From owner-sci-resources@net.bio.net Mon Feb 05 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 4 Febrary 1996 Date: 6 Feb 1996 12:08:16 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 73 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4f8cfg$89l@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Program Guideline Title: NSF 96-40 Dear Colleague Letter File size (bytes): STIS Filename: nsf9640.txt Document Type: Recruit Title: Physical Science Administrator (Lower Atmospheric Observing Facilities Manager) File size (bytes): STIS Filename: vex969.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 113194 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 125281 STIS Filename: phnorg.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve 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 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Thu Feb 08 22:00:00 1996 Path: biosci!biosci!not-for-mail From: kcowing@aibs.org (Keith L. Cowing) Newsgroups: bionet.sci-resources Subject: NASA Space Life Science Proposal Solicitation Date: 8 Feb 1996 20:34:36 -0800 Organization: American Institute of Biological Sciences Lines: 58 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4feiss$3ui@net.bio.net> NNTP-Posting-Host: net.bio.net COMMERCE BUSINESS DAILY ISSUE OF FEBRUARY 7,1996 A -- RESEARCH OPPORTUNITIES IN SPACE LIFE SCIENCES SOL NRA-96-OLMSA-O1A DUE 051596 POC Dr. Ronald J. White tel: 202/358-2530 The National Aeronautics and Space Administration (NASA) Life Sciences Division solicits proposals to participate in research opportunities in space life sciences and in research and development opportunities in advanced life support and environmental technologies for Human Exploration and Development of Space. This solicitation is open to U.S. and foreign proposers in all categories of Governmental and private sector organizations, agencies, and institutions. It will be open for the period through May 15, 1996; proposals may be submitted at any time throughout the period. This solicitation is available electronically via the Internet at http://peer1.idi.usra.edu/. Paper copies of the Announcement are available to those who do not have access to the Internet by calling 202-358-4180. Specific questions concerning this annoucement should be directed to: Ms. Victoria Thorne, Life Sciences Division, Code UL, NASA Headquarters, Washington, DC 20546-0001; telephone (202) 358-2530, email: vthorne@gm.olmsa.hq.nasa.gov. (0036) COMMERCE BUSINESS DAILY ISSUE OF FEBRUARY 7,1996 A -- ADV. LIFE SUPPT & ENVIRON. TECH. FOR HUMAN EXPLOR. & DEVELOP. OF SPACE SOL NRA-96-OLMSA-01B DUE 051596 POC Dr. Ronald J. White tel: 202/358-2530 ADVANCED LIFE SUPPORT AND ENVIRONMENTAL TECHNOLOGIES FOR HUMAN EXPLORATION AND DEVELOPMENT OF SPACE. The National Aeronautics and Space Administration (NASA) Life Sciences Division solicits proposals to participate in research opportunities in space life sciences and in research and development opportunities in advanced life support and environmental technologies for Human Exploration and Development of Space. This solicitation is open to U.S. and foreign proposers in all categories of Governmental and private sector organizations, agencies, and institutions. It will be open for the period through May 15, 1996; proposals may be submitted at any time throughout the period. This solicitation is available electronically via the Internet at http://peer1.idi.usra.edu/. Paper copies of the Announcement are available to those who do not have access to the Internet by calling 202-358-4180. Specific questions concerning this announcement should be directed to: Ms. Victoria Thorne, Life Sciences Division, Code UL, NASA Headquarters, Washington, DC 20546-0001; telephone (202) 358-2530, email: vthorne@gm.olmsa.hq.nasa.gov. (0036) -- Keith L. Cowing - Manager of Planning and Operations American Institute of Biological Sciences 10700 Parkridge Blvd Suite 380 - Reston, VA, USA 22091 703-758-1212 voice - 703-758-1222 fax kcowing@aibs.org - gopher://aibs.org From owner-sci-resources@net.bio.net Thu Feb 08 22:00:00 1996 Path: biosci!biosci!not-for-mail From: "Marvin.Stodolsky" Newsgroups: bionet.sci-resources Subject: DOE Human Genome Program Announcement R&D Date: 8 Feb 1996 20:49:19 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 123 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4fejof$61s@net.bio.net> NNTP-Posting-Host: net.bio.net Office of Energy Research Notice 96-08 Human Genome Program - Technological Advances DEPARTMENT OF ENERGY OFFICE OF ENERGY RESEARCH Energy Research Financial Assistance Program Notice 96-08: Human Genome Program - Technological Advances AGENCY: U.S. Department of Energy (DOE) ACTION: Notice inviting grant applications SUMMARY: The Office of Health and Environmental Research (OHER) of the Office of Energy Research (ER), U.S. Department of Energy, hereby announces its interest in receiving grant applications in support of the DOE Human Genome Program (HGP). This program is a coordinated, multidisciplinary, goal-oriented research effort to obtain a detailed understanding of the human genome at the molecular level. The objective of this notice is to promote substantive improvements in high-throughput, integrated approaches to large-scale human genome sequencing and its analysis. The solicited topics are: (1) supportive instrumentation and automation systems; (2) assembly of multi-megabase scale, ordered and sequence-ready DNA clones; (3) informatics for the rapid assembly, analysis, and annotation of data from high-throughput sequencing; and (4) informatics for facile submission, retrieval, and visualization of data for single or multiple related databases, specifically including the Genome Data Base and the Genome Sequence Data Base. Applicants must address clearly how the proposed work will help achieve the sequencing goals of the HGP. Collaborative, multidisciplinary efforts are specifically encouraged. DATES: Potential applicants are strongly encouraged to submit a brief preapplication. All preapplications, referencing Program Notice 96-08, should be received by DOE by 4:30 P.M. E.S.T., March 28, 1996. A response discussing the potential program relevance of a formal application generally will be communicated to the applicant within 30 days of receipt. The deadline for receipt of formal applications submitted in response to this notice must be received by 4:30 p.m., E.D.T., July 11, 1996, in order to be accepted for merit review in September 1996 and to permit timely consideration for awards in fiscal year 1997. ADDRESSES: All preapplications, referencing Program Notice 96-08, should be sent to Ms. Joanne Corcoran, U.S. Department of Energy, Office of Health and Environmental Research, ER-72, 19901 Germantown Road, Germantown, MD 20874- 1290. After receiving notification from DOE concerning successful preapplications, applicants may prepare formal applications and send them to: U.S. Department of Energy, Office of Energy Research, Grants and Contracts Division, ER-64, 19901 Germantown Road, Germantown, MD 20874-1290, ATTN: Program Notice 96-08. The above address for formal applications also must be used when submitting formal applications by U.S. Postal Service Express Mail, any commercial mail delivery service, or when handcarried by the applicant. FOR FURTHER INFORMATION CONTACT: Dr. Gerald Goldstein, if referencing topic (1); Dr. Marvin Stodolsky, if referencing topic (2); and Dr. Jay Snoddy, if referencing topics (3) or (4) at the U.S. Department of Energy, Office of Health and Environmental Research, ER-72, 19901 Germantown Road, Germantown, MD 20874-1290, by telephone (301) 903-6488, by facsimile (301) 903-8521, or preferably by E-mail, joanne.corcoran@oer.doe.gov. General HGP information can also be obtained on the World Wide Web (WWW) Internet browsers at: http://www.er.doe.gov/production/oher/hug_top.html, http://www.ornl.gov/techresources/human_genome/home.html, and sites linked to these WWW pages. The 5-year goals of the U.S. HGP are published in the journal, Science, volume 262, pages 43-46. SUPPLEMENTARY INFORMATION: The brief preapplication, in accordance with 10 CFR 600.10(d)(2), should consist of two to three pages of narrative describing the research objectives and methods of accomplishment. The preapplications will be reviewed for relevance to the notice, and further instructions will be provided with the response. Preapplications determined by staff of the Office of Health and Environmental Research to be insufficiently directed at the goals of this notice will be returned without further review to the applicant. Telephone and FAX numbers are required parts of the preapplication, and electronic mail addresses are desirable. It is anticipated that approximately $2,000,000 will be available for grant awards in this area during FY 1997, contingent upon availability of appropriated funds. Multiple year funding of grant awards is expected, and is also contingent upon availability of funds, progress of the research, and continuing program need. Projected awards will be in the range of $50,000 per year up to $1,000,000 per year with terms of 2 to 3 years. Information on the development and submission of applications, eligibility, limitations, evaluation, selection process, and other policies and procedures may be found in 10 CFR Part 605, and in the Application Guide for the Office of Energy Research Financial Assistance Program. The Application Guide is available from the U.S. Department of Energy, Office of Health and Environmental Research, Health Effects and Life Sciences Research Division, ER-72, 19901 Germantown Road, Germantown, MD 20874-1290. Telephone requests may be made by calling (301) 903-6488. Internet requests can be made to: joanne.corcoran@oer.doe.gov. Electronic access to ER's Financial Assistance Guide is possible via the Internet using the following E- mail address: http://www.er.doe.gov The Office of Energy Research, as part of its grant regulations, requires at 10 CFR 605.11(b) that a grantee funded by ER and performing research involving recombinant DNA molecules and/or organisms and viruses containing recombinant DNA molecules shall comply with the National Institutes of Health "Guidelines for Research Involving Recombinant DNA Molecules" (59 FR 34496, July 5, 1994) or such later revision of those guidelines as may be published in the Federal Register. The Catalog of Federal Domestic Assistance Number for this program is 81.049, and the solicitation control number is ERFAP 10 CFR part 605. Issued in Washington, D.C. John Rodney Clark Associate Director for Resource Management Office of Energy Research Published in the Federal Register February 7, 1996, Vol. 61, No. 26, pages 4630-4631. ----------------------------- This document is also available as at: http://www.er.doe.gov/production/grants/fr96_08.html From owner-sci-resources@net.bio.net Thu Feb 08 22:00:00 1996 Path: biosci!biosci!not-for-mail From: "Marvin.Stodolsky" Newsgroups: bionet.sci-resources Subject: DOE Human Genome Program Announcement, ELSI Date: 8 Feb 1996 20:50:06 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 185 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4fejpu$648@net.bio.net> NNTP-Posting-Host: net.bio.net Office of Energy Research Notice 96-09 Human Genome Program - Ethical, Legal, and Social Implications DEPARTMENT OF ENERGY OFFICE OF ENERGY RESEARCH Energy Research Financial Assistance Program Notice 96-09: Human Genome Program - Ethical, Legal, and Social Implications AGENCY: U.S. Department of Energy (DOE) ACTION: Notice inviting grant applications. SUMMARY: The Office of Health and Environmental Research (OHER) of the Office of Energy Research (ER), U.S. Department of Energy, hereby announces its interest in receiving applications in support of the Ethical, Legal, and Social Implications (ELSI) subprogram of the Human Genome Program (HGP). This program is a coordinated, multidisciplinary, directed research effort aimed at obtaining a detailed understanding of the human genome at the molecular level. This particular research notice encompasses research grants that address ethical, legal, and social issues that may arise from the use of information and knowledge resulting from the HGP. DATES: Potential applicants are strongly encouraged to submit a brief preapplication. All preapplications referencing Program Notice 96-09, should be received by DOE by 4:30 P.M. E.S.T., March 28, 1996. A response discussing the potential program relevance of a formal application generally will be communicated to the applicant within 30 days of receipt. The deadline for receipt of formal applications submitted in response to this notice must be received by 4:30 p.m., E.D.T., July 11, 1996, to be accepted for merit review in September 1996 and to permit timely consideration for award in fiscal year 1997. ADDRESSES: Preapplications referencing Program Notice 96-09 should be sent to Dr. Daniel W. Drell, U.S. Department of Energy, Office of Health and Environmental Research, ER-72, 19901 Germantown Road, Germantown, MD 20874-1290. After receiving notification from DOE concerning successful preapplications, applicants may prepare formal applications and send them to: U.S. Department of Energy, Office of Energy Research, Grants and Contracts Division, ER-64, 19901 Germantown Road, Germantown, MD, 20874-1290, ATTN: Program Notice 96-09. The above address for formal applications also must be used when submitting formal applications by U.S. Postal Service Express Mail, and commercial mail delivery service, or when handcarried by the applicant. FOR FURTHER INFORMATION CONTACT: Dr. Daniel W. Drell, U.S. Department of Energy, Office of Health and Environmental Research, ER-72, 19901 Germantown Road, Germantown, MD 20874-1290, by telephone (301) 903-6488, by FAX (301) 903-8521, or preferably by E-mail, joanne.corcoran@oer.doe.gov. SUPPLEMENTARY INFORMATION: The DOE encourages the submission of applications to conduct research on privacy and confidentiality issues from the creation, use, maintenance, and disclosure of genetic information. This may include (but is not limited to) issues of ownership, commercialization, and control of genetic information, and the protection of the privacy of genetic information in various settings, including the workplace. Applications should demonstrate knowledge of the relevant literature and should include detailed plans for the gathering and analysis of factual information and the associated ethical, legal, and social implications. All applications should include, where appropriate, detailed discussion of human subjects protection issues, e.g., storage of, manipulation of, and access to data. Provisions to ensure the inclusion of women, minorities, and potentially disabled individuals must be described, unless specific exclusions are scientifically necessary and justified in detail. All proposed research applications should address the issue of efficient dissemination of results to the widest appropriate audience. All applications involving collaborations should include letters of support from the potential collaborators; these letters should specify the contributions the collaborator intends to make if the application is accepted and funded. The DOE also solicits applications for the preparation and dissemination of educational materials in any appropriate medium that will enhance understanding of scientific, as well as the ethical, legal, and social aspects of the HGP among public or specified groups. If an educational effort for a specific group is proposed, the value to the HGP of that group or community should be explained in detail. In addition, the DOE encourages applications for the support of conferences focusing on the ethical, legal, and social implications of the HGP. Issues to be examined may include (but are not limited to) implications of advances in the genetic characterization of complex traits (e.g., disease predisposition or susceptibility genes) and the impacts of advances in knowledge about polygenic conditions for various communities potentially faced with these impacts (e.g., courts, schools, etc.). Educational and conference applications should demonstrate awareness of the relevant literature and include detailed plans for the accomplishment of project goals. In applications that propose the production of series for broadcast, audio-visuals, or other educational materials, the DOE requests that samples of previous similar work by the producers and writers be submitted along with the application. In applications for the support of educational activities, the DOE requests inclusion of a plan for assessment of the effectiveness of the proposed activities. For conference applications, a detailed and largely complete roster of speakers is necessary. At the completion of the conference, a summary or report is required. Educational and conference applications must also demonstrate awareness of the need to reach the widest appropriate audience. Ordinarily, DOE does not encourage applications dealing with issues consequent to genetic testing protocols. Additionally, DOE does not encourage survey-based research, unless a compelling case is made that this methodology is critical to address an issue of uncommon significance. For applications that propose the development of college-level curricula, DOE requests both detailed justification of the need for external support beyond normal departmental and college resources, evidence of commitment from the parent department or college, and a dissemination plan. Applications for the writing of scholarly publications or books should include justifications for the relevance of the publications or book to the goals of the HGP as well as discussion of the estimated readership and impact. DOE ordinarily will not provide unlimited support for a funded program and, thus, strongly encourages the inclusion of plans for transition to self-sustaining status. The brief preapplication, in accordance with 10 CFR 600.10(d)(2), should consist of two to three pages of narrative describing the research project objectives and methods of accomplishment. The preapplications will be reviewed for relevance to the notice, and further instructions will be provided with the response. Preapplications determined by staff of the Office of Health and Environmental Research to be insufficiently directed at the goals of the notice will be returned without further review to the applicant. Telephone and facsimile numbers are required parts of the preapplication, and electronic mail addresses are desirable. It is anticipated that approximately $1,300,000 will be available for grant awards in this area during FY 1997, contingent upon availability of appropriated funds. Multiple year funding of grant awards is expected, and is also contingent upon availability of funds. Previous awards have ranged from $50,000 per year up to $500,000 per year with terms from 1 to 3 years; most awards average about $200,000 per year for 2 or 3 years. Similar award sizes are anticipated for new grants. Information about development and submission of applications, eligibility, limitations, evaluation, selection process, and other policies and procedures may be found in 10 CFR Part 605, and in the Application Guide for the Office of Energy Research Financial Assistance Program. The Application Guide is available from the U.S. Department of Energy, Office of Health and Environmental Research, Health Effects and Life Sciences Research Division, ER-72, 19901 Germantown Road, Germantown, MD 20874-1290. Telephone requests may be made by calling (301) 903-6488. Internet requests can be made to: joanne.corcoran@oer.doe.gov. Electronic access to ER's Financial Assistance Guide is possible via the Internet using the following E- mail address: http//www.er.doe.gov The Office of Energy Research, as part of its grant regulations, requires at 10 CFR 605.11(b) that a grantee funded by ER and performing research involving recombinant DNA molecules and/or organisms and viruses containing recombinant DNA molecules shall comply with the National Institutes of Health "Guidelines for Research Involving Recombinant DNA Molecules" (59 FR 34496, July 5, 1994), or such later revision of those guidelines as may be published in the Federal Register. The dissemination of materials and research data in a timely manner is essential for progress towards the goals of the DOE HGP. The OHER requires the timely sharing of resources and data. Applicants should, in their applications, discuss their plans for disseminating research results and materials that may include, where appropriate, publication in the open literature, wide-scale mailings, etc. Once OHER and the applicant have agreed upon a distribution plan, it will become part of the award conditions. Funds to defray the costs of disseminating results and materials are allowable; however, such requests must be sufficiently detailed and adequately justified. Applicants should also provide timelines projecting progress toward achieving proposed goals. The Catalog of Federal Domestic Assistance Number for this program is 81.049, and the solicitation control number is ERFAP 10 CFR part 605. Issued in Washington, D.C. John Rodney Clark Assoicate Director for Resource Management Office of Energy Research Published in the Federal Register February 7, 1996, Vol. 61, No. 26, pages 4631-4633. ----------------------------- This announcement is also available at: http://www.er.doe.gov/production/grants/fr96_09.html From owner-sci-resources@net.bio.net Mon Feb 12 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 11 February 1996 Date: 12 Feb 1996 22:45:53 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 154 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4fpc31$d4k@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: News Title: Media Tipsheet February 5, 1996 File size (bytes): STIS Filename: tip60203.txt Document Type: Press Release Title: CAREER GRANTS INTEGRATE TEACHING AND RESEARCH File size (bytes): STIS Filename: pr965.txt Title: "LASER TWEEZER" TECHNIQUE MEASURES DNA "MECHANICS" File size (bytes): STIS Filename: pr966.txt Document Type: Recruit Title: VEP 96000 Assistant Director for Social, Behavioral, and Economic Sciences (SBE) File size (bytes): 5523 STIS Filename: vep96000.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 9328 STIS Filename: cmmtg.txt Document Type: International Document Title: INT 96-02 - STATUS ON RESEARCH AND PRODUCTION PRACTICES IN INDUSTRIAL MACHINERY AND MACHINE TOOLS INDUSTRY IN JAPAN File size (bytes): 25184 STIS Filename: int9602.txt Also available: int9602.doc Title: INT 96-03 . Emerging Manufacturing Technologies and Research Activities in Japan File size (bytes): 23750 STIS Filename: int9603.txt Also available: int9603.doc Document Type: Letter Title: Current List of REU Sites File size (bytes): 83906 STIS Filename: reulist.txt Document Type: News Title: Geometry and Cosmology File size (bytes): 1173 STIS Filename: mpslect.txt Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 113419 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 125281 STIS Filename: phnorg.txt Document Type: Program Guideline Title: NSF 93-116 RESEARCH COLLECTIONS IN SYSTEMATICS AND ECOLOGY File size (bytes): 25692 STIS Filename: nsf93116.txt Title: NSF 94-66 Biotic Surveys and Inventories File size (bytes): 30678 STIS Filename: nsf9466.txt Document Type: Recruit Title: VEP 96000 Assistant Director for Social, Behavioral, and Economic Sciences (SBE) File size (bytes): 5523 STIS Filename: vep96000.txt Document Type: Report Title: NSF-car95 Fiscal Year 1995 Career Program Awards File size (bytes): 45946 STIS Filename: nsfcar95.txt Also available: nsfcar95.xls nsfcar95.dlm Title: NSF-car95 Fiscal Year 1995 Career Program Awards File size (bytes): 45946 STIS Filename: nsfcar95.txt Also available: nsfcar95.xls nsfcar95.dlm Document Type: STIS Title: Document Types on STIS File size (bytes): 2532 STIS Filename: stistype.txt Title: Document Types on STIS File size (bytes): 2532 STIS Filename: stistype.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve stistype.txt, the text of your message should be as follows: get stistype.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve stistype.txt, you would enter: ftp> get stistype.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Sat Feb 17 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 03, pt. 1of2, 9 February 1996 Date: 18 Feb 1996 14:27:16 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1499 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4g8944$cak@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19960209 V25N03 P1O2 ************************************ X-comment: RFAS described: ES-96-004, PA-96-022, PA-96-023, PA-96-024, PA-96- X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.02.09 NIH GUIDE - Vol. 25, No. 3 - February 9, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** RESEARCH SUPPLEMENTS TO PROMOTE THE RECRUITMENT OF INDIVIDUALS WITH DISABILITIES INTO BIOMEDICAL RESEARCH CAREERS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** RESEARCH SUPPLEMENTS FOR UNDERREPRESENTED MINORITIES National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** ANIMAL CARE AND USE: HOT ZONES, GRAY ZONES, AND GO SLOW ZONES National Institutes of Health Public Responsibility in Medicine and Research Tufts University School of Veterinary Medicine INDEX: NATIONAL INSTITUTES OF HEALTH; PUBLIC RESPONSIBILITY IN MEDICINE & RESEARCH; TUFTS UNIVERSITY $$INDEX N4 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** ELECTRODES FOR FUNCTIONAL ELECTRICAL STIMULATION (RFP NIH-NINDS-96-03) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX R2 ********************************************************** INSULATING BIOMATERIALS (RFP NIH-NINDS-96-04) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX R3 ********************************************************** CHANGES IN CLEARANCE OF ANTIEPILEPTIC DRUGS DURING PUBERTY (RFP NIH-NINDS-96-05) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX R4 05/08/96 ************************************************* LINKING OF ENVIRONMENTAL AGENTS AND DISEASE (RFA ES-96-004) National Institute of Environmental Health Sciences INDEX: ENVIRONMENTAL HEALTH SCIENCES $$INDEX P1 ********************************************************** HUMAN MODELS AND MARKERS OF SKELETAL AGING (PA-96-022) National Institute on Aging National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Dental Research National Institute of Diabetes and Digestive and Kidney Diseases INDEX: AGING; ARTHRITIS, MUSCULOSKELETAL; SKIN DISEASES; DENTAL RESEARCH; DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX P2 ********************************************************** PILOT PROJECT RESEARCH GRANT PROGRAM FOR THE NIA (PA-96-023) National Institute on Aging INDEX: AGING $$INDEX P3 ********************************************************** NIDCD PROGRAM FOR POSTDOCTORAL RESEARCH TRAINING IN CLINICAL TRIALS (PA-96-024) National Institute on Deafness and Other Communication Disorders INDEX: DEAFNESS, OTHER COMMUNICATIONS DISORDERS $$INDEX P4 ********************************************************** NICHD SMALL GRANTS PROGRAM (PA-96-025) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT ERRATA $$INDEX E1 ********************************************************** NOVEL PHARMACOTHERAPIES FOR COCAINE AND OTHER PSYCHOSTIMULANT DEPENDENCE (RFA DA-96-003) National Institute on Drug Abuse INDEX: DRUG ABUSE THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: GIRG@DRGPO.DRG.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN NOT-96-002 *********************************************** RESEARCH SUPPLEMENTS TO PROMOTE THE RECRUITMENT OF INDIVIDUALS WITH DISABILITIES INTO BIOMEDICAL RESEARCH CAREERS NIH GUIDE, Volume 25, Number 3, February 9, 1996 P.T. 34, DD; K.W. 0710030, 0720005 National Institutes of Health BACKGROUND A recent report, titled "Changing America: The New Face of Science and Engineering" and issued by the President's Task Force on Women, Minorities, and the Handicapped in Science and Technology, December 1989, has documented a very low participation rate for Americans with disabilities in the science and engineering workforce. To address this problem for the biomedical and behavioral research workforce, the National Institutes of Health (NIH) and its awarding components have developed an initiative that is designed to extend opportunities to individuals with qualifying disabilities who are capable of entering or resuming research careers. Under this initiative, individuals with disabilities are encouraged to pursue biomedical research careers in areas within the missions of all the awarding components of the NIH through supplemental awards to certain ongoing research grants. It is hoped that the plan to provide funding at several different stages in a research career will substantially increase the number of individuals with disabilities in biomedical research. The NIH hereby notifies Principal Investigators holding certain NIH research grants of the availability of funds for administrative supplements to existing grants for the support and recruitment of scientists and students with disabilities. Supplemental awards are available to support individuals with disabilities from each of the following population groups: o HIGH SCHOOL STUDENTS. Supplements under this program are designed to foster an interest in biomedical and behavioral research. o UNDERGRADUATE STUDENTS. This program provides support for undergraduate students to encourage them to continue on to graduate level training in the biomedical and behavioral sciences. o GRADUATE RESEARCH ASSISTANTS. Graduate students can receive support under this program to develop their research capabilities. o INDIVIDUALS IN POSTDOCTORAL TRAINING. This program provides support during postdoctoral training to enable the development of an independent career in biomedical research. o INVESTIGATORS DEVELOPING INDEPENDENT RESEARCH CAREERS. Staff and faculty members with a doctoral degree can receive short-and long-term support for participation in an ongoing research project while further developing their own independent research potential. o ESTABLISHED INVESTIGATORS WHO BECOME DISABLED. This program will provide additional support for established NIH investigators and project leaders on components of program projects and center grants who become disabled. The additional support may be requested for assistants or special equipment that will facilitate a continuing contribution to the goals of the parent grant. Because this program differs in substantial ways from the other supplemental awards listed here, it is described in a separate section below. GENERAL PROVISIONS For all of the supplemental programs listed above, the proposed research experience must be an integral part of the approved, ongoing research of the parent grant. Also, with the exception of the supplemental program for Established Investigators Who Become Disabled, which is described in a separate section, individuals with disabilities must be given the opportunity to interact with individuals on the parent grant, to contribute intellectually to the research, and to enhance his/her research skills and knowledge regarding the particular area of biomedical science. Furthermore, the Principal Investigator must demonstrate a willingness and understanding that the purpose of the award is to enhance the research capability of the student or faculty member with a disability, and that the research experience is intended to provide opportunities for individuals with disabilities to develop into independent, competitive research investigators. All awards made under these programs will be consistent with the goals of strengthening the existing research program and the overall programmatic balance and priorities of the funding component at the NIH . Awards will be made according to the policies and provisions stated in this announcement. Applicants are encouraged to contact the NIH institute staff identified in the INQUIRIES section below prior to submission in order to obtain specific information about application characteristics and requirements. It is also recognized that individual circumstances vary and, for unusual situations, NIH program administrators should be consulted for a determination of eligibility. REASONABLE ACCOMMODATIONS As a part of these awards, funds may be requested to make changes or adjustments in the research setting that will make it possible for an otherwise qualified employee with disabilities to perform the essential functions associated with his/her role on the project. The accommodations requested under this program must be DIRECTLY related to the performance of the proposed role on the research project and must be appropriate to the disabilities of the individual. Some types of accommodations that might be provided under these awards include: specialized equipment, assistive devices, and personnel such as readers, interpreters, or assistants. In all cases, the total funds for accommodations requested from the supplement must be reasonable in relationship to the direct costs of the parent grant and the nature of the supplemental award. ELIGIBILITY RESEARCH GRANTS ELIGIBLE FOR SUPPLEMENTAL AWARDS: Principal Investigators at domestic institutions who hold an active R01, R10, R18, R22, R24, R35, R37, P01, P20, P30, P40, P41, P50, P51, P60, U01, or U10 grant are eligible to submit a request for an administrative supplement to the awarding component of the parent grant for any of the supplemental programs offered here. Principal Investigators holding an active First Independent Research Support and Transition (FIRST) Award (R29), an Academic Research Enhancement Award (R15) or a Small Grant Award (R03) also may apply for a supplement under this program. An R29 awardee may apply only when the minority candidate is a high school, undergraduate, or graduate student. An R15 awardee or an R03 awardee may apply only when the minority candidate is a high school or an undergraduate student. However, exceptions to these rules may be made. Applicants should check with their awarding component. Minority supplements to R29, R15 and R03 awards may provide support above the established dollar limits. The P20 and P30 award mechanisms are eligible for supplements only when they contain research components. In all cases, the parent grant must have support remaining for a reasonable period at the time of a supplemental award. Principal Investigators are encouraged to submit an application no later than three months before the anniversary date of the last two years remaining on the parent grant. Usually, each parent grant may have only one supplement for a person with disabilities. Appointment of more than one individual to a single grant depends on the nature of the parent grant, the circumstances of the request, and the program balance of the awarding component. Supplemental awards under these programs do not preclude a separate supplement to support an underrepresented minority. CANDIDATES ELIGIBLE FOR SUPPORT BY A SUPPLEMENTAL AWARD: The purpose of the request will be to support a high school student, an undergraduate student, a graduate research assistant, an individual in postdoctoral training, or a staff or faculty member with disabilities to participate in ongoing research projects. Awards will be limited to citizens, non-citizen nationals of the United States, and individuals who have been lawfully admitted for permanent residence (i.e., in possession of an Alien Registration Receipt Card) at the time of application. Other specific eligibility requirements relative to each type of award are set forth in the individual program descriptions below. Individuals with disabilities may receive support under these programs on only one grant at any time, but may be supported by more than one grant during the development of their research careers. Support under the supplement programs is not transferable to another individual. The research supplement programs for individuals with disabilities have been designed to attract disabled individuals into research careers and are not intended to provide an alternative means of supporting disabled individuals who already receive support from a research grant or a research training grant or any other PHS funding mechanism. Disabled graduate students or disabled individuals in postdoctoral training who are supported by a National Research Service Award (NRSA) research training grant may not be transferred to supplemental support prior to the completion of their appointed period of training. individuals may not be transferred to supplemental support simply to increase the availability of funds to the parent grant for any other uses. APPLICATION PROCEDURES A request for a supplement may be submitted at any time. IN MAKING REQUESTS, THE GRANTEE INSTITUTION, ON BEHALF OF THE PRINCIPAL INVESTIGATOR OF THE PARENT GRANT AND IN COOPERATION WITH THE INDIVIDUAL WITH DISABILITIES, MUST SUBMIT THE REQUEST FOR SUPPLEMENTAL FUNDS DIRECTLY TO THE AWARDING COMPONENT THAT SUPPORTS THE PARENT GRANT. The request is not to be submitted to the NIH Division of Research Grants. Principal Investigators are encouraged to obtain the address for submission from the NIH program administrator on the parent grant. The request for a supplemental award must include the following: 1. A completed face page (with appropriate signatures) from Grant Application Form PHS 398. Include the title and grant number of the parent grant in Item 1. 2. A brief three to four page description, prepared by the Principal Investigator of the parent grant, that includes: a. A summary or abstract of the funded grant or project. b. A description of the research experience proposed for the disabled individual. c. A description of how the research experience will expand and foster the training or independent research capabilities of the candidate and how the research experience will relate to the specific research goals and objectives of the parent grant. 3. A signed statement from the candidate with disabilities outlining his/her research objectives and career goals. 4. A biographical sketch of the candidate that includes evidence of scientific achievement or interest. 5. Social security number. The PHS requests the Social Security Number for the purpose of accurate identification, referral, and review of applications and for efficient management of PHS grant programs. 6. A signed statement from the principal investigator establishing the eligibility of the individual with disabilities for support under this program, including information on citizenship, and a description of any previous PHS research grant support the candidate has received. This must include information certifying the individual's citizenship, the nature of the disability, any occupational limitations associated with the disability, and the types of accommodations that will permit the individual to undertake the proposed research experience. Also, the institution must indicate its contribution to aid accommodation of the candidate to the research environment. 7. A proposed budget entered on budget pages from Grant Application Form PHS 398, related to the percent effort (where appropriate) for the research experience in the first and future years. All special accommodations requested must be detailed and justified in the budget section. If the initial budget period requested is less than 12 months, the budget should be prorated accordingly. 8. Documentation, if applicable, that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) of the grantee institution must be provided. Adherence to the NIH policy for including women and minorities in clinical studies must also be insured if additional human subjects~ involvement is planned for the supplement component. 9. A copy of the most recent official transcript if the candidate is a high school, undergraduate or graduate student. 10. If the individual with disabilities is a student at another institution, the application also must include an appropriately signed letter from a responsible official at the institution of matriculation indicating that participation at the stated level of effort is approved and will not detract from or interfere with his/her course of studies. 11. If any of the research is to be conducted at a site other than the grantee institution, an appropriately signed letter from the institution where the research is to be conducted must be submitted. The request must be signed by the individual with disabilities, the Principal Investigator, and the appropriate institutional business official. REVIEW CRITERIA The staff of the particular awarding component will review requests for supplements using the following general criteria: 1. The qualifications of the individual with disabilities including career goals, prior research training, research potential and any relevant experience. 2. The plan for the proposed research experience in the supplemental request and its relationship to the parent grant. 3. The appropriateness of the proposed accommodations for the candidate and his/her role on the research project. The appropriateness of the costs of the proposed accommodations to be paid from the supplement relative to the cost of the parent project and the nature of the requested supplemental award. Evidence that the proposed accommodations, including those provided by the grantee institution, will be sufficient to enable the candidate to adapt to the research environment. 4. Evidence from the Principal Investigator that the experience will enhance the research potential, knowledge, and/or skills of the candidate. 5. Evidence from the Principal Investigator that the activities of the individual with disabilities will be an integral part of the project. 