From owner-sci-resources@net.bio.net Sun Jun 01 23:00:00 1997 Path: biosci!biosci!not-for-mail From: izumi@pinoko.berkeley.edu (Izumi Ohzawa) Newsgroups: bionet.sci-resources Subject: Re: Journals on-line Date: 2 Jun 1997 09:10:38 -0700 Organization: University of California, Berkeley Lines: 11 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5mt8nu$3sv@agate.berkeley.edu> References: Reply-To: izumi@pinoko.berkeley.edu NNTP-Posting-Host: net.bio.net In article mcbsp@leonis.nus.sg (Paolo A. Sabelli) writes: >does anybody know where I can get a list of scientific journals whose >contents is available on-line (either free or by subscription). Any help >will be appreciated. A list of journals (med/bio) with full-text access can be found at: http://www.ncbi.nlm.nih.gov/PubMed/fulltext.html From owner-sci-resources@net.bio.net Sun Jun 01 23:00:00 1997 Path: biosci!biosci!not-for-mail From: "Stephen C. Lougheed" Newsgroups: bionet.sci-resources Subject: Biodiversity Workshop Date: 1 Jun 1997 17:52:54 -0700 Organization: Department of Biology, Queen's University Lines: 68 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <339086D5.509F@biology.queensu.ca> NNTP-Posting-Host: net.bio.net INTERNATIONAL SUMMER SCHOOL ON BIODIVERSITY AND SYSTEAMTCIS 1997 * The Canadian Museum of Nature and Queen's University are presenting an intensive workshop dedicated to providing a limited number of students (25) the opportunity to interact with, and be taught by, some of the pre-eminent researchers in the fields of ECOLOGY, EVOLUTION, CONSERVATION, ECONOMICS, POLICY and LAW (SEE FACULTY LIST BELOW); all assembled to provide a uniquely integrated approach to the study of biodiversity. For anyone who has experienced the anonymity of large college classes or giant conferences/professional meetings, the opportunity to discuss major concepts and issues with some of the foremost thinkers in these fields will prove an exciting, involving, and intellectually rewarding experience. * The course runs from July 9 through August 7 in Ottawa and Kingston (Canada), and at the Queen's Biological Station (north of Kingston). Although the course is 4 weeks long, the first five days (Ottawa) comprise an overview module that can be attended without continuing for the remainder of the course. This primary module allows more time-constrained participants an immersion into the field of issues centred on biodiversity and systematics. * Further details and an on-line application form is provided at our web site: http://biology.queensu.ca/~biodiv or call 613-545-6128. FACULTY LIST * Dr. James ANDERSON - University of Toronto * Dr. Robert ANDERSON - Canadian Museum of Nature * Mr. Ian ATTRIDGE, LL.B. Canadian Institute of Environmental Law and Policy * Dr. Robert BAILEY - University of Western Ontario * Dr. Jamie BENEDICKSON - University of Ottawa * Dr. Irwin BRODO - Canadian Museum of Nature * Dr. Adele CROWDER - Queen's University * Dr. Chris ECKERT - Queen's University * Dr. Joel ELLIOTT - Queen's University * Dr. Mark ENGSTROM - Royal Ontario Museum * Dr. Scott FINDLAY - University of Ottawa * Dr. Claude GASCON - INPA (Brasil) & Smithsonian Institution * Dr. Paul HANDFORD - University of Western Ontario * Dr. John HARTWICK - Queen's University * Dr. Chris HUMPHRIES - Natural History Museum, London * Dr. Michael HUSTON - Oakridge National Laboratory * Mr. Jeremy KERR, M.Sc. - York University * Mr. Dale KRISTENSEN, M.Sc. - Queen's University * Dr. Avrim LAZAR - Asst. Deputy Minister, Environment Canada (Fed) * Dr. Thomas LOVEJOY - Smithsonian Institution * Dr. Denis LYNN - University of Guelph * Mr. Kevin MCNAMEE, Canadian Nature Federation * Dr. Don MCALLISTER - Canadian Museum of Nature * Dr. Robert MONTGOMERIE - Queen's University * Dr. Karl NIKLAS - Cornell University * Dr. Tom NUDDS - University of Guelph * Dr. Allen ORR, University of Roshester * Dr. Lawrence PACKER - York University * Dr. Stuart PIMM - University of Tennessee * Ms. Irene PISANTY, M.Sc. - Commision for Environmental Co-operation * Dr. Steven POLASKY - Oregon State University * Mr. Steven PRICE, M.Sc. - WWF Canada * Ms. Leslie RYE, M.Sc. - University of Guelph * Dr. Michael SANDERSON - University of California at Davis * Dr. Gilles SEUTIN - McGill University * Dr. Dan SIMBERLOFF - Florida State University * Dr. Gordon SURGEONER - University of Guelph * Dr. Debora VANNIJNATTEN - Queen's University * Dr. Peter WAINWRIGHT - Florida State University * Dr. Stephen C. Lougheed Director International Summer School on Biodiversity and Systematics Department of Biology Queen's University Kingston, Ontario K7L 3N6 Canada Telephone: (613) 545-6128 FAX: (613) 545-6617 email: lougheed@biology.queensu.ca or biodiv@biology.queensu.ca http://biology.queensu.ca/~biodiv From owner-sci-resources@net.bio.net Sun Jun 01 23:00:00 1997 Path: biosci!biosci!not-for-mail From: alm13@cornell.edu (Andreas Matern) Newsgroups: bionet.sci-resources Subject: Re: Journals on-line Date: 1 Jun 1997 17:51:47 -0700 Organization: Cornell University Lines: 51 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: References: NNTP-Posting-Host: net.bio.net Here are some (although technically most are not journals): http://science.springer.de/ http://www.sciencemag.org/ http://www.america.nature.com/ http://www.ornl.gov/ORNL/EINS_Reports/Review/text/home.html http://www.amsci.org/amsci/amsci.html http://www.elsevier.com/ http://biomednet.com/hmsbeagle/ http://www.oup.co.uk:80/oup/smj/journals/ed/titles/nar/ http://www.oup.co.uk/oup/smj/journals/ed/ http://tto.trends.com/ I'm sure there are a lot more! In article , mcbsp@leonis.nus.sg (Paolo A. Sabelli) wrote: > Dear Netters, > > does anybody know where I can get a list of scientific journals whose > contents is available on-line (either free or by subscription). Any help > will be appreciated. > Thank you > > > Paolo Sabelli > > ---------------------------------------------------- > > Dr. Paolo A. Sabelli > Institute of Molecular & Cell Biology > National University of Singapore > 10 Kent Ridge Crescent > Singapore 119260 > Republic of Singapore > > Tel: (65) 772 3019 > Fax: (65) 779 1117 > E-mail: mcbsp@leonis.nus.sg > > ---------------------------------------------------- -- Andreas Matern alm13@cornell.edu 266 Emerson Hall Dept of Plant Breeding and Biometry Cornell University Ithaca, NY 14853 From owner-sci-resources@net.bio.net Sun Jun 01 23:00:00 1997 Path: biosci!biosci!not-for-mail From: Bob Kolouch Newsgroups: bionet.sci-resources Subject: Drosophila KcO Cell Cultures Date: 2 Jun 1997 09:15:14 -0700 Organization: Rosenstiel Center Lines: 16 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5murii$3lu@net.bio.net> Reply-To: Kolouch@binah.cc.brandeis.edu NNTP-Posting-Host: net.bio.net I hope you someone may be able to help me with this question: Would anyone be able to direct me to a lab or facility that could supply me with Drosophila Kc0 tissue culture cells? I am particularly interested in obtaining several liters of cells to prepare nuclear extracts from. I have checked or am in the process of checking American Type Culture Collection, Cell Culture and Hybridoma Facility, and Flybase; but I would appreciate any other suggestions. Bob Kolouch Brandeis University Rosenstiel Center Waltham, MA From owner-sci-resources@net.bio.net Sun Jun 01 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 31 May 1997 Date: 2 Jun 1997 15:26:46 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 88 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5mvhb6$mf@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 May 31, 1997. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: News Title: Sea Sawdust Enriches Tropical Oceans - Tipsheet File size (bytes): 4976 STIS Filename: tip70527.txt Document Type: Program Guideline Title: Industry/University Cooperative Research Centers: Model Partnerships (NSF 93-97, Revised 7/96) File size (bytes): 377777 STIS Filename: nsf9397.txt Title: NSF 97-99 Interdisciplinary Grants in the Mathematical Sciences File size (bytes): 11776 STIS Filename: nsf9799.txt Document Type: Recruit Title: Program Assistant (OA) File size (bytes): 7739 STIS Filename: vgs9756a.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Letter Title: REULIST -- Current List of REU Sites File size (bytes): 111547 STIS Filename: reulist.txt Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 112311 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Directory File size (bytes): 127152 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 Mon Jun 02 23:00:00 1997 Path: biosci!biosci!not-for-mail From: Bob Kolouch Newsgroups: bionet.sci-resources Subject: Drosophila KcO Cell Cultures Date: 2 Jun 1997 17:22:40 -0700 Organization: Rosenstiel Center Lines: 16 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5mvo4g$k16@net.bio.net> Reply-To: Kolouch@binah.cc.brandeis.edu NNTP-Posting-Host: net.bio.net I hope you someone may be able to help me with this question: Would anyone be able to direct me to a lab or facility that could supply me with Drosophila Kc0 tissue culture cells? I am particularly interested in obtaining several liters of cells to prepare nuclear extracts from. I have checked or am in the process of checking American Type Culture Collection, Cell Culture and Hybridoma Facility, and Flybase; but I would appreciate any other suggestions. Bob Kolouch Brandeis University Rosenstiel Center Waltham, MA From owner-sci-resources@net.bio.net Tue Jun 03 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DE-97-002 - V26(18) 05/30/97 Date: 4 Jun 1997 13:31:34 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 267 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5n4jb6$gv8@net.bio.net> NNTP-Posting-Host: net.bio.net COMPREHENSIVE ORAL HEALTH RESEARCH CENTERS OF DISCOVERY NIH GUIDE, Volume 26, Number 18, May 30, 1997 RFA: DE-97-002 P.T. 04; K.W. 0715048, 0710030 National Institute of Dental Research Letter of Intent Receipt Date: March 1, 1998 Application Receipt Date: May 8, 1998 PURPOSE The National Institute of Dental Research (NIDR) invites applications for Comprehensive Oral Health Research Centers of Discovery (COHRCD). Each COHRCD will be organized around an unifying scientific theme related to dental, oral and craniofacial diseases and disorders. Individual COHRCDs will encompass a full range of outstanding multidisciplinary research pertinent to these diseases and disorders and will be expected to: include basic, translational and applied research projects with behavioral, health services and clinical research components; accelerate transfer of research findings to application by health professionals and the public as well as to facilitate the development of marketable products and other effective health promoting interventions; support research concerning demonstration and outreach programs; and enhance the training of health professionals and the public concerning health promotion and the prevention, improved diagnosis and treatment of the dental, oral or craniofacial diseases and disorders relating to the chosen theme. 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), Comprehensive Oral Health Research Centers of Discovery, is related to the priority area of Oral 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). ELIGIBILITY REQUIREMENTS Applications may be submitted by all domestic for-profit and non- profit organizations, public and private, including universities, colleges, hospitals, laboratories, units of State and local governments and eligible agencies of the Federal government. Applicants need not have submitted proposals or been awarded funds for the developmental grants for these centers (RFA: DE-96-004) nor are applicants required to use the same central theme as the one that may have been supported through the developmental grants. Foreign organizations are not eligible to apply; however, domestic applications may include international components. The NIDR encourages applications that include investigators who are racial/ethnic minority individuals, women and persons with disabilities. Although an application must be submitted from a single institution, collaborative arrangements with other institutions are strongly encouraged. Also, applications are not restricted to traditional dental, oral and craniofacial research settings. MECHANISM OF SUPPORT The mechanism for the support of applications in response to this RFA is the Comprehensive Center (P60). Choice of an appropriate theme and the direction and execution of the proposed activities are solely the responsibility of the applicant. This RFA is a onhealth departments, industry and primate centers. These comprehensive centers may include free-standing specialized centers, program projects, and investigator-initiated research projects as integral components and could typically include research cores, newly proposed research projects, support for feasibility studies and support for demonstration and outreach research. Support will not be provided for routine patient care costs or training expenses. The strength of the COHRCDs lies in the fact that, as thematically-based organizations, they will be capable of incorporating the full range of expertise needed to accomplish the desired objectives. Each COHRCD must be a clearly defined organizational entity with a Director responsible for management of the center. Evidence of his/her strong and effective scientific leadership must be provided. The Director will be responsible for the organization and operation of the center, for communication within the center and with the NIDR on scientific and administrative matters, for maintaining high quality research efforts and for ensuring effective collaboration and communication among scientists and cooperating institutions. 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by March 1, 1998, a letter of intent that includes the number and title of this RFA and a descriptive title for the COHRCD grant. Potential applicants also are asked to provide the name, mailing address, FAX, email address and telephone number of the Center Director and the identities of other key personnel and participating institutions and departments. 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 is helpful in estimating the potential review workload and avoiding conflict of interest in the review. The letter of intent is to be sent to Dr. Ann L. Sandberg at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Division 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 RFA label available in the PHS 398 application form kit must be affixed to the bottom of the face page of the original and the original must be placed on top of the entire package. 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, in order to identify the application as a response to this RFA, the RFA title (Comprehensive Oral Health Research Centers of Discovery) and number DE-97-002 must be typed in item 2 of the face page of the application form and the YES box must be checked. The instructions accompanying Form PHS 398 must be followed as far as possible. Submit a signed, typewritten original of the application, including a cover letter, the checklist and three signed photocopies in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to: Dr. H. George Hausch Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-38D 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Applications must be received by May 8, 1998. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIDR. If NIDR staff finds that the application io appropriateness and relevance of the cores, their modes of operation and the suitability of their facilities; o the provision of an environment conducive to training of health professionals; o approach and potential effectiveness of outreach research; o evidence that the COHRCD will be able to establish partnerships with other research organizations and agencies that can provide educational and outreach activities; o feasibility of success of the demonstration research; o evidence of the availability of appropriate study populations and ability of the COHRCD to recruit adequate samples consistent with the NIH guidelines; o evidence of the ability to develop potentially marketable products and other effective interventions; o appropriateness of the budget for the proposed activities; o ability to obtain and effectively utilize leveraged funding; and o a plan for monitoring and evaluating the productivity of each of the components and the entire COHRCD. AWARD CRITERIA The earliest anticipated date of award is May, 1999. Applicants should be aware that, in addition to scientific merit, program priorities and program balance, the total cost of the proposed project and the availability of funds will be considered by the NIDR staff and the National Advisory Dental Research Council in making funding recommendations. In addition, the NIDR values complementary funding from other public and private sources including foundations and industrial concerns. In circumstances in which applications have similar scientific merit, but vary in cost-competitiveness, the NIDR is likely to select the more cost-competitive application for funding. INQUIRIES Written, email and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Ann L. Sandberg Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-24A 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2419 FAX: (301) 480-8318 Email: ann.sandberg@nih.gov Direct inquiries regarding grants management issues to: Mr. Martin R. Rubinstein Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-44A 45 Center Drive, MSC 6402 Bethesda, MD 20892-6402 Telephone: 301-594-4800 Email: Martin.Rubinstein@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121. 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 Jun 03 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 18, pt. 1of1, 30 May 1997 Date: 4 Jun 1997 13:27:41 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 812 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5n4j3t$db2@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 26, No. 18 - May 30, 1997 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** THE NATIONAL DISEASE RESEARCH INTERCHANGE National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX N2 ********************************************************** INTEGRATED PRECLINICAL/CLINICAL AIDS VACCINE DEVELOPMENT (PAR-97-056) National Institute of Allergy and infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX N3 ********************************************************** AIDS VACCINE EVALUATION GROUP MUCOSAL IMMUNOLOGY LABORATORY (RFP NIH- NIAID-DAIDS-98-06) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** RESEARCH UNITS ON PEDIATRIC PSYCHOPHARMACOLOGY: AUTISM AND OTHER PERVASIVE DEVELOPMENTAL DISORDERS (RFP NIMH-97-CR-0001) National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX R2 ********************************************************** EVALUATION OF VACCINE AND THERAPEUTICS AGAINST INFECTIOUS DISEASES OTHER THAN AIDS IN THE ELDERLY AND IN ADULTS (RFP NIH-NIAID-DMID-98-12) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R3 08/26/97 ************************************************* COMMUNITY CLINICAL ONCOLOGY PROGRAM (RFA CA-97-015) National Cancer Institute INDEX: CANCER $$INDEX R4 05/08/98 ************************************************* COMPREHENSIVE ORAL HEALTH RESEARCH CENTERS OF DISCOVERY (RFA DE-97-002) National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX P1 ********************************************************** ALCOHOL, HORMONES, AND MEDICAL COMPLICATIONS (PA-97-062) National Institute on Alcohol Abuse and Alcoholism National Institute on Aging National Institute of Diabetes and Digestive and Kidney Diseases INDEX: ALCOHOL ABUSE, ALCOHOLISM; AGING; DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX P2 ********************************************************** PLANNING GRANTS FOR NCI CANCER RESEARCH CENTERS (PAR-97-063) National Cancer Institute INDEX: CANCER $$INDEX P3 ********************************************************** INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARD IN SLEEP RESEARCH (PA- 97-064) National Heart, Lung, and Blood Institute National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Child Health and Human Development National Institute on Drug Abuse National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research INDEX: HEART, LUNG, BLOOD; AGING; ALCOHOL ABUSE, ALCOHOLISM; CHILD HEALTH, HUMAN DEVELOPMENT; DRUG ABUSE; MENTAL HEALTH; NEUROLOGICAL DISORDERS, STROKE; NURSING RESEARCH ERRATA $$INDEX E1 ********************************************************** EDWARD R. ROYBAL CENTERS FOR RESEARCH ON APPLIED GERONTOLOGY (RFA AG-97-005) National Institute on Aging INDEX: AGING The NIH GUIDE is available electronically via LISTSERV subscription, and is also on the nih gopher (gopher.nih.gov) and the NIH web site (http://www.nih.gov). Alternative access is available 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. All competing (new, renewal, amended (revised) applications for grants, cooperative agreements, and fellowships from 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) ASKNIH is a service of the Division of Extramural Outreach & Information Resources, Office of Extramural Research, Office of the Director, NIH. ASKNIH is the point of contact for obtaining general information about NIH extramural research & research training programs, requesting publications, and learning more about obtaining the NIH GUIDE and other information on the NIH web site. ASKNIH is also the contact to which organizations should request application kits and forms. ASKNIH NATIONAL INSTITUTES OF HEALTH EMAIL: ASKNIH@odrockm1.od.nih.gov FAX: (301) 480-0525 TELEPHONE: (301) 435-0714 INQUIRIES ABOUT THE NOTICES, PAS, AND RFAS IN THIS PUBLICATION SHOULD BE DIRECTED TO THE NIH STAFF MEMBER IDENTIFIED AT THE END OF EACH ITEM. 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. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** THE NATIONAL DISEASE RESEARCH INTERCHANGE NIH GUIDE, Volume 26, Number 18, May 30, 1997 P.T. 34; K.W. 0780005 National Center for Research Resources The National Disease Research Interchange (NDRI) is a center for the procurement, preservation and distribution of normal and diseased human tissues and organs available for biomedical research. NDRI currently provides 165 different types of human tissues obtained from autopsies, eye banks, surgical procedures, and organ retrieval programs. NDRI tailors the procurement and preservation of human tissue to the individual researcher's scientific protocol. To receive human tissue for research, investigators must submit a formal brief application. The requests are reviewed by a committee of advisors for scientific merit and feasibility. Once approved, a protocol is developed with the investigator for each specific tissue, outlining the constraints with regard to donor criteria, tissue size, preservation and processing needs, and time/delivery limitations. Investigators may request tissue to be delivered fresh with or without tissue culture media, fixed, or frozen. A modest service fee for the retrieval, preservation, and delivery of tissue is paid by the investigator. INQUIRIES Direct requests for applications and resource inquiries to: The National Disease Research Interchange 2401 Walnut Street, Suite 408 Philadelphia, PA 19103 Telephone: (800) 222-NDRI or (215) 557-7361 NDRI is supported by a cooperative agreement award from the Clinical Research area, National Center for Research Resources, NIH. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** INTEGRATED PRECLINICAL/CLINICAL AIDS VACCINE DEVELOPMENT NIH GUIDE, Volume 26, Number 18, May 30, 1997 PA NUMBER: PAR-97-056 P.T. 34; K.W. 0715008, 0740075 National Institute of Allergy and infectious Diseases This notice is an addendum to Program Announcement (PA) PAR-97-056, Integrated Preclinical/Clinical AIDS Vaccine Development, which was published in the NIH Guide for Grants and Contracts, Vol. 26, No. 13, April 25, 1997. The purpose of this notice is to inform potential applicants of the following modification under MECHANISM OF SUPPORT concerning the first year total costs: P01 grant applications submitted in response to this PA should not request more than $1 million first-year total (direct plus indirect) costs. This limit may be exceeded, but applicants will need to provide a comprehensive and detailed justification for doing so. This justification should be included as part of the application and will be reviewed by the Scientific Peer Review Group. INQUIRIES Direct inquiries regarding this addendum to: Dr. Steven Bende Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2A29 Bethesda, MD 20892-7620 Telephone: (301) 435-3756 FAX: (301) 402-3684 Email: sb22k@nih.gov $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** AIDS VACCINE EVALUATION GROUP MUCOSAL IMMUNOLOGY LABORATORY NIH GUIDE, Volume 26, Number 18, May 30, 1997 RFP AVAILABLE: NIH-NIAID-DAIDS-98-06 P.T. 34; K.W. 0715008, 0740075, 0710070 National Institute of Allergy and Infectious Diseases This following correction is issued for RFP NIH-NIAID-DAIDS-98-06, which was published in the NIH Guide, Vol. 26, No. 16, May 16, 1997. Responses to this RFP will be due by the close-of-business on July 21, 1997. INQUIRIES Lawrence Butler Contract Management Branch National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3C07 Bethesda, MD 20892 Telephone: (301) 496-0192 FAX: (301) 402-0972 Email: lb13t@NIH.GOV $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NIMH-97-CR-0001 ****************************************** RESEARCH UNITS ON PEDIATRIC PSYCHOPHARMACOLOGY: AUTISM AND OTHER PERVASIVE DEVELOPMENTAL DISORDERS NIH GUIDE, Volume 26, Number 18, May 30, 1997 RFP AVAILABLE: NIMH-97-CR-0001 P.T. 34; K.W. 0710100, 1715162, 0745070, 0740021 National Institute of Mental Health In September 1996, NIMH funded Research Units on Pediatric Psychopharmacology (RUPPs), that are currently active in conducting research in children and adolescents with anxiety disorders. The NIMH plans to augment these sites with RUPPs which will focus on the much understudied area of autism and other pervasive developmental disorders. The purpose of this requirement, "Research Units on Pediatric Psychopharmacology: Autism and Other Pervasive Developmental Disorders," is to support the establishment of qualified clinical research units that, by building on existing research resources at the host institution and combining the necessary expertise in clinical pharmacology and child psychiatry, can become national resources where the safety and efficacy of psychotropic medications for patients suffering from autism, other pervasive developmental disorders, and other psychiatric disorders of childhood can be conducted in a prompt and cost effective manner. These units will work as a network of research sites and conduct high priority clinical studies in various pediatric ages, addressing various aspects of pediatric psychopharmacology, including (but not limited to): dose ranges, dosing regimen, pharmacokinetics, general safety profile, efficacy and effectiveness, and long-term effects on cognition, behavior and development. The successful offeror will need to exhibit the availability of staff, facilities, and institutional support necessary to conduct clinical trials on children, using FDA approved psychotropic medications. The offeror will also need to exhibit the ability to obtain funding support from non-Federal sources to perform clinical trials of this type. NIMH proposes to issue an unrestrictive competitive solicitation for this requirement and anticipates the award of a cost reimbursement contract for a period of three years. INQUIRIES Request for Proposal (RFP) No. NIMH-97-CR-0001 will be available electronically on or about May 27, 1997, with proposals due on or about July 14,1997. The RFP may be accessed through either the NIH Home Page, the NIH Gopher or the NIMH Home Page by using the following electronic addresses and instructions: 1. NIH Home Page (via the World Wide Web): Access the NIH Home Page by using http://www.nih.gov. Once you are at the NIH Home Page, select "Grants and Contracts," then select "NIH Gopher directory," item listed under the "Contracts Page" Section. The Uniform Resource Locator (URL) for this gopher director is: gopher://gopher.nih.gov:70/11/res/rd-rfp 2. To access the NIH Gopher: Point your gopher client to GOPHER.NIH.GOV (you should now be in the NIH Gopher). Select "Grants and Research Information," then select "R&D Requests for Proposals (RFP)." 3. NIMH Home Page: Access the NIMH Home page by using http://www.nimh.nih.gov. Once you are there, select "Grants, Contracts & Committees," item listed under "NIMH Request for Proposals (RFP)." Please note that the RFP for this procurement has been revised to include only the Statement of Work, deliverable and reporting requirements, special requirements and mandatory qualifications, if any, the Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Following proposal submission and the initial review process, offerors comprising the competitive range will be requested to provide additional documentation to the Contracting Officer. All responsible sources may submit a proposal that will be considered by the NIMH. $$R1 END ************************************************************ $$R2 BEGIN NIH-NIAID-DMID-98-12 ************************************* EVALUATION OF VACCINE AND THERAPEUTICS AGAINST INFECTIOUS DISEASES OTHER THAN AIDS IN THE ELDERLY AND IN ADULTS SOL NIH GUIDE, Volume 26, Number 18, May 30, 1997 RFP AVAILABLE: NIH-NIAID-DMID-98-12 P.T. 34; K.W 0715125, 0740075 National Institute of Allergy and Infectious Diseases The Clinical Studies Section of the Clinical and Regulatory Affairs Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases has a requirement for a specialized research unit to evaluate vaccines and therapeutics against infectious diseases in the elderly and in adults with compromised immune function as a result of underlying disorders and diseases other than AIDS. This Unit will conduct clinical evaluations (including, but not limited to, Phase I and Phase II studies) of vaccines and therapeutic agents against infectious diseases, perform research studies that evaluate the senescent and/or compromised immune system (other than from HIV infection), and conduct infectious disease surveillance of these populations. Such a unit will provide volunteer populations, staff, facilities, and expertise to carry out such work. It is anticipated that one cost-reimbursement, level of effort contract will be awarded for a period of five years. RFP NIH-NIAID-DMID-98-12 will be available electronically on or about May 30, 1997, and may be accessed through either the NIAID Contract Management Branch (CMB) Home Page or the NIH Gopher by using the following electronic addresses and instructions: 1) NIAID/CMB Home Page (via the World Wide Web): Access by using http://www.niaid.nih.gov/contract and select the "RFPs" link. 2) To access the NIH Gopher: Point your gopher client to GOPHER.NIH.GOV PORT 70 (you should now be in the NIH Gopher). Select "Grants and Research Information", then select "R&D Requests for Proposals (RFP)." Please note that the RFP for this procurement has been revised to include only the Work Statement, deliverable and reporting requirements, special requirements and mandatory qualification, if any, the Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. 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 August 8, 1997. Any responsible offeror may submit a proposal which will be considered by the Government. This advertisement does not commit the Government to award a contract. Point of Contact: Sara Southard, Contract Specialist, (301) 402-6289. $$R2 END ************************************************************ $$R3 BEGIN CA-97-015 FULL-TEXT ************************************** COMMUNITY CLINICAL ONCOLOGY PROGRAM NIH GUIDE, Volume 26, Number 18, May 30, 1997 RFA AVAILABLE: CA-97-015 P.T. 34; K.W. 0715035, 0755015, 0745020, 0745027 National Cancer Institute Letter of Intent Receipt Date: July 10, 1997 Application Receipt Date: August 26, 1997 PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), invites applications from domestic institutions for cooperative agreements to the Community Clinical Oncology Program (CCOP). Applicants for new and currently funded Community Clinical Oncology Programs (CCOP) and research bases are invited to respond to this Request For Applications (RFA). Using the national resource of highly trained oncologists in community practice, the CCOP: 1) provides support for expanding the clinical research effort in the community setting; 2) stimulates quality care in the community through participation in protocol studies; 3) fosters the growth and development of a scientifically viable community cancer network able to work closely with NCI-supported clinical cooperative groups and cancer centers; 4) supports development of and community participation in cancer prevention and control intervention research, which includes chemoprevention, biomarkers and early detection, patient management, rehabilitation, and continuing care research; 5) involves primary care providers and other specialists in cancer prevention and control clinical trials; and 6) increases the involvement of minority and underserved populations in clinical research. Combining the expertise of community physicians and other health care professionals with NCI-approved cancer treatment and prevention and control clinical trials provides the opportunity for the transfer of the latest research findings to the community level. This issuance of the CCOP RFA seeks to build on the strength and demonstrated success of the CCOP over the past fourteen years by: 1) continuing the program as a vehicle for supporting community participation in cancer treatment and prevention and control clinical trials through research bases (clinical cooperative groups and cancer centers supported by NCI); 2) expanding and strengthening the cancer prevention and control research effort; 3) utilizing the CCOP network for conducting NCI-assisted cancer prevention and control research; and 4) evaluating on a continuing basis CCOP performance and its impact in the community. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Community Clinical Oncology Program, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). 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. Margaret E. Holmes, Ph.D. Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute 6130 Executive Boulevard, Room 502, MSC 7383 Bethesda, MD 20892-7383 Telephone: (301) 496-8531 FAX: (301) 402-0181 Email: mh67g@nih.gov $$R3 END ************************************************************ $$R4 BEGIN DE-97-002 FULL-TEXT ************************************** COMPREHENSIVE ORAL HEALTH RESEARCH CENTERS OF DISCOVERY NIH GUIDE, Volume 26, Number 18, May 30, 1997 RFA AVAILABLE: DE-97-002 P.T. 04; K.W. 0715048, 0710030 National Institute of Dental Research Letter of Intent Receipt Date: March 1, 1998 Application Receipt Date: May 8, 1998 PURPOSE The National Institute of Dental Research (NIDR) invites applications for Comprehensive Oral Health Research Centers of Discovery (COHRCD). Each COHRCD will be organized around an unifying scientific theme related to dental, oral and craniofacial diseases and disorders. Individual COHRCDs will encompass a full range of outstanding multidisciplinary research pertinent to these diseases and disorders and will be expected to: include basic, translational and applied research projects with behavioral, health services and clinical research components; accelerate transfer of research findings to application by health professionals and the public as well as to facilitate the development of marketable products and other effective health promoting interventions; support research concerning demonstration and outreach programs; and enhance the training of health professionals and the public concerning health promotion and the prevention, improved diagnosis and treatment of the dental, oral or craniofacial diseases and disorders relating to the chosen theme. 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), Comprehensive Oral Health Research Centers of Discovery, is related to the priority area of Oral 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) and 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. Ann L. Sandberg Division of Extramural Research National Institute of Dental Research 45 Center Drive, Room 4AN-24A, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2419 FAX: (301) 480-8318 Email: ann.sandberg@nih.gov $$R4 END ************************************************************ $$P1 BEGIN PA-97-062 FULL-TEXT ************************************** ALCOHOL, HORMONES, AND MEDICAL COMPLICATIONS NIH GUIDE, Volume 26, Number 18, May 30, 1997 PA AVAILABLE: PA-97-062 P.T. 34; K.W. 0404003, 0760025, 0710010, 0755030 National Institute on Alcohol Abuse and Alcoholism National Institute on Aging National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites applications to investigate how alcohol-induced hormonal changes can lead to medical complications. Alcohol intake can influence the synthesis, secretion, and action of many hormones resulting in physiological and pathological disturbances. Either blunting or overstimulation of hormonal activities can disturb intercellular signaling and create adverse consequences. For example, alcohol-induced hormonal changes are associated with pancreatitis, perturbed alcohol metabolism and associated liver injury, osteoporosis, immune system impairment, and impaired fertility. Studies are encouraged to establish cause-and-effect relationships and to clarify the biochemical and molecular mechanisms by which alcohol influences the synthesis, secretion and action of various hormones. Also, studies are encouraged to interpret the mechanisms of interactive effects of alcohol and hormones which may cause tissue injury. Such studies will provide information that can be used to ameliorate alcohol-hormone-related medical complications. The National Institute on Aging (NIA) is interested in research applications examining how alcohol use influences the development of age-related changes in the endocrine system. The Endocrinology Research Programs at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), in particular, are interested in studies that focus on hormonal regulation of gene expression under normal and pathological conditions, including alcohol-induced altered conditions of hormonal release and response. 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 is related to the priority area of reducing the medical complications of alcohol abuse and alcoholism. 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. Vishnudutt Purohit, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4224 FAX: (301) 594-0673 Email: vpurohit@willco.niaaa.nih.gov $$P1 END ************************************************************ $$P2 BEGIN PAR-97-063 FULL-TEXT ************************************* PLANNING GRANTS FOR NCI CANCER RESEARCH CENTERS NIH GUIDE, Volume 26, Number 18, May 30, 1997 PA AVAILABLE: PAR-97-063 P.T. 04; K.W. 0715035, 0413001, 0745020, 0745027 National Cancer Institute Application Receipt Date: January 7, 1998 PURPOSE The Cancer Centers Branch (CCB), Division of Cancer Treatment, Diagnosis, and Centers (DCTDC), of the National Cancer Institute (NCI) invites planning grant applications for the development of Cancer Research Centers in a variety of organizational settings. The purpose is to expand the scientific, geographic and demographic diversity of the Cancer Centers Program of the NCI by encouraging research-oriented organizations to develop the qualities of a strong cancer research center and become competitive for a Cancer Center Support Grant. Cancer center planning strategies may focus on a specific research theme (e.g., diagnosis, therapy, epidemiology) or integrate a broad spectrum of research to include the basic, clinical, prevention and control, and population sciences (i.e., an NCI-designated comprehensive cancer center). All approaches to planning cancer centers are encouraged, as long as they address the six essential features of an NCI Cancer Center (i.e., cancer focus, institutional commitment, organizational capabilities, facilities, center director authority, and interdisciplinary coordination and collaboration) and as long as they take advantage of the full range of the organization's capabilities in cancer research. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Planning Grants for Cancer Research Centers, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00473-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington DC 20402-9235 (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. Margaret E. Holmes, Ph.D. Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute 6130 Executive Boulevard, Room 502, MSC 7383 Bethesda, MD 20892-7383 Telephone: (301) 496-8531 FAX: (301) 402-0181 Email: mh67g@nih.gov $$P2 END ************************************************************ $$P3 BEGIN PA-97-064 FULL-TEXT ************************************** INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARD IN SLEEP RESEARCH NIH GUIDE, Volume 26, Number 18, May 30, 1997 PA AVAILABLE: PA-97-064 P.T. 44; K.W. 0715187, 0720005, 0710030 National Heart, Lung, and Blood Institute National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Child Health and Human Development National Institute on Drug Abuse National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research PURPOSE The National Institutes of Health (NIH) invites applications for Institutional National Research Service Award (NRSA) in Sleep Research. The overall goal of this training program is to increase the number of sleep researchers that are available to investigate the basic biology of sleep; to explore epidemiological, behavioral, and clinical aspects of sleep-related disorders; and to develop new approaches for the treatment and prevention of these conditions. A specific objective is to ensure that scientists, highly trained in sleep research, are available in adequate numbers to address important gaps in our biomedical and biological understanding of sleep including those outlined in the NIH Director's Sleep Disorders Research Plan. Potential applicants are strongly urged to contact the NCSDR before preparing an application. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, National Research Service Award Institutional Training Grants in Sleep Research, is related to the priority areas of heart disease and stroke, chronic disabling conditions, mental health and disorders, and clinical prevention services. 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 printing office, Washington DC 20402-9325 (Telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH Gopher (gopher://gopher.nih.gov) and by mail and E-mail from the program contact listed below. James P. Kiley, Ph.D. National Center on Sleep Disorders Research National Heart, Lung, and Blood Institute/NIH 6701 Rockledge Drive, Suite 7024, MSC 7920 Bethesda, MD 20892-7920 Telephone: (301) 435-0199 FAX: (301) 480-3557 Email: kileyj@gwgate.nhlbi.nih.gov $$P3 END ************************************************************ ERRATA $$E1 BEGIN R9 19970502 APPEND RFA AG-97-005 BOTH *********************** EDWARD R. ROYBAL CENTERS FOR RESEARCH ON APPLIED GERONTOLOGY NIH GUIDE, Volume 26, Number 18, May 30, 1997 RFA: AG-97-005 P.T. 04; K.W. 0710010, 0404000 National Institute on Aging Letter of Intent Receipt Date: July 24, 1997 Application Receipt Date: October 24, 1997 The following correction is issued for RFA AG-97-005, which was published in the NIH Guide, Vol. 26, No. 14, May 2, 1997. ELIGIBILITY REQUIREMENTS Domestic public and private, for-profit and non-profit institutions and organizations, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government are eligible to respond to this RFA. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible to apply. The principal investigator (PI) is required to have at least two R01 (or similar) grants as principal investigator. One of these grants must be currently active at the receipt date of this RFA, and the other grant must have been awarded within 10 years of the receipt date of this RFA. Including the two grants held by the PI, the members of the investigative team are required to have a total of at least three R01 (or similar) grants awarded within 10 years of the receipt date of this RFA. INQUIRIES Questions about eligibility may be referred to: Dr,. Jared B. Jobe Behavioral and Social Research National Institute on Aging 7201 Wisconsin Avenue, Room 533, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-3137 FAX: (301) 402-0051 Email: Jared_Jobe@nih.gov $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Tue Jun 03 23:00:00 1997 Path: biosci!biosci!not-for-mail From: Alex! ID-DLO Lelystad NL Newsgroups: bionet.sci-resources Subject: Re: Journals on-line Date: 3 Jun 1997 17:34:59 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 17 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5n0sa9$ss3@mserv1.dl.ac.uk> NNTP-Posting-Host: net.bio.net A 'complete' (biological) science orientated list of journals on-line (full, abstract, contents, and/or editorial), books on-line (science based), as well as other biology orientated resources, can be found at this FREQUENTLY updated site: http://www.flnet.nl/~0bossers01/ Over 70 journals can be found from there! Good Luck! From owner-sci-resources@net.bio.net Tue Jun 03 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-97-015 - V26(18) 05/30/97 - P2/2 Date: 4 Jun 1997 13:31:09 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 453 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5n4jad$gje@net.bio.net> NNTP-Posting-Host: net.bio.net organizational chart and a description of the research base operations showing the relationship(s) between the scientific and administrative functional units of the research base, vis-a-vis the conduct of treatment and/or cancer prevention and control clinical trials, must be provided. The organizational focus within the research base for cancer prevention and control research must be described, including the composition and activities of the research base cancer prevention and control committee, or equivalent, and its relationship to other clinical trial committees and activities. 2.d. Collaboration with affiliated CCOPs/Minority-Based CCOPs in treatment and/or cancer prevention and control research, as applicable, is required. CCOP-research base affiliation agreements must be included in the application. For treatment research, each applicant must demonstrate the ability to accrue a minimum of 50 credits per year from affiliated CCOPs/Minority-Based CCOPs to treatment clinical trials. During the initial funding period a research base must demonstrate that they have developed sufficient CCOP affiliations to accrue a minimum of 50 cancer treatment credits by the end of the third year. For cancer prevention and control research, each applicant must demonstrate the ability to accrue a minimum of 50 credits per year >From affiliated CCOPs/Minority-Based CCOPs, members and other affiliates to cancer prevention and control clinical trials. During the initial funding period a research base must develop cancer prevention and control protocols to allow accrual of a minimum of 50 cancer prevention and control credits by the end of the third year. It is expected that selected cooperative group members and/or Cooperative Group Outreach/cancer center affiliates other than the CCOPs will participate in cancer prevention and control research. The applicant must indicate the participants and their expected level of participation, and describe their ability to participate. 2.e. A designated Principal Investigator is required and his/her qualifications and experience must be described. An individual must be designated to coordinate cancer prevention and control research. His or her qualifications and experience within the research base structure should also be described. Each applicant must also demonstrate the ability to access professionals with the appropriate expertise to design and implement the proposed treatment and/or cancer prevention and control clinical trials. Basic scientists, medical, surgical, radiation and other oncology specialists, nurse oncologists, epidemiologists, health educators and/or other public health professionals may be included. 2.f. Each applicant's ability to manage the data from multi-institutional treatment and/or cancer prevention and control clinical trials must be described. Data management includes development of data collection forms, procedures for data transmittal, procedures for data entry, data editing, compilation, and analysis, as well as procedures for quality control and verification of submitted data. Standards should exist for determining eligibility and evaluability of patients/subjects entered on protocols. Statistical capability must exist to develop protocol statistical parameters, analyze the data, and report results. 2.g. Each applicant must demonstrate the ability to initiate procedures for training and maintaining the proficiency of personnel >From affiliated CCOPs/Minority-Based CCOPs on techniques for successful management of treatment and/or cancer prevention and control clinical trials research. Depending on the clinical trials initiated and the interventions involved, this will include training for data managers/nurses and any other individuals responsible for data collection, monitoring, or carrying out the intervention(s). 2.h. Each applicant's ability to provide mechanisms for periodic review of the performance of affiliated CCOPs/Minority-Based CCOPs, including on-site monitoring (auditing) and written procedures and criteria for continued affiliations, must be described. Similar measures must be described for other member/affiliates participating in cancer prevention and control research. 2.i. Each applicant must describe their plans for independent data and safety monitoring for all phase III prevention and control clinical trials. 2.j. Requests for funds must reflect operations/statistical costs for quality control and data management costs for CCOP participation in protocols. This estimate is based on the expected accrual credits of affiliated CCOPs/Minority-Based CCOPs and for member/affiliate accrual credits in cancer prevention and control. CCOP-research base affiliation agreements must be included. Each applicant should include a budget for monitoring and auditing activities. Funding can be requested for scientific development and pilot testing of new cancer prevention and control research initiatives (including support of a cancer prevention and control committee for the research base), and funds can also be requested for appropriate travel to meetings directly related to study activities (such as NCI-sponsored strategy sessions/workshops). Specific justification must be provided. METHOD OF APPLYING The research grant application form PHS-398 must be used in applying for cooperative agreements. These forms are available at most institutional business offices; from the Office of Extramural Outreach and Information Resources, 6701 Rockledge Drive, MSC 7910, Bethesda, MD, 20892-7910, Phone number (301) 435-0714, E-mail: asknih@odrockm1.od.nih.gov; and from the NCI program official named in the LETTER OF INTENT Section. A suggested format will be sent to all applicants requesting an RFA or submitting a letter of intent. All applicants are encouraged to obtain and use the suggested format instructions for organizing the specific information concerning the RFA programmatic requirements in the PHS 398. The RFA label available in the PHS-398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to DRG at the address below. The photocopies must be clear and single sided. DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard - Room 636 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) It is important to send these copies at the same time that the original and three copies are sent to DRG; otherwise, the NCI cannot guarantee that the applications will be reviewed in competition with other applications received on or before the designated receipt date. Applications must be received by August 26, 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. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS A. REVIEW PROCEDURES Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI staff will return it. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applicants will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and received a second level review by the appropriate National Cancer Advisory Board. B. REVIEW CRITERIA 1. CCOP Applicants All applicants will be evaluated on the following criteria: 1.a. Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. In describing the study population, it is required that a description of the gender and minority population and subpopulation served be provided, as well as an outreach plan. This information may be based on the institutional records and/or prior experience. 1.b. Ability to accrue a minimum of 50 credits per year to treatment clinical trials and a minimum of 50 credits per year to cancer prevention and control clinical trials. Established CCOPs will be funded at a yearly accrual goal that may be higher than 50 credits for treatment clinical trials and 50 credits for cancer prevention and control clinical trials. These established CCOPs will be evaluated for their past performance in meeting these accrual goals. The minimum accrual requirement may be waived for applicants whose specialty is pediatrics, or for applicants with an outstanding record in prevention and control. Each applicant's ability to access the appropriate populations, professional disciplines, and facilities to participate with affiliated research bases in NCI-approved cancer prevention and control intervention protocols will be appraised. Any prior participation in cancer treatment and prevention and control research will be considered. 