From owner-sci-resources@net.bio.net Mon Aug 01 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 31 July 1994 Date: 1 Aug 1994 20:01:59 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 78 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <31kcv7$r9b@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Program Guideline Title: Faculty Early Career Development (CAREER) Program File size (bytes): 30974 STIS Filename: nsf94101 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 100822 STIS Filename: phnalpha Title: NSF Organizational Directory File size (bytes): 124413 STIS Filename: phnorg Document Type: Program Guideline Title: NSF 94-96 Macromolecular Structure Database Program Announcement File size (bytes): 27535 STIS Filename: nsf9496 Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 57855 STIS Filename: sesvac ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve sesvac, the text of your message should be as follows: get sesvac Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve sesvac, you would enter: ftp> get sesvac WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Wed Aug 03 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 29, pt. 1of1, 5 August 1994 Date: 4 Aug 1994 13:35:06 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1461 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <31rjdq$uf@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940805 V23N29 P1O1 ************************************ X-comment: RFAs described: HL-94-018, CA-94-028 NIH GUIDE - Vol. 23, No. 29 - August 5, 1994 $$INDEX BEGIN ******************************************************* NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** INNOVATIVE VENTRICULAR ASSIST SYSTEM (RFP NHLBI-HV-94-25) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R2 ********************************************************** SYNTHESIS AND TESTING OF NEW ANTIPROGESTATIONAL AGENTS (RFP NICHD-CD- 94-13) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R3 10/20/94 ************************************************* NHLBI MINORITY TRAINING AND DEVELOPMENT PROGRAMS (RFA HL-94-018) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R4 11/23/94 ************************************************* MOLECULAR EPIDEMIOLOGY OF PROSTATE CARCINOGENESIS (RFA CA-94-028) National Cancer Institute National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Environmental Health Sciences INDEX: CANCER; DIABETES, DIGESTIVE, KIDNEY DISEASES; ENVIRONMENTAL HEALTH SCIENCES ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** STENT PATENCY AND STENOSIS IN TIPS (PA-94-090) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASE $$INDEX P2 ********************************************************** MECHANISMS UNDERLYING SIGN LANGUAGE ACQUISITION AND USE (PA-94-091) National Institute on Deafness and Other Communication Disorders INDEX: DEAFNESS, OTHER COMMUNICATION DISORDERS $$INDEX P3 ********************************************************** NEW INSIGHTS INTO CHRONIC FATIGUE SYNDROME (PA-94-092) National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Mental Health INDEX: ALLERGY, INFECTIOUS DISEASES; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; MENTAL HEALTH ERRATA $$INDEX E1 ********************************************************** NEUROENDOCRINOLOGY OF AGING (PA-94-087) National Institute on Aging National Institute of Diabetes and Digestive and Kidney Diseases INDEX: AGING; DIABETES, DIGESTIVE, KIDNEY DISEASES ATTENTION: The new mailing list for the NIH Guide will be activated in September. Until then, the existing mailing list will be maintained. See INTENT TO MODIFY (NIH Guide, Vol. 23, No. 23, June 17, 1994) for additional information. This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NHLBI-HV-94-25 ******************************************* INNOVATIVE VENTRICULAR ASSIST SYSTEM NIH GUIDE, Volume 23, Number 29, August 5, 1994 RFP AVAILABLE: NHLBI-HV-94-25 P.T. 34; K.W. 0706040, 0740035, 0705015 National Heart, Lung, and Blood Institute The Bioengineering Section, Heart Program, Division of Heart and Vascular Diseases, National Heart, Lung, and Blood Institute (NHLBI) has an interest in encouraging innovation in the development of totally implantable ventricular assist systems that are designed to achieve at least a five-year lifetime with 90 percent reliability. It is anticipated that the proposed systems will incorporate the latest advances in our understanding of circulatory support requirements, materials science, physics and bioengineering, biocompatibility, quality control, and manufacturing. It is expected that this five-year research and development program will be a multi-disciplinary effort and that offerors will include in their proposals theoretical bases for new and improved concepts; mathematical, computer, and physiological modeling; in vitro and animal testing of prototype systems; human fitting studies; evaluation of the biocompatibility of candidate materials; system monitoring; device maintenance; device replacement; environmental issues; and quality control. This solicitation is not intended to support formal device readiness testing nor is it intended to support human subject experimentation. However, the outcome of this program should be the availability of one or more ventricular assist systems that may be considered for future clinical studies. Four to six awards are anticipated. These incrementally funded contracts will be awarded for five years. This is not a Request for Proposals (RFP). RFP NHLBI-HV-94-25 will be released on or about August 3, 1994, with proposals due December 2, 1994. INQUIRIES Written requests must include three self-addressed mailing labels and cite RFP NHLBI-HV-94-25. FAX requests will be accepted. Requests for copies of the RFP are to be sent to: Sharon M. Kraft Contracts Operations Branch National Heart, Lung, and Blood Institute 7550 Wisconsin Avenue MSC 9070 Federal Building, Room 4C04 Bethesda, MD 20892-9070 FAX: (301) 496-9501 $$R1 END ************************************************************ $$R2 BEGIN NICHD-CD-94-13 ******************************************* SYNTHESIS AND TESTING OF NEW ANTIPROGESTATIONAL AGENTS NIH GUIDE, Volume 23, Number 29, August 5, 1994 RFP AVAILABLE: NICHD-CD-94-13 P.T. 34; K.W. 1003006, 1003012, 0750020 National Institute of Child Health and Human Development The Contraceptive Development Branch of the Center for Population Research, National Institute for Child Health and Human Development (NICHD) has a requirement for the synthesis and testing of antiprogestational agents as postcoital antifertility agents. The goals of this acquisition are to design, synthesize, and test antiprogestational agents that are at least ten-fold more potent orally than mifepristone in standard assays for antiprogestational activity in laboratory animals. The selected prototypes for further structural modification may be mifepristone or other leads that have demonstrated oral activity. Such antagonists should, desirably, also have minimal hormonal and other antihormonal activities for use as contraceptive agents. Such antiprogestational agents must also be devoid of effects on central nervous and cardiovascular systems. The Government will carry out in vivo biological assays required to establish the antiprogestational activity of compounds submitted to the Contraceptive Development Branch under the auspices of this acquisition. Offerors must undertake standard in vitro progesterone and glucocorticoid binding assays on all the newly synthesized compounds in house or through subcontracting. Specifically excluded from consideration are (a) inhibitors of progesterone biosynthesis, and (b) estrogens. Organizations must have adequate facilities and capabilities to carry out the proposed synthetic chemical program and in vitro binding assays as mentioned above. The Government estimates the effort to be approximately 4.9 technical person-years annually. The principal investigator must be a synthetic organic and/or medicinal chemist with a Ph.D. degree, who will devote approximately 25 percent of her/his time to the project and must have five years of experience in drug synthesis. All responsible sources may submit a proposal that will be considered by the agency. It is anticipated that four cost- reimbursement incrementally funded type contracts will be awarded as a result of the request for proposals (RFP) for a period of 36 months, beginning June 1, 1995. This announcement is not an RFP. RFP NICHD-CD-94-13 will be available on or about August 19, 1994. Proposals will be due approximately 120 days thereafter. INQUIRIES Requests for copies of the RFP must cite the RFP number and be addressed to: Paul J. Duska Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Building, Room 7A07 Bethesda, MD 20892 FAX: (301) 402-3676 $$R2 END ************************************************************ $$R3 BEGIN HL-94-018 FULL-TEXT ************************************** NHLBI MINORITY TRAINING AND DEVELOPMENT PROGRAMS NIH GUIDE, Volume 23, Number 29, August 5, 1994 RFA AVAILABLE: HL-94-018 P.T. 44, FF; K.W. 0720005, 0715040, 0715032, 0715165 National Heart, Lung, and Blood Institute Application Receipt Date: October 20, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACTS LISTED IN "INQUIRIES" BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Heart, Lung, and Blood Institute (NHLBI) invites grant applications for research training and career development programs directed at developing the research capabilities of minority individuals in areas relevant to cardiovascular, pulmonary, and hematologic diseases and resources. The specific minority research training and development programs encompassed under this RFA include: (1) the Minority Institutional Research Training program; (2) the Minority School Faculty Development Award program; (3) the Short-Term Training for Minority Students program; and, (4) the Research Development Award for Minority Faculty program. The purpose of these programs is to encourage the enhancement of research skills by minority individuals and to increase the number of minority individuals involved in research endeavors in the areas of interest to the NHLBI. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, NHLBI Minority Training and Development Programs, is related to the priority area of heart disease and stroke. 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 202-783-3238). ELIGIBILITY REQUIREMENTS Awards for the programs described in this RFA will be made to domestic U.S. institutions or organizations, including minority institutions, engaged in health related-research in areas related to heart, lung, or blood disorders. Candidates for the career development awards and trainees appointed to the training programs must be either citizens or noncitizen nationals of the United States or have been lawfully admitted to the United States for permanent residence. Individuals on temporary or student visas are not eligible. MECHANISMS OF SUPPORT The mechanisms of support will be the National Institutes of Health (NIH) Institutional National Research Service Award (NRSA) (T32), Short-Term Training grant (T35), and Career Development Award (K14). Responsibility for the planning, direction, and execution of the proposed training and career development programs will be solely that of the applicant. The total project period for an application in response to this RFA may not exceed five years. The anticipated award date is May 1, 1995. Funding beyond the first year of the grant is contingent upon satisfactory progress during the preceding year and the availability of funds. Indirect costs will be awarded based on eight percent of total direct costs exclusive of equipment and tuition and fees. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the entire program is expected to approximate $2 million in fiscal year 1995. The number of awards is estimated to be two awards for Minority Institutional Research Training Program, three awards for the Minority School Faculty Development Award Program, 10 awards for the Short-Term Training for Minority Students Program, and 12 awards for the Research Development Award for Minority Faculty. The actual amounts for the specific mechanisms may vary, depending on the response to the RFA and availability of funds. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES The present RFA is designed to offer research training and career development opportunities for minority individuals and encourage their participation in cardiovascular, pulmonary, and hematologic research. The Minority Research Training and Career Development programs are intended to: o Bolster the participation and research capabilities of minority individuals in research areas relevant to heart, lung, and blood diseases. o Increase the pool of qualified minority investigators pursuing research in heart, blood vessel, lung, and blood disease and transfusion medicine. See the RFA for specific objectives for the individual minority training and development programs. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248. Applications must be received by October 20, 1994. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Guidelines and supplemental instructions for each of the specific programs may be obtained from NHLBI staff listed under INQUIRIES. REVIEW CONSIDERATIONS All applications will be reviewed for scientific and technical merit by the Research Training Review Committee of the Division of Extramural Affairs, NHLBI, followed by a second level review by the National Heart, Lung, and Blood Advisory Council. The general review criteria for applications submitted under this RFA are those considered when assessing the merit of career development applications, including the Minority School Faculty Development Award and the Research Development Award for Minority Faculty, or institutional National Research Service Award research training applications, including the Minority Institutional Research Training program and the Short-Term Training for Minority Students program. AWARD CRITERIA Funding decisions will be made on the basis of technical merit of the application as determined by peer review, availability of funds, and program balance among the research areas of the RFA. INQUIRIES Written and telephone requests for this RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA, program guidelines, and supplemental instructions, and inquiries regarding programmatic issues to: John Fakunding, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Federal Building, Room 3C04 Bethesda, MD 20892 Telephone: (301) 496-1724 Direct inquiries regarding review issues and mail two copies of the application to: Kathryn Ballard, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 550 Bethesda, MD 20892 Telephone: (301) 594-7450 Direct inquiries regarding fiscal matters to: Jane Davis Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A15C Bethesda, MD 20892 Telephone: (301) 594-7436 Schedule Application Receipt Date: October 20, 1994 Scientific Review Date: December 1994 Advisory Council Date: February 9-10, 1995 Earliest Award Date: May 1, 1995 AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance Numbers 93.837, 93.838, and 93.839. Awards are made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 288 and administered under PHS grants policies and Federal Regulations at 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R3 END ************************************************************ $$R4 BEGIN CA-94-028 FULL-TEXT ************************************** MOLECULAR EPIDEMIOLOGY OF PROSTATE CARCINOGENESIS NIH GUIDE, Volume 23, Number 29, August 5, 1994 RFA AVAILABLE: CA-94-028 P.T. 34; K.W. 0785055, 0715035, 0760002 National Cancer Institute National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Environmental Health Sciences Letter of Intent Receipt Date: October 17, 1994 Application Receipt Date: November 23, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Division of Cancer Etiology, National Cancer Institute (NCI); Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); and Chemical Exposures and Molecular Biology Branch, National Institute of Environmental Health Sciences (NIEHS) invite investigator-initiated research grant applications for molecular epidemiologic studies to further the understanding of prostate cancer etiology. A major emphasis of this RFA is to stimulate the use of biochemical and molecular markers for identifying and assessing risk factors of prostate cancer, which could lead to effective prevention strategies. 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, Molecular Epidemiology of Prostate Carcinogenesis, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Domestic and foreign, non-profit and for-profit, public and private institutions, and units of local, State, and Federal governments are eligible to apply. Foreign institutions and organizations are not eligible for the First Independent Research Support and Transition (FIRST) (R29) awards. Minority and women investigators are encouraged to apply. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) individual research project grants (R01), FIRST awards (R29), and competing supplements (S01) to current R01 awards. 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 the present RFA may not exceed five years. The earliest award date is July 1, 1995. Because the nature and scope of the research proposed may vary, it is anticipated that the size of an average award will vary also ranging from $150,000 to $500,000 in total costs per year. If direct costs exceed $500,000 in any year, the funded study may be considered for an award as a cooperative agreement (U01) (refer to NIH Guide, Vol. 22, Nos. 43 and 45, November 26, and December 17, 1993). Total direct cost award for the five-year R29 grant period may not exceed $350,000 and the direct cost award in any R29 budget period should not exceed $100,000. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary NIH peer review procedure. FUNDS AVAILABLE Approximately $3.75 million ($2,000,000 from NCI, up to $1,000,000 from NIDDK, and $750,000 from NIEHS) in total costs per year for five years will be committed to specifically fund applications which are submitted in response to this RFA. It is anticipated that 8 to 12 awards will be made. Should the NCI, NIDDK, and NIEHS determine that there are sufficient continuing program needs, recipients of awards under this RFA will be invited to submit competing continuation awards. RESEARCH OBJECTIVES The purpose of this RFA is to stimulate innovative molecular epidemiologic research into the origins of prostate cancer, including the biological basis for the striking increase in prostate cancer incidence with age. The types of studies could include, but are not limited to: characterization and validation of biomarkers relevant to prostate carcinogenesis including consideration of variables such as ethnicity, genetic predisposition, diet, and lifestyle; assessment of sex hormonal profiles in body fluids; identification of premalignant lesions; elucidation of the natural history of invasive cancer or progressive stages of the carcinogenic process; exploration of timing of environmental exposures relevant to prostate cancer development; evaluation of micronutrients, macronutrients, xenobiotics and their interactions with hormones and hereditary factors; and clarification of the possible relationships of benign prostatic hyperplasia or chronic prostatitis to prostate cancer. SPECIAL REQUIREMENTS Successful grant awardees under this RFA are strongly encouraged to participate in two, one-day program meetings to be held in Bethesda, Maryland during the second and fifth years of the grant. NIH program staff will coordinate the meetings, which will provide the opportunity for investigators to discuss their work in progress and to consider methodological and scientific issues. The respondents may request sufficient funds within the budget to accommodate expenses for one to two participants at each meeting. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are encouraged to submit, by October 17, 1994, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, participating institutions, and estimated amount of direct costs if anticipated to exceed $500,000 for any year. Potential applicants for research of this magnitude are encouraged to contact the NCI prior to making detailed plans or submitting their applications. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. The letter of intent is to be sent to Dr. Kumiko Iwamoto at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be received by November 23, 1994, on form PHS 398 (rev. 9/91), available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group followed by a second level of review by the National Cancer Advisory Board, the National Advisory Council for Diabetes and Digestive and Kidney Diseases, and the National Advisory Environmental Health Sciences Council. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA, inquiries regarding programmatic issues, and address the letter of intent to: Dr. Kumiko Iwamoto Epidemiology and Biostatistics Program National Cancer Institute 6130 Executive Boulevard, Room 535 Bethesda, MD 20892 Telephone: (301) 496-9600 FAX: (301) 402-4279 Direct inquiries regarding fiscal matters to: Ms. Theresa A. Mercogliano Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 243 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.393 and 93.894. 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 Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R4 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-94-090 ************************************************ STENT PATENCY AND STENOSIS IN TIPS NIH GUIDE, Volume 23, Number 29, August 5, 1994 PA NUMBER: PA-94-090 P.T. 34; K.W. 0715040, 0715115 National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The purpose of this Program Announcement (PA) is to encourage research on the nonsurgical Transjugular Intrahepatic Porto-Systemic Shunt (TIPS) procedure in the areas of stent patency and stent stenosis. The TIPS procedure has recently become available for the treatment of portal hypertension, variceal bleeding, and ascites. At present the long term effectiveness of TIPS is related to shunt patency and stent stenosis. Studies related to technological advances that improve long term patency as well as studies on stent occlusion and fibrosis are encouraged. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000" a PHS-led national activity for setting priority areas. This PA, Stent Patency and Stenosis in TIPS, 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research and Transition (FIRST) (R29) awards. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The support for this program announcement will be through the NIH research project grant (R01) award and the FIRST (R29) award. Applications seeking support of technological improvements of stents may consider the Small Business Innovation Research (SBIR) program (R43) or the Small Business Technology Transfer (STTR) program (R41) of the NIH, in which the NIDDK participates. For-profit applicants for the SBIR and STTR programs must qualify as a small business concern in accordance with the definition given in the latest edition of the OMNIBUS SOLICITATION OF THE PUBLIC HEALTH SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH (SBIR) GRANT AND COOPERATIVE AGREEMENT APPLICATIONS, available from: MTL, Inc., 13687 Baltimore Avenue, Laurel, MD 20707-5096, telephone (301) 206-9385; FAX (301) 206-9722, Internet address: a2y@cu.nih.gov. RESEARCH OBJECTIVES Transjugular intrahepatic porto-systemic shunt has recently become available for the treatment of portal hypertension, variceal bleeding and ascites. The TIPS procedure is highly effective in reducing portal pressure and is thus beneficial in the medical management of patients with acute variceal hemorrhage. However, TIPS is an invasive procedure and is associated with several potential complications. These complications can be categorized according to those relating to transhepatic needle puncture, transvenous access to the portal vein, portal venous cannulation, portosystemic shunting and the stent. At present, long term efficacy is related to shunt patency. For the first year after undergoing the procedure, delayed stenosis or occlusion of the shunt has been reported in 33 to 66 percent of the patients. The pathological process results from either hyperplasia and collagen deposition within the stent or the narrowing of the vascular lumen at the portal venous end of the TIPS stent. New technologies or advances in existing technologies to develop stent materials should be directed to improve long term patency. Further studies to develop research should be directed at elucidating methods to reduce fibrosis and or occlusion of the stent. The latter studies could focus on the role of anticoagulation agents, anti-collagen or fibrotic agents, or anti-inflammatory regimens, such as cytokines, in the maintenance of stent patency. Thus, applications are requested that would improve the technology involving stent patency. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Applications will be accepted at the regular application deadlines as indicated in the application kit. The receipt dates for applications for AIDS- related research are found in the PHS 398 instructions. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institute of Health, Westwood Building, Room 449,Bethesda, MD 20992, telephone 301/594- 7248. The title and number of this program announcement must be typed in Section 2a on the face page of the application. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institute of Health Westwood Building Room 240 Bethesda, MD 20892** Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or a Principal Investigator must be included with the application. FIRST Award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines and will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by an appropriate National Advisory Council. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Thomas F. Kresina, Ph.D. Division of Digestive Diseases and Nutrition National Institute of Digestive Diseases and Kidney Diseases Westwood Building, Room 3A17 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7578 Direct inquiries regarding fiscal matters to: Ms. Paulette Badman Grants Management Branch National Institute of Digestive Diseases and Kidney Diseases Westwood Building, Room 639 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7543 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848. 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. $$P1 END ************************************************************ $$P2 BEGIN PA-94-091 ************************************************ MECHANISMS UNDERLYING SIGN LANGUAGE ACQUISITION AND USE NIH GUIDE, Volume 23, Number 29, August 5, 1994 PA NUMBER: PA-94-091 P.T. 34; K.W. 0775005, 0410001 National Institute on Deafness and Other Communication Disorders PURPOSE The understanding of the mechanisms by which deaf and hearing individuals acquire and use a manual communication system is limited. Research is needed to determine optimal conditions for such learning, prerequisite abilities for successful acquisition and use of a manual system, as well as the interindividual variations of acquisition of manual communication. The National Institute on Deafness and Other Communication Disorders (NIDCD) encourages applications for the support of studies of the sensory, perceptual, cognitive, neural, and molecular mechanisms underlying acquisition and use of a signed language. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Mechanisms Underlying Sign Language Acquisition and Use, is related to the priority area of diabetes and chronic disabling conditions and, special population objectives. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-11474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-11473-1) 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 organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applications from minority individuals, women, and individuals with disabilities are encouraged. MECHANISM OF SUPPORT The support mechanisms for grants in this area will be the individual investigator-initiated research project grant (R01) and the FIRST (R29) award. RESEARCH OBJECTIVES A large proportion of individuals born deaf or who lose their hearing before they acquire spoken language use a form of sign language as their primary mode of communication, either English-language based signing systems or American Sign Language (ASL). Research is needed to increase the understanding of the processes that underlie the acquisition and use of a manual communication system by deaf individuals. Studies concerning the processes and bases of sign language acquisition and use may identify the optimal conditions for learning a manual sign system. This will lead to the development of a model of language that can address the relationship of spoken and signed languages and may also help delineate new methods of successfully introducing and using English with deaf children. Acquisition and processing of signed languages. Language acquisition for deaf children with signing deaf parents typically involves use of American Sign Language (ASL). Previous research, although limited, has indicated that in those individuals exposed to ASL from birth, linguistic competence, on-line sentence processing and underlying neural mechanisms for language may be similar to those found in hearing users of native spoken languages. Additional studies are needed of cognitive, motor, neural, and molecular processes involved in acquisition of ASL among deaf children of deaf parents. A better understanding also is needed of typical patterns of sign language development, and the processes involved in perception and production of sign language in deaf children of hearing parents. Recent evidence suggests that increasing numbers of hearing parents are using sign communication with their deaf children. They commonly use English-based signing, but there is a growing interest in the use of ASL by hearing parents and siblings. There is also a need for additional studies of patterns of acquisition and the cognitive, motor, neural, and molecular processes involved in signing. Recent research findings, concerning the acquisition of ASL by deaf children of hearing parents at various ages beyond infancy, indicate that there is a critical period for the acquisition of ASL, just as there is for the acquisition of spoken languages by hearing individuals. Competency in and efficiency of processing ASL appears to be related to age of exposure to ASL, with a decline in competency and efficiency and possible changes in neural organization for later learners. A full explanation of this phenomenon awaits further investigation. Cognitive, perceptual, and motor processes, and psychosocial issues related to sign language acquisition and use. Acquisition of the ability to employ a signed language depends on the development of a number of interrelated cognitive and linguistic abilities that contribute to the perception and production of sign language. In addition, the nonlinguistic/cognitive outcomes in deaf children exposed to various kinds of sign language are undocumented and warrant investigation. The relation of cognitive and psychosocial development to sign language acquisition and use requires further investigation. Sign language production makes use of space and movement; thus the perception of sign language requires the processing of complex arrays of dynamic motion. Investigations are needed of sign language perception, particularly the processing of motion and form and how such visual-dynamic information is processed linguistically. Comparison of the processes of spoken language perception and signed language perception in hearing and deaf individuals provides a unique means of determining those aspects of language that are independent of the modality (signed or spoken) of communication. Neural underpinnings of sign language acquisition and use. The interface of sign language acquisition to other biological phenomena is important to our understanding of brain-behavior relationships. Electrophysiologic findings indicate that, in spite of the very different input/output systems employed, the same or similar areas in the left hemisphere of the brain are involved in language tasks in native ASL signers as in speakers of English. However, studies of this type, examining the organization of the brain and its relation to sign language acquisition and use, are limited. Studies of brain mapping of sign language function are needed, as are continued investigations of differences and similarities in the way the brain processes spoken and signed languages. Questions remain concerning the ways in which cortical organization may be influenced by age of acquisition and by early perceptual and linguistic experience. Examples of issues to be addressed in applications submitted in response to this Program Announcement include, but are not limited to, the following: o The acquisition of ASL or other signing systems in children exposed to these languages from birth as well as in children whose access to a first natural language is delayed or incomplete; o The relation between cognitive and psychosocial development and the acquisition of ASL in deaf children of deaf parents and in deaf children of hearing parents; o The relation of infants' early acquisition of sign language phonology, assessed through tests of sign perception, to the acquisition of other levels of a signed language, such as the acquisition of signs (lexicon), sign meanings (semantics) and grammatical constructions (syntax); o The underlying perceptual and motor processes in sign language, for example, basic and higher level processes underlying the perception and use of space, form and movement in sign language; o The nature of parallel processing of simultaneous visual and auditory information in deaf children and adults; o Identification and characterization of the neural systems that underlie the representation, perception and production of signed languages in both adults and children using, when appropriate, techniques such as measuring event-related potentials and imaging technology; o The specialization of the cerebral hemispheres for language and other types of cognitive processing in deaf individuals, including the ways in which the neural organization and function of the basic sensory systems may be changed by deafness and/or by acquisition of sign language; o Critical periods for the natural acquisition of signed languages, and the effects of delayed exposure to spoken or signed language on the development of linguistic competence and cognitive and academic abilities. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and 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 18, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. These kits are available from most institutional offices of sponsored research; the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and the NIDCD Program Administrator listed under INQUIRIES. The title and number of the program announcement must be typed in Section 2a on the face page of the application. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by an appropriate Initial Review Group within the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific/technical review, the applications will receive a second-level review by the appropriate national advisory council. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that ICD. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review. o Availability of funds. o Program priorities among research areas of the announcement. INQUIRIES Written and telephone inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Judith A. Cooper, Ph.D. Division of Communication Sciences and Disorders National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 496-5061 FAX: (301) 402-6251 Direct inquiries regarding fiscal matters to: Sharon Hunt Grants Management Office National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-B 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 402-0909 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.173. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 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. $$P2 END ************************************************************ $$P3 BEGIN PA-94-092 ************************************************ NEW INSIGHTS INTO CHRONIC FATIGUE SYNDROME NIH GUIDE, Volume 23, Number 29, August 5, 1994 PA NUMBER: PA-94-092 P.T. 34; K.W. 0715043 National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Mental Health PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), and National Institute of Mental Health (NIMH) invite investigator-initiated research grant applications to support research on the etiology, natural history, and pathogenesis of chronic fatigue syndrome (CFS). 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, New Insights into Chronic Fatigue Syndrome, is related to the priority area of chronic disabling diseases. 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 20402-0325 (telephone 202-783-3238). 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. Applications from minority individuals and women are encouraged. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT Traditional research project grant (R01) and FIRST award (R29) applications may be submitted in response to this program announcement. The R01 mechanism can be used to support small studies. Funds and time requested should be appropriate for the research proposed. RESEARCH OBJECTIVES Background Chronic fatigue syndrome (CFS) is a multisystem syndrome thought to be triggered by acute infectious illness and characterized by months of debilitating fatigue frequently associated with myalgia, headache, sore throat, low grade fever, cognitive complaints, gastrointestinal symptoms, and tender lymph nodes. There have been reports of immunologic and, more recently, neuroendocrine parameters that differ in CFS patients as a group compared to healthy controls. However, no single marker has been identified that can be used to diagnose the syndrome. CFS is diagnosed three to four times more frequently in women than in men and about 10 times more often in white Americans than in other American population groups. The cause and pathogenic mechanisms of the illness are unknown. Research Objectives and Experimental Approaches Well-designed studies are needed to provide a better understanding of CFS and to develop diagnostic and intervention strategies. Studies should include appropriate sample sizes and test biologically rational hypotheses concerning etiology, natural history or pathogenesis of the syndrome. Applications for small studies that explore new ideas are also encouraged and could provide the basis for submission of a subsequent larger grant application. Clinical epidemiologic studies may identify factors that affect prognosis or that are associated with susceptibility, including immunogenetic, behavioral, environmental, and psychosocial factors. Several observations reported in the literature merit further study to determine their biologic and/or epidemiologic basis, generalizability and/or role in CFS. These include, but are not limited to: o lymphocyte patterns suggestive of immune activation (e.g., alterations in T-cell subsets number and function, altered cytokine levels and function) o low levels of cortisol and corticotropin-releasing hormone in CFS patients in the absence of documented adrenal-hypothalamic axis dysfunction attributable to other causes o increased frequency of sleep disturbances (hypersomnia or insomnia) o overlapping symptomatology with fibromyalgia o low tolerance to physical exertion manifested by prolonged generalized fatigue after very moderate exercise o demographic risk factors (gender, age, race, socioeconomic class) o reactivation of latent viruses (e.g., use of sensitive and specific assays to measure viral reactivation in carefully defined and controlled specimens) o increased frequency of psychiatric diagnoses in CFS patients (except those that would exclude an individual from the CFS case definition) o increased frequency of atopy in CFS patients compared with the U.S. population as a whole o highly active lifestyle prior to onset of CFS Multidisciplinary studies and collaboration among investigators with expertise in appropriate disciplines are encouraged. When investigators are at different institutions, individual R01 applications may include consortium arrangements. Collaborative arrangements with on-going studies that provide patient populations, specimens and data are encouraged. Such arrangements should be clearly delineated in the application. The methodologies and personnel involved in statistical/epidemiological analyses should be described in the application and evident in the study design. The hypothesis(es) to be tested should be clearly stated. The constructs and measurements to be used operationally to obtain statistically and biologically meaningful results should be clearly defined and enumerated. The value of studies of patients or their specimens will be directly related to the care exercised in selection and initial characterization of cases and controls. A detailed description of case recruitment procedures, the criteria to be used for case definition and the manner in which the criteria are to be applied must be included. Similar care should be given to descriptions of enrollment of comparison groups. Investigators are encouraged to use the CFS case definition as initially presented in Holmes, et al. (Annals of Internal Medicine: 108, 387-389, 1988) and subsequently modified in Schluederberg, et al. (Annals of Internal Medicine: 117, 325-331, 1992) and in Fukuda, et al (in press). If other case definitions are proposed, they should be clearly defined and the rationale for their choice clearly delineated. Parameter Measurements Applications to estimate the frequency of physiological or behavioral variables or responses or to address other quantitative aspects in relevant populations should pay particular attention to sample sizes required to attain the degree of precision sought or needed for statistically and biologically meaningful results. The reliability and validity of markers chosen for measurement should be demonstrated. Applications attempting to examine interrelationships among two or more separate factors are encouraged to the extent that the types and numbers of subjects are sufficient for such comparisons. The measurement of cellular phenotypes, cytokine activities and other immunological and viral markers are highly dependent on the assay system chosen and its execution. Thus, it is very important that applicants clearly define the methodologies to be used, the rationale for choosing that methodology and for validating results as well as methods of collection, processing, and storage of samples. When conflicting results have been reported in the literature, applicants should provide possible explanations for such variability and indicate how their approach might resolve the issue. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact persons listed below. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted on the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Each application must be identified by checking "YES" on line 2a of the PHS face page, and the number and title of this announcement must be typed in section 2a. 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. 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 Westwood Building, Room 240 Bethesda, MD 20892** 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 by study sections of the Division of Research Grants, NIH, 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. AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications assigned to that ICD. 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 announcement, availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Susan Spring, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A14 6003 Executive Boulevard MSC 7630 Bethesda, MD 20892-7630 Telephone: (301) 496-7453 FAX: (301) 496-8030 Susana A. Serrate-Sztein, Ph.D Arthritis Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 405 Bethesda, MD 20892 Telephone: (301) 594-9953 FAX: (301) 594-9673 Fred Altman, Ph.D. Basic Prevention and Behavioral Medicine Research Branch National Institute of Mental Health Parklawn Building, Room 11C06 Rockville, MD 20857 Telephone: (301) 443-4337 FAX: (301) 443-4822 Direct inquiries regarding fiscal matters to: Ms. Victoria Putprush Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B35 6003 Executive Boulevard MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Mr. Joseph L. Brown Grants Management Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 722C Bethesda, MD 20892 Telephone: (301) 594-9970 FAX: (301) 594-9950 Mr. Bruce Ringler Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C08 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-3065 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.856, Microbiology and Infectious Disease Research, No. 93.846, Arthritis, Musculoskeletal, and Skin Diseases Research and No. 93.242, Mental Health 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 grant policies and Federal Regulations at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P3 END ************************************************************ ERRATA $$E1 BEGIN P2 19940729 APPEND PA-94-087 BOTH *************************** NEUROENDOCRINOLOGY OF AGING NIH GUIDE, Volume 23, Number 29, August 5, 1994 PA NUMBER: PA-94-087 P.T. 34; K.W. 0710010, 0785105 National Institute on Aging National Institute of Diabetes and Digestive and Kidney Diseases The following correction is issued for PA-94-087, which was published in the NIH Guide, Vol. 23, No. 28, July 29, 1994. The second sentence under MECHANISM OF SUPPORT should read: Foreign institutions are NOT eligible for FIRST (R29) awards. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Andrew A. Monjan, Ph.D., M.P.H. Neuroscience and Neuropsychology of Aging Program National Institute on Aging Gateway Building, Suite 3C307 Bethesda, MD 20892 Telephone: (301) 496-9350 FAX: (301) 496-1494 $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Wed Aug 03 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-94-018 - V23(29) 08/05/94 Date: 4 Aug 1994 13:35:14 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 595 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <31rje2$10q@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL94018 HL-94-018 P1O1 *************************************** NHLBI MINORITY TRAINING AND DEVELOPMENT PROGRAMS NIH GUIDE, Volume 23, Number 29, August 5, 1994 RFA: HL-94-018 P.T. 44, FF; K.W. 0720005, 0715040, 0715032, 0715165 National Heart, Lung, and Blood Institute Application Receipt Date: October 20, 1994 PURPOSE The National Heart, Lung, and Blood Institute (NHLBI) invites grant applications for research training and career development programs directed at developing the research capabilities of minority individuals in areas relevant to cardiovascular, pulmonary, and hematologic* diseases and resources. The specific minority research training and development programs encompassed under this request for applications (RFA) include: (1) the Minority Institutional Research Training program; (2) the Minority School Faculty Development Award program; (3) the Short-Term Training for Minority Students program; and, (4) the Research Development Award for Minority Faculty program. The purpose of these programs is to encourage the enhancement of research skills by minority individuals and to increase the number of minority individuals involved in research endeavors in the areas of interest to the NHLBI. * Within NHLBI, the term "hematologic" means research on thrombosis and hemostasis, immunohematology, blood cell disorders, hematopoiesis, thalassemia, sickle cell disease, transfusion medicine, blood resources including blood component and derivative therapy, blood substitutes and blood resource management, aspects of AIDS-products in AIDS prevention and treatment, and AIDS-related bone marrow and hematologic disorders. Other Institutes of the NIH are responsible for research on disorders of white cells, including the leukemias and other blood malignancies, and basic immunology related to the lymphoid system. Therefore, NHLBI cannot provide support for such studies. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, NHLBI Minority Training and Development Programs, is related to the priority area of heart disease and stroke. 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 202-783-3238. ELIGIBILITY REQUIREMENTS Awards for the programs described in this RFA will be made to domestic U.S. institutions or organizations, including minority institutions, engaged in health related-research in areas related to heart, lung, or blood disorders. Candidates for the career development awards and trainees appointed to the training programs must be either citizens or noncitizen nationals of the United States or have been lawfully admitted to the United States for permanent residence. Individuals on temporary or student visas are not eligible. Individual eligibility requirements for the specific grant awards listed above are as follows: Minority Institutional Research Training Program (T32). Awards in this program will be made to domestic minority institutions, each of which will collaborate with a research center that has well-established cardiovascular, pulmonary, or hematologic research and research training programs. A minority school is defined as a domestic medical or non-medical college, university or equivalent school in which students of minority ethnic groups including Blacks, Hispanics, American Indians, Asians, or Pacific Islanders comprise a majority of the school's enrollment. The program director at the minority school will be responsible for the selection and appointment of trainees and the overall direction of the training program. Trainees appointed to the program will be placed with a mentor who is an accomplished investigator at the cooperating research center and who will assist the advisor at the minority institution in the trainee's development and research plan. Trainees must: (1) be training at the post-baccalaureate level (i.e., predoctoral level) in a relevant biomedical or behavioral science and have made a strong commitment to completing a doctoral degree, (2) be enrolled in a minority health professional school, or (3) have a doctoral degree or equivalent in a biomedical or behavioral science (i.e., postdoctoral level). The collaborating research center should be a university, medical school, or comparable institution that has strong, well-established research and research training programs in areas relevant to heart, lung, and blood diseases. Cooperation between institutions is needed to provide each trainee with a mentor who is recognized as an accomplished investigator in cardiovascular, pulmonary, or hematologic research and who will assist the advisor at the minority institution in the trainee's development and research plan. Minority School Faculty Development Award Program (K14). Awards in this program will be made to domestic minority institutions on behalf of individuals, each of whom will work with a mentor at a nearby (within 100 miles) research center. The mentor must be recognized as an accomplished investigator in the area proposed and must provide guidance for the awardee's development and research plan in research areas related to heart, lung, or blood disorders. The commitment of the institution to the faculty candidate's research and development must clearly be presented in the application. This must include statement(s) from the Dean and departmental chair indicating that the candidate will be provided with sufficient release time from other duties to accomplish the research goals stated in the application. Candidates for this award are minority school faculty members who: (1) are citizens of the United States, non-citizen nationals, or permanent residents at the time of application, (2) have a doctoral degree or equivalent in a biomedical or behavioral science, (3) wish to receive specialized training in cardiovascular, pulmonary, or hematologic research, and (4) have the background and potential to benefit from the training. Each candidate must identify and complete arrangements with a nearby mentor (within approximately 100 miles) who is recognized as an accomplished investigator in the research area proposed and who will provide guidance for the awardee's development and research plan. Plans for the intensive training during the summer period (two to three months) as well as during the academic years must be developed with the mentor. Short-Term Training for Minority Students Program (T35). Awards in this program will be made to domestic institutions or organizations, including minority institutions, engaged in research in areas related to heart, lung, or blood disorders. These grants will support short-term research training experiences of two to three months duration for minority undergraduate students, minority students in health professional schools, and minority graduate students. The grantee institution will be responsible for the selection and appointment of trainees. Special attention should be given to the recruitment of individuals from minority groups that are underrepresented nationally in the biomedical and behavioral sciences, i.e., Blacks, Hispanics, Native Americans, Alaska Natives, and Pacific Islanders. Trainees must have successfully completed at least one undergraduate year at an accredited school or university or have successfully completed one semester at a school of medicine, optometry, osteopathy, dentistry, veterinary medicine, pharmacy or public health, or an institution with an accredited graduate program, prior to participating in the program. Trainees appointed to the program need not be from the grantee institution, but may include a number of minority students from other institutions, schools, colleges, or universities. These grants are intended to introduce students to research that would not otherwise be available through their regular course of studies. For graduate students, this may include graduate students in programs, such as mathematics, where they would not normally be exposed to biomedical research or graduate students who may need a specialized research experience to supplement their normal graduate education. Individuals holding Ph.D., M.D., D.V.M., or equivalent doctoral degrees in the health sciences are not eligible. Research Development Award for Minority Faculty (K14). Awards in this program will be made to domestic institutions or organizations, including minority institutions, on behalf of individuals. Individuals applying for this program must have been awarded a doctoral degree (Ph.D., M.D., D.V.M., D.O. degree or its equivalent), have a faculty appointment at an accredited college or university at the time of award, and be members of an underrepresented minority group. For the purpose of this program, underrepresented minority faculty members are defined as individuals belonging to a particular ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical or behavioral research. In making grant awards under this program, the NHLBI will give priority to projects involving Black, Hispanic, Native American, Pacific Islander, and other ethnic or racial group members who have been found to be underrepresented in biomedical or behavioral research nationally. Candidates must be nominated by an institution on the basis of qualifications, interests, accomplishments, motivation, and potential for performing quality research. The candidate's academic background, previous experience, and career goals should determine both the necessary length and the kind of program that is appropriate. Each candidate must identify a sponsor(s) who is an accomplished investigator in the research area proposed, who is engaged in research in areas related to heart, lung, or blood disorders, and has experience in developing independent investigators. The sponsor is not required to be affiliated with the applicant institution. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) National Research Service Award (NRSA) Institutional research training grant (T32), Short-Term Training grant (T35), and Career Development Award (K14). Responsibility for the planning, direction, and execution of the proposed training and career development programs will be solely that of the applicant. The total project period for an application in response to this RFA may not exceed five years. The anticipated award date is May 1, 1995. Funding beyond the first year of the grant is contingent upon satisfactory progress during the preceding year and the availability of funds. Indirect costs will be awarded based on eight percent of total direct costs exclusive of equipment and tuition and fees. Specific characteristics of each program are as follows: Minority Institutional Research Training Program (T32). Minority Institutional NRSA Research Training programs may support predoctoral, postdoctoral, and short-term trainees in health professional schools. The stipend level for predoctoral and short-term trainees is $10,008 per year, and stipend levels for postdoctoral trainees range from $19,608 to $32,300 per year. Stipends may be supplemented from non-Federal sources. Training related expenses ($1,500 annually for predoctoral trainees and $2,500 annually for postdoctoral trainees), tuition and fees, and travel expenses ($800 per trip) may also be requested for trainees, although the levels may vary depending on the type of training to be supported. The trainees may be appointed for 9 to 12 months (for short-term trainees, the period of appointment may be of 2 to 3 months duration) at any time during the course of the budget period after acceptance as a full-time student. A strong interest in a cardiovascular, pulmonary, or hematologic research career must be evident. Minority School Faculty Development Award Program (K14). The awardee may receive salary support up to a maximum of $50,000 per year plus fringe benefits for five years. All funds must be used to support the awardee. Awardees must commit 100 percent effort during the summer and/or off quarter periods and at least 25 percent effort during the academic year. In addition to the salary requested for the candidate, support for up to 10 percent of the mentor's salary during the summer experience may also be requested. Up to $20,000 per year will be provided for research support. Details regarding the apportionment of these funds between the minority institution and the research center must be worked out with the mentor at the research center and agreed to by representatives of both institutions. If funds are to be transferred to the mentor's institution for any purpose, arrangements for the transfer or conduct of activities should be formalized in a contract or written agreement with the mentor's institution and submitted as part of the application. The award is non-renewable and may not be transferred to another institution or another faculty member. The indirect cost rate on subcontract costs for the mentor's institution may not exceed eight percent of total costs. Short-Term Training for Minority Students Program (T35). Institutions may request support for short-term training programs for at least four and not more than 24 trainees per year. Trainees may be minority undergraduate, graduate, or health professional students. The stipend level for trainees is $834 per month. Stipends may be supplemented from non-federal funds. Training-related expenses up to $125 per month per trainee may be requested. In addition, up to $500 per trainee may be requested to cover domestic travel to and from the training site and up to $250 per month per trainee may be requested to cover the cost of housing at the training site. Trainee tuition and fees, where necessary to the research training, must be covered by the Training Related Expenses. Research Development Award for Minority Faculty (K14). The awardee may receive salary support up to a maximum of $50,000 plus fringe benefits per year for five years. All funds must be used to support the awardee. A minimum of 80 percent effort must be devoted to the research program. The remainder may be devoted to other teaching, clinical, or administrative pursuits that are consistent with the program goals, i.e., the candidate's development into an independent biomedical scientist or the maintenance of the teaching and clinical skills needed for an academic research career. In addition to the salary request for the candidate, support for up to five percent of the sponsor's salary may be requested. Up to $30,000 per year will be provided for research support. Substitution of another sponsor and/or a change of institution may be permitted with the prior approval of the NHLBI. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the entire program is expected to be approximately $2 million in fiscal year 1995. The actual amounts for the specific mechanisms may vary, depending on the response to the RFA and availability of funds, but the anticipated number of awards for each mechanism is as follows: Minority Institutional Research Training Program: 2 new awards Minority School Faculty Development Award Program: 3 new awards Short-Term Training for Minority Students Program: 10 new awards Research Development Award for Minority Faculty: 12 new awards RESEARCH OBJECTIVES Many studies have emphasized the need for minority individuals to participate in modern research activities to develop their investigative talents. Whereas approximately 12 percent of the U.S. population is Black, less than 0.25 percent of individuals holding a Ph.D. degree in biomedical science are Black. Furthermore, the number of doctorates, both M.D.s and Ph.D.s, awarded to other ethnic minority groups, such as Native Americans or Hispanics, is proportionally lower than for Blacks. There are existing programs at the NIH that are designed to answer this need. These include the Minority Biomedical Research Support Program, the Minority Access to Research Careers Program, and the Minority Research Supplements Program. Even though these programs appear successful in meeting their specific objectives and career development goals, minority graduate students, health professional students, and postdoctoral students in minority schools need further opportunities to develop biomedical and behavioral research skills and become productive investigators. While there is strong interest in the scientific community in attracting minority students into research careers, few minority students opt for science degrees and research careers, and few minority graduates of health professional schools go on to investigative careers. The shortage of qualified minority investigators in academic research positions may even exacerbate the situation due to a lack of visible role models for students. One method of addressing this problem is by attracting minority students to research opportunities and by providing them with research training to develop their research capabilities in cardiovascular, pulmonary, and hematologic disease areas. In addition, by increasing the research capabilities of minority faculty members and faculty members at minority institutions, these individuals may serve as role models for minority undergraduate and graduate students, and stimulate these students to become more cognizant of research opportunities in cardiovascular, pulmonary, and hematologic disease areas. The present RFA is designed to offer research training and career development opportunities for minority individuals and encourage their participation in cardiovascular, pulmonary, and hematologic research. The Minority Research Training and Career Development programs are intended to: o Bolster the participation and research capabilities of minority individuals in research areas relevant to heart, lung, and blood diseases. o Increase the pool of qualified minority investigators pursuing research in heart, blood vessel, lung, and blood disease and transfusion medicine. Specific objectives for the individual programs are as follows: The Minority Institutional Research Training Program is intended to: o Train graduate students, health professional students, and postdoctoral students at minority schools that have the potential to develop a meritorious program in cardiovascular, pulmonary, or hematologic research for research careers in areas relevant to these diseases. o Stimulate cardiovascular, pulmonary, and hematologic diseases and hematologic resources research, prevention, control, and education by offering minority school graduate students, health professional students, and postdoctoral students the opportunity to enhance their research capabilities in these areas. The Minority School Faculty Development Award is intended to: o Encourage the development of faculty investigators at minority schools in areas relevant to cardiovascular, pulmonary, and hematologic diseases and transfusion medicine. o Stimulate cardiovascular, pulmonary, and hematologic disease research, prevention, control, and education by offering minority school faculty members the opportunity to enhance their research capabilities in these areas. The Short-Term Training for Minority Students program is intended to: o Provide minority undergraduate students, graduate students, and students in health professional schools exposure to opportunities inherent in research careers in areas relevant to cardiovascular, pulmonary, and hematologic diseases. o Attract highly qualified minority students into biomedical and behavioral research careers and increase the already short supply of minority investigators. The Research Development Award for Minority Faculty is intended to: o Encourage research-oriented minority faculty to develop independent research skills and gain experience in advanced methods and experimental approaches in the basic and applied sciences relevant to heart, blood vessel, lung, and blood diseases and transfusion medicine. o Increase the pool of highly trained minority investigators who can use advanced technologies to address the major problems in heart, blood vessel, lung, blood diseases, and transfusion medicine. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248. Guidelines and supplemental instructions for each of the specific programs may be obtained from NHLBI staff listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. 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 Westwood Building, Room 240 Bethesda, MD 20892** Two additional copies of the application must be sent to: Scientific Review Administrator NHLBI Research Training Review Committee National Heart, Lung, and Blood Institute Westwood Building, Room 550 Bethesda, MD 20892 Telephone: (301) 594-7450 Applications must be received by October 20, 1994. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS All applications will be reviewed for scientific and technical merit by the Research Training Review Committee of the Division of Extramural Affairs, NHLBI, followed by a second level review by the National Heart, Lung, and Blood Advisory Council. The following criteria will be considered when assessing the merit of career development applications, including the Minority School Faculty Development Award and the Research Development Award for Minority Faculty. o Candidate -- The candidate's overall competence as demonstrated by academic record and performance, potential for a career in independent research, and commitment or interest in pursuing an academic research career. o Sponsor(s) -- The sponsor's accomplishments in the scientific research area(s) proposed, experience and track record in training investigators, and commitment for the duration of a candidate's research development. o Environment -- The applicant institution's ability to provide adequate facilities, resources, and opportunities necessary for the candidate's training, and the institutional commitment to the candidate. If different from the applicant institution, the quality and extent of interaction of the faculty in the basic and clinical sciences, and the quality of the research and research training programs at the sponsor's institution. o Career Development Plan -- The adequacy of the research career development plan, based on the candidate's past research experience, training, and career goals. o Research Project -- Scientific merit of the proposed research project and its appropriateness as a vehicle for developing the candidate's research skills. o If applicable, adequacy of adherence to NIH policy concerning the inclusion of women and minorities in clinical research study populations. The following criteria will be considered when assessing the merit of a research training grant application, including the Minority Institutional Research Training program and the Short-Term Training for Minority Students program. o Adequacy of faculty, facilities, and resources for the proposed research training; o Commitment of the relevant faculty and the institution to the goals of the training program and the caliber of preceptors as researchers including successful competition for research support; o Past research training record for the program director and designated preceptors in terms of the success of trainees pursuing research activities; o Objectives, design, and direction of the research training program. AWARD CRITERIA The following will be considered in making funding decisions: o Technical merit of the application as determined by peer review o Availability of funds o Program balance among the research areas of the announcement INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding program guidelines, supplemental instructions, or programmatic issues to: John Fakunding, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Federal Building, Room 3C04 Bethesda, MD 20892 Telephone: (301) 496-1724 LeeAnn Jensen, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute Federal Building, Room 5C04 Bethesda, MD 20892 Telephone: (301) 496-8387 Mary Reilly, M.S. Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 640A Bethesda, MD 20892 Telephone: (301) 594-7466 Thomas Blaszkowski, Ph.D. Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute Federal Building, Room 208A Bethesda, MD 20892 Telephone: (301) 496-1841 James P. Kiley, Ph.D. National Center for Sleep Disorders Research National Heart, Lung, and Blood Institute Building 31, Room 4A11 Bethesda, MD 20892 Telephone: (301) 496-7443 Direct inquiries regarding fiscal matters to: Jane Davis Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A15C Bethesda, MD 20892 Telephone: (301) 594-7436 AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance numbers 93.837, 93.838, and 93.839. Awards are made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 288) and administered under PHS grant policies and Federal Regulations at 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. 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 Aug 03 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-94-028 - V23(29) 08/05/94 Date: 4 Aug 1994 13:35:20 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 581 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <31rje8$113@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA94028 CA-94-028 P1O1 *************************************** MOLECULAR EPIDEMIOLOGY OF PROSTATE CARCINOGENESIS NIH GUIDE, Volume 23, Number 29, August 5, 1994 RFA: CA-94-028 P.T. 34; K.W. 0785055, 0715035, 0760002 National Cancer Institute National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Environmental Health Sciences Letter of Intent Receipt Date: October 17, 1994 Application Receipt Date: November 23, 1994 PURPOSE The Division of Cancer Etiology, National Cancer Institute (NCI); Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and Chemical Exposures and Molecular Biology Branch, National Institute of Environmental Health Sciences (NIEHS) invite investigator-initiated research grant applications for molecular epidemiologic studies to further the understanding of prostate cancer etiology. The purpose of this initiative is to stimulate the use of biochemical and molecular markers for identifying and assessing risk factors, which could lead to effective prevention strategies. 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), Molecular Epidemiology of Prostate Carcinogenesis, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202-783-3238. ELIGIBILITY REQUIREMENTS Domestic and foreign, non-profit and for-profit, public and private institutions, such as colleges, universities, hospitals, research laboratories, units of State and local governments, and agencies of the Federal government are eligible to apply. Foreign institutions and organizations are not eligible for the First Independent Research Support and Transition (FIRST) awards (R29) but may submit applications for individual research project grants (R01); foreign applicants may also participate in laboratory or clinical programs through subcontract or consortium arrangements. Minority and women investigators are encouraged to apply. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) individual research project grants (R01), FIRST awards (R29), and competing supplements (S01) to current R01 awards. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary NIH peer review procedures. However, should the NCI, NIDDK, and NIEHS determine that there are sufficient continuing program needs, recipients of awards under this RFA will be invited to submit competing continuation applications for review. It is anticipated that the size of an award will vary due to the nature and scope of the proposed research with the average R01 award ranging from $150,000 to $500,000 per year in total costs. If direct costs exceed $500,000 in any year, the funded study may be considered for an award as a cooperative agreement (U01) (refer to NIH Guide, Vol. 22, No. 43, November 26, 1993 and Vol. 22, No. 45, December 17, 1993). The total project period for applications may not exceed five years. The total direct cost award for the five-year R29 grant period may not exceed $350,000 and the direct cost award in any R29 budget period may not exceed $100,000. The earliest feasible start date for the initial awards will be July 1, 1995. FUNDS AVAILABLE Approximately $3.75 million ($2,000,000 from NCI, up to $1,000,000 from NIDDK and $750,000 from NIEHS) in total costs per year for five years will be committed specifically to fund applications that are submitted in response to this RFA. It is anticipated that 8 to 12 awards will be made. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in financial plans of the NCI, NIDDK, and NIEHS, the award of grants pursuant to this RFA is contingent upon the availability of funds at the time the awards are made. RESEARCH OBJECTIVES Background In the United States, prostate cancer has become the most frequently diagnosed neoplasm and the second leading cause of cancer mortality in men after lung cancer. Its incidence rate has continued to increase rapidly during the past two decades, especially in men over the age of 50 years, and 165,000 new incident cases comprising 27 percent of male cancers were expected to be diagnosed in 1993 (1). Prostate cancer develops more rapidly with advancing age than any other form of cancer and since the population is aging, its impact is a major public health concern. The etiology of prostate cancer is obscure. Clues may be derived from descriptive epidemiology characterizing the steep slope of incidence in the elderly, variation in race-specific and international incidence patterns, and high prevalence of latent (histologically apparent and clinically silent) carcinoma. The most compelling hypothesis supports a hormonal etiology based on the androgen-dependency of the prostate gland for growth and function. Studies in animal models have demonstrated the role of androgens in the induction of prostate cancer. Moreover, in humans, men castrated before puberty do not develop prostate cancer, and prostate cancer has responded to estrogen therapy (2). Case-control studies of serum testosterone and other hormones have thus far, however, reported inconsistent results (3), although it has been reported that populations with low levels of serum androgens have a lower incidence of prostate cancer (4). Although studies of familial aggregation and genetic analyses have indicated a heritable component in risk (5), the wide geographic variation in rates as well as migrant studies suggest a role for environmental factors, including diet and nutrition. African-American men have the highest incidence and mortality rates in the world, two-fold higher than among U.S. whites and much higher than among African populations. The incidence varies widely around the world: a 50-fold difference exists between countries with the highest (blacks in Detroit, Michigan: 91.1 per 100,000) and lowest (Shanghai, China: 1.8 per 100,000) incidence rates of prostate cancer (6). In addition, immigrants from low-risk countries (e.g., China or Japan) experience an increased risk after migrating to a high-risk country (e.g., United States). Evidence from case- control and cohort studies has suggested that dietary fat may be associated with invasive prostate cancer (7-9) while certain micronutrients such as vitamin D may be protective (10). The role of other environmental exposures (e.g., occupation, ionizing radiation, viruses) and the effects of lifestyle factors (e.g., smoking, alcohol consumption, sexual behavior, vasectomy) have yet to be clarified. The special characteristic of latent prostatic tumors, detected most often at autopsy and estimated to affect one third of all males older than 50 years, has remained an enigma in the understanding of the natural history and biology of invasive prostate cancer. Interestingly, there are no clear racial or geographic differences in the occurrence of small intraprostatic foci of latent cancer, whereas the prevalence of larger focal lesions parallels the variations in mortality rates. It has been hypothesized that environmental factors may affect the transition of latent to invasive cancer by acting as tumor promoters (11). Little is known about the molecular events and processes involved in the progressive transition to invasive cancer. To date, genetic alterations in chromosomes 5q, 8p, 10q, 16p, and 17p have been reported in relation to prostate carcinogenesis (12, 13). An advisory workshop was organized and sponsored by the NCI and co-sponsored by the National Institute on Aging (NIA), NIDDK, and NIEHS in Bethesda, Maryland, on September 27, 1993. The objective was to determine the status of laboratory technology for endocrine biomarkers and to identify directions for advancing molecular epidemiologic research in the etiology of prostate cancer. The power of molecular epidemiology studies, which incorporate laboratory advances in molecular biology, genetics and biochemistry with epidemiologic study designs, was emphasized. Workshop recommendations identified research needs in the following general areas: (a) methodological considerations in the measurement of hormonal profiles (e.g., androgen and androgen metabolites) in body fluids; (b) studies of androgen metabolism in prostatic tissue, including measures of 5-alpha-reductase isoenzymes and androgen receptors; (c) assessment of biological markers of genetic susceptibility, premalignant lesions (e.g., prostatic intraepithelial neoplasia), and later progressive stages of the carcinogenic process; (d) characterization of androgen receptor mutations and other molecular alterations at the gene and cellular levels; and (e) determination of risk associated with micronutrients and macronutrients (e.g., fatty acids) and interactions with hormones and hereditary factors. The objectives of this RFA were derived from the major recommendations of the workshop. Research Goals and Scope The purpose of this initiative is to stimulate innovative molecular epidemiologic research into the origins of prostate cancer, including the biological basis for the striking increase in prostate cancer incidence with age. Collaborations of several disciplines and research institutions are encouraged with utilization of shared laboratory and specimen resources whenever possible. Applications will be welcomed from investigators who are participating in ongoing collaborative organizations such as the George M. O'Brien Kidney and Urologic Research Centers, the Specialized Programs of Research Excellence in Prostate Cancer (SPORES), the NIEHS Environmental Health Sciences Centers and the General Clinical Research Centers (GCRCs). It is suggested that the collaborative organization be identified as the resource for conducting the proposed research, and a letter of agreement from the program director or principal investigator be included with the application. Proposals to expand an ongoing epidemiologic study by the addition of a laboratory component will be considered. Transitional molecular epidemiology studies characterizing and validating biomarkers while determining optimal biological specimens and the most suitable procedures for collection, processing, and storage are of particular interest. Selected measurements or biomarkers should be relevant to the processes of prostate carcinogenesis. Additionally, there is a need for demonstration of the utility of hormonal biomarkers with an evaluation of sensitivity, specificity, intra- and inter-individual variability. We strongly encourage investigations in understudied populations and in study populations of contrasting risk. Projects will be evaluated on the basis of their potential for enhancing understanding of prostate cancer etiology. The initiative invites a range of epidemiologic and interdisciplinary investigations of prostate cancer including, but not limited to: o Epidemiologic studies to: a. evaluate prostate cancer risk of lifestyle factors (e.g., smoking, alcohol intake), occupation (e.g., cadmium and zinc exposures, rubber industry, farming), exposure to radiation (e.g., ionizing, electromagnetic, and ultraviolet), environmental hazards (e.g., organochlorine compounds including DDT, PCBs, and dioxins or other pesticides), dietary intake (e.g., fatty acids, vitamins A, D, and E), and xenoestrogens utilizing available biomarkers and sources of specimens (e.g., prostate tissue, prostatic fluid, blood components) whenever possible; b. assess interactions of the above factors or their interrelationships with biochemical parameters (e.g., growth factors, prolactin, steroid receptors, androgen conjugates, 5-alpha-reductase isoenzymes); o Epidemiologic studies to identify risk factors (e.g., environmental, hormonal, viral exposure, sexually transmitted diseases, lifestyle, ethnicity) associated with benign prostatic hyperplasia or chronic prostatitis and to clarify their possible relationships to prostate cancer; o Population-based studies of the relationship between prostatic intraepithelial neoplasia, dysplasia, atypical hyperplasia, and invasive prostate cancer; o Analytic epidemiologic studies utilizing developed markers (e.g., biologic, biochemical, morphologic) to identify premalignant processes or risk factors (e.g., hormonal, environmental) that contribute to prostate carcinogenesis, including the transition from latent to invasive cancer; o Studies to further develop identified biomarkers (e.g., androgen receptor mutations, 5-alpha-reductase isoenzymes, epithelial cell receptors) for application in epidemiologic research by characterization and validation (in the laboratory and in humans) including consideration of biologic variables, e.g., age, genetic predisposition, ethnicity, nutritional status, hormonal profiles, preexisting disease and lifestyle; o Experimental laboratory or population-based studies to explore and elucidate the role of timing of environmental exposures during critical developmental and other time periods (e.g., fetal period, the window from birth to puberty, puberty, after castration or vasectomy) of the prostate gland relevant to future risk of carcinogenesis including, but not limited to: (a) cellular, genetic, and hormonal effects of environmental factors on normal and abnormal prostate growth and development, and (b) mechanism of how environmental exposures acting as initiating or promoting agents during time periods of interest affect the latency of prostate cancer; o Biochemical epidemiologic studies to: a. validate and compare prostate tissue levels of hormones (e.g., androgens, estrogens), their metabolites and receptors with other sources of specimens such as blood components and prostatic fluid; b. evaluate panels of circulating hormones (e.g., dihydrotestosterone [DHT] and its precursors, testosterone, DHEAS, DHEA, androstenedione and its metabolites such as DHT sulfate, DHT glucuronide, 3-alpha-diol glucuronide) in populations of varying risk, including men younger than 50 years old; o Molecular epidemiology studies to explore differences in genetic predisposition to prostate cancer due to variations in susceptibility genes, hormone metabolism, DNA repair activities, chromosome sensitivity to mutagens or other factors. SPECIAL REQUIREMENTS Awardees under this RFA are strongly encouraged to participate in two (2), one-day meetings to be held in Bethesda, Maryland, during the second and fifth years of the grant. Program directors from the NCI, NIDDK, and NIEHS will coordinate these meetings which will provide the opportunity for principal investigators to discuss their work in progress and to consider methodological and scientific issues. Applicants may request sufficient funds in the budget to accommodate expenses for one to two participants at each meeting. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting errors in the earlier publication, and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are encouraged to submit, by October 17, 1994, a letter of intent that includes a descriptive title of the proposed research, the name and address of the principal investigator, the names of other key personnel, participating institutions, number and title of the RFA in response to which the application may be submitted, and estimated amount of direct costs if anticipated to exceed $500,000 for any year. Potential applicants for research of this magnitude are encouraged to contact the NCI prior to making detailed plans or submitting their application(s). Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications, including the avoidance of conflict of interest. The letter of intent is to be sent to: Dr. Kumiko Iwamoto National Cancer Institute Executive Plaza North, Suite 535 Bethesda, MD 20892 Telephone: (301) 496-9600 FAX: (301) 402-4279 APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91), available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants (DRG), National Institutes of Health, Room 449, Westwood Building, Bethesda, MD 20892, telephone (301) 594-7248. The format and instructions applicable to research grant applications must be followed. The RFA label available in the application form PHS 398 (rev. 9/91) must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the number and title of the RFA must be typed on line 2a of the face page of the application and YES must be checked. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Submit a signed, typewritten original of the application, including the Checklist, and three signed clear and single-sided photocopies in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, send two additional copies of the application to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Suite 636 Bethesda, MD 20892 Applications must be received by November 23, 1994. If an application is received after that date, it will be returned without review. The DRG will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application, and no application will be accepted that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and for responsiveness by the NCI, NIDDK, and NIEHS. Incomplete applications will be returned to the applicant without further consideration. If the application is determined to be nonresponsive 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 NCI, NIDDK, and NIEHS in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to this RFA. Applications judged to be competitive will be discussed and assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. The peer review will be followed by a second level of review by the National Cancer Advisory Board, the National Advisory Council for Diabetes and Digestive and Kidney Diseases, and the National Advisory Environmental Health Sciences Council to consider the special needs of each Institute. Review criteria for RFAs are generally the same as those for unsolicited research grant applications: 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 resources necessary to perform the research. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each scored application. AWARD CRITERIA The earliest anticipated date of award is July 1, 1995. The following will be considered in making funding decisions: o quality of the proposed project as determined by peer review; o availability of funds; o balance among research activities relevant to selected areas of programmatic emphasis. INQUIRIES Written and telephone inquiries concerning this RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct inquiries regarding programmatic issues to: Dr. Kumiko Iwamoto Epidemiology and Biostatistics Program National Cancer Institute Executive Plaza North, Suite 535 Bethesda, MD 20892 Telephone: (301) 496-9600 FAX: (301) 402-4279 Dr. David G. Longfellow Chemical and Physical Carcinogenesis Branch National Cancer Institute Executive Plaza North, Suite 700 Bethesda, MD 20892 Telephone: (301) 496-5471 FAX: (301) 496-1040 Dr. Ralph L. Bain Urology Program National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A-05B Bethesda, MD 20892 Telephone: (301) 594-7556 FAX: (301) 594-7501 Dr. Gwen W. Collman Chemical Exposures and Molecular Biology Branch National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-4980 FAX: (919) 541-2843 Direct inquiries regarding fiscal matters to: Ms. Theresa A. Mercogliano Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 243 FAX: (301) 496-8601 Ms. Trude McCain Division of Extramural Affairs National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649 Bethesda, MD 20892 Telephone: (301) 496-7467 FAX: (301) 594-7594 Mr. David L. Mineo Grants Management Branch National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-7628 FAX: (919) 541-2860 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.393, 93.849, and 93.894. 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 HHS policies and grant regulations. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. References 1. Boring CC, Squires TS, Tong T. Cancer statistics, 1993. CA Cancer J Clin 1993; 43:7-26. 2. Pienta KJ, Esper PS. Risk factors for prostate cancer. Ann Intern Med 1993; 118:793-803. 3. Nomura AMY, Kolonel LN. Prostate cancer: a current perspective. Epid Rev 1991; 13:200-227. 4. Ross RK, Bernstein L, Judd H. Serum testosterone levels in young black and white men. J Natl Cancer Inst 1976;76:45-48. 5. Steinberg GD, Carter BS, Beaty TH, et al. Family history and the risk of prostate cancer. Prostate 1990; 17:337-347. 6. Muir C, Waterhouse J, Mack T, et al, eds. Cancer incidence in five continents. Vol 5. Lyon, France:International Agency for Research on Cancer, 1987. (IARC scientific publication no. 88). 7. Giovannuci E, Rimm EB, Colditz GA, et al. A prospective study of dietary fat and risk of prostate cancer. J Natl Cancer Inst 1993; 85:1571-1579. 8. Ross RK, Shimizu H, Paganini-Hill A, et al. Case-control studies of prostate cancer in blacks and whites in southern California. J Natl Cancer Inst 1987; 78:869-74. 9. Kolonel LN, Yoshizawa CN, Hankin JH. Diet and prostatic cancer: a case-control study in Hawaii. Am J Epidemiol 1988; 127:999-1012. 10. Corder EH, Guess HA, Hulka BS, et al. Vitamin D and prostate cancer: a prediagnostic study with stored sera. Cancer Epidemiol, Biomarkers & Prev 1993; 2:467-472. 11. Chiarodo A. National Cancer Institute roundtable on prostate cancer: future research directions. Cancer Res 1991; 51:2498-2505. 12. Bova GS, Carter BS, Bussemakers MJG, et al. Homozygous deletion and frequent allelic loss of chromosome 8p22 loci in human prostate cancer. Cancer Res 1993; 53:3869-3873. 13. Carter BS, Ewing CM, Ward WS, et al. Allelic loss on chromosomes 10q and 16q in human prostate cancer. Proc Natl Acad Sci 1990; 87:8751-8755. From owner-sci-resources@net.bio.net Mon Aug 08 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 7 August 1994 Date: 8 Aug 1994 19:40:20 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 125 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <326qak$j0f@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: News Title: President Clinton Appoints Science and Technology Advisors File size (bytes): 20267 STIS Filename: whpr941 Title: White House Releases National Science Policy Report File size (bytes): 5060 STIS Filename: whpr942 Title: Science in the National Interest File size (bytes): 49157 STIS Filename: whrpt941 Document Type: Program Guideline Title: NSF 94-100 - University-Industry Cooperative Research Programs in the Mathematical Sciences File size (bytes): 38407 STIS Filename: nsf94100 Title: Faculty Early Career Development (CAREER) Program File size (bytes): 30982 STIS Filename: nsf94101 Title: NSF 94-104 - Postdoctoral Research Associates in Computational Science and Engineering and Associates in Experimental Science File size (bytes): 13645 STIS Filename: nsf94104 Title: NSF 94-106 - CISE Research Infrastructure Program File size (bytes): 35556 STIS Filename: nsf94106 Title: NSF 94-98 - SHEBA- Surface HEat Budget of the Arctic Ocean File size (bytes): 18600 STIS Filename: nsf9498 Document Type: Recruit Title: Secretary File size (bytes): 4988 STIS Filename: vgs94104 Title: Computer Specialist File size (bytes): 6726 STIS Filename: vgs94105 Title: Employee Relations Specialist File size (bytes): 6296 STIS Filename: vgs94106 Document Type: SRS Data Brief Title: DB 94-308 Federal Academic S&E Obligations Increased by 8 Percent in FY 1992 File size (bytes): 7279 STIS Filename: db94308 Also available: db94308.ps Title: DB 94-309 Federal Funding for R&D and for R&D Plant Expected to Decrease in FY 1994 File size (bytes): 6593 STIS Filename: db94309 Also available: db94309.ps Title: DB 94-310 Changes in the Immigration Law of 1990 Stimulate Major Increases in Immigrant Scientists & Engineers File size (bytes): 9414 STIS Filename: db94310 Also available: db94310.ps Title: DB 94-310 Changes in the Immigration Law of 1990 Stimulate Major Increases in Immigrant Scientists & Engineers File size (bytes): 9414 STIS Filename: db94310 Also available: db94310.ps ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve db94310, the text of your message should be as follows: get db94310 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve db94310, you would enter: ftp> get db94310 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Wed Aug 10 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 30, pt. 1of1, 12 August 1994 Date: 11 Aug 1994 13:06:10 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 873 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <32e0bi$l5@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940812 V23N30 P1O1 ************************************ X-comment: RFAs described: DK-94-023, AG-94-003 NIH GUIDE - Vol. 23, No. 30 - August 12, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINAL FINDINGS OF SCIENTIFIC MISCONDUCT Public Health Service INDEX: PUBLICH HEALTH SERVICE $$INDEX N2 ********************************************************** ADDITION OF THE FEMALE CONDOM TO A PROSPECTIVE OBSERVATIONAL STUDY OF BARRIER CONTRACEPTION FOR PREVENTION OF SEXUALLY TRANSMITTED DISEASES National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX N3 ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** DISTRIBUTION OF MOUSE MODELS FOR NEURAL TUBE DEFECTS (RFP NICHD-CRMC-95-07) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R2 11/18/94 ************************************************* NUTRIENT MODULATION OF CELL INTEGRITY AND REPAIR MECHANISMS (RFA DK-94-023) National Institute of Diabetes and Digestive and Kidney Diseases National Cancer Institute National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental Research National Institute of Environmental Health Sciences National Institute of Neurological Disorders and Stroke Office of Research on Minority Health INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES; CANCER; AGING; ALCOHOL ABUSE, ALCOHOLISM; ALLERGY, INFECTIOUS DISEASES; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; CHILD HEALTH, HUMAN DEVELOPMENT; DEAFNESS, OTHER COMMUNICTIONS DISORDERS; DENTAL RESEARCH, ENVIRONMENTAL HEALTH SCIENCES; NEUROLOGICAL DISORDERS, STROKE; MINORITY HEALTH $$INDEX R3 11/29/94 ************************************************* ENHANCING FAMILY CAREGIVING FOR ALZHEIMER'S DISEASE AND RELATED DISORDERS (RFA AG-94-003) National Institutes on Aging INDEX: AGING ATTENTION: The new mailing list for the NIH Guide will be activated in September. Until then, the existing mailing list will be maintained. See INTENT TO MODIFY (NIH Guide, Vol. 23, No. 23, June 17, 1994) for additional information. This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** FINAL FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 23, Number 30, August 12, 1994 P.T. 34; K.W. 1014004 Public Health Service Notice is hereby given that the Office of Research Integrity (ORI) has made final findings of scientific misconduct in the following cases: Anand Tewari, M.D., Stanford University. The Division of Research Investigations (DRI) of the Office of Research Integrity (ORI) conducted an investigation into possible scientific misconduct on the part of Dr. Tewari while a postdoctoral fellow in the Department of Surgery, Stanford University School of Medicine. ORI concluded that Dr. Tewari committed scientific misconduct in clinical research supported by an NIH grant by fabricating ophthalmologic examination results; fabricating and falsifying blood gas data; fabricating and falsifying values for glycerol determinations; falsifying standard errors and including fabricated data on platelet counts in a published article, "Effects of interleukin-1 on platelet counts" (The Lancet 336:712-714 (1990)), and related abstracts; and providing to his supervisors summaries of data that included falsified and fabricated data which were used in a PHS grant application. The published article containing the falsified and fabricated data was retracted on August 22, 1992. The Lancet 340:496. Dr. Tewari accepted the ORI findings and agreed to a Voluntary Exclusion and Settlement Agreement under which he may not apply for Federal grant or contract funds except for the non-research training or practice of clinical medicine, and may not serve on PHS advisory committees, boards, or peer review groups for a five-year period beginning March 1, 1994. Annmarie Surprenant, Ph.D., Glaxo Institute for Molecular Biology. An inquiry and investigation conducted by the Oregon Health Sciences University (OHSU) found that Annmarie Surprenant, Ph.D., had misrepresented her academic credentials in a grant application for Public Health Service (PHS) research funds. The OHSU found that Dr. Surprenant had falsely stated that she had earned an M.D. degree from the University of Illinois at Chicago in 1976. As a result of the OHSU investigation, Dr. Surprenant resigned from the OHSU faculty. During its oversight review of the OHSU report, the Office of Research Integrity (ORI) discovered that Dr. Surprenant had also falsely claimed to have earned an M.D. on two additional PHS research grant applications. Based upon the OHSU report, as well as the information obtained by ORI during its oversight review, ORI found that Dr. Surprenant engaged in scientific misconduct by falsely claiming to have earned an M.D. in three PHS research grant applications. Dr. Surprenant accepted the ORI finding and agreed to a Voluntary Exclusion and Settlement Agreement under which she will not apply for Federal grant or contract funds and will not serve on PHS advisory committees, boards, or peer review groups for a three-year period beginning June 8, 1994. Mark S. Chagnon, Sc.D., Molecular BioQuest, Inc. A report of the Office of Research Integrity (ORI) of its investigation into allegations of possible scientific misconduct made against Mark S. Chagnon found that he engaged in scientific misconduct by misrepresenting his academic credentials in five research grant applications submitted to the National Institutes of Health. ORI found that Dr. Chagnon falsely claimed to have completed undergraduate and graduate studies in chemistry at the Massachusetts Institute of Technology (MIT), Lowell University (Lowell Institute of Technology) and Northeastern University. ORI also concluded that Dr. Chagnon falsely claimed to have earned an M.S. degree in organic chemistry from MIT. Although he neither admits nor denies the ORI finding of scientific misconduct, Dr. Chagnon has agreed to a Voluntary Exclusion and Settlement Agreement under which he will not apply for Federal grant or contract funds and will not serve on PHS advisory committees, boards, or peer review groups for a three-year period beginning June 28, 1994. INQUIRIES The Office of Research Integrity will continue to publish findings of scientific misconduct as further cases are closed. For further information, contact: Director Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** ADDITION OF THE FEMALE CONDOM TO A PROSPECTIVE OBSERVATIONAL STUDY OF BARRIER CONTRACEPTION FOR PREVENTION OF SEXUALLY TRANSMITTED DISEASES NIH GUIDE, Volume 23, Number 30, August 12, 1994 P.T. 34; K.W. 0715182, 0750020 National Institute of Child Health and Human Development National Institute of Child Health and Human Development Contract Number N01-HD-1-3135 has been modified to expand the requirements in the amount of $4,824,822 for the addition of the female condom to other contraceptive choices available in a study of barrier contraception for the prevention of sexually transmitted diseases among a group of high-risk women. INQUIRIES Inquiries regarding this notice may be directed to: Charles W. Grewe Office of Grants and Contracts National Institute of Child Health and Human Development Executive Building, Room 7A07 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS NIH GUIDE, Volume 23, Number 30, August 12, 1994 P.T. 42; K.W. 0201011, 1014003 National Institutes of Health The National Institutes of Health, Office for Protection from Research Risks is continuing to sponsor workshops on implementing the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Each of the workshops scheduled for Fiscal Year 1994 and 1995 will focus on a specific theme. The workshops are open to institutional administrators, members of Institutional Animal Care and Use Committees, laboratory animal veterinarians, investigators and other institutional staff who have responsibility for high-quality management of sound institutional animal care and use programs. Ample opportunities will be provided to exchange ideas and interests through question and answer sessions and informal discussions. DATES: September 29-30, 1994 TOPIC: Use of Animals in Research and Alternatives LOCATION: The Monteleone Hotel, New Orleans, LA SPONSORS Louisiana State University Medical Center Xavier University of Louisiana REGISTRATION Ms. Lois Herbez Louisiana State University Medical Center 1542 Tulane Avenue New Orleans, LA 70112 Telephone: (504) 568-4198 FAX: (504) 568-4843 FEE: $150 DESCRIPTION: The theme of the workshop will address various aspects of the use of animals in research and the role of animals and alternatives in research and education. The workshop will address such issues as: (1) Adequacy of Computer Searches; (2) NIH, USDA, FDA Alternatives Initiative; (3) Occupational Health - Implementation, Update and Biosafety Concerns; (4) Roles of Animals and Alternatives in Education. DATES: December 1-2, 1994 TOPIC: New Frontiers in Surgery LOCATION Sheraton Charleston 170 Lockwood Drive Charleston, SC 29403 Telephone: (803) 723-3000 FAX: (803) 723-3000 SPONSOR Medical University of South Carolina REGISTRATION M. Michael Swindle, D.V.M. MUSC/Comparative Medicine 171 Ashley Avenue Charleston, SC 29425-2211 Telephone: (803) 792-3625 FAX: (803) 792-9067 FEE: $150.00 (Before Nov 15, 1994) $175.00 (After Nov 15, 1994) DESCRIPTION: The Workshop will address ethics, protocol review and technical and training aspects related to new surgical and interventional technologies. Topics to be discussed in the program include xenographic procedures, fetal intervention, transgenic technologies, and use of biomaterials in orthopedic surgery. DATES: January 12-13, 1995 TOPIC: Considerations For Use of Wild Vertebrates in Research LOCATION Westward Look Resort 245 Ina Road Tucson, AZ 85704 Telephone: (602) 297-1151 or 1-800-722-2500 FAX: (602) 297-9023 SPONSORS Northern Arizona University University of Arizona Health Science Center REGISTRATION Dr. Terry May Director of Research Administration Northern Arizona University P.O. Box 4130 Flagstaff, AZ 86011-4130 Telephone: (602) 523-6788 FAX: (602) 523-1075 E Mail: tam1@nauvax.ucc.nau.edu Dr. Susan Sanders, Director University of Arizona Animal Care 2205 E. Speedway Boulevard Tucson, AZ 85719 Telephone: (602) 621-3454 FAX: (602) 621-3355 FEE: $175 - Full Workshop $70 - Daily Registration as Space Available DESCRIPTION: This Workshop will focus on three general themes related to the inclusion of native vertebrates in research: (1) Federal and institutional policies and procedures as they relate to the responsibilities of the Institutional Animal Care and Use Committee (IACUC) in considering research on both captive and free- living wild vertebrates; (2) standards for the husbandry and housing of captive wild vertebrates; and (3) occupational health considerations with an emphasis on rodent-borne hantavirus. DATES: March 12-14, 1995 TOPIC: Animal Care and Research: Challenges and Changes for the Institutional Animal Care and Use Committee LOCATION San Diego Princess 1404 West Vacation Road San Diego, CA 92109-7994 Telephone: (619) 274-4630 or (1-800) 344-2626 FAX: (619) 581-5929 SPONSORS Tufts University School of Veterinary Medicine Public Responsibility in Medicine and Research REGISTRATION Ms. Danielle Demko Public Responsibility in Medicine and Research 132 Boylston Street Boston, MA 02116 Telephone: (617) 423-4112 FAX: (617) 423-1185 FEE: $300 DESCRIPTION: The Workshop will focus on revisions to the Institutional Animal Care and Use Committee Guidebook; assessment and reduction of pain and distress in animal research; occupational health risks ad biohazards; and a host of other regulatory and administrative issues that are central to the successful operation of laboratory animal care and research programs. Immediately preceding the Tufts University School of Veterinary Medicine/NIH/OPRR Workshop, Applied Research Ethics National Association (ARENA) will sponsor its annual animal issues meeting on Sunday, March 12, also at the San Diego Princess. INQUIRIES For further information concerning these workshops and future NIH/OPRR Animal Welfare Education Workshops, contact: Mrs. Roberta Sonneborn Office of Protection from Research Risks National Institutes of Health Building 31, Room 5B63 Bethesda, MD 20892-2180 Telephone: (301) 496-7163 FAX: (301) 402-2803 $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NICHD-CRMC-95-07 ***************************************** DISTRIBUTION OF MOUSE MODELS FOR NEURAL TUBE DEFECTS NIH GUIDE, Volume 23, Number 30, August 12, 1994 RFP AVAILABLE: NICHD-CRMC-95-07 P.T. 34; K.W. 0755020, 1002002, 1002030 National Institute of Child Health and Human Development The National Institutes of Child Health and Human Development (NICHD) is seeking organizations to maintain and distribute four mouse models for neural tube defects to the scientific community. The organization needs to have expertise and the facilities to house and maintain breeding stocks of mutant mice and the capability to distribute them to interested investigators in a timely manner. This announcement is a recompetition of an existing contract. The issuance of the RFP will be on August 17, 1994, and proposals will be due by 4:00 pm, EST, October 12, 1994. The NICHD expects to make one award from this solicitation. All requests must cite the RFP number and written requests should include two self addressed mailing labels. All sources who consider themselves qualified are encouraged to submit a proposal. This does not commit the Government to making an award. Requests for the RFP are to be addressed to: Mrs. Lynn Salo Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Building, Room 7A07 Bethesda, MD 20892 Telephone: (301) 496-4611 FAX: (301) 402-3676 $$R1 END ************************************************************ $$R2 BEGIN DK-94-023 FULL-TEXT ************************************** NUTRIENT MODULATION OF CELL INTEGRITY AND REPAIR MECHANISMS NIH GUIDE, Volume 23, Number 30, August 12, 1994 RFA AVAILABLE: DK-94-023 P.T. 34; K.W. 1002004, 1002008, 0710095, 0765020 National Institute of Diabetes and Digestive and Kidney Diseases National Cancer Institute National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental Research National Institute of Environmental Health Sciences National Institute of Neurological Disorders and Stroke Office of Research on Minority Health Application Receipt Date: November 18, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE This RFA is designed to encourage research grant applications focusing on mechanisms (primarily molecular and genetic mechanisms) that underlie nutrient modulation of cellular repair processes and maintenance of cellular integrity. Research should be aimed at the normal processes involved in the effects of specific nutrients or their metabolites on cellular, genetic, and metabolic functions as well as elucidation of defective mechanisms. This initiative should offer unique opportunities afforded by the basic sciences and new technologies (e.g., molecular biology, NMR, ESR, PET) to enrich nutrition sciences. 