6. Evidence of educational achievement and interest in science if the candidate is a student. Additional criteria related to the specific programs may also apply and are described below. FUNDING The decision to fund a supplement will take approximately eight weeks from receipt of a completed application. Applicants for summer-only research appointments must submit early enough to ensure that funding and accommodations are in place by the time the summer experience is scheduled to begin. In most cases, during the first budget period, funds will be provided as an administrative supplement to the parent grant. In subsequent years, continued funding for the supplement is contingent on funding of the parent grant and cannot extend beyond the current competitive segment of the parent grant and availability of funds. Continuation of support for the individual with disabilities in the remaining years of the competitive segment of the grant will depend upon a satisfactory review by the awarding component of progress on both the parent grant and the supplemental project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. In non-competing applications, the progress report and budget for the individual with disabilities must be clearly delineated from the progress report for the parent grant. The progress report in both non-competing and competing applications must include information about the research activities supported by the supplement even if support for future years is not requested. In future competing applications, funds for continuation of support of the individual with disabilities will depend on the successful renewal of the parent grant and will be handled as follows: For students who have not yet completed their research experience, funds for the continuation of support must be requested as a research supplement to ensure continued tracking of the individual supported. The request for continued support should not be included in the competing renewal, but instead, should be prepared as a letter with information on research progress and accomplishments of the candidate. The request must be addressed to the program administrator of the parent grant and must be submitted promptly in anticipation of a renewal award to avoid an interruption of support. Support to individual students by this mechanism will be limited to five years. Additional time may be considered, but must be well justified. Funds for the continuation of support for a postdoctoral fellow or an investigator with disabilities must be requested by name in the parent grant application at the time of renewal and may not be requested as a research supplement. Postdoctoral fellows and investigators are expected to be fully integrated in the research laboratory when considered for continuation of support. A Statement of Appointment form (PHS 2271, rev. 1/95), which will be provided by the NIH awarding component, must be completed and sent to the awarding component whenever an individual is appointed to a research supplement. In addition, the Statement of Appointment Form must be completed and submitted each time an individual is reappointed in a new budget period and whenever the name or permanent mailing address of the appointed individual changes. The form must be signed by both the appointed individual and the Principal Investigator of the supplemental research grant. DESCRIPTION OF THE INDIVIDUAL RESEARCH SUPPLEMENT PROGRAMS 1. HIGH SCHOOL STUDENTS The purpose of this program is to provide high school students with disabilities, who have demonstrated an interest and an aptitude for scientific pursuits, with a meaningful experience in various aspects of health-related research to stimulate interest in a career in science. ELIGIBILITY Any qualified high school student with disabilities who is enrolled in good standing at a local high school and is interested in biomedical or behavioral research is encouraged to participate in this program. PROVISIONS This supplement is not to exceed $2,000 in direct cost, including supplies during a summer research experience. A part-time experience during the regular school year would be reimbursed at the same hourly rate. Funds over and above this $2,000 limit may be requested to permit accommodation to the research environment. This may include research equipment if it is directly related to both the project and to accommodating the disabilities of the student. In all cases, equipment may only be purchased with prior approval of the NIH awarding component. Students are expected to devote sufficient effort to the research project and related activities during the period of support to gain insight into the process of scientific discovery. Support may be for a minimum of three months during any one year which may include a mixture of full-time summer experience and part-time experience during the school year. Principal Investigators are encouraged to seek high school students who will devote at least two years to this program (i.e., equivalent to two three-month, full-time, periods).Exceptions to the latter will be considered, depending on the circumstances of the applicant, the parent grant, and the specific request. See the GENERAL PROVISIONS section (above) for information about application procedures, review criteria, and funding. 2. UNDERGRADUATE STUDENTS DESCRIPTION This supplemental program provides an opportunity for any qualified undergraduate student with disabilities, who is interested in biomedical or behavioral research, to participate in a research project at a research institution during the summer months or during the school year. This experience will be separate and apart from any requirement of the regular academic program. The success of this program is dependent on the ability of the Principal Investigator to identify appropriate students. A number of procedures may be used to match investigators to appropriate college students: (1) the Principal Investigator may identify a student and initiate the request for the supplement; (2) the institution may make the pairing of the student with the Principal Investigator; (3) the student may contact a grantee institution or an investigator and request a research experience. ELIGIBILITY The student may be affiliated with either the applicant institution or any other academic institution. Any qualified undergraduate student with disabilities who is interested in biomedical or behavioral research is encouraged to participate in this program. PROVISIONS This supplement generally should not exceed $6.00 per hour for salary plus $125 per month for supplies and travel. Funds over and above this limit may be requested to permit accommodation to the research environment. This may include research equipment, but only if it is directly related to both the project AND to accommodating the disabilities of the student. In all cases, equipment may only be purchased with prior approval of the NIH awarding component. Students are expected to devote an equivalent of at least three months full-time effort to the research project and related activities in any one year, and in most cases the period of support for any individual should last at least two years. Exceptions to the latter will be considered, depending on the circumstances of the applicant, the parent grant, and the specific request. See the GENERAL PROVISIONS section (above) for information about application procedures, review criteria, and funding. 3. GRADUATE RESEARCH ASSISTANTS DESCRIPTION The objective of this program is to offer additional encouragement to graduate students with disabilities who have the potential to become researchers in biomedical or behavioral sciences and give them an opportunity to develop their research capability further. ELIGIBILITY Any graduate student with disabilities who is enrolled in a masters or a doctoral degree program in biomedical or behavioral sciences is eligible for consideration. PROVISIONS The NIH will provide salary support in addition to other necessary expenses, such as supplies and travel, to enable the individual to participate as a graduate research assistant in funded research projects. As in the past, the NIH will continue to consider the compensation for the personal services of graduate students and other employees rendered to an NIH research project to be allowable as long as the compensation is reasonable and (1) conforms to the established, consistently applied salary and wage policies of the institutions and (2) reflects the percentage of time actually devoted to the PHS-funded project. For graduate students this compensation may include tuition remission paid as, or in lieu of, wages provided that, the student is in a bona fide employer-employee relationship with the institution for the work performed, and payment is conditioned explicitly on the performance of necessary work. Reasonable compensation for graduate students must not exceed the amount allowable for a first year postdoctoral level staff member, at the same institution, performing comparable work. Additional funds up to $3000 per year may be requested for supplies and travel. Funds may not be used to purchase equipment. Funds may also be requested to permit accommodation to the research environment. This may include research equipment, but only if it is directly related to both the project AND to accommodating the disabilities of the student. In all cases, equipment may only be purchased with prior approval of the NIH awarding component. See the GENERAL PROVISIONS section (above) for information about application procedures, review criteria, and funding. 4. INDIVIDUALS IN POSTDOCTORAL TRAINING DESCRIPTION These supplements provide support to individuals with disabilities in the postdoctoral phase of training to participate in ongoing research projects that will assist in the development of a career in biomedical or behavioral research. Toward the end of the supplement award, candidates should be encouraged to apply for fellowships, FIRST awards, and sources of independent support. ELIGIBILITY The individual in postdoctoral training may be affiliated with either the applicant institution or any other institution. Only under extraordinary circumstances, that must be well justified in the application, would it be acceptable for the candidate to continue working with his/her former predoctoral mentor. PROVISIONS Support will be provided for a salary in addition to other necessary expenses, such as supplies and travel, to enable the individual to participate as a postdoctoral research assistant in funded research projects. The requested salary must be in accordance with the salary structure of the grantee institution and consistent with the level of effort. Additional funds up to $6,000 may be requested for supplies and travel. Funds may also be requested to permit accommodation to the research environment. This may include research equipment, but only if it is directly related to both the project AND to accommodating the disabilities of the individual. In all cases, equipment may only be purchased with prior approval of the NIH awarding component. See the GENERAL PROVISIONS section (above) for information about application procedures, review criteria, and funding. 5. INVESTIGATORS DEVELOPING INDEPENDENT RESEARCH CAREERS DESCRIPTION These supplements provide either short- or long-term research support for staff or faculty members with disabilities to enhance their research skills leading to an independent research career. o Short-term Investigator Research Supplement. This supplement provides short-term support for staff or faculty members to conduct full-time research for three to five months each year, during the summer or another portion of the academic year, over a maximum period of four years. o Long-term Investigator Research Supplement. This supplement provides long-term research support for staff or faculty members to conduct research in the biomedical or behavioral sciences. Support is provided for up to four years at a minimum of 30 percent effort during each 12-month period. ELIGIBILITY The investigator with disabilities may be affiliated with either the applicant institution or any other institution. The investigator must have a doctoral degree, be beyond the level of a research trainee, be a member of the staff or faculty, and have at least one year of postdoctoral experience. The investigator may have received prior research or research training support from the NIH or support under the Minority Biomedical Research Support (MBRS), Minority- Research Infrastructure Support Program (M-RISP), Minority Access to Research Careers (MARC), Career Opportunities in Research Education and Training (COR), small grants, or Academic Research Enhancement Awards (AREA) programs. But, an individual who has received independent research support as a Principal Investigator on an individual research grant (e.g., R01, R29) or as a project leader on a program project or center grant (e.g., P01, P50), or as a Principal Investigator on an individual research career award (e.g., K01, K02, K08) is not eligible for support under this program. PROVISIONS The faculty or staff supplemental award is for a maximum of $50,000 in direct costs per year. A maximum of $40,000 may be requested for salary and fringe benefits. Funds up to $10,000 may also be requested for research supplies and travel. Funds over and above this $50,000 limit may be requested to permit accommodation to the research environment. This may include research equipment, but only if it is directly related to both the project AND to accommodating the disabilities of the investigator. In all cases, equipment may only be purchased with prior approval of the NIH awarding component. The maximum period of support for any investigator is four years. The amount of salary requested must be consistent with the policies of the parent grantee institution (and, if applicable, the disabled investigator's employing institution) and must be related to the percent effort of the investigator. See the GENERAL PROVISIONS section (above) for application procedures, review criteria, and funding. 6. SUPPLEMENTS FOR ESTABLISHED INVESTIGATORS WHO BECOME DISABLED DESCRIPTION Established investigators on NIH research, program project, or center grants, who become disabled during the current project period, may request special accommodations to permit completion of the currently funded research project. ELIGIBILITY Any currently funded Principal Investigator or Co-Investigator or other senior staff (hereinafter referred to as Established Investigator) on an NIH research project grant, program project grant, or center grant may request support for special equipment, an assistant, or other modifications to facilitate accommodation to a disabling injury or illness that has occurred during the current project period. PROVISIONS Support will be limited to items that will permit the investigator to complete the remaining years of a currently funded research project. This might include: salary support for an individual who can assist the Established Investigator in meeting the goals of the research project, specialized equipment, or modifications of the working environment. In all cases, the requested support must be consistent with the type of disability and the nature of the approved research. The total amount of support requested under this supplement must be reasonable in relationship to the direct costs of the parent award and the Established Investigator's role and effort on the project. In future competing applications, funds for continuation of the accommodations provided under this supplement must be requested in the parent grant application and may NOT be requested as a research supplement. APPLICATION PROCEDURES A request for a supplement may be submitted at any time. In making requests, the grantee institution, on behalf of the Established Investigator, must submit the request for supplemental funds directly to the awarding component that supports the parent grant. The request must include the following: o A completed face page from Grant Application Form PHS 398 with the title and grant number of the parent grant and a statement that specifies which type of supplement is being requested. o A statement by the Established Investigator describing the nature of the disability and the attendant limitations on his/her capacity to complete the goals established for the current project period. o A statement from the institution certifying the disability and describing the types of accommodations requested and their relationship to the research project and the disabilities of the Established Investigator. o A proposed budget entered on budget pages from Grant Application Form PHS 398. The budget must reflect all special accommodations to support the adaptation of the Established Investigator to the research environment. The request must be signed by the Principal Investigator, the Established Investigator with disabilities (if other than the Principal Investigator), and the appropriate institutional business official. REVIEW CRITERIA The staff of the particular awarding component will review requests for supplements using the following criteria: o The appropriateness of the proposed accommodations for the Established Investigator regarding his/her role on the research project and the nature of the disability. o The appropriateness of the cost of the proposed accommodations to be paid from the supplement in relationship to the total direct cost of the parent project. FUNDING See the section on funding in the GENERAL PROVISIONS section, above. INQUIRIES Principal Investigators interested in participating in any of these supplemental programs are encouraged to contact NIH staff administering the parent grant. For general information about the Supplements for Individuals with Disabilities, contact the following staff person in the appropriate awarding component: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM Director, Alcohol Research Centers Program Willco Building, Room 402 Bethesda, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 Email: tvanderv@willco.niaaa.nih.gov NATIONAL INSTITUTE ON AGING Deputy Associate Director, Office of Extramural Affairs Gateway Building, Suite 2C218 Bethesda, MD 20892-9205 Telephone: (301) 496-9322 FAX: (301) 402-2945 Email: rb42h@nih.gov NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES Director, Office of Science Training and Manpower Development Solar Building, Room 3C21 Bethesda, MD 20892 Telephone: (301) 496-7291 FAX: (301) 402-0369 Email: mh35c@nih.gov NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES Director, Centers Program Natcher Building, Room 5AS-19F Bethesda, MD 20892 Telephone: (301) 594-5052 FAX: (301) 480-4543 Email: freemanj@ep.niams.nih.gov NATIONAL CANCER INSTITUTE Deputy Director, Division of Extramural Activities Executive Plaza North, Suite 600 Bethesda, MD 20892 Telephone: (301) 496-4218 FAX: (301) 402-0956 Email: grayp@dea.nci.nih.gov NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT Special Assistant to the Deputy Director Building 31, Room 2A03, MSC 2425 Bethesda, MD 20892-2425 Telephone: (301) 496-0104 FAX: (301) 402-1104 Email: topperh@hd03.nichd.nih.gov NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS Deputy Director, Division of Human Communication 6120 Executive Boulevard, Room 400C, MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 496-5061 FAX: (301) 402-6251 Email: Judith_Cooper@nih.gov NATIONAL INSTITUTE OF DENTAL RESEARCH Assistant Director for Program Development Natcher Building, Room 4AN-24B, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2089 FAX: (301) 480-8318 Email: bravemann@de45.nidr.nih.gov NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES Assistant Director for Grants 45 Center Drive, Room 6AS-49E, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8842 FAX: (301) 480-3504 Email: garthunej@ep.niddk.nih.gov NATIONAL INSTITUTE ON DRUG ABUSE Chief, Special Populations Office 5600 Fishers Lane, Room 10A-10 Rockville, MD 20857 Telephone: (301) 443-0441 FAX: (301) 443-9127 Email: Lula_Beatty@nih.gov NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES Director, Division of Extramural Research and Training Building 3, Room 301A P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-7723 FAX: (919) 541-2843 Email: sassaman@niehs.nih.gov NATIONAL EYE INSTITUTE Research Resources Officer 6120 Executive Boulevard, Suite 350, MSC 7164 Rockville, MD 20892-7164 Telephone: (301) 496-5301 FAX: (301) 402-0528 Email: rjh@eps.nei.nih.gov NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES Assistant Director, Referral and Liaison 45 Center Drive, Room 2AN-18F, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-3833 FAX: (301) 402-0156 Email: renea@gm1.nigms.nih.gov NATIONAL HEART, LUNG AND BLOOD INSTITUTE Director, Division of Extramural Affairs 6701 Rockledge Drive, Suite 7100, MSC 7924 Bethesda, MD 20892 Telephone: (301) 435-0260 FAX: (301) 480-3460 Email: rg33k@nih.gov NATIONAL CENTER FOR HUMAN GENOME RESEARCH Chief, Mapping Technology Branch Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: bettie_graham@nih.gov NATIONAL LIBRARY OF MEDICINE Acting Associate Director, Division of Extramural Programs Building 38A, 5N505 Bethesda, MD 20892 Telephone: (301) 496-4621 FAX: (301) 402-0421 Email: corn@1hc.nlm.nih.gov NATIONAL INSTITUTE OF MENTAL HEALTH Deputy Associate Director for Special Populations 5600 Fishers Lane, Room 17C-14 Rockville, MD 20857 Telephone: (301) 443-2847 FAX: (301) 443-8552 Email: sragland@nih.gov NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE Deputy Director, Division of Extramural Activities Federal Building, Room 1016 Bethesda, MD 20892 Telephone: (301) 496-4188 FAX: (301) 402-4370 Email: ed25b@nih.gov NATIONAL INSTITUTE OF NURSING RESEARCH Director, Extramural Programs 45 Center Drive, Room 3AN-12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-6906 Fax: (301) 480-8260 Email: depdir@ep.ninr.nih.gov NATIONAL CENTER FOR RESEARCH RESOURCES Senior Advisor to the Director Building 12A, Room 4007, MSC 5662 Bethesda, MD 20892-5662 Telephone: (301) 496-5795 FAX: (301) 402-0006 Email: rogere@od12a.ncrr.nih.gov AUTHORITY AND REGULATIONS The statutory authorities for these grant awards are sections 301, 510, 515, and 504 of the Public Health Service Act. Federal regulations at 42 CFR Part 52, "Grants for Research Projects" and 45 CFR Part 74, "Administration of Grants," are applicable to these awards. Grants must be administered in accordance with the Public Health Service Grants Policy Statement. $$N1 END ************************************************************ $$N2 BEGIN NOT-96-003 *********************************************** RESEARCH SUPPLEMENTS FOR UNDERREPRESENTED MINORITIES NIH GUIDE, Volume 25, Number 3, February 9, 1996 P.T. 34, FF; K.W. 0710030, 0720005 National Institutes of Health BACKGROUND During 1987 and 1988, the Director of the National Institutes of Health (NIH) and the Advisory Committee to the Director (ACD) held a series of regional meetings throughout the United States. At these meetings, testimony was presented by concerned individuals and organizations regarding the underrepresentation of minorities in biomedical and behavioral research. Although the NIH currently provides opportunities for minorities through the traditional research grant programs and through special initiatives supported by various components of the NIH (see APPENDIX for listing), the testimony indicated that efforts of the NIH should be increased. In addition, the NIH recognizes the need to increase the number of underrepresented minority scientists participating in biomedical and behavioral research. In response to these concerns, the NIH is emphasizing the use of administrative supplements to attract underrepresented minorities into biomedical and behavioral research. The mechanisms described in this announcement have been endorsed by all the awarding components of the NIH and are designed to provide support for research experiences at grantee institutions for minorities throughout the continuum from high school to the faculty level. The NIH hereby notifies all Principal Investigators holding NIH research grants that funds are available for administrative supplements to existing grants for the support and recruitment of underrepresented minority investigators and students. The aim of these supplements is to attract and encourage minority individuals to enter and pursue biomedical and behavioral research careers in areas within the missions of all the awarding components of the NIH by providing supplemental funds to certain ongoing research grants (see the Eligibility section under GENERAL PROVISIONS). For the purpose of this announcement, underrepresented minority students and investigators are defined as individuals belonging to a particular ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical or behavioral research. Awards will be limited to citizens or non- citizen nationals of the United States or to individuals who have been lawfully admitted for permanent residence (i.e., in possession of an Alien Registration Receipt Card) at the time of application. In awarding supplements, the NIH will give priority to projects involving African American (Black), Hispanic American, Native American and Alaskan Natives, and Pacific Islander or other ethnic or racial group members who have been found to be underrepresented in biomedical or behavioral research nationally. Before submitting an application for a research supplement, applicants are encouraged to call their program administrator at the NIH to discuss any aspects of this program that need clarification. The NIH anticipates, that by providing scientific opportunities such as those listed below the number of minorities entering and remaining in biomedical research careers will increase. o MINORITY HIGH SCHOOL STUDENTS: This program will support minority high school students who have expressed an interest in biomedical or behavioral sciences. o MINORITY UNDERGRADUATE STUDENTS: This program will support minority undergraduate students who have demonstrated an interest in biomedical or behavioral sciences and wish to pursue graduate level training in these areas. o MINORITY GRADUATE RESEARCH ASSISTANTS: This program will provide support to assist minority predoctoral students who wish to develop research capabilities in the biomedical and behavioral sciences. o MINORITY INDIVIDUALS IN POSTDOCTORAL TRAINING: This program will provide support for minority individuals who wish to participate as postdoctoral researchers in ongoing research projects in preparation for independent careers in biomedical or behavioral research. o MINORITY INVESTIGATORS: This program will provide short- and long-term opportunities for minority staff and faculty who wish to participate in ongoing research projects while further developing their own independent research potential. GENERAL PROVISIONS In all cases, the proposed research experience must be an integral part of the approved ongoing research of the parent grant. As part of this research experience, the minority individual must be given the opportunity to interact with individuals on the parent grant, to contribute intellectually to the research, and to enhance her/his research skills and knowledge regarding the particular area of biomedical science. Furthermore, the Principal Investigator must demonstrate a willingness and understanding that the purpose of the award is to enhance the research capability of the minority student or faculty member and that the research experience is intended to provide opportunities for minority individuals to develop as independent, competitive research investigators. Supplemental awards will be consistent with the goal of strengthening the existing research program and with the overall programmatic balance and priorities of the funding component of the NIH. Awards will be made according to the policies and provisions stated in this announcement or as further specified by the NIH component funding the parent grant. Applicants are encouraged to contact the NIH institute staff listed under INQUIRIES prior to submission to obtain specific information about preparing and submitting an application. It is also recognized that individual circumstances vary, and for unusual situations, NIH program administrators should be consulted for a determination of eligibility. ELIGIBILITY Principal Investigators at domestic institutions who hold an active R01, R10, R18, R22, R24, R35, R37, P01, P20, P30, P40, P41, P50, P51, P60, U01, U10, U41, or U42 grant are generally eligible to submit a request for an administrative supplement to the awarding component of the parent grant for any of the supplemental programs offered here. Principal Investigators holding an active First Independent Research Support and Transition (FIRST) Award (R29), an Academic Research Enhancement Award (R15) or a Small Grant Award (R03) also may apply for a supplement under this program. An R29 awardee may apply only when the minority candidate is a high school, undergraduate, or graduate student. An R15 awardee or an R03 awardee may apply only when the minority candidate is a high school or an undergraduate student. However, exceptions to these rules may be made. Applicants should check with their awarding component. Minority supplements to R29, R15 and R03 awards may provide support above the established dollar limits. The P20, P30 and P60 award mechanisms are eligible for supplements only when they contain research components. In all cases, the parent grant must have support remaining for a reasonable period at the time of a supplemental award. Principal Investigators are encouraged to submit an application no later than three months before the anniversary date of the last two years remaining on the parent grant. The purpose of the application is to request support for an underrepresented minority high school student, undergraduate student, graduate research assistant, individual in postdoctoral training, or a staff or faculty member to participate in an ongoing research project. Specific eligibility requirements relative to each type of award are set forth in the description of the individual supplement programs (below). Usually, each parent grant may support only one minority supplement. Appointment of more than one individual to a single grant depends on the nature of the parent grant, the circumstances of the request, and the program balance of the NIH awarding component. Minority individuals may receive support from only one of these supplement programs at a time, but may be supported by more than one minority supplement during the development of their research careers. Support under the supplement programs is not transferable to another individual or transportable to another institution. The minority supplement programs have been designed to attract underrepresented minority individuals into research careers and are not intended to provide an alternative means of supporting minority individuals who already receive support from a research grant or a research training grant or any other PHS funding mechanism. Minority graduate students or individuals in postdoctoral training who are supported by a National Research Service Award (NRSA) Institutional research training grant may not be transferred to supplemental support prior to the completion of their appointed period of training. Individuals may not be transferred to a minority supplement to increase the availability of funds to the parent grant for any other uses. APPLICATION PROCEDURES A request for a supplement may be submitted at any time. In making requests, the grantee institution, on behalf of the Principal Investigator of the parent grant and in cooperation with the minority individual, must submit the request for supplemental funds directly to the awarding component that supports the parent grant. The request should not be submitted to the NIH Division of Research Grants. Principal Investigators are encouraged to obtain the address for submission from the NIH program administrator on the parent grant. The request for a supplemental award must include the following: 1. A completed face page (with appropriate signatures) from grant application form PHS 398. Include the title and grant number of the parent grant on line 1 and the type of supplement being requested on line 2. 2. A brief three to four page description, prepared by the Principal Investigator of the parent grant, that includes: a. a summary or abstract of the funded grant or project. b. a description of the research experience proposed for the minority individual. c. a description of how the research experience will expand and foster the independent research capabilities of the minority individual, and how the proposed experience relates to the specific research goals and objectives of the parent grant. 3. A signed statement from the minority individual outlining her/his research objectives and career goals. 4. A biographical sketch of the minority individual that includes evidence of scientific achievement or interest. 5. Social security number of the minority individual. (The PHS uses the Social Security Number for the purpose of accurate identification, referral, and review of applications and for efficient management of PHS grant programs. Although provision of the Social Security Number is voluntary, it will facilitate the processing of your request.) 6 A signed statement from the Principal Investigator establishing the eligibility of the minority individual for support under this program including information on ethnicity, citizenship, and a description of any previous PHS research grant support the minority individual has received. 7. A proposed budget entered on budget pages from grant application form PHS 398, related to the percent effort (where appropriate) for the research experience of the minority individual during the first and future years. If the initial budget period requested is less than 12 months, the budget must be prorated accordingly. 8. Documentation, if applicable, that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) of the grantee institution must be provided. Adherence to the NIH policy for including women and minorities in clinical studies must also be insured if additional human subjects' involvement is planned for the supplement component. 9. A copy of the most recent official transcript, if the minority candidate is a high school, undergraduate, or graduate student. 10. If the minority individual is a student at another institution, the application must include an appropriately signed letter from a responsible official at the institution of matriculation indicating that participation at the stated level of effort is approved and will not detract from or interfere with the students course of studies. 11. If any of the research is to be conducted at a site other than the grantee institution, an appropriately signed letter from the institution where the research is to be conducted must be submitted. The request must be signed by the minority individual, the Principal Investigator, and the appropriate institutional business official. REVIEW CRITERIA The staff of the particular awarding component will review requests for supplements using the following general criteria: 1. The qualifications of the minority individual including career goals, prior research training, research potential and any relevant experience. 2. Evidence of educational achievement and interest in science, if the minority candidate is a student. 3. The plan for the proposed research experience in the supplemental request and its relationship to the parent grant. 4. Evidence from the Principal Investigator that the experience will enhance the research potential, knowledge and/or skills of the minority individual, and that adequate mentorship will be provided. 5. Evidence from the Principal Investigator that the activities of the minority individual are an integral part of the project. FUNDING The decision to fund a supplement will take approximately eight weeks from receipt of a complete application. Applicants for summer-only research appointments must submit early enough to ensure that funding is in place by the time the summer experience is scheduled to begin. In most cases, during the first budget period, funds will be provided as an administrative supplement to the parent grant. In subsequent years, continued funding for the supplement is contingent on continued funding of the parent grant and cannot extend beyond the current competitive segment of the parent grant and the availability of funds. Continuation of support for the minority individual in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent grant and the supplemental project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. In non-competing continuation applications, the progress report and budget for the minority supplement must be clearly delineated from the progress report and budget for the parent grant. The progress report must include information about the research activities supported by the supplement, even if support for future years is not requested. In future competing applications, funds for continuation of support of the minority individual will depend on the successful renewal of the parent grant and will be handled as follows: For minority students who have not yet completed their research experience, funds for the continuation of support must be requested as a research supplement to ensure continued tracking of the individual supported. The request for continued support should not be included in the competing renewal, but instead, should be prepared as a letter with information on research progress and accomplishments of the minority individual. The request must be addressed to the program administrator of the parent grant and must be submitted promptly in anticipation of a renewal award to avoid an interruption of support. Support to individual students by this mechanism will be limited to five years. Additional time may be considered, but must be well justified. Funds for the continuation of support for a minority postdoctoral fellow or a minority investigator must be requested by name in the parent grant application at the time of renewal and may not be requested as a research supplement. Minority postdoctoral fellows and investigators are expected to be fully integrated in the research laboratory when considered for continuation of support. A Statement of Appointment form (PHS 2271, rev. 1/95), which will be provided by the NIH awarding component, must be completed and sent to the awarding component whenever an individual is appointed to a Research Supplement for Underrepresented Minorities. In addition, the Statement of Appointment Form must be completed and submitted each time an individual is reappointed in a new budget period and whenever the name or permanent mailing address of the appointed individual changes. DESCRIPTIONS OF THE INDIVIDUAL RESEARCH SUPPLEMENT PROGRAMS 1. RESEARCH SUPPLEMENTS FOR UNDERREPRESENTED MINORITY HIGH SCHOOL STUDENTS DESCRIPTION The purpose of this program is to provide minority high school students an opportunity to obtain a meaningful experience in various aspects of health-related research to stimulate their interest in careers in biomedical or behavioral science. ELIGIBILITY Any minority high school student who is currently enrolled and in good standing at her or his high school and is interested in biomedical or behavioral research is encouraged to participate in this program. PROVISIONS This supplement is not to exceed $2,000 per student in direct cost, including supplies, for a summer experience. A part-time experience during the regular school year would be reimbursed at the same hourly rate. Equipment may not be purchased using these funds. Students are expected to devote sufficient effort to the research project and related activities during the period of support to gain insight into the process of scientific discovery. Support for at least three months is encouraged during any one year, which may include a mixture of full-time summer experience and part-time experience during the school year. Principal Investigators are encouraged to seek minority high school students who will devote at least two years to this program (i.e., equivalent to two three-month, full-time periods). Exceptions to the latter will be considered, depending on the circumstances of the applicant, the parent grant, and the specific request. See the GENERAL PROVISIONS section for information about application procedures, review criteria, and funding. 2. RESEARCH SUPPLEMENTS FOR UNDERREPRESENTED MINORITY UNDERGRADUATE STUDENTS DESCRIPTION This supplemental program provides an opportunity for minority undergraduate students interested in biomedical or behavioral research to participate in a research project at a research institution during the summer months or during the school year. This experience will be separate from any requirement of the regular academic program. ELIGIBILITY The student may be affiliated with either the applicant institution or another academic institution. Any undergraduate minority student interested in biomedical or behavioral research is encouraged to participate in this program. PROVISIONS This supplement generally should not exceed $6.00 per hour for salary plus $125 per month for supplies and travel. Institutional rates for undergraduate salary which exceed $6.00 per hour must be strongly justified. Equipment may not be purchased from these funds. Students are expected to devote the equivalent of at least three months full-time effort to the research project and related activities in any one year and, in most cases, the period of support for any individual should last at least two years. Exceptions to these requirements will be considered, depending on the circumstances of the applicant, the parent grant, and the specific request. See the GENERAL PROVISIONS section for information about application procedures, review criteria, and funding. 3. RESEARCH SUPPLEMENTS FOR UNDERREPRESENTED MINORITY GRADUATE RESEARCH ASSISTANTS DESCRIPTION The objective of this program is to reach out to minority graduate students already in biomedical and behavioral sciences and provide an opportunity to further develop their research capabilities. ELIGIBILITY Any minority graduate student who is enrolled in a masters or a doctoral degree program in biomedical or behavioral sciences is eligible for consideration. Students enrolled in a masters degree program in nursing sciences or social work may also be eligible. Minority students in medical school are encouraged to use this program to gain research experience. PROVISIONS The NIH will provide salary support in addition to other necessary expenses, such as supplies and travel, to enable the individual to participate as a graduate research assistant in funded research projects. As in the past, the NIH will continue to consider the compensation for the personal services of graduate students and other employees rendered to an NIH research project to be allowable as long as the compensation is reasonable and (1) conforms to the established, consistently applied salary and wage policies of the institution and (2) reflects the percentage of time actually devoted to the PHS-funded project. For graduate students this compensation may include tuition remission paid as, or in lieu of, wages provided that, the student is in a bona fide employer-employee relationship with the institution for the work performed, and payment is conditioned explicitly on the performance of necessary work. Reasonable compensation for graduate students must not exceed the amount allowable for a first year postdoctoral level staff member, at the same institution, performing comparable work. Additional funds up to $3000 per year may be requested for supplies and travel. Funds may not be used to purchase equipment. See the GENERAL PROVISIONS section for information about application procedures, review criteria, and funding. 