From owner-sci-resources@net.bio.net Mon Sep 02 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 31 August 1996 Date: 3 Sep 1996 15:04:29 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 141 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <50ia1d$od5@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending August 31, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Graduate Fellowships Title: FMAPPL Application Form with instructions File size (bytes): 272 STIS Filename: fmappl.txt Also available: fmappl.pdf fmappl.doc Title: FMINFO Information form with instructions File size (bytes): 271 STIS Filename: fminfo.txt Also available: fminfo.pdf fminfo.doc Document Type: Recruit Title: Auditor File size (bytes): 8564 STIS Filename: vgs9654.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Graduate Fellowships Title: FMCRSRPT Course Report Form File size (bytes): 260 STIS Filename: fmcrsrpt.txt Also available: fmcrsrpt.doc fmcrsrpt.pdf Title: FMGENINS General Instructions & Inventory List File size (bytes): 278 STIS Filename: fmgenins.txt Also available: fmgenins.doc fmgenins.pdf Title: FMGFKITD - Instructions for MS Word for Windows 6.0 Forms Kit File size (bytes): 3238 STIS Filename: fmgfkitd.txt Also available: fmgfkitd.doc Title: FMGFKITD - Instructions for MS Word for Windows 6.0 Forms Kit File size (bytes): 3238 STIS Filename: fmgfkitd.txt Also available: fmgfkitd.doc Title: FMGFKITP - Instructions for PDF Forms Kit File size (bytes): 3248 STIS Filename: fmgfkitp.txt Also available: fmgfkitp.pdf Title: FMGFKITP - Instructions for PDF Forms Kit File size (bytes): 3248 STIS Filename: fmgfkitp.txt Also available: fmgfkitp.pdf Title: FMGPA Undergraduate GPA Form File size (bytes): 256 STIS Filename: fmgpa.txt Also available: fmgpa.doc fmgpa.pdf Title: FMGRE GRE Information and GRE Candidate Identification Form File size (bytes): 288 STIS Filename: fmgre.txt Also available: fmgre.doc fmgre.pdf Title: FMPRERES Previous Research Experience Form File size (bytes): 273 STIS Filename: fmpreres.txt Also available: fmpreres.pdf fmpreres.doc Title: FMPROPLN Proposed Plan of Study or Research Form File size (bytes): 279 STIS Filename: fmpropln.txt Also available: fmpropln.doc fmpropln.pdf Title: FMREFRPT Reference Report Form File size (bytes): 262 STIS Filename: fmrefrpt.txt Also available: fmrefrpt.doc fmrefrpt.pdf Title: FMTRSREQ Transcript Request Form File size (bytes): 263 STIS Filename: fmtrsreq.txt Also available: fmtrsreq.doc fmtrsreq.pdf Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 113967 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 125372 STIS Filename: phnorg.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg.txt, the text of your message should be as follows: get phnorg.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg.txt, you would enter: ftp> get phnorg.txt 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". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Wed Sep 04 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 30, pt. 1of1, 6 September 1996 Date: 5 Sep 1996 16:27:00 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 579 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <50nnk4$bhs@net.bio.net> NNTP-Posting-Host: net.bio.net X-comment: RFAs described: PA-96-072 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.09.06 NIH GUIDE - Vol. 25, No. 30 - September 6, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** 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 $$INDEX N2 ********************************************************** NCI PROGRAM PROJECT APPLICATION INFORMATION National Cancer Institute INDEX: CANCER NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** TB RESEARCH MATERIALS AND VACCINE TESTING (RFP NIH-NIAID-DMID-97-06) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX P1 ********************************************************** MECHANISMS OF AIDS PATHOGENESIS (PA-96-072) National Institute of Allergy and Infectious Diseases National Institute of Dental Research INDEX: ALLERGY, INFECTIOUS DISEASES; DENTAL RESEARCH THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** SMALL BUSINESS INNOVATION RESEARCH PROGRAM NIH GUIDE, Volume 25, Number 30, September 6, 1996 P.T. 34; K.W. 0710030 National Institutes of Health Centers for Disease Control and Prevention Contract Proposal Receipt Date: November 5, 1996 Innovative technologies and methodologies fuel progress in biomedical and behavioral research and represent an increasingly important area of the economy. The Small Business Innovation Research (SBIR) program provides support for research and development (R&D) of new or improved technologies and methodologies that have the potential to succeed as commercial products. 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 (PHS 97-1)" with a due date for receipt of proposals of November 5, 1996; 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. Beginning October 1, 1996 (FY 1997) through FY 2000, Public Law 102-564, dated October 28, 1992, requires the Public Health Service (PHS), Department of Health and Human Services, and certain other federal agencies to reserve 2.5 percent of their extramural research or R&D budgets for an SBIR program. The PHS SBIR set-aside requirement for FY 1997 is estimated to be $230-$240 million. 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(s) at a research institution; for the scientist(s) 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. (However, see ~Fast-Track~ Pilot Initiative below.) 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: Normally, 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: Normally, 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. "FAST-TRACK" PILOT INITIATIVE (Applicable only to proposals submitted to National Institutes of Health [NIH]) Fast-Track is a parallel review option available to those small business concerns (offeror organizations) whose proposals satisfy additional criteria which enhance the probability of the project's commercial success. Proposals that do not meet these criteria may be redirected for review through the standard review procedures described in the PHS SBIR Contract Solicitation under section VIII, Method of Selection and Evaluation Criteria. Fast-Track offers two major advantages: 1. Concurrent peer review of both Phase I and Phase II projects. Fast-Track SBIR proposals for both Phase I and Phase II must be submitted together for concurrent initial peer review and evaluation. To Identify the proposals as Fast-Track, check the box marked "Yes" next to the words "Fast-Track Proposal" shown on the Phase I Proposal Cover Sheet (Appendix A). The Phase I proposal must specify clear, measurable goals (milestones) that should be achieved prior to initiating Phase II. Failure to provide clear, measurable goals may be sufficient reason for the peer review committee to exclude the Phase II proposal from Fast-Track review, retaining it for Phase I consideration only. The peer review committee will evaluate the goals and may suggest other milestones that should be achieved prior to the Phase II award. The Phase I and Phase II proposals will be scored individually and the scores for both phases totaled. Following the initial peer review, Fast-Track proposals may receive secondary review by the program staff of the respective NIH awarding component. 2. Minimal or no funding gap between Phase I and Phase II. Fast-Track Phase II proposals may be funded following submission of the Phase I progress report and other documents necessary for continuation. Phase II proposals will be selected for award based on the project's scientific and technical merit of the proposed Phase II research; the awarding component's assessment of the Phase I progress report and determination that the Phase I objectives were met and feasibility demonstrated; the potential of the proposed research for technological innovation; and the availability of funds. (See section VIII of the PHS SBIR Contract Solicitation for discussion of the Technical Evaluation Criteria.) SBIR contract proposals submitted to the NIH are eligible for the Fast-Track review process upon meeting the following criteria: 1. The Phase II proposal must be accompanied by a commitment(s) for funds and/or resources for commercialization of the product(s) or service(s) resulting from the SBIR contract. Although a specific level of commitment is not specified, funds or resources matching or greater than the Phase II award are encouraged. Any commitment(s) >From an investor or partner organization must be described in a letter of agreement or contract signed by an official of the investor or partner organization with the authority to legally bind the organization. Details of the commitment(s) must be included in a COMMITMENT APPENDIX to the Phase II proposal. 2. The COMMITMENT APPENDIX must specify the amount of funds and/or the nature of resources that will be dedicated to activities directly related to the SBIR project and must describe those activities. Non- federal commitments may support additional research and development on the project or activities that are beyond the scope of federal SBIR funding, such as market research. The activities supported by the commitment(s) should begin in Phase II and provide for a smooth transition into Phase II commercialization. 3. Because of the risk involved, the commitment(s) may be contingent upon the small business concern receiving the Phase II award, achieving technical objectives, and the technology continuing to be scientifically and economically viable in the marketplace. Details of commitment contingencies must be described in the COMMITMENT APPENDIX. Withdrawal of the commitment(s) may be considered sufficient reason by the participating awarding component to remove the Phase II proposal from consideration under Fast-Track or withhold further Phase II support. 4. The small business concern must submit a concise Product Development Plan (limited to five pages) as a PRODUCT DEVELOPMENT PLAN APPENDIX to the Phase II proposal addressing each of the following areas: a. Company information, including size, specialization area(s), products with significant sales, and history of previous federal and non-federal funding, regulatory experience, and subsequent commercialization. b. Value of SBIR project, including lay description of key technology objectives, current competition, and advantages to competing products or services. c. Commercialization plans, milestones, target dates, market analyses of market size, and estimated market share after first year sales and after five years. d. Patent status or other protection of project intellectual property. Following are the research topics contained in the SOLICITATION OF THE PUBLIC HEALTH SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH (SBIR) CONTRACT PROPOSALS (PHS 97-1) for the proposal receipt date of November 5, 1996: NATIONAL INSTITUTES OF HEALTH NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM (NIAAA) o Antibodies to peptides and proteins mediating alcohol-related behaviors (from DBR); NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES (NIAMS) o Markers of Osteoarthritis NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) o Assays for Identification of High Risk Individuals for the Development of Insulin Dependent Diabetes (IDDM) o Transplantation of Human Islets or Beta Cells o Improved Methods for Production of Clinical Gene Therapy Vectors for Diseases of Interest to NIDDK o Development of Materials for Screening and Recruitment of Clinical Trial Participants o Self-study Materials for Achieving Intensive Management of Glycemic Levels o Methods to Detect and Quantify Kidney Damage o Acute Renal Failure o New Noninvasive Body Iron Test NATIONAL INSTITUTE ON DRUG ABUSE (NIDA) o Drug Supply Services Support o Develop Animal Model(s) with Compromised Immune Function Induced by Abused Drug(s) to Screen Potential HIV/AIDS Medicating Agents o Develop Animal Models to Assess the Potential for Genetic Predisposition or Increased Sensitivity to Cardiovascular Complications Associated with Abused Substance(s) o Computerized Neuropsychological Testing Software o Development of a Computerized Problem Oriented Screening Instrument for Teenagers (Posit) o Development of Improved HIV Risk Reduction Questionnaire and Interview o Questionnaires or Brief Interviews for Assessment of Drug Abuse in Individuals Seen in Primary Health Care Settings o Handbook for Conducting Drug Abuse Research with Ethnic/Racial Minority Populations o International Drug Abuse Epidemiology Data Bank NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES (NIEHS): o Development of a Transgenic Teleost Animal Model for Assessing Mutagenesis o Better Nitrone Spin Traps for Oxygen-Centered Radicals o Commercialization of Laboratory Methods for Assessing the Genetic Responses to Chemicals o Device/Capability for Quantitative Assessment of Bone Strength in Rodents o Methods for Assessing the Estrogenicity and Other Endocrine Activity of Environmental Chemicals o Development of Device and Procedure for Collecting DNA by Mail with a Cheek Swab NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) o Stage- and Tissue-Specific Animal Models of Hemophilia o Radio-frequency Coils for High Field MRI o ECG Monitoring in MRI to Detect Cardiac Ischemia NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) o Animal Models o Models for Screening Antiepileptic and Antiepileptogenic Therapy o Alertness Measures o Improved EEG/ICU/OR Interface o Medication Dispensing Monitor o Improving Magnetic Resonance Imaging to Evaluate the Central Nervous System of Critically-ill Neonates o Development of Neuronal Pluripotential Neuronal Stem Cells o Quantitative Tremor Measurement o Inducible Knockout Technology o Genome Scanning o Direct Gene Transfer NATIONAL CENTER FOR RESEARCH RESOURCES (NCRR) o General Software Tools for Biomedical Research CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) NATIONAL CENTER FOR HEALTH STATISTICS (NCHS) o Electronic Death Registration System Prototype NATIONAL IMMUNIZATION PROGRAM (NIP) o Design a Multi-channel, Needleless Injector Device to Administer Vaccines PUBLIC HEALTH PRACTICE PROGRAM OFFICE (PHPPO) o Distance Learning (DL) Support Technology. INQUIRIES Eligibility requirements, definitions, submission procedures, review considerations, contract proposal forms and instructions, and other pertinent information, including the "Fast-Track" Pilot Initiative, are contained in the Solicitation of the PHS for SBIR Contract Proposals for the proposal receipt date of November 5, 1996, which will be available electronically on or about September 6, 1996, through the NIH Home Page at: HTTP://WWW.NIH.GOV. A limited number of hard copies of the Solicitation will be available on or about September 13, 1996, from: PHS SBIR/STTR Solicitation Office 13687 Baltimore Avenue Laurel, MD 20707-5096 Telephone: (301) 206-9385 FAX: (301) 206-9722 Email: a2y@cu.nih.gov Those interested in the PHS SBIR GRANT program may access -- electronically -- the OMNIBUS SOLICITATION OF THE PUBLIC HEALTH SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH (SBIR) GRANT APPLICATIONS for the calendar year 1996 receipt dates of April 15, August 15, and December 15 (same dates each year) at: HTTP://WWW.NIH.GOV:80/GRANTS/OEP/SBIR/SBIR962.HTM. The "Fast-Track" review option is a pilot initiative for SBIR grant applications also. Hard copies of the PHS SBIR GRANT Solicitation may be obtained from the PHS SBIR/STTR Solicitation Office at the address above. See also the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 25, Number 7, March 8, 1996. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NCI PROGRAM PROJECT APPLICATION INFORMATION NIH GUIDE, Volume 25, Number 30, September 6, 1996 P.T. 34; K.W. 1014006, 0715035 National Cancer Institute Application Submission There are three receipt deadlines for all NCI Program Project (P01) applications. Regardless of whether the application is new, a competing renewal, amended, or a request for a supplement, the only receipt dates are: February 1, June 1, and October 1. Incoming applications are assigned to the review round that follows the date that they are received by the Division of Research Grants. For example, a grant application received in March would be assigned to the June 1 review cycle. Also note that effective June 1, 1996, NIH Program Staff are required to notify the Division of Research Grants Receipt and Referral Office of any new application requesting $500,000 (direct costs) or more in any one year, before the application is received. In order to do this, Program Staff must be notified in advance of the intent to submit such an application. Since the vast majority of NCI P01s exceed $500,000 per year, you must inform the NCI Referral Officer of your intent to submit a new P01 application. The mailing address, telephone number and E- mail address are as follows: Referral Officer Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636A - MSC 7405 Bethesda, MD 20892-7405 Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: FRIEDBET@DEA.NCI.NIH.GOV Amended Applications The Office of the Director, NIH, issued a notice in June 1996 that beginning with the October 1, 1996 receipt date the NIH no longer accepts applications amended more than twice. This policy applies to all applications, including new and competing continuation program projects. Applicants approaching this limit are strongly advised to consider alternative funding mechanisms (e.g., concurrent submission of individual R01s) at the time of submission of any A2 (second amended) P01 application. Instructions to Applicants Copies of the NCI P01 Guidelines can be obtained from the NCI Referral Office (address shown above). The Guidelines may also be accessed via the NCI Home Page at: HTTP://WWW.NCI.NIH.GOV/EXTRA/DEAWEB/DEA.HTM INQUIRIES Questions related to NCI P01 review may be directed to: David Irwin, Ph.D. Division of Extramural Activities 6130 Executive Boulevard, Room 635E - MSC 7405 Bethesda, MD 20892-7405 Telephone: (301) 402-0371 FAX: (301) 496-6497 Email: IrwinD@DEA.NCI.NIH.GOV $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NIH-NIAID-DMID-97-06 ************************************* TB RESEARCH MATERIALS AND VACCINE TESTING NIH GUIDE, Volume 25, Number 30, September 6, 1996 RFP AVAILABLE: NIH-NIAID-DMID-97-06 P.T. 34; K.W. 0740075, 0715165 National Institute of Allergy and Infectious Diseases The Respiratory Diseases Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases has a requirement for a contractor to supply tuberculosis research materials to the scientific community and to provide animal models for aerosol challenge studies. Integral to this project will be efforts, in cooperation with other interested tuberculosis researchers, directed toward identification and evaluation of the major M. tuberculosis antigens associated with protection against tuberculosis. It is anticipated that one cost-reimbursement, completion contract will be awarded for a period of seven years. RFP NIAID-DMID-97-06 is available electronically and may be accessed through the World Wide Web by using the following Web address or URL (uniform resource locator): http://www.anser.org/nih/. This RFP is only available via this RFP Home Page, and proposals in response to this RFP must be submitted electronically. Instructions for this procurement and for proper submission are set forth at the Web Site mentioned above. Following proposal submission and the initial review process, offerors comprising the competitive range will be requested to provide additional documentation to the Contracting Officer. Responses to this RFP will be due on October 28, 1996. Any responsible offeror may submit a proposal that will be considered by the Government. This advertisement does not commit the Government to award a contract. Questions regarding this acquisition may be directed to Mr. Carl Henn at (301) 496-0993, or internet address ch24v@nih.gov. $$R1 END ************************************************************ $$P1 BEGIN PA-96-072 FULL-TEXT ************************************** MECHANISMS OF AIDS PATHOGENESIS NIH GUIDE, Volume 25, Number 30, September 6, 1996 PA AVAILABLE: PA-96-072 P.T. 34; K.W. 071508, 0765033, 0705048 National Institute of Allergy and Infectious Diseases National Institute of Dental Research PURPOSE This Program Announcement (PA) is intended to foster applications for integrated, multi-disciplinary pathogenesis research linking in vitro studies to in vivo disease, focusing on the following targeted areas of research identified in the 1995 NIAID HIV/AIDS Research Agenda: (1) possible direct and indirect mechanisms of HIV-mediated immunodeficiency; (2) events at cell and organ levels that characterize or predict HIV entry or disease progression; (3) host genes, alleles, corresponding proteins and their mechanisms of action that control susceptibility to HIV infection, level of infectivity for HIV transmission, and/or rate of disease progression; and (4) impact of vaccine-induced immune responses on mucosal transmission and in vivo pathogenesis. The mechanisms of support will be research project grants (R01), Interactive Research Project Grants (IRPG), the First Independent Research Support and Transition (FIRST) (R29) award, and the Small Research Grants (R03). Research support may also be obtained through applications for a competitive supplement to ongoing NIH-funded grants. 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, Mechanisms of AIDS Pathogenesis, 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 Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Opendra Sharma, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C04 - MSC 7620 Bethesda, MD 20892-7620 Telephone: (301) 496-9041 Email: os4g@nih.gov Eleni Kousvelari, D.D.S; D.Sc Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-24 Bethesda, MD 20892-6402 Telephone: (301) 594-2427 Email: Kousvelari@de45.nidr.nih.gov $$P1 END ************************************************************ From owner-sci-resources@net.bio.net Wed Sep 04 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-072 - V25(30) 09/06/96 Date: 5 Sep 1996 16:27:40 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 368 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <50nnlc$bjg@net.bio.net> NNTP-Posting-Host: net.bio.net MECHANISMS OF AIDS PATHOGENESIS NIH GUIDE, Volume 25, Number 30, September 6, 1996 PA NUMBER: PA-96-072 P.T. 34; K.W. 071508, 0765033, 0705048 National Institute of Allergy and Infectious Diseases National Institute of Dental Research PURPOSE This Program Announcement (PA) is intended to foster applications focusing on an hypothesis for AIDS-related pathogenesis applying state-of-the-art methods and approaches to in vivo research. In vivo research includes studies of human clinical or epidemiologic cohorts, animal models, or appropriate specimens from humans or animals. Where scientifically justified, applicants are encouraged to include both human and animal studies. While the research necessary to test a proposed pathogenesis hypothesis may be possible within a single laboratory, some applications may require separate components at the same or different institutions specializing in different scientific disciplines (e.g., molecular biology, biochemistry, cellular biology, cellular immunology, pathology, genetics and biophysics). 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, Mechanisms of AIDS Pathogenesis, 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 Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local government, and eligible agencies of the Federal government. The total requested project period for an application submitted in response to this PA may not exceed five years; a foreign application may not request more than three years of support and will receive no support for indirect costs. Domestic applications may include international components but these components will receive no support for indirect costs. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) Award. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The mechanisms of support will be investigator-initiated research project grants (R01), Interactive Research Project Grants (IRPG), the First Independent Research Support and Transition (FIRST) (R29) award, and the Small Research Grants (R03). Research support may also be obtained through applications for a competitive supplement to ongoing NIH-funded grants. Information on the IRPG mechanism is available in program announcement PA-96-001, published in the NIH Guide for Grants and Contracts, Vol. 24, No. 35, October 6, 1995. Applicants for R03 grants may request up to $50,000 annual direct costs for a period not to exceed two (NIDR) or three (NIAID) years. Applicants for R03 grants must follow special application guidelines, which are referenced below. Publications containing IRPG and R03 application guidelines are available from the program staff listed under INQUIRIES. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Applicants are encouraged to coordinate, through the use of consortium arrangements or subcontracts, integrated approaches with individuals or institutions having relevant reagents and expertise in their use, demonstrated ability in a particular area of relevant research, or access to relevant animal or patient populations. Potential applicants are encouraged to contact the program staff listed under INQUIRIES for guidance concerning the organization and scope of the proposed work, the most appropriate support mechanism, and the preparation of the application. RESEARCH OBJECTIVES This PA encourages hypothesis-focused applications for HIV pathogenesis research linking in vitro studies to in vivo disease on the targeted areas of research identified in the 1995 NIAID HIV/AIDS Research Agenda listed below. Additionally, this PA encourages investigators with current NIH-funded grants on in vivo AIDS pathogenesis to submit competitive supplement applications to examine the effect of vaccination on lentiviral mucosal transmission and/or viral disease. The targeted research areas below are not listed in priority order and are intended to be illustrative rather than exhaustive examples. o Possible direct and indirect mechanisms of HIV-mediated immunodeficiency; e.g., the effect of HIV infection on immune regulation including signaling ligands, receptors, pathways, and cellular maturation processes. o Events at the cell and organ system levels that characterize or predict HIV entry or disease progression; e.g., virus and infected cell trafficking, viral burden and characteristics in blood and tissues (particularly in lymph nodes, oral and gut mucosa, spleen, bone marrow, and brain), and sites and kinetics of CD4+ cell destruction in vivo. o Host genes, alleles, corresponding proteins and their mechanisms of action that control susceptibility to HIV infection, level of infectivity for HIV transmission, and/or rate of disease progression, e.g., adhesion proteins, receptors, cytokines/chemokines and regulatory pathways. o Impact of vaccine-induced immune responses on mucosal transmission and in vivo pathogenesis. The most relevant studies are expected to examine molecular and cellular biology, virology, and immunology within the context of animal models and/or well-defined human cohorts or patient samples. Investigators are encouraged to minimize the number of new animals entered into research studies (and related support expenses) by using, whenever possible, animals in ongoing supported non-human primate research. Descriptive research that is not structured around a specific hypothesis(es) is not within the scope of this PA. For example, natural history epidemiologic studies in many DAIDS-supported cohorts are critically important for collecting information on the cause and course of disease. Although the information provided by such studies may provide a foundation for hypotheses that may be tested in research, this PA is intended to encourage the next step in research, the testing of these hypotheses. Clinical trials and recruitment or retention of cohorts are not encouraged under this PA. However, identified costs for patient visits, sample storage and handling specific to the applicant's proposed research are appropriate. Proposed analyses of samples acquired from epidemiologic or clinical trials are also appropriate. Investigators are encouraged to use existing supported epidemiologic or clinical cohorts instead of requesting funds to support or establish additional cohorts. Applicants are responsible for establishing components and/or collaborative arrangements. Program staff listed under INQUIRIES may be able to assist in forming collaborations and suggesting relevant cohorts or reagent resources. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. The receipt dates for applications for AIDS-related research are also 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 Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: ASKNIH@odrockm1.od.nih.gov. The title and number of this program announcement must be typed in Section 2 on the face page of the application (i.e., "Mechanisms of AIDS Pathogenesis," PA-96-072). The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) NIAID R03 APPLICANTS ONLY Applicants for NIAID R03 grants must follow application guidelines for SMALL RESEARCH GRANTS - NIAID, which appeared in the NIH Guide for Grants and Contracts, Vol. 25, No. 9, March 22, 1996, and are available from the NIAID program staff listed under INQUIRIES. The completed original and three legible single-sided copies of the application must be sent or delivered to the Division of Research Grants at the above address. In addition, mail two copies of the R03 application and all five sets of any appendices to the address below. Also, direct inquiries regarding review issues and special instructions for application preparation to the address below. Stanley Oaks, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4C06 - MSC 7042 Bethesda, MD 20892-7610 Telephone: (301) 496-7042 FAX: (301) 402-2638 Email: os4g@nih.gov NIDR R03 APPLICANTS ONLY Applicants for NIDR R03 grants must follow the guidelines for the Small Grants Program, which appeared in the NIH Guide for Grants and Contracts, Vol. 20, No.12, March 22, 1991. Applicants are also required to follow the R03 page limitations described in the NIH Guide Vol. 22, No. 1, January 8, 1993. Copies of these guidelines are available from the NIDR staff listed under INQUIRES. The completed original and three legible single-sided copies of the application must be sent or delivered to the Division of Research Grants at the above address. In addition, mail two copies of the R03 application to the address below. Also, direct inquiries regarding review issues and special instructions for application preparation to the address below. William Gartland, Ph.D. Division of Extramural Research National Institute of Dental Research Building 45, Room 4AN-32 Bethesda, MD 20892-6402 Telephone: (301) 594-2372 FAX: (301) 480-8303 Email: GartlandW@de45.nidr.nih.gov FIRST (R29) AWARD APPLICANTS ONLY 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. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by study sections of the Division of Research Grants, NIH (or by the review group of the relevant Institute, Center, or Division), in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria o Scientific, technical, or medical significance and originality of proposed research; o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o Availability of the resources necessary to perform the research; o Appropriateness of the proposed budget and duration in relation to the proposed research; o For studies involving human subjects, adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. 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 Institute priority for area of proposed research INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Opendra K. Sharma, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C06 - MSC 7620 Bethesda, MD 20892-7620 Telephone: (301) 496-8378 FAX: (301) 402-3211 Email: os4g@nih.gov) Eleni Kousvelari, D.D.S., D.Sc Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-24 Bethesda, MD 20892-6402 Telephone: (301) 594-2427 FAX: (301) 480-8318 Email: Kousvelari@de45.nidr.nih.gov Direct inquiries regarding fiscal matters to: Ms. Jackie Johnson Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C16 - MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: jj19e@nih.gov Mr. Martin Rubinstein Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-44A Bethesda, MD 20892-6402 Telephone: (301) 594-4800 FAX: (301) 480-8301 Email: Martin.Rubinstein@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, 93.856 - Microbiology and Infectious Diseases Research and 93.855 - Immunology, Allergy and Transplantation 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 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun Sep 08 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 7 September 1996 Date: 9 Sep 1996 16:29:48 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 114 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <51299c$3n6@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending September 7, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Graduate Fellowships Title: FMINFINS Instructions for completing the Information Form File size (bytes): 4735 STIS Filename: fminfins.txt Document Type: Press Release Title: nsf pr96-46-OCEAN SEDIMENTS CONTAIN RECORD OF PAST VEGETATION FIRES IN AFRICA May Provide File size (bytes): 4540 STIS Filename: pr9646.txt Title: pr96-47 - JURIS HARTMANIS TO LEAD NSF'S DIRECTORATE FOR COMPUTER AND INFORMATION SCIENCE AND ENGINEERING File size (bytes): 4086 STIS Filename: pr9647.txt Document Type: Program Guideline Title: NSF 96-138 - Research on Education, Policy and Practice (REPP) File size (bytes): 35259 STIS Filename: nsf96138.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Dir of Awards Title: Minority Graduate Fellowship Awards Program for Fiscal Year 1996 File size (bytes): 14768 STIS Filename: gf96mawd.txt Also available: gf96mawd.dlm Title: Minority Graduate Fellowship Honorable Mention Recipients - FY 1996 File size (bytes): 21630 STIS Filename: gf96mhm.txt Also available: gf96mhm.dlm Title: Graduate Fellowship Awards for Fiscal Year 1996 File size (bytes): 69540 STIS Filename: gf96rawd.txt Also available: gf96rawd.dlm Title: Graduate Fellowship Honorable Mention Recipients for Fiscal Year 1996 File size (bytes): 112050 STIS Filename: gf96rhm.txt Also available: gf96rhm.dlm Document Type: Graduate Fellowships Title: FMGINS General Instructions File size (bytes): 11840 STIS Filename: fmgins.txt Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 114864 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Directory File size (bytes): 125406 STIS Filename: phnorg.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg.txt, the text of your message should be as follows: get phnorg.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg.txt, you would enter: ftp> get phnorg.txt 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". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Sun Sep 15 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 14 September 1996 Date: 16 Sep 1996 15:45:46 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 72 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <51klaq$6rf@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending September 14, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: International Document Title: INT 96-24 Special Scientific Report 96-01, Cooperative Studies of Crustal Deformation using Borehole Strain File size (bytes): 5280 STIS Filename: int9624.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: News Title: MPSLECT - The Big Crunch File size (bytes): 2090 STIS Filename: mpslect.txt Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 113527 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 126460 STIS Filename: phnorg.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg.txt, the text of your message should be as follows: get phnorg.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg.txt, you would enter: ftp> get phnorg.txt 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". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Thu Sep 19 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: BIOSCI/bionet miniFAQ & Fundraiser Date: 20 Sep 1996 14:11:52 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 240 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <199609200900.CAA10257@net.bio.net> NNTP-Posting-Host: net.bio.net (LAST REVISION: 30-JUL-95) This BIOSCI "miniFAQ" is designed to answer the questions that come up the *most frequently*. The main BIOSCI FAQ (Frequently Asked Questions) is accessible on the World Wide Web at URL http://www.bio.net/. If you can not find an answer to your question in this or other documentation, the BIOSCI technical support staff answers e-mail queries sent to biosci-help@net.bio.net We can only answer questions about the use of the newsgroups and mailing lists. We unfortunately do not have the staff to do Internet information searches or answer scientific questions. Please post those to the appropriate BIOSCI/bionet newsgroups. Contents: -------- 0) BIOSCI NEEDS YOUR SUPPORT!! 