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, Nutrient Modulation of Cell Integrity and Repair Mechanisms, is related to the priority areas of nutrition, physical activity and fitness, heart disease and stroke, cancer, and diabetes and 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, hospitals, laboratories, units of State and local government and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) award. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support of this program will be through the research project grant (R01) and FIRST (R29) 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. Generally, future unsolicited competing continuation applications will compete with all investigator-initiated applications and will be reviewed by a DRG study section. The total project period for applications submitted in response to the present RFA may not exceed five years. A maximum of three years may be requested for foreign awards. The maximum dollar request for R01s is limited to $160,000 in direct costs for the initial budget period. The earliest possible award date will be July 1, 1995. FUNDS AVAILABLE For FY 1995, $4 million will be committed to fund applications submitted in response to this RFA. It is anticipated that 20 to 25 awards will be made. However, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the participating Institutes, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. APPLICATION PROCEDURES Applications are to be submitted on the research grant application form PHS 398 (rev. 9/91), available in the office of sponsored research at most academic or research institutions and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-594-7248. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. Detailed instructions on submission procedures are described in the RFA. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated by an appropriate peer review group convened by the NIH in accordance with the usual peer review procedures. Following review, the applications will be given a secondary review by an Institute Advisory Council/Board unless not recommended for further consideration by the initial review group. Applications that are incomplete or unresponsive to the RFA will be returned to the applicant or held until the next regular receipt date and reviewed by the Division of Research Grants. AWARD CRITERIA The anticipated date of award is July 1, 1995. The following will be considered in making funding decisions. o Quality of the proposed project as determined by peer review o Availability of funds o Programmatic balance among the studies recommended for funding INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Requests for the RFA and inquiries regarding programmatic issues may be directed to: Michael K. May, Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A18A Bethesda, MD 20892 Telephone: (301) 594-7520 FAX: (301) 594-7504 Inquiries regarding fiscal matters may be directed to: Ms. Paulette Badman Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 639 Bethesda, MD 20892 Telephone: (301) 594-7543 FAX: (301) 594-7594 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848. 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. $$R2 END ************************************************************ $$R3 BEGIN AG-94-003 FULL-TEXT ************************************** ENHANCING FAMILY CAREGIVING FOR ALZHEIMER'S DISEASE AND RELATED DISORDERS NIH GUIDE, Volume 23, Number 30, August 12, 1994 RFA AVAILABLE: AG-94-003 P.T. 34; K.W. 0715180, 0730052 National Institutes on Aging Letter of Intent Receipt Date: October 1, 1994 Application Receipt Date: November 29, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Institute on Aging (NIA) invites applications for cooperative agreements for (a) sites to carry out social and behavioral research on interventions designed to enhance family caregiving for Alzheimer's disease and related disorders (ADRD) and (b) a Coordinating Center to provide coordination for this set of research projects. Theory-based interventions may consist of psycho/social/educational services (i.e., individual and/or family counseling by professionals or peers), behavioral technology (skill-training), innovations in community services (i.e., modifications in respite services, day care, home care), high-tech environmental modifications (e.g., computerized telephone systems, computer networks, etc.), or any combination of these. Given the paucity of prior controlled studies, this initiative is designed to examine the feasibility and outcomes of different intervention approaches rather than to provide definitive information on the one best intervention strategy for enhancing dementia-specific family caregiving. 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, Interventions for Enhancing Family Caregiving for ADRD, is related to the priority area of older adults and preventive services. 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. No foreign or international components will be considered in this RFA. Applications from minorities and women are encouraged. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U01), an assistance mechanism (rather than an acquisition mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in, and otherwise working jointly with, the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Applicants will be responsible for the planning, direction, and execution of their individual proposed project and for planning and participating in collaborative activities with other award recipients under this RFA. The duration for this research endeavor is five years, with an anticipated award date of August 1, 1995. FUNDS AVAILABLE It is expected that up to $2,050,000 million (total cost) for first year expenses will be available in Fiscal Year 1995 to fund five Clinical Sites plus a Coordinating Center. While separate applications must be submitted if an institution seeks selection as both a Site and Coordinating Center, any one institution may only apply for one Site and/or one Coordinating Center. The requested total funding (direct plus indirect costs) for the first-year may not exceed an average of $350,000 for Clinical Site applications and $300,000 for Coordinating Center applications. For the entire five years of the project, total (direct plus indirect) costs requested may not exceed $1.9 million for each of the individual research projects, and $1.6 million for the Coordinating Center. Although this program is provided for in the financial plans of the NIA, the award of grants pursuant to this RFA is contingent upon receipt of applications of high scientific merit and upon the availability of funds. RESEARCH OBJECTIVES The primary goal of this RFA is to examine the effectiveness of social and behavioral interventions to help family members care for individuals with ADRD. This RFA is not designed to support large scale demonstration programs. However, building on such studies is appropriate and encouraged if key definitions and measures are not predetermined by the initial study. The cooperative nature of this award provides a mechanism for establishing standardized outcome measures, particularly those of well-being and burden, to be used to assess the impact of different strategies on caregivers and, secondarily, on care receivers. Specific Research Foci Investigators must propose at least one social and behavioral intervention. While this is not a drug trial study per se, investigators may propose a drug arm as a comparison treatment strategy. Proposed research designs must rule out alternative explanations for intervention effects. All applicants must address: The nature of the proposed intervention (e.g., type, intensity, duration, frequency) and the underlying behavioral or social theory for expected outcomes. Previous research providing some support for the effectiveness of the proposed intervention is recommended. Clinical, behavioral or social factors that might affect the impact of the proposed intervention. Investigators must identify and propose standardized measurements for assessing key variables, such as disease characteristics (e.g., stage of disease, presence of co-morbid conditions); caregiving characteristics (nature and extent of caregiving responsibilities; time in caregiving role); and caregiver characteristics (e.g., definition of primary caregiver; relationship of caregiver). Intervention outcomes for caregivers and care receivers. All investigators must propose at least one primary health or functional outcome for each that would be common across all Sites. At least one common measure of caregiver burden (or its obverse, caregiver well- being) must also be identified. Other outcomes may be proposed if well justified and not burdensome for study participants). A final selection of common measures will be made by the steering committee from among those proposed. For those who propose more than one intervention, the comparison of different interventions in terms of their health outcomes and relative costs. Persons with medical diagnoses of ADRD, at the mild or moderate stage, are the preferred target group as are caregivers who are at increased risk due to burdens of care. All applicants should provide their working definition of a "primary caregiver"; while theoretically interesting attention to "secondary" and "tertiary" caregivers is optional. Attention should be paid to anticipated changes in the health and functioning of the person needing care for ADRD as well as in caregiver responsibilities and roles. The proposed timing and frequency of data collection for proposed outcome measures should be indicated and related to projected rates of change. Although research designs are expected to vary according to specific interventions being examined, baseline common core data should be collected and transmitted to the coordinating center, as soon as available, beginning no later than the start of the second year of the project. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the March 18, 1994 "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are encouraged to submit, by October 1, 1994, 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 allows NIA staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Marcia Ory at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the PHS 398 (rev. 9/91) application form. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and from the NIA program administrator listed under INQUIRIES. The RFA label contained in the application kit must be affixed at the bottom of the face page of the application. Failure to use this label could delay processing of the application. In addition, the RFA title, number and type of application: "Clinical Site or "Coordinating Center," must be typed on line 2a of the face page of the application form and the YES box must be checked. Submit a signed, original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Two copies of the application with appendices must also be sent to: Chief, Scientific Review Office National Institute on Aging Gateway Building, Suite 2C212 Bethesda, MD 20892 The deadline for receipt of applications is November 29, 1994. Materials will not be accepted after this date. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete and nonresponsive applications will be returned to the applicant without further consideration. Those applications that are complete and responsive will be evaluated for scientific/technical merit by an appropriate peer review group convened by the NIA. Applications may be subjected to triage by a NIA peer review group to determine their scientific merit relative to other applications received in response to this RFA. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. The letter of intent and requests for the RFA may be addressed to: Dr. Marcia Ory Behavioral and Social Research Program National Institute on Aging Gateway Building, Room 533 Bethesda, MD 20892 Telephone: (301) 496-3136 Direct inquiries regarding fiscal matters to: Ms. Joanne Colbert Grants and Contracts Management Office National Institute on Aging Gateway Building, Room 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 Other institutes and agencies are also interested in research dealing with Alzheimer's disease and related disorders. For information concerning related research interests, contact: National Institute of Nursing Research, Dr. Mary Lucas, Westwood Building, Room 754, Bethesda, MD 20892, (301) 594-7397 National Institute of Mental Health, Dr. Enid Light, Parklawn Building, Room 7103, Rockville, MD 20857, (301) 443-1185 Agency for Health Care Policy and Research: Ms. Linda Siegenthaler, 2101 E. Jefferson St, Room 502, Rockville, MD 20852, (301) 594-1357 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866 (Aging 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 Part 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R3 END ************************************************************ From owner-sci-resources@net.bio.net Wed Aug 10 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DK-94-023 - V23(30) 08/12/94 Date: 11 Aug 1994 13:06:17 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 581 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <32e0bp$lk@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DK94023 DK-94-023 P1O1 *************************************** NUTRIENT MODULATION OF CELL INTEGRITY AND REPAIR MECHANISMS NIH GUIDE, Volume 23, Number 30, August 12, 1994 RFA: DK-94-023 P.T. 34; K.W. 1002004, 1002008, 0710095, 0765020 National Institute of Diabetes and Digestive and Kidney Diseases National Cancer Institute National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental Research National Institute of Environmental Health Sciences National Institute of Neurological Disorders and Stroke Office of Research on Minority Health Application Receipt Date: November 18, 1994 PURPOSE This request for applications (RFA) is designed to encourage research grant applications focusing on mechanisms (primarily molecular and genetic mechanisms) that underlie nutrient modulation of cellular repair processes and maintenance of cellular integrity. Research should be aimed at the normal processes involved in the effects of specific nutrients or their metabolites on cellular, genetic, and metabolic functions, as well as elucidation of defective mechanisms. This initiative should offer unique opportunities afforded by the basic sciences and new technologies (e.g., molecular biology, NMR, ESR, PET) to enrich nutrition science. Nutrition science supported by the National Institutes of Health (NIH) includes studies designed to assess the consequences of food or nutrient intake, utilization in the intact organism, and the metabolic and behavioral mechanisms involved. Further support is needed for studies of nutrient variables at the cellular and subcellular levels; elucidation of the metabolic functions of nutrients in both animal models and humans; examination of genetic-nutrient-environmental interactions; and ultimately, studies of the role of diet in the maintenance of health, and the prevention and treatment of disease. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Nutrient Modulation of Cell Integrity and Repair Mechanisms, is related to the priority areas of nutrition, physical activity and fitness, heart disease and stroke, cancer, and diabetes and 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, hospitals, laboratories, units of State and local government and eligible agencies of the Federal government. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) award. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The mechanisms available for support of applications in response to the RFA include research project grants (R01) and FIRST (R29) Awards. 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. Generally, future unsolicited competing continuation applications will compete with all investigator-initiated applications and will be reviewed by a DRG study section. The total project period for an application submitted in response to the present RFA may not exceed five years. A maximum of three years may be requested for foreign awards. The maximum dollar request for R01s is limited to $160,000 in direct costs for the initial budget period. Applicants for R29s should refer to guidelines in the PHS 398 packet for preparation of budgets. The earliest possible award date will be July 1, 1995. FUNDS AVAILABLE The NIH will allocate approximately $4 million to support projects received in response to this RFA during FY 1995. It is anticipated that 20 to 25 awards will be made, provided that applications of sufficient scientific merit are received. Although this program is provided for in the financial plans of the NIH, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. Subsequent support will be dependent upon submission of a renewal application through established NIH procedures for research grants related to nutrition. RESEARCH OBJECTIVES Background The major objective of this initiative is to further encourage application of the basic sciences and new technologies (e.g., molecular biology, NMR, ESR, PET) to nutrition questions. Five of the ten leading causes of morbidity and mortality for Americans today are diet-related, including coronary heart disease, stroke, diabetes, and several forms of cancer. Among individuals with acquired immunodeficiency syndrome (AIDS), chronic diarrhea and wasting are important medical complications associated with impaired nutrient absorption. In addition, there is considerable diversity in response to nutrients in the human population, and special concerns exist for the groups that are most nutritionally vulnerable, that is, certain ethnic groups, premature infants, pregnant and lactating women, postmenopausal women, older persons, and immunocompromised individuals. Furthermore, there is strong evidence implicating nutritional factors in obesity, osteoporosis, malabsorption syndromes, immune function, and impaired muscular, sensory, and intellectual performance. The genome is influenced by events occurring in utero during stages of development and throughout the life span of the maturing organism when molecular events can be altered by nutritional and other external factors. These events are a composite of interactions of environmental, genetic, and metabolic processes. Mechanistic investigations are expected to lead to explanations of observations reported from clinical nutrition and epidemiological studies and to provide leads to effective interventions and rational therapies for individuals with chronic and acute diseases. New methodologies based on molecular techniques have the potential to create new and more reliable indicators of nutrient requirements for optimal health and functional capacity. Newer technologies (NMR, ESR) have been developed that allow investigation of "in vivo" metabolism and interactions. Innovative utilization of technologies from other disciplines, but applied to nutritional investigations are encouraged. These methodologies should be used to increase understanding of nutrient-cell interactions that underlie the biological basis of the transition from healthy cells with normal biological functions to diseased cells with disturbed biological functions. The fundamental knowledge gained will ultimately be applied in clinical settings to treat or ameliorate disease and be translated to the general public. Research Objective and Scope Each of the Institutes and Centers at the NIH supports nutrition research related to its own mission and mandates. Nutrients have been shown to modulate or regulate the expression of genetic potential and to stimulate regulatory hormones, which in turn influences gene expression and the metabolic pathways. In bionutrition research, molecular biology and other newer technologies should be applied to the study of (a) intermediary metabolism; (b) the mechanisms of subcellular, cellular, and tissue responses to nutrient(s); and (c) the understanding of human genetic variation and the extent to which exposure to environmental factors modify normal physiological functions in an effort to ensure optimal outcomes in prevention and treatment of disease. All applications should clearly identify the nature in which a dietary nutrient or functional component is a study parameter. Collaborative interactions between nutritional sciences investigators and those in other disciplines are encouraged to promote utilization of newer technologies, especially technologies not traditionally used for nutrition research. Furthermore, collaborative efforts that include interactions between the basic and clinical sciences are encouraged. Applications from new, independent investigators (at the FIRST (R29) award level) and applications that include newly established interactions and collaboration are also encouraged. The NIH expects to fund a range of nutrition research grants dealing with disease-related, age-related, and environment-related factors. Examples of relevant research topics are provided below. However, the list of examples is neither complete nor restrictive. o The use of new technologies (e.g., electron spin resonance, NMR, PET) to investigate mechanisms of nutrient and nutrient metabolite interactions and functions in vivo, for example: antioxidant protection from lipoprotein oxidation and interactions of antioxidants and free radicals and other oxidative products o Antioxidant or other nutrient-mediated protection against genetic damage o Aging and disease-related alterations in antioxidant defense/prevention of oxidation and response to nutrient antioxidants o Nutrient modulation of cell repair and regeneration, including cellular and/or tissue damage, which may be caused by environmental factors, and influence on mechanisms involved in cell death o Nutritional interactions associated with molecular regulation/control of carcinogen activation, inhibition, or potentiation o Nutritional control of cell differentiation, proliferation, and cellular/malignant transformation o Nutrient influence on DNA repair and the role of nutrients in modulating gene expression o Nutrient modulation of cell receptor expression and functions, including consequences from exposure to environmental agents o Role of nutritional factors in the regulation of genes that control immune system structure and function o Nutrient modulation/control of cell-cell signaling at the molecular level o Influence of nutrients on the expression and action of regulators of cellular processes such as cytokines, lymphokines, and adhesion molecules o Aging and disease-related changes in retinoid and vitamin D metabolism, cellular receptors, and expression of responsive genes o Nutrient modulation of transport mechanisms at the molecular level, including consequences from exposure to environmental agents o Nutritional approaches to ameliorate wasting in AIDS and other chronic disorders and to improve absorptive capabilities of damaged intestinal epithelium o Studies on the potential alteration of nutrient requirements resulting from exposure to environmental agents o Interactions between normal and abnormal neurological processes and nutrients o Investigations that may identify genetic predisposition for differential nutrient needs or responsiveness among subpopulations based on gender or ethnic origin. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minority in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting errors in the earlier publication, and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES The research grant application form PHS-398 (rev. 9/91) is to be used in applying for these grants. The form is available from most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and check the YES box. Submit a signed, typewritten original of the application, including the Checklist, plus five signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Applications must be received by November 18, 1994. If an application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, it is allowable to submit the same project as both an R01 or R29 and as a component project of a program project. 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 previously reviewed. Such applications must not only include an introduction addressing the previous critique but also be responsive to this RFA. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST (R29) award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed by the DRG for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NIH staff function. If the application is not responsive to the RFA, NIH staff will contact the applicant to determine whether it should be returned to the applicant, or whether it should be held until the next regular receipt date and reviewed in competition with all other applications. 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 ICDs in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non- competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Those applications judged to be competitive will be reviewed for scientific and technical merit in accordance with the usual NIH peer review procedures by an initial review group specifically convened for this RFA. Following this review, the applications will be given a secondary review by an Institute Advisory Council/Board unless not recommended for further consideration by the initial review group. Review criteria for this RFA are generally the same as those for unsolicited research grant applications. o scientific/technical merit criteria specific to the objectives of the RFA; o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively in the area of the proposed research; o availability of resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and o if an application involves activities that could have an adverse effect upon humans, animals, or the environment, the adequacy of the proposed-means for protecting against or minimizing such effects. AWARD CRITERIA The anticipated date of award is July 1, 1995. The following will be considered in making funding decisions. o Quality of the proposed project as determined by peer review o Availability of funds o programmatic balance among the studies recommended for funding. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Inquiries regarding programmatic issues may be directed to: Michael K. May, Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A18A Bethesda, MD 20892 Telephone: (301) 594-7520 FAX: (301) 594-7504 Carolyn K. Clifford, Ph.D. Division of Cancer Prevention and Control National Cancer Institute 6130 Executive Plaza North, Suite 212 Rockville, MD 20852 Telephone: (301) 496-8573 FAX: (301) 402-0553 Pamela Starke-Reed, Ph.D. Office of Nutrition National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892 Telephone: (301) 496-6402 FAX: (301) 402-0010 Mary C. Dufour, M.D., M.P.H. Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 514 6000 Executive Boulevard, MSC 7003 Rockville, MD 20892-7003 Telephone: (301) 443-4898 FAX: (301) 443-8614 Eugene M. Zimmerman, Ph.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A24 Bethesda, MD 20892 Telephone: (301) 496-8973 FAX: (301) 402-2571 Joan A. McGowan, M.N.S., Ph.D. Bone Biology and Bone Disease Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 403 Bethesda, MD 20892 Telephone: (301) 594-9957 FAX: (301) 594-9673 Ephraim Y. Levin, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Building, Room 4B11 Bethesda, MD 20892 Telephone: (301 496-5593 FAX: (301) 402-2085 Rochelle Small, Ph.D. Division of Communication Sciences and Disorders National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 402-3464 FAX: (301) 402-6251 Joseph E. Ciardi, Ph.D. Caries, Nutrition and Fluoride Program National Institute of Dental Research Westwood Building, Room 509 Bethesda, MD 30892 Telephone: (301) 594-7641 FAX: (301) 594-9720 Jerry Robinson, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences 104 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-7724 FAX: (919) 541-2843 Philip H. Sheridan, M.D. Developmental Neurology Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 8C10, MSC 9165 Bethesda, MD 20892-9165 Telephone: (301) 496-6701 FAX: (301) 402-0887 Inquiries regarding fiscal matters may be directed to: Ms. Paulette Badman Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 639 Bethesda, MD 20892 Telephone: (301) 594-7543 FAX: (301) 594-7594 Mr. Robert E. Hawkins Grants Administration Branch National Cancer Institute 6120 Executive Boulevard Executive Plaza South, Room 243 Rockville, MD 20852 Telephone: (301) 496-7800, Ext. 213 FAX: (301) 496-8601 Mr. Robert Pike Office of Extramural Affairs\ National Institute on Aging Gateway Building, Suite 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 FAX: (301) 402-3672 Ms. Linda Hilley Grants Management Branch National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard, MSC 7003 Rockville, MD 20982-7003 Telephone: (301) 443-0915 FAX: (301) 443-8614 Mr. Jeffrey Carow Immunology Grants Management Section National Institute of Allergy and Infectious Diseases Solar Building, Room 4B29 Bethesda, MD 20892 Telephone: (301) 496-7075 FAX: (301) 496-8973 Ms. Mary Graham Grants Management Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 726B Bethesda, MD 20892 Telephone: (301) 594-9974 FAX: (301) 594-9673 Mr. E. Douglas Shawver Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Building, Room 8A17 Bethesda, MD 20892 Telephone: (301) 496-1303 FAX: (301) 402-0915 Ms. Sharon Hunt Grants Management Officer National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-B 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 402-0909 FAX: (301) 402-6251 Ms. Theresa Ringler Grants Management Office National Institute of Dental Research Westwood Building, Room 510 Bethesda, MD 20892 Telephone: (301) 594-7629 FAX: (301) 594-7600 Ms. Laura Williams Grants Management Branch National Institute of Environmental Sciences 104 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-7629 FAX: (919) 541-2860 Schedule Application Receipt Date: November 18, 1994 Initial Review: February/March 1995 Second Level Review: May/June 1995 Anticipated Date of Award: July 1, 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848. 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 Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. 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 Aug 10 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AG-94-003 - V23(30) 08/12/94 Date: 11 Aug 1994 13:06:21 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 755 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <32e0bt$lt@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AG94003 AG-94-003 P1O1 *************************************** ENHANCING FAMILY CAREGIVING FOR ALZHEIMER'S DISEASE AND RELATED DISORDERS NIH GUIDE, Volume 23, Number 30, August 12, 1994 RFA: AG-94-003 P.T. 34; K.W. 0715180, 0730052 National Institutes on Aging Letter of Intent Receipt Date: October 1, 1994 Application Receipt Date: November 29, 1994 PURPOSE The National Institute on Aging (NIA) invites applications for cooperative agreements for (a) sites to carry out social and behavioral research on interventions designed to enhance family caregiving for Alzheimer's Disease and related disorders (ADRD) and (b) a Coordinating Center to provide coordination for this set of research projects. Theory-based interventions may consist of psycho/social/educational services (i.e., individual and/or family counseling by professionals or peers), behavioral technology (skill-training), innovations in community services (i.e., modifications in respite services, day care, home care), high-tech environmental modifications (e.g., computerized telephone systems, computer networks, etc.), or any combination of these. Given the paucity of controlled studies, this initiative is designed to examine the feasibility and outcomes of different intervention approaches rather than to provide definitive information on the one best intervention strategy for enhancing dementia-specific family caregiving. This Request for Applications (RFA) supplements, but does not replace, previous NIA program announcements on related issues (see NIH Guide for Grants and Contracts Vol. 18, No. 6, February 24, 1989 for Alzheimer's Disease and Related Disorders: Issues in Caregiving). In contrast to a previous RFA on Special Care Units focused on institutional care, this RFA will focus on characterizing and testing the most promising home and community based interventions for enhancing family caregiving. Because the caregiving experience in minority families has been particularly neglected, applications that propose studies in populations that are predominantly or totally of minority composition are strongly encouraged. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Enhancing Family Caregiving for ADRD, is related to the priority area of older adults and preventive services. 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Due to the need for close coordination and monitoring and the emphasis on caregiving in the United States, no foreign or international components will be considered in this RFA. Applications from minorities and women are encouraged. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity, working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of the study to be funded under cooperative agreement(s) are discussed under the section "Terms and Conditions of Award." Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000, revised April 1, 1994 and interim updates. The duration for this research endeavor is five years. Proposed research should pose hypotheses or questions that can be successfully addressed in this period. The anticipated award date is August 1, 1995. There may be a renewed U01 competition after the initial award period to test more systematically, and in larger, more diverse populations, the most successful interventions identified in the initial investigations. If the program of cooperative agreements is not continued, the awardees may submit research grant applications to extend the research funded by this initiative through the usual investigator-initiated grants program. FUNDS AVAILABLE It is expected that up to $2,050,000 million (total cost) for first year expenses will be available in Fiscal Year 1995 to fund five Sites plus a Coordinating Center from applications submitted in response to this RFA. If an institution seeks to be selected as both a Site and a Coordinating Center, separate applications must be filed for each component, with distinct budgets that are independent of each other and do not overlap in either objectives or budget items. Institutions may only apply for one Site and one Coordinating Center. The requested total funding (direct plus indirect costs) for the first year may not exceed an average of $350,000 for Site applications and $300,000 for Coordinating Center applications. For the entire five-year project period, total (direct plus indirect) costs requested per application may not exceed $1.9 million for each Site and $1.6 million for the Coordinating Center. Within these limits, escalations after the first year for recurring costs are limited to four percent per year. Applications failing to meet these requirements will not be reviewed. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program will be provided for in the financial plans of the NIA, the award of grants pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Approximately four million Americans are estimated to be afflicted with Alzheimer's disease and related disorders (ADRD). Costs associated with care are largely reflected in the time spent by family members or significant others caring for older persons with ADRD, most of whom are cared for at home. Caregivers of persons with ADRD often face a "triple jeopardy"; they experience significant emotional stress, extreme physical and financial burdens, and in some cases, also have to deal with apathy or even hostility from the ADRD person. These burdens often make caregivers "hidden patients" who require outside assistance and support to maintain their own health and functioning. Family caregivers are an important resource that need special attention. Organizations such as the Alzheimer's Association have developed an array of services and supports to preserve and enhance the informal support network. In association with chapters and local agencies the Alzheimer's Association has designed programs that educate and support caregivers in the decisions and challenges faced on a daily basis. Through programs such as the National Respite Care Demonstration chapters work with volunteer and government agencies to develop and expand respite care and other needed services at a local level. Other techniques and services designed to assist caregivers have been suggested and developed. While it is often unclear what specific elements of proposed strategies are actually being tested or if any one approach produces superior effects in either the caregiver or the person with ADRD, research findings on caregivers of persons with ADRD have identified several promising approaches for helping family caregivers. These include: o strategies to increase caregiver's knowledge of the disease or alter perceptions of support (e.g., psycho-educational); o strategies to provide emotional support to the caregiver and to assist in skill development; o strategies directed at changing or controlling the severity of behavioral problems (wandering, agitation, etc.) which can lead to deterioration in caregiver's physical and mental health; o the provision of external resources to strengthen caregiver supports (community and home-based services); o new technological approaches designed to reduce emotional stress and feelings of isolation, and to expand caregiver's repertoire of problem-solving strategies (e.g., home-centered computer networks). Research is needed to specify the components of designated interventions and to begin to sort through the complex relationships among types of interventions, caregiver and care receiver variables, and intervention outcomes. Systematic evaluations of strategies, or combination of strategies, are needed to determine to what extent different strategies are effective in enhancing family caregiving at different stages in the progression of ADRD. An understanding of the theoretical underpinnings of different intervention strategies is critical for implementing successful interventions in other populations and settings. Objectives and Scope The primary goal of this RFA is to examine the effectiveness of social and behavioral interventions to help family members care for individuals with ADRD. There is a need to direct research on interventions that can broaden the options available to caregivers and determine how formal care services intersect and complement informal support networks. The design of interventions and their assessment require attention to the nature of the problem (e.g., enhancing caregiver supports, strengthening caregiver skills, minimizing caregiver responsibilities), the characteristics of the intervention, and the processes which produce particular types of outcomes. It is desirable to establish standardized outcome measures, particularly those of well-being and burden, to be used to assess the impact of comparable strategies on caregivers and, secondarily, on care receivers. This RFA is not designed to support large scale demonstration programs. However, building a research component on existing services or programs is appropriate if key definitions and measures are not predetermined. Specific Research Foci Investigators must propose at least one social and behavioral intervention designed to enhance family caregiving for persons with Alzheimer's disease and related disorders. Interventions need to be based on theory driven models of care and its effectiveness. While this is not a drug study per se, investigators may propose a drug arm as a comparison treatment strategy. Proposed research designs must rule out alternative explanations for intervention effects. All applicants must address: The nature of the proposed intervention (e.g., type, intensity, duration, frequency) and the underlying behavioral or social theory for expected outcomes. The conduct of previous research providing some support for the effectiveness of the proposed intervention is advisable. Clinical, behavioral or social factors that might affect the impact of the proposed intervention. Investigators must identify and propose standardized measurements for assessing key variables, such as disease characteristics (e.g., stage of disease, presence of co-morbid conditions); caregiving characteristics (nature and extent of caregiving responsibilities; time in caregiving role); caregiver characteristics (e.g., definition of primary caregiver; relationship to care receiver). Intervention outcomes for caregivers and care receivers (all investigators must propose at least one primary health or functional outcome for each that would be common across all Sites. At least one common measure of caregiver burden (or its obverse, caregiving well-being) must also be identified. Other outcomes may be proposed if well justified and not burdensome for study participants). The final common measures will be determined by the steering committee from those proposed at each site. For those who propose more than one intervention, the comparison of different interventions in terms of their health outcomes and relative costs. SPECIAL REQUIREMENTS The broad areas of interest presented above are illustrative only as a point of departure. Studies proposed for Sites should include discussion of design issues (including recruitment, attrition, and selection bias), eligibility criteria, standardization of proposed intervention, the content of baseline and follow-up assessments and related statistical and data management issues. Research plans should indicate recommendations for common measurements, including the rationale for measurement selection and frequency of assessment (e.g., it is likely than more than one annual assessment will be needed to capture anticipated changes). All prospective awardees should describe strategies for the establishment of collaborative arrangements with other awardees. The initial meetings of awardees of all Components (Sites and Coordinating Center) and NIH program staff will serve to coordinate the individual research projects by developing operational definitions for health and caregiver variables, determining the feasibility of adopting common eligibility criteria and establishing a common data set for baseline and follow-up assessments. It is anticipated that approximately nine months will be required for the development of a protocol and the drafting of a manual of procedures for the generation of the common data set. The NIA program administrator will meet in Bethesda with Principal Investigators and key staff up to four times in the first year and at least every six months thereafter to discuss new developments, review research progress and difficulties, coordinate ongoing research and plan future research activities. Applicants should include a statement about their willingness to participate in such activities. Travel funds for key staff (two to three people) to attend these meetings should be included as a budget line item in each application. Organizational Components 1. Intervention Sites An intervention Site is the institution that receives an award for conducting the investigation(s) under this RFA. The Principal Investigator (PI) is encouraged (as appropriate) to form a multidisciplinary team. Applications for individual Sites should provide evidence of ability to recruit an adequate number of subjects at each site in order to address the primary hypotheses about the impact of the proposed psychosocial intervention(s). There should be evidence of strong institutional support for the Site and a stated willingness to follow shared aspects of design, measures and analysis as approved by the Steering Committee. An organizational structure for the Site should be set forth in the application, designating lines of authority and responsibility. 2. Coordinating Center Applications are also requested for one Coordinating Center (CC) to interact with the Sites, an Advisory Panel, and the NIA program administrator on a variety of topics ranging from seeking and compiling information, to providing technical assistance, to conducting cross-site analyses. In consultation with other organizational components, the CC will have the primary responsibility for instrument development and testing activities (e.g., compiling the listing of proposed common measures; reviewing the literature and assessing the advantages and disadvantages of different measures for common study variables; conducting psychometric analyses on the common data set; and making recommendations at the end of the study about the most parsimonious set of measures to be archived). Its staff may author articles on measurement and statistical issues, alone or in conjunction with others involved in this cooperative agreement. Additionally, the CC will be responsible for tracking recruitment and retention across the different Sites, and advising the Sites on strategies for enhancing recruitment/retention, especially in minority or ethnic populations. The CC will also have the responsibility of standardizing data collection and management and analysis of the common data set. It will work with projects to maximize the potential for cross-site comparability of data; and, ensure that common protocols and definitions are consistent across projects through training sessions. It will provide key assistance in designing the data collection system (e.g., centralized and/or distributive) for the shared data and will also be responsible for developing and monitoring quality control. The CC will be responsible for printing and distributing all final data collection forms. Visits to Sites to set up common data systems should be described and budgeted. Its staff will collect, edit, store, and analyze shared data generated by the Sites and participate with other awardees as co-authors in preparing manuscripts that report results from the common data set. The CC will have primary responsibility for performing cross-site analyses to evaluate the relative outcomes of different site-specific interventions (e.g., through pre-planned meta-analyses). In addition, the CC will perform a variety of functions, such as, developing a cross-project Manual of Procedures; maintaining a directory of investigators and co-investigators; arranging all conference calls and meetings, e.g., for the Steering Committee and ad-hoc meetings of project directors; and facilitating information exchange among the Sites and NIH, and between the NIH and the general research community. The latter role will include compiling specific reports and developing and implementing common formats across Sites for all reports, protocols and descriptions (e.g., progress reports, instrument protocols, manuals of operation). The CC will also devise plans for the dissemination of information resulting from these studies, including the preparation of slides for presentation of study objectives, methods, and findings. The CC budget should include all costs required to convene the Advisory Panel (8 members) at least once per year. Up to $20,000 per year for cross-site consultants and small working group sessions should also be budgeted. Two completely separate applications from different applicant-investigators must be filed if an institution seeks selection as both a Site and the Coordinating Center. 4. Steering Committee The Steering Committee will serve as the main decision-making body for the shared aspects of the study. The Steering Committee will have overall responsibility for the study and will develop modifications in the site-specific protocols to facilitate establishment of a common data set using the information provided in this RFA as a guide. The Committee will consist of the Principal Investigator from each Site, the Coordinating Center, and the NIA Program Administrator. The Steering Committee will meet every three to six months as needed. The chairperson, who will be someone other than an NIH staff member, will be selected by the Steering Committee. 