4. RESEARCH SUPPLEMENTS FOR UNDERREPRESENTED MINORITY INDIVIDUALS IN POSTDOCTORAL TRAINING DESCRIPTION These supplements provide research support to permit minority individuals in the postdoctoral phase of their training to participate in ongoing research projects as a means of assisting them in their development into independent biomedical or behavioral researchers. Toward the end of the supplement award, candidates should be encouraged to apply for fellowships, FIRST awards, and other sources of independent support. ELIGIBILITY The minority individual in postdoctoral training may be affiliated with either the applicant institution or some other institution. Only under extraordinary circumstances, which must be well justified in the application, would it be acceptable for the postdoctoral candidate to work with his or her former predoctoral mentor. PROVISIONS The NIH will provide support for salary in addition to other necessary expenses, such as travel and supplies, to enable the minority individual to participate as a postdoctoral research assistant or associate on the funded research project. The requested salary must be in accordance with the salary structure of the grantee institution and consistent with the level of effort. Additional funds, up to $6000, may be requested for supplies and travel. Support may not be used to purchase equipment. See the GENERAL PROVISIONS section for application procedures, review criteria and funding. 5. RESEARCH SUPPLEMENTS FOR UNDERREPRESENTED MINORITY INVESTIGATORS DESCRIPTION These supplements provide either short- or long-term research support for minority staff or faculty members to enhance their research skills leading to an independent research career. o Short-term Minority Investigator Research Supplement. This supplement provides short-term support for minority staff or faculty members to conduct full-time research for three to five months each year during the summer or another portion of the academic year, over a maximum period of four years. o Long-term Minority Investigator Research Supplement. This supplement provides long-term research support for minority staff or faculty members to conduct research in the biomedical or behavioral sciences. Support is provided for up to four years at a minimum of 30 percent effort during each 12-month period. ELIGIBILITY The minority investigator may be affiliated with the applicant institution or some other institution. The investigator must have a From owner-sci-resources@net.bio.net Sat Feb 17 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-022 - V25(03) 02/09/96 Date: 18 Feb 1996 14:29:51 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 473 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4g898v$cli@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA96022 PA-96-022 P1O1 *************************************** HUMAN MODELS AND MARKERS OF SKELETAL AGING NIH GUIDE, Volume 25, Number 3, February 9, 1996 PA NUMBER: PA-96-022 P.T. 34; K.W. 0755020, 0710010, 0715031 National Institute on Aging National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Dental Research National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The National Institute on Aging (NIA), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Dental Research (NIDR) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite research grant applications to develop or refine models and markers using human bone, bone marrow or bone cell constituents which more accurately reflect those age-related and/or pathophysiological processes occurring within the mature human skeleton that lead to osteoporosis and other age-related skeletal diseases. It is expected that improved human models and markers of age-related changes in skeletal tissue structure and function will enhance the accuracy and reliability of diagnostic and prognostic capabilities and serve to expedite the development of more effective, targeted preventive and therapeutic strategies. Model development and refinement should be conducted from the perspective of facilitating a) the identification of better prognostic indicators of the occurrence, progression, cessation or reversal of skeletal involution (due to aging, menopause, age- related morbidity, drugs); b) the identification of age-related pathologies/co-morbidities contributing to compromises in peripheral, axial and craniofacial skeletal integrity; c) the prediction of response or non-response to various therapeutic agents and/or d) further epidemiologic studies of risk factors for age-related bone disease and bone loss and fracture outcomes. 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, Human Models and Markers of Skeletal Aging is related to the priority area of osteoporosis. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications may be submitted by single institutions or by a consortia of institutions. Foreign institutions are not eligible for First Independent Research and Support and Transition (FIRST) awards (R29), but may submit applications for individual research project grants (R01): foreign applicants may also participate in laboratory or clinical programs through subcontract or consortium arrangements. 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 announcement will use the NIH investigator-initiated research project grant (R01) and FIRST (R29) award mechanisms. It is anticipated that the size of an award will vary due to the nature and scope of the proposed research, with the R01 award ranging from $150,000 to $500,000 in total (direct plus indirect) costs per year. FUNDS AVAILABLE Approximately $900,000 from NIA and up to $500,000 from NIAMS in total costs for the first year of funding will be made available in Fiscal Year 1997 to specifically fund applications submitted in response to this PA for the February/March 1996, June/July 1996 and October/November 1996 application receipt deadlines. An additional $300,000 from NIA and $200,000 from NIAMS will be made available in Fiscal Year 1998 to fund applications for this PA which are submitted by the February/March 1997 deadline. NIDR maintains a special interest in research focused on oral/craniofacial hard tissues, including related model systems and intends to fund 2-4 additional high quality applications in FY 1997. NIDDK also maintains an active interest in research questions related to the hormonal regulation of bone in health and disease and anticipates funding of 2-3 additional applications as funds warrant in FY97. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIA, NIAMS, NIDR and NIDDK, the award of grants pursuant to this PA is contingent upon the availability of funds at the time the awards are made. RESEARCH OBJECTIVES Background Our ability to predict, prevent, slow or reverse age-related bone loss and bone diseases such as osteoporosis is limited because so few studies have focused on cells and skeletal tissue from the aging human skeleton. Although osteoporosis and age-related diseases such as Paget's disease occur primarily in the mature, aging human skeleton, in vitro models used to study bone biology have consisted primarily of transformed cell lines from human or rodent osteosarcomas, or cell systems derived from fetal or neonatal rodent bone. In addition to marked differences in the chemical composition and macro- and microarchitectural organization of bone, other anomalies imposed by current models that reflect inappropriate age, species and other phenotypic characteristics limit the generalizability of putative biological mechanisms to those occurring in the human skeleton. Appropriate model systems are needed to develop markers that are more sensitive and specific in predicting changes in bone mass, bone competence and fracture susceptibility. Significant improvements in techniques to assess the status of bone cell activity in the skeleton are necessary to provide answers to key clinical questions such as 1) is a given individual currently losing bone?, 2) by which mechanisms is bone being lost? 3) at what anatomic site/compartment(s) is bone being lost?, 4) at what rate is bone being lost?, 5) is a promising new treatment likely to be effective, and if so, for which patients and 6) if a treatment is initially effective, for how long will it continue to be effective? Models and markers which better reflect the proliferative capability, differentiated function and qualitative features of bone cells in the mature human skeleton will facilitate improved techniques to assess the cellular and metabolic status of skeletal tissue. Such advances will further enhance the accuracy of diagnoses, prognoses and decision-making with respect to available and future treatment options and also facilitate the evaluation and targeting of potential new therapies (based on an understanding of how responses to these therapies are modified by age, gender, genetics and ethnicity). The acceleration of advances in bone biology and related fields as well as the development of many new promising technologies (such as transgenic animal models, in situ hybridization, immunocytochemistry and reverse transcriptase polymerase chain reaction (RT-PCR) in conjunction with histomorphometric, densitometric, qualitative, etc. techniques) provide improved capabilities to address these problems. A Workshop on Human Models of Skeletal Aging was organized and sponsored by the NIA and the NIDR in Washington, D.C., on March 1-2, 1994. Its objective was to address methodological issues integral to facilitating clinically relevant studies on the causes and consequences of bone loss and osteoporosis at the cellular and tissue levels in the aging human skeleton. The proceedings of this Workshop have been published [Calcif Tissue Int (1995) 56(Suppl 1); pp S1-S56; eds., Gehron Robey P and Sherman S]. Research Goals and Scope The purpose of this initiative is to stimulate studies to develop or refine and validate models and markers which more accurately reflect processes mediating aging or age-related skeletal diseases of the axial, peripheral and craniofacial skeleton, such as osteoporosis. Research applications submitted in response to this PA must combine all three of the following components in the research plan proposed for the project period of the application (maximum five years): 1. Development of model systems for human skeletal aging and age-related disease, using human bone, bone marrow or other bone cell constituents. 2. Use of these model systems to define new markers for diagnosis and/or prognosis of age-related physiologic and pathologic changes, and/or prediction of responsiveness to specific therapies AND, 3. Validation of these models and markers against in vivo parameters of skeletal status such as changes in bone mass, bone strength, architecture, histomorphometric indices of bone turnover, or the occurrence of fractures. The validation of models and markers against in vivo parameters of skeletal status is a required component for projects submitted in response to this PA. The validation component must include a plan to determine the extent to which proposed models and markers reflect changes due to age and/or age-related skeletal disease. Validation of markers should also include an assessment of their sensitivity, specificity, intra- and inter-individual variability (including effects of age, gender, and ethnicity). Types of models and markers that might be developed include, but are not limited to: o Models of mature osteoblast, osteoclast, osteocyte, and bone lining cell function o Models of osteoprogenitor cell recruitment, proliferation, differentiation and function o Validated peripheral blood cell models (e.g. monocytes, CD 34+ cells) of osteoclast or osteoclast-like function o Markers of bone cell phenotype and stage of differentiation o Models that reflect embryonic origin (e.g., neuroectoderm versus mesoderm) o Models using bone from multiple anatomic (peripheral, axial and craniofacial) sites, and different types of bone, bone matrix, bone marrow and other cellular constituents; development of techniques requiring minimal amounts of skeletal material or constituents o Models derived from or synthesizing lamellar bone (of cortical or trabecular origin) o Models that can reconstitute the "BMU" (basic multicellular unit) which contains osteocytes, lining cells, osteoblasts, osteoclasts, vascular components, etc. In vivo parameters that could be used to validate these models and markers include but are not limited to: o In vivo responses of bone (changes in bone mass, strength, etc) to regulatory factors (hormones, cytokines, etc.) and pharmacologic agents (measured by existing or new imaging techniques) o Bone cell or bone marrow progenitor proliferative capacity, morphology, surface markers, gene expression, and/or expression of differentiated function o Rates of bone formation and bone resorption (e.g., using histomorphometric techniques) o In vivo/in vitro or in situ spatial organization of cells and temporal sequence of events during the bone remodelling process o Qualitative and quantitative changes in organic and inorganic skeletal tissue components (structure, extent of mineralization, etc.) Because age-related bone loss and osteoporosis are heterogeneous and multifactorial in nature, applicants are encouraged to adopt interdisciplinary approaches, establishing or strengthening interactions and integration of efforts between clinical and basic science investigators. Research teams should include, where possible, a diverse range of expertise in areas such as bone biology, molecular biology, bone densitometry, orthopedics, histomorphometry, endocrinology, geriatrics, epidemiology and biostatistics. Because the current state of knowledge on skeletal aging and therapeutics in men is extremely limited, research proposing to include men (as well as women) as participants is strongly encouraged. In their application(s), applicants are encouraged to request funds for one to two participants to meet annually in Bethesda, Maryland with investigators of similar projects. Program directors from participating institutes will coordinate these meetings which will provide the opportunity for principal investigators to share findings, discuss their work in progress and to raise cross-cutting methodological and scientific issues. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 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. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: girg@drgpo.drg.nih.gov. The title and number of this program announcement must be typed in Section 2 on the face page of the application. Applications for the FIRST (R29) award must include at least three sealed letters of reference attached to the face page of the original application. FIRST (R29) award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. 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 will be assigned on the basis of established Public Health Service referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with 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. The review criteria to be used in the evaluation of applications submitted in response to this program announcement are: o Scientific, technical, or medical significance and originality of proposed research; o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o Inclusion of all three required research components described under Research Goals and Scope o Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o Availability of the resources necessary to perform the research; o Appropriateness of the proposed budget and duration in relation to the proposed research; o Adequacy of the provisions for the protection human subjects and safety of the research environment; and o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that IC. 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 priority. INQUIRIES Inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Sherry Sherman, Ph.D. Geriatrics Program National Institute on Aging Gateway Building, Suite 3E327 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1033 FAX: (301) 402-1784 Email: ShermanS@gw.nia.nih.gov Joan A. McGowan, Ph.D. Bone Diseases Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-43E 45 Center Drive, MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-5055 FAX: (301) 480-4543 Email: mcgowanj@ep.niams.nih.gov Joseph E. Ciardi, Ph.D. Craniofacial Development and Disorders Program National Institute of Dental Research Natcher Building, Room 4AN-24E 45 Center Drive, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2337 FAX: (301) 480-8318 EMail: ciardiJ@de45.nidr.nih.gov Ronald Margolis, Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 5AN-12J, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8819 FAX: (301) 480-3503 Email: rm76f@nih.gov Direct inquiries regarding fiscal matters to: Mr. Joseph Ellis Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: EllisJ@gw.nia.nih.gov Ms. Vicki Maurer Grants Management Office National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-49A 45 Center Drive, MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-3504 FAX: (301) 480-5450 Email: maurerv@ep.niams.nih.gov Mr. Martin R. Rubinstein Grants Management Office National Institute of Dental Research Natcher Building, room 4AN-44A 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-4800 FAX: (301) 480-8308 Email: Martin.Rubinstein@NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.866, 93.846, 93.847 and 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 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 Feb 17 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA ES-96-004 - V25(03) 02/09/96 Date: 18 Feb 1996 14:29:23 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 390 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4g8983$cgr@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA ES96004 ES-96-004 P1O1 *************************************** LINKING OF ENVIRONMENTAL AGENTS AND DISEASE NIH GUIDE, Volume 25, Number 3, February 9, 1996 RFA: ES-96-004 P.T. 34; K.W. 1007001, 0705048 National Institute of Environmental Health Sciences Letter of Intent Receipt Date: April 5, 1996 Application Receipt Date: May 8, 1996 PURPOSE The National Institute of Environmental Health Sciences (NIEHS) supports research to identify the role of environmental agents in perturbations of normal physiologic processes leading to human disease. Although direct links between environmental agents and health outcomes have been established for some diseases, there are numerous chronic dysfunctions and diseases where there are minimal scientific data to substantiate a role for the environment in their etiology or progression, despite the plausibility of these hypotheses. Therefore, the goal of this Small Grants Program (R03), Request for Applications (RFA) is to encourage research that will establish whether there is sufficient evidence either mechanistically or from epidemiologic studies to justify further investigations into the role of environmental agents in the initiation or exacerbation of human diseases. Research is specifically encouraged to determine the sound scientific connection between environmental agent and the initiation or progression of disease. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Linking of Environmental Agents and Disease, is related to the priority area of environmental 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 domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments and eligible agencies of the Federal government. Foreign institutions and organizations are not eligible. Applications from minority individuals and women are encouraged. Submission of an application precludes concurrent submission of a regular research projfect grant application (R01 or R29) containing the same research proposal. In addition, small grant research support may not be used to supplement research projects currently supported by Federal or non-Federal funds or to provide interim support for projects under review by the Public Health Service. MECHANISM OF SUPPORT This RFA will use the NIH Small Grants Program (R03) awards. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The requested costs and project period will be $50,000 (direct cost) for a maximum of one year. Small grants are not renewable but may be extended at the discretion of the applicant organization. FUNDS AVAILABLE The total estimated funds available for this small grants program is $750,000 which will support approximately 10 to 12 awards. This level of support is dependent on the receipt of sufficient number of applications of high scientific merit. Although this program is provided for within the financial plans of the NIEHS, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Objectives and Scope A major goal of the NIEHS is to improve our understanding of the contribution of environmental factors to the development of disease. In order for NIEHS to successfully carry out this mission, it is imperative to have information on the role of the environment in a wide variety of disease states. Preliminary data are needed to foster the development of mechanistically-based research on the relationship between environmental agents and diseases. This RFA is designed specifically to develop preliminary data on the possible role of the environment in diseases in which links to exposure are suggested but remain unproven. It is anticipated that these preliminary data will support development of hypothesis-based research to establish the cause and effect relationship between environmental exposures and disease etiology. Research Goals The goals and scope of the RFA are two-fold. The first is to encourage and support mechanistically-based research designed to establish the linkage between exposure to an environmental agent, tested at environmentally relevant concentrations, and the initiation or exacerbation of diseases. The second area of emphasis is to utilize human populations studies to develop hypotheses relating environmental exposure to the initiation or exacerbation of diseases. In either situation, emphasis should be placed on developing the preliminary data that would lead to the development of an R01 or R29 application. The role of environmental agents in disease may be approached using animal models, human tissue/cell-lines or human epidemiologic studies. In any case, environmentally relevant concentrations using dose-response data is encouraged. The effect of age and the timing of exposure relative to the toxicity or effect should also be included as part of the experimental design. The purpose of this RFA is to expand data on non-cancer diseases. Therefore, research on the role of environmental agents in the initiation or exacerbation of cancers of any type will be considered nonresponsive. SPECIAL REQUIREMENTS Animal Welfare Considerations Investigators are encouraged to consider alternative methods and approaches in their research applications that do not require the use of whole animals, that use alternative species such as nonmammals or invertebrates, that reduce the number of animals required, and that incorporate refinements to procedures that will result in the elimination or further minimization of pain and distress to animals. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103 43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, which have been published in the Federal Register of March 28, 1994 (FR 58 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by April 5, 1996, a letter of intent that includes a descriptive title of the proposed research, the name, address and telephone number of the Principal Investigator, the identities of other key personnel and consultants, the 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 application, the information that it contains is helpful in planning for the review of applications. It allows NIEHS staff to estimate the potential review work load and to avoid conflict of interest in the review. The letter of intent is to be sent to: Ethel B. Jackson, D.D.S. Extramural Division National Institute of Environmental Health Sciences P.O. Box 12233, MD 17-09 104 T.W. Alexander Drive, Building 17, Room 1717 Research Triangle Park, NC 27709 Telephone: (919) 541-7826 FAX: (919) 541-2503 EMAIL: jackson4@niehs.nih.gov 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 Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0715, email: girg@drgpo.drg.nih.gov. The following supplemental instructions are given: Only one small grant application may be submitted by a principal investigator. Due to the limited size of awards, no specific budget categories and percent efforts will be required. This will be a $50,000 award - direct cost. Equipment will be limited to $5,000. The applicant must be explicit in describing the proposed interface between an environmentally relevant agent and the induction or exacerbation of a specific disease. Background information must suggest, or at least not preclude, a possible interaction between these parameters. Since this award is to support pilot studies, preliminary data are not required except to indicate the expertise of the PI to carry out the proposed studies. The Research Plan (Specific Aims, Background and Significance, Preliminary Studies, Research Design and Methods sections) is not to exceed 10 pages. Tables and figures are included in the 10 page limitation. Applications that exceed page limitations or PHS 398 requirements for font size (height or letters), type density (characters per inch), and margins (see PHS 398 directions) will be returned to the investigator. Do not submit an appendix. The RFA Label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on Line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed, clear, and single sided photocopies in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to Dr. Ethel Jackson, at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants. Otherwise the NIEHS cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by May 21, 1996. If an application is received after that date, it will be returned to the applicant without review. Responsiveness of Applications to RFA Upon receipt, all applications will undergo an administrative review by senior scientific staff of the NIEHS for their responsiveness to the RFA. Only those applications considered to be responsive to the RFA will be forwarded for peer review. Applications considered non-responsive to the RFA will be returned to the applicant without further consideration. The following criteria will be considered: o Is the application focused on an environmental agent and its linkage to a disease state that is within the mission of the National Institute of Environmental Health Sciences? o Is the application focused on the linkage of exposure to an environmental agent and a non-cancer disease endpoint? o Is there reasonable evidence or suggestion that there may exist a linkage between an environmental exposure and a disease state? o Is there a plausible biological mechanism suggested linking the environmental exposure and the disease state? o Areas of science in which there are sufficient preliminary data that would support the submission of a regular research project grant application do not qualify under this RFA. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIEHS in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score. Review Criteria o scientific, technical, or medical significance of the proposed research as it relates to the connection between an environmental agent and the initiation or exacerbation of human disease; o potential of the proposed research to result in the development of hypothesis-based research establishing cause and effect relationships; o appropriateness and adequacy of the experimental design and methods proposed to carry out the research; innovativeness or promise of the research idea; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o reasonableness/appropriateness of the requested budget in relation to the proposed research; o availability of resources necessary to perform the research; and o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA The anticipated date of award is September, 1996 pending availability of funds. 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 announcement. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Jerrold J. Heindel, Ph.D. Organs and Systems Toxicology Branch National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 104 T.W. Alexander Drive, Building 3, Room 316 Research Triangle Park, NC 27709 Telephone: (919) 541-0781 FAX: (919) 541-2843 EMAIL: heindel_j@niehs.nih.gov Gwen W. Collman, Ph.D. Chemical Exposures and Molecular Biology Branch National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-04 104 T.W. Alexander Drive, Building 3, Room 306 Research Triangle Park, NC 27709 Telephone: (919) 541-4500 FAX: (919) 541-2843 EMAIL: collman@niehs.nih.gov Direct inquiries regarding fiscal matters to: Mr. David L. Mineo Grants Management Branch National Institute of Environmental Health Sciences P.O. Box 12233, MD 2-01 104 T.W. Alexander Drive, Building 2, Room 203B Research Triangle Park, NC 27709 Telephone: (919) 541-7628 FAX: (919) 541-2860 EMAIL: mineo@niehs.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.113 and 93.115. 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, 43 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 Feb 17 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 03, pt. 2of2, 9 February 1996 Date: 18 Feb 1996 14:28:35 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 942 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4g896j$cfh@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19960209 V25N03 P2O2 ************************************ doctoral degree, be beyond the level of a research trainee and be a member of the staff or faculty with at least one year of postdoctoral experience. The minority individuals are still eligible if they have previously received support from these programs: the Minority Biomedical Research Support Program (MBRS), Minority - Research Infrastructure Support Program (M-RISP), the Minority Access to Research Career Program (MARC), Career Opportunities in Research Education and Training (COR), small grants (R03), National Research Service Award (NRSA) predoctoral (F31) and postdoctoral (F32) fellowships, or the Academic Research Enhancement Award (AREA) Program (R15) is also eligible for these supplements. On the other hand, an individual who has received previous funding from NIH as an independent Principal Investigator on a regular research grant (e.g., R01, R29), or as the project leader on a component of a program project or center grant (e.g., P01, P50, G12), or as Principal Investigator on an individual research career award (e.g., K01, K02, K05, K07, K08, K11, K14, K15, K20, and K21) is not eligible. PROVISIONS The minority investigator supplemental award is for a maximum of $50,000 in direct costs per year. A maximum of $40,000 may be requested for salary and fringe benefits; additional funds up to $10,000 may be requested for supplies and travel. Equipment may not be purchased except in unusual circumstances and not without prior approval of the NIH awarding component. The maximum period of support for any investigator is four years. The amount of salary requested must be consistent with the policies of the parent grantee institution (if applicable, the minority investigator's employing institution) and must be related to the percent effort of the minority investigator. See the GENERAL PROVISIONS section for application procedures, review criteria, and funding. INQUIRIES Principal Investigators interested in participating in these programs are encouraged to contact NIH staff administering the parent grant. For general information about the Research Supplements for Underrepresented Minorities, contact the following staff person in the appropriate awarding component: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM Director, Alcohol Research Centers Program 6000 Executive Boulevard, Room 402 - MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 Email: tvanderv@willco.niaaa.nih.gov NATIONAL INSTITUTE ON AGING Deputy Associate Director, Office of Extramural Affairs Gateway Building, Suite 2C218 Bethesda, MD 20892-9205 Telephone: (301) 496-9322 FAX: (301) 402-2945 Email: rb42h@nih.gov NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES Director, Office of Science Training and Manpower Development Solar Building, Room 3C21 Bethesda, MD 20892 Telephone: (301) 496-7291 FAX: (301) 402-0369 Email: mh35c@nih.gov NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES Director, Centers Program Natcher Building, Room 5AS-19F Bethesda, MD 20892 Telephone: (301) 594-5052 FAX: (301) 480-4543 Email: freemanj@ep.niams.nih.gov NATIONAL CANCER INSTITUTE Deputy Director, Division of Extramural Activities Executive Plaza North, Suite 600 Bethesda, MD 20892 Telephone: (301) 496-4218 FAX: (301) 402-0956 Email: grayp@dea.nci.nih.gov NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT Special Assistant to the Deputy Director Building 31, Room 2A03, MSC 2425 Bethesda, MD 20892-2425 Telephone: (301) 496-0104 FAX: (301) 402-1104 Email: topperh@hd03.nichd.nih.gov NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS Deputy Director, Division of Human Communication 6120 Executive Boulevard, Room 400C - MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 496-5061 FAX: (301) 402-6251 Email: Judith_Cooper@nih.gov NATIONAL INSTITUTE OF DENTAL RESEARCH Assistant Director for Program Development Natcher Building, Room 4AN-24B, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2089 FAX: (301) 480-8318 Email: bravemann@de45.nidr.nih.gov NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES Assistant Director for Grants 45 Center Drive, Room 6AS-49E - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8842 FAX: (301) 480-3504 Email: garthunej@ep.niddk.nih.gov NATIONAL INSTITUTE ON DRUG ABUSE Chief, Special Populations Office 5600 Fishers Lane, Room 10A-10 Rockville, MD 20857 Telephone: (301) 443-0441 FAX: (301) 443-9127 Email: Lula_Beatty@nih.gov NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES Director, Division of Extramural Research and Training Building 3, Room 301A P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-7723 FAX: (919) 541-2843 Email: sassaman@niehs.nih.gov NATIONAL EYE INSTITUTE Research Resources Officer 6120 Executive Boulevard, Suite 350, MSC 7164 Rockville, MD 20892-7164 Telephone: (301) 496-5301 FAX: (301) 402-0528 Email: rjh@eps.nei.nih.gov NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES Assistant Director, Referral and Liaison 45 Center Drive, Room 2AN-18F, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-3833 FAX: (301) 402-0156 Email: renea@gm1.nigms.nih.gov NATIONAL HEART, LUNG AND BLOOD INSTITUTE Director, Division of Extramural Affairs 6701 Rockledge Drive, Suite 7100 - MSC 7924 Bethesda, MD 20892 Telephone: (301) 435-0260 FAX: (301) 480-3460 Email: rg33k@nih.gov NATIONAL CENTER FOR HUMAN GENOME RESEARCH Chief, Mapping Technology Branch Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: bettie_graham@nih.gov NATIONAL LIBRARY OF MEDICINE Acting Associate Director, Division of Extramural Programs Building 38A, Room 5N505 Bethesda, MD 20892 Telephone: (301) 496-4621 FAX: (301) 402-0421 Email: corn@1hc.nlm.nih.gov NATIONAL INSTITUTE OF MENTAL HEALTH Deputy Associate Director for Special Populations 5600 Fishers Lane, Room 17C-14 Rockville, MD 20857 Telephone: (301) 443-2847 FAX: (301) 443-8552 Email: sragland@nih.gov NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE Deputy Director, Division of Extramural Activities Federal Building, Room 1016 Bethesda, MD 20892 Telephone: (301) 496-4188 FAX: (301) 402-4370 Email: ed25b@nih.gov NATIONAL INSTITUTE OF NURSING RESEARCH Director, Extramural Programs 45 Center Drive, Room 3AN-12 - MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-6906 FAX: (301) 480-8260 Email: depdir@ep.ninr.nih.gov NATIONAL CENTER FOR RESEARCH RESOURCES Senior Advisor to the Director Building 12A, Room 4007, MSC 5662 Bethesda, MD 20892-5662 Telephone: (301) 496-5795 FAX: (301) 402-0006 Email: rogere@od12a.ncrr.nih.gov AUTHORITY AND REGULATIONS The statutory authorities for these grant awards are sections 301, 510, 515, and 504 of the Public Health Service Act. Federal regulations at 42 CFR Part 52, "Grants for Research Projects" and 45 CFR Part 74, "Administration of Grants," are applicable to these awards. Grants must be administered in accordance with the Public Health Service Grants Policy Statement. $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** ANIMAL CARE AND USE: HOT ZONES, GRAY ZONES, AND GO SLOW ZONES NIH GUIDE, Volume 25, Number 3, February 9, 1996 P.T. 34; K.W. 0201011, 1014003 National Institutes of Health Public Responsibility in Medicine and Research Tufts University School of Veterinary Medicine The Office for Protection from Research Risks (OPRR), Public Responsibility in Medicine and Research (PRIM&R), and Tufts University School of Veterinary Medicine announce the annual conference on the care and use of laboratory animals in research. Attendees can expect to receive (1) the first comprehensive revision in a decade of the "Guide for the Care and Use of Laboratory Animals," and (2) a copy of the 1996 reprint of the Public Health Service Policy on Humane Care and Use of Laboratory Animals." Officials from OPRR, the U.S. Department of Agriculture, and the National Academy of Sciences will present briefings on these key documents. Keynote speakers include Dr. Judith Vaitukaitis, director, National Center for Research Resources; Dr. Bill Raub, Science Advisor for the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services; and Drs. Nancy and Gerald Jaax, central figures in the response and management of disease outbreak storied in "The Hot Zone." Among other forefront issues, the conference will address (1) the search for alternatives to painful procedures, and (2) the ethics, science, and risk of animal-to-human xenotransplantation. In addition to plenary addresses, panel discussions, and more than 24 workshops, the conference will include a Resource Room stocked with organizational resources and articles relevant to animal care and research, a Poster Session in which individuals who work in the areas of public and/or institutional education will display and discuss their programs, and a demonstration of computer, Internet, and other technical aids that can ease the administrative burden and enhance the ethical vigilance of the IACUC. There are a limited number of auditor-status scholarships for full- time students and others demonstrating need, and places for members of the press. INQUIRIES PRIM&R 132 Boylston Street Boston, MA 02116 Telephone: (617) 423-4112 FAX: (617) 423-1185 Email: primr@delphi.com $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 25, Number 3, February 9, 1996 P.T. 42; K.W. 0783005 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human subjects. The meetings should be of special interest to those persons currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all other Public Health Service agencies. The current schedule includes the following: DATES: April 11-12, 1996 TITLE: The Ends of the Spectrum: From Children to Geriatrics LOCATION: Emory Conference Center Hotel, Emory University Campus, Atlanta, GA SPONSORS: Emory University, Atlanta, GA; Clark Atlanta University, Atlanta, GA; Centers for Disease Control, Atlanta, GA; Wesley Woods Geriatric Center, Atlanta, GA; Department of Veterans Affairs, Atlanta, GA REGISTRATION Continuing Medical Education Emory University School of Medicine 1440 Clifton Road, N.E. 107 WHSCAB Atlanta, GA 30322 Telephone: (404) 727-5965 FAX: (404) 727-5667 REGISTRATION FEE: $195 DESCRIPTION: "The Ends of the Spectrum: Child and Geriatric Research" is a seminar designed for researchers, physicians, Institutional Review Board members, psychologists, students, and research administrators. The program is open to anyone interested in human subject research. Acknowledged leaders in the field will present lectures, and breakout sessions will be provided on both days. There will be ample time for discussion and exchange of ideas. Learning objectives include: (a) To identify issues of concern regarding the protection of human subjects in research of children and geriatric subjects; (b) To explore a broad range of contemporary scientific, ethical, regulatory and legal issues relating to biomedical and behavioral research involving human subjects; (c) To discuss and clarify regulations and institutional requirements governing the conduct of research; and (d) To heighten the awareness to specifics related to both ends of the spectrum. INQUIRIES For further information regarding these workshops or future NIH/FDA National Human Subject Protections Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, Suite 3B01 Rockville, MD 20892-7507 Telephone: (301) 496-8101 x233 FAX: (301) 402-0527 Email: RossD@od6100m1.od.nih.gov $$N4 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NIH-NINDS-96-03 ****************************************** ELECTRODES FOR FUNCTIONAL ELECTRICAL STIMULATION NIH GUIDE, Volume 25, Number 3, February 9, 1996 RFP AVAILABLE: NIH-NINDS-96-03 P.T. 34; K.W. 0750005, 0740050 National Institute of Neurological Disorders and Stroke The Neural Prosthesis Program of the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), has a requirement for the design, fabrication, and testing in an animal model, of electrodes for use in functional neuromuscular stimulation (FNS) systems. The objective of this research and development project is to develop stimulating electrodes suitable for chronic FNS in humans that permit safe, reliable, graded activation of selected muscles. In order to encourage the broadest competition, the particular type of electrode and the muscles to be activated are not specified. Offerors will define this focus in association with a collaborating clinical research group. The contract will not support performance of the clinical program. The research efforts will concentrate on developing electrodes that are capable of selectively activating specific functional muscle groups required by the collaborating clinical group. Offerors are encouraged to consider innovative approaches to the design of electrodes with a focus on obtaining reliable, selective, controlled, graded stimulation. Human studies will not be supported under the contract, but it is expected that the research effort will conclude at a point where human studies will be the next logical step. Prospective offerors shall be required to obtain institutional approval for all animal studies and follow the PHS guidelines for the Care and Use of Laboratory Animals. Performance of the research project will require expertise in biomedical engineering, material science, physiology, rehabilitation medicine, and animal testing. It is anticipated that one award, on a cost-reimbursement basis, will made for a period of three years. INQUIRIES This is not a Request for Proposals (RFP). RFP No. NIH-NINDS-96-03 will be issued on or about February 9, 1996, with responses due approximately 60 days thereafter. Interested organizations should request either a streamlined version or an entire RFP document. If no selection is made, a streamlined version of the RFP will be provided. The streamlined version includes only the Statement of Work, deliverable and reporting requirements, special requirements, and technical evaluation criteria. After examination of these documents, any organization interested in responding to the RFP must request the entire