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 stren