1) Using the WWW to access the BIOSCI/bionet newsgroups. 2) What to do about "spams," i.e., junk mail, ads, etc. 3) Examples of subscribing and unsubscribing to the mailing lists. 4) The BIOSCI user address and research interest directory. 0) BIOSCI NEEDS YOUR SUPPORT!! ------------------------------ BIOSCI's government funding has been expended, and we are now operating solely from advertising revenue that we have raised from our Web site at http://www.bio.net/. We need just a few minutes of your time to help us serve you. You can do two important things which will take very little time for you individually and will immensely help us continue to help you. First, please use our WWW system at http://www.bio.net/ to access the archives. You can post or reply to messages via your Web browser as described in item #1 below. Your usage helps attract sponsors. If you contact any of our sponsors, please be sure to thank them for supporting BIOSCI. It is critical for them to get this feedback if they are to continue their sponsorship for the long term. Second, if you work for a company or organization that provides products or services of interest to the biology community, please pass this message on to your marketing or marketing communications department or other appropriate group. Please ask them to help support BIOSCI by sponsoring our Web site and explain the uses and benefits of the system to the biology community. If they are interested, they can then contact us for further information at our tech support address, biosci-help@net.bio.net. 1) Using the WWW to access the BIOSCI/bionet newsgroups. -------------------------------------------------------- As of 10 December 1995, all BIOSCI/bionet full newsgroups are accessible through the World Wide Web (WWW) at URL http://www.bio.net. One can read and reply publicly or privately to both recent postings and archived messages through one's Web browser if it is configured properly to send e-mail. Each newsgroup is equipped with its own WAIS index. The main BIOSCI home page also has access to the BIO-JOURNALS Table of Contents database WAIS index and the BIOSCI user address database described in another item further below. 2) What to do about "spams," i.e., junk mail, ads, etc. ------------------------------------------------------- BIOSCI is a set of parallel USENET newsgroups (the "bionet" groups), mailing lists, and a hypermail archive at URL http://www.bio.net/. The same postings are distributed on all media (except for a small number of mailing-list-only groups at net.bio.net). Unfortunately it is becoming a despicable practice on the Internet (by a few people out to make a fast buck) to do automated mass postings to thousands of newsgroups and mailing lists. These attempts to grab free advertising are refered to as "spams" in the usual, somewhat boneheaded, net terminology. USENET is more susceptible to this practice, and many spams originate on the USENET groups and then are passed on to the mailing lists. However, spammers also get lists of mailing addresses and hit these too, so neither medium is immune. What should you do personally if you get junk mail? --------------------------------------------------- Just delete it and move on without reading it further. Filing a protest is becoming increasingly useless because spammers are often disguising the addresses where the messages are sent from. Unless you really understand Internet mail systems, your attempt at protest by sending replies to the message will often end up being sent to the address of an innocent person that the spammer is victimizing. What can BIOSCI/bionet do to protect its newsgroups? ---------------------------------------------------- The only solution currently available is to moderate the newsgroup. If this newsgroup is already moderated, then you are in good shape. Moderation protects the USENET distribution from about 95% of the spams that are being sent to date and protects the mailing lists completely. Moderation means, however, that someone has to take the time to review each message before it goes out. We have set up software here that simply allows the moderator to forward to an address at net.bio.net messages that (s)he wishes to have distributed. This takes no more time than that needed to read the message and pass it on, say about 1 min. per message. Most newsgroups currently have a discussion leader who is responsible for their newsgroup. The discussions leaders and their e-mail addresses are listed in the BIOSCI Information Sheet which is available on the Web at http://www.bio.net/. If a newsgroup is being hit with too many junk postings, please contact the discussion leader for that group and see if there is interest in moderating the group. Please do not assume that by simply posting a complaint to the newsgroup itself, anyone on the BIOSCI staff will act on your complaint. With close to 100 newsgroups to run, the BIOSCI staff has to rely on the discussion leaders of each newsgroup to report problems directly to us at biosci-help@net.bio.net. We will moderate any of our newsgroups if the discussion leader tells us that the readership of the group wishes to do so and if a moderator is willing to do the work. For most BIOSCI/bionet groups, this entails only a few minutes of work each day. Moderating a newsgroup will resolve probably 95% of the junk postings on the USENET distribution. Unfortunately there are easy ways for determined spammers to override the moderation mechanism on USENET, but we can protect our e-mail subscribers from unwanted postings if the newsgroup is moderated. You can also access our newsgroups over the WWW at URL http://www.bio.net. While this Web interface will not stop spammers from trying to post to the groups, this will give you yet another way, besides using USENET news, to keep the junk out of your personal mail files. For those of you with local USENET news systems, the Web interface will also give you faster access to new newsgroups and recent postings. 3) Examples of subscribing and unsubscribing to the mailing lists. ------------------------------------------------------------------ PLEASE NOTE: The BIOSCI management does NOT act on subscription/unsubscription requests that are posted improperly to the newsgroups and mailing lists. People who do this only bother everyone on the lists to no avail. Please be sure to follow the proper procedures below. Gory details are in the BIOSCI Information sheets on the Web at http://www.bio.net. Below we give an example utilizing the METHODS-AND-REAGENTS list at both of our two BIOSCI sites: Users in the Americas and Pacific Rim countries who use the BIOSCI ------------------------------------------------------------------ node at computer net.bio.net: ---------------------------- A) Determine the "listname" which is the <=8 character mail address ^^^^^^^^^^^^^ for the group. These can be found in the BIOSCI Info. Sheet. For the METHODS-AND-REAGENTS group the mailing address is methods@net.bio.net. The listname is the portion of the address to the left of the @ sign, i.e., "methods". The listname is used with the "subscribe" and "unsubscribe" commands illustrated below. B) Mail all commands in the body of a mail message addressed to biosci-server@net.bio.net. Do NOT send commands to the newsgroup posting addresses! Leave the Subject: line blank, any text on it will be ignored. C) In the body of your message put one or more of the following commands with an "end" command on the last line, e.g., subscribe methods unsubscribe methods end Do NOT put your e-mail address or other text on these lines. The server only allows you to cancel your subscription if the address on your mail header matches the address on our mailing list. Please ask for help at biosci-help@net.bio.net if your address has changed, e.g., if you know you are on the list but the server tells you that you are not a member. Users in Europe, Africa, and Central Asia who use the BIOSCI node at -------------------------------------------------------------------- computer daresbury.ac.uk (also known as dl.ac.uk): ------------------------------------------------- To subscribe and unsubscribe to/from the BIOSCI lists, you need to specify the full USENET newsgroup name with "bionet-news." prepended. The USENET newsgroup names are listed in the BIOSCI Information sheet on the Web at http://www.bio.net/. For the METHODS-AND-REAGENTS list the USENET newsgroup name is bionet.molbio.methds-reagnts, thus the appropriate commands are sub bionet-news.bionet.molbio.methds-reagnts unsub bionet-news.bionet.molbio.methds-reagnts These commands are included in a message addressed to mxt@dl.ac.uk, NOT to the newsgroup mailing addresses. As usual, include the text in the body of the message as text on the Subject: line is ignored. To unsubscribe from all the lists at the UK node, use unsub bionet-news Please note that if the address in the list is different than the one in your mail message header, you will not be able to unsubscribe by this method. If you have problems, please mail biosci@daresbury.ac.uk. 4) The BIOSCI user address and research interest directory. ----------------------------------------------------------- Please take this opportunity to add your name, address, and research interest information to the BIOSCI User Address Database if you have not already done so. You can fill out the address form directly through our Web page at URL http://www.bio.net/adrform.html. The address database is reindexed nightly for WWW access (the URL is http://www.bio.net/). If you are not directly on the Internet but can reach it by e-mail, please use our waismail server to access the user directory. waismail use is described above. You can also request a user address form by e-mail from biosci-help@net.bio.net. Please check your database entry from time-to-time to see if your address information is still up-to-date. Because of our limited personnel resources, we ask that you resubmit a *complete* form to revise your entry; we only replace complete entries and do not have resources to edit old forms. Sincerely, Dave Kristofferson BIOSCI/bionet Manager biosci-help@net.bio.net From owner-sci-resources@net.bio.net Sun Sep 22 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 21 September 1996 Date: 23 Sep 1996 15:22:49 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 94 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5272jp$9b3@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending September 21, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: BUL 96-10 -- NSF October Bulletin V-24; No. 2 File size (bytes): 103930 STIS Filename: bul9610.txt Document Type: International Document Title: INT 96-25 Special Scientific Report 96-03, Suzuki Research Group, Department of Physics, University of Tokyo File size (bytes): 4400 STIS Filename: int9625.txt Title: INT 96-26 Special Scientific Report 96-04, IBM ARC System Workshop File size (bytes): 6681 STIS Filename: int9626.txt Document Type: Press Release Title: NSF NAMES NEW ADMINISTRATION HEAD File size (bytes): 2501 STIS Filename: pr9648.txt Document Type: Program Guideline Title: NSF 96-142 - Earth System History (ESH) File size (bytes): 13557 STIS Filename: nsf96142.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Letter Title: REULIST -- Current List of REU Sites File size (bytes): 89814 STIS Filename: reulist.txt Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 115376 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 128596 STIS Filename: phnorg.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg.txt, the text of your message should be as follows: get phnorg.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg.txt, you would enter: ftp> get phnorg.txt 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". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Tue Sep 24 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-96-009 - V25(31) 09/20/96 Date: 24 Sep 1996 17:25:44 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1016 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <529u68$gpe@net.bio.net> NNTP-Posting-Host: net.bio.net ADOLESCENT MEDICINE HIV/AIDS RESEARCH NETWORK NIH GUIDE, Volume 25, Number 31, September 20, 1996 RFA: HD-96-009 P.T. National Institute of Child Health and Human Development National Institute of Allergy and Infectious Diseases National Institute on Drug Abuse Letter of Intent Receipt Date: October 15, 1996 Application Receipt Date: November 19, 1996 PURPOSE The National Institute of Child Health and Human Development (NICHD), the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institute on Drug Abuse (NIDA) invite applications for cooperative agreements to expand the clinical science component of an existing adolescent health research network, the Adolescent Medicine HIV/AIDS Research Network. This Network is conducting basic and clinical research on the medical, biobehavioral, and psychosocial aspects of HIV/AIDS in adolescents infected with HIV through sexual or drug-taking behaviors. The network, established in 1994, is recruiting adolescents ages 12 through 18 years. Additional funding >From Health Resources and Services Administration (HRSA) has been provided to the Network to fund the infrastructure to support research in clinical sites including outreach efforts and to develop and disseminate treatment and policy guidelines specific to HIV-infected adolescents. 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), Adolescent Medicine HIV/AIDS Research Network, centers on a high priority research area: the health and well-being of several special population groups, viz. people in minority groups (particularly Hispanic and African Americans) and people with low income, as well as specific research HIV infection Needs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal Government. Racial/ethnic minority investigators, women, and persons with disabilities are encouraged to apply. It is required that applicants for the Clinical Science Group have clinical experience pertinent to the objectives of the network delineated in this RFA. Applications from individuals without this experience will be returned without review. Applicants to join the existing Clinical Science Group of this Network must be providing comprehensive health care and support services to HIV-infected adolescents. Furthermore, they must demonstrate the proven capacity to reach sufficient numbers of adolescents with HIV infection to satisfy subject accrual expectations. In addition, applicants must be willing and able to participate in a cooperative program of research and evaluation with other successful applicants and current Clinical Science Group members. 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 the performance of the activity. [GRANTS POLICY STATEMENT, DHHS PUBLICATION (OASH) 90-50,000 (REV) APRIL 1, 1994]. Under the cooperative agreement mechanism, 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. Specifically, members of the NICHD, NIAID, NIDA, and HRSA scientific and program staff will cooperate with principal investigators as partners in the projects and serve as science collaborators or program managers. All parties will agree to accept the participatory and cooperative nature of the group process. Details of the responsibilities, relationship, and governance of the study to be funded under cooperative agreements are discussed later in this document under the section "Terms and Conditions of Award." The total project period for applications submitted in response to the present RFA may not exceed three years. The anticipated award date is February, 1997. At this time, NICHD, NIAID, NIDA, and HRSA have not determined whether or how this solicitation will be continued beyond the present RFA. Awards and level of support depend on receipt of a sufficient number of applications of high merit. Although this program is provided for in the financial plans of NICHD, NIAID, NIDA, and HRSA, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. FUNDS AVAILABLE It is estimated that $ 1,044,000 (total costs in fiscal year 1997) will be available to fund approximately three to six awards to support the scientific and subject accrual activity of the members of the Clinical Science Group who are recruited through this RFA. Future year funding will be determined based on initial funding level. The National Institute of Child Health and Human Development will provide the total of these funds. RESEARCH OBJECTIVES Background of the Problem Through December 1995, 2,354 AIDS cases in adolescents (aged 13-19 years) were reported to the National Centers for Disease Control and Prevention. Although adolescents comprise less than one percent of all reported AIDS cases, the impact of HIV infection acquired during adolescence is far more profound for several reasons. First, the long incubation period between initial HIV infection and the development of AIDS-defining conditions suggests that the majority of AIDS cases in persons between 20 and 29 years of age, which constitute nearly 20 percent of all reported AIDS cases, can be attributed to infection as teenagers. Secondly, HIV infection, and to some extent AIDS cases under the new case definition, are not accurately estimated through reporting mechanisms because adolescents lack easy access to medical care for diagnosis. Many may actually succumb to competing causes of mortality (e.g., violence). Recent blinded HIV serosurveys indicate a range of estimates: from prevalence rates of 0.34 per 1000 in 17-19 year-old applicants to the military, 1.7 per 1000 in the users of student health services on selected college campuses, 3.9 per 1000 in Job Corps applicants, to 88 per 1000 in an urban homeless youth center. Of the groups affected by HIV, the U.S. adolescent population is the one in which basic biologic issues are the most poorly understood and the one in which therapeutic and clinical management trials have not been effectively initiated. At the present time, it is not known how HIV infection affects continuing development in those adolescents who have been infected through sexual or injecting drug use practices. It is not clear how age at infection influences the course of maturation nor is it clear how maturation might proceed in HIV+ adolescents with repeated HIV sexual exposure, drug abuse, sexually transmitted disease co-morbidity, and/or pregnancy. The heterosexual transmission of HIV is attaining increasing importance as a mode of HIV spread to uninfected individuals. This mode of HIV transmission is particularly important in the adolescent population due to the high prevalence of high-risk behaviors. The factors which modulate the heterosexual transmission of HIV have not been determined. However, it is likely that the replication of HIV at genital mucosal surfaces plays a major role in the likelihood of the occurrence of viral transmission following heterosexual exposure. Background of the Adolescent Medicine HIV/AIDS Research Network and the Scope of Its Research Agenda This Adolescent Medicine HIV/AIDS Research Network initiative calls for a descriptive examination of the full spectrum of HIV disease and its behavioral manifestations in adolescents who have become infected with HIV through sex and drug-taking behaviors in order to identify and pursue an HIV/AIDS-specific research agenda in the adolescent population between the ages of 12 and 19 years of age. The ultimate goal of this project is to achieve a better understanding of HIV disease progression and co-morbidity in adolescents and thus improve health care management. This goal is being addressed through the enrollment of HIV-infected adolescents into a standardized base protocol to characterize a population-based spectrum of disease, disease progression, and the effect of comorbidity with drug abuse, other sexually-transmitted diseases and pregnancy in the adolescent population. A secondary goal involves the resolution of remaining questions related to HIV infection in adolescents through the development of special studies to be undertaken in the assembled cohort enrolled in the base protocol. These unresolved questions include but are not limited to the susceptibility, infectivity, and transmissibility of HIV in adolescents, particularly related to developing genital mucosa; the characterization of the variation in adolescent immune function; the identification of useful adolescent-specific clinical markers of HIV disease progression; the effect of HIV on adolescent neuropsychologic function and development; and the influence and effect of specific adolescent behavioral patterns on risk-taking and health-seeking activities. Organizational Components The NIH entered into cooperative agreements establishing the network in 1994. The Adolescent Medicine HIV/AIDS Research Network consists of two interactive groups, Basic Science and Clinical Science, managed by Steering and Executive Committees, supported by a Data and Operations Center, advised by a Community Advisory Board, and reviewed by a Scientific Advisory Panel. The current Network includes an eight member Basic Science Group, a twelve member Clinical Science Group, and a Data and Operations Center. The Basic Science Group, in collaboration with the Clinical Science Group and a Data and Operations Center, has produced a base protocol which addresses the primary objective of the initiative. The study began accruing research subjects in February 1996. This solicitation seeks cooperative agreements with investigators to augment the subject accrual capacity of the Clinical Science Group in order to establish a subject cohort of sufficient size to address more completely the research objectives outlined above and thus permit the conduct of a wide- ranging, multi-stage series of investigations which examine specific facets of HIV infection in adolescents. This RFA is intended to recruit additional members of the Clinical Science Group with responsibility for the (1) implementation of the base protocol and secondary protocols where feasible and the recruitment and monitoring of study participants, associated data collection, and quality control; (2) participation in the production of the supplemental research agenda through review and evaluation at regularly scheduled interactive Network meetings; (3) clinical management guidelines for the standardization of health care delivery across network sites which address the unique biological, biobehavioral, and psychosocial issues of adolescence including pharmacologic prophylaxis, the scope and frequency of medical monitoring, and service organization, overcoming barriers to care, among others; and (4) the convening of consensus panels on the dissemination of clinical management guidelines and the definition of adolescent- specific HIV policy among other tasks consistent with functioning as a national resource body. SPECIAL REQUIREMENTS Applications to become members of the Clinical Science Group must submit evidence of clinical experience, comprehensiveness of health care and support services, and availability of subjects. All members of the Clinical Science Group are expected to participate in conference calls and attend two Network meetings per year contributing to the research and policy life of the Network. Applicants must implement an existing base protocol which measures health status, service utilization, sexual and drug-taking behaviors, and psychological state at three month intervals over the duration of the project. Sensitive information is collected through an interactive computer interview and the data collected in this manner are not available to the site personnel. Health status measures include routine physical examinations and twice-yearly genital examinations including PAP smears, cervicophotography, cervico-vaginal lavage, and swabs. Anal swabs, radiologic examination of the wrist to assess bone age, and drug assays are performed on all subjects. HIV-positive youth will be assessed for disease progression through virologic and immunologic measures, entailing blood draws, urine collection, and delayed-type hypersensitivity assessment. No measure will entail risk greater than that encountered within routine history and physical examination for sexually active youth. There will be no therapeutic intervention in this protocol, although medical management (primary therapy, prophylaxis, and immunization schedule) will be measured and its influence on outcome evaluated within statistical constraints secondary to sample size. Applicants should have access to AIDS Clinical Trials Group certified immunology and/or virology laboratories. Applicants should appropriately complete the human subjects sections of the PHS 398; however, human subjects review by institutional review boards (IRB) should be deferred until applications have been evaluated by the NIH scientific review group. All applicants meeting review criteria and recommended for funding will be provided a copy of the base protocol and supporting documents for submission for human subjects review while award criteria are evaluated. Successful applicants will be required to have approved assurance and IRB certification on file with the Office for Protection from Research Risks, National Institutes of Health, and acquire a Certificate of Confidentiality prior to the award of funds. Terms and Conditions of Award The following terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Part 74 and 92 and other HHS, PHS, and NIH grant administration policies. Business management aspects of these awards will be administered by the NICHD Grants Management Office in accordance with HHS, PHS, and NIH Grant Administration policies. All awarded funds will be administered by the NICHD Grants Management Office. 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 and HRSA 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 project as a whole, although specific tasks and activities in carrying out the studies will be shared among awardees and the NICHD, NIAID, NIDA, and HRSA staff collaborators. The research effort will be a cooperative venture with participation by all awardees as outlined below, the NICHD, the NIAID, NIDA, and HRSA. The Primary Rights and Responsibilities of the Awardees Basic Science Group: The Basic Science Group consists of those awardees whose submissions were chosen on the basis of scientific merit, representative(s) of the Data and Operations Center (DOC), and the NICHD, NIAID, NIDA staff collaborators. The Basic Science Group has a chair and vice chair elected by its members for a two year term; NIH and HRSA staff collaborators may not serve as officers. The Basic Science Group does Retain the primary responsibility for defining and prioritizing the research agenda and submitting the agenda to the Steering Committee for approval; Specify research objectives for the base study to characterize a population-based spectrum of disease and disease progression and secondary special studies, develop corresponding protocols, provide for monitoring the progress of various studies, and analyze and interpret study protocol results. It is expected that this responsibility will be undertaken with significant interaction with the members of the Clinical Science Group; Consult and review Clinical Science Group plans for the evaluation of clinical management guidelines which address the unique biological, biobehavioral and psychosocial issues of adolescence including pharmacologic prophylaxis, the scope and frequency of medical monitoring, and organization of services, among others; The full database for the base protocol will come from all funded clinical sites; the full database for nested substudies may come from all or a subset of the clinical sites. These databases will be physically located at the Data and Operations Center and the use and publication of these data will be governed by policies established by the Executive Committee. NICHD, NIAID, NIDA, and HRSA staff collaborators, in collaboration with the Executive Committee, may have access to data generated under this cooperative agreement and may use these data to generate internal reports of the Network activities. Basic Science Group awardees, as a group, will retain custody of and have primary rights to the protocol data developed under these awards, subject to government rights of access consistent with current HHS, PHS, and NIH policies. Protocol development for special studies shall be undertaken when two-thirds of the Basic Science Group members approve the research concept; Performance Reports: Basic Science Group members must submit a progress report as part of the annual application for noncompetitive renewal. Clinical Science Group: The Clinical Science Group will consist of awardees, and the NICHD and HRSA staff collaborators. The Clinical Science Group has a chair and vice chair elected by its members for a two year term; NIH and HRSA staff collaborators may not serve as officers. The Clinical Science Group does Participate in the production of the research agenda through review and evaluation at regularly scheduled interactive Network meetings; and by submitting concepts for study (both primary or secondary analyses). Clinical Science Group members will be strongly encouraged to submit research concepts to the Basic Science Group and may participate in their subsequent protocol development. Decisions related to protocol development and protocol team formation are the responsibility of the Basic Science Group; Retain primary responsibility for the implementation of the base protocol and secondary protocols where feasible and the recruitment and monitoring of study participants, associated data collection, and quality control; Awardees will be required to accept and implement the common protocol developed by the Basic Science Group and all procedures approved by the Steering Committee; Derive clinical management guidelines for the standardization of health care delivery across network sites which address the unique biological, biobehavioral, and psychosocial issues of adolescence including pharmacologic prophylaxis, the scope and frequency of medical monitoring, and service organization, overcoming barriers to care, among others; and submit a corresponding evaluation plan to the Basic Science Group for consultation and review; The full database for the base protocol will be developed from research data collected in all funded clinical sites; the full database for nested substudies may come from all or a subset of the clinical sites. These databases will be physically located at the Data and Operations Center and the use and publication of these data will be governed by policies established by the Executive Committee. Data from individual sites may have limited value or may have substantial independent scientific value for specific research questions. The Executive Committee may establish policies encouraging or limiting publication of such site- specific institutional data as appropriate for a given circumstance. NICHD, NIAID, NIDA, and HRSA staff collaborators, in collaboration with the Executive Committee, may have access to data generated under this cooperative agreement; and may use these data to generate internal reports of the Network activities. Clinical Science awardees, as a group, will retain custody of and have primary rights to the data specific to guidelines evaluation developed under these awards, subject to government rights of access consistent with current HHS, PHS, and NIH policies. Study development for the secondary analyses of data generated through the clinical management guideline evaluation shall be undertaken when two-thirds of the Clinical Science Group members approve the research concept; Clinical Science awardees, as a group, will convene consensus panels on the dissemination of clinical management guidelines and the definition of adolescent- specific HIV policy among other tasks consistent with functioning as a national resource body; Clinical Science Group members will recruit two adolescent/family member community representatives from each clinical site (one as primary representative, and the other as an alternate), at least one of whom from each site must be an adolescent between 15 and 19 years, to serve on the Community Advisory Board; Satisfy the expectations of participation in the Network committee and group activities, research subject recruitment and retention, timely data reporting and quality control measures. Individual awards may be curtailed or terminated by the government if these expectations are not met, or a major breach of protocol, or substantive protocol changes are undertaken without prior approval >From the staff collaborators and Basic Science Group members; Performance Reports: Clinical Science Group members must submit as part of the progress report for the non-competing continuation application information detailing progress towards achieving patient accrual and retention goals and other measures of performance (including followup activities, data quality, timeliness of data submission, proportion of required repository specimen volumes collected and sent to Central Repository, and specific contributions to the Network's agenda which involves active participation in the scientific and clinical research activities of the Network). The purpose of this report is to inform funding requirements for the remaining budget period. Future year funding is contingent upon persistent satisfactory performance in meeting goals and measures noted above; Existing Track B awardees will be required to comply with the reporting requirements imposed on HRSA funded Title IV Pediatric-Adolescent Demonstration Projects. The Data and Operations Center (DOC): The Data and Operations Center does Manage all meetings of the Network, Basic and Clinical Science Groups as well as the Community and Scientific Advisory Boards including necessary conference calls among members; Support protocol development and distribution; and assume responsibility for protocol site registration and training, site-monitoring for subject safety, data collection practices, and regulatory compliance; Support development of clinical management guidelines assuming responsibility for required consensus conferences and guidelines dissemination; Remain responsible for the integrity of the scientific databases and provide statistical consultation during protocol development as well as timely analyses; Program Staff Involvement: The research effort is a cooperative venture with participation by all awardees as outlined above, the NICHD, the NIAID, the NIDA, and HRSA. One NICHD, one NIAID, one NIDA, and one HRSA staff collaborator do: Participate in the Steering Committee which oversees the establishment and maintenance of the Network and Network progress in achieving program goals; Assist the Basic Science Group in the selection of research topics and the development of protocols for specific studies and interventions; Assist the Clinical Science Group in the development and evaluation of the clinical management guidelines; Arrange, when necessary, for the external peer review of the protocols for the base study, special studies, and clinical management guideline evaluation clearing these studies for implementation; Explore mechanisms to offer study subjects the opportunity to participate in clinical drug trials funded through mechanisms outside the network and provide this information and organizational support to clinical sites; Assist the Executive Committee in monitoring the progress of ongoing studies, including field data collection, standardization of methods across study sites, and adherence to protocol and quality control measures; Assist in data analyses, interpretation and publication of study results. Collaborative Responsibilities: The Research Network The Research Network is composed of all principal investigators of the Basic Science Group, all principal investigators of the Clinical Science Group, all members of the Study Coordinators Group, all representatives of the Community Advisory Board, the principal investigator and project coordinator from the Data and Operations Center, the NICHD, the NIAID, NIDA, and HRSA. The entire Network will attend interactive annual meetings to inform and review the research agenda. The Steering Committee The Steering Committee is the main governing body of the Network. The Committee is composed of the Chair, Vice Chair, and two elected representatives from the Basic Science Group; the Chair, Vice Chair, and two elected representatives from the Clinical Science Group; the Chair and Vice Chair of the Study Coordinators Group; the Chair and Vice Chair of the Community Advisory Board; the principal investigator and project coordinator from the Data and Operations Center; and the NICHD, the NIAID, the NIDA, and the HRSA staff collaborators. All members will have one vote each; NICHD, NIAID, NIDA, and HRSA will have one vote each, and motions will carry with simple majority. The Chair and Vice Chair of the Steering Committee will