RFP either in writing or by FAX. Supply this office with two self-addressed mailing labels. All responsible sources may submit a proposal that will be considered by the Government. Laurie Leonard Contracts Management Branch National Institute of Neurological Disorders and Stroke 7550 Wisconsin Avenue, Room 901, MSC 9190 Bethesda, MD 20892-9190 ATTN: RFP NIH-NINDS-96-03 FAX: (301) 402-4225 $$R1 END ************************************************************ $$R2 BEGIN NIH-NINDS-96-04 ****************************************** INSULATING BIOMATERIALS NIH GUIDE, Volume 25, Number 3, February 9, 1996 RFP AVAILABLE: NIH-NINDS-96-04 P.T. 34; K.W. 0750005, 0740050 National Institute of Neurological Disorders and Stroke The Neural Prosthesis Program of the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), supports research on the evaluation and development of biomaterials for neural prostheses. This research contract will develop biomaterials for the long-term insulation of implantable stimulating and recording microelectrodes and interconnect cables. In-vivo and in-vitro studies will be conducted. Neural prosthetic implants need to function in the hostile ionic environment of extracellular fluids for periods of decades. Studies by NPP investigators have demonstrated reliable operation in in-vitro soak tests of both fluorocarbon and silicone insulated silicon microdevices and wires for prolonged periods. Accelerated testing of these materials at elevated temperatures suggests that they will function reliably for periods of decades. In-vivo testing of these materials has begun but significant additional work is required before they can be used with confidence in chronic applications for many decades. The primary emphasis of this research is to evaluate, in an animal model, biomaterials that, by in-vitro testing, appear to be capable of functioning for decades. Additional studies will evaluate potential insulating biomaterials by accelerated and long-term in-vitro testing. Research to determine the underlying chemical and physical basis of successful insulating materials with the goal of the rational design of new materials with improved properties will also be required. Histopathological studies to evaluate tissue response to the implanted biomaterials are supported through a separate research contract and are not a major focus of this work. Offerers are encouraged to subcontract a portion of the work if they lack facilities or expertise to respond to all aspects of the RFP within their organizations. Prospective offerors shall be required to obtain institutional approval for all animal studies and follow the PHS guidelines for the Care and Use of Laboratory Animals. Performance of the research project will require expertise in material science, biomaterials, microelectronic packaging, and animal testing. It is anticipated that one award, on a cost-reimbursement basis, will made for a period of three years. INQUIRIES This is not a Request for Proposals (RFP). RFP No. NIH-NINDS-96-04 will be issued on or about February 9, 1996, with responses due approximately 60 days thereafter. Interested organizations should request either a streamlined version or an entire RFP document. If no selection is made, a streamlined version of the RFP will be provided. The streamlined version includes only the Statement of Work, deliverable and reporting requirements, special requirements, and technical evaluation criteria. After examination of these documents, any organization interested in responding to the RFP must request the entire RFP either in writing or by FAX. Requests must cite the RFP number. Supply this office with two self-addressed mailing labels. All responsible sources may submit a proposal that will be considered by the Government. Laurie Leonard Contracts Management Branch National Institute of Neurological Disorders and Stroke, 7550 Wisconsin Avenue, Room 901, MSC 9190 Bethesda, MD 20892-9190 FAX: (301) 402-4225 ATTN: RFP NIH-NINDS-96-04 $$R2 END ************************************************************ $$R3 BEGIN NIH-NINDS-96-05 ****************************************** CHANGES IN CLEARANCE OF ANTIEPILEPTIC DRUGS DURING PUBERTY NIH GUIDE, Volume 25, Number 3, February 9, 1996 RFP AVAILABLE: NIH-NINDS-96-05 P.T. 34; K.W. 0740010, 0755010, 0785035 National Institute of Neurological Disorders and Stroke The National Institute of Neurological Disorders and Stroke (NINDS), NIH will solicit proposals for performance of an observational study that will use a cross-sectional design to investigate the clearance of antiepileptic drugs (phenytoin, carbamazepine, valproate, and lamotrigine) in male and female patients during age ranges that will include pre-, peri-, and post-pubertal stages. Offerors are required to have an existing, appropriate laboratory for assay of antiepileptic drugs in blood or plasma. Performance of work under this project will require an offeror to have access to a patient population sufficient to enroll and complete a target number of 64 patients being medically treated for epilepsy at their site. Offerors shall have personnel on staff with established clinical expertise in the treatment of epilepsy and experience in evaluating and recruiting suitable patients. It is anticipated that up to 10 contracts will be awarded for a maximum period of 21 months each. Payment will be on a cost-reimbursement basis for the three-month preparation phase and on a fixed price per patient basis for the eighteen-month study conduct phase. INQUIRIES This is not a Request for Proposals (RFP). RFP No. NIH-NINDS-96-05 will be issued on or about February 5, 1996. Proposals will be due approximately sixty days after issuance of the RFP. All responsible sources may submit a proposal that will be considered by the NINDS. To receive a copy of the RFP, submit a written request and two self-addressed mailing labels to: Raina Cervantes Contracts Management Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 901 7550 Wisconsin Avenue, MSC 9190 Bethesda, MD 20892-9190 Reference: RFP No. NIH-NINDS-96-05 $$R3 END ************************************************************ $$R4 BEGIN ES-96-004 FULL-TEXT ************************************** LINKING OF ENVIRONMENTAL AGENTS AND DISEASE NIH GUIDE, Volume 25, Number 3, February 9, 1996 RFA AVAILABLE: ES-96-004 P.T. 34; K.W. 1007001, 0705048 National Institute of Environmental Health Sciences Letter of Intent Receipt Date: April 5, 1996 Application Receipt Date: May 8, 1996 PURPOSE The goal of this Small Grants Program (R03), Request for Applications (RFA), is to encourage research that will establish whether there is sufficient evidence either mechanistically or from epidemiologic studies to justify further investigations into the role of environmental agents in the initiation or exacerbation of human diseases. Research is specifically encouraged to determine the sound scientific connection between environmental agents and the initiation or progression of disease. The total estimated funds available for support of this program is $750,000, which will support approximately 10 to 12 awards. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Linking of Environmental Agents and Disease, is related to the priority area of environmental health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: (202) 512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Jerry Heindel, Ph.D. Organs and Systems Toxicology Branch National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 104 Alexander Drive, Building 3, Room 316 Research Triangle Park, NC 27709 Telephone: (919) 541-3319 EMAIL: heindel_j@niehs.nih.gov $$R4 END ************************************************************ $$P1 BEGIN PA-96-022 FULL-TEXT ************************************** HUMAN MODELS AND MARKERS OF SKELETAL AGING NIH GUIDE, Volume 25, Number 3, February 9, 1996 PA AVAILABLE: PA-96-022 P.T. 34; K.W. 0755020, 0710010, 0715031 National Institute on Aging National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Dental Research National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The National Institute on Aging (NIA), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Dental Research (NIDR) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite research grant applications (R01 and R29) to develop or refine models and markers using human bone, bone marrow or bone cell constituents which more accurately reflect those age-related and/or pathophysiological processes occurring within the mature human skeleton that lead to osteoporosis and other age-related skeletal diseases. It is expected that improved human models and markers of age-related changes in skeletal tissue structure and function will enhance the accuracy and reliability of diagnostic and prognostic capabilities and serve to expedite the development of more effective, targeted preventive and therapeutic strategies. Approximately $900,000 from NIA and up to $500,000 from NIAMS in total costs for the first year of funding will be made available in FY 1997 to fund applications submitted in response to this PA for the Feb/Mar 1996, Jun/Jul 1996 and Oct/Nov 1996 application receipt deadlines. NIDR intends to fund two to four additional applications in FY 1997. NIDDK anticipates funding two to three additional applications as funds warrant in FY 97. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit and upon the availability of funds at the time the awards are made. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Human Models and Markers of Skeletal Aging, is related to the priority area of osteoporosis. 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. Sherry Sherman, Ph.D. Geriatrics Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3E327, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1033 FAX: (301) 402-1784 Email: ShermanS@gw.nia.nih.gov Joan A. McGowan, Ph.D. Bone Diseases Program National Institute of Arthritis and Musculoskeletal and Skin Diseases 45 Center Drive, Room 5AS-43E, MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-5055 FAX: (301) 480-4543 Email: mcgowanj@ep.niams.nih.gov Joseph E. Ciardi, Ph.D. Division of Extramural Research National Institute of Dental Research 45 Center Drive, Room 4AN-24E, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2337 FAX: (301) 480-8318 Email: ciardiJ@de45.nidr.nih.gov Ronald Margolis, Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 5AN-12J, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8819 FAX: (301) 480-3503 Email: rm76f@nih.gov $$P1 END ************************************************************ $$P2 BEGIN PA-96-023 FULL-TEXT ************************************** PILOT PROJECT RESEARCH GRANT PROGRAM FOR THE NIA NIH GUIDE, Volume 25, Number 3, February 9, 1996 PA AVAILABLE: PA-96-023 P.T. 34; K.W. 0710010, 0710030 National Institute on Aging PURPOSE The National Institute on Aging (NIA) is seeking small grant (R03) applications to stimulate and facilitate the entry of promising new investigators into targeted, high priority areas of aging research. This Small Grant (R03) Program provides support for pilot research that is likely to lead to a subsequent individual research project grant (R01) or a FIRST (R29) award application and/or a significant advancement of aging research. HEALTHY PEOPLE 2000 The 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, Pilot Project Research Grant Program for the NIA, is related to the priority areas of unintentional injuries, diabetes and chronic disabling conditions, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-11474-0 or Summary Report: Stock No. 017-001-11473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Dr. David B. Finkelstein National Institute on Aging 7201 Wisconsin Avenue, Suite 2C212, MSC 9205 Bethesda, MD 20892 Telephone: (301) 496-6402 FAX: (301) 402-0010 Email: NIAPILOT@gw.nia.nih.gov $$P2 END ************************************************************ $$P3 BEGIN PA-96-024 FULL-TEXT ************************************** NIDCD PROGRAM FOR POSTDOCTORAL RESEARCH TRAINING IN CLINICAL TRIALS NIH GUIDE, Volume 25, Number 3, February 9, 1996 PA AVAILABLE: PA-96-024 P.T. 44; K.W. 0720005, 0755015 National Institute on Deafness and Other Communication Disorders PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) invites applications for the support of Institutional National Research Service Award (NRSA) (T32) programs of postdoctoral research training in the design and conduct of clinical trials for individuals trained in the clinical disciplines of human communication. The purpose of this initiative is to foster the development of trained professionals into independent investigators capable of conducting clinical trials of the efficacy of treatment for diseases and disorders affecting hearing, balance, smell, taste, voice, speech, or language. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), NIDCD Program for Postdoctoral Research Training in Clinical Trials, is related to the priority areas of clinical prevention services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-11474-0 or Summary Report: Stock No. 017-001-11473-1) 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. Daniel A. Sklare, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard Room 400C, MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 496-1804 FAX: (301) 402-6251 Email: daniel_sklare@nih.gov $$P3 END ************************************************************ $$P4 BEGIN PA-96-025 FULL-TEXT ************************************** NICHD SMALL GRANTS PROGRAM NIH GUIDE, Volume 25, Number 3, February 9, 1996 PA AVAILABLE: PA-96-025 P.T. 34; K.W. 1014006, 0413000, 0775013, 0710030, 0404000 National Institute of Child Health and Human Development PURPOSE The National Institute of Child Health and Human Development (NICHD) Small Grants Program provides limited financial support for new research projects relevant to the NICHD mission. Applications may be submitted by new or more established investigators for support of research in any scientific area relevant to the Institute's programs in the Center for Population Research, the Center for Research for Mothers and Children, and the National Center for Medical Rehabilitation Research. While proposals may involve a wide variety of biomedical, biobehavioral, or clinical disciplines, relevance to the mission of NICHD must be clear. 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, NICHD Small Grants Program, is related to the priority areas of nutrition, family planning, educational and community-based programs, unintentional injuries, maternal and infant health, diabetes and chronic disabling conditions, HIV infection, sexually transmitted diseases, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (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 contacts listed below. Florence P. Haseltine, M.D. Center for Population Research National Institute of Child Health and Human Development Building 61E, Room 8B07 MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1101 FAX: (301) 496-0962 Email: haseltif@hd01.nichd.nih.gov Sumner J. Yaffe, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development Building 61E, Room 4B05 MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5097 FAX: (301) 402-2085 Email: yaffes@hd01.nichd.nih.gov Marcus Fuhrer, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Building 61E, Room 2A03 MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 FAX: (301) 402-0832 Email: fuhrerm@hd01.nichd.nih.gov $$P4 END ************************************************************ ERRATA $$E1 BEGIN N1 19950112 APPEND NOTICE *********************************** NOVEL PHARMACOTHERAPIES FOR COCAINE AND OTHER PSYCHOSTIMULANT DEPENDENCE NIH GUIDE, Volume 25, Number 3, February 9, 1996 RFA: DA-96-003 P.T. 34; K.W. 0404009, 0740020 National Institute on Drug Abuse Letter of Intent Receipt Date: January 19, 1996 Application Receipt Date: February 21, 1996 PURPOSE This notice will correct the Schedule listed in the NIH Guide, Vol. 24, No. 41, December 1, 1995 publication of this Request for Applications (RFA). The Letter of Intent and Receipt Date do not change. However, the initial review, advisory council date and start date were incorrect in the December 1, publication. The correct schedule is: Letter of Intent Receipt Date: January 19, 1996 Application Receipt Date: February 21, 1996 Initial Review Date: June/July 1996 Advisory Council Date: September 1996 Earliest Start Date: September 30, 1996 All other aspects of the RFA remain the same. INQUIRIES Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-2755 $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Sat Feb 17 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-023 - V25(03) 02/09/96 Date: 18 Feb 1996 14:30:17 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 317 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4g899p$cmq@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA96023 PA-96-023 P1O1 *************************************** PILOT PROJECT RESEARCH GRANT PROGRAM FOR THE NIA NIH GUIDE, Volume 25, Number 3, February 9, 1996 PA NUMBER: PA-96-023 P.T. 34; K.W. 0710010, 0710030 National Institute on Aging PURPOSE The National Institute on Aging (NIA) is seeking small grant (R03) applications to stimulate and facilitate the entry of promising new investigators into targeted, high priority areas of aging research. This Small Grant (R03) Program provides support for pilot research that is likely to lead to a subsequent individual research project grant (R01) or a First Independent Research Support and Transition (FIRST) (R29) award application and/or a significant advancement of aging research. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Pilot Project Research Grant Program for the NIA, is related to the priority areas of unintentional injuries, diabetes and chronic disabling conditions, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-11474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-11473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign organizations and institutions are not eligible. Participation in the program by investigators at minority institutions is strongly encouraged. Pilot project grants awarded through this Program Announcement may not be used to support thesis or dissertation research. To be eligible for this award, the proposed Principal Investigator must, at a minimum, be an independent investigator at the beginning of her/his research career as defined by the eligibility requirements for a FIRST (R29) award. Established investigators proposing research unrelated to a currently funded research program are also eligible to apply for these grants. MECHANISM OF SUPPORT Applicants may request up to $50,000 (direct costs) for one year through the small grant (R03) mechanism. However, the grants will be awarded under Expanded Authorities and are eligible for a single one-year no cost extension. These awards are not renewable. Before completion of the R03, investigators are encouraged to seek continuing support for research through a research project grant (R01) or FIRST (R29) award. The award may not be used for salary support for the principal investigator, but may be used to support the costs of technicians or fellows to carry out the research. Replacement of the Principal Investigator on this award is not permitted. RESEARCH OBJECTIVES The Small Grant program is designed to support independent basic and clinical scientists who are interested in entering the area of aging research. Targeted aims For 1996, investigators may apply for a small grant to support research on one of the following topics relevant to aging research: o Aging muscle: basic underlying mechanisms o Molecular basis of cardiovascular aging o Aging immunobiology: basic underlying mechanisms o Animal models of aging o Clinical studies focusing on a systems physiology (i.e., integrative) approach in defining age-associated changes in the human cardiovascular system o Clinical studies of the physiologic/metabolic consequences of age-related changes in the mass and/or other properties of skeletal muscle o Neural mechanisms of age-related changes in attention o Aging protein: Protein structure changes with aging with special emphasis on the nervous system o Mechanisms underlying changes in spatial and temporal processing in sensory systems of the aging brain o Mechanisms underlying changes in sleep processes in older organisms o Social Cognition and Aging o Effect of immigrant flow on population aging o Biodemography of Aging o Health, Work and Retirement Applications for support in areas other than those stated will be returned to the proposed Principal Investigator without review. The National Institute on Aging will modify the selected topic areas annually by reissuing the program announcement. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects of the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES The submission, review, and award schedule for the Small Grant Program for 1996 is: Application Receipt Dates: 03/12/96 07/12/96 11/12/96 Institute Committee Review: Jun-Jul Oct-Nov Feb-Mar Earliest funding: Sept Jan May Only one Small Grant application may be submitted by a principal investigator per receipt date. Applicants may not submit R01 or R29 applications on the same topic concurrent (to be considered at the same review cycle) with the submission of a Small Grant application. Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and prepared according to the directions in the application packet, with the exceptions noted below. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: girg@drgpo.drg.nih.gov. On the face page of the application: Item 2 Type "Pilot Project Research Grant Program for the NIA". Check the "YES" box. Sections 1-4: Do not exceed a total of ten pages for the following sections: specific aims, background and significance, progress report/preliminary studies, and experimental design and methods. Tables and figures are included in the ten page limitation. Applications that exceed the page limitation or PHS requirements for type size and margins (Refer to PHS 398 application for details) will be returned to the investigator. The ten page limitation does not include Sections 5-9 (Human Subjects, Consortia, Literature cited). Appendix materials are not allowed. Submit a signed, original of the application, including the checklist, and three 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 courier/overnight service) In addition, to expedite the review of the application, submit two additional exact photocopies of the application directly to Chief, Scientific Review Office National Institute on Aging Gateway Building Suite 2C212, MSC 9205 7201 Wisconsin Avenue Bethesda, MD 20892-9205 In order not to delay review, it is important that applicants comply with this request. REVIEW CONSIDERATIONS A review committee of the NIA will evaluate each Small Grant application in accordance with the usual NIH peer review procedures and criteria. Applications will be evaluated with respect to the following criteria: o Importance of the area to aging research o Feasibility of the proposed exploratory research o Likelihood of the proposed pilot project leading to the development of an R01/R29 grant application, or significant advancement of aging research. o Adequacy of approach and scientific originality and significance o "High risk" with likelihood for "high gain" o Appropriateness of the proposed budget and timetable in relation to the scope of the proposed research. o Qualifications and research experience of the principal investigator. o Availability of resources necessary for the research, including any needed to supplement the budget. o The adequacy of the proposed means for protecting against or minimizing potential adverse effects upon humans, animals, or the environment. o Adequacy of adherence to guidelines for including gender and minority representation in any study population. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o quality of the proposed project as determined by peer review; o availability of funds; o program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Biology of Aging Program Dr. David B. Finkelstein Telephone: (301) 496-6402 FAX: (301) 402-0010 Email: BAPquery@gw.nia.nih.gov Behavioral and Social Research Dr. Jared Jobe Telephone: (301) 496-3137 FAX: (301) 402-0051 Email: BSRquery@gw.nia.nih.gov Geriatrics Program Dr. Andre Premen Telephone: (301) 496-6761 FAX: (301) 402-1784 Email: GPquery@gw.nia.nih.gov Neuroscience and Neuropsychology of Aging Program Dr. Judy Finkelstein Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: NNAquery@gw.nia.nih.gov The address and general EMail address for all the above is: National Institute on Aging Gateway Building, Suite 2C212 7201 Wisconsin Avenue MSC 9205 Bethesda, MD 20892 Email: NIAPILOT@gw.nia.nih.gov Direct inquiries regarding fiscal matters to: Robert Pike Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 7201 Wisconsin Avenue MSC 9205 Bethesda, MD 20892 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: pikeR@gw.nia.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.366. 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 recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sat Feb 17 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-019 - V25(02) 02/02/96 Date: 18 Feb 1996 14:40:38 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 457 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4g89t6$dpu@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA96019 PA-96-019 P1O1 *************************************** INTERVENTION RESEARCH TO PREVENT ALCOHOL-RELATED PROBLEMS NIH GUIDE, Volume 25, Number 2, February 2, 1996 PA NUMBER: PA-96-019 P.T. 34; K.W. 0404003, 0745027, 0795005 National Institute on Alcohol Abuse and Alcoholism PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks to stimulate the design, development, and/or testing of interventions that have the potential of preventing alcohol abuse and alcohol-related problems among appropriate target populations. Investigators are encouraged to move beyond preintervention studies into the domain of efficacy and effectiveness studies that directly assess the impact of preventive interventions. 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, Intervention Research to Prevent Alcohol-Related Problems, is related to the priority areas of alcohol abuse reduction and alcoholism prevention. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit 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 applicants are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29). Research Project Grant (R01) applications from foreign institutions are limited to three years. MECHANISM OF SUPPORT Research support may be obtained through applications for a regular research project grant (R01), First Independent Research Support and Transition (FIRST) Award (R29) or Small Grant (R03). 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 (R01) applications and, to a limited extent, FIRST Award applications from investigators who wish to collaborate on research, but do not require extensive shared physical resources. Further information on the IRPG mechanism is available in program announcement PA-96-001, NIH Guide for Grants and Contracts, Vol. 24, No. 35, October 6, 1995.Program Project Grants applications (P01) will not be accepted under this program announcement. Investigators who wish to submit an application that exceeds $500,000 for direct costs in any one year must contact program staff before submitting an application. FUNDS AVAILABLE The NIAAA estimates that the average research project grant award size will be approximately $250,000 in total costs per year. Although the financial plans of NIAAA provide for the support of this program, the award of grants pursuant to this announcement is contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Intervention and prevention strategies may be initiated and implemented by the investigators themselves for the specific purpose of testing their effects; or the interventions may occur naturally outside the control of the investigator, through actions of public and private organizations. Studies of naturally occurring interventions are called "natural experiments." It may be possible to nest an investigator-initiated intervention within a natural experiment, permitting effects of both types of interventions to be studied simultaneously. Thus, investigators might develop and test an intervention like media advocacy or physician guidance that calls attention to and helps implement a new law or policy for preventing alcohol abuse. Applicants should justify their choice of interventions for study based on relevant theories of behavioral change for individuals or groups and, where possible, on existing data suggesting positive intervention effects. Although natural experiments tend to be empirically-rather than theory-driven, the applicant should still explain why the chosen intervention should (or should not) be expected to have a preventive effect. Applicants may propose small-scale feasibility or pilot studies as a prelude to later designing more complex intervention research. Feasibility studies might address the following types of issues: determining ways to ensure effective recruitment, retention, compliance, and followup of representative study participants (e.g., parents, ethnic minorities, school drop outs); operationalizing interventions for use in real-world environments; determining the acceptability of intervention and data collection protocols by necessary gatekeepers and target groups; developing and testing procedures for training intervention implementors and data collectors; constructing or adapting protocols for use among culturally diverse populations; determining how necessary outcome data can be most effectively, efficiently, and completely collected. Examples of Investigator-Initiated Interventions include, but are not limited to: College-Based Studies: There is a paucity of attempts to develop and test strategies to reduce drinking, binge drinking, and alcohol-related problems on college campuses. Interventions currently being tested include brief motivational counseling and challenging of alcohol expectancies. Applicants are encouraged to expand the breadth of strategies being tested, to focus on high-risk groups, to consider approaches to normative change, and to collaborate with college administrators in designing and implementing prevention policies to be studied. Worksite Studies: Recent preintervention studies of work-related alcohol problems and policies have laid the groundwork for tests of new and modified primary prevention strategies among unionized and nonunionized workers and managers in a range of work settings. Studies of the effectiveness of secondary prevention approaches for early detection of problems and appropriate referral (e.g., through EAPs) are also encouraged. Interventions may attempt to change formal and informal alcohol policies, organizational goals, work environments, work-group norms, and/or perceptions, beliefs, and attitudes of individuals. Family Studies: Data suggest that family involvement can enhance the effectiveness of school-based prevention programs. Moreover, family-focused interventions may themselves reduce alcohol-related problems among youth and adults, including elderly family members. This is an underdeveloped area of alcohol prevention research that needs systematic expansion. Studies may focus on families in general or those at high risk for alcohol problems. Applicants should attempt to develop and test strategies that could ultimately prove to be cost-effective. Labor-intensive interventions should be justified by the magnitude of the problem being prevented. Health-Care Systems: Increasing attention is being given to the possible role of health-care systems and professionals in preventing alcohol-related problems before they occur and in facilitating the early detection of problematic drinking. Experimental and quasi-experimental designs may be used in health-care settings to test the efficacy of preventive strategies. These may include various forms of advice, monitoring, and risk assessment (e.g., anticipatory guidance for teenagers and pregnant women, medication counseling for the elderly). Alcohol and AIDS: Numerous studies have determined that alcohol is an important co-factor in increased risk of HIV infection. Applicants are encouraged to develop and test single or multiple interventions that target populations in which alcohol use or misuse contributes to HIV risk behaviors. These interventions can be aimed at individuals, social networks, and/or social institutions to change alcohol/sexual expectancies, behavioral norms, and risky behaviors. Alcohol-Related Violence: Existing studies show two-way relationships between alcohol use and physical and sexual violence. Research indicates that victims of child abuse are at excess risk of developing alcohol problems later in life and that abusers of alcohol may be at increased risk of perpetrating violence against others. Few attempts have been made to design and test interventions to prevent alcohol- related violence. Such strategies could target potential perpetrators or victims of violence (e.g., partners of alcohol abusers), drinking establishments and hazardous environments (e.g., student vacation sites), or alcohol-availability policies. Alcohol-Related Birth Defects: NIAAA supports a large portfolio of grants concerned with biomedical and epidemiological aspects of fetal alcohol syndrome (FAS) and other alcohol-related birth defects. However, only a small proportion of NIAAA studies have addressed prevention issues. Since fetal alcohol syndrome is the largest preventable cause of mental retardation, there is a compelling need for studies that develop and test interventions that have the potential of reducing rates of FAS among high-risk populations. Heavy-drinking women in the child bearing years are an especially important target group. Genetic/Behavioral Risk Counseling: Vulnerability to alcoholism and alcohol problems reflects a complex interaction of genetic, behavioral, and environmental factors. Mechanisms and modes of inheritance may differ for various subtypes of the illness or condition. The time has come to explore the possible benefits of counseling for high-risk families that takes into account aggregate familial risk factors including genetics. Such interventions should: be developmentally age appropriate, address the initiation and progression of drinking, deal with mediating behavioral processes and family dynamics, and avoid misattribution, labeling, and stigmatization. Outcome measures could assess changes in risk perceptions, attitudes, and behaviors of target individuals and families. Media/Communication Strategies: Previous research suggests that media interventions alone are relatively weak prevention strategies, but they clearly can be an important adjunct to other community initiatives such as road blocks and zero tolerance BAC laws. Ongoing research is assessing the utility of communication strategies in preventing alcohol problems among youth. Applicants are encouraged to develop and test promising messages, communication technologies, persuasive styles, and formats to determine the most efficacious and effective media/communication approaches for varied target groups. Special Populations: There is a critical need for preventive intervention research that focuses on understudied populations including racial/ethnic subpopulations, rural populations, older Americans, disabled persons, heavy-drinking women in the child bearing years, and lesbians. Preintervention studies among these groups have identified risk and protective factors for alcohol abuse, populations at excess risk, etiologic processes, and potentially effective prevention strategies. However, very few studies have actually tested the impact of preventive interventions among these populations. Natural Experiments Naturally occurring preventive interventions are being implemented by Federal, State, and local governments, educational institutions, and the private sector to address such problems as drinking and driving, underage drinking, alcohol-related violence, worksite alcohol abuse, fetal alcohol syndrome, and sexual risk-taking. Policy-driven strategies have proven highly effective in reducing alcohol consumption and attendant problems. Examples include increasing the legal minimum drinking age, lowering legal blood alcohol levels for drivers, administrative license revocation, and higher taxes on alcoholic beverages (generally implemented for revenue rather than prevention purposes). Naturally occurring multidimensional community prevention programs have also shown positive results. Natural experiments have both advantages and disadvantages. In their favor: they take place in real-world settings where generalizations to analogous populations are highly plausible; the interventions do not have to be subsidized by the research project; where government bodies initiate the interventions study results are likely to be policy relevant, indicating whether the strategies are worthy of diffusion and how they could be improved; and established methods (such as time series analysis) exist to assess the impact of natural interventions. On the negative side: naturally occurring interventions rarely permit efficacy studies where strategies being evaluated are implemented under optimal conditions. Nor is it generally possible to conduct randomized controlled trials. Effectiveness studies based on quasi-experimental designs are usually the only option. Time pressures may also negate or limit collection of pristine baseline data before the intervention is implemented; acceptance of the intervention and the quality of its implementation may vary across sites; and identification of appropriate control or comparison groups can be difficult, particularly for universal interventions. In selecting natural interventions for possible study, applicants should consider: the state of the science on that issue, the generalizability of research findings, whether a methodologically sound study can be launched, potential cooperation with the initiating body (including possible co-funding), types of pre and post outcome data available or collectable over the proposed time period, relevant target groups, and the appropriateness of subgroup analyses (e.g., by gender, ethnicity, and age). Researchers are also encouraged to collect prospective and retrospective process data (qualitative and quantitative) to shed light on causal linkages between interventions and outcomes. Current naturally occurring interventions of interest for research include: strategies to reduce drunk driving such as per se laws, interlock devices, vehicle impoundment, combinations of jail and other sentences, victim impact panels, and special licensing procedures for youth; controls on youth access to alcohol such as keg registration, increased law enforcement, and constraints on false identification; server training programs; college and school-based strategies that implement legislative and administrative policies; constraints on alcohol availability (e.g., at sports events); dram shop liability laws; constraints on alcohol advertising and promotions; health promotion and moderate drinking messages by advocacy groups and the alcohol industry; zoning controls on location and density of alcohol outlets; and other community-initiated prevention programs. Natural interventions that have implications for alcohol-problem prevalence are important to study even if prevention is not a stated goal (e.g., alcohol taxes or privatization of outlets). The NIAAA recognizes that Government and private initiatives to prevent alcohol problems are continually being implemented. Where grant review and funding schedules would seriously delay the proposed research, applicants should discuss these timing problems with the listed program administrator. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, National Institutes of Health, 6701 Rockledge Drive, MSC 7910 Bethesda, MD 20892-7910, telephone: 301-435-0714, email girg@drgpo.drg.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. Small Grants do not receive a second level review by a national advisory council. Review Criteria Criteria to be used in the scientific and technical merit review of research grant (R01) applications will include the following: 1. The scientific, technical, health or medical significance, and originality of the proposed research. 2. The appropriateness and adequacy of the research design and methodology proposed to carry out the research. 3. The adequacy of the qualifications (including level of education and training) and relevant research experience of the principal investigator and key research personnel. 4. The availability of adequate facilities, general environment for the conduct of the proposed research, other resources, and collaborative arrangements necessary for the research and the feasibility of implementing the project (including recruitment of subjects, implementation of the intervention or innovation, cooperation of relevant organizations, and/or availability and quality of necessary data). 5. The appropriateness of budget estimates and duration in relation to the proposed research. 6. Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment. The review criteria for FIRST Awards (R29) are contained in the FIRST program announcement (revised February 1994). The review criteria for Small Grants (R03) are contained in the Small Grants program announcement for NIAAA PA-91-08 dated October, 1990. AWARD CRITERIA Applications recommended for approval will be considered for funding on the basis of the overall scientific and technical merit of the application as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Potential applicants may obtain copies of specific specific announcements from the National Clearinghouse for Alcohol and Drug Information, P.O. Box 2345, Rockville, MD 20852, telephone: 301-468-2600 or 1-800-729-6686. Further information on grant mechanisms and areas of research interest may be obtained from the program staff listed under INQUIRIES. Direct inquiries regarding potential research to: Capt. Patricia Mail Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-8744 or 443-1677 FAX: (301) 443-8774 Email: pmail@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Linda Hilley Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0915 FAX: (301) 443-3891 Email: lhilley@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sat Feb 17 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-018 - V25(02) 02/02/96 Date: 18 Feb 1996 14:40:17 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 504 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4g89sh$dot@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA96018 PA-96-018 P1O1 *************************************** DRUG ABUSE PREVENTION INTERVENTION FOR WOMEN AND MINORITIES NIH GUIDE, Volume 25, Number 2, February 2, 1996 PA NUMBER: PA-96-018 P.T. 34, FF, II; K.W. 0404009, 0745027, 0411005 National Institute on Drug Abuse PURPOSE The purpose of this program announcement (PA) is to advance research to develop, refine, and test the efficacy and effectiveness of theory-based, universal, selective, and indicated drug abuse prevention interventions for minorities and women. These interventions should combine what is known from drug abuse prevention research with what is known, in particular, about culturally diverse and/or gender specific experiences. This scientific research initiative will seek to identify risk and protective factors that may be associated with core cultural and/or gender value systems and life experiences in order to design and test under controlled conditions comprehensive, theory-based preventive interventions that are sensitive to cultural and/or gender norms or needs. It is imperative that ethnic and/or gender status be treated as an explanatory variable and not just a descriptive one; that is, there must be a theoretical basis offered that lends guidance to the intervention designed and that will allow for discussions of outcomes in a manner that contributes to a detailed scientific understanding of prevention theory and program priorities that best meet the unique needs of minority sub-populations and women. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Drug Abuse Prevention Intervention for Women and Minorities, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit, public and private organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) individual research project grant (R01) and FIRST (R29) award. Because the type and scope of proposed research responsive to this PA may vary, it is anticipated that the size and period of the award will vary also. RESEARCH OBJECTIVES Background A major priority of the National Institute on Drug Abuse (NIDA) is to gather and expand the use of scientific information concerning the prevention of drug abuse and addiction that could lead to HIV infection and AIDS. NIDA support of such research rests on a general assumption that the negative consequences of drug abuse may have differential impact and may require targeted prevention intervention strategies for some of the population groups found within the United States. Although NIDA encourages research on the extent and nature of drug abuse among underserved groups, no existing research grant program addresses the unique risk and protective factors of specific underserved populations. Thus, the purpose of this program announcement is to develop, implement, refine, and test the efficacy and effectiveness of theory-based, comprehensive drug abuse prevention intervention models for minority populations and women. A gestalt position that has been embraced by many is that America is an umbrella social system where cultures and traditions blend into one all inclusive community, reflective of common goals, opportunities and experiences. While the various racial/ethnic groups in the United States may share a common culture with many similarities in areas such as values, spirituality, family functioning, and language, there are important sociodemographic differences, (e.g., country of origin, level of education, and acculturation level) which may explain why a consensus model of ethnic and cultural melding has remained theoretical and underdeveloped. To advance the field of prevention, researchers must first acknowledge and then accept that groups have retained their own value, belief, and behavior systems and that the cultural diversity within these groups has been generally overlooked. When classifying ethnic minority status, four general population categories have traditionally been defined as: (1) Blacks or African American; (2) Hispanics; (3) Native Americans or American Indians; (4) Asians or Pacific Islanders. This simplified division has produced epidemiologic and etiologic data delineating major sociodemographic differences across these communities and have enabled researchers to study each population as if it was an unvarying, cohesive whole -- a distinct culture. However, nested within each group are a variety of cultural variations, traditions and styles that are as distinct and different as constructs measured across populations. As such, there is no Black or African American community; there are individuals who are descendants of American slaves, foreign born blacks, and individuals that are racially mixed. The Hispanic group includes Puerto Ricans, Mexican Americans, Cubans, Central and Latin Americans, and individuals from Spain. Likewise, the Native-American group is not one homogenous community; there are a variety of Southwestern tribes, Northern Plains tribes, Eastern Woodlands and Pacific Northwestern groups. The most complex, and the least studied, is the Asian and Pacific Islander populations which consists of individuals from 26 countries/island groups and who have the fastest growth rate (82 percent) of any group in the 1980s. Prevention intervention research needs to address diverse culturally relevant contexts and drug abuse etiologies. For example, population studies indicate that American Indians, particularly those on reservations, have the highest rates of drug abuse compared with any other minority group. Is this statistic a commonality across all American Indians or is it specific to the Southwestern tribes? What are the implications for the design and testing of prevention interventions? Research focused on the role of acculturation suggests that Puerto Rican youth who identified less with Puerto Rican cultural values were more likely to abuse drugs than those who were more identified. Is acculturation strain equivocal across Hispanic groups (e.g., Mexican Americans) and does it impact on initiation of drug abuse to the same extent? What prevention interventions could be developed and tested to address social adaptation issues? Data show that African-Americans are more likely to use drugs intravenously. Is this pattern consistent for foreign born as well as American born Blacks? What are the key factors promoting IV drug abuse and are these factors amenable to change through prevention interventions? Attitudes regarding health and addiction within the Asian and Pacific Islander groups also vary greatly. For example, Samoans do not view drug abuse as an addiction but, rather, as an episodic mistake in the judgement of the user. This interpretation of the nature of addiction is incompatible with the beliefs of other Asian cultures who consider drug abuse as an imbalance in spiritual matters. To what extent can prevention interventions address drug related belief structures that are indigenous to a culture? Notwithstanding some shared, basic underlying cultural similarities across minority groups, their very real within group differences (e.g., rituals, values, attitudes, etc) make it critical to fine tune existing prevention intervention research efforts. There is a scarcity of prevention intervention research that addresses the unique set of physical, biological, social and psychological problems that are specific to women (the term woman is used to refer to females of all ages. Elsewhere, where appropriate, the terms 'girls' and 'adolescent females' are used). Although females comprise 51 percent of the population, they have been neglected in this field of research, and therefore, unserved as a group distinct from males. Gender differences in the epidemiology of drug abuse are quite apparent, with the number of male drug abusers and addicts exceeding that of females. The consequences of drug abuse by women, however, are more severe and data indicate that after initial use women may proceed more rapidly to drug abuse than men. The causes, correlates and consequences of drug abuse and addiction appear also to differ with respect to men and women. For women, for example, a fairly high correlation appears to exist between eating disorder and substance abuse. Preliminary data from NIDA research indicates that the more severely a woman diets and engages in binge eating the more likely she is to experience negative consequences >From drinking alcohol, and the more likely she is to meet the criteria for substance abuse or dependence. Women's initiation into drug use also differs from that of men's. Preliminary results from a study on gender differences in cocaine initiation and abuse indicate that approximately 90 percent of women reported that men played some role in their involvement with crack cocaine. By contrast, only 17 percent of men reported that women were involved in their initiating or maintaining the use of crack cocaine. Women were more likely to begin or maintain cocaine use in order to develop more intimate relationships, while men were more likely to use the drug with male friends and in relation to the drug trade. With regard to antecedent conditions, while conduct disorders and other observable behaviors signal risk for males, the etiology of female drug abuse appears to lie in predisposing psychiatric disorders prior to abusing drugs. Preliminary data from studies of antecedents of crack cocaine abuse among African American women found preexisting psychiatric problems to be a major cofactor. Specifically, there was a strong correlation between the age of first drug use and the first depressive episode. Additionally, these women had conflicting relationships with, and less attachment to, their mothers. Women who have been victims of crime, likewise, appear to have increased vulnerability to substance abuse. Research conducted among a population of women in residential or outpatient drug treatment programs found that 80 percent had been crime victims. Additionally, female crime victims were more likely to have major drug and alcohol problems than nonvictims. Female crime victims who suffered from Post Traumatic Stress Disorder (PTSD) were almost 10 times more likely to have major alcohol problems and 17 times more likely to have major drug abuse problems than nonvictims. Numerous studies have shown PTSD to be a strong predictor of substance abuse. Many questions remain to be addressed regarding prevention intervention activities for females. For example, to what extent does initiation of drug use and progression from use to abuse and dependence differ for females when compared to males? To what degree this occurs, will provide important information which needs to be incorporated in targeted drug prevention intervention efforts. Different types of 'victimization' (e.g., sexual abuse, physical abuse, being the daughter of a drug abusing mother and/or father, etc.) create different patterns of subsequent drug abuse. How should prevention interventions differ as a function of this? Does the descent from various ethnic cultures promote specific native gender roles and to what extent are these congruent, complementary, or in conflict with society, at large? The scientific answers to these and many other questions are necessary to advance prevention intervention activities. Research Goals and Issues NIDA encourages research applications that test the efficacy and effectiveness of theory-based preventive interventions at the universal, selective, and indicated level. NIDA will also commit to investigating the relationship between the intrapersonal, interpersonal, familial, cultural community roles, and other larger societal factors upon the prevention of drug abuse among minorities and other underserved populations. This scientific research initiative seeks to identify risk and protective factors in order to design and test comprehensive, theory based preventive interventions that are sensitive to cultural norms and responsive to community needs. Prevention intervention research should focus upon the strengths of cultural systems as experienced and promulgated by the family and community. For example, research is needed to know how positive family sanctions and strong religious values may protect culturally diverse youth from drugs of abuse during their early school years. Prevention intervention research is needed to know how family values and community networks of friends, volunteers, and relatives interact. Research is needed to design and test promising drug prevention programs that build upon the cultural, social, family, and religious values that appear to protect or inoculate many culturally diverse youth from drug abuse and HIV/AIDS. Prevention intervention strategies for these groups should entail a comprehensive approach to their needs at the Universal, Selective and Indicated levels. Specifically, Universal prevention interventions are targeted to the general public or a whole population group that has not been identified on the basis of individual risk or resilience status. Selective prevention interventions are targeted to individuals or a subgroup of the population with well defined risk factors within their life profiles and whose risk to resilience status to developing substance abuse disorders is significantly higher than average. Indicated preventive interventions are targeted to individuals or subgroups who are identified as having minimal but detectable signs or symptoms foreshadowing drug abuse, dependence, and addiction, or with biological markers indicating predisposition for substance use disorders AND who have not met diagnostic levels according to DSM-IIIR or DSM-IV. For strategies to be potentially effective and interpretable, they must be guided by theory, take advantage of the cumulative progress in the field, and must target ethnic minority youth and young adults and/or women. How mechanisms of predisposition and/or protection are affected by intervention and how this is linked to outcome needs to be explored. Investigators should pay careful attention to operationalizing definitions and defining the independent variable that describe the intervention processes. Especially encouraged is research that investigates resiliency and other protective factors among underserved populations and women who may otherwise be at risk of abusing drugs but do not. Studies that aid in the development of methodologies which can lead to the early identification of those at risk for drug abuse and HIV/AIDS among the various ethnic/racial groups and females are particularly encouraged. All applicants are urged to address issues of project feasibility and collaborative arrangements at the community level. The research proposal should include a randomized or well-controlled quasi-experimental study design, as well as state of the art sampling procedures, instrumentation and measurement, data collection, quality control, client tracking and follow-up, and data analysis. It is essential that applicants discuss potential barriers to implementing this type of study as well as strategies to deal with relevant issues. Particularly critical to discuss are issues related to community collaboration, confidentiality, anticipated staff, and further types of sub-studies. Power analyses must be included to support proposed cell sizes of the research design and overall number of study participants. Tests to determine the potential effects of differential attrition should be included. Finally, state of the art econometric techniques for measuring the cost-benefit or cost-effectiveness of prevention interventions should be included in the proposed research. NIDA will accept prevention intervention research applications that: o Demonstrates knowledge of the culture, diversity and potential predispositions to risk behaviors and relevant risk/protective factors of minority populations and/or women and applies this knowledge to the proposed prevention research at the conceptual, design, and analyses level. Limitations pertaining to the adequacy to which culture and diversity are addressed should be identified. o Demonstrates familiarity with the approaches and problems associated with working with underserved populations. Knowledge of previous prevention intervention research, theories, methods, and measures is essential. Challenges from a specified problem or approach must be identified and solutions proposed. o Advances theoretical development by incorporating aspects of culture and risk/protective factors in the conceptual base used for the proposed prevention intervention(s). o Establishes working relationships with minority communities and professionals. o When appropriate, assessment of gender differences is encouraged. o Demonstrates focus on theory-based preventive intervention efforts that will address salient risk and protective factors specific to culturally diverse and ethnic minority sub-populations as well as women. Addresses questions pertaining to the fit or match of specific prevention approaches to the diversity of the underserved population under investigation. Prevention intervention strategies may demonstrate differential effects within various ethnic groups and socioeconomic populations. Multiple intervention strategies may be needed to deter and delay the initiation of drug use behavior and to impede progression to drug dependency and associated social, psychological, and physiological sequelae. o Demonstrates attention to the design and testing of theory- based prevention programs focused upon the prevention of the precursors to the drug abuse problem, such as early signs of aggression, violence, problems with interpersonal relationships, oppositional behavior, and changing risk factors to abuse that may emerge after drug use has been initiated. o Conducts and rigorously tests culturally sensitive drug abuse prevention intervention efforts previously developed but not empirically tested. o Proposes a randomized or well-controlled quasi-experimental research design, a technically sound measurement model that employees culturally relevant instruments, and advanced statistical procedures for hypotheses testing. o The dual epidemics of drug abuse and HIV infection have significantly heightened the urgency of developing effective prevention activities which target HIV risk behaviors. Drug abuse-related HIV transmission occurs through the sharing of contaminated injection equipment and high risk sexual behaviors (e.g., unprotected sex with multiple partners). Researchers are encouarged to specifically address these behaviors in the design and research of interventions. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. Confidentiality. The PHS has a formal policy concerning Certificates of Confidentiality and communicable disease reporting. In brief, the policy reflects the expectation that research projects will cooperate with State and local health departments to assure that the purposes of reporting are accomplished, and the expectation that health departments will develop relationships with research projects that assist their mission without thwarting the research goals. A description of the policy as well as Instructions for Applicants can be obtained after award. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard receipt dates 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: girg@drgpo.drg.nih.gov. The title and number of this PA must be typed in Item 2 on the face page of the application. The completed original and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC-7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight service) REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council on board. Review Criteria o scientific or technical significance and originality of the proposed research; o appropriateness and adequacy of the research approach and methodology proposed to carry out the research; o qualifications and research experience of the principal investigator and staff; o availability of resources necessary to the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and o adequacy of plans to include 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 safety of the research environment. AWARD CRITERIA Applicants 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: Ro Nemeth-Coslett, Ph.D. Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-53 Rockville, MD 20857 Telephone: (301) 443-1514 Email: RNEMETH@AOADA.SSW.DHHS.GOV Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Email: GFLEMING@AOADA2.SSW.DHHS.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are authorized under the Public Health Service Act, Section 301 and administered under PHS policies and Federal Regulations CFR 52 and 45 CFR Part 74. "Confidentiality of Alcohol and Drug Abuse Patient Records" may be applicable to these awards. Program is not subject to the inter-governmental review requirements of Executive Order 12372. 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 Feb 17 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 02, pt. 1of1, 2 February 1996 Date: 18 Feb 1996 14:39:44 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 689 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4g89rg$dnk@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19960202 V25N02 P1O1 ************************************ X-comment: RFAs described: PA-96-018, PA-96-019, PA-96-020, PA-96-021 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.02.02 NIH GUIDE - Vol. 25, No. 2 - February 2, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N2 ********************************************************** TUITION COSTS ON NIH NRSA TRAINING GRANT AND FELLOWSHIP AWARDS -- NEW POLICY National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** RESEARCH AND DEVELOPMENT FACILITY DESIGN GUIDELINES SYMPOSIUM National Cancer Institute Office of Research Services, NIH International Society for Pharmaceutical Engineering INDEX: CANCER; NATIONAL INSTITUTES OF HEALTH; INTERNATIONAL SOCIETY FOR PHARMACEUTICAL ENGINEERING NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** PRODUCTION OF ANTIBODIES TO NEW CRANIOFACIAL GENES RELEVANT TO ANOMALIES AND ORAL CANCERS (RFP NLM 96-100/MLM) National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX P1 ********************************************************** DRUG ABUSE PREVENTION INTERVENTION FOR WOMEN AND MINORITIES (PA-96- 018) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P2 ********************************************************** INTERVENTION RESEARCH TO PREVENT ALCOHOL-RELATED PROBLEMS (PA-96-019) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX P3 ********************************************************** ACADEMIC RESEARCH ENHANCEMENT AWARD (PA-96-020) National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX P4 ********************************************************** HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS (PA-96-021) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM ERRATA $$INDEX E1 PAR-96-015 *********************************************** SMALL GRANT PROGRAM FOR CONFERENCE SUPPORT (PAR-96-015) Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY RESEARCH THIS PUBLICATION IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 4350714 EMAIL: GIRG@DRGPO.DRG.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 25, Number 2, February 2, 1996 P.T. 34; K.W. 1014004, 1014006 Department of Health and Human Services Notice is hereby given that the Office of Research Integrity (ORI) has made final findings of scientific misconduct in the following case: Durga K. Paruchuri, Ph.D., University of North Carolina, Chapel Hill: Based on an investigation conducted by the University of North Carolina, Chapel Hill (UNC), and information obtained during its oversight review, the Office of Research Integrity (ORI), concluded that Dr. Durga K. Paruchuri committed scientific misconduct by falsifying research records and falsely reporting to her supervisor and in a grant application submitted to the Public Health Service (PHS) that she had produced a clone of meningococcal bacteria transferrin binding protein 1, labeled "pUNCH 701," and used it to obtain a second clone, "pUNCH 702." Furthermore, ORI accepted the UNC finding that Dr. Paruchuri falsified research records at the Lineberger Cancer Research Center oligonucleotide synthesis facility in an attempt to support her false claim. The research was supported by PHS grant R37 AI26837 and reported in grant application 1 R01 AI32115-01A1. Dr. Paruchuri accepted the ORI findings and agreed to exclude herself voluntarily for a period of two years beginning December 21, 1995, >From any contracting or subcontracting with any agency of the United States Government and from eligibility for, or involvement in nonprocurement transactions (e.g., grants and cooperative agreements) of the United States Government. Dr. Paruchuri further agreed that for a period of one year in addition to and immediately following the two year exclusion period, any institution which submits an application for PHS support for a research project on which Dr. Paruchuri's participation is proposed, or which uses Dr. Paruchuri in any capacity on PHS supported research, or which submits a report of PHS funded research in which Dr. Paruchuri is involved, must concurrently submit a plan of supervision and certification of data accuracy. Dr. Paruchuri also agreed to exclude herself voluntarily >From serving in any advisory capacity to the PHS for a period of three years beginning December 21, 1995. INQUIRIES For further information contact: Director, Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** TUITION COSTS ON NIH NRSA TRAINING GRANT AND FELLOWSHIP AWARDS -- NEW POLICY NIH GUIDE, Volume 25, Number 2, February 2, 1996 P.T. 22, 44; K.W. 1014006 National Institutes of Health As a follow-up to the Public Forum on the National Research Service Award Tuition Policy held on June 5, 1995 (NIH Guide for Grants and Contracts, Vol. 24, No 13, April 7, 1995 and Vol. 24, No. 15, April 28, 1995), the NIH will implement a new policy for the support of tuition costs, beginning with competing National Research Service Act (NRSA) research training grants made in fiscal year 1996. Implementation for NRSA fellowships will begin with competing awards made in fiscal year 1997. The tuition policy is based on recommendations from the NIH Task Force on NIH Tuition Policy, which officiated at the Public Forum. The complete text of these recommendations is available under the NIH Home Page on the World Wide Web (http://www.nih.gov). o Tuition, for the purpose of this policy, means the combined cost of tuition, fees and self-only health insurance. o The new tuition policy will be phased in with competing (Type 1, Type 2) awards. o Support for tuition costs of training grants and fellowships for which the new (Type 1) or competing renewal (Type 2) award was made prior to the implementation dates will remain consistent with policies in effect at the time of the competitive award. o For competing training grant awards made in fiscal year 1996 and henceforth, the NIH will reimburse 100 percent of the cost of tuition up to $2,000 and 60 percent of tuition costs above $2,000 for each predoctoral trainee and each undergraduate trainee supported by the Minority Access to Research Careers (MARC) and Career Opportunities in Research (COR) training grants. This policy will also apply to individual predoctoral fellowships awarded in fiscal year 1997 and henceforth. This policy does not however apply to the Minority Fellowship Program of the National Institute of Mental Health (NIMH). o As in the past, support for the tuition costs of postdoctoral trainees are limited to the cost of self-only health insurance and the costs of specific courses in support of the approved research training program. Postdoctoral tuition costs for a trainee will continue to require prior approval on a case-by-case basis by the NIH awarding component and will be paid according to the policy described above for predoctoral trainees and fellows. This policy also will apply to postdoctoral fellowship awards beginning in fiscal year 1997. o Non-competing (Type 5) of awards of Type 1 and Type 2 awards made under this policy will reimburse tuition costs in the amount paid in the previous award year, unless there is a change in scope of the award. o Carry over of unobligated training grant funds will continue to be permissible only with the prior written approval of the NIH awarding component. o The awardee institution retains full authority to rebudget funds into or within the stipend and tuition cost categories of an institutional training grant. Rebudgeting funds into the trainee travel and the institutional cost categories will continue to require the prior written approval of the NIH awarding component. $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** RESEARCH AND DEVELOPMENT FACILITY DESIGN GUIDELINES SYMPOSIUM NIH GUIDE, Volume 25, Number 2, February 2, 1996 P.T. 42; K.W. 0780000 National Cancer Institute Office of Research Services, NIH International Society for Pharmaceutical Engineering The National Institutes of Health (NIH) and the International Society for Pharmaceutical Engineering (ISPE) ( a non-profit group) will sponsor a symposium to introduce the NIH biomedical facility design guidelines. The emphasis will be on the design of biomedical research laboratories, the application of the NIH guidelines, and arm chair tours of the most recently constructed NIH laboratories. Attendance at this symposium will benefit researchers, architects, engineers, research management, and others involved with the design or operation of biomedical research facilities. The NIH has pioneered the development of design guidelines for the intramural NIH biomedical research facilities. As a result, NIH receives many questions asking how NIH designs facilities and what design changes NIH anticipates in response to emerging research needs. The intent of this symposium is to share NIH~s current expertise and experiences with the broader biomedical community. DATES: March 4-6, 1996 LOCATION: Natcher Conference Center, NIH, Bethesda, MD REGISTRATION FEE: $595 (before December 15); $645 (after December 15). Space is limited and confirmation will be on a first-come, first-served basis. Payment must be included with registration. Topic 1 - NIH Guidelines: Technical Overview These sessions will present an introduction and overview of the technical aspects of the NIH guidelines for biomedical research facilities, followed by break out sessions for in-depth discussions. In the breakout sessions, NIH~s senior design staff and consultants will present the technical architectural and engineering requirements included in the new NIH Guidelines. Presentations will include the discipline-specific information for the design and construction of biomedical research facilities at NIH. Topic 2 - NIH Guidelines: Application These sessions will describe how NIH applies the NIH Guidelines to the planning, design, and construction of new and renovated biomedical research facilities. These sessions will include an introduction, brief summaries of the detailed presentations to follow, and breakout sessions. In the breakout sessions, NIH~s senior design staff and consultants will discuss NIH~s planning, design, and construction of biomedical research facilities, including the guidelines for the laboratories, the vivaria, and the other support spaces within the facilities. There will be sessions on the planning for new and renovated facilities, the design and construction of new facilities, and the design and construction of renovations to existing facilities. Topic 3 - Armchair Tours These sessions will Include ~armchair tours~ of three of NIH~s newest facilities as representations of different aspects of NIH~s design and construction of biomedical research facilities. These tours will be preceded by an introduction and followed by a look into the future of the design and construction of biomedical research facilities from the perspective of the research and of the facility requirements. INQUIRIES For more information and to register, contact: International Society for Pharmaceutical Engineering Headquarters 3816 W. Linebaugh Avenue, Suite 412 Tampa, FL 33624 Telephone: (813) 960-2105 FAX: (813) 264-2816 $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NLM-96-100 *********************************************** PRODUCTION OF ANTIBODIES TO NEW CRANIOFACIAL GENES RELEVANT TO ANOMALIES AND ORAL CANCERS NIH GUIDE, Volume 25, Number 2, February 2, 1996 RFP AVAILABLE: NLM 96-100/MLM P.T. 34; K.W. 0780000, 0780005 National Institute of Dental Research The National Institute of Dental Research (NIDR) has a requirement to generate a library of antibody reagents for the characterization of novel genes expressed in teeth and craniofacial tissues during embryonic development. Polyclonal antibodies are to be produced in rabbits against purified proteins obtained from selected cDNA clones expressed in E. coli by relatively standard methods. The antibodies are to be evaluated by Western immunoblot analysis and immunocytochemistry for their ability to react with embryonic craniofacial tissues. The project's goal will be to produce a library of approximately 100 characterized antibodies against these novel genes. The Contractor must have experience in recombinant DNA technologies and must demonstrate that they have successfully generated polyclonal antibodies against recombinant proteins previously. The laboratory must be certified by the Federal government as meeting Good Laboratory Practice Regulations (Title 21 of the U.S. Code of Federal Regulations, Part 58) and must be accredited by the American Association for the Accreditation of Laboratory Animal Care (AAALAC) with an assurance statement on file with the Office for Protection from Research Risks (OPRR). It is anticipated that a three-year, cost reimbursement (completion) type contract will be awarded. This project is being initiated by the NIDR. However, the contracts office of the National Library of Medicine (NLM) will be conducting the solicitation. Therefore, all telephone calls and correspondence must be directed to the NLM. INQUIRIES Request for Proposal (RFP) No. NLM 96-100/MLM will be available on or about February 20, 1996, with proposals due on or about April 22, 1996. All responsible sources may submit a proposal, which will be considered by the NIDR. Verbal requests for the RFP will not be accepted; requests must be submitted in writing, addressed to: Lynn Montalvo Office of Acquisitions Management National Library of Medicine Building 38A, Room B1N17 Bethesda, MD 20894 $$R1 END ************************************************************ $$P1 BEGIN PA-96-018 FULL-TEXT ************************************** DRUG ABUSE PREVENTION INTERVENTION FOR WOMEN AND MINORITIES NIH GUIDE, Volume 25, Number 2, February 2, 1996 PA AVAILABLE: PA-96-018 P.T. 34, FF, II; K.W. 0404009, 0745027, 0411005 National Institute on Drug Abuse PURPOSE The purpose of this program announcement (PA) is to advance research to develop, refine and test the efficacy and effectiveness of theory-based universal, selective and indicated drug abuse prevention interventions for minorities and women. This initiative will seek to identify risk and protective factors that may be associated with core cultural and/or gender value systems and life experiences in order to design and test under controlled conditions comprehensive, theory-based preventive interventions that are sensitive to cultural and/or gender norms or needs. There must be a theoretical basis offered that lends guidance to the intervention designed and that will allow for discussions of outcomes in a manner that contributes to a detailed scientific understanding of prevention theory and program priorities that best meet the unique needs of minority sub-populations and women. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Drug Abuse Prevention Intervention for Women and Minorities, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Ro Nemeth-Coslett, Ph.D. Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-53 Rockville, MD 20857 Telephone: (301) 443-1514 Email: RNEMETH@AOADA.SSW.DHHS.GOV $$P1 END ************************************************************ $$P2 BEGIN PA-96-019 FULL-TEXT ************************************** INTERVENTION RESEARCH TO PREVENT ALCOHOL-RELATED PROBLEMS NIH GUIDE, Volume 25, Number 2, February 2, 1996 PA AVAILABLE: PA-96-019 P.T. 34; K.W. 0404003, 0745027, 0795005 National Institute on Alcohol Abuse and Alcoholism PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks to stimulate the design, development, and/or testing of interventions that have the potential of preventing alcohol abuse and alcohol-related problems among appropriate target populations. Investigators are encouraged to move beyond preintervention studies into the domain of efficacy and effectiveness studies that directly assess the impact of preventive interventions. Research support may be obtained through applications for a regular research project grant (R01), First Independent Research Support and Transition (FIRST) Award (R29) or Small Grant (R03). Applicants may also submit Investigator-Initiated Interactive Research Project Grants under this program announcement. 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, Intervention Research to Prevent Alcohol-Related Problems, is related to the priority areas of alcohol abuse reduction and alcoholism prevention. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Capt. Patricia Mail Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-8744 or 443-1677 FAX: (301) 443-8774 Email: pmail@willco.niaaa.nih.gov $$P2 END ************************************************************ $$P3 BEGIN PA-96-020 FULL-TEXT ************************************** ACADEMIC RESEARCH ENHANCEMENT AWARD NIH GUIDE, Volume 25, Number 2, February 2, 1996 PA AVAILABLE: PA-96-020 P.T. 34; K.W. 1014006 National Institutes of Health Application Receipt Date: June 26, 1996 PURPOSE The National Institutes of Health (NIH) is continuing to make a special effort to stimulate research in educational institutions that provide baccalaureate training for a significant number of the Nation's research scientists, but historically have not been major recipients of NIH support. Since Fiscal Year (FY) 1985, Congressional appropriations for the NIH have included funds for this initiative, the Academic Research Enhancement Award (AREA) program. The AREA funds are intended to support new research projects or expand ongoing research activities proposed by faculty members of eligible institutions in areas related to the health sciences. Applications received in June 1995 for AREA grants to be awarded this year (FY 1996) have been reviewed for scientific merit and program relevance. Approximately $14 million will be available for the NIH AREA program in FY 1996. As a result, about 140 AREA grants will be made from the applications received June 1995. Since it is anticipated that additional funds will be available next year, the NIH is inviting grant applications at this time for AREA grants to be awarded competitively in FY 1997. INQUIRIES AREA Program Guidelines The AREA Program Guidelines are appended to the Program Announcement in the electronic editions of the NIH Guide and will be available through the NIH Home Page on the World Wide Web (http://www.nih.gov) under the Grants and Contracts sub-menu. Application Forms Form PHS 398 (rev. 5/95) application packages may be obtained from: Office of Extramural Outreach and Information Resources Office of Extramural Research National Institutes of Health 6701 Rockledge Drive, Room 6207 - MSC 7910 Bethesda, MD 20892-7910 Telephone: (301) 435-0714 FAX: (301) 480-3963 Email: girg@drgpo.drg.nih.gov Questions regarding eligibility, policies, procedures, and other administrative aspects of the NIH AREA program should be referred FIRST to the Office of Sponsored Programs at the educational institution. Issues that remain AFTER consultation with the institutional Office of Sponsored Programs and that are NOT ADDRESSED in the AREA Program Guidelines may be directed to: Special Programs Office of Extramural Research National Institutes of Health 6701 Rockledge Drive, Room 6186 - MSC 7910 Bethesda, MD 20892-7910 Telephone: (301) 435-2770 FAX: (301) 480-0146 Email: sk13n@nih.gov $$P3 END ************************************************************ $$P4 BEGIN PA-96-021 FULL-TEXT ************************************** HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS NIH GUIDE, Volume 25, Number 2, February 2, 1996 PA AVAILABLE: PA-96-021 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) seeks health services research grant applications that are aimed at developing a knowledge base to improve the efficiency and effectiveness of services for alcohol-related problems. This program announcement invites research applications related to improving the availability, accessibility, delivery, quality, cost effectiveness, impact, and outcomes of alcohol-related treatment and prevention services. The research objectives include, but are not limited to, four major areas: (1) determining impacts 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 the utilization and cost of treatment services for alcohol-related problems; (3) identifying and assessing the effectiveness and outcomes of alcohol-related treatment and preventive services; and (4) identifying factors that influence the organization, management, and delivery services for alcohol-related problems across regions, populations, and settings. 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, Health Services Research on Alcohol-Related Problems, is related to the priority areas of alcohol abuse reduction and alcoholism treatment. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations and award criteria for this program, 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. Robert B. Huebner, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0786 FAX: (301) 443-8774 Email: bhuebner@willco.niaaa.nih.gov $$P4 END ************************************************************ ERRATA $$E1 BEGIN P3 19960126 APPEND PAR-96-015 BOTH ************************** SMALL GRANT PROGRAM FOR CONFERENCE SUPPORT NIH GUIDE, Volume 25, Number 2, February 2, 1996 PA NUMBER: PAR-96-015 P.T. 42; K.W. 0710030 Agency for Health Care Policy and Research The following correction is issued for PAR-96-015, which was published in the NIH Guide for Grants and Contracts, Vol. 25, No. 1, January 26, 1996. Delete the sixth line in the heading, which reads "Application Receipt Dates: May 1 and November 15 annually. This is an ongoing program announcement. See APPLICATION PROCEDURES section regarding the process surrounding and timing of applications. INQUIRIES Written and telephone inquiries concerning this PA are encouraged. Direct inquiries regarding programmatic issues including information on the policy of inclusion of women and minorities in study populations to: Christine G. Williams, M.Ed. Acting Director, Center for Health Information Dissemination Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 501 Rockville, MD 20852-4908 Telephone: (301) 594-1360, ext. 145 FAX: (301) 594-2286 $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Sat Feb 17 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-96-006 - V25(04) 02/16/96 Date: 18 Feb 1996 14:36:08 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 506 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4g89ko$d5k@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA96006 CA-96-006 P1O1 *************************************** MINORITIES IN MEDICAL ONCOLOGY NIH GUIDE, Volume 25, Number 4, February 16, 1996 RFA: CA-96-006 P.T. 34, FF; K.W. 0785140 National Cancer Institute Letter of Intent Receipt Date: March 14, 1996 Application Receipt Date: May 14, 1996 PURPOSE The Comprehensive Minority Biomedical Program of the National Cancer Institute (NCI) announces the availability of minority medical oncology awards. The purpose of these awards is to: o Encourage recently trained underrepresented minority clinicians to acquire clinical training and research experience in clinical oncology; o Increase representation of minorities in clinical oncology. These awards will provide the opportunity for recent, clinically trained underrepresented minority physicians and D.O.'s to gain sufficient research and clinical experience to become practicing clinical oncologists with experience in biomedical 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 Request For Applications (RFA), Minorities in Medical Oncology, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-0001-00474-0 or Summary Report: Stock No. 017-0001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS This award is designed to provide an intensive, supervised clinical and research experience for underrepresented minority physicians. The award is intended for individuals with an M.D. or D.O. degree. For the purpose of this award, underrepresented minorities are defined as individuals who are African Americans, Latinos (Mexican American, Cuban, Puerto Rican, Central American), Native Americans, and non-Asian Pacific Islanders. Awards will be limited to individuals who are citizens or permanent residents of the United States. Candidates for the award should have broad clinical training, demonstrate individual competence in clinical activities, must document a serious intent for a research and/or clinical career in clinical oncology, and must document a sensitivity to cultural issues impinging upon the practice of medicine among the major U.S. ethnic populations. The candidates must be nominated by an institution on the basis of qualifications, interests, accomplishments, motivation, and the potential for a career in oncology. Evidence of the institution's commitment to the applicant's clinical and/or research development must be documented. Candidates must have at least one sponsor or advisor who is recognized as an accomplished clinician, and at least one sponsor or advisor who is recognized as an accomplished independent investigator in the proposed research area. Applicants for this award may not concurrently submit an application for an NIH Research Career Development Award, or a Mentored Research Scientist Development Award (K01). Current principal investigators on PHS research grants are not eligible applicants. The grantee institution must be a domestic non-profit research institution, school or comparable institution with well- established training programs in clinical oncology and biomedical research in oncology including clinical trials, adequate numbers of highly trained faculty in the clinical and biomedical sciences areas as they relate to cancer, and a demonstrated commitment to the development of the clinical and research careers of young physicians in oncology. MECHANISM OF SUPPORT Awards in response to this RFA will use the Clinical Investigator Award (K08). Planning, direction and execution of the proposed training program will be the responsibilities of the applicant and the sponsor(s). The total project period for an application submitted in response to this RFA may not exceed four years. The anticipated award date is September 30, 1996. Each award is non-renewable and non-transferable from one awardee to another awardee. Funding beyond the first year of the award is contingent upon satisfactory progress during the preceding year, as documented in the required Progress Report. FUNDS AVAILABLE The estimated total costs available for the first year support of the program is $750,000. There will be approximately nine new awards made at a direct cost level of $65,000 per year. RESEARCH OBJECTIVES Background Substantial national and local efforts have been made and are continuing to be made to reduce cancer morbidity and mortality in the general population. However, in spite of these efforts, projections made for 1994 were 1.2 million newly diagnosed cancer cases and approximately 550,000 cancer deaths. Past patterns of cancer incidence and mortality predict that a disproportionate share of this increase in U.S. cancer incidence and mortality will be borne by minorities. Specifically, past and current SEER data show Hispanics residing in New Mexico and Arizona have been excess cancer incidences of the cervix, stomach and gallbladder. American Indians from New Mexico and Arizona show excess cancer rates for stomach, cervix uteri, liver and gallbladder cancers, with the incidence rate for gallbladder cancer being the highest of any racial group; and rates for this group for the period 1975-1984 showed the poorest survival of any racial group for 8 evaluated cancer sites. Alaska Natives have the highest cancer incidence rates among any racial group for cancer of the oral cavity and pharynx, colon and rectum, cervix uteri, and kidney and pelvis; and the incidence of gallbladder cancer is comparable to that of American Indians. Finally, cancer mortality rates for all sites for Blacks are almost 2.5- times greater than for Whites. Contributing to the cancer burden of U.S. minorities is their limited access for treatment to minority physicians with appropriate cultural sensitivities. This is largely due to the small numbers of U.S. minority clinical oncologists. Data from the American Medical Association for 1994 show that of 11,224 U.S. oncologists, only 184 (1.6 percent) were of African American descent, 336 (3.0 percent) were of Hispanic descent, and 3 (0.03 percent) were of Native American descent. Current statistics on medical specialties among U.S. medical school graduates do not portend a significant change in this situation. Specifically, of the total 1993 medical school graduates (15,555), only 0.9 percent had selected oncology as their area of specialization, and only 0.2 percent (30) of graduates selecting an oncology specialization were underrepresented minorities. In 1994, only 11.2 percent of all medical school applicants were underrepresented minorities, a proportion that had not changed significantly from the value of 10.8 percent six years earlier. A reduction in the overall mortality rate in minority populations would substantially impact known cancer statistics. Cultural barriers to cancer diagnosis/treatment and to preventive health care advice will take on added importance as the techniques of molecular epidemiology are increasingly applied to identify minority individuals and family members at high risk for cancer. As a result of this new technology, physicians will increasingly be called upon to deal with culturally sensitive issues, such as prophylactic surgery for family members, and/or major changes in lifestyle possibly even including childbearing. It is therefore imperative that a sufficient number of minority oncologists be available so that access to care is not limited by the number of oncologists sensitive to cultural issues. Additionally, the oncologists must have an understanding of the new technologies being developed that will assist in the diagnosis/treatment of cancers and the predictions of cancer risk. This understanding can best be provided by a research experience in the development/application of these technologies. Areas of research of particular interest for this purpose might include but are not limited to the development and applications of biomarkers for assessing cancer risk in minority populations; cancer treatment or prevention clinical trials targeting minority populations; and psychosocial aspects of cancer prevention and control in defined populations. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical research" which have been published in the federal register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by March 14, 1996, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone and FAX numbers of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Lester Gorelic, Ph.D. Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 620 - MSC 7405 Bethesda, MD 20892-7405 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-7344 FAX: (301) 402-4551 Email: gorelicl@dea.nci.nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: girg@drgpo.drg.nih.gov; and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (express/courier service) At time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636 - MSC 7405 Bethesda, MD 20892-7405 Rockville, MD 20852 (express/courier service) Applications must be received by May 14, 1996. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Information to be Included in the Application Candidates must provide a description of the proposed research and clinical career training development for the period of the award in section 2 of the application under "Research Plan." The candidate must be prepared to commit full-time effort to the objectives of this award. It is required that a minimum of 25 percent effort be devoted to the research program, and that the remaining effort be devoted to clinical training in medical oncology. The percent effort devoted to research can be uniformly distributed over the four-year award period, or can be concentrated during one year of the four-year award period. The reasons for a commitment to clinical oncology practice in underserved minority populations and to research in these populations must be clearly described. The sponsor(s)/advisor(s) for the clinical and research aspect of this award must provide: o Her/his concept of a clinical and/or a research plan for the candidate. o A current curriculum vitae with a complete bibliography and listing of research support. o A letter indicating her/his evaluation of the proposed candidate and her/his willingness to provide guidance and support Evidence of the commitment of the institution to the candidate's clinical and research training, and career development, must be provided. Finally, adequate access to underserved populations for the purposes of clinical training and research must be demonstrated. The applicant institution must provide a signed statement of the candidate's eligibility for this award in terms of both being a minority underrepresented nationally in clinical oncology and a U.S. citizen. Where appropriate, the candidate must provide a copy of the Alien Registration Receipt card. The candidate also must provide, where applicable, information on other past, current and pending awards, including all federal and non-federal fellowships, grants or contracts. For each grant listed, the candidate must provide the complete grant number, the subject of the research, the title of the candidate's position, and the candidate's percent effort. The candidate should provide a detailed plan for her/his clinical and research development programs. This plan should not be prepared by the sponsor. The candidate's input should be shown clearly, as this input represents a criterion for evaluating the candidate's clinical and research potentials. This plan should include the following information: o Aspects of the candidate's educational and training background that qualify her/him for participation in the program described; o Areas in the candidate's educational and training background that can be developed by the proposed program; o Sufficient detail in the description of the proposed clinical training program to permit adequate evaluation. (If, during the course of the outlined study, the awardee should find that she/he would like to alter the direction or emphasis of the research, such a change may be made with the approval of the sponsor and of the National Cancer Institute); o How these plans are intended to promote the candidate's career in clinical oncology; o The strength of the commitment of the candidate to the practice of clinical oncology in the U.S. minority population. o Adequate justification of all budget items; o A list of all centers, institutions or laboratories that will participate in the clinical and research development programs. This list should include the names of the sponsors and other investigators who have agreed to participate in the program, and the resources and space available to the candidate. Each sponsor and institution must provide a letter indicating support of this program and a commitment of space and resources. These letters must be submitted as part of the application; o Four copies of each of the candidate's publications. The candidate must also provide three letters of reference. These letters should be forwarded by the referees directly to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636 - MSC 7405 Bethesda, MD 20892-7405 Rockville, MD 20851 (express/courier service) Budget Salary: The proposed salary should be based upon the candidate's training, experience and accomplishments,but should not exceed $50,000 per year (excluding fringe benefits). The salary must be consistent with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications,rank and responsibilities. Allowable Costs: Supplies, Travel, Equipment, Fringe Benefits, and Other Expenses. The award will provide up to a total of $15,000 per year for the costs necessary for the pursuit of the objectives of this program. The award may not be used to support the awardee's private clinical practice, professional consultation, or other comparable activities. Any fees for providing medical services generated by the awardee must be handled as specified by PHS policy. An awardee may, however,engage in scholarly writing, deliver occasional outside lectures and serve in an advisory capacity to the public or to non-profit organizations, provided such activities are incidental in the amount of time involved and are consistent with institutional policy. Awards will not be made to individuals who have substantial administrative responsibilities. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI program staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, DRG staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate NCI peer review group with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. Review Criteria o the candidate's potential for a career in clinical oncology. o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. o the overall merit of the candidate's plan for clinical training. o the overall merit of the candidate's plan for research and the development of research skills appropriate to the practice of modern clinical oncology. o the candidate's commitment to the servicing of the U.S. medically underserved populations. o the quality of the candidate's clinical training and experience. o objectives, design, and direction of the clinical and research training programs. o caliber of research advisors including successful competition for research support. o training environment, including the institutional commitment, the quality of the facilities, and the availability of research and clinical support. o appropriateness of the proposed budget and duration in relation to the proposed research. The initial review group will also examine the adherence to special requirements, and the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA The anticipated date of award is September 30, 1996. 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 Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Lester S. Gorelic, Ph.D. Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 620 - MSC 7405 Bethesda, MD 20892-7405 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-7344 FAX: (301) 402-4551 Email: gorelicl@dea.nci.nih.gov Direct inquiries regarding fiscal matters to: Mrs. Joan Metcalfe Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 - MSC 7150 Bethesda, MD 20892-7150 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-7800 ext 228 FAX: (301) 496-8601 Email: metcalfj@gab.nci.nih.gov AUTHORITY AND REGULATIONS This program is described in the catalog of Federal Domestic Assistance No. 93.398. 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 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 Feb 17 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DK-96-009 - V25(04) 02/16/96 Date: 18 Feb 1996 14:35:38 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 367 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4g89jq$d4g@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DK96009 DK-96-009 P1O1 *************************************** SUPPORT OF MINORITIES IN DIABETES, DIGESTIVE AND KIDNEY DISEASE NIH GUIDE, Volume 25, Number 4, February 16, 1996 RFA: DK-96-009 P.T. 34, FF; K.W. 0715075, 0715085, 0715133 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: March 14, 1996 Application Receipt Date: April 26, 1996 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) recognizes the need to increase the number of underrepresented minority individuals committed to scientific careers in research areas served by the NIDDK. This program is aimed primarily at recently trained M.D. and/or Ph.D. minority investigators. The program will enable the minority applicant to accept a tenure-earning position, gain additional research experience and obtain preliminary data on which to base a subsequent research grant application in an area of diabetes, endocrinology, metabolism, digestive diseases and nutrition, kidney, urology or hematology. 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, Support of Minorities in Diabetes, Digestive and Kidney Disease, is related to the priority area of increasing underrepresented minority health scientists. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state or local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Applicant must be African-American, Hispanic, Native American, Pacific Islander or other ethnic or racial group members underrepresented in biomedical or behavioral research. To apply, one must be a citizen of, or have been lawfully admitted to, the United States for permanent residence. An applicant must have a doctoral degree (M.D., Ph.D., D.O., D.D.S., D.V.M.). He or she should have received at least two years of postgraduate research training in an area of research applicable to research supported in this institute, and have direct access to an expert in the area of the proposed research. Applicants may not hold, nor apply concurrently for any other PHS research project grant at the time of this application. Priority will be given to those applicants who have not previously been a Principal Investigator on a major research grant. Applicants are encouraged to apply for other research project grants (R01, R29) during the course of, or following, this award. MECHANISM OF SUPPORT Support will be provided through the Small Research Grant (R03) program administered by the Division of Diabetes, Endocrinology and Metabolism, the Division of Digestive Diseases and Nutrition, and the Division of Kidney, Urologic and Hematologic Diseases in the NIDDK. Responsibility for the planning, direction, and execution of the proposed project will be that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. 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. This RFA is a one-time solicitation. Should the NIDDK determine that there is a sufficient continuing program need, a request for new applications will be announced. The total project period for applications submitted in response to the present RFA may be for one year, but should not exceed two years. Direct costs requested must not exceed $50,000 per year. A grant cannot be renewed. The anticipated award date is September 30, 1996. FUNDS AVAILABLE For FY 1996, $250,000 in total direct costs for year 01 will be committed in each of the three research divisions in the NIDDK. It is anticipated that a total of five awards will be made in each of the three divisions in FY 1996. This level of support depends on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIDDK, the award of grants pursuant to this RFA is contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The primary purpose of this RFA is to increase the number of underrepresented minority Principal Investigators conducting research in areas supported by the NIDDK. Surveys of research and training programs administered by the NIDDK disclose the need to increase the access to NIDDK support of recently-trained minority scientists who are U.S. citizens or permanent residents. Those who receive several years of training via an individual postdoctoral fellowship or an institutional training grant funded by a National Research Service Award still require research experience and preliminary data to support an independent research career at this stage of development. An additional period of training may not be feasible for minority individuals with pressing economic burdens. Such individuals may be lost to academic research through a lack of opportunity to obtain an additional one or two years of support essential for establishing a research career. This program was designed to help alleviate some of the above-noted problems experienced by underrepresented minorities who may wish to pursue a career in academic research. The program will allow the minority investigator to hold a tenure-earning position, gain additional research experience and to obtain preliminary data on which to base a subsequent research grant application. SPECIAL REQUIREMENTS Applicants are required to have available a recognized expert in the area of proposed research for guidance and consultation. It is expected that this expert will assist the applicant in the design and conduct of his/her research. It is not necessary that the expert be at the same institution as the applicant, but he/she should be within a reasonable proximity to be available for guidance and consultation. Following the research plan, the applicant is required to provide a brief summary of his/her long-term career plans and objectives. The application should state how this award would make a difference in and enhance the applicant's development as a scientist. The department chairman/head should provide a brief paragraph indicating his/her plans for the applicant. This official should indicate the extent to which time, space and other necessary support will be provided to the applicant to conduct the proposed investigation(s). A letter from a recognized expert in the area of the proposed research should accompany the application packet. The letter should attest to his/her willingness to provide counsel and advice to the applicant, and an initial plan for ongoing contacts with the applicant. 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) which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS Volume 23, Number 11, March 18, 1994. Investigators may also obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by March 14, 1996, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, it is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDDK staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS 37-E, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. The form is available at most institutional offices of sponsored research and from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: girg@drgpo.drg.nih.gov. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number 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: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE. ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application, and five copies of any appendix material, must be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS 37-E, MSC 6600 Bethesda, MD 20892-6600 Applications must be received by April 26, 1996. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications previously reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications for the R03 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 NIDDK in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the NIDDK program division to which the application has been assigned. Review Criteria o the applicants previous research training, experience and publications; o his/her ability to complete the proposed research plan; o the overall scientific merit of the research plan; o whether the aims and scope of the research plan can provide definitive data within a one or two year period; o the potential of the proposed research to provide the bases for future studies; o the institutions willingness to commit facilities and departmental support to the applicant; o the applicants plans and career goals; o the availability of a recognized expert in the area of the proposed research for council and advice as attested to by a letter of agreement. AWARD CRITERIA The anticipated date of award is September 30, 1996. Applications will compete for available funds with all other applications submitted in response to this RFA and recommended by the initial review group. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the RFA. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Charles H. Rodgers, Ph.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS 19J, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 Email: rodgersc@ep.niddk.nih.gov Judith M. Podskalny, Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN 12E, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8876 Email: podskalnyj@ep.niddk.nih.gov Ronald Margolis, Ph.D. Division of Diabetes, Endocrinology and Metabolism National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 5AN 12J, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8819 Email: margolisr@ep.niddk.nih.gov Direct inquiries regarding fiscal matters to: Ms Nancy C. Dixon Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN 44C, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8854 Email: dixonn@ep.niddk.nih.gov Schedule Letter of Intent Receipt Date: March 14, 1996 Application Receipt Date: April 12, 1996 Technical/Scientific Review: September 1996 Review by Divisions/NIDDK: September 1996 Anticipated Award Date: September 30, 1996 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sat Feb 17 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH MAIL Distribution problems Date: 18 Feb 1996 14:53:27 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 140 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4g8al7$flf@net.bio.net> NNTP-Posting-Host: net.bio.net $$MAIL BEGIN *********************************************************** As many of you may have observed, we had significant problems distributing the 1/26 E-Guide. The furlough and subsequent govenment closings due to snow caused the 1/26 guide to be very large (14 parts). As a result, it took longer than normal to edit and created a significant problem for our distribution machine here at NIH. The NIHDIS-L list is so large (more than 4,600) subscribers that our machine which runs LISTSERV can only accommodate it over the weekend when other traffic is minimal. Primarily due to the size of this E-Guide, the editing required for distribution could not be completed until Monday morning. I attempted to transmit small portions of it Monday and Tuesday evenings, but it wreaked havoc with our underpowered processor. On Wednesday, Ross Smith from NYU graciously offered to set up a temporary list to finish the distribution. He did so, and I mailed the remaining parts to him for transmission. Again, due to the large size of the list, the NYU machine also had significant problems attempting to transmit it. Thanks to a lot of work on Ross's part, the last piece was sent out on Saturday morning. Unfortunately, there appeared to be problems that implied that everyone did not get all of the 14 parts. For those who did not receive all or part of the 1/26 E-Guide, the text below describes how to read or transmit the missing sections. We will shortly be moving the NIH LISTSERV facility to a larger machine, so this hopefully won't happen again. If our new machine still has problems, I will look into some kind of distributed service, but this hopefully won't be necessary. ACCESSING ARCHIVED ISSUES OF THE E-GUIDE 1. NIH Grant Line Bulletin Board The NIH Grant Line includes information about NIH extramural programs, including the NIH Guide for Grants and Contracts. Files can be emailed or downloaded via the modem and communications software. To access the NIH Grant Line, the terminal emulator must be configured as follows: 1200 or 2400 baud, even parity, 7 data bits, 1 stop bit, half duplex. Using the procedure specified in the communication software, dial 1-301-402-2221. When a response indicates that a connection has been made, type ,GEN1 (the comma is mandatory) and press ENTER; the NIH system will prompt for INITIALS?. Type BB5 and press ENTER. A prompt will ask for ACCOUNT? Type CCS2 and press ENTER. Messages and a menu will be displayed that allow one to read Bulletins and download Files. Back issues of the NIH Guide are found in different Directories. GUIDE90 has issues going back to July 6, 1990; GUIDE91, GUIDE92, and GUIDE93 have all issues for each year. Type F (for FILES) to access any of the files that are arranged into directories. To get an overview of the kinds of information available, type D (for Directory). Access to the NIH Grant Line via the Internet To access the NIH Grant Line in an interactive Internet session, Telnet to wylbur.cu.nih.gov and, when a message has been received that the connection is open, type VT100. At the INITIALS? prompt, type BB5 and at the ACCOUNT? prompt, type CCS2. This puts the user into the NIH Grant Line. Questions about the NIH Grant Line can be sent to Dr. John James, jqj@cu.nih.gov. 2. World Wide Web (WWW) The Gopher files containing E-Guide issues may be accessed via the NIH home page on the World Wide Web, URL http://www.nih.gov. Click on Grants and Contracts and then NIH Guide to Grants and Contracts. NYU provides a Web page for the NIH Guide which includes an excellent searching facility. It's URL is http://www.med.nyu.edu/nih-guide.html. 3. The NIHGDE-L list archives Each mailing distributed via the NIHGDE-L LIST is automatically archived by LISTSERV. All issues after 1/19/90 have been saved with the text of each RFA and PA as a separate document. Retrieving files >From the LISTSERV archives is a two step process: a list of the available archive files is obtained by sending an INDEX NIHGDE-L command to LISTSERV@list.nih.gov. These files can then be retrieved by means of a GET NIHGDE-L filetype command or by using the database search facilities of LISTSERV. Send an INFO DATABASE command for more information on the latter. The following is a sample of the INDEX command file information: filename filetype GET PUT -fm lrecl nrecs date time Remarks -------- -------- --- --- --- ----- ----- -------- -------- NIHGDE-L 90-00027 PRV OWN V 80 969 90/01/18 16:12:44 -> NIH ... The information for each entry consists of two lines. The first line contains information necessary for retrieval and the beginning of the Remarks, and the second contains the rest of the Remarks. The important information is the number (90-xxxxx) and the Remarks. The Remarks field is the subject line of the mail distributed and shows which documents can be retrieved. The number is the value used in the GET command. To retrieve files, send mail to LISTSERV@jhuvm.hfc.jhu.edu that contains one line for each document as follows: GET NIHGDE-L number For example, to get the main body of the NIH Guide for 1/19/90, the mail would contain the line: GET NIHGDE-L 90-00027 The documents referenced in the GET commands will be sent back as files. It is possible to use any of the publicly available LISTSERV commands with the NIHGDE-L list. More information on LISTSERV commands can be found in the "General Introduction Guide," which can be retrieved by sending an INFO GENINTRO command to LISTSERV@jhuvm.hfc.jhu.edu. 4. ANONYMOUS FTP The NIH Guide is available via Anonymous ftp at the NIH Computer Utility. The files contain both the main body of the printed edition of the NIH Guide and the full text of the Program Announcements and Requests For Applications. The format of the delimited records is slightly different and is explained in the README file. The file names are of the form Gmmddyy, where mmddyy is the month/day/year of the date of the NIH Guide. To access the NIH Guide via Anonymous ftp: ftp ftp.cu.nih.gov (specify ANONYMOUS as the userid and GUEST as the password) cd nih-eguide All normal ftp commands are available. The output will look quite different from other installations because the NIH implementation is under MVS. $$MAIL END************************************************************** From owner-sci-resources@net.bio.net Sat Feb 17 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-021 - V25(02) 02/02/96 Date: 18 Feb 1996 14:41:38 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 511 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4g89v2$dsa@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA96021 PA-96-021 P1O1 *************************************** HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS NIH GUIDE, Volume 25, Number 2, February 2, 1996 PA NUMBER: PA-96-021 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) seeks health services research grant applications that are aimed at developing a knowledge base to improve the efficiency and effectiveness of services for alcohol-related problems. This program announcement invites research applications related to improving the availability, accessibility, delivery, quality, cost effectiveness, impact, and outcomes of alcohol-related treatment and prevention services. The research objectives include, but are not limited to, four major areas: (1) determining impacts 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 the utilization and cost of treatment services for alcohol-related problems; (3) identifying and assessing the effectiveness and outcomes of alcohol-related treatment and preventive services; and (4) identifying factors that influence the organization, management, and delivery services for alcohol-related problems across regions, populations, and settings. 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, Health Services Research on Alcohol-Related Problems, 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: 202-512-1800). 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 applicants are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29). Regular research grant applications (R01) from foreign institutions are limited to three years. MECHANISM OF SUPPORT Research support may be obtained through applications for a regular research project grant (R01) or First 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. Program Project Grants applications (P01) will not be accepted under this program announcement. The NIAAA also seeks to increase the pool of health services researchers who have expertise in the alcohol field. NIAAA encourages interested institutions to undertake programs of research training and career development in the area of alcohol-related health services research. FUNDS AVAILABLE The NIAAA estimates that the average research grant (R01) award size will be approximately $250,000 in total costs for the first year. Outyear budgets should conform to NIH cost-containment policies. Investigators who wish to submit an application that request more than $500,000 in direct costs in any one year must contact program staff before submitting an application. Although the financial plans of NIAAA provide for the support of this program, the award of grants pursuant to this program announcement is contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES In June 1992, "The ADAMHA Reorganization Act" (Public Law 101-321) directed NIAAA to expand its program of health services research. Health services research is defined in the legislation 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" (Section 409). Health services research also is concerned with identifying factors that influence the effectiveness of health services in "real world" settings. This program announcement invites research applications related to understanding and improving the financing, utilization, effectiveness, and organization of health services for the prevention and treatment of alcohol-related problems. For the purposes of this program 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 effectiveness of prevention services as well as their financing, organization, management, implementation, cost, and utilization. As directed by subsequent legislation (P.L. 103-43), for the purposes of this announcement health services research does not include studies of the efficacy of specific preventive, diagnostic, and treatment services where the analysis is directed at the individual as distinct >From the service system. Applications whose main objective is to establish and support treatment or prevention services are not eligible for funding under this program announcement. Support for research-related treatment, rehabilitation, or prevention services and programs may be requested only for those particular costs and for that period of time required by the research. These costs must be justified in terms of research objectives, methods, and designs that promise to yield important generalizable knowledge and/or to make a significant contribution to theoretical concepts. Applicants should adopt the most carefully controlled and rigorous research designs feasible in conducting treatment and prevention services research and studies (see Lettieri 1992; Sechrest, Persin, and Bunker 1990; Cook and Campbell 1979). As elaborated in the "Review Criteria" section of this program announcement, applications will judged on the basis of the scientific and technical merit of the proposed research as well as on the adequacy and appropriateness of the proposed methodology. Applicants may wish to consult generic publications in health services research as well as alcohol-specific examples of prevention and treatment research. The following list of research topics is for illustrative purposes. Topics not mentioned below that fall within the research objectives of this program announcement will also be accepted. Financing and Reimbursement of Services o Investigating the impact of innovative financing and reimbursement approaches on the quality, cost effectiveness, and supply of alcohol treatment and/or prevention services, as well as demand for and barriers to those services. o Assessing how alternative managed care systems affect availability, quality, cost, and outcomes of treatment and prevention services. o Developing uniform ways to measure insurance benefits and payments for treatment of alcohol-related problems in order to compare performance of alternative health plans. Alcohol-related problems include medical consequences of alcohol abuse and alcoholism; such as, alcohol poisoning, or cardiovascular, gastrointestinal and/or neurological disorders. o Identifying the impact of changes in compensation incentives on the behavior of consumers, clinicians, and institutions, and on treatment appropriateness and outcomes. o Modeling and assessing the impact of health care reform legislation and other policy changes on the organization, management, financing, availability, appropriateness, and cost of alternative alcohol-related health policies and treatment services. Utilization and Cost of Services o Identifying health service factors and individual characteristics influencing access to, or compliance with, treatment interventions for alcohol-related problems (including symptomatic medical problems), particularly among underserved, uninsured, and HIV-infected populations. o Identifying care-seeking behavior of people with alcohol problems, including utilization of informal resources (e.g., self-help groups) and alternative (e.g., acupuncture) health resources, as well as general medical and specialty alcohol services. o Developing standardized criteria for identifying episodes of alcohol treatment to apply in longitudinal analyses of cost and utilization data. o Determining whether or not prevention programs have significant effects on the utilization and cost of treatment services. o Determining the extent to which costs of treatment or prevention services are offset by subsequent reductions in health care costs. For example, evaluating characteristics of individuals, programs, service systems, and insurance benefits associated with greater cost offsets and cost effectiveness. Effectiveness and Outcomes of Services o Developing and assessing criteria to classify and measure objectives, components, and processes involved in delivering major types of services for alcohol-related problems, and examining linkages between treatment content, quality of care, and functional as well as alcohol-specific outcomes. o Assessing the effectiveness of brief interventions to treat problem drinking and its medical and social consequences. Research may assess brief interventions in inpatient or outpatient acute and specialty as well as primary care settings. o Assessing adequacy and appropriateness of treatment services to meet needs and demands of different groups such as women, youth, minorities, rural residents, and the elderly. o Determining the impact of organization, financing, and management on the effectiveness of treatment interventions when they are delivered to heterogeneous populations in natural rather than experimental settings. o Developing classification or measurement systems for use by clinicians to better assign patients to treatment modalities or to improve outcomes, particularly management of post-treatment relapse. o Assessing the potential of prevention activities, programs, or policies to reduce the need for, demand for, or utilization of health care, for either chronic or acute conditions related to the use of alcohol. o Applying cost effectiveness research to estimate the costs and effectiveness of particular alcohol-related health services (including treatment and prevention) from the perspective of consumers or their families as well as from the perspectives of payers, providers, or employers. o Assessing the effects of participation in Alcoholics Anonymous on treatment utilization, outcome, and cost. Service System Delivery, Organization, and Management o Examining organization and management of alcohol treatment services, including social, economic, demographic, geographic, legal or health policy, and other factors that may facilitate or impede effective and efficient linkage and delivery of those services. o Determining the impact of system-level, service integration initiatives on the coordination, comprehensiveness and continuity of alcohol treatment services. o Identifying different organizational models needed for delivery of alcohol treatment services to different subpopulations such as the elderly, youth, women, minorities, rural residents, or HIV-positive individuals. o Developing and testing innovative management approaches to improve productivity and efficiency in implementing treatment services. o Examining organizational, provider, and consumer responses to changes in the following areas: (a) financing and reimbursement policies, (b) structural aspects of managed-care systems, (c) insurance coverage characteristics of populations in the service area, (d) number and characteristics of other organizations and providers in the area, and (e) demographic factors such as population density, and/or other factors that may lead to changes in organizational and provider behavior with ultimate consequences for access to and outcomes of treatment services. 