1.c. Qualifications and experience of the principal investigator/associate principal investigator, in terms of ability to organize and manage a community oncology program that includes both cancer treatment and prevention and control research as well as accrual to such protocols, and related activities. 1.d. Training, experience, and commitment of participating physicians for accruing individuals to protocols in which the applicant has agreed to participate. The experience of proposed investigators in the entry and treatment of cancer patients on research trials (gained >From residency, fellowships, postdoctoral training and/or subsequent practice) will be appraised. For multidisciplinary studies, evidence of the availability of appropriate professional resources (e.g., radiotherapy, pediatrics, surgery, gynecology, urology, pathology, internal medicine, family practice, nursing, and nutrition) will be required. Experience or special skills in cancer prevention and control research and related activities will be considered, together with availability of other community resources and personnel for such clinical trials. 1.e. Stability of the functional unit or group applying to become a CCOP. Preexisting organizational affiliations of at least a core of the group applying, and evidence of stable working relationships, will be appraised. Examples of established consortium arrangements, and committee structure which demonstrates the participation of appropriate physicians and administrators, may be submitted. Evidence of previous success as a group in implementing clinical cancer treatment and prevention and control research and related activities will be considered. 1.f. Qualifications and experience of all proposed support personnel relative to their position descriptions. The relevant credentials and expected contributions to the program of personnel resources not fiscally supported by the award will be considered. 1.g. Adequacy of quality assurance mechanisms for both cancer treatment and prevention and control interventions, and adequacy of procedures for investigational drug monitoring and data management and identification of false or otherwise unreliable data. 1.h. Adequacy of available facilities, including laboratories, in- patient and outpatient resources, cancer registries, etc., and adequacy of space for administrative activities and personnel. 1.i. Appropriateness of research base affiliations and of the cancer treatment and prevention and control research protocols chosen. Affiliation agreements must be provided in the application. 1.j. For competitive continuations, adequacy of progress during the funding period, including ability to meet the accrual goals in cancer treatment and prevention and control, progress made as a CCOP, and evaluation of CCOP performance by affiliated research bases(s). Consideration will be given to previous accrual and the ability to meet the previous accrual projections for which the CCOP was funded. The research base evaluation report(s) must be provided in the application. Plans for continued accrual and follow-up of subjects on protocols will be evaluated. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each favorably recommended application. Allowable items in the budget are requests for full or part-time administrative personnel, clinical research associates, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); and appropriate travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/workshops, local travel). Funding is not allowed for clinical care provided to patients (e.g., patient care reimbursement, transportation costs). Funding is not allowed for clinical support personnel (e.g. pharmacist, physicist, clinical psychologist, dosimetrist). Physician compensation is only an allowable cost for the Principal Investigator (PI) and Co-PI, specifically for time spent on CCOP organizational/administrative tasks. Justification must be provided for personnel time and effort and funds requested. The initial review group will also examine the provisions for the protection of human subjects, recruitment plans for the inclusion of women, minorities and sub-populations to clinical trials, and the safety of the research environment. 2. Research Base Applicants All research base applicants will be evaluated on the following criteria: 2.a. Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. In describing the study population, it is required that a description of the gender and minority population and subpopulation served be provided, as well as an outreach plan. This information may be based on the institutional records and/or prior experience. 2.b. Experience in conducting multi-institutional clinical trials; demonstrated ability to develop such studies and act as a coordinating and statistical center; adequate facilities to conduct the clinical trials; adequate procedures to collect, monitor, and analyze the data and assure the safety of patients/subjects. 2.c. Quality and availability of cancer treatment and/or prevention and control protocols, as applicable, which are appropriate for CCOP participation, or the potential for developing such clinical trials. For new applications, a detailed description of at least two examples of actual or planned cancer prevention and control protocols, with professional expertise to assure the quality of the proposed intervention clinical trial will be evaluated. 2.d. The ability to accrue a minimum of 50 credits per year from affiliated CCOPs/Minority-Based CCOPs to treatment clinical trials. The ability to accrue a minimum of 50 credits per year from affiliated CCOPs/Minority-Based CCOPs to cancer prevention and control clinical trials. Experience as well as the potential for developing future clinical trials will be considered. Documentation must include CCOP-research base affiliation agreements. 2.e. Organizational structure for involving appropriate personnel in the design and implementation of treatment and/or cancer prevention and control research. The organizational focus within the research base for cancer prevention and control research, including the composition and activities of the cancer prevention and control committee, and the designation of protocol chairpersons and its relationship to other clinical trial committees and activities will be assessed. 2.f. Qualifications and experience of the principal investigator and/or the individual responsible for directly relating to the CCOPs. The availability and experience of multidisciplinary health professionals and allied professionals with skills needed to develop, utilize, and analyze treatment and/or cancer prevention and control clinical trials will also be evaluated. 2.g. Experience in working with community oncologists, orienting community data management personnel to protocol requirements, organizing scientific and educational meetings for those participating in the clinical trials, and participating in intergroup clinical trials. 2.h. Ability to establish quality control, quality assurance, and data management procedures. Experience in data management and analysis of multi-institutional clinical trials and adequacy of data management staff will be appraised. The use of mechanisms for periodic review of quality control, quality assurance, and data management procedures, safety monitoring, including procedures for data safety and monitoring committee and on-site auditing program will be assessed. 2.i. For competitive continuations, adequacy of progress in implementing a prevention and control clinical trials program including cancer prevention and control protocol development and implementation, accrual, data management, evaluation of performance sites; current status of each protocol and progress towards meeting planned accrual goals from CCOPs and members/affiliates; summary of prior activities with a clear presentation of annual accrual; completion of clinical trials, interim analyses, publication of findings, or other dissemination of trial findings throughout the research base; and other progress in meeting the requirements for a CCOP research base. During the initial funding period, a research base must demonstrate the adequacy of progress in implementing a cancer prevention and control clinical trials program that will result in attainment of accrual goals by the end of the third year. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each favorably recommended application. Requests for funds must reflect operations/statistical costs for quality control and data management costs for CCOP participation in protocols. This estimate is based on the expected accrual credits of affiliated CCOPs/Minority-Based CCOPs and for member/affiliate accrual credits in cancer prevention and control. Research bases should include a budget for monitoring and auditing costs. Funding may be requested for scientific development and pilot testing of new cancer prevention and control research initiatives, other costs related to implementation of specific cancer prevention and control protocols (including support of a cancer prevention and control committee for the research base), or for appropriate travel to meetings directly related to study activities (such as NCI-sponsored strategy sessions/workshops). Specific justification must be provided. The initial review group will also examine the provisions for the protection of human subjects, the plans for the accrual of women, minorities and sub-populations to clinical trials, and the safety of the research environment. AWARD CRITERIA The anticipated date of award is June 1, 1998. NCI program staff will take into account demographic and geographic distribution of applicants in the final funding selection process to assure inclusion of minority and underserved populations. Multiple CCOP applicants for funding who are competing for the same patient population will be considered, but all may not be awarded unless warranted by the population density. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA or inquiries about whether or not specific proposed research would be responsive are encouraged. The program official welcomes the opportunity to clarify any issues or questions from potential applicants. Jeffrey A. Perlman, M.D., M.Sc. Division of Cancer Prevention and Control National Cancer Institute 6130 Executive Boulevard, Room 300-D - MSC-7340 Bethesda, MD 20892-7340 Telephone: (301) 496-8541 Email: PerlmanJ@dcpcepn.nci.nih.gov Direct inquiries regarding fiscal matters to: Ms. Crystal Wolfrey Grants Administration Branch Office of the Director, NCI Executive Plaza South - Room 243 6120 Executive Boulevard Bethesda, Maryland 20892 Telephone: (301) 496-7800, Ext. 282 E-mail: WolfreyC@gab.nci.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 13.399, Cancer Control. Awards are under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410 as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. 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 Jun 03 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-97-015 - V26(18) 05/30/97 - P1/2 Date: 4 Jun 1997 13:30:47 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1498 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5n4j9n$g8e@net.bio.net> NNTP-Posting-Host: net.bio.net COMMUNITY CLINICAL ONCOLOGY PROGRAM NIH GUIDE, Volume 26, Number 18, May 30, 1997 RFA: CA-97-015 P.T. 34; K.W. 0715035, 0755015, 0745020, 0745027 National Cancer Institute Letter of Intent Receipt Date: July 10, 1997 Application Receipt Date: August 26, 1997 PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), invites applications from domestic institutions for cooperative agreements to the Community Clinical Oncology Program (CCOP). Applicants for new and currently funded Community Clinical Oncology Programs (CCOP) and research bases are invited to respond to this Request For Applications (RFA). Using the national resource of highly trained oncologists in community practice, the CCOP: 1) provides support for expanding the clinical research effort in the community setting; 2) stimulates quality care in the community through participation in protocol studies; 3) fosters the growth and development of a scientifically viable community cancer network able to work closely with NCI-supported clinical cooperative groups and cancer centers; 4) supports development of and community participation in cancer prevention and control intervention research, which includes chemoprevention, biomarkers and early detection, patient management, rehabilitation, and continuing care research; 5) involves primary care providers and other specialists in cancer prevention and control clinical trials; and 6) increases the involvement of minority and underserved populations in clinical research. Combining the expertise of community physicians and other health care professionals with NCI-approved cancer treatment and prevention and control clinical trials provides the opportunity for the transfer of the latest research findings to the community level. This issuance of the CCOP RFA seeks to build on the strength and demonstrated success of the CCOP over the past fourteen years by: 1) continuing the program as a vehicle for supporting community participation in cancer treatment and prevention and control clinical trials through research bases (clinical cooperative groups and cancer centers supported by NCI); 2) expanding and strengthening the cancer prevention and control research effort; 3) utilizing the CCOP network for conducting NCI-assisted cancer prevention and control research; and 4) evaluating on a continuing basis CCOP performance and its impact in the community. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Community Clinical Oncology Program, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "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 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted from domestic institutions for cooperative agreements to continue the Community Clinical Oncology Program (CCOP). New applicants and currently funded programs are eligible as described below. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. A. CCOP Applicants 1. An applicant may be a hospital, a clinic, a group of practicing physicians, a health maintenance organization (HMO), or a consortium of hospitals and/or clinics and/or physicians and/or HMOs that agree to work together with a principal investigator and a single administrative focus. 2. A university, Veterans Administration hospital, or military treatment facility (MTF) may be included in an application as a member of a consortium led by a community institution, but may not be the applicant organization or the major contributor to accrual. An unfunded, non-university clinical trials cooperative group member is eligible to apply. 3. Funded Cooperative Group Outreach Program (CGOP) participants are eligible to apply, but should state in the application that CGOP support will be relinquished if a CCOP award is received. 4. Institutions not eligible to apply as the CCOP applicant organization include: a. A comprehensive, consortial, or clinical cancer center holding an NCI Cancer Center Support (CORE) grant; b. A university hospital that is the major teaching institution for that university; or c. A university hospital clinical trials cooperative group member funded by the Division of Cancer Treatment, Diagnosis, and Centers,(DCTDC), NCI. B. Research Base Applicants An applicant may be: 1. An NCI-funded clinical trials cooperative oncology group; 2. An NCI-funded clinical center, consortium, or comprehensive cancer center. Cooperative groups must participate in both cancer treatment and prevention and control clinical trials; cancer centers as CCOP research bases may participate in both cancer treatment and prevention and control studies or cancer prevention and control research only. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U10), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility,m or a dominant role in the activity. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section "Terms and conditions of Award." The total project period for applications submitted in response to this RFA may not exceed 3 years for new applicants, and no more than 5 years for applicants currently supported under this program. Currently supported applicants will be funded for 3, 4, or 5 years depending upon priority score/percentile, review committee recommendations, and programmatic considerations. The anticipated award date is June 1, 1998. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the sizes of awards will vary also. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. NCI has determined that there is a continuing program need for community participation in cancer clinical research trials, both cancer treatment and prevention and control. While this RFA is a one-time issuance, it is expected that a CCOP RFA will be published in the NIH Guide for Grants and Contracts annually in the future provided that funds are available. FUNDS AVAILABLE It is anticipated that up to $4.2 million in total costs per year for 5 years will be committed to specifically fund applications which are submitted in response to this RFA. Approximately four research base awards and twelve CCOP awards will be made. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES A. Background The CCOP was initiated in 1983 to bring the benefits of clinical research to cancer patients in their own communities by providing support for physicians to enter patients onto treatment research protocols. In the first three years of the CCOP, 62 community programs in 34 states were funded and accrued 14,000 patients to NCI approved treatment clinical trials. The CCOPs were clearly effective in accruing patients to treatment clinical trials. The second CCOP RFA, issued in 1986, expanded the focus to include cancer prevention and control research based on the rationale that the multi-institutional clinical trials model essential for testing new treatment regimens is also central for conducting large-scale cancer prevention and control trials. In 1996, there were 51 programs in 30 states plus the District of Columbia involving over 300 hospitals and over 3,300 physicians. Approximately 3,700 patients were entered onto treatment trials and 2,200 subjects on cancer prevention and control trials in 1996. Cancer prevention and control research in the CCOPs is aimed at reducing cancer incidence, morbidity, and mortality through the identification, testing, and evaluation of interventions in controlled clinical trials. The development of cancer prevention and control research in the CCOP network has been increasing steadily since funding started in 1987. Protocols cover the full spectrum of cancer prevention and control research, from chemoprevention and the validation of biomarkers, screening and early detection, pain control and symptom management, and other rehabilitation and continuing care interventions. Several large chemoprevention trials have been implemented through the CCOP network, including the breast cancer prevention trial with tamoxifen, two head and neck chemoprevention trials using 13-cis retinoic acid (13-cRA), the prostate cancer prevention trial with finasteride, and other 13-cis retinoic secondary tumor prevention trials. The CCOPs are a vital resource for conducting NCI cancer prevention and control research because they provide access to: 1) a national network for cancer prevention and control trials which require large sample sizes for completion; 2) geographic areas which include cross sections of the population, providing mixes of patients/subjects not always available in university or urban settings; 3) large populations of cancer patients free of disease which provide a unique resource for chemoprevention clinical trials; and 4) cancer patients' family members and others who may be at increased risk of developing cancer and thus be candidates for prevention and detection studies. Participation in cancer prevention and control research by CCOPs also further expands the network of community physicians, increasing the potential for diffusion of state-of-the-art cancer prevention and control practices. B. Goals and Scope The CCOP initiative is designed to: o Bring the advantages of state-of-the-art cancer treatment and prevention and control research to individuals in their own communities by having practicing physicians and their patients/subjects participate in NCI-approved cancer treatment and prevention and control clinical trials; o Provide a basis for involving a wider segment of the community in cancer prevention and control research and investigate the impact of cancer therapy and control advances in community medical practices; o Increase the involvement of primary health care providers and other specialists (e.g., surgeons, family practitioners, urologists, gynecologists) with the CCOP investigators in cancer treatment and prevention and control research, providing an opportunity for education and exchange of information; o Facilitate wider community participation, including minorities, women, and other underserved populations, in cancer treatment and prevention and control research approved by NCI; and o Reduce cancer incidence, morbidity, and mortality by accelerating the transfer of newly developed cancer prevention, early detection, treatment, patient management, rehabilitation, and continuing care technology to widespread community application. Participating community programs (CCOPs) will be required to enter patients onto NCI-approved cancer treatment and prevention and control clinical trials through the research base(s) with which each CCOP is affiliated. CCOPs may relate directly to NCI for assistance and participation in selected cancer prevention and control protocols. CCOP performance will be evaluated on a continuing basis by the NCI program director. Participating research bases will be required to continue providing clinical treatment and/or cancer prevention and control research protocols, as applicable, and as studies progress and findings indicate, to develop new protocols. Cancer prevention and control research should be intervention-oriented and may include such areas as cancer prevention, early detection, patient management, rehabilitation, and continuing care. Research bases will be expected to monitor the quality of protocol conduct, follow CCOP accrual, and participate on a continuing basis in program evaluation. SPECIAL REQUIREMENTS A. Terms and Conditions of Award for CCOP Awardees The administrative and funding instrument used for this program is a cooperative agreement (U10), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NCI Program Staff. The following terms and conditions pertaining to the scope and nature of the interaction between NCI and the investigators will be incorporated in the Notice of Award. These terms will be in addition to the customary programmatic and financial negotiations which occur in the administration of grants. The "Terms and Conditions of Award: Nature of NCI Staff Involvement" and "Terms and Conditions: Responsibilities of Awardees" described in this section are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines; DHHS grant administration regulations 45 CFR 74; other DHHS, PHS, and NIH grant administration policy statements; and other NCI administrative terms of award. 1. Responsibilities of CCOP Awardees The awardee's programmatic responsibilities for the conduct of the research supported by this cooperative agreement are described in the INVESTIGATOR'S HANDBOOK, a Manual for Participants in Clinical Trials of Investigational Agents Sponsored by the Division of Cancer Treatment, Diagnosis, and Centers (DCTDC), National Cancer Institute and the NCI-CTMB GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS AND CCOP RESEARCH BASES and any subsequent modifications of these documents. These documents are hereby incorporated by reference as term of award and are available on request from the Cancer Therapy Evaluation Program (CTEP) or the CORB/DCPC. 1.a. Protocols All protocols used by the CCOPs must be reviewed and approved for CCOP use by the Cancer Control Protocol Review Committee (CCPRC), Division of Cancer Prevention and Control (DCPC), and/or the Protocol Review Committee (PRC), Division of Cancer Treatment, Diagnosis, and Centers (DCTDC), NCI, prior to implementation. To be eligible to receive credit for accrual to a research base protocol, the CCOP must have an affiliation agreement with the research base responsible to NCI for that protocol. The research base is responsible for the development and implementation of high quality cancer treatment and prevention and control clinical trials, and for evaluation of the results of such studies. 1.b. Research Base Affiliation(s) Each CCOP must affiliate with a national multi-specialty cooperative group having a spectrum of cancer treatment and prevention and control clinical trials. Each CCOP can affiliate with a maximum of four additional research bases. Note: A list of currently eligible research bases may be obtained >From the program official listed in the Letter of Intent Section. If participation in the protocols of one group competes with that of another group with which the CCOP is affiliated, the CCOP must prioritize the protocols in order to avoid bias in the allocation of patients to competing protocols. Initial affiliations should be maintained for the duration of the funding cycle. When circumstances require changes in research base affiliations, prior written approval from the DCPC Program Director is required. 1.c. Accrual Each CCOP is required to accrue a minimum of 50 credits* per year to treatment clinical trials that have been approved by the PRC, DCTDC, NCI. (For applicants whose specialty is pediatrics, the 50 credit minimum requirement may be waived for those applicants who are able to place a majority of their eligible patients on protocols.) As one measure of performance, it is expected that at least 10 percent of patients for whom protocols are available will be placed on clinical trials by CCOP physicians. Each CCOP is required to accrue a minimum of 50 credits* per year to cancer prevention and control clinical trials that have been approved by the CCPRC, DCPC. The CCOPs ability to meet projected accrual goals to both cancer treatment and prevention and control clinical trials will be assessed. For CCOPs that have demonstrated an outstanding record of accrual to cancer prevention and control clinical trials, the 50 credit minimum for treatment may be waived. * Each protocol approved for CCOP use will be assigned a credit value. Credits will be based on the complexity of the intervention, the amount of data management required, and the duration of follow- up. For example, each patient accrued to an average Phase II or Phase III treatment protocol will count 1 credit; an NCI-designated high-priority treatment protocol 1.5 credits; and a childhood acute lymphocytic leukemia protocol 2 credits. Cancer prevention and control protocols will be assessed for credit using a similar approach. For example, a randomized Phase III chemoprevention protocol will be assigned a value of 1 credit per subject entered. Cancer control protocols involving limited interventions will receive credit that is commensurate with the amount of data management effort required, usually an assignment of 0.3 or 0.5 credit per subject entered. Follow-up credit for chemoprevention protocols may also be assigned. 1.d. Quality Control The CCOP must establish and follow procedures for the assurance of data quality and quality control in accordance with research base guidelines and NCI policies. The CCOP must follow NCI-approved procedures developed by the research base for the prevention and/or identification of false or otherwise unreliable data and for quality assurance of data collected by the research base. The CCOP must follow policies developed by the research base and approved by the NCI for auditing the accuracy of scientific data submitted to them by the research base participants. 1.e. Data Management The CCOP must provide the DCPC Program Director with access to all data generated under this award for periodic review of data management procedures of the CCOP. Data must also be available for external monitoring if required by NCI's agreement with other federal agencies, such as the FDA, and with NCI's agreements with pharmaceutical companies for the co-development of investigational agents. The awardees will retain custody of and primary rights to their data. 1.f. Investigational Drug Management Investigators performing trials under cooperative agreements will be expected, in cooperation with NCI, to comply with all FDA monitoring and reporting requirements for investigational agents. 1.g. Organizational Changes Certain CCOP organizational changes must have the prior written approval of the DCPC Program Director. These include the addition/deletion of a participating physician, a health professional other than a physician (who actively enters patients to cancer prevention and control trials), an affiliate, component, or research base. 1.h. Radiotherapy Equipment Radiotherapy equipment must have its calibration verified according to standards set by the Radiologic Physics Center (RPC) in order for institutions to participate in protocols requiring radiation therapy, as required by the affiliated research base(s). 1.i. Monitoring Each CCOP must agree to periodic on-site audits by representatives of its research base(s), NCI, or an NCI-designee. Such on-site audits may include review of the following: use of investigational drugs; compliance with regulations for Institutional Review Board (IRB) approval and informed consent (compliance with 45 CFR 46); compliance with protocol specifications; quality control and accuracy of data recording; and completeness of reporting adverse drug reactions. Reports of such on-site audits will be reviewed by the Clinical Trials Monitoring Branch (CTMB), Cancer Therapy Evaluation Program (CTEP), DCTDC, and by the DCPC Program Director. In addition, NCI program and grants management staff will review protocol accrual, fiscal and administrative procedures. CCOP members/affiliate performance sites and/or individual investigators participating or collaborating on NCI-supported multi- institutional clinical trials must be in compliance with the monitoring standards established by the research base. They should include the following standards: o Medical records submitted in support of NCI multi-institutional trials must conform to usual standard for the maintenance of clear, accurate, and unambiguous medical records. White-outs on medical records are unacceptable. o If it is the usual and customary practice of a department, laboratory, clinic or office to prepare or issue official reports, then only that department, laboratory, clinic or office can change the report, and alterations of the medical record must be initialed and dated by the person making such alterations. For clinical progress notes, the change must be dated and initialled by the person making the change. Only one line should be placed through the initial entry, so that both the original entry and the change are legible. o The improper modification of important patient records will result in additional investigations by the NCI Clinical Trials Monitoring Branch (CTMB) and may lead to suspension of accrual and funding. 1.j. Reporting Requirements Annual progress reports must be submitted to DCPC. A suggested format developed by the DCPC Program Director for this purpose will be provided. The inability of a CCOP to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. 1.k. Network Participation CCOPs are part of a national network for conducting cancer treatment and prevention and control clinical trials. As such, each CCOP may be asked to participate in strategy sessions or workshops and in the continuing evaluation of the program and its impact in the community. 1.l. Patient/Subject Log Each CCOP may be asked to periodically maintain a new patient/subject log or minimal registry to include as applicable age, sex, race, insurance status, risk factors, primary site of cancer, stage of disease, and disposition for the potentially eligible patient/subject pool seen by the CCOP investigators. 1.m. Federally Mandated Regulatory Requirements Each CCOP must establish mechanisms to meet DHHS/PHS regulations for the protection of human subjects. At a minimum, these include: o methods for assuring that each facility at which CCOP investigators are conducting clinical trials has a current, approved assurance on file with the Office for Protection from Research Risks (OPRR); that each protocol is reviewed by the responsible IRB prior to patient entry; and that each protocol is reviewed annually by the IRB so long as the protocol is active; o methods for assuring or documenting that each patient (or patient's parent/legal guardian) gives fully informed written consent to participation in a research protocol prior to the initiation of the experimental intervention; o a system for assuring timely reporting of all serious and unexpected toxicities to the Investigational Drug Branch, CTEP, DCTDC, according to DCTDC guidelines and/or to DCPC according to DCPC guidelines; and o implementation of DCPC/DCTDC requirements for storage and accounting for investigational agents provided under DCPC/DCTDC sponsorship. 1.n. Publications Timely publication of major findings is encouraged. Publication or oral presentation of work done under this agreement requires acknowledgement of NCI support. 2. Nature of NCI Staff Involvement 2.a. Protocol Review All protocols used by the CCOPs must be reviewed and approved for CCOP use by the Cancer Control Protocol Review Committee (CCPRC), DCPC, NCI, and/or the Protocol Review Committee (PRC), DCTDC, NCI, prior to implementation. NCI will not provide investigational drugs, permit expenditure of NCI funds, or allow accrual credit for a protocol that has not been approved, or that has been closed (except for patients already on study). 2.b. Monitoring There will be periodic on-site audits of each CCOP by representatives of its research base(s), NCI, or an NCI-designee, such as DCTDC's current Clinical Trials Monitoring Service contractor. The DCPC and CTMB/CTEP will review and provide advice regarding mechanisms established for study monitoring including the on-site auditing program. DCPC/CTEP and/or its contractor staff may attend the on-site audits conducted by the Research Base or its NCI designee as observers. 2.c. Data Management The DCPC Program Director will have access to all data generated under this award and will periodically review the data management procedures of the CCOP. Data must also be available for external monitoring if required by NCI's agreement with other federal agencies, such as the Food and Drug Administration (FDA). 2.d. Investigational Drug Management The Regulatory Affairs Branch (RAB), Pharmaceutical Management Branch (PMB), CTEP, DCTDC, and Chemoprevention Branch (CB), Chemoprevention Research Program (CPRP), and DCPC staff will advise investigators of specific requirements and changes in requirements about investigational drug management that the FDA and NCI may mandate. 2.e. Organizational Changes The DCPC program director will review requests for certain organizational changes and provide written approval. These changes include the addition/deletion of a participating physician or other health professional entering patients/subjects in cancer prevention and control research in the CCOP, an affiliate, component, or research base. 2.f. Program Review The DCPC program director will review the annual progress report submitted by each CCOP. A suggested format will be developed by the DCPC Program Director for this purpose. The DCPC Program Director will review the progress of each CCOP through consideration of the CCOP annual report, program site visits, and reports from affiliated research bases. This review may include, but not be limited to, overall accrual credits, percent of available patients/subjects placed on study, eligibility and evaluability of individuals entered on study, and timeliness and quality of data reporting. The inability of a CCOP to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. 2.g. Strategy Sessions The DCPC Program Director or designee will sponsor strategy sessions when indicated, attended by principal investigators from the CCOPs and appropriate DCPC/DCTDC staff. At these meetings, information relevant to the CCOPs will be reviewed and discussed, including such issues as overall CCOP performance and the science of current or proposed clinical trials. Data will be analyzed and the outstanding research questions established and prioritized into national research goals by CCOP investigators and the DCPC/DCTDC attendees. The principal investigators will have the primary responsibility for analyzing and prioritizing the research questions to be developed into clinical trials. The DCPC Program Director will also assist the CCOP investigators in exploring mutual interests in cancer prevention and control research. 2.h. Federally Mandated Regulatory Requirements The DCPC Program Director or designee and DCTDC staff will review mechanisms established by each CCOP to meet the Department of Health and Human Services (DHHS)/Public Health Service (PHS) regulations for the protection of human subjects and FDA requirements for the conduct of research using investigational agents. 2.i. Arbitration Process The Terms and Conditions of Award require that the DCPC Program Director make post-award administrative decisions related to program performance, programmatic decisions on scientific-technical matters, and funding adjustments. NCI will establish an arbitration process when a mutually acceptable agreement cannot be obtained between the awardee and the DCPC Program Director. An arbitration panel (with appropriate expertise) composed of one member of the recipient group, one NCI nominee, and a third member chosen by the other two will be formed to review the NCI decision and recommend a course of action to the Director, DCPC. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS regulations 45 CFR Part 16. B. Terms and Conditions of Award for Research Base Awardees 1. Responsibilities of Awardees It is the responsibility of the Research Base in accordance with its constitution, bylaws, policies and procedures to develop the details of the research design, including definition of objectives and approaches, planning, implementation, analysis, and publication of results, interpretations and conclusions of studies. The research base shall designate research base investigators to serve as Protocol Chairpersons for each proposed study. Protocols will be developed in accordance with the instructions in the INVESTIGATOR'S HANDBOOK. 1.a. Protocol Development The research base is responsible for the development and implementation of high quality cancer treatment and prevention and control clinical trials, and for evaluation of the results of such clinical trials. The protocol should be a document mutually acceptable to the research base and to DCPC/DCTDC. Communication at the various stages of development is encouraged. 1.b. Concept/Protocol Submission All research base protocols utilized by the CCOPs must be reviewed and approved for CCOP use by the Cancer Control Protocol Review Committee (CCPRC), DCPC, and/or the Protocol Review Committee (PRC), DCTDC, NCI, prior to implementation. Treatment and cancer prevention and control protocols should be submitted to the Protocol Information Office (PIO), CTEP, DCTDC for review by the appropriate committee. All cancer prevention and control protocols must be preceded by the submission of a concept proposal for review by the DCPC Cancer Control Concept Review Committee (CCCRC). The CCCRC considers scientific merit and the feasibility of implementing prospective cancer control protocols in the CCOP research network. Similarly, concept proposals for cancer treatment protocols must precede protocol development. Cancer treatment concepts are reviewed by the CTEP Protocol Review Committee (PRC) in the DCTDC. All concept and protocol documents should be submitted to the PIO, CTEP, DCTDC. DCTDC may also require a letter of intent for new cancer treatment trials. 1.c. Accrual A research base for treatment research is required to accrue a minimum of 50 credits* per year from affiliated CCOPs to treatment clinical trials that have been approved by the PRC, DCTDC, NCI. During the initial funding period, a research base is required to develop sufficient affiliations to accrue 50 cancer treatment credits by the end of the third year. A research base for cancer prevention and control research is required to accrue a minimum of 50 credits* per year from CCOPs, members and other affiliates to cancer prevention and control clinical trials that have been approved by the CCPRC, DCPC. During the initial funding period, a research base is required to develop cancer prevention and control protocols to allow accrual of 50 cancer control credits by the end of the third year. * Each protocol approved for CCOP use will be assigned a credit value. Credits will be based on the complexity of the intervention, the amount of data management required, and the duration of follow- up. For example, each patient accrued to an average Phase II or Phase III treatment protocol will count 1 credit; an NCI-designated high-priority treatment protocol 1.5 credits; and a childhood acute lymphocytic leukemia protocol 2 credits. Cancer prevention and control protocols will be assessed for credit using a similar approach. For example, a randomized Phase III chemoprevention protocol will be assigned a value of 1 credit per subject entered. An additional 0.3 credits may be assigned for chemoprevention trials requiring multiply years of follow-up. Cancer control protocols involving limited interventions will receive credit that is commensurate with the amount of data management effort required. 1.d. Data Management and Analysis The research base shall establish and implement mechanisms for data management and analysis that ensure that data collection and management procedures are: (a) adequate for quality control and analysis; (b) as simple as appropriate in order to encourage maximum participation of physicians entering patients and to avoid unnecessary expense; and (c) sufficiently uniform across research bases. CCOP members/affiliate performance sites are required to follow procedures for data management and analysis. Data generated is the property of the awardee; however, the research base must provide DCPC/DCTDC with access to all data generated under this award. Data must also be available for external monitoring if required by NCI's agreement with other Federal agencies, such as the FDA and by NCI's agreements with pharmaceutical companies for the co-development of investigational agents. 1.e. Quality Control A DCPC/DCTDC-funded research base must follow all the policies and procedures for quality control established by NCI. Similar policies and procedures for quality control will be expected from cancer centers. The research bases shall establish mechanisms for quality control of all procedures and modalities employed in its trials. CCOP member/affiliates are required to follow research base procedures for quality control. The research base shall establish mechanisms for study monitoring. CCOP Members/Affiliates are required to follow the awardee procedures for study monitoring. The research base is responsible for assuring accurate and timely knowledge of the progress of each study through: o tracking and reporting of patient accrual and adherence to defined accrual goals; o ongoing assessment of case eligibility and evaluability; o timely medical review and assessment of patient data; o Medical records used in support of NCI multi-institutional trials must conform to usual standard for the maintenance of clear, accurate, and unambiguous medical records. White-outs on medical records are unacceptable; o rapid reporting of treatment-related morbidity and measures to ensure communication of this information to all parties; o interim evaluation and consideration of measures of outcome as consistent with patient safety and good clinical trials practice; o timely communication of results of studies; and o an on-site monitoring program. The research base is responsible for ensuring that all performance sites have routine audits which are reported to the NCI in accordance with the NCI/CTMB GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS AND CCOP RESEARCH BASES. In the event that the NCI determines that the awardee failed to comply with these guidelines, the accrual of new patients/subjects to the research base's protocols at the affected performance site shall be suspended immediately upon notice of the NCI determination. The suspension will remain in effect until the awardee conducts the required audit and the audit report is accepted by the NCI. The research base will be responsible for notifying any affected performance site of the suspension. During the suspension period, no funds from this award may be provided to the performance site for new accruals, and no changes to the award for new accruals will be permitted. The NCI will also notify an institution that is the direct recipient of a cooperative agreement from the NCI if it is necessary to suspend accrual at that institution. 1.f. Quality Assurance of Data The research base must develop and follow procedures for the assurance of data quality and quality control in accordance with research base guidelines and NCI policies. The research base must follow NCI-approved procedures for the prevention and/or identification of false or otherwise unreliable data and for quality assurance of data collected. The research base must develop and implement NCI-approved policies for auditing the accuracy of scientific data submitted to them. In the event that there is a finding through the quality assurance and/or quality control programs of any indication of a pattern of non-compliance with protocol or regulatory requirements or a finding of possible alteration of data, these findings must be reported in accordance with the NCI-CTMB GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS AND CCOP RESEARCH BASES. 1.g. Data and Safety Monitoring Committees The research base must establish and maintain Data and Safety Monitoring Committees (DSMCs) for Phase III prevention and control clinical trials. The policies and procedures of the DSMC must be approved by the NCI. The research base must comply with the approved policies and procedures of the DSMC. 1.h. Protocol Closure The research base shall establish a mechanism for interim monitoring of results and monitoring protocol progress. If the research base wishes to close accrual to a study prior to meeting the initially established accrual goal, the interim results and other documentation should be made available to NCI staff for review and concurrence prior to closure. It is recommended that statistical guidelines for early closure be presented as explicitly as possible in the protocol in order to facilitate these decisions. In the event that the DSMC has recommended early closure, DSMC procedures regarding notification of DCPC must be followed. 1.i. Protocol Reporting Requirements Reporting requirements will be in agreement with FDA regulations and NCI procedures. Interim reports of each activated and ongoing study shall appear in the minutes of each research base meeting and shall include specific data on patient/subject accrual as well as, when appropriate, detailed reports of treatment-associated morbidity. Quarterly accrual reports must be provided as appropriate to CTEP for all active studies. A system for providing such information in a timely manner should be in place. 1.j. Annual Progress Report Annual progress reports, including an annual performance report on each affiliated CCOP, must be submitted to DCPC. A suggested format developed by the DCPC Program Director for this purpose will be provided. The DCPC Program Director will review the performance of each research base. The annual report will include, at a minimum, information on: overall case accrual credits; cancer prevention and control research, existing or planned; eligibility and evaluability of patients/subjects entered on study; timeliness and quality of data reporting; and results of quality control review and audits if performed during that year. Research base funding is contingent on accrual from affiliated CCOPs/Minority-Based CCOPs and annual adjustments may be made. The inability of a research base to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. 1.k. Adverse Event Procedures In order to be in compliance with FDA regulations, all recipients of NCI support for clinical trials, including research bases responsible for coordinating and monitoring such trials, must promptly report adverse events (including adverse drug reactions) to the NCI and any other trial sponsors according to directions provided in the adverse event reporting section of the protocol. The awardee will notify all institutions/investigators participating in this project, funded or unfunded, about the above requirement and about the institutions'/investigators' responsibility to report adverse events as specified in the protocol. The awardee will also notify the Investigational Drug Branch (IDB),CTEP, DCTDC Drug Monitor for DCTDC-sponsored investigational agents and the Program Director for other agents, of serious or life-threatening events, as specified in the protocol. 1.l. Performance Review The research base shall establish policies and procedures for credentialing participating CCOPS and conducting periodic review of the performance and membership status of each performance site conducting prevention and control clinical trials. This review should examine scientific contributions, patient accrual, data accuracy and timeliness, protocol compliance, and audit results. 1.m. Data Files Available to NCI Upon Request Upon the request of the Grants Management Officer, NCI, true copies of data files and supporting documentation for all NCI-supported protocols that have a major impact on patterns of care, as determined by the NCI, shall be made available to the NCI in a timely manner. 1.n. Investigational Drug Management Investigators performing trials under cooperative agreements will be expected, in cooperation with DCPC/DCTDC to comply with all FDA distribution, monitoring, and reporting requirements for investigational agents. 1.o. Network Participation Research bases are part of a national network for conducting cancer treatment and prevention and control clinical trials. As such, each research base may be asked to participate in strategy sessions or workshops and the continuing evaluation of the program and its impact in the community. 1.p. Federally Mandated Regulatory Requirements Each research base must establish mechanisms to meet FDA regulatory requirements for clinical trials involving DCPC/DCTDC-sponsored investigational agents and DHHS/PHS regulations for the protection of human subjects. These regulations include but are not limited to Title 21 CFR 50,56 and 312 and Title 45 CFR 46. At a minimum the research base must be able to: o demonstrate that each participant has a current approved assurance on file with the NIH Office for Protection from Research Risks (OPRR). o demonstrate that each protocol and informed consent is approved by the responsible Institutional Review Board (IRB) prior to patient entry, that each investigator has a current FDA Form 1572 and curriculum vitae on file with the Pharmaceutical Management Branch, (PMB), CTEP. o demonstrate that each patient (or legal representative) gives written informed consent prior to entry on study. o implement the CTEP requirement for storage and accounting for investigational agents provided under DCPC/DCTDC sponsorship. o establish an on-site audit program for periodic data verification and review of regulatory responsibilities at each CCOP, cooperative group member, and Cooperative Group Outreach/cancer center affiliate institution. o provide a method, upon DCPC/DCTDC request, of summarizing efficacy and toxicity data to be included in DCPC/DCTDC's annual reports to the FDA for each investigational agent. o establish a method for the timely reporting of all serious and unexpected toxicities. 1.q. CCOPS/Minority-Based CCOPs Research bases must agree to affiliate with CCOPs/Minority-Based CCOPs when they are funded, according to guidelines established by each research base for its affiliates, and as appropriate. 1.r. Publications Timely publication of major findings is encouraged. Publication or oral presentation of work done under this agreement requires acknowledgement of NCI support. 1.s. Procedures in the Event of Scientific Misconduct If a duly authorized governmental or institutional body issues a final determination that scientific misconduct has occurred or if the awardee determines that other events have occurred which have significantly affected the quality or integrity of the Group data or patient safety, the awardee is responsible for notifying the Group Data and Safety Monitoring Committee (DSMC), the CTMB, the collaborating investigators, the appropriate Institutional Review Boards (IRBs), and other sponsors of the affected work. The awardee is also responsible, if the events described above have occurred, for ensuring that submitted but unpublished abstracts and manuscripts are corrected, if possible. If publication deadlines have passed or if abstracts and/or manuscripts containing the affected data have already been published, the awardee is responsible, within 90 days after learning of the event(s) significantly affecting the quality of the Group data or patient safety, for submitting to NCI a re-analysis of the results deleting the false or otherwise unreliable data, and disclosing within the text the reason(s) for the reanalysis. The awardee must submit the reanalysis for publication. The NCI may disseminate information about the reanalysis as broadly as it deems necessary. The awardee must use its best efforts to notify all scientists, research laboratories, and other organizations to which the awardee has sent research materials affected by false or otherwise unreliable data. True copies of data files and other supporting documentation from studies affected by scientific misconduct or other findings affecting the quality or integrity of data or patient safety shall be made available to the NCI in a timely manner upon the request of the Grants Management Officer, NCI. The NCI reserves the right to reanalyze, to publish, or to distribute its analyses of these data when it is in the interest of public health. Prior to release, publication or distribution of such analyses, the NCI will provide such analyses to the awardee. 