be elected by the entire committee from among the principal investigators of the Basic Science Group and the Clinical Science Group; none of the NICHD, NIAID, NIDA, or HRSA staff collaborators are eligible to serve as Chair or Vice Chair of the Steering Committee. The Steering Committee will Maintain primary responsibility for the identification of adolescent HIV/AIDS research issues; Approve the direction of the research effort, and facilitate the conduct and monitoring of the studies; Approve the research agenda specific to its feasibility and clinical relevance and advise on the development of implementation strategies; Approve the clinical management guidelines addressing the unique biological, biobehavioral, and psychosocial issues of adolescence including pharmacologic prophylaxis, the scope and frequency of medical monitoring, and service organization, among others; and the plans for their evaluation. The Executive Committee The Steering Committee chairperson will chair the Executive Committee as well. The Executive Committee, composed of the Steering Committee chair and vice chair, the chair and vice-chair of the Basic Science Group, the chair and vice chair of the Clinical Science Group, the principal investigator and project coordinator of the Data and Operations Center, the NICHD, NIAID, NIDA, and HRSA staff collaborators, will supervise the functioning of the network and will Establish timelines for the completion of tasks and monitor progress; Coordinate the integration of data collection for base protocol and guidelines evaluation procedures; Oversee site participation and performance informing the appropriate program managers; Define rules regarding access to data and publication and direct the publication process. Study Coordinators Group The Study Coordinators Group is composed of all the primary research nurses or associates at the clinical sites supported by the grant award. The Study Coordinators Group, with a chair and a vice chair elected for a two year term, does Recommend issues of concern to be studied within the research agenda and collaborate on their development; Advise on the Network's subject recruitment and retention strategies; Review and evaluate the study and evaluation research protocols for acceptability and feasibility; Review and evaluate subject protection procedures and confidentiality of records in support of the Clinical Science Group principal investigators; Review and evaluate the integrity of data collection procedures in support of the Clinical Science Group principal investigators; Provide consultation to the Clinical Science Group at consensus conferences for policy or management affecting HIV+ youth. Community Advisory Board The Community Advisory Board will consist of two adolescent or family member community representatives from each clinical site, one of whom must be an adolescent between 15 and 19 years of age and who are to be chosen by the principal investigator at the corresponding clinical site. The Community Advisory Board will Recommend issues of concern to be studied within the research agenda; Choose a chair and vice-chair to coordinate and organize its Community Advisory Board meetings and conference calls and represent community interests on the Steering Committee; Advise the Network on subject recruitment and retention strategies; Review and evaluate the study and evaluation research protocols for acceptability and feasibility; Provide consultation to the Clinical Science Group at consensus conferences for policy or management affecting HIV+ youth. Scientific Advisory Panel A Scientific Advisory Panel, consisting of federal and non-federal experts in the disciplines related to the Network's research agenda, will be appointed by the NICHD in consultation with NIAID, NIDA, and HRSA and will report directly to the Director, NICHD. The Scientific Advisory Panel will undertake the following functions: Review and evaluate the overall direction, objectives, content and progress of the Basic Scientific Research Agenda in an annual meeting or more frequently if necessary; Review and evaluate the overall direction, objectives, content and progress of the Clinical Management Evaluation Research Agenda in an annual meeting or more frequently if necessary. Data and Safety Monitoring Board The intention of the Network is to establish a cohort of adolescents for whom an observational study will be conducted. No primary intervention studies were envisioned in the original RFA. However, the potential for the implementation of intervention studies exists, particularly in the area of secondary prevention strategies and the evaluation of clinical management guidelines. If this potential is realized, the NICHD, NIAID, NIDA, and HRSA science collaborators will establish a Data and Safety Monitoring Board and establish procedures for its conduct. Any Data and Safety Monitoring Board will report to the NIH and HRSA science collaborators and the Network Steering Committee. Approval Process for Research Undertaken in the Network The Basic Scientific Agenda will be approved in the following manner: Potential research areas will be proposed through multiple mechanisms, including professional (internal and external to Network) and community presentations/ sessions at the Research Network meetings, as well as individual concept proposals submitted by principal investigators (alone or in collaboration); The Basic Science Group, supported by the Data and Operations Center, will define and prioritize the agenda, assess the merit of concept sheets, proposing protocol development around those with specific study hypotheses consistent with the research agenda, returning others to proposing investigators with constructive comments attached; The Clinical Science Group will review and evaluate the agenda and proposed protocol(s); The Community Advisory Board will review and evaluate the agenda and proposed protocol(s); The Steering Committee will vote to approve the Network Scientific Agenda; if approved the protocol will be forwarded to the Scientific Advisory Panel; if unapproved, the protocol will be returned to the Basic Science Group; Before implementation of the base protocol in the first year, the Scientific Advisory Panel will review its direction, its objectives, and its content; the Scientific Advisory Panel will meet annually (or more frequently if necessary) thereafter to review the direction and progress of the Network Scientific Research Agenda. The Clinical Management Evaluation Research Agenda will be approved in the following manner: The development of the Clinical Management Guidelines is the responsibility of the Clinical Science Group, alone or in consultation with clinical expertise and community experience external to the Network, and supported by the Data and Operations Center; The Clinical Science Group will define the scope of the guidelines and propose hypothesis-driven evaluation for their effectiveness; The Basic Science Group will review the research protocol for the clinical management guidelines evaluation; The Community Advisory Board will review the evaluation research protocol; The Steering Committee will vote to approve the evaluation research protocol; if approved the protocol will be forwarded to the Scientific Advisory Panel; if unapproved, the protocol will be returned to the Clinical Science Group; Before implementation of the evaluation protocol in the first year, the Scientific Advisory Panel will review its direction, its objectives, and its content; the Scientific Advisory Panel will meet annually (or more frequently if necessary) thereafter to review the direction and progress of the Clinical Management Evaluation Research Agenda. Arbitration Process These procedures will be in addition to the customary programmatic and financial negotiations that occur in the administration of grants. Arbitration procedures will be invoked only when agreement cannot be reached on programmatic issues that may arise between awardee(s) and the science collaborator(s) after the award has been made. In that event, an arbitration panel will be composed of three members-- one selected by the executive committee (with the NICHD, NIAID, NIDA, and HRSA science collaborators not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by the science collaborators, and a third member selected by the two prior selected members. The decision of the arbitration panel by majority vote will be binding. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS Regulations at 42 CFR Part 50, Subpart D and HHS Regulation at 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by October 15, 1996, a letter of intent that includes a descriptive title of the proposed research, the name, address and telephone number of the Principal Investigator and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NICHD staff to estimate potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Audrey Smith Rogers, Ph.D., M.P.H. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B11, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-7339 APPLICATION PROCEDURES Applications are to be submitted on PHS Form 398 (rev. 5/95). Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov; and from the NIH program administrator named below. Materials to Include in the Application To permit evaluation of the merits of an application (peer review), information is needed on the following topics. Applications to become members of the Clinical Science Group must include 1. Documentation of three or more years of clinical experience in adolescent health care for the physician candidate for the Clinical Science Group; 2. A description of the physical structure and administrative arrangement for the site at which health care and support services are provided (including hours of operation, provision for off-hour coverage, and established patterns of referral); 3. Evidence of an interdisciplinary approach to the delivery of adolescent health care and support services ( the breadth of services and qualifications of the corresponding providers should be listed and described); 4. Demonstration of availability of on-site gynecologic services and case management, on-site or established and functioning referral networks for mental health services, substance abuse treatment, and enabling services such as childcare and transportation; 5. Numbers of the adolescent population categorized by ages 10-11, 12-14, 15- 17 years currently served by the clinic; 6. Description of the population in #5 must include gender, race/ethnicity, and should include (if available) socioeconomic strata, educational achievement, blinded serosurveys of HIV infection, AIDS cases numbers (cumulative and annual), STD and pregnancy rates, substance abuse statistics, and other evidence of high risk behaviors. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear and compelling rationale must be provided; 7. Evidence of ability to enroll 20 HIV-infected adolescents and 10 HIV- negative but high risk adolescents between the ages of 12 and 19 years within the first year of funding; 8. The interaction between the clinic and the community it serves should be described. Of specific interest are community advisory or consultative groups which have substantial adolescent participation, efforts at parental or community education, clinic policies for adolescent involvement in their own care and details of existing or planned community outreach and prevention programs to identify adolescents and bring them into care; 9. Budgets for the Clinical Science Group applications should include physician principal investigator salary support at 0.10 FTE, clinical associate/research nurse at 1.0 FTE, and three research visits for study subjects (estimated by comprehensive routine physical/laboratory examination costs, HIV RNA PCR and culture, and immunologic panel for subjects for three research encounters). Travel for the principal investigator and the research nurse should be requested to two (three day meetings) in the Washington DC area. A budget worksheet is available on request and its use is strongly recommended. This application will be used to judge the clinical expertise and technical proficiency of the applicant and should not exceed the 25 page limit (including graphics) for the entire submission. For all applications, the RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for evaluation. In addition, the RFA title ("Adolescent Medicine HIV/AIDS Research Network") and number must be typed on line 2 of the face page of the application form and the "YES" box must be marked. The signed, typewritten original of the application, including the Checklist, and three signed photocopies must be sent or delivered in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE ROOM 1040 MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, in addition to the applications and copies mailed to the Division of Research Grants, two copies of the application must be sent under separate cover to: Susan Streufert, Ph.D., Director Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E01 - MSC 7510 Bethesda, MD 20892 Bethesda, MD 20852 (for express/courier service) Applications must be received by close of business on November 19, 1996. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must follow the guidance in the PHS 398 application instructions for the preparation of revised applications, including an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NICHD. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, the application will be returned to the applicant. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, a process may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be evaluated for scientific and technical merit and assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified and receive a summary statement containing reviewers' comments. Review Criteria: Clinical training and experience of project staff specific to adolescent care; Evidence of an interdisciplinary approach; Adequacy of site characteristics as described in this RFA; Appropriateness of the plans for inclusion of women and minorities; Appropriateness of recruitment and retention methods and willingness to work as part of the cooperative study with existing awardees and NICHD, NIAID, NIDA, and HRSA scientists. The review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and the appropriateness of accompanying budget. AWARD CRITERIA Applications recommended by the National Advisory Council to the National Institute of Child Health and Human Development will be considered for award based upon (a) merit as reflected in the priority score; (b) program balance including sufficient compatibility of features to make a successful collaborative program likely; (c) availability of funds; (d) identified needs in the established network. Schedule Letter of Intent Receipt Date: October 15, 1996 Application Receipt Date: November 19, 1996 Review by NICHD Advisory Council: January 1997 Anticipated Award Date: February 1, 1997 INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Audrey Smith Rogers, Ph.D., M.P.H. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B11 - MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-7339 FAX: (301) 496-8678 Email: rogersa@hd01.nichd.nih.gov Judy Lew, M.D. Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, MSC 7620 Bethesda, MD 20892-7620 Telephone: (301) 496-6178 Email: jlew@exec.niaid.pc.niaid.nih.gov Katherine Davenny, M.P.H. or Vincent Smeriglio, Ph.D. Division of Clinical and Services Research National Institute of Drug Abuse 5600 Fishers Lane, Room 11A33 Rockville, MD 20857 Telephone: (301) 443-1801 Email: kdavenny@aoada.ssw.dhhs.gov Email: vsmerigl@aoada.ssw.dhhs.gov Direct inquiries regarding administrative/fiscal matters to: Ms. Mary Daley Tozzolo Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17F - MSC 7510 Bethesda, MD 20852-7510 Telephone: (301) 496-1303 Email: tozzolom@hd01.nichd.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Sep 24 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-96-022 - V25(31) 09/20/96 Date: 24 Sep 1996 17:25:22 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 640 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <529u5i$glj@net.bio.net> NNTP-Posting-Host: net.bio.net TUBERCULOSIS ACADEMIC AWARD NIH GUIDE, Volume 25, Number 31, September 20, 1996 RFA: HL-96-022 P.T. 34, K.W. National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: October 4, 1996 Application Receipt Date: November 1, 1996 THIS RFA USES "JUST-IN-TIME" PROCEDURES. THE FULL RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE FOLLOWED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA. PURPOSE The primary objective of this Request for Applications (RFA) is to stimulate the development and/or improvement of the quality of medical curricula, physician/patient/nurse/and community education, and clinical practice for the prevention, management, and control of Mycobacterium tuberculosis (TB) in the United States. 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, Tuberculosis Academic Award, is related to the priority areas of immunization and infectious diseases and HIV Infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Institutions Applications may be submitted by domestic schools of medicine or osteopathy. In this competition, there is an interest in a diversity of types of applications. These include, but are not limited to, applications from any of the following: o established researchers and/or faculty specializing in the field of tuberculosis; o minority faculty members interested in medical education; o minority medical institutions; o institutions serving a high proportion of minority medical students or minority patients; o institutions having other tuberculosis research projects to which this award would be complementary; o institutions located in those areas where there is a high incidence of TB; Candidates A candidate for an award must: o be an established physician and a medical faculty member in an accredited school of medicine or osteopathy in the United States, its territories or possessions; o have the unqualified support of the Dean and the educational leadership at the institution and demonstrate knowledge and commitment to medical education for medical students, physicians, patients, nurses, and the public; o have sufficient clinical training, and practical experience in the control of TB to develop and implement a high quality curriculum in TB encompassing current knowledge and methods applicable to the control of tuberculosis in individuals of all ages and to provide leadership in applied research in control of TB; o be aware of the training and educational needs of health care professionals at all levels who are working in the area of TB control, and be a leader in providing the appropriate instructional programs for these individuals; o be a citizen or non-citizen national of the United States or have been lawfully admitted to the United States for permanent residence at the time of application; o commit 30-50 percent effort for a five year period. Individuals who have held another NIH career development award (K series) or a regular research grant (R01) are eligible to apply for the Tuberculosis Academic Award. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA is part of the Academic Award Program (K07) of the National Heart, Lung, and Blood Institute. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years and is non-renewable. It is anticipated that support for this program will begin July 1, 1997. Application instructions have been modified to implement "just in time" streamlining efforts being considered by the NIH. This requires an applicant to submit certain information only when and if it is likely that an award will be made. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NHLBI staff. For this RFA, no budgetary information is required in the application. However, the anticipated level of effort in all years and a brief description of responsibilities for the Principal Investigator and key personnel must be included in the research plan. In addition, instructions for completing the Biographical Sketch have been modified and no "Other Support" information or "Checklist" page is required in the initial application. If an award is likely, necessary budget, Other Support, and Checklist information will be requested by NHLBI staff. The SPECIAL REQUIREMENTS section of this RFA provides specific modifications to standard PHS 398 application kit. FUNDS AVAILABLE Awards will be limited to a maximum of $62,000 for the salary of the PI, plus applicable fringe benefits, and a maximum of $20,000 for technical support. Indirect costs may not exceed 8 percent The estimated funds (total costs) for this fiscal year will be $300,000. It is anticipated that three new grants will be awarded. The specific number, however, will depend upon the merit and scope of the applications received and the availability of funds. The total TBAA program will be advertised for competition each year through 1997. RESEARCH OBJECTIVES Background Despite major advances in the understanding of the pathogenesis, detection and treatment of tuberculosis, in the early 1990s, more than 25,000 cases/year were reported in the United States. TB was spreading rapidly, especially in some population groups. From 1985 through 1990, the number of TB cases increased by 44 percent in the 25-44 year old age group. There was a 12 percent increase among Asians, a 25 percent increase among non-Hispanic whites, a 55 percent increase among blacks, and a 77 percent increase among Hispanics. There is also a high prevalence of TB among HIV infected patients. It is estimated that about 12 percent of all AIDS cases develop TB. HIV-associated TB has occurred in virtually all age groups, both men and women, all race/ethnic groups and in all HIV-transmission categories, although the largest numbers of cases have occurred in intravenous drug users and homosexual/bisexual men. Other groups at high risk for TB include persons living or working in a group or institutional settings such as hospitals and correctional facilities. Frequent outbreaks of multidrug resistant TB continues to occur. These outbreaks are a dramatic manifestation of serious underlying problems in public and private efforts to control TB. Very recently, the numbers of TB cases have begun to show a slight decline, probably, in large measure, because of the increased efforts in prevention and control. In order to assure that this encouraging trend continues, efforts to educate health care professionals about TB must also continue. Although considered "curable" since the development of effective chemotherapy in 1950, the TB problem has not been dealt with adequately. This has been attributed to a lack of sufficient awareness of the problem and inadequate resources, as well as clinical management errors and patient nonadherence to treatment regimens. The management errors include failing to diagnose and treat the cases in a timely manner, relying heavily on Isoniazid (INH) therapy even in patients likely to have INH-resistant organisms, using a single drug therapy, prescribing inappropriate drug dosages, and failing to isolate patients appropriately with infectious TB thereby missing opportunities to prevent the spread of the disease. Surveillance has often been slow or incomplete. Noncompliance with treatment regimens for chronic diseases has been a major problem with approximately 50 percent not taking their medicine. A study in 1988 in New York City reported 89 percent of the patients at one hospital failed to complete therapy, more than half failed to keep their first clinic appointment, and within twelve months of discharge 27 percent of the patients had been readmitted at least once with confirmed active TB. The concept for this initiative originated with the Tuberculosis Education Planning Committee convened by the NHLBI in December 1991, which emphasized the need for increased efforts to educate health care workers, patients, and the public on tuberculosis. They also recommended that public health officials identify populations and geographic areas in the community where tuberculosis screening programs should be intensified as well as conduct public education campaigns targeted to high risk populations to encourage symptomatic patients to seek prompt treatment. In addition, in 1987 the Department of Health and Human Services established an Advisory Council for the Elimination of TB (ACET), and in 1992 a "National Action Plan to Combat Multidrug Resistant Tuberculosis" was published to complement and supplement the "Strategic Plan for the Elimination of Tuberculosis." These plans indicate the urgency to improve the control of TB in the United States. In summary, in spite of major advances in the ability to diagnose, treat, and prevent TB, this disease remains a major health problem in the U.S. today, largely because of inadequate education of health professionals, patients, their families, and the larger community. Objectives The objectives of the Tuberculosis Academic Award are to: o encourage the development of high quality curricula in schools of medicine or osteopathy that will significantly increase the opportunities for students, house staff, and others, including practicing physicians and nurses, to learn the principles and practice of preventing, managing, and controlling TB; o develop and implement interdepartmental programs with common goals and standardized diagnostic and therapeutic approaches; o promote interdepartmental communication between primary care and other specialists to ensure appropriate control and treatment strategies; o encourage applied research in the control of TB; o promote the development of a faculty capable of providing appropriate instruction in diagnosis and management of TB, with special emphasis on minority faculty, nursing, and infection control personnel; o promote coordinated clinical approaches to the care of patients of various ages and ethnic groups who have TB; o provide for outreach programs from medical centers to health practitioners in the community, especially home care agencies, to enhance optimal care, especially in areas of high TB morbidity; o contribute to updating the knowledge and skills of practicing physicians, nurses and other health care providers in the community; o to focus educational efforts on health care providers in those areas where there is a persistently high incidence of TB, such as in immigrant communities, refugee centers, shelters for the homeless, and in correctional institutions; o enhance the awareness of health care providers of the unique ethnic, cultural, socioeconomic, and medical dimensions of TB; o coordinate and collaborate with other community organizations to control TB in areas with a high incidence of TB; o facilitate an interchange of ideas and methods between awardees and institutions; o enhance tuberculosis education programs in minority medical schools and promote TB education in the communities served by these institutions. Of particular interest are programs targeted to inner city populations and to rural areas that may be in need of education about tuberculosis, and among physicians, nurses, and other health care workers, who are or who will be caring for medically underserved populations. Because this is a medical education program, funds may be requested for technical support staff who have complementary expertise to the principal investigator. Such personnel may include medical educators, curricula specialists, program evaluators, or other specialists. SPECIAL REQUIREMENTS Use the following modifications in completing the standard PHS 398 application: BUDGET INFORMATION - No current/future year budgets or justifications (Form Pages 4 and 5) are required in the application. However, the anticipated level of effort in all years and a brief description of responsibilities for the Principal Investigator and all key personnel must be specifically stated at the beginning of the research plan. Necessary budget information will be requested by NHLBI staff if there is a possibility for an award. BIOGRAPHICAL SKETCH - In addition to the standard information requested on Form Page 6, the applicant has the option of providing the title and source of any sponsored support relevant to the proposed research. OTHER SUPPORT - No other support information is required on the "Other Support" page (Form Page 7). Selected other support information relevant to the proposed research may be included in the Biographical Sketch as indicated above. Complete other support information will be requested by NHLBI staff if there is a possibility for an award. CHECKLIST - No "Checklist" page is required as part of the initial application. A completed Checklist will be requested by NHLBI staff if there is a possibility for an award. FACE PAGE - Currently, the Division of Research Grants requires that requested costs be reflected on the face page for computer system tracking purposes. Because no budgetary information is required as part of the "just-in-time" application process, we are requesting that standard amounts be shown on the face page. IT IS UNDERSTOOD THAT THESE LEVELS ARE STRICTLY FOR ADMINISTRATIVE PURPOSES AND THAT ACTUAL AWARD LEVELS ARE SUBJECT TO NEGOTIATION, PRIOR TO AWARD. The following amounts must be entered on the face page: 7a. Direct Costs for Initial Budget Period - $70,000; 7b. Total Costs for Initial Budget Period - $75,000; 8a. Direct Costs for Proposed Period of Support - $350,000 and; 8b. Total Costs for Proposed Period of Support - $375,000. The applicant should be prepared to provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. In the event that budget information, Other Support pages and/or Checklist pages are submitted with the application, they will be removed prior to review to allow for consistency with other applications. The following sections are specific cost guidelines that will apply to those applications selected for award consideration. 1. Principal Investigator's Salary The salary for the principal investigator must not exceed the actual institutional salary rates for the effort being devoted to the Academic Award. In addition, salary rates must not exceed an annual salary level of $125,000 plus fringe benefits (a maximum of $62,500 for 50 percent effort). A candidate must devote at least 30 percent effort and no greater than 50 percent effort to this award. A principal investigator may devote up to a combined total of 100 percent effort on the Academic Award and as an investigator on any other NIH-supported grant(s) or contract(s) and may receive remuneration from such sources accordingly. 2. Program Support Technical support will be provided up to a maximum of $20,000 per year for the following: o personnel other than the PI if requested for the development, implementation, and evaluation of the program. Salaries will be allowable for technical and support staff and consultants, e.g., educational and evaluation specialists. o consumable supplies essential to the proposed program are allowable, but equipment costs are not allowable; o funds for educational development to enable the awardee to develop educational skills; o funds for travel for the Principal Investigator to meet with other investigators and NHLBI staff to exchange ideas, to develop collaborative projects, and to provide needed technical support. (Investigators may be requested to meet as a group up to two times a year; $2,000 should be allocated for this purpose.) 3. Indirect Costs Awards will be provided for the reimbursement of actual indirect costs at a rate up to, but not exceeding, 8 percent of the total direct costs of each award. 4. Conditions of the Award Institutions must provide documentation that the applicant would have the necessary time and resources to implement the proposed plan. In some cases, it may be necessary for the applicant to be relieved of some responsibilities for the five years of the grant award in order to implement the proposed plan. An institution may apply for an award on behalf of a named individual meeting the criteria for this award. Awards will be limited to one >From each eligible school over the life of the award. After the first year, grants will be renewed for a maximum of four years on a noncompetitive basis depending upon progress being made in meeting the program's objectives. An annual report will be required that summarizes activities relevant to curriculum development at the institution and other elements of the program plan and outlines future plans. This report will serve as the principal basis for renewal of the grant. Awards may not be transferred from one institution to another. If an awardee moves to another institution, the award will continue at the original institution only upon acceptance by the Division of Lung Diseases of a suitable replacement proposed by the grantee institution. Such a replacement will not lengthen the overall term of the award. 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 4922B 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 (F 59 1115), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. 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. Although the TB Academic Award is not primarily a mechanism to support research, human subjects may be involved. If so, protection for human subjects must be addressed, and the approximate percent of women and each minority group that you expect in the total population must be included. LETTER OF INTENT Prospective applicants are asked to submit, by October 4, 1996, a letter of intent that includes 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 NIH 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. C. James Scheirer, at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. To identify the application as a response to this RFA, check "Yes" in item 2 of page 1 of the application and enter the title "Tuberculosis Academic Award" HL-96-022. The RFA label available in form PHS 398 application kit (rev. 5/95) must be affixed to the bottom of the face page of the original completed 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. Send or deliver the completed application and three signed photocopies in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 1040 - MSC-7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) Send two additional copies of the application to the Chief, Review Branch, DEA at the address listed under INQUIRIES. 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, otherwise, the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by November 1, 1996. If an application is received after this date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness to this RFA by the NHLBI. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NHLBI staff will return the application to the applicant. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Affairs, NHLBI in accordance with the review criteria stated below. As part of the initial merit review, a process may be used by the initial review group in which applications will be determined to be competitive or noncompetitive 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 noncompetitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria Applications for this Tuberculosis Academic Award will be evaluated in terms of the following criteria: o description of the magnitude of the tuberculosis problem and the need for the program in the area to be served; o the overall merit of the proposed five year plan for improving the institution's interdepartmental curricula in tuberculosis control; o the qualifications and background of the candidate, including experience in teaching, curriculum development, and administration in a medical school, planning and conduct of research, and level of effort; o the ability and commitment to work cooperatively with other investigators to make innovative tuberculosis curricula, materials, and programs available; o the institution's commitment to implement the proposed curriculum and to maintain a program in education about tuberculosis control after the termination of the award; o the significant involvement of appropriate disciplines in the development, implementation, and evaluation of the program; o design and evaluation of educational interventions for health care providers and for patients with tuberculosis in areas with high incidence of TB; o plans for communication and cooperation between specialists in adult and pediatric pulmonary medicine, infectious disease, and community medicine to ensure optimal treatment; o plans for collaborative projects with other organizations that have responsibility for and interest in tuberculosis control, for example, health departments, medical and nursing associations, voluntary health agencies, and home care agencies; o plans for and availability of expertise to implement and evaluate the proposed program, including strategies for both process and impact evaluation; o the potential of the program for making an impact on the control of tuberculosis among populations served; o the potential for replication or adaptation of the program at other sites. AWARD CRITERIA The anticipated date of award is July 1, 1997. Factors that will be taken into consideration in making awards include the scientific merit of the proposed program as evidenced by the priority score and the availability of funds. Subject to the availability of necessary funds and consonant with the objectives of the Tuberculosis Academic Award, the Division of Lung Diseases will provide funds for a project period up to five years. INQUIRIES Inquiries concerning this RFA are encouraged, and the opportunity to clarify any issues or questions from potential applicants is welcome. To obtain a copy of the RFA please contact: Melonie Shine Division of Lung Diseases National Heart, Lung, Blood Institute 6701 Rockledge Drive, Suite 10018, MSC-7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: ShineM@NIH.GOV Direct inquiries regarding programmatic issues to: Mary S. Reilly, M.S. Division of Lung Diseases National Heart, Lung, Blood Institute 6701 Rockledge Drive, Suite 10018, MSC-7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: ReillyM@NIH.GOV Direct inquiries regarding review matters to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7220, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0266 FAX: (301) 480-3541 Email: ScheireJ@NIH.GOV Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7154 Bethesda, MD 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310) Email: ZimmermR@NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Grants are made under the authorization of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended by Public Law 99-158, 42 US 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 to a review by a Health Systems Agency. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Sep 24 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 31, pt. 1of1, 20 September 1996 Date: 24 Sep 1996 17:24:54 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1244 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <529u4m$gkn@net.bio.net> NNTP-Posting-Host: net.bio.net X-comment: RFAs described: HL-96-022, HD-96-009, HL-96-019, PAR-96-073 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.09.20 NIH GUIDE - Vol. 25, No. 31 - September 20, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIH NATIONAL RESEARCH SERVICE AWARDS FOR INDIVIDUAL POSTDOCTORAL FELLOWS GUIDELINES National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** NIMH POLICY CHANGES FOR CAREER AWARDS (K-SERIES) AND SUPPLEMENTAL INSTRUCTIONS TO THE NIH K AWARD PROGRAM ANNOUNCEMENTS National Institute of Mental Health INDEX: MENTAL HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 11/01/96 ************************************************ TUBERCULOSIS ACADEMIC AWARD (RFA HL-96-022) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R2 11/19/96 ************************************************ ADOLESCENT MEDICINE HIV/AIDS RESEARCH NETWORK (RFA HD-96-009) National Institute of Child Health and Human Development National Institute of Allergy and Infectious Diseases National Institute on Drug Abuse INDEX: CHILD HEALTH, HUMAN DEVELOPMENT; ALLERGY, INFECTIOUS DISEASES; DRUG ABUSE $$INDEX R3 02/13/97 ************************************************ GENE TRANSFER PRINCIPLES FOR HEART, LUNG AND BLOOD DISEASES (RFA HL-96-019) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX P1 ********************************************************** EXPLORATORY/DEVELOPMENTAL GRANTS FOR HIGH RISK/HIGH IMPACT RESEARCH (PAR-96-073) National Institute on Deafness and Other Communication Disorders INDEX: DEAFNESS, OTHER COMMUNICATION DISORDERS THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NIH NATIONAL RESEARCH SERVICE AWARDS FOR INDIVIDUAL POSTDOCTORAL FELLOWS GUIDELINES NIH GUIDE, Volume 25, Number 31, September 20, 1996 P.T. National Institutes of Health based on PA-94-055, NIH Guide for Grants and Contracts Vol. 23, No. 15, April 15, 1994 and Notice of New Policy on Tuition Costs on NIH NRSA Training Grant and Fellowship Awards, ibid. Vol. 25, No. 2, February 2, 1996 Purpose The Congress of the United States enacted the National Research Service Act (NRSA) Program in 1974 to help ensure that highly trained scientists would be available in adequate numbers and in appropriate research areas to carry out the Nation's biomedical and behavioral research agenda. Under this congressional authority, the National Institutes of Health (NIH) awards NRSA individual postdoctoral fellowships (F32) to the most promising applicants to support full- time research training related to the mission of the NIH constituent institutes and centers. Eligibility Requirements Citizenship. By the time of award, individuals must be citizens or noncitizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence (i.e., possess a currently valid Alien Registration Receipt Card I-551, or other legal verification of such status). Noncitizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. Degree Requirements. Before an NRSA award can be activated, the individual must have received a Ph.D., M.D., D.O., D.D.S., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.S., Pharm.D., D.S.W., Psy.D., or equivalent doctoral degree from an accredited domestic or foreign institution. Certification by an authorized official of the degree-granting institution that all degree requirements have been met is also acceptable. Sponsorship. Before submitting a fellowship application, the applicant must identify a sponsoring institution and an individual who will serve as a sponsor and will supervise the training and research experience. The sponsoring institution may be private (profit or nonprofit) or public, including the NIH Intramural Programs and other Federal laboratories. The applicant's sponsor should be an active investigator in the area of the proposed research who will directly supervise the candidate's research. The sponsor must document, in the application, the availability of staff, research support, and facilities for high- quality research training. Applicants proposing training at their doctorate institution or at the institution where they have been training for more than a year must document thoroughly the opportunity for new training experiences that would broaden their scientific background. Foreign Sponsorship. Applicants requesting foreign training must show in the application that the foreign institution and sponsor offer special opportunities that are not currently available in the United States. Only if there is a clear scientific advantage will foreign training be supported. Period of Support Individuals may receive up to 3 years of aggregate NRSA support at the postdoctoral level, including any combination of support from institutional training grants and individual fellowship awards. Exceptions to the 3-year limit require a waiver from NIH. Individuals interested in a waiver should consult with staff of the relevant NIH institute. Characteristics of Programs The proposed NRSA training must be within the scope of biomedical or behavioral research and must offer an opportunity for individuals to broaden their scientific background or to extend their potential for research in health-related areas. For those who have a health professional degree, the proposed training may be part of a research degree program. Individuals are required to pursue their research training on a full- time basis, devoting at least 40 hours per week to the training program. Research clinicians must devote full-time to their proposed research training and must restrict clinical duties within their full-time research training experience to those that are part of the research training experience. The Secretary, U.S. Department of Health and Human Services (DHHS), is required by law, considering the Nation's overall needs for biomedical personnel, to give special consideration to physicians who agree to undertake a minimum of 2 years of biomedical or behavioral research. NIH recognizes the critical importance of training clinicians to become researchers and encourages them to apply. Women, minorities, and individuals with disabilities are also encouraged to apply. An NRSA fellowship (F32) may not be used to support studies leading to the M.D., D.O., D.D.S., D.V.M., or other similar health- professional degrees. Neither may these awards be used to support the clinical years of residency training. Payback As required by the NIH Revitalization Act of 1993, postdoctoral fellows incur a service obligation of 1 month for each month of support during the first 12 months of the NRSA postdoctoral support. The 13th and subsequent months of NRSA support are acceptable postdoctoral payback service. Thus, individuals who continue under the award for 2 years would have paid off their first year obligation by the end of the second year. Applicants accepting an award for the first 12 months of NRSA postdoctoral support must sign a payback agreement (PHS Form 6031) in which they agree to engage in health-related research training, research, and/or teaching for 12 months. Those who do not pay back their obligation through continued NRSA support may satisfy their obligation by serving in a full-time position in which health-related research, research training, or teaching are the primary activities or by engaging in such research, research training, or teaching in a position(s) for more than an average of 20 hours per week of a full work-year. Payback service may be conducted in an academic, governmental, commercial, or nonacademic environment, in the United States or in a foreign country. Examples of acceptable payback service include research associateships/assistantships, postdoctoral research fellowships, and college or high school science teaching positions. Examples of unacceptable payback service include clinical practice and administrative responsibilities not directly related to scientific research. Payback service positions are arranged by the individual, not by NIH. The NIH institute supporting the fellowship will review and approve the activity at the end of the year in which it occurs. Service to satisfy any outstanding obligation must be initiated within 2 years after termination of NRSA support, and must be performed on a continuous basis. For individuals who fail to fulfill their service obligation, the United States is entitled to recover the total amount of NRSA funds paid to the individual for the obligated period plus interest at a rate determined by the Secretary, U.S. Department of Treasury. Financial payback must be completed within 3 years, beginning on the date the United States becomes entitled to recover such amount. Under certain conditions, the Secretary, DHHS, may extend the period for starting service, permit breaks in service, extend the period of repayment, or otherwise waive, in whole or in part, the payback obligation of an individual. Questions on payback should be directed to the appropriate NIH institute contact. Leave Fellows may continue to receive stipends during periods of vacation and holidays available to individuals in comparable training positions at the sponsoring institution. Also, fellows may continue to receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth pursuant to the Pregnancy Discrimination Act [42 USC 2000 e (k)]. Fellows may continue to receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee or sponsoring institution have access to paid leave for this purpose and the use of parental leave is approved by the sponsor. A period of terminal leave is not permitted and payment may not be made from grant funds for leave not taken. Individuals requiring extended periods of time away from their research training experience must seek approval from the NIH awarding component for an unpaid leave of absence. Stipends NRSA awards provide stipends to postdoctoral researchers as a subsistence allowance to help defray living expenses during the research training experience. The awards are not provided as a condition of employment with either the Federal government or the sponsoring institution. The stipend level for the first year of NRSA support is determined by the number of years of relevant postdoctoral experience at the time the award is issued. Relevant experience may include research experience (including research in industry), teaching, internship, residency, clinical duties, or other time spent in full-time studies in a health-related field beyond that of the qualifying doctoral degree. Postdoctoral stipends are as follows: Full Years of Relevant Experience Annual Amount <1 $19,608 1 20,700 2 25,600 3 26,900 4 28,200 5 29,500 6 30,800 >7 32,300 The stipend for each subsequent year of NRSA support is the next level in the stipend structure and begins on the anniversary date of the award. No departure from the standard stipend schedule may be negotiated between the institution and the fellow. For fellows sponsored by domestic nonfederal institutions, the stipend will be paid through the sponsoring institution. For fellows sponsored by Federal or foreign institutions, the monthly stipend payment will be deposited in the fellow's U.S. bank account or paid directly to the fellow by U. S. Department of Treasury check. Stipend Supplementation. Supplementation or additional support to offset the cost of living may be provided by the sponsoring institution, but must not require any additional obligation from the fellow. Federal funds may not be used for supplementation unless specifically authorized under the terms of both the program from which such supplemental funds are to be received and the program whose funds are to be supplemented. Under no circumstances may Public Health Service (PHS) funds be used for supplementation. Compensation. An institution may provide additional funds to a fellow in the form of compensation (such as salary and/or tuition remission) for services such as teaching or laboratory assistantships. A fellow may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a PHS research grant. However, compensated services should occur on a limited, part-time basis apart from the normal research training activities, which require a minimum of 40 hours per week. In addition, compensation may not be paid from a research grant supporting research that is part of the research training experience. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the fellow's approved NRSA training program. Additionally, compensation must be in accordance with institutional policies applied consistently to both federally and non-federally supported activities and supported by acceptable accounting records determined by the employer-employee relationship agreement. Educational Loans or G.I. Bill. An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation. Concurrent Awards. An NRSA fellowship may not be held concurrently with another Federally sponsored fellowship or similar award that provides a stipend or otherwise duplicates provisions of the NRSA. Tax Liability The Internal Revenue Code, Section 117, applies to the tax treatment of all scholarships and fellowships. Under that section, non-degree candidates are required to report, as gross income, all stipends and any monies paid on their behalf for course tuition and fees required for attendance. Degree candidates may exclude from gross income reported for tax purposes any amount used for tuition and related expenses, such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization. The taxability of stipends, however, in no way alters the relationship between NRSA fellows and institutions. NRSA stipends are not considered salaries. NRSA fellows are not considered to be in an employee-employer relationship with NIH or with the institution in which they are pursuing research training. The interpretation and implementation of the tax laws are the domain of the Internal Revenue Service (IRS) and the courts. NIH takes no position on the status of a particular taxpayer, and it does not have the authority to dispense tax advice. Individuals should consult their local IRS office about the applicability of the law to their situations and for information on the proper steps to be taken regarding their tax obligations. The business office of the sponsoring institution is responsible for the annual preparation and issuance of the IRS form 1099 (statement of miscellaneous income) for fellows paid through the institution (fellows at domestic nonfederal institutions). NIH will issue the form for all fellows training at Federal or foreign laboratories and receiving a stipend check from the U.S. Treasury. Other Training Costs NIH will provide an institutional allowance of $3,000 per 12-month period to nonfederal, nonprofit sponsoring institutions to help defray such awardee expenses as research supplies, equipment, and travel to scientific meetings. This allowance is intended to cover training-related expenses for the individual awardee. The allowance is not available until the fellow officially activates the award. If an individual fellow is not enrolled or engaged in training for more than 6 months of the award year, only one-half of that year's allowance may be charged to the grant. The Notice of Research Fellowship Award will be revised and the balance must be refunded to NIH. Beginning in fiscal year 1997, NIH will provide up to $1,000 for fellows sponsored by Federal laboratories or for-profit institutions for expenses associated with travel to scientific meetings and books. For fellows at for-profit institutions, the $1,000 will be paid to the institution for disbursement to the fellow. Funds for fellows at Federal laboratories will be disbursed from the NIH awarding institute. Additional funds may be requested by the institution when the training of a fellow involves extraordinary costs for: travel to field sites remote from the sponsoring institution; or, accommodations for fellows who are disabled, as defined by the Americans With Disabilities Act. The funds requested for extraordinary costs must be reasonable in relationship to the total dollars awarded under the fellowship and must be directly related to the approved research training experience. Such additional funds shall be provided only in exceptional circumstances that are fully justified and explained by the institution. Tuition and Fees. Beginning in Fiscal Year 1997, the NIH will offset the combined cost of tuition, fees, and self-only health insurance at the following rate: 100 percent of all costs up to $2,000 and 60 percent of costs above $2,000. Costs associated with tuition and fees are allowable only if they are required for specific courses in support of the research training experience supported by the fellowship. Family medical insurance is not allowable under an NRSA fellowship. A description of this policy change appeared in the NIH Guide for Grants and Contracts, Volume 25, No. 2, February 2, 1996. Travel Expenses. Awards for training at a foreign site include a single economy or coach round-trip travel fare. No allowance is provided for dependents. U.S. flag air carriers must be used to the maximum extent possible when commercial air transportation is the means of travel between the United States and a foreign country or between foreign countries. Funds are not provided to cover the cost of travel between the fellow's place of residence and a domestic training institution. However, in cases of extreme need or hardship, a one-way travel allowance may be authorized by the sponsoring institution. Such travel must be paid from the institutional allowance. Indirect costs are not allowed on individual fellowship awards. Application Procedures Individuals must submit the application form, PHS Individual National Research Service Award (PHS 416-1, rev. 8/95), and include at least three letters of reference. If the applicant has been lawfully admitted to the United States for permanent residence, the appropriate item should be checked on the Face Page of the application. Applicants who have applied for and have not yet been granted admission as a permanent resident should also check the Permanent Resident block on the Face Page of the PHS 416-1 application, and also write in the word ~pending.~ A notarized statement documenting legal admission for permanent residence must be submitted prior to the issuance of an award. Applicants and sponsoring institutions must comply with policies and procedures governing the protection of human subjects, the humane care and use of live vertebrate animals, and the inclusion of women and minorities in study populations. On the application face page, applicants should indicate in Item 3 the initials of the NIH institute (e.g., NIA, NIGMS) most appropriate to the research area of the application. The list of institutes at the end of this announcement will be helpful in selecting the appropriate initials. Alternatively, if the application is submitted in response to a Program Announcement (PA) or Request for Application (RFA) from a particular NIH institute, the applicant should identify the number of the PA or RFA in Item 3. This information will be used as a guide in the application assignment process. Applications kits and the brochure "Helpful Hints on Preparing a Fellowship Application to the National Institutes of Health," are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. Concurrent Applications. An individual may not have more than one individual NRSA fellowship or comparable application pending concurrently with the NIH or other DHHS agencies. Application Receipt Dates and Review Schedule F32 applications undergo a review process that takes between 5 and 8 months. The three annual review cycles are as follows: Application Initial Secondary Range of Receipt Review Review Likely Date Date Date Start Dates Apr 5 Jun/Jul Aug/Sep Sep 1 - Dec 1 Aug 5 Oct/Nov Dec/Jan Jan 1 - Mar 1 Dec 5 Feb/Mar Apr/May May 1 - Jul 1 Review Considerations Applications receive two sequential levels of review. Initial review groups (IRGs), composed primarily of nongovernment scientists who have been selected for their competence in particular scientific areas, evaluate applications for merit. A scientific review administrator (SRA), a designated Federal official, coordinates the review of applications for each IRG. After the initial review meeting, the SRA prepares the summary statement for each application and forwards it to the appropriate NIH institute. There, a second level of review is provided by institute staff members before a funding decision is made. Review Criteria The review criteria focus on three main components: o qualifications and potential of the applicant. o the scientific merit and training potential of the proposed research. o the training resources and environment, including the sponsor. It is important to remember that the F32 program is a training award and not a research award. Major considerations in the review are the applicant's potential for a productive scientific career, the applicant's need for the proposed training, and the degree to which the research training proposal, the sponsor, and the environment will satisfy these needs. For more details, see the Peer Review Process in the PHS 416-1 application instructions. Notification Shortly after the initial review meeting, each candidate will be sent a mailer that includes the IRG recommendation, the priority score, and the name of a program official in one of the NIH institutes or centers. The institute automatically forwards a copy of the summary statement to the applicant as soon as possible after receipt from the IRG. Following the second-level review, the institute will notify each applicant of the final disposition of the application. Any questions about initial review recommendations and funding possibilities should be directed to the appropriate institute program official, not the scientific review administrator of the IRG. Award Criteria The staff of the NIH institutes use the following criteria in making awards: o IRG recommendation of the overall merit of the application o relevance of the application to institute research priorities and program balance o availability of funds. Activation. An awardee has up to 6 months from the issue date on the award notice to activate the award. Under unusual circumstances, an NIH institute may grant an extension of the activation period upon receipt of a specific request from the fellow. Terms and Conditions of Support Fellowships must be administered in accordance with the current National Research Service Award Guidelines for Individual Awards and Institutional Grants, the current PHS Grants Policy Statement, and any terms and conditions specified on the award notice. The following policies are noted: Certification and Reporting Procedures. No application will be accepted without the applicant signing the certification block, which indicates, among other things, intent to meet the payback provisions required under law. Individuals admitted to the United States as permanent residents must submit notarized evidence of legal admission prior to the award. No funds may be disbursed until the fellow has started training under the award and an activation notice (PHS 416-5) has been submitted to NIH, accompanied by a Payback Agreement (PHS 6031) when the award is for the individual's initial 12 months of NRSA postdoctoral support. When support ends, the fellow must submit a Termination Notice (PHS 416-7) to the NIH, and if the fellow has a payback obligation, he or she must notify the NIH of any change in address and submit Annual Payback Activities Certification forms (PHS 6031-1) until the payback service obligation is satisfied. Inventions and Publications. Fellowships made primarily for educational purposes are exempted from the PHS invention requirements. F32 awards will not contain any provision giving PHS rights to inventions made by the awardee. PHS policy is to make available to the public the results and accomplishments of the activities that it funds. Therefore, it is incumbent upon fellows to make results and accomplishments of their F32 activities available to the public. There should be no restrictions on the publication of results in a timely manner. Except as otherwise provided in the terms and conditions of the award, the recipient is free to arrange for copyright without approval when publications, data, or other copyrightable works are developed in the course of work under a PHS grant-supported project or activity. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes. Nondiscrimination. The NIH research training and career development programs are conducted in compliance with applicable laws that provide that no person shall, on the grounds of race, color, national origin, handicap, or age, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity (or, on the basis of sex, with respect to any education program or activity) receiving Federal assistance. Authority and Regulations NRSA awards are made under the authority of Section 487 of the Public Health Service Act as amended (42 USC 288), and Title 42 of the Code of Federal Regulations, Part 66. The following Catalog of Federal Domestic Assistance numbers are applicable to these awards: 93.121, 93.172, 93.173, 93.272, 93.278, 93.282, 93.306, 93.361, 93.398, 93.821, 93.837-93.839, 93.846-93.849, 93.853-93.856, 93.859, 93.862- 93.867, 93.880, 93.894, and 93.929. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Additional Information For further information, contact the appropriate individual listed below: National Institute of Aging (NIA) Dr. Robin Barr Telephone: (301) 496-9322 Email: rb42h@nih.gov National Institute on Alcohol Abuse and Alcoholism (NIAAA) Dr. Ernestine Vanderveen Telephone: (301) 443-1273 Email: tvanderv@willco.niaaa.nih.gov National Institute of Allergy and Infectious Diseases (NIAID) Dr. Milton Hernandez Telephone: (301) 496-7291 Email: mh35c@nih.gov National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Dr. Richard Lymn Telephone: (301) 594-5128 Email: rl28b@nih.gov National Cancer Institute (NCI) Dr.Vincent Cairoli Telephone: (301) 496-8580 Email: cairoliv@dcbdcep1.nci.nih.gov National Institute of Child Health and Human Development (NICHD) Dr. Danuta Krotoski Telephone: (301) 402-2242 Email: krotoskd@hdo1.nichd.nih.gov National Institute of Deafness and Other Communication Disorders (NIDCD) Dr. Daniel Sklare Telephone: (301) 496-1804 Email: daniel_sklare@nih.gov National Institute of Dental Research (NIDR) Dr. James Lipton Telephone: (301) 594-2618 Email: liptonj@de45.nidr.nih.gov National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Division of Diabetes, Endocrinology, and Metabolic Diseases Dr. Ronald Margolis Telephone: (301) 594-8819 Email: margolisr@ep.niddk.nih.gov Division of Digestive Diseases and Nutrition Dr. Judith Podskalny Telephone: (301) 594-8876 Email: podskalnyj@ep.niddk.nih.gov Division of Kidney, Urologic, and Hematologic Diseases Dr. Charles Rodgers Telephone: (301) 594-7726 Email: rodgersc@ep.niddk.nih.gov National Institute on Drug Abuse (NIDA) Division of Basic Research Dr. Charles Sharp Telephone: (301) 443-1887 Email: cs107m@nih.gov Division of Clinical and Services Research Dr. Arthur Horton Telephone: (301) 443-4060 Email: ah61x@nih.gov Division of Epidemiology and Prevention Research Ms. Ann Blanken Telephone: (301) 443-6543 Email: ab108v@nih.gov Medications Development Division Dr. Jamie Biswas Telephone: (301) 443-5280 Email: jb168r@nih.gov National Institute of Environmental Health Sciences (NIEHS) Dr. Michael Galvin, Jr. Telephone: (919) 541-7825 Email: galvin@niehs.nih.gov National Eye Institute (NEI) Dr. Maria Giovanni Telephone: (301) 496-0484 Email: mg37u@nih.gov National Institute of General Medical Sciences (NIGMS) Dr. Michael Martin Telephone: (301) 594-3910 Email: martinm@gm1.nigms.nih.gov National Heart, Lung, and Blood Institute (NHLBI) Ms. Mary Reilly Telephone: (301) 435-0222 Email: mr50w@nih.gov National Institute of Mental Health (NIMH) Office on AIDS Dr. Leonard L. Mitnick Telephone: (301) 443-7281 Email: lmitnick@nih.gov Division of Neuroscience and Behavioral Science Dr. Henry Khachaturian Telephone: (301) 443-8033 Email: hkhach@helix.nih.gov Division of Clinical and Treatment Research Dr. George T. Niederehe Telephone: (301) 443-3264 Email: gniedere@nih.gov Division of Epidemiology and Services Research Dr. Kenneth G. Lutterman Telephone: (301) 443-3373 Email: klutterma@nih.gov National Institute of Neurological Disorders and Stroke (NINDS) Mr. Edward Donohue Telephone: (301) 496-4188 Email: ed25b@nih.gov National Institute of Nursing Research (NINR) Dr. Lynn Amende Telephone: (301) 594-5965 Email: la18g@nih.gov National Center for Human Genome Research (NCHGR) Dr. Bettie Graham Telephone: (301) 496-7531 Email: grahamb@odder.nchgr.nih.gov National Center for Research Resources (NCRR) Dr. Harriet Gordon Telephone: (301) 435-0790 Email: harrietg@ep.ncrr.nih.gov Office of Alternative Medicine (OAM) Dr. Richard Nahin Telephone: (301) 496-4792 Email: nahinr@od31em1.od.nih.gov Note: The Office of Alternative Medicine (announced in the NIH Guide for Grants and Contracts, Vol. 23, No. 1, January 7, 1994) will provide funds for a limited number of postdoctoral fellowships in fiscal year 1997. The funds will be provided to the appropriate institute identified above, which will award and administer the fellowship. Interested applicants should consult the program announcement, PA-94-025, and if applicable, indicate the PA number in item 3 on the face page of the application. Other DHHS Organization Making F32 Awards: Agency For Health Care Policy and Research (AHCPR) Training Officer Office of Scientific Affairs Agency for Health Care Policy and Research 2101 E. Jefferson Street, Suite 400 Rockville, Maryland 20852 Telephone: (301) 594-1449 FAX: (301) 594-0154 Email: training@po7.ahcpr.gov Other NIH Programs That Support Research Training For a complete description of NIH programs that provide research training support at levels from high school to the senior investigator level, at research institutions, colleges, and universities around the United States, in other countries, and at the NIH facilities, please refer to Research Training and Career Development Programs Supported by the National Institutes of Health (NIH Publication No. 93-2273), which can be obtained from the NIH website at http://www.nih.gov/, and the Grants Information Office, Extramural Outreach and Information Resources Office, Office of Extramural Research, 6701 Rockledge Drive, Room 6207, MSC 7910, Bethesda, MD 20892-7910, 301-435-0714, ASKNIH@ODROCKM1.OD.NIH.GOV. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NIMH POLICY CHANGES FOR CAREER AWARDS (K-SERIES) AND SUPPLEMENTAL INSTRUCTIONS TO THE NIH K AWARD PROGRAM ANNOUNCEMENTS NIH GUIDE, Volume 25, Number 31, September 20, 1996 P.T. National Institute of Mental Health This Notice is intended to provide current National Institute of Mental Health (NIMH) career award (K series) holders and prospective applicants with the latest policy changes regarding these awards. This Notice supplements (with the exceptions noted below) the previous Notice, which appeared in the NIH Guide, Vol. 24, No. 18, May 19, 1995. The NIH program announcements addressed in this Notice are the following: PA-95-049: Mentored Research Scientist Development Award (K01) PA-95-050: Independent Scientist Award (K02) PA-95-051: Senior Scientist Award (K05) PA-95-052: Academic Career Award (K07) PA-95-053: Mentored Clinical Scientist Development Award (K08) POLICY CHANGES Senior Scientist Award (K05) Independent Scientist Award (K02) Effective January 1, 1997, NIMH will restrict the K05 awards to one five year term only, and make these awards only to investigators who are NIMH grantees at the time of award. To implement this policy, competing K05 renewal applications (type 2) will not be accepted, by the NIMH after January 1, 1997. K02 awards will continue to be available for two five year terms (which includes one renewal). Investigators with research support >From other NIH Institutes may receive an initial K02 award from NIMH. However, those individuals who previously have held an NIMH K01 or K08 award must have NIMH research support at the time of their first K02 award. Eligibility for renewal of K02 awards will be limited to NIMH grantees at the time of award. Scientists who hold a position with firm salary support for research or whose primary responsibility is administrative, must demonstrate a compelling need for a K02 or K05 award. For the purpose of these policies, NIMH grantees are Principal Investigators (PIs) on R01, R10, R18, R21, R24, R29, R37, P01, P20, P30, P50, and U01 grants (investigators who direct subprojects on P series grants are not eligible). These policies will govern all K02 and K05 applications submitted after January 1, 1997. The NIMH expects that these policy changes will result in distributing limited career award funds to greater numbers of junior investigators seeking careers in mental health research. The NIMH recognizes that these policy changes may have a significant impact on the research programs and plans of current holders of K02 and K05 awards, especially those currently in the last year of their award. Current K02 and K05 awardees who would be affected adversely by this policy should contact an NIMH program official, listed under INQUIRIES, for further assistance. Academic Career Award (K07) After January 1, 1997, NIMH will no longer accept new or revised applications for grant support via the K07 mechanism. Prospective candidates for K07 awards are advised to consider applying instead for the K08 award, which has similar eligibility criteria and provides comparable forms of support for scientific career development. Any K07 applications submitted after January 1, 1997 receipt deadlines will be administratively re-coded and reviewed as K08 applications. Individuals submitting K07 applications will be allowed to submit supplemental information addressing issues pertinent to the K08 mechanism before their application is reviewed. These changes do not apply to current K07 awardees or to K07 applications submitted on or before January 1, 1997. Institutional Environment and Commitment All of the following conditions apply to K01, K02, and K08 applicants, unless otherwise specified: The sponsoring institution must document the availability of a strong, well-established research program related to the candidate's area of interest, including a high-quality research environment with senior staff competent to collaborate with the candidate (K02 applicants), or the names of experienced faculty members in departments relevant to the candidate's proposed training (K01 and K08 applicants). The sponsoring institution must also provide a statement of commitment to the candidate's research career development (K01 and K08) or research career enhancement (K02). Specifically, evidence must be provided to ensure that the applicant's salary is not contingent upon the receipt of this award. Further, the K01 and K08 are not intended to be used in order to maintain a promising person in postdoctoral status. The most appropriate evidence of the sponsoring institution's commitment to K01 or K08 candidates is a full-time faculty appointment. Evidence must also be provided to ensure the feasibility of the proposed research development (K01 and K08) or research enhancement (K02) plan, including availability of office and laboratory space, equipment and other resources, as well as access to clinical and/or other research populations. The sponsoring institution should also describe actions it will take to ensure that the candidate will be able to devote essentially full time (at least 75 percent) to research. A description of the department's overall research programs and details of relevant research are required. The department chairperson or research director is to submit information on the institution's research programs in mental health; plans to develop these programs; and specific plans for the candidate. The institution should provide plans for the use of institutional (non-PHS) funds that would be released as a result of the award. It is expected that such funds will revert to the individual awardee's department and be used in a manner which will further the spirit of the award, i.e., to expand mental health research programs. Consequently, when the award relieves a staff member of major teaching or clinical duties, it is expected that the salary funds released will be used to bring in another person to resume these duties, thus enhancing the general capability of the department in the awardee's specialty area. Some departments use these funds to hire persons of lower rank and apply the remaining excess funds to related research needs, e.g., equipment or research assistance. INQUIRIES Consultation with NIMH staff is encouraged especially during the planning phase of the application. Below are the names of the NIMH staff who can provide further information: Henry Khachaturian, Ph.D. Division of Neuroscience and Behavioral Science 5600 Fishers Lane, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-8033 FAX: (301) 443-1731 Email: hk11b@nih.gov Kenneth G. Lutterman, Ph.D. Division of Epidemiology and Services Research 5600 Fishers Lane, Room 10-95 Rockville, MD 20857 Telephone: (301) 443-3373 FAX: (301) 443-4045 Email: klutterm@nih.gov Leonard L. Mitnick, Ph.D. Office on AIDS 5600 Fishers Lane, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: lmitnick@nih.gov George Niederehe, Ph.D. Division of Clinical and Treatment Research 5600 Fishers Lane, Room 18-101 Rockville, MD 20857 Telephone: (301) 443-3264 FAX: (301) 443-6784 Email: gniedere@nih.gov $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN HL-96-022 FULL-TEXT ************************************** TUBERCULOSIS ACADEMIC AWARD NIH GUIDE, Volume 25, Number 31, September 20, 1996 RFA AVAILABLE: HL-96-022 P.T. National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: October 4, 1996 Application Receipt Date: November 1, 1996 PURPOSE The purpose of this solicitation is to stimulate the development and/or improvement of the quality of medical curricula, physician/patient/nurse/and community education, and clinical practice for the prevention, management, and control of Mycobacterium tuberculosis (TB) in the United States. The candidate for the award must be an established physician and a faculty member, who has sufficient clinical training and practical experience in the control of TB, and who is aware of the training and educational needs of health care professionals at all levels who are working in the area of TB control. The candidate must also be a leader in providing the appropriate instructional programs for these individuals, and must have the unqualified support of the Dean and the educational leadership at the institution. The mechanism of support is the National Institutes of Health Academic Award (K07). Up to five years of support may be requested. The estimated funds (total costs) available for the first year of support for the entire program is $300,000. It is anticipated that no more than three awards will be issued under this program. 