, and pharmacologic fields; o Focused interventions that test specific theories or hypotheses regarding possible neurobiological mechanisms; o Design and evaluation of pharmacologic agents specifically for the core symptoms of autism and/or that are useful in differentiating subtypes in autism; o Essential vs non-essential components of treatment "packages" for specific subtypes of clients; o Generalizability of subject change across situations or environments and/or generalizability of the method across implementors; o Interaction of persons with autism with specific aspects of their environments that typically affect child outcome. Needed are studies of parent-child and sibling-sibling interaction over time, and of the effects of physical environments, behavioral modeling, relationships, and exposure to language models that could contribute to more or less successful outcomes, carried out in concert with relevant neurobiological studies. SPECIAL REQUIREMENTS Clinical Component(s). All funded projects must include at least one clinical component. Annual Meetings: Principal Investigators from funded program projects are expected to attend an annual meeting at the NIH to share findings, research approaches, and core instrumentation. The first such meeting is expected to take place in March 1997. Provision for funds for travel to this annual meeting should be included in the budget and budget justification. Advisory Board: Applicants are encouraged to propose and design an external Advisory Board to provide outside counsel and review for the program project. Applicants are not to select or contact proposed Advisory Board members at this time. Details of the operation of the Board, including size, structure, function, and frequency of meetings should be specified, as well as the type of expertise and level of seniority of Board members to be recruited. Members of the Advisory Board are to be selected and confirmed within three months of the award date and notification sent to program staff. Names of prospective Board members are not to appear in the application or appendices. Provision for costs of the Advisory Board are to be included in the budget and budget justification. Research Population: The selection of the core research population should be based upon the need to conduct integrated, prospective, developmental, longitudinal investigations incorporating biomedical and behavioral studies. Well-justified, cross-sectional studies should also be considered. Such cross-sectional studies must be related meaningfully to the questions being asked within the longitudinal studies. It is expected that not all children within the research population will manifest the entire range of characteristics of autism. In fact, it is likely that there will be subgroups and subtypes of subjects with significantly different patterns of strengths and deficits, different patterns of comorbidity, levels of severity, and different psychological/cognitive profiles. Applicants, then, should consider research protocols that are capable of identifying well-defined subgroups and subtypes that exist within the sample. Investigators should also consider a broad enough sample to ensure a representative number of subtypes and contrast groups within the study population. For example, of interest are subtypes of children with autism who display no comorbid conditions, a single comorbid condition, or a combination of comorbid deficits, e. g., deficits in intellectual functioning and attention. Access to Subjects: Applicants must document access to a sufficient number of well-characterized subjects with autism. Subject Selection Criteria: The samples for study must be rigorously defined so that complete replication in another site can be accomplished. Within this context, applicants should provide clearly documented and operationalized definitions for their subject selection criteria. Investigators are expected to use standard diagnostic procedures that operationalize DSM-IV/ICD 10 criteria in order to promote replicability and encourage communication among scientists, clinicians, and parents. Identification of autism on the basis of a criterion of "school identified" or "clinic identified" is discouraged unless clearly identified diagnostic criteria in these cases match the applicant's a priori established selection criteria. Likewise, criteria for selection of contrast group(s) must be clearly specified and justified. All patient participants selected for study must be defined with reference to age, age of onset (congenital vs. regression), gender, ethnicity, socioeconomic status (SES), severity of autism, comorbid conditions, intellectual, cognitive, and linguistic status. As far as possible, comparison groups should be comparable on most of these characteristics and comparison norms should take into account age, ethnicity, and gender. Failure to control for such variables is one reason why replication rates of previous studies, especially biomedical studies, are so low. Use of structured instruments for assessment of current and past history of neurologic and psychiatric disorders and family history is strongly encouraged. Measurement Criteria: Standardized tests, laboratory tasks, observational measures, and other assessment procedures (e.g., dynamic assessment procedures) should be selected on the basis of known reliability and validity as well as appropriateness to the population under study. If reliability and validity characteristics are not yet known for a particular assessment or measurement procedure, the application should contain specific plans for establishing these features. The valid measure of change over time will be critical to much of the research called for in this RFA since the study of developmental course is one of the primary concerns. Statistical Methodologies: New statistical methodologies are currently emerging to make longitudinal studies more informative. Models such as individual growth curve models acknowledge consistent individual differences expressed in different trajectories. To reduce both the time and cost of longitudinal studies, investigators are encouraged to investigate accelerated lifetime sampling or other available methods, where subjects are entered into study at different ages and followed for some period of time, in such a way that age spans over which subjects are followed overlap each other. Investigators are encouraged to explore these and other cost-effective strategies that are particularly appropriate to the study of this disorder. Gene Mapping Studies: Program projects proposing a gene mapping component must include documentation of access to a large enough sample of well- characterized subjects. For genetic linkage of complex disorders of this sort, a variety of factors, e.g., genetic heterogeneity, subtypes etc., will affect the power of a linkage analysis. This necessitates very large samples to allow detection of genetic effects. Successful applicant teams must have relevant training and experience in diagnosis and classification in autism for definition of the phenotype, as well as training and experience in genetics. Applicants are encouraged to become familiar with the resources available at NIH for genotyping and for consultation regarding genetic analysis and statistical genetics. Multisite collaborative teams may be needed to encompass the necessary expertise and to have documented access to a large enough sample of well-characterized cases. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by July 1, 1996, a letter of intent that includes a descriptive title of the proposed research; the name, address, telephone, fax, and, if available, e-mail numbers of the overall program project Principal Investigator; titles and principal investigators of the component subprojects and cores; names of other key personnel and participating institutions; a statement of relevance of the project to autism; and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows Institute staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Marie M. Bristol, Ph.D, Center for Research for Mothers and Children National Institute of Child Health and Human Development Executive Building, Room 4B09 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852-7510 (for express/courier service) Telephone: (301) 496 1383 FAX: (301) 496 3791 Email: BRISTOLM@HD01.NICHD.NIH.GOV APPLICATION PROCEDURES Applications are to be submitted on grant application form PHS 398 (rev. 5/95) and will be accepted only at the announced deadline. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. Applications should be prepared in a manner consistent with the information presented in NICHD PO1 PROGRAM PROJECT GUIDELINES, (rev. Nov 1993), which are available from the MRDD, CRMC, NICHD office listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC-7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent under separate cover to: Susan C. Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development Executive Building, Room 5E03 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852-7510 (for express/courier service) Applications must be received by September 20, 1996. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is 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 then reviewed for responsiveness to the RFA by NICHD and NIDCD staff. Incomplete applications will be returned to the applicants without further consideration. If the application is not responsive to the RFA, DSR staff may contact the applicant to determine whether to return the application to the applicant or to submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council(s) of NICHD and/or NIDCD. Review Criteria Review criteria for RFAs are generally the same as those for unsolicited program project grant applications. The scientific, technical, or medical significance and originality of the overall program and of the individual projects are the most critical elements in the review. In addition, applications received in response to this RFA will be evaluated according to the following criteria: Overall Program Criteria o documentation of the ability to recruit and maintain a sufficient number of well-characterized participants with autism; o coordination, interrelationship, cohesiveness, and synergism among the individual research projects and core components; relationship of the program objectives to autism; evidence that the proposed program project will have greater significance as a whole than the individual projects standing alone; o relevance of the program to the NICHD mission, and/or to the mission of NIDCD; o likelihood that this research will contribute to the discovery of a biological/diagnostic marker(s) for autism; o the leadership ability, scientific stature, and administrative competence of the program director, including appropriate commitments of time and direction; o demonstration of the program director's ability to develop a well-defined central research theme for the overall program project; o participation of a suitable number of responsible, experienced investigators who have well-designed research projects; o previous experience of participating investigators in collaborative research, preferably with a prior history of collaborative scholarly productivity; o an appropriate organizational and administrative structure for effective attainment of program objectives, including specific procedures for both regular and extraordinary scientific and fiscal communication, collaboration, and cooperation among project investigators within and across projects and sites; o arrangements for internal quality control of ongoing research, the allocation of funds, day-to-day management, and contractual agreements; o the quality of the intellectual and physical environment in which the research would be conducted, including the availability of space, equipment, human subjects, and other resources, and the potential for interaction with scientists from multiple departments, institutions, and with internal and external advisory committees; o the appropriateness of the program size; small enough to afford effective interaction focused on a specific central theme and large enough to achieve synergy and economies not provided by regular research grants; o institutional commitment to the research and to the program including fiscal responsibility and management capability to assist the program director and staff in adhering to NIH policies; o qualifications and research experience of the overall Program Director for the entire program project, and of the principal investigators for the component projects; o for multisite projects, evidence that the multiple sites make substantial contributions to the scientific enterprise in a cost-effective manner, e.g., range of scientific expertise, access to well-characterized subjects, and/or additional institutional resources; Individual Projects and Core Unit Criteria: The review criteria for the component research projects and core units are: o the scientific merit and relevance to autism of each individual project in the program context; o sufficient pilot data to support the feasibility and scientific merit of each subproject, if appropriate; o qualifications, experience, and commitment of the investigators, and their ability to devote the required time and effort to the program; o appropriateness and adequacy of the experimental approaches proposed to carry out the research; o the multidisciplinary scope of the program; o the specific scientific objectives of each project that will benefit from, depend upon, or contribute to collaborative interactions with the other component projects within the PO1, even if the component projects are located at different sites (i.e., objectives that can be uniquely accomplished, specific contributions to the accomplishments of objectives in other projects, objectives that can be accomplished with greater effectiveness, and/or economy of effort, etc.); o appropriateness of the proposed budget for each component research project and core unit, and duration in relation to the proposed research; cost effectiveness and quality control of core services; o quality of and justification for proposed core facilities and the appropriateness of the research projects' use of core services; o specific plans to enhance communication, cooperation, and collaboration among the investigators; o as appropriate, adequacy of plans for the protection of human subjects, animals, and/or the environment; and o for all human subject research, the appropriateness of study samples in terms of adequate representation of women and minorities. AWARD CRITERIA In addition to the scientific and technical merit of the application as determined by peer review, other factors may be considered in making the awards. These criteria are: o clear relevance of each subproject to the biology and behaviors of autism; o scientifically appropriate, novel approaches to autism research; o use of multiple levels of analysis to address autism including etiology, neurobiology; pathophysiology; and/or treatment in autism within a single program project; o inclusion of diagnostic, neurobiological and/or genetic, imaging, and intervention studies on a common sample (or subsample of the total sample). o relevance to national needs, NIH Institute priorities, portfolio balance, and geographic distribution. The anticipated date of the award is March 1, 1997. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic and scientific issues to: Marie M. Bristol, Ph.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development Executive Building, Room 4B09 - MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1383 FAX: (301) 496-3791 Email: BRISTOLM@HD01.NICHD.NIH.GOV Judith Cooper, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400C-11 - MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 496-5061 FAX: (301) 402-6251 Email: JUDITH_COOPER2NIH.GOV For fiscal and administrative inquiries, potential applicants may contact: Mr. E. Douglas Shawver Grants Management Branch National Institute of Child Health and Human Development Executive Building, Room 8A017 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496 1303 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865, Research for Mothers and Children. Awards are made under authorization of the Public Health Services Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun May 05 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 5 May 1996 Date: 6 May 1996 16:07:09 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 117 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4mm0mt$g6i@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: International Document Title: INT 96-12 - THE REPUBLIC OF KYRGYZTAN File size (bytes): STIS Filename: int9612.txt Title: INT 96-13 - JAPAN's BASIC LAW FOR SCIENCE AND TECHNOLOGY File size (bytes): STIS Filename: int9613.txt Document Type: Press Release Title: PROGRESS IN MATH AND SCIENCE PERFORMANCE PROMPTS -CAUTIOUS OPTIMISM- AT NSF File size (bytes): STIS Filename: pr9616.txt Title: RESEARCH GROUP CULTIVATING FAMILY TREE OF PLANT LIFE File size (bytes): STIS Filename: pr9617.txt Document Type: Program Guideline Title: NSF 95-133 Arctic Research Program File size (bytes): STIS Filename: nsf95133.txt Title: NSF 96-92 Earthquake Engineering Research Centers File size (bytes): STIS Filename: nsf9692.txt Document Type: Recruit Title: Director, Office of Information and Resource Management File size (bytes): STIS Filename: vep962c.txt Title: Director, Office of Information and Resource Management File size (bytes): STIS Filename: vep962i.txt Title: Director, Office of Information and Resource Management File size (bytes): STIS Filename: vep962l.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: CMMTG -- NSF Advisory Committee Meetings File size (bytes): 5850 STIS Filename: cmmtg.txt Document Type: News Title: Quantum Physics in the 21st Century File size (bytes): Much More is Different. 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From owner-sci-resources@net.bio.net Thu May 09 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-96-052 - V25(15) 05/10/96 Date: 9 May 1996 20:03:50 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 574 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4mubmm$hga@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PAR96052 PAR-96-052 P1O1 ************************************* SCIENCE EDUCATION PARTNERSHIP AWARD NIH GUIDE, Volume 25, Number 15, May 10, 1996 PA NUMBER: PAR-96-052 P.T. 34; K.W. 0720005, 0710030, 0404000 National Center for Research Resources Application Receipt Date: October 1, annually PURPOSE The Science Education Partnership Award (SEPA) Program encourages active biomedical and/or behavioral scientists to work as partners with educators, media experts, community leaders and other interested organizations on projects to improve the student (K-12) and the public understanding of the health sciences. In FY 1991, 24 pilot projects were funded under a joint National Institutes of Health (NIH)/Alcohol, Drug Abuse and Mental Health Administration (ADAMHA) Request For Applications to determine the feasibility of such partnerships for increasing the scientific literacy of Americans. In FY 1994, the National Center for Research Resources (NCRR) solicited applications to further develop existing models and plan strategies for their dissemination to larger audiences; 15 of these projects were supported. This Program Announcement (PA) is intended to support either the development (Phase I) or the dissemination (Phase II) of highly meritorious and innovative models for enhancing K-12 student and/or general public health science education. The NCRR encourages the submission of grant applications from eligible organizations to 1) develop and evaluate model biomedical and/or behavioral science education partnership programs or 2) develop effective strategies for the dissemination of successful existing innovative biomedical and/or behavioral science education partnership models. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000", a PHS-led national activity for setting priority areas. This PA, Science Education Partnership Award (SEPA), is related to all priority areas. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Domestic organizations with a scientific and/or educational mission are eligible to submit applications. Such entities include colleges and universities, state and local education agencies, professional societies, museums, research laboratories, media producers, private foundations and industries, and other public and private education-related organizations, for-profit or non-profit. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign entities are not eligible. MECHANISM OF SUPPORT Awards under this PA will use the education projects (R25) grant mechanism. The applicant will be solely responsible for the planning, direction, and execution of the program. This PA is a continuing solicitation and is effective until otherwise announced in the NIH Guide. The earliest annual award date for SEPA applications will be July 1. Because of the wide range of programs that may be proposed, it is anticipated that the duration and size of awards may vary also. However, requests may not exceed three years of support and requested annual direct costs may not exceed $250,000. Indirect costs, other than those awarded to State or local government agencies, will be reimbursed at eight percent of total allowable direct costs. State and local government agencies will receive reimbursement at their full indirect cost rate. The award of grants pursuant to this PA is contingent upon the number of highly meritorious applications received and the availability of funds. Conditions of Award Publications or audiovisual materials costing over $25,000 each may be produced with project funds only if prior written approval is obtained from the funding agency. Two copies of the finished product must be supplied along with the annual or final progress report. Any products derived from the project activity must be publicized and must be freely available in the public domain. Any project funded under the SEPA program may not be used to endorse or publicize any profit-making activities. All publications, audiovisual materials and other products resulting >From SEPA activities supported entirely or in substantial part by NIH should include the following or comparable acknowledgement of support: "This project was supported by a Science Education Partnership Award, RR-XX-XXX, from the National Center for Research Resources, National Institutes of Health." An annual progress report must be filed with the Grants Management Officer, NCRR, and a final report is due within 90 days of the end of the project period. Reports should summarize the goals, methods, and results of the activity undertaken. It should be accompanied by at least two copies of any materials intended for dissemination developed as part of the SEPA project. The conditions of award cited above represent only a portion of applicable Public Health Service policy under which SEPA awards will be administrated. All awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000 (Rev.) April 1, 1994. All SEPA program awardees should have access to a copy of this document. RESEARCH OBJECTIVES Background In order for the NIH to fulfill its mission, it is necessary for adequate numbers of students to enter and remain in mathematics and science education tracks so that there will be a sufficient supply of scientists, engineers and technicians to meet the Nation's future workforce needs in the biomedical sciences and in the sciences related to health. The NIH also is dependent on a scientifically literate public that understands the behaviors that increase the risk of disease and the necessity for basic research to make progress toward improving health. The first SEPA program, initiated in 1991, seeded the development of a variety of model programs in the health- related sciences. The programs funded were designed to convey the importance and excitement of biomedical science in ways that create interest and enthusiasm among the students involved. Programs aimed at the general population were directed to increasing knowledge of scientific terms, concepts and reasoning, and the ability to understand health- related scientific policy issues. Priority was given to models that were innovative and had the potential to be replicated for widespread use. The programs focused on biomedical science areas, behavioral science areas, and related issues such as health promotion, disease prevention, and the inclusion of underrepresented groups. The 1994 SEPA program focused on a) the finalization of those model pilot programs that needed additional time to evolve and mature into finished products, and b) the