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. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extamural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0715, email: girg@drgpo.drg.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-related health services research grant applications will include the following: 1. The scientific, technical, health or medical significance, and originality of the proposed research 2. The appropriateness and adequacy of the research design and methodology proposed to carry out the research. 3. The adequacy of the qualifications (including level of education and training) and relevant research experience of the principal investigator and key research personnel. 4. The availability of adequate facilities, general environment for the conduct of the proposed research, other resources, and collaborative arrangements necessary for the research. This includes the feasibility of implementing the project (including recruitment of subjects, implementation of the intervention or innovation, cooperation of relevant organizations, and/or availability and quality of necessary data). 5. The appropriateness of budget estimates and duration in relation to the proposed research. 6. Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment. The review criteria for FIRST Awards (R29), IRPGs, career development awards, and institutional training grants are contained in the relevant program announcements. AWARD CRITERIA Applications recommended for approval will be considered for funding on the basis of the overall scientific and technical merit of the application as determined by peer review, programmatic needs and balance, and the availability of funds. The NIAAA is interested in maintaining a portfolio of research activities that is balanced among the four major issues described in the "Research Objectives" section of this program announcement. In order to expedite the achievement of such balance, special consideration will be given to applications that focus on: (a) Financing and Reimbursement of Services or (b) Service System Delivery, Organization, and Management. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. A copy of the NIH program announcement for National Research Service Awards for Institutional Research Training Grants as published in the June 3, 1994, issue of the NIH Guide for Grants and Contracts may be obtained from the program staff listed under INQUIRIES. Potential applicants may obtain copies of specific announcements from the National Clearinghouse for Alcohol and Drug Information, P.O. Box 2345, Rockville, Maryland, 20852, telephone: 301-468-2600 or 1-800-729- 6686. Further information on grant mechanisms and areas of research interest may be obtained from the program staff listed in the Inquiries section of this program announcement. Direct general inquiries regarding health services research to: Robert B. Huebner, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0786 FAX: (301) 443-8774 Email: bhuebner@willco.niaaa.nih.gov Direct inquiries regarding health services treatment research to: Harold I. Perl, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0788 FAX: (301) 443-8774 Email: hperl@willco.niaaa.nih.gov Direct inquiries regarding health services prevention research to: Michael Hilton, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-8753 FAX: (301) 443-8774 Email: mhilton@willco.niaaa.nih.gov Direct inquiries regarding health services epidemiologic research to: Harold Yahr, Ph.D. Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 594-6230 FAX: (301) 443-8614 Email: hyahr@willco.niaaa.nih.gov Direct inquiries regarding research training and career development opportunities to: Frances Cotter, M.P.H. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1207 FAX: (301) 443-8774 Email: fcotter@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Linda Hilley Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0915 FAX: (301) 443-3891 Email: lhilley@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. References Cook, T.D. and Campbell, D.T. Quasi-Experimentation: Design and Analysis Issues for Field Settings. Boston: Houghton Mifflin, 1979. Lettieri, D.J. A Primer of Research Strategies in Alcoholism Treatment Assessment. DHHS Pub. No. (ADM) 92-1882. Rockville, MD: National Institute on Alcohol Abuse and Alcoholism, 1992. Sechrest, L.; Persin, E.; and Bunker, J., eds. Methodology: Strengthening Causal Interpretations of Nonexperimental Data. DHHS Pub. No. (PHS) 90-3454. Rockville, MD: Agency for Health Care Policy and Research, 1990. From owner-sci-resources@net.bio.net Sat Feb 17 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-020 - V25(02) 02/02/96 Date: 18 Feb 1996 14:41:14 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1257 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4g89ua$dra@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA96020 PA-96-020 P1O1 *************************************** ACADEMIC RESEARCH ENHANCEMENT AWARD NIH GUIDE, Volume 25, Number 2, February 2, 1996 PA NUMBER: PA-96-020 P.T. 34; K.W. 1014006 National Institutes of Health Application Receipt Date: June 26, 1996 PURPOSE The National Institutes of Health (NIH) is continuing to make a special effort to stimulate research in educational institutions that provide baccalaureate training for a significant number of the Nation's research scientists, but historically have not been major recipients of NIH support. Since Fiscal Year (FY) 1985, Congressional appropriations for the NIH have included funds for this initiative, the Academic Research Enhancement Award (AREA) program. The AREA funds are intended to support new research projects or expand ongoing research activities proposed by faculty members of eligible institutions in areas related to the health sciences. Applications received in June 1995 for AREA grants to be awarded this year (FY 1996) have been reviewed for scientific merit and program relevance. Approximately $14 million will be available for the NIH AREA program in FY 1996. As a result, about 140 AREA grants will be made from the applications received June 1995. Since it is anticipated that additional funds will be available next year, the NIH is inviting grant applications at this time for AREA grants to be awarded competitively in FY 1997. ELIGIBILITY REQUIREMENTS Applicant Institutions o All domestic health professional schools and other academic institutions offering baccalaureate or advanced degrees in the sciences related to health are eligible, EXCEPT those that have received research grants and/or cooperative agreements from the NIH totaling more than $2 million per year (direct and indirect costs) in each of four or more years during the period from FY 1989 through FY 1995. o For purposes of eligibility for the AREA program, "research grants and cooperative agreements" include the following activity codes ONLY: K01, K02, K04, K05, K06, K08, K11, K12, K14, K15, K16, K20, K21, P01, P40, P41, P42, P50, P60, R01, R03, R10, R21, R22, R23, R24, R29, R35, R37, R55, U01, U10, U24, U41, U42, and U54. o "Health professional schools" (schools of medicine, dentistry, osteopathy, pharmacy, nursing, veterinary medicine, public health, optometry, allied health, and podiatry) means an accredited public or non-profit private school in a State that provides training leading to a degree granted by that school, for example, a doctor of medicine, a doctor of dentistry, or equivalent degree. The term "accredited" means a school or program that is accredited by a recognized body or bodies approved for such purpose by the Secretary of Education. o "Other academic institutions" means, as a SINGLE eligible component, all other schools, departments, colleges and free-standing institutes of the institution, EXCEPT the health professional schools. o Several applications proposing different research projects may be submitted by an applicant institution. Proposed Principal Investigators o Must not have active research grant support as the principal investigator at the time of award of an AREA grant. o May not submit an application to NIH for a research project grant (e.g., R01, R29) for essentially the same project as a pending AREA application. o Are expected to conduct the majority of the proposed research at their own institution, although limited access to special facilities or equipment at another institution is permitted. o May not be awarded more than one AREA grant at a time nor be awarded a second AREA grant to continue the research initiated under the first AREA grant. APPLICATION PROCEDURES Applications for the AREA program will be accepted under the application submission procedures of the Division of Research Grants (DRG), NIH. The research grant application form PHS 398 (revised 5/95) is to be used in applying for an AREA grant. Applicants must obtain the AREA Program Guidelines containing supplemental instructions for AREA applications (see ~Inquiries~ below). These instructions identify the AREA program (R15) as a ~just in time~ mechanism and must be followed in preparing an application. AREA grants are awarded on a competitive basis. Applicants may request support for up to $75,000 for direct costs (plus applicable indirect costs) for a period not to exceed 36 months. No more than $35,000 may be requested for direct costs for any one year. Although this award is non-renewable, it will enable qualified individual scientists within the eligible institutions to receive support for feasibility studies, pilot studies, and other small-scale research projects preparatory to seeking more substantial funding from the NIH research grant programs. REVIEW CONSIDERATIONS Applications for the AREA program will be subjected to the standard peer review process involving two sequential levels of review. The first level of review is performed by initial review groups composed primarily of non-Federal scientists selected for their competence in particular scientific fields. The second level of review is made by the National Advisory Council or Board of the NIH awarding component to which the grant application has been assigned by the DRG for potential funding. These groups are composed of both scientific and lay representatives who are chosen for their expertise, interest, or activity in matters related to the mission of the individual awarding component. Council or Board recommendations are based on both scientific merit and relevance to awarding component program goals. AWARD CRITERIA Funding decisions will be based on the proposed research project's scientific merit and relevance to NIH programs and the institution's contribution to the undergraduate preparation of doctoral-level health professionals. Among projects of essentially equivalent scientific merit and program relevance, preference will be given to those submitted by institutions that have granted baccalaureate degrees to 25 or more individuals who have obtained academic or professional doctoral degrees in the health related sciences during the period 1986-1995. Scientists working in eligible minority and women's educational institutions are encouraged to participate in this program. Since a primary purpose of the AREA program is to furnish support to those undergraduate institutions that provide student training in the sciences, principal investigators are encouraged to include the participation of students in the proposed Research Plan to the extent practicable. INQUIRIES AREA Program Guidelines The AREA Program Guidelines may be accessed through the NIH Home Page on the World Wide Web (http://www.nih.gov) or by contacting the office named below. The AREA Program Guidelines are appended to the Program Announcement in the electronic editions of the NIH Guide and will be available through the NIH Home Page on the World Wide Web (http://www.nih.gov) under the Grants and Contracts sub-menu. Printed copies may be requested from the Office of Extramural Outreach and Information Resources. Application Forms Form PHS 398 (rev. 5/95) application packages may be obtained from: Office of Extramural Outreach and Information Resources Office of Extramural Research National Institutes of Health 6701 Rockledge Drive, Room 6207 - MSC 7910 Bethesda, MD 20892-7910 Telephone: (301) 435-0714 FAX: (301) 480-3963 Email: girg@drgpo.drg.nih.gov Questions regarding eligibility, policies, procedures, and other administrative aspects of the NIH AREA program should be referred FIRST to the Office of Sponsored Programs at the educational institution. Issues that remain AFTER consultation with the institutional Office of Sponsored Programs and that are NOT ADDRESSED in the AREA Program Guidelines may be directed to: Special Programs Office of Extramural Research National Institutes of Health 6701 Rockledge Drive, Room 6186 - MSC 7910 Bethesda, MD 20892-7910 Telephone: (301) 435-2770 FAX: (301) 480-0146 Email: sk13n@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.390. Grants will be awarded under authority of the Public Health Service Act, Title III, Section 301 (Public Law 78- 410, as amended; 42 USC 241) and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR Part 52 and 45 CFR Part 74. 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. NATIONAL INSTITUTES OF HEALTH ACADEMIC RESEARCH ENHANCEMENT AWARD (AREA) PROGRAM GUIDELINES Application Receipt Date: June 26, 1996 INTRODUCTION The National Institutes of Health (NIH) is continuing to make a special effort to stimulate research in educational institutions which provide baccalaureate training for a significant number of our nation's research scientists but which historically have not been major recipients of NIH support. Since Fiscal Year (FY) 1985, Congressional appropriations for the NIH have included funds for this initiative, which NIH has implemented through the Academic Research Enhancement Award (AREA)program. Grant applications received in June 1995 for AREA grants to be awarded this year (FY 1996) have been reviewed for scientific merit and program relevance; the most highly rated will receive funding shortly. (Approximately $14 million will be available for the AREA program in FY 1996. As a result, about 140 AREA grants will be made from the applications received in June 1995.) It is anticipated that additional funds will be available next year. Therefore, these AREA Program Guidelines are intended for the grant application receipt date of June 26, 1996, which is the single receipt date for the FY 1997 competition for AREA grants. It is anticipated that FY 1997 awards will be issued beginning April 1, 1997. AREA grants are for the support of new or expanded health-related research projects conducted by faculty in institutions that are not research-intensive. The AREA will enable qualified individual scientists to receive support for feasibility studies and other small scale research projects. These grants create a research opportunity for scientists and institutions otherwise unlikely to participate extensively in NIH programs, to participate in the nation's biomedical research effort. It is anticipated that principal investigators supported under the AREA program will benefit from this unique opportunity to conduct independent, preliminary research studies preparatory to seeking more substantial funding through other traditional NIH grant mechanisms; that the grantee institution will benefit from the strengthened research environment initiated through AREA grants and furthered by participation in the diverse extramural programs of the NIH; and that students will benefit from exposure to, and participation in, research and thus be encouraged to pursue graduate studies in the health sciences. The following information and guidelines have been prepared to assist interested faculty in preparing a research grant application for submission to the AREA program. BACKGROUND The NIH is the principal research arm of the Department of Health and Human Services (HHS). At present, 21 awarding components and several support and service divisions constitute the NIH. The NIH fosters the development of new knowledge in the biomedical and behavioral sciences, the ultimate goal of which is to combat disease and improve the health of mankind. To achieve its goals, NIH conducts research in its own laboratories and clinics and funds research by means of grants, cooperative agreements, and contracts in research and academic institutions throughout the world. The majority of grantees are academic institutions, but other research-oriented organizations-- including for-profit organizations -- participate significantly as well. The NIH provides funds for research projects, research training, career development of new and established scientists, and research and medical library resources. Research grant awards represent the largest proportion of all NIH extramural awards. The research plan for each research grant application is generated and developed by an investigator, referred to as the "principal investigator." The institution, on behalf of the investigator, submits the research grant application to the NIH for consideration for support. Principal investigators listed on NIH grant applications are most frequently affiliated with universities or medical schools, and most of them hold doctorate degrees. The Division of Research Grants (DRG), a service component of the NIH, receives all grant applications submitted to the NIH for support; assesses each one for relevance to the health mission of the NIH; and assigns those that are acceptable to the appropriate initial review group (IRG) for scientific merit review, and to the appropriate NIH awarding component for consideration for an award. Since its inception, the NIH has used a dual peer review system for the evaluation of applications. The NIH system, which has a statutory base, ensures that only the most meritorious and relevant proposals are considered for funding. The first level of review involves panels composed primarily of non-Federal experts, referred to as IRGs or study sections, which are established generally according to scientific disciplines. These panels of experts render an impartial review and evaluation of each application. They consider not only the scientific merit of a proposal, but also the background and experience of the principal investigator, the research facilities available for the project, and the appropriateness of the budget estimate. Each application will receive a "priority score" ranging from best (100) to worst (500), unless the IRG determines that an application (1) should be deferred for additional information or (2) should be "not recommended for further consideration" (NRFC). NRFC means that an application does not have "significant and substantial merit." The second level of review is made by the National Advisory Council or Board of the awarding component to which the application is assigned. These groups, composed of scientists, physicians, and leaders in public affairs, are chosen for their expertise, interest, or activity in matters related to the awarding component's mission. The council or board will take into account the scientific merit review of the IRG, plus elements such as the relevance of the goals of the proposed research to the mission of the awarding component, program balance, and the availability of funds. The AREA program and its application, review, and award procedures have been developed within this established framework for NIH grant-supported research activities. AREA ELIGIBILITY REQUIREMENTS 1. Applicant Institutions All domestic health professional schools and other academic institutions offering baccalaureate or advanced degrees in the sciences related to health are eligible, except those that have received research grants and cooperative agreements from the NIH totaling more than $2 million per year (direct and indirect costs) in each of four or more years during the period from FY 1989 through FY 1995. For purposes of eligibility to apply for the AREA program, "research grants and cooperative agreements" include the following activity codes only: K01, K02, K04, K05, K06, K08, K11, K12, K14, K15, K16, K20, K21, P01, P40, P41, P42, P50, P60, R01, R03, R10, R21, R22, R23, R24, R29, R35, R37, R55, U01, U10, U24, U41, U42, and U54. (These and all other activity codes are presented in a booklet entitled "Activity Codes, Organization Codes, and Definitions Used in Extramural Programs" prepared by the DRG, NIH, and available by calling Ms. Felicia Shingler on [301] 435-0996.) "Health professional schools" (schools of medicine, dentistry, osteopathy, pharmacy, nursing, veterinary medicine, public health, optometry, allied health, and podiatry) means an accredited public or non-profit private school in a State that provides training leading to a degree granted by that school, for example, a doctor of dentistry or equivalent degree, a degree of bachelor of science in nursing or equivalent degree, etc. The term "accredited" means a school or program that is accredited by a recognized body or bodies approved for such purpose by the Secretary of Education. "Other academic institutions" means, as a single eligible component, all other schools, departments, colleges, and free-standing institutes of the institution, except the health professional schools. Multiple applications proposing different research projects may be submitted by an applicant institution. 2. Proposed Principal Investigators (a) Must not have active research grant support as the principal investigator (including an AREA) from the NIH at the time of award of an AREA grant. (b) May not submit a regular NIH research grant application for essentially the same project as a pending AREA application. (c) Are expected to conduct the majority of their research at their own institution, although limited access to special facilities or equipment at another institution is permitted. (d) May not be awarded more than one AREA grant at a time nor be awarded a second AREA grant to continue the research initiated under the first AREA grant. Questions regarding eligibility, policies, procedures, and other administrative aspects of the AREA program should be referred to the Office of Sponsored Programs at the academic institution. Administrative questions that remain after consultation with the institutional Office of Sponsored Programs and that are not addressed in these AREA Program Guidelines may be directed to: Special Programs, Office of Extramural Research, NIH, 6701 Rockledge Drive, Room 6186, MSC 7910, Bethesda, MD 20892-7910, phone: (301) 435-2770, fax: (301) 480-0146, e-mail: sk13n@nih.gov. Questions of a scientific program nature should be addressed to the program representative of the appropriate awarding component listed below. In conformance with the spirit of the House Committee Report 98-911 (to accompany H.R. 6028, HHS Appropriations for FY 1985) special consideration will be given in the funding decision process to applications from those "smaller, less prominent, four-year, public and private colleges and universities which provide undergraduate training for a significant number of our nation's research scientists but which have not shared adequately in the growth of the NIH extramural program." (The NIH implements this direction through the following policy statement: Among projects of essentially equivalent scientific merit and program relevance, preference will be given to those submitted by institutions that have granted baccalaureate degrees to 25 or more individuals who have obtained academic or professional doctoral degrees in the health-related sciences during the period 1986-1995.) Scientists working in eligible minority and women's educational institutions are encouraged to participate in this program. Since a primary purpose of the AREA program is to furnish support to those undergraduate institutions which provide for student training in the sciences, we would encourage principal investigators to include the participation of students in the proposed Research Plan to the extent practicable. SCIENTIFIC PROGRAM INFORMATION AREA grants will support small scale, new or expanded health-related research projects, such as pilot research projects and feasibility studies; development, testing, and refinement of research techniques; secondary analysis of available data sets; and similar discrete research projects that demonstrate research capability. Listed below, by awarding component, are research topics which may be of particular interest to potential principal investigators under the AREA program. Also listed is the appropriate awarding component program representative whom a potential applicant is encouraged to contact for additional scientific program information and for pre-application guidance. National Institute on Aging (NIA) Program Contact: Dr. Miriam Kelty Associate Director, Office of Extramural Affairs National Institute on Aging 7201 Wisconsin Avenue, Room 2C218 Bethesda, MD 20892-9205 Phone: (301) 496-9322 Fax: (301) 402-2945 E-mail: mk46u@nih.gov The NIA is interested in, and has responsibilities for, aging research that includes fundamental studies of biological processes, including studies of aging at the molecular, organelle, cellular, organ, and organ system levels; the interaction of aging and diseases of aging; biomedical and psychosocial factors in maintaining health and effective functioning in the middle and later years; relevant social and behavioral relationships; and research that broadens the base of knowledge underlying adequate health services for the aging and the aged. The Institute is interested in normal physiological and biochemical changes with aging, involving areas such as immunology, neurobiology, endocrinology, nutrition, and exercise physiology, as well as clinical diseases and disorders of aging such as Alzheimer's disease, osteoporosis, osteoarthritis, falls, and urinary incontinence. The Institute also has responsibility for research concerned with the biological, social, psychological, cultural, and economic factors that affect both the process of growing old and the status and roles of older people in society. Under this broad mandate, health and well-being are viewed as the outcome of complex biological, physiological, medical, psychological, and socioenvironmental processes. National Institute on Alcohol Abuse and Alcoholism (NIAAA) Program Contact: Dr. Ernestine Vanderveen Associate Director, Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 Bethesda, MD 20892-7003 Phone: (301) 443-1273 Fax: (301) 594-0673 E-mail: tv9f@nih.gov The NIAAA supports basic and applied research on mechanisms of action of alcohol on biobehavioral processes and effects of alcohol on the mind and body. Support is available to develop new knowledge in a wide range of areas relevant to alcohol abuse and alcoholism; biochemical, physiologic, and behavioral mechanisms leading to pathologic drinking behavior; alcohol-induced organ damage; and clinical, behavioral, and epidemiological studies that will lead to more effective diagnosis, prevention, and treatment. The NIAAA supports alcohol-relevant research involving all of the life-science disciplines. National Institute of Allergy and Infectious Diseases (NIAID) Program Contact: Mr. Al Czarra Director, Office of Program Coordination and Operations Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 3C28 Bethesda, MD 20892 Phone: (301) 496-7291 Fax: (301) 402-0369 E-mail: ac20a@nih.gov The objective of NIAID's research program is to acquire the knowledge which will eventually lead to the treatment and prevention of infectious, allergic, and immunologic diseases. The Institute's overall strategy of attacking the array of problems on a broad front relies on free-ranging research in microbiology and includes the following research problem areas: isolation, characterization, and biology of disease-causing microbes; antibiotic or drug resistance among bacteria, viruses, and parasites; development of successful and safe antimicrobial compounds, particularly for viruses and parasites; and new approaches to understand and manipulate the immune system. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Program Contact: Dr. Steven J. Hausman Deputy Director National Institute of Arthritis and Musculoskeletal and Skin Diseases Building 31, Room 4C32 Bethesda, MD 20892-2350 Phone: (301) 402-1691 Fax: (301) 480-6069 E-mail: sh41g@nih.gov The NIAMS supports basic and clinical studies related to the rheumatic diseases and diseases and disorders of connective tissue, bone, and skin. Areas of research include: Inflammation, infectious agents and genetic factors related to rheumatic diseases; structure and function of cartilage and connective tissue; arthritis in children; systemic lupus erythematosus; rheumatoid arthritis; osteoarthritis; spondylitis and related syndromes; gout and pseudogout; the structure and function of skeletal muscle; bone structure, formation, degradation and repair; osteoporosis; biomaterials, biomechanics, and joint replacement; inherited connective tissue diseases; bone immunology and transplantation; metabolism of epidermis, dermis and subcutaneous fat; immunologically mediated cutaneous disorders; photobiology, photoallergy, and phototoxic reactions; vitiligo; psoriasis; bullous diseases of the skin; and acne. National Cancer Institute (NCI) Program Contact: Dr. Vincent T. Oliverio Associate Director for Program Coordination Division of Extramural Activities National Cancer Institute Executive Plaza North, Suite 600 Bethesda, MD 20892-7405 Phone: (301) 496-9138 Fax: (301) 402-0956 E-mail: vo3c@nih.gov The NCI is the Federal Government's principal agency for cancer research and control. Programs of the NCI focus on: (1) cancer etiology including laboratory, field, and epidemiologic and biometric research on the cause and natural history of cancer and means for preventing cancer, as well as studies on the mechanisms of cancer induction and promotion by chemicals, viruses, and environmental agents; (2) cancer biology and diagnosis research in the areas of cell biology, immunology, molecular biology, developmental biology, biochemistry, genetics, and pathology; (3)cancer treatment research in the areas of drug development, biological response modifiers, and radiotherapy development, including diagnostic imaging and clinical trials for curing or controlling cancer; and (4) cancer prevention and control research, development, technology transfer, demonstration, and education and information dissemination programs to expedite the use of new information relevant to prevention, detection, and diagnosis of cancer and pretreatment evaluation, treatment, rehabilitation, and continuing care of cancer patients. National Institute of Child Health and Human Development (NICHD) Program Contact: Ms. Hildegard Topper Special Assistant, Office of the Director National Institute of Child Health and Human Development Building 3l, Room 2A-03 Bethesda, MD 20892-2425 Phone: (301) 496-0104 Fax: (301) 402-1104 E-mail: ht20t@nih.gov The goal of NICHD's research programs is the improvement of maternal, infant, and child health through support of basic and clinical research to elucidate normal and abnormal growth, development, and maturation, from gametogenesis through maturity. To this end, NICHD supports research in: reproductive biology, chemistry, and medicine; fertility regulation; contraceptive development and evaluation; perinatology, pregnancy, and labor; developmental and clinical genetics; population dynamics; developmental endocrinology; social, cognitive, and affective development; and the biological bases of behavioral development. The NICHD also supports biomedical and behavioral research on mental retardation and developmental disabilities; pediatric, adolescent, and maternal HIV infection and AIDS; and, in the context of its National Center for Medical Rehabilitation Research, NICHD also supports the development of medical, behavioral, psychological, social, and technological interventions designed to optimize functioning after impairment, disability, or handicap. National Institute on Deafness and Other Communication Disorders (NIDCD) Program Contact: Dr. Judith Cooper Deputy Director, Division of Human Communication National Institute on Deafness and Other Communication Disorders Executive Plaza South, Suite 400-C Bethesda, MD 20892-7180 Phone: (301) 496-5061 Fax: (301) 402-6251 E-mail: jc148m@nih.gov Programs of the NIDCD focus on the identification, encouragement, and support of research aimed at improved diagnosis, treatment, and prevention of disorders of human communication. This would include research in all aspects of speech, hearing, language, equilibrium, and the special senses (taste, touch, smell). Basic and clinical studies of anatomical, physiological, biochemical, behavioral, acoustical and pathological aspects of communicative disorders and otolaryngological diseases are encouraged. National Institute of Dental Research (NIDR) Program Contact: Dr. Norman S. Braveman Assistant Director for Program Development National Institute of Dental Research Building 45, Room 4AN-24 Bethesda, MD 20892-6401 Phone: (301) 594-2089 Fax: (301) 480-8318 E-mail: nb10u@nih.gov The mission of the NIDR is the advancement of knowledge concerning the oral-facial complex in all of its aspects. This includes the conduct and support of research into the etiology, epidemiology, prevention, diagnosis, and treatment of such dental diseases as caries and periodontal disease; increasing our knowledge about craniofacial development and malformations; studies of various oral soft tissue diseases, including herpes and oral cancer; and increasing knowledge about orofacial pain and other oral sensory and motor dysfunctions. Cutting across these oral disease or dysfunction areas are research activities in such areas as salivary glands and secretions, mineralization and fluorides, tooth pulp biology, nutrition, behavioral studies, and research related to dental implants, replants, and transplants and to dental restorative biologically compatable and derived materials. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Program Contact: Dr. Walter S. Stolz Director, Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 6AS-25C Bethesda, MD 20892-6600 Phone: (301) 594-8834 Fax: (301) 480-3504 E-mail: ws23e@nih.gov The NIDDK conducts and supports research focused on a number of diseases that are characterized by chronicity and long-term disabling effects. Areas of interest include: diabetes, cystic fibrosis, and other errors of metabolism; diseases of the gastrointestinal tract, including the liver and gallbladder; endocrine disorders; diseases of the blood; kidney and urological diseases; and studies of nutrition and nutrition-related disorders. NIDDK's responsibilities in these areas encompass investigations of etiology, pathogenesis, diagnosis, and treatment. National Institute on Drug Abuse (NIDA) Program Contact: Ms. Eleanor C. Friedenberg Director, Office of Extramural Program Review National Institute on Drug Abuse Parklawn Building, Room 10-42 5600 Fishers Lane Rockville, MD 20857 Phone: (301) 443-2755 Fax: (301) 443-0538 E-mail: ef27d@nih.gov The research programs of the NIDA are devoted to increasing the understanding of the causes and consequences of drug abuse. This goal is accomplished by support of extramural research projects that improve and refine the methods for the assessment, treatment and prevention of drug abuse. The scientific studies supported are broad and include: fundamental studies on the mechanisms of action of abused drugs; biochemical strategies for identifying and developing successful drug abuse treatment agents; behavioral and clinical pharmacology; services research; epidemiology, natural history and prevention of drug abuse; treatment research; community-based research on reduction of drug-taking behaviors; and studies of drug abuse as a contributing factor in the AIDS epidemic. National Institute of Environmental Health Sciences (NIEHS) Program Contact: Dr. Jerrold Heindel National Institute of Environmental Health Sciences P.O. Box 12233, North Campus MD 3-03 Research Triangle Park, NC 27709 Phone: (919) 541-0781 Fax: (919) 541-2843 E-mail: jh190f@nih.gov The NIEHS is the principal Federal agency for biomedical research on the effects of chemical, physical, and biological environmental agents on human health and well-being. The Institute supports research and training focused on the identification, assessment, and mechanism of action of potentially harmful agents in the environment. Research results form the basis for preventive programs for environmentally-related diseases and for action by regulatory agencies. The NIEHS, thus, has responsibility for providing knowledge to assist in societal decisions involving current and future chemicals, processes, and other factors which may have impact on human health either directly or indirectly by altering man's environment. This responsibility mandates efforts toward a thorough understanding of the early manifestations and the mechanism of human disease brought about by toxic agents and the development of more accurate and more rapid methods to predict and assess the toxicity of such agents. National Eye Institute (NEI) Program Contact: Dr. Ralph J. Helmsen Research Resources Officer National Eye Institute Executive Plaza South, Suite 350 Bethesda, MD 20892-7164 Phone: (301) 496-5301 Fax: (301) 402-0528 E-mail: rh27v@nih.gov The mission of the NEI is to gain new knowledge concerning the normal functions of the eye and visual system and the pathology of visual disorders. Working to this end, the NEI supports research and research training aimed at improving the prevention, diagnosis, and treatment of visual disorders and fosters research in the rehabilitation of the visually handicapped. Both laboratory and clinical research are funded under the following major NEI programs: Retinal and Choroidal Diseases; Corneal Diseases; Cataract; Glaucoma; Strabismus, Amblyopia and Visual Processing. Within each program, research ranges from attempts to elucidate the fundamental biological processes that underlie disease to the development and clinical testing of new diagnostic and therapeutic techniques. National Institute of General Medical Sciences (NIGMS) Program Contact: Dr. Michael R. Martin Deputy Associate Director for Extramural Activities National Institute of General Medical Sciences Building 45, Room 2AN-32K Bethesda, MD 20892-6200 Phone: (301) 594-3910 Fax: (301) 480-1852 E-mail: mm72k@nih.gov The NIGMS supports non-disease-targeted research in the basic biomedical sciences. Research areas of interest include biophysics, cell biology, molecular biology, genetics, pharmacology, and those areas of chemistry which have relevance to biomedical problems. The emphasis is on understanding basic biological mechanisms, particularly at the cellular, subcellular, and molecular levels. National Heart, Lung, and Blood Institute (NHLBI) Program Contact: Dr. Ronald Geller Director, Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7100 Bethesda, MD 20892-7922 Phone: (301) 435-0260 Fax: (301) 480-3460 E-mail: rg33k@nih.gov The NHLBI supports basic and clinical research pertaining to the structure, function, and diseases of the cardiovascular, pulmonary, and blood systems. The Institute's research program also includes transfusion medicine and blood resources. The NHLBI carries out its mission through a number of research programs that provide support for projects ranging from studies at the molecular level to whole body studies in man and animals. Examples of research areas supported by the Institute include atherosclerosis, hypertension, cerebrovascular disease (directed at the dependent variable of blood, heart, or blood vessel), coronary heart disease, peripheral vascular diseases, arrhythmias, heart failure, and shock, congenital and rheumatic heart diseases, cardiomyopathies and infections of the heart, circulatory assistance, structure and function of the lung, chronic obstructive lung diseases, pediatric pulmonary diseases, occupational and immunologic interstitial lung diseases, respiratory failure, pulmonary vascular diseases, bleeding and clotting disorders, disorders of the red blood cell, sickle cell disease, and blood resources. National Institute of Mental Health (NIMH) Program Contact: Dr. Hugh Stamper Director, Division of Extramural Activities National Institute of Mental Health Parklawn Building, Room 9-105 5600 Fishers Lane Rockville, MD 20857 Phone: (301) 443-3367 Fax: (301) 443-0954 E-mail: hs19s@nih.gov The NIMH exerts leadership on behalf of the Nations's mentally ill citizens by creating a firm scientific foundation for the clinical care of mental disorders; by developing and assessing innovative approaches to diagnosis, treatment, and prevention of mental illnesses; and by exchanging information nationally and internationally with all relevant individuals and organizations to improve the state of mental health knowledge and its application. The NIMH conducts and supports an integrated program of basic and clinical research and research training in biology, neuroscience, epidemiology, and psychology and other behavioral sciences, as well as services research on the organization, administration, and financing of mental health services and service systems. These studies include theoretical, laboratory, epidemiologic, clinical, methodologic and field research on well and ill human subjects and populations of all ages, and on animals where appropriate to the research questions. National Institute of Neurological Disorders and Stroke (NINDS) Program Contact: Mr. Edward Donohue Deputy Director, Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 1016 Bethesda, MD 20892-9190 Phone: (301) 496-4188 Fax: (301) 402-4370 E-mail: ed25b@nih.gov The NINDS serves as the focal point at the NIH for research on the nervous system, including cerebrovascular disease (when the dependent variable is the nervous system), the neuromuscular apparatus, and the special senses of touch and pain. National Institute of Nursing Research (NINR) Program Contact: Dr. Lynn Amende Director, Extramural Research National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Phone: (301) 594-5968 Fax: (301) 480-8260 E-mail: la18g@nih.gov The NINR supports research on the biological and behavioral aspects of critical health problems that confront the Nation. According to its broad mandate, the Institute seeks to reduce the burden