5. Advisory Panel An Advisory Panel (AP) will be selected by the Steering Committee to serve in an advisory capacity to the study and to all of its organizational components. The functions of the AP include reviewing project-specific and common core protocols and making suggestions to the awardee(s) and the NIA Program Administrator; monitoring individual project performance, using materials provided by the Coordinating Center; monitoring protocols and information supplied through the Coordinating Center for possible adverse effects associated with the studies; reviewing and advising the awardee(s) and the NIA Program Administrator regarding design and/or protocol changes requested by individual investigators; and reviewing and advising the awardee(s) and the NIA Program Administrator regarding analyses and publications involving multi-project use of common core data. The Panel will consist of experts in relevant clinical, social and behavioral, statistical, and bioethical fields and will convene once per year. Interim conference calls and review of protocols and other correspondence may be necessary between meetings. Candidates should not be contacted or recruited to serve on the Panel or be named prior to the onset of the project. However, applicants are encouraged to enumerate areas of expertise appropriate for representation on the Panel. The experts must be independent of all Components participating in the cooperative agreement (i.e., not scientifically or fiscally involved). A chair will be elected by members of the Advisory Panel with input from the NIA Program Administrator. The chairperson of the Steering Committee, the Principal Investigator from the Coordinating Center, and the NIA Program Administrator will all participate as non-voting members during each Panel meeting. Per NIH policy, Panel members will be reimbursed for necessary travel and receive the standard government honorarium for attendance at Advisory Board meetings, but will not receive consultant fees for input to individual projects. Travel funds for members of the AP are to be included as a line item in the budget of Coordinating Center applications. Terms and Conditions of Award The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92 and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is a cooperative agreement (U01), an assistance mechanism (rather than an acquisition mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility or a dominant role in this activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the collaborative aspects will be shared among the awardees and the NIA Program Administrator. 1. Awardee Rights and Responsibilities Awardees will have primary authorities and responsibilities to define objectives and research design, and for participant recruitment and follow-up, quality control, data analysis and interpretation, and for preparation of publications from their site-specific protocols. The Sites will prepare a detailed manual of operations which will be updated on a regular basis throughout the course of the award. Awardees at the Sites shall retain custody of, and primary rights to the site-specific data developed under their award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. A condition of this RFA is that all Sites agree to make their Site-specific data publically available within a year of the end of the initial funding period by placing the data in an archive, such as the National Archive for Computerized Data on Aging at the University of Michigan. In addition, awardees of all organizational components (Sites and Coordinating Center) will engage in collaborative activities through participation in Steering Committee meetings and conference calls in the development and implementation of a common protocol establishing a shared data set. During the course of the award, data for the shared data set will be submitted at regular intervals (e.g., bi-weekly or monthly) to the Coordinating Center where it will be made available for cross-site analyses and archived for public use within a year after the end of the initial award period. Protocols developed by the Steering Committee will define rules regarding access to data and publication of findings from analysis of the shared data set which will be available to the Sites, the CC, and the NIH program administrator. An Advisory Panel will be established to serve in an advisory capacity to the study. 2. Staff Responsibilities The NIA Program Administrator will have substantial scientific/programmatic involvement during conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants. The awardee agrees to accept assistance from the NIA Program Administrator, as described below: o Participation in the development of the protocol for common measures o Monitoring of performance issues relating to steering committee assignments necessary for the development of the common protocol, recruitment, follow-up, quality control, adherence to protocol and attainment of study objectives. o Providing technical assistance in the formulation or consideration of refinements and adjustments of study objectives, designs and protocols. o Assistance in analysis and reporting of intervention study results The NIA Program Administrator may provide advice on staffing, statistical requirements, and will cooperate with awardees in considering protocol adjustments. In instances where there has been significant involvement in study design and analysis by the NIA Program Administrator, and in accordance with Publication Guidelines developed by the Steering Committee and with NIH policies regarding staff co-authorship of publications resulting from extramural awards, he/she may cooperate with awardees as co-authors in preparing manuscripts that report results from these studies. 3. Collaborative Responsibilities A Steering Committee, composed of the Principal Investigators of each Site, the Principal Investigator of the Coordinating Center, and the NIA Program Administrator will be the main governing board of the study and will have primary responsibility for developing a protocol for the shared aspects of the study. The Steering Committee will develop modifications in the site-specific protocols to facilitate establishment of a common data set using the information provided in this RFA as a guide. The Steering Committee will also establish subcommittees to oversee major operational components of the study. One vote will be given to each Principal Investigator and to the NIH. The Steering Committee will meet every three to six months as needed. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NIH may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Steering Committee (with the NIH member not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by the NIH, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is other wise appealable in accordance with the PHS regulations at 42 CFR part 50, subpart D and HHS Regulation at 45 CFR part 16. STUDY POPULATIONS Persons with medical diagnoses of ADRD, at the mild or moderate level, are the preferred target group as are caregivers who are at increased risk due to burdens of care. All awardees should provide their working definition of a "primary caregiver"; while theoretically interesting attention to "secondary" and "tertiary" caregivers is optional. Conceptual and analytical attention should be paid to anticipated changes in the health and functioning of the person needing care for ADRD as well as in caregiver responsibilities and roles. The proposed timing and frequency of data collection for proposed outcome measures should be indicated and related to projected rates of change. Although research designs are expected to vary according to specific interventions being examined, baseline common core data should be collected and transmitted to the coordinating center as soon as available, beginning no later than the start of the second year of the project. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are strongly encouraged to submit, by October 1, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the PI, 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 allows NIA staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Marcia G. Ory at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the PHS 398 (rev. 9/91) application form. This form is available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and from the NIH program administrator listed under INQUIRIES. Essential information on budgets and direct and indirect cost limits is discussed under FUNDS AVAILABLE, budget information on travel for steering committee meetings is discussed under SPECIAL REQUIREMENTS, and budget information about travel to advisory committee meetings is under the description of the advisory committee. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator must be included with the application. The RFA label available in the application kit must be affixed to the bottom of the face page of the application. Failure to use this label could delay processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title, number, and type of application: "Site," "Coordinating Center," must be typed on line 2a of the face page of the application form and the YES box must be checked. Submit a signed, original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Two copies of the application with appendices must also be sent to: Chief, Scientific Review Office National Institute on Aging Gateway Building, Suite 2C212 Bethesda, MD 20892 The deadline for receipt of applications is November 29, 1994. Materials will not be accepted after this date. If an application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. Nor will the DRG 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. Applicants must obtain Institutional Review Board (IRB), and if applicable, Institutional Animal Care and Use Committee approval of their application prior to submission. Applications not having these approvals are incomplete and will be returned without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete and nonresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIA in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. The second level of review will be provided by the National Advisory Council on Aging. The major review criteria to be used in the evaluation of applications for all Sites are: significance of the proposed activities to the goals of the RFA; qualifications, experience and commitment of the investigators and their ability to devote the required time and effort to the project; an understanding of the scientific objectives of the program, as evidenced by discussion of issues relating to the design and implementation of the collaborative aspects of the program; adequacy of inclusion of women and minorities; the willingness to work collaboratively with other awardees and with the NIA program administrator in the manner summarized in the RFA; institutional commitment to the requirements of the project; and appropriateness of the total budget and budgetary requests. Substantive review criteria for Sites are: evidence of a conceptual model driving the selection of the proposed intervention(s); specification of the selected intervention (e.g., type, frequency, intensity, and duration); justification for proposed sample sizes, assurance that projected sample sizes can be obtained, estimates of subject attrition; designation of measures to be included in the common data set, with rationale for the selection of primary and secondary outcome measures; and specification of analysis plans, with evidence of adequate statistical and data management support for site-specific data collection and analysis. Review criteria for the Coordinating Center are: prior experience in functioning as a Coordinating Center in a multi-site study; experience of the Principal Investigator and other key personnel in instrument development and psychometric testing, data management, statistical analysis, quality control, study coordination and administrative aspects of multi-center clinical studies; and proposed data collection and monitoring system. Substantive familiarity with dementia and family caregiving issues is desirable. AWARD CRITERIA Applications recommended by the National Advisory Council on Aging and other relevant council(s) will be considered for award based upon (a) scientific and technical merit; (b) program balance, including in this instance, sufficient compatibility of features to make a successful collaborative program a reasonable likelihood; (c) adequate inclusion of women and minorities in the common studies; and (d) availability of funds. Letter of Intent Receipt Date: October 1, 1994 Application Receipt Date: November 29, 1994 Council Review: May 25, 1995 Anticipated Award Date: August 1, 1995 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: Dr. Marcia G. Ory Behavioral and Social Research Program National Institute on Aging Gateway Building, Room 533 Bethesda, MD 20892 Telephone: (301) 496-3136 Direct inquiries regarding fiscal matters to: Ms. Joanne Colbert Grants and Contracts Management Office National Institute on Aging Gateway Building, Room 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 Other institutes and agencies are also interested in research dealing with Alzheimer's disease and related disorders. For information concerning related research interests, contact: National Institute of Nursing Research, Dr. Mary Lucas, Westwood Building, Room 754, Bethesda, MD 20892, (301) 594-7397 National Institute of Mental Health, Dr. Enid Light, Parklawn Building, Room 7103, Rockville, MD 20857, (301) 443-1185 Agency for Health Care Policy and Research, Ms. Linda Siegenthaler, 2101 E. Jefferson St, Room 502, Rockville, MD 20852, (301) 594-1357 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866 (Aging 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 Part 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun Aug 14 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 14 August 1994 Date: 15 Aug 1994 16:34:14 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 58 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <32ou1m$oso@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: NSF September Bulletin, Vol. 22; No. 1 File size (bytes): 45608 STIS Filename: bul9409 Document Type: Program Guideline Title: NSF 94-109 - Special Competetion in Systematic Biology File size (bytes): 24821 STIS Filename: nsf94109 ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf94109, the text of your message should be as follows: get nsf94109 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf94109, you would enter: ftp> get nsf94109 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Thu Aug 18 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Rich Hirsh Newsgroups: bionet.sci-resources Subject: Postdoctoral Research Associates in Computational Science and Engineering Date: 18 Aug 1994 19:58:56 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 288 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <33175g$q9o@net.bio.net> NNTP-Posting-Host: net.bio.net The announcement for the FY95 Postdoctoral Research Associates in Computational Science and Engineering has just been placed on STIS (NSF 94-104). It is also attached at the end of this message. This very successful program has been supporting postdocs from all disciplines for the last four years; in FY94 sixteen postdocs were supported, 2 in Biology, 2 in Chemistry, 3 in Computer Science, 3 in Engineering, 3 in Materials, 2 in Math, and 1 in Physics. This year the deadline for submission has been moved up to November 1, 1994. Could you please notify the researchers in your community who would be interested in this activity that it is continuing, and let them know the announcement is available. >>>Rich Hirsh o-o-o-o-o-o-o-o-o-o-o-o-o-o-o-o-o-o-o DIVISION OF ADVANCED SCIENTIFIC COMPUTING OFFICE OF CROSS DISCIPLINARY-ACTIVITIES DEADLINE: NOVEMBER 1, 1994 NATIONAL SCIENCE FOUNDATION CISE Postdoctoral Research Associates in Computational Science and Engineering and, Associates in Experimental Science The Computer and Information Science and Engineering (CISE) Directorate of the National Science Foundation plans a limited number of grants for support of Postdoctoral Research Associateships contingent upon available funding. The Associates are of two types: o Associateships in Computational Science and Engineering (CS&E Associates) supported by the New Technologies Program in the Division of Advanced Scientific Computing (DASC) in cooperation with other NSF CS&E disciplines (CS&E Associates). The objective of these Associateship awards is to increase expertise in the development of innovative methods and software for applying high performance, scalable parallel computing systems in solving large scale CS&E problems. o Associateships in Experimental Science (ES Associates) supported by the Office of Cross Disciplinary Activities (CDA) . The objective of the ES Associateship awards is to increase expertise in CISE experimental science by providing opportunities for associates to work in established laboratories performing experimental research in one or more of the research areas supported by the CISE Directorate. These awards provide opportunities for recent Ph.D.s to broaden their knowledge and experience and to prepare them for significant research careers on the frontiers of contemporary computational science and engineering and experimental science. It is assumed that CS&E Associates will conduct their research at academic research institutions or other centers or institutions which provide access, either on site or by network, to high performance, scalable parallel computing systems and will be performing research associated with those systems. It is assumed that ES Associates will conduct their research in academic research institutions or other institutions devoted to experimental science in one or more of the research areas supported by the CISE Directorate. Who may submit Universities, colleges, and other research institutions as described in Grants Proposal Guide (GPG), (NSF-94-2) are eligible to submit proposals to this program. For CS&E Associateships the institution must have access to high performance, emerging parallel computing systems. For ES Associateships, the institution should have an established laboratory performing research in CISE experimental areas, as described in Guide to Programs, NSF 93-167. Associateship awards will be based on proposals submitted by the sponsoring institution. The principal investigator will serve as an unreimbursed scientific advisor for the research associate. Research associates should not be listed as co-principal investigators. Each proposal must include a research and training plan for the proposed research associate in an activity of computational science and engineering in any of the fields supported by DASC, other NSF CS&E programs or experimental research supported by the CISE Directorate. To be eligible for this support, individuals must: (1) be eligible to be appointed as a research associate or research assistant professor in the institution which has submitted the proposal, (2) fulfill the requirement for the doctoral degree in computational science and engineering, computer science and engineering or a closely related discipline by September 30, 1995. Award Amounts, Stipends and Research Expense Allowances Awards will range from $33,200-$46,200 for a 24 month period. The award will include $29,000-$42,000 to support the Research Associate (to be matched equally by the sponsoring institution). There will also be an allowance of $4,200 to the sponsoring institution, in lieu of indirect costs, as partial reimbursement for expenses incurred in support of the research. The annual award to the research associate will be composed of two parts: an annual stipend (salary and benefits) that may range from $25,000-$38,000, and a $4,000 per year research expense allowance expendable at the Associate's discretion for travel, publication expenses, and other research-related costs. There is no allowance for dependents. The effective date of the award cannot be later than January 1996. Matching Funds The institution must match the NSF award on a dollar for dollar basis excluding the $4,200 granted in lieu of indirect costs. Matching funds may come from grants from other NSF programs, other agencies' programs, or from other institutional resources. Matching fund arrangements are the responsibility of the submitting institution and must be detailed in the budget request. Evaluation and Selection Proposals will be reviewed by panel in accordance with established Foundation procedures and the general criteria described in the GPG brochure, and additional criteria specific to the Postdoctoral Research Associateships Program. The review panel will consider: the candidate's ability, accomplishments, potential as evidenced by the quality and significance of past research, long range career goals, the likely impact of the proposed postdoctoral training and research on the future scientific development of the applicant and on the parallel computing infrastructure of the US (for CS&E Associates) or on Experimental Science in CISE disciplines (for ES Associates), the aspects of the candidate's research and education, such as broadening research associates' knowledge and experience by a change in institution, advisor, or research area, and the adequacy of the sponsoring institution's access to high performance and/or experimental computational resources to support the proposed research. Application Procedures and Proposal Materials To be eligible for consideration, a proposal must contain forms which can be found in the GPG brochure. Required are a Supplementary Application Information Form (NSF Form 1225-one copy), a Current and Pending Support Form (NSF Form 1239-one copy) to be completed by the Principal Investigator (the scientific advisor), and one original and twelve copies of: (a) Cover page with institutional certificates (Form 1207). Title should indicate whether the proposal is an CS&E Postdoctoral Associate or ES Postdoctoral Associate. (b) Budget (Form 1030). (c) Statement with details regarding matching funds and their source. (d) Personal career goals statement not to exceed one single-spaced page, written by the research associate applicant, that describes the career goals of the applicant and what role the chosen research, scientific advisor and sponsoring institution will play in enhancing the realization of these long-range career goals. (e) Statement of results from prior NSF support (of the Principal Investigator) related to the proposed research. (f) Biographical sketch of the principal investigator as called for in the GPG brochure. (g) Up-to-date curriculum vitae of the research associate applicant including a complete list of publications, but no reprints (a thesis should not be included, but a thesis abstract may be included). (h) Proposal abstract, less than 250 words, of the training and research plan. (i) Training and research plan (not to exceed three single-spaced typewritten pages). This should propose research which could be carried out during the award period. The creativity, description and essential elements of the research proposal must be those of the research associate applicant. The research plan should show the broadening aspects of the proposed research. (j) Statement from the proposed postdoctoral advisor nominating the research associate indicating the nature of the postdoctoral supervision to be given if the award is made. (k) Statement from the advisor clearly describing the computing facilities and resources that will be available to support the proposed research. (l) Three recommendations (normally including one from the doctoral advisor). Training and research plans should be provided to your references to assist their recommendations. Please note that the research description page limit is less than the research description page limit specified in GPG. All application materials must be: (1) received by NSF no later than the deadline date November 1, 1994; (2) be postmarked no later than five (5) days prior to the deadline date; or (3) be sent via commercial overnight mail no later than two (2) days prior to the deadline date, to be considered for award. Send completed proposals with supporting application materials to: National Science Foundation - PPU Announcement No. 4201 Wilson Blvd. Arlington, VA 22230 Additional Information If you wish additional information, please contact New Technologies Program Director, DASC, at 703-306-1970 (e-mail: ntpd@nsf.gov) for CS&E Associates or Program Director, CDA, at 703-306-1980 (e-mail: espd@nsf.gov) for ES Associates. Copies of most program announcements are available electronically using the Science and Technology Information System (STIS). The full text can be searched on-line, and copied from the system. Instructions for use of the system are in NSF 94-4 "STIS Flyer." The printed copy is available from the Forms and Publications Unit. An electronic copy may be requested by sending a message to "stis@nsf.gov" (Internet). The Foundation provides awards for research in the sciences and engineering. The awardee is wholly responsible for the conduct of such research and preparation of the results for publication. The Foundation does not assume responsibility for such findings or their interpretation. The Foundation welcomes proposals on behalf of all qualified scientists and engineers and strongly encourages women, minorities, and persons with disabilities to compete fully in any of the research and research-related programs described in this document. Facilitation Awards for Scientists and Engineers with Disabilities provide funding for special assistance or equipment to enable persons with disabilities (investigators and other staff, including student research assistants) to work on an NSF project. See program announcement (NSF 91-54), or contact the program coordinator (703) 306-1697 for more information. In accordance with Federal statutes and regulations and NSF policies, no person on grounds of race, color, age, sex, national origin, or disability shall be excluded from participation in, denied the benefits of, or be subject to discrimination under any program or activity receiving financial assistance from the National Science Foundation. NSF has TDD (Telephone Device for the Deaf) capability which enables individuals with hearing impairments to communicate with the Division of Human Resource Management for information relating to NSF programs, employment, or general information. This number is (703) 306-0090. Grants awarded as a result of this announcement are administered in accordance with the terms and conditions of NSF GC-1, "Grant General Conditions," or FDP-II, "Federal Demonstration Project General Terms and Conditions," depending on the grantee organization. Copies of these documents are available at no cost from the NSF Forms and Publications Unit, at (703) 306-1130, or via e-mail (Internet:pubs@.nsf.gov). More comprehensive information is contained in the NSF Grant Policy Manual (July 1989) for sale through the Superintendent of Documents, Government Printing Office, Washington, DC 20402. "Catalog of Federal Domestic Assistance Number 47.070, Computer and Information Science and Engineering." The information requested on this application material is solicited under the authority of the National Science Foundation Act of 1950, as amended. It will be used in connection with the selection of qualified proposals and may be used and disclosed to qualified reviewers and staff assistants as part of the review process and to other government agencies. See Systems of Records, NSF-50, Principal Investigator/Proposal File and Associated Records" and NSF-51, "Reviewer/Proposal File and Associated Records" 56 Federal Register 54907 (October 23, 1991). Submission of the information is voluntary. Failure to provide full and complete information, however, may reduce the possibility of your receiving an award. Public reporting burden for this collection of information is estimated to average 120 hours per response, including the time for reviewing instructions. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Herman G. Fleming Reports Clearance Officer Division of Contracts, Policy, and Oversight National Science Foundation 4201 Wilson Boulevard Arlington, VA 22230 And to: Office of Management and Budget Paperwork Reduction Project (3145-0058) Washington, DC 20503 OMB#3145-0058 P.T. 34 K.W.1004000,0600000 From owner-sci-resources@net.bio.net Sat Aug 20 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 31, pt. 1of1, 19 August 1994 Date: 21 Aug 1994 08:33:41 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 909 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <337s4m$imb@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940819 V23N31 P1O1 ************************************ X-comment: RFAs described: CA-94-029, HS-95-002 NIH GUIDE - Vol. 23, No. 31 - August 19, 1994 $$INDEX BEGIN ******************************************************* NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** CLINICAL TRIALS COOPERATIVE GROUP National Institute on Deafness and Other Communication Disorders INDEX: DEAFNESS, OTHER COMMUNICATIONS DISORDERS $$INDEX R2 11/29/94 ************************************************* PLANNING GRANTS FOR PROSPECTIVE CANCER CENTERS (RFA CA-94-029) National Cancer Institute INDEX: CANCER $$INDEX R3 01/24/95 ************************************************* GRANTS FOR HEALTH SERVICES DISSERTATION RESEARCH (RFA HS-95-002) Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** NASAL AND ORAL TRIGEMINAL CHEMORECEPTION (PA-94-093) National Institute on Deafness and Other Communication Disorders INDEX: DEAFNESS, OTHER COMMUNICATIONS DISORDERS ATTENTION: The new mailing list for the NIH Guide will be activated in September. Until then, the existing mailing list will be maintained. See INTENT TO MODIFY (NIH Guide, Vol. 23, No. 23, June 17, 1994) for additional information. This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN XX-XX-XXX ************************************************ CLINICAL TRIALS COOPERATIVE GROUP NIH GUIDE, Volume 23, Number 31, August 19, 1994 SOURCES SOUGHT ANNOUNCEMENT P.T. 34; K.W. 0755015, 0715050 National Institute on Deafness and Other Communication Disorders The National Institute on Deafness and Other Communication Disorders (NIDCD) is soliciting the interest of organizations that have the capability and resources to organize a consortium, hereinafter called Cooperative Group, of an estimated 15 to 20 Clinical Facilities with Clinical Research Capabilities and Experience (e.g., Academic Health Centers or Independent Research Clinics) that, as a group, would plan, implement, conduct, analyze, and disseminate results of high priority clinical trial research in the treatment for diseases and disorders affecting hearing, balance, smell, taste, voice, speech, and language. A Clinical Trial is defined as a prospective study evaluating an experimental interaction with a control or standard, or comparing two or more existing treatments/interventions where the outcome is likely to contribute to change(s) in standard of care or contribute to change in public health policy. Many clinical trials address the efficacy of a treatment that is already in current practice. The Cooperative Group would, of necessity, have the following components: o Executive Policy Board and Chairperson -- to establish policy and procedures and be representative of each participating institution and the "grantee" organization. o Steering Committee of the Executive Policy Board -- to be responsible for the development of research designs and protocols. o Coordinating Center -- a cooperating facility to provide statistical support, audit, and technical services and address methodological issues. o Independent Data and Safety Monitoring Committee -- to monitor the clinical trials and assure integrity, safety, and well-being of study subjects, informed consent, compliance, and data review. o Clinical Facilities with Clinical Research Capabilities and Experience -- to provide for an adequate patient base and clinical expertise for the conduct of diverse clinical trials in the seven areas of NIDCD. Not every Facility will be expected to participate in each trial. o Grantee organization -- to facilitate the development, organization, and conduct of the Cooperative Group and its required entities and be responsible for fiscal resources and operations. The Cooperative Group Steering Committee would initially select between five and seven hypotheses for which clinical trial protocols would be designed to answer high priority questions in any of the seven areas of the NIDCD. These protocols would involve as few or as many of the Clinical Facilities that are necessary for the recruitment of research subjects and to reach significant statistical power. It is anticipated that although most studies will be done in "series," some concomitant studies are possible. Each protocol will be independently peer reviewed prior to commencement of the grant. Interim protocols judged of the highest program priority can be entered as supplemental applications. This effort is a long-term, five-year renewable commitment by NIDCD with the grantee organization and the Cooperative Group of Clinical Facilities. The grantee organization will be responsible for yearly progress reports and semiannual meetings with NIDCD staff. During the fourth year a comprehensive evaluation of the program will be conducted by NIDCD. The NIDCD would provide resources for the conduct of the clinical trials at the Clinical Facilities, principal staff for the grantee organization and funding for Executive Policy Board, Steering Committee, Coordinating Units, Independent Data and Safety Monitoring Board and other resources necessary for the successful completion of this Cooperative Group approach to the study of clinical issues. INQUIRIES This Sources Sought Announcement is a request for information to assist the NIDCD in planning for future clinical trials. It may or may not result in a solicitation; at this time, no funds are available for these purposes. Interested parties are encouraged to respond by October 14, 1994. Respondents are invited to discuss additional terms or conditions with NIDCD by contacting: Ralph F. Naunton, M.D. Division of Communication Sciences and Disorders National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400C-17 Bethesda, MD 20892-7180 Telephone: (301) 496-1804 FAX: (301) 402-6251 $$R1 END ************************************************************ $$R2 BEGIN CA-94-029 FULL-TEXT ************************************** PLANNING GRANTS FOR PROSPECTIVE CANCER CENTERS NIH GUIDE, Volume 23, Number 31, August 19, 1994 RFA AVAILABLE: CA-94-029 P.T. 34; K.W. 0715035, 0710030 National Cancer Institute Letter of Intent Receipt Date: September 29, 1994 Application Receipt Date: November 29, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Cancer Centers Branch (CCB), Division of Cancer Biology, Diagnosis, and Centers (DCBDC), National Cancer Institute (NCI) announces the availability of planning and development grants to assist eligible institutions in developing the organizational capability to form and/or further development cancer centers in underrepresented areas of the nation. In addition to basic cancer research, these new centers should plan to emphasize clinical and prevention/control research. 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, Planning Grants for Prospective Cancer Centers, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by the following institutions: 1. Domestic medical research organizations, public and private such as universities, that fulfill the following requirements and that do not currently have a Cancer Center Support Grant (CCSG) (P30) or Planning Grant for Prospective Cancer Centers (P20) 2. Institutions that currently hold a Planning Grant for Prospective Cancer Centers (P20), but have not yet developed their research base to be eligible to apply for a CCSG. Applicant institutions must intend to develop cancer research centers that, at a minimum, will have a strong basic research and clinical research foundation, and will develop or include prevention and control research. Eligible institutions must come from states that do not currently have an NCI-designated Comprehensive, Clinical, or Consortium Cancer Center, and/or are located outside of the regional service area of an existing Comprehensive, or Clinical Cancer Center. In addition, to be eligible, institutions must have three or more externally funded, peer-reviewed, cancer research project grants or contracts (e.g., R01, P01, N01, U01), or equivalent types of research projects. Eligible institutions may request up to three years of support. Institutions that already have a fully established organizational capability as a cancer center and a sufficient peer-reviewed cancer research base of $1.5 million dollars or greater in cancer specific research are not eligible under this program. Potential applicants are strongly advised to contact NCI program staff listed under INQUIRIES to discuss eligibility requirements prior to preparing an application. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) exploratory grant mechanism (P20). Each institution may apply for no more than $175,000 in direct costs. Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in the RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (rev. 4/1/94). This RFA is a one-time solicitation for applications for new and competing renewal awards. The earliest feasible start date for the initial awards will be August 1, 1995. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. FUNDS AVAILABLE Approximately $750,000 in total costs per year will be committed specifically to fund applications submitted in response to this RFA. It is anticipated that three to five awards will be made. This funding level is dependent on the receipt of a sufficient number of applications of high merit. The total proposed project period for an application submitted in response to the present RFA may not exceed three years. RESEARCH OBJECTIVES The primary goal of this RFA is to provide support to those institutions that wish to develop the organizational capability that will lead to the formation and/or development of new centers of cancer research excellence in underrepresented geographic areas in the United States. Applicants must demonstrate their potential and/or actual progress toward fulfilling the essential characteristics described below and obtaining the required research base.Ultimately, the development of these centers should provide wider access of regional populations to the benefits of state-of-the art clinical,prevention, and control research. It is anticipated that these new centers,after completion of the planning and development effort, will be in a position to compete for NCI cancer center designation through submission of a CCSG application. The Planning and Development Process is the institutional effort to provide the research capability, the organizational structure, financing,and facilities needed for the cancer center. These objectives should take into account the following considerations: (1) the identification of the special problems that need to be resolved, (2) the overall objectives and purposes of the parent institution, (3) the identification of the specialized needs of the institution's geographic area and its populations that can be addressed through research, (4) the effect that the establishment of a cancer-oriented center will have on the internal structure or organization of an institution, (5) the level of commitment and resources the parent institution can provide a new cancer center, (6) the definition of the interactive and translational research activities to be included in the new center, the heart of the cancer center concept, and(7) the relevance of the center to the mission of the National Cancer Institute. The following elements are essential in the planning and subsequent development of a cancer center: (1) the planning director, (2) the planning and advisory committees, (3) Research program definition and implementation, (4) the shared resources,(5) the definition of the relationship of research activities to patient care,educational, and other outreach activities of the center, and (6) a description of the use of developmental funds. SPECIAL REQUIREMENTS Allowable budget items for these planning and development grants are limited to a portion of the salaries of the planning director (Principal Investigator), key scientific personnel, administrative and clerical support personnel, travel and per diem expenses for outside advisors (the use of commercial consultants is discouraged), supplies, travel expenses for the planning director or other key personnel, and other justifiable operating expenses of the planning effort. The level of effort of personnel on this grant should reflect the commitment of the individual to the planning and development process although the salaries may be paid in part from other sources (these other sources must be described). In addition, developmental funds may be requested up to a maximum level of $35,000/year. All budget items must be justified in terms of their support of the planning and development process. Budget requests for applications submitted under this RFA must not exceed $175,000 direct costs per year. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines on the Inclusion of Women and Minorities as subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are requested to submit, by September 29, 1994, a letter of intent that includes a descriptive title of the proposed cancer center, the name, address, and telephone/fax number of the planning director, the names of other key personnel, the participating institutions, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, it is requested in order to provide an indication of the number and scope of applications to be reviewed. The letter of intent is to be sent to J. Blanche O'Neill at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. Supplemental instructions for preparing the application are provided in the RFA. The receipt date for applications under this RFA is November 29, 1994. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the (ICD) in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non- competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. AWARD CRITERIA The earliest anticipated award date is August 1, 1995. The RFA provides the specific criteria. INQUIRIES Written and telephone inquiries concerning the objectives, scope, application procedures, and allowable budget items for this RFA and inquiries about whether specific applications would be responsive are encouraged and must be directed to the Cancer Centers Branch, NCI, program officer listed below. The Branch staff welcomes the opportunity to clarify any issues or questions from potential applicants. In addition, questions of a more administrative nature not directly related to the programmatic aspects of this RFA may be directed to the Grants Administration Branch official listed below. J. Blanche O'Neill Division of Cancer Biology, Diagnosis and Centers National Cancer Institute Executive Plaza North, Room 502 Bethesda, MD 20892 Telephone: (301) 496-8531 Direct inquiries regarding fiscal matters to: Crystal Wolfrey Grants Administration Branch National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 282 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.397. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78- 410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R2 END ************************************************************ $$R3 BEGIN HS-95-002 FULL-TEXT ************************************** GRANTS FOR HEALTH SERVICES DISSERTATION RESEARCH NIH GUIDE, Volume 23, Number 31, August 19, 1994 RFA AVAILABLE: HS-95-002 P.T. 34; K.W. 0730050, 0730020 Agency for Health Care Policy and Research Application Receipt Date: January 24, 1995 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Agency for Health Care Policy and Research (AHCPR) announces the availability of an RFA for grants for health services dissertation research. The AHCPR conducts and supports research that will enhance the quality, appropriateness, and effectiveness of health care services, and access to such services. The provision of dissertation grant support is part of AHCPR's effort to stimulate the development of innovative and timely research on issues related to the delivery of health care services. Grant support is designed to aid the career development of new health services researchers and to encourage individuals from a variety of academic disciplines and programs to study complex issues with respect to health care services. 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. AHCPR urges applicants to submit grant applications with relevance to the specific objectives of this initiative. 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 A student applying for a dissertation research grant (the Principal Investigator) must be enrolled in an accredited doctoral degree program in the social, management, medical, or health sciences. The student also must be conducting or intending to conduct dissertation research on issues related to the delivery of health care services as described below. The proposed principal investigator must be a registered doctoral candidate in resident or nonresident status. All requirements for the doctoral degree other than the dissertation must be completed by the time of the award. Prior to submission of the application, the dissertation proposal must be approved by the dissertation faculty committee and certified by the faculty advisor. This information must be verified in a letter of certification from the thesis chairperson and submitted with the grant application (see APPLICATION PROCEDURES). The applicant may be either the public or private non-profit institution that will administer the grant on behalf of the proposed Principal Investigator or the proposed Principal Investigator applying as an individual. Applications from minority and women investigators are encouraged. A proposed Principal Investigator for dissertation research grant support need not be a citizen of the United States. However, an investigator who is not a U.S. citizen and does not have a permanent resident visa must apply through a public or private nonprofit institution. Also, an application from a student enrolled in a foreign institution will be accepted if the application is in English and the investigator applies through an institution. The proposed investigator who receives support for dissertation research under a grant from the AHCPR may not at the same time receive support under a predoctoral training grant or fellowship grant awarded by any other agency of the U.S. Department of Health and Human Services. MECHANISM OF SUPPORT This RFA will employ the small research grant (R03) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the proposed principal investigator. The total direct costs must not exceed $20,000 for the entire project period. An application that exceeds this amount will be returned to the applicant. The proposed principal investigator may request support only for the amount of time necessary to complete the dissertation. A dissertation research grant usually is awarded for a period of 12 months or less, but may be awarded for up to 17 months. FUNDS AVAILABLE The AHCPR expects to award up to $500,000 in fiscal year 1995 to support about 20 dissertation research projects. The number of awards will be contingent on the availability of funds and the quality of the applications. RESEARCH OBJECTIVES Only applications that propose studies in areas identified in section 902 of the Public Health Service Act are eligible for support. Areas of health services research authorized under section 902 in which AHCPR is interested in dissertation grants include, but are not limited to: o Effectiveness, efficiency, and quality of health care services; o Outcomes of health care services and procedures; o Clinical practice, including primary care and practice-oriented research; o Health care costs, productivity, and market forces; o Health care technologies, facilities, and equipment; o Health promotion and disease prevention; o Medical liability; o AIDS/HIV infection with respect to issues of access and delivery of health care services; o Rural health services; and o Health of low-income, minority, elderly, and other underserved populations. SPECIAL REQUIREMENTS Allowable Costs Expenses usually allowed under PHS research grants will be covered by AHCPR dissertation research grants. Allowable costs include: the investigator's salary; direct project expenses such as travel, data processing, and supplies; and, for institutional applicants only, indirect costs. Fees for maintaining matriculation or other fees imposed on those preparing dissertations are allowable costs, provided the fees are required of all students of similar standing, regardless of the source of funding. Applicants are expected to work full time on the project. Any level of effort that is less than full time must be fully justified. For the purpose of calculating indirect costs, dissertation research grants are considered to be training grants. Therefore, in accordance with PHS policy, indirect costs, payable only when the applicant is an institution, are limited to eight percent of total allowable direct costs exclusive of tuition and related fees and expenditures for equipment, or at the institution's actual indirect cost rate, whichever results in a lesser dollar amount. Other Conditions The following conditions apply to dissertation grants: o A Principal Investigator who discontinues or suspends a project during the grant period must inform the AHCPR immediately in writing. The AHCPR may suspend or terminate the grant as requested by the Principal Investigator or on its own initiative. o The dissertation constitutes the final report of the grant. The dissertation must be officially accepted by the faculty committee or university official responsible for the candidate's dissertation and must be signed by the responsible officials. Three copies of the dissertation must be submitted to the AHCPR. o The dissertation and all financial status reports must be submitted in English. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the AHCPR policy on the inclusion of women and minorities in study populations. See the RFA for details. APPLICATION PROCEDURES The RFA contains important information on application procedures, including special instructions for health services dissertation research applications, and may be obtained from the AHCPR staff listed under INQUIRIES. The application receipt date is January 24, 1995. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants, in accordance with the instructions described in the RFA and the instructions in the application. The application form PHS 398 is available at most institutional offices of sponsored research; the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and, for AHCPR applications, from Global Exchange Inc., 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3015, telephone (301) 656-3100 (FAX 301-652-5264). Also, a letter from the faculty committee or university official directly responsible for supervising the development and progress of the dissertation research must be submitted with the application. Details of the requirements for the letter are given in the RFA. REVIEW CONSIDERATIONS Applications will be reviewed initially by the Referral Office at Division of Research Grants, NIH, for completeness and by the AHCPR for responsiveness to the RFA. Incomplete and/or non-responsive applications will be returned to applicants without further consideration. Applications will be evaluated in accordance with the criteria stated in the RFA for scientific/technical merit by an appropriate AHCPR peer review group. Further review considerations and special review criteria are in the RFA. INQUIRIES Direct inquiries regarding programmatic issues, including suitability of their research topics and information on the policy of inclusion of women and minorities in study populations, to: Julius Pellegrino Center for General Health Services Extramural Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 502 Rockville, MD 20852 Telephone: (301) 594-1357 ext.138 Direct inquiries regarding fiscal and administrative matters to: Ralph L. Sloat Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1447 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.226. Awards are made under authorization of the Public Health Service Act, Title IX and Section 1142 of the Social Security Act. Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR Part 67, Subpart A, and 45 CFR Part 74 (45 CFR Part 92 for State and local governments). This program is not subject to the intergovernmental review requirements of Executive Order 12372. $$R3 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-94-093 ************************************************ NASAL AND ORAL TRIGEMINAL CHEMORECEPTION NIH GUIDE, Volume 23, Number 31, August 19, 1994 PA NUMBER: PA-94-093 P.T. 34; K.W. 0755017, 0760075 National Institute on Deafness and Other Communication Disorders PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) invites applications for the support of basic studies on the nasal and oral trigeminal chemosensory system and its interactions with the olfactory and gustatory systems. It is expected that research in this area will advance the understanding of the contributions of trigeminal chemoreception to odor and taste perception, particularly in relation to dietary preferences. In addition, this research is expected to elucidate a variety of reflexes elicited by nasal and oral trigeminal chemoreceptors that serve to protect the individual from noxious stimuli. This initiative is intended to foster a better understanding of the molecular events that underlie the function of the nasal and oral trigeminal chemosensory system and its interactions with the olfactory and gustatory systems. 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, Nasal and Oral Trigeminal Chemoreception, is related to the priority areas of nutrition, environmental health, occupational safety and health, and oral health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-11474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-11473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The support mechanisms for grants in this area will be the investigator-initiated research project grant (R01), and the FIRST (R29) award. RESEARCH OBJECTIVES Trigeminal nerve fibers in the nasal and oral cavities are sensitive to chemical stimuli as well as to mechanical, thermal, nociceptive, and proprioceptive stimuli. Since chemical stimulation of the nasal and oral cavities involves the trigeminal nerve in addition to the olfactory and gustatory nerves, information from the trigeminal nerve forms an integral part of our perceptions of odor and taste. Nasal trigeminal stimuli include volatile organic compounds that may be present in the workplace and home environment and may give rise to complaints of indoor pollution and sick building syndrome. Oral trigeminal chemosensory stimulation can evoke a number of qualities of perception such as coolness, heat, astringency, irritation and pain. Research on trigeminal chemoreceptors has lagged behind the olfactory, gustatory, and vomeronasal systems. While trigeminal chemoreceptors contribute to smell and taste in the detection of chemicals in the environment and maintenance of nutritional balance, they are also responsible for the detection of irritants and potentially harmful compounds and may mediate strong protective reflexes. Stimulation of trigeminal nerve fibers may give rise to the release of neuropeptide mediators such as substance P (SP) and calcitonin-gene-related peptide (CGRP) at four possible sites: the stimulation site, peripheral terminals, collateral terminals, and central terminals. The release of these neuropeptides can affect a variety of functions including respiration, vasodilation, vascular permeability, glandular secretions and cellular immunity. Nasal trigeminal collateral terminals have been demonstrated in the olfactory bulb, and therefore, peripheral activation may influence central processing of olfactory information. This initiative seeks to encourage research on trigeminal chemoreception at all levels extending from peripheral mechanisms to central processing and including reflexes elicited by the activation of trigeminal chemoreceptors. A broad range of research techniques are appropriate including molecular, cellular, biochemical and psychophysical approaches. Research studies may include, but are not limited to, the topics listed below: o The role of trigeminal chemosensory sensations in the regulation of eating and its disorders; o The contribution of the trigeminal chemosensory system to food palatability, particularly with respect to food texture and temperature; o The relative contributions of trigeminal, olfactory and gustatory stimulation to the perception of chemical stimuli; o Individual differences in sensitivity to trigeminal chemoreception throughout the life span; o Responses to mixtures of trigeminal chemosensory stimulants including excitatory and inhibitory interactions among trigeminal modalities such as temperature and touch; o Cellular mechanisms underlying the diverse qualities of trigeminal chemosensory sensations; o Receptor and perireceptor mechanisms following trigeminal activation leading to sensitization and desensitization of trigeminal nerve endings; o Long- and short-term effects of trigeminal stimulants on the olfactory, gustatory, and vomeronasal epithelia; o Demonstration of trigeminal reflexes including effects on the perireceptor milieu (e.g., mucous secretion, salivary flow, vasoconstriction, and vasodilation), respiratory and oropharyngeal functions, and the immune system; o Localization of receptors for SP, CGRP, neuropeptide Y, neurokinins, and others in the lingual and nasal epithelia; and o Entry of viruses into the central nervous system via trigeminal nerve fibers and the possible sequestration of viruses in the trigeminal (gasserian) ganglion. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. The receipt dates for applications for AIDS-related research are found in the PHS 398 instructions. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248. The title and number of the program announcement must be typed in Section 2a on the face page of the application. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that ICD. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Written and telephone inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Rochelle Small, Ph.D. Division of Communication Sciences and Disorders National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 402-3464 FAX: (301) 402-6251 Direct inquiries regarding fiscal matters to: Sharon Hunt Grants Management Office National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-B 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 402-0909 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.173. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 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. $$P1 END ************************************************************ From owner-sci-resources@net.bio.net Sat Aug 20 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HS-95-002 - V23(31) 08/19/94 Date: 21 Aug 1994 08:33:46 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 424 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <337s4q$imk@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HS95002 HS-95-002 P1O1 *************************************** GRANTS FOR HEALTH SERVICES DISSERTATION RESEARCH NIH GUIDE, Volume 23, Number 31, August 19, 1994 RFA: HS-95-002 P.T. 34; K.W. 0730050, 0730020 Agency for Health Care Policy and Research Application Receipt Date: January 24, 1995 PURPOSE The Agency for Health Care Policy and Research (AHCPR) announces the availability of a request for applications (RFA) for grants for health services dissertation research. The AHCPR conducts and supports research that will enhance the quality, appropriateness, and effectiveness of health care services, and access to such services. The provision of dissertation grant support is part of AHCPR's effort to stimulate the development of innovative and timely research on issues related to the delivery of health care services. Grant support is designed to aid the career development of new health services researchers and to encourage individuals from a variety of academic disciplines and programs to study complex issues with respect to health care services. 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. AHCPR urges applicants to submit grant applications with relevance to the specific objectives of this initiative. 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 A student applying for a dissertation research grant (the Principal Investigator) must be enrolled in an accredited doctoral degree program in the social, management, medical, or health sciences. The student also must be conducting or intending to conduct dissertation research on issues related to the delivery of health care services as described below. The proposed principal investigator must be a registered doctoral candidate in resident or nonresident status. All requirements for the doctoral degree other than the dissertation must be completed by the time of the award. Prior to submission of the application, the dissertation proposal must be approved by the dissertation faculty committee and certified by the faculty advisor. This information must be verified in a letter of certification from the thesis chairperson and submitted with the grant application (see APPLICATION PROCEDURES). The applicant may be either the public or private nonprofit institution that will administer the grant on behalf of the proposed Principal Investigator or the proposed Principal Investigator applying as an individual. Applications from minority and women investigators are encouraged. A proposed Principal Investigator for dissertation research grant support need not be a citizen of the United States. However, an investigator who is not a U.S. citizen and does not have a permanent resident visa must apply through a public or private nonprofit institution. Also, an application from a student enrolled in a foreign institution will be accepted if the application is in English and the investigator applies through an institution. The proposed investigator who receives support for dissertation research under a grant from the AHCPR may not at the same time receive support under a predoctoral training grant or fellowship grant awarded by any other agency of the U.S. Department of Health and Human Services. MECHANISM OF SUPPORT This RFA will employ the small research grant (R03) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the proposed principal investigator. The total direct costs must not exceed $20,000 for the entire project period. An application that exceeds this amount will be returned to the applicant. The proposed principal investigator may request support only for the amount of time necessary to complete the dissertation. A dissertation research grant usually is awarded for a period of 12 months or less, but may be awarded for up to 17 months. FUNDS AVAILABLE The AHCPR expects to award up to $500,000 in fiscal year 1995 to support about 20 dissertation research projects. The number of awards will be contingent on the availability of funds and the quality of the applications. RESEARCH OBJECTIVES Only applications that propose studies in areas identified in section 902 of the Public Health Service Act are eligible for support. Areas of health services research authorized under section 902 in which AHCPR is interested in dissertation grants include, but are not limited to: o Effectiveness, efficiency, and quality of health care services; o Outcomes of health care services and procedures; o Clinical practice, including primary care and practice-oriented research; o Health care costs, productivity, and market forces; o Health care technologies, facilities, and equipment; o Health promotion and disease prevention; o Medical liability; o AIDS/HIV infection with respect to issues of access and delivery of health care services; o Rural health services; and o Health of low-income, minority, elderly, and other underserved populations. Applicants are encouraged to discuss the general policy priority of their research topics by letter or by telephone with AHCPR staff listed under INQUIRIES. SPECIAL REQUIREMENTS Allowable Costs Expenses usually allowed under PHS research grants will be covered by AHCPR dissertation research grants. Allowable costs include: the investigator's salary; direct project expenses such as travel, data processing, and supplies; and, for institutional applicants only, indirect costs. Fees for maintaining matriculation or other fees imposed on those preparing dissertations are allowable costs, provided the fees are required of all students of similar standing, regardless of the source of funding. Applicants are expected to work full time on the project. Any level of effort that is less than full time must be fully justified. For the purpose of calculating indirect costs, dissertation research grants are considered to be training grants. Therefore, in accordance with PHS policy, indirect costs, payable only when the applicant is an institution, are limited to eight percent of total allowable direct costs exclusive of tuition and related fees and expenditures for equipment, or at the institution's actual indirect cost rate, whichever results in a lesser dollar amount. Other Conditions The following conditions apply to dissertation grants: o A Principal Investigator who discontinues or suspends a project during the grant period must inform the AHCPR immediately in writing. The AHCPR may suspend or terminate the grant as requested by the Principal Investigator or on its own initiative. o The dissertation constitutes the final report of the grant. The dissertation must be officially accepted by the faculty committee or university official responsible for the candidate's dissertation and must be signed by the responsible officials. Three copies of the dissertation must be submitted to the AHCPR. o The dissertation and all financial status reports must be submitted in English. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of AHCPR that women and members of minority groups must be included in all AHCPR supported health services research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. A new NIH policy resulting from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) supersedes and strengthens NIH's previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which were in effect since 1990 and which AHCPR had adopted. The new NIH policy contains some provisions that are substantially different from the 1990 policies. AHCPR plans to publish guidelines specific to AHCPR. In the interim, AHCPR will follow the NIH guidelines, as applicable. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," 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 NIH policy from the AHCPR program staff listed under INQUIRIES. AHCPR program staff may also provide additional relevant information concerning this policy. APPLICATION PROCEDURES The application receipt date is January 24, 1995. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants, in accordance with the instructions described here and the instructions in the application. These forms are available at most institutional offices of sponsored research; the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and, for AHCPR applications, from Global Exchange Inc., 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3015, telephone (301) 656-3100 (FAX 301-652-5264). The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the original copy 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, type "RFA HS-95-002" in Section 2a on the face page of the application form and the YES box must be marked. The completed, signed, original application and five legible copies of form PHS 398 and the letter from the faculty committee must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Applications submitted under this RFA must be received in the Division of Research Grants, NIH, by January 24, 1995. If an application is received after that date, it will be returned to the applicant. An application that does not conform to the instructions in this RFA will be returned. Resubmitted applications are seldom funded. Therefore, individuals considering resubmissions are strongly encouraged to contact the Dissertation Program Coordinator, at the address listed in INQUIRIES below, prior to resubmitting revised applications. Special Instructions Whenever feasible, the proposed Principal Investigator for a dissertation grant is encouraged to have the application administered through an institution. This may be either the degree-granting institution or another non-profit institution with which the proposed Principal Investigator is professionally affiliated. In determining which institution is more appropriate, the student must consider the extent to which the resources of the designated institution are capable of supporting the proposed research effort. A letter from the faculty committee or university official directly responsible for supervising the development and progress of the dissertation research must be submitted with the application. The letter must (1) certify approval of the dissertation proposal, (2) certify that all requirements for the doctoral degree except the dissertation are completed (or will be completed by the time of the grant award), and (3) note that the faculty committee expects the doctoral candidate to proceed with the approved dissertation proposal with or without AHCPR support. The application must identify all members of the faculty advisory committee, by listing the information in form 398, page 2, and providing a brief separate biographical sketch for each on form 398, page 6. Applicants for a dissertation grant should take special care in reading the instructions in the research grant application form PHS 398. Special care should be taken to thoroughly understand and carefully address the matters of human subject certifications and assurances, including issues related to gender and minority representation, as described in the application form PHS 398 (especially pages 11-13, 21-23, and 25-26). In the instructions for the form PHS 398, "human subject" is defined by regulations as "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information." The human subject regulations encompass graphic, written, or recorded information derived from individually identifiable human subjects. Applicants also should take careful note of the instructions on form 398, page 2, for preparing the description in the space designated. This description should be carefully crafted because it serves a variety of purposes and audiences. Initially it is employed in the application review process and serves as a significant criterion in the initial evaluation of the competitiveness of the application. Applicants are advised to have their faculty advisor(s) carefully review the description. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Referral Office, Division of Research Grants, NIH, for completeness, and by AHCPR staff for responsiveness to the RFA. Incomplete and nonresponsive applications will be returned to the applicant without further consideration. The determination of any application as nonresponsive will be the sole responsibility of AHCPR. The general review criteria for AHCPR grant agreement applications are: significance and originality from a scientific and technical viewpoint; adequacy of the proposed method(s); availability of data or proposed plan to collect data required for the project; adequacy of the plan for organizing and carrying out the project; qualifications and experience of the principal investigator and proposed staff; reasonableness of the proposed budget; and adequacy of the facilities and resources available to the applicant. Dissertation research grant applications will be reviewed under AHCPR review procedures by non-Federal or Federal experts. Reviewers will be selected on the basis of their health services research accomplishments and knowledge and their experience in research career development. Because reviews are rigorous, considerable methodological detail is important in the narrative of the application. All elements of the application will be considered in the review process. Primary emphasis will be given to the significance, scientific merit, and feasibility of the project. Applications may be subject to triage to determine their scientific merit relative to other applications received in response to this RFA. The AHCPR will withdraw from further competition those applications judged by triage to be noncompetitive for award and notify the Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Review results and funding decisions will be announced approximately six months after the submission date. Special review criteria, funding decisions, and continuation of support are described below. Applications will be evaluated in accordance with the criteria stated above for scientific/technical merit and the special review criteria listed below by an appropriate AHCPR peer review group. Special Review Criteria Applications are reviewed to determine their suitability in four major areas: problem or policy significance, research design, investigator's qualifications and support structure, and budgetary appropriateness. Problem Significance o The project is focused on a significant problem or policy in the delivery of health care. o The methodology or anticipated results of the project have national interest, provide a basis for generalized conclusions, or have important practical applicability. Research Design o The problem to be addressed by the research is clearly defined. o The application reflects an adequate knowledge of other research related to the problem. o Questions to be answered or hypotheses to be tested are well formulated and clearly stated. o Research methodology is fully described, including, where applicable, explanation of sampling procedures, description of types and sources of data to be gathered, discussion of methodological problems expected to be encountered, and description of specific analyses to be undertaken. o The application adequately describes the plans for managing the project, including a tentative schedule for the main steps of the investigation within the project period requested. Investigator's Qualifications and Support Structure o The applicant shows promise as a health services research investigator. o The applicant's experience and training are sufficient to carry out the research. o The available facilities and organizational arrangements are appropriate to the research. o Faculty advice, composition of dissertation committee, and support are suitable to the research being undertaken, as evidenced by the letter of support. Budgetary Appropriateness o The allocation of time and money reflects an understanding of the research tasks to be accomplished and of the problems likely to arise. o Where appropriate and feasible, the proposed approach uses data available or being collected through government and other sources. AWARD CRITERIA Applications will compete for available funds with all other applications for this RFA. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, and availability of funds. The earliest anticipated date of award for applications will be August 1, 1995. INQUIRIES Those considering applying in response to this RFA are strongly encouraged to discuss their project with AHCPR program administrators before formal submission. The AHCPR welcomes the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues, including suitability of their research topics and information on the policy of inclusion of women and minorities in study populations, to: Julius Pellegrino, Dissertation Program Coordinator Center for General Health Services Extramural Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 502 Rockville, MD 20852 Telephone: (301) 594-1357 ext.138 Direct inquiries regarding fiscal and administrative matters to: Ralph L. Sloat, Grants Management Officer Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1447 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.226. Awards are made under authorization of the Public Health Service Act, Title IX and Section 1142 of the Social Security Act. Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR Part 67, Subpart A, and 45 CFR Part 74 (45 CFR Part 92 for State and local governments). This program is not subject to the intergovernmental review requirements of Executive Order 12372. From owner-sci-resources@net.bio.net Sat Aug 20 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-94-029 - V23(31) 08/19/94 Date: 21 Aug 1994 08:33:50 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 979 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <337s4u$imt@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA94029 CA-94-029 P1O1 *************************************** PLANNING GRANTS FOR PROSPECTIVE CANCER CENTERS NIH GUIDE, Volume 23, Number 31, August 19, 1994 RFA: CA-94-029 P.T. 34; K.W. 0715035, 0710030 National Cancer Institute Letter of Intent Receipt Date: September 29, 1994 Application Receipt Date: November 29, 1994 PURPOSE The Cancer Centers Branch (CCB), Division of Cancer Biology, Diagnosis and Centers (DCBDC), National Cancer Institute (NCI) announces the availability of planning and development grants for cancer centers in underrepresented areas of the nation. This initiative provides applicant institutions with the opportunity to either initiate or continue their planning and development activities toward this goal. The overall intent of these grants is to further assist eligible institutions to develop the organizational capability that will lead to the formation and/or development of cancer research centers. The ultimate goal of this Request for Applications (RFA) initiative is to encourage the development of cancer research centers in geographic areas that are currently not served by existing NCI-designated clinical or comprehensive cancer centers. In addition to basic cancer research, these new centers should plan to emphasize clinical and prevention/control research that will ultimately impact on the populations in their regions, paying particular attention to minority, rural, and other underserved populations. It is anticipated that after completion of these planning and development grants, recipient institutions will be in a position to compete for Cancer Center Support Grants (CCSG) from the NCI. 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, Planning Grants for Prospective Cancer Centers, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by the following institutions: 1) Domestic medical research organizations, public and private such as universities, that fulfill the following requirements and that do not currently have a Cancer Center Support Grant (CCSG) (P30) Planning Grant for Prospective Cancer Centers and (P20); 2) Institutions that currently hold a P20 Planning Grant for Prospective Cancer Centers, but have not yet developed their research base to be eligible to apply for a CCSG. Applicant institutions must intend to develop cancer research centers that, define at a minimum, will have a strong basic research and clinical research foundation, and will develop or include prevention and control research in their long-term objectives. Eligible institutions must come from states that do not currently have an NCI-designated Comprehensive, Clinical, or Consortium Cancer Center. The NCI will also consider accepting applications from other institutions if they are located outside of the regional service area of an existing Comprehensive, or Clinical Cancer Center. In addition, eligible institutions must have three or more externally funded, peer-reviewed, cancer research project grants or contracts (e.g., R01, P01, N01, U01), or equivalent types of research projects. The Cancer Centers Branch in its 1992 "Guidelines for Cancer Center Support Grant," established the bases for identifying funded peer-reviewed cancer research projects. This is the standard that will be followed in determining eligibility of institutions to apply for a planning grant. Eligible institutions may request up to three years of support under a planning and development grant to develop the institutional capability to form a successful cancer research center of excellence. Institutions that already have a fully established organizational capability as a cancer center and a sufficient peer-reviewed cancer research base of $1.5 million dollars or greater in cancer specific research (See 1992 "Guidelines for Cancer Center Support Grants") are not eligible under this program. Potential applicants are strongly advised to contact NCI program staff listed under INQUIRIES , to discuss eligibility requirements prior to preparing an application. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) exploratory grant mechanism (P20). Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in the RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH 90-50,000, revised October 1, 1990) This RFA is a one-time solicitation. The earliest feasible start date for the initial awards will be July 1, 1995. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. FUNDS AVAILABLE Approximately $750,000 in total costs per year will be committed specifically to fund applications submitted in response to this RFA, but no single institution may apply for more than $175,000 in direct costs (See Review Criteria). It is anticipated that three to five awards will be made. This funding level is dependent on the receipt of a sufficient number of applications of high merit. The total project period for applications submitted in response to the present RFA may not exceed three years. RESEARCH OBJECTIVES Background The Cancer Centers Program was developed in the late 1960s and was formally authorized by the National Cancer Act of 1971. The language of the Congress indicated that the NCI should develop an expanded Cancer Centers Program of both comprehensive and specialized types that would "be expected to perform fundamental research in clinical and basic science disciplines; take the lead in planning and coordinating organ site programs; develop the special competence of each individual center; serve as focal points for testing and evaluating outputs of the research and development efforts; and couple the output of the cancer research efforts to medical practice." In the last ten years, legislative language has repeatedly stressed the need for cancer centers to develop research compatibility in the area of prevention and control. The Cancer Centers Program of the NCI currently supports multidisciplinary cancer research centers in a variety of institutions through Cancer Center Support Grants using the P30 grant mechanism. These NCI-designated cancer centers are responsible for implementing a major portion of the National Cancer Program in all aspects of cancer research, including basic, clinical, control, and prevention. These research activities favorably impact on the cancer treatment, control, prevention, and other adjunct service functions that are associated with clinical and comprehensive cancer centers. NCI-designated Cancer Centers provide the national standards of excellence in cancer detection, diagnosis, treatment, rehabilitation, prevention, control, and continuing care. Additionally, they serve as major resources for health professionals and the public in their regions. Although the cancer research programs of NCI-designated Cancer Centers are independently funded through a variety of peer-reviewed grants and contracts from NIH and other funding sources, the Cancer Center Support Grant (CCSG) undergirds these research activities by providing core support through partial funding of shared research resources that provide cost-effective access to sophisticated equipment, state-of-the-art technologies, and essential services. The CCSG also supports central administrative expenses, partial salary support for the center's senior leadership and other key research personnel, the recruitment of key new members to the center, and the exploration of new research opportunities. These functions, as well as detailed application information, are described for the Cancer Center Support Grant in "Guidelines: Cancer Center Support Grants (1992)." This document is available from Cancer Centers Branch DCBDC/NCI. To be eligible to apply for a CCSG, a prospective applicant must have a minimum amount of peer reviewed cancer research. (currently, $1,500,000 in direct costs) Since the passage of the National Cancer Act, Congress has emphasized in legislative language the need for better geographic distribution of NCI-designated cancer centers around the U.S. A majority of funded NCI designated Comprehensive, Clinical, and Consortium Cancer Centers are located on the east and west coasts and around the Great Lakes, which reflects both the U.S. population density and the locations of medical research centers. Nonetheless, there are medical institutions existing in currently under-represented areas that have sufficient peer-reviewed cancer research and could provide the base for developing cancer research centers. However, the planning and development process requires a significant investment of institutional resources; this may have prevented some institutions from exploring the possibility of forming a new cancer center. This RFA, like the previous RFA (RFA CA-91-15) published in 1991, is designed to encourage qualified institutions to make the investment necessary to establish a cancer research center. Detailed planning and development is crucial to the formation of a new cancer research center with a broad range of research capabilities (i.e., basic, clinical, and prevention and control research). Since a new cancer center must be an entity that has its own distinct administrative identity and a measure of autonomy, it may need to be 'created' within the parent institution, which is often a complex process. The goals of the new center must be clearly defined. Space and personnel must be dedicated to the cancer center. The center must have distinct multidisciplinary and interdisciplinary cancer research programs. These programs may need to be developed and members recruited from within and outside the parent institution. In addition, specific central research resources must be identified for inclusion or development as part of the cancer center. Finally, the parent institution must give tangible support to the new center. These planning elements are based on the recognized essential characteristics of a cancer center as described in the CCSG guidelines mentioned above. The essential characteristics of cancer centers include: (a) adequate commitment of the parent institution that recognizes the center as a major organizational element of the institution; (b) appropriate and adequate organization; (c) availability and configuration of facilities devoted to the cancer center to facilitate the research and other activities of the center; (d) a qualified and effective director with adequate authority over appointments, space, equipment, and identifiable clinical research facilities to ensure smooth and effective coordination; (e) clear cancer research focus and intent; and (f) coordination of interdisciplinary and translational research activities. The intent of this RFA is to provide support to new institutions that need time and resources to develop their centers in order to meet the essential characteristics of an NCI-designated cancer center and/or to expand their research base. A successful implementation of this RFA will allow a larger proportion of the U.S. population to have direct access to the most up-to-date cancer research, education, and care through these regional research centers of excellence. Goals and Scope The primary goal of this RFA is to provide support to those institutions that wish to develop the organizational capability that will lead to the formation and/or development of new centers of cancer research excellence in underrepresented geographic areas in the United States. Applicants must demonstrate their potential and/or actual progress toward fulfilling the essential characteristics and obtaining the required research base. Ultimately, the development of these centers should provide wider access of regional populations to the benefits of state-of-the art clinical and prevention and control research. It is anticipated that these new centers, after completion of the planning and development effort, will be in a position to compete for NCI cancer center designation through submission of a CCSG application. The Planning and Development Process A. Definition of the planning and development effort The planning process involves identification of and the proposed methods for achieving, goals and objectives that together will provide the research capability, the organizational structure, financing, and facilities needed for the cancer center. These objectives should take into account the following considerations: 1. The identification of the special problems that need to be resolved in order to develop a competitive cancer research center. Plans and contingencies should be noted. 2. The overall objectives and purposes of the parent institution. The development of a cancer research center should be compatible with the long-term goals and objectives of the parent institution and its leadership. 3. The identification of the specialized needs of the institution's geographic area and its populations that can be addressed through research. The special needs of the center's region or service population, especially as they relate to cancer incidence, mortality, and survival must be strongly considered in the development of research programs. Research programs are included in a CCSG application. These same considerations influence the development of the education, outreach, and service programs of the center. Such programs are not included for support in a CCSG application, but are clearly a significant aspect of any cancer center desiring to have an impact on its region. 4. The effect that the establishment of a cancer-oriented center will have on the internal structure or organization of an institution. Cancer centers must actively promote multidisciplinary research and service activities which transcend and work effectively across traditional academic departments and disciplines. Consideration of the administration and organization of the center and its relationship to other organizational elements within the parent institution is critical to the planning process as are scientific, clinical, and technical considerations. For example, the center, to be effective, should have its own administrative identity within the parent institution and should have, at a minimum, equivalent status to academic departments. 5. The level of commitment and resources the parent institution can provide a new cancer center. The development of a cancer center requires substantial institutional investment in areas such as facilities, staff, administrative reorganizations, and financial resources. A realistic view of the potential resources that could be made available on a regular, stable basis to the new center is needed if the goals and objectives of the institution are to be achieved. 6. Definition of the interactive and translational research activities to be included in the new center is at the heart of the cancer center concept. Multidisciplinary research 'programs' must be defined in terms of the current research activities and new research activities that must be added to the center in order to give it greater balance and effectiveness. However, the center must also consider how it will capitalize on its unique capabilities and opportunities. The usual structural elements of the cancer research activities at a center include multi-disciplinary research 'programs,' shared resources for peer-reviewed research, and administrative support services. 7. The relevance of the center to the mission of the National Cancer Institute. All of the above must be considered with respect to how the planned activities of the cancer center are compatible with the mission of the NCI. B. Elements of a planning and development effort The following elements are essential in the planning and subsequent development of a cancer center: 1. Planning director. A senior level person competent in scientific administration must be assigned the responsibility for directing the planning and development effort. This person must devote a significant proportion of his/her time to this endeavor. The planning director will be the Principal Investigator of the planning and development grant. It is both customary and desirable that the planning director be the director of the new center. 2. Planning and advisory committees. An internal planning committee must assist the planning director. Committee members should be selected from within the institution that is developing the center. Additional members from the community can also be selected where appropriate. This committee is responsible for evaluating scientific, medical, institutional, and regional considerations and should ensure that all available resources and research opportunities are considered in the planning process. It may be advisable for all elements of the institution affected by the center to be represented on this committee. In addition, an external advisory group, consisting of senior individuals who can contribute to or are familiar with the functions and organization of NCI-designated cancer centers, should be convened periodically to give the planning director insightful advice on the development of a cancer research center as well as unbiased and independent assessments of the new center's progress in achieving its objectives and goals. 3. Research program definition and implementation. The cancer research programs that will comprise the cancer center should be defined in terms of their leadership, relevance to the cancer problem, productivity, individual membership (present and future), peer-reviewed grant/contract research base, space needs and utilization, and availability of patient resources for clinical research (if applicable). The research programs must be multidisciplinary in nature and may focus on basic, clinical, and prevention and control investigations. They should build on the current strengths of the institution. Their definition and its subsequent implementation must also include consideration of local, regional, and national needs. 4. Shared resources. It is important to identify and establish shared resources that will best support the peer-reviewed research projects of the center programs. 5. Definition of the relationship of research activities to patient care, education, and other outreach activities of the center. The relationship between the center's research activities and the patient care, education (both professional and lay), community outreach, and other activities of the center must be defined. Mechanisms must be developed so that the results of cancer research performed at the center and elsewhere can impact quickly and positively on the populations served by the center in its geographic area. Such translational activities are a fundamental aspect of a cancer center. 6. Description of the use of developmental funds. Developmental funds can serve to stimulate the planning and implementation of the center through careful allocation of "seed monies" or recruitment monies in areas of particular need or importance to the center. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research 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 Guide for Inclusion of Women and Minorities in Clinical Research", which have been published in the Federal Register of March 28, 1994 (59 FR 14508-14513), to correct typesetting errors in the earlier publication, and reprinted in the NIH Guide for Grants and Contracts on March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from the sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are requested to submit, by September 29, 1994, a letter of intent that includes a descriptive title of the proposed cancer center, the name, address, and telephone/fax number of the planning director, the names of other key personnel, the participating institutions, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, it is requested in order to provide an indication of the number and scope of applications to be reviewed. This advance information provides you with an opportunity to work with NCI program staff with regard to the policies and guidelines of the Cancer Centers Program before you submit your application and ensures that the NCI review staff will have the lead time to assemble highly qualified group of peer-reviewers. Prospective applicants are strongly encouraged to contact the NCI staff listed below before the submission of a letter of intent and/or an application. Such contact is advantageous to the prospective applicant because it will start a dialogue with the NCI staff where issues such as eligibility requirements and application procedures may be discussed. The letter of intent is to be sent to J. Blanche O'Neill at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, 5333 Westbard Avenue, Bethesda, MD 20892, telephone 301/594-7248; and from the NCI Program Director listed under INQUIRIES. Before submitting the application, affix the RFA label in the application form PHS 398 to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title must by typed on line 2a of the face page of the application form. Submit a signed, typewritten original of the application (without appendices), including Checklist, and three signed, exact, clear, and single-sided photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, send two additional copies of the application to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Rockville, MD 20852 (If hand-delivered or delivery service) Bethesda, MD 20892-7148 (If using U.S. Postal Service) It is important to send these copies at the same time the original and three copies are sent to DRG; otherwise, the NCI cannot guarantee that the application will be reviewed in competition with other applications received on or before the designated receipt date. Appendix materials should be retained by the applicant until specifically requested by NCI staff. Five copies of the appendices will be requested. Applications must be received by November 29, 1994. If an application is received after that date, it will be returned. If the application submitted in response to this RFA is substantially similar to another grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Complete information about the proposed planning and development effort must be submitted with the application. Follow the instructions in form PHS 398 where appropriate. However, the form PHS 398 was developed for research grant applications. To provide the required information, the following supplemental instructions must be used to prepare the application. It is also advisable for the prospective applicant to examine the review criteria for these applications, described in the section "Review Criteria," below. The narrative portions of the application, sections I, II, III described below, must be limited to fifty pages of text or it will be returned without any further action. The application must be a complete document that includes all essential information necessary for its evaluation. Additional explanatory material may be submitted as appendices. There is no page limitation on appendices. However, appendices should not be used to bypass page limitations in the application because only selected reviewers will receive copies of the appendices. The application should be prepared using the standard PHS 398. List the planning director as the Principal Investigator of the application. The planning director should be the primary author of the application. The application should contain the following elements: Narrative Descriptions and Supporting Documents Include the following sections on the form PHS 398 continuation pages: Section I. THE NEW CENTER AND THE PROPOSED PLANNING AND DEVELOPMENT EFFORT: (A) Description of the current or planned cancer center. Discuss the institution's concept of a cancer center. List and discuss proposed short-term and long-term goals and objectives of the center. These goals must include cancer research objectives (such as basic, clinical, and/or prevention research) appropriate for the institution as well as goals designed to translate the results of the research into improved patient care, prevention, control, education/ information, and other activities of the center. This discussion must include references to the proposed relationship between the center's research activities and its goals for its community and geographic region, making special reference to opportunities related to minority and other special populations (see Section III below). The special significance of the new cancer center to the institution and its relationship to other existing centers or comparable entities should be addressed. Also, the relationship of the center to other existing programs funded by the NCI in its region should be discussed (see Section III for examples). (B) Description and discussion of progress to date toward attaining the goals and objectives of the center. Discuss the history of the new center and its current strengths. Describe the evolution of the relationship between the parent institution and the center. Describe the benefits the local community and region have received or will receive from the center. Discuss the level of progress that has been made toward achieving the short- and long-term goals of the center. Discuss whether the center is at a preliminary or advanced stage of development in terms of its eligibility to apply for a CCSG grant. (See 1992 "Guidelines for Cancer Center Support Grants"). (C) Description of the Planning Director and his/her responsibilities and authority to carry out the proposed planning and development process. Discuss the selection of this individual as planning director and his/her future role in the center. If the planning director is not the current center director or the director designate of a new center, discuss the status of the institution's search for a permanent director. The planning director is considered to be the pivotal person responsible for implementing the planning and development effort. It is essential that this section adequately present his/her scientific qualifications and administrative experience as well as the formal authorities of the planning director that will enable him/her to guide the formation and development of a new center during its formative stage. (D) Description of planning and advisory committees. List the membership of the internal planning committee and the center director's external advisory committee. Discuss the selections for the committees. Each of these advisory groups will have different, but important, roles in the development of the center. Thus, it is critical that their duties and responsibilities be clearly described in the application. (E) Description of other key personnel and their duties. Discuss the selection and duties of the key personnel for the planning effort. Describe the key personnel's current positions in the parent institution. Describe their role in the planning and development process and their current/future responsibilities in the cancer center. (F) Description of issues at the parent institution that will need to be resolved through the planning and development process. Discuss the major issues and obstacles that must be considered in the planning and development process. Examples of such issues are an adequate cancer research base and implementation of the six essential characteristics of a cancer center (see (H) below and/or the CCSG guidelines). (G) Describe how award of this planning and development grant to your institution will help resolve the issues listed in (F) above and aid in the development of the center. Describe how other institutional resources will be combined with the planning grant to achieve overall objectives. (H) Detailed description of the planning and development proposed. Include, where appropriate, discussions of plans to: 1. attain the necessary peer-reviewed cancer research base relative to the current research base; 2. implement the essential characteristics of cancer centers: a. institutional commitment, b. appropriate organizational capability c. appropriate facilities, d. center director with adequate authority, e. a cancer research focus and f. interdisciplinary coordination and collaboration; 3. identify multidisciplinary basic, clinical, and prevention and control research programs that are or would be included in the center; 4. identify appropriate staff from the parent institution for center membership and areas where additional recruitment is necessary; 5. identify shared research resources for inclusion or development by the center and the research capability of the center; 6. address the efforts needed to develop appropriate long-term, productive relationships with the parent institution and with departments and/or other centers within the institution. Section II. THE PARENT INSTITUTION'S RESEARCH BASE, ENVIRONMENT, AND RESOURCES: (A) Current cancer research activities and publications. Discuss whether all peer-reviewed cancer research projects located at the parent institution (listed in Section IV (B) below) will be associated with the cancer center. If not, explain. Describe plans to expand the peer-reviewed grant/contract base. (B) Description of the parent institution. Discuss the environment of the parent institution and its suitability for attracting appropriate research expertise. Describe the institutional officials who will be associated with and support the proposed center and the planning effort, the experience of the institution with developing similar centers or programs, and the effect that the new cancer center will have on other programs and centers at the institution. Include discussions of the history of cancer research activities, access to appropriate patient and client populations, special programs to include women and minorities in clinical trials, local referral patterns, community interactions, financial resources, appropriate current or proposed facilities, and organizational capabilities. (C) Description of the resources that will be allocated by the institution to the new center during and after the proposed planning and development effort. Discuss the space, personnel, administrative, financial, and other resources that have been allocated and are planned to be allocated to the new or developing center. For example, the applicant may describe institutional payment of part of the salaries of staff involved in the planning effort, seed money to help start new cancer research projects or new shared resources, and funds for the recruitment of new scientific and support staff for the center. Section III. THE IMPACT OF THE NEW CENTER ON ITS GEOGRAPHIC AREA AND ITS POPULATIONS: (A) Description of the parent institution's current relationship to and recognition within its geographic area. Discuss the resources related to cancer that the institution currently provides to its region. (B) Discussion of the need in the institution's geographic area for an NCI-designated cancer center. Discuss how the region is underserved from the perspective of the linkage of high quality cancer research with patient care, prevention, control, and other activities. Describe the potential impact of the new center on its region. Discuss how new research programs initiated through the center would ultimately benefit the populations in its area. Discuss special problems of the region as they relate to higher incidence and mortality rates of certain cancers and to special populations and minorities. Describe how the potential cancer center can address these problems through its research programs. (C) Description of the potential relevance of the new center to other programs of the NCI that already exist or could be implemented in its region. Examples of such programs are national cooperative groups, cancer information service (CIS), drug discovery groups, and the community clinical oncology program (CCOP). Section IV. ESSENTIAL SUPPORTING DOCUMENTS: (A) Biographical sketches of the planning director and other key personnel. Use forms provided in the form PHS 398. These sketches are limited to two pages. (B) Peer-Reviewed Research Grants and Contracts. This is a list of the research base of the center and additional to page GG of the PHS 398 form. List the currently active, peer-reviewed, research grants and contracts that will be included as the existing research base of the center at the parent institution. The Cancer Centers Branch has defined peer-reviewed cancer research projects in the 1992 "Guidelines for Cancer Center Support Grants." Each entry for a peer-reviewed research project on the list should include the Principal Investigator, his/her percent effort on the project, funding agency, I.D. number, title, total grant period, and current year's direct cost award. Other sources of support that contribute to the overall research capability of the center (e.g., cancer development awards, training grants) may be listed. This must be a separate listing. (C) Bibliography. Provide a bibliography of cancer research publications from the parent institution during the previous three years. (D) Letters or statements from senior officials of the parent institution documenting their support for the proposed planning and development process. These documents must include a description of substantive actions by the parent institution to promote the development of a center, e.g., the commitment of space and funds, recruitment packages, funds to the programs, as well as substantive authority to the planning director, who will provide scientific and administrative leadership during the planning period. B. Allowable Budget Items Allowable budget items for these planning and development grants are limited to a portion of the salaries of the planning director (Principal Investigator), key scientific personnel, administrative and clerical support personnel, travel and per diem expenses for outside advisors (the use of commercial consultants is discouraged), supplies, travel expenses for the planning director or other key personnel, and other justifiable operating expenses of the planning effort. The level of effort of personnel on this grant should reflect the commitment of the individual to the planning and development process although the salaries may be paid in part from other sources (these other sources must be described). In addition, developmental funds may be requested up to a maximum level of $35,000/year. If developmental funds are requested, it must be entered in the composite budget on page 4 of the PHS 398 form as a line item under other expenses. A detailed budget for the potential uses of developmental funds must be provided on a separate budget page and fully justified. These developmental funds may be used by the planning director to help recruit new scientific staff to the center, to support pilot studies that will help expand the peer-reviewed research base of the center, and to initiate new shared resources that will be needed by the center. Developmental funds may not be used for major equipment purchases. All budget items must be justified in terms of their support of the planning and development process. Budget requests for applications submitted under this RFA must not exceed $175,000 direct costs per year. In addition, unless otherwise noted, allowable costs and policies governing the research grant program of the NIH will prevail. Overlapping support between the planning and development grant and other NIH grants and contracts to the applicant institution will be administratively reviewed and, if appropriate, adjustments will be made to avoid duplication of funding. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG staff and responsiveness by NCI staff. Incomplete and non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer-review group convened by the NCI in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. Questions concerning the relevance of proposed work to the RFA may be directed to program staff listed under INQUIRIES. The second level of review will be performed by the National Cancer Advisory Board. This Board considers the special needs of the NCI and the priorities of the National Cancer Program. Review Criteria Applications will be assessed in three general areas: (1) the technical merit of the proposed planning and development process; (2) the institutional commitment and environment; and (3) the potential of the proposed center to enhance its impact on the quality of patient care, prevention, control, and related activities in its geographic area. Peer- reviewers will be asked to specifically comment on these three areas. An unacceptable evaluation in any one of these review categories can be grounds for Not Recommended For Further Consideration of the application. The final priority scores will reflect the peer-reviewers' overall assessment based on their judgements of the three review areas. Below are the specific criteria that will be used by the peer-review group in the evaluation of these three major areas. 1. The technical merit of the proposed planning and development process. If the application is a renewal, the application should stress the progress that has been made during the past grant period, making specific reference to the previous summary statement as needed. If the application is new, emphasis should be placed on the potential for these investigators and the proposed activities to form a viable center. a. Clarity and appropriateness of the goals and objectives of the new or proposed cancer center; the extent to which the proposed concept of a cancer center is consistent with the concept of cancer centers as illustrated by the 1992 "Guidelines for Cancer Center Support Grants"; b. Extent to which the application appropriately defines the problems that need to be resolved to achieve the formation or development of a center of cancer research excellence; c. Extent to which the proposed detailed planning and development effort has clear and appropriate plans and is of adequate scope with regard to important issues including: (1) Adequacy of the peer-reviewed cancer research base; identification with the parent institution of independent investigators in basic, clinical, prevention, and control research who will be important in providing the leadership necessary to develop multidisciplinary cancer research programs; identification of shared resources that will be important for multidisciplinary research programs for inclusion or development in the center; (2) Progress toward implementing or the potential to implement the six essential characteristics of a cancer center: institutional commitment, organizational capabilities, adequate facilities, center director with adequate authority, progress toward and potential for developing an appropriate cancer research focus, and interdisciplinary coordination; (3) Progress and/or plans to develop the appropriate leadership, stable research infrastructure, and administrative capacity within the parent institution, paying special attention to the status of the cancer center relative to other organizational components (e.g., departments, other centers); d. Qualifications of the proposed planning director to lead the planning and development effort, his/her leadership experience and scientific background, and the adequacy of the director's authority from the institution with respect to recruitment, staff appointments and promotions, space allocation, fiscal and administrative responsibilities, and review and direction of the planning effort; e. Potential effectiveness of the planning director's external advisory committee in assisting the director in planning the center; the appropriateness of the proposed membership and stated functions of this advisory group; f. Appropriateness of the membership and stated functions of the proposed internal planning committee to assist the director in the planning and development effort; g. Qualifications and appropriateness of the key personnel designated to assist the planning director; the potential of listed key personnel to become senior leaders or major program leaders in the new center; h. Adequacy of the applicant's consideration and assessment of such factors as the utilization and need for space, staff recruitment, availability of patients for research, patient referral patterns in the community, and financial planning; i. Current level of progress of the new or proposed center toward realization of its objectives; if the applicant is at an advanced stage of development, consideration should be given to whether a planning and development grant is appropriate or whether the applicant should directly apply for a CCSG. 2. Institutional commitment and environment. If the application is a renewal, the applicants should stress the progress that has been made during the past grant period; making specific reference to the previous Summary Statement as needed. If the application is new, emphasis should be placed on the potential for these investigators and the proposed activities to form a viable center. a. Adequacy of the institution's commitment to cancer research; include an evaluation of the plans to expand the peer-reviewed cancer research grant/contract funding base through appropriate recruitment, encouragement of existing faculty, and other appropriate measures; b. Evidence for a substantial institutional commitment to the cancer center planning and development effort in terms of space, personnel, organizational, and financial resources that have been allocated to the effort; c. Adequacy of the administrative, organizational, and management capabilities and the facilities of the applicant institution; and d. Adequacy of the environment of the applicant institution with regard to its ability to recruit qualified scientists that will enhance the center's multidisciplinary research capability, the track record of the institution in developing similar programs in other fields, if any, the potential for adequate continuity of institutional commitment for the center, and the potential effect of the new cancer center on other programs within the institution. 3. The potential of the proposed center to enhance the level of cancer research in its region and, ultimately, to enhance the impact of that research on the quality of patient care, prevention and control, and related activities in its geographic area. If the application is a renewal, the applicants should stress the progress that has been made during the past grant period; making specific reference to the previous Summary Statement as needed. If the application is new, emphasis should be placed on the potential for these investigators and the proposed activities to form a viable center. a. Extent to which the institution's geographic area is underserved by high quality cancer research that is effectively linked to patient care, prevention, control, and other activities; the role in cancer already played by the institution within its community and region; b. Proposed role and potential impact of the new cancer center in its geographic area; a demonstrated understanding of the cancer incidence and mortality rates in the region, especially with regard to minorities and special populations; the adequacy of proposed mechanisms to move the results of research into improvements of cancer treatment, prevention, control, education, and other activities that will benefit the center's local community and region. c. Potential relevance of the new center to other NCI programs (e.g., national cooperative groups, cancer information service, and the community cancer oncology program) that already exist or could be implemented in its geographic area; d. Extent to which award of a planning and evaluation grant will enhance the ability of the institution to form and/or develop a cancer center that will benefit its region; In the overall evaluation, the appropriateness of the proposed multi-year planning and development effort to allow the new cancer center to reach a level of excellence that would be comparable to current NCI-designated cancer centers will be considered. The review group will recommend an appropriate budget for each rated application. Requests for equipment and commercial consultants are discouraged and, if present in an application, such requests will be highly scrutinized. AWARD CRITERIA The anticipated date of award is August 1, 1995. Grant applications recommended for approval by the National Cancer Advisory Board and selected for funding will be negotiated by the NCI staff with the applicant institution. A Notice of Grant Award will summarize the results of the negotiations. Award of funds for the approved future years of the grant will require the submission of a noncompeting continuation application, form PHS 2590 (rev. 10/88) at least two months prior to the anniversary date of the award. As with research grants, interim and terminal progress reports must be submitted to the NCI in accordance with the current PHS Grants Policy Statement. The interim progress reports will be a part of the non- competing continuation application and should include the following information: (a) a brief statement and critique of progress toward achieving originally stated objectives; (b) a description or listing of related issues, positive or negative, considered to be significant by the planning director; and (c) plans for the next funding period. Terminal progress reports must be submitted within 90 days after the end of the project and should include items (a) and (b) above. INQUIRIES Written and telephone inquiries concerning the objectives, scope, application procedures, and allowable budget items for this RFA and inquiries about whether specific applications would be responsive are encouraged and must be directed to the Cancer Centers Branch, NCI, program officer listed below. The Branch staff welcomes the opportunity to clarify any issues or questions from potential applicants. In addition, questions of a more administrative nature not directly related to the programmatic aspects of this RFA may be directed to the Grants Administration Branch official, also listed below. J. Blanche O'Neill Division of Cancer Biology, Diagnosis and Centers National Cancer Institute Executive Plaza North, Room 502 Bethesda, MD 20892 Telephone: (301) 496-8531 Crystal Wolfrey Grants Administration Branch National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 282 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.397. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Aug 26 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: UNSUBSCRIBING, BIOSCI ARCHIVES, ADDRESS DATABASE & BIOSCI FAQ Date: 26 Aug 1994 21:18:14 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 322 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <33meq6$2t8@net.bio.net> NNTP-Posting-Host: net.bio.net Four important items follow: How to cancel e-mail subscriptions to BIOSCI newsgroups, BIOSCI archive searching, the BIOSCI FAQ, and the BIOSCI User Address Directory form. If you have not yet listed yourself in our BIOSCI user directory, please take a few minutes to complete and return the form below. If your personal information has changed since you listed yourself, please send us a complete new updated form. We can not make manual revisions to existing entries. Sincerely, Dave Kristofferson BIOSCI/bionet Manager biosci-help@net.bio.net **** How to cancel a BIOSCI e-mail subscription **** If you want to cancel your e-mail subscription to this group, PLEASE DO NOT POST YOUR UNSUBSCRIBE REQUEST TO THE NEWSGROUP ADDRESS (NOR REPLY TO A MESSAGE POSTED TO THE NEWSGROUP)!!! This would send your request to all of the readers of the newsgroup, but it might still not be seen by the BIOSCI staff - thus you would annoy many people and possibly not accomplish your goal anyway. IF YOU ARE LOCATED IN THE AMERICAS OR PACIFIC RIM COUNTRIES, please send a message to biosci@net.bio.net Instructions will be returned automatically, so the contents of your message do not matter. IF YOU ARE LOCATED IN EUROPE, AFRICA OR CENTRAL ASIA, please send a message to MXT@dl.ac.uk containing the word help in the body of the message to retrieve e-mail server instructions. Any text placed on the Subject: line of your message will be ignored, so be sure to put the "help" command in the body of the message. If you need personal assistance, a BIOSCI staff member can be contacted at either of the following addresses. Please contact the address designated for your location. Support Address Location --------------- -------- biosci@daresbury.ac.uk Europe, Africa, and Central Asia biosci-help@net.bio.net Americas and the Pacific Rim **** SEARCHING BIOSCI ARCHIVES **** The easiest way to search the BIOSCI archives is to use gopher software and connect over the Internet to net.bio.net, the U.S. BIOSCI computer. We maintain three indexes which are searchable from the main gopher menu on net.bio.net: (1) an index of all BIOSCI postings; (2) an index of individual journal article references from the Table of Contents postings on the BIO-JOURNALS newsgroup; and (3) an index of BIOSCI users including regular mail and e-mail addresses, phone/FAX numbers, research interests, and newsgroup participation. E-mail users can search the BIOSCI archives by using our waismail e-mail server. For instructions send the message help to waismail@net.bio.net. Leave the Subject: line blank (anything entered on the Subject: line is ignored). WAIS software can also be used to search the archives as described in the BIOSCI FAQ (see below). Finally, the BIOSCI archive files are accessible by anonymous FTP to net.bio.net [134.172.2.69] in the directory pub/BIOSCI. **** BIOSCI FREQUENTLY ASKED QUESTIONS (FAQ) SHEET **** New users of BIOSCI/bionet may want to read the "Frequently Asked Questions" or "FAQ" sheet for BIOSCI. The FAQ provides details on how to participate in these forums and is available for anonymous FTP from net.bio.net [134.172.2.69] in pub/BIOSCI/doc/biosci.FAQ or for retrieval by gopher to net.bio.net, port 70. It may also be requested by sending the command info faq in the body of an e-mail message to the Internet address biosci-server@net.bio.net. Please do not enter the info faq command on the Subject: line of your message since the e-mail server ignores text on the Subject: line. The FAQ is also posted on the first of each month to the newsgroup BIONEWS/bionet.announce immediately following the posting of the BIOSCI information sheet. **** BIOSCI USER ADDRESS DIRECTORY **** Please take this opportunity to add your name and address information to the BIOSCI User Address Database if you have not already done so. Below is the address form that we would like each reader of the BIOSCI/bionet newsgroups to complete and return if you would like to be listed in our database. The database serves as a directory that enables biologists, who are currently using (or even just reading) the BIOSCI newsgroups, to look up e-mail addresses and other information about our users. The address database is reindexed nightly for WAIS, waismail, and gopher access. If you have access to gopher, connect to net.bio.net to search the database. If you have access to WAIS, please use our WAIS source biologists-addresses.src. If you are not on the Internet, please use our waismail server (send the word "help" to waismail@net.bio.net to get instructions; any text on the Subject: line of your message will be ignored, so put the help command in the body of the mail message.). Please carefully follow the instructions for completing the form below and return it to either of the following two addresses (whichever is more convenient for you). Thanks in advance for taking the time to complete and return the form. Addresses for returning forms Location Network ----------------------------- -------- ------- biovote@net.bio.net U.S.A. Internet/BITNET biovote@daresbury.ac.uk U.K. JANET MAKING SURE THAT YOUR INFORMATION IS CURRENT This notice will be mailed bimonthly to each newsgroup. You should check your database entry from time-to-time to see if your address information is still up-to-date. Using Gopher to complete the form --------------------------------- If you don't want to use a text editor, you can also use Dan Jacobson's gopher site to fill out the address database form as follows. Otherwise skip this section on gopher and proceed to the instructions for filling out the form below. > To add yourself to the database just point your > gopher client at merlot.gdb.org and select the following: > > --> 15. Searching For Biologists/ > > --> 9. E-mail Addresses of Biosci-Bionet Users/ > > --> 1. Add (or Correct) Your Address to the BIOSCI User Address > Data.. > > > And fill out the form. or Rob Harper's gopher site in Europe as follows: > Europeans can point their gopher client at gopher.csc.fi and add their > information to the database. All entries will be mailed directly to > Dave for incorporation in a wais source. > > The path to the questionare is as follows. > > ---> 10. Finnish EMBnet BioBox/ > > ---> 8. FAQ Files/ > > FAQ Files > > 1. EMBnet: Information. > 2. EMBnet: Internet resources guide. > 3. A Biologist's Guide to Internet Resources/ > 4. All FAQs (Frequently Asked Questions) Searches and Archives/ > --->5. Bionauts Address Database (questionaire) IMPORTANT INSTRUCTIONS - PLEASE READ CAREFULLY Please enter all responses after the : on each line, leaving one (1) blank space after the : (i.e., before the start of your text). Please do NOT extend your responses past the end of each line (80 characters). PLEASE DO NOT alter any of the field identifiers such as "first name: ". If you have nothing to enter after a field identifier, PLEASE LEAVE IT - do not delete it even if there is no data on the line in question. Several lines are provided at the end of the form for comments, but, please adhere to the line length restriction. On the date: line, please enter the date in the DD-MM-YY format, e.g., 15-05-93 for 15 May 1993. This line will tell others when the information was last updated. Please be sure to include the 0's for single digit days or months, e.g., 15-05-93, not 15-5-93. Note that the "e-mail network: " line below is for specifying, e.g., "Internet," "BITNET," "EARN," "JANET," or whatever other network that your computer may be on. If you are uncertain about any field, please feel free to leave it blank, but please DO NOT DELETE the field identifier from the form! In the first field below, "New information or Update ...", please enter "N" if this is the first time that you have registered in the directory or "U" if you are correcting a listing that you sent to us previously. The comment: lines may be used for anything that you like but PLEASE DO NOT DELETE THEM FROM THE FORM OR ALTER THEM. One suggested use is to list the names of the newsgroups in which you participate. Please use the MAILING LIST name (see below - the latest version of the list can be requested from biosci@net.bio.net) instead of the USENET name even if you don't participate by e-mail. WAIS might get confused by the periods in the USENET names. This allows one to retrieve via WAIS or waismail the list of participants in a particular group. For example: comment: ARABIDOPSIS PLANT-BIOLOGY BIONEWS On the comment: lines use these names below ---- NOT the USENET names below MAILING LIST NAME USENET Newsgroup Name ----------------- --------------------- ACEDB-SOFT bionet.software.acedb AGEING bionet.molbio.ageing AGROFORESTRY bionet.agroforestry ARABIDOPSIS bionet.genome.arabidopsis BIOFORUM bionet.general BIO-INFORMATION-THEORY bionet.info-theory BIONAUTS bionet.users.addresses BIONEWS bionet.announce BIO-JOURNALS bionet.journals.contents BIO-MATRIX bionet.molbio.bio-matrix BIOPHYSICAL-SOCIETY bionet.prof-society.biophysics BIOPHYSICS bionet.biophysics BIO-SOFTWARE bionet.software BIOTHERMOKINETICS bionet.metabolic-reg CELL-BIOLOGY bionet.cellbiol CHLAMYDOMONAS bionet.chlamydomonas CHROMOSOMES bionet.genome.chromosomes COMPUTATIONAL-BIOLOGY bionet.biology.computational CYTONET bionet.cellbiol.cytonet DROSOPHILA bionet.drosophila EMBL-DATABANK bionet.molbio.embldatabank EMPLOYMENT bionet.jobs GDB bionet.molbio.gdb GENBANK-BB bionet.molbio.genbank GENETIC-LINKAGE bionet.molbio.gene-linkage GRASSES-SCIENCE bionet.biology.grasses HIV-MOLECULAR-BIOLOGY bionet.molbio.hiv HUMAN-GENOME-PROGRAM bionet.molbio.genome-program IMMUNOLOGY bionet.immunology INFO-GCG bionet.software.gcg JOURNAL-NOTES bionet.journals.note METHODS-AND-REAGENTS bionet.molbio.methds-reagnts MOLECULAR-EVOLUTION bionet.molbio.evolution MYCOLOGY bionet.mycology NEUROSCIENCE bionet.neuroscience N2-FIXATION bionet.biology.n2-fixation PARASITOLOGY bionet.parasitology PHOTOSYNTHESIS bionet.photosynthesis PLANT-BIOLOGY bionet.plants POPULATION-BIOLOGY bionet.population-bio PROTEIN-ANALYSIS bionet.molbio.proteins PROTEIN-CRYSTALLOGRAPHY bionet.xtallography PROTISTA bionet.protista RAPD bionet.molbio.rapd SCIENCE-RESOURCES bionet.sci-resources STRUCTURAL-NMR bionet.structural-nmr TROPICAL-BIOLOGY bionet.biology.tropical VIROLOGY bionet.virology WOMEN-IN-BIOLOGY bionet.women-in-bio YEAST bionet.molbio.yeast Listing newsgroups on the comment: line is optional, of course. Thanks again for your cooperation! --------------- please cut here and return portion below --------------- New information or Update to old record (enter N or U): date (DD-MM-YY): first name: middle initial: family name: job title: e-mail address: e-mail network: phone number: FAX number: institution: address1: address2: address3: city: state/province: country: postal code: research interest: research interest: comment: comment: comment: comment: comment: From owner-sci-resources@net.bio.net Wed Aug 31 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 28 August 1994 Date: 31 Aug 1994 18:35:22 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 94 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <343b4q$3ba@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Letter Title: NSF 94-115 Division of Earth Sciences Letter File size (bytes): 2487 STIS Filename: nsf94115 Document Type: News Title: TIP40812 - - NSF TIPSHEET - August 12, 1994 File size (bytes): 5040 STIS Filename: tip40812 Title: WHPR943 - PRESIDENT NAMES THIRTY PRESIDENTIAL FACULTY FELLOWS File size (bytes): 4066 STIS Filename: whpr943 Document Type: Program Guideline Title: NSF 94-124 Oceanographic Centers and Facilities Section (OCES) Guidelines File size (bytes): 419 STIS Filename: ns94124a Also available: ns94124a.wp5 Title: NSF 94-124 Oceanographic Centers and Facilities Section (OCES) Guidelines File size (bytes): 419 STIS Filename: ns94124b Also available: ns94124b.wp5 Title: NSF 94-114 Postdoctoral Fellowships in Biosciences Related to the Environment File size (bytes): 285 STIS Filename: nsf94114 Also available: nsf94114.doc Title: NSF 94-120 Scholars Awards in Methodological Training for Cultural Anthropologists File size (bytes): 5392 STIS Filename: nsf94120 Document Type: Recruit Title: Geologist (Associate Program Director) File size (bytes): 5130 STIS Filename: vex9440 ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve vex9440, the text of your message should be as follows: get vex9440 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve vex9440, you would enter: ftp> get vex9440 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Wed Aug 31 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 21 August 1994 Date: 31 Aug 1994 18:43:56 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 62 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <343bks$3lj@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Letter Title: NSF94-111 Mathematical Science Dear Colleague Letter File size (bytes): 2075 STIS Filename: nsf94111 Document Type: Recruit Title: Program Analyst File size (bytes): 6483 STIS Filename: vgs94111 Title: Public Affairs Specialist File size (bytes): 5629 STIS Filename: vgs94112 ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve vgs94112, the text of your message should be as follows: get vgs94112 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve vgs94112, you would enter: ftp> get vgs94112 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Wed Aug 31 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-94-028 - V23(32) 08/26/94 - P1/2 Date: 31 Aug 1994 18:56:42 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1499 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <343ccq$543@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AI94028 AI-94-028 P1O2 *************************************** ADULT AIDS CLINICAL TRIALS GROUPS NIH GUIDE, Volume 23, Number 32, August 26, 1994 RFA: AI-94-028 P.T. 34; K.W. 0715008, 0755015 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: September 15, 1994 Application Receipt Date: January 12, 1995 PURPOSE The Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for cooperative agreement (U01) awards from institutions interested in participating in a cooperative group(s) that will perform Phase I, II, and III clinical evaluations of promising new interventions for the treatment of HIV disease, AIDS, and opportunistic diseases resulting from HIV infection including malignancies and neurologic complications. The institutions will conduct multi-center clinical trials involving adult participants. Each group of collaborating institutions awarded cooperative agreements as a result of this competition will be referred to as an Adult AIDS Clinical Trials Group (ACTG). 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), Adult AIDS Clinical Trial Group, is related to the priority area of HIV infection. 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 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit organizations, public and private organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Applications from minority individuals and women are encouraged; funds are being set-aside for minority institutions (see FUNDS AVAILABLE). Eligible institutions may apply for one or more of the following types of awards: o Adult ACTG Central Group o AIDS Clinical Trials Unit (ACTU) o Statistical and Data Management Center Separate applications must be submitted for each type of award. Each Adult ACTG Central Group applicant must identify a single Statistical and Data Management Center with which it is proposing to work. Each applicant for an ACTU award must identify in a cover letter and in the body of the application the Adult ACTG Central Group with which the applicant ACTU it is proposing to collaborate. Each applicant for a Statistical and Data Management Center must identify both in a cover letter and in the body of the application the Adult ACTG Central Group with which the applicant is proposing to collaborate. (See SPECIAL INSTRUCTIONS FOR THE PREPARATION OF COOPERATIVE AGREEMENT APPLICATIONS, Identification of Potential Applicants and Formation of ACTGs, for further details.) It is the responsibility of potential applicants for an Adult ACTG Central Group award and a Statistical and Data Management Center award, as components of the ACTG, to identify themselves to each other and establish affiliations. The NIAID will facilitate the formation of an ACTG by: (1) identifying potential Adult ACTG Central Group applicants and unaffiliated potential ACTU applicants to each other; and (2) holding a pre-application meeting on September 28, 1994. Each applicant for an Adult ACTG Central Group must demonstrate the ability to recruit and support a minimum capacity of 1,250 new patients per year. Each ACTU applicant must demonstrate the capability to accrue a minimum of 75 new patients per year. It is anticipated that once the AIDS Clinical Trial Units (ACTUs) are selected and the ACTG(s) formed, the combined capacity of the ACTG or ACTGs will allow for accrual of 2,500 to 3,500 new patients per year. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be the cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIAID purpose is to support and/or stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the studies to be funded under these cooperative agreements are discussed later in this document under the section "Terms and Conditions of Award." The total project period for an application submitted in response to the present RFA may not exceed five years. At present, the NIAID is administratively limiting the duration of U01 cooperative agreements to four years; this administrative limitation may change in the future. The anticipated award date is January 1, 1996. 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 NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. This RFA is a recompetition of an ongoing program (the Adult AIDS Clinical Trials Group [ACTG]). Reissuance of this initiative is uncertain. If it is determined that there is sufficient programmatic need for continuation of this program, the NIAID will invite applications for extension of this program. FUNDS AVAILABLE Approximately $60,000,000 total costs will be available in fiscal year 1996 for the first year of support for awards made under this RFA. Of this total, at least $3.5 million will be reserved exclusively to support meritorious clinical trials units (ACTUs) at minority institutions. In Fiscal Year 1996, the NIAID plans to fund one or two ACTG Central Groups, one Statistical and Data Management Center per Central Group, and 22 to 29 ACTUs. Minority institutions are defined as those that have more than 50 percent minority student enrollment and award an M.D., D.D.S., D.V.M or other doctorate degrees in the health professions. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of individual awards will vary. The level of support will be dependent upon the number of applications of high merit received and the availability of funds. Funding beyond the initial budget period at the level awarded in the first year of support will be contingent on the continued availability of funds for this purpose, and the continued progress of the ACTG. RESEARCH OBJECTIVES A. Background The emergence of the AIDS epidemic in the United States has had a major impact on public health, as well as medical, social, and economic institutions in this country. Within the U.S., over 350,000 persons have developed AIDS and over one million Americans are believed to be infected with HIV-1. In addition, it is estimated that 40,000 adults are newly infected with HIV in the U.S. every year. Particularly hard hit by the epidemic are urban centers, where an increasing number of minorities, women, and injection drug users are being infected. One critical goal of the NIAID in the field of AIDS research is the discovery and development of therapies that will improve the quality and duration of life of HIV-infected individuals. While the interests and mission of the pharmaceutical industry and NIAID overlap in the field of applied therapeutics research and development, NIAID's overall responsibility is to focus on those research opportunities of utmost importance to the public health that are not being addressed elsewhere. Considerable strides have already been made in the clinical development of antiretroviral therapies, as well as for the treatment and prophylaxis of a myriad of opportunistic infections that occur in severely immunosuppressed patients with AIDS. Nonetheless, the impact on survival and clinical disease progression of the existing approved antiretroviral therapies is of limited magnitude and duration. Furthermore, the current treatments for some of the opportunistic infections are not always effective, and breakthrough infections occur despite prophylaxis therapies. It is apparent that clinical investigations of new, innovative interventions are crucial in order to make a significant impact on survival and quality of life of the HIV-infected individual. B. Definitions Adult AIDS Clinical Trials Group (ACTG) - A collaborative group of institutions composed of a Central Group, AIDS Clinical Trials Units (ACTUs), and a Statistical and Data Management Center, which together conduct all phases of clinical trials, and laboratory studies. (see Organization of ACTG for description of all component parts.) Each ACTG consists of experienced investigators in multiple disciplines (e.g. infectious diseases, virology, immunology, clinical pharmacology, oncology, neurology, gynecology, and biostatistics). Advanced Technology Laboratory (ATL) - Additional, central laboratory capabilities that enable the ACTG to investigate the feasibility, validity, standardization and implementation of state-of-the-art assays/technologies related to the scientific agenda. Awards for ATLs are made through the ACTG Central Group award. AIDS Clinical Trials Unit (ACTU) - A clinical site that is a member of the collaborating group of institutions comprising the ACTG. The ACTU is required to participate and enroll patients in clinical trials and conduct or obtain protocol mandated laboratory tests. Collaborating Institution - An institution that is an ACTG awardee either as a Central Group, Statistical and Data Management Center, or an ACTU. Cooperative Agreement - An assistance mechanism in which substantial NIAID programmatic involvement with the recipient is anticipated during performance of the planned activity. Data Safety and Monitoring Board - The Data and Safety Monitoring Board (DSMB) is charged with the responsibility of monitoring performance of the trial, the safety of participants, the efficacy of treatments being tested, and to make recommendations to NIAID concerning the continuation, termination or modification of the trial based on observed beneficial or adverse effects of any of the interventions under study. This panel is funded separately by the NIAID. Division of AIDS (DAIDS) - The division within the NIAID that has the primary responsibility for basic and clinical research on AIDS. Executive/Steering Committee - The main governing body of the ACTG that is established and chaired by the Group Leader. This committee will be responsible for making the ultimate decisions on all scientific and operational issues of the ACTG (See Terms and Conditions of Awards). Group Leader - The individual who directs the development and implementation of the research agenda and the organizational structure and governing procedures that form the basis of ACTG operations. The Group Leader is responsible for the leadership and coordination of all ACTG activities both scientifically and administratively, and serves as the Principal Investigator for the ACTG Central Group award. The Group Leader may also be associated with an ACTU. Operations Office - An administrative unit within the ACTG Central Group that will take responsibility for coordinating ACTG activities, including protocol development and distribution, administrative support for the Group Leader and scientific leadership of the ACTG and of scientific and other committees, training sites and monitors; assembly and submission of documents to DAIDS for registration of sites for individual trials; maintenance of ACTG administrative records and archives; planning of two national meetings per year, at least one of which is held in collaboration with the Pediatric ACTG in the Washington metropolitan region; and, in conjunction with the ACTG Statistical and Data Management Center, preparation of administrative reports of ACTG activities as requested by DAIDS. Participant Subunit - An institution supported through a subcontractual agreement with one of the primary, collaborating institutions. A subunit may be established to support the scientific agenda and/or patient accrual goals. All subunits are subject to the same policies and procedures mandated by Federal regulations, DAIDS and NIAID policies and the bylaws of the ACTG. Statistical and Data Management Center - The statistical and data management unit that is responsible to the ACTG for the statistical aspects of study design and data analyses and management. Therapeutic Research Program (TRP) - A program within the DAIDS that is responsible for the scientific, administrative, and operational management of clinical therapeutic research programs funded by the division. C. Organization of an ACTG The ACTG Central Group will consist of: o Principal Investigator (ACTG Group Leader) o Key Scientific and Management Leadership o Operations Office o Resources for Advanced Technology Laboratories o Executive/Steering Committee The Statistical and Data Management Center will consist of: o Principal Investigator o Experts in Statistics, Study Design and Analysis o Data Management Resources and Facilities The AIDS Clinical Trials Units (ACTUs) will consist of: o Principal Investigator o Clinical Facilities and Staff o Clinical Laboratory Facilities and Staff o Study Subjects DAIDS staff, DAIDS contractors (such as those for laboratory quality assurance, clinical site monitoring, and management of virology, immunology, and pharmacology laboratory data) and a Data and Safety Monitoring Board will support the efforts of these awardees. (See Terms and Conditions of Award for specific on the roles and responsibilities of each contributing unit.) D. Functions of an ACTG The activities of an ACTG and its component parts awarded under this RFA are delineated below. (See "Terms and Conditions of Award" for further specifications of selected roles and responsibilities of an Adult ACTG Central Group.) Specifically, an ACTG Central Group will be responsible for: 1. Developing, implementing, monitoring, and updating the ACTG's scientific agenda for therapeutic research consistent with the NIAID HIV\AIDS Therapeutic Research Agenda. 2. Provision of the key scientific and managerial leadership required to carry out the ACTG scientific agenda. 3. Identification of a Statistical and Data Management Center responsible for the statistical aspects of study design, and the collection and analysis of data from the clinical trials conducted by the ACTG. 4. Development and management of an Operations Office that will provide the necessary infrastructure and staff to support the ACTG Group Leader in the management and administration of the ACTG. 5. Organizational structures and management mechanisms for effective communication and collaboration among ACTG components including: committee structure, bylaws, procedures for protocol development and modification, performance evaluation, and monitoring of research progress. 6. Identification, selection and management of Advanced Technology Laboratories (ATLs) that will investigate the feasibility, validity, standardization and implementation of state-of-the-art pharmacologic, immunologic and virologic assays/technologies for use in support of the ACTG clinical trials. 7. Criteria and processes for: assessing the performance of ACTG components, including individual ACTUs, subunits, ATLs, the operations office and the statistical and data management center; the addition, reduction, expansion, or removal of ACTUs based on the needs of the scientific agenda and the performance of ACTUs; and the modification of the activities of the ATLs, the operations office and the statistical and data management center. 8. Mechanisms to ensure the involvement and participation of community representatives at all levels of scientific planning and study conduct. 9. Procedures for encouraging the participation in the proposed research of new investigators, women and minorities. Each AIDS Clinical Trials Unit will be expected to perform the following activities. (See "Terms and Conditions of Award" for further specification of selected activities of an Adult ACTU). 1. Participate in single and multi-institutional clinical trials according to the agenda of the ACTG. 2. Perform on site and/or obtain (via collaboration) virology, immunology (including flow cytometry), and pharmacology laboratory services as required for protocol mandated evaluation of patients enrolled in ACTG clinical trials. 3. Identify and recruit HIV-infected patient populations to support patient accrual, with a minimum of 75 new patients per ACTU per year. 4. Enroll and retain ethnically diverse patient populations that are representative of the local community and the population(s) most affected by HIV and AIDS, including women. 5. Provide or have access to gynecological and outreach related resources to assist in evaluating the efficacy of treatments for and to address the needs of women infected with HIV. 6. Obtain input and involve community representation of the populations most affected by HIV and AIDS in the planning, conduct and dissemination of information on clinical trials. 7. Encourage the participation of new investigators, women and minorities in scientific and managerial aspects of the ACTU. 8. Agree to follow the organizational structures and managerial mechanisms of the ACTG. The Statistical and Data Management Center for an ACTG will be responsible for the following activities. (See "Terms and Conditions of Award" for further specifications of selected roles and responsibilities of a Statistical and Data Management Center.) 1. Statistical aspects of study design, data analyses and data management. 2. Development and maintenance of systems for registration and randomization of participating patients into Phase 1, 2, and 3 clinical trials. 3. Centralized storage, security, processing and retrieval of ACTG and ACTU information. 4. Design and implement procedures for the collection, reporting and quality control of data (including standardized case report forms) and for submission of information by the ACTG, the ACTUs and collaborating institutions. 5. Training of clinical site staff and external site monitors (external site monitoring is performed by a DAIDS contractor) in the areas of data management and clinical trials methodology. 6. Receipt, recording, and reporting of adverse experience reports from the ACTUs to DAIDS and the FDA. 7. Analyses for IND annual reports to the FDA, and interim reports for NIAID, FDA, and DSMB review. 8. Agree to follow the organizational structures and managerial mechanisms of the ACTG. E. Objectives and Scope The primary goal of this initiative is to evaluate, in Phase 1, 2, and 3 clinical trials, innovative therapeutic strategies and interventions for HIV infection and its complications. These interventions will be based on emerging knowledge of the biology and potential therapeutic targets of HIV and associated pathogens, the pathogenesis of HIV infection and resulting opportunistic diseases, and factors influencing disease progression and treatment outcome. This initiative is specifically designed to strengthen the coordination of the ACTG research agenda with progress in basic research and it emphasizes the rapid utilization of these discoveries in multi-disciplinary clinical research. The goal is to allow the ACTG to capitalize on the latest insights into the biology of HIV and its associated pathogens and into host-pathogen relationships for the purpose of developing more effective treatments while enhancing knowledge of the pathogenesis of HIV disease and its complications. The NIAID HIV/AIDS Research Agenda comprehensively documents the Institute's major scientific programs, priorities, and plans in each of five broad scientific areas: pathogenesis, epidemiology and natural history, therapeutics research and development, vaccine research and development, and pediatric disease. The Agenda is the basis for NIAID's scientific planning, program management and evaluation, and communication on the scope and nature of the Institute's efforts in HIV research. Through the performance of clinical trials, the ACTG will play a critical role in helping to fulfill the goals and priorities delineated in the Therapeutics Section of the Institute's HIV/AIDS Research Agenda as summarized below. Copies of the Therapeutics Section of the NIAID HIV/AIDS Research Agenda are available from the program staff listed under INQUIRIES. The ACTG Central Group will identify the highest priority research questions from the major therapeutic areas, and develop a comprehensive clinical trials agenda consistent with the HIV/AIDS Therapeutics Research Agenda. The ACTG will be responsible for addressing the major areas in the NIAID's Agenda and establishing areas of emphasis. 1. Primary Disease Therapeutics. Considerable progress has been made in developing, evaluating, and instituting into clinical practice nucleoside analogues that inhibit HIV-1 replication and enhance disease free survival in infected individuals. However, the clinical utility of these agents are of limited duration and magnitude. Therefore, it is crucial to base further progress in primary disease therapeutics on additional knowledge of HIV life cycle and pathogenesis. Innovative approaches should focus on the following: o Development of antiretroviral therapies aimed at interfering with the life cycle of HIV as well as therapeutic strategies to treat the primary disease processes of HIV infection. These approaches should complement the efforts of industry and should be targeted to the entire spectrum of immunodeficiency, from acute infection through the chronic asymptomatic stage, and the stages of AIDS-related complications. o Determination of the clinical implications of the development of resistance of HIV-1 and the role of viral phenotypes. o Identification and validation of surrogate markers both as indicators of biologic activity and as predictors of overall clinical outcome. o Improvements in the therapeutic index of existing and/or approved anti-HIV therapies through the use of novel combinations of agents, alternative dosage schedules, or improved drug formulations, including antiviral and immunomodulators in combination. 