development of effective strategies for the dissemination of well-evaluated, successful programs to reach a larger, preferably regional or national, audience and thereby have a significant impact on scientific literacy in the biomedical and/or behavioral sciences. Program Characteristics This SEPA Program is intended to 1) support the development and evaluation of model biomedical and/or behavioral science education partnership programs (Phase I) or 2) provide funding for the development of effective strategies for the dissemination of successful existing innovative biomedical and/or behavioral science education partnership models (Phase II). The program will support grants designed to encourage scientists to work with educators, community leaders and others to improve student and public understanding of science, and increase interest of young people in health science careers. The focus of student activities is to be at the kindergarten through 12th grade (K-12) level. The scientists who study disease and illness, and those who carry out basic research relating to these disorders, have a major contribution to make by conveying their knowledge and also the excitement in doing research. However, it is essential that scientists work with elementary and secondary school educators and administrators, community leaders, foundations, industry, museums, the media, and others in order to make effective contributions to improving science education and improving public understanding of both the process and accomplishments of science. The program will support the development or the dissemination of model programs that join working scientists, educators and others in enhancing the precollege science education and public understanding in biomedical science areas such as molecular biology, molecular genetics, immunology, neuroscience, and bioinformatics; behavioral science areas such as health promotion and prevention of disease, such as AIDS; and ethical issues relating to, for example, genetic engineering, environmental health, and responsible use of animals and humans in research. These are but a few examples; any of numerous other biomedical and/or behavioral science areas may be proposed. While SEPA projects must represent new activities and focus on health-related science, coordination with existing science education improvement programs, such as those funded by the National Science Foundation, the Department of Energy, the Department of Education, and others, are encouraged. The types of activities that may be proposed include, for example, the enhancement of current concepts in health sciences for current and prospective precollege teachers; development of innovative curricula involving state-of-the- art technologies; facilitation of linkages between biomedical scientists and local community and school programs, involving students, teachers and parents; inclusion of a variety of media options in an educational partnership program; and the provision of scientific/educational consultation to professional or educational organizations or community groups to facilitate scientific literacy. Many other types of activities may be proposed. Use of advanced technologies that incorporate modern pedagogical approaches, such as technology-based curricula and interactive computer strategies for enhancing student and teacher learning, are encouraged, as are programs which support the enhancement of biomedical science literacy for underrepresented groups in science, including women and minorities. Programs aimed at selected target populations, such as ethnic, racial, or gender-specific activities, must be culturally appropriate for these populations. Grant funds may be requested for expenses clearly related and necessary to conduct the projects, including both direct costs that can be specifically identified with the project and allowable indirect costs of the institution. Expenses must be itemized and justified for each year of the proposed project. SPECIAL REQUIREMENTS An annual SEPA Principal Investigator Meeting will be convened to foster collaboration, discuss newly emerging national strategies, coordinate dissemination, share evaluation methodologies and outcomes and minimize duplication of efforts. Travel funds for these activities should be included in the budget request for each year, and a statement regarding willingness to participate in these activities should be included in the application. 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 429B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research using human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available in most institutional offices of sponsored research and may be requested from the Office of Extramural Outreach and Information Resources, Office of Extramural Research, National Institutes of Health, 6701 Rockledge Drive, Room 6207, MSC 7910, Bethesda, Md 20892-7910, telephone 301/435-0714, fax 301-480-0525, Email: asknih@odrockm1.od.nih.gov. Applicants must follow the instructions provided in form PHS 398 except for the following: Face Page Item 1. Also indicate whether this is a Phase I or a Phase II application. Item 2. Check "YES" and identify the number and title of this PA. Items 4 and 5 must be completed. Item 6. The project period begin date should be the anticipated award date (i.e., July 1 or later). The length of the project period may not exceed three years. Research Plan Except as noted below, the following guidelines are applicable to both Phase I and Phase II applications. In general, the research plan should be structured to provide information sufficient to allow the reviewers to assess the project in terms of the review criteria stated below. Note that there are separate sets of review criteria; one for plans to develop new SEPA models (Phase I), another for plans to develop strategies to disseminate SEPA-type models that have already been developed (Phase II). Goals and Objectives (Phase I and Phase II applications) Identify the long range goals for the project and describe the specific objectives for the proposed project period. Significance and Rationale (Phase I and Phase II applications) Briefly summarize the background leading to the development of this plan. Explain why the particular strategy was chosen. Include information on the process and rationale for selecting the scientific area, the educational approach, and the target population, and indicate how this project will address an unmet need. Describe the advantages and limitations of the model selected, and its potential for widespread dissemination and adaptability for use by others. Preliminary Studies (Phase I applications only) For Phase I (model development), include any preliminary studies relevant to this application by the principal investigator and/or other key personnel. Also provide any other information that will help to establish the experience and competence of both program leadership and partnership organizations to effectively carry out the proposed project. Progress Report (Phase II applications only) For Phase II (dissemination), provide a detailed progress report of achievements with the existing pilot model, including: A description of the educational approach, the scientific content, and the nature and extent of existing educational and scientific partnerships and collaborative interactions. A detailed description of the educational material produced. Identify the actual materials as "Exhibits" and include in the application. Do not label these materials as appendices. Some examples of exhibit items are: Print materials (newsletters, booklets), videos, diskettes, and other computer software. Limit exhibits to items that are readily portable and to materials considered to be essential to review. A description of the evaluation process. Summarize the results of this process. Include the evaluation instruments in the appendix. A summary of the impact of the current pilot model to date. Include numbers of students, teachers and/or the public impacted by this approach, and other relevant outreach accomplishments. A description of any dissemination activities to date, or a description of the stage of development of the current model with respect to future dissemination plans. Proposed Plan (Phase I and Phase II applications) Describe in detail the activities proposed and how they will contribute to achieving the stated goals of the program. Give quantitative data on the numbers of teachers, students, and/or members of the general public projected to be involved and the quantity and types of educational materials to be produced and/or disseminated. Explain the relevance and potential of this project for dissemination to a broad population, including efforts aimed at underrepresented groups in science, including both women and minorities. Explain clearly the nature and extent of educational and scientific partnerships and collaborations to be developed (or, for those already established, any plans for expansion or modification), and the roles of key participants in the planning and conduct of the project. Provide documentation of the interest and commitment of partnership members to this project. Describe the administrative plan to organize and manage the overall project, and provide a timetable for the various tasks and activities for the entire project period requested. Describe the development and implementation of the plan for formative and summative evaluations of project activities. Include strategies for revisions to evaluative instruments and educational processes and/or materials. Specifically address the commitment of the applicant organization (and partnership members as appropriate) to this project by including evidence of contributions to project costs, and/or in-kind, resource, or other contributions. For Phase II (dissemination), describe the plans for continuation of the program following termination of SEPA program support. Appendix Material Information essential for the review of the application should not be included in the appendix. Appendix materials submitted with the application must adhere to the PHS 398 requirements. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, and one copy of the Appendix, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application, and four copies of the Appendix, are to be sent to: Office of Review National Center For Research Resources 6705 Rockledge Drive, Suite 6018, MSC 7965 Bethesda, MD 28092-7965 Bethesda, MD 20817 (for express/courier service) Applications must be received by the October 1 deadline. If an application is received after the deadline, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Applications will be reviewed by NIH staff for completeness and responsiveness. Applications that are incomplete or nonresponsive to this PA will be returned to the applicant. Applications that are considered complete and responsive will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCRR in accordance with NIH peer review procedures, using the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Research Resources Council, NCRR. Review Criteria Phase I - Development of New Models Significance of Model o Appropriateness of proposed model to NCRR SEPA goals. o Significance and merit of the proposed educational pilot model in terms of educational goals to be achieved for the target population and evidence of unmet needs to be addressed. Potential adaptability of the model for use by others. o Significance of biomedical and/or behavioral science content and participation by active scientists in appropriate disciplines. o Relevance and potential for dissemination to a broad population, including underrepresented groups in science. Program Design and Evaluation o Overall quality, feasibility, and adequacy of the design of the program to achieve its specific aims and long term objectives. o Merit of the program's evaluation plans, including formative and summative evaluation strategies. Resources and Personnel o Qualifications, experience and commitment of the principal investigator and other key personnel. o Appropriateness of proposed educational and biomedical and/or behavioral scientific partnerships and collaborations. o Adequacy of institutional commitment from partnership members, including evidence of contributions to the project, availability of resources, and/or other examples of institutional commitment. Phase II - Dissemination of Existing Models Significance of Model o Appropriateness of selected model to NCRR SEPA goals. o Significance and merit of the selected educational pilot model in terms of educational goals to be achieved for the target population and evidence of unmet needs to be addressed. o Relevance and potential impact of dissemination to a broad population, including underrepresented groups in science. o Adequacy of biomedical and/or behavioral science content, and participation by active scientists in appropriate disciplines. Progress and Current Status of Model o Significance of past progress, including evaluation of existing model, program impact to date, and readiness for dissemination. o Effectiveness of existing resources and personnel, including partnerships and collaborations. o Applicability of model to broad populations. Program Design and Evaluation o Overall quality, feasibility, and adequacy of the design of the program to achieve its specific aims and long term objectives. o Merit of the plans to evaluate dissemination activities, including formative and summative evaluation strategies. o Adequacy of accessibility, feasibility, scope, and cost effectiveness of dissemination strategies. o Appropriateness of plans to sustain the program after the period of grant support ends. Resources and Personnel o Appropriateness and qualifications of the program leadership and other personnel to implement future plans as proposed. o Adequacy of scientific and educational partnerships and collaborations for the proposed dissemination activities. o Adequacy of institutional commitment from partnership members, including evidence of contributions to the project, availability of resources, and/or other examples of institutional commitment. AWARD CRITERIA Award decisions will be based on the technical merit of the application as determined by peer review, availability of funds, and other programmatic priorities to ensure a balance among the various types of programs, populations served, and/or geographic distribution. Consideration will be given to reaching underrepresented groups, including women and minorities. INQUIRIES Written and telephone inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Robert F. Hendrickson Research Infrastructure National Center for Research Resources 6705 Rockledge Drive, Suite 6030, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0760 Email: roberth@ep.ncrr.nih.gov Direct inquiries regarding fiscal matters to: Ms. Mary V. Niemiec Office of Grants and Contracts Management National Center for Research Resources 6705 Rockledge Drive, Suite 6086, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0844 Email: maryn@ep.ncrr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.922. Awards will be made under authorization of the Public Health Service Act, Title III, Part A (Public Law 78-410, as amended under Public Law 99- 158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR, Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. The PHS strongly encourages all grant and contract recipients to provide a smoke free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Thu May 09 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-051 - V25(15) 05/10/96 Date: 9 May 1996 19:49:38 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 423 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4muas2$g9l@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA96051 PA-96-051 P1O1 *************************************** ROLE OF MICROBES IN AUTOIMMUNE AND IMMUNE-MEDIATED DISEASES NIH GUIDE, Volume 25, Number 15, May 10, 1996 PA NUMBER: PA-96-051 P.T. 34; K.W. 0715015, 0715120, 1002027 National Institute of Allergy and Infectious Diseases National Institute of Neurological Disorders and Stroke National Institute of Arthritis and Musculoskeletal and Skin Diseases PURPOSE The National Institute of Allergy and Infectious Diseases gives special consideration for funding to scientifically meritorious applications in response to Program Announcements. Program Announcements identify areas of ongoing research emphasis for the NIAID. The National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Neurological Disorders and Stroke (NINDS) and National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invite applications for basic and preclinical studies to increase knowledge of the role of microbes in the development and regulation of chronic pathologic immune responses, including autoimmune diseases, and to identify the genetic factors that increase or decrease the susceptibility to pathogen-induced immune disease. Exploitation of animal models of microbe-induced autoimmune disease to molecularly dissect the etiology and pathogenesis of autoimmune disease would be relevant. The knowledge developed through research into the mechanisms by which microbes break tolerance to self antigens should provide information about the underlying basis of autoimmunity. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement (PA), Role of Microbes in Autoimmune and Immune-mediated Diseases, is related to the priority area of diabetes and chronic disabling 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 20402-0325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) award. MECHANISM OF SUPPORT Traditional research project grant (R01), FIRST (R29), and small research grants (R03) may be submitted in response to this program announcement. The total requested project period for an application submitted in response to this PA may not exceed five years; a foreign application may not request more than three years of support. NIAID uses R03 grants to support small highly innovative or pilot projects. Applicants for R03 grants may request up to $50,000 annual direct costs for a period not to exceed three years. Funds and time requested should be appropriate for the research proposed. Applicants for R03 grants must follow special application guidelines, SMALL RESEARCH GRANTS -NIAID, which appeared in the NIH Guide for Grants and Contracts, Vol. 25, No. 9, March 22, 1996, and are available from the NIAID program staff listed under INQUIRIES. NINDS and NIAMS do not utilize the R03 mechanism. RESEARCH OBJECTIVES Background Infectious agents and/or their products have been implicated in the pathogenesis of autoimmune and chronic inflammatory diseases. Reiter's syndrome and Lyme disease are chronic immune-mediated inflammatory diseases that are clearly induced by infectious agents. Infection with Campylobacter jejuni is a common antecedent of the Guillain-Barre syndrome. A workshop recently convened by the NIAID on the Role of Infectious Agents in the Development of Autoimmunity highlighted this area as important for advancing our understanding of the pathogenesis of autoimmune disease. An association of rheumatoid arthritis with various organisms, including mycoplasma, Epstein-Barr virus, parvovirus, and rubella, has been suggested, but not convincingly proven. Insulin dependent diabetes mellitus (IDDM), a metabolic disease caused by immune destruction of the pancreatic beta cells, has also been associated epidemiologically with various infectious agents, including rubella and Coxsackie virus. Recently, cross reactivity of T cell clones to both Coxsackie protein and glutamic decarboxylase (GAD65), a pancreatic islet beta cell protein and IDDM-associated antigen, has provided molecular evidence for the association of IDDM with Coxsackie virus (1-2). In addition, various viral and bacterial peptides are able to activate myelin basic protein specific T cell clones, which were isolated from patients with multiple sclerosis (3). Various mechanisms by which pathogens could induce autoimmune or immune-mediated diseases have been suggested. The organism may directly generate an immune response by its continued presence. Alternately, the organism may induce an immune response, possibly by revealing self antigens that are normally sequestered from the immune system, and this autoreactive response then becomes self-sustaining. A role for superantigens, which can be of viral or bacterial origin, has also been postulated. Superantigens are products of microbes that activate a large proportion of the host's T cells by interaction with the MHC and the variable domain of the beta-chain of their antigen receptors. Recently, isolation of islet infiltrating lymphocytes from the pancreata of two patients with newly onset IDDM provided suggestive evidence that a superantigen may be involved in the origin of this disease (4). Many of the immune diseases associated with infection have a genetic component, suggesting that genetic susceptibility may play a role in the development of pathologic immune responses to microorganisms. In fact, the cross reactivity of T cell clones to Coxsackie protein and GAD65 was only evident in mice with a diabetes susceptible MHC background (2). Animal models also provide evidence that infectious agents may play a role in either initiating or in protecting the host from the development of autoimmune disease. For example, the maintenance of HLA-B27 transgenic mice in germ-free conditions prevents the development of the inflammatory disease (5). However, the NOD mouse develops diabetes at an increased frequency when kept in a "clean" facility. Investigation of the role of pathogens in the development and regulation of the immune response in autoimmune or chronic immune-mediated inflammatory diseases may lead to new preventive or therapeutic strategies for these diseases. Research Objectives and Scope This PA is designed to support basic and preclinical research on the role of pathogens in autoimmune and immune-mediated diseases. Relevant topics of research include, but are not limited to, the following: o mechanisms by which pathogens initiate, potentiate, or perpetuate a chronic immune response o definition of the genetic susceptibility to chronic immunologic injury related to pathogens o molecular, cellular, immunologic, and biological mechanisms of a host autoimmune associated response to pathogens or pathogen products o exploitation of the known animal models of microbially-induced autoimmune disease and of the known animal models of autoimmunity for information on the role of infectious agents in their pathogenesis o examination of whether persistence of the pathogen in the host is necessary to cause disease, or can the pathogen initiate a cascade of irreversible or reversible immunologic consequences. What factors determine the mechanism: the host, the pathogen, or both? o hypothesis-driven investigations to establish the role of infectious agents in the etiology of various human autoimmune diseases and to determine the fraction of cases attributable to infectious agents. The above examples of research approaches are not meant to be all inclusive or restrictive. Investigators are encouraged to develop their own innovative approaches to achieve the goals of this PA. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applicants for Small Research (R03) grants are to follow the application guidelines in the NIH Guide notice entitled "SMALL RESEARCH GRANTS - NIAID". Applicants are strongly encouraged to call program staff early in project development with any questions regarding the responsiveness of their proposed project to the goals of this PA. Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted on the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301)435-0714, email: asknih@odrockm1.od.nih.gov. Each application must be identified by checking "YES" on line 2 of the face page, and the number and title of this program announcement must be typed in section 2. The completed original and five legible, single-sided copies of the application must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) R03 APPLICANTS ONLY: Direct inquiries regarding review issues and special instructions for application preparation and mail two copies of the R03 application and all five sets of any appendices to: Stanley Oakes, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C06 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-7042 FAX: (301) 402-2638 Email: stanley_oaks@nih.gov FIRST (R29) applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. REVIEW CONSIDERATIONS Applicants for all Small Research (R03) grants must see the REVIEW CONSIDERATIONS section of the notice "SMALL RESEARCH GRANTS - NIAID." Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally about 50 percent of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. Review Criteria o scientific, technical, or medical significance and originality of 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. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. Concerns expressed by the initial review group about any of these factors may influence the recommendation of the National Advisory Allergy and Infectious Diseases Council or the advisory council for NIAMS or NINDS. AWARD CRITERIA The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance among research areas of the program announcement, availability of funds. INQUIRIES Written and telephone inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Elaine Collier, M.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A20 6003 Executive Boulevard - MSC 7640 Bethesda, MD 20892-7640 Telephone: (301) 496-7104 FAX: (301) 402-2571 Email: ec5x@nih.gov A. P. Kerza-Kwiatecki, Ph. D. Division of Demyelinating, Atrophic, and Dementing Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 804 7550 Wisconsin Avenue - MSC 9150 Bethesda, MD 20892-9150 Telephone: (301) 496-1431 FAX: (301)402-2060 Email: ak45w@nih.gov Susana Serrate-Sztein, M.D. Arthritis Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS37G Telephone: (301) 594-5032 FAX: (301) 480-4543 Email: szteins@ep.niams.nih.gov Direct inquiries regarding fiscal matters to: Mrs. Pamela Fleming Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B30 Executive Boulevard - MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: pf49e@nih.gov Ms. Dianna Jessee Division of Extramural Affairs National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 7550 Wisconsin Avenue - MSC 9190 Bethesda, MD 20892-9190 Telephone: (301) 496-9231 FAX: (301) 402-0219 Email: dj35j@nih.gov Ms. Carol Fitzpatrick Grants Management Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS43K Telephone: (301) 594-3506 FAX: (301) 480-4543 Email: fitzpatric@ep.niams.nih.gov AUTHORITY AND REGULATIONS The program is described in the Catalog of Federal Domestic Assistance, No. 93.855 - Immunology, Allergy and Transplantation Research, No. 93.853 - Clinical Research of Neurological Disorders and Stroke, and No 93.846 - Arthritis, Musculoskeletal and Skin Diseases Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. References 1. Atkinson, MA, Bowman, MA, Campbell, L, Darrow, BL, Kaufman, DL, and MacLaren, NK. Cellular Immunity to a Determinant Common to Glutamate Decarboxylase and Coxsackie Virus in Insulin-dependent Diabetes. Journal of Clinical Investigation 94:2125-2129, 1994. 2. Tian, J, Lehrmann, PV, and Kaufman, DL. T Cell Cross-reactivity between Coxsackie virus and Glutamate Decarboxylase is Associated with a Murine Diabetes Susceptibility Allele. Journal of Experimental Medicine 180: 1979-1984, 1994. 3. Wucherpfennig, Kai W., and Strominger, Jack L. Molecular mimicry in T cell-mediated autoimmunity: viral peptides activate human T cell clones specific for myelin basic protein. Cell 80:695-705, 1995. 4. Conrad, B, Weidmann, E, Trucco, G, Rudert, WA, Behboo, R, Ricordi, C, Rodriquez-Rilo, H, Finegold, D, and Trucco, M. Evidence for superantigen involvement in insulin-dependent diabetes mellitus aetiology. Nature 371: 351-355, 1994. 5. Taurog, JD, Richardson, JA, Croft, JT, Simmons, WA, Zhou, M, Fernandez-Sueiro, JL, Balish, E, and Hammer, RE. The Germfree State Prevents Development of Gut and Joint Inflammatory Disease in HLA-B27 Transgenic Rats. Journal of Experimental Medicine 180:2359-2364, 1994. From owner-sci-resources@net.bio.net Thu May 09 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-054 - V25(15) 05/10/96 Date: 9 May 1996 20:06:56 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 544 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4mubsg$huo@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA96054 PA-96-054 P1O1 *************************************** FUNCTIONAL IMAGING AND ALCOHOL-MOTIVATED BEHAVIOR NIH GUIDE, Volume 25, Number 15, May 10, 1996 PA NUMBER: PA-96-054 P.T. 34; K.W. 0706030, 0404003 National Institute on Alcohol Abuse and Alcoholism PURPOSE With the rapid advances in noninvasive imaging technology (e.g., ligand PET and SPECT scanning, functional magnetic resonance imaging, magnetic resonance spectroscopy, magnetoencephalography), it is now possible to directly correlate functional biologic activity in the brain with the performance of cognitive tasks. To capitalize on the advances in neuroimaging, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking applications that apply functional imaging technology to identify the neuronal systems involved in the reinforcing properties of alcohol which lead to and maintain addictive alcohol-seeking behavior. Studies that use noninvasive functional imaging technologies to measure alcohol's actions on mood, emotional states, self-administration, tolerance or cognition while simultaneously assessing metabolic, physiologic, and receptor function in the brain provide a means of detecting neuronal systems involved in the initiation of alcohol-seeking behavior in humans. In addition, measurement of subjective experiences and corresponding brain function during withdrawal and abstinence from alcohol could elucidate neural mechanisms underlying alcohol craving and relapse. Initiatives that apply functional imaging technology to the study of the neuroanatomical and neurochemical mechanisms underlying the motivational/drive aspects of the alcohol addiction process will eventually lead to new treatments for alcoholism. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Functional Imaging and Alcohol-Motivated Behavior, is related to the priority areas of alcohol abuse reduction and alcoholism treatment. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29). Research project grant (R01) applications from foreign institutions are limited to three years. MECHANISM OF SUPPORT Research support may be obtained through applications for a regular research project grant (R01) or FIRST (R29) Award. Applicants may also submit Investigator-Initiated Interactive Research Project Grants (IRPG) under this program announcement. Interactive Research Project Grants require the coordinated submission of related regular research project grant applications and, to a limited extent, FIRST Award applications from investigators who wish to collaborate on research, but do not require extensive shared physical resources. Further information on the IRPG mechanism is available in program announcement PA-96-001, NIH Guide for Grants and Contracts, Vol. 24, No. 35, October 6, 1995. Program Project Grants applications (P01) will not be accepted under this program announcement. RESEARCH OBJECTIVES In order to develop new pharmacotherapies for alcohol abuse and alcoholism, it is critical to understand the neuroanatomical and neurochemical circuits that control the emotional, cognitive, motivational, and reinforcing effects of alcohol. Functional imaging techniques that allow simultaneous measurement of brain functional activity and behavior in humans may provide more sensitive tools for understanding brain regions and biochemical pathways underlying craving for alcohol and impaired control over drinking. To date, the majority of noninvasive imaging studies in the alcohol field have used structural magnetic resonance imaging (MRI) to investigate structural brain changes produced by chronic alcoholism. These studies have yielded important findings about quantitative changes in tissue volume of grey and white matter that occur as a result of chronic alcohol ingestion, the interactive effects of aging and alcoholism, and the reversal of these structural changes following abstinence (Pfefferbaum and Rosenbloom, 1993; Jernigan, 1991a,b). However, structural MRI studies have failed to demonstrate a consistent relationship between the degree of cognitive deficits associated with chronic alcoholism, particularly memory impairment, and the extent of damage to structures thought to subserve memory functions, e.g., the hippocampus and mammillary bodies (Sullivan, et al., 1995; Davila, et al., 1994; Jernigan, et al., 1991b; DiSclafani, et al., 1995), possibly because these structural changes do not accurately reflect changes in cellular function. In contrast, functional imaging technologies that measure brain metabolism and blood flow (such as PET and SPECT), have found more consistent correlations between performance on tests of frontal lobe function (i.e., higher order reasoning, concept formation and abstraction) and cerebral metabolism in subdivisions of the frontal lobes of older alcoholic patients (Adams, et al., 1993; Adams, et al., 1995). These studies indicate that functional imaging may be more sensitive than structural imaging in demonstrating relationships between alcohol-induced behavioral impairments and alterations in underlying neural substrates. Furthermore, in these studies, cerebral metabolic activity and cognitive performance were measured in separate sessions. With the use of radioactive isotopes for PET that have short half-lives (e.g., 15-oxygen) or functional magnetic resonance imaging (fMRI) techniques, it is possible to measure simultaneously cerebral activity and behavior in the same individual under a variety of conditions. For example, the same subject can be studied in a resting state or while performing a task (cognitive activation). Multiple studies in the same subject improve resolution and permit subtraction of the resting state condition or a matched control task, leaving only those areas that are directly involved in the task of interest. The use of these "activation" techniques in chronic alcoholics will elucidate the entire neuroanatomical circuit involved in a particular cognitive task and allow comparison of functional activity in alcoholic subjects with controls. More importantly, the functional neuroanatomy or neurochemistry of alcohol's subjective effects, including mood, emotional changes, and craving could be studied in PET, SPECT, or functional magnetic resonance imaging (fMRI) activation paradigms. Most PET and SPECT studies in humans and animals to date have investigated the acute and chronic effects of alcohol on local cerebral glucose metabolism (LCGU) or regional cerebral blood flow (RCBF) to establish detailed patterns of changes in functional activity throughout the brain. Both human and animal studies have shown that dose, route and/or method of administration, time of measurement after alcohol administration (i.e., at different points on the ascending or descending limb of the blood alcohol curve), and individual experience with ethanol determine alcohol's effects on functional activity in specific regions of the brain (Eckardt, et al., 1988, 1992; for reviews see Volkow, et al., 1995a; Lyons and Porrino, 1995). Since alcohol's acute effects are biphasic, carefully controlled research is needed in humans and animals, particularly with respect to dose and pharmacokinetics, to yield more consistent data on the regional and temporal pattern of brain metabolic activity following acute alcohol administration. Longitudinal studies following chronic ingestion are needed to distinguish withdrawal-related changes in brain metabolism from irreversible changes, and to determine the effects of abstinence on recovery of brain metabolic function. Coupled with behavioral measures, these latter studies could reveal neural circuits associated with craving or cognitive deficits, the reversibility of cognitive deficits relative to brain functional metabolic deficits, and could shed light on how cognitive changes contribute to excessive drinking and relapse. Knowledge of the functional effects of alcohol, i.e., which neuronal structures are altered and how they are altered (stimulated or inhibited) is important for the development of pharmacotherapies. However, where PET and SPECT show the most promise for the alcohol field is in bridging the gap between brain chemistry and behavior. Although many of the amine and polypeptide receptor ligands have been labeled with radioactive tracers, only a few studies using PET or SPECT have measured alcohol's effects on neurotransmission. The NIAAA has supported research using PET and 2-deoxy-2-[F18]fluoro-D-glucose (FDG) to evaluate whether the function of the GABA system differs between alcoholics and nonalcoholics. A challenge dose of the benzodiazepine lorazepam, which exerts its effect by facilitating GABA activity, resulted in a reduced cerebral metabolic response (blunted response) in the thalamus, basal ganglia, and orbitofrontal cortex in alcoholics (Volkow, et al., 1993). A similar blunted metabolic responses to lorazepam challenge was observed in the cerebellum of individuals with a positive family history of alcoholism (Volkow, et al., 1995b). These findings suggest that disrupted activity of the benzodiazepine-GABA receptors may be both a consequence of chronic alcoholism and a potential marker for alcoholism risk. With the availability of receptor ligands for many neurotransmitter systems, more direct mechanistic studies of receptor function can be performed in animals and humans. For example, many aspects of dopamine biochemistry, a neurotransmitter that is associated with the reinforcing properties of alcohol, can be examined in the human brain. D2-dopamine receptors can be imaged and quantified with the tracer [11C]N-methyl spiperone. Dopamine release can be measured by its competitive inhibition of tracers that bind to dopamine receptors. The availability of both presynaptic and postsynaptic receptors, including the presynaptic dopamine transporter can be assessed. A few alcohol researchers have begun to use functional imaging techniques to study neurotransmitter function, such as quantifying D2 receptors in alcoholics. Much more research is needed combining functional imaging, neurochemistry, and behavior to eventually understand the mechanisms underlying the reinforcing/motivational aspects of alcoholism and to use this information to develop new treatments and pharmacotherapies. Magnetic resonance spectroscopy (MRS) and magnetoencephalography (MEG) are functional imaging techniques that have had relatively little application to neurobiological mechanisms of alcoholism. MRS detects signals of compounds that participate in energy metabolism and phospholipid metabolism, such as adenosine triphosphate (ATP, a cofactor in energy metabolism), creatine (an energy metabolite), phosphomonoesters and phosphodiesters (products of membrane phospholipids), and N-acetyl aspartate (an amino acid localized in neurons). The chronic effects of alcohol consumption on cerebral phosphorous metabolites and neuronal loss have been investigated using MRS techniques (Fein, et al., 1994; Meyerhoff, et al., 1995). Alcohol can also be detected in the brain by proton MRS (Mendelson, et al., 1990), and this method has been used to study alcohol tolerance in the human brain (Mendelson, et al., 1992). The amino acid glutamate and glutamate-related amino acids; such as, glutamine, aspartate, and gamma- amino-butyric acid (GABA), can be detected by 1H MRS (Vion-Dury, et al., 1994). Recently, MRS methods have been developed in animals and humans to measure cerebral blood flow (McLaughlin, et al., 1992), and cerebral metabolic rates for oxygen and glucose (Shulman, et al., 1992; 1994). Thus, issues involving alcohol's effects on brain biochemistry and glucose metabolism could be addressed using this method. Finally, MEG noninvasively measures actual electrical activity of the brain with millisecond temporal resolution. This technique has been used (most recently in combination with other imaging techniques) to image selective attention (Aine, et al., 1995), map auditory and visual cortex, and study memory processes (see Naatanen, et al., 1994 for review). Since alcohol's acute effects are biphasic, MEG could be used to delineate the temporal sequence of brain changes associated with acute alcohol-induced cognitive processing deficits. Areas needing further research include, but are not limited to: o Use of functional imaging technologies in combination with behavioral measures (e.g., craving questionnaires, mood inventories, cue-reactivity, self-administration paradigms), or drug challenge paradigms to elucidate the neuroanatomical and biochemical circuits underling the reinforcing properties of alcohol during initiation and/or withdrawal from alcohol. o Use of functional imaging technologies (PET and SPECT ligands) in humans and animals to characterize neurochemical processes associated with alcohol reinforcement and/or craving including neurotransmitter release, receptor concentrations, neurotransmitter synthesis, and neurotransmitter transporters. o Use of functional imaging technologies to study neural circuits underlying cognitive deficits associated with acute and chronic alcohol intake, particularly studies that elucidate how functional deficits in specific neuranatomical circuits and their related cognitive deficits may contribute to excessive alcohol intake. o Use of functional imaging technologies to study neurobiological markers of vulnerability to alcohol abuse and alcoholism in children and/or adolescents, particularly MRS, MEG, or fMRI that do not involve radioactive tracers. Applicants planning alcohol challenges to human subjects should obtain a copy of the "Recommended Council Guidelines on Ethyl Alcohol Administration in Human Experimentation" (rev. June 1989) from the program contact listed under INQUIRIES. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: asknih@odrockm1.od.nih.gov. The title and number of the program announcement must be typed in section 2 on the face page of the application. Applications for the FIRST award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. Review Criteria Criteria to be used in the scientific and technical merit review of applications for research project grants (R01) will include the following: 1. The scientific, technical, or medical significance, and originality of the proposed research. 2. The appropriateness and adequacy of the research design and methodology proposed to carry out the research. 3. The adequacy of the qualifications (including level of education and training) and relevant research experience of the principal investigator and key research personnel. 4. The availability of adequate resources and equipment to conduct the proposed research. 5. The appropriateness of budget estimates and duration in relation to the proposed research. 6. 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. The review criteria for FIRST Awards (R29), and IRPGs, are contained in the relevant program announcements. AWARD CRITERIA Applications recommended for approval will be considered for funding on the basis of the overall scientific and technical merit of the application as determined by peer review, programmatic needs and balance, and the availability of funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct general inquiries regarding research issues to: Ellen Witt, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-6545 FAX: (301) 594-0673 Email: ewitt@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Linda Hilley Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0915 FAX: (301) 443-3891 Email: lhilley@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. References Adams, K., Gilman, S., Koeppe, R., Kluin, K., Brunberg, J., Dede, D., Berent, S., and Kroll,P. (1993) Neuropsychological deficits are correlated with frontal hypometabolsim in positron emission tomography studies of older alcoholics. Alcoholism: Clinical and Experimental Research, 17(2):205-10. Adams, K., Gilman, S., Koeppe, R., Kluin, K., Junck, L., Lohman, M., Johnson-Greene, D., Berent, S., Dede, D., and Kroll,P. (1995) Correlation of neuropsychological function with cerebral metabolic rate in subdivisions of the frontal lobes of older alcoholic patients measured with [F18]fluorodeoxyglucose and positron emission tomography. Neuropsychology, 9(3):275-80. Aine, C., Supek, S., and George, J. Temporal dynamics of visual-evoked neuromagnetic sources: effects of stimulus parameters and selective attention. (1995) International Journal of Neuroscience, 80:79-104. Davila, M., Shear, P., Lane, B., Sullivan, E., and Pfefferbaum, A. (1994) Mammillary body and cerebellar shrinkage in chronic alcoholics: An MRI and neuropsychological study. Neuropsychology, 8:433-44. DiSclafani, V., Ezekiel, F., Meyerhoff, D., MacKay, S., Dillon, W., Weiner, M., and Fein, G. (1995) Brain atrophy and cognitive function in older abstinent alcoholic men. Alcoholism: Clinical and Experimental Research, 19(5):1121-6. Eckardt, M., Campbell, G., Marietta, C., Majchrowicz, E., and Weight, F. Acute ethanol administration selectively alters localized cerebral glucose metabolism. (1988) Brain Research, 444:53-8. Eckardt, M. Campbell, G., Marietta, C., Majchrowicz, Rawlings, R., and Weight, F. Ethanol dependence and withdrawal selectively alter localized cerebral glucose utilization. (1992) Brain Research, 584:244- 50. Fein, G., Meyerhoff, D., DiSclafani, V., Ezekiel, F., Poole, N., MacKay, S., Dillon, W., Constans, J., Weiner, M. 1H magnetic resonance spectroscopic imaging separates neuronal from glial changes in alcohol related brain atrophy. (1994) In: NIAAA Research Monograph 27: Alcohol and Glial Cells, Lancaster, F.(ed.), NIH Pub. No., 94-3742, Bethesda, MD, pp. 227-42. Jernigan, T. L., Schafer, K., Butters, N., and Cermak, L. (1991a) Magnetic resonance imaging of alcoholic Korsakoff patients. Neuropsychopharmacology, 4:175-86. Jernigan, T., Butters, N., DiTraglia, G., Schafer,K., Smith, T., Irwin, M., Grant, I., Schuckit, M., and Cermak, L. (1991b) Reduced cerebral grey matter observed in alcoholics using magnetic resonance imaging. Alcoholism: Clinical and Experimental Research, 15(3):418-27. Lyons, D. and Porrino, L. Visualizing neural pathways affected by alcohol in animals. (1995) Alcohol, Health and Research World, 19(4): 300-05. McLaughlin, A., Pekar, J., Ligeti, L., Ruttner, Z., Lyon, R., Sinnwell, T., van Gelderen, P., Fiat, D., and Moonen, C. In vivo measurement of cerebral blood flow and oxygen consumption using 17O magnetic resonance imaging. (1992) In: NIAAA Research Monograph 21: Imaging in Alcohol Research, Zakhari, S. and Witt, E. (eds.), DHHS Pub. No. (ADM)92-1890, Rockville, MD, pp. 273-86. Mendelson, j., Woods, B., Chiu, T., Mello, N., Luckas, S., Teoh, S., Sintavanarong, P., Cochin, J., Hopkins, M., and Dobrosielski, M. (1990) In vivo proton magnetic resonance spectroscopy of alcohol in the human brain. Alcohol, 7:443-47. Mendelson, J.,Chiu, T., Amass, L., Mello, N., Teoh, S., Woods, B., and Rhoades, E. Detection of ethanol tolerance in human brain with in vivo proton magnetic resonance spectroscopy. (1992). In: NIAAA Research Monography 21: Imaging in Alcohol Research, Zakhari, S. and Witt, E. (eds.), DHHS Pub. No. (ADM)92-1890, Rockville, MD, pp. 287-96. Meyerhoff, D., MacKay, S., Sappey-Marinier, D., Deicken, R., Calabrese, G., Dillon, W., Weiner, M., Fein, G. Effects of chronic alcohol abuse and HIV infection on brain phosphorus metabolites. (1995) Alcoholism: Clinical and Experimental Research, 19(3):685-92. Naatanen, R., Ilmoniemi, R., and Alho, K. Magnetoencephalography in studies of human cognitive brain function. (1994) Trends in Neuroscience, 17:389-95. Pfefferbaum, A. and Rosenbloom, M. In vivo imaging of morphological brain alterations associated with alcoholism. (1993) In: NIAAA Research Monograph 22: Alcohol induced brain damage, Hunt, W.A. and Nixon S.J. (eds.), NIH Pub. No. 93-3549, Rockville, MD, pp. 71-88. Shulman, R., Behar, L., Rothman, D., and Mason, G. NMR studies of cerebral metabolism. (1992) In: NIAAA Research Monography 21: Imaging in Alcohol Research, Zakhari, S. and Witt, E. (eds.), DHHS Pub. No. (ADM)92-1890, Rockville, MD, pp. 195-200. Shulman, R., Rothman, D., and Blamire, A. NMR studies of human brain function. (1994) Trends in Biochemical Sciences, 19:522-26. Sullivan, E., Marsh, L., Mathalon, D., Lim, K., and Pfefferbaum, A. (1995) Anterior hippocampal volume deficits without explicit memory impairment in chronic alcoholics. Alcoholism: Clinical and Experimental Research, 19:110-22. Vion-Dury, J., Meyerhoff, D., Cozzone, P., and Weiner, M. What might be the impact on neurology of the analysis of brain metabolism by in vivo magnetic resonance spectroscopy? (1994) Journal of Neurology, 241:354- 71. Volkow, N., Wang, G., Hitzemann, R., Fowler, J., Wolf, A., Pappas, N., Biegon, A., and Dewey, S. Decreased cerebral response to inhibitory neurotransmission in alcoholics. (1993) American Journal of Psychiatry Research, 150:417-22. Volkow, N., Wang, G., and Doria, J. Monitoring recovery of cognitive functioning with positron emission tomography. (1995a) Alcohol, Health and Research World, 19(4): 296-99. Volkow, N. Wang, G., Begleiter, H., Hitzemann, R., Pappas, N., Burr, G., Pascani, K., Wong, C., Fowler, J., and Wolf, A. Regional brain metabolic response to lorazepam in subjects at risk for alcoholism. (1995b) Alcoholism: Clinical and Experimental Research, 19(2):510-16. From owner-sci-resources@net.bio.net Thu May 09 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-053 - V25(15) 05/10/96 Date: 9 May 1996 20:05:12 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 424 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4mubp8$hj9@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA96053 PA-96-053 P1O1 *************************************** GENDER IN THE PATHOGENESIS OF AUTOIMMUNITY: MECHANISMS NIH GUIDE, Volume 25, Number 15, May 10, 1996 PA NUMBER: PA-96-053 P.T. 34; K.W. 0715015, 0765033 National Institute of Allergy and Infectious Diseases National Institute of Neurological Disorders and Stroke National Institute of Diabetes, Digestive and Kidney Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Dental Research Office of Research on Women's Health PURPOSE The National Institute of Allergy and Infectious Diseases gives special consideration for funding to scientifically meritorious applications in response to Program Announcements. Program Announcements identify areas of ongoing research emphasis for the NIAID. The National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Dental Research (NIDR), and the Office of Research on Women's Health (ORWH) invite applications for basic studies that will increase knowledge of the mechanisms by which gender influences the development of autoimmune disease and the regulation of the immune response in individuals with these diseases. Although it is clear that autoimmune diseases disproportionately affect women, the reasons for this are not clear. Research into the basic mechanisms by which sex hormones or non-hormonal gender differences affect the immune response and protect from or contribute to a break in self tolerance should allow for the development of improved therapeutic and preventive strategies for autoimmune disease. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Mechanism of Gender's Effect in Pathogenesis of Autoimmunity, is related to the priority area of diabetes and chronic disabling 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 20402-0325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) award. MECHANISM OF SUPPORT Traditional research project grant (R01), FIRST (R29), and small research grants (R03) may be submitted in response to this announcement. The total project period for an application submitted in response to this PA may not exceed five years; a foreign application may not request more than three years of support. NIAID uses R03 grants to support small highly innovative or pilot projects. Applicants for R03 grants may request up to $50,000 annual direct costs for a period not to exceed three years. Funds and time requested should be appropriate for the research proposed. Applicants for R03 grants must follow the special application guidelines available from the program staff listed under INQUIRIES. NINDS and NIAMS do not utilize the R03 mechanism. RESEARCH OBJECTIVES Background Autoimmune diseases, which disproportionately affect women, are a significant source of morbidity, often severe, in the population, costing billions of dollars annually in health care expenses and lost productivity. Systemic lupus erythematosus (SLE) affects women seven to nine times more frequently than men; Sj"gren's syndrome is found nine times as frequently in women; multiple sclerosis is twice as common in women; rheumatoid arthritis is three to four times as common; and autoimmune thyroid disease, including both thyroiditis and Grave's disease, is six to ten times as common in women as men. Many of these diseases increase in frequency after puberty, suggesting a role for sex hormones in their pathogenesis. However, autoimmune disease is also more common in prepubertal females than prepubertal males. Furthermore, pregnancy may exacerbate the course of some autoimmune diseases, while it ameliorates the course of other autoimmune diseases. Thus, factors other than sex hormones may be important in modulating the immune response in these diseases. Both human and animal studies suggest that the genetic background plays a significant role in the development of autoimmune disease. For example, although estrogens have been shown to accelerate the development of autoimmune disease in certain inherited animal models of SLE, and testosterone has been shown to inhibit the onset of disease in these same models, other models of SLE show minimal effects of sex hormones, suggesting an interaction of genetic and hormonal influences on the immune response. Additionally, data in both humans with multiple sclerosis and an animal model of this disease suggest differences in the response of males and females in the development of tolerance after feeding of oral antigens, implying that the efficacy of immunotherapies may be in part gender associated. A recent NIH-sponsored meeting on GENDER AND AUTOIMMUNITY reviewed the state of current knowledge concerning the reasons women disproportionally are afflicted by autoimmune diseases and identified several areas in which further research is needed. The role of sex hormones in modulating the normal and autoreactive immune response is not clear and more information is needed at the molecular and cellular level. Non-hormonal influences of gender, including imprinting, genetic, and environmental factors may also be important, but are not clearly defined. The breakdown of tolerance to self is a key component of autoimmune diseases, yet the mechanisms by which gender affects the development, maintenance, or loss of tolerance are unknown. Objectives and Scope This PA will support basic research on the role of gender in the pathogenesis of autoimmunity and autoimmune diseases. Relevant topics include, but are not limited to: o the role of non-hormonal intrinsic aspects of gender, including X-chromosome inactivation and other genetic/chromosomal factors in regulating the immune response; o neuroimmunological and neuroendocrine influences on the development of an autoreactive response; o genetic influences on the immune response of males versus females; o examination of the effects of sex hormones on the immune response at the molecular and cellular level. Examples include: sex hormone effects on T cell subset differentiation, i.e., Th1 versus Th2; cytokine networks; thymic selection; B cell repertoire development and activation; antigen presenting cell function and cellular trafficking; o mechanism(s) by which the autoreactive immune response is altered during pregnancy and in the post partum period; o the role of imprinting in the development of autoimmune disease; and o mechanism(s) by which gender regulates the response to therapies for autoimmune disease. The above examples of research topics and approaches are not meant to be all inclusive or restrictive. Investigators are encouraged to develop their own innovative hypothesis-driven approaches to achieve the goals of this PA. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applicants are strongly encouraged to call program staff early in project development with any questions regarding the responsiveness of their proposed project to the goals of this PA. Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted on the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: asknih@odrockm1.od.nih.gov. Each application must be identified by checking "YES" on line 2 of the PHS face page, and the number and title of this program announcement must be typed in section 2. The completed original and five legible, single-sided copies of the application must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) R03 APPLICANTS ONLY: Direct inquiries regarding review issues and special instructions for application preparation and mail two copies of the R03 application and all five sets of any appendices to: Stanley Oakes, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C06 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-7042 FAX: (301) 402-2638 Email: stanley_oaks@nih.gov FIRST (R29) applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. REVIEW CONSIDERATIONS Applicants for all Small Research (R03) grants must see the REVIEW CONSIDERATIONS section of the notice "SMALL RESEARCH GRANTS - NIAID," which appeared in the NIH Guide for Grants and Contracts, Vol. 22, No. 9, March 22, 1996, and are available from the NIAID program staff listed under INQUIRIES. Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally about 50 percent of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. Review Criteria o scientific, technical, or medical significance and originality of 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. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. Concerns expressed by the initial review group about any of these factors may influence the recommendation of the National Advisory Allergy and Infectious Diseases Council concerning funding of that application. AWARD CRITERIA The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance among research areas of the program announcement, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Elaine Collier, M.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A20 6003 Executive Boulevard - MSC 7640 Bethesda, MD 20892-7640 Telephone: (301) 496-7104 FAX: (301) 402-2571 Email: ec5x@nih.gov A. P. Kerza-Kwiatecki, Ph. D. Division of Demyelinating, Atrophic, and Dementing Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 804 7550 Wisconsin Avenue - MSC 9150 Bethesda, MD 20892-9150 Telephone: (301) 496-1431 FAX: (301) 402-2060 Email: ak45w@nih.gov Ronald Margolis, Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 5AN.12J 45 Center Drive - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8819 FAX: (301) 480-3503 Email: rm76f@nih.gov Susana Serrate-Sztein, M.D. Arthritis Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS37G Telephone: (301) 594-5032 FAX: (301) 480-4543 Email: ss86e@nih.gov Eleni Kousvelari, D.D.S., D.Sc. Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN 18A Telephone: (301) 594-2427 FAX: (301) 480-8318 Email: ek17w@nih.gov Direct inquiries regarding fiscal matters to: Mrs. Pamela Fleming Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B30 6003 Executive Boulevard - MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: pf49e@nih.gov Ms. Dianna Jessee Division of Extramural Affairs National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 7550 Wisconsin Avenue - MSC 9190 Bethesda, MD 20892-9190 Telephone: (301) 496-9231 FAX: (301) 402-0219 Email: dj35j@nih.gov Ms. Kim Law Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 6AS-49A 45 Center Drive - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8869 FAX: (301) 480-3404 Email: LAWK@EP.NIDDK.NIH.GOV Ms. Carol Fitzpatrick Grants Management Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS43K Telephone: (301) 594-3506 FAX: (301) 480-4543 Email: fitzpatric@ep.niams.nih.gov Mr. Martin Rubinstein Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AS-55 Telephone: (301) 594-4800 FAX: (301) 480-8301 Email: mr49c@nih.gov AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301 (c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citation is No. 93.855 - Immunology, Allergy, and Transplantation Research, No. 93.853 - Clinical Research of Neurological Disorders and Stroke, No. 93.847 - Diabetes, Endocrinology, and Metabolic Diseases, No. 93.121 - Oral Diseases and Disorders Research, and No. 93.846 - Arthritis, Musculoskeletal and Skin Diseases Research. Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Thu May 09 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 15, pt. 1of1, 10 May 1996 Date: 9 May 1996 19:48:00 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 650 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4muap0$g3c@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19960510 V25N15 P1O1 ************************************ X-comment: RFAs described: PA-96-051, PAR-96-052, PA-96-053, PA-96-054 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.05.10 NIH GUIDE - Vol. 25, No. 15 - May 10, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N2 ********************************************************** MULTI-INSTITUTIONAL COOPERATIVE AGREEMENTS FOR CLINICAL EVALUATION OF MAGNETIC RESONANCE IMAGING IN BREAST CANCER - ADDENDUM (RFA CA-96- 012) National Cancer Institute INDEX: CANCER NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** PREPARATION OF BASEMENT MEMBRANE REAGENT COMPONENTS (RFP NLM 96- 108/VMS) National Library of Medicine INDEX: NATIONAL LIBRARY OF MEDICINE $$INDEX R2 ********************************************************** THIN-FILM INTRACORTICAL RECORDING MICROELECTRODES (RFP NIH-NINDS-96-10) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX P1 ********************************************************** ROLE OF MICROBES IN AUTOIMMUNITY/IMMUNE-MEDIATED DISEASES (PA-96-051) National Institute of Allergy and Infectious Diseases National Institute of Neurological Disorders and Stroke National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: ALLERGY, INFECTIOUS DISEASES; NEUROLOGICAL DISORDERS, STROKE; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES $$INDEX P2 ********************************************************** SCIENCE EDUCATION PARTNERSHIP AWARD (PAR-96-052) National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX P3 ********************************************************** GENDER IN THE PATHOGENESIS OF AUTOIMMUNITY: MECHANISMS (PA-96-053) National Institute of Allergy and Infectious Diseases National Institute of Neurological Disorders and Stroke National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Dental Research Office of Research on Women's Health INDEX: ALLERGY, INFECTIOUS DISEASES; NEUROLOGICAL DISORDERS, STROKE; DIABETES, DIGESTIVE, KIDNEY DISEASES; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; DENTAL RESEARCH; WOMEN'S HEALTH $$INDEX P4 ********************************************************** FUNCTIONAL IMAGING AND ALCOHOL-MOTIVATED BEHAVIOR (PA-96-054) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 25, Number 15, May 10, 1996 P.T. 34; K.W. 1014004, 1014006 Department of Health and Human Services Notice is hereby given that the Office of Research Integrity (ORI) has made final findings of scientific misconduct in the following case: Andrew Friedman, M.D., Harvard Medical School: Based on a report >From Harvard Medical School and Dr. Friedman's admission, ORI found that Andrew Friedman, M.D., former Harvard Medical School Associate Professor of Obstetrics, Gynecology, and Reproductive Biology at the Brigham and Women's Hospital, committed scientific misconduct by falsifying and fabricating data in research supported in part by a Public Health Service (PHS) grant to the Brigham and Women's Hospital General Clinical Research Center. Between 1992 and 1995, Dr. Friedman altered and fabricated information in permanent patient medical records and notes by changing dates, changing and adding text, and fabricating notes for clinical visits that did not occur. Dr. Friedman admitted that he had falsified and fabricated approximately 80 percent of the data in research reports published in Fertility and Sterility (Friedman, A.J. and Thomas, P.P. "Gonadotrophin-releasing hormone agonist plus estrogen-progestin 'add-back' therapy for endometriosis-related pelvic pain." Fertility and Sterility 30:236-41, 1993.), in Obstetrics and Gynecology (Friedman, A.J. and Thomas P.P. "Does low- dose combination oral contraceptive use affect uterine size or menstrual flow in premenopausal women with leiomyomas?" Obstetrics and Gynecology, pp. 631-635, 1995.), and in an unpublished manuscript. Dr. Friedman has entered into a Voluntary Exclusion Agreement with ORI in which he has voluntarily agreed: (1) to exclude himself from any contracting or subcontracting with any agency of the United States Government and from eligibility for, or involvement in, nonprocurement transactions (e.g., grants and cooperative agreements) of the United States Government, as defined in 45 C.F.R. Part 76 and 48 C.F.R. Subparts 9.4 and 309.4 (Debarment Regulations) for a period of three years beginning April 19, 1996; (2) that for a period of two years immediately following the three year voluntary exclusion above, any institution that submits an application for PHS support for a research project on which Dr. Friedman's participation is proposed or that uses him in any capacity on PHS supported research must concurrently submit a plan for supervision of his duties; the supervisory plan must be designed to ensure the scientific integrity of Dr. Friedman's research contribution, and the institution must submit a copy of the plan to ORI; and (3) to exclude himself from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for a period of three years beginning April 19, 1996. The voluntary exclusion in (1) above shall not apply to Dr. Friedman's future training or practice of clinical medicine whether as a medical student, resident, fellow, or licensed practitioner, as the case may be, unless that practice involves research or research training. A statement retracting the article entitled "Gonadotrophin-releasing hormone agonist plus estrogen-progestin 'add-back' therapy for endometriosis-related pelvic pain." (Fertility and Sterility 30:236- 41, 1993) has been published in Fertility and Sterility (65(1):211, January 1996), and a statement retracting the article entitled "Does low-dose combination oral contraceptive use affect uterine size or menstrual flow in premenopausal women with leiomyomas?" (Obstetrics and Gynecology, pp. 631-635, 1995) has been published in Obstetrics and Gynecology (85(5):728, November 1995). INQUIRIES For further information, contact: Director, Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** MULTI-INSTITUTIONAL COOPERATIVE AGREEMENTS FOR CLINICAL EVALUATION OF MAGNETIC RESONANCE IMAGING IN BREAST CANCER - ADDENDUM NIH GUIDE, Volume 25, Number 15, May 10, 1996 RFA: CA-96-012 P.T. 34; K.W. 0715036, 0706030, 0735015 National Cancer Institute The National Cancer Institute (NCI) announces the following addendum to the Request for Applications (RFA) CA-96-012 entitled "Multi- Institutional Cooperative Agreements for Clinical Evaluation of Magnetic Resonance Imaging in Breast Cancer," which appeared in the NIH Guide for Grants and Contracts, Vol. 25, No. 12, April 19, 1996: "Recent discoveries have made it clear that mutations in certain genes, such as BRCA1 and BRCA2, can define a population of women having increased genetic susceptibility for the development of breast cancer. The immanent commercial availability of genetic testing in the near future heightens the need to evaluate the effectiveness of new technologies such as breast MRI for the screening of women at increased genetic risk, particularly since it is expected that many women who are found to carry mutations will be in younger age groups, where the sensitivity of conventional film mammographic screening is problematic. In addition to responding to the major focus of this RFA, applicants anticipating access to meaningful numbers of patients with mutations in known breast-cancer genes are strongly encouraged also to propose pilot studies that evaluate the potential role of breast MRI in detecting early breast cancer in women at increased genetic risk." To accommodate applicants who plan to incorporate MRI screening studies of breast cancer in women at increased genetic risk into their response to this RFA, applications also will be accepted on August 27, 1996, in addition to the previously published receipt date of July 30, 1996. INQUIRIES Questions regarding this addendum may be directed to: Dr. Carl Mansfield Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute 6130 Executive Boulevard, Suite 800 - MSC 7440 Bethesda, MD 20892-7440 Telephone: (301) 496-6111 FAX: (301) 480-5785 Email: mansfieldc@dtpepn.nci.nih.gov $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NLM-96-108/VMS ******************************************* PREPARATION OF BASEMENT MEMBRANE REAGENT COMPONENTS NIH GUIDE, Volume 25, Number 15, May 10, 1996 RFP AVAILABLE: NLM-96-108/VMS P.T. 34; K.W. 0780005 National Library of Medicine This procurement is a 100 percent set-aside for small businesses. The National Institute of Dental Research (NIDR) has a requirement to furnish the necessary services, personnel, material, equipment, and facilities, not otherwise provided by the Government, to prepare and deliver Laminin-1-sterile, Collagen IV, and EHS tumor. It is anticipated that a two-year, fixed-price type contract will be awarded. The total project effort is estimated at 2,080 labor hours over the two year period of performance. Request for Proposals (RFP) No. NLM 96-108/VMS will be available on or about May 3, 1996. All responsible sources may submit a proposal that will be considered by the NIDR. This acquisition is being managed for the National Institute of Dental Research by the Office of Acquisitions Management at the National Library of Medicine. INQUIRIES Copies of the RFP may be obtained by writing to: Valerie M. Syed Office of Acquisitions Management National Library of Medicine 8600 Rockville Pike Building 38A, Room B1N17 Bethesda, MD 20894 $$R1 END ************************************************************ $$R2 BEGIN NIH-NINDS-96-10 ****************************************** THIN-FILM INTRACORTICAL RECORDING MICROELECTRODES NIH GUIDE, Volume 25, Number 15, May 10, 1996 RFP AVAILABLE: NIH-NINDS-96-10 P.T. 34; K.W. 0740027, 0706010 National Institute of Neurological Disorders and Stroke The Neural Prosthesis Program (NPP) of the National Institute of Neurological Disorders and Stroke (NINDS) is supporting the development of a microelectrode array capable of recording from up to 64 sites located on a probe with multiple penetrating shanks. The broad objectives of the project are to develop multi-channel penetrating electrode arrays for both central nervous system (CNS) and peripheral nervous system (PNS) recording that will operate reliably in the hostile ionic environment within the body over decades of use in chronic implants. This will require the integration of micromachined electrode structures with active electronics and with integral flexible ribbon cables or with integral telemetry systems. This project will support the development and testing of the chronic recording electrode arrays. Electrode systems that include active electronics and ribbon cables will be tested in-vitro and in chronic animals. Probes will be furnished to the NPP for testing by other investigators. The goal is to design, fabricate, and test multiple-site intracortical recording microelectrode probes. The contractor shall also acquire or develop associated cables, connectors, and head mounts to produce a reliable signal path between the recording sites on a microelectrode probe and an extracoporal mating connector. This project will require established expertise in micormachining, bioengineering, integrated circuit design, integrated circuit fabrication, and animal studies. It is anticipated that one award, on a cost-reimbursement basis, will be made for a period of three years. INQUIRIES This is not a Request for Proposals (RFP). RFP NIH-NINDS-96-10 will be issued on or about May 15, 1996 with responses due approximately 60 days thereafter. Interested organizations should request either a streamlined version or the entire RFP document. If no selection is made, a streamlined version of the RFP will be provided, which includes only the Statement of Work, deliverable and reporting requirements, special requirements, and technical evaluation criteria. After examination of these documents, organizations interested in responding must request the entire RFP in writing or by FAX. Requests must cite the RFP number and supply this office with two self-addressed mailing labels. All responsible sources may submit a proposal that will be considered by the Government. Contracting Officer ATTN: RFP NIH-NINDS-96-10 Contracts Management Branch National Institute of Neurological Disorders and Stroke 7550 Wisconsin Avenue, Room 901 - MSC-9190 Bethesda, MD 20892-9190 FAX: (301) 402-4225 $$R2 END ************************************************************ $$P1 BEGIN PA-96-051 FULL-TEXT ************************************** ROLE OF MICROBES IN AUTOIMMUNITY/IMMUNE-MEDIATED DISEASES NIH GUIDE, Volume 25, Number 15, May 10, 1996 PA AVAILABLE: PA-96-051 P.T. 34; K.W. 0715015, 0715120, 1002027 National Institute of Allergy and Infectious Diseases National Institute of Neurological Disorders and Stroke National Institute of Arthritis and Musculoskeletal and Skin Diseases PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Neurological Disorders and Stroke (NINDS), and National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invite applications for basic and preclinical studies to increase knowledge of the role of microbes in the development and regulation of chronic pathologic immune responses, including autoimmune diseases, and to identify the genetic factors which increase or decrease the susceptibility to pathogen-induced immune disease. Exploitation of animal models of microbe-induced autoimmune disease to molecularly dissect the etiology and pathogenesis of autoimmune disease would be relevant. The knowledge developed through research into the mechanisms by which microbes break tolerance to self antigens should provide information about the underlying basis of autoimmunity. The mechanisms of support will be the research project grant (R01), the First Independent Research Support and Transition (FIRST) award, and the Small Research Grant (R03). HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Role of Microbes in Autoimmunity/Immune-Mediated Diseases, is related to the priority area of diabetes and chronic disabling 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 20402-0325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Elaine Collier, M.