of illness and disability by understanding and easing the effects of acute and chronic illness; to improve health-related quality of life by preventing or delaying the onset of disease or slowing its progression; to establish better approaches to promoting health and preventing disease; and to improve clinical environments by testing interventions that influence patient health outcomes and reduce costs and demand for care. The NINR is interested in studies containing innovative ideas and sound methodologies in all aspects of nursing research consistent with its mission. Examples of areas of special interest include biobehavioral aspects of pain; management of symptoms associated with specific diseases or disorders; effects of life threatening illnesses; prevention or reduction of risk factors, particularly in young children; interactions among genetic factors, environment, and life style; developmental issues related to life-stage transitions; ameliorating effects of chronic illnesses; and health of minorities and other underserved populations. National Library of Medicine (NLM) Program Contact: Dr. Roger W. Dahlen Chief, Biomedical Information Support Branch National Library of Medicine Building 38A, Room 5S522 Bethesda, MD 20894 Phone: (301) 496-4221 Fax: (301) 402-0421 E-mail: rd57e@nih.gov The objective of NLM's research program is the support of investigations related to the generation, organization, and utilization of health knowledge. Such support may involve: (1) medical informatics research, a branch of investigation of the fundamental issues of health knowledge communication vis-a-vis advanced computer technologies; (2) research in health science librarianship and information science; or (3) assistance for the preparation and publication of scientific works in the health area. National Center for Research Resources (NCRR) Program Contact: Dr. Louise E. Ramm Deputy Director National Center for Research Resources Building 12A, Room 4009 Bethesda, MD 20892-5662 Phone: (301) 496-6023 Fax: (301) 402-0006 E-mail: lr34m@nih.gov The NCRR administers programs that develop and ensure the availability of resources essential to the efficient and effective conduct of human health related research. NCRR programs are primarily institutional in nature but, while support is generally in the form of resource grants, the NCRR makes awards for support of projects which contribute to improvement of the capability of resources to serve biomedical research. The following are research areas appropriate to the NCRR interests: (1) Research and Development in Instrumentation and Specialized Technologies for Biomedical Research. This encompasses instruments, devices, and processes to facilitate research in biomolecular and cellular structure and function. (Instrumentation includes mass spectrometry, nuclear magnetic resonance, electron spin resonance, equipment for fast kinetic research, X-ray diffraction, electron microscopy, and flow cytometry.) The application of computer science, computer engineering, and biomedical engineering to biomedical research problems is also of interest. (This includes knowledge engineering, information technology, computer graphics, image processing, computer modeling and simulation, task dedicated computer systems, and development of implantable microsensors and transducers.);(2) Research in Laboratory Animal Sciences. (This includes the etiology, pathogenesis, and control of laboratory animal diseases, as well as the environmental requirements of laboratory animals.);and (3) Development of Biomedical Research Methods Employing Lower Organisms, Tissues/Cells in Culture, or Mathematical and Computer Simulations. National Center for Human Genome Research (NCHGR) Program Contact: Dr. Bettie J. Graham Chief, Research Grants Branch National Center for Human Genome Research Building 38A, Room 610 Bethesda, MD 20894 Phone: (301) 496-7531 Fax: (301) 480-2770 E-mail: bg30t@nih.gov The NCHGR is currently engaged in a research program designed to characterize the human genome and the genomes of selected model organisms. This research program has the following interrelated goals: the construction of high resolution genetic linkage maps; the development of a variety of physical maps; the determination of the complete nucleotide sequence of the DNA of selected organisms; the development of the capability for collecting, storing, distributing, and analyzing the data produced; and the development of appropriate new technologies to achieve these goals. This project will develop a series of resources that will be available to the research community to facilitate both basic research and the application of the knowledge gained to the prevention, diagnosis, and therapy of disease. APPLICATION AND REVIEW PROCESS The deadline for receipt of applications is June 26, 1996. The budget request in each application may be for up to $75,000 for direct costs (plus applicable indirect costs) for a period not to exceed 36 months. However, no more than $35,000 may be requested for direct costs for any one year. Allowable direct costs include salaries for the principal investigator and other research personnel, supplies, equipment, travel, and other items specifically associated with the proposed research project. Applications will be received by the DRG and will be reviewed for scientific and technical merit and program relevance as described above (see Background). In carrying out the scientific and technical merit review of AREA applications, the IRGs will take into account: (a) the significance, originality, and technical merit of the proposed study, including, where appropriate, the project's potential as a basis for more extensive research; (b) the adequacy of the methodology; (c) the competency of the principal investigator, including academic qualifications, research experience, productivity, and any special attributes; (d) the facilities, resources, and environment of the applicant institution, including existing relevant equipment, animal and/or computer resources, and departmental or interdepartmental cooperation; (e) the appropriateness of the proposed budget and duration, including the justification for requested items in terms of the aims and methods of the proposed study; and (f) 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. CRITERIA FOR AWARD The NIH expects that approximately $14 million will be available for this program. It is anticipated that approximately 140 awards will be made from applications received June 26, 1996, with expected start dates beginning April 1, 1997. Funding decisions will be based on a project's scientific merit as determined by peer review and relevance to NIH programs, and on an institution's contribution to the undergraduate preparation of doctoral-level health professionals. Among projects of essentially equivalent scientific merit and program relevance, preference will be given to those submitted by institutions that have granted baccalaureate degrees to 25 or more individuals who have obtained academic or professional doctoral degrees in the health-related sciences during the period 1986-1995. ADMINISTRATIVE HIGHLIGHTS All PHS discretionary grants, including those awarded under the AREA program, are governed broadly by the grants administration policies set forth in the PHS Grants Policy Statement. Of particular relevance to grant recipients is the broad subject of POSTAWARD ADMINISTRATION which is dealt with on pages 8-1 through 8-26 of the PHS Grants Policy Statement. Among the various postaward administrative topics covered in that document are the following: o Changes in Expenditures/Activities o Property Management and Accountability o Patents and Inventions o Publications o Procurement Standards o Reporting Requirements o Audit Process o Closeout Procedures o Grant Appeals Procedures It is important to note the following "AREA program" exceptions to information and guidance contained in the PHS Grants Policy Statement: (1) Grant-supported research projects under the AREA program (a) may not be renewed (investigators may apply for further support through other established mechanisms); and (b) in most cases, will be funded by a single grant award in an amount up to $75,000 direct costs (plus applicable indirect costs) for a period not to exceed 36 months. (2) AREA grants may be administratively transferred to a replacement grantee institution only if the replacement is an AREA-eligible institution also. SUPPLEMENTARY INSTRUCTIONS TO FORM PHS 398 (REVISED 5/95) Applications must be submitted on Form PHS 398, revised 5/95. Copies of the "398" application package may be obtained by contacting: Office of Extramural Outreach and Information Resources Office of Extramural Research National Institutes of Health 6701 Rockledge Drive, Room 6207 - MSC 7910 Bethesda, MD 20892-7910 Phone: (301) 435-0714 Fax: (301) 480-3963 E-mail: girg@drgpo.drg.nih.gov Read the application package carefully and use its instructions except as indicated below. The Department of Health and Human Services has designated the NIH a "reinvention laboratory." One reinvention objective is to simplify and improve each stage in the grant process: application, review, award, and administration. The AREA program is part of an experiment to determine how to reduce the administrative burden in applying for an NIH grant without compromising the information needed by the initial peer review group to assess the scientific and technical merit of the proposed project and the reasonableness of the proposed budget. Some of the instructions below refer to items that have been modified and others that should not be completed at the time of submission of the application, but will be requested by the NIH awarding component if the application has a likelihood for funding. Page 7--Item 2 (Face Page)--Check the "YES" box and enter PA-96-20 and "Academic Research Enhancement award." Page 9--Item 6 (Face Page)--The entire proposed project period must not exceed three years and will begin on or after April 1, 1997. Page 9--Item 8a (Face Page)--This amount must not exceed $75,000. Page 11--Type of Appointment/Months (Form Page 4)--Do not complete at the time of application. This information will be requested by the NIH awarding component if the application has a likelihood for funding. Page 12--Institutional Base Salary (Form Page 4)--Do not complete at the time of application. This information will be requested by the NIH awarding component if the application has a likelihood for funding. Page 12--Salary Requested (Form Page 4)--Do not complete at the time of application. This information will be requested by the NIH awarding component if the application has a likelihood for funding. Page 12--Totals (Form Page 4)--Do not complete at the time of application. However, you must show the Subtotals. Page 12--Consultant Costs (Form Page 4)--Provide the total dollar amount requested. Itemize and justify according to the instructions only if this category exceeds $10,000 or a consultant is identified as "Key Personnel" on form page 2. Page 13--Equipment (Form Page 4)--Provide the total dollar amount requested. Itemize and justify according to the instructions only if this category exceeds $15,000. Page 13--Travel (Form Page 4)--Provide the total dollar amount requested. Itemize and justify according to the instructions only if this category exceeds $5,000. Page 13--Other Expenses (Form Page 4)--Provide the total dollar amount requested. Itemize and justify according to the instructions only if this category exceeds $5,000. Page 14--Other Support (Format Page 7)--Do not complete at the time of application. This information will be requested by the NIH awarding component if the application has a likelihood for funding. Page 15 Resources (Form Page 8)--In addition to the information requested under "Other," provide an estimate of the number of individuals who have obtained the baccalaureate degree at the applicant institution and who have obtained academic or professional doctoral degrees in the health-related sciences during the period 1986-1995. Page 15--Research Plan--Do not exceed 20 pages for the entire Research Plan (including literature citations). No appendix may be included. There is no further limitation on the number of pages for the entire application. Page 15--Introduction--Do not submit an introduction unless this is a revised application. Page 16--Preliminary Studies/Progress Report--This section is optional. However, should it be used, three to four pages are recommended, including literature citations as indicated on page 18 of the application package. Page 16--Research Design and Methods--There is no specific recommended number of pages for this section. However, the entire Research Plan (including Specific Aims; Background and Significance; Preliminary Studies/Progress Report, if used; Research Design and Methods; Literature Citations) may not exceed 20 pages. Page 19--Appendix--Do not submit an appendix. Page 20--Indirect Costs--Checklist--Questions concerning negotiation of indirect cost rate agreements should be directed to the appropriate regional office of the HHS Division of Cost Allocation. The address and telephone number of each office is provided on the final page of these Guidelines. Page 21--Receipt Date--The application receipt date is June 26, 1996. SUPPLEMENTAL FUNDING OF EXISTING GRANTS The NIH recognizes the need to increase the number of underrepresented minority scientists participating in biomedical and behavioral research. As a result, the NIH is emphasizing the use of administrative supplements to existing grants in order to attract underrepresented minorities into biomedical and behavioral research. See the NIH Guide for Grants and Contracts, Vol. 22, No. 43 November 26, 1993, for a full discussion of this additional funding opportunity and procedures for submitting a request for a supplement. This information may also be obtained from the Office of Extramural Outreach and Information Resources, Office of Extramural Research, NIH, at the address shown above. Principal Investigators at domestic institutions who hold an active NIH research grant (including an active AREA grant) are eligible to submit a request for an administrative supplement to the awarding component which issued the parent grant. For purposes of the active AREA grant, the request will be to support a minority candidate who is a high school or undergraduate student. Exceptions to this rule may be made by the awarding component which issued the AREA grant. The NIH recognizes also the need to extend opportunities to individuals with disabilities who are capable of entering or resuming research careers. According to the Americans With Disabilities Act, a "disabled individual" is one who has a physical or mental impairment that substantially limits one or more major life activities, who has a record of such impairment, or who is regarded as having such an impairment. Accordingly, Principal Investigators of an active AREA grant may submit a request for an administrative supplement for this purpose also to the awarding component which issued the parent grant. See the NIH Guide for Grants and Contracts, Vol. 21, No. 3, January 24, 1992, for a full discussion of this additional funding opportunity and procedures for submitting a request for a supplement. This information may also be obtained from the Office of Extramural Outreach and Information Resources, Office of Extramural Research, NIH, at the address shown above. DEPARTMENT OF HEALTH AND HUMAN SERVICES DIVISION OF COST ALLOCATION Region Address For Grantees Located In Northeast 26 Federal Plaza , Room 41-118 New York, NY 10278 Telephone: (212) 264-2069 Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, Vermont, Puerto Rico, Virgin Islands Mid-Atlantic Cohen Building, Room 1067 330 Independence Ave., S.W. Washington, DC 20201 Telephone: (202) 245-0483 Alabama, Delaware, District of Columbia, Florida, Georgia, Kentucky, Maryland, Mississippi, North Carolina, Pennsylvania, South Carolina, Tennessee, Virginia, West Virginia Central 1200 Main Tower Building Room 1115 Dallas, TX 75202 Telephone: (214) 767-3261 Arkansas, Illinois, Indiana, Iowa, Kansas, Louisiana, Michigan, Minnesota, Missouri, Nebraska, New Mexico, Ohio, Oklahoma, Texas, Wisconsin Western 50 United Nations Plaza Room 304 San Francisco, CA 94102 Telephone: (415) 556-1704 Alaska, Arizona, California, Colorado, Hawaii, Idaho, Montana, Nevada, North Dakota, Oregon, South Dakota, Utah, Washington, Wyoming From owner-sci-resources@net.bio.net Sat Feb 17 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-024 - V25(03) 02/09/96 Date: 18 Feb 1996 14:30:46 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 299 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4g89am$cno@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA96024 PA-96-024 P1O1 *************************************** NIDCD PROGRAM FOR POSTDOCTORAL RESEARCH TRAINING IN CLINICAL TRIALS NIH GUIDE, Volume 25, Number 3, February 9, 1996 PA NUMBER: PA-96-024 P.T. 44; K.W. 0720005, 0755015 National Institute on Deafness and Other Communication Disorders PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) invites applications for the support of Institutional National Research Service Award (NRSA) (T32) programs of postdoctoral research training in the design and conduct of clinical trials for individuals trained in the clinical disciplines of human communication. The purpose of this initiative is to foster the development of trained professionals into independent investigators capable of conducting clinical trials of the efficacy of treatment for diseases and disorders affecting hearing, balance, smell, taste, voice, speech, or language. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), NIDCD Program for Postdoctoral Research Training in Clinical Trials, is related to the priority areas of clinical prevention services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-11474-0 or Summary Report: Stock No. 017-001-11473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications will be accepted from non-profit domestic public and private institutions, such as schools of public health, universities and research institutions. Consortia arrangements are encouraged. The trainees appointed under this training program must hold a clinical doctoral degree (e.g., M.D., D.D.S., Ph.D. in a clinical discipline, or comparable doctoral degree) from an accredited domestic or foreign institution and have completed postgraduate clinical training with specialty emphasis in one or more areas of human communication, such as diseases and disorders of hearing, balance, smell, taste, voice, speech or language. In the case of Ph.D.-level health professionals trained in the disciplines of human communication, such as speech pathology, language pathology and audiology, clinical training may have preceded the completion of the doctoral degree. Ideally, the trainees will have had prior experience in clinical research. MECHANISM OF SUPPORT The support mechanism for grants made in response to this PA will be the NIH Institutional National Research Service Award (NRSA) (T32), often referred to as the institutional training grant. The provisions of this mechanism are detailed in the NIH-wide announcement for NRSA Institutional Research Training Grants (T32), published in the NIH Guide for Grants and Contracts, Vol, 23, No. 21, June 3, 1994, and apply to this initiative, except as noted in this program announcement. The NIH-wide announcement is available from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: girg@drgpo.drg.nih.gov. RESEARCH OBJECTIVES Background The need to increase the number of clinical investigators in the United States capable of transferring scientific knowledge from the laboratory to the clinic has been underscored by several National Institutes of Health (NIH) advisory groups and in recent reports from the Institute of Medicine and the National Research Council. Furthermore, the need for clinical trials addressing diseases and disorders affecting human communication has been highlighted in all sections of the National Strategic Research Plan published recently by NIDCD. This program announcement (PA) is one of several NIDCD initiatives to address this public health need for clinical research in human communication. Another initiative is a Request for Applications (RFA) issued on September 29, 1995 (NIH Guide for Grants and Contracts, Vol. 24, No. 34), offering support for Clinical Trials Cooperative Groups to conduct efficacy studies of new and improved treatments for diseases and disorders affecting human communication. The objective of this program is to train clinical investigators in the development, conduct and interpretation of clinical trials in order that they may function effectively as members of clinical trials teams and eventually be capable of directing single- and multicenter cooperative clinical trials of the efficacy of treatments for diseases and disorders affecting human communication. The training program will provide each trainee with two years of full-time research training, including didactic instruction, mentoring, and supervised research experience in the conduct of a clinical trial or trials of the efficacy of therapeutic approaches to human disease. The clinical trial of treatment efficacy in which the trainee receives practical experience need not be in a disease or disorder affecting hearing, balance, smell, taste, voice, speech or language. Plans must be presented for each trainee to be guided by a qualified preceptorial team experienced in the conduct of clinical trials. Training should include, but not be limited to, instruction in the following areas: (1) clinical trials design and conduct; (2) biostatistics; (3) data management and analysis; (4) epidemiology; (5) experimental therapeutics; (6) reporting results of controlled clinical trials; and (7) bioethics and the responsible conduct of research, with emphasis on clinical trials. 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 be familiar with the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (FR 59 14508-14513) to correct typesetting and errors in the earlier publication, and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994. Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applicants may request up to five years of support through the T32 mechanism. The number of full-time postdoctoral training positions requested should be justified by the applicant. Short-term research training positions may not be requested through this PA. The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained >From the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: girg@drgpo.drg.nih.gov. The title and number of this program announcement must be typed in Section 2 on the face page of the application. The completed original application and four legible copies must be sent or delivered by May 10 of each year 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) To ensure that the application is received in sufficient time for the review, send one copy of the application to: Acting Chief, Scientific Review Branch National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400C 6120 Executive Boulevard MSC-7180 BETHESDA, MD 20892-7180 REVIEW CONSIDERATIONS Applications that are complete and responsive to this PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDCD in accordance with NIH peer review procedures and criteria for T32 applications. All applications judged to be competitive during the initial merit review will be discussed, assigned a priority score and receive a second level review by the National Deafness and Other Communication Disorders Advisory Council. The applicant must have access to a training environment with ongoing multi-institutional clinical trials of the efficacy of therapy. Ideally, the applicant organization serves as a coordinating center which provides the clinical trials with ongoing biostatistical, epidemiologic and research design expertise. The review criteria for applications received in response to this PA are similar to those for unsolicited T32 applications. Specifically, these are: o Past research training record of both the program, if applicable, and the designated preceptors, as determined by the success of former trainees in establishing independent and productive research careers in the design and conduct of clinical trials; o Past research training record in terms of the success of former trainees in obtaining individual research awards and career awards for further development; o Commitment to the objectives, design and direction of a research training program responsive to this PA; o Caliber of preceptors as investigators with expertise in biostatistics, epidemiology, and clinical trials, including successful competition for research support; o The training environment, including access to ongoing multi-institutional clinical trials of treatment efficacy, the institutional commitment, the quality of the facilities, the availability of appropriate didactic courses, and the availability of research support; o Recruitment and selection plans for trainees, and the availability of eligible candidates; o The record of the research training program in retaining health-professional postdoctoral trainees for at least two years in research training activities. Additional review considerations related to the recruitment of trainees from underrepresented minority groups and training in the responsible conduct of research are described in the above-referenced NIH-wide PA for institutional NRSA applications. AWARD CRITERIA The NIDCD anticipates awarding up to three training grants in response to this PA. Applications for this program will compete for available funds with other T32 applications received and reviewed by the NIDCD. The following will be considered in making funding decisions: o Responsiveness to the purpose of this announcement o Quality of the proposed training program, as determined by peer review o Availability of funds INQUIRIES Consultation with NIDCD staff is strongly encouraged, especially during the planning phase of the application process, in order to ensure that the application is responsive to the scientific mission and the research training goals of the NIDCD. The staff person listed below is responsible for the NIDCD extramural research training and career development program, and can respond to inquiries concerning programmatic issues: Daniel A. Sklare, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400C 6120 Executive Boulevard MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 496-1804 FAX: (301) 402-6251 Email: daniel_sklare@nih.gov Direct inquiries regarding fiscal matters to: Sharon Hunt Division of Extramural Activities National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-B 6120 Executive Boulevard, MSC 7180 Bethesda MD 20892-7180 Telephone: (301) 402-0909 FAX: (301)-402-1758 Email: SH79F@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.173.. Awards are made under authorization of the Public Health Service (PHS) 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 Feb 17 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAS-96-027 - V25(04) 02/16/96 Date: 18 Feb 1996 14:35:15 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 349 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4g89j3$d3i@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PAS96027 PAS-96-027 P1O1 ************************************* DEVELOPMENTAL AND GENETIC DEFECTS OF IMMUNITY NIH GUIDE, Volume 25, Number 4, February 16, 1996 PA NUMBER: PAS-96-027 P.T. 34; K.W. 0710070, 0775000, 1002019 National Institute of Child Health and Human Development The Jeffrey Modell Foundation Application Receipt Dates: June 1, October 1, 1996 and February 1, 1997 PURPOSE The National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH), in collaboration with the Jeffrey Modell Foundation (JMF), invites investigator-initiated research grant applications for basic studies to identify the genes and elucidate the molecular and genetic mechanisms that are responsible for normal and defective development of the fetal, neonatal, and infant/child immune system. 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), Developmental and Genetic Defects of Immunity, is related to the priority areas of maternal and infant health, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) award. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanisms of support will be investigator-initiated research project grant (R01) and FIRST (R29) awards. Applications for FIRST Awards and R01s from new investigators are particularly encouraged. The total project period for an application submitted in response to this PA may not exceed five years; and a foreign application may not request more than three years of support. FUNDS AVAILABLE The estimated funds available for the total (direct and indirect) first-year costs of all awards made under this PA, for applications assigned to the NICHD, will be $500,000 ($400,000 from the NICHD and $100,000 from the JMF). In Fiscal Year 1997, the NICHD and the JMF plan to fund two to three R01 and/or R29 grants. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. The usual PHS policies governing grants administration and management, including indirect costs, will apply. Although this program is provided for in the financial plans of the NICHD and the JMF, awards pursuant to this program announcement are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. New applications submitted for the June 1 and October 1, 1996 and February 1, 1997 receipt dates will be eligible for funding under this announcement. Competing continuation applications for already funded projects will NOT be eligible for awards from NICHD and JMF under this PA. Although the NICHD has a continuing interest in the research areas of this PA, the latest anticipated award date with set-aside funds is September 30, 1997. RESEARCH OBJECTIVES Background An important mission of the NICHD is to conduct and support basic, clinical and translational research on birth defects. This includes basic research in developmental genetics and developmental immunology. Of particular interest to NICHD are studies that focus on the ontogeny of immunity and the genetic defects that give rise to inherited or primary immune deficiencies. Currently, more than 70 primary immunodeficiencies of varying phenotypes and severity have been described. It has been estimated that approximately 500,000 individuals in the United States are affected, mostly with a mild form. There are, however, 5,000-10,000 individuals, primarily infants and young children, with a severe, life-threatening form. Because long term and/or intensive treatments are required, the total medical, economic, and emotional impact on society is enormous. Recently, more defective genes causing immunodeficiency have been identified, cloned, and characterized. However, they represent a small percentage of the many defective genes responsible for primary immunodeficiencies. Moreover, the cellular, biochemical, genetic, and molecular bases and mechanisms underlying most of the primary immunodeficiencies have not been elucidated. In recent years, the rapid advances in molecular biology and molecular genetics provide the opportunity and technology for identifying the defective genes and for elucidating the abnormal genetic processes that cause the immunodeficiencies. These advances will also provide important information on normal genes and their role and function in the development of the immune system. Previous studies of naturally-occurring human and experimentally-induced animal "knockouts" have been extremely beneficial for identifying defective genes and studying the mechanisms and factors in normal and defective immune development. One goal of this program announcement is to encourage basic research that will lead to new and improved diagnostic, therapeutic, and preventive strategies for primary immunodeficiencies. This program announcement was stimulated in part by a workshop on the "Molecular Mechanisms of Primary Immunodeficiencies," which was sponsored by the Developmental Biology, Genetics and Teratology Branch of the NICHD. The workshop revealed important gaps in our knowledge and promising new opportunities and approaches for research in the molecular and genetic mechanisms of normal immune system development and primary immunodeficiencies. The workshop was sponsored partially by the JMF. The JMF is a non-profit research foundation devoted to primary immune deficiency. It sponsors symposia and workshops; supports research and training; and provides diagnostic, clinical, informational, and educational services on primary immunodeficiency disorders. The JMF was established by Vicki and Fred Modell in memory of their son Jeffrey, who died in 1986, at the age of 15, of an inherited immune deficiency. Scope The objective of this PA is to encourage and promote new and innovative research and approaches to identify the genes and elucidate the molecular and genetic mechanisms responsible for normal and defective development of the immune system. The following are examples of research topics that are appropriate for this PA; however, they are not to be considered as exclusive or limiting: o Identify, clone, and characterize the genes important in the normal ontogeny of the immune system as well as those mutant genes which cause immunodeficiency. o Elucidate the cellular, biochemical, molecular and genetic mechanisms underlying normal and defective development of the immune system. o Identify and characterize genes encoding specific proteins that are critical for normal immune system development; identify those mutant genes that alter expression of specific proteins and result in defective immune system development and immunodeficiency. o Identify and characterize the genes and proteins involved in cytokine-receptor signalling pathways; elucidate the molecular mechanisms of signal transduction that are important in normal and defective immune system development. o Identify and characterize X chromosome genes and their products that are important for development of the immune system. o Identify MHC molecules and their genes that are important in immune system development; and conversely, identify genetic mutations that cause defects in the expression of MHC and defective immune system development. o Develop animal models (natural and/or experimental) that will be useful for studying the genes and genetic mechanisms responsible for primary immunodeficiencies. Applications submitted in response to this PA should focus on identifying the genes and elucidating the basic mechanisms responsible for normal development of the immune system and primary immunodeficiencies. The areas of interest listed above are not in any order of priority. They are only suggested examples of areas of research to consider. Applicants are encouraged to propose other areas that are related to the objectives and scope of this PA. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their 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 on the standard application deadlines as indicated in the application kit. Requests for continued funding of already funded projects (Type 2) will NOT be considered under this program announcement. Applications may be submitted for the following receipt dates only: June 1, October 1, 1996 and February 1, 1997. Awards resulting from this program announcement will be made on or about April 1, July 1, and September 30, 1997. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: girg@drgpo.drg.nih.gov. For identification purposes, in item 2 of the application face page, check the box marked "YES" and type in the number and title of this program announcement. The completed original 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 mail/courier service) FIRST (R29) applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be 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 or board. Review Criteria o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications assigned to the NICHD will compete for available set-aside funds provided by the NICHD and the JMF. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, program priority and balance among research areas of the program announcement, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct programmatic inquiries to: Allan Lock, D.V.M. Developmental Biology, Genetics and Teratology Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5541 FAX: (301) 402-4083 Email: LockA@HD01.NICHD.NIH.GOV Direct fiscal inquiries to: Mr. E. Douglas Shawver Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (301) 402-0915 Email: ShawverD@HD01.NICHD.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865 - Research for Mothers and Children. Awards are made under authorization of the Public Health 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 Feb 17 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 04, pt. 1of1, 16 February 1996 Date: 18 Feb 1996 14:34:46 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 942 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4g89i6$d2h@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19960216 V25N04 P1O1 ************************************ X-comment: RFAS described: DK-96-009, CA-96-006, CA-96-007, NR-96-001, AI-96- X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.02.16 NIH GUIDE - Vol. 25, No. 4 - February 16, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** CHANGE IN NATIONAL CANCER INSTITUTE POLICY ON THE USE OF MERIT (R37) AWARDS National Cancer Institute INDEX: CANCER $$INDEX N2 ********************************************************** NIDA RESEARCH CENTER GRANT PROGRAM GUIDELINES National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX N3 ********************************************************** ANIMAL CARE AND USE: HOT ZONES, GRAY ZONES, AND GO SLOW ZONES National Institutes of Health Public Responsibility in Medicine and Research Tufts University School of Veterinary Medicine INDEX: NATIONAL INSTITUTES OF HEALTH; PUBLIC RESPONSIBILITY IN MEDICINE AND RESEARCH; TUFTS UNIVERSITY SCHOOL OF VETERINARY MEDICINE $$INDEX N4 ********************************************************** NATIONAL GENE VECTOR LABORATORIES National Center for Research Resources National Cancer Institute National Heart, Lung, and Blood Institute National Institute of Diabetes and Digestive and Kidney Diseases INDEX: RESEARCH RESOURCES; CANCER; HEART, LUNG, BLOOD; DIABETES, DIGESTIVE, KIDNEY DISEASES NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 04/26/96 ************************************************* SUPPORT OF MINORITIES IN DIABETES, DIGESTIVE AND KIDNEY DISEASE (RFA DK-96-009) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX R2 05/14/96 ************************************************ MINORITIES IN MEDICAL ONCOLOGY (RFA CA-96-006) National Cancer Institute INDEX: CANCER $$INDEX R3 05/14/96 ************************************************* MINORITY ENHANCEMENT AWARDS (RFA CA-96-007) National Cancer Institute INDEX: CANCER $$INDEX R4 05/15/96 ************************************************* SYMPTOM MANAGEMENT OF PERSONS INFECTED WITH HIV (RFA NR-96-001) National Institute of Nursing Research INDEX: NURSING RESEARCH $$INDEX R5 06/11/96 ************************************************* PEDIATRIC AIDS CLINICAL TRIALS GROUPS (RFA AI-96-001) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R6 07/17/96 ************************************************* COOPERATIVE CONTRACEPTIVE DEVELOPMENT RESEARCH CENTERS (RFA HD-96-001)) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX P1 ********************************************************** MOLECULAR PHARMACOLOGY OF ANESTHETIC ACTION (PA-96-026) National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES $$INDEX P2 ********************************************************** DEVELOPMENTAL AND GENETIC DEFECTS OF IMMUNITY (PAS-96-027) National Institute of Child Health and Human Development The Jeffrey Modell Foundation INDEX: CHILD HEALTH, HUMAN DEVELOPMENT; JEFFREY MODELL FOUNDATION THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.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. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: GIRG@DRGPO.DRG.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** CHANGE IN NATIONAL CANCER INSTITUTE POLICY ON THE USE OF MERIT (R37) AWARDS NIH GUIDE, Volume 25, Number 4, February 16, 1996 P.T. 34; K.W. 1014006 National Cancer Institute While the National Cancer Institute (NCI) continues to recognize outstanding established investigators supported by individual research project grant (R01) awards by nomination for a Method to Extend Research in Time (MERIT) (R37) Award, a change in the NCI use of MERIT awards is being implemented. This change is due in part to the uncertainty of future funding and to the rapidity with which competition in research arises as fields expand in response to novel discoveries. Decreasing the NCI's use of these long-term grant awards will allow more funding for competing grants. Therefore, the criteria for NCI MERIT nominations and administrative extensions have been made more stringent. (The original purpose of the MERIT Award is delineated in the NIH Guide for Grants and Contracts, Vol. 15, No. 13, August 1, 1986.) For initial MERIT nominations: 1. The candidate must be the principal investigator (PI) on an unamended competing continuation (Type 2) R01 research grant application that has a history of continuous NCI support for at least seven years, and has been approved by the National Cancer Advisory Board (NCAB) for five years of additional support with a priority score within the 5th percentile. This grant should represent the PI's principal area of research, and be in an area of special importance or promise. 2. The candidate PI must be an established scientist, at the leading edge in the proposed research area as indicated by a continuous record of publications in the highest quality journals for that respective field. MERIT extensions also must now meet higher standards, as being applied to initial MERIT nominations: 1. A proposed MERIT extension must be a logical continuation of the current award, not initiating new, unrelated lines of research and/or significantly increasing the level of effort of the PI or other personnel. MERIT extension applicants proposing such changes will be advised to submit a regular Type 2 R01 competing application. 2. Progress made by the awardee during the current award period must demonstrate continued leadership in the field. The research proposed for the extension period must continue to be at the cutting edge of the discipline, in an area of continued importance to the NCI mission and goals. MERIT extensions may be approved administratively for a period of one to five years, based on the degree to which the awardee and the research demonstrate continuing scientific promise, originality, and productivity. With these more stringent criteria for MERIT awards, some applicants for MERIT award extension may be advised that an administrative extension will be limited