2. Immune Based Therapeutics/Immune Reconstitution. The development of immunodeficiency in HIV-1 infection can be evident at its earliest stages, far in advance of clinically apparent disease. The immunodeficiency is relentless in its progression, ultimately leading to opportunistic infections and malignancies. The infected individual generates a myriad of immunological responses to HIV-1, however, it remains unclear which, if any, of these responses is protective. In addition, recent gains in our understanding of HIV pathogenesis have identified many factors contributing to the progressive immunosuppression, including CD4+ T-cell depletion, CD4+ T-cell qualitative dysfunction, loss and dysfunction of T-cell precursor cells and the developmental microenvironment, cytokine dysregulation, abnormal immune activation, apoptosis, and superantigen effects. Therefore, strategies could include the: o Development of immune-based approaches to the treatment of HIV disease and reconstitution of the immune system, e.g., passive and active immunotherapies, cytokines/cytokine modulators, adoptive cell transfer/stem cell therapies, and inhibitors of immune activation. 3. Treatment and Prevention of HIV-Related Opportunistic Infections. The morbidity and mortality caused by the multiple opportunistic infections (OIs) associated with HIV infection are substantial. Several of these pathogens have been associated with other immunocompromised states. However, the frequency and severity of some HIV-related OIs surpasses previous experience. For most OIs, there are only a limited number of agents effective in prophylaxis or treatment, many of which have significant toxicities associated with their use. There are no known effective therapies for some OIs including cryptosporidiosis and the emergence of drug resistance will limit the effectiveness of currently available agents. Support of basic, preclinical and clinical research on HIV-related OI pathogens is viewed as an important role of the NIAID. Innovative strategies may include, but are not limited to: o Develop approaches to provide safe and effective simultaneous prophylaxis against multiple OIs, recognizing that long term utility of these regimens will be dependent on patient acceptability and tolerance. Risks and benefits of widespread prophylaxis, including the development of drug-resistant organisms, pharmacokinetic interactions, and additive toxicity must also be specifically evaluated. o Assess markers for the optimal initiation of prophylaxis. Evaluate new methods for more rapid diagnosis of opportunistic infections, determine drug susceptibility, and evaluate response to therapy, including predictors of relapse. o Evaluate the use of active/passive immunization, cytokine modulation, and other immune based therapies as adjunctive therapies in the management of selected opportunistic infections. o Develop improved agents for the treatment and prevention of HIV-associated CMV, disseminated Mycobacterium avium Complex, enteric pathogens, and azole-resistant candida. o Develop new agents and combinations for the prophylaxis and treatment of disease caused by Mycobacterium tuberculosis infection, including strains that are resistant to standard agent(s). Develop and evaluate regimens, formulations or delivery vehicles that enhance patient compliance through convenience or improved tolerance. o Evaluate the role of OIs, for example CMV, MAI, TB, as cofactors in the progression of HIV-disease. 4. Oncology Treatment Research. Proposed research could focus on development and implementation of a coordinated research agenda in conjunction with the National Cancer Institute that will address the development of better therapeutic strategies to treat Kaposi's sarcoma, lymphoma, CNS lymphoma and human papilloma-virus associated malignancies in HIV-infected individuals. 5. Neurology Treatment Research. Proposed research could focus on development and implementation of a coordinated research agenda with the National Institute of Neurologic Diseases and Stroke that will facilitate the development of therapeutic strategies for the neurologic manifestations of AIDS, including AIDS dementia complex, neuropathy, progressive multifocal leukoencephalopathy, CNS lymphoma, and CMV encephalitis. NOTE: In addition the National Institute of Mental Health is interested in receiving applications, independent of this RFA, that will advance the development of therapeutics for the neuropsychiatric and neuropsychological manifestations associated with HIV infection, including early cognitive impairment, AIDS Dementia Complex, and associated mania, psychosis, depression and anxiety disorders. Methodological studies focused on the identification of markers of disease progression to AIDS-associated cognitive and motor impairment are strongly encouraged. For further information contact Dr. Walter L. Goldschmidts, Office on AIDS, NIMH, (301) 443-7281. 6. Women's Health Treatment Research. Proposed research could focus on development and implementation of a research agenda that will facilitate better understanding and treatment of women's specific health issues of HIV infection, such as drug pharmacokinetics in women, cervical neoplasia, pelvic inflammatory disease and vaginal candidiasis. 7. Pharmacology. Proposed research could focus on development of a research agenda that will define the pharmacokinetics and pharmacodynamics of new drugs and study the interactions of drugs used in combination to treat HIV and opportunistic infections. 8. Methodology for Trials. Using data from group trials increase the understanding of HIV/AIDS and related diseases and improve the design and conduct of trials. SPECIAL REQUIREMENTS In the terms and conditions of award listed below, reference is made to other research programs in AIDS, principally funded through NIAID cooperative agreements and contracts. Information concerning these programs will be discussed at a pre-application meeting scheduled for September 28, 1994. For additional information contact Dr. Frederick H. Batzold at the address listed under INQUIRIES. A. Terms and Conditions of Award The following terms and conditions will be incorporated into the award statement and provided to each Principal Investigator as well as the institutional officials at the time of award. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable Office of Management and Budget (OMB) administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grants Administration policy statements. The administrative and funding instrument used for this program is the cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardees for the ACTG as a whole, although specific tasks and activities in carrying out the study will be shared among the awardees and the NIAID and its contractors. The cooperative agreement funding mechanism will require collaboration between the DAIDS Associate Director of the Therapeutics Research Program (TRP), and the Group Leader(s) of the ACTG(s). The DAIDS will assist in coordinating the activities of the ACTG(s) as defined below and will facilitate the exchange of information. B. Awardee Rights and Responsibilities Awardees will have primary responsibility for defining the details for the project within the guidelines of the RFA and for performing the scientific activity, and agree to accept close coordination, cooperation, and participation of NIAID staff in all aspects of scientific and technical management of the project. Specifically, awardees have primary responsibilities as described below. 1. Responsibilities of the ACTG Central Group a. Research Agenda The Principal Investigator (Group Leader) of an ACTG Central Group, in collaboration with other investigators constituting the scientific leadership of the ACTG, is responsible for the development and implementation of a comprehensive clinical trials research agenda, consistent with the research goals and priorities established in NIAID's HIV/AIDS Therapeutic Research Agenda and complementary to the research conducted by the Community Programs for Clinical Research on AIDS (CPCRA), the Division of AIDS Treatment Research Initiative (DATRI), NIAID Division of Intramural Research, and other AIDS clinical trials mechanisms. These research goals will be reviewed and discussed quarterly with DAIDS staff. b. Bylaws/Operating Procedures The Group Leader will be responsible for ensuring that there are well-documented policies and operating procedures guiding all aspects of ACTG activities (e.g., protocol development, review, initiation, conduct, and closure, data collection, publication, etc.) and bylaws delineating the requirements and expectations of collaborating institutions, membership criteria and process for new site consideration by the ACTG, standards of performance, and procedures for removing institutions due to poor performance. c. Executive/Steering Committee The ACTG will establish this governing committee that will be chaired by the Group Leader. At a minimum the committee will include representatives from the Statistical and Data Management Center, the Operations Office, and a member of the community. In addition, there will be one voting member of the committee from the DAIDS Therapeutics Research Program. This committee will be responsible for overseeing all scientific and operational activities of the ACTG including, but not limited to: scientific direction, policies and bylaws, standards of performance, study oversight, evaluation of collaborating institutions, and criteria and review procedures for distributing discretionary funds. d. Protocol Development The ACTG will initiate development of each protocol only when there is sufficient commitment among the principal investigators of clinical units and other scientific leaders to proceed expeditiously to write the protocol, complete accrual, and analyze and publish the study results. Early notification that the ACTG is considering a trial must be provided to the DAIDS to allow for comment on scientific rationale, feasibility, costs, and compatibility with overall NIAID research priorities and activities in other clinical trials programs. The ACTG must have clear procedures for designating members of protocol teams and for selecting sites for limited-site trials. The ACTG must develop a mechanism to actively monitor progress, from initiation through publication, and must provide status reports to the DAIDS on each study, in a format and on a schedule to be mutually agreed upon. e. Administrative Support The Operations Office will be responsible for coordinating, administering, and supporting all research activities at the direction of the Group Leader or designee. These activities include, but are not limited to: protocol development; administrative support of scientific and other committees; assembly, review, and submission of regulatory documents for registration of sites for clinical trials; maintenance of group administrative records and archives; organization/support of, at a minimum, one annual national group meeting in collaboration with the Pediatric ACTG; and in conjunction with the group's Statistical and Data Management Center, preparation of administrative and scientific reports. f. Data Management and Analysis Each ACTG will develop standard procedures to ensure that data collection and management are: (1) adequate for quality control and analysis and (2) as simple as appropriate in order to minimize data collection burden on the part of the clinical sites. g. Protocol Submission Prior to implementation of a clinical trial, the ACTG leadership must submit a final draft to DAIDS for review and approval based on consistency with the NIAID HIV/AIDS Therapeutic Research Agenda and overlap with other NIAID clinical trial programs. DAIDS will communicate all decisions in writing to the ACTG; it will be the ACTG's responsibility to disseminate this information to member investigators and others as appropriate. Implementation may not proceed in the case of disapproval. (See "B. NIAID Staff Responsibilities" below for additional information on the approval and appeal processes.) h. Quality Assurance: Data Management The ACTG's Statistical and Data Management Center will design and implement systems to promote and ensure the quality of clinical trials data. The center will develop quality assurance procedures to be employed by staff at each clinical site and the managers of the central database, including types of manual and computerized procedures and edit checks that will be used to identify and correct data errors, the process that will be used to verify that eligibility criteria have been met, the process that will be used to verify endpoint data, and the average time period that erroneous computerized data will remain on-line before errors are corrected. Procedures will be developed to assure data security and recovery in the event of lost data. i. Quality Assurance: Laboratory Quality Control and Data Management All virology, immunology, and pharmacology laboratories supported through the ACTG (i.e., laboratories performing protocol-mandated testing and Advanced Technology Laboratories) should adhere to methodological and analytic guidelines set forth by the scientific committees of the ACTG. All laboratories must participate in quality assurance programs supported under contract with the DAIDS and overseen jointly with the ACTG (See. "B. NIAID Staff responsibilities"). In addition, all ACTG-supported laboratories should utilize a laboratory data management system for specimen tracking and data transmission provided by a contractor to the DAIDS. j. Advanced Technology Laboratories The Group Leader, in consultation with the Executive/Steering Committee of the ACTG, will be responsible for identifying the centralized advanced technology laboratory capabilities required in virology, immunology and pharmacology to support the ACTG research agenda. With the designated funds awarded to the ACTG Central Group, the Executive/Steering Committee will identify suitable laboratories, determine appropriate distribution of resources, develop a mechanism to monitor laboratory performance and annually assess allocation of the ATL funds. k. Study Oversight Responsibility The ACTG leadership must establish procedures to assure adequate protection of the rights and safety of volunteers involved in its clinical investigations, and for the quality and integrity of these studies and resulting data. This study oversight by the ACTG includes compliance with all Federal regulations and NIAID policies and procedures. The ACTG must also maintain accurate and timely information on the progress of each study it conducts. l. ACTG Compliance with Federal Regulatory Requirements The ACTG must be in compliance with all Federal regulations and NIH policies applying to the conduct of research involving human subjects. These include, but are not limited to, Title 21 CFR 50, 56, 312, and Title 45 CFR 46. The ACTG must be able to demonstrate that each institution conducting ACTG trials has a current, approved Assurance Number on file with the NIH Office for the Prevention of Research Risks (OPRR), that each protocol and informed consent is approved by the responsible Institutional Review Board (IRB) prior to patient entry, that each investigator has a current Food and Drug Administration Form 1572 and curriculum vitae on file at DAIDS, and that each patient (or legal representative) gives written informed consent prior to entry on study. The ACTG must assure timely reporting of all serious and unexpected toxicities to DAIDS in accordance with DAIDS established policy and procedures delineated in the "ACTG Adverse Experience Reporting Manual." m. Reporting Requirements The ACTG Group Leader will submit to the DAIDS an annual progress report summarizing data on protocol performance by the ACTG as a whole and by each participating clinical unit. These reports will include, at a minimum: patient accrual and retention rates; patient demographics; timeliness and completeness of all data, including adverse events; timeliness of IRB approvals of new protocol versions; completeness and quality of laboratory data; and scientific contributions, including publications. These data should be compiled across all studies and by protocol, as appropriate. Reporting requirements will be in agreement with Federal regulations and NIAID procedures. The ACTG Group Leader will submit to the NIAID data summary reports prior to the due dates to the Food and Drug Administration (FDA) required of IND sponsors. At the time of protocol review, for each clinical study DAIDS will identify the types and frequencies of reports needed to monitor the safety and clinical effectiveness of the therapeutic interventions. These reports may include (1) a line listing and summary tables of all serious adverse events submitted as frequently as every two weeks; (2) a report on patient status submitted every two weeks for each Phase I and I/II study; (3) a quarterly and annual report summarizing adverse events and patient status for each protocol, including unblinded analysis for the DAIDS medical monitor with the approval of the Data and Safety Monitoring Board. The ACTG will submit to DAIDS a narrative summary of the data contained in these reports and future plans for each study one month in advance of each IND report's due date. A system for providing such information in a timely manner must be implemented by the ACTG. n. Publication of Data Prompt and timely presentation and publication in the scientific literature of major findings is required. Publications or oral presentations of work done under this cooperative agreement will require acknowledgement of NIAID support to the ACTG. Prior to the submission of manuscripts for publication the ACTG will provide a preprint to the Division of AIDS. Although the awardee will retain custody and primary rights to the data consistent with current HHS, PHS and NIH policies, DAIDS will have access to all data generated under this cooperative agreement and may periodically review it. o. Progress Review The ACTG Executive/Steering Committee will establish procedures for regularly evaluating the performance of its members including data management/quality, accrual of adequate numbers of patients, adherence to requirements for enrolling women and minorities, observance of protocol requirements, scientific contributions/participation, and timely publication of data. This mechanism will include a procedure for recommending to DAIDS an adjustment of institutional funds within the group as appropriate for the level of contribution and performance. p. Interaction with DAIDS The ACTG Group Leader will meet with the Associate Director, TRP quarterly. The purpose of the meeting will alternate as follows: semi-annual meetings will be held to discuss research progress, establish priorities, and plan future activities. Also, semi-annual meetings will be held with investigators representing other NIAID clinical trials programs to ensure coordination of research agendas. Additional meetings between DAIDS and the ACTG Group Leader may be held as needed. q. National Meetings It is expected that an ACTG will hold two national meetings per year, at least one of which is held in conjunction with the Pediatric ACTG and located in the Washington metropolitan area. These meetings will be open to the public. Through calendar year 1996, the DAIDS will provide logistical support for two national meetings (and one smaller meeting of ACTG leadership), e.g., contracting with local hotels and vendors; however, the ACTG will be responsible for organizing the scientific content and format of the meeting. As of 1997, funds will be transferred to the ACTG Operations Office to cover the costs associated with all aspects of meeting planning, including logistics (e.g., hotel, scheduling). r. Conflict of Interest The ACTG will develop, establish, monitor and enforce a Conflict of Interest (COI) Policy, acceptable to NIAID, for addressing and resolving any conflict of interest issues that may arise through financial ties between members of the ACTG and the private sector. A report on the ACTG's activities regarding COI issues will be part of the biannual review. s. Discretionary Fund The Operations Office will maintain and manage a Discretionary Fund. The Executive/Steering Committee will develop criteria and review procedures for allocating discretionary funds, based on scientific and administrative needs and priorities of the group. Appropriate uses may include funding innovative pilot studies, supplementing budgets of collaborating institutions which are undertaking resource intensive studies, facilitating the initiation of large efficacy studies, accommodating non-routine protocol mandated requirements on an as needed basis, and supporting additional clinical or laboratory sites needed by the group. 2. Responsibilities of AIDS Clinical Trials Units (ACTUs) a. Staffing Each ACTU must have experienced physician investigators associated with the project who have demonstrated expertise in multi-center AIDS clinical trials. Adequate staffing must also include nursing, pharmacy, data management and outreach personnel to recruit and screen potential patients, implement clinical research protocols, perform protocol required assessments, dispense investigational agents and appropriately document clinical data, meeting all data reporting requirements. b. Clinical Studies Each ACTU will be required to have the capability to accrue a minimum of 75 patients per year, and develop and implement a community outreach program. All clinical trials conducted at each ACTU must be in compliance with the policies and bylaws of the ACTG. c. Routine Laboratory Assays For those laboratory studies that will not be carried out in centralized ATLs, each ACTU must have the capability to perform and/or obtain (via collaboration) virology, immunology (including flow cytometry) as required for evaluation of patients enrolled in the ACTG's clinical trials. Plans may entail arrangements including both on-site and off-site testing. Applicants proposing to obtain laboratory testing from off-site collaborators (outside of their institution) must provide the appropriate documentation (e.g., letters of agreement) to substantiate the collaborative arrangement. Use of existing DAIDS-certified laboratories in the same community, whenever possible, is strongly encouraged. All laboratories performing protocol mandated tests must participate in relevant laboratory quality assurance programs. d. Quality Assurance: Investigational Drug Management Investigators performing trials under cooperative agreements must be NIAID registered investigators (Form 1572 and curriculum vitae on record with DAIDS) and must comply with requirements described in the DAIDS Standard Operating Procedures. Investigators must comply with the "Pharmacy Guidelines and Instructions for ACTG" for storage, dispensing and accountability of investigational agents and must comply with all Federal regulations for investigational agents. e. Quality Assurance: Internal Quality Control Each ACTU must establish an internal quality control program to assess the quality of its research records, which must be approved by and consistent with the quality control policies developed by the ACTG. These policies should include, but are not limited to, quality control measures for collection, reporting and recording of data. Each ACTU's internal audit plan should apply to the main unit as well as any subunits that might be established in affiliation with it. Each clinical unit must submit a pharmacy plan to the Chief, Pharmaceutical and Regulatory Affairs Branch (PRAB) for approval for compliance with FDA requirements. Upon approval, sites must register for each protocol sponsored under an NIAID IND by submitting a package of regulatory documents. This package will be verified complete and accurate by the ACTG Operations Office. Once a site is registered for a protocol, drug will be supplied by the NIAID Clinical Research Products Management Center, and patients can be enrolled. Each ACTU will be required to cooperate with the DAIDS Clinical Site Monitoring Contractor, which will conduct external site monitoring to assure site compliance with all Federal regulations and NIH policies with respect to patient safety, data completeness and accuracy. 3. Statistical and Data Management Center Responsibilities a. Study Design, Conduct, Analysis and Publication The statistical staff will be responsible for providing statistical scientific leadership for the ACTG; collaborating with other protocol team members in all stages of protocol development and implementation; performing timely interim analyses of safety and efficacy results for review by protocol teams and/or the DAIDS Data and Safety Monitoring Board; performing final analyses for publication, participating in the writing of scientific papers and publish study results in conjunction with other protocol team members; producing timely study monitoring reports, deliverable to the Group Leader and DAIDS; conducting secondary analyses of ACTG data to improve the planning, design, conduct and interpretation of ACTG trials; and summary tables and data analyses for use in IND annual and interim submissions to the FDA and function in accordance with the policies and bylaws of the ACTG. b. Data Management The data management staff will provide for central registration and randomization of patients on all studies; develop case report forms; develop standardized criteria for verification of clinical endpoints; design and implement a system to provide for the efficient transfer of study results from clinical sites to a central database, using either a centralized or distributed data entry approach; in conjunction with the laboratory data management project and the NIAID AIDS Specimen Repository, provide support for tracking and identification of laboratory specimens; provide for processing, storage in a central database and retrieval of study results; provide limited online access for ACTUs to their own blinded data in the central database; prepare selected, significant public access datasets, with adequate documentation, deliverable to a location designated by DAIDS; provide for an electronic mail system, capable of exchanging messages through the Internet, to facilitate communication among clinical sites, other ACTG components, and DAIDS; provide data management training of the clinical unit staff and external site monitors; and develop reports detailing site performance in data management, deliverable to the Group Leader and DAIDS. The data management staff should function in accordance with policies and bylaws of the ACTG. c. Collaboration When circumstances require the ACTG to collaborate with one or more other clinical trial groups (e.g., CPCRA), the ACTG will agree to follow procedures for trial conduct to be determined by DAIDS in consultation with the leadership of each clinical trials group. Normally, one group will be given the lead responsibility by DAIDS and its procedures will be followed by all other collaborators. In addition, the Statistical and Data Management Center will be required to provide registration and randomization of patients for, and accept data from, any organization funded by NIAID to participate in adult ACTG trials, such as the National Hemophilia Foundation. (Oversight for the performance of such organizations will be the responsibility of the NIAID.) Annual patient accrual to ACTG protocols by other programs will not exceed five percent of the total ACTG accrual. 4. NIAID Staff Responsibilities The NIAID will have substantial scientific/programmatic involvement during the conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. The role of the DAIDS staff as described throughout these terms of cooperation is to assist and facilitate, but not to direct the research activities. Communication and interaction will occur primarily with the Group Leader and the scientific leadership of the ACTG; however, DAIDS will also interact directly with the Principal Investigator of any of the collaborating institutions as needed. This project is part of a larger program of therapeutics research supported by NIAID. Each of the DAIDS staff listed below has specific responsibilities in terms of investigational drug research and the role of the DAIDS as a drug sponsor as defined in 21 CFR Part 312. a. DAIDS' Scientific Role in NIAID-Supported Clinical Research The Associate Director, TRP and/or designated staff will work closely with the ACTG Executive/Steering Committee to assure that the research efforts of the ACTG are consistent with the NIAID agenda for HIV-related clinical research and are complementary to those of the other clinical trials mechanisms supported by DAIDS, specifically the CPCRA and DATRI. DAIDS will serve as a resource, and will disseminate information regarding promising new agents, therapeutic strategies, or developments. DAIDS staff will advise the clinical investigators, as requested or needed, of results from other trials (e.g., adverse experiences and early terminations) that could influence the design, development, or conduct of clinical trials and will serve as the liaison between the pharmaceutical company representatives, the FDA and the ACTG investigators. b. DAIDS Role in Protocol Review and Development In order for a clinical trial to be initiated by an ACTG, the study proposal must be mutually approved by the ACTG and the DAIDS Clinical Science Review Committee (CSRC), chaired by the Associate Director, TRP, DAIDS. Once notified that a trial is under serious consideration within the ACTG, DAIDS will evaluate the priority of the proposed trial in relation to the NIAID HIV/AIDS Therapeutic Research Agenda, to other NIAID trials, likelihood of timely completion; patient safety; compliance with Federal regulatory requirements; plans for interim monitoring of results; and resource requirements. DAIDS staff will also estimate the costs associated with the protocol. The Associate Director, TRP will return comments and recommendations in writing to the ACTG within 30 days. In addition, DAIDS pharmacists will participate on ACTG protocol teams, consulting on available dosage forms and placebos. They will also interact with pharmaceutical companies to ensure adequate and timely supply of products. In the event a protocol is disapproved, the Associate Director, TRP will work with the ACTG Executive/Steering Committee to resolve specific concerns and ensure consistency between the research interests, abilities and priorities of the ACTG and NIAID. Nonetheless, DAIDS will not provide investigational materials or permit expenditure of NIAID funds for a protocol that has not been approved. Disagreements arising pursuant to protocol approval may be submitted to an arbitration panel for resolution. A panel composed of one ACTG designee, one DAIDS designee, and a third member with HIV/AIDS clinical trials expertise chosen by the other two members will be formed to review the DAIDS decision and recommend an appropriate course of action to the Director, DAIDS. These special arbitration procedures in no way affect the awardee's right to appeal an adverse determination in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. For protocols under a DAIDS IND, DAIDS will be responsible for filing the protocol to the IND. d. DAIDS Role During Protocol Conduct For ongoing clinical trials, DAIDS Medical Officer will monitor the safety and efficacy of the treatment being evaluated. Therefore, interim and final reports on efficacy and toxicity for all sponsored clinical trials will be routinely provided to the DAIDS Medical Officer. In addition, for protocols in which the DAIDS is the IND sponsor, DAIDS will assign medical monitors who will review blinded and unblinded safety and efficacy data with the protocol statistician on behalf of the DAIDS Data and Safety and Monitoring Board to permit appropriate monitoring. e. DAIDS Role in Protocol Closure The Associate Director, TRP and/or designated staff will monitor the progress of ACTG trials by reviewing reports periodically submitted to DAIDS, through the Data and Safety Monitoring Board which consists of experts from several disciplines, and through semi-annual meetings with ACTG leadership. DAIDS may deem it necessary to deny access to further investigational drug supplies and deny the expenditure of additional NIAID funds (except where volunteers are already enrolled) if any of the following reasons apply: (a) risk of patient safety, (b) scientific question no longer relevant, (c) slow accrual, or (d) study will not answer question. Appeal of such a decision by the ACTG would proceed in the same manner as an appeal regarding the disapproval of a protocol prior to opening. f. Access to Data The Chief, Coordinating Centers Branch (CCB) and/or designated monitoring contractor staff will have access to all data generated under these cooperative agreements and may periodically review the data as recorded on case report forms and/or maintained in the central database. Data must be available for external checking against original source documents as required by NIAID policy and Federal regulations relative to the responsibility of DAIDS as an IND sponsor. The awardees will retain custody and primary rights to the data consistent with current HHS, PHS, and NIH policies, including a policy to provide public access to selected, significant data sets generated with the use of public funds, within a reasonable period of time after primary analysis and publication by the ACTG. g. Clinical Trials Agreements It is expected that for most clinical trials, a pharmaceutical company collaborator will provide investigational agents for the trials. In order for the ACTG, DAIDS and the company to understand their respective responsibilities and rights, a Clinical Trials Agreement (CTA) will be negotiated and signed by DAIDS and the company. Important terms of the agreement include IND sponsorship, safety and data monitoring, and access to trial data. Concurrence with the ACTG Group Leader will normally be obtained prior to execution of the final agreement. In general, terms in the CTA covering data access and sharing will conform to policies developed jointly by the group leadership and DAIDS. h. Laboratory Quality Assurance and Data Management The DAIDS will provide the ACTG with contractual support for virology, immunology and pharmacology laboratory quality assurance services. Administrative, fiduciary and other aspects of contract management will be the responsibility of DAIDS. Scientific and technical oversight for these quality assurance programs will be provided by DAIDS in conjunction with advisory groups comprised of ACTG and other investigators, and the Chief, Drug Development and Clinical Sciences Branch working in a cooperative manner. The DAIDS will also provide the ACTG with contractual support for the management of virology, immunology and pharmacology laboratory data. Given the complex nature of these data, the large volume to be collected and the highly technical aspects of its collection, this activity will be supported by its own project, distinct from, but coordinated with, the group's data management system/facility. i. DAIDS Involvement in Investigational New Drug Applications The DAIDS will have the option to cross file or independently file an IND on investigational drugs evaluated in the ACTG clinical trials. The Chief, PRAB will advise investigators of specific requirements and changes in requirements concerning IND sponsorship that the FDA may mandate. Investigators performing trials under cooperative agreements will be expected, in cooperation with the DAIDS, to comply with all FDA regulations associated with investigational drug studies. j. DAIDS Review of ACTG Compliance with Federally Mandated Regulatory Requirements The Chief, PRAB will advise the ACTG regarding mechanisms to meet (1) FDA regulations for DAIDS-sponsored studies involving investigational agents, and (2) the NIH Office for Protection from Research Risks (OPRR) regulations for the protection of human volunteers. For DAIDS-sponsored trials with investigational agents, the DAIDS has established an external DAIDS Clinical Site Monitoring Contract to document good clinical research practices, including regulatory compliance, proper protocol implementation, and test agent accountability. The DAIDS Clinical Site Monitoring contractor will visit ACTUs on a quarterly basis (approximately five days per visit) to review specific priority protocols, train in specific protocols, review, internal quality assurance plans, audit pharmacies, and document error resolution. In order to provide for consistent reporting of adverse experiences across clinical trials groups, DAIDS has established policies and procedures delineated in the "ACTG Adverse Experience Reporting Manual." The ACTG, as the largest of the groups, will have the responsibility for ongoing maintenance of the modified ICD-9 system for classifying and coding the types of adverse experiences reported. This will require collaboration with staff from the DAIDS and other trials groups. k. DAIDS as a Resource for Site Evaluation The Chief, Clinical Site Management Branch (CSMB) will assist the ACTG in developing criteria to evaluate the performance of the collaborating institutions. The Chief, CSMB will also provide ongoing data pertaining to each site's performance as well as data on the cost of the ACTG's research activities, including protocol specific costs. l. Review of Performance The performance of the ACTG as a whole and that of the individual institutions will be reviewed at least annually by the Associate Director, TRP on the basis of information provided in annual progress reports, evaluations of site performance conducted by the Executive\Steering Committee, and site monitoring reports provided to DAIDS by its contractor. Substandard data management/quality, insufficient patient accrual, inadequate progress in executing the research agenda, or noncompliance with the Terms and Conditions of Award may result in a reduction in budget, withholding support, suspension, or termination of award. m. DAIDS Review of Quality Control and Study Monitoring Procedures The Chief, PRAB will periodically conduct a review of the ACTG and its sites for the reliability of and compliance with clinical and regulatory systems, and will advise on the same. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their 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 1003-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women 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. A copy is also available through the NIH Grant Line (data line (301) 402-2221). Investigators may obtain copies from these sources or from Dr. Frederick H. Batzold (see "INQUIRIES") who may also provide relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by September 15, 1994, a letter of intent that includes a descriptive title of the proposed application (Adult ACTG Central Group, Adult ACTU, or Adult ACTG Statistical and Data Management Center); the name, address, and telephone number of the Principal Investigator; the number and title of this RFA; a list of the key investigators and their institution(s); and for Adult ACTU and Statistical and Data Management Center applicants, the identity of the ACTG Central Group with which the applicant plans to affiliate. The letter of intent is requested to provide an indication of the scope and number of applications that will be received and to promote early interaction among potential applicants and between the applicants and NIAID staff. Letters of intent from potential applicants for ACTG Central Group awards will be used by DAIDS program staff to refer unaffiliated potential applicants for ACTUs to potential ACTG Central Groups. The letter of intent does not commit the sender to submit an application, nor is it a requirement for submission of an application. The letter of intent is to be sent to Dr. Peter Jackson at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the standard research grant application form PHS 398 (rev. 9/91). For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the RFA number and the words "ADULT ACTG - CENTRAL GROUP" or "ADULT ACTG - ACTU" or "ADULT ACTG - STATISTICAL AND DATA MANAGEMENT CENTER", as appropriate must be typed in. The research grant application form PHS 398 (rev. 9/91) must be used in applying. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7441. The RFA label in the form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application. Submit a signed, typewritten original of the application, including the Checklist, and three signed exact photocopies. Each application for the ACTG Central Group, Statistical and Data Management Center, and each ACTU must be submitted separately. Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application and all five copies of appendices must also be sent to: Peter Jackson, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C14 6003 Executive Boulevard MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-8426 FAX: (301) 402-2638 The deadline for the receipt of applications is January 12, 1995. Applications received after this date will be considered as non-responsive to this RFA and will be returned without review. Special Instructions for the Preparation of Cooperative Agreement Applications A. Identification of Potential Applicants and Formation of ACTGs It is the responsibility of potential applicants for an ACTG Central Group award, ACTU award, and Statistical and Data Management Center award as components of an ACTG to identify themselves to each other and establish affiliations. In addition to the standard communication channels among investigators, the NIAID will facilitate the formation of an ACTG by: (1) providing the identity of potential ACTG Central Group applicants to unaffiliated potential ACTUs applicants and the names of unaffiliated potential ACTU applicants to potential ACTG Central Group applicants based on the letters of intent; and (2) holding a pre-application meeting on September 28, 1994. B. Pre-Application Meeting - September 28, 1994 The purpose of this meeting, to be held in the Bethesda, MD area, is to provide potential applicants with: (1) additional information about the structures and functions of DAIDS clinical research programs; (2) the opportunity to ask questions and obtain clarifications; and (3) the opportunity to establish affiliations (when these have not already been established). For further information contact: Dr. Frederick H. Batzold at the address listed under INQUIRIES. Potential applicants that request the RFA but are unable to attend the pre-application meeting will be sent a summary of the discussion and any materials that are distributed. C. Application Preparation All applications must be submitted on the form PHS 398 (rev. 9/91). Successful applications for each ACTG component (ACTG Central Group, Statistical and Data Management Center, and ACTUs) will be awarded as separate cooperative agreements to the sponsoring institutions and will include the Terms and Conditions of Award specified in this RFA. Each individual application must contain a Detailed Budget for the First 12-Month Period and a Budget for the Entire Proposed Project Period for Direct Costs. All applications, including that of the ACTG Central Group, the Statistical and Data Management Center, and the ACTUs should describe the scientific and administrative experience of key personnel. On page 2 of the PHS 398 form, in the section entitled PERSONNEL ENGAGED ON PROJECT, it is imperative that all applicants list all individuals and their institutions participating in the scientific execution of the project in the format as specified including those with no requested salary support. All applicants must ensure that the list is complete using as many continuation pages as necessary. Biographical Sketches and Other Support pages should be placed at the end of each individual application with the Principal Investigator first followed by other key personnel in alphabetical order; biographical sketches are limited to two pages each. The key feature of this RFA for the Adult ACTG(s) is that it requires an ACTG Central Group application to be submitted by a Group Leader/Principal Investigator of the ACTG Central Group. All ACTUs seeking membership in a collaborative group must submit a separate application identifying the Central Group to which they are seeking membership. The Statistical and Data Management Center application must be submitted separately, and must also identify the ACTG Central Group with which it is affiliated. In summary, for each ACTG being proposed, applications in response to this RFA must include the following elements: o Adult ACTG Central Group Application o Scientific Agenda and Research Plan Operational/Management Plan Plan/Budget for Advanced Technology Laboratories Outreach Plan Operations Office Procedures o AIDS Clinical Trials Unit Application Principal Investigator Association with One ACTG Central Group Ability to Contribute to the Scientific Agenda Demonstrated Clinical Trials Capabilities and Expertise Ability to Provide Protocol Mandated Laboratory Tests Accrual Potential Demographic Diversity/Community Outreach Plan o Statistical and Data Management Center Application o Principal Investigator Association with One Central Group Ability to Provide Expertise in Statistics and Study Design and Analysis Data Management Capabilities The specific requirements for each application are listed below. 1. Adult ACTG Central Group Application The Group Leader is required to assemble the scientific leadership required to produce a comprehensive research agenda on behalf of an ACTG, and identify the scientific and managerial leadership required for the ACTG to effectively and efficiently carry out its research plan. The ACTG Central Group application is not subject to the page limitations as stated in the form PHS 398. However, the Research Plan (see pages 19 through 23 of the PHS 398 application brochure) must be limited to 250 pages. (Note: the Research Plan includes the scientific agenda, the key scientific and managerial leadership, the organizational and governance structure, the Operations Office procedures, and the plan for establishing ATLs.) The application should be as concise as possible to ensure a thorough review. The use of tables, diagrams, organization and flow charts is strongly encouraged. Suggested format and page limitations for the Central Group Application. Applicants may request reallocation of the page limits from Dr. Frederick H. Batzold (see INQUIRIES). Scientific Agenda and Research Plan: 130 pages including identification of the Group Leader/Principal Investigator, key scientific leadership and a statistical and data management center. Operational/Management Plan: 25 pages including organizational chart, governance structure, plans for establishing bylaws, and key managerial leadership. Advanced Technology Laboratory Plan/Budget: 35 pages Outreach Plan: 10 pages including plans for ensuring access to under-represented populations especially women and minorities, for involving community representatives in ACTG activities. Operations Office Procedures: 50 pages including plans for developing, implementing, and monitoring protocols, and plans for carrying out regulatory responsibilities to the extent possible these plans can be included as appendices. Otherwise, these procedures should be described in detail within the text of the application. In addition to the support needed for the Operations Office, this application should include a budgetary request by the Group Leader for administrative/managerial support. The application should also include a budget request for central ATLs. The total budget request and planned distribution among virology, immunology and pharmacology should be based on the scope of activities proposed directly in support of the ACTG research agenda. The Group Leader may also request a discretionary budget in this application that will be used to fund innovative pilot studies, to supplement the budgets of collaborating institutions, which are undertaking resource intensive studies, to facilitate the initiation of large efficacy studies, accommodate non-routine protocol mandated requirements on an as needed basis, and support any additional clinical or laboratory sites needed by the group. The Discretionary Funds may not exceed $2,000,000 and the application must describe the criteria and review procedures that will be used by the Executive/Steering Committee for distributing these funds. In addition to the proposed detailed overall first year budget and summary budgets for future years, the applicant should identify the annual budgets for the following four categories of activities: (1) administrative support for the Group Leader and scientific leadership of the ACTG; (2) the Operations Office; and, within the Operations From owner-sci-resources@net.bio.net Wed Aug 31 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AG-94-006 - V23(32) 08/26/94 Date: 31 Aug 1994 18:56:37 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 485 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <343ccl$53p@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AG94006 AG-94-006 P1O1 *************************************** NATHAN SHOCK CENTERS OF EXCELLENCE IN BASIC BIOLOGY OF AGING NIH GUIDE, Volume 23, Number 32, August 26, 1994 RFA: AG-94-006 P.T. 04; K.W. 0715210, 0710010 National Institute on Aging Letter of Intent Receipt Date: October 15, 1994 Application Receipt Date: November 29, 1994 PURPOSE The National Institute on Aging (NIA) invites applications for support of centers of excellence in research on basic biological mechanisms of aging, to be known as Nathan Shock Centers of Excellence in Basic Biology of Aging. These Centers will provide support for a research development core; a core to support resources such as animal resources, biometric services, molecular/cell biology services, and shared equipment; and a program enrichment core in support of basic biological research on aging. The purpose of this core center grant is to provide funding for core facilities and associated staff that serve the various ongoing research on aging projects on a shared basis so as to enhance the quality of research in the basic biology of aging, facilitate the planning and coordination of research on aging activities, and provide a suitable environment for fellows and junior faculty to acquire research skills and experience at institutions that have demonstrated commitment to, and expertise in, research on basic biology of aging. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Nathan Shock Centers of Excellence in Basic Biology of Aging, 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit organizations and institutions, State and local governments and their agencies, and authorized Federal institutions. To be eligible for award as a Nathan Shock Center of Excellence, the applicant institution must currently support a minimum of fifteen peer-reviewed, externally funded research projects. In the case of currently funded program projects (P01s), or similar grants, each research component will be deemed to be a separate project. Supportive core components do not qualify. Minority individuals and women from qualifying institutions are encouraged to apply. MECHANISM OF SUPPORT The Nathan Shock Centers will be supported through the NIH Core Center Grants (P30) mechanism. 