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A20 - MSC 7640 Bethesda, MD 20892-7640 Telephone: (301) 496-7104 FAX: (301) 402-2571 Email: ec5x@nih.gov $$P1 END ************************************************************ $$P2 BEGIN PAR-96-052 FULL-TEXT ************************************* SCIENCE EDUCATION PARTNERSHIP AWARD NIH GUIDE, Volume 25, Number 15, May 10, 1996 PA AVAILABLE: PAR-96-052 P.T. 34; K.W. 0720005, 0710030, 0404000 National Center for Research Resources Application Receipt Date: October 1, annually PURPOSE The Science Education Partnership Award (SEPA) Program encourages active biomedical and/or behavioral scientists to work as partners with educators, media experts, community leaders and other interested organizations on projects to improve the student (K-12) and the public understanding of the health sciences. This Program Announcement (PA) is intended to support either the development (Phase I) or the dissemination (Phase II) of highly meritorious and innovative models for enhancing K-12 student and/or general public health science education. The National Center for Research Resources (NCRR) encourages the submission of grant applications from eligible organizations to: (1) develop and evaluate model biomedical and/or behavioral science education partnership programs or (2) develop effective strategies for the dissemination of successful existing innovative biomedical and/or behavioral science education partnership models. Awards under this program will use the education project (R25) grant mechanism. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Science Education Partnership Award (SEPA), is related to all priority areas. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221), the NIH GOPHER (gopher.nih.gov), the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Dr. Robert F. Hendrickson Research Infrastructure National Center for Research Resources 6705 Rockledge Drive, Suite 6030, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0760 Email: roberth@ep.ncrr.nih.gov $$P2 END ************************************************************ $$P3 BEGIN PA-96-053 FULL-TEXT ************************************** GENDER IN THE PATHOGENESIS OF AUTOIMMUNITY: MECHANISMS NIH GUIDE, Volume 25, Number 15, May 10, 1996 PA AVAILABLE: PA-96-053 P.T. 34; K.W. 0715015, 0765033 National Institute of Allergy and Infectious Diseases National Institute of Neurological Disorders and Stroke National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Dental Research Office of Research on Women's Health PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Dental Research (NIDR), and the Office of Research on Women's Health (ORWH) invite applications for basic studies that will increase knowledge of the mechanisms by which gender influences the development of autoimmune disease and the regulation of the immune response in individuals with these diseases. Although it is clear that autoimmune diseases disproportionately affect women, the reasons for this are not clear. Research into the basic mechanisms by which sex hormones or non-hormonal gender differences affect the immune response and protect from or contribute to a break in self tolerance should allow for the development of improved therapeutic and preventive strategies for autoimmune disease. The mechanisms of support will be the individual research project grant (R01), the First Independent Research Support and Transition (FIRST) (R29) award, and the Small Research Grant (R03). HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement, Gender in the Pathogenesis of Autoimmunity: Mechanisms, is related to the priority area of diabetes and chronic disabling 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 20402-0325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Elaine Collier, M.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A20 - MSC 7640 Bethesda, MD 20892-7640 Telephone: (301) 496-7104 FAX: (301) 402-2571 Email: ec5x@nih.gov $$P3 END ************************************************************ $$P4 BEGIN PA-96-054 FULL-TEXT ************************************** FUNCTIONAL IMAGING AND ALCOHOL-MOTIVATED BEHAVIOR NIH GUIDE, Volume 25, Number 15, May 10, 1996 PA AVAILABLE: PA-96-054 P.T. 34; K.W. 0706030, 0404003 National Institute on Alcohol Abuse and Alcoholism PURPOSE With the rapid advances in noninvasive imaging technology (e.g., ligand PET and SPECT scanning, functional magnetic resonance imaging, magnetic resonance spectroscopy, magnetoencephalography), it is now possible to directly correlate functional biologic activity in the brain with the performance of cognitive tasks. To capitalize on the advances in neuroimaging, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking applications that apply functional imaging technology to identify the neuronal systems involved in the reinforcing properties of alcohol that lead to and maintain addictive alcohol-seeking behavior. Studies that use noninvasive functional imaging technologies to measure alcohol's actions on mood, emotional states, self-administration, tolerance or cognition while simultaneously assessing metabolic, physiologic, and receptor function in the brain provide a means of detecting neuronal systems involved in the initiation of alcohol-seeking behavior in humans. In addition, measurement of subjective experiences and corresponding brain function during withdrawal and abstinence from alcohol could elucidate neural mechanisms underlying alcohol craving and relapse. Initiatives that apply functional imaging technology to the study of the neuroanatomical and neurochemical mechanisms underlying the motivational/drive aspects of the alcohol addiction process will eventually lead to new treatments for alcoholism. Research support may be obtained through applications for a regular research project grant (R01) or First Independent Research Support and Transition (FIRST) Award (R29). Applicants may also submit Investigator-Initiated Interactive Research Project Grants (IRPG) under this program announcement. Interactive Research Project Grants require the coordinated submission of related regular research project grant applications and, to a limited extent, FIRST Award applications from investigators who wish to collaborate on research, but do not require extensive shared physical resources. Further information on the IRPG mechanism is available in program announcement PA-96-001, which was published in the NIH Guide for Grants and Contracts, Vol. 24, No. 35, October 6, 1995. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Functional Imaging and Alcohol-Motivated Behavior, is related to the priority areas of alcohol abuse reduction and alcoholism treatment. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Ellen Witt, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-6545 FAX: (301) 594-0673 Email: ewitt@willco.niaaa.nih.gov $$P4 END ************************************************************ From owner-sci-resources@net.bio.net Sun May 12 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 12 May 1996 Date: 13 May 1996 15:21:56 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 93 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4n8cm4$oj6@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 96-66 Directory of NSF-Supported Young Scholars Projects File size (bytes): STIS Filename: nsf9666.txt Document Type: Grant Conditions Title: FDP-AFO AIR FORCE OFFICE OF SCIENTIFIC RESEARCH (AFOSR) Specific Requirements (October 95) File size (bytes): STIS Filename: fdposr2.txt Document Type: Program Guideline Title: NSF 96-94 EXPERIMENTS IN DISTRIBUTED DESIGN AND FABRICATION AND RAPID PROTOTYPING USING AGILE NETWORKING File size (bytes): STIS Filename: nsf9694.txt Document Type: Recruit Title: Deputy Director, Division of Integrative Biology and File size (bytes): STIS Filename: vep963i.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 114048 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 124919 STIS Filename: phnorg.txt Document Type: STIS Title: Document Types on STIS File size (bytes): 2783 STIS Filename: stistype.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 stistype.txt, the text of your message should be as follows: get stistype.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve stistype.txt, you would enter: ftp> get stistype.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 Fri May 17 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 16, pt. 1of1, 17 May 1996 Date: 17 May 1996 20:26:09 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 703 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4njg0h$4nt@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19960517 V25N16 P1O1 ************************************ X-comment: RFAs described: DC-96-004, CA-96-014 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.05.17 NIH GUIDE - Vol. 25, No. 16 - May 17, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** JUST-IN-TIME PROCEDURES FOR FIRST AND CAREER AWARDS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** NIH PROCEDURES FOR HANDLING NON-ELECTION OF TITLE TO PATENTABLE BIOLOGICAL MATERIALS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** RESOURCES AVAILABLE FOR CANCER RESEARCH National Cancer Institute INDEX: CANCER $$INDEX N4 ********************************************************** BEHAVIORAL THERAPIES DEVELOPMENT PROGRAM (PA-94-078) National Institute on Drug Abuse INDEX: DRUG ABUSE NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** CONTRACEPTIVE EFFICACY TESTING (RFP SS-NICHD-96-01) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R2 ********************************************************** RESEARCH UNITS ON PEDIATRIC PSYCHOPHARMACOLOGY (RFP NIMH-96-CR-0005) National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX R3 07/18/96 ************************************************* NIDCD/ORMH MINORITY DISSERTATION RESEARCH GRANTS IN HUMAN COMMUNICATION (RFA DC-96-004) National Institute on Deafness and Other Communication Disorders Office of Research on Minority Health INDEX: DEAFNESS, OTHER COMMUNICATION DISORDERS; MINORITY HEALTH $$INDEX R4 08/20/96 ************************************************* COMMUNITY CLINICAL ONCOLOGY PROGRAM (RFA CA-96-014) National Cancer Institute INDEX: CANCER THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************** NOTICES $$N1 BEGIN ********************************************************** JUST-IN-TIME PROCEDURES FOR FIRST AND CAREER AWARDS NIH GUIDE, Volume 25, Number 16, May 17, 1996 P.T. 34; K.W. 1014006 National Institutes of Health Additional instructions for the Just-In-Time Procedures for First and Career Awards, which appeared in the NIH Guide for Grants and Contracts, Vol. 25, No. 10, March 29, 1996. These additional instructions apply only to the following Mentored Career Awards: o Mentored Research Scientist Development Award (K01) o Mentored Clinical Scientist Development Award (K08) o Developmental Academic Award (K07) The March 29 Just-In-Time notice indicates that the "Other Support Page" [format page 7 of the PHS 398 (rev. 5/95)] will no longer be needed for the Principal Investigator and other key personnel in applications for Career Awards and FIRST awards. It is still necessary, however, to provide information about the research activity of the sponsor and co-sponsor on mentored career awards. Information about the level and nature of the sponsor(s) research support will continue to be used by review committees to judge the strength of the research environment available to the candidate during the award period. Applicants are to provide information on the sponsor's and cosponsor's current and pending research support relevant to the candidate's research plan in a table within the section titled Statement by the Sponsor(s) Consultant(s), and Collaborator(s) in Section II, Part 2 of the application. Within this table, the following information on all related research projects must be provided: the funding source, the title of the project, the name of the Principal Investigator, the dates of the approved or proposed project, the annual direct costs, and a brief description of the major goals. Those applications that include the information about the sponsor's and cosponsor's current and pending research support on the "Other Support Page" will be accepted for the June 1, 1996 receipt date as part of the transition. However, all future applications must follow the Just-In-Time Procedures described above. INQUIRIES Questions about these procedures may be directed to: Walter T. Schaffer, Ph.D. Office of Extramural Research National Institutes of Health 6701 Rockledge Drive, MSC 7010 Bethesda, MD 20892-7910 Telephone: (301) 435-2770 Email: ws11q@nih.gov. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NIH PROCEDURES FOR HANDLING NON-ELECTION OF TITLE TO PATENTABLE BIOLOGICAL MATERIALS NIH GUIDE, Volume 25, Number 16, May 17, 1996 P.T. 36; K.W. 0780010, 1014006 National Institutes of Health A. Purpose This notice sets forth the National Institutes of Health (NIH) policy for allowing contractors and grantees (hereafter "Contractor") to license biological materials on which the contractor elects not to file a patent application and which are submitted to the NIH for review and possible election of government title under the Bayh-Dole Act. B. Background The NIH Office of Technology Transfer (OTT) has been delegated the authority to elect title to extramural inventions on behalf of the NIH. Under the Bayh-Dole Act, the NIH Contractor may elect title to inventions developed with NIH funding, but must file a patent application within one year of such election. Where the Contractor elects not to file a patent application, the Government may request title. Typically, the Contractor's election not to file a patent application on an invention is an indication that the Contractor is not interested in retaining domain over the invention. However, this is not necessarily the case with regard to patentable biological materials, which may frequently be licensed for commercial use without patent protection. The policy and procedures established by this notice are intended to simplify: (1) the reporting by Contractors of their intention to not file a patent application on the invention but to license the tangible biological material; and (2) the non-election of title to these inventions by the Federal Government where certain terms and conditions are met. C. Policy It is the policy of the United States Public Health Service (PHS) to make available to the public the results and accomplishments of the activities it funds. Restricted availability of unique research resources, upon which further studies are dependent, can impede the advancement of research and delivery of medical care. A notice in the NIH Guide for Grants and Contracts (Vol. 23, No. 26, July 15, 1994) and the PHS Grants Policy Statement explain in full PHS policy with regard to the distribution of research resources developed with PHS funds. The NIH Guide notice referenced above and the PHS Grants Policy Statement also set forth PHS policy encouraging the commercialization of the products of research developed with PHS funding, and allow institutions to make materials available to others for commercial purposes with appropriate restrictions and licensing terms. To ensure consistency with its public availability goals, the NIH Guide notice (referenced above) and the PHS Grants Policy Statement require that where the product of research developed with federal funding is a patentable, but unpatented, research product, the terms of a license must be no more restrictive than they would have been if the product had been patented. Accordingly, where the Contractor agrees with the conditions set forth below, which ensure the availability of unique research resources, NIH will not request title to the subject invention and will grant a Contractor's request to distribute the unpatented, tangible material through licensing. D. Procedures A contractor electing title to patentable biological materials and requesting to distribute them through licensing as unpatented tangible research materials must agree to the following conditions: 1. The Contractor must make a written request to the Division of Extramural Inventions and Technology Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7750, Bethesda, MD 20814-7750 2. Information describing the invention must be made publicly available either through publication in the scientific literature or by other appropriate means; 3. The licensing strategy must ensure that the research resource will be made available to the nonprofit research community. Generally, this can be accomplished through nonexclusive licensing, or exclusive licensing for distribution or sale of the materials. If an exclusive license is negotiated for internal use by a for-profit entity, the license must address continuing availability of the material to the nonprofit research community. Any exclusive license must provide for conversion to nonexclusive status or termination of licensee's rights upon failure to comply with the terms addressing continuing availability; 4. If an exclusive license is executed, provision must be made for independent maintenance of the material, such as at a national repository, or the originating grantee laboratory; 5. The government shall have a worldwide, irrevocable, unlimited royalty free, paid-up license in the material to make, use or distribute, or to have it made, used, or distributed for the Government. Upon request, sufficient quantities of the biological material shall be provided to the Government with such documentation as the Government is needed to preserve, use, and replicate the material to meet PHS needs; and 6. If the Contractor fails to fulfill the conditions of paragraphs 1-4 above, NIH shall automatically have the right to: (1) distribute the material, or (2) require the Contractor to comply with the Unique Research Resource requirements of its grant. F. Effective Date The policies and procedures set forth in this notice are effective immediately. INQUIRIES For additional information on this notice, contact: Ms. Sue Ohata Division of Extramural Inventions and Technology Resources National Institutes of Health 6701 Rockledge Drive MSC 7750 Bethesda, MD 20892-7750 Telephone: (301) 435-1986 FAX: (301) 480-0272 Email: Sue_Ohata@nih.gov $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** RESOURCES AVAILABLE FOR CANCER RESEARCH NIH GUIDE, Volume 25, Number 16, May 17, 1996 P.T. 34; K.W. 0780005 National Cancer Institute The Biological Carcinogenesis Branch, Division of Cancer Biology of the National Cancer Institute's (NCI) announces to the scientific community the availability of the following resources/services for cancer related research: 1. Cell Culture Identification Service. Using Isozyme Analysis, Immunofluorescence, Karyotypic Analysis (Chromosome Banding), Fluorescence In-Situ Hybridization and DNA Fingerprinting. Contact: Dr. Joseph Kaplan, Children's Hospital of Michigan, 3901 Beaubien Boulevard, Detroit, MI 48201, telephone (313) 745-5570, FAX (313) 993-7158 Citing Contract: #N01-CB-33063 Cost: Reasonable; inquire with specific requests 2. Goat Antisera Against: Avian, Bovine, Feline, Murine, and Primate Intact Viruses and Viral Proteins; Antibodies to Immunoglobulins for a number of species. Preimmune Sera are available to match Antisera for some Viruses. Contact: Dr. Steven R. Per, BCB Repository, Quality Biotech, Inc., 1667 Davis Street, Camden, NJ 08104, telephone (609) 966-8000, FAX (609) 342-8078 Citing Contract: #N01-CB-62600 Cost: $75.00/5 ml. Antisera; $25.00/5 ml. Preimmune Sera; $65.00/100 ml. Immunoglobulins (Frozen material); (Plus Shipping and Handling) 3. Viruses: Avian, Feline, Murine, and Primate Viruses Produced in vivo and in vitro. Contact: Dr. Steven R. Per, BCB Repository, Quality Biotech, Inc., 1667 Davis Street, Camden, NJ 08104, telephone (609) 966-8000, FAX (609) 342-8078 Citing Contract: #N01-CB-62600 Cost: Reasonable; inquire with specific requests. 4. Monoclonal Antibodies are available with specificities for synthetic peptides representing the amino acid sequences of the left end, right end and active site of the oncogene products of avian and mammalian retroviruses. Blocking peptides are also available, as are a limited number of cell lines producing the monoclonal antibodies. Contact: Dr. Steven R. Per, BCB Repository, Quality Biotech, Inc., 1667 Davis Street, Camden, NJ 08104, telephone (609) 966-8000, FAX (609) 342-8078 Citing Contract: #N01-CB-62600 Cost: Peptides $25.00/mg.; Ascites Fluid $45.00/ml.; Cell Culture $100.00/culture; (Plus Shipping and Handling) 5. Human sera from donors with various malignancies (including nasopharyngeal carcinoma), non-malignant disorders, and from normal individuals. Contact: Ms. Leota F. Hall, Division of Cancer Biology, National Cancer Institute, Executive Plaza North, Room 540, 6130 Executive Boulevard, MSC 7398, Bethesda, MD 20892-7398, telephone (301) 496-1951, FAX (301) 496-2025 Cost: Shipping and handling charges only $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** BEHAVIORAL THERAPIES DEVELOPMENT PROGRAM NIH GUIDE, Volume 25, Number 16, May 17, 1996 PA NUMBER: PA-94-078 P.T. 34; K.W. 0404009, 0404000, 0415001, 0745007, 0745060 National Institute on Drug Abuse PURPOSE This notice is an addendum to program announcement PA-94-078, published in the NIH Guide, Vol. 22, No. 26, July 15, 1994. The purpose of this addendum is to encourage research on the development and testing of assessment instruments and brief behavioral therapies for drug abuse and dependence and related HIV/AIDS risk behaviors for patients that are seen in office- based (e.g., pediatrics, adolescent medicine, family medicine, internal medicine, ob-gyn) and other health care settings. Many patients seek medical treatment for medical problems related to undetected or untreated drug abuse, and there is a need for screening instruments to detect these individuals and interventions to treat their drug abuse. The National Institute on Drug Abuse (NIDA) is supporting the study of behavioral therapies (including, but not limited to, psychotherapy, behavior therapy, cognitive therapy, family therapy, skills training, and counseling approaches) that will potentially have a significant impact on reducing drug abuse and addiction and reducing HIV/AIDS risk behaviors. For those investigators applying for grants under the Behavioral Therapies Development Program, this notice is meant to supplement Program Announcement PA-94-078, which is still in effect and should be consulted in conjunction with this addendum. RESEARCH OBJECTIVES Individuals who abuse psychoactive drugs (nicotine, marijuana, cocaine, prescription drugs, etc.) receive health care in a variety of office-based treatment settings from health professionals who may fail to recognize drug abuse or be unsure how to intervene once the problem is identified. Most of the screening and assessment tools currently in use have been developed to identify alcohol abuse and alcohol-related problems. There is a need to develop and test a) psychometrically reliable and valid screening and assessment instruments to detect drug use disorders and b) brief therapeutic interventions directed at the drug abuse and related health risk behaviors that can be used by health professionals in health care settings outside the conventional drug treatment program system. Such instruments and interventions may provide an opportunity for brief therapeutic interventions with individuals in early stages of drug abuse disorders and/or may increase patient acceptance of referrals to more intensive treatment for individuals more refractory to brief behavioral interventions. These approaches have been primarily studied in individuals who abuse alcohol and/or tobacco and are now just beginning to be studied in individuals who abuse illicit drugs and engage in other health risk behaviors. Research on brief therapeutic interventions that may be delivered by a range of health professionals (physicians, nurses, social workers, counselors, and others) is needed. Studies are needed to determine: o effects of brief behavioral interventions given prior to or instead of intensive treatment; o effects of brief interventions upon referrals to intensive treatment and upon treatment outcome; o effects of brief interventions upon treatment compliance; o the critical elements that account for therapeutic efficacy; and o the appropriate duration and intensity of this treatment approach. In addition, studies are sought on the development and testing of psychometrically reliable and valid screening and assessment instruments to detect drug abuse and addiction and related health risk behaviors in office-based and other health care settings by a variety of health professionals. Applicants are strongly encouraged to develop and test brief behavioral therapies that address the unique needs and perspectives of women, children, adolescents, and racial and ethnic minorities. In addition, applicants are encouraged to address reducing drug abuse related health risk behaviors such as injection and high risk sexual behaviors relevant to HIV/AIDS transmission in the development and testing of brief behavioral therapies. All applications must be submitted on the grant application form PHS (rev. 5/95) using the receipt dates in the form. INQUIRIES Direct inquiries regarding programmatic issues to: Dorynne Czechowicz, M.D. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-12 Rockville, MD 20857 Telephone: (301) 443-0107 Email: dczechow@aoads.ssw.dhhs.gov $$N4 END ************************************************************ NOTICES OF AVAILABILITY OF (RFPs/RFAs/PAs) $$R1 BEGIN SS-NICHD-96-01 ******************************************* CONTRACEPTIVE EFFICACY TESTING NIH GUIDE, Volume 25, Number 16, May 17, 1996 SOURCES SOUGHT: SS-NICHD-96-01 P.T. 34; K.W. 0750020, 0750005 National Institute of Child Health and Human Development The announcement for Contraceptive Efficacy Testing published in the NIH Guide, Vol. 25, No. 12, April 19, 1996 is hereby amended as follows: The Contraceptive Development Branch of the Center for Population Research, National Institute of Child Health and Human Development (NICHD), is establishing a Contraceptive Clinical Trials Network to evaluate new devices and drugs plans to initiate contraceptive efficacy testing of synthetic, new material condoms in August 1996. Interested companies with condoms appropriate for this testing must submit documentation that they have the capability to manufacture approximately 41,000 condoms of each new condom type over a period of 18 months with incremental supply (actual number will be adjusted depending on study drop out rates and enrollment factors) as follows: supply 13,000 condoms by startup of study (for initial start up); supply an additional 9,000 by the 5th month of the study; supply an additional 7,000 by the 8th month of the study; supply an additional 6,000 by the 11th month of the study; and supply an additional 6,000 by the 14th month of the study. Documentation must also be provided supporting the ability to package according to specifications for masked studies. Additionally, documentation must support that these synthetic, new material condoms; 1) currently have a cleared FDA premarket notification or 2) will have undergone sufficient in vitro and clinical testing to have an FDA investigational device exemption (21 CFR part 812) for contraceptive efficacy testing by August 1996. An original and four copies of the requested documentation must be submitted by May 30, 1996, to: Paul J. Duska Contracts Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Suite 7A07 Bethesda, MD 20892 $$R1 END ************************************************************ $$R2 BEGIN NIMH-96-0005 ********************************************* RESEARCH UNITS ON PEDIATRIC PSYCHOPHARMACOLOGY NIH GUIDE, Volume 25, Number 16, May 17, 1996 RFP AVAILABLE: NIMH-96-CR-0005 P.T. 34; K.W. 0710100, 0785170, 0785185 National Institute of Mental Health The National Institute of Mental Health (NIMH) has a requirement to (1) establish qualified clinical research units that, by the building of existing research resources at the host institution and combining the necessary expertise in clinical pharmacology and child psychiatry, can become national resources where studies on the safety and efficacy of psychotropic medications can be conducted in a prompt and cost effective manner; and (2) fund selected research projects of particular public health significance to be conducted at these units. The units will work as a network of research sites and conduct high priority clinical studies in various pediatric ages, conducting research on various aspects of pediatric psychopharmacology, including, but not limited to: dose ranges, dosing regimen, pharmacokinetics, general safety profile, efficacy and effectiveness, and effects on cognition, behavior and development. It is anticipated that a three-year, cost reimbursement (completion) type contract will be awarded. INQUIRIES Request for Proposal (RFP) No. NIMH-96-CR-0005 is now available and proposals are due on or about July 8, 1996. All responsible sources may submit a proposal that will be considered by the NIMH. Telephone requests will not be honored. Requests must be submitted in writing or by FAX and addressed to: Patricia L. Gibbons Contracts Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 9C-15 Rockville, MD 20857 FAX: (301) 443-0143 $$R2 END ************************************************************ $$R3 BEGIN DC-96-004 FULL-TEXT ************************************** NIDCD/ORMH MINORITY DISSERTATION RESEARCH GRANTS IN HUMAN COMMUNICATION NIH GUIDE, Volume 25, Number 16, May 17, 1996 RFA AVAILABLE: DC-96-004 P.T. 34, FF; K.W. 0710010, 0710030 National Institute on Deafness and Other Communication Disorders Office of Research on Minority Health Application Receipt Date: July 18, 1996 PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) and the Office of Research on Minority Health (ORMH) announce the availability of small grants (R03) to support doctoral dissertation research in human communication for minority doctoral candidates. Grant support is designed to aid the research of new minority investigators and to encourage minority individuals from a variety of academic disciplines and programs to conduct research in hearing, balance, smell, taste, voice, speech, and language. The mechanism of support is the NIH small grant (R03). Grants may be made for up to two years. Grants to support dissertation research will provide no more than $30,000 in direct costs over the two-year period, and no more than $25,000 in direct costs in any one year. The NIDCD and ORMH anticipate funding up to 10 grants with a total cost of up to $300,000. These grants are not eligible for competitive renewal. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), NIDCD/ORMH Minority Dissertation Research Grants in Human Communication, is related to several priority areas applicable to human communication. Potential candidates for the awards may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Dr. Judith A. Cooper Division of Human Communication National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C - MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 496-5061 FAX: (301) 402-6251 Email: judith_cooper@nih.gov $$R3 END ************************************************************ $$R4 BEGIN CA-96-014 FULL-TEXT ************************************** COMMUNITY CLINICAL ONCOLOGY PROGRAM NIH GUIDE, Volume 25, Number 16, May 17, 1996 RFA AVAILABLE: CA-96-014 P.T. 34; K.W. 0715035, 0403004, 0795003 National Cancer Institute Letter of Intent Receipt Date: July 10, 1996 Application Receipt Date: August 20, 1996 PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), invites applications from domestic institutions for cooperative agreements (10) to the Community Clinical Oncology Program (CCOP). New community and research base applicants and currently funded programs are invited to respond to this Request for Applications (RFA). 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 three research base awards and ten 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. 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 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Dr. Leslie G. Ford, M.D. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 300-D - MSC 7340 Bethesda, MD 20892-7340 Telephone: (301) 496-8541 FAX: (301) 496-8667 Email: fordl@dcpcepn.nci.nih.gov $$R4 END ************************************************************ From owner-sci-resources@net.bio.net Fri May 17 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DC-96-004 - V25(16) 05/17/96 Date: 17 May 1996 20:26:53 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 407 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4njg1t$4p1@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DC96004 DC-96-004 P1O1 *************************************** NIDCD/ORMH MINORITY DISSERTATION RESEARCH GRANTS IN HUMAN COMMUNICATION NIH GUIDE, Volume 25, Number 16, May 17, 1996 RFA: DC-96-004 P.T. 34, FF; K.W. 0710010, 0710030 National Institute on Deafness and Other Communication Disorders Office of Research on Minority Health Application Receipt Date: July 18, 1996 PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) and the Office of Research on Minority Health (ORMH) announce the availability of small grants (R03) to support doctoral dissertation research in human communication for minority doctoral candidates. Grant support is designed to aid the research of new minority investigators and to encourage minority individuals from a variety of academic disciplines and programs to conduct research in hearing, balance, smell, taste, voice, speech, and language. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), NIDCD/ORMH Minority Dissertation Research Grants in Human Communication, is related to several priority areas applicable to human communication. Potential candidates for the awards may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Minority Status. Applicants must be from ethnic/racial groups that are underrepresented in the biomedical or behavioral research sciences in the U.S. For purposes of this RFA, the NIDCD will give priority consideration to applications from African Americans, Hispanics, Native Americans, Alaskan Natives, and Pacific Islanders. Within this group, women and persons with disabilities are particularly encouraged to apply. The applicant for dissertation research grant support must be a citizen of the United States or have been lawfully admitted for permanent residence. The doctoral candidate must have a dissertation topic approved by the institutional committee established for that purpose. This information must be verified in a letter of certification from the thesis chairperson and submitted with the grant application (see APPLICATION PROCEDURES). Research topics must address issues in human communication, focusing on one or more of the areas described under RESEARCH OBJECTIVES. The applicant organization must be a domestic institution supporting doctoral level training, such as a university or college. The performance site may be foreign or domestic. MECHANISM OF SUPPORT The mechanism of support is the NIH small grant (R03). Grants may be made for up to two years. Grants to support dissertation research will provide no more than $30,000 in direct costs over the two-year period, and no more than $25,000 in direct costs in any one year. FUNDS AVAILABLE The NIDCD and ORMH anticipate funding up to 10 grants with a total cost of up to $300,000. These grants are not eligible for competitive renewal. RESEARCH OBJECTIVES This research initiative is to provide minority students assistance to perform their dissertation research on a topic related to human communication and thereby increase the pool of minority researchers in hearing, balance, smell, taste, voice, speech and language. The research supported by NIDCD includes basic or fundamental sciences as well as clinical or applied sciences, such as molecular and cellular biology, genetics, epidemiology, and imaging. The descriptions below of the research foci of NIDCD are provided to help potential applicants determine whether a topic may be appropriate for this initiative. Questions on the relevance of a particular topic can be addressed to the program contact listed under INQUIRIES. HEARING. Diseases and disorders of the auditory system including otitis media, otosclerosis, autoimmune-mediated hearing loss, and genetic deafness/hearing impairment; the normal auditory system, including plasticity, development and regeneration of auditory structures, cochlear mechanics, and perception of complex auditory signals; auditory system disorders, including drug ototoxicity, tinnitus, effects of noise on hearing, and speech recognition with sensorineural hearing loss; rehabilitation devices, including cochlear prostheses, hearing aid device development and selection procedures, and vibrotactile and other communication aids for the deaf. BALANCE. Human balance control, structure and function of the peripheral and central regions of the vestibular system; development and regeneration of vestibular structures; molecular bases of vestibular function; adaptive plasticity in the vestibular system; vestibulo-autonomic regulation; diseases and disorders primarily affecting balance and the vestibular system, including Meniere's disease, vestibular toxicity and presbyastasis; clinical assessment of balance and the vestibular function; and medical therapeutics and physical rehabilitation of balance and vestibular disorders. SMELL. Normal and abnormal olfactory functions, including development and regeneration of olfactory receptor neurons; transport of substances to and from the brain via the olfactory receptor neurons, including transport of pathogens; associations between olfaction and diseases throughout life. TASTE. Normal and abnormal sense of taste, including development and regeneration of taste bud cells; central processing; and the diagnosis of gustatory disorders. VOICE. The neural basis of vocal learning and vocalization; examination of neural mechanisms and physiology of the larynx; voice disorders, including assessment, characteristics of specific populations, and treatment of voice disorders. SPEECH. Speech perception; characterization of normal speech production; and disorders of speech production such as neurogenic speech disorders (apraxia and dysarthia), speech of deaf individuals, and stuttering. LANGUAGE. Normal language processing; brain basis for language; adult aphasia; the grammatical abilities and writing deficits associated with Alzheimer's disease; language acquisition in deaf individuals; American Sign Language; literacy in deaf individuals; and language disorders in children, including specific language impairment, early expressive language delay, and language deficits associated with autism. SPECIAL REQUIREMENTS Additional Material. In addition to the completed PHS 398 form described under APPLICATION PROCEDURES, applicants must also submit: o A letter from the faculty committee or university official directly responsible for supervising the development and progress of the dissertation research. The letter must be countersigned by a representative of the graduate school of the sponsoring institution. The letter must: (a) fully identify the members of the committee and certify their approval of the dissertation topic and, (b) certify that the author of the letter has read the application and that it reflects the work to be completed in the dissertation. o A transcript of the investigator's graduate school record o Biography of mentors, limited to 2 pages (use the Biographical Sketch page in form PHS 398) o Statement of the investigator's career goals to be placed under "Background" (see the Research Plan instructions in PHS 398) o A signed statement from the sponsoring institution establishing the eligibility for support under this program including information on ethnicity and citizenship. (See Eligibility Requirements). Grant Conditions. The following conditions apply to dissertation grants: o The doctoral candidate must be the designated Principal Investigator on the grant and the doctoral candidate must be the only individual on the grant for whom salary support is requested. o The principal investigator's salary may not exceed $12,000 per twelve months. o Work on the funded project must be initiated within three months after the date of the award. o Investigators may request support for up to 24 months. An application that requests support beyond this time period will be returned. o Grantees who are approved for two years of support must submit a satisfactory progress report no later than 10 months after the start of the first year of the grant. This report should contain a brief summary of the work completed to date together with copies of any publications supported wholly or in part by the dissertation grant. o A copy of the dissertation must be submitted and constitutes the final report of the grant. The dissertation must be officially accepted by the faculty committee or university official responsible for the candidate's dissertation and must be signed by the responsible officials. An applicant who receives support for dissertation research under a grant from the NIDCD/ORMH may not at the same time receive support under a predoctoral or fellowship grant, nor be supported under any other research project grant awarded by a Federal agency. Allowable Costs. Expenses usually allowed under PHS research grants will be covered by the NIDCD/ORMH dissertation research grants, but may not exceed $30,000 for the total project. Allowable costs include the investigator's salary (not to exceed $12,000 per 12 months); direct research project expenses such as travel to one scientific meeting per year (limited to $1000 per year), data processing, supplies, and dissertation preparation costs. Any level of effort by the candidate that is less than full time must be fully justified. No tuition is allowed. It is expected that most equipment needed for the research will be available at the site or laboratory in which the dissertation is to be performed. Therefore, any requests for equipment must be specially justified. Indirect costs are limited to eight percent of requested direct costs, less equipment. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508- 14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research as well as from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, FAX (301) 480-0525, email ASKNIH@ODROCKM1.OD.NIH.GOV. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number (NIDCD/ORMH Minority Dissertation Research Grants in Human Communication, DC-96-004) must be typed on line 2 of the face page of the application form and the YES box must be marked. Instructions for completing the applications are found in the PHS 398 form. These instructions must be followed except that under C. Specific Instructions - Research Plan, no more than 10 pages may be used for items 1 to 4 (instead of 25 pages as stated in the standard instructions). Applications that exceed the 10 page limit for this section will be returned. Appendices are not allowed. Submit a signed original of the application (with the supporting letter and graduate school transcript), including the Checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight service) At the time of submission, two additional copies of the application (with the supporting letter and the graduate school transcript) must be sent to: Chief, Scientific Review Branch Division of Extramural Activities National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard - MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 496-8683 FAX: (301) 402-6250 ATTN: Minority Dissertation Applications must be received by July 18, 1996. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA (as judged by NIDCD Program Staff) will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDCD in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score. Review Criteria o scientific and technical merit, health significance, and originality of the proposed research; o appropriateness and adequacy of the literature review, experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator (the student); o qualifications, research and training experience of the mentor, particularly, but not exclusively, in the proposed area of research; o quality and availability of research resources needed to complete the dissertation; o appropriateness of the proposed budget and duration in relation to the proposed research; o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA The anticipated date of award is September 1996. Final funding decisions are based on the recommendations of the reviewers, the relevance of the project to NIDCD priorities, and the availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Interested investigators are strongly encouraged to contact the person named below who can provide clarifying information about material described in this RFA. The investigator will then be referred to the relevant program to discuss the suitability of the research topic. Dr. Judith A. Cooper Division of Human Communications National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard - MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 496-5061 FAX: (301) 402-6251 Email: judith_cooper@nih.gov Direct inquiries relating to fiscal matters to: Ms. Sharon Hunt Grants Management Branch National Institute on Deafness and Other Communication Disorders Executive Plaza South , Room 400-B 6120 Executive Boulevard - MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: sh79f@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.173 Awards are made under authorization of the Public Health Service Act Title IV, Part A (Public Law 79-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. The requirements of Executive Order 12372, "Intergovernmental Review of Federal Programs," are not applicable to NIDCD research grant programs. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103- 227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri May 17 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-96-014 - V25(16) 05/17/96 - P1/2 Date: 17 May 1996 20:29:28 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1499 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4njg6o$521@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA96014 CA-96-014 P1O2 *************************************** COMMUNITY CLINICAL ONCOLOGY PROGRAM NIH GUIDE, Volume 25, Number 16, May 17, 1996 RFA: CA-96-014 P.T. 34; K.W. 0715035, 0403004, 0795003 National Cancer Institute Letter of Intent Receipt Date: July 10, 1996 Application Receipt Date: August 20, 1996 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 thirteen 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 202-512-1800). 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 the Division of Cancer Treatment, Diagnosis, and Centers,(DCTDC), NCI. B. Research Base Applicants An applicant may be: 1. An NCI-funded clinical trials cooperative oncology group; 2. An NCI-funded clinical center, consortium, 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 applications 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 in the future provided that 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. Approximately three research base awards and ten 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 central for conducting large-scale cancer prevention and control trials. In 1995, there were 52 programs in 30 states involving over 300 hospitals and over 3,400 physicians. Approximately 3,400 patients were entered onto treatment trials and 2,800 subjects on cancer prevention and control trials in 1995. 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 which require large sample sizes for completion; 2) geographic areas which 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 treatment and/or cancer prevention and control research 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 for CCOP Awardees 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. Responsibilities of CCOP 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, Diagnosis, and Centers (DCTDC), National Cancer Institute 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. 