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), Tuberculosis Academic Award, is related to the priority areas of immunization and infectious diseases and HIV Infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202- 512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Melonie Shine Division of Lung Diseases National Heart, Lung, Blood Institute 6701 Rockledge Drive, Suite 10018, MSC-7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: ShineM@NIH.GOV $$R1 END ************************************************************ $$R2 BEGIN HD-96-009 FULL-TEXT ************************************** ADOLESCENT MEDICINE HIV/AIDS RESEARCH NETWORK NIH GUIDE, Volume 25, Number 31, September 20, 1996 RFA AVAILABLE: HD-96-009 P.T. National Institute of Child Health and Human Development National Institute of Allergy and Infectious Diseases National Institute on Drug Abuse Letter of Intent Receipt Date: October 15, 1996 Application Receipt Date: November 19, 1996 PURPOSE The National Institute of Child Health and Human Development (NICHD), the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institute on Drug Abuse (NIDA) invite applications for cooperative agreements (U01) to expand the clinical science component of an existing adolescent health research network, the Adolescent Medicine HIV/AIDS Research Network. This Network is conducting basic and clinical research on the medical, biobehavioral, and psychosocial aspects of HIV/AIDS in adolescents infected with HIV through sexual or drug-taking behaviors. The network, established in 1994, is recruiting adolescents ages 12 through 18 years. Additional funding from Health Resources and Services Administration (HRSA) has been provided to the Network to fund the infrastructure to support research in clinical sites including outreach efforts and to develop and disseminate treatment and policy guidelines specific to HIV-infected adolescents. 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), Adolescent Medicine HIV/AIDS Research Network, is related to the priority areas of maternal and infant health and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Telephone: 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Audrey Smith Rogers, Ph.D., M.P.H. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B11 - MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-7339 FAX: (301) 496-8678 Email: rogersa@hd01.nichd.nih.gov $$R2 END ************************************************************ $$R3 BEGIN HL-96-019 FULL-TEXT ************************************** GENE TRANSFER PRINCIPLES FOR HEART, LUNG AND BLOOD DISEASES NIH GUIDE, Volume 25, Number 31, September 20, 1996 RFA AVAILABLE: HL-96-019 P.T. National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: January 10, 1997 Application Receipt Date: February 13, 1997 PURPOSE The National Heart, Lung, and Blood Institute (NHLBI) invites Program Project (P01) grant applications for support of research efforts to advance gene transfer technology and its potential application to cardiovascular, pulmonary, and hematologic diseases. The overall objective of this program is to foster research that will provide the basic science foundation necessary for gene transfer technology and its application to somatic gene transfer by: (1) promoting the alliance of a critical mass of talented and dedicated investigators with expertise in the diverse areas essential for successful implementation of this research program; (2) providing the infrastructure needed to establish the collaboration of experts in a wide-ranging number of scientific areas; and (3) funding innovative pilot and feasibility studies to attract new and established investigators into the field of gene transfer for cardiovascular, pulmonary, and hematologic diseases. 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), Gene Transfer Principles for Heart, Lung, and Blood Diseases, is related to the priority area of heart disease and stroke, diabetes and chronic disabling diseases, and maternal and infant health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No.017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Sonia Skarlatos, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 10186 Bethesda, MD 20892-7956 Telephone: (301) 435-0550 FAX: (301) 480-2858 Email: SKARLATS@GWGATE.NHLBI.NIH.GOV $$R3 3ND ************************************************************ $$P1 BEGIN PAR-96-073 FULL-TEXT ************************************* EXPLORATORY/DEVELOPMENTAL GRANTS FOR HIGH RISK/HIGH IMPACT RESEARCH NIH GUIDE, Volume 25, Number 31, September 20, 1996 PA AVAILABLE: PAR-96-073 P.T. National Institute on Deafness and Other Communication Disorders Application Receipt Date: November 20, 1996 PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) invites grant applications from basic and clinical investigators who are interested in pursuing high risk/high impact (HR/HI) research focused on hearing, balance, smell, taste, voice, speech, or language related to the specific mission of the NIDCD. This HR/HI research involves pilot/feasibility studies in which the technological, methodological, or theoretical approach to the problem lacks a traditional historical basis or pilot data, but which could have a major impact on a scientific area or field. Descriptions for the characteristics of this HR/HI research have included "groundbreaking," "revolutionary," and "paradigm shifting" (High Risk/Innovative Research Identification in NIH Peer Review Notes, Division of Research Grants, June 1993). This research program will be supported through Exploratory/Developmental (R21) Grants restricted in level of support and in time. These grants provide support for the development of a basis for more extensive research projects. This Program Announcement (PA) is a solicitation for a single receipt date, November 20, 1996. 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, Exploratory/Developmental Grants for High Risk/High Impact Research, is related to the priority areas of diabetes and chronic disabling conditions and special population objectives. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Dr. Chyren Hunter Division of Human Communication National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C - MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3458 Email: Chyren_Hunter@nih.gov FAX: (301) 402-6251 $$P1 END ************************************************************ From owner-sci-resources@net.bio.net Tue Sep 24 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-96-019 - V25(31) 09/20/96 Date: 24 Sep 1996 17:26:07 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 653 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <529u6v$gtb@net.bio.net> NNTP-Posting-Host: net.bio.net GENE TRANSFER PRINCIPLES FOR HEART, LUNG, AND BLOOD DISEASES NIH GUIDE, Volume 25, Number 31, September 20, 1996 RFA: HL-96-019 P.T. National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: January 10, 1997 Application Receipt Date: February 13, 1997 PURPOSE The National Heart, Lung, and Blood Institute (NHLBI) invites Program Project grant applications for support of research efforts to advance gene transfer technology and its potential application to cardiovascular, pulmonary, and hematologic diseases. The overall objective of this program is to foster research that will provide the basic science foundation necessary for gene transfer technology and its application to somatic gene transfer by:(1)promoting the alliance of a critical mass of talented and dedicated investigators with expertise in the diverse areas essential for successful implementation of this research program; (2)providing the infrastructure needed to establish the collaboration of experts in a wide-ranging number of scientific areas; and (3)funding innovative pilot and feasibility studies to attract new and established investigators into the field of gene transfer for cardiovascular, pulmonary, and hematologic diseases. 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), "Fundamental Biological Principles for Gene transfer for Cardiovascular, Pulmonary, and Hematologic Diseases", is related to the priority area of Heart Disease and Stroke, Diabetes and Chronic Disabling Diseases, and Maternal and Infant Health. Methodologies and biotechnological advances resulting from these studies may also be applicable to the priority areas of Cancer, and Food and Drug Safety. 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, D.C. 20402-9325 (telephone 202-783-3283). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and nonprofit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under this RFA. Awards under this announcement will not be made to foreign institutions. MECHANISM OF SUPPORT This RFA will use the NIH Program Project grant (P01) mechanism of support (containing research projects and the requisite shared infrastructural resources (cores) as subcomponents under the aegis of the parent grant). A Program Project grant is for the support of a broadly-based multidisciplinary or multifaceted research program that has a specific major objective or central theme. The award may support research components and core functions. Collectively, these components should demonstrate essential elements of unity and interdependence and result in a greater contribution to program goals than if each activity were pursued individually. Applications must be prepared and awards will be made according to NHLBI Program Project policies. NHLBI Guidelines for the preparation of the Program Project Grant applications may be obtained from Dr. C. James Scheirer at the address listed under LETTER OF INTENT. Applicants are expected to furnish their own estimates of time required to achieve the objectives of the proposed research project. Up to 5 years of support may be requested. 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 peer review procedures. It is anticipated that support for this program will begin in September 1997. Administrative adjustments in project period and/or amount may be required at the time of the award. FUNDS AVAILABLE It is anticipated that for fiscal year 1997, approximately $5,130,000 total costs will be available for the first year of support for this initiative. Applicants may request up to $1,140,000 direct costs, not including indirect costs for collaborating institutions, in the first year with a maximum increase of no more than 4 percent in each additional year requested. Award of grants pursuant to this RFA is contingent upon receipt of funds for this purpose. It is anticipated that three program project grants will be awarded under this program. The specific number to be funded will, however, depend on the merit and scope of the applications received and on the availability of funds. Pilot and feasibility studies may be submitted to pursue promising but untested methodologies or highly novel research. Funding for such projects is included in the $1,140,000 direct cost cap. Each pilot and feasibility project may request up to $60,000 in total costs per year for a maximum of two years. New projects, subjected to the same dollar and time limits, may be proposed to replace those that terminate. At any one time, a maximum of 3 pilot and feasibility projects will be allowed per program project research grant. The mechanism for selecting and reviewing initial and subsequent pilot/feasibility projects during the 5 year tenure of this program is detailed in the special guidelines governing this program, available from the program administrators listed at the end of this announcement. Equipment is included in the budget limitation. However, requests for special equipment that cause an application to exceed this limit may be permitted on a case-by-case basis following staff consultation. Such equipment requires strong justification. Final decisions will depend on the nature of the justification and the availability of funds. CONSORTIUM ARRANGEMENTS If a grant application includes research activities that involve institutions other than the grantee institution, the program is considered a consortium effort. Such activities may be included in a Program Project grant application, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. In addition, NHLBI requires that at least half of both the subprojects and cores submitted and funded be in the applicant institution. The published policy governing consortia is available in the business offices of institutions that are eligible for Federal grants-in-aid. Consult the latest published policy governing consortia before developing the application. If clarification of the policy is needed, contact William Darby, (301)435- 0177. Applicants for Program Project grants should clearly describe the interactions of the participants and the integration of the consortium project(s) with those of the parent institution, because synergism and cohesiveness can be diminished when projects are located outside the group at the parent institution. Indirect costs paid as part of a consortium agreement are excluded from the limit on the amount of direct costs that can be requested. INTER- AND INTRA-INSTITUTIONAL COLLABORATIONS A key ingredient for the success of this program is the multidisciplinary collaboration of investigators skilled in pursuing basic science principles in areas such as gene expression with researchers who are skilled in the application of such principles to gene transfer for cardiovascular, pulmonary and hematologic diseases. Hence, one of the objectives of this program is to foster the alliance of a critical mass of talented and dedicated investigators with expertise in the diverse areas essential for successful implementation of this research program. This intensive, multi-disciplinary enterprise will require substantial interaction and coordination among individuals skilled in molecular biology, virology, developmental biology, cellular biology, bioengineering, pathology, genetics, biochemistry, physiology and other disciplines dealing with biologic mechanisms and health and diseases. Program Project guidelines require that at least half of both the subprojects and cores submitted and funded be in the applicant institution. INFRASTRUCTURAL RESOURCES Another important objective of this initiative is to provide the infrastructure needed to establish the collaboration of experts in a wide-ranging number of scientific areas. In order to provide the appropriate infrastructure, funds may be utilized to support core resources as shared facilities. These "shared" resources form the structural foundation for the areas of scientific need and are an important goal of this program. Rather than being purely service oriented cores for performance of routine functions, there may be a need for some of these cores to be involved in technological developments, such as in the area of vectors. These "shared" infrastructural resources must be flexible enough to meet the needs of the constantly evolving science. As such, the investigators will be required to provide yearly progress reports delineating the functions of these cores for the previous and future project periods to assure that the cores are meeting the scientific and technical needs requisite for advancing gene therapy. PILOT AND FEASIBILITY STUDIES An important goal of this program is to attract new and established investigators into the field of gene therapy by providing access to critical technologies (in the form of shared resources described above) and funds to pursue innovative pilot/feasibility studies. Pilot and feasibility studies, when combined with appropriate core support, will provide established investigators who have not previously worked in gene transfer and new young investigators with state-of-the-art core technologies to be competitive in the field. In addition, pilot and feasibility studies will allow investigators to pursue promising but untested methodologies or highly novel, research avenues that may offer significant results and insight. However, funds for these pilot/feasibility studies are not intended to support or supplement ongoing funded research of an investigator. It is anticipated that by providing preliminary results and establishing feasibility data, these pilot studies will lead to new research proposals in the area of gene transfer as it will relate to prevention and treatment of cardiovascular, pulmonary and hematologic diseases. Applicants are requested to propose a Pilot and Feasibility Committee that will be responsible for developing and selecting those projects most likely to aid progress in achieving successful gene transfer. Each pilot and feasibility project may request up to $60,000 in total costs per year for a maximum of two years. New projects, subjected to the same dollar and time limits, may be proposed to replace those that terminate. At any one time, a maximum of 3 pilot and feasibility projects will be allowed per program project research grant. RESEARCH OBJECTIVES Background The introduction of genetic material into human cells with successful expression of the inserted gene is a historic technological advance. It allows the development of novel strategies for prevention control, and treatment of disease through the use of gene transfer. Conceptually, gene transfer can be used to correct or replace defective genes. Current approaches for gene transfer attempt to introduce genes in addition to the endogenous genome in an effort to restore or enhance normal cellular activities or to confer new cellular activities. This approach does not attempt to correct resident, nonfunctional mutant genes. The introduction of genetic material to prevent the expression of disease-causing genes is another gene transfer approach. At the present time, however, molecular genetic interventions for cardiovascular, pulmonary, and hematologic diseases face many difficult technical hurdles. Critical basic science issues must be addressed prior to transfer of this technology to the clinic. Expanded and new research efforts are necessary to develop the basic tasks involved in gene transfer, such as insuring regulated, stable and cell-specific expression of transferred genes in target cells, developing efficient gene transfer delivery systems, and producing animal models of cardiovascular, pulmonary, and hematologic disease in order to develop and test novel therapeutic approaches. In addition, gene transfer research affords the opportunity to further the understanding of the genetic components of single gene and multifactorial gene diseases. Hence, it is critical to facilitate research efforts that include molecular, cellular, genetic and preclinical studies to advance gene transfer technology and its application to a wide range of cardiovascular, pulmonary, and hematologic diseases. The potential of gene transfer to treat cardiovascular diseases is substantial. However, there are unique features of cardiovascular diseases that require special gene transfer approaches. For example, the focal nature of coronary artery disease and restenosis may require direct delivery of therapeutic genetic material to specific myocardial or vascular sites. Additional challenges encountered with cardiovascular cells include the non-dividing nature of some cell types, such as heart myocytes. Strategies for other cardiovascular diseases might include gene transfer to: treat myocardial ischemia by promoting collateral circulation; prevent vascular smooth muscle proliferation following angioplasty; and prevent cardiac transplantation rejection by altering the cell surface properties to deter an immune response. There are many opportunities for application of gene transfer techniques to prevention and treatment of pulmonary disorders. Although there have been several promising advances in the use of gene transfer approaches for cystic fibrosis, major barriers for this and other pulmonary diseases to further progress exist. Mechanisms that underlie the immune response to viral vectors need to be elucidated. The development and characterization of more efficient gene transfer delivery systems need to be established. The use of gene transfer to ameliorate or prevent inflammatory lung disorders such as ARDS and asthma is just beginning to be explored. Gene transfer to the pulmonary vasculature is also largely unexplored. The role of this approach to treating pulmonary thrombosis, pulmonary hypertension, or other conditions needs to be evaluated. Bronchopulmonary dysplasia, pulmonary fibrosis, and chronic obstructive pulmonary disease are other potential targets for the use of gene transfer. Many of the problems and needs relevant to gene transfer in the cardiovascular and pulmonary areas are generally applicable to hematologic genetic diseases, such as hemophilia, sickle cell disease, and thalassemia. Choice of the appropriate target cell ranges from important to critical for hematologic disorders. In the case of hemophilia, the normal site of production of factors VIII and IX is believed to be the liver; however, other target cells such as myoblasts and fibroblasts have been used in preliminary experiments. Also critical is access of the secreted gene product to the circulation. Studies of mechanisms of development and suppression of immunity to newly expressed gene products will also be an important issue. Thus, although much progress has been made, many basic issues crucial to clinical success remain. OBJECTIVES In order for key advances to take place in the needs outlined above, there are critical biological tasks that must be solved. Hence, the focus of this initiative will be on the fundamental questions related to applications of gene transfer technology for use in the cardiovascular, pulmonary, and hematologic systems. Clinical gene transfer trials are beyond the scope of this initiative. Research needs include: Gene Expression: It is important to understand the underlying mechanisms that determine how the transferred gene is expressed in sufficient amounts in the physiologically correct manner. Too much, too little, or inappropriately timed expression may be harmful. More information is also needed about secretion of expressed proteins into appropriate compartments or into the circulation. An understanding of cell specific and tissue specific gene expression, as it relates to gene transfer, is required. An understanding of the biological consequences of recombinant gene expression needs to be gained. Studies aimed at examining the effect of gene transfer on the normal biological function of the target cell, tissue and animal will be important. Gene Delivery and Transfer: Current techniques for inserting genes into target cells must be improved and new ones need to be developed to insure efficient gene transfer. Studies might involve viral, physical, chemical and fusion techniques to develop improved packaging and more effective gene delivery. Recent developments in controlled drug release technology, including the use of biodegradable polymers in the form of layers or microspheres and containing the desired gene, may be applicable to gene delivery. Relevant issues of immunity, safety, efficacy, and production require exploration. Research aimed at designing methods to insure cell-specific and stable long-term expression of transferred genes is essential. Development of techniques to target genes to specific chromosomal locations by homologous recombination need further exploration. Target Cells: There is a need to identify appropriate target cell populations for successful gene transfer treatment of cardiovascular, pulmonary, and hematologic diseases. Identification of stem cell populations, if appropriate, would be encouraged. In addition, methods for improved cell purification and routine isolation of highly purified cell populations, as have been developed for bone marrow cells, need to be established for other cells. Improved cell culture techniques for growth and maintenance of nontransformed cells are necessary and may involve the identification and use of cytokines and receptors that regulate cell growth. Efforts need to be directed toward isolating, purifying and maintaining cardiac and vascular myocytes, endothelial cells and cells in other organs that participate in cardiovascular, pulmonary, and hematologic disorders. Disease Pathophysiology: Basic studies in disease pathophysiology are critical to the eventual success of gene therapy. Such studies can lead to a better definition of the important target cell(s) and to more effective designs of therapeutic approaches. Cellular and Humoral Immunity: The role of cellular and humoral immunity in the gene transfer process needs clarification. Interventions to suppress the immune response are in need of exploration, as well as the development of novel vector systems that selectively minimize or repress the immune response of the host organism. Model Systems: Model systems (in vivo and in vitro) need to be developed and explored to assess the safety and efficacy of viral and nonviral vector systems. Animal models of human diseases allow researchers to design and evaluate gene transfer strategies that cannot be assessed in humans. Naturally occurring animal models that mimic human diseases occur occasionally. It is now possible, however, to use transgenic and gene targeting approaches to create and utilize animal models of human diseases. Hence, the generation and use of genetically altered animal models to develop and test gene transfer approaches needs to be encouraged. Clinical Applications: While funding for clinical gene therapy trials is beyond the scope of this initiative, the development of programs which will lead to cardiovascular, pulmonary, and hematologic gene transfer trials is encouraged. This might include the identification of candidate therapeutic genes; development of vector systems to optimize gene delivery and expression in target cells; and to test the safety and efficiency of gene expression in animal models. SPECIAL REQUIREMENTS Upon initiation of the program, the NHLBI will sponsor periodic meetings to encourage exchange of information among investigators who participate in this program. In the budget for the grant application, applicants should request travel funds for a 1-day meeting each year, most likely to be held in Bethesda, Maryland. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. 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), that 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 to Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by January 10, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be mailed, or faxed, to: Dr. C. James Scheirer Chief, Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7220, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301)435-0266 FAX: (301)480-3541 Email: James_Scheirer@NIH.GOV APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained >From the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov; and from the program staff listed under INQUIRIES. Special program project guidelines have been developed to meet the special features and needs of this RFA program and must be used in applying for these grants. These guidelines can be obtained from Dr. Sonia Skarlatos at the address listed under INQUIRIES. The RFA label found in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application and three signed, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to Dr. C. James Scheirer, at the same address given above in the section on LETTER OF INTENT. Applications must be received by February 13, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness by the NHLBI. Incomplete applications will be returned to the applicant without further consideration. If NHLBI staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a triage process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Heart, Lung, and Blood Advisory Council. The NIH will withdraw from further competition those applications judged to be noncompetitive for award and notify the applicant Principal Investigator and institutional official. The personnel category will be reviewed for appropriate staffing based on the requested percent effort and any changes requested in future years. The total budget request will be reviewed for consistency with the proposed methods and specific aims. The duration of support will be reviewed to determine if it is appropriate to ensure successful completion of the recommended scope of the project. Other review criteria will include: 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 appropriateness and design of the shared core facilities proposed to provide infrastructural support to the major scientific components of the gene therapy effort, including plans to monitor their performance and ability to meet changing scientific needs o adequacy and availability of the resources and facilities to support proposed clinical and basic research o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research originality of proposed research Investigator and staff, particularly, but not exclusively, in the area of the proposed research originality of proposed research o adequacy of internal and external procedures for monitoring and evaluating the proposed research and for providing on-going quality control and scientific review o scientific merit of any proposed pilot/feasibility studies and the quality of the internal and external review mechanism established by the parent institution to evaluate the scientific merit of the initial and subsequently selected pilot/feasibility projects, including development of a detailed plan for maintaining oversight and review of on-going pilot/feasibility studies and for providing written documentation of these actions, copies of which will be forwarded to the NHLBI Program Administrators o commitment of the grantee institution and any cooperating institution to the program, and the appropriateness of its resources and policies for the administration of a research program of the type proposed; and the appropriateness of the requested budget to the work proposed The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. Schedule Letter of Intent Receipt Date: January 10, 1997 Application Receipt Date: February 13, 1997 Initial Review: April/May 1997 Review by NHLBI Advisory Council: September 1997 Anticipated Award Date: September 30, 1997 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and requests for the Program Project Guidelines to: Sonia Skarlatos, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 10186 Bethesda, MD 20892-7956 Telephone: (301)435-0550 FAX: (301) 480-2848 Email: SKARLATS@GWGATE.NHLBI.NIH.GOV Susan Banks-Schlegel, Ph.D. Division of Lung Diseases National Heart, Lung and Blood Diseases 6701 Rockledge Drive, Suite 10220 Bethesda, MD 20892-7952 Telephone: (301)435-0202 FAX: (301)435-3557 Email: SCHLEGES@GWGATE.NHLBI.NIH.GOV Carol Letendre, Ph.D. Division of Blood Diseases and Resources National Heart, Lung and Blood Diseases 6701 Rockledge Drive, Suite 10162 Bethesda, MD 20892-7950 Telephone: (301) 435-0080 FAX: (301) 435-0867 Email: LETENDRC@GWGATE.NHLBI.NIH.GOV Direct inquiries regarding fiscal matters to: Mr. William Darby Grants Operations Branch National Heart, Lung, and Blood Institute Two Rockledge Center 6701 Rockledge Drive, Suite 7128 Bethesda, MD 20892-7128 Telephone: (301) 435-0177 FAX: (301) 480-3310 Email: William_Darby@NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.837. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants' policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Sep 24 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-96-073 - V25(31) 09/20/96 Date: 24 Sep 1996 17:26:33 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 362 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <529u7p$h2n@net.bio.net> NNTP-Posting-Host: net.bio.net EXPLORATORY/DEVELOPMENTAL GRANTS FOR HIGH RISK/HIGH IMPACT RESEARCH NIH GUIDE, Volume 25, Number 31, September 20, 1996 PA NUMBER: PAR-96-073 P.T. National Institute on Deafness and Other Communication Disorders Application Receipt Date: November 20, 1996 PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) invites grant applications from basic and clinical investigators who are interested in pursuing high risk/high impact (HR/HI) research focused on hearing, balance, smell, taste, voice, speech, or language related to the specific mission of the NIDCD. This HR/HI research involves pilot/feasibility studies in which the technological, methodological, or theoretical approach to the problem lacks a traditional historical basis or pilot data, but which could have a major impact on a scientific area or field. Descriptions for the characteristics of this HR/HI research have included "groundbreaking," "revolutionary," and "paradigm shifting" (High Risk/Innovative Research Identification in NIH Peer Review Notes, Division of Research Grants, June 1993). This research program will be supported through Exploratory/Developmental (R21) Grants restricted in level of support and in time. These grants provide support for the development of a basis for more extensive research projects. This Program Announcement is a solicitation for a single receipt date, November 20, 1996. 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), Exploratory/Developmental Grants for High Risk/High Impact Research, is related to the priority areas of diabetes and chronic disabling conditions and special population objectives. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state or local governments, and eligible agencies of the Federal government. Applications from minority individuals, women, and individuals with disabilities are encouraged. Foreign organizations or organizations in foreign countries are not eligible; subcontracts to these organizations are allowable, with sufficient justification. Submission of an application under this Program Announcement precludes concurrent submission of any other application containing substantially the same research proposal. In addition, these R21 awards may not be used to supplement research projects currently supported by Federal or non-Federal funds, or to provide interim support of projects under review by the Department of Health and Human Services. MECHANISM OF SUPPORT Support for this program will be provided through the National Institutes of Health (NIH) Exploratory/Developmental Grants (R21) mechanism. These pilot/feasibility projects provide support for HR/HI activities that lack a traditional historical basis or preliminary data. Indeed, areas of science in which there is a sufficient historical basis or sufficient preliminary data to support the submission of a regular research project grant application do not qualify as HR/HI under this Program Announcement. However, the applicant does have the responsibility for developing a demonstrably sound research plan designed to assess the feasibility of the proposed pilot projects. This initiative provides nonrenewable, one-year awards of up to $50,000 in direct costs; indirect costs applicable to sub-contract/consortium activity must be included under the direct cost ceiling levels. The grants may be extended in time, but not amount, at the discretion of the applicant organization. It is expected that the preliminary data generated by these grants will serve as a basis for more extensive research projects. Investigators are encouraged to consider carefully whether their research can best be accomplished through this or other grant mechanisms, such as the R01, the broad program of Small Grants for Innovative Technology of the National Center for Research Resources (NCRR) (NIH Guide, Vol. 20, No. 31, August 16, 1991), or the Small Grant Program of the NIDCD for scientists who are in the early stages of pursuing an independent research career (NIH Guide, Vol. 34, No. 38, October 27, 1995). Investigators who have questions about the appropriateness of their research plan to this initiative should contact one of the program officials listed under INQUIRIES. RESEARCH OBJECTIVES The purpose of this PA is to encourage the submission of applications >From basic and clinical investigators who are interested in pursuing HR/HI research that has the potential for leading to a technological, methodological, or conceptual breakthrough or major contribution in biomedical or behavioral research. Studies that enhance payoff potential by bridging one line of investigation with another are encouraged. The research must be focused on one or more areas within the scientific mission of the NIDCD: hearing, balance, smell, taste, voice, speech, or language. 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 was reprinted in the Federal Register of March 28, 1994 (FR 59 14508-14513) to correct typesetting and errors in the earlier publication, and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The title and number of the program announcement must be typed in Section 2 on the face page of the application. The following modifications regarding the budget are to be used in conjunction with the information accompanying application form PHS-398 (rev. 5/95). Detailed Budget for Initial Budget Period (page 4). Do not submit this page. Certain details of the budget may be requested prior to any award. Budget for Entire Proposed Period of Support (page 5). Enter total direct costs requested in the box at the bottom of the table. Justification (page 5) o List the name, role on project and percent effort for all project personnel (salaried or unsalaried) and provide a narrative justification for each person based on his/her role on the project and proposed level of effort. o Identify all consultants by name and organizational affiliation and describe the services to be performed. o Provide a narrative justification for any major budget items, other than personnel, that are requested for the conduct of the project that would be considered unusual for the scope of research. No specific costs for items or categories should be shown. o Indirect costs will be calculated at the time of the award using the institution's actual indirect cost rate. Applicants will be asked to identify the indirect cost exclusions prior to award. o If consortium/contractual costs are requested, provide the percentage of the subcontract total costs (direct and indirect) relative to the total direct costs of the overall project. The subcontract budget justification should be prepared following the instructions provided above. The completed original application and three legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (EXPRESS MAIL) At the time of submission, send two additional copies of the application to: Chief, Scientific Review Branch National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard MSC 7180 Bethesda, MD 20892-7180 Schedule The application receipt date is November 20, , 1996. Applications received after this date will be returned to the applicant. The earliest date of award is July, 1997. This program announcement may be reissued. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications whose specific aims are not relevant to the mission of NIDCD will not be accepted for review under this Program Announcement. Applications will be reviewed for scientific and technical merit in accordance with the standard NIH procedures by a review group convened by the NIDCD. As part of the initial review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level of review by the NDCD Advisory Council. Review Criteria o potential scientific, technical, or medical significance of the proposed pilot/feasibility studies, including the potential to lead to a major conceptual breakthrough or to remove a major obstacle to progress; o originality of proposed exploratory/developmental research; o appropriateness and adequacy of the experimental approach and methodology, including a demonstrably sound research plan designed to assess the feasibility of these pilot projects; o qualifications and research experience of the Principal Investigator and staff in the areas of the proposed research, particularly those demanding unusual technical sophistication; o availability of the resources necessary to perform the research; o availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions; o appropriateness of the budget and timeline for the proposed research; and o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. The initial review group will also examine the provisions for the protection of human subjects and animal welfare and the safety of the research environment. REPORTING REQUIREMENTS If an award is made in response to a R21 application, a Final Progress Report, an Invention Statement, and a Financial Status Report must be submitted within ninety days after the termination of the award. This reporting requirement is the same as that of other types of research grants and is in accord with 42 CFR 52 and 45 CFR 74. This information will be of assistance to the NIDCD in evaluating the usefulness of this R21 mechanism. If an R21 leads to the submission of another research grant, a statement to that effect would also be much appreciated; the applicant is not required to submit this statement. AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications. Funding decisions will be based on the quality of the proposed project as determined by peer review, relevance to the mission of the NIDCD, program priorities, and availability of funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is encouraged. Direct inquiries regarding programmatic issues to: Hearing: Dr. Chyren Hunter Telephone: (301) 402-3458 E-Mail: Chyren_Hunter@nih.gov Balance/Vestibular: Dr. Daniel Sklare Telephone: (301) 496-1804 E-Mail: Daniel_Sklare@nih.go Smell/Taste: Dr. Jack Pearl Telephone: (301) 402-3464 E-Mail: Jack_Pearl@nih.gov Dr. Rochelle Small Telephone: (301) 402-3464 E-Mail: Rochelle_Small@nih.gov Voice/Speech: Dr. Beth Ansel Telephone: (301) 402-3461 E-Mail: Beth_Ansel@nih.gov Language: Dr. Judith Cooper Telephone: (301) 496-5061 E-Mail: Judith_Cooper@nih.gov The address and FAX number for the above named persons are: Division of Human Communication National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard MSC-7180 Bethesda, MD 20892-7180 FAX: (301) 402-6251 Direct inquiries regarding fiscal matters to: Sharon Hunt, Chief Grants Management Branch Division of Extramural Activities National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-B 6120 Executive Boulevard, MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: SH79F@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.173. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410), as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Sep 27 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 32, pt. 1of1, 27 September 1996 Date: 27 Sep 1996 20:19:03 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 838 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <52i5f7$prf@net.bio.net> NNTP-Posting-Host: net.bio.net X-comment: RFAs described: OD-97-001, PA-96-074, PA-96-075 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.09.27 NIH GUIDE - Vol. 25, No. 32 - September 27, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** MODIFIED COMPETING AND NONCOMPETING APPLICATION INSTRUCTIONS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** AHCPR POSTPONEMENT OF NRSA APPLICATION RECEIPT DATE Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH $$INDEX N3 ********************************************************** DEVELOPMENT OF NEW GENE THERAPY VECTORS AND DELIVERY SYSTEMS National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** THE PROTECTIVE EFFECTS OF PATTERNED ELECTRICAL STIMULATION ON THE DEAFENED AUDITORY SYSTEM (RFP NIH-DC-97-03) National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX R2 03/11/97 ************************************************* INFORMED CONSENT IN RESEARCH INVOLVING HUMAN PARTICIPANTS (RFA OD-97- 001) National Cancer Institute National Center for Human Genome Research National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute on Drug Abuse National Institute of Mental Health National Institute of Nursing Research Office of Extramural Research Department of Energy Department of Veteran Affairs INDEX: CANCER; HUMAN GENOME RESEARCH; AGING; ALCOHOL ABUSE, ALCOHOLISM; ALLERGY, INFECTIOUS DISEASES; CHILD HEALTH, HUMAN DEVELOPMENT; DRUG ABUSE; MENTAL HEALTH; NURSING RESEARCH; DEPARTMENT OF ENERGY; DEPARTMENT OF VETERAN AFFAIRS $$INDEX P1 ********************************************************** DRUG USE, SEXUAL RISK BEHAVIORS, AND HIV IN MEN (PA-96-074) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P2 ********************************************************** ECONOMICS OF DRUG TREATMENT SERVICES (PA-96-075) National Institute on Drug Abuse INDEX: DRUG ABUSE THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** MODIFIED COMPETING AND NONCOMPETING APPLICATION INSTRUCTIONS NIH GUIDE, Volume 25, Number 32, September 27, 1996 P.T. 34; K.W. 1014006 National Institutes of Health As part of the design and implementation of Electronic Research Administration, the National Institutes of Health (NIH) is assessing measures for protecting private information, including the Social Security Number (SSN), currently collected about personnel identified in research grant and cooperative agreement applications. Although the provision of the SSN is voluntary, it is critically important to NIH for the accurate identification, referral, and review of applications and for management of NIH grant programs. NIH is pursuing long-term strategies in this area. Interim measures are being implemented immediately, however, to further enhance the protection of this private information. Thus, effective with the October 1, 1996, submission date, instructions for submitting competing applications to the NIH are modified as follows: 1. The Social Security Number (SSN) of the Principal Investigator, Program Director, or Fellowship applicant should be provided along with the applicant~s name at the top of the Personal Data form page only (PHS Form 398, page KK, and PHS Form 416-1, page GG). The SSN should not be listed on the face page of the application, nor provided elsewhere in the application, e.g., top of each application page. 2. In accordance with the instructions for completing the Personal Data form page, do not attach copies of that form to the duplicated copies of the application. Upon receipt of the application by NIH, this form is separated from the application and the data, including the SSN, are encrypted in the NIH database. A partially completed Personal Data form page is acceptable to NIH, i.e., applicants may elect to provide some items but not all. 3. When submitting competing renewal applications using the PHS 398 grant application kit, do not complete or submit the Personnel Report form page (JJ). This form page will be requested, if necessary, at time of award. Effective immediately, instructions for submitting non-competing applications have also changed as follows: 1. The Social Security Number of the Principal Investigator, Program Director, or Fellow should not be provided on the face page of the application. 2. When using the PHS 2590 kit, the Personnel Report form page (G) should be completed and submitted only with the original application. Do not attach copies of that form to the duplicated copies of the application. Similar changes affecting Small Business Innovation Research Grant and Small Business Technology Transfer Grant application forms will be implemented for the Fiscal Year 1997 solicitations. Applicants are strongly encouraged, to the extent possible, to follow the new procedures for the October 1 submission date. INQUIRIES Questions regarding these procedures may be directed to the Referral Office, Division of Research Grants at 301/435-0715 for issues relating to receipt of competing applications, or to Institute or Center grants management offices for issues relating to noncompeting applications. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** AHCPR POSTPONEMENT OF NRSA APPLICATION RECEIPT DATE NIH GUIDE, Volume 25, Number 32, September 27, 1996 P.T. 44; K.W. 0720005, 1014006 Agency for Health Care Policy and Research This notice is to inform the research community that the Agency for Health Care Policy and Research (AHCPR) will not accept applications for National Research Service Award (NRSA) institutional training grants (T32) on January 10, 1997 as stated in the Program Announcement (PAR-95-002) "NRSA Fellowships - Institutional Grants Policy and Guidelines,"NIH Guide, Vol. 23, No. 36, October 14, 1994. The purpose of the NRSA program is to help ensure that adequate numbers of highly trained individuals are available to carry out the Nation's health services research agenda. AHCPR plans to accept NRSA applications in September 1997, contingent upon publication of an AHCPR RFA in the spring of 1997 for the support of training programs. The RFA will encourage greater emphasis on issues relevant to the changing health care delivery system identified in the Institute of Medicine report "Health Services Research: Work Force and Educational Issues," and by the National Advisory Council on Health Care Policy, Research, and Evaluation, and by others. Grants enable eligible institutions to develop or enhance research training opportunities for individuals seeking to prepare for careers in conducting health services research which systematically examines the organization, provision, and financing of health care services. AHCPR currently supports 22 institutional programs. Grant support for each of these is scheduled to expire either in the summer of 1998 or 1999. It is the intent of AHCPR to honor all continuation commitments, to the extent feasible, during the transition period. INQUIRIES Office of Scientific Affairs Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 400 Rockville, MD 20852-4908 Telephone: (301) 594-1398 Email: training@po7.ahcpr.gov $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** DEVELOPMENT OF NEW GENE THERAPY VECTORS AND DELIVERY SYSTEMS NIH GUIDE, Volume 25, Number 32, September 27, 1996 P.T. 34; K.W. 0745032, 0740022 National Heart, Lung, and Blood Institute Annual Receipt Dates: April 1, August 1, and December 1 for STTR April 15, August 15, and December 15 for SBIR PURPOSE The purpose of this notice is to emphasizes the importance of this research topic to the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH). Collaboration between small business concerns and research institutions, including colleges and universities, is encouraged to design and develop gene therapy vectors and delivery systems for cardiovascular, pulmonary and hematologic gene therapy. Such collaboration is essential in order to qualify for support under the Small Business Technology Transfer (STTR) program and is permissible under the Small Business Innovation Research (SBIR) program. The "development of new gene therapy vectors and delivery systems" is a research topic of special interest to the NHLBI, NIH, and is identified in the OMNIBUS SOLICITATION OF THE NATIONAL INSTITUTES OF HEALTH FOR STTR GRANT APPLICATIONS (PHS 95-4) on pages 78-81, subtopics NN and E. It is identified also in the OMNIBUS SOLICITATION FOR SBIR GRANT APPLICATIONS (PHS 96-2) on pages 122-127, subtopics JJJ, BB, Q,and Y. The solicitations are available electronically through the NIH, Office of Extramural Research "Small Business Funding Opportunities" Home Page located at: HTTP://WWW.NIH.GOV/GRANTS/FUNDING/SBIR.HTM. In addition, a limited number of hard copies of the solicitations have been produced. Subject to availability, they may be obtained from the PHS STTR/SBIR Solicitation Office, phone (301) 206-9385; fax: (301) 206-9722; e-mail: a2y@cu.nih.gov. RESEARCH OBJECTIVES Background Gene therapy or the introduction of genetic material into human cells with successful expression of the inserted gene is a historic technological advance. It allows the development of novel strategies for prevention, control, and treatment of disease through the use of gene transfer. However, gene therapy is still in its infancy and faces many difficult biotechnical hurdles before it can achieve widespread clinical application. Somatic gene therapy entails two critical steps: delivery of the gene to the appropriate cells and its subsequent maintenance and expression. In order to deliver the gene to the appropriate cell, there must be a vehicle, or vector that will enter the cell and transfer the genetic material into the host genome without adverse effects. To date, several vector systems such as RNA viruses (retroviruses), DNA viruses (adenoviruses, adeno-associated viruses, herpesviruses, and poxviruses), and naked or complexed DNA have been developed. However, none of these vectors are entirely satisfactory. Presently, retroviruses and adenoviruses are the most extensively employed vectors in clinical protocols. However, both have advantages and disadvantages. Most retroviruses are efficient in entering cells and integrating the transferred material into the host genome but only if the cells are dividing. In addition, their preparation is cumbersome, titer yields are often low and they have a limited carrying capacity for added genetic material. On the other hand, adenoviruses can enter dividing or nondividing cells, have high titers and levels of expression, and relative ease of handling. Their major drawback is that they may elicit immunogenic responses from the host. Experience with other DNA viral or nonviral systems is less extensive and in its infancy. Expanded and new research in collaboration with industry will enhance the development of gene transfer technology. Development of novel vectors, modifications of existing vectors, and production of GMP- grade vectors for clinical testing are areas particularly suited to industry/academia collaborations. Modern biotechnology and pharmaceutical companies have important attributes: (1) skill in translational research and the development of drug products; (2) significant experience in meeting high manufacturing and quality control standards; (3) professional staffs expert in regulatory and clinical issues; and(4) high level of scientific and technical expertise. Involvement of industry in gene therapy technology will facilitate the transfer of technology from the bench to the bedside and bring products into the marketplace and into clinical practice at the most rapid rate. The potential of gene transfer to treat cardiovascular diseases is substantial. However, there are unique features of cardiovascular diseases that require special gene transfer approaches. For example, the focal nature of coronary artery disease and restenosis may require direct delivery of therapeutic genetic material to specific myocardial or vascular sites. Additional challenges encountered with cardiovascular cells include the non-dividing nature of some cell types, such as heart myocytes. Strategies for other cardiovascular diseases might include gene transfer to: treat myocardial ischemia by promoting collateral circulation; modify vascular smooth muscle contractility to reduce the total peripheral vascular resistance observed to occur in hypertensive patients; and prevent cardiac transplantation rejection by altering the cell surface properties to deter an immune response. There are many opportunities for application of gene transfer techniques to prevention and treatment of pulmonary disorders. Although there have been several promising advances in the use of gene transfer approaches for cystic fibrosis, major barriers for this and other pulmonary diseases to further progress exist. Mechanisms that underlie the immune response to viral vectors need to be elucidated. The development and characterization of more efficient gene transfer delivery systems need to be established. The use of gene transfer to ameliorate or prevent inflammatory lung disorders such as ARDS and asthma is just beginning to be explored. Gene transfer to the pulmonary vasculature is also largely unexplored. The role of this approach to treating pulmonary thrombosis, pulmonary hypertension, or other conditions needs to be evaluated. Bronchopulmonary dysplasia, pulmonary fibrosis, and chronic obstructive pulmonary disease are other potential targets for the use of gene transfer. Many of the problems and needs relevant to gene transfer in the cardiovascular and pulmonary areas are generally applicable to hematologic genetic diseases such as hemophilia, sickle cell disease, and thalassemia. Choice of the appropriate target cell ranges from important to critical for hematologic disorders. In the case of hemophilia, the normal site of production of factors VIII and IX is believed to be the liver; however, other target cells such as myoblasts and fibroblasts have been used in preliminary experiments. Studies of mechanisms of development and suppression of immunity to newly expressed gene products will also be an important issue. Thus, although much progress has been made, many basic issues crucial to clinical success remain. Objectives This program is open to all approaches for effective gene therapy vector designs and delivery methods. Research needs include, but are not limited to, the following: Gene Expression: The transferred gene must be expressed in sufficient amounts and in a physiologically correct manner. Gene Delivery and Transfer: Studies might involve viral, physical, chemical and fusion techniques to develop improved packaging and more effective gene delivery. Recent developments in controlled drug release technology, including the use of biodegradable polymers in the form of layers or microspheres and containing the desired gene, may be applicable to gene delivery. Target Cells: Appropriate target cell population for gene transfer of cardiovascular, pulmonary, and hematologic diseases should be identified. Cellular and Humoral Immunity: Interventions to suppress the immune response are in need of exploration, as well as the development of novel vector systems that selectively minimize or repress the immune response of the host organism. Model Systems: Model systems (in vivo and in vitro) need to be developed to assess the safety and efficacy of viral and nonviral vector systems. INQUIRIES Eligibility requirements, definitions, application procedures, review considerations, application forms and instructions, and other pertinent information (including policy information, for example, Inclusion of Women and Minorities in Research Involving Human Subjects) are contained in the STTR and SBIR solicitations identified in ~Purpose~ above. Inquiries concerning this notice are encouraged. Direct inquiries regarding programmatic issues to: Sonia Skarlatos, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 10186, MSC 7956 Bethesda, MD 20892-7956 Telephone: (301) 435-0550 FAX: (301) 480-2848 Email: ss90g@nih.gov Susan Banks-Schlegel, Ph.D. Division of Lung Diseases National Heart, Lung and Blood Diseases 6701 Rockledge Drive, Suite 10220, MSC 7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0202 FAX: (301) 480-3557 Email: ss141w@nih.gov Carol Letendre, Ph.D. Division of Blood Diseases and Resources National Heart, Lung and Blood Diseases 6701 Rockledge Drive, Room 10162, MSC 7950 Bethesda, MD 20892-7950 Telephone: (301) 435-0080 FAX: (301) 480-0867 Email: cl44m@nih.gov Direct inquiries regarding fiscal matters to: Ms. Marie Willett Grants Operations Branch National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 7128, MSC 7128 Bethesda, MD 20892-7128 Telephone: (301) 435-0177 FAX: (301) 480-3310 Email: mw48f@nih.gov $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NIH-DC-97-03 ********************************************* THE PROTECTIVE EFFECTS OF PATTERNED ELECTRICAL STIMULATION ON THE DEAFENED AUDITORY SYSTEM NIH GUIDE, Volume 25, Number 32, September 27, 1996 RFP AVAILABLE: NIH-DC-97-03 P.T. 34; K.W. 0715050, 0740030 National Institutes of Health The National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health, is recompeting an ongoing project, which is currently being performed by the Regents of the University of California, San Francisco (Contract No. N01-DC-4-2143). This requirement is for research to develop methods of protecting the remaining portions of the auditory system from degeneration after hair cell loss. Previous studies have shown that certain forms of electrical stimulation provide such a protective effect. The offeror shall evaluate the possibility that certain forms of chronic electrical stimulation of selected portions of the auditory system can maintain and possibly enhance the anatomical and physiological viability of the remaining auditory system following loss of hair cells in a manner compatible with preserving and possibly extending the function of an implanted auditory prosthesis. It is anticipated that a cost reimbursement, term type contract will be awarded for a three year period. The offeror will be required to come to Bethesda yearly to present progress on their work at the Neural Prosthesis Workshop sponsored by the Neural Prosthesis Program. It is planned that RFP No. NIH-DC-97-03 will be available on or about October 11, 1996. Proposals will be due approximately 60 days after the date of issuance of the solicitation. All responsible sources may submit a proposal that will be considered by the Government. INQUIRIES Copies of the solicitation can be obtained by sending a written request to: Donna M. Winters Division of Research Contracts National Institutes of Health 6100 Executive Boulevard, Room 6E01, MSC 7540 Bethesda, MD 20892-7540 $$R1 END ************************************************************ $$R2 BEGIN OD-97-001 FULL-TEXT ************************************** INFORMED CONSENT IN RESEARCH INVOLVING HUMAN PARTICIPANTS NIH GUIDE, Volume 25, Number 32, September 27, 1996 RFA AVAILABLE: OD-97-001 P.T. 34; K.W. 0783005 National Cancer Institute National Center for Human Genome Research National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute on Drug Abuse National Institute of Mental Health National Institute of Nursing Research Office of Extramural Research Department of Energy Department of Veteran Affairs Application Receipt Date: March 11, 1997 PURPOSE The National Cancer Institute (NCI), the National Center for Human Genome Research (NCHGR), the National Institute on Aging (NIA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Allergy and Infectious Diseases ((NIAID), the National Institute of Child Health and Human Development (NICHD), the National Institute on Drug Abuse (NIDA), the National Institute of Mental Health (NIMH), the National Institute of Nursing Research (NINR), the Department of Energy (DOE), and the Department of Veterans Affairs (VA) invite applications for a three year research grant program to stimulate investigations into the informed consent process in scientific research. There is an ethical as well as a legal responsibility to ensure that individuals both consent to and understand their participation in research. For consent to participate in research to be truly informed, the information imparted to potential participants must clearly explain study procedures, distinguish research from treatment, realistically portray the potential for medical or other benefits from participation and the nature of potential benefit, carefully explain the potential for discomfort, toxicity, or other risks that may accompany participation in the research, and clearly delineate the participant~s rights and limits regarding confidentiality and withdrawal from participation. The sponsoring organizations are jointly issuing this Request for Applications (RFA) because voluntary informed consent is the defining aspect of interactions between researchers and participants, and is integral to the conduct of the scientific research funded by all of these organizations. One of the goals of this RFA is to bring together perspectives of these different agencies, since their different research foci reflect a diversity of issues relating to informed consent. Of course, many facets of understanding the informed consent process are shared, and hence a combined effort is efficient for the agencies and scientists alike. Little empirical work exists to document the degree of understanding achieved by research participants regarding: (1) identity of the sponsoring federal agency or agencies; (2) purposes for which the research is being conducted; (3) comprehension of a study's methods and procedures; (4) relative risks and benefits (including financial) of deciding to consent or refuse participation; (5) confidentiality and any exceptions to confidentiality; (6) the implications of withdrawal from a study and (7) planned and other possible use of the data. Such data should be useful in designing informed consent procedures that are readily comprehended by prospective participants and impart all critical information. The goal of the present initiative is to develop and test alternative strategies for obtaining informed consent in diverse populations and determine optimal ways to obtain informed consent for research participation. This RFA will use the NIH individual research project grant (R01) mechanism of support. However, specific application instructions have been modified to reflect "Modular Grant" and "Just-in-Time" procedures being used under an NIH Reinvention Initiative. INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contacts listed below. Eric Meslin, Ph.D. National Center for Human Genome Research 38 Library Drive, Room 617, MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 402-4997 FAX: (301) 402-1950 Email: Eric_Meslin@nih.gov Leslie G. Ford, M.D. National Cancer Institute 6130 Executive Boulevard, Room 300 Rockville, MD 20852-7343 Telephone: (301) 496-0265 FAX: (301) 496-8667 Email: Fordl@DCPCEPN.NCI.NIH.GOV Andrew A. Monjan, Ph.D., M.P.H. Neuroscience and Neuropsychology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3C307 - MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: MonjanA@GW.NIA.NIH.GOV Theodore Pinkert, M.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 - MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1206 FAX: (301) 443-8774 Email: tpinkert@willco.niaaa.nih.gov Amy R. Sheon, PhD, MPH Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, MSC 7620 Bethesda, MD 20892-7620 Telephone: (301) 496-6177 FAX: (301) 402-3684 Email: as31r@nih.gov Sarah L. Friedman National Institute of Child Health and Human Development Building 61E, Room 4B05 Bethesda, MD 20892 Telephone: (301) 496-6591 FAX: (301) 402-2085 Email: SF2@NIHCU(BITNET) Dorynne Czechowicz, M.D. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-08 Rockville, MD 20857 Telephone: (301) 443-0107 FAX: (301) 443-2317 Email: Dczechow@aoada2.ssw.dhhs.gov John K. Hsiao, M.D. Division of Clinical and Treatment Research National Institute of Mental Health Parklawn Building, Room 18C-14 Rockville, MD 20857 Telephone: (301) 443-3524 FAX: (301) 443-6000 Email: jhsiao@helix.nih.gov June Lunney, Ph.D., RN Division of Extramural Programs National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-6908 FAX: (301) 480-8260 Email: Jlunney@ep.ninr.nih.gov Susan L. Rose, Ph.D. U.S. Department of Energy ER-72/OHER 19901 Germantown Road Germantown, MD 20874-1290 Telephone: (301) 903-5468 FAX: (301) 903-8521 Email: Susan.L.Rose@oer.doe.gov Dennis Roth Department of Veterans Affairs Office of Research and Development (12) 810 Vermont Avenue, N.W., Room 775J Washington, DC 20420 Telephone: (202) 273-8284 FAX: (202) 273-6526 Email: Roth@mail.va.gov $$R2 END ************************************************************ $$P1 BEGIN PA-96-074 FULL-TEXT ************************************** DRUG USE, SEXUAL RISK BEHAVIORS, AND HIV IN MEN NIH GUIDE, Volume 25, Number 32, September 27, 1996 PA AVAILABLE: PA-96-074 P.T. 34; K.W. 0715008, 0404009, 0411005 National Institute on Drug Abuse PURPOSE The purpose of this program announcement (PA) is to support epidemiological and HIV prevention research on drug use, sexual risk behaviors, and HIV in an especially high risk group: men who use drugs and have sex with men (DU MSM). DU MSM use drugs by injection and/or noninjection means (e.g., crack cocaine and smokable or intranasal forms of methamphetamine and heroin) and have same-gender sex regardless of their self-identified sexual orientation (gay, bisexual, or heterosexual). Because DU MSM may engage in both high risk drug use and sexual practices, and may have multiple and different drug use and sex partners and networks, they not only constitute an important HIV risk group in and of themselves but also have the potential to serve as a bridge for HIV transmission to heterosexual injecting drug users (IDUs) and non-IDU MSM. Promising directions for the epidemiology and prevention of HIV in this dual risk group will draw from cumulative research related to the epidemiology and prevention of HIV in MSM, IDUs, and noninjecting drug users. This PA seeks to stimulate research on (1) the co-occurrence of HIV risk behaviors among men who use injection and/or non-injection drugs and who have sex with men, and the adverse health consequences, (2) antecedents and correlates of high risk, especially social/situational contexts of HIV risk and protective behaviors among DU MSM and their drug use and/or sex partners and networks; (3) the efficacy and effectiveness of behavioral and biological HIV prevention interventions for diverse groups of DU MSM, including comparative evaluations of intervention outcomes and costs/benefits of community-based outreach, prevention, and treatment approaches to averting new HIV infection; and (4) development and evaluation of new behavioral therapies, drug abuse treatment approaches, health services, and health care services delivery to DU MSM. Within these research themes, investigators are encouraged to expand, test, and improve current identification and recruitment strategies, research designs, methods, and measures of behavioral risk and intervention effects among hard-to-reach subgroups of DU MSM. Research support mechanisms under this PA will include investigator-initiated research project grant (R01), Small Grant (R03), and First Independent Research Support and Transition (FIRST) (R29) awards. 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, Drug Use, Sexual Risk Behaviors, and HIV in Men, is related to the priority areas of reducing alcohol and other drug use and the transmission of HIV. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Richard H. Needle, Ph.D., M.P.H. or Elizabeth Y. Lambert, M.Sc. and Helen Cesari, M.Sc. Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-42 Rockville, MD 20857 Telephone: (301) 443-6720 FAX: (301) 443-2636 Email: RN28E@NIH.GOV or EL46I@NIH.GOV or HC30X@NIH.GOV $$P1 END ************************************************************ $$P2 BEGIN PA-96-075 FULL-TEXT ************************************** ECONOMICS OF DRUG TREATMENT SERVICES NIH GUIDE, Volume 25, Number 32, September 27, 1996 PA AVAILABLE: PA-96-075 P.T. 34; K.W. 0404009, 0745070, 0408006 National Institute on Drug Abuse PURPOSE This program announcement (PA) encourages research on the economics of drug abuse treatment services. This field of economic research is concerned with the behavior of consumers, providers, governments, and third party payers, and how they respond to economic incentives related to drug abuse treatment services. Applications are sought that would employ the methods of economic analysis to the most pressing problems facing the financing and delivery of drug abuse treatment services in the United States. Particular concern is directed to understanding the structure of public and private drug abuse treatment markets at a time when new insurance benefits and alternative organizations for service delivery are being created. Applied research on alternative payment systems, public and private financing systems, and the design of insurance for drug abuse treatment is of special interest. Research support mechanisms under this PA will include investigator-initiated research project grant (R01), Small Grant (R03), and First Independent Research Support and Transition (FIRST) (R29) awards. 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, Economics of Drug Treatment Services, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. William S. Cartwright, Ph.D. Services Research Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 10A30 Rockville, MD 20857 Telephone: (301) 443-4060 FAX: (301) 443-2317 Email: WC34B@NIH.GOV $$P2 END ************************************************************ From owner-sci-resources@net.bio.net Fri Sep 27 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA OD-97-001 - V25(32) 09/27/96 Date: 27 Sep 1996 20:19:29 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 891 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <52i5g1$psg@net.bio.net> NNTP-Posting-Host: net.bio.net INFORMED CONSENT IN RESEARCH INVOLVING HUMAN PARTICIPANTS NIH GUIDE, Volume 25, Number 32, September 27, 1996 RFA: OD-97-001 P.T. 34; K.W. 0783005 National Cancer Institute National Center for Human Genome Research National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute on Drug Abuse National Institute of Mental Health National Institute of Nursing Research Office of Extramural Research Department of Energy Department of Veteran Affairs Application Receipt Date: March 11, 1997 PURPOSE The National Cancer Institute (NCI), the National Center for Human Genome Research (NCHGR), the National Institute on Aging (NIA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Allergy and Infectious Diseases ((NIAID), the National Institute of Child Health and Human Development (NICHD), the National Institute on Drug Abuse (NIDA), the National Institute of Mental Health (NIMH), the National Institute of Nursing Research (NINR), the Department of Energy (DOE), and the Department of Veterans Affairs (VA) invite applications for a three year research grant program to stimulate investigations into the informed consent process in scientific research. There is an ethical as well as a legal responsibility to ensure that individuals both consent to and understand their participation in research. For consent to participate in research to be truly informed, the information imparted to potential participants must clearly explain study procedures, distinguish research from treatment, realistically portray the potential for medical or other benefits from participation and the nature of potential benefit, carefully explain the potential for discomfort, toxicity, or other risks that may accompany participation in the research, and clearly delineate the participant~s rights and limits regarding confidentiality and withdrawal from participation. The sponsoring organizations are jointly issuing this Request for Applications (RFA) because voluntary informed consent is the defining aspect of interactions between researchers and participants, and is integral to the conduct of the scientific research funded by all of these organizations. One of the goals of this RFA is to bring together perspectives of these different agencies, since their different research foci reflect a diversity of issues relating to informed consent. Of course, many facets of understanding the informed consent process are shared, and hence a combined effort is efficient for the agencies and scientists alike. Little empirical work exists to document the degree of understanding achieved by research participants regarding: (1) identity of the sponsoring federal agency or agencies; (2) purposes for which the research is being conducted; (3) comprehension of a study's methods and procedures; (4) relative risks and benefits (including financial) of deciding to consent or refuse participation; (5) confidentiality and any exceptions to confidentiality; (6) the implications of withdrawal from a study and (7) planned and other possible use of the data. Such data should be useful in designing informed consent procedures that are readily comprehended by prospective participants and impart all critical information. The goal of the present initiative is to develop and test alternative strategies for obtaining informed consent in diverse populations and determine optimal ways to obtain informed consent for research participation. ELIGIBILITY Applications may be submitted by any domestic or foreign, for-profit or non-profit organizations, public or private, such as universities, colleges, hospitals, laboratories, units of State and local governments, or eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the NIH individual research project grant (R01) mechanism of support. However, specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" procedures being used under an NIH Reinvention Initiative. The modular grant concept established specific modules (increments) in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under the approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and government staff. For this RFA, funds must be requested in $50,000 direct cost modules and a maximum of four modules ($200,000 direct costs) per year may be requested. A feature of the modular grant concept is that no escalation is provided for future years, and all anticipated expenses for all years of the project must be included within the number of modules being requested. Only limited budget information will be required and any budget adjustments recommended by the Initial Review Group will be in modules of $50,000. In accordance with JUST-IN-TIME procedures, instructions for completing the Biographical Sketch have also been modified. In addition, Other Support information and the application Checklist page are not required as part of the initial application. If the initial review suggests that there is a possibility for an award, the necessary budget, Other Support, and Checklist information will be requested by NIH staff. The APPLICATION PROCEDURES section of this RFA provides specific details of modifications to standard PHS 398 application kit instructions. FUNDS AVAILABLE It is anticipated that for fiscal year 1997, $2,250,000 total funds (direct and indirect costs) will be available. Award of grants pursuant to this RFA is contingent upon receipt of such funds for this purpose. Between 8 to 11 awards are anticipated. The exact amount of funding awarded will depend on the quality of applications and the availability of funds. Applicants are requested to furnish estimates of the time required to achieve the objective of the proposed research project. Applicants may request support for up to three years. The usual PHS policies governing grants administration and management will apply. Annual awards will be made, subject to continued availability of funds and progress achieved. This RFA is a one-time solicitation. At the end of the official award period, competitive renewal applications may be submitted for peer review and competition for support through the regular grant programs of the NIH. It is anticipated that awards resulting from RFA OD-97-001 will begin October 1, 1997. Administrative adjustments in project period of amount of support may be required at the time of the award. Since a variety of approaches would represent valid responses to this RFA, it is anticipated that there will be a range of costs among the grants awarded. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded in connection with this RFA. RESEARCH OBJECTIVES Background This RFA is a joint effort of the Department of Health and Human Services, the Department of Energy, and the Department of Veterans Affairs. The co-sponsoring organizations share a common vision of how research should be conducted, as indicated by their support of the common rule (45 CFR Part 46, Subpart A: June 18, 1991). This program is being coordinated under the auspices of the Office of Extramural Research (OER) Office of the Director, of the National Institutes of Health. The OER is responsible for developing regulations, policies, and procedures concerning the NIH extramural program, including the oversight of the protection of human subjects for the entire Department of Health and Human Services. Several of NIH's Institutes and Centers have joined together in the support of this project, and each seeks to encourage research related to its own mission. The NCHGR supports research activities that address the ethical, legal, and social issues that may arise from human genetics research, and is especially interested in research on informed consent as it pertains to participation in genetics research, the role of IRBs in dealing with genetics research, the involvement of individuals and families in genetics research, policies related to maintaining privacy and confidentiality of genetic information obtained through genetics research participation, issues raised by the commercialization of products from genetics research, and issues surrounding the development and use of experimental gene-based diagnostic tools and therapies. The National Cancer Institute seeks to advance understanding of the informed consent process by supporting research to simplify the process, improve comprehension, and to identify methods to provide study-specific information to diverse populations in cancer prevention and treatment trials. The National Institute on Aging conducts and supports biomedical, social, and behavioral research and training related to the special needs and capacities of elderly participants in research, and is particularly interested in the role of cognitive function in aging, and the ability of the elderly to understand and remember so that information related to the consent process is meaningful. The National Institute on Alcohol Abuse and Alcoholism is interested in research designed to improve the informed consent process for clinical research, especially with regard to special populations such as women of child bearing age, alcohol dependent individuals, and individuals with a family history of alcohol problems. The National Institute of Allergy and Infectious Diseases supports research to prevent and treat allergic and immunologic diseases and disorders, and is interested in research to enhance the process of informed consent for participation in a variety of clinical trials, including asthma, transplantation, sexually transmitted disease, and HIV therapies, vaccines and other preventative measures. The National Institute of Child Health and Human Development supports research on biological and behavioral human development, including reproduction and population studies, perinatal biology, maternal and infant well-being, congenital defects, developmental biology and nutrition, human learning and behavior, mental retardation and developmental disabilities, and medical rehabilitation. The National Institute of Drug Abuse supports research on the causes and consequences, prevention, and treatment of drug abuse and addiction, and is interested in research to understand and improve the informed consent process for participation in clinical research. The National Institute of Mental Health conducts and supports research on mental illness and mental health, including studies of the brain, behavior, and mental health services, and is interested in research to understand and enhance the informed consent process for participation in clinical mental health research. Finally, the National Institute of Nursing Research is interested in establishing better approaches to promoting health and preventing disease; and to improving clinical environments by testing interventions that influence patient health outcomes and participation in clinical research. Joining the NIH in funding this RFA is the Department of Energy (DOE), Office of Health and Environmental Research (OHER) which supports fundamental science to identify, understand, and anticipate the long-term health and environmental consequences of energy production, development, and use. With respect to this RFA, the DOE is particularly interested in consent issues arising in research related to mapping the structure of the human genome, developing advanced medical technologies and radiopharmaceutical. and determining biological structure and function at the molecular and cellular level. Also co-sponsoring this RFA is the Department of Veterans Affairs (VA), which conducts biomedical, health services, and rehabilitation research related to the special needs of veterans. The VA seeks to ensure that clinical research in its medical centers is conducted in full compliance with the spirit and letter of the common rule, and is interested in research relevant to any component of informed consent or other requirements for the protection of human subjects. Full consideration of the components of informed consent is an essential part of every research project involving human subjects. Indeed, the Code of Federal Regulations (45 CFR Part 46, Subpart A: June 18, 1991) requires that "...no investigator may involve a human being as a subject in research...unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative." As stated in 45 CFR Part 46: (a) ...in seeking informed consent, the following information shall be provided to each subject: 1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; 2) A description of any reasonably foreseeable risks or discomforts to the subject; 3) A description of any benefits to the subject or to others which may reasonably be expected from the research; 4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; 5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; 6) For research involving more than minimal risk, an explanation as to whether any compensation and any medical treatments are available if injury occurs and, if so, what they consist of or where further information may be obtained; 7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; 8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. (b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall be provided to each subject: 1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable; 2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent; 3) Any additional costs to the subject that may result from participation in the research; 4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; 5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and 6) The approximate number of subjects involved in the study. While 45 CFR Part 46 is quite specific about the content of informed consent, the responsibility for ensuring that this information is presented and understood is left to the researcher and his or her Institutional Review Board. It is clear that informed consent involves much more than a signature on a consent form. Willingness to participate in research may wax and wane depending on a participant~s expectations and satisfaction. This may be further complicated by changes in cognitive abilities and judgment over time. In some instances, obtaining consent from a legally authorized representative may be a requirement, as with research on children, comatose patients, or older participants with advanced dementias. The issues of substituted judgment can be germane as well, if an individual's competency to consent is in question. Finally, the research setting may play a role in the informed consent process. For instance, the degree of risk is affected by whether a study involves inpatients or outpatients, how closely these participants are monitored, and by different legal requirements in community, clinical, and institutional research settings. Since these and other complex issues have an impact on informed consent, there is much to be learned and understood about this process. Research Goals and Topics Through this RFA, the NIH, DOE, and VA seek to encourage research designed to gather empirical data on the informed consent process, particularly with respect to studies involving research populations. Possible research topics are listed below. This list should not be considered exhaustive; it is expected that applicants will identify other topics as well. This RFA encourages research with a focus on: o Evaluating the degree of comprehension and reasoning ability required to understand and consent to specific experimental procedures and risks (e.g., placebo controls, stored tissue), differentiate between research and standard treatment, and distinguish between discretionary and obligatory activities o Applying existing knowledge in basic behavioral, cognitive neuroscience, social, and educational research to develop methods for efficiently assessing comprehension and reasoning ability in a research setting o Identifying the cognitive processes underlying complex decisions, and evaluating methods for enhancing the decision making process o Identifying the determinants for participation, retention, and satisfaction in research (e.g., altruism, remuneration, hopes for new or better treatment, closer follow up, free care, interest in science, risk-taking behavior) o Developing and assessing innovative methods for clearly and efficiently conveying consent information that 1) meets basic requirements, and 2) offers extra material for the active information seeker (e.g., audio-visual aids, computer-assisted instruction) o Developing and evaluating outcome measures to monitor progress in improving the consent process (e.g., resource use, number and type of procedural reviews, incidence of injuries, exposure to unwarranted risk, educational outcomes) o Assessing whether a participant understands experimental procedures over time, including assessment throughout the full duration of participation in a study; developing methods to inform patients of new relevant information during participation In a trial o Determining if appropriate inclusion of a participant's relatives or friends in the consent process changes participation and retention rates within a study or alters the reported satisfaction with participation in research o Determining the impact of families, communities of interest, limited -English proficiency, durable powers of attorney, or advance directives on participation and outcomes o Identifying and developing ways to address special issues related to records (e.g., protection of confidentiality while providing a mechanism for future patient notification of unanticipated benefits or risks resulting from study participation) o quantifying and defining comprehension of social harms, and improving participant understanding of the risk of social harms associated with research participation (e.g., discrimination by insurance companies or in employment resulting from participation in HIV treatment or vaccine research, genetics research) o Identifying and determining the impact of special age-related issues related to informed consent in research involving: 1) children and adolescents (e.g., parental responsibilities and consent, autonomy issues in adolescents, emancipated or institutionalized minors, additional protections from risk and meaning of minimal risk, young children~s ability to understand in relation to giving assent, sense of altruism in children volunteering for research to help others), and 2) older individuals whose cognitive states may affect their abilities to fully comprehend the conditions of the experiment o Examining the role of cultural and educational differences, ethnicity, and gender on the informed consent process and participation in research o Identifying and determining the impact of special issues related to informed consent in specialized populations such as women of child bearing potential, drug abusers, HIV positive, mentally ill, institutionalized, alcohol dependent, terminally ill, or comatose individuals, individual with genetic disorders, and individuals with questionable competence (e.g., worsening of cognitive impairment over the course of a study, durable power of attorney) o Assessing the impact of special informed consent issues in research involving individuals in specialized settings such as emergency care, the workplace, the military, prisons, and outer space (e.g., potential for confusion resulting from similarity of the research project to routine duties and procedures; effect of generalized deference to authority; effect of presence or absence during recruitment of unit officers, prison guards or other official personnel) o Examining how the research setting, timing, presence of an ombudsman, and qualities of the individual obtaining informed consent (e.g., cultural similarity, gender) affect the process. ANNUAL MEETINGS AND COLLABORATION Successful applicants will be asked to participate in yearly meetings to report progress, discuss problems, and share information related to the conduct of their grants. It is recommended that costs associated with attendance at these meetings, to be held in the Washington DC area, be included as a part of the budget proposal. Previous experience with meetings of this kind has shown that they can provide an opportunity to work collaboratively with other Investigators on various issues, which might include common core instruments, joint publication, sharing of protocols and data, or other avenues of collaboration that may arise. 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 the Public Service Act, added by 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 has been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources of from the program staff or contact the person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit by January 30, 1997, a letter of intent that includes a descriptive title of the proposed research and identification of any other participating institutions. Such letters are requested only for the purpose of providing an indication of the number and scope of applications to be received: Therefore, their receipt is usually not acknowledged. A letter of intent is not binding, and it will not enter into the review of any application subsequently submitted, nor is it necessary to have sent a letter of intent to submit an application. The letter of intent is to be sent to: Referral Office Division of Research Grants National Institutes of Health MSC 7720 6701 Rockledge Drive Bethesda MD 20892-7720 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3034--MSC 7762, Bethesda, MD 20892-7910, telephone 301/435-0714, E-mail: girg@drgpo.drg.nih.gov. This RFA use the Just-in-Time" concept. The following modifications must be made to the standard PHS 398 application instructions (applications not conforming to these Guidelines will be considered unresponsive to this RFA and will be returned without further review): o INITIAL BUDGET PERIOD - Only the names of personnel and level of effort must be itemized in the Personnel section of the "Detailed Budget for the Initial Period" (Form Page 4). In addition, list consultants, equipment, supplies, travel, patient care activities, alterations and renovations, and other needs, as appropriate. Costs are not to be indicated for these individual items or categories. If subcontracts are involved, state the name(s) of collaborating institutions in the "Consortium/Contractual Costs" section and provide individual budgets as detailed in the "SUBCONTRACTS section below. The "Total Direct Costs" line at the bottom of the page must be completed based on the number of $50,000 modules being requested. Applicants may not request a change in the amount of each module. A maximum of four modules ($200,000 direct costs) per year may be requested. Any large one-time purchases, such as large equipment requests, must be accommodated within these limits. o FUTURE BUDGET PERIODS - It is anticipated that direct cost budgets will remain the same for each year of the period of award (i.e., the same number of modules requested for each and every budget period). Any necessary escalation must be considered when determining the number of modules to be requested. However, in the event that the number of modules requested must change in any future year, appropriate justification must be provided. The "Budget for Entire Proposed Project Period" (top section of Form Page 5) must include Total Direct Costs requested for each year and the Total Direct Costs for the Entire Proposed Project Period. The Justification section must be completed based on instructions provided on Form Page 5. o SUBCONTRACTS - If collaborations or subcontracts are involved that require transfer of funds from the grantee to other institutions, it is necessary to establish formal subcontract agreements with each collaborating institution. A letter of agreement from each collaborating institution must be submitted with the application. Initial and future year budgets for subcontracts must be prepared using the same guidelines as for the main grant except that total subcontract costs need not be in $50,000 modules. Requested amounts must be based on individual needs of the subcontract and must reflect both direct and indirect costs. The subcontract costs are included in the total budget request, which must conform with the number of $50,000 modules requested. o BIOGRAPHICAL SKETCH - In addition to the standard information requested on Form Page 6, the applicant has the option of providing the title and source of any sponsored support relevant to the proposed research. o OTHER SUPPORT - No other support information is required on "Other Support" pages (Form Page 7). Selected other support information relevant to the proposed research may be included in the Biographical Sketch as indicated above. Complete other support information will be requested by NIH staff if there is a possibility for an award. o CHECKLIST - No "Checklist" page is required as part of the initial application. A completed Checklist will be requested by NIH staff if there is a possibility for an award. o The applicant must provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. To identify the application as a response to this RFA, the RFA title "Informed consent in research involving human participants," and number "OD-97-001," must be typed under item 2 of the face page of the application form, and YES box must be checked. The RFA label available in the PHS 398 application kit 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 the application such that it may not reach the review committee in time for review. Submit a signed, typewritten original of the application and four signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At time of submission, an additional copy of the application must also be sent under separate cover to: Susan D. Solomon, Ph.D. Office of Extramural Research National Institutes of Health Building One, Room 156 One Center Drive, MSC 0155 Bethesda, MD 20892 All applicants must provide a Protection of Human Subjects Assurance Identification/Certification/Declaration as specified in the policy described on the Optional Form 310. If there is a question regarding the applicability of this assurance, contact the Office for Protection from Research Risks of the National Institutes of Health at (301) 496-7041. Applications must be received by March 11, 1997. 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. 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, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG, and for responsiveness by the NIH, DOE, and/or VA program staff. Incomplete applications will be returned to the applicant without further consideration. In addition, if program staff find that the application is not responsive to the RFA, it will be returned to the applicant without review. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, and assigned a priority score; those with the potential for funding will receive a second level review by the National Advisory Council of the relevant NIH institute. Applications will be judged on the following criteria: o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human participants and the safety of the research environment. Receipt and Review Schedule Application Receipt Date: March 11, 1997 Initial Review: June/July Advisory Council Review: September Earliest Start Date: October 1, 1997 AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program priorities and balance, potential policy and practice relevance, and the availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Program staff of the NIH, DOE, and VA are available for consultation concerning application development before or during the process of preparing an application. Potential applicants should contact program staff as early as possible for information and assistance in initiating the application process and developing an application. Inquiries regarding programmatic issues may be directed to: Eric Meslin, Ph.D. National Center for Human Genome Research 38 Library Drive, Room 617, MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 402-4997 FAX: (301) 402-1950 Email: Eric_Meslin@nih.gov Leslie G. Ford, M.D. National Cancer Institute 6130 Executive Boulevard, Room 300 Rockville, MD 20852-7343 Telephone: (301) 496-0265 FAX: (301) 496-8667 Email: Fordl@DCPCEPN.NCI.NIH.GOV Andrew A. Monjan, Ph.D., M.P.H. Neuroscience and Neuropsychology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3C307 - MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: MonjanA@GW.NIA.NIH.GOV Theodore Pinkert, M.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 - MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1206 FAX: (301) 443-8774 Email: tpinkert@willco.niaaa.nih.gov Amy R. Sheon, PhD, MPH Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, MSC 7620 Bethesda, MD 20892-7620 Telephone: (301) 496-6177 FAX: (301) 402-3684 Email: as31r@nih.gov Sarah L. Friedman National Institute of Child Health and Human Development Building 61E, Room 4B05 Bethesda, MD 20892 Telephone: (301) 496-6591 FAX: (301) 402-2085 Email: SF2@NIHCU(BITNET) Dorynne Czechowicz, M.D. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-08 Rockville, MD 20857 Telephone: (301) 443-0107 FAX: (301) 443-2317 Email: Dczechow@aoada2.ssw.dhhs.gov John K. Hsiao, M.D. Division of Clinical and Treatment Research National Institute of Mental Health Parklawn Building, Room 18C-14 Rockville, MD 20857 Telephone: (301) 443-3524 FAX: (301) 443-6000 Email: jhsiao@helix.nih.gov June Lunney, Ph.D., RN Division of Extramural Programs National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-6908 FAX: (301) 480-8260 Email: Jlunney@ep.ninr.nih.gov Susan L. Rose, Ph.D. U.S. Department of Energy ER-72/OHER 19901 Germantown Road Germantown, MD 20874-1290 Telephone: (301) 903-5468 FAX: (301) 903-8521 Email: Susan.L.Rose@oer.doe.gov Dennis Roth Department of Veterans Affairs Office of Research and Development (12) 810 Vermont Avenue, N.W., Room 775J Washington, DC 20420 Telephone: (202) 273-8284 FAX: (202) 273-6526 Email: Roth@mail.va.gov Direct inquiries regarding fiscal matters to: Jean M. Cahill Grants and Contracts Management Branch National Center for Human Genome Research 38 Library Drive, Room 613 - MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 402-0733 FAX: (301) 402-1951 Email: Jean_Cahill@nih.gov Eileen Natoli Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496 7800 ext 256 FAX: (301) 496 8601 Email: natolie@gab.nci.nih.gov David Reiter National Institute on Aging 7201 Wisconsin Avenue, Room 2N212 Bethesda, MD 20892-9205 Telephone: (301) 466-1472 FAX: (301) 402-3672 Email: reiterd@gw.nia.nih.gov Linda Hilley Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4703 FAX: (301) 443-3891 Email: lhilley@willco.niaaa.nih.gov Jane Unsworth Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4B22 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: Jane_Unsworth@nih.gov Douglas E. Shawver Grants Management Branch National Institute of Child Health and Human Development Building 61 E, Room 8A 17F Bethesda, MD 20982 Telephone: (301) 496-1303 FAX: (301) 496 0915 Email: Douglas_Shawver@nih.gov Gary Fleming, J.D., M.A. Office of Planning and Resource Management National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gfleming@aoada2.ssw.dhhs.gov Diana Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-3056 FAX: (301) 443-6885 Email: diana_trunnell@nih.gov Jeff Carow Grants and Contracts Management Branch National Institute of Nursing Research Building 45, Room 3AN-32 Bethesda, MD 20892-6301 Telephone: (301) 594-5074 FAX: (301) 480-8256 Email: JCAROW@ep.ninr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.172 (NCHGR), 93.242 (NIMH), 93.273 (NIAAA), 93.279 (NIDA), 93.361 (NINR), 93.395 (NCI), 93.856, 93.855 (NIAID), 93.865 (NICHD), and 93.886 (NIA). Awards are made under authorization of section 301 and Title IV (42 USC 241 and 281) of the Public Health Service Act, and are 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. Awards by PHS agencies will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (April 1, 1994). The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the nonuse of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Sep 27 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-074 - V25(32) 09/27/96 Date: 27 Sep 1996 20:19:53 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 487 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <52i5gp$q00@net.bio.net> NNTP-Posting-Host: net.bio.net DRUG USE, SEXUAL RISK BEHAVIORS, AND HIV IN MEN NIH GUIDE, Volume 25, Number 32, September 27, 1996 PA NUMBER: PA-96-074 P.T. 34; K.W. 0715008, 0404009, 0411005 National Institute on Drug Abuse PURPOSE The purpose of this program announcement (PA) is to support epidemiological and HIV prevention research on drug use, sexual risk behaviors, and HIV in an especially high risk group: men who use drugs and have sex with men (DU MSM). DU MSM use drugs by injection and/or noninjection means (e.g., crack cocaine and smokable or intranasal forms of methamphetamine and heroin) and have same-gender sex regardless of their self-identified sexual orientation (gay, bisexual, or heterosexual). Because DU MSM may engage in both high risk drug use and sexual practices, and may have multiple and different drug use and sex partners and networks, they not only constitute an important HIV risk group in and of themselves but also have the potential to serve as a bridge for HIV transmission to heterosexual injecting drug users (IDUs) and non-IDU MSM. Promising directions for the epidemiology and prevention of HIV in this dual risk group will draw from cumulative research related to the epidemiology and prevention of HIV in MSM, IDUs, and noninjecting drug users. This PA seeks to stimulate research on (1) the co-occurrence of HIV risk behaviors among men who use injection and/or non- injection drugs and who have sex with men, and the adverse health consequences, (2) antecedents and correlates of high risk, especially social/situational contexts of HIV risk and protective behaviors among DU MSM and their drug use and/or sex partners and networks; (3) the efficacy and effectiveness of behavioral and biological HIV prevention interventions for diverse groups of DU MSM, including comparative evaluations of intervention outcomes and costs/benefits of community-based outreach, prevention, and treatment approaches to averting new HIV infection; and (4) development and evaluation of new behavioral therapies, drug abuse treatment approaches, health services, and health care services delivery to DU MSM. Within these research themes, investigators are encouraged to expand, test, and improve current identification and recruitment strategies, research designs, methods, and measures of behavioral risk and intervention effects among hard-to-reach subgroups of DU MSM. 