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 five years. The anticipated award date is July 1995. FUNDS AVAILABLE Support may be requested for a period of five years. The direct costs requested for the first year may not exceed $325,000, exclusive of indirect consortium costs. Applications with budget requests exceeding this amount will not be accepted by the NIA and will be returned to the applicant. Budget increments for subsequent years will be limited to no more than four percent. Plans are to make two or three awards in fiscal year 1995 and further awards in fiscal years 1996 and 1997 depending upon availability of funds. RESEARCH OBJECTIVES Background Human life expectancy has increased some 25 years in less than a century, a figure that is nearly equal to the gain that had been achieved in the preceding 5,000 years. This has resulted in an unprecedented increase in the number and proportion of older persons in the population. It is therefore important for social, cultural, and economic reasons that research efforts to understand the underlying mechanisms of aging be expanded. One of the mandates of the NIA is to develop research approaches to extend the vigorous and productive years of life. It is clear that aging is not only complex, but also highly variable. Why is individual aging so varied? How do we explain a longer life expectancy for women than men in view of the fact the women report more illness and health care utilization than men at every age comparison? How can physiological age be determined and related to chronological age? How can the various theories of aging be integrated to provide a more unified description of biological aging and thus, an indicator for fruitful directions for future research on aging? The goal of the Core Center program is to enhance the ability of institutions with well-developed research programs in basic research on aging to provide the strongest environment for the conduct of research on aging by providing state-of-the-art research resources to find answers to the many complex questions of aging. Thus, institutions without a substantial ongoing program of basic research on aging are not encouraged to apply for a Nathan Shock Center of Excellence in Basic Biology of Aging award. Objective and Scope A Core Center grant for aging research is awarded to enhance the quality of research in the basic biology of aging, facilitate the planning and coordination of aging research activities, and provide support and a suitable environment for fellows and junior faculty to acquire research skills and experience at institutions that have demonstrated commitment to, and expertise in, basic biology of aging research. The purpose of the core grant is to provide funding for core facilities and associated staff that serve the various aging research projects on a shared basis. The Core Center is a mechanism designed to enhance and extend the effectiveness of a group of related projects and investigators that are already funded through other mechanisms such as research projects grants (R01), program projects (P01), FIRST awards (R29), MERIT awards (R37), or other Federal or non-Federal peer-reviewed extramurally- funded grants. In this respect, the Core Center mechanism builds upon an established base of research excellence that emphasizes common themes or foci. Each Core Center Grant must include (a) a core resources component and (b) a limited program enrichment component in support of administrative functions and advisory committee expenses. Activities such as animal facilities, biometric support, molecular/cell biology and/or equipment, which must be utilized by three or more projects on aging research that are already funded, would be supported in the Resources core. A research development core and an expanded program enrichment core to support conferences, symposia, travel to scientific meetings and special consultants are optional. The research development core would provide support for pilot/feasibility projects or temporary salary support to investigators just entering the research on aging arena to a point where they can compete for independent support. Such salary support usually would not exceed two years. An appropriately qualified scientist must be named as a director of each core proposed as well as a Center Director for overall direction. Resources Core (Required) This core will provide support for personnel, equipment, supplies and renovation costs needed to develop new, or improve existing resources that foster shared use and collaborative research. Renovation costs may not exceed $150,000 for the entire award period. Since a supply of appropriate animal models that are free of disease is essential for research on biological aging, support will be provided for the development and maintenance of animal resources to meet this need. Support may be requested for necessary personnel, facility improvement costs, animal model development costs, and equipment, supplies and animal purchase costs for the operation of a quality animal core resource facility in support of three or more basic research projects. Simply having appropriate animals available for the conduct of research is not enough; it is necessary that they be used in an effective manner (experimental design) to achieve reliable data for hypothesis testing. Proper experimental design and subsequent data analysis is a necessity for meaningful results, not only of animal studies, but of all research. Therefore, personnel and equipment costs for biometrics support of all center research may be requested. To gain insight into the mechanisms of aging through understanding the underlying intrinsic biology of aging requires a molecular/cellular biology capability. Therefore, this core may also provide molecular/cellular research resources for on-going funded research projects at the institution. Examples of such core resources include, but are not limited to: o Cell culture facility o DNA sequencing o Computing and statistical analysis o Cell sorting/flow cytometry o Monoclonal antibody production o Preparation of cloning vectors o Ultracentrifugation equipment o Analytical services, e.g., mass spectrometry, HPLC, GLC Support may be requested both to purchase equipment and for personnel to operate and maintain the equipment. Any equipment or facility supported in this core should involve sharing by at least three independently supported research projects and must be justified in terms of need to meet the goals of these projects. Since this component may consist of several cores, each may use a maximum of 10 pages. Research Development Core (Optional) The Research Development Core is to provide support for personnel, equipment, and other resources that will enhance the quality of currently supported research, support pilot study projects, and serve as a resource for pursuing an exciting new finding beyond the limits that current support allows. Activities that focus resources from a variety of disciplines on understanding biological processes of aging are encouraged. The focus of proposed core activities should conform with needs of funded research projects at the institution. Applicants should describe concisely the currently supported projects that will use the core facilities. The description of the projects proposed should include a rationale to show how the core will support the research effort in a cost effective manner, and how they will enhance the quality of research and/or provide a suitable environment for training and career development of research fellows and junior faculty in basic biology of aging. This core may also provide temporary salary support, not to exceed 24 months, for one newly named principal investigator in specified areas of research complementary to ongoing activities of the group. No more than three junior faculty may receive salary support through this core at any one time and no individual may receive salary support for more than three years. It must be clearly described how any requested salary support in this core will enhance the existing program. The budget for each pilot project may not exceed $50,000 per year (direct cost) and the total budget for pilot projects under this core may not exceed $100,000 per year (direct cost). Request for Research Development Core support must contain (1) a plan for the selection of junior faculty to be supported, (2) a general plan for the career development of individuals who will be selected for these positions, (3) a plan for review and selection of pilot projects to be pursued, and (4) a list of senior faculty who will participate in research career development, along with their curriculum vitae and current research support. The institution must be able to demonstrate adequate resources for the support of the research efforts of proposed junior investigators and a plan for monitoring their progress and development toward independence. The research development core may also serve to encourage the career development of other junior faculty (in addition to those receiving salary support from this core) by coordinating the use of research core resources by those whose salary support will be provided from other sources. Funds may also be requested for salary support for a director of the research development core, who will be responsible for coordination of all activities within said core. Narrative description of this core is limited to 10 pages and description of individual pilot projects to one page. Program Enrichment Core (Required) This core is required in so far as it provides support for the administrative management of the overall Center as well as support for the required outside advisory panel. The remaining elements of this core, i.e., conferences, symposia, meeting travel, are optional. The Center Director should be a scientist who can provide effective administrative and scientific leadership. The Administrator (if one is used) will assist the Director in managing the Center, addressing issues of fiscal management and compliance with institutional, PHS, NIH and NIA policies. In addition, each Center must have an advisory panel of experts from outside the institution that will meet at least once a year to review Center activities. This panel should not be named until after the review process is completed, but must be approved by NIA prior to funding of awards. This panel will provide a written evaluation report on the progress of the Center which must be included with each Center's annual progress report to NIA. Funds may be requested to permit travel by junior staff (whose travel is not otherwise covered) to scientific meetings or by the Director and one other senior staff to Bethesda for meetings with NIA staff and/or staff of other Centers. Narrative description of this core is limited to 10 pages. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and 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 Potential applicants are asked to submit, by October 15, 1994, 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 NIA staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Richard L Sprott at the address listed under INQUIRIES. APPLICATION PROCEDURES The applicant is to submit the application using PHS 398 (rev. 9/91). Application kits containing this form and the necessary instructions are available in most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248. Applicants are urged to obtain from the NIA Scientific Review Office, guidelines for preparing multicomponent applications, which contain information not found in the standard PHS 398 kit. NIA program staff are available to provide guidance, in relation to both scientific and administrative issues, in the development of the application. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed in line 2a of the face page of the application form and the YES box must be marked. Send or deliver the original, signed application and three legible complete photocopies to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Send two additional copies of the application to: Michael Oxman, Ph.D. Scientific Review Office National Institute on Aging Gateway Building, Room 2C212 7201 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-9666 FAX: (301) 402-0066 It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants. Any application received after the receipt date will be returned to the applicant without review. REVIEW CONSIDERATIONS Applications must be received by November 29, 1994. Upon receipt, applications will be reviewed for completeness and responsiveness by NIA staff. To be complete, an application must be approved, as appropriate, by an applicant institution's IRB and IACUC. Incomplete applications will be returned to the applicant without further consideration. If NIA staff find that the application is not responsive to the RFA, or if the first year budget request exceeds $325,000 in direct costs, exclusive of indirect costs requested for consortiums, 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 NIA in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and, if found to have significant and substantial merit, will be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. Because a site visit is not currently anticipated, each application must be thorough and complete enough to stand on its own merits. The second-level review will be made by the National Advisory Council on Aging at its May 1995 meeting, for funding beginning in July 1995. The primary criterion for review by the NIA review committee in evaluating each grant application will be the potential of the proposed center to enhance research programs on basic mechanisms of aging. Not all additional criteria are applicable to every application, depending on number and extent of proposed cores. Specific review criteria are: 1. Contribution of cores to enhancement of ongoing research at the proposed Center to better understand basic mechanisms of aging. 2. Extent to which cores would provide opportunities for research experience for fellows and junior faculty. 3. Leadership ability and scientific stature of the program director and his/her ability to meet the program's demands of time and effort. 4. Qualifications, experience, and commitment of the investigators responsible for core units and their ability to devote the required time and effort to the program. 5. Presence of an administrative and organizational structure conducive to attaining the objectives of the proposed program. 6. Arrangements for internal quality control of ongoing research, the allocation of funds, day-to-day management, contractual agreements, and the internal communication and cooperation among investigators in the program. 7. Resource-related expenses on existing research project grants which can be transferred to the budget for this center to achieve greater efficiency and promote collaboration. 8. Quality of proposed external review process. 9. Appropriateness of the total budget and budgetary requests for the cores and new program development projects. 10. Academic and physical environment as it bears on space and equipment and on the potential for interaction among scientists within the center and with scientists from other departments, and/or institutions. 11. Institutional commitment to the requirements of the program. 12. The adequacy of the means for protecting against risks to human subjects, vertebrate animals and/or the environment. AWARD CRITERIA The anticipated date of the first year award will be July 1995. Funding criteria will be scientific merit (based on the review criteria listed above), availability of funds, and programmatic priorities. 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 and address the letter of intent to: Richard L. Sprott, Ph.D. Biology of Aging Program National Institute on Aging Gateway Building, Room 2C231 7201 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-4996 FAX: (301) 402-0010 Direct inquiries regarding fiscal issues to: Robert Pike Grants and Contracts Management Office National Institute on Aging Gateway Building, Room 2N212 7201 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-1472 FAX: (301) 402-3672 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 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 Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. 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 Aug 31 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 32, pt. 1of1, 26 August 1994 Date: 31 Aug 1994 18:56:31 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1396 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <343ccf$53e@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940826 V23N32 P1O1 ************************************ X-comment: RFAs described: AG-94-006, AI-94-028 NIH GUIDE - Vol. 23, No. 32 - August 26, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIH GUIDE PUBLICATION DATES $$INDEX N2 ********************************************************** SMALL BUSINESS TECHNOLOGY TRANSFER PROGRAM National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** SMALL BUSINESS INNOVATION RESEARCH PROGRAM National Institutes of Health Centers for Disease Control and Prevention INDEX: NATIONAL INSTITUTES OF HEALTH; CENTERS FOR DISEASE CONTROL AND PREVENTION $$INDEX N4 ********************************************************** MINORITY INSTITUTIONS RESEARCH DEVELOPMENT PROGRAM National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX N5 ********************************************************** AVAILABILITY OF FISH OIL TEST MATERIALS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** CARDIOVASCULAR HEALTH STUDY-MAGNETIC RESONANCE IMAGES READING CENTER (RFP NHLBI-HC-94-32) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R2 11/29/94 ************************************************* NATHAN SHOCK CENTERS OF EXCELLENCE IN BASIC BIOLOGY OF AGING (RFA AG-94-006) National Institute on Aging INDEX: AGING $$INDEX R3 01/25/95 ************************************************* ADULT AIDS CLINICAL TRIALS GROUPS (RFA AI-94-028) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES ATTENTION: The new mailing list for the NIH Guide will be activated in September. Until then, the existing mailing list will be maintained. See INTENT TO MODIFY (NIH Guide, Vol. 23, No. 23, June 17, 1994) for additional information. This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** THE NIH GUIDE FOR GRANTS AND CONTRACTS WILL NOT BE PUBLISHED ON SEPTEMBER 1 AND SEPTEMBER 9. THE NEXT ISSUE OF THE NIH GUIDE WILL BE ON SEPTEMBER 16, 1994. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** SMALL BUSINESS TECHNOLOGY TRANSFER PROGRAM NIH GUIDE, Volume 23, Number 32, August 26, 1994 P.T. 34; K.W. 0710030 National Institutes of Health Application Receipt Date: December 1, 1994 Innovative technologies and methodologies fuel progress in biomedical and behavioral research and represent an increasingly important area of the economy. The Small Business Technology Transfer (STTR) program provides support to small business concerns -- in collaboration with U.S. research institutions -- for research or research and development (R&D) of new technologies and methodologies that have the potential to succeed as commercial products. The purpose of this notice is to inform the public about the opportunities that the STTR program offers to small business concerns as well as to scientists at research institutions, including colleges and universities. The applicant organization must be the small business concern. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent is to be performed by the research institution. The STTR program is a three-year pilot program that began in fiscal year (FY) 1994 and consists of the following three phases; Phase I: The objective of this phase is to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort and the quality of performance of the small business concern, prior to providing further Federal support in Phase II. Phase II: The objective of this phase is to continue the research or R&D efforts initiated in Phase I. Funding shall be based on the results of Phase I and the scientific and technical merit and commercial potential of the Phase II application. Phase III: The objective of this phase, where appropriate, is to pursue with non-STTR funds the commercialization of the results of the research or R&D funded in Phases I and II. The amount and period of support for STTR awards are as follows: Phase I: Awards may not exceed $100,000 for direct costs, indirect costs, and negotiated fixed fee for a period normally not to exceed one year. Phase II: Awards may not exceed $500,000 for direct costs, indirect costs, and negotiated fixed fee for a period normally not to exceed two years, that is, generally, a two-year Phase II project may not cost more than $500,000 for that project. A Phase I award must have been issued in order to apply for a Phase II award. (ONLY Phase I awards will be issued in FY 1995.) It is anticipated that approximately 80 STTR Phase I grants will be awarded by the NIH in FY 1995 from funds set aside for this purpose. INQUIRIES Eligibility requirements, definitions, application procedures, review considerations, application forms and instructions, and other pertinent information are contained in the OMNIBUS SOLICITATION OF THE NATIONAL INSTITUTES OF HEALTH FOR SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) GRANT APPLICATIONS. The Solicitation, which is for the single application receipt date of December 1, 1994, for grant awards to be made in FY 1995, will be available the middle of September 1994. Hard copies of the NIH STTR Solicitation are available directly from the following office ONLY: PHS SBIR/STTR Solicitation Office 13687 Baltimore Avenue Laurel, MD 20707-5096 Telephone: (301) 206-9385 FAX: (301) 206-9722 Internet: a2y@cu.nih.gov In addition, the Solicitation will be available electronically using Business Gold, the National Technology Transfer Center's bulletin board system. (This does NOT include STTR application forms, which should be obtained in hard copy from the PHS SBIR/STTR Solicitation Office above.) Connect via Internet by telneting to "iron.nttc.edu" or by dialing (304) 243-2560 for high speed modems (9600+) or (304) 243-2561 for 1200-2400 baud modems and logging in as "guest." For more information on their electronic bulletin board system, contact: National Technology Transfer Center Wheeling Jesuit College 316 Washington Avenue Wheeling, WV 26003-6295 Telephone: (800) 678-6882 (toll-free within U.S.) Following are contact points for discussion of program interests pertaining to the NIH awarding components participating in the STTR grant program: Dr. Miriam F. Kelty Office of Extramural Affairs National Institute on Aging 7201 Wisconsin Avenue, Suite 2C218 Bethesda, MD 20892 Telephone: (301) 496-9322 FAX: (301) 402-2945 Internet: mk46u@nih.gov Dr. Laurie Foudin National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 6000 EXECUTIVE BLVD MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4224 FAX: (301) 594-0673 Internet: lf29z@nih.gov Mr. Allan Czarra National Institute of Allergy and Infectious Diseases Solar Building, Room 3C28 Bethesda, MD 20892 Telephone: (301) 496-7291 FAX: (301) 402-0369 Internet: ac20a@nih.gov Dr. Michael Lockshin National Institute of Arthritis and Musculoskeletal and Skin Diseases Building 31, Room 4C32 Bethesda, MD 20892 Telephone: (301) 496-0802 FAX: (301) 480-6069 Internet: ml47h@nih.gov Ms. Jo Anne Goodnight Cancer Biology and Diagnosis National Cancer Institute Executive Plaza North, Room 500 Bethesda, MD 20892 Telephone: (301) 496-5307 FAX: (301) 496-8656 Internet: jg128w@nih.gov Dr. Jack Gruber Cancer Etiology National Cancer Institute Executive Plaza North, Room 540 Bethesda, MD 20892 Telephone: (301) 496-9740 FAX: (301) 496-2025 Internet: jg65y@nih.gov Dr. Ruthann M. Giusti Cancer Treatment National Cancer Institute Building 31, Room 3A49 Bethesda, MD 20892 Telephone: (301) 496-6404 FAX: (301) 496-0826 Internet: rg39r@.nih.gov Dr. Barry Portnoy Cancer Prevention and Control National Cancer Institute Building 31, Room 10A49 Bethesda, MD 20892 Telephone: (301) 496-1071 FAX: (301) 496-9931 Internet: bp22z@nih.gov Ms. Connie Dresser Interactive Multimedia Technologies for Cancer Prevention National Cancer Institute Executive Plaza North, Room 241 Bethesda, MD 20892 Telephone: (301) 496-0273 FAX: (301) 496-8675 Internet: cd34b@nih.gov Ms. Hildegard Topper National Institute of Child Health and Human Development Building 31, Room 2A03 Bethesda, MD 20892 Telephone: (301) 496-0104 FAX: (301) 402-1104 Internet: ht20t@nih.gov Ms. Jacqueline P. Downing National Institute on Drug Abuse Parklawn Building, Room 10A-55 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-1056 FAX: (301) 443-6277 Internet: jd96j@nih.gov Dr. Daniel A. Sklare Division of Communication Sciences and Disorders National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-1804 FAX: (301) 402-6251 Internet: ds104i@nih.gov Dr. Joyce A. Reese National Institute of Dental Research Westwood Building, Room 509 Bethesda, MD 20892 Telephone: (301) 594-7648 FAX: (301) 594-9720 Internet: r2j@cu.nih.gov Mr. John R. Garthune National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 637 Bethesda, MD 20892 Telephone: (301) 594-7569 FAX: (301) 594-7594 Internet: jg60d@nih.gov Dr. Michael J. Galvin, Jr. Environmental Health Resources Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 104 Alexander Drive, MD 3-03 Research Triangle Park, NC 27709 Telephone: (919) 541-7825 FAX: (919) 541-2843 Internet: mg63c@nih.gov Dr. Ralph Helmsen National Eye Institute Executive Plaza South, Suite 350 6120 EXECUTIVE BLVD MSC 7164 Bethesda, MD 20892-7164 Phone: (301) 496-5301 FAX: (301) 402-0528 Internet: rh27v@nih.gov Dr. Michael R. Martin National Institute of General Medical Sciences Westwood Building, Room 936 Bethesda, MD 20892 Telephone: (301) 594-7753 FAX: (301) 594-7731 Internet: mm72k@nih.gov Dr. David Robinson Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Federal Building, Room 416 Bethesda, MD 20892 Telephone: (301) 496-5656 FAX: (301) 402-3508 Internet: dr14j@nih.gov Dr. Thomas Blaszkowski Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute Federal Building, Room 208A Bethesda, MD 20892 Telephone: (301) 496-1841 FAX: (301) 496-0075 Internet: tb33i@nih.gov Dr. Carol Vreim Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 6A16 Bethesda, MD 20892 Telephone: (301) 594-7430 FAX: (301) 594-7408 Internet: cv2@cu.nih.gov Dr. George Nemo Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute Federal Building, Room 504 Bethesda, MD 20892 Telephone: (301) 496-1537 FAX: (301) 496-4843 Internet: gn6y@nih.gov Dr. Michael Huerta National Institute of Mental Health Parklawn Building, Room 11-103 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4885 FAX: (301) 443-4822 Internet: hmi@cu.nih.gov Mr. Edward Donohue National Institute of Neurological Disorders and Stroke Federal Building, Room 1016 Bethesda, MD 20892 Telephone: (301) 496-4188 FAX: (301) 402-4370 Internet: ed25b@nih.gov Dr. Judith Laughlin National Institute of Nursing Research Westwood Building, Room 738 Bethesda, MD 20892 Telephone: (301) 594-7493 FAX: (301) 594-7603 Internet: jl97v@nih.gov Dr. Louise E. Ramm National Center for Research Resources Westwood Building, Room 854 Bethesda, MD 20892 Telephone: (301) 594-7906 FAX: (301) 594-9121 Internet: lr34m@nih.gov Dr. Bettie J. Graham National Center for Human Genome Research Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-7531 FAX: (301) 480-2770 Internet: bg30t@nih.gov Mr. Peter Clepper National Library of Medicine Building 38A, Room 5S518 Bethesda, MD 20894 Telephone: (301) 496-4221 FAX: (301) 402-0421 Internet: pc49n@nih.gov $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** SMALL BUSINESS INNOVATION RESEARCH PROGRAM NIH GUIDE, Volume 23, Number 32, August 26, 1994 P.T. 34; K.W. 0710030 National Institutes of Health Centers for Disease Control and Prevention Contract Proposal Receipt Date: December 5, 1994 The purpose of this notice is to (1) announce the issuance of the SOLICITATION OF THE PUBLIC HEALTH SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH (SBIR) CONTRACT PROPOSALS with a due date for receipt of proposals of December 5, 1994; and (2) inform the public about the opportunities that the SBIR program offers to small business concerns as well as to scientists at research institutions, including colleges and universities. Public Law 102-564, signed by the President October 28, 1992,requires the Public Health Service (PHS), Department of Health and Human Services, and certain other Federal agencies to reserve a specified amount of their extramural research or R&D budgets for an SBIR program. In fiscal years 1995 and 1996, 2.0 percent of the PHS extramural budget will be reserved for the SBIR program, amounting to $170-$175 million (estimated); and in fiscal years 1997 and beyond, the set-aside requirement will be 2.5 percent. The offeror organization must be a small business concern, and the primary employment of the principal investigator MUST be with the small business concern at the time of award and during the conduct of the proposed project. In accord with the intent of the SBIR program to increase private sector commercialization of innovations derived from Federal R&D, scientists at research institutions can play an important role in an SBIR project by serving as consultants and/or subcontractors to the small business concern. Normally, up to one-third of the Phase I budget may be spent on consultant and/or subcontractual costs, and up to one-half of the Phase II budget may be spent on such costs. In this manner, a small business concern with limited expertise and/or research facilities may benefit from teaming with a scientist at a research institution; for the scientist at a research institution, this team effort provides support for R&D not otherwise obtained. The SBIR program consists of the following three phases: PHASE I: The objective of this phase is to determine the scientific and technical merit and feasibility and potential for commercialization of the proposed research or R&D efforts and the quality of performance of the small business concern, before consideration of further Federal support in Phase II. PHASE II: The objective of this phase is to continue the research or R&D efforts initiated in Phase I. Funding shall be based on the results of Phase I and the scientific and technical merit and commercial potential of the Phase II proposal. Only Phase I contractors are eligible to apply for Phase II funding, and Phase II proposals may be submitted upon the request of the Contracting Officer ONLY. PHASE III: The objective of this phase, where appropriate, is for the small business concern to pursue with non-SBIR funds the commercialization of the results of the research or R&D funded in Phases I and II. The amount and period of support for SBIR awards are as follows: PHASE I: Awards may not exceed $100,000 for direct costs, indirect costs, and negotiated fixed fee for a period normally not to exceed six months. PHASE II: Awards may not exceed $750,000 for direct costs, indirect costs, and negotiated fixed fee for a period normally not to exceed two years, that is, generally, a two-year Phase II project may not cost more than $750,000 for that project. Only one Phase II award may be made for any SBIR project. INQUIRIES Eligibility requirements, definitions, submission procedures, review considerations, contract proposal forms and instructions, and other pertinent information are contained in the Solicitation of the PHS for SBIR Contract Proposals, available the middle of September from: PHS SBIR/STTR Solicitation Office 13687 Baltimore Avenue Laurel, MD 20707-5096 Telephone: (301) 206-9385 FAX: (301) 206-9722 Internet: a2y@cu.nih.gov In addition, the ENTIRE Solicitation will be available electronically using Business Gold, the National Technology Transfer Center's bulletin board system. Connect via Internet by telneting to "iron.nttc.edu" or by dialing (304) 243-2560 for high speed modems (9600+) or (304) 243- 2561 for 1200-2400 baud modems and logging in as "guest". For more information on their electronic bulletin board system, contact: National Technology Transfer Center Wheeling Jesuit College 316 Washington Avenue Wheeling, WV 26003-6295 Telephone: (800) 678-6882 (toll-free within U.S.) Anyone interested in the PHS SBIR Grant program may obtain the current edition of the OMNIBUS SOLICITATION OF THE PHS FOR SBIR GRANT AND COOPERATIVE AGREEMENT APPLICATIONS from the above sources also. See also the NIH GUIDE FOR CONTRACTS AND GRANTS, Volume 23, Number 15, April 15, 1994. $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** MINORITY INSTITUTIONS RESEARCH DEVELOPMENT PROGRAM NIH GUIDE, Volume 23, Number 32, August 26, 1994 P.T. 34, FF; K.W. 0710030 National Institute on Drug Abuse PURPOSE The purpose of this notice is to inform the research community that the National Institute on Drug Abuse (NIDA) will accept competing continuation (renewal) applications for participation in the Minority Institutions Research Development Program (MIRDP). The MIRDP was designed to increase the capacity of predominantly minority institutions and their faculty to conduct alcohol, drug abuse, and mental health research. NIDA is accepting renewal applications specific to drug abuse research. APPLICATION PROCEDURES Renewal applications are to be submitted on the grant application form PHS 398 (rev. 9/91), with a cover letter indicating the request for renewal. The application face page must also indicate across top margin "RENEWAL APPLICATION" and must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Renewals must be received in accordance with the standard receipt dates for competing continuation (renewal) applications (i.e., March 1, July 1, and November 1). Competing continuation (renewal) applications must include a progress report containing the following information: 1. Summary of institution's research projects developed or expanded through the MIRDP award; 2. Outline of drug abuse-related research development activities by institution, faculty and staff; 3. Demonstration of increased involvement or interest by minority students in drug-related research projects or pursuing drug-related research careers through participation in MIRDP-sponsored activities; 4. Review of any infrastructure enhancements to institution, including faculty ability to conduct drug abuse-related research. Include any examples of laboratory improvement, faculty development, data and statistical analysis capability, resource development, and the like. The competing continuation (renewal) application should, as in the original: (1) assess the current institutional and faculty capacity to conduct drug-related research, (2) identify unmet needs, and (3) describe the activities to further develop the institutional infrastructure and faculty capacity to conduct drug research. The continuation application should include both an institutional research development program and one or more individual investigator projects. The applicant must submit a budget detailing the costs associated with the proposed renewal, including personnel (percent effort, rate, and fringe benefits), supplies and equipment, shipping and handling expenses, laboratory costs, and expenses for study subjects including travel reimbursements, if applicable. The NIH peer review process will be used. A NIDA study section with expertise in the subject area will evaluate the scientific merit of the application, using evaluation criteria described in the MIRDP program announcement dated April 1989. INQUIRIES Questions regarding programmatic aspects and matters pertaining to the review of the application may be directed to: Lula A. Beatty, Ph.D. Special Populations Office National Institute on Drug Abuse 5600 Fishers Lane Parklawn Building, Room 10A08 Rockville, MD 20857 Telephone: (301) 443-0441 Questions regarding administrative or budgetary issues may be directed to: Gary Fleming Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane Parklawn Building, Room 8A54 Rockville, MD 20857 Telephone: (301) 443-6710 $$N4 END ************************************************************ $$N5 BEGIN ********************************************************** AVAILABILITY OF FISH OIL TEST MATERIALS NIH GUIDE, Volume 23, Number 32, August 26, 1994 P.T. 34; K.W. 0780017 National Institutes of Health This notice supplements the previous announcement published in the NIH Guide for Grants and Contracts, Vol. 19, No. 11, March 16, 1990. SUMMARY AND PURPOSE Additional Test Materials Currently Available The Fish Oil Test Materials Program announces the availability of purified EPA (approx. 90 %) and DHA (approx. 90%) in kilogram quantities to qualified applicants conducting research studies. o EPA ethyl ester, packaged in 1 gm soft gelatin capsules (contain tocopherols(1-2 mg/g) and TBHQ(.02%) o DHA ethyl ester, packaged in 1 gm soft gelatin capsules (contain tocopherols(1-2 mg/g) and TBHQ(.02%) o Placebo ethyl esters, packaged in 1 gm soft gelatin capsules (described with other products listing) Processing and Specifications of Biomedical Test Materials o EPA Ethyl Ester The ethyl ester of EPA is prepared from fish oil using transesterification, short-path distillation and urea adduction to yield an n-3 ethyl ester concentrate. The purified ethyl ester of EPA is attained by preparative chromatographic techniques. The product contains 95% ethyl esters; of the ethyl esters EPA is 95%, other n-3's are <4%, n-6's are <1% and other fatty acid esters are <1%. It contains 0.2 mg/g TBHQ as antioxidant and 2 mg/g tocopherols. o DHA Ethyl Ester The ethyl ester of DHA is prepared from fish oil using transesterification, short-path distillation and urea adduction to yield an n-3 ethyl ester concentrate. The purified ethyl ester of DHA is attained by preparative chromatographic techniques. The product contains >95% ethyl esters; of the ethyl esters DHA is 86%, other n-3's are <9%, n-6's are <3% and other fatty acid esters are <1%. It contains 0.2 mg/g TBHQ as antioxidant and 2 mg/g tocopherols. FISH OIL TEST MATERIALS PROGRAM The Fish Oil Test Materials Program is administered by the National Institute on Alcohol Abuse and Alcoholism, NIH. The program was established in 1986 through the cooperation of the National Institutes of Health (NIH), the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA), and the National Oceanic and Atmospheric Administration/Department of Commerce (NOAA/DOC). This program has been designed to provide a long-term, consistent supply of quality-assured/quality-controlled test materials to researchers to facilitate the evaluation of the role of omega-3 fatty acids in health and disease. Fish Oil Test Materials Advisory Committee A Fish Oil Test Materials Advisory Committee (FOTMAC) is chaired by scientific staff from NIH and is composed of scientists representing the funding agencies (NIH), the research community, Department of Commerce (DOC) and the Food and Drug Administration (FDA). The FOTMAC provides scientific advice to the DOC regarding the types of materials needed by research scientists, shipping procedures for the materials, and additional quality control and production issues. The committee is advisory to the Fish Oil Test Materials Program on general programmatic issues such as future directions, and has produced an information sheet on Considerations in the Study of the Effects of Dietary Fish Oils. In addition, the committee provided guidance to DOC during the production of the Drug Master File submitted to the FDA by the FOTMAC. Manuals on Analytical Methods for the Quality Assurance of Fish Oil, Production Methods/Safety and Distribution were produced by the DOC and are available to investigators. Fish Oil Test Materials Distribution Committee A Fish Oil Test Materials Distribution Committee (FOTMDC) is composed of NIH and other Federal scientists. The Distribution committee processes the applications received from investigators, advises the DOC of applicants that have fulfilled the application process, and makes recommendations regarding the distribution of requested materials. Other Test Materials Currently Available o n-3 ethyl ester concentrate, prepared from menhaden oil, bulk packed or soft-gel encapsulated (80% n-3 fatty acids including EPA and DHA) o Ethyl esters of olive oil, corn oil, and safflower oil (70% linoleic), bulk packed or soft-gel encapsulated o Deodorized menhaden oil, bulk packed or soft-gel encapsulated o Commercial preparations of corn, olive, or safflower oil, soft-gel encapsulated only o DHA Ethyl Ester and EPA Ethyl Ester in small gram quantities, bulk packed Processing and Specification of Biomedical Test Materials o n-3 Ethyl Ester Concentrate The n-3 ethyl ester concentrate is prepared from vacuum-deodorized menhaden oil using transesterification, urea adduction and short-path distillation. The concentrate contains >90% ethyl esters, of which approximately 80% are n-3 fatty acid ethyl esters (44% EPA, 24% DHA, 10-12% other n-3 fatty acid ethyl esters), 3% C18 (other than n-3), 6% C16 and the remainder as other esters. It contains 0.2 mg/g TBHQ as antioxidant, 2 mg/g tocopherols and 2.0 mg/g cholesterol. The concentrate is available in 1 g soft-gel capsules (100 capsules/bottle) or packaged in bulk in quantities suitable to investigators' needs. o Placebo Ethyl Esters The olive, corn and safflower ethyl esters contain >85% esters. The olive oil ethyl esters contain approximately 70% oleic acid, 10% C16, and 6% C18 (<6 mg/g n-3) fatty acid ethyl esters. The corn oil ethyl ester contains approximately 50% linoleic, 23% oleic acid and 10% C16 (>6 mg/g n-3) fatty acids. The safflower ethyl esters contain approximately 72% linoleic, 8% oleic and 6% C16 (>2 mg/g n-3) fatty acids. The preparations are available in 1 g soft-gel capsules (100 capsules/bottle) or packaged in bulk in quantities suitable to investigators' needs. o Deodorized Menhaden Oil Deodorized menhaden oil is prepared from oil that has been winterized and alkali refined; it is processed through a two stage wiped-film evaporator to remove cholesterol, volatile oxidation products and any traces of organic contaminants. The oil contains approximately 30% n-3 fatty acids in the triglyceride form; 14% EPA, 8% DHA, 8% other n-3. It contains 0.2 mg/g TBHQ as antioxidant, 2 mg/g tocopherols and 2.0 mg/g cholesterol. The deodorized oil is available in 1 g soft-gel capsules (100 capsules/bottle) or is packaged in bulk quantities suitable to investigates needs. Special requests for antioxidants-free oil will be considered, e.g., for studies involving varying levels of antioxidants. o Placebo Oils Commercial preparations of corn, olive, and safflower oil have been soft-gel encapsulated to serve as placebos for studies involving encapsulated menhaden oil. These oils contain 0.2 mg/g TBHQ as antioxidant and 2 mg/g tocopherols. The major fatty acids for each oil are: corn (58% 18:2n-6, 26% 19:1n-9) olive 17% 18:2n-6, 57% 18:1n-9), safflower 80% 18:2n-6, 9% 18:1n-9). They are available in 1 g soft-gel capsules (100 capsules/bottle). Although vegetable oils will not be supplied in bulk form, investigators may request analysis of antioxidants and tocopherol levels in vegetable oils that they purchase for their studies. APPLICATION PROCEDURES To qualify to receive materials described in this announcement the applicant must: (1) have peer-reviewed research indicating the need for the requested materials, and (2) submit a correctly completed application form and a signed waiver of liability. The committee will not be responsible for assessing the scientific merit of the application. Regulations on human subjects and animal research apply. In accordance with federal regulations, an IND number will be required for the use of these materials in human studies. The FOTMAC has established a drug master file at the FDA that includes manufacturing, chemical composition, and toxicological data relevant to these products. Investigators approved for the use of NOAA/DOC materials may reference this file in order to expedite their IND requests. Availability of materials are contingent on DOC/NOAA production capabilities. When prioritization is necessary, the order will be: (1) NIH funded, (2) other U.S. government funded, (3) peer-reviewed, other funded, (4) NIH approved, not funded, and (5) other. Kilogram quantities of purified EPA ethyl ester and DHA ethyl ester are available for research purposes. The awarded materials are provided free of charge (Researchers are asked to pay shipping costs). For further information, contact Dr. Patricia Fair at (803) 762-1200. Additional information will be provided to the investigator including extensive quality assurance data for each lot of test material shipped, stability data and storage instructions. INQUIRIES Investigators may obtain further information and apply for available fish oil test materials for relevant studies by requesting an application form from: Fish Oil Test Materials Program Program Coordinator National Institute on Alcohol Abuse and Alcoholism DANAC #4, Room 55C 12501 Washington Avenue Rockville, MD 20852 Telephone: (301) 443-2393 FAX: (301) 594-0035 $$N5 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NHLBI-HC-94-32 ******************************************* CARDIOVASCULAR HEALTH STUDY-MAGNETIC RESONANCE IMAGES READING CENTER NIH GUIDE, Volume 23, Number 32, August 26, 1994 RFP AVAILABLE: NHLBI-HC-94-32 P.T. 34; K.W. 0706030, 0785055 National Heart, Lung, and Blood Institute The National Heart, Lung, and Blood Institute (NHLBI) requires a reading center to continue work begun in 1991 for interpretation of cerebral magnetic resonance images (MRI) performed in the epidemiological research study of the major factors contributing to the occurrence of heart disease and stroke in elderly adults entitled "Cardiovascular Health Study (CHS)." The MRI Reading Center will assist in protocol development for the performance of repeat cerebral MRI scans on about 3,400 participants at four CHS Field Centers, and will perform measurements and interpretations of these images in a standardized and reproducible manner. The period of performance is July 1, 1995 through May 31, 2000. This is an announcement for a Request for Proposal (RFP). RFP NHLBI-HC-94-32 is now available. Proposals are due October 27, 1994. One award is anticipated to be made during June 1995. Interested organizations may request either a streamlined or full RFP package. If no selection is made, a streamlined version of the RFP will be provided, which includes only the Statement of Work, deliverables, reporting requirements, and technical evaluation criteria. After examination of these documents, any organization interested in responding to this RFP must request the entire RFP in writing or by FAX. Telephone requests will only be honored if confirmed by FAX or written request. All requests for RFP must cite RFP No. NHLBI-HC-94-32. INQUIRIES Requests for copies of the RFP may be directed to: Patricia A. Smith Division of Extramural Activities National Heart, Lung, and Blood Institute Federal Building, Room 3C16 Bethesda, MD 20892 FAX: (301) 496-0075 $$R1 END ************************************************************ $$R2 BEGIN AG-94-006 FULL-TEXT ************************************** NATHAN SHOCK CENTERS OF EXCELLENCE IN BASIC BIOLOGY OF AGING NIH GUIDE, Volume 23, Number 32, August 26, 1994 RFA AVAILABLE: AG-94-006 P.T. 04; K.W. 0715210, 0710010 National Institute on Aging Letter of Intent Receipt Date: October 15, 1994 Application Receipt Date: November 29, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Institute on Aging (NIA) invites applications for support of centers of excellence in research on basic biological mechanisms of aging, to be known as Nathan Shock Centers of Excellence in Basic Biology of Aging. The purpose of this core center grant is to enhance the quality of research in the basic biology of aging, facilitate the planning and coordination of aging research activities, and provide a suitable environment for fellows and junior faculty to acquire research skills and experience through support of core activities at institutions that have demonstrated commitment to, and expertise in, basic biology of aging research. 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, Nathan Shock Centers of Excellence in Basic Biology of Aging, 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit organizations and institutions, State and local governments and their agencies, and authorized Federal institutions. To be eligible for award as a Nathan Shock Center of Excellence, the center must currently support a minimum of fifteen peer-reviewed, externally funded research projects. In the case of currently funded program projects (P01s) or similar grants, each research component will be deemed to be a separate project. Supportive core components do not qualify. Minority individuals and women from qualifying institutions are encouraged to apply. MECHANISM OF SUPPORT The Nathan Shock Centers will be supported through the NIH core center grants (P30). 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 may years. The anticipated award date is July 1995. FUNDS AVAILABLE Support may be requested for a period of five years. The direct costs requested for the first year may not exceed $325,000, exclusive of indirect consortium costs. Applications with budget requests exceeding this amount will not be accepted by the NIA and will be returned to the applicant. Budget increments for subsequent years will be limited to no more than four percent. Plans are to make two or three awards in fiscal year 1995 and further awards in fiscal years 1996 and 1997 depending upon availability of funds. RESEARCH OBJECTIVES The Core Center is a mechanism designed to enhance and extend the effectiveness of a group of related projects and investigators already funded through other mechanisms such as research project grants (R01), program projects (P01), FIRST awards (R29), MERIT awards (R37), or other Federal or non-Federal externally peer reviewed grants. In this respect, the Core Center mechanism builds upon an established base of research excellence, which emphasizes common themes or foci. Each Core Center Grant must include a core resources component and a limited program enrichment component that supports administrative functions and advisory committee expenses. Activities such as animal facilities, biometric support, molecular/cell biology and/or equipment, which must be utilized by three or more projects on aging research that are already funded, would be supported in the resources core. Core center grants also may include a research development core and an expanded program enrichment core. The expanded program enrichment core would support conferences, symposia, travel to scientific meetings and special consultants. The research development core would provide support for pilot/feasibility projects or temporary salary support to investigators just entering the research on aging arena to a point where they can compete for independent support. Such salary support usually would not exceed two years. An appropriately qualified scientist must be named as a director of each core proposed as well as a Center Director for overall direction. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. APPLICATION PROCEDURES The applicant must submit the application using PHS 398 (rev. 9/91). Application kits containing this form and the necessary instructions are available in most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248. Applicants are urged to obtain from the NIA Scientific Review Office guidelines for preparing multicomponent applications, which contain information not found in the standard PHS 398 kit. NIA program staff are available to provide guidance on programmatic and administrative issues, in the development of the application. REVIEW CONSIDERATIONS Applications must be received by November 29, 1994. Upon receipt, applications will be reviewed for completeness by the Division of Research Grants (DRG), and responsiveness by NIA staff. Incomplete applications will be returned to the applicant without further consideration. If NIA staff find that the application is not responsive to the RFA, or if the first year budget request exceeds $325,000 in direct costs, exclusive of indirect costs requested for consortiums, 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 NIA in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. Because a site visit is not anticipated, each application must be thorough and complete enough to stand on its own merits. The second-level review will be made by the National Advisory Council on Aging at its May 1995 meeting, for funding beginning in July 1995. The primary criterion for review by the NIA review committee in evaluating each grant application will be the potential of the proposed center to contribute to enriching programs leading to understanding basic mechanisms of aging. It is recognized that not all criteria will be applicable to every application, depending on number and extent of proposed cores. Specific criteria are listed in the RFA. AWARD CRITERIA The anticipated date of the first year award will be July 1995. Funding criteria will be scientific merit (based on the review criteria listed above), availability of funds, and programmatic priorities. Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA, inquiries regarding programmatic issues, and address the letter of intent to: Richard L. Sprott, Ph.D. Biology of Aging Program National Institute on Aging Gateway Building, Room 2C231 7201 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-4996 FAX: (301) 402-0010 Direct inquiries regarding fiscal issues to: Robert Pike Grants and Contracts Management Office National Institute on Aging Gateway Building, Room 2N212 7201 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-1472 FAX: (301) 402-3672 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 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. $$R2 END ************************************************************ $$R3 BEGIN AI-94-028 FULL-TEXT ************************************** ADULT AIDS CLINICAL TRIALS GROUPS NIH GUIDE, Volume 23, Number 32, August 26, 1994 RFA AVAILABLE