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, Diagnosis, and Centers (DCTDC), 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.b. 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.c. 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, DCTDC, 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 be assessed. For CCOPs that have demonstrated an outstanding record of accrual to cancer prevention and control clinical trials, the 50 credit minimum for treatment may be waived. * 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.d. 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.e. 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.f. 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.g. 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.h. 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.i. 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), DCTDC, 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 individual investigators participating or collaborating 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.j. 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.k. 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.l. 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.m. 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, DCTDC, according to DCTDC guidelines and/or to DCPC according to DCPC guidelines; and o implementation of DCPC/DCTDC requirements for storage and accounting for investigational agents provided under DCPC/DCTDC sponsorship. 1.n. Publications Timely publication of major findings is encouraged. Publication or oral presentation of work done under this agreement requires acknowledgement of NCI support. 2. Nature of NCI Staff Involvement 2.a. 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, NCI, and/or the Protocol Review Committee (PRC), DCTDC, 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). 2.b. 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 DCTDC'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. 2.c. 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). 2.d. Investigational Drug Management The Regulatory Affairs Branch (RAB), PMB, CTEP, DCTDC, and Chemoprevention Branch (CB), 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. 2.e. 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. 2.f. 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. 2.g. Strategy Sessions The DCPC Program Director or designee will sponsor strategy sessions when indicated, attended by principal investigators from the CCOPs and appropriate DCPC/DCTDC 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/DCTDC 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. 2.h. Federally Mandated Regulatory Requirements The DCPC Program Director or designee and DCTDC 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. 2.i. 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. a. Terms and Conditions of Award for Research Base Awardees 1. 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 INVESTIGATOR'S HANDBOOK and the GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS COOPERATIVE GROUP and CCOP RESEARCH BASES. 1.a. 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/DCTDC. Communication at the various stages of development is encouraged. 1.b. 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), DCTDC, NCI, prior to implementation. Treatment and cancer prevention and control protocols should be submitted to the Protocol Information Office (PIO), CTEP, DCTDC 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 DCTDC. All concept and protocol documents should be submitted to the PIO, CTEP, DCTDC. DCTDC may also require a letter of intent for new cancer treatment trials. 1.c. 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, DCTDC, 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. 1.d. 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/DCTDC 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. 1.e. Quality Control A DCPC/DCTDC-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 Medical records used 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 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. 1.f. 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. 1.g. 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. 1.h. 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 DSMC has recommended early closure, DSMC procedures regarding notification of DCPC must be followed. 1.i. 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. 1.j. 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. 1.k. 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),CTEP, DCTDC Drug Monitor for DCTDC-sponsored investigational agents and the Program Director for other agents, of serious or life-threatening events, as specified in the protocol. 1.l. 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. 1.m. 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. 1.n. Investigational Drug Management Investigators performing trials under cooperative agreements will be expected, in cooperation with DCPC/DCTDC to comply with all FDA distribution, monitoring, and reporting requirements for investigational agents. 1.o. 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. 1.p. Federally Mandated Regulatory Requirements Each research base must establish mechanisms to meet FDA regulatory requirements for clinical trials involving DCPC/DCTDC- 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/DCTDC 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/DCTDC request, of summarizing efficacy and toxicity data to be included in DCPC/DCTDC's annual reports to the FDA for each investigational agent. o establish a method for the timely reporting of all serious and unexpected toxicities. 1.q. 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. 1.r. Publications Timely publication of major findings is encouraged. Publication or oral presentation of work done under this agreement requires acknowledgement of NCI support. 1.s. 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 described 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. 1.t. 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 which allows direct notification of the patient by the NCI. 2. Nature of NCI Staff Involvement 2.a. Scientific Resource The Division of Cancer Prevention and Control (DCPC) and Division of Cancer Treatment, Diagnosis, and Centers (DCTDC) 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), DCTDC, Chemoprevention Branch (CB), DCPC, 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. Protocol Development The protocol should be a document mutually acceptable to the research base and to DCPC/DCTDC. Communication at the various stages of development is encouraged. DCPC/DCTDC 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/DCTDC will also comment on the scientific rationale, programmatic relevance, priority, design, statistical requirements, and implementation of the proposed study. 2.c. Concept/Protocol Review All research base protocols utilized by the CCOPs must be reviewed and approved for CCOP use by the (CCPRC), DCPC, NCI and/or the (PRC), DCTDC, NCI, prior to implementation. The major considerations in protocol review by DCPC or DCTDC 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/DCTDC 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.d. Data Management and Analysis The awardees will retain custody of and primary rights to their data; however, DCPC/DCTDC will have access to all data generated under this award. The DCPC Program Director or a DCTDC 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/DCTDC 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.e. Quality Control and Monitoring The Clinical Trials Monitoring Branch (CTMB), CTEP, DCTDC/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 DCTDC/DCPC for awardees conducting cancer treatment and prevention and control clinical trials. 2.f. 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.g. 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.h. Investigational Drug Management The Regulatory Affairs Branch, CTEP, DCTDC, 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.i. 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.j. Protocol Closure DCPC/DCTDC will review research base mechanisms for interim monitoring of results and will monitor protocol progress. DCPC/DCTDC 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.k. Federally Mandated Regulatory Requirements The DCPC Program Director and a DCTDC 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.l. CCOPs/Minority-Based CCOPs The DCPC Program Director will notify research bases when CCOPs/Minority-Based CCOPs are funded. 2.m. 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. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH- supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines 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 in earlier publication, 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, 1996, 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. 5/95). 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 Applicants 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 or those with an outstanding record in cancer prevention and control accrual). 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 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 with which 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, as well as experience in accruing patients/subjects to treatment and cancer prevention and control clinical trials 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 which 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, clinical research associates, 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 trials 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 operations showing the relationship(s) between the scientific and administrative functional units of the research base, vis-a-vis the conduct of treatment and/or cancer prevention and control clinical trials, must be provided. The organizational focus within the research base for cancer prevention and control research must be described, including the composition and activities of the research base cancer prevention and control committee, or equivalent, and its relationship to other clinical trial committees and activities. 2.d. Collaboration with affiliated CCOPs/Minority-Based CCOPs in treatment and/or cancer prevention and control research, as applicable, is required. CCOP-research base affiliation agreements must be included in the application. For treatment research, each applicant must demonstrate the ability to accrue a minimum of 50 credits per year from affiliated From owner-sci-resources@net.bio.net Fri May 17 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-96-014 - V25(16) 05/17/96 - P2/2 Date: 17 May 1996 20:30:12 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 424 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4njg84$560@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA96014 CA-96-014 P2O2 *************************************** CCOPs/Minority-Based CCOPs to treatment clinical trials. For cancer prevention and control research, each applicant must demonstrate the ability to accrue a minimum of 50 credits per year >From affiliated CCOPs/Minority-Based CCOPs to cancer prevention and control clinical trials. It is expected that selected cooperative group members and/or Cooperative Group Outreach/cancer center affiliates other than the CCOPs will participate in cancer prevention and control research. The applicant must indicate the participants and their expected level of participation, and describe their ability to participate. 2.e. A designated Principal Investigator is required and his/her qualifications and experience must be described. An individual must be designated to coordinate cancer prevention and control research. His or her qualifications and experience within the research base structure should also be described. Each applicant must also demonstrate the ability to access professionals with the appropriate expertise to design and implement the proposed treatment and/or cancer prevention and control clinical trials. Basic scientists, medical, surgical, radiation and other oncology specialists, nurse oncologists, epidemiologists, health educators and/or other public health professionals may be included. 2.f. Each applicant's ability to manage the data from multi- institutional treatment and/or cancer prevention and control clinical trials must be described. Data management includes development of data collection forms, procedures for data transmittal, procedures for data entry, data editing, compilation, and analysis, as well as procedures for quality control and verification of submitted data. Standards should exist for determining eligibility and evaluability of patients/subjects entered on protocols. Statistical capability must exist to develop protocol statistical parameters, analyze the data, and report results. 2.g. Each applicant must demonstrate the ability to initiate procedures for training and maintaining the proficiency of personnel >From affiliated CCOPs/Minority-Based CCOPs on techniques for successful management of treatment and/or cancer prevention and control clinical trials research. Depending on the clinical trials initiated and the interventions involved, this will include training for data managers/nurses and any other individuals responsible for data collection, monitoring, or carrying out the intervention(s). 2.h. Each applicant's ability to provide mechanisms for periodic review of the performance of affiliated CCOPs/Minority-Based CCOPs, including on-site monitoring (auditing) and written procedures and criteria for continued affiliations, must be described. Similar measures must be described for other member/affiliates participating in cancer prevention and control research. 2.i. Each applicant must describe their plans for independent data and safety monitoring for all phase III prevention and control clinical trials. 2.j. Requests for funds must reflect operations/statistical costs for quality control and data management costs for CCOP participation in protocols. This estimate is based on the expected accrual credits of affiliated CCOPs/Minority-Based CCOPs and for member/affiliate accrual credits in cancer prevention and control. CCOP-research base affiliation agreements must be included. Each applicant should include a budget for monitoring and auditing activities. Funding can be requested for scientific development and pilot testing of new cancer prevention and control research initiatives (including support of a cancer prevention and control committee for the research base), and funds can also be requested for appropriate travel to meetings directly related to study activities (such as NCI-sponsored strategy sessions/workshops). Specific justification must be provided. B. METHOD OF APPLYING The research grant application form PHS 398 (rev. 5/95) is to be used in applying for cooperative agreements. Applications kits are available at most institutional offices of sponsored research; from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email ASKNIH@odrockm1.od.nih.gov; and from the program staff listed under INQUIRIES. A suggested format will be sent to all applicants requesting the RFA or submitting a letter of intent. All applicants are encouraged to obtain and use the suggested format instructions for organizing the specific information concerning the RFA programmatic requirements in the PHS 398. The RFA label available in the PHS-398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact clear and single-sided photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North - Room 636 6130 Executive Boulevard Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) It is important to send these copies at the same time that the original and three copies are sent to DRG; otherwise, the NCI cannot guarantee that the applications will be reviewed in competition with other applications received on or before the designated receipt date. Applications must be received by August 20, 1996. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS A. Review Procedures Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI staff will return it. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applicants will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and received a second level review by the appropriate National Cancer Advisory Board. B. Review Criteria 1. CCOP Applicants All applicants will be evaluated on the following criteria: 1.a. 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. In describing the study population, it is required that a description of the gender and minority population and subpopulation served be provided, as well as an outreach plan. This information may be based on the institutional records and/or prior experience. 1.b. Ability to accrue a minimum of 50 credits per year to treatment clinical trials and a minimum of 50 credits per year to cancer prevention and control clinical trials. Established CCOPs will be funded at a yearly accrual goal that may be higher than 50 credits for treatment clinical trials and 50 credits for cancer prevention and control clinical trials. These established CCOPs will be evaluated for their past performance in meeting these accrual goals. The minimum accrual requirement may be waived for applicants whose specialty is pediatrics, or for applicants with an outstanding record in prevention and control. Each applicant's ability to access the appropriate populations, professional disciplines, and facilities to participate with affiliated research bases in NCI-approved cancer prevention and control intervention protocols will be appraised. Any prior participation in cancer treatment and prevention and control research will be considered. 1.c. Qualifications and experience of the principal investigator/associate principal investigator, in terms of ability to organize and manage a community oncology program that includes both cancer treatment and prevention and control research as well as accrual to such protocols, and related activities. 1.d. Training, experience, and commitment of participating physicians for accruing individuals to protocols in which the applicant has agreed to participate. The experience of proposed investigators in the entry and treatment of cancer patients on research trials (gained >From residency, fellowships, postdoctoral training and/or subsequent practice) will be appraised. For multidisciplinary studies, evidence of the availability of appropriate professional resources (e.g., radiotherapy, pediatrics, surgery, gynecology, urology, pathology, internal medicine, family practice, nursing, and nutrition) will be required. Experience or special skills in cancer prevention and control research and related activities will be considered, together with availability of other community resources and personnel for such clinical trials. 1.e. Stability of the functional unit or group applying to become a CCOP. Preexisting organizational affiliations of at least a core of the group applying, and evidence of stable working relationships, will be appraised. Examples of established consortium arrangements, and committee structure which demonstrates the participation of appropriate physicians and administrators, may be submitted. Evidence of previous success as a group in implementing clinical cancer treatment and prevention and control research and related activities will be considered. 1.f. Qualifications and experience of all proposed support personnel relative to their position descriptions. The relevant credentials and expected contributions to the program of personnel resources not fiscally supported by the award will be considered. 1.g. Adequacy of quality assurance mechanisms for both cancer treatment and prevention and control interventions, and adequacy of procedures for investigational drug monitoring and data management and identification of false or otherwise unreliable data. 1.h. Adequacy of available facilities, including laboratories, in-patient and outpatient resources, cancer registries, etc., and adequacy of space for administrative activities and personnel. 1.i. Appropriateness of research base affiliations and of the cancer treatment and prevention and control research protocols chosen. Affiliation agreements must be provided in the application. 1.j. For competitive continuations, adequacy of progress during the funding period, including ability to meet the accrual goals in cancer treatment and prevention and control, progress made as a CCOP, and evaluation of CCOP performance by affiliated research bases(s). Consideration will be given to previous accrual and the ability to meet the previous accrual projections for which the CCOP was funded. The research base evaluation report(s) must be provided in the application. Plans for continued accrual and follow-up of subjects on protocols will be evaluated. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each favorably recommended application. Allowable items in the budget are requests for full or part-time administrative personnel, clinical research associates, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); and appropriate travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/workshops, local travel). Funding is not allowed for clinical care provided to patients (e.g., patient care reimbursement, transportation costs). Funding is not allowed for clinical support personnel (e.g. pharmacist, physicist, clinical psychologist, dosimetrist). Physician compensation is only an allowable cost for the Principal Investigator (PI) and Co-PI, specifically for time spent on CCOP organizational/administrative tasks. Justification must be provided for personnel time and effort and funds requested. The initial review group will also examine the provisions for the protection of human subjects, recruitment plans for the inclusion of women, minorities and sub-populations to clinical trials, and the safety of the research environment. 2. Research Base Applicants All research base applicants will be evaluated on the following criteria: 2.a. 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. In describing the study population, it is required that a description of the gender and minority population and subpopulation served be provided, as well as an outreach plan. This information may be based on the institutional records and/or prior experience. 2.b. Experience in conducting multi-institutional clinical trials; demonstrated ability to develop such studies and act as a coordinating and statistical center; adequate facilities to conduct the clinical trials; adequate procedures to collect, monitor, and analyze the data and assure the safety of patients/subjects. 2.c. Quality and availability of cancer treatment and/or prevention and control protocols, as applicable, which are appropriate for CCOP participation, or the potential for developing such clinical trials. For new applications, a detailed description of at least two examples of actual or planned cancer prevention and control protocols, with professional expertise to assure the quality of the proposed intervention clinical trial will be evaluated. 2.d. The ability to accrue a minimum of 50 credits per year from affiliated CCOPs/Minority-Based CCOPs to treatment clinical trials. The ability to accrue a minimum of 50 credits per year from affiliated CCOPs/Minority-Based CCOPs to cancer prevention and control clinical trials. Experience as well as the potential for developing future clinical trials will be considered. Documentation must include CCOP-research base affiliation agreements. 2.e. Organizational structure for involving appropriate personnel in the design and implementation of treatment and/or cancer prevention and control research. The organizational focus within the research base for cancer prevention and control research, including the composition and activities of the cancer prevention and control committee, and the designation of protocol chairpersons and its relationship to other clinical trial committees and activities will be assessed. 2.f. Qualifications and experience of the principal investigator and/or the individual responsible for directly relating to the CCOPs. The availability and experience of multidisciplinary health professionals and allied professionals with skills needed to develop, utilize, and analyze treatment and/or cancer prevention and control clinical trials will also be evaluated. 2.g. Experience in working with community oncologists, orienting community data management personnel to protocol requirements, organizing scientific and educational meetings for those participating in the clinical trials, and participating in intergroup clinical trials. 