1.t. Notification of Patients by the Awardee During Patient's Lifetime In order for there to be an appropriate response in the event the NCI determines, either while a protocol is active or (if relevant) during the lifetime of the subjects following protocol closure, that a medically important toxicity or side effect is associated with protocol-directed treatment or that the medical care of one or more subjects may have been compromised by scientific misconduct or other finding affecting the integrity of the data or patient safety at the awardee institution or at a third-party institution, funded or unfunded, the awardee shall assure that the institution(s) responsible for these subject(s') accrual, whether funded or unfunded, will have procedures in place to; (a) contact each subject individually at his or her last known address on file with the institution and which give each subject contacted appropriate information and the right to communicate with an appropriate institutional representative and, in the event of misconduct, to meet with a physician not connected with the clinical trial or study in which the subject has participated; and (b) encourage subjects to notify the institution of any changes of address. The procedure must provide for informing the subjects fully of the consequences of the toxicity or misconduct for their care and well-being, if any, and the availability of follow-up; and their opportunity to examine any portion of their medical records relevant to the potential effect of the toxicity or side effect upon them or that may be affected by scientific misconduct or other findings affecting the quality or integrity of the data or patient safety. It is understood that under regulations at 45 CFR Section 74.53, NCI has a right of access to research records pertinent to the NCI funding. In exceptional circumstances, such as a public health emergency, the institutions will be required to provide subject names and treatments to the NCI in a format which allows direct notification of the patient by the NCI. 2. Nature of NCI Staff Involvement 2.a. Scientific Resource The Division of Cancer Prevention and Control (DCPC) and Division of Cancer Treatment, Diagnosis, and Centers (DCTDC) staff will serve as a resource for specific scientific information on cancer prevention and control clinical trials, treatment regimens, and clinical trial design. The DCPC Program Director will assist the research base as appropriate in developing information concerning the scientific basis for specific trials and will also be responsible for advising the research base of the nature and results of relevant trials being carried out nationally or internationally. The DCPC Program Director will sponsor strategy sessions when indicated, attended by leading investigators from the research bases, other extramural scientists, and appropriate experts to discuss specific research initiatives. The Investigational Drug Branch (IDB), Cancer Therapy Evaluation Program (CTEP), DCTDC, Chemoprevention Branch (CB), DCPC, through the DCPC Program Director, will provide updated information on the efficacy, toxicity and availability of all Investigational New Drugs (INDs) supplied by NCI to the research base. 2.b. Protocol Development The protocol should be a document mutually acceptable to the research base and to DCPC/DCTDC. Communication at the various stages of development is encouraged. DCPC/DCTDC will assist the research base in protocol design as appropriate by providing information regarding: a) the existence and nature of concurrent clinical trials in the area of research, with an emphasis on preventing duplication of effort; b) relevant pharmacokinetic and pharmacodynamic data on investigational agents; c) availability of investigational agents, including biologic response modifiers; d) feasibility and appropriateness of the research for use by the CCOPs and/or in a community setting; and e) basic research in cancer centers and other NCI-funded programs which may be ready for clinical trials. DCPC/DCTDC will also comment on the scientific rationale, programmatic relevance, priority, design, statistical requirements, and implementation of the proposed study. 2.c. Concept/Protocol Review All research base protocols utilized by the CCOPs must be reviewed and approved for CCOP use by the (CCPRC), DCPC, NCI and/or the (PRC), DCTDC, NCI, prior to implementation. The major considerations in protocol review by DCPC or DCTDC include; a) strength of the scientific rationale supporting the study; b) importance of the question being proposed; c) avoidance of undesirable duplication with ongoing clinical trials; d) appropriateness and feasibility of study design; e) satisfactory projected accrual rate and follow-up period; f) patient/subject safety; g) compliance with NIH and the federal regulatory requirements; h) adequacy of data management; and i) appropriateness of patient/subject selection, evaluation, assessment of toxicity, response to intervention, and follow-up. The DCPC/DCTDC review committee chairperson will provide the research base with a consensus review that describes recommended modifications and other suggestions as appropriate. If a protocol is disapproved, reasons will be communicated to the research base principal investigator as a consensus review within a reasonable time. The DCPC Program Director will work with the research base, where appropriate, to develop a mutually acceptable protocol compatible with the research interests, abilities, and needs of the base, its affiliates, and NCI. Credit will be assigned following final approval of the protocol. NCI will not provide investigational drugs, permit expenditure of NCI funds, or allow accrual credit for a protocol that has not been approved. 2.d. Data Management and Analysis The awardees will retain custody of and primary rights to their data; however, DCPC/DCTDC will have access to all data generated under this award. The DCPC Program Director or a DCTDC representative may review data management and analysis procedures of the research base, under mutually agreeable circumstances, for consistency with policies and procedures established by DCPC/DCTDC for awardees conducting cancer treatment and prevention and control clinical trials. Data must also be available for external monitoring if required by NCI's agreement with other federal agencies, such as the Food and Drug Administration (FDA) and by NCI's agreements with pharmaceutical companies for the co-development of investigational agents. 2.e. Quality Control and Monitoring The Clinical Trials Monitoring Branch (CTMB), CTEP, DCTDC/DCPC Program Director may review quality control and monitoring procedures of the research base including the on-site auditing program for consistency with policies and procedures established by DCTDC/DCPC for awardees conducting cancer treatment and prevention and control clinical trials. 2.f. Review of Quality Control and Study Monitoring The DCPC and CTMB/CTEP will review and provide advice regarding mechanisms established for study monitoring including the on-site auditing program. DCPC/CTEP and/or its contractor staff may attend as observers, the on-site audits conducted by the Research Base or its NCI designee. The frequency of participation by an NCI representative as observer will be determined by the NCI. 2.g. Data and Safety Monitoring Committees The NCI Staff will assess the research base compliance with NCI established policies on Data and Safety Monitoring Committees for Phase III trials. One or more DCPC/CTEP staff will serve as non- voting members on the DSMC. 2.h. Investigational Drug Management The Regulatory Affairs Branch, CTEP, DCTDC, and CISB, CPRP, DCPC, staff will advise investigators of specific requirements and changes in requirements concerning investigational drug management that the FDA may mandate. 2.i. Program Review Annual progress reports, including an annual performance report on each affiliated CCOP, must be submitted to DCPC. DCPC staff will provide a suggested format for this purpose. The DCPC Program Director will review the progress of each research base through consideration of the research base quarterly accrual reports, annual report and program site visits. The DCPC program director will make funding recommendations based on accrual from affiliated CCOPs/Minority-Based CCOPs and annual adjustments in funding may be made. The inability of a research base to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. 2.j. Protocol Closure DCPC/DCTDC will review research base mechanisms for interim monitoring of results and will monitor protocol progress. DCPC/DCTDC may request that a protocol study be closed for reasons including: a) insufficient accrual rate; b) accrual goal met; c) poor protocol performance; d) patient/subject safety; e) already conclusive study results; and f) emergence of new information which diminishes the scientific importance of the study question. NCI will not provide investigational drugs, permit expenditure of NCI funds, or allow accrual credit for a study after requesting closure (except for patients already on study). 2.k. Federally Mandated Regulatory Requirements The DCPC Program Director and a DCTDC representative will review mechanisms established by each research base to meet Department of Health and Human Services (DHHS)/Public Health Service (PHS) regulations for the protection of human subjects and FDA requirements for the conduct of research using investigational agents. 2.l. CCOPs/Minority-Based CCOPs The DCPC Program Director will notify research bases when CCOPs/Minority-Based CCOPs are funded. 2.m. Arbitration Process The Terms and Conditions of Award require that the DCPC Program Director make post-award decisions related to protocol review, program performance and adjustments in funding. NCI will establish an arbitration process when a mutually acceptable agreement cannot be obtained between the awardee and NCI staff. An arbitration panel (with appropriate expertise) composed of one member of the recipient group, one NCI nominee, and a third member chosen by the other two will be formed to review the NCI decision and recommend an appropriate course of action to the Director, DCPC. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS regulations 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register of March 28, 1994 (59 FR 14508-14513) and in the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 23, Number 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by July 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 subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Jeffrey A. Perlman, M.D., M.Sc. Division of Cancer Prevention and Control National Cancer Institute 6130 Executive Boulevard, Room 300-D - MSC-7340 Bethesda, MD 20892-7340 Telephone: (301) 496-8541 Email: PerlmanJ@dcpcepn.nci.nih.gov APPLICATION PROCEDURES A. PREPARATION OF APPLICATION General instructions for the preparation of the cooperative agreement application are contained in the Grant Application Form PHS-398 (rev. 5/95). Responses to the instructions concerning "Human Subjects" verification must be provided when the application is initially submitted. 1. CCOP Applicants Because the Terms and Conditions of Award (discussed in the SPECIAL REQUIREMENTS Section above) will be included in all awards issued as a result of this RFA, it is critical that each applicant include specific plans for responding to these terms. Plans must describe how the applicant will comply with NCI staff involvement as well as how all the responsibilities of awardees will be fulfilled. An application from a currently funded program will be a competitive continuation and must include a progress report, which at a minimum consists of: (1) a summary of prior CCOP activities/accomplishments, including a clear presentation of annual accrual over the funding period. Accrual tables from previous annual progress reports should be included. A summary of accrual to all cancer treatment and a summary of accrual to all cancer prevention and control protocols by gender and ethnicity must be provided; progress in meeting DCPC's established accrual goals must be presented; (2) a plan for continuing to meet prevention and control accrual requirements including plans for follow-up of subjects from the large prevention trials as well as plans for implementation of additional cancer control protocols; (3) tables of the current budget and FTEs with a justification for any request for additional resources; (4) an evaluation of CCOP performance by affiliated research base(s); and (5) a complete description of how the applicant has met the special cooperative agreement terms and conditions of the award. For ALL Applicants: 1.a. Each applicant must delineate its catchment area. A map of the service area, designating counties or zip codes from which approximately 80 percent of the patients will be drawn, should be provided. A description of other cancer care resources in the catchment area (i.e., hospitals, clinics, physicians, cancer centers) which are not part of the application should be included. In describing the study population, a breakdown by percentage of the gender and minority composition of the study population should be provided. This information may be based on the institutional records and/or prior experience. 1.b. Each applicant must demonstrate the potential and stated commitment to accrue a minimum of 50 credits per year to treatment clinical trials (except if waived for applicants whose specialty is pediatrics or those with an outstanding record in cancer prevention and control accrual). Documentation must include any prior participation in treatment research clinical trials with a clear presentation of the total number of patients and credits accrued to NCI-approved treatment clinical trials. A list of the NCI approved treatment protocols in which the applicant expects to participate and the projected accrual to each must be provided. Plans for recruiting women and minority participants must be included. 1.c. Each applicant must demonstrate the potential and plans for accrual of a minimum of 50 credits per year to cancer prevention and control protocols. Documentation must include any prior participation in cancer prevention and control research clinical trials with a clear presentation of the total number of patients and credits accrued to NCI approved cancer prevention and control clinical trials. A list of the NCI approved prevention and control protocols in which the applicant expects to participate and the projected accrual must be provided. Plans for recruiting women and minority subjects must be included. For NEW Applicants: New applicants must provide at least two examples of NCI-approved intervention cancer prevention and control protocols appropriate for CCOP's participation. The applicant should describe their implementation, including specifics on patient/subject recruitment, compliance and follow-up. These studies must come from research base's with which they propose to affiliate. The CCOP applicant must document the ability to access the appropriate physicians and patient/subject populations, and adequate facilities to participate in the proposed clinical trials. 1.d. A designated Principal Investigator is required. An associate principal investigator should also be named to assure continuity in the event of resignation of the principal investigator. The qualifications and experience of both, in terms of ability to organize and manage a community oncology program that includes cancer treatment and prevention and control research and related activities, as well as experience in accruing patients/subjects to treatment and cancer prevention and control clinical trials must be described. 1.e. Each applicant is expected to have a committed multidisciplinary professional group appropriate for its expected protocol participation. This team may include medical oncologists, surgeons, radiation oncologists, pathologists, oncology nurses, data managers, health educators, and other disciplines (e.g., gynecology, urology, pediatrics, internal medicine, family practice) as appropriate. The training and experience of participating physicians must be provided, along with a description of working relationships. Any experience working together as a group, particularly in implementing clinical cancer treatment and prevention and control research and related activities, should be included. An organizational chart showing how the group will function must also be included. 1.f. Each applicant must provide the qualifications and experience of all proposed support personnel as well as a description of the proposed duties for each position. 1.g. Through formal affiliations with a maximum of five research bases, only one of which may be a national multi-specialty cooperative group, each applicant must demonstrate access to both cancer treatment and prevention and control research protocols. Evidence must be provided that an affiliation has been established with at least one NCI-approved research base which has the capacity to provide both clinical cancer treatment and prevention and control protocols. In addition, affiliations with research bases offering only cancer prevention and control protocols are appropriate. The conditions of affiliation must be provided in the CCOP-research base affiliation agreement(s). Initial affiliations should be maintained during the funding cycle. Multiple research base affiliations are permitted provided they are not conflicting. The affiliation agreements must state specifically how the problem of competing protocols will be resolved. Note: A list of currently eligible research bases may be obtained >From the program official listed in the Letter of Intent Section. 1.h. Quality control procedures must be described in detail. Assurance of quality is the joint responsibility of the CCOP and its research base(s). Quality control procedures of the research base will be applied to the CCOPs and should be specified in the CCOP- research base affiliation agreement. Procedures for investigational drug monitoring and data management must also be described. 1.i. The availability of facilities, including laboratories, inpatient and outpatient resources, cancer registries, etc., must be described. A statement of commitment from each participating institution or organization and/or documentation of consortium arrangements must be provided. Evidence of involvement with community-based voluntary organizations may be submitted. In addition, each applicant must have a defined space for administrative activities and administrative personnel which will serve as a focus for data management, quality control, and communication. 1.j. Allocation of funds to support community costs for receipt, handling, and quality control of patient data must be specified. Allowable items in the budget are requests for full or part-time administrative personnel, clinical research associates, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); and appropriate travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/workshops, local travel). Funding is not allowed for clinical care provided to patients (e.g., reimbursement of patient care expenses; transportation costs). Funding is not allowed for clinical support personnel (e.g. pharmacist, physicist, clinical psychologist, dosimetrist). Physician compensation is only an allowable cost for the Principal Investigator (PI) and Co-PI, specifically for time spent on CCOP organizational/administrative tasks. Justification must be provided for personnel time, effort and funds requested. 2. RESEARCH BASE Applicants Because the Terms and Conditions of Award (discussed in the Special Requirements Section above) will be included in all awards issued as a result of this RFA, it is critical that each applicant include specific plans for responding to these terms. Plans must describe how the applicant will comply with NCI staff involvement as well as how all the responsibilities of awardees will be fulfilled. An application from a currently funded research base will be a competitive continuation and must include a progress report, which at a minimum consists of: 1) a summary of prior research base activities/accomplishments, including a clear presentation of annual accrual to cancer treatment and annual accrual to cancer prevention and control protocols (gender and racial/ethnic minority composition) >From affiliated CCOPs over the funding period; 2) progress in developing and implementing a cancer prevention and control research program. Include the process and organizational structure for protocol development and implementation, selection and evaluation (auditing) of performance sites, data management, quality control, statistical analysis, and study safety monitoring; 3) a clear presentation of annual accrual to each NCI-approved prevention and control clinical trial for CCOPs, and research base members and affiliates; (4) status of concepts and protocols under development; (5) a description of how the applicant has met the special cooperative agreement terms and conditions of the award. Cooperative groups must participate in both cancer treatment and prevention and control clinical trials; cancer centers may participate in cancer treatment and prevention and control clinical trials or cancer prevention and control research only. In describing the study population, it is required that a description of the gender and minority population and subpopulation served be provided, as well as an outreach plan. This information may be based on the institutional records and/or prior experience. 2.a. Each applicant must demonstrate the ability to design and implement multi-institutional treatment clinical trials (if applicable). A list of treatment protocols available for CCOP participation must be provided. 2.b. Each applicant must demonstrate the ability to design and implement multi-institutional cancer prevention and control clinical trials. A list of cancer prevention and control protocols available for CCOP participation must be provided. New research base applicants must also provide a least two examples of active or proposed cancer prevention and control intervention clinical trials and describe plans for study design, intervention(s), and statistical considerations; access to potential patients/subjects to be studied; and procedures for data management, quality control, and follow-up. The availability of appropriate expertise to design, implement, and analyze the results of the proposed clinical trials must be documented. 2.c. Each applicant must have an organizational structure for involving appropriate personnel in the design and implementation of treatment and/or cancer prevention and control research. An From owner-sci-resources@net.bio.net Tue Jun 03 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-062 - V26(18) 05/30/97 Date: 4 Jun 1997 13:31:50 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 478 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5n4jbm$h6p@net.bio.net> NNTP-Posting-Host: net.bio.net ALCOHOL, HORMONES, AND MEDICAL COMPLICATIONS NIH GUIDE, Volume 26, Number 18, May 30, 1997 PA NUMBER: PA-97-062 P.T. 34; K.W. 0404003, 0760025, 0710010, 0755030 National Institute on Alcohol Abuse and Alcoholism National Institute on Aging National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites applications to investigate how alcohol-induced hormonal changes can lead to medical complications. Alcohol intake can influence the synthesis, secretion, and action of many hormones resulting in physiological and pathological disturbances. Either blunting or overstimulation of hormonal activities can disturb intercellular signaling and create adverse consequences. For example, alcohol-induced hormonal changes are associated with pancreatitis, perturbed alcohol metabolism and associated liver injury, osteoporosis, immune system impairment, and impaired fertility. Studies are encouraged to establish cause-and-effect relationships and to clarify the biochemical and molecular mechanisms by which alcohol influences the synthesis, secretion and action of various hormones. Also, studies are encouraged to interpret the mechanisms of interactive effects of alcohol and hormones which may cause tissue injury. Such studies will provide information that can be used to ameliorate alcohol-hormone-related medical complications. The National Institute on Aging (NIA) is interested in research applications examining how alcohol use influences the development of age-related changes in the endocrine system. The Endocrinology Research Programs at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), in particular, are interested in studies which focus on hormonal regulation of gene expression under normal and pathological conditions, including alcohol-induced altered conditions of hormonal release and response. 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 is related to the priority area of reducing the medical complications of alcohol abuse and alcoholism. 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, D.C. 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29). MECHANISM OF SUPPORT Research support may be obtained through applications for a research project grant (R01) or First Independent Research Support and Transition (FIRST) Award (R29). Applicants may also submit Investigator-Initiated Interactive Research Project Grants (IRPG) under this program announcement. Interactive Research Project Grants require the coordinated submission of related regular research project grant applications and, to a limited extent, FIRST Award applications from investigators who wish to collaborate on research, but do not require extensive shared physical resources. Further information on the IRPG mechanism is available in program announcement PA-96-001, NIH Guide for Grants and Contracts, Vol. 24, No. 35, October 6, 1995, and from the program staff listed under INQUIRIES at the end of this announcement. The FIRST Award and IRPG program announcements are also available on the NIAAA Home Page at http://www.niaaa.nih.gov. Program project grant applications (P01) will not be accepted for this announcement. Investigators who wish to submit an application that requests more than $500,000 for direct costs in any one year must contact program staff prior to submitting an application. RESEARCH OBJECTIVES Examples of important research on consequences of alcohol-induced hormone disorders include, but are not limited to the following: 1. Alcoholic Liver Disease (ALD): Despite recent advances in our understanding of ALD, it remains a major cause of mortality and morbidity in this country. Of the 25,407 people who died of cirrhosis in this country in 1992, at least 11,868 deaths were due to alcoholic cirrhosis (NIAAA, 1996). Alcohol-induced liver damage occurs not only from exposure to high blood alcohol concentrations in the portal circulation, but also from toxic metabolites generated by alcohol metabolism. The metabolism of alcohol is known to generate reactive oxygen intermediates (ROI) which have been implicated in the genesis of ALD. In addition, alcohol metabolism is influenced by a number of hormones. For example, the activity of liver alcohol dehydrogenase (ADH) is influenced by growth hormone (GH), testosterone, thyroid hormones, and glucocorticoids (Mezey et al., 1993), the plasma levels of which are affected by alcohol. Also, GH, known to be influenced by alcohol intake, was shown to regulate the production of CYP2E1 in hepatic microsomes (Chen et al., 1995). Whether alcohol-induced hormone alterations can significantly influence the course of liver injury via modulating the activities of ADH and CYP2E1 and subsequent alcohol metabolism needs investigation. Women are more susceptible than men to alcohol-induced liver injury (NIAAA, 1993) which could be due in part to the effects of estrogen. Estrogen has recently been shown to sensitize Kupffer cells to LPS leading to increased production of NO and TNF, known mediators of liver injury (Ikejima et al., 1996). The role of alcohol-induced changes in sex hormones in the susceptibility to liver injury needs clarification. 2. Pancreatitis: Chronic alcohol abuse is associated with 70 to 80 percent of cases of chronic pancreatitis in this country (Serles et al., 1989), affecting about 100,000 people annually. This condition can lead to maldigestion, diabetes, and pancreatic cancer. Animal studies suggest that premature activation of pancreatic enzyme precursors within the pancreas itself injures the tissue by autodigestion, triggering the process of pancreatitis. Chronic alcohol intake increases the activity of pancreatic proteolytic enzymes (Ponnappa et al., 1990). Several studies suggest that the intestinal hormone cholecystokinin (CCK) is associated with alcohol-induced pancreatitis. In rats, both intragastric and intravenous infusions of alcohol increase by several-fold the plasma levels of CCK ( Liddle et al., 1984; Saluja et al., 1993), a hormone known to stimulate pancreatic enzymes. In addition, a CCK analogue (caerulin) induces pancreatitis in experimental animals (Saluja et al., 1987). Furthermore, alcohol-fed rats were more susceptible than control rats to the development of caerulin-induced pancreatitis (Quon et al., 1991). Studies are required to elucidate the molecular and biochemical mechanisms by which alcohol stimulates the synthesis and/or secretion of CCK from the intestinal epithelial cells. 3. Osteoporosis: Chronic heavy alcohol intake is associated with decreased bone mineral density, increased bone loss, and increased risk for bone fractures (Bikle, 1993; Griffiths et al., 1993). An estimated 20-25 million Americans are afflicted with osteoporosis, resulting in an estimated 1.5 million fractures each year (Peck et al., 1988). Adverse effects of alcohol on bone appear to be direct as well as indirect. Alcohol directly inhibits the proliferation and function of the bone forming cells, osteoblasts (Chavassieux et al., 1993) and increases the activity of the bone resorbing cells, osteoclasts (Cheung et al., 1995). In addition, alcohol can influence the plasma levels of various hormones which play important roles in the bone remodeling process. For example, chronic alcohol consumption can depress plasma levels of testosterone (Mendelson et al., 1978), required for maintaining bone mineral density in males (Rosen et al., 1995). In women, estrogens are required for maintaining bone integrity as observed by the increased incidence of osteoporosis in postmenopausal women. Surprisingly, moderate alcohol consumption in postmenopausal women is associated with increased plasma levels of estradiol (Tivis and Gavaler, 1994), a hormone commonly used to prevent bone loss in postmenopausal women. Furthermore, both moderate (Laitinen et al., 1991) and heavy (Felson et al., 1995) alcohol intake were associated with increased bone mineral density in postmenopausal women. In contrast, in premenopausal women, alcohol consumption was not associated with increased plasma estrogens levels (Dorgan et al., 1994), and there was a negative correlation between alcohol intake and axial bone mineral density (Stevenson et al., 1989). Alcohol also influences plasma levels of other hormones which regulate the bone remodeling process, such as GH, glucocorticoids, parathyroid hormone, vitamin D3, and calcitonin. It is important to understand the mechanisms of hormone-mediated effects of alcohol on bone formation and bone resorption. 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. 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 Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0715, E-mail: asknih@odrockm1.od.nih.gov. The title and number of the program announcement must be typed in section 2 on the face page of the application. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. Review Criteria Criteria to be used in the scientific and technical merit review of alcohol research grant applications will include the following: 1. The scientific, technical, or medical significance and originality of the proposed research. 2. The appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. 3. The adequacy of the qualifications (including level of education and training) and relevant research experience of the principal investigator and key research personnel. 4. The availability of adequate facilities, general environment for the conduct of the proposed research, other resources, and collaborative arrangements necessary for the research. 5. The reasonableness of budget estimates and duration in relation to the proposed research. 6. When applicable, the adequacy of procedures to protect or minimize effects on animal and human subjects and the environment. 7. When applicable, compliance with NIH policy on inclusion of women and minorities in research involving human subjects. The review criteria for FIRST Awards (R29) are contained in the FIRST program announcement (revised August 1996). AWARD CRITERIA Applications will compete for available funds with all other approved applications. Applications approved by the appropriate National Advisory Council will be considered for funding on the basis of the overall scientific and technical merit of the application as determined by peer review, programmatic needs and balance, and the availability of funds. INQUIRIES The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding scientific aspects of proposed research to: Vishnudutt Purohit, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4224 FAX: (301) 594-0673 Email: vpurohit@willco.niaaa.nih.gov Jules Selden, V.M.D., Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-2678 FAX: (301) 594-0673 Email: jselden@willco.niaaa.nih.gov Frank Bellino, Ph.D. Biology of Aging Program National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892-9205 Telephone: (301) 496-6402 FAX: (301) 402-0010 Email: bellinof@gw.nia.nih.gov Ronald N. Margolis, Ph.D. Endocrinology Section National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 5AN-12J Bethesda, MD 20892-6600 Telephone: (301) 594-8819 FAX: (301) 480-3503 Email: rm76f@nih.gov Direct inquiries regarding fiscal matters to: Linda Hilley Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 504 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-3891 Email: lhilley@willco.niaaa.nih.gov Robert Pike Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: pikeb@gw.nia.nih.gov Kim Law Grants Management Specialist National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 6AS-49A Bethesda, MD 20892-6600 Telephone: (301) 594-8869 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, Nos. 93.273 (NIAAA), 93.866 (NIA), and 93.847 (NIDDK). Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. References: Bikle DD: Alcohol-induced bone diseases. World Rev Nutr Diet 73:53-79, 1993 Chavassieux P, Serre CM, Vergnaud P, Delmas PD, Meunier PJ: In Vitro evaluation of dose effects of ethanol on human osteoblastic cells. Bone Mineral 22:95-103, 1993 Chen G, Ronis MJ, Badger TM: Pituitary Regulation of rat hepatic microsomal CYP2E1. Toxicologist 15:113, 1995 Cheung RCY, Gray C, Boyde A, Jones SJ: Effects of ethanol on bone cells in vitro resulting in increased resorption. Bone 16:143-147, 1995 Dorgan JF, Reichman ME, Judd JT, Brown C: The relationship of reported alcohol ingestion to plasma levels of estrogens and androgens in premenopausal women. Cancer Causes Control 5:53-60, 1994 Felson DT, Zhang Y, Hannan MT, Kannel WB, Kiel DP: Alcohol intake and bone mineral density in elderly men and women. Am J Epidemiol 142:485-492, 1995 Griffiths HJ, Parantainen H, Olson P: Alcohol and bone disorders. Alcohol Health and Res World 17:299-304, 1993 Keith LD, Crabbe JC, Robertson LM, Kendall JW: Ethanol stimulated endorphin and corticotropin secretion in vitro. Brain Res 367:222-229, 1986 Laitinen KL, Valimaki M, Keto P: Bone mineral density measured by dual energy X-ray absorptiometry in healthy Finnish women. Calcif Tissue Int 48:224-231, 1991 Liddle RA, Goldfine ID, Williams JA: Bioassay of plasma cholecystokinin in rats: effects of food, trypsin inhibitor, and alcohol. Gastroenterology 87:542-549, 1984 MacGregor RR: Alcohol and immune defense. JAMA 256:1474-1479, 1986 Mendelson JH, Ellingboe J, Mello NK, Kuehnle J: Effects of alcohol on plasma testosterone and luteinizing hormone levels. Alcohol Clin Exp Res 2:255-258, 1978 Mezey E, Potter JJ, Yang VW: Hormonal regulation of the rat class I alcohol dehydrogenase. Alcohol Alcohol Suppl 2:57-62, 1993 NIAAA: Alcohol and Health. Eighth Special Report to the U.S. Congress, NIAAA, NIH, PHS, DHHS, pp 166, 1993 NIAAA: State trends in alcohol-related mortality, 1979-1992. Alcohol Epidemiological Data Reference Manual 5, First Edition:166-171, 1996 Peck WA, Riggs BL, Bell NH, Wallace RB, Johnston CC, Gordon SL: Research directions in osteoporosis. Am J Med 84:275-282, 1988 Ponnappa BC, Hoek JB, Jubinski E: Ethanol withdrawal stimulates protein synthesis in rat pancreatic lobules. Biochem Biophys Acta 1036:107-112, 1990 Quon MG, Kugelmas M, Wood RL, Chandrasoma P, Valenzuela JE: Cellular events of caerulin-induced pancreatitis in alcoholic rats. Gastroenterology 100:A295, 1991 Redei E, Branch BJ, Taylor AN: Direct effect of ethanol on adrenocorticotropin (ACTH) release in vitro. J Pharmacol Exp Ther 237:59-64, 1986 Rivier C, Bruhn T, Vale F: Effect of ethanol on the hypothalamic-pituitary-adrenal axis in the rat: Role of corticotropin-releasing Factor (CRF). J Pharmacol Exp Ther 229:127-131, 1984 Rivier C: Alcohol stimulates ACTH secretion in the rat: mechanisms of action and interactions with other stimuli. Alcohol Clin Exp Res 20:240-254, 1996 Rosen HN, Tollin S, Balena R, Middlebrooks VL: Bone density is normal in male rats treated with finasteride. Endocrinology 136:1381-1387, 1995 Saluja A, Hashimoto S, Saluja M, Powers RE, Meldolesi J, Steer ML: Subcellular redistribution of lysosomal enzymes during caerulin-induced pancreatitis. Am J Physiol 253(4 Pt 1)G508-16, 1987 Saluja A, Maitre N, Runzi M, Saluja M, Dawya R, Nishino H, Steer ML: Ethanol-induced increase in plasma cholecystokinin level mediated by the release of CCK-releasing into the duodenum. Gastroenterology 104:A333, 1993 Sarles H, Bernard JP, Johnson C, Chir M: Pathogenesis and epidemiology of chronic pancreatitis. Ann Rev Med 40:453-468, 1989 Stevenson JC, Lees B, Davenport, M, Cust MP, Ganger RF: Determinants of bone density in normal women: risk factors for future osteoporosis. Br Med J 298:924-928, 1989 Tivis LJ, Gavaler JS: Alcohol, hormones, and health in postmenopausal women. Alcohol Health and Research World 18:185-191, 1994 Wand G: Differential regulation of anterior pituitary corticotrope function is observed in vivo but not in vitro in two lines of ethanol sensitive mice. Alcohol Clin Exp Res 14:100-106, 1990 From owner-sci-resources@net.bio.net Tue Jun 03 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-063 - V26(18) 05/30/97 Date: 4 Jun 1997 13:32:07 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 231 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5n4jc7$hec@net.bio.net> NNTP-Posting-Host: net.bio.net PLANNING GRANTS FOR NCI CANCER RESEARCH CENTERS NIH GUIDE, Volume 26, Number 18, May 30, 1997 PA NUMBER: PAR-97-063 P.T. 04; K.W. 0715035, 0413001, 0745020, 0745027 National Cancer Institute Application Receipt Date: January 7 PURPOSE The Cancer Centers Branch (CCB), Division of Cancer Treatment, Diagnosis, and Centers (DCTDC), of the National Cancer Institute (NCI) invites planning grant applications for the development of Cancer Research Centers in a variety of organizational settings. The purpose is to expand the scientific, geographic and demographic diversity of the Cancer Centers Program of the NCI by encouraging research-oriented organizations to develop the qualities of a strong cancer research center and become competitive for a Cancer Center Support Grant. Cancer center planning strategies may focus on a specific research theme (e.g. diagnosis, therapy, epidemiology) or integrate a broad spectrum of research to include the basic, clinical, prevention and control, and population sciences (i.e., an NCI-designated comprehensive cancer center). All approaches to planning cancer centers are encouraged, as long as they address the six essential features of an NCI Cancer Center (i.e. cancer focus, institutional commitment, organizational capabilities, facilities, center director authority, and interdisciplinary coordination and collaboration) and as long as they take advantage of the full range of the organization's capabilities in cancer research. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Planning Grants for Cancer Research Centers, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00473-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington DC 20402-9235 (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, and laboratories units of State and local governments, and eligible agencies of the Federal government. Applications may be >From a single institution or several institutions (collaborating institutions or consortia) that do not have a Cancer Center Support Grant (CCSG), is not one of a set of collaborating institutions that make up a CCSG-supported NCI cancer center, or has not been supported by a CCPG or a CCSG in the last three years. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support for the planning and development of NCI cancer research centers will be through the National Institutes of Health (NIH) planning grant (P20) mechanism, which the NCI refers to in this PA as the cancer center planning grant (CCPG). CCPGs provide up to $175,000 in direct costs in the first year with cost-of-living increases in future years according to existing NCI policy. Applicants may request up to five (5) years of support. Applicants will be responsible for the execution of all activities supported by this grant. Applications submitted in response to this program announcement will compete with other CCPG applications submitted during the same fiscal year. The time and amount of all CCPG awards will be contingent upon the recommendations of peer reviewers and the availability of funds. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (rev. 4/94). RESEARCH OBJECTIVES Background: The Cancer Centers Program of the NCI currently supports multidisciplinary cancer research centers in a variety of institutions through the Cancer Centers Support Grant (P30) mechanism). Since the National Cancer Act of 1971, the legislative charge of the Program has been to support cancer centers that perform research in the basic, clinical, prevention and control, and population sciences; that promote and enhance multidisciplinary, interdisciplinary and translational research; and that influence how the results of research are coupled to medical practice in the communities and regions that they serve. While every cancer center does not meet all of these broad expectations (i.e. some are specialized in their research approaches), all cancer centers are organized to take maximum advantage of their research capability and opportunities in such a way that they can have an impact on reducing cancer incidence, mortality and morbidity. Research Goals and Scope: The strength of the NCI's Cancer Centers Program is founded in the diversity of academic, free-standing, and consortial institutions that have become NCI-supported cancer centers. The aim of this initiative is to ensure that the scientific, institutional, geographical and demographic diversity of the Program is maintained and expanded by encouraging new research-oriented organizations to apply for CCPGs and develop the research, leadership and organization capabilities expected of an NCI cancer center. The ultimate goal is to see new institutions become successful in competing for Cancer Center Support Grants and be designated as NCI cancer centers. 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 clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 4928 of Public Law 103-43). 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 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). Applications must be received by January 7 each year. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0715, email: asknih@odrockm1.od.nih.gov. The title and number of the announcement must be typed in Section 2 on the face page of the application. The format for submission of a Cancer Center Planning Grant is detailed in NCI guidelines entitled, "Planning Grants for NCI-Supported Cancer Research Centers. These guidelines can be obtained from the Cancer Centers Branch of the NCI (see INQUIRIES section). Submit a signed, typewritten original of the application, and three 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 the same time of submission, please submit two additional copies of the application to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892 Rockville, MD 20852 (for express mail) REVIEW CONSIDERATIONS The review criteria for CCPGs are outlined in the NCI guidelines entitled, "Planning Grants for NCI-Supported Cancer Research Centers. These guidelines can be obtained from the Cancer Centers Branch of the NCI (see INQUIRIES section). 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. INQUIRIES In order to obtain the NCI guidelines for "Planning Grants for NCI- Supported Cancer Research Centers," which are needed to prepare the application in the proper format and which contain the specific criteria for peer review, and for information regarding programmatic issues please contact: Margaret E. Holmes, Ph.D. Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute 6130 Executive Boulevard, Room 502, MSC 7383 Bethesda, MD 20892-7383 Telephone: (301) 496-8531 FAX: (301) 402-0181 Email: mh67g@nih.gov Written and telephone inquiries about Cancer Center Planning Grants and the Cancer Centers Program in general are encouraged. Direct inquiries regarding fiscal matters to: Ms. Carolyn Mason Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 259 FAX: (301) 496-8601 email: CM113G@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal and Domestic Assistance No. 93.397, Cancer Research. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended, Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations at 42 CFR Part 52 and 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of 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 Jun 03 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-064 - V26(18) 05/30/97 Date: 4 Jun 1997 13:32:24 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1055 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5n4jco$hmo@net.bio.net> NNTP-Posting-Host: net.bio.net INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARD IN SLEEP RESEARCH NIH GUIDE, Volume 26, Number 18, May 30, 1997 PA NUMBER: PA-97-064 P.T. 44; K.W. 0715187, 0720005, 0710030 National Heart, Lung, and Blood Institute National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Child Health and Human Development National Institute on Drug Abuse National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research PURPOSE The National Institutes of Health (NIH) invites applications for National Research Service Award (NRSA) Institutional Training Grants (T32) to develop or enhance sleep research training opportunities for individuals selected by eligible institutions. A specific objective is to ensure that scientists, highly trained in sleep research, are available in adequate numbers to address important gaps in our biomedical and biological understanding of sleep including those outlined in the NIH Director's Sleep Disorders Research Plan. For this program announcement, the National Center on Sleep Disorders Research (NCSDR) will serve as a primary contact for applicants and work closely with relevant NIH Institutes to support the training opportunities identified in this announcement. Potential applicants are strongly urged to contact the NCSDR before preparing an application. Background It has become apparent over the past decade that sleep disorders and sleep deprivation are major public health problems affecting as many as 40 million Americans. Progress in understanding the neurobiology of sleep/awake states and the pathophysiological mechanisms of sleep disorders, especially molecular and genetic aspects, has been hampered by an inadequate number of health professionals trained in sleep biology, sleep disorders medicine and relevant research. Currently, there is a critical shortage of scientists with the needed skills to bring state-of-the-art multidisciplinary approaches to sleep research. In addition, few or no investigators are studying some key research areas identified in the NIH Director's Sleep Disorders Research Plan (http://www.nhlbi.nih.gov/nhlbi/ sleep/sleep.htm) developed and coordinated by the NCSDR. The overall goal of this training program is to increase the number of sleep researchers that are available to investigate the basic biology of sleep; to explore epidemiological, behavioral, and clinical aspects of sleep-related disorders; and to develop new approaches for the treatment and prevention of these conditions. A specific objective is to ensure that scientists, highly trained in sleep research, are available in adequate numbers to address important gaps in our biomedical and biological understanding of sleep including those outlined in the NIH Director's Sleep Disorders Research Plan. Among the areas identified in the Plan is basic research at molecular, cellular, and systems levels to understand the mechanisms for sleep regulation and homeostasis; the fundamental functions of sleep during development and with age; the cause of chronic sleepiness; the effects of sleep deprivation; the interactions between circadian and neurophysiological systems that regulate sleep and wakefulness; and the genetic factors influencing sleep control and responsible for sleep-related disorders such as narcolepsy and restless legs syndrome. The Sleep Disorders Research Plan also identifies areas of patient-oriented clinical and applied research to study the effects of chronic sleepiness and sleep disturbances on performance and lifestyle; the pathogenesis of sleep disorders and its pathophysiological links to cardiovascular disease, psychiatric disorders, and other morbid conditions; the epidemiology of sleep disorders to determine etiology and the role of factors such as gender, age, and ethnicity; and the relative efficacy and effectiveness of different treatment modalities for common sleep disorders such as sleep apnea and insomnia. Addressing these questions will require a combination of approaches. Innovative, multidisciplinary and collaborative training programs with interactive training provided by investigators from different disciplines and with complementary skills are strongly encouraged. Successful training programs will attract individuals with backgrounds in relevant scientific disciplines and should have flexibility to provide interdisciplinary training to individual candidates. It is important that trainees receive thorough training in multidisciplinary approaches to modern basic and patient-oriented research. The possibility exists for this goal to be achieved through collaborative arrangements with one or more cooperating institutions offering unique opportunities for sleep research training. In these cases, the parent program must have a continuous and substantive role in the training process. It is anticipated that this new sleep training program will act as a source of trainees and activities to enhance the research programs of the participating NIH Institutes. The application should indicate how this goal will be achieved. It is essential that the applicant institution as well as all participating academic units and departments fully support the training 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 PA, "National Research Service Award Institutional Training Grants in Sleep Research," is related to the priority areas of heart disease and stroke, chronic disabling conditions, mental health and disorders, and clinical prevention services. 