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, Drug Use, Sexual Risk Behaviors, and HIV in Men, is related to the priority areas of reducing alcohol and other drug use and the transmission of HIV. Potential applicants may obtain a copy of "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through Superintendent of Documents, Government Printing Office, Washington DC 20402 (Telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT Research support mechanisms under this PA will include the traditional research project grant (R01), small grants (R03), and FIRST (R29) awards. Because the nature and scope of the research proposed in response to this PA may vary, it is anticipated that the size of an award will also vary. RESEARCH OBJECTIVES Background Historically, HIV epidemiology and prevention research has focused on the highest prevalence and incidence exposure groups, i.e., either men who have sex with men or injecting drug users and noninjecting users of crack cocaine. Little attention has been given to the dual risk category of DU MSM, who may acquire HIV infection either sexually or parenterally. Nor has much attention focused on DU MSM who have recently initiated injecting drug use, though a recent report suggests new drug injectors may be at especially high risk for the HIV infection and hepatitis B and C, possibly from sexual activity prior to injecting drugs (Garfein et al., 1996). Fifteen years into the HIV/AIDS epidemic, attention has begun to focus on exposure groups in which HIV infection is emerging or increasing in prevalence and on the need to formulate new strategies for primary prevention and behavior change interventions for these populations. Compared to men who report sex with men as their only HIV risk factor (in whom the incidence of HIV is stable or declining), increasing proportions of HIV incidence cases are occurring among men who report injecting drug use as their only risk and among men who report dual risks from both drug injecting and sex with men, especially men of color. Since first recognized in early 1981, AIDS has been diagnosed in 434,719 male adolescents and adults in the U.S.(CDC, 1995). Of these, 259,672 cases (60%) occurred in MSM; 95,244 (22%) in IDUs; and 33,195 (8%) in the dual risk category of IDU MSM. In addition, an estimated half of all HIV incident infections in the U.S. are occurring among injecting drug users (Holmberg, 1996). Drug injection has gained a proportionately greater share of cases as a HIV risk category among Hispanic, African American, and American Indian/Alaskan Native men. HIV/AIDS surveillance data do not provide reports about noninjecting drug use among MSM; however, this group is at high risk, especially if they trade sex for drugs and/or money or engage in high risk sexual practices as a result of drug use before or during sex. Noninjecting drug users may have been former injectors or may never have injected drugs out of concern of exposure to the HIV infection from contaminated syringes, but many of these men are using crack, methamphetamines, and other drugs as well as engaging in high risk sexual practices. In certain situations and settings, they are also at risk of initiating injection drug use and resulting health consequences. Though the epidemiology, determinants, and mediators of high risk drug and sex practices, as well as HIV prevention strategies have been researched for some time with respect to IDUs, crack cocaine users, and gay men, the risk behaviors, consequences, and prevention strategies to limit the spread of HIV among the dual risk group of DU MSM remain inadequately understood. Only a handful of studies have focused on this group, though their risks of HIV infection are strikingly high. A recent multivariate analysis of data from NIDA~s Cooperative Agreement for AIDS Community-Based Outreach/ Intervention Research Program found that the strongest single predictor of HIV seropositivity in a sample of not-in-treatment male drug users was being homosexual. Other significant predictors were having ever injected drugs and residing in a high HIV seroprevalence (15% and higher) area. Bisexual status alone was not a significant predictor of seropositivity, but being both bisexual and African American increased the likelihood to over 4 times that of heterosexual IDUs. In 1995, NIDA and CDC initiated a multi-site pilot study of the drug use and sex risk behaviors of not-in-treatment MSM who injected drugs or used crack cocaine. Although all the men reported drug use and having sex with men, there was a wide range in types and frequencies of drugs us-ed and in sex partners and sexual risk behaviors as well as a wide array of age groups and racial/ethnic categories involved. Findings from this study attest to the diversity of the DU MSM population and point to the need to go beyond uniform health models to better address their HIV risk-taking behaviors. NIDA and CDC plan to use study data to develop appropriate HIV intervention strategies, but to date, no prevention programs have been specifically tailored for this under-researched population. It is important to understand the extent to which HIV research and prevention efforts designed to study and moderate the risk behaviors of gay men and/or heterosexual drug users can be adopted and made effective for the dual risk group of DU MSM, especially with respect to contextual factors that influence HIV risk behaviors. Moreover, understanding the future of this epidemic will improve dramatically if researchers begin to shift their thinking from an individual-level perspective of behavior to viewing risk behaviors as social transactions between individuals and groups and begin to focus on the contexts in which multiperson use of drug injection equipment and sex risks take place. Applicants are encouraged to pay attention to social factors which can influence the initiation of risk as well as behavior change among DU MSM and that involve not only the individual but also couples, groups, or networks to which the DU MSM belongs and in which norms of behavior are practiced and preserved. Various research approaches, including epidemiology, ethnography, controlled clinical trials, and evaluation are applicable to a comprehensive HIV prevention research portfolio alone or in phased stages of multidisciplinary study. Research Areas This PA will support research on the epidemiology and prevention of HIV-related behaviors and adverse health consequences among DU MSM. Researchers are encouraged to review the cumulative literature on the epidemiology and prevention of HIV in gay men, IDUs, and non-injection drug users and to adapt and refine research protocols and models of HIV prevention that have proven to be effective with drug using men or men who have sex with men. Investigators are encouraged to integrate such information into new theory-based primary prevention and behavior change interventions and health services. A broad range of studies are envisioned, including but not limited to the following research areas: (1) Epidemiology of HIV-related behaviors and health consequences (morbidity/mortality) in DU MSM. Suggested topics include, but are not limited to: o Studies in areas of high, moderate, and low HIV seroprevalence of the incidence, prevalence, trends and predictions of DU MSM~s drug use patterns and the co- occurrence of high risk drug use and sex behaviors (e.g., types of drug used, multiperson use of injection equipment, numbers and types of sex partners). o Studies of syringe acquisition, drug acquisition, drug preparation, injection practices, and syringe disposal behaviors among IDU MSM as well as biological/ serological studies of the HIV transmissibility risks associated with these behaviors. o Studies of risk and/or protective antecedents and correlates associated with the initiation of drug injection among MSM, including factors influencing the transition from non-injection to injection use (e.g., roles of community culture, social networks, peer influence) and the continuation of use (may involve injection/non-injection patterns associated with specific drugs or drug combinations). o Research on the epidemiology of physical, sexual, and emotional violence (including stigmatization) against or among DU MSM, and on the relationship of such violence to the co-occurrence of HIV-related risk behaviors and other adverse health consequences. o Research to improve epidemiologic methods and measures for monitoring, reporting, and predicting the course and spread of HIV seroincidence in DU MSM and among their drug use and sex partners. (2) Antecedents, correlates, and contexts of HIV risk/protective behaviors. Suggested topics include, but are not limited to: o Studies of the effects of macro-level factors on the epidemiology and adoption, maintenance, change, and relapse of HIV-related behaviors of DU MSM (e.g., community policies toward needle exchange and condom distribution programs, including closures/relocations of services); law enforcement practices in areas where sex is traded for drugs or money or where drugs are used in public settings; and other access and barrier issues related to community-based HIV/AIDS education and prevention programs. o Social network research to characterize the HIV-related behaviors of DU MSM in their immediate injection/non- injection drug use risk networks, sex risk networks, and combined drug use and sex risk networks. Social network research is also needed to understand the out-group contacts and mixing strategies of DU MSM who act as bridges to other networks (e.g., networks of non-drug using MSM; networks of IDUs who do not engage in same- gender sex). o Research on intrapersonal, dyadic, and group factors affecting the adoption, maintenance, and change of HIV risk and protective behaviors among DU MSM (e.g., testing seropositive or learning that one's drug use or sex risk partner has seroconverted, interpersonal skills at negotiating behavior change, economic dependence on one~s partner, affiliative ties, coercion and violence) as well as factors associated with relapse to risky behavior, relapse prevention, and recovery. o Factors which influence HIV seropositive DU MSM to notify injecting drug use and sex risk partners of their serostatus, to take precautions against secondary spread of the HIV infection to others, or to risk transmitting HIV to persons who are not infected by sharing injecting equipment and/or by engaging in unprotected sex. (3) Evaluation of behavioral and biological HIV prevention interventions specifically tailored for DU MSM. Multilevel, multicomponent interventions are encouraged, and the complexity of sexual and drug-related risks should be addressed when developing appropriate interventions. Suggested studies include, but are not limited to: o Theoretically guided, community-based studies to investigate the effectiveness and acceptability of new HIV prevention and intervention approaches, singly or in combination, among divergent groups and risk networks of DU MSM. Studies of community outreach, condom and bleach distribution, syringe exchange, HIV counseling and testing, and partner notification projects are needed to evaluate what works, for whom it works, under what circumstances it works, and how long it works. o Studies of the optimal sequencing of risk reduction interventions taking into account the types and levels of risk engaged in as well as the episodic nature of HIV risk behaviors/ behavior change and need for intermittent reinforcement. o Studies of the diffusion of innovative interventions, including credible opinion leaders and social change processes affecting the adoption and/or maintenance of lower sexual and drug using risk behaviors of DU MSM. o Single-site studies or comparative evaluations are needed to address the attributes and relative costs/benefits of peer-initiated, social network-based, and community-based risk reduction interventions and/or treatment programs with respect to changing multiple risk behaviors and averting HIV infections. (4) Research on Drug Abuse Treatment and Health Care Delivery for DU MSM. Suggested topics include but are not limited to: o Research to develop and pilot test new behavioral therapies for drug abuse or to modify existing therapies for use with DU MSM. o Studies to identify, develop, and pilot test HIV risk reduction interventions which can be integrated within drug abuse treatment programs for DU MSM. o Clinical trials of well-specified behavioral therapies and risk reduction interventions identified as promising in pilot testing with divergent groups of DU MSM both within and outside of the gay community. o Health services research on the delivery of drug abuse treatment and other health care to DU MSM, including studies of factors that impact access and utilization of services, effectiveness of services, barriers to effective service delivery, and strategies for improving service delivery. NIDA POLICY ON HIV COUNSELING AND TESTING Researchers funded by NIDA, who are conducting research in community outreach settings, clinics, hospital settings, or clinical laboratories, and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk-reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing services. Persons at risk for HIV infection include injection drug users, crack cocaine users, and sexually active drug users and their sex partners. 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 may also obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning this policy. Confidentiality. The Public Health Service (PHS) has a formal policy concerning Certificates of Confidentiality and communicable disease reporting. In brief, the policy reflects the expectation that research projects will cooperate with State and local health departments to assure that the purposes of reporting are accomplished, and the expectation that health departments will develop relationships with research projects that assist their mission without thwarting the research goals. A description of the policy as well as Instructions for Applicants can be obtained after award. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard AIDS receipt dates indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, NIH, 6701 Rockledge Drive, MSC 7762, Bethesda, MD 20892-7762, telephone 301-435-0714, email: asknih@odrockm1.od.nih.gov. The title and number of this PA must be typed in Item 2 on the face page of the application. The completed original and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE MSC-7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight service) REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria o scientific or technical significance and originality of the proposed research; o appropriateness and adequacy of the research approach and methodology proposed to carry out the research; o qualifications and research experience of the principal investigator and staff; o availability of resources necessary to the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and o adequacy of plans to include minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, and safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the Institute. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues involving epidemiologic and HIV prevention and intervention research to: Richard H. Needle, Ph.D., M.P.H. or Elizabeth Y. Lambert, M.Sc. and Helen Cesari, M.Sc. Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-42 Rockville, MD 20857 Telephone: (301) 443-6720 FAX: (301) 443-2636 Email: RN28E@NIH.GOV; EL46I@NIH.GOV; HC30X@NIH.GOV Direct inquiries regarding programmatic issues involving research in clinical/drug abuse treatment settings to: Robert J. Battjes, D.S.W. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-38 Rockville, MD 20857 Telephone: (301)443-6697 FAX: (301) 443-2317 Email: RB97H@NIH.GOV Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8-A-54 Rockville, MD 20857 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: GF6S@NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279 and 93.242. Awards are authorized under the Public Health Service Act, Section 301 and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. Grants will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (DHHS Publication No. (OASH) 82-50-000 GPO 0017-020-0090-1 (rev. April 1994). This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103- 227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care of early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Sep 27 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-075 - V25(32) 09/27/96 Date: 27 Sep 1996 20:20:13 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 506 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <52i5hd$q0v@net.bio.net> NNTP-Posting-Host: net.bio.net ECONOMICS OF DRUG TREATMENT SERVICES NIH GUIDE, Volume 25, Number 32, September 27, 1996 PA NUMBER: PA-96-075 P.T. 34; K.W. 0404009, 0745070, 0408006 National Institute on Drug Abuse PURPOSE This program announcement encourages research on the economics of drug abuse treatment services. This field of economic research is concerned with the behavior of consumers, providers, governments, and third party payers, and how they respond to economic incentives related to drug abuse treatment services. Applications are sought that would employ the methods of economic analysis to the most pressing problems facing the financing and delivery of drug abuse treatment services in the United States. Particular concern is directed to understanding the structure of public and private drug abuse treatment markets at a time when new insurance benefits and alternative organizations for service delivery are being created. Applied research on alternative payment systems, public and private financing systems, and the design of insurance for drug abuse treatment is of special interest. 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, ECONOMICS OF DRUG TREATMENT SERVICES, is related to the priority area of Health Promotion/Alcohol and Other Drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and nonprofit organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) award. MECHANISM OF SUPPORT Research support mechanisms include the research project grant (R01), small grant (R03), and FIRST awards (R29). There are special requirements for FIRST and R03 mechanisms; the applicant intending to apply utilizing either of these mechanisms, should contact the program officer under INQUIRIES for further information. Because the nature and the scope of the research proposed in response to this announcement may vary, it is anticipated that the size of an award will also vary. RESEARCH OBJECTIVES Summary. Research studies are sought on (1) financing of drug abuse treatment services, including health insurance and/or payment mechanisms, (2) alternative delivery systems and managed care, (3) cost-benefit, cost-effectiveness, and cost-utility analysis, (4) cost of drug abuse treatment, and (5) methodological research. Studies of financing include issues of health insurance and/or payment mechanisms. Background. Economic research on drug abuse treatment services has the goal to inform society about fundamental issues in health care reform and managed care as restructuring of the health care system proceeds at a rapid pace. In this environment of social experimentation and institutional change, there are numerous natural experiments available for the application of economic analysis that would increase understanding of the demand and supply for drug abuse treatment and the unique factors that contribute to public and private markets for drug treatment. Applied research on alternative payment systems, public and private financing systems, and the design of insurance for drug abuse treatment must be grounded in sound microeconomic principles. The economics of drug abuse treatment services studies factors that determine supply such as: (1) the price of drug abuse treatment; (2) technological factors in drug abuse treatment; (3) price of resource inputs; (4) prices of related goods; (5) market organization; and (6) special influences such as government treatment standards, subsidies, insurance, and risk sharing. The economics of drug abuse treatment also studies factors that determine demand for drug treatment: (1) the price of drug abuse treatment; (2) average income of patients; (3) population characteristics and need for treatment; (4) price of related goods; (5) preferences or tastes; and (6) special influences such as patient health, court intervention, family intervention, barriers, drug testing, insurance coverage and benefit structure. Drug abuse treatment services research is complicated by the factor of direct government involvement in the production, financing, and regulation of treatment services. Market segmentation between the private and public treatment providers is another special consideration. There is face validity to the notion of competitive market failure given external costs of drug abuse, imperfect information, insurance coverage, and interdependence of preferences among addicts, families, courts, employers, and treatment providers. Financing of drug abuse treatment is derived from Federal, State, and local government funds and also private sector funds from health insurance, consumer out-of-pocket expenditures, and charity. The scientific inquiry into financing of drug treatment requires normative and positive economic analysis on allocation and distribution issues. For example, because different levels of government are involved in public financing, fiscal federalism is a central issue. For health services needs of the poor, distributive issues must be addressed. Analysis of both public and private provision of health insurance is essential to financing studies. Furthermore, payment mechanisms for drug abuse treatment affect the allocation and distribution of drug treatment resources within specific health care delivery systems that are created through public policy. The history of medical and behavioral delivery systems has been a move from traditional, fee-for-service to alternatives such as Health Maintenance Organizations (HMOs), Preferred Provider Organizations (PPOs), and Point of Service (POS) plans. In the drug abuse treatment field, there has been the rise of the behavioral health care organization, usually for profit, to administer the mental health, alcohol, and drug abuse treatment benefits in private or public insurance plans. Under these organizations, managed care is a set of mechanisms designed to manage the quality, access, outcomes, and costs of service delivery to enhance the efficiency and equity of the system. Managed care systems require research on principal-agent relationships and the design of incentives, contracts, and regulations. Cost-benefit, cost-effectiveness, and cost-utility analyses are collaborative activities by economic and drug abuse treatment researchers who are investigating the effectiveness of innovative medical and behavioral therapies as well as effectiveness in real-world health care delivery systems. Methodological work is needed on measuring common denominators, the costs of services, and benefits. Economic analysis also has a role in interpreting the results of monitoring outcomes to improve the allocation and distribution of resources within a delivery system. Areas of research interest include direct and indirect treatment costs as well as social benefits and costs. Treatment costs for other disease disorders can be increased if a drug disorder is present, and cost savings (or "cost-offsets") are recognized as a major consideration in integrated health care networks. From a social viewpoint, measurement of cost-offsets in criminal justice populations is also needed. Unfortunately, information on the unit service costs of drug treatment has been rudimentary, which has hampered full cost pricing of service delivery for innovative and standard drug abuse treatments. Conceptualizing and measuring the relationships among accounting costs, marginal costs, average costs, and total costs in drug treatment programs and systems has received little attention. Research in these areas is needed so that a precise measurement of treatment costs can be established and further economic analysis be stimulated in such areas as the drug abuse treatment cost function. Researchers are encouraged to develop rigorous designs for studies in the economics of drug abuse treatment services. The following are illustrative of problem areas that may be addressed under this announcement. The examples are not exhaustive, and other types of studies are anticipated to be submitted. Financing of Drug Abuse Treatment Services Research is needed on financing of public and private drug abuse treatment. For analysis, such fundamental questions must be asked: (1) What criteria should be applied in judging budget policies?; (2) What are the social, political, economic, and historical forces which have formed the shape of the present funding pattern and which will determine the formulation of contemporary and future funding patterns?; and (3) What are the interactions between the private and public treatment sectors as various funding plans are devised? Research topics in this broad area may be further refined into two subtopic areas: Health Insurance. Research is encouraged on issues concerning the provision of private and public health insurance for drug abuse treatment. Examples of research topics include: o Incentives, structure, and behavior of private and public insurers; o Incentives and behavior of patients with insurance coverage and those patients without coverage; o Analysis of market functioning, moral hazard, adverse selection, and risk pool development; o Design of drug abuse treatment benefits in public and private health insurance packages; o Economic evaluation of regulatory controls and mandates; o Analysis of the prevalence of drug treatment insurance coverage and types of coverage among the insured, underinsured, as well as studies about the uninsured in need of treatment; o Economic barriers to the adoption of effective pharmacotherapies in standard drug treatment services; o Insurance studies related to patients with HIV/AIDS; and o Prevalence impact and consequences of cost shifting among various payers. Payment Mechanisms. Payment mechanisms affect the delivery, access to services, utilization, and quality of drug abuse treatment services. Examples of such studies include: o Federal and State health care reform and payment mechanisms; o Prepayment, fee-for-service, capitation, and price regulation; o Risk sharing, coinsurance, deductibles, catastrophic limits, stop-limits, and reinsurance; o Risk adjustment methods; and o Reimbursement levels and service adjustments. Alternative Delivery Systems and Managed Care Studies of managed care and behavioral health care organizations are encouraged. Some illustrative, but by no means exhaustive areas of consideration are: o Economic evaluation of well-defined managed care systems on quality, access, outcomes, and costs of service delivery; o Managed care effects on clinical decision making and on the structure and function of the treatment provider organization; o Organization of drug abuse treatment delivery that is either "carved-out of" or "integrated into" a managed care system; o Impact of managed care systems on Medicaid or Medicare; and o Economics of drug abuse treatment to HIV/AIDS patients under a managed care system. Cost-Benefit, Cost-Effectiveness, and Cost-Utility Analysis The analysis of the economic costs and benefits of drug abuse treatment has been derived in conjunction with effectiveness studies. Additional studies are needed to assess the economic benefits and costs of a variety of treatment interventions. Cost-effectiveness studies are useful in comparing novel treatment technologies to a standard treatment technology. Examples of such studies include: o Cost-benefit or cost-effectiveness of innovative treatment methods, targeted at special populations of injection drug users, women, pregnant women, and women with children, correction's populations, adolescents, and patients with co-occurring disorders; o Cost-benefit or cost-effectiveness analysis of the utilization of new or alternative medications for treating drug disorders and other brain and behavioral disorders; o Cost-benefit or cost-effectiveness of medical, mental health, alcohol, and drug treatment service integration; and o Cost-benefit or cost-effectiveness of integrating drug abuse treatment with criminal justice interventions. Cost of Drug Abuse Treatment Improved measures of costs are needed for management decisions that will assist clinical and program treatment staff as well as local, State and national health policy makers. For scientific research, measures of costs must be improved both conceptually and operationally so that precise costs of treatment interventions may be determined. Examples of such cost research include: o Estimation of the direct and indirect costs of treatment as well as the cost of ancillary services; o Measurement of component unit service costs and full costs of drug abuse treatment services that comprise standard and innovative treatments; and o Cost-offset studies of integrated drug abuse treatment and other health services. Methodological Research Research is encouraged that will develop and test the application of new methods of economic analysis in drug abuse treatment services research. Examples include: o Improvements for assessing economic efficiency and equity associated with the problems of drug abuse treatment; o Improvements in health insurance theory and practices associated with drug abuse treatment services; o Improvements in assessing the impacts of alternative delivery systems and managed care; o Development of new statistical methods associated with economic analysis of drug abuse treatment studies; o Development of simulation models that advance analysis of drug abuse treatment financing at the national and State levels; and Improving methodologies of cost-benefit, cost-effectiveness, and cost-utility analysis. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, telephone 301-435-0714, email: ASKNIH@ODROCKM1.OD.NIH.GOV. The title and number of the program announcement must be typed in Item 2 on the face page of the application. FIRST award applicants must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original and five legible copies must be delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM MSC-7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score and receive a second level review by the appropriate national advisory board or council. Small grants do not receive a second-level review. Review Criteria o scientific, technical, or medical significance and originality of proposed research; appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and o adequacy of the plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. The initial review group will also examine the provisions for the protection of human and animal subjects, and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the Institute. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: William S. Cartwright, Ph.D. Services Research Branch National Institute on Drug Abuse 5600 Fishers Lane, Room l0A30 Rockville, MD 20857 Telephone: (301) 443-4060 FAX: (301) 443-2317 Email: WC34B@NIH.GOV Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Email: GF6S@NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. 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. Grants must be administered in accordance with the Public Health Service Grants Policy Statement, (DHHS Publication No. (OASH) 82-50-000 GPO 0017-020-0090-1 (rev. 10/01/90). The PHS strongly encourages all grant recipients to provide a smoke-free work place and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. References Cartwright, W.S. and Ingster, L. "A Patient Based Analysis of Drug Disorder Diagnosis on Length of Stay and Total Charges for the Medicare Population," Health Care Financing Review, 15, 1993, pp. 89-101. Feldstein, P.J. Health Care Economics, 4th Edition. New York: Delmar Publishers Inc., 1993. Frank, R.G. and Manning, Jr., W.G. Economics and Mental Health. Baltimore: The Johns Hopkins Press, 1992. Gerstein, D.R. and Harwood, H.J. (Eds.) Treating Drug Problems, Volumes 1 and 2. Washington, DC: National Academy Press, 1990. Ginzberg, E.(ed.) Health Services Research, Key to Health Policy. A report for the Foundation for Health Services Research, Cambridge: Harvard University Press, 1991. Greenberg, W. Competition, Regulation, and Rationing. Michigan: Health Administration Press, 1991. Institute of Medicine, Broadening the Base of Treatment For Alcohol Problems. Washington, DC: National Academy Press, 1990. Hu, T. and Rupp, A (Eds.). Advances in Health Economics and Health Services Research, Volume 14. Greenwich: JAI Press Inc., 1993. Musgrave, R.A. and Musgrave, P.B. Public Finance in Theory and Practice. New York: McGraw-Hill Book Company, 1973. National Institute on Drug Abuse. "Recommendations" in Economic Costs, Cost-Effectiveness, Financing, and Community Drug Treatment. NIDA Research Monograph 113. DHHS Pub. No.(ADM)91-1823. Washington DC: U.S. Government Printing Office, 1991, pp. 205-211. Rice, D.P.; Kelman, S.; Miller, L.S.; and Dunmeyer, S. The Economic Costs of Alcohol and Drug Abuse and Mental Illness: 1985. Report submitted to the Office of Financing and Coverage Policy of the Alcohol, Drug Abuse, and Mental Health Administration, U.S. Department of Health and Human Services. San Francisco: Institute of Health and Aging, University of California, 1990. From owner-sci-resources@net.bio.net Sun Sep 29 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 28 September 1996 Date: 29 Sep 1996 22:22:47 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 168 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <52nlf7$bsc@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending September 28, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: International Document Title: INT 96-27 Special Scientific Report 96-05, Investigation of Thermal and Fluid Dynamic Phenomena for Design of Cryogenic Pulse Tube Cooler Components for Optimum Performance. File size (bytes): 3508 STIS Filename: int9627.txt Title: INT 96-28 Special Scientific Report 96-07, Reliable Logic Circuits with Byte Error Control Codes - A Feasibility Study - File size (bytes): 7050 STIS Filename: int9628.txt Title: INT 96-30 Special Scientific Report 96-09, INTELLIGENT CONTROL OF COMPLEX ROBOT SYSTEMS File size (bytes): 2527 STIS Filename: int9630.txt Title: INT 96-31- TRM 96-22 Overview of Japanese National School* Facilities File size (bytes): 26658 STIS Filename: int9631.txt Title: INT 96-33- TRM 96-24 Venture Business Laboratories at Japanese National Universities File size (bytes): 5515 STIS Filename: int9633.txt Title: INT 96-34- TRM 96-23 Technology Policy in a World Economy File size (bytes): 32900 STIS Filename: int9634.txt Document Type: Issuance Title: iin91 - Principles Related to the Use and Operation of National Science Foundation-Supported Research Instrumentation and Facilities File size (bytes): 14905 STIS Filename: iin91.txt Document Type: Press Release Title: MAJOR PLANT GENOME RESEARCH PROJECT UNDERWAY File size (bytes): 4184 STIS Filename: pr9650.txt Title: GLOBAL NEIGHBORHOOD WATCH File size (bytes): 4025 STIS Filename: pr9651.txt Document Type: Recruit Title: Secretary (Office Automation) File size (bytes): 16139 STIS Filename: v2362-cj.txt Title: Engineer (Program Director) File size (bytes): 6979 STIS Filename: vex9630.txt Title: Office Automation Clerk File size (bytes): 9989 STIS Filename: vgs9648a.txt Title: Program Assistant (Office Automation) File size (bytes): 10241 STIS Filename: vgs9649a.txt Title: Librarian File size (bytes): 10574 STIS Filename: vgs9658.txt Title: Civilian Pay Technician (Office Automation) File size (bytes): 9418 STIS Filename: vgs9659.txt Title: Accountant File size (bytes): 8691 STIS Filename: vgs9660.txt Document Type: Report Title: NSF 96-139 -- Shaping the Future New Expectations for Undergraduate Education in Science, Mathematics, Engineering, and Technology File size (bytes): 220402 STIS Filename: nsf96139.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Bulletin Title: BUL 96-09 -- NSF September 1996 Bulletin V-24; No. 1 File size (bytes): 63305 STIS Filename: bul9609.txt Title: BUL 96-10 -- NSF October Bulletin V-24; No. 2 File size (bytes): 103928 STIS Filename: bul9610.txt Document Type: International Document Title: INT 96-33- TRM 96-24 Venture Business Laboratories at Japanese National Universities File size (bytes): 5515 STIS Filename: int9633.txt Title: INT 96-33- TRM 96-24 Venture Business Laboratories at Japanese National Universities File size (bytes): 5515 STIS Filename: int9633.txt Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 113585 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 128568 STIS Filename: phnorg.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg.txt, the text of your message should be as follows: get phnorg.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg.txt, you would enter: ftp> get phnorg.txt 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". If you have problems with the above procedures: Send a message to "stis@nsf.gov".