2.h. Ability to establish quality control, quality assurance, and data management procedures. Experience in data management and analysis of multi-institutional clinical trials and adequacy of data management staff will be appraised. The use of mechanisms for periodic review of quality control, quality assurance, and data management procedures, safety monitoring, including procedures for data safety and monitoring committee and on-site auditing program will be assessed. 2.i. For competitive continuations, adequacy of progress in implementing a prevention and control clinical trials program including cancer prevention and control protocol development and implementation, accrual, data management, evaluation of performance sites; current status of each protocol and progress towards meeting planned accrual goals from CCOPs and members/affiliates; summary of prior activities with a clear presentation of annual accrual; completion of clinical trials, interim analyses, publication of findings, or other dissemination of trial findings throughout the research base; and other progress in meeting the requirements for a CCOP research base. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each favorably recommended application. Requests for funds must reflect operations/statistical costs for quality control and data management costs for CCOP participation in protocols. This estimate is based on the expected accrual credits of affiliated CCOPs/Minority-Based CCOPs and for member/affiliate accrual credits in cancer prevention and control. Research bases should include a budget for monitoring and auditing costs. Funding may be requested for scientific development and pilot testing of new cancer prevention and control research initiatives, other costs related to implementation of specific cancer prevention and control protocols (including support of a cancer prevention and control committee for the research base), or for appropriate travel to meetings directly related to study activities (such as NCI- sponsored strategy sessions/workshops). Specific justification must be provided. The initial review group will also examine the provisions for the protection of human subjects, the plans for the accrual of women, minorities and sub-populations to clinical trials, and the safety of the research environment. AWARD CRITERIA The anticipated date of award is June 1, 1997. NCI program staff will take into account demographic and geographic distribution of applicants in the final funding selection process to assure inclusion of minority and underserved populations. Multiple CCOP applicants for funding who are competing for the same patient population will be considered, but all may not be awarded unless warranted by the population density. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Leslie G. Ford, M.D. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 300-D - MSC 7340 Bethesda, MD 20892-7340 Telephone: (301) 496-8541 FAX: (301) 496-8667 Email: fordl@dcpcepn.nci.nih.gov Direct inquiries regarding fiscal matters to: Ms. Crystal Wolfrey Grants Administration Branch National Cancer Institute Executive Plaza South - Room 243 6120 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7800, Ext. 282 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 13.399, Cancer Control. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410 as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun May 19 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 19 May 1996 Date: 20 May 1996 08:48:31 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 125 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4nq48f$95@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: 1996 Graduate Fellowship Awards File Formats File size (bytes): STIS Filename: gf96info.txt Title: 1996 MINORITY Graduate Fellowship AWARDS File size (bytes): 229 STIS Filename: gf96mawd.txt Also available: gf96mawd.dlm Title: 1996 MINORITY Graduate Fellowship HONORABLE MENTIONS File size (bytes): 239 STIS Filename: gf96mhm.txt Also available: gf96mhm.dlm Title: 1996 Graduate Fellowship AWARDS File size (bytes): 220 STIS Filename: gf96rawd.txt Also available: gf96rawd.dlm Title: 1996 Graduate Fellowship HONORABLE MENTIONS File size (bytes): 229 STIS Filename: gf96rhm.txt Also available: gf96rhm.dlm Document Type: News Title: Media Tipsheet May 10, 1996 File size (bytes): STIS Filename: tip60510.txt Document Type: Recruit Title: Director, Division of Science Resources Studies File size (bytes): STIS Filename: vep964.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Dir of Awards Title: 1996 MINORITY Graduate Fellowship AWARDS File size (bytes): 229 STIS Filename: gf96mawd.txt Also available: gf96mawd.dlm Title: 1996 MINORITY Graduate Fellowship HONORABLE MENTIONS File size (bytes): 239 STIS Filename: gf96mhm.txt Also available: gf96mhm.dlm Title: 1996 Graduate Fellowship AWARDS File size (bytes): 220 STIS Filename: gf96rawd.txt Also available: gf96rawd.dlm Title: 1996 Graduate Fellowship HONORABLE MENTIONS File size (bytes): 229 STIS Filename: gf96rhm.txt Also available: gf96rhm.dlm Document Type: Letter Title: REULIST -- Current List of REU Sites File size (bytes): 89674 STIS Filename: reulist.txt Title: REULIST -- Current List of REU Sites File size (bytes): 89674 STIS Filename: reulist.txt Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 63118 STIS Filename: sesvac.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 sesvac.txt, the text of your message should be as follows: get sesvac.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve sesvac.txt, you would enter: ftp> get sesvac.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 Tue May 21 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: IMPORTANT - BIOSCI Fundraising Update! Date: 21 May 1996 19:42:30 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 154 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <199605200900.CAA17718@net.bio.net> NNTP-Posting-Host: net.bio.net BIOSCI is about halfway to its funding goal!! I'm interrupting the usual monthly posting of the BIOSCI miniFAQ to bring you up to date on BIOSCI fundraising progress, a topic of concern to your future use of this resource. Thank you in advance for taking the time to read this message carefully. Last year we announced that BIOSCI was going to adopt the U.S. Public Broadcasting System model to fund its operations after our DOE/NSF grant runs out later this year. Unlike PBS, we are not soliciting contributions from users; we are only selling ads on our Web pages solely to cover our operating costs. Our goal is to seek sponsorships until we build up an operating reserve of about $100,000 and then cease further promotions until we need to build the reserve back up. (The accountants among our readership will be familiar with the problem of deferred revenue which we can not safely utilize until ads have been displayed for a period of time.) We are only about halfway to our funding goal and need to raise further funds to avoid having to curtail services at net.bio.net. Fundraising is time-consuming, however, and we need your help as explained further below. Our operating costs consist of our network connection, phone lines, hardware maintenance (we will be getting newer and faster hardware soon!), plus 0.7 FTE of salaries covering UNIX systems admin, technical support, quality assurance, i.e., testing, of our system, and administrative costs (such as the time it takes to actually find/write/call potential sponsors and raise money!). Although the BIOSCI staff does get compensated for a portion of the work that they do, this project has always received a lot of free after-hours and "vacation" time labor, so we hope that no one will begrudge the time that we do charge to the project to serve you. All of the three part-time staff members, Dave Mack, Julie Lawrence, and myself, have full time day jobs and families in addition to working hard to keep this service running for all of you. Julie and Dave Mack are subcontractors for BIOSCI; my time that is charged to the project defrays a portion of my regular salary instead of adding to my income. Besides having to relocate the project, we were very busy this last year building new infrastructure such as our WWW hypermail interface to the system. This was released last December along with scores of WAIS indices for the newsgroups. Virtually everything is complete, although we do continue to find and fix bugs (many through your helpful feedback!). We are still having some problems with our WAIS indexing. The archives continue to grow rapidly. We are running over 100 indexes now versus three previously and any systems crashes cause greater havoc with the indexing than before! We are still working to fix this as fast as our resources permit and appreciate your patience, but we have been able to automate a lot of the infrastructure to reduce labor as compared to past requirements. We have also implemented new software to make moderation of BIOSCI/bionet newsgroups much easier and combat the growing problem of Internet junk mail and USENET "spamming." About 20% of our groups are now moderated, many of them by the BIOSCI staff! This, for example, made a major difference last year in the quality of content in our EMPLOYMENT/bionet.jobs.offered newsgroup which many commercial concerns and recruiting firms are using **without charge** to recruit candidates for positions in the biological sciences. We are also now in a position to have sponsors for individual newsgroups as you will have noticed if you have visited http://www.bio.net/ and clicked on "Access the BIOSCI/bionet newsgroups" recently. So, how can you help?? ---------------------- As noted above it can take a lot of time to contact potential sponsors if I have to do it all myself. Our request is quite simple. You can do two important things which will take very little time for you individually. First, please use our WWW system at http://www.bio.net/ to access the archives. You can now post or reply to messages via your Web browser. Your usage helps attract sponsors. If you contact any of our sponsors, please be sure to thank them for supporting BIOSCI. It is critical for them to get this feedback if they are to continue their sponsorship for the long term. Second, if you work for a company or organization that provides products or services of interest to the biology community, please pass this message on to your marketing or marketing communications department or other appropriate group. Please ask them to help support BIOSCI by sponsoring our Web site and explain the uses and benefits of the system to the biology community. If they are interested, they can then contact us for further information at our tech support address, biosci-help@net.bio.net. Our hope is to quickly raise several large corporate/institutional sponsors on our heavily-used WWW locations (some stats appended below), and then end this sponsorship campaign so that our resources can continue to be used for service provision, not fundraising. Many of our specialty newsgroup WWW archives are still used by small communities of scientists (and they haven't been heavily promoted yet). While these may be valuable niche markets to some advertisers, it will generate more labor and overhead having to find these sponsors, fairly price the locations, and deal with lots of smaller sponsorships than fewer mid-to large sponsors. We are striving to keep our operation as lean and efficient as possible since we are not trying to make careers out of running BIOSCI. We are trying if at all possible to avoid the administrative overhead entailed with processing lots of small payments to reach our fundraising goals. I'd like to thank all of you for your help in advance. In helping us, you are also helping yourselves, not only in keeping this resource available for all of the both large and small research communities that we serve, but also by alleviating the need for us to go back and compete with researchers for tight grant dollars! We promised NSF when we were awarded the BIOSCI grant that we would carry out this mission to make the service self-supporting. With your help, we will succeed in continuing BIOSCI's work into its second decade. Thank you very much! Sincerely, Dave Kristofferson BIOSCI/bionet Manager biosci-help@net.bio.net A list of our prime WWW sponsorship locations follow. Please contact us for further details. ---------------------------------------------------------------------- The overall BIOSCI WWW pages are currently visited by users from close to 5500 unique computer hosts per week. Web servers only log the Internet computer/host name and frequently more than one individual can connect to us from a particular host. Main home page, http://www.bio.net, visited recently by about 2100 unique hosts per week Main Newsgroups archives page, http://www.bio.net/archives.html, visited recently by about 1200 Unique hosts per week BIO-JOURNALS archive page, http://www.bio.net/BIO-JOURNALS.html, visited recently by about 1000 unique hosts per week. EMPLOYMENT archive pages: http://www.bio.net:80/hypermail/EMPLOYMENT/ and monthly header pages, visited recently by about 800 unique hosts per week. Address database search page, http://www.bio.net/addrsearch.html, visited recently by about 450 unique hosts per week. Methods newsgroup archive pages, http://www.bio.net:80/hypermail/METHDS- REAGNTS/ and monthly header pages, visited recently by about 350 unique hosts per week. Ads can also be displayed on various combinations of other BIOSCI/bionet newsgroups. Please contact us at biosci-help@net.bio.net for details. ---------------------------------------------------------------------- From owner-sci-resources@net.bio.net Tue May 28 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide - vol. 25, no. 17, pt. 1of1, 24 May 1996 Date: 28 May 1996 21:22:05 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 738 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4ogjdd$1vi@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19960524 V25N17 P1O1 ************************************ X-comment: RFAs described: CA-96-015 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.05.24 NIH GUIDE - Vol. 25, No. 17 - May 24, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIH GUIDE PUBLICATION DATES $$INDEX N2 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N3 ********************************************************** NOTICE OF AHCPR SPECIAL EMPHASIS AREA - SMALL GRANTS Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH $$INDEX N4 ********************************************************** SYMPOSIUM ON THE PAST, PRESENT AND FUTURE OF PEER REVIEW National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N5 ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N6 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** LUNG VOLUME REDUCTION SURGERY FOR EMPHYSEMA: A MULTI-CENTER ASSESSMENT AND PROSPECTIVE PATIENT REGISTRY (RFP NHLBI-HR-97-02) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R2 ********************************************************** CLINICAL COORDINATING CENTER FOR LUNG VOLUME REDUCTION SURGERY FOR EMPHYSEMA: A MULTI-CENTER ASSESSMENT AND PROSPECTIVE PATIENT REGISTRY (RFP NHLBI-HR-97-01) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R3 07/30/96 ************************************************* REGIONAL CONFERENCES ON RECRUITMENT AND RETENTION OF MINORITY PARTICIPANTS IN CLINICAL CANCER RESEARCH (RFA CA-96-015) National Cancer Institute INDEX: CANCER THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** THE NIH GUIDE FOR GRANTS AND CONTRACTS WILL NOT BE PUBLISHED ON MAY 31, 1996. THE NEXT ISSUE OF THE NIH GUIDE WILL BE ON JUNE 7, 1996. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 25, Number 17, May 24, 1996 P.T. 34; K.W. 1014004, 1014006 Department of Health and Human Services Notice is hereby given that the Office of Research Integrity (ORI) has made final findings of scientific misconduct in the following case: Michael W. Washabaugh, Ph.D., Johns Hopkins University: Based on an investigation conducted by the institution as well as information obtained by ORI during its oversight review, ORI found that Michael W. Washabaugh, Ph.D., Associate Professor of Biochemistry, Department of Biochemistry, Johns Hopkins University School of Hygiene and Public Health, committed scientific misconduct by reporting falsified and/or fabricated research data in two grant applications submitted to the National Institutes of Health. Specifically, Dr. Washabaugh (1) reported falsified results of experiments concerning the number of DTNB (5, 5'-dithiobis [2- nitrobenzoate]) reactive thiols in native thiamin binding protein in a grant application entitled "Mechanism of a periplasmic permease," and (2) reported falsified and/or fabricated portions of data presented in two separate figures to support his hypothesis of thiamin binding to thiamin binding protein in grant applications entitled "Mechanism of a periplasmic permease" and "Mechanisms of enzymic and non-enzymic thiamin reactions." Dr. Washabaugh has entered into a Voluntary Exclusion Agreement with ORI in which he has voluntarily agreed, for the four year period beginning May 7, 1996, to exclude himself from: (1) any contracting or subcontracting with any agency of the United States Government and from eligibility for, or involvement in, nonprocurement transactions (e.g., grants and cooperative agreements) of the United States Government as defined in 45 C.F.R. Part 76 (Debarment Regulations), and (2) serving in any advisory capacity to the Public Health Service (PHS), including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant. No scientific publications were required to be corrected as part of this Agreement. INQUIRIES For further information, contact: Director, Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NOTICE OF AHCPR SPECIAL EMPHASIS AREA - SMALL GRANTS NIH GUIDE, Volume 25, Number 17, May 24, 1996 P.T. 34; K.W. 0730050 Agency for Health Care Policy and Research The Agency for Health Care Policy and Research (AHCPR) announces a special emphasis area under its ongoing Small Project Grant Program. AHCPR and the Robert Wood Johnson Foundation (RWJ) are entering a one-time partnership to co-sponsor this special emphasis small grants initiative for funding projects that involve collaboration between medical and public health organizations. (See PA: PAR-96-028 published in the NIH Guide for Grants and Contracts, February 23, 1996.) This activity is intended to advance and continue the work of the national Medicine/Public Health Initiative. The purpose is to create an ongoing working partnership between the two professions to improve the health and health care of the American people. A conference held in March 1996, "National Congress: Medicine and Public Health Initiative," yielded recommendations for potential new collaborative activities, such as this special emphasis area. A copy of the conference summary can be obtained by contacting Dr. Stanley J. Reiser at 713-792-5140. AHCPR's special program emphasis under this initiative is for research and demonstration grants facilitating medicine and public health collaboration in health services research or demonstrations. Of particular interest are projects focused on addressing the health needs of populations through enhanced cooperation between medical practitioners, public health entities and health care delivery organizations. Meritorious applications will be funded under the AHCPR Small Project Grant Program. RWJ separately plans to fund small project and conference grants under this initiative that facilitate convening key stakeholders within a community to promote collaboration between medical and public health organizations. It should be noted that because of limited funding for these special emphasis small grants, AHCPR expects to limit individual awards to up to $25,000 for direct costs, with approximately four to five awards. RWJ expects to limit awards to less than $20,000 total costs, with approximately five to six awards. For information on RWJ indirect cost policies, applicants should contact RWJ's designated representative for this initiative, Stanley J. Reiser, M.D., M.P.A., Ph.D. See Inquiries. (Note: RWJ's funding of indirect costs is different from the AHCPR/Department policies for funding indirect costs.) To facilitate this partnership initiative, a single one-time receipt date of July 31, 1996, has been established. Applications for Research and Demonstration Grants under this initiative involving medicine and public health collaboration in health services research should be submitted to AHCPR no later than July 31, at Office of Scientific Affairs, Attention: Medicine/Public Health Initiative, Small Project Grants, Suite 400, 2101 East Jefferson Street, Rockville, MD 20852. Applications submitted to AHCPR will be reviewed in accordance with ongoing AHCPR Small Project Grant review criteria and procedures, and grants will be administered in accordance with AHCPR and Department grants policies. Applications for RWJ funding for Project and Conference Grants addressing RWJ interests should be submitted no later than July 31, to: Attention: Stanley J. Reiser, M.D., M.P.A., Ph.D., Program on Humanities and Technology in Health Care, University of Texas, 6431 Fannin, P.O. Box 20708, Houston, TX 77225. Applications submitted for RWJ funding will be reviewed in accordance with RWJ procedures for grants review and will be administered in accordance with RWJ grants policies and procedures. While investigators may apply to both AHCPR and RWJ, they are encouraged to focus on only one topic, and select one or the other potential funding source, depending on the topic selected. Applications submitted for this initiative will not be funded jointly by AHCPR and RWJ. AHCPR and RWJ intend to operate separate, parallel review processes and to share funding decisions prior to awards to avoid duplicative funding. Investigators will be asked to provide a signed statement specifically authorizing the sharing of applications and, as applicable, summary statements of initial reviews, between AHCPR and RWJ. INQUIRIES For AHCPR application materials, contact: Global Exchange, Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20814-3015 Telephone: (301) 656-3100 FAX: (301) 652-5264 For specific questions and information about this initiative, contact: Carolyn M. Clancy, M.D.; Director, or Kelly Morgan, Program Analyst, Center for Primary Care Research, AHCPR, telephone (301) 594-1357, email kmorgan@po3.ahcpr.gov. For information about RWJ application procedures and specific questions about this initiative, contact the RWJ designated representative: Stanley J. Reiser, M.D., M.P.A., Ph.D., at (713) 792-5140. $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** SYMPOSIUM ON THE PAST, PRESENT AND FUTURE OF PEER REVIEW NIH GUIDE, Volume 25, Number 17, May 24, 1996 P.T. 42; K.W. 1014006, 1014004 National Institutes of Health Division of Research Grants 1996 marks the 50th anniversary of the founding of the Division of Research Grants. The National Institutes of Health and the Division of Research Grants are marking this occasion with a symposium on the Past, Present, and Future of Peer Review. This symposium will be held Thursday, June 20 at the Natcher Conference Center on the Bethesda campus of NIH. The symposium will start at 8:00 a.m. and conclude with a reception at the Natcher Center in the late afternoon. This is an opportunity for colleagues, friends, and others to discuss fifty years of excellence in peer review and its impact on biomedical research. There is no fee for the symposium, but advance registration is required. The registration deadline is May 31, 1996. The Natcher facility is fully accessible in compliance with the Americans with Disabilities Act. INQUIRIES Information is available on the DRG home page - http://www.drg.nih.gov or can be requested from: Administrative Office Division of Research Grants 6701 Rockledge Drive MSC 7760 Bethesda, MD 20892-7760 Telephone: (301) 435-1099 FAX: (301) 480-3963 Questions about the symposium may be addressed to: Suzanne E. Fisher, Ph.D. Division of Research Grants National Institutes of Health Rockledge Building, Room 2030 - MSC 7720 Bethesda, MD 20892-7720 Telephone: (301) 435-0715 FAX: (301) 480-1987 Email: fys@drgpo.drg.nih.gov $$N4 END ************************************************************ $$N5 BEGIN ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS NIH GUIDE, Volume 25, Number 17, May 24, 1996 P.T. 42; K.W. 0201011, 1014003 National Institutes of Health The National Institutes of Health (NIH), Office of Extramural Research (OER), Office for Protection from Research Risks (OPRR) is continuing to sponsor workshops on implementing the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Each of the workshops scheduled for Fiscal Year 1996 will focus on a specific theme. The workshops are open to institutional administrators, members of Institution