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 printing office, Washington D.C. 20402-9325 (Telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applicant Eligibility Requirements Only domestic, non-profit, private or public institutions, may apply for grants to support the research training programs described herein. The applicant institution must have a strong research program in the area proposed for research training and must have the staff and facilities required for a substantive portion of the proposed program. Collaborative arrangements with one or more cooperating institutions may be proposed to provide multidisciplinary sleep research training not available at the applicant institution. The research training program director at the parent institution will be responsible for the selection and appointment of trainees to receive NRSA support and for the overall direction of the program. Trainees appointed to the training program must have the opportunity to carry out supervised research with the primary objective of developing or extending their research skills and knowledge in preparation for a basic science or clinical research career in the field of sleep and sleep disorders. Levels of Training Predoctoral: Predoctoral research training must lead to the Ph.D. or a comparable research doctorate degree in a sleep-related science. Relevant disciplines include, but are not limited to, neuroscience, physiology, cellular biology, epidemiology, behavioral science, psychology, endocrinology, immunology, pharmacology, biochemistry, and genetics. The completion of two years of training at the post- baccalaureate level in a relevant science program leading to the Ph.D. or an equivalent degree prior to being appointed to this T32 is encouraged. Students enrolled in health-professional programs that are not part of a formal, combined program (i.e., M.D./Ph.D.) and who wish to postpone their professional studies in order to gain experience in sleep research may also be appointed. Predoctoral research training must emphasize fundamental training in areas of basic biomedical and behavioral sciences related to sleep and sleep disorders. Since some NIH Institutes support pre-doctoral research training on a limited basis, applicants are strongly urged to contact the NCSDR or appropriate Institute staff, before requesting predoctoral training positions in a T32 application. Postdoctoral: Postdoctoral research training is for individuals who have received a Ph.D., an M.D., or comparable health-professional doctoral degree from an accredited domestic or foreign institution. Comparable doctoral degrees include, but are not limited to the following: D.D.S., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.Sc., D. Pharm., D.S.W., and Psy.D. Research training at the postdoctoral level must emphasize specialized training to meet national research priorities in the biomedical, behavioral, epidemiologic and patient-oriented aspects of sleep and sleep disorders. Research training grants are a desirable mechanism for the postdoctoral training of physicians and other health professionals who may have had extensive clinical training, but limited research experience. For such individuals, the training may be a part of a research degree program; in all cases, health-professional postdoctoral trainees should agree to engage in at least two years of research, research training, or comparable experiences beginning at the time of appointment. Short-Term Research Training Positions for Health-Professional Students: T32 applications may include a request for short-term positions reserved specifically to train medical or other health- professional students on a full-time basis during the summer or other "off quarter" periods. Short-term appointments are intended to provide health-professional students with opportunities to participate in sleep related biomedical and/or behavioral research in an effort to attract these individuals into sleep research careers. Short-term positions should be longer than two months but may not last longer than three months. Students should be encouraged to obtain two or more periods of short-term research training during their studies leading to a health professional degree. Such appointments may be consecutive or may be reserved for summers or other "off quarter" periods. Since some NIH Institutes support short-term research training positions on a limited basis, applicants are strongly urged to contact the appropriate NIH Institute representative listed at the end of this announcement, before requesting short-term research training positions in a T32 application. Trainee Eligibility Requirements To be appointed to a research training grant, an individual must be a citizen or a non-citizen national of the United States or must have been lawfully admitted for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or must be in possession of other legal verification of such status). Individuals on temporary or student visas are not eligible. Predoctoral Trainees: Predoctoral trainees must have received a baccalaureate degree in a relevant science program at the beginning date of their NRSA appointment. Health-professional students who wish to interrupt their studies for a year or more to engage in full- time research training before completing their professional degrees are also eligible. Postdoctoral Trainees: Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a Ph.D., M.D., or comparable doctoral degree from an accredited domestic or foreign institution. Written certification by an authorized official of the degree-granting institution that all degree requirements have been met, prior to the date training is to begin, is acceptable. Short-Term Health Professional Trainees: To be eligible for short- term research training positions, health-professional students must have completed at least one quarter in a program leading to a clinical doctorate prior to participating in the program. Individuals matriculated in a formal research degree program or those holding an M.S., a Ph.D., or an M.D./Ph.D. degree or equivalent graduate level research degree are not eligible for short-term training positions. Within schools of pharmacy, only individuals who are candidates for the Pharm.D. degree are eligible for short-term positions. MECHANISM OF SUPPORT The support mechanism for grants made in response to this program announcement will be the NIH National Research Service Award (NRSA) Institutional Training Grant (T32). The announcement will remain in effect through the end of fiscal year 2000. Institutional NRSA research training grants may be made for periods up to five years and are renewable. Awards within an approved competitive segment are normally made in 12-month increments with support for additional years contingent on satisfactory progress and the availability of funds. GENERAL PROVISIONS Positions on NRSA institutional grants may not be used for study leading to the M.D., D.D.S., or other clinical, health-professional degrees except when those studies are a part of a formal combined research degree program such as the M.D./Ph.D. Similarly, trainees may not accept NRSA support for studies which are a part of residency training leading to a medical specialty or subspecialty except when the residency program credits a period of full-time, postdoctoral research training toward board certification and the trainee intends to pursue a research career. Students enrolled in health-professional doctoral degree programs may receive support for short-term research training for one or more periods lasting up to three months each. Such students may also interrupt their studies for a year or more to engage in full-time research training before completing their professional degree. Trainees are required to pursue their research training on a full- time basis, devoting at least 40 hours per week to the program. Within the 40 hours per week training period, research trainees in clinical areas must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience. Duration of Support Trainee appointments are normally made in 12-month increments with support for additional years dependent on satisfactory progress and the continued availability of funds. No trainee may be appointed for less than nine months during the initial period of appointment, except with the prior approval of the NIH awarding unit or when health-professional students are appointed to approved, short-term research training positions. No individual trainee may receive more than five years of aggregate NRSA support at the predoctoral level or three years of aggregate NRSA support at the postdoctoral level, including any combination of support from institutional training grants and individual fellowship awards. Any exception to the total duration of trainee support at either the predoctoral or postdoctoral level requires a waiver from the director of the NIH Institute or Center that supports the award. Requests for extension must be made in writing by the trainee, endorsed by the director of the training program and the appropriate institutional official, and addressed to the director of the awarding component. The request must include a sound justification for an extension of the statutory limits on the period of support. Recruitment and Appointment of Trainees The primary objective of the NRSA program is to prepare qualified individuals for careers that significantly impact the Nation's research agenda. Within the framework of the program's longstanding commitment to excellence and projected needs for investigators in particular areas of research, it is important that attention also be given to recruiting individuals from minority groups that are underrepresented nationally in the biomedical and behavioral sciences. Groups that have been shown to be underrepresented in biomedical and behavioral research nationally include: African Americans, Hispanics, Native Americans, Alaskan Natives, and Pacific Islanders. In the science areas of some sponsoring Institutes, additional groups have been identified. Applicants should contact the appropriate NIH Institute representative listed at the end of this announcement for further information. Future use of the term "minority" in this announcement will refer to the underrepresented groups identified by the appropriate Institute. Other considerations relate to the duration of training and the movement of trainees to individual support mechanisms. Studies have shown that the length of the appointment to a training grant for postdoctoral trainees with health-professional degrees is strongly correlated with subsequent application for and receipt of independent NIH research support. Program directors, therefore, are strongly encouraged to limit appointments to individuals who plan to remain on the grant or in some other type of research experience for a minimum of two years. It has also been shown that individuals who have been supported by an individual postdoctoral fellowship are more likely to apply for and receive NIH research support than individuals who have received support from a training grant alone. Program directors are therefore encouraged to identify candidates for individual postdoctoral fellowships or early career development (K awards) in order to stimulate applications. During the review of applications, peer reviewers will examine the training record to determine the average duration of training for health-professional postdoctoral trainees and whether there is a record of transition to individual support mechanisms. Past studies have shown that trainees from programs oriented exclusively toward health-professionals are less likely to apply for and receive research grant support than health-professionals who train with postdoctoral researchers who have an intensive background in research. Programs that focus on research training for individuals with an M.D. or other health-professional degrees should consider developing strong ties to basic science departments or modifying their program to include individuals with research doctoral degrees if such changes are consistent with the goals of the program. Applications should describe the contribution of basic science departments to the research training experience and indicate whether both health professional trainees and trainees with research doctorates are included in the training program. Payback Provisions As specified in the NIH Revitalization Act of 1993, NRSA recipients incur a service payback obligation only during the first 12 months of postdoctoral support. Additionally, the NIH Revitalization Act of 1993 specifies that the second and subsequent years of postdoctoral NRSA training will serve to pay back a postdoctoral service payback obligation. Accordingly, the following guidelines apply: o Predoctoral trainees are not required to sign the Payback Agreement Form (PHS Form 6031) and do not incur a service payback obligation. o Postdoctoral trainees in the first twelve months of postdoctoral NRSA support must sign the payback agreement form and incur a period of service payback obligation equal to the period of support. o Postdoctoral trainees in the thirteenth and subsequent months of NRSA support are not required to sign the Payback Agreement Form and do not incur a service payback obligation. o The thirteenth and subsequent months of postdoctoral NRSA support are considered acceptable payback service for prior postdoctoral support. Individuals appointed to their initial NRSA postdoctoral period on or after June 10, 1993, and who continue under that award for two years, have fulfilled their obligation by the end of the second year. Service payback obligations can also be paid back by conducting health-related research or teaching for more than 20 hours per week of a full year after terminating NRSA support. Recipients must begin to undertake any remaining obligated service on a continuous basis within two years after termination of NRSA support. The period for undertaking payback service may be delayed for such reasons as temporary disability, completion of residency requirements, or completion of the requirements for a graduate degree. Requests for an extension must be made in writing to the awarding unit specifying the need for additional time and the length of the required extension. Recipients of NRSA support are responsible for informing the awarding unit of changes in status or address. For individuals who fail to fulfill their obligation through service, 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 of the Treasury. Financial payback must be completed within three years, beginning on the date the United States becomes entitled to recover such amount. Under certain conditions, the Secretary, Department of Health and Human Services (or those delegated this authority) may extend the period for starting service or repayment, permit breaks in service, or in rare cases in which service or financial repayment would constitute an extreme hardship, the approving official may waive or suspend the payback obligation of an individual. Officials at the awardee institution have the responsibility of explaining the terms of the payback requirements to all prospective training candidates before appointment to the training grant. Additionally, all trainees recruited into the training program should be provided with information related to the career options available to individuals who complete the program and whether the types of positions available are consistent with the nature of the training provided and where applicable whether those positions are likely to satisfy any outstanding service payback obligation. Trainee Reporting Requirements The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant at the beginning of the appointment period. Additionally, a completed Payback Agreement (PHS Form 6031) must be submitted for each trainee in their first twelve months of postdoctoral support. Within 30 days of the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS Form 416-7). Failure to submit the required forms in a timely manner may result in an expenditure disallowance or a delay in any continuation funding for the award. Leave In general, trainees may receive stipends during periods of vacation and holidays observed by individuals in comparable training positions at the grantee institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Trainees may 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)). Trainees may also 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 institution have access to paid leave for this purpose and the use of parental leave is approved by the program director. A period of terminal leave is not permitted and payment may not be made from grant funds for leave not taken. Individuals requiring periods of time away from their research training experience longer than specified here must seek approval from the NIH awarding component for an unpaid leave of absence. At the beginning of a leave of absence, the trainee must submit a Termination Notice (PHS Form 416-7) and upon return from the leave of absence, the trainee must be formally reappointed to the grant by submitting an updated Statement of Appointment (PHS Form 2271). Trainees within the first twelve months of postdoctoral support must also submit a Payback Agreement (PHS Form 6031) upon return from a leave of absence. Stipends National Research Service Awards provide funds, in the form of stipends, to graduate students and postdoctoral trainees. A stipend is provided as a subsistence allowance for trainees to help defray living expenses during the research training experience. It is not provided as a condition of employment with either the Federal Government or the awardee institution. Stipends must be paid to all trainees at the levels approved by the Secretary of the Department of Health and Human Services. Predoctoral: Beginning in FY 97, the annual stipend for predoctoral trainees is $11,496. For appointments of less than a year, the stipend will be based on a monthly proration that is currently $958 per month. Postdoctoral: The current annual stipend for postdoctoral trainees is determined by the number of FULL years of relevant postdoctoral experience at the time of appointment. Relevant experience may include research experience (including industrial), teaching, internship, residency, clinical duties, or other time spent in full- time studies in a health-related field following the qualifying doctoral degree. The stipend for each additional year of NRSA support is the next level on the stipend scale. Current postdoctoral stipends are as follows: Years of Relevant Experience Annual Amount Less than 1 $20,292 Greater than or equal to 1 but less than 2 21,420 Greater than or equal to 2 but less than 3 25,600 Greater than or equal to 3 but less than 4 26,900 Greater than or equal to 4 but less than 5 28,200 Greater than or equal to 5 but less than 6 29,500 Greater than or equal to 6 but less than 7 30,800 Greater than or equal to 7 32,300 A trainee with a health-professional doctoral degree who is enrolled in a graduate degree program is considered to be in postdoctoral training and will receive the appropriate postdoctoral stipend listed above. No departure from the established stipend schedule may be negotiated by the institution with the trainee. The stipend for each additional full year of stipend support is the next level in the stipend structure and does not change mid-year. The sponsoring institution is allowed to provide funds to an individual in addition to the stipends paid by the NIH. Such additional amounts may be either in the form of augmented stipends (supplementation) or in the form of compensation, such as salary or tuition remission for services such as teaching or serving as a laboratory assistant, provided the following conditions are met: Stipend Supplementation: Supplementation or additional support to offset the cost of living may be provided by the awardee institution but must not require any additional obligation from the trainee. 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 DHHS funds be used for supplementation. Compensation: An institution may provide additional funds to a trainee in the form of compensation (as salary and/or tuition remission) for services such as teaching or serving as a laboratory assistant. A trainee may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS 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 that supports 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 trainee's approved NRSA training program. 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 may not be held concurrently with another Federally-sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA. More specific information on stipend supplementation and compensation is available in the current Guidelines for NRSA Individual Awards - Institutional Grants and in the current PHS Grants Policy Statement. Tax Liability Section 117 of the Internal Revenue Code applies to the tax treatment of all scholarships and fellowships. Under that section, non-degree candidates are required to report all stipends, and any monies paid on their behalf for course tuition and fees required for attendance as gross income. Degree candidates may exclude from gross income (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 trainees and institutions. NRSA stipends are not considered salaries. In addition, trainees supported under the NRSA are not considered to be in an employee-employer relationship with the NIH or the awardee institution. It must be emphasized that the interpretation and implementation of the tax laws are the domain of the Internal Revenue Service and the courts. The PHS takes no position on what the status may be for 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. Tuition, Fees, and Health Insurance Tuition, fees, and self-only medical insurance, are allowable trainee costs if such charges are required of all individuals in a similar training status at the institution, regardless of their source of support. Family medical insurance coverage is not an appropriate charge to the NRSA research training grant. Tuition at the postdoctoral level is limited to that required for specific courses in support of the approved research training program. On an annual basis, for each trainee, the training grant will cover 100 percent of the first $2,000 of the combined cost of tuition, fees, and self-only health insurance and 60 percent of any amount above $2,000. Institutions are instructed to request the full amount of these costs in competing applications. Noncompeting awards will reimburse tuition, fees, and health insurance costs in the amount paid in the previous award year, unless there is a change in the scope of the award. Other Training Costs Trainee travel, including attendance at scientific meetings that the institution determines to be necessary to the individual's research training, is an allowable trainee expense. In addition, support for travel to a research training experience away from the grantee institution may be permitted. Research training experiences away >From the parent institution must be justified considering the type of opportunities for training available, how these opportunities differ >From those offered at the parent institution, and the relationship of the proposed experience to the trainee's career stage and career goals. This type of research training requires prior approval from the NIH. Letters requesting such training may be submitted to the NIH awarding component at any time during the award period. Institutional costs of up to $1,500 per year per predoctoral trainee and up to $2,500 per year per postdoctoral trainee may be requested to defray the costs of other research training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and staff travel. Under exceptional circumstances, which can include accommodating the disabilities of a trainee, it is possible to request institutional costs above the standard rate. These additional costs must be explained in detail and carefully justified in the application. Consultation with program staff in advance of such requests is strongly advised. The institution may receive up to $125 per month to offset the cost of tuition, fees, health insurance, travel, supplies, and other expenses for each short-term, health-professional research training position. A facilities and administration allowance (indirect cost allowance) based on eight percent of total allowable direct costs (this excludes amounts for tuition, fees, health insurance, and equipment), may be requested. APPLICATION PROCEDURES Applicants must use the grant application form PHS 398 (rev. 5/95). It contains special instructions for Institutional National Research Service Awards (T32). Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division 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 PA title and number should be typed on line 2 of the application face page. Applicants must observe the 25-page limit on the narrative section of the PHS 398 application. Applicants who wish to include a request for short-term research training positions for Health Professional Students should identify the short-term positions separately within the "Stipends" and "Training Related Expenses" categories on the budget page. Under "Stipends," short-term positions should be listed in the "Other" category. Tuition, fees, health insurance, and trainee travel, and other expenses, are to be included in "Training Related Expenses." The description of the short-term research training program should be included in the application for the regular research training program, but should be separated from the description of the regular program within each section of the application. In addition to the information requested in the "Program Plan" section, the applicant should address the relationship of the proposed short-term program to the regular research training program and provide assurance that the short-term program will not detract from the regular program. Submit an original of the application with both required signatures and checklist, and five exact single-sided copies of the application 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) Application Schedule Many Institutes review T32 applications only once or twice per year. Applicants should contact the NCSDR or appropriate Institute staff for specific schedule information before preparing and submitting an application. The following table provides general guidance for possible receipt dates and the review of applications: Application Receipt Date: Jan 10 May 10 Initial Review Meeting: Jun Oct/Nov Council/Board Meeting: Sep/Oct Jan/Feb Earliest Start Date: Dec 1 Apr 1 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Division of Research Grants. Incomplete applications will be returned to the applicant without further consideration. Review Criteria Applications are evaluated for merit by NIH initial review groups based on the following criteria: o Past research training record of both the program and the designated preceptors as determined by the success of former trainees in establishing independent and productive research careers. Evidence of further career development can include receipt of fellowships, career awards, further training appointments, and similar accomplishments. Evidence of a productive scientific career can include a record of successful competition for research grants, receipt of special honors, a record of publications, receipt of patents, promotion to scientific positions, and any other measure of success consistent with the nature and duration of the training received. o Objectives, design, and direction of the training program in sleep related research; o Caliber of preceptors as researchers in sleep-related disciplines, including successful competition for research support; o The institutional training environment, including the level of institutional commitment, the quality of the facilities, availability of appropriate courses, and the availability of support for sleep research; o Recruitment and selection plans for trainees, and the availability of high quality candidates; o The record of the research training program in retaining health- professional postdoctoral trainees for at least two years in research training or other research activities; o When appropriate, the concomitant research training of health-professional postdoctorates (i.e., individuals with the M.D., D.O., D.D.S., etc.) with basic science postdoctorates (i.e., individuals with a Ph.D., etc.) or linkages with basic science departments. Short-Term Research Training Positions: In addition to the above criteria, applications that request short-term research training positions will also be assessed using the following criteria: o The quality of the proposed short-term training program in sleep research including the commitment and availability of the participating faculty, the program design, the availability of research support, and the training environment; o Access to candidates for short-term research training and the ability to recruit high quality, short-term trainees from the applicant institution or some other health-professional school; o The characteristics of the research training program that might be expected to persuade short-term trainees to consider academic/research careers in sleep research, particularly in clinical areas; o The success in attracting students back for multiple appointments (competing renewal applications); o The effects of the short-term training program on the quality of the regular research training program, including the appropriateness of the number of short-term positions, and the plan to integrate the short-term training program into the regular research training program; o The plan to follow former short-term trainees and assess the effect of such research training on their subsequent careers in sleep research. Additional Review Considerations Minority Recruitment Plan: The NIH remains strongly committed to increasing the participation of individuals from underrepresented minority groups in biomedical and behavioral research. As announced in 1989, all competing applications for institutional NRSA research training grants must include a specific plan to recruit underrepresented minorities, and competing continuation applications also must include a report on the recruitment and retention record during the previous award period. If an application is received without a plan, or without a report on the previous award period, the application will be considered incomplete and may be returned to the applicant without review. Additional information on this requirement was published in the NIH Guide for Grants and Contracts, Volume 22, Number 25, July 16, 1993. Competing renewal applications for research training grants must include a detailed account of experiences in recruiting individuals >From underrepresented groups during the previous award period. Information on the types of recruitment strategies used and which have been successful and unsuccessful must be included. The report should provide information on the racial/ethnic distribution of: (a) students and/or postdoctorates in the department(s) relevant to the training grant, (b) individuals who applied for research training, (c) individuals who were offered admission, and (d) individuals who were appointed to the research training grant. For those trainees who were appointed to the grant, the report should include information about the duration of research training and whether those trainees have finished their training in good standing. After the overall educational and technical merit of an application has been assessed, peer reviewers will examine and evaluate the minority recruitment plan and any record of recruitment and retention. For competing continuation applications, the reviewers will examine and evaluate the record of the program in recruiting and retaining underrepresented minority trainees during the previous award period. The panel also will consider whether the experience in recruitment during the previous award period has been incorporated into the formulation of the recruitment plan for the next award period. The findings of the panel will be included in an administrative note in the summary statement. If the minority recruitment plan or if the record of recruitment and retention of minorities is judged to be unacceptable, funding will be withheld until a revised plan that addresses the deficiencies is received. Staff within the NIH awarding component, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable. Training in the Responsible Conduct of Research: Every predoctoral and postdoctoral NRSA trainee supported by an institutional research training grant must receive instruction in the responsible conduct of research. For more information on this provision, please consult a notice in the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992. Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. o Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged strongly to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Within the context of training in scientific integrity it is also beneficial to discuss the mutual responsibilities of the institution and the graduate students or postdoctorates appointed to the program. o Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, trainee attendance, and the frequency of instruction. The rationale for the proposed plan of instruction must be provided. o Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in future competing and noncompeting applications. The NIH encourages institutions to provide instruction in the responsible conduct of research to all graduate students and postdoctorates in a training program or department, regardless of the source of support. NIH initial review groups will assess the applicant's plans on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction. The plan will be discussed after the overall determination of merit, so that the quality of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until a revised, acceptable plan is provided by the applicant. The acceptability of the revised plan will be judged by staff within the awarding component at the NIH. Following initial review, applications are also reviewed by the appropriate NIH Institute or Center Council, Board, or other advisory group. These advisory groups will consider, in addition to the assessment of the scientific and educational merit of the research training grant application, the initial review group's comments on the recruitment of individuals from underrepresented minority groups into the research training program and the plan for instruction in the responsible conduct of research. AWARD CRITERIA Applications are selected for funding primarily on the basis of scientific and educational merit, but other factors are considered, such as: availability of funds, research program priorities, balance among types of research training supported by the awarding component, the acceptability of the plan for minority recruitment, and the acceptability of the proposal for instruction in the responsible conduct of research. The awarding NIH Institute will notify the applicant of the final action shortly after the advisory group meeting. Additional information For additional information, see the document titled "Guidelines for National Research Service Awards, Individual Awards - Institutional Grants" available from the applicant's institution or by contacting 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, E-mail: asknih@odrockm1.od.nih.gov. INQUIRIES Applicants are strongly encouraged to contact the individuals designated below, in advance of preparing an application, for additional information concerning the areas of research, receipt dates, and other types of pre-application consultation. Direct inquiries regarding programmatic issues to: James P. Kiley, Ph.D. National Center on Sleep Disorders Research National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 7024, MSC 7920 Bethesda, MD 20892-7920 Telephone: (301) 435-0199 Email: kileyj@gwgate.nhlbi.nih.gov Additional contacts for Institute-specific program issues are: Andrew 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 Email: am39m@nih.gov Ellen D. Witt, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-6545 Email: ewitt@willco.niaaa.nih.gov Marian Willinger, Ph.D. Pregnancy and Perinatology Branch National Institute of Child Health and Human Development 6100 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-5575 Email: willingm@hd01.nichd.nih.gov Paul Coulis, Ph.D. National Institute on Drug Abuse 5600 Fishers Lane, Room 10A/08 Rockville, MD 20857 Telephone: (301) 443-1801 Email: pcoulis@aoada.ssw.dhhs.gov Israel Lederhendler, Ph.D. National Institute of Mental Health 5600 Fishers Lane, Room 11/102 Rockville, MD 20857 Telephone: (301) 443-1576 Email: ilu@cu.nih.gov Joseph Drage, M.D. Training and Special Programs Officer National Institute of Neurological Disorders and Stroke Federal Building, Room 1016 Bethesda, MD 20892 Telephone: (301) 496-4188 Email: dragej@nswide.ninds.nih.gov Mary Leveck, Ph.D., R.N. National Institute of Nursing Research 45 Center Drive, Room 3AN12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5963 Email: mleveck@ep.ninr.nih.gov Direct inquires regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 7160, MSC 7926 Bethesda, MD 20892-7920 Telephone: (301) 435-0171 Email: zimmermr@gwgate.nhlbi.nih.gov Crystal Ferguson Grants Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2C212, MSC 9205 Bethesda, MD 20892-9205 (Courier Zip: 20814) Telephone: (301) 496-1472 Email: Ferguson%nihniagw.bitnet@cu.nih.gov Linda Hilley Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 504 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0915 Email: lhilley@wilco.niaaa.nih.gov Douglas Shawver Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17 Bethesda, MD 20892 Telephone: (301) 496-1303 Email: Shawver@hd01.nichd.nih.gov Gary Fleming Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20892 Telephone: (301) 443-6710 Email: gfleming@aoada.ssw.dhhs.gov Diana Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-3065 Email: dt21a@nih.gov Karen Shields Grants Management Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 Bethesda, MD 20892-9190 Telephone: (301) 496-9231 Jeff Carow Grants Management Officer National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6301 Telephone: (301) 594-6869 Email: jcarow@ep.ninr.nih.gov AUTHORITY AND REGULATIONS NRSA Institutional Research Training Grants are made under the authority of Section 487 of the Public Health Service Act as amended (42 USC 288). Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program. This program is also described under the following numbers in the Catalog of Federal Domestic Assistance: 93.121, 93.172, 93.173, 93.233, 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, 93.862-93.868, 93.871, 93.880, 93.894, and 93.929. 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 Sat Jun 14 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 7 June 1997 Date: 14 Jun 1997 22:02:27 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 115 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5nvt13$68a@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 June 7, 1997. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: International Document Title: INT 97-22 NSF/Tokyo Report: US-Japan Seminar: Classification of Algebraic Variables File size (bytes): 4952 STIS Filename: int9722.txt Document Type: News Title: COASTAL GROWTH, NOT CLIMATE CHANGE, BLAMED FOR JUMP IN HURRICANE TOLLS File size (bytes): 4656 STIS Filename: tip70606.txt Document Type: Press Release Title: REACTIONS FOLLOWING DISASTERS DON'T FIT STEREOTYPES File size (bytes): 3697 STIS Filename: pr9742.txt Document Type: Program Guideline Title: NSF 97106 -106 -- High Performance International Internet Services File size (bytes): 38107 STIS Filename: nsf97106.txt Title: NSF- NIST Interaction in Chemistry and Chemical Engineering (NSF 97-109) File size (bytes): 6291 STIS Filename: nsf97109.txt Title: NSF 97-112 - INTEGRATIVE GRADUATE EDUCATION AND RESEARCH TRAINING PROGRAM File size (bytes): 34053 STIS Filename: nsf97112.txt Document Type: Recruit Title: Program Manager(Inspections) File size (bytes): 7404 STIS Filename: vex9715.txt Title: Secretary (OA) File size (bytes): 10452 STIS Filename: vgs9762.txt Title: Supervisory Accountant (Branch Chief) File size (bytes): 10816 STIS Filename: vgs9764.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Letter Title: REULIST -- Current List of REU Sites File size (bytes): 111587 STIS Filename: reulist.txt Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 113120 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Directory File size (bytes): 127101 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 Sat Jun 14 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HS-98-001 - V26(20) 06/13/97 Date: 14 Jun 1997 21:34:20 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 860 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5nvrcc$38o@net.bio.net> NNTP-Posting-Host: net.bio.net NATIONAL RESEARCH SERVICE AWARD--INSTITUTIONAL GRANTS POLICY AND GUIDELINES NIH GUIDE, Volume 26, Number 20, June 13, 1997 RFA: HS-98-001 P.T. 22, 44; K.W 0720005, 1014006 Agency for Health Care Policy and Research Letter of Intent Receipt Date: July 10, 1997 Application Receipt Date: September 23, 1997 PURPOSE The Agency for Health Care Policy and Research (AHCPR) awards National Research Service Award (NRSA) institutional training grants (T32) to eligible institutions to develop research training opportunities for qualified individuals selected by the institution who have demonstrated an interest in health services research and who seek to prepare for careers in the systematic examination of the organization, provision, financing, and effectiveness of health care services. 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, in order to improve quality, assure value for health dollars spent, and enhance access to services. A goal is to equip students with the necessary knowledge, skills, and experiences to conduct future research which will meet the needs of patients, providers, plans, purchasers, and/or policy makers. Accomplishing the above effectively will require fostering a mixture of academic and applied training opportunities to meet the needs of students who wish to pursue traditional academic careers, as well as those who opt for careers in applied research settings. Applicants are encouraged to foster cooperation and partnerships with relevant components of the health care delivery system. NRSA institutional training grants assist domestic institutions in supporting predoctoral and postdoctoral academic training. The awards allow trainees to gain one or more years of experience in applying research methods to the evaluation of health services. The AHCPR will not support short-term training through this mechanism. Predoctoral Training. Predoctoral research training must lead to the Ph.D. Degree or a comparable research doctoral degree. Students enrolled in health-professional programs that are not part of a formal, combined program (e.g., M.D./Ph.D.) and who wish to postpone their professional studies in order to gain research experience may also be appointed to a T32 grant. Predoctoral research training must emphasize fundamental training in areas relevant to health services research. Postdoctoral Training. Postdoctoral research training is for individuals who have a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Research training at the postdoctoral level must emphasize specialized training to meet national priorities in health services research. A research training grant is a desirable mechanism for the postdoctoral training of physicians and other health professionals who have extensive clinical training, but limited research experience. For such individuals, the training may be a part of a research degree program. In all cases, health-professional postdoctoral trainees should agree to engage in at least two years of research, research training, or comparable activities beginning at the time of appointment since the duration of training has been shown to be strongly correlated with post-training research activity. 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 high priority areas. AHCPR encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001- 00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202- 512-1800. ELIGIBILITY REQUIREMENTS Applicant Institutions Only domestic non-profit private and public institutions may apply for grants to support doctoral and postdoctoral health services research training programs. The applicant institution must have the staff and facilities required for the proposed program. The research training program director at the institution will be responsible for the selection and appointment of trainees and for the overall direction of the program. Institutions may apply for support for predoctoral students, postdoctoral students, or a combination. Applicants should include a rationale for their proposed choice of supporting the level(s) of students requested. An applicant may request as many postdoctoral or predoctoral positions as the proposed program can adequately accommodate; but the number of positions awarded will be determined by the review process, program needs, and availability of funds. Institutions currently approved for receipt of AHCPR institutional training support beyond FY 1997 in response to applications they submitted under AHCPR's program announcement entitled, "National Research Service Award-- Institutional Grants Policy and Guidelines (PAR-95-002, NIH guide, Volume 23, Number 36, October 14, 1994) are eligible to apply. If these institutions opt not to apply, they will still continue to receive support under conditions stipulated in their existing grant. However, upon completion of the existing grant projects, the next opportunity for these institutions to apply for competing grant support from AHCPR will be when AHCPR announces a new RFA. Trainees Trainees appointed to the proposed training program must have the opportunity to carry out supervised health services research with the primary objective of extending their research skills and knowledge in preparation for a health services research career. Prospective trainees must be U.S. citizens or noncitizen nationals or permanent residents of the United States in possession of an Alien Registration Receipt Card I-551, or other legal verification of such status at the time of appointment. Individuals on temporary or student visas are not eligible. Positions on NRSA institutional grants may not be used for study leading to the M.D., D.D.S., or other clinical, health-professional degrees except when those studies are a part of a formal combined research degree program, such as the M.D./Ph.D. Similarly, trainees may not accept NRSA support for studies which are part of residency training leading to certification in a medical specialty or subspecialty, except when the residency program credits a period of full-time, postdoctoral research training toward board certification and the trainee intends to pursue a research career. A postdoctoral student, as of the beginning date of the NRSA appointment, must have a Ph.D., M.D., O.D., D.D.S., Dr.P.H., Sc.D, D.N.Sc. or other doctoral degree, or an equivalent degree from any accredited domestic or foreign institution. (Persons holding the J.D. as the sole advanced degree are not considered postdoctoral for purposes of NRSA appointments.) Certification by an authorized official of the degree-granting institution that all requirements for the doctoral degree have been met is acceptable. Trainees are required to pursue their research training on a full-time basis, devoting at least 40 hours per week to the program. Within the 40 hours per week training period, research trainees in clinical areas must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience. MECHANISM OF SUPPORT The mechanism of support will be the National Research Service Award (NRSA) institutional training grant (T32). The total requested project period for an application may not exceed 5 years. The earliest anticipated award date is May 1, 1998. FUNDS AVAILABLE Depending on the availability of funds, AHCPR expects to award up to $3,500,000 in FY 1998 to support the first year for approximately 15-24 projects under this RFA. The number of awards is dependent on the number of high quality applications and their individual budget requirements; it is not the intent of AHCPR that the awards be equal in size. Funding beyond the initial budget period will depend upon annual progress reviews by AHCPR and the availability of funds. RESEARCH OBJECTIVES Areas of Training AHCPR-sponsored NRSA Awards emphasize multidisciplinary health services research training. Training should provide individuals with rigorous academic and health services research experiences that will allow them to address emerging issues in our changing health care system. It is expected that AHCPR-supported health services research training programs be responsive to research needs associated with the ongoing shifts in the source and demand for services, and provide training in identified areas of need, such as outcomes/health status measurement, biostatistics, epidemiology, health economics, decision analysis, cost- effectiveness analysis, and health policy. At the conclusion of the training program, trainees should have the conceptual, methodological, and practical foundation to conduct research that would: o Help consumers make more informed choices; o Determine what works best in clinical care; o Measure and improve quality of care; o Monitor and evaluate health care delivery; o Improve the cost-effective use of health care resources; o Provide health care policy makers with the information needed to make informed decisions; o Address issues of relevance to priority populations, including women, children, persons with chronic diseases or disabilities, the elderly, and minority populations; and o Build and sustain the health services research infrastructure. Duration of Support Institutional NRSA research training grants may be made for periods of up to five years. Awards are normally made in 12-month increments with support for additional years based on satisfactory progress and the continued availability of funds. As noted below, an award received in response to this RFA will supersede previous AHCPR approved NRSA institutional awards, which extend beyond FY 1997. Trainee appointments are normally made in 12-month increments. No trainee may be appointed for less than nine months during the initial period of appointment, except with the prior approval of the Grants Management Office. No individual trainee may receive more than five years of aggregate NRSA support at the predoctoral level and three years of aggregate NRSA support at the postdoctoral level, including any combination of support from institutional training grants and individual fellowship awards. Any exception to this policy requires a waiver from AHCPR. Payback Provisions As specified in the NIH Revitalization Act of 1993, NRSA recipients incur a service payback obligation only during their first 12 months of postdoctoral support. Additionally, the NIH Revitalization Act of 1993 specifies that the second and subsequent years of postdoctoral NRSA training will serve to pay back a postdoctoral service payback obligation. Accordingly, the following guidelines apply: o Predoctoral trainees are not required to sign the payback agreement and do not incur a service payback obligation. o Postdoctoral trainees in the first 12 months of postdoctoral NRSA support must sign the payback agreement form (PHS form 6031) and will incur 1 month of service payback obligation for each month of support. o Postdoctoral trainees in the 13th and subsequent months of NRSA postdoctoral support are not required to sign the payback agreement form and will not incur a service payback obligation. o The 13th and subsequent months of postdoctoral NRSA support are considered acceptable payback service for prior postdoctoral support. Individuals who continue under that award for 2 years, have fulfilled their obligation by the end of the second year. Service payback obligations can also be paid back by conducting health-related research or teaching averaging more than 20 hours per week of a full work year after the award. o Recipients must begin to undertake obligated service on a continuous basis within two years of NRSA support termination. The period for undertaking payback service may be delayed for such reasons as temporary disability, completion of residency requirements, or completion of the requirements for a graduate degree. Requests for an extension must be made in writing to AHCPR's Grants Management Office, specifying the need for additional time and the length of the required extension. o Recipients of NRSA support are responsible for informing the AHCPR Grants Management Office of changes in status or address. o For individuals who fail to fulfill their obligation through service, 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 of the Treasury. Financial payback must be completed within 3 years, beginning on the date the United States becomes entitled to recover such amount. o Under certain conditions, the Secretary, U.S. Department of Health and Human Services (or those delegated this authority), may extend the period for starting service or repayment, permit breaks in service, or in cases in which service or financial repayment would constitute an extreme hardship, the approving official may waive or suspend the payback obligation of an individual. o Officials at the awardee institution have the responsibility of explaining the terms of the payback requirements to all prospective training candidates before appointment to the training grant. Additionally, all trainees recruited into the training program should be provided with information related to the career options available to individuals who complete the program and whether the types of positions available are consistent with the nature of the training provided and where applicable whether those positions are likely to satisfy any outstanding service payback obligation. Trainee Reporting Requirements The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant. Additionally, a completed Payback Agreement (PHS Form 6031) must be submitted for each trainee in his/her first twelve months of postdoctoral support. At the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS Form 416-7). Failure to submit the required forms in a timely manner may result in an expenditure disallowance. Leave In general, trainees may receive stipends during periods of vacation and holidays observed by individuals in comparable training positions at the grantee institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training, and is not considered to be a vacation or a holiday. Trainees may 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(l)). Trainees may also 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 institution have access to paid leave for this purpose and the use of parental leave is approved by the program director. A period of terminal leave is not permitted and payment may not be made from grant funds for leave not taken. Individuals requiring periods of time away from their research training experience longer than specified must seek approval from AHCPR's Grants Management Office for an unpaid leave of absence. At the beginning of a leave of absence, the trainee must submit a Termination Notice (PHS Form 416- 7) and upon return form 2271). Trainees within the first twelve months of postdoctorate support must also submit a Payback Agreement (PHS Form 6031) upon return from a leave of absence. Stipends and Other Trainee Support Stipends National Research Service Awards provide funds in the form of stipends to predoctoral and postdoctoral trainees. A stipend is provided as an allowance for trainees to help defray living expenses during the research training experience. It is not provided as a condition of employment with either the Federal Government or the institution. Stipends must be paid to all trainees at the levels approved by the Secretary of the Department of Health and Human Services. Trainees may not receive stipends for periods during which they are not enrolled in the training program. For predoctoral trainees at all levels of experience, the stipend level (effective October 1, 1996) is $11,496 per year. For appointments of less than a year, the stipend will be based on a monthly proration. For postdoctoral trainees, the current annual stipend for postdoctoral trainees is determined by the number of FULL years of relevant postdoctoral experience at the time of appointment. Relevant experience may include research experience (including industrial), teaching, internship, residency, clinical duties, or other time spent in full-time studies in a health-related field following the date of the qualifying doctoral degree. Current postdoctoral stipend levels, effective October 1, 1996, are as follows: Full years of relevant experience Stipend Less than 1 $20,292 1 21,420 2 25,600 3 26,900 4 28,200 5 29,500 6 30,800 7 or more 32,300 A trainee with a health-professional doctoral degree who is enrolled in a graduate degree program is considered to be in postdoctoral training and will receive the appropriate postdoctoral stipend listed above. No departure from the established stipend schedule may be negotiated by the institution with the trainee. The stipend for each additional full year of stipend support is the next level in the stipend structure and does not change in the middle of an appointment. The grantee institution is allowed to provide funds to an individual in addition to the stipends paid by the AHCPR. Such additional amounts may be either in the form of augmented stipends (supplementation) or in the form of compensation, such as salary or tuition remission for services such as teaching or serving as a laboratory assistant, provided the following conditions are met: o Stipend Supplementation. Supplementation or additional support to offset the cost of living may be provided by the grantee institution, but must not require any additional obligation from the trainee. 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 PHS funds be used for supplementation. o Compensation. An institution may provide additional funds to a trainee in the form of compensation (as salary and/or tuition remission) for services such as teaching or serving as a laboratory assistant. A trainee 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 trainee's approved NRSA training program. 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. A NRSA traineeship may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA. Tax Liability 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 (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 trainees and institutions. NRSA stipends are not considered salaries. In addition, trainees supported under the NRSA are not considered to be in an employee-employer relationship with the AHCPR or the awardee institution. It must be emphasized that the interpretation and implementation of the tax laws are the domain of the Internal Revenue Service (IRS) and the courts. AHCPR takes no position on what the status may be for 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 situation and for information on their tax obligations. Tuition Fees and Health Insurance Tuition and fees, including self-only medical insurance, are allowable trainee costs if such charges are required of all individuals in a similar training status at the institution, regardless of their source of support. Family medical insurance coverage is not an appropriate charge to the NRSA research training grant. Tuition at the postdoctoral level is limited to that required for specific courses in support of the approved research training program. On an annual basis, for each trainee, the training grant will cover 100% of the first $2,000 of the combined cost of tuition, fees, and self-only health insurance and 60% of any amount above $2,000. Institutions are instructed to reflect the full amount of these costs in competing applications. Other Training Costs Trainee travel, including attendance at scientific meetings that the institution determines to be necessary to the individual's research training, is an allowable trainee expense. In addition, support for travel to a research training experience away from the institution may be permitted. Research training experiences away from the parent institution must be justified considering the type of opportunities for training available, how these opportunities differ from those offered at the parent institution, and the relationship of the proposed experience to the trainee's career stage and goals. Justification for research training experience away from the institution must be described in detail in the budget justification section of the application. Institutional costs of up to $1,500 a year per predoctoral trainee and up to $2,500 a year per postdoctoral trainee may be requested to defray the costs of other research training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and staff travel. Under exceptional circumstances, which can include accommodating the disabilities of a trainee, it is possible to request institutional costs above the standard rate. Requests for additional costs must be explained in detail and carefully justified in the application. Consultation with program staff in advance of such requests is strongly advised. A facilities and administration allowance (indirect cost allowance) based on 8 percent of total allowable direct costs (this excludes tuition) may be requested. Applications from State and local government agencies may request full indirect cost reimbursement (see PHS Grants Policy Statement). SPECIAL REQUIREMENTS Confidentiality of Data Information obtained in the course of this study that identifies an individual or entity must be treated as confidential in accordance with section 903(c) of the Public Health Service Act. Applicants must describe in the Human Subjects section of the application procedures for ensuring the confidentiality of identifying information. The description of the procedure should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers will be safeguarded. This special term of award is in addition to, and not in lieu of, otherwise applicable PHS grant policies and Federal regulations. INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS INVOLVING HUMAN SUBJECTS It is the policy of AHCPR that women and members of minority groups be included in all AHCPR-supported 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. The NIH policy resulting from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) supersedes and strengthens the NIH's previous policies (concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which were in effect since 1990 and which AHCPR had adopted. The NIH policy contains provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which has been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. AHCPR follows the revised NIH Guidelines, as applicable. Investigators may obtain copies from those sources or from the AHCPR contractor, Global Exchange, Inc., listed under INQUIRIES. AHCPR is also encouraging investigators to consider including children in study populations, as appropriate. AHCPR announced in the NIH Guide, Volume 26, Number 15, May 9, 1997, that it is developing a policy and implementation plan on the inclusion of children in health services research. The Notice is available through AHCPR's WEB site (http://www.ahcpr.gov) and AHCPR Instant FAX. For instruction in using Instant FAX, call (301) 594-2800, using a fax machine with a telephone handset. AHCPR program staff may also provide information concerning this policy (See INQUIRIES). LETTER OF INTENT Prospective applicants are asked to submit, by July 10, 1997, a letter of intent that includes the names, addresses, and telephone numbers of the proposed Program Director and other key personnel; and the number and title of the RFA. Although a letter of intent is not required, is not binding, and does not enter into the consideration of any subsequent application, the information allows AHCPR staff to estimate the potential review workload and avoid conflicts of interest in the review. AHCPR will not provide responses to letters of intent. The letter of intent is to be addressed to: Karen Rudzinski, Ph.D. NRSA Project Officer Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 400 Rockville, MD 20852-4908 Email: training@ahcpr.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. State and local government applicants may use form PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. Applicants are reminded that the 25-page limit on the narrative section must be observed. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, Office of Extramural Research, National Institutes of Health, 6701 Rockledge Drive MSC 7910, Bethesda, MD 20892-7910, Telephone: 301-435-0714, E-mail: asknih@odrockm1.od.nih.gov. AHCPR applicants should obtain application materials from the AHCPR contractor: Global Exchange, Inc., 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3015, Telephone: 301- 656-3100, Fax: 301-652-5264. The RFA label available in the form PHS 398 (rev. 5/95) must be affixed to the bottom of the face page of the original application. Failure to do so could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and YES must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Karen Rudzinski, Ph.D. NRSA Project Officer Office of Scientific Affairs Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 400 Rockville, MD 20852-4908 Applications submitted under this RFA must be received in the Division of Research Grants, NIH, by September 23, 1997. If an application is received after that date, it will be returned to the applicant without review. Applications received on that date will be for awards to begin no earlier than July 1, 1998. REVIEW CONSIDERATIONS Applications will be reviewed for technical and educational merit by an AHCPR peer review group. Review Criteria The peer review group will consider the following criteria in its review: Program Characteristics o Objectives, design, and direction of the research training program -- including the probability of achieving stated goals. o Substantive and methodological content of the proposed program and its relevance to the Program Objectives noted above, including relevant descriptions of courses and experiential opportunities offered and/or required. o The extent to which proposed approaches address areas in need of research given changes in the health care delivery system. Program Support and Organizational Structure and Plans o The institutional training environment, including the level of institutional commitment, quality of the facilities, availability of appropriate courses, and availability of research support. o Organizational structure of the proposed training program, including delineation of administrative responsibilities for planning, oversight, and evaluation. o Demonstration of cooperation by any proposed collaborating facilities, institutions, or departments in providing research experiences and/or sites for trainees, including (where applicable) documentation of mechanisms by which trainees will be integrated into the ongoing health services research activities of other entities. o Demonstration of extent to which and ways in which AHCPR support will be (has been in the past) leveraged through the use of other Federal and private resources to maximize health services research training within the institution. o Availability of other relevant support. Trainee Recruitment & Retention Plans o Recruitment and selection plans for trainees and the availability of high quality candidates, including minority trainees (see below for details). o When appropriate, record of the research training program in retaining health-professional postdoctoral trainees for at least two years in research training or other research activities. Program Record and Evaluation Plans o Past research training record of both the program and the designated preceptors as determined by the success of former trainees in seeking further career development and in establishing productive scientific careers. Evidence of further career development can include receipt of fellowships, career awards, a prestigious training appointment, and similar accomplishments. Evidence of a productive scientific career can include a record of successful competition for individual research grants, receipt of special honors, a record of publications, receipt of patents, promotion to prestigious positions in academe, industry, or health policy and any other appropriate measure of success consistent with the nature and duration of the training received. o Record of the research training program in recruiting and retaining trainees, noting past annual success rates in filling committed slots; o Proposed methods for monitoring and evaluating performance of trainees and the overall program, including tracking of graduates after completion of training, record of trainees in obtaining individual research awards or fellowships following training and in establishing careers in health services research. Budget o Reasonableness of the proposed budget, including number and levels of trainees, in relation to the research training. Additional Review Considerations Minority Recruitment Plan: The AHCPR remains committed to increasing the participation of individuals from underrepresented minority groups in health services research. As announced in 1989, all applications for institutional NRSA research training grants must include a specific plan to recruit minorities. If an application is received without a plan, it will be considered incomplete and may be returned to the applicant without review. Additional information on this requirement was published in the NIH Guide for Grants and Contracts, Volume 22, Number 25, July 16, 1993. After the overall educational and technical merit of an application has been assessed, peer reviewers will examine and evaluate the minority recruitment plan and any record of recruitment and retention. The findings of the panel will be included in an administrative note in the summary statement. If the minority recruitment plan of the application is judged to be unacceptable, funding will be withheld until a revised plan that addresses the deficiencies is received. Staff within the AHCPR will determine whether amended plans and reports submitted after the initial review are acceptable. Training in the Responsible Conduct of Research: Every Predoctoral and Postdoctoral NRSA trainee supported by an institutional research training grant must receive instruction in the responsible conduct of research. (or more information on this provision, see the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992.) Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. o Although the AHCPR does not establish specific curricula or formal requirements, all programs are encouraged strongly to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, data management, and confidentiality and privacy. Within the context of training in scientific integrity it is also useful to discuss the mutual responsibilities of the institution and the graduate students or postdoctorates appointed to the program. o Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, trainee attendance, and the frequency of instruction. o The rationale for the proposed plan of instruction must be provided. o Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in future competing continuation and noncompeting applications. The AHCPR encourages institutions to provide instruction in the responsible conduct of research to all graduate students and postdoctorates in a training program or department, regardless of the source of support. AHCPR initial review groups will assess the applicant's plans on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction. The plan will be discussed after the overall determination of merit, so that the quality of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until a revised, acceptable plan is provided by the applicant. The acceptability of the revised plan will be judged by AHCPR staff. AWARD CRITERIA Funding decisions will be based on peer review, research program priorities, the need for research personnel in specified program areas, balance among types of research training supported by AHCPR, and the availability of funds. Awards made under this announcement will automatically supersede all prior awards received in response to AHCPR's program announcement entitled, "National Research Service Award--Institutional Grants Policy and Guidelines" (PAR-95- 002, NIH Guide, Volume 23, Number 36, October 14, 1994). INQUIRIES Written and telephone inquires concerning this RFA are encouraged. Copies of the RFA and related materials are available from: Global Exchange, Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20814-3015 Telephone: (301) 656-3100 FAX: (301) 652-5264 This RFA is available through the AHCPR's website: http:\\www.ahcpr.gov and through AHCPR InstantFAX at 301- 594-2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Follow the voice prompt in order to obtain a copy of the table of contents which has the document order number (not the same as the RFA number). The RFA will be sent at the end of the ordering process. AHCPR InstantFAX operates 24 hours a day, 7 days a week. For questions about this service, call AHCPR's Division of Communications at 301-594-1364, ext. 1389. Direct inquiries regarding programmatic issues, including information on the inclusion of women, minorities, and children in study populations, to: Karen Rudzinski, Ph.D. NRSA Project Officer Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 400 Rockville, MD 20852-4908 Telephone: (301) 594-1452 Email: training@ahcpr.gov Direct fiscal and administrative inquiries to: Mable L. Lam Grants Management Officer Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1447, ext. 1165 FAX: (301) 594-3210 Email: mlam@ahcpr.gov AUTHORITY AND REGULATIONS NRSA Institutional Research Training Grants are made under the authority of Section 487 of the Public Health Service Act as amended (42 U.S.C. 288). Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program. This program is also described the Catalog of Federal Domestic Assistance No. 93.225. The 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-fee 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 Sat Jun 14 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-067 - V26(20) 06/13/97 Date: 14 Jun 1997 21:36:29 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 497 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5nvrgd$3ks@net.bio.net> NNTP-Posting-Host: net.bio.net MBRS RESEARCH INITIATIVE FOR SCIENTIFIC ENHANCEMENT (RISE) NIH GUIDE, Volume 26, Number 20, June 13, 1997 PA NUMBER: PAR-97-067 P.T. 14, FF; K.W. 0502000, 0710030 National Institute of General Medical Sciences Application Receipt Dates: February 1, June 1, October 1 PURPOSE The purpose of the MBRS Research Initiative for Scientific Enhancement (RISE) program is to enhance the research environment at minority serving institutions. The goal is to increase the opportunities for underrepresented minority faculty and students to become acquainted with, and motivated to pursue biomedical research careers. The RISE program replaces and expands upon the student development component of the traditional MBRS (S06) program and the MBRS program for undergraduate colleges (S14). The RISE program should provide enhanced flexibility in faculty and student development activities, as well as provide the opportunity for development of the institution's research and research education capability. In addition, NIGMS recognizes that minority and minority-serving institutions are diverse in institutional environment and mission. Therefore, with respect to evaluation activities, this program requires that the institution set its own specific goals and measurable objectives. ELIGIBILITY To be eligible for a grant under this program, an applicant must be located in a State, the District of Columbia, Puerto Rico, the Virgin Islands, the Canal Zone, Guam, American Samoa, or the successor States of the Trust Territory of the Pacific Islands (the Federated States of Micronesia, the Republic of the Marshall Islands, the Republic of Palau), and be one of the following: a. a public or private nonprofit university, two-year or four-year college, or other institution offering undergraduate, graduate, or health-professional degrees, with a traditionally high (more than 50 percent) underrepresented minority student enrollment; b. a public or private nonprofit university, two-year or four-year college, or other institution offering undergraduate, graduate, or health-professional degrees with a student enrollment, a significant proportion of which (but not necessarily more than fifty per cent) is derived from underrepresented minorities, provided the Secretary of the Department of Health and Human Services determines that said institution has a demonstrated commitment to the special encouragement of, and assistance to, underrepresented minority faculty, students, and investigators; or c. an Indian tribe that has a recognized governing body and that performs substantial governmental functions, or an Alaska Regional Corporation (ARC), as defined in the Alaska Native Claims Settlement Act (43 U.S.C. 1601 et seq.). For the purposes of this announcement, underrepresented minorities are individuals belonging to a particular ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical or behavioral research. Historically, individuals who have been found to be underrepresented in biomedical or behavioral research include, but are not limited to, U.S. citizens who are Hispanic Americans, African Americans, Native Americans (including Alaskan natives) and natives of the U.S. Pacific Islands A written statement containing the following information is required in order to establish eligibility: a. the total student enrollment at the institution and percentages of various underrepresented minorities in the total student population (i.e., Native American, African American, Hispanic American, or natives of the U.S. Pacific Islands); b. number of underrepresented minority students in science departments; c. evidence of the institution's commitment to the advancement of underrepresented minority faculty and investigators, including numbers of underrepresented minority faculty in science departments; and d. evidence of efforts to recruit and retain underrepresented minority students and faculty in the participating departments. The RISE Program replaces the student involvement category of the traditional MBRS program (S06) and the faculty and student enrichment portion of the undergraduate (S14) program. Therefore, institutions currently funded for the student involvement category in the traditional S06 program and the S14 program are eligible and are encouraged to apply for a RISE Program award with a start date to coincide with the end of their current project period. In general, existing policies and provisions will remain in effect for current S14 and S06 recipients until completion of the non-competing years of their current project period. June 1, 1998 will be the final date for submission of new and competitive renewals of traditional MBRS (S06) and S14 grant applications. Institutions supported by the Initiative for Minority Student Development (NIH Guide, Vol. 25, No. 4, 1996) are not eligible for the RISE Program. Institutions may have only one active RISE program. MECHANISM OF SUPPORT Awards under this program will use the institutional education project (R25) grant mechanism. Responsibility for the planning, direction, execution, and tracking for evaluation of the proposed project will be solely that of the applicant institutions. The total project period for an application submitted in response to this program announcement may not exceed four years and is renewable. A budget for each year must be provided. Facilities and Administration (F&A) costs will be paid at 8% of the direct costs, minus appropriate exclusions, for faculty and student development activities. RESEARCH OBJECTIVES As of 1992, underrepresented minorities constituted only 4.5 percent of the postdoctoral fellows in the life sciences and less than 2.7 percent of the principal investigators of NIH research grants. In addition, the number of underrepresented minority applicants for research grants and training positions is very low. In the NIH Revitalization Act of 1993, NIH was encouraged to increase the number of underrepresented minorities participating in biomedical and behavioral research. In response to the Act, the goal of this initiative is to increase the opportunities for underrepresented minority faculty and students to become acquainted with and motivated to pursue biomedical research careers. The MBRS RISE program supports faculty, student and institutional development activities at both undergraduate and graduate institutions. Applicants may propose any one or more of the following: Faculty and Student Development Activities Applicants should provide detailed information on their plans to provide opportunities for faculty and students to prepare for, and participate in, biomedical research. The applicant institution should describe, if applicable, specific arrangements for providing faculty and students with off-campus research experiences. For each activity proposed include: o specific and measurable objectives; o rationale for and feasibility of the approach chosen for each faculty and student development activity; o detailed description of the activity; o information on the student pool, and a plan for attracting and retaining the desired student pool; o information on participating faculty; o information on personnel and other resources; o letters of commitment and other expressions of interest by on-campus or off-campus scientists' laboratories and/or institutions, including the qualifications of the scientists to mentor and train students and faculty, and their current research support; and o evaluation plans for faculty and student development activities; Examples of these activities are: (1) an interdisciplinary biomedical seminar series for faculty and students; (2) on-campus or off-campus workshops, specialty courses, etc., for faculty and students on biomedical research techniques or methodologies (the objective of this activity is to provide an opportunity for faculty and/or students to enhance their research skills); (3) travel to scientific meetings for both faculty and students; (4) off-campus research experiences for science faculty during the academic year and/or during the summer (this allows faculty to engage in biomedical research in established laboratories of research intensive universities, government and industry); (5) support for students to engage in on-campus research experiences in established laboratories during the academic year (this allows students to engage in biomedical research in established laboratories of researchers supported by other funding sources (such as the MBRS S06, R01, NSF grants, etc.), as well as laboratories of other research intensive universities, government and industry); and (6) support for students to engage in off-campus research experiences during the summer (this allows students to engage in biomedical research in established laboratories of research intensive universities, government and industry). Institutional Development An important objective of this program is the strengthening of the institution's capabilities to support research and research-related activities. Examples of the types of activities supported include remodeling or renovating an existing facility (up to $40,000) to provide space for an investigator(s) to carry out developmental activities. In addition, small pieces of equipment for classroom demonstration projects, or other justifiable uses are allowable. For each activity proposed include: o detailed description and justification of the renovation, remodeling activity or equipment, including price quotations; o specific and measurable objectives in terms of added value of the renovation, remodeling, or equipment to the goals of the institution; and o evaluation plans. 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103 43). 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 in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. APPLICATION PROCEDURES An application must be made in the name of an institution, not an individual. It must have the approval of the institution's chief executive or an official designee. The research grant application form PHS 398 (rev. 5/95) and supplemental MBRS RISE program instructions should be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division 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 MBRS program office listed under INQUIRIES. Applications that do not comply with the PHS form 398 and/or the supplemental instructions will be returned without review. Submit a signed, typewritten original of the application, including the Checklist, and three photocopies of the signed application in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20872-7710 BETHESDA, MD 20817 (for express/courier service) Application receipt dates are February 1, June 1 and October 1. At the time of submission, two additional copies of the application must also be sent to the Chief, Office of Scientific Review listed under INQUIRIES. Applicants are urged to contact MBRS program staff at an early stage for assistance and guidance in developing an application. ALLOWABLE COSTS Costs for overall development of the program are allowable, provided that adequate justification is given, and include: salary support (up to 25 percent effort) for the Program Director for that portion of time or effort specifically employed in directing the MBRS program; salary support for secretarial or clerical help when directly related to support of the MBRS program; and support for evaluation activities. Allowable costs for developmental activities include support for technical assistance salaries, consultant fees, equipment, travel (when benefits are provided to the program), renovations, supplies, alteration and renovation costs (up to $40,000) when strongly justified, animal maintenance, publication costs, computer charges, equipment maintenance, service contracts, tuition remission in lieu of salary, consortium arrangements, and contractual costs for support services. Faculty salaries: Support for faculty salaries, with justification, are allowable. The MBRS RISE program provides funds to cover that portion of the academic-year salary that is proportionate to the time spent on the MBRS developmental activities (defined as percent effort), and that is consistent with the institution's policy. The maximum summer-salary support provided by the program cannot exceed the equivalent of three months at 100 percent effort, or time specified by the institution as its policy; Grant funds may not be used to increase or supplement faculty salaries above the institutional scale for an individual's salary. Summer salary support can be paid when the institution's academic schedule permits such release, when the institution approves, and when the investigator will engage in research and research-related activities at the agreed-upon level of participation. Student Salaries: Students participating in the MBRS student development activities are eligible to receive compensation. The maximum amount of MBRS funds to be paid as salary to a student should not exceed the salary levels normally paid to employees doing comparable work at the same institution. Students who participate in research may also be compensated for work-related activities such as workshops and other on-campus developmental activities. Graduate students are allowed tuition costs as part of a compensation package. When requesting support for a graduate student, the applicant institution should provide in the budget justification section of the application the basis for the compensation level. If not provided, this information will be obtained from the institution's business office for any request that appears excessive. NIGMS staff will review the requested compensation level and, if it is reasonable, will award the actual amount requested, up to a maximum of $23,000 (NIH GUIDE, Volume 25, Number 8, March 15, 1996). UNALLOWABLE COSTS Undergraduate tuition, housing, food, or recruitment expenses of any kind are not allowable costs under this program. Salary support solely for faculty mentoring is not allowable. Renovation costs above $40,000 are not allowable. UNIFIED PLAN Institutions with active or pending Support for Continuous Research Excellence (SCORE), Minority Access to Research Careers (MARC) USTAR (NIH Guide, Vol. 25, No. 4, 1996), Bridges to the Future Program (NIH Guide Vol. 25, No. 34, 1966), Research Infrastructure in Minority Institutions (RIMI, NIH Guide Vol. 24, No. 12, 1995), and/or other minority student/faculty support programs may also apply for the MBRS RISE Program. However, the institution must describe how the funds from the RISE program will complement these other awards. In particular, describe how the students and faculty supported by each will interact. EVALUATION Institutions should note that evaluation is a mandatory component of every MBRS program; this program requires that each institution set its own specific goals and measurable objectives. The NIGMS recognizes that minority and minority-serving institutions are diverse in institutional environment and mission. Therefore, the emphasis of the evaluation activities of the MBRS RISE Program will be on improvement as defined in the specific goals and measurable objectives which the applicant institution sets for itself to fulfill the objectives of this announcement. NIGMS is hoping to achieve a significant increase in the numbers of underrepresented minorities going on to biomedical research careers. At each competitive and non-competitive renewal, in the progress report, the investigators will describe what difference the award has made towards meeting this goal. A central aspect of each grant application (that distinguishes it from previous programs) is that each successful application specifies MEASURABLE objectives, provides a plan to evaluate whether those objectives have been met and a measure of the efficacy of specific interventions. REVIEW CONSIDERATIONS Upon receipt, NIH staff will administratively review applications. Incomplete and/or unresponsive applications will be returned to the applicant without further consideration. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific and technical merit by appropriate peer review groups. The National Advisory General Medical Sciences Council will provide the second level of review. General Review Criteria In carrying out the scientific and technical merit review of the overall application, the initial review group will take into account: o the difference that the program will make as defined by the stated goals and specific measurable objectives relative to the institutional baseline of the previous 4 years; o the merit of the institution's plan and the likelihood that the activities proposed will make a significant difference; o the degree to which the institution's plan may be expected to meet the goals of this announcement; o the appropriateness of the plan for evaluating the impact of the program, including a system to track the future course of program participants; o qualifications of the Program Director and faculty to carry out the proposed program; o availability of significant numbers of underrepresented minority students in the participating science departments interested in further study in biomedical and health-related fields, and a plan for attracting and retaining the desired student pool; o evidence of underrepresented minority student graduates progressing to, and completing, higher education in the biomedical sciences; o evidence of institutional commitment to promote the development of underrepresented minority faculty potential to become participants in biomedical research, and to enhance the career potential of underrepresented minority students in the sciences; and o appropriateness of the administrative plan for managing the proposed program, including space for workshops, additional courses, and research training; and the budget and cost effectiveness of the program, including its appropriateness to the scope of the program, benefit to the students, number of students involved, and reasonable personnel costs. Review Criteria for Faculty and Student Development Activities In carrying out the scientific and technical merit review of faculty and student development activities, the initial review group will take into account: o inclusion of specific and measurable objectives; o adequacy of the plans to provide opportunities for faculty to upgrade their research skills and to initiate collaborative research with scientists at major biomedical research laboratories; o adequacy of the plans to provide opportunities for students to become acquainted with and engage in biomedical research; o letters of commitment and other expressions of interest by on-campus or off-campus scientists' laboratories and/or institutions, including the qualifications of the scientists to mentor and train students and their current research support; and o evaluation plans for student development activities Review Criteria for Institutional Development Activities In carrying out the scientific and technical merit review of institutional development activities, the initial review group will take into account: o the relevance of the proposed alternations, renovations, equipment, etc., to the objectives stated in the application; and o the ability of the institution to maintain the requested equipment. AWARD CRITERIA The MBRS program's mission is to increase significantly the number of underrepresented minorities conducting biomedical research. Towards this end, the goal of the MBRS program is to strengthen the biomedical research capability of institutions with significant underrepresented minority enrollments. Priorities for funding will be based on the technical merit of the application, and the likelihood that the applicant institution can further the goals of the MBRS program. Awards will be made only to institutions with financial management systems and management capabilities that are acceptable under PHS policy. Awards will be administered under the PHS Grants Policy Statement. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Questions on the program and its policies should be directed to: Ernest D. Marquez, Ph.D. MBRS Branch National Institute of General Medical Sciences 45 Center Drive, Suite 2AS.37, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-3900 FAX: (301) 480-2753 Email: marqueze@gm1.nigms.nih.gov Questions on the review of applications should be directed to the Chief, Office of Scientific Review, Helen R. Sunshine, Ph.D. Office of Scientific Review National Institute of General Medical Sciences 45 Center Drive, Room 1 AS.13, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-2881 FAX: (301) 480-8506 Email: sunshinh@gm1.nigms.nih.gov Questions on grants management and fiscal matters should be directed to: Antoinette Holland Grants Management Office National Institute of General Medical Sciences 45 Center Drive, Room 2AN.50, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-5132 FAX: (301) 480-2554 Email: hollanda@gm1.nigms.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93-375. Awards are authorized by sections 301 and 405 of the Public Health Service Act, as amended, and administered under PHS grants policies and Federal Regulations 42 CFR part 52c, 45 CFR part 74, and 45 CFR part 92. See also Senate Appropriations Committee Report, No. 92-316, July 29, 1971, Executive Order 12900 , Educational Excellence for Hispanic Americans February 22, 1994, and Executive Order 12876, Historically Black Colleges and Universities, November 1, 1993. Applications are 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 Sat Jun 14 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-064 - V26(20) 06/13/97 Date: 14 Jun 1997 21:36:05 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1052 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5nvrfl$3i9@net.bio.net> NNTP-Posting-Host: net.bio.net INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARD IN SLEEP RESEARCH NIH GUIDE, Volume 26, Number 20, June 13, 1997 PA NUMBER: PA-97-064 P.T. 44; K.W. 0715187, 0720005, 0710030 National Institutes of Health THIS PROGRAM ANNOUNCEMENT IS A REVISION OF THE PA APPEARING IN THE MAY 30 ISSUE OF THE NIH GUIDE. THIS REVISION REFLECTS THE FACT THAT THIS IS AN NIH-WIDE PROGRAM ANNOUNCEMENT. PURPOSE The National Institutes of Health (NIH) invites applications for National Research Service Award (NRSA) Institutional Training Grants (T32) to develop or enhance sleep research training opportunities for individuals selected by eligible institutions. A specific objective is to ensure that scientists, highly trained in sleep research, are available in adequate numbers to address important gaps in our biomedical and biological understanding of sleep including those outlined in the NIH Director's Sleep Disorders Research Plan. For this program announcement, the National Center on Sleep Disorders Research (NCSDR) will serve as a primary contact for applicants and work closely with relevant NIH Institutes to support the training opportunities identified in this announcement. Potential applicants are strongly urged to contact the NCSDR before preparing an application. Background It has become apparent over the past decade that sleep disorders and sleep deprivation are major public health problems affecting as many as 40 million Americans. Progress in understanding the neurobiology of sleep/awake states and the pathophysiological mechanisms of sleep disorders, especially molecular and genetic aspects, has been hampered by an inadequate number of health professionals trained in sleep biology, sleep disorders medicine and relevant research. Currently, there is a critical shortage of scientists with the needed skills to bring state-of-the-art multidisciplinary approaches to sleep research. In addition, few or no investigators are studying some key research areas identified in the NIH Director's Sleep Disorders Research Plan (http://www.nhlbi.nih.gov/nhlbi/ sleep/sleep.htm) developed and coordinated by the NCSDR. The overall goal of this training program is to increase the number of sleep researchers that are available to investigate the basic biology of sleep; to explore epidemiological, behavioral, and clinical aspects of sleep-related disorders; and to develop new approaches for the treatment and prevention of these conditions. A specific objective is to ensure that scientists, highly trained in sleep research, are available in adequate numbers to address important gaps in our biomedical and biological understanding of sleep including those outlined in the NIH Director's Sleep Disorders Research Plan. Among the areas identified in the Plan is basic research at molecular, cellular, and systems levels to understand the mechanisms for sleep regulation and homeostasis; the fundamental functions of sleep during development and with age; the cause of chronic sleepiness; the effects of sleep deprivation; the interactions between circadian and neurophysiological systems that regulate sleep and wakefulness; and the genetic factors influencing sleep control and responsible for sleep-related disorders such as narcolepsy and restless legs syndrome. The Sleep Disorders Research Plan also identifies areas of patient-oriented clinical and applied research to study the effects of chronic sleepiness and sleep disturbances on performance and lifestyle; the pathogenesis of sleep disorders and its pathophysiological links to cardiovascular disease, psychiatric disorders, and other morbid conditions; the epidemiology of sleep disorders to determine etiology and the role of factors such as gender, age, and ethnicity; and the relative efficacy and effectiveness of different treatment modalities for common sleep disorders such as sleep apnea and insomnia. Addressing these questions will require a combination of approaches. Innovative, multidisciplinary and collaborative training programs with interactive training provided by investigators from different disciplines and with complementary skills are strongly encouraged. Successful training programs will attract individuals with backgrounds in relevant scientific disciplines and should have flexibility to provide interdisciplinary training to individual candidates. It is important that trainees receive thorough training in multidisciplinary approaches to modern basic and patient-oriented research. The possibility exists for this goal to be achieved through collaborative arrangements with one or more cooperating institutions offering unique opportunities for sleep research training. In these cases, the parent program must have a continuous and substantive role in the training process. It is anticipated that this new sleep training program will act as a source of trainees and activities to enhance the research programs of the participating NIH Institutes. The application should indicate how this goal will be achieved. It is essential that the applicant institution as well as all participating academic units and departments fully support the training 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 PA, "National Research Service Award Institutional Training Grants in Sleep Research," is related to the priority areas of heart disease and stroke, chronic disabling conditions, mental health and disorders, and clinical prevention services. 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 printing office, Washington D.C. 20402-9325 (Telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applicant Eligibility Requirements Only domestic, non-profit, private or public institutions, may apply for grants to support the research training programs described herein. The applicant institution must have a strong research program in the area proposed for research training and must have the staff and facilities required for a substantive portion of the proposed program. Collaborative arrangements with one or more cooperating institutions may be proposed to provide multidisciplinary sleep research training not available at the applicant institution. The research training program director at the parent institution will be responsible for the selection and appointment of trainees to receive NRSA support and for the overall direction of the program. Trainees appointed to the training program must have the opportunity to carry out supervised research with the primary objective of developing or extending their research skills and knowledge in preparation for a basic science or clinical research career in the field of sleep and sleep disorders. Levels of Training Predoctoral: Predoctoral research training must lead to the Ph.D. or a comparable research doctorate degree in a sleep-related science. Relevant disciplines include, but are not limited to, neuroscience, physiology, cellular biology, epidemiology, behavioral science, psychology, endocrinology, immunology, pharmacology, biochemistry, and genetics. The completion of two years of training at the postbaccalaureate level in a relevant science program leading to the Ph.D. or an equivalent degree prior to being appointed to this T32 is encouraged. Students enrolled in health-professional programs that are not part of a formal, combined program (i.e., M.D./Ph.D.) and who wish to postpone their professional studies in order to gain experience in sleep research may also be appointed. Predoctoral research training must emphasize fundamental training in areas of basic biomedical and behavioral sciences related to sleep and sleep disorders. Since some NIH Institutes support pre-doctoral research training on a limited basis, applicants are strongly urged to contact the NCSDR or appropriate Institute staff, before requesting predoctoral training positions in a T32 application. Postdoctoral: Postdoctoral research training is for individuals who have received a Ph.D., an M.D., or comparable health-professional doctoral degree from an accredited domestic or foreign institution. Comparable doctoral degrees include, but are not limited to the following: D.D.S., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.Sc., D. Pharm., D.S.W., and Psy.D. Research training at the postdoctoral level must emphasize specialized training to meet national research priorities in the biomedical, behavioral, epidemiologic and patient-oriented aspects of sleep and sleep disorders. Research training grants are a desirable mechanism for the postdoctoral training of physicians and other health professionals who may have had extensive clinical training, but limited research experience. For such individuals, the training may be a part of a research degree program; in all cases, health-professional postdoctoral trainees should agree to engage in at least two years of research, research training, or comparable experiences beginning at the time of appointment. Short-Term Research Training Positions for Health-Professional Students: T32 applications may include a request for short-term positions reserved specifically to train medical or other health- professional students on a full-time basis during the summer or other "off quarter" periods. Short-term appointments are intended to provide health-professional students with opportunities to participate in sleep related biomedical and/or behavioral research in an effort to attract these individuals into sleep research careers. Short-term positions should be longer than two months but may not last longer than three months. Students should be encouraged to obtain two or more periods of short-term research training during their studies leading to a health professional degree. Such appointments may be consecutive or may be reserved for summers or other "off quarter" periods. Since some NIH Institutes support short-term research training positions on a limited basis, applicants are strongly urged to contact the appropriate NIH Institute representative listed at the end of this announcement, before requesting short-term research training positions in a T32 application. Trainee Eligibility Requirements To be appointed to a research training grant, an individual must be a citizen or a non-citizen national of the United States or must have been lawfully admitted for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or must be in possession of other legal verification of such status). Individuals on temporary or student visas are not eligible. Predoctoral Trainees: Predoctoral trainees must have received a baccalaureate degree in a relevant science program at the beginning date of their NRSA appointment. Health-professional students who wish to interrupt their studies for a year or more to engage in full-time research training before completing their professional degrees are also eligible. Postdoctoral Trainees: Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a Ph.D., M.D., or comparable doctoral degree from an accredited domestic or foreign institution. Written certification by an authorized official of the degree-granting institution that all degree requirements have been met, prior to the date training is to begin, is acceptable. Short-Term Health Professional Trainees: To be eligible for short-term research training positions, health-professional students must have completed at least one quarter in a program leading to a clinical doctorate prior to participating in the program. Individuals matriculated in a formal research degree program or those holding an M.S., a Ph.D., or an M.D./Ph.D. degree or equivalent graduate level research degree are not eligible for short-term training positions. Within schools of pharmacy, only individuals who are candidates for the Pharm.D. degree are eligible for short-term positions. MECHANISM OF SUPPORT The support mechanism for grants made in response to this program announcement will be the NIH National Research Service Award (NRSA) Institutional Training Grant (T32). The announcement will remain in effect through the end of fiscal year 2000. Institutional NRSA research training grants may be made for periods up to five years and are renewable. Awards within an approved competitive segment are normally made in 12-month increments with support for additional years contingent on satisfactory progress and the availability of funds. GENERAL PROVISIONS Positions on NRSA institutional grants may not be used for study leading to the M.D., D.D.S., or other clinical, health-professional degrees except when those studies are a part of a formal combined research degree program such as the M.D./Ph.D. Similarly, trainees may not accept NRSA support for studies which are a part of residency training leading to a medical specialty or subspecialty except when the residency program credits a period of full-time, postdoctoral research training toward board certification and the trainee intends to pursue a research career. Students enrolled in health-professional doctoral degree programs may receive support for short-term research training for one or more periods lasting up to three months each. Such students may also interrupt their studies for a year or more to engage in full-time research training before completing their professional degree. Trainees are required to pursue their research training on a full-time basis, devoting at least 40 hours per week to the program. Within the 40 hours per week training period, research trainees in clinical areas must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience. Duration of Support Trainee appointments are normally made in 12-month increments with support for additional years dependent on satisfactory progress and the continued availability of funds. No trainee may be appointed for less than nine months during the initial period of appointment, except with the prior approval of the NIH awarding unit or when health-professional students are appointed to approved, short-term research training positions. No individual trainee may receive more than five years of aggregate NRSA support at the predoctoral level or three years of aggregate NRSA support at the postdoctoral level, including any combination of support from institutional training grants and individual fellowship awards. Any exception to the total duration of trainee support at either the predoctoral or postdoctoral level requires a waiver from the director of the NIH Institute or Center that supports the award. Requests for extension must be made in writing by the trainee, endorsed by the director of the training program and the appropriate institutional official, and addressed to the director of the awarding component. The request must include a sound justification for an extension of the statutory limits on the period of support. Recruitment and Appointment of Trainees The primary objective of the NRSA program is to prepare qualified individuals for careers that significantly impact the Nation's research agenda. Within the framework of the program's longstanding commitment to excellence and projected needs for investigators in particular areas of research, it is important that attention also be given to recruiting individuals from minority groups that are underrepresented nationally in the biomedical and behavioral sciences. Groups that have been shown to be underrepresented in biomedical and behavioral research nationally include: African Americans, Hispanics, Native Americans, Alaskan Natives, and Pacific Islanders. In the science areas of some sponsoring Institutes, additional groups have been identified. Applicants should contact the appropriate NIH Institute representative listed at the end of this announcement for further information. Future use of the term "minority" in this announcement will refer to the underrepresented groups identified by the appropriate Institute. Other considerations relate to the duration of training and the movement of trainees to individual support mechanisms. Studies have shown that the length of the appointment to a training grant for postdoctoral trainees with health-professional degrees is strongly correlated with subsequent application for and receipt of independent NIH research support. Program directors, therefore, are strongly encouraged to limit appointments to individuals who plan to remain on the grant or in some other type of research experience for a minimum of two years. It has also been shown that individuals who have been supported by an individual postdoctoral fellowship are more likely to apply for and receive NIH research support than individuals who have received support from a training grant alone. Program directors are therefore encouraged to identify candidates for individual postdoctoral fellowships or early career development (K awards) in order to stimulate applications. During the review of applications, peer reviewers will examine the training record to determine the average duration of training for health-professional postdoctoral trainees and whether there is a record of transition to individual support mechanisms. Past studies have shown that trainees from programs oriented exclusively toward health-professionals are less likely to apply for and receive research grant support than health-professionals who train with postdoctoral researchers who have an intensive background in research. Programs that focus on research training for individuals with an M.D. or other health-professional degrees should consider developing strong ties to basic science departments or modifying their program to include individuals with research doctoral degrees if such changes are consistent with the goals of the program. Applications should describe the contribution of basic science departments to the research training experience and indicate whether both health professional trainees and trainees with research doctorates are included in the training program. Payback Provisions As specified in the NIH Revitalization Act of 1993, NRSA recipients incur a service payback obligation only during the first 12 months of postdoctoral support. Additionally, the NIH Revitalization Act of 1993 specifies that the second and subsequent years of postdoctoral NRSA training will serve to pay back a postdoctoral service payback obligation. Accordingly, the following guidelines apply: o Predoctoral trainees are not required to sign the Payback Agreement Form (PHS Form 6031) and do not incur a service payback obligation. o Postdoctoral trainees in the first twelve months of postdoctoral NRSA support must sign the payback agreement form and incur a period of service payback obligation equal to the period of support. o Postdoctoral trainees in the thirteenth and subsequent months of NRSA support are not required to sign the Payback Agreement Form and do not incur a service payback obligation. o The thirteenth and subsequent months of postdoctoral NRSA support are considered acceptable payback service for prior postdoctoral support. Individuals appointed to their initial NRSA postdoctoral period on or after June 10, 1993, and who continue under that award for two years, have fulfilled their obligation by the end of the second year. Service payback obligations can also be paid back by conducting health-related research or teaching for more than 20 hours per week of a full year after terminating NRSA support. Recipients must begin to undertake any remaining obligated service on a continuous basis within two years after termination of NRSA support. The period for undertaking payback service may be delayed for such reasons as temporary disability, completion of residency requirements, or completion of the requirements for a graduate degree. Requests for an extension must be made in writing to the awarding unit specifying the need for additional time and the length of the required extension. Recipients of NRSA support are responsible for informing the awarding unit of changes in status or address. For individuals who fail to fulfill their obligation through service, 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 of the Treasury. Financial payback must be completed within three years, beginning on the date the United States becomes entitled to recover such amount. Under certain conditions, the Secretary, Department of Health and Human Services (or those delegated this authority) may extend the period for starting service or repayment, permit breaks in service, or in rare cases in which service or financial repayment would constitute an extreme hardship, the approving official may waive or suspend the payback obligation of an individual. Officials at the awardee institution have the responsibility of explaining the terms of the payback requirements to all prospective training candidates before appointment to the training grant. Additionally, all trainees recruited into the training program should be provided with information related to the career options available to individuals who complete the program and whether the types of positions available are consistent with the nature of the training provided and where applicable whether those positions are likely to satisfy any outstanding service payback obligation. Trainee Reporting Requirements The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant at the beginning of the appointment period. Additionally, a completed Payback Agreement (PHS Form 6031) must be submitted for each trainee in their first twelve months of postdoctoral support. Within 30 days of the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS Form 416-7). Failure to submit the required forms in a timely manner may result in an expenditure disallowance or a delay in any continuation funding for the award. Leave In general, trainees may receive stipends during periods of vacation and holidays observed by individuals in comparable training positions at the grantee institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Trainees may 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)). Trainees may also 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 institution have access to paid leave for this purpose and the use of parental leave is approved by the program director. A period of terminal leave is not permitted and payment may not be made from grant funds for leave not taken. Individuals requiring periods of time away from their research training experience longer than specified here must seek approval from the NIH awarding component for an unpaid leave of absence. At the beginning of a leave of absence, the trainee must submit a Termination Notice (PHS Form 416-7) and upon return from the leave of absence, the trainee must be formally reappointed to the grant by submitting an updated Statement of Appointment (PHS Form 2271). Trainees within the first twelve months of postdoctoral support must also submit a Payback Agreement (PHS Form 6031) upon return from a leave of absence. Stipends National Research Service Awards provide funds, in the form of stipends, to graduate students and postdoctoral trainees. A stipend is provided as a subsistence allowance for trainees to help defray living expenses during the research training experience. It is not provided as a condition of employment with either the Federal Government or the awardee institution. Stipends must be paid to all trainees at the levels approved by the Secretary of the Department of Health and Human Services. Predoctoral: Beginning in FY 97, the annual stipend for predoctoral trainees is $11,496. For appointments of less than a year, the stipend will be based on a monthly proration that is currently $958 per month. Postdoctoral: The current annual stipend for postdoctoral trainees is determined by the number of FULL years of relevant postdoctoral experience at the time of appointment. Relevant experience may include research experience (including industrial), teaching, internship, residency, clinical duties, or other time spent in full-time studies in a health-related field following the qualifying doctoral degree. The stipend for each additional year of NRSA support is the next level on the stipend scale. Current postdoctoral stipends are as follows: Years of Relevant Experience Annual Amount Less than 1 $20,292 Greater than or equal to 1 but less than 2 21,420 Greater than or equal to 2 but less than 3 25,600 Greater than or equal to 3 but less than 4 26,900 Greater than or equal to 4 but less than 5 28,200 Greater than or equal to 5 but less than 6 29,500 Greater than or equal to 6 but less than 7 30,800 Greater than or equal to 7 32,300 A trainee with a health-professional doctoral degree who is enrolled in a graduate degree program is considered to be in postdoctoral training and will receive the appropriate postdoctoral stipend listed above. No departure from the established stipend schedule may be negotiated by the institution with the trainee. The stipend for each additional full year of stipend support is the next level in the stipend structure and does not change mid-year. The sponsoring institution is allowed to provide funds to an individual in addition to the stipends paid by the NIH. Such additional amounts may be either in the form of augmented stipends (supplementation) or in the form of compensation, such as salary or tuition remission for services such as teaching or serving as a laboratory assistant, provided the following conditions are met: Stipend Supplementation: Supplementation or additional support to offset the cost of living may be provided by the awardee institution but must not require any additional obligation from the trainee. 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 DHHS funds be used for supplementation. Compensation: An institution may provide additional funds to a trainee in the form of compensation (as salary and/or tuition remission) for services such as teaching or serving as a laboratory assistant. A trainee may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS 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 that supports 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 trainee's approved NRSA training program. 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 may not be held concurrently with another Federally-sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA. More specific information on stipend supplementation and compensation is available in the current Guidelines for NRSA Individual Awards - Institutional Grants and in the current PHS Grants Policy Statement. Tax Liability Section 117 of the Internal Revenue Code applies to the tax treatment of all scholarships and fellowships. Under that section, non-degree candidates are required to report all stipends, and any monies paid on their behalf for course tuition and fees required for attendance as gross income. Degree candidates may exclude from gross income (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 trainees and institutions. NRSA stipends are not considered salaries. In addition, trainees supported under the NRSA are not considered to be in an employee-employer relationship with the NIH or the awardee institution. It must be emphasized that the interpretation and implementation of the tax laws are the domain of the Internal Revenue Service and the courts. The PHS takes no position on what the status may be for 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. Tuition, Fees, and Health Insurance Tuition, fees, and self-only medical insurance, are allowable trainee costs if such charges are required of all individuals in a similar training status at the institution, regardless of their source of support. Family medical insurance coverage is not an appropriate charge to the NRSA research training grant. Tuition at the postdoctoral level is limited to that required for specific courses in support of the approved research training program. On an annual basis, for each trainee, the training grant will cover 100 percent of the first $2,000 of the combined cost of tuition, fees, and self-only health insurance and 60 percent of any amount above $2,000. Institutions are instructed to request the full amount of these costs in competing applications. Noncompeting awards will reimburse tuition, fees, and health insurance costs in the amount paid in the previous award year, unless there is a change in the scope of the award. Other Training Costs Trainee travel, including attendance at scientific meetings that the institution determines to be necessary to the individual's research training, is an allowable trainee expense. In addition, support for travel to a research training experience away from the grantee institution may be permitted. Research training experiences away from the parent institution must be justified considering the type of opportunities for training available, how these opportunities differ from those offered at the parent institution, and the relationship of the proposed experience to the trainee's career stage and career goals. This type of research training requires prior approval from the NIH. Letters requesting such training may be submitted to the NIH awarding component at any time during the award period. Institutional costs of up to $1,500 per year per predoctoral trainee and up to $2,500 per year per postdoctoral trainee may be requested to defray the costs of other research training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and staff travel. Under exceptional circumstances, which can include accommodating the disabilities of a trainee, it is possible to request institutional costs above the standard rate. These additional costs must be explained in detail and carefully justified in the application. Consultation with program staff in advance of such requests is strongly advised. The institution may receive up to $125 per month to offset the cost of tuition, fees, health insurance, travel, supplies, and other expenses for each short-term, health-professional research training position. A facilities and administration allowance (indirect cost allowance) based on eight percent of total allowable direct costs (this excludes amounts for tuition, fees, health insurance, and equipment), may be requested. APPLICATION PROCEDURES Applicants must use the grant application form PHS 398 (rev. 5/95). It contains special instructions for Institutional National Research Service Awards (T32). Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division 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 PA title and number should be typed on line 2 of the application face page. Applicants must observe the 25-page limit on the narrative section of the PHS 398 application. Applicants who wish to include a request for short-term research training positions for Health Professional Students should identify the short-term positions separately within the "Stipends" and "Training Related Expenses" categories on the budget page. Under "Stipends," short-term positions should be listed in the "Other" category. Tuition, fees, health insurance, and trainee travel, and other expenses, are to be included in "Training Related Expenses." The description of the short-term research training program should be included in the application for the regular research training program, but should be separated from the description of the regular program within each section of the application. In addition to the information requested in the "Program Plan" section, the applicant should address the relationship of the proposed short-term program to the regular research training program and provide assurance that the short-term program will not detract from the regular program. Submit an original of the application with both required signatures and checklist, and five exact single-sided copies of the application 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) Application Schedule Many Institutes review T32 applications only once or twice per year. Applicants should contact the NCSDR or appropriate Institute staff for specific schedule information before preparing and submitting an application. The following table provides general guidance for possible receipt dates and the review of applications: Application Receipt Date: Jan 10 May 10 Initial Review Meeting: Jun Oct/Nov Council/Board Meeting: Sep/Oct Jan/Feb Earliest Start Date: Dec 1 Apr 1 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Division of Research Grants. Incomplete applications will be returned to the applicant without further consideration. Review Criteria Applications are evaluated for merit by NIH initial review groups based on the following criteria: o Past research training record of both the program and the designated preceptors as determined by the success of former trainees in establishing independent and productive research careers. Evidence of further career development can include receipt of fellowships, career awards, further training appointments, and similar accomplishments. Evidence of a productive scientific career can include a record of successful competition for research grants, receipt of special honors, a record of publications, receipt of patents, promotion to scientific positions, and any other measure of success consistent with the nature and duration of the training received. o Objectives, design, and direction of the training program in sleep related research; o Caliber of preceptors as researchers in sleep-related disciplines, including successful competition for research support; o The institutional training environment, including the level of institutional commitment, the quality of the facilities, availability of appropriate courses, and the availability of support for sleep research; o Recruitment and selection plans for trainees, and the availability of high quality candidates; o The record of the research training program in retaining health- professional postdoctoral trainees for at least two years in research training or other research activities; o When appropriate, the concomitant research training of health-professional postdoctorates (i.e., individuals with the M.D., D.O., D.D.S., etc.) with basic science postdoctorates (i.e., individuals with a Ph.D., etc.) or linkages with basic science departments. Short-Term Research Training Positions: In addition to the above criteria, applications that request short-term research training positions will also be assessed using the following criteria: o The quality of the proposed short-term training program in sleep research including the commitment and availability of the participating faculty, the program design, the availability of research support, and the training environment; o Access to candidates for short-term research training and the ability to recruit high quality, short-term trainees from the applicant institution or some other health-professional school; o The characteristics of the research training program that might be expected to persuade short-term trainees to consider academic/research careers in sleep research, particularly in clinical areas; o The success in attracting students back for multiple appointments (competing renewal applications); o The effects of the short-term training program on the quality of the regular research training program, including the appropriateness of the number of short-term positions, and the plan to integrate the short-term training program into the regular research training program; o The plan to follow former short-term trainees and assess the effect of such research training on their subsequent careers in sleep research. Additional Review Considerations Minority Recruitment Plan: The NIH remains strongly committed to increasing the participation of individuals from underrepresented minority groups in biomedical and behavioral research. As announced in 1989, all competing applications for institutional NRSA research training grants must include a specific plan to recruit underrepresented minorities, and competing continuation applications also must include a report on the recruitment and retention record during the previous award period. If an application is received without a plan, or without a report on the previous award period, the application will be considered incomplete and may be returned to the applicant without review. Additional information on this requirement was published in the NIH Guide for Grants and Contracts, Volume 22, Number 25, July 16, 1993. Competing renewal applications for research training grants must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous award period. Information on the types of recruitment strategies used and which have been successful and unsuccessful must be included. The report should provide information on the racial/ethnic distribution of: (a) students and/or postdoctorates in the department(s) relevant to the training grant, (b) individuals who applied for research training, (c) individuals who were offered admission, and (d) individuals who were appointed to the research training grant. For those trainees who were appointed to the grant, the report should include information about the duration of research training and whether those trainees have finished their training in good standing. After the overall educational and technical merit of an application has been assessed, peer reviewers will examine and evaluate the minority recruitment plan and any record of recruitment and retention. For competing continuation applications, the reviewers will examine and evaluate the record of the program in recruiting and retaining underrepresented minority trainees during the previous award period. The panel also will consider whether the experience in recruitment during the previous award period has been incorporated into the formulation of the recruitment plan for the next award period. The findings of the panel will be included in an administrative note in the summary statement. If the minority recruitment plan or if the record of recruitment and retention of minorities is judged to be unacceptable, funding will be withheld until a revised plan that addresses the deficiencies is received. Staff within the NIH awarding component, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable. Training in the Responsible Conduct of Research: Every predoctoral and postdoctoral NRSA trainee supported by an institutional research training grant must receive instruction in the responsible conduct of research. For more information on this provision, please consult a notice in the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992. Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. o Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged strongly to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Within the context of training in scientific integrity it is also beneficial to discuss the mutual responsibilities of the institution and the graduate students or postdoctorates appointed to the program. o Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, trainee attendance, and the frequency of instruction. The rationale for the proposed plan of instruction must be provided. o Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in future competing and noncompeting applications. The NIH encourages institutions to provide instruction in the responsible conduct of research to all graduate students and postdoctorates in a training program or department, regardless of the source of support. NIH initial review groups will assess the applicant's plans on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction. The plan will be discussed after the overall determination of merit, so that the quality of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until a revised, acceptable plan is provided by the applicant. The acceptability of the revised plan will be judged by staff within the awarding component at the NIH. Following initial review, applications are also reviewed by the appropriate NIH Institute or Center Council, Board, or other advisory group. These advisory groups will consider, in addition to the assessment of the scientific and educational merit of the research training grant application, the initial review group's comments on the recruitment of individuals from underrepresented minority groups into the research training program and the plan for instruction in the responsible conduct of research. AWARD CRITERIA Applications are selected for funding primarily on the basis of scientific and educational merit, but other factors are considered, such as: availability of funds, research program priorities, balance among types of research training supported by the awarding component, the acceptability of the plan for minority recruitment, and the acceptability of the proposal for instruction in the responsible conduct of research. The awarding NIH Institute will notify the applicant of the final action shortly after the advisory group meeting. Additional information For additional information, see the document titled "Guidelines for National Research Service Awards, Individual Awards - Institutional Grants" available from the applicant's institution or by contacting 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, E-mail: asknih@odrockm1.od.nih.gov. INQUIRIES Applicants are strongly encouraged to contact the individuals designated below, in advance of preparing an application, for additional information concerning the areas of research, receipt dates, and other types of pre-application consultation. Direct inquiries regarding programmatic issues to: James P. Kiley, Ph.D. National Center on Sleep Disorders Research National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 7024, MSC 7920 Bethesda, MD 20892-7920 Telephone: (301) 435-0199 Email: kileyj@gwgate.nhlbi.nih.gov Additional contacts for Institute-specific program issues are: Andrew 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 Email: am39m@nih.gov Ellen D. Witt, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-6545 Email: ewitt@willco.niaaa.nih.gov Marian Willinger, Ph.D. Pregnancy and Perinatology Branch National Institute of Child Health and Human Development 6100 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-5575 Email: willingm@hd01.nichd.nih.gov Paul Coulis, Ph.D. National Institute on Drug Abuse 5600 Fishers Lane, Room 10A/08 Rockville, MD 20857 Telephone: (301) 443-1801 Email: pcoulis@aoada.ssw.dhhs.gov Israel Lederhendler, Ph.D. National Institute of Mental Health 5600 Fishers Lane, Room 11/102 Rockville, MD 20857 Telephone: (301) 443-1576 Email: ilu@cu.nih.gov Joseph Drage, M.D. Training and Special Programs Officer National Institute of Neurological Disorders and Stroke Federal Building, Room 1016 Bethesda, MD 20892 Telephone: (301) 496-4188 Email: dragej@nswide.ninds.nih.gov Mary Leveck, Ph.D., R.N. National Institute of Nursing Research 45 Center Drive, Room 3AN12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5963 Email: mleveck@ep.ninr.nih.gov Direct inquires regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 7160, MSC 7926 Bethesda, MD 20892-7920 Telephone: (301) 435-0171 Email: zimmermr@gwgate.nhlbi.nih.gov Crystal Ferguson Grants Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2C212, MSC 9205 Bethesda, MD 20892-9205 (Courier Zip: 20814) Telephone: (301) 496-1472 Email: Ferguson%nihniagw.bitnet@cu.nih.gov Linda Hilley Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 504 MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0915 Email: lhilley@wilco.niaaa.nih.gov Douglas Shawver Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17 Bethesda, MD 20892 Telephone: (301) 496-1303 Email: Shawver@hd01.nichd.nih.gov Gary Fleming Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20892 Telephone: (301) 443-6710 Email: gfleming@aoada.ssw.dhhs.gov Diana Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-3065 Email: dt21a@nih.gov Karen Shields Grants Management Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 Bethesda, MD 20892-9190 Telephone: (301) 496-9231 Jeff Carow Grants Management Officer National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6301 Telephone: (301) 594-6869 Email: jcarow@ep.ninr.nih.gov AUTHORITY AND REGULATIONS NRSA Institutional Research Training Grants are made under the authority of Section 487 of the Public Health Service Act as amended (42 USC 288). Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program. This program is also described under the following numbers in the Catalog of Federal Domestic Assistance: 93.121, 93.172, 93.173, 93.233, 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, 93.862-93.868, 93.871, 93.880, 93.894, and 93.929. 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 Sat Jun 14 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HS-98-004 - V26(20) 06/13/97 Date: 14 Jun 1997 21:35:41 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 649 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5nvret$3e1@net.bio.net> NNTP-Posting-Host: net.bio.net EFFECTIVENESS OF CHILDREN'S MENTAL HEALTH AND SUBSTANCE ABUSE TREATMENT IN THE GENERAL HEALTH SECTOR NIH GUIDE, Volume 26, Number 20, June 13, 1997 RFA: HS-98-004 P.T. 34, AA; K.W. 0715095, 0404009, 0415001, 0745070 Agency for Health Care Policy and Research National Institute on Drug Abuse, NIH National Institute of Mental Health, NIH Substance Abuse and Mental Health Services Administration Letter of Intent Receipt Date: November 13, 1997 Application Receipt Date: January 6, 1998 PURPOSE The Agency for Health Care Policy and Research(AHCPR), in cooperation with the: National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH); the National Institute of Mental Health (NIMH), NIH; and the Substance Abuse and Mental Health Services Administration (SAMHSA) invites applications for research on the effectiveness and/or cost-effectiveness of child mental health and substance abuse treatment interventions and guideline-based treatment strategies for children, adolescents, and youth in the general health sector. Guideline- and other evidence- based aids for clinical decisionmaking may go beyond specific treatment interventions to include possible combinations of specific treatments. Guideline- and other evidence-based aids may include algorithms, practice guidelines, treatment protocols, and practice parameters. 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. Applicants are encouraged to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202-512-1800. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic or foreign, public or private, organizations, including universities, clinics, units of State and local governments, firms, and foundations. AHCPR, by statute, can make grants only to non-profit organizations; however, for-profit organizations may participate as members of consortia or subcontractors. NIH can make R01 grants to for-profit organizations. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible. Women, members of minority groups, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The RFA mechanism of support is the research project grant R01. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. AHCPR is particularly interested in research and evaluation projects that will produce results within 1 to 3 years although longer projects will also be supported. Project support may not exceed 5 years (awards to foreign applicants are limited to three years). FUNDS AVAILABLE AHCPR expects to award up to $1.5 million in fiscal year 1998 to support the first year of approximately 3-5 projects under this RFA. The number of awards is dependent on the number of high quality applications and their individual budget requirements; it is not the intent of AHCPR that the awards be equal in size. The earliest anticipated AHCPR award date is July 1, 1998. NIDA expects to award up to $0.5 million in fiscal year 1998, dependent on the quality of the applications relevant to drug abuse and the availability of funds. NIMH expects to award up to $1.0 million, and SAMHSA up to $0.5 million, in fiscal year 1998, dependent upon the quality of the applications and the availability of funds. Funding beyond the initial budget period will depend upon annual progress reviews and the availability of funds. PUBLIC-PRIVATE PARTNERSHIPS In order to better leverage public funds, and to address important health issues that cross both the public and private spheres, creative public-private research partnerships are encouraged. Researchers have found that such partnerships help to more quickly translate the findings of their research into real-world information for physicians and other health professionals. Applicants are free to seek additional funding sources or research collaborators for these projects. Where additional parties are anticipated, their proposed role should be described in both the project narrative and the financial portions of the application. In addition, private sector entities are encouraged to consider providing additional support for meritorious applications. RESEARCH OBJECTIVES Background Substantial numbers of children and youth are estimated to need treatment for mental health and substance abuse problems. Many of the affected children go untreated, but among those who receive care, a large percentage obtain it in general health sector settings, and that proportion may be growing. Continuing dramatic changes in the financing, organization, and delivery of health care in the United States have put increasing emphasis on the delivery of services by nonspecialists. New cost-cutting demands have also generated renewed emphasis on the need for scientific evidence on the effectiveness of health interventions. In the arena of child mental health and substance abuse, such evidence will be useful for a variety of purposes, including: the design of systems of care for children, adolescents, and youth; prospective evaluation of proposed alternative approaches to treatment; evaluation of care provided; and examination, monitoring, and improvement of the efficiency and quality of care. Additional evidence about the effectiveness of child substance abuse and mental health services will be important to inform policy makers on issues of access to these services. To date, most effectiveness research on child mental health and substance abuse has not examined the effectiveness of specific treatments in real world clinical settings. Rather, much of the work has focused on the effects of systems aspects such as settings and comprehensiveness of services. While systems considerations are integral to designing and providing mental health and substance abuse services to children, understanding the effectiveness of the specific treatments provided within those systems of care is also critical. Once a problem is detected or diagnosed, treatment is an essential system component. Only a small percentage of mental health services research has taken place in primary care and other general health sector settings. Objectives and Scope Research conducted under this solicitation will be expected to help build the evidence base on the effectiveness and cost-effectiveness of mental health and substance abuse treatments for children, adolescents, and youth in general health sector settings. o Definition of children, and children with special life situations Children, adolescents, and youth are defined using the definition of the American Academy of Pediatrics, that is, those individuals from birth to roughly age 21. Children of both genders, all racial and ethnic origins, and financial circumstances can be affected by mental health or substance abuse problems. It is recognized that problems may be exacerbated by specific life circumstances. Such situations include, but are not limited to: transitions from pre- to early adolescence; school environments and transitions, including transitions to college; pregnancy and parenting; academic problems; trouble with the law; neighborhood environments; and other illnesses and disabilities. o General health sector The general health sector is defined as health care settings other than specialty mental health and substance abuse settings. General health sector settings include, but may not be limited to: integrated delivery systems (i.e., managed care other than mental health carveouts); primary care settings such as offices and clinics where pediatricians, family practitioners, internal medicine specialists, nurses, nurse practitioners, and physician assistants provide health services to children, adolescents, and youth; other ambulatory and outpatient facilities; general acute care inpatient hospitals; and general acute care hospital emergency departments. This RFA's reference to specific practitioners does not exclude from potential study treatments provided by teams that include mental- health and substance-abuse specialists (e.g., social workers, psychologists, licensed drug abuse counselors, licensed professional counselors, psychiatrists), as long as they work in general health sector settings and with non- specialist providers. o Treatments Mental health and substance abuse treatments are those services designed to maintain (if improvement is not possible), or improve identified (diagnosed or subclinical) mental health and substance abuse problems, such as those described in the American Psychiatric Association's Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) or the American Academy of Pediatrics' Classification of Child and Adolescent Mental Diagnoses in Primary Care: Diagnostic and Statistical Manual for Primary Care, Child and Adolescent Version (DSM-PC). Research under this solicitation can be used to test the effectiveness of specific treatments (e.g., single pharmacotherapies or psychosocial treatments) or evidence- based treatment guidelines for specific disorders or combinations of disorders. For purposes of this solicitation, the term "specific treatments" includes both psychosocial and psychopharmacological treatments. Evidence-based treatment guidelines can include comprehensive strategies that involve multiple interventions and the procedures for their integration into a single plan of treatment. Applications should describe all treatments (including comparison treatments) in enough detail so that they would be reproducible by other practitioners or researchers in other settings. The use of generic terms that are sometimes found in the literature (e.g., "office-based brief intervention"), with no further explanation, should be avoided. NIMH is interested in studies of the effectiveness of treatments for specific diagnosable mental disorders, such as attention-deficit hyperactivity disorder, affective disorders, anxiety disorders, obsessive-compulsive disorders, autism, and disruptive behavior disorders. SAMHSA is particularly interested in supporting projects that examine the effectiveness of interventions targeted to children with, or at risk for, serious emotional disturbances, and their families. Children with serious emotional disturbances have a diagnosable disorder which affects the degree or level of functioning in the family, school, and/or community, with an expected duration of more than one year. This solicitation does not cover the development of guidelines or protocols for treatments; thus, only treatment guidelines that have been developed by the time of the award should be used in the research. Screening and diagnostic services are not included under this RFA. Research Methods The research conducted under this solicitation is expected to take place in real world settings such as pediatric or family practice office or clinic settings, hospital or other emergency facilities, and managed care organizations. Effectiveness is defined as the extent to which medical (including psychosocial and psychopharmacological) interventions achieve health and/or functional improvements in real world practice settings. Real world settings include university-affiliated health care settings. This RFA strongly encourages experimental effectiveness research (i.e., randomized and controlled studies). Health and/or functional outcomes should be used to measure the expected effects of the treatment interventions. The use of previously-validated outcome measures is strongly encouraged, as is the use of measures using children's own self-reports. Health outcomes are the end results of the structure and processes of health care on the health and well-being of patients and populations. Examples of relevant health outcomes include reduction in symptoms, improved scores on validated mental health or substance abuse assessment instruments, and reductions in mortality or morbidity associated with mental health or substance abuse problems. Functional outcome measures incorporate a multidimensional definition of health that encompasses physical, psychological, behavioral, and social aspects, and attempt to capture the broader impact of disease and treatment from a patient's (or parent's) own perspective. For example, can children participate in normal school activities? Can they play with friends? Can they avoid juvenile justice/law enforcement involvement? Can they live a life free of painful symptoms? Any cost-effectiveness studies should use health and/or functional outcome measures as described above, and use as a guide suggestions found in the report of the task force on cost-effectiveness in health and medicine, Cost- Effectiveness in Health and Medicine, published in 1996. Interdisciplinary research consortia and real world settings In order to improve the generalizability of findings, consortia of interdisciplinary research teams and real-world clinical settings are encouraged. Existing examples of real-world settings in which research is conducted include, but may not be limited to, the Practice Research Networks of the American Psychiatric Association and the Pediatric Research in Office Settings of the American Academy of Pediatrics. Interdisciplinary research teams should include physician-researchers, nurse-researchers, psychologists, sociologists, economists, and other researchers, as appropriate. SPECIAL REQUIREMENTS Budget Preparation The costs of clinical care provided to any research participants will not be paid out of grant funds. Confidentiality of Data Information obtained in the course of a study supported by AHCPR that identifies an individual or entity must be treated as confidential in accordance with section 903(c) of the Public Health Service Act. Applicants must describe in the Human Subjects section of the application procedures for ensuring the confidentiality of identifying information. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers will be safeguarded. Informed Consent To the extent informed consent regulations will apply to the proposed research, applicants are expected to comply fully with those requirements and to outline their proposed efforts as part of their applications. Rights in Data AHCPR grantees may copyright or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHCPR funds. Such copyrights and patents are subject to a Federal Government license to use these products and materials for AHCPR purposes. AHCPR purposes may include, subject to statutory confidentiality protections, making research materials, data bases, and algorithms available for verification or replication by other researchers; and subject to AHCPR budget constraints, final products may be made available to the health care community and the public by AHCPR, or its agents, if such distribution would significantly increase access to a product and thereby produce public health benefits. Ordinarily, to accomplish distribution, AHCPR publishes research findings but relies on grantee efforts to market grant-supported products. In keeping with AHCPR's legislative mandates to make both research results and data available, copies of all products and materials developed under a grant supported in whole or in part by AHCPR funds are to be made available to AHCPR promptly and without restriction, upon request by AHCPR. The special terms of award described above are in addition to and not in lieu of otherwise applicable PHS grant policies and Federal regulations. INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS INVOLVING HUMAN SUBJECTS It is the policy of AHCPR and NIH that women and members of minority groups be included in all AHCPR-supported 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. Because this RFA applies solely to children, the policy on women applies to female children, adolescents, and youth. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which were published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. AHCPR follows the revised NIH Guidelines, as applicable. Investigators may obtain copies from those sources or from the AHCPR contractor, Global Exchange, Inc., listed under INQUIRIES. In general, AHCPR is also encouraging investigators to consider including children in study populations, as appropriate. Clearly this RFA focuses exclusively on children. AHCPR announced in the NIH Guide, Volume 26, Number 15, May 9, 1997, that it is developing a policy and implementation plan on the inclusion of children in health services research. This Notice is available through AHCPR's WEB site (http://www.ahcpr.gov) and InstantFAX (see instructions under INQUIRIES). NIH published a similar Notice on the inclusion of children as subjects in clinical research, in the NIH Guide, Volume 26, Number 3, January 31, 1997. Program staff may also provide information concerning these policies (See INQUIRIES). LETTER OF INTENT Prospective applicants are asked to submit, by November 13, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the proposed Principal Investigator and other key personnel; and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the consideration of any subsequent application, the information allows AHCPR to estimate the potential review workload and avoid conflicts of interest in the review. AHCPR will not provide responses to letters of intent. The letter of intent is to be addressed to: Charlotte Mullican Center for Outcomes and Effectiveness Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 605 Rockville, MD 20852-4908 Telephone: (301) 594-1485, ext. 1201 FAX: (301) 594-3211 Email: chdmhrfa@ahcpr.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. State and local government applicants may use form PHS-5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, Office of Extramural Research, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714 (email: ASKNIH@odrockm1.od.nih.gov). AHCPR applicants should obtain application materials from the AHCPR contractor: Global Exchange, Inc. (see INQUIRIES). The RFA label available in the form PHS 398 (rev. 5/95) must be affixed to the bottom of the face page of the original applicants. Failure to do so could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and YES must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Charlotte Mullican Center for Outcomes and Effectiveness Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 605 Rockville, MD 20852-4908 Telephone: (301) 594-1485, ext. 1201 FAX: (301) 594-3211 Email: chdmhrfa@ahcpr.gov Applications submitted under this RFA must be received in the Division of Research Grants, NIH, by January 6, 1998. If an application is received after that date, it will be returned to the applicant without review. CONFERENCE FOR PROSPECTIVE APPLICANTS AHCPR, NIDA, NIMH, and SAMHSA plan to convene a special technical assistance workshop to assist potential applicants. The purpose of this conference is to give background information and respond to any questions about the preparation of an application in response to this RFA. The workshop will be held in the Rockville/Bethesda, Maryland, area approximately 3-4 months after the publication of this announcement. Attendance is not a prerequisite to applying. Attendees must pay for their own travel and accommodation costs. The workshop will be open to any individual or organization intending to apply. A synthesis of pertinent Questions and Answers discussed at the prospective applicants' meeting will be available from the AHCPR contractor, Global Exchange, Inc., listed under INQUIRIES. For further information on the conference, contact: Margaret Coopey or Charlotte Mullican, AHCPR; Dorynne Czechowicz, M.D., NIDA; Kimberly Hoagwood, Ph.D., NIMH; or Diane L. Sondheimer, SAMHSA, also listed under INQUIRIES. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with established peer review procedures. As part of the merit review, all applications will receive a written critique, and also may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. General Review Criteria Review criteria for grant applications are: significance and originality from a scientific and technical viewpoint; adequacy of the method(s); availability of data or proposed plan to collect data required for the project; adequacy of the plan for organizing and carrying out the project and achieving outcome measures; qualifications and experience of the Principal Investigator and proposed staff; reasonableness of the proposed budget; adequacy of the facilities and resources available to the applicant; the extent to which women and minorities are adequately represented in study populations; and when applicable, the adequacy of the proposed means for protecting human subjects. Special Review Criteria In addition to the general criteria above, the reviewers will assess the application's responsiveness to the RFA; generalizability of results; feasibility of answering the proposed research question(s) within the project period; research design; and the validity of outcome(s) measures. AWARD CRITERIA Applications will compete for available funds with all other applications under this RFA. The following will be considered in making the funding decisions: quality of the proposed project as determined by peer review, program balance, and availability of funds. Preference in funding will be accorded by AHCPR to meritorious applications which focus on issues concerning minority populations. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Copies of the RFA should be obtained from: Global Exchange Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20814-3015 Telephone 301/656-3100 FAX 301/652-5264 The RFA is also available on AHCPR's website, http://www.ahcpr.gov and through AHCPR InstantFAX at 301/ 594-2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Follow the voice prompt in order to obtain a copy of the table of contents, which has the document order number (not the same as the RFA number). The RFA will be sent at the end of the ordering process. AHCPR InstantFAX operates 24 hours a day, 7 days a week. For questions about this service, call AHCPR's Division of Communications at 301/594-1364, ext. 1389. Direct inquiries regarding programmatic issues, including information on the policy of inclusion of women (females), minorities, and children in study populations, to: AHCPR: Margaret Coopey Office of the Forum for Quality and Effectiveness in Health Care Agency for Health Care Policy and Research 6000 Executive Boulevard, Suite 310 Rockville, MD 20852 Telephone: (301) 594-4015, ext.1788 FAX: (301) 594-4027 Email: chdmhrfa@ahcpr.gov Charlotte Mullican Center for Outcomes and Effectiveness Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 605 Rockville, MD 20852-4908 Telephone: (301) 594-1485, ext. 1201 FAX: (301) 594-3211 Email: chdmhrfa@ahcpr.gov Dorynne Czechowicz, M.D. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-10 Rockville, MD 20857 Telephone: (301) 443-0107 FAX: (301) 443-8674 Email: dc97@nih.gov Kimberly Hoagwood, Ph.D. Division of Epidemiology Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10C-06 Rockville, MD 20857 Telephone: (301) 443-3364, ext. FAX: (301) 443-4045 Email: khoagwoo@nih.gov Diane L. Sondheimer Center for Mental Health Services Substance Abuse and Mental Health Services Administration 5600 Fishers Lane, Room 18-49 Rockville, MD 20857 Telephone: (301) 443-1333 FAX: (301) 443-3693 Email: dsondhei@samhsa.gov Direct inquiries regarding fiscal matters to: Mable L. Lam Office of Grants Management Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852-4908 Telephone: (301) 594-1447, ext. 1165 FAX: (301) 594-3210 Email: mlam@ahcpr.gov Gary Fleming, J.D. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gf6s@nih.gov Diana S. Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: dt21a@nih.gov Christine Chen Division of Grants Management Substance Abuse and Mental Health Services Administration 5600 Fishers Lane, Room 618 Rockville, MD 20857 Telephone: (301) 443-8926 FAX: (301) 443-1358 Email: cchen@samhsa.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Numbers 93.104, 93.180, 93.226, 93.230, 93.242, and 93.279. Awards are made under authorization of: for AHCPR, Title IX of the PHS Act (42 U.S.C. 299-299c-6) and Section 1142 of the Social Security Act (42 U.S.C. 1320b-12); for NIDA and NIMH, PHS Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 U.S.C. 241 and 285); and for SAMHSA, PHS Act, Title V, Section 561 et seq (42 U.S.C. 290 ff et seq), and Section 501(d)(i) (42 U.S.C. 290aa). Awards are administered under the PHS Grants Policy Statement and Federal regulations 42 CFR 67, Subpart A, 42 CFR 52, and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The 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 Sat Jun 14 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-068 - V26(20) 06/13/97 Date: 14 Jun 1997 21:36:53 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 450 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5nvrh5$3mm@net.bio.net> NNTP-Posting-Host: net.bio.net MBRS SUPPORT OF CONTINUOUS RESEARCH EXCELLENCE (SCORE) NIH GUIDE, Volume 26, Number 20, June 13, 1997 PA NUMBER: PAR-97-068 P.T. 34, FF; K.W. 0710030 National Institute of General Medical Sciences Application Receipt Dates: February 1, June 1, October 1 PURPOSE The purpose of the Minority Biomedical Research Support (MBRS) Support of Continuous Research Excellence (SCORE) program is to provide financial assistance to competitive research programs in all areas of biomedical and behavioral research at institutions with significant underrepresented minority student enrollment. The intent of this announcement is to provide grants to support research by faculty members at minority serving institutions. The SCORE program replaces the research component of the traditional MBRS (S06) program and the pilot research projects of the S14 program. By eliminating or modifying some of the restrictions of the traditional S06 and S14 programs, the SCORE program allows enhanced flexibility in the development of research projects. In addition, the MBRS Branch recognizes that minority and minority-serving institutions are diverse in institutional environment and mission. Therefore, with respect to evaluation activities, this program requires that the institution set its own specific goals and measurable objectives. ELIGIBILITY REQUIREMENTS To be eligible for a grant under this program, an applicant must be located in a State, the District of Columbia, Puerto Rico, the Virgin Islands, the Canal Zone, Guam, American Samoa, or the successor States of the Trust Territory of the Pacific Islands (the Federated States of Micronesia, the Republic of the Marshall Islands, the Republic of Palau), and be one of the following: a. a public or private nonprofit university, two-year or four-year college, or other institution offering undergraduate, graduate, or health-professional degrees, with a traditionally high (more than 50 percent) underrepresented minority student enrollment; b. a public or private nonprofit university, two-year or four-year college, or other institution offering undergraduate, graduate, or health-professional degrees with a student enrollment, a significant proportion of which (but not necessarily more than fifty percent) is derived from underrepresented minorities, provided the Secretary of the Department of Health and Human Services determines that said institution has a demonstrated commitment to the special encouragement of, and assistance to, underrepresented minority faculty, students, and investigators; or c. an Indian tribe that has a recognized governing body and that performs substantial governmental functions, or an Alaska Regional Corporation (ARC), as defined in the Alaska Native Claims Settlement Act (43 U.S.C. 1601 et seq.). For the purposes of this announcement, underrepresented minorities are individuals belonging to a particular ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical or behavioral research. Historically, individuals who have been found to be underrepresented in biomedical or behavioral research include, but are not limited to, U.S. citizens who are Hispanic Americans, African Americans, Native Americans (including Alaskan natives) and natives of the U.S. Pacific Islands A written statement containing the following information is required in order to establish eligibility: a. the total student enrollment at the institution and percentages of various underrepresented minorities in the total student population (i.e., Native American, African American, Hispanic American, natives of the U.S. Pacific Islands); b. number of underrepresented minority students in science departments; c. evidence of the institution's commitment to the advancement of underrepresented minority faculty and investigators, including numbers of minority faculty in science departments; and d. evidence of efforts to recruit and retain underrepresented minority students and faculty in the participating departments. The SCORE program replaces the faculty research category of the traditional MBRS program (S06) and the pilot research projects of the MBRS Program for Undergraduate Colleges (S14). An institution may hold only one active SCORE award. Institutions currently funded for the traditional S06 or S14 programs are encouraged to apply for the SCORE program, with a start date to coincide with the end of their current project period. In general, existing policies and provisions will remain in effect for current S06 and S14 recipients until completion of the non-competing years of their current project period. June 1, 1998 will be the final date for submission of new and competitive renewals of traditional MBRS (S06) and S14 grant applications. Institutions supported by the Initiative for Minority Student Development (NIH Guide, Vol. 25, No. 4, 1996) are not eligible for the SCORE Program. Institutions may have only one active SCORE program. MECHANISM OF SUPPORT Awards under this program will be administered using the S06 grant mechanism. The responsibility for planning, direction, execution, data acquisition, and the institutional evaluation activities of the proposed program lies solely with the applicant institution. The maximum grant period may not exceed four years, with the opportunity for competing renewal at the end of that period. RESEARCH OBJECTIVES As of 1992, underrepresented minorities constituted only 4.5 percent of the postdoctoral fellows in the life sciences and less than 2.7 percent of the principal investigators of NIH research grants. In addition, the number of underrepresented minority applicants for research grants and training positions is very low. In the NIH Revitalization Act of 1993, NIH was encouraged to increase the number of underrepresented minorities participating in biomedical and behavioral research. In response to the Act, the objective of this initiative is to significantly improve the research capabilities of minority and minority-serving institutions. The MBRS SCORE program offers research opportunities for faculty of eligible institutions through support of faculty-initiated, scientifically meritorious, biomedically relevant research projects, including pilot research projects. Support for faculty participating in pilot projects is preparatory to seeking more substantial funding from NIH research grant programs (e.g. MBRS SCORE (S06) research program, Academic Research Enhancement Award (AREA), K awards, R29 (FIRST Awards), and R01 awards) as well as funding from other agencies and private sources. Funds intended to support pilot projects may not be used to supplement ongoing research projects. Applicants should note that evaluation is a necessary component of every MBRS program; this program requires that each institution set its own specific goals and measurable objectives. 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103 43). 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 in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) and supplemental MBRS SCORE program instructions should be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division 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 MBRS program office listed under INQUIRIES. Submit a signed, typewritten original of the application, including the Checklist, and three photocopies of the signed application in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20872-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to the Chief, Office of Scientific Review listed under INQUIRIES. Applicants are urged to contact MBRS program staff at an early stage for assistance and guidance in developing an application. ALLOWABLE COSTS Applicants may apply for support for from one to as many as twenty (20) research projects and one to eight (8) pilot projects per program. An institution need not apply for both research and pilot projects; they may apply for support of pilot projects only or research projects only. Individual investigators may apply for either a research project or a pilot research project, but not both. Grant funds may be used for payment of any allowable and necessary direct cost (i.e., salaries, consultant fees, equipment, travel, renovations (up to $40,000), supplies, etc.) for biomedical research under the MBRS program. Certain costs for managing a complex program are allowable and may vary, depending upon the size and complexity of the program's activities. The costs budgeted for MBRS grants may not duplicate cost items already budgeted in other cost centers of the institution for example, accounts which make up the Facilities and Administration (F&A) cost pool. The grantee institution must be prepared to provide documentation showing the direct relationship of these costs to the program and that costs of this type are charged in a uniform manner to all other work at the institution. Salary (up to 25 percent) for the Program Director for that portion of time or effort specifically employed in directing the MBRS program is allowable. Salaries for secretarial or clerical help are allowable only when in direct support of the MBRS program. Costs for evaluation activities are allowable, as are costs for an External Scientific Advisory Committee (ESAC). Direct costs associated with research and pilot projects are allowable when adequate justification is provided. These include faculty salaries, reimbursed according to percent effort, salaries for technicians, post-doctoral research associates, research associates, and research assistants, and costs for consultants. Costs of equipment and supplies, including costs for animals, necessary to carry out the proposed research may be included. Travel costs are permitted when direct benefits are provided to the program, and when adequate justification is provided. Alterations and Renovations costs (up to $40,000) are allowable and includes repairs, painting, removal or installation of partitions, shielding, etc.. Other costs might include animal maintenance (unit care costs and number of care days), donor fees, publication costs, computer charges, rentals and leases, equipment maintenance, service contracts, and tuition remission in lieu of salary. Consortium arrangements may involve personnel costs, supplies, and other allowable costs, including indirect costs. Contractual costs for support services, such as the laboratory testing of biological materials, clinical services, or data processing, are allowable expenses. Faculty Pilot Research Projects The faculty pilot research project is developmental and is intended for faculty without current research support. Therefore, investigators with funded or pending support from other mechanisms such as the S06, AREA, FIRST, R01, or funding from another agency, are not eligible. For faculty pilot projects, applicants may request support for up to $25,000 in direct costs per project per year, up to a total of $75,000 for a period not to exceed four years, and this support is non-renewable. EVALUATION The MBRS Branch recognizes that minority and minority-serving institutions are diverse in institutional environment and mission. Therefore, the emphasis of the evaluation activities of the MBRS SCORE program will be on the improvement, as defined by specific goals and measurable objectives, which the applicant institution sets for itself. The applicant institution should evaluate the benefits of the SCORE program's activities on specific, measurable outcomes identified by the applicant. Those outcomes will include, but are not limited to, measures of the faculty research projects' success. Since the intent of this program is to support institutions with competitive research programs, measurable outcomes might include progress in completing the specific aims of each research project outlined in the application, numbers of faculty publications in peer-reviewed journals or book chapters, numbers of faculty presentations at national scientific organization/society meetings, unexpected (but important) research findings, etc. At each competitive and non-competitive renewal, in the progress report, the investigators will evaluate what difference the award has made. A central aspect of each grant application (that distinguishes it from previous programs) is that each successful application has specific, MEASURABLE objectives and a plan to evaluate whether those objectives have been met. REVIEW CONSIDERATIONS Upon receipt, NIH staff will administratively review applications. Incomplete and/or unresponsive applications will be returned to the applicant without further consideration. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific and technical merit by appropriate peer review groups. The National Advisory General Medical Sciences Council will provide the second level of review. The review of an MBRS SCORE application involves a review of the individual research projects, pilot research projects and of the overall program Review Criteria for Individual Research Projects In carrying out the scientific and technical merit review of individual faculty research project applications, the initial review group will take into account: o the appropriateness of, and rationale for, the hypothesis driven research plan; o the appropriateness/adequacy of the methodology proposed to carry out the research; o the quality of the literature review in terms of being complete and current, and containing a critical analysis of the literature, including identification of gaps in the knowledge; o the availability of, or plans to acquire, the necessary resources to conduct the research; o the qualifications and experience of the principal investigator(s) to conduct the work; o the biomedical relevance of the research problem; o the reasonableness of the proposed budget and the requested period of support in relation to the proposed research; o in renewal applications, the scientific productivity of investigators currently supported by the MBRS SCORE or traditional S06 program, as evidenced by publications in peer-reviewed journals (chapters or articles), presentations at national or international scientific meetings, and attempts to secure other research funding. (The reviewers will evaluate the investigator's progress report.); and o the adequacy of the proposed means for protecting against or minimizing any adverse effects upon humans, animals, or the environment, where an application involves such activities. Review Criteria for Faculty Pilot Projects In carrying out the scientific and technical merit review of pilot research project applications, the initial review group will take into account: o the clarity and focus of the proposed research goal; o the appropriateness/adequacy of the methodology proposed to carry out the research; o the quality of the literature review in terms of being complete and current, and containing a critical analysis of the literature, including identification of gaps in the knowledge; o the availability of, or plans to acquire, the necessary resources to conduct the research; o the qualifications and experience of the principal investigator(s) to conduct the work; o the biomedical relevance of the research problem; o the reasonableness of the proposed budget and the requested period of support in relation to the proposed research; o the adequacy of the proposed means for protecting against or minimizing any adverse effects upon humans, animals, or the environment, where an application involves such activities. Review of the Overall Program In carrying out the review of the overall program, the initial review group will examine evidence of the institutional commitment to the goal of fostering the participation of underrepresented minorities in biomedical research. This includes: o an assessment of attempts to increase the numbers of underrepresented minority faculty participating in the research projects; o the commitment, responsibility, and leadership of the Program Director and institutional officials, as reflected by completeness, accuracy, and organization of the application according to application instructions and MBRS guidelines; o adequacy and availability of the institution's research resources such as facilities and fiscal management; o the commitment of the institution to faculty research development and sustaining faculty research efforts as reflected by an adequate plan to assure that the NIH approved and funded percent effort will be applied to research; o the overall scientific merit of the application based on the quality of the individual research projects submitted; and o the adequacy of the evaluation plan. AWARD CRITERIA The MBRS program's mission is to increase significantly the number of underrepresented minorities conducting biomedical research. Towards this end, one of the goals of the MBRS program is to strengthen the biomedical research capability of institutions with significant underrepresented minority enrollments. Priorities for funding will be based on the scientific and technical merit of the application, and the likelihood that the applicant institution can further the goals of the MBRS program. Awards will be made only to institutions with financial management systems and management capabilities that are acceptable under PHS policy. Awards will be administered under the PHS Grants Policy Statement. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Questions on the program and its policies should be directed to: Ernest D. Marquez, Ph.D. MBRS Branch National Institute of General Medical Sciences 45 Center Drive, Suite 2AS.37, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-3900 FAX: (301) 480-2753 Email: marqueze@gm1.nigms.nih.gov Questions on the review of applications should be directed to: Helen R. Sunshine, Ph.D. Office of Scientific Review National Institute of General Medical Sciences 45 Center Drive, Room 1 AS.13, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-2881 FAX: (301) 480-8506 Email: sunshinh@gm1.nigms.nih.gov Questions on grants management and fiscal matters should be directed to: Antoinette Holland Grants Management Branch National Institute of General Medical Sciences 45 Center Drive, Room 2AN.50, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-5132 FAX: (301) 480-2554 Email: hollanda@gm1.nigms.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93-375. Awards are authorized by sections 301 and 405 of the Public Health Service Act, as amended, and administered under PHS grants policies and Federal Regulations 42 CFR part 52c, 45 CFR part 74, and 45 CFR part 92. See also Senate Appropriations Committee Report, No. 92-316, July 29, 1971, Executive Order 12900 , Educational Excellence for Hispanic Americans February 22, 1994, and Executive Order 12876, Historically Black Colleges and Universities, November 1, 1993. Applications are 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 Sat Jun 14 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HS-98-002 - V26(20) 06/13/97 Date: 14 Jun 1997 21:34:54 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 498 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5nvrde$3at@net.bio.net> NNTP-Posting-Host: net.bio.net AHCPR INSTITUTIONAL TRAINING INNOVATION INCENTIVE AWARD PROGRAM NIH GUIDE, Volume 26, Number 20, June 13, 1997 RFA: HS-98-002 P.T. 44; K.W. 0720005, 0730050 Agency for Health Care Policy and Research Letter of Intent Receipt Date: July 10, 1997 Application Receipt Date: September 23, 1997 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications for incentive awards for innovative approaches to health services research training that are responsive to the research and analytic needs of the evolving health care delivery system. The intent of the awards is to support the design and implementation of new models for training health services researchers in order to address emerging issues in health care policy and delivery and to respond to the changing analytic needs of health care providers, payers, and policymakers. The awards represent seed money to support developmental efforts not readily supported by existing training mechanisms. They are aimed at developing and sustaining novel and unique educational approaches geared to enhancing established health services research training programs. Applications may address a wide spectrum of activities, including seminars, structured short-term research experiences designed to motivate and acquaint students with alternative career opportunities in health services research, hands-on research experiences in non-academic settings, cross-institutional collaboration to develop training curricula or other innovative strategies to advance areas where current capacity is limited, comprehensive and integrated curriculum and faculty development within and between academic institutions or between academic and non- academic settings, and the development of model programs to strengthen the recruitment and retention of minority health services research trainees. Applicants are encouraged to develop partnerships with traditionally minority academic institutions and health professional organizations to foster collaboration and experiential training. The overall intent is to maintain the solid academic base of existing training programs, while broadening that base to include an enhanced appreciation of the changing health care delivery system and related analytic and research needs. 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 high priority areas. AHCPR encourages applicants to address these 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 non-profit private and public institutions with established programs in predoctoral and/or postdoctoral health services research training. MECHANISM OF SUPPORT The mechanism of support will be the Education Projects (R25), which is designed for the development and/or implementation of programs related to education. The total project period for each application submitted in response to the RFA may not exceed 5 years. The earliest anticipated award date is May 1, 1998. FUNDS AVAILABLE AHCPR expects to award up to $1 million in Fiscal Year 1998, depending on the overall availability of funds to support the first year for approximately 20 projects under this RFA. Awards will reflect a balance between short- and longer-term projects. The number of awards is dependent on the number of high- quality applications and their individual budget requirements; it is not the intent of AHCPR that the awards be of equal size, but it is expected that the average annual award will approximate $50,000 in direct costs. For longer- term projects, funding beyond the initial budget period will depend upon annual progress reviews by AHCPR and the availability of funds. RESEARCH OBJECTIVES Background AHCPR currently supports institutional training programs through the National Research Service Award (NRSA) program. The purpose of these training programs is to help ensure that adequate numbers of highly trained individuals are available to carry out the Nation's health services research agenda. However, NRSA funds can be used only for a limited set of activities. This program provides support not readily available through other mechanisms for the development and/or implementation of innovative models for training health services researchers. The program will help ensure that health services research training programs reflect and address the restructuring occurring in the broader health care system, as discussed in the recent report by the Institute of Medicine, entitled Health Services Research: Work Force and Educational Issues, and by a 1996 expert meeting of researchers, providers, and payers, convened by AHCPR to address emerging issues in training. Areas of Training Traditionally, AHCPR has supported research that examines the availability, quality, appropriateness, effectiveness, and costs of health care services. AHCPR further seeks to address these issues specifically within the context of the current, rapidly evolving health care delivery system in order to meet the needs of patients, providers, plans, purchasers, and/or policy makers. Thus, a goal of this educational initiative is to equip students with the necessary knowledge, skills, and experiences to conduct future research which will address these needs. This will be accomplished by supporting the development and implementation of innovative training models which will enhance the existing substantive and methodological bases of established health services research training programs by providing students with the conceptual, methodological, and practical foundations to conduct research to: o Help consumers make more informed choices; o Determine what works best in clinical care; o Measure and improve quality of care; o Monitor and evaluate health care delivery; o Improve the cost-effective use of health care resources; o Provide health care policymakers with the information needed to make informed decisions; o Address issues of relevance to priority populations, including women, children, persons with chronic diseases or disabilities, the elderly, and minority populations; and o Build and sustain the health services research infrastructure Types of Projects Existing health services research training programs with established track records are eligible to compete for these innovative awards. Applicants are encouraged to address activities, such as the following: o Curriculum and/or faculty development. These initiatives would enhance the infrastructure to support training. Applications could focus on the administrative and programmatic needs required to put together worthy training initiatives. For example, this type of program would allow an institution and its faculty to: design and implement a new curriculum of critical importance to the education of health services researchers and responsive to the needs of the changing health care delivery system; to develop course content in areas of identified need (such as outcomes/health status measurement, quality of health care, evidence-based research findings, effectiveness research, biostatistics, epidemiology, health economics, decision analysis, cost- effectiveness analysis, and health policy); or to foster faculty development through such avenues as research experiences in nonacademic settings that would provide a direct benefit to students. o Development of partnerships with non-academic organizations and community health care providers. These partnerships would be designed to provide experience in applied research focused on identified delivery system needs that would translate into improved training. A variety of partnership arrangements are anticipated, including participation in curriculum development, the inclusion of highly-qualified, non-academic personnel in the training experiences of students; development of health services research student internships or practicums in non-academic research settings; and the leveraging of resources to expand the capacity for health services research training. o Facilitating recruitment and retention of minority trainees. Partnerships, as those noted above, would be developed with traditionally minority academic institutions and health professional organizations. o Short-Term Training. These programs can range from one day to several weeks and would focus on state-of-the-art research techniques and methodology needed in conducting applied HSR. They can take on many forms, such as seminars offered within or outside of the existing grantee institution, workshops, summer institutes, or short courses. They can be designed for a variety of purposes including, but not limited to, exposing students to careers in health services research, affording mid-career personnel exposure to new creative educational opportunities and technologies, or introducing and integrating community providers to health services research. Proposed activities of this nature need to be related to the basic thrust of existing training programs. SPECIAL REQUIREMENTS Budget Preparation and Allowable Costs In general, allowable costs must be consistent with PHS policy. These costs include, but are not limited to: supplies, personnel costs, consultant costs, equipment, travel (excluding foreign travel except where foreign travel is critical to achieving the objectives of the grant), sub- contractual costs, and other expenses. These awards are made to institutions and not students. Stipends and other routine student training expenses, such as tuition and fees, are not allowable. Faculty members participating in the design and implementation of education programs can request with proper justification the percent of their time devoted to curriculum design and specialized organizational, coordinating, and implementation activities which are essential to achieving the goals of their proposed educational program. Faculty-student preceptor-type interactions and activities, however, will be considered as a regular, nonreimbursable part of one's academic duties. In all cases, faculty compensation should not exceed levels commensurate with the institution's policy for similar positions. Applicants receive indirect costs in addition to the direct costs of the project. For the purpose of calculating indirect costs, education project grants are considered to be training grants. Therefore, in accordance with PHS policy, indirect costs are limited to eight percent of total allowable direct costs exclusive of expenditures for equipment, or at the institution's actual indirect cost rate, whichever results in a lesser dollar amount. Rights in Data AHCPR grantees may copyright or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHCPR funds. Such copyrights and patents are subject to a Federal Government license to use these products and materials for AHCPR purposes. AHCPR purposes may include, subject to statutory confidentiality protections, making research materials, data bases, and algorithms available for verification or replication by other researchers; and subject to AHCPR budget constraints, final products may be made available to the health care community and the public by AHCPR, or its agents, if such distribution would significantly increase access to a product and thereby produce public health benefits. Ordinarily, to accomplish distribution, AHCPR publishes research findings but relies on grantee efforts to market grant-supported products. In keeping with AHCPR's legislative mandates to make both research results and data available, copies of all products and materials developed under a grant supported in whole or in part by AHCPR funds are to be made available to AHCPR promptly and without restriction, upon request by AHCPR. The special terms of award described above are in addition to and not in lieu of otherwise applicable PHS grant policies and Federal regulations. LETTER OF INTENT Prospective applicants are asked to submit, by July 10, 1997, a letter of intent that includes a descriptive title of the proposed project; the names, addresses, and telephone numbers of the proposed Training Program Director and other key personnel; and the number and title of the RFA. Although a letter of intent is not required, is not binding, and does not enter into the consideration of any subsequent application, the information allows AHCPR staff to estimate the potential review workload and avoid conflicts of interest in the review. AHCPR will not provide responses to letters of intent. The letters of intent is to be addressed to: Karen Rudzinski, Ph.D. NRSA Project Officer Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 400 Rockville, MD 20852-4908 Email: training@ahcpr.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. State and local government applicants may use form PHS 5161-1, "Application for Federal Assistance" (rev. 5/96), and follow those requirements for copy submission. Applicants are reminded that the 25-page limit on the narrative section must be observed. In completing the PHS 398 form, designed primarily for research grants, applicants should make reasonable accommodations so that the requirements outlined in this RFA for an education grant are appropriately addressed. In particular, applicant should ensure that the substantive content of the application addresses the issues under Review Considerations. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, Office of Extramural Research, National Institutes of Health, 6701 Rockledge Drive MSC 7910, Bethesda, MD 20892-7910, Telephone: 301-435-0714, E-mail, asknih@odrockm1.od.nih.gov. AHCPR applicants should obtain application materials from the AHCPR contractor: Global Exchange, Inc., 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3015, Telephone: 301- 656-3100, Fax: 301-652-5264. The RFA label available in the form PHS 398 (rev. 5/96) must be affixed to the bottom of the face page of the original application. Failure to do so could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/carrier service) At the time of submission, two additional copies of the application must be sent to: Karen Rudzinski, Ph.D. NRSA Project Officer Office of Scientific Affairs Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 400 Rockville, MD 20852-4908 Applications submitted under this RFA must be received in the Division of Research Grants, NIH, by September 23, 1997. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Applications that are complete and responsive will be evaluated for technical and educational merit by an appropriate peer review group in accordance with AHCPR peer review procedures. Review Criteria Grant applications should be characterized by innovation, scholarship, and responsiveness to the special and/or changing needs of and demands for health services researchers. To ensure these objectives, educational program applicants will be evaluated using the following criteria: Project Characteristics o The novelty, significance, and rationale of the proposed project to health services research training and its responsiveness to the evolving needs of payers, providers, and/or policy makers; the manner in which the initiative logically builds upon and enhances the existing health services research training program. o The quality and adequacy of the design of the innovation proposed -- including the probability of achieving stated short- and long-term goals. o Substantive and methodological content of the proposed project and its relevance to the Program Objectives noted above, including relevant descriptions of courses and experiential opportunities offered and/or required. o The significance, quality, feasibility, and likely outcome of the unique, new dimension being proposed to enhance the basic training program. Program Leadership and Organizational Plans and Support o The institutional training environment, including criteria such as the level of institutional commitment, quality of the facilities, availability of appropriate courses, and availability of research support. o Program leadership in terms of past records of achievement and qualifications of the Training Program Director and key personnel to implement plans as proposed. o Organizational structure of the proposed training project, including delineation of administrative responsibilities for planning, oversight, and evaluation. o Demonstration of cooperation by any proposed collaborating facilities, institutions, or departments in providing research experiences and/or sites for trainees, including (where applicable) documentation of mechanisms by which trainees will be integrated into the ongoing health services research activities of other entities. o Evidence of the institution's commitment and plans to continue the project or output from the project once grant support ends, particularly when the innovative component involves curricula development aimed at strengthening the educational capability of the overall training program or when the project consists of educational activities directed toward or involving the larger community. o For projects involving students, the qualifications and experience of preceptors and their research support to impart specialized research skills. Project Institutionalization, Evaluation, and Dissemination Plans o Proposed methods for monitoring and evaluating performance of the project, particularly in reference to achieving Program Objectives noted above. o Demonstration of extent to which and ways in which AHCPR support will be leveraged to maximize the potential for innovation in health services research training. o Where appropriate, the adequacy of plans to diffuse or disseminate knowledge gained from the project to the health services research and/or health care delivery system community through appropriate publication in professional periodicals and journals, presentations at national meetings, and other vehicles. Budget o Reasonableness and value of the proposed budget relative to goals proposed. Combining the above factors, as appropriate, peer reviewers will determine an overall level of merit for the application, which will be reflected in a priority score. AWARD CRITERIA Funding decisions for these innovative awards to health services research training programs will be based on peer review, AHCPR research program priorities, the need for research personnel in specified program areas, balance among types of research training supported by AHCPR, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Copies of the RFA and related materials are available from: Global Exchange, Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20814-3015 Telephone: 301-656-3100 Fax: 301-652-5264 This RFA is available through the AHCPR's website: http:\\www.ahcpr.gov and through AHCPR InstantFAX at 301- 594-2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Follow the voice prompt in order to obtain a copy of the table of contents which has the document order number (not the same as the RFA number). The RFA will be sent at the end of the ordering process. AHCPR InstantFAX operates 24 hours a day, 7 days a week. For questions about this service, call AHCPR's Division of Communications at 301-594-1364, ext. 1389. Direct inquiries regarding programmatic issues to: Karen Rudzinski, Ph.D. NRSA Project Officer Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 400 Rockville, MD 20852-4908 Telephone: 301-594-1452, ext. 1610 E-mail: training@ahcpr.gov Direct fiscal and administrative inquiries to: Mable L. Lam Grants Management Officer Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: 301-594-1447, ext. 1165 Fax: 301-594-3210 Email: mlam@ahcpr.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.226. Awards are made under authorization of Title IX of the Public Health Services Act (42 U.S.C. 299-299c-6). Awards are administered under HHS and PHS Grant Policies and Federal regulations 42 CFR 67, Subpart A; and 45 CFR, Parts 74 and 92. The program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant 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 Sat Jun 14 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-060 - V26(19) 06/06/97 Date: 14 Jun 1997 21:30:18 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 341 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5nvr4q$2qu@net.bio.net> NNTP-Posting-Host: net.bio.net EXPLORATORY GRANTS FOR MULTIDISCIPLINARY CLINICAL STUDIES OF SARCOPENIA NIH GUIDE, Volume 26, Number 17, May 23, 1997 PA NUMBER: PA-97-060 P.T. 34; K.W. 0715136, 0710010, 0710030, 074030, 0785055 National Institute on Aging National Institute of Arthritis and Musculoskeletal and Skin Diseases THIS PROGRAM ANNOUNCEMENT IS A REVISION OF THE PA APPEARING IN THE MAY 9 ISSUE OF THE NIH GUIDE. THIS REVISION ADDS THE NIAMS AS A SPONSORING INSTITUTE OF THIS PROGRAM ANNOUNCEMENT. PURPOSE The National Institute on Aging (NIA) invites exploratory research grant (R21) applications for multidisciplinary, clinical studies on the mechanisms underlying the physical functional consequences of sarcopenia in older persons. This NIA exploratory grants program is intended to facilitate new collaborative efforts in the development of novel scientific hypotheses on the causes of changes in skeletal muscle morphology and/or metabolism which lead to physical disabilities in old age, by providing research support for the appropriate pilot/feasibility studies to refine these hypotheses. Multidisciplinary approaches may include collaborations between various types of clinical research expertise (e.g., epidemiology, geriatrics, rehabilitation medicine, biomechanics, exercise physiology), or between basic and clinical researchers, with or without previous aging research experience. 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 Grants for Multidisciplinary Clinical Studies of Sarcopenia, is related to the priority areas of chronic diseases and disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications for exploratory (R21) research grants may be submitted by foreign and domestic non-profit and for-profit, public and private, institutions such as a university, college, hospital, laboratory, units of State and local government; and eligible agencies of the Federal government. Applications may include collaborative arrangements between scientists from a single institution or multiple institutions. Simultaneous submissions of the same research project as both an exploratory grant and a regular research grant (RO1) will not be allowed. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as Principal Investigators. 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 should be included with the application. MECHANISM OF SUPPORT This program will use the NIH exploratory grant (R21) mechanism. Applicants may request up to $100,000 per year in direct costs, exclusive of indirect costs for any collaborating institutions. Funds may be included to support travel for the collaborators and/or the purchase of equipment, as justified by the needs of the proposed research. Because the nature and the scope of the research proposed in response to this PA may vary, it is anticipated that the size of awards will vary as well. The total project period for an application submitted in response to this PA may not exceed two years. These grants are non-renewable and continuation of projects developed under this program will be through the traditional unsolicited grants program. RESEARCH OBJECTIVES Background The physical functional consequences of sarcopenia in the elderly include mobility problems, falls and an increased risk for physical functional dependence. Numerous studies have attributed the inability of older persons to perform various tasks to a decline in muscle function (e.g., loss of strength, decreased muscle power), but there is a paucity of clinical information about the mechanisms leading to muscle dysfunction in old age. In the meantime, various animal models and in vitro systems developed to study specific alterations in muscle quality suggest that factors such as age-associated changes in muscle contractility, satellite cell function, innervation/denervation and myofibrillar protein turnover could play a role in muscle dysfunction. From a clinical perspective, it has been difficult to interpret the animal and in vitro data since very few clinical studies have attempted to bridge the gap between these mechanistic data and the clinical assessment of the physical functional status of the elderly. Given the wide variety of age-related changes in muscle quality which are thought to contribute to physical functional problems in old age, multidisciplinary approaches will be needed to better define the relationship between sarcopenia and deficits in physical performance. To initiate discussions on promising multidisciplinary approaches and novel methodologies available for elucidating the alterations in muscle quality underlying deficits in physical performance in the elderly, the NIA convened the workshop, "Sarcopenia and Physical Performance in Old Age" on July 9-10, 1996. Diverse research backgrounds (e.g., aging and non-aging research expertise, clinical and basic science investigators, skeletal muscle biology, exercise physiology, neurology, statistics) were represented by the workshop participants in the scientific sessions, which included: 1) Specific Study Design Considerations, 2) Muscle Function and Physical Performance and 3) Muscle Function and Pathophysiology. Abstracts of the presentations and a summary of the workshop recommendations will be published as a supplement to Muscle & Nerve, in early 1997. The main goals of the workshop were to: 1) stimulate more clinical studies of the relationship between changes in muscle function and specific limitations in physical performance, 2) encourage a focus on disabled and frail elderly populations, as well as minorities, 3) promote more comprehensive evaluations of muscle quality in clinical studies, particularly through the use of non-invasive measures of muscle properties, and 4) explore the possibility of more detailed analysis of human muscle biopsy samples through the adaptation of in vitro methods commonly used in animal studies. The NIA exploratory grants program is intended to encourage collaborations between various scientific disciplines to operationalize the workshop goals into future clinical studies of sarcopenia and its physical functional consequences. It is anticipated that the pilot/feasibility studies supported by the NIA exploratory grants program will constitute the scientific framework for larger, innovative clinical studies of the mechanisms underlying disabilities related to sarcopenia in old age. Objectives This initiative will provide research support to explore novel multidisciplinary approaches for understanding the clinical relevance of changes in skeletal muscle (i.e., at the cellular or organ level) in the context of the physical functional status of an older individual and, vice versa. Applications submitted in response to this PA must address the mechanistic aspects (i.e., alterations in skeletal muscle mass/quality with aging) of physical disabilities associated with sarcopenia. Topics of interest include, but are not limited to: o Quantitative assessment of muscle quality and function associated with various levels of physical performance (e.g., relationship between muscle fatigue and ability/inability to climb stairs; rate of muscle force development and ability to react to "time-critical" situations) o Pilot studies of the clinical application of basic research findings o Correlative data between non-invasive measures of muscle quality and measures from animal or in vitro experimental measures of muscle properties (e.g., blood supply, contractility) o Feasibility studies required to "translate" findings from small-scale mechanistic studies to population-based studies of the functional consequences of sarcopenia o Potential ethnic or gender differences in the determinants (i.e., of changes in muscle quality/function) of physical disabilities associated with sarcopenia o Impact of chronic diseases on muscle function/quality and its physical functional consequences in old age 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous 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 February 1, June 1 and October 1 application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division 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 completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. As part of the initial merit review, all 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 of review by the appropriate national advisory council. Review Criteria o Scientific, technical, or medical significance and originality of the proposed research; o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o Qualifications and research experience of the Principal Investigator, collaborators and key research personnel, particularly but not exclusively, in the area of proposed research; o Availability of adequate facilities, general environment for the conduct of the proposed research and feasibility of the collaborative arrangements; o Appropriateness of the proposed budget and duration in relation to the proposed research; o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, and the safety of the research environment. AWARDS CRITERIA Scored applications will compete for available funds with all other scored applications assigned to that Institute/Center. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review; o Availability of funds; and o Program balance among research areas of the program announcement. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applications is welcome. Direct inquiries regarding programmatic issues to: Chhanda Dutta, PhD Geriatrics Program National Institute on Aging Gateway Building, Suite 3E-327 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 435-3048 FAX: (301) 402-1784 Email: DuttaC@gw.nia.nih.gov Richard W. Lymn, PhD Muscle Biology and Musculoskeletal Fitness Program Director National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS 49E Bethesda, MD 20892-6500 Telephone: (301) 594-5128 FAX: (301) 480-4543 Email: lymnr@ep.niams.nih.gov Direct inquiries regarding fiscal matters to: Mr. Joseph Ellis Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: EllisJ@gw.nia.nih.gov Ms. Sally A. Nichols National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS 49F Bethesda, MD 20892-6500 Telephone: (301) 594-3535 FAX: (301) 480-5450 Email: nicholss@ep.niams.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866, Aging Research and No. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sat Jun 14 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 20, pt. 1of1, 13 June 1997 Date: 14 Jun 1997 21:33:39 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 602 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5nvrb3$33n@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 26, No. 20 - June 13, 1997 $$INDEX BEGIN ******************************************************* NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 09/23/97 ************************************************* NATIONAL RESEARCH SERVICE AWARD--INSTITUTIONAL GRANTS POLICY AND GUIDELINES (RFA HS-98-001) Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH $$INDEX R2 09/23/97 ************************************************* AHCPR INSTITUTIONAL TRAINING INNOVATION INCENTIVE AWARD PROGRAM (RFA HS-98-002) Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH $$INDEX R3 09/16/97 ************************************************* HEALTH CARE QUALITY IMPROVEMENT AND QUALITY ASSURANCE RESEARCH (RFA HS-98-003) Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH $$INDEX R4 01/06/98 ************************************************* EFFECTIVENESS OF CHILDREN'S MENTAL HEALTH AND SUBSTANCE ABUSE TREATMENT IN THE GENERAL HEALTH SECTOR (RFA HS-98-004) Agency for Health Care Policy and Research National Institute on Drug Abuse National Institute of Mental Health Substance Abuse and Mental Health Services Administration INDEX: HEALTH CARE POLICY, RESEARCH; DRUG ABUSE; MENTAL HEALTH; SUBSTANCE ABUSE, MENTAL HEALTH SERVICES $$INDEX P1 ********************************************************** INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARD IN SLEEP RESEARCH (PA- 97-064) National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX P2 ********************************************************** MBRS RESEARCH INITIATIVE FOR SCIENTIFIC ENHANCEMENT (RISE) (PAR-97- 067) National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES $$INDEX P3 ********************************************************** MBRS SUPPORT OF CONTINUOUS RESEARCH EXCELLENCE (SCORE) (PAR-97-068) National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES The NIH GUIDE is available electronically via LISTSERV 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. 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) ASKNIH is a service of the Division of Extramural Outreach & Information Resources, Office of Extramural Research, Office of the Director, NIH. ASKNIH is the point of contact for obtaining general information about NIH extramural research & research training programs, requesting publications, and learning more about obtaining the NIH GUIDE and other information on the NIH web site. ASKNIH is also the contact aid which organizations should request application kits and forms. ASKNIH NATIONAL INSTITUTES OF HEALTH EMAIL: ASKNIH@odrockm1.od.nih.gov FAX: (301) 480-0525 TELEPHONE: (301) 435-0714 INQUIRIES ABOUT THE NOTICES, PAs, AND RFAs IN THIS PUBLICATION SHOULD BE DIRECTED TO THE NIH STAFF MEMBER IDENTIFIED AT THE END OF EACH ITEM. 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. $$INDEX END ********************************************************* $$R1 BEGIN HS-98-001 FULL-TEXT ************************************** NATIONAL RESEARCH SERVICE AWARD--INSTITUTIONAL GRANTS POLICY AND GUIDELINES NIH GUIDE, Volume 26, Number 20, June 13, 1997 RFA AVAILABLE: HS-98-001 P.T. 22, 44; K.W. 0720005, 1014006 Agency for Health Care Policy and Research Letter of Intent Receipt Date: July 10, 1997 Application Receipt Date: September 23, 1997 PURPOSE The Agency for Health Care Policy and Research (AHCPR) awards National Research Service Award (NRSA) institutional training grants (T32) to eligible institutions to develop research training opportunities for qualified individuals selected by the institution who have demonstrated an interest in health services research and who seek to prepare for careers in the systematic examination of the organization, provision, financing, and effectiveness of health care services. 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, in order to improve quality, assure value for health dollars spent, and enhance access to services. A goal is to equip students with the necessary knowledge, skills, and experiences to conduct future research which will meet the needs of patients, providers, plans, purchasers, and/or policy makers. Accomplishing the above effectively will require fostering a mixture of academic and applied training opportunities to meet the needs of students who wish to pursue traditional academic careers, as well as those who opt for careers in applied research settings. Applicants are encouraged to foster cooperation and partnerships with relevant components of the health care delivery system. NRSA institutional training grants assist domestic institutions in supporting predoctoral and postdoctoral academic training. The awards allow trainees to gain one or more years of experience in applying research methods to the evaluation of health services. The AHCPR will not support short-term training through this mechanism. Predoctoral Training. Predoctoral research training must lead to the Ph.D. Degree or a comparable research doctoral degree. Students enrolled in health-professional programs that are not part of a formal, combined program (e.g., M.D./Ph.D.) and who wish to postpone their professional studies in order to gain research experience may also be appointed to a T32 grant. Predoctoral research training must emphasize fundamental training in areas relevant to health services research. Postdoctoral Training. Postdoctoral research training is for individuals who have a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Research training at the postdoctoral level must emphasize specialized training to meet national priorities in health services research. A research training grant is a desirable mechanism for the postdoctoral training of physicians and other health professionals who have extensive clinical training, but limited research experience. For such individuals, the training may be a part of a research degree program. In all cases, health-professional postdoctoral trainees should agree to engage in at least two years of research, research training, or comparable activities beginning at the time of appointment since the duration of training has been shown to be strongly correlated with post-training research activity. Depending on the availability of funds, AHCPR expects to award up to $3,500,000 in FY 1998 to support the first year for approximately 15 to 24 projects under this RFA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting high priority areas. AHCPR encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001- 00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202-512-1800. 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), the NIH Website (http://www.nih.gov), the AHCPR Website (http://www.ahcpr.gov), and by mail and fax from Global Exchange at the address listed below. Global Exchange, Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20814-3015 Telephone: (301) 656-3100 FAX: (301) 652-5264 $$R1 END ************************************************************ $$R2 BEGIN HS-98-002 FULL-TEXT ************************************** AHCPR INSTITUTIONAL TRAINING INNOVATION INCENTIVE AWARD PROGRAM RFA AVAILABLE: HS-98-002 P.T. 44; K.W. 0720005, 0730050 Agency for Health Care Policy and Research Letter of Intent Receipt Date: July 10, 1997 Application Receipt Date: September 23, 1997 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications for incentive awards for innovative approaches to health services research training that are responsive to the research and analytic needs of the evolving health care delivery system. The intent of the awards is to support the design and implementation of new models for training health services researchers in order to address emerging issues in health care policy and delivery and to respond to the changing analytic needs of health care providers, payers, and policymakers. The awards represent seed money to support developmental efforts not readily supported by existing training mechanisms. They are aimed at developing and sustaining novel and unique educational approaches geared to enhancing established health services research training programs. Applications may address a wide spectrum of activities, including seminars, structured short-term research experiences designed to motivate and acquaint students with alternative career opportunities in health services research, hands-on research experiences in non-academic settings, cross-institutional collaboration to develop training curricula or other innovative strategies to advance areas where current capacity is limited, comprehensive and integrated curriculum and faculty development within and between academic institutions or between academic and non- academic settings, and the development of model programs to strengthen the recruitment and retention of minority health services research trainees. Applicants are encouraged to develop partnerships with traditionally minority academic institutions and health professional organizations to foster collaboration and experiential training. The overall intent is to maintain the solid academic base of existing training programs, while broadening that base to include an enhanced appreciation of the changing health care delivery system and related analytic and research needs. AHCPR expects to award up to $1 million in Fiscal Year 1998, depending on the overall availability of funds to support the first year for approximately 20 projects under this RFA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting high priority areas. AHCPR encourages applicants to address these 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 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), the NIH Website (http://www.nih.gov), the AHCPR Website (http://www.ahcpr.gov), and by mail and fax from Global Exchange at the address listed below. Global Exchange, Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20814-3015 Telephone: (301) 656-3100 FAX: (301) 652-5264 $$R2 END ************************************************************ $$R3 BEGIN HS-98-003 FULL-TEXT ************************************** HEALTH CARE QUALITY IMPROVEMENT AND QUALITY ASSURANCE RESEARCH NIH GUIDE, Volume 26, Number 20, June 13, 1997 RFA AVAILABLE: HS-98-003 P.T. 34; K.W. 0730050, 0730021 Agency for Health Care Policy and Research Letter of Intent Receipt Date: August 1, 1997 Application Receipt Date: September 16, 1997 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications for research and demonstration projects on the use of measurement in improving the quality of health care. Applications are sought in three areas: (1) methods and measures to allow translation of scientific information about medical care into quality measures and strategies to improve clinical practice; (2) studies of the relationship between organizational change and quality measurement and improvement in health care; and (3) studies of the use of information derived from measurement about quality of care by consumers, patients, employers, providers, and insurers to make decisions. AHCPR is especially interested in projects that will produce results within one to two years, although a balance is sought between short- and long-term projects, and projects of up to five years will be considered. Depending on the availability of funds, AHCPR expects to award up to $2.0 million in fiscal year 1998 to support the first year of 8 to 10 projects under this RFA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. AHCPR encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202-512-1800. 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), the NIH Website (http://www.ahcpr.gov), and by mail and fax from Global Exchange at the address listed below. Global Exchange Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20814-3015 Telephone: (301) 656-3100 FAX: (301) 652-5264 $$R3 END ************************************************************ $$R4 BEGIN HS-98-004 FULL-TEXT ************************************** EFFECTIVENESS OF CHILDREN'S MENTAL HEALTH AND SUBSTANCE ABUSE TREATMENT IN THE GENERAL HEALTH SECTOR NIH GUIDE, Volume 26, Number 20, June 13, 1997 RFA AVAILABLE: HS-98-004 P.T. 34, AA; K.W. 0715095, 0404009, 0415001, 0745070 Agency for Health Care Policy and Research National Institute on Drug Abuse National Institute of Mental Health Substance Abuse and Mental Health Services Administration Letter of Intent Receipt Date: November 13, 1997 Application Receipt Date: January 6, 1998 PURPOSE The Agency for Health Care Policy and Research (AHCPR), in cooperation with the National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), and the Substance Abuse and Mental Health Services Administration (SAMHSA) invites applications for research on the effectiveness and/or cost-effectiveness of child mental health and substance abuse treatment interventions and guideline-based treatment strategies for children, adolescents, and youth in the general health sector. Guideline- and other evidence-based aids for clinical decisionmaking may go beyond specific treatment interventions to include possible combinations of specific treatments. Guideline- and other evidence-based aids may include algorithms, practice guidelines, treatment protocols, and practice parameters. AHCPR expects to award up to $1.5 million in fiscal year 1998 to support the first year of approximately three to five projects under this RFA. The number of AHCPR awards is dependent on the number of high quality applications and their individual budget requirements. NIDA expects to award up to $0.5 million in fiscal year 1998, dependent on the quality of the applications relevant to drug abuse and the availability of funds. NIMH expects to award up to $1.0 million, and SAMHSA up to $0.5 million, in fiscal year 1998, dependent upon the quality of the applications and the availability of funds. 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. Applicants are encouraged to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202-512-1800. 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), the NIH Website (http://www.nih.gov), the AHCPR Website http://www.ahcpr.gov), and by mail and fax from Global Exchange at the address listed below. Global Exchange Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20814-3015 Telephone: (301) 656-3100 FAX: (301) 652-5264 $$R4 END ************************************************************ $$P1 BEGIN PA-97-064 FULL-TEXT ************************************** INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARD IN SLEEP RESEARCH NIH GUIDE, Volume 26, Number 20, June 13, 1997 PA AVAILABLE: PA-97-064 P.T. 44; K.W. 0715187, 0720005, 0710030 National Institutes of Health THIS PROGRAM ANNOUNCEMENT IS A REVISION OF THE PA APPEARING IN THE MAY 30 ISSUE OF THE NIH GUIDE. THIS REVISION REFLECTS THE FACT THAT THIS IS AN NIH-WIDE PROGRAM ANNOUNCEMENT. PURPOSE The National Institutes of Health (NIH) invites applications for Institutional National Research Service Award (NRSA) in Sleep Research. The overall goal of this training program is to increase the number of sleep researchers that are available to investigate the basic biology of sleep; to explore epidemiological, behavioral, and clinical aspects of sleep-related disorders; and to develop new approaches for the treatment and prevention of these conditions. A specific objective is to ensure that scientists, highly trained in sleep research, are available in adequate numbers to address important gaps in our biomedical and biological understanding of sleep including those outlined in the NIH Director's Sleep Disorders Research Plan. Potential applicants are strongly urged to contact the NCSDR before preparing an application. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, National Research Service Award Institutional Training Grants in Sleep Research, is related to the priority areas of heart disease and stroke, chronic disabling conditions, mental health and disorders, and clinical prevention services. 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 printing office, Washington DC 20402-9325 (Telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH Gopher (gopher://gopher.nih.gov) and by mail and E-mail from the program contact listed below. James P. Kiley, Ph.D. National Center on Sleep Disorders Research National Heart, Lung, and Blood Institute/NIH 6701 Rockledge Drive, Suite 7024, MSC 7920 Bethesda, MD 20892-7920 Telephone: (301) 435-0199 Email: kileyj@gwgate.nhlbi.nih.gov $$P1 END ************************************************************ $$P2 BEGIN PAR-97-067 FULL-TEXT ************************************* MBRS RESEARCH INITIATIVE FOR SCIENTIFIC ENHANCEMENT (RISE) NIH GUIDE, Volume 26, Number 20, June 13, 1997 PA AVAILABLE: PAR-97-067 P.T. 14, FF; K.W. 0502000, 0710030 National Institute of General Medical Sciences Application Receipt Dates: February 1, June 1, October 1 PURPOSE The purpose of the MBRS Research Initiative for Scientific Enhancement (RISE) program is to enhance the research environment at minority serving institutions. The goal is to increase the opportunities for underrepresented minority faculty and students to become acquainted with, and motivated to pursue biomedical research careers. The RISE program replaces and expands upon the student development component of the traditional MBRS (S06) program and the MBRS program for undergraduate colleges (S14). The RISE program should provide enhanced flexibility in faculty and student development activities, as well as provide the opportunity for development of the institution's research and research education capability. The MBRS RISE program supports faculty, student and institutional development activities at both undergraduate and graduate institutions. Applicants may propose activities in any one or more of these areas. INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Ernest D. Marquez, Ph.D. MBRS Branch National Institute of General Medical Sciences 45 Center Drive, Suite 2AS.37, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-3900 FAX: (301) 480-2753 Email: marqueze@gm1.nigms.nih.gov $$P2 END ************************************************************ $$P3 BEGIN PAR-97-068 FULL-TEXT ************************************* MBRS SUPPORT OF CONTINUOUS RESEARCH EXCELLENCE (SCORE) NIH GUIDE, Volume 26, Number 20, June 13, 1997 PA AVAILABLE: PAR-97-068 P.T. 34, FF; K.W. 0710030 National Institute of General Medical Sciences Application Receipt Dates: February 1, June 1, October 1 PURPOSE The purpose of the Minority Biomedical Research Support (MBRS) Support of Continuous Research Excellence (SCORE) program is to provide financial assistance to competitive research programs in all areas of biomedical and behavioral research at institutions with significant underrepresented minority student enrollment. The intent of this announcement is to provide grants to support research by faculty members at minority serving institutions. The SCORE program replaces the research component of the traditional MBRS (S06) program and the pilot research projects of the S14 program. By eliminating or modifying some of the restrictions of the traditional S06 and S14 programs, the SCORE program allows enhanced flexibility in the development of research projects. In addition, the MBRS Branch recognizes that minority and minority-serving institutions are diverse in institutional environment and mission. Therefore, with respect to evaluation activities, this program requires that the institution set its own specific goals and measurable objectives. INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Ernest D. Marquez, Ph.D. MBRS Branch National Institute of General Medical Sciences 45 Center Drive, Suite 2AS.37, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-3900 FAX: (301) 480-2753 Email: marqueze@gm1.nigms.nih.gov $$P3 END ************************************************************ From owner-sci-resources@net.bio.net Sat Jun 14 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-066 - V26(19) 06/06/97 Date: 14 Jun 1997 21:30:57 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 363 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5nvr61$2t1@net.bio.net> NNTP-Posting-Host: net.bio.net SECONDARY ANALYSIS OF EXISTING HEALTH SERVICES DATA SETS NIH GUIDE, Volume 26, Number 19, June 6, 1997 PA NUMBER: PA-97-066 P.T. 34; K.W. 0404003, 0730050, 0408006 National Institute on Alcohol Abuse and Alcoholism PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is soliciting exploratory/developmental research grant applications (R21) to support the secondary analysis of existing data sets relevant to developing a knowledge base to improve the delivery of services for alcohol-related problems, including both treatment and preventive interventions. Exploratory/developmental grants for the Secondary Analysis of Existing Health Services Data Sets are intended to more fully utilize currently available data sets and to provide support for substantive exploratory or confirmatory studies that increase knowledge related to improving the availability, accessibility, delivery, quality, effectiveness, cost-effectiveness, and outcomes of alcohol-related treatment and prevention services. Data used in secondary analyses may be obtained from current or past investigator-initiated research activities or from other archival data sets from public or private sources. In addition, research that employs new analytic techniques that demonstrate or promote methodological advances in the area of alcohol-related health services research are of particular interest. Grants supported under this announcement must be limited to a 2-year effort and a maximum of $100,000 in direct costs per year. Research objectives of this announcement include, but are not limited to, five major areas: (1) determining the effects of financing and reimbursement mechanisms on alcohol-related health care program availability, accessibility, delivery, organization, content, quality, and outcomes; (2) assessing sources of variation in access to and utilization of treatment and prevention interventions for alcohol-related problems; (3) identifying organizational and managerial factors that influence the delivery of treatment and prevention services for alcohol-related problems, either within or across regions, populations, and settings; (4) evaluating the cost, cost-effectiveness, cost-benefit, and cost-utility of alcohol-related treatment and prevention services; and (5) identifying and assessing the effectiveness and outcomes of alcohol-related treatment and preventive services. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS-led national activity for setting priority areas. This program announcement is related to the priority areas of alcohol abuse reduction and alcoholism treatment. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0, or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (Telephone: 202-783-3238). 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. MECHANISM AND PERIOD OF SUPPORT Research support may be obtained through an application for an exploratory/developmental research grant (R21). Grant applications must be limited to up to $100,000 in direct costs per year for up to 2 years. The number of new awards made in any fiscal year will depend on the quality of applications, the availability of funds, and program priorities at the time of award. Continuation awards will be made subject to continued availability of funds and progress achieved. RESEARCH OBJECTIVES The National Institute on Alcohol Abuse and Alcoholism wishes to promote the use of secondary analyses of data in the expansion of knowledge to improve the delivery of services for alcohol-related problems where appropriate data sets and analytic techniques are available and can be employed. The specific objectives of this announcement on the Secondary Analysis of Existing Health Services Data Sets are to provide support for (a) applying new approaches to analyze current data sets that would benefit from further exploration or (b) reanalyzing previously collected data that would provide cost effective ways of obtaining additional insights into alcohol-related health services research issues. Grants under this announcement are not intended as a means to carry out currently ongoing data analysis or for the maintenance and distribution of data sets. BACKGROUND Health services research projects typically generate data sets with potential utility beyond the specific hypotheses and questions for which the study was designed. Very often these data are not fully analyzed, sometimes due to a lack of resources once a project's funding has ended. Reanalysis of existing data may be prompted by a need to confirm new findings in the field or to aid in the development of new research questions. Other data sets, including survey and epidemiologic data as well as health care utilization, cost, and insurance claims data, are compiled by Federal, State, and local government agencies, or by private entities such as insurance companies, third-party payors, and large to mid-size corporations. Such data sets are potentially rich sources of information that can illuminate a wide range of research questions and policy-relevant topics. In some cases, use of existing data sets may provide an expeditious and cost-effective means of advancing knowledge. When appropriate, secondary data analyses may serve as an alternative approach to expensive and time-consuming data collection projects. Existing data sets may be used to cross-validate exploratory analyses in ongoing studies, to test specific hypotheses or complex statistical models, and in special circumstances to provide comparison groups for experimental studies. Meta-analyses, in which effects from many studies may be compared or combined, may also be considered a form of secondary data analysis for the purposes of this program announcement. Moreover, potential applicants should note that secondary analysis may extend to all types of data, including qualitative information, and also covers the integration of quantitative and qualitative data. AREAS OF RESEARCH INTEREST Health services research is defined as "research endeavors that study the impact of the organization, financing and management of health services on the quality, cost, access to and outcomes of care" (PL 101-321, Section 409). Health services research also is concerned with assessing the effectiveness of health services in everyday practice. For the purposes of this announcement, health services research includes: (a) the assessment of the impact of health services and the effects of organizational and financing arrangements in "real world" clinical settings on the quality and outcomes of care provided to patients with alcohol abuse and alcoholism or with medical problems consequent to alcoholism; and (b) the assessment of the impact of prevention services on the demand for and utilization of alcohol-related services as well as the financing, organization, management, implementation, cost, and utilization of the prevention services themselves. It should be noted further that, as directed by legislation (P.L. 103-43), for the purposes of this announcement, health services research does not include studies of the efficacy of preventive, diagnostic, and treatment modalities. Applicants may choose to carry out analyses relevant to alcohol-related health services research using large, nationally-representative data sets or smaller, regional, and locally-based data sets. A number of such data sets exist in the public domain, which contain items relevant to alcohol use and abuse and may not have been fully analyzed. Two resource documents are readily available from NIAAA which list data sets that may be of potential interest to health services researchers: (1) Inventory of Databases for Health Services Research on Alcohol Treatment and Prevention, which lists publicly- and privately-supported data sets containing information on the utilization, cost, financing, management, organization, or effectiveness of alcohol treatment or prevention services (copies may be obtained from the NIAAA Health Services Research Program, 6000 Executive Boulevard, MSC 7003, Bethesda, MD 20892-7003; 301/443-0786); and (2) Alcohol Epidemiologic Data Directory, which identifies national-scope and special population data sets that are available for expanded epidemiologic study (copies may be obtained from CSR Incorporated, Suite 200, 1400 Eye Street, NW, Washington, D.C. 20005; 202/842-7600). Other examples include many longitudinal or cross-sectional surveys carried out by agencies of the Federal Government (including, for example, the National Center for Health Statistics and the Centers for Disease Control and Prevention), various State governments, and regional or local governments. Alternatively, applicants may of their own initiative secure access to other data sets that are not in the public domain, such as those collected under research grant funds, sponsored by private agencies, or originally collected for purposes other than research. Examples of general types of secondary analyses that may be considered within the scope of this announcement are given below. This list is illustrative and not exhaustive; prospective proposals should not be limited by these examples. Any proposed research should be guided by scientific considerations and the potential benefit of the proposed analyses. Large sample or multiple sample comparisons: In this category, investigators may seek large archival data sets with identified subgroups or multiple data sets for comparison with each other. For example, an investigator may wish to obtain two or more data sets for the development and testing of integrated research hypotheses for multiple cohorts, different genders, or different ethnic groups. Methodology development: Single or multiple data sets may be obtained to demonstrate new or improved research design, measurement, or analytic techniques. For example, researchers may wish to develop new analytic techniques for longitudinal designs that take into account transitions between alcohol and other drug use behavior over time, or the simulation of complex systems that predict alcohol use at an individual, group, or community level. Measurement issues may also be addressed for different variable and construct domains to facilitate more accurate item equating, norming and further validation of outcome measures, or the development of new measures. The development of improved techniques to measure the costs, cost-effectiveness, or cost-benefits of alcohol treatment and prevention services is encouraged under this announcement. New analyses of a current study: This would allow the investigator to take advantage of opportunities for additional analyses if they are justified as a new stand-alone research project grant for secondary data analysis. These additional analyses may be ideal for cross-validation of results on appropriate comparison groups and lead to improved generalizability of results. Developmental Projects: Some investigators may be interested in examining the feasibility of using certain types of data records or certain kinds of data sets as resources for answering alcohol-related health services research questions, especially if the proposed secondary analyses have not yet been widely-used on those types of records or data sets. Examples include abstracting from medical encounter records, accessing insurance claims and reimbursement data, and analyzing epidemiological or general health data. 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 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 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 completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) REVIEW CONSIDERATIONS Applications that are complete and responsive to the program announcement 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 council. REVIEW CRITERIA Scientific, technical, or medical significance and originality of proposed research; Appropriateness and adequacy of the analytic approach and methodology proposed to carry out the research; Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; Availability of the resources necessary to perform the research; Appropriateness of the proposed budget and duration in relation to the proposed research; and 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, confidentiality of information, 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: Harold I. Perl, Ph.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: 301-443-0788 FAX: 301-443-8774 E-mail: hperl@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Edward Ellis Grants Management Branch National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard, MSC 7003 Bethesda, Maryland 20892-7003 Telephone: 301-443-4703 FAX: 301-443-3891 E-mail: eellis@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sat Jun 14 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-065 - V26(19) 06/06/97 Date: 14 Jun 1997 21:30:35 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 520 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5nvr5b$2s3@net.bio.net> NNTP-Posting-Host: net.bio.net SOCIAL COGNITION AND AGING NIH GUIDE, Volume 26, Number 19, June 6, 1997 PA NUMBER: PA-97-065 P.T. 34; K.W. 0710010, 0414005 National Institute on Aging PURPOSE The National Institute on Aging (NIA) invites qualified researchers to submit research and training grant applications on social cognition and aging. The social cognitive paradigm concerns the ways in which mental representations of social events, societal and cultural norms and personal characteristics influence behavior, reasoning, emotion and motivation. Specifically, the approach addresses attributions, self and social goals, mental representations of the self and others, and the role of social facilitation in decision-making, memory and judgment. Research suggests that complex cognitive functioning-involved in coping, everyday problem-solving and decision-making in health and social domains-depends not only on basic cognitive mechanisms, but also on socially-derived content and organization of existing knowledge structures as well as on socially-derived emotional and motivational influences on performance. The NIA encourages the application of social-cognitive approaches to research on middle-aged and older people. The ultimate goal of such research is to improve health maintenance and promotion, coping with age-related losses, social relationships, and adaptive functioning in daily life as people age. This announcement is coordinated with the National Institute of Mental Health (NIMH), which supports a range of topics in social cognition, and with the National Institute of Child Health and Human Development (NICHD), which supports applications about the normative cognitive, social, motivational and affective development of children from infancy through adolescence. (See INQUIRIES, below) HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS-led national activity for setting priority areas. This PA is related to the priority area of Diabetes and Chronic Disabling Conditions. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by 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. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) awards (R29). 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 the investigator-initiated research project grant (R01) and FIRST award (R29). Also see "Pilot Grants in the Behavioral and Social Science of Aging," NIH Guide to Grants and Contracts, Volume 26, Number 5, February 14, 1997. RESEARCH OBJECTIVES The NIA seeks grant applications for the study of social cognition and aging that address one or more of the following: (A) age-related changes in knowledge structures/schemas, self representation, and defense mechanisms; (B) the effects of context (e.g., cultural, cohort, social situational) on cognitive performance and social reasoning as people age; (C) the interaction among aging, social cognition, emotion, and motivation; and (D) the effect of age-related changes in basic cognitive skills on social judgments.The following examples suggest areas that are appropriate for submissions. They are intended to be illustrative rather than exhaustive. A. AGE-RELATED CHANGES IN KNOWLEDGE STRUCTURES OR SCHEMAS A substantial literature exists on mental representations about the self and others, social scripts, stereotypes, implicit theories and the role of beliefs in health and illness. These knowledge structures play an important role in the interpretation of events, organization of new information, goal setting and motivation to act in specific ways. To date, however, relatively little empirical evidence exists on possible age differences in the elaboration, consistency and consequences of knowledge structures, or on the ways in which these knowledge structures influence thought and action as people age. 1. How do knowledge structures change as a function of development and changing environments in adulthood and aging? Are some types of social knowledge more likely to change than others? Do individuals' belief in a "just world" and needs for consistency change with aging? 2. How do individual differences in knowledge and beliefs facilitate adaptation in old age? How do age-related differences influence the interpretation of events, the motivation to engage in cognitive performance or specific behaviors (e.g., health-medical decisions)? How do social cognitive processes and schemas affect older people's conceptions of specific diseases? How do they affect health-related behaviors such as medication use? What methods aid in the restructuring of beliefs to encourage adaptive health practices as people age? 3. How do older adults mentally represent social problems (e.g., in terms of causal attributions, problem interpretation and importance)? What effects do such representations have on everyday problem solving? 4. How do stereotypic beliefs about aging and the elderly influence conceptions of self and others? Do individuals' stereotypes change with their own aging and, if so, with what effects? 5. How do social cognitive processes affect adaptation to cognitive and health-related changes with age without showing deteriorated performance in everyday functioning? Similarly, how do older people maintain a sense of well-being when age is associated with numerous threats to the self? 6. Do self-efficacy beliefs change with aging? Which age-related processes or conditions promote stability or change? How are self-efficacy beliefs accessed and modified? What are the mechanisms by which self-efficacy, once activated, influences behavior and do these mechanisms change with aging? (Viz. Sense of Control throughout the Life Course, NIH Guide to Grants and Contracts, vol. 18, no. 13, April 1, 1989.) B. CONTEXTUAL AND FUNCTIONAL PERSPECTIVES ON SOCIAL COGNITION AND AGING Multiple layers of social context-from the immediate environment of the individual to the larger sociocultural context-influence development and aging. In order to understand the individual in context, both the properties of context and the nature of the individual's representations of those properties need to be considered, especially as they both may change with aging. For example, how do age-related sociocultural and socio-contextual influences on self-representations and knowledge structures affect memory, decision-making, cognition, problem-solving and coping? 1. How do perceptions of problems, self-schemas, and defense mechanisms influence and are influenced by social interactions? Although most people discuss concerns with other people prior to making decisions and resolving problems, a meager amount of research examines decision-making as a social process in the middle and later years. 2. How does the social environment influence cognitive processing in old age? How do interactions with social partners enhance memory, e.g., collaborative memory? How do older individuals access and use information under particular kinds of situational/environmental demands? 3. Do causal attributions of social interactions change with age? Are these attributions predictive of changes in social behavior? Are there age differences in person perception? 4. Given that cultural transmission of sociocultural information to younger adults has been espoused as a prototypic cognitive task for older adults, how do social cognitive processes operate in the context of group processes, dyadic interactions, etc.? How do mismatches in social knowledge affect communication among older adults and health professionals, caregivers, financial advisers, etc.? 5. As people grow older, how do particular social roles and situations such as gender, birth cohort, culture, socio-economic status, ethnicity, etc. influence social knowledge? C. AGING, SOCIAL COGNITION, EMOTION, AND MOTIVATION Emotional states importantly influence cognitive performance, and social cognitive appraisals influence emotional experience. Similarly, important reciprocal relations exist between motivation and social cognition. On the one hand, various motivational factors may bias the (social) cognitive process, affecting its extent, depth and directionality. On the other hand, goals (fundamental motivational constructs) have important social cognitive components. They are formed, activated, and applied in the same way as are other cognitive structures. These issues could be relevant to aging. Although complex models illuminating these issues are emerging in the social and behavioral sciences, application to research of aging is infrequent. 1. What societal beliefs about emotion influence emotional experience in old age? To what extent do current cohorts of older adults anticipate negative experience in emotional arenas? What is the impact of age-related beliefs about emotion on social attitudes and behaviors? 2. Is the relationship between mood and memory altered with age? Does the relationship between arousal and performance vary across the adult life span? What is the role of social cognitive processes in these relationships? 3. Some evidence suggests that information processing becomes increasingly "emotional" with age. If so, how do such changes improve or impede social reasoning about, for example, medical decision-making or advice giving, interpersonal relationships? 4. What age-related qualitative and/or adaptive changes take place in emotional development and regulation? In contrast to the cognitive representation of emotions, what is the phenomenological experience of emotion (the current level of functioning of emotional experience) of the older adult? How do social cognitive processes affect this experience? 5. Does the lowering of energy resources presumably occurring during aging affect the individual's nondirectional cognitive motivations? For instance, is aging positively correlated with a rising need for cognitive closure? If so, is aging characterized by stereotyping, insufficient adjustment of initial opinions in light of new information, a preference for similarly minded others, etc? 6. Does aging affect the configuration of individual directional motivations? For instance, do achievement, or social dominance and power motivations decline, while affiliation motivation, and health concerns increase with aging? What effects might these have on various information-processing biases, such as attribution of (positive or negative) achievement vs. health-related outcomes? 7. How do goals and goal-setting processes differ, if at all, as people age? Do people's goals change qualitatively and/or quantitatively as they become older (e.g., more short term, more specific and concrete, less self-focused)? To what extent are the characteristics of goals in old age mediated by meta-cognitions about, e.g. the amount of time left for goal accomplishment? 8. How are age-related changes in motivation related to social preferences and social goals? What is the role of social motivation in social network composition? Are there motivated changes in qualitative aspects of social relationships? How are age-related changes in motivation related to qualitative differences in processing social information (e.g., interpretation of a problem situation)? D. NORMAL CHANGES IN BASIC COGNITIVE SKILLS AND SOCIAL COGNITION Many models of social cognition emphasize the importance of basic information processing skills in the construction of representations about social events. For example, the formation of impressions of others depends on the activation of appropriate categorical knowledge, the ability to attend to relevant aspects of behavior, the efficiency with which attributes are encoded and the integration of specific aspects of behavioral information into a coherent representation. Since the nature of representations in memory has a major impact on the types of decisions and judgments people make in reference to specific others or social events, an important issue concerns the extent to which normal (nonpathological) aging-related changes in basic cognitive skills influence the representation of social information and its subsequent use. 1. How is information about specific events represented in memory as people age? Do age-related changes in processing skills influence the type of information represented in memory and, subsequently, the types of decisions and judgments that are made about the event? 2. Are there age-related changes in the ability to access and/or use specific types of social information? 3. Do age-related changes in memory skills have an impact on the ability to acquire new or alter existing social knowledge? SELECTED BACKGROUND READINGS Abeles, R. P. (1987). Life-span perspectives and social psychology. Hillsdale, NJ: Lawrence Erlbaum Associates. Bdckman, L. & Dixon, R. (1992). Psychological compensation: A theoretical framework. Psychological Bulletin, 112, 259-283. Baltes, M. & Carstensen, L. L. (1996). The process of successful ageing. Ageing and Society., 16, 397-422 Baltes, P. B. (1993). The aging mind: Potentials and limits. Gerontologist, 33, 580-594. Bandura, A. (1986). Social foundations of thought and action: A social cognitive theory. Englewood Cliffs, NJ: Prentice-Hall. Blanchard-Fields, F. & Abeles, R. (1996). Social cognition and aging. In J. E. Birren & K. W. Schaie (Eds.), Handbook of the psychology of aging (pp. 150- 161). San Diego: Academic Press. Blanchard-Fields, F. (1996). Social cognitive development in adulthood and aging. In F. Blanchard-Fields and T. M. Hess (Eds.), Perspectives on cognitive change in adulthood and aging (pp.454-487). New York: McGraw-Hill. Carstensen, L. L. (1995). Evidence for a life-span theory of socioemotional selectivity. Current Directions in Psychological Science, 4, 151-156. Cornelius, S. W. (1990). Aging and everyday cognitive abilities. In T. M. Hess (Ed.), Aging and cognition: Knowledge organization utilization (pp. 411-460). Amsterdam: North-Holland. Fiske, S. T. (1993). Social Cognition and social perception. Annual Review of Psychology, 44, 155-194. Fiske, S. T., & Taylor, S. E. (1991). Social cognition. New York: McGraw-Hill. Hess, T. M. (1994). Social cognition in adulthood: Aging-related changes in knowledge and processing mechanisms. Developmental Review, 14, 373-412. Labouvie-Vief, G. (1992) A neo-Piagetian perspective on adult cognitive development. In R. J. Sternberg & C.A. Berg (Eds.), Intellectual development (pp. 239-252). New York: Cambridge University Press. Markus, H., & Herzog, A. R. (1991). The role of the self-concept in aging. In K. W. Schaie (Ed.), Annual review of gerontology and geriatrics (Vol. 11). New York: Springer. Sternberg, R. (1990). Wisdom: Its nature, origins, and development. N. Y.: Cambridge University Press. Wyer, R. S., Jr., & Srull, T. K. (1989). Memory and cognition in its social context. Hillsdale, NJ: Lawrence Erlbaum Associates. 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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, March 9, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies of the policy from the program staff listed under INQUIRIES or from the Internet at http://www.med.nyu.edu. 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. Applications 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 the program announcement must be typed in line 2 on the face page of the application. Applications for the FIRST award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. FIRST Award applicants are reminded that they must follow "just-in-time" procedures (NIH Guide to Grants and Contracts, Volume 25, March 29, 1996). The completed original application and five legible copies must delivered 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) Receipt dates for new Research Project Grants and FIRST Awards applications are February 1, June 1, and October 1 of each year. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. 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 * 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; * Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; * Availability of the resources necessary to perform the research; * Appropriateness of the proposed budget and duration in relation to the proposed research; * 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. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that Institute/Center (IC). 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: Jared Jobe, Ph.D. Behavioral and Social Research National Institute on Aging 7201 Wisconsin Avenue, Suite 533 MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-3137 FAX: (301) 402-0051 Email: Jared_Jobe@nih.gov Direct inquiries regarding fiscal matters to: Mr. Joseph Ellis Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: Joseph_Ellis@nih.gov The NIMH supports research on a range of topics in social cognition (e.g., attitude accessibility, persuasion, stereotyping, self and social identity, stigma about mental disorders) across the life-span in normative, at-risk, and mentally ill populations. Inquiries about NIMH's sponsorship of these activities may be directed to: Della M. Hann, Ph.D. Division of Neuroscience and Behavioral Sciences National Institute of Mental Health 5600 Fishers Lane, Room 11C-16 Rockville, MD 20857 Telephone: (301) 443-3942 FAX: (301) 443-4822 Email: dhann@nih.gov The National Institute of Child Health and Human Development (NICHD) is interested in the topics of this Program Announcement (PA) as they pertain to children's and adolescents' development. More specifically, NICHD is interested in supporting meritorious applications in the following areas: (a) Normative age-related changes in knowledge structure; (b) Contextual and functional perspectives on the normative development of social cognition; (c) The interaction of social cognition, emotion and motivation during childhood and adolescence and (d) Developmental changes in cognitive skills and social cognition. Inquiries about NICHD's support for research in social cognition may be directed to: Sarah L. Friedman, Ph.D. Center for Research for Mothers and Children, National Institute of Diabetes and Digestive and Kidney Diseases Building 61E, Room 4B05 Bethesda, MD 20892 Telephone: (301) 496-9849 FAX: (301) 480-7773 Email: FriedmaS@HD01.NICHD.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866, Aging Research, No. 93.399, Cancer Control Research, No. 93.393, Cancer Cause and Prevention Research, No. 93.396, Cancer Biology Research, No 93.399, Cancer Treatment Research, No. 93.361, Nursing Research, and No. 93.242, Mental Health Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS 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 Sat Jun 14 23:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HS-98-003 - V26(20) 06/13/97 Date: 14 Jun 1997 21:35:17 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 571 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5nvre5$3ci@net.bio.net> NNTP-Posting-Host: net.bio.net HEALTH CARE QUALITY IMPROVEMENT AND QUALITY ASSURANCE RESEARCH NIH GUIDE, Volume 26, Number 20, June 13, 1997 RFA: HS-98-003 P.T. 34; K.W. 0730050, 0730021 Agency for Health Care Policy and Research Letter of Intent Receipt Date: August 1, 1997 Application Receipt Date: September 16, 1997 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications for research and demonstration projects on the use of measurement in improving the quality of health care. Applications are sought in three areas: (1) methods and measures to allow translation of scientific information about medical care into quality measures and strategies to improve clinical practice; (2) studies of the relationship between organizational change and quality measurement and improvement in health care; and (3) studies of the use of information derived from measurement about quality of care by consumers, patients, employers, providers, and insurers to make decisions. AHCPR is especially interested in projects that will produce results within one to two years, although a balance is sought between short- and long-term projects, and projects of up to five years will be considered. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. AHCPR encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202-512-1800. ELIGIBILITY REQUIREMENTS Applications may be submitted by public or private non- profit organizations, including universities, clinics, units of State and local governments, non-profit firms, and non-profit foundations. For-profit entities may participate as members of consortia or subcontractors if the applicant is non-profit. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible. AHCPR encourages women, members of minority groups, and persons with disabilities to apply as Principal Investigators. MECHANISM OF SUPPORT The RFA mechanisms of support are the research project grant (R01), and the research demonstration project grant (R18). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The earliest anticipated award date is February 1, 1998. FUNDS AVAILABLE Depending on the availability of funds, AHCPR expects to award up to $2.0 million in fiscal year 1998 to support the first year of 8 to 10 projects under this RFA. The number of awards is dependent on the number of high quality applications and their individual budget requirements; it is not the intent of AHCPR that the awards be equal in size. Funding beyond the initial budget period will depend upon annual progress reviews by AHCPR and the availability of funds. RESEARCH OBJECTIVES Background AHCPR is charged with improving the quality, appropriateness, and effectiveness of health care services and access to such services. Research on quality measurement and improvement is essential to AHCPR's efforts to integrate knowledge about health care into clinical practice, especially at this time of rapid and profound changes in the health care system. There are anecdotes, but not much reliable information, about the effects of these changes on quality of care and the effectiveness of attempts to assess and assure quality. Understanding the effects of these changes requires reliable and valid information about clinical quality of care and methods for obtaining and using that information to assure and improve quality. As efforts are made to increase the efficiency with which health care is provided and to curtail unnecessary expenditures, the ability to assess and maintain or improve quality is essential. In recent years, AHCPR has undertaken a number of initiatives related to quality of care. AHCPR documents cited below may be requested from the AHCPR Clearinghouse, 800/358-9295. In particular, AHCPR has: o Developed a prototype performance measurement information system called CONQUEST. (For information on CONQUEST, see R. Heather Palmer, et al. Understanding and Choosing Clinical Performance Measures for Quality Improvement: Development of a Typology. Final Report, Contract No. 282-93-0038, Delivery Order #3. Agency for Health Care Policy and Research, January 31, 1995.) o Funded a group of cooperative agreements under the name "QSpan" (for Expansion of Quality Measures). These projects address different conditions and populations for which quality measures are scarce or nonexistent, and in some cases take different approaches. Some focus on health plan quality, others on provider performance. For details, see "Expansion of Quality Measures." AHCPR Publication No. 96-R064, rev. November 5, 1996. o Established a program called CAHPS, for Consumer Assessments of Health Plans; the program comprises cooperative agreements with a group of three consortia collaborating with AHCPR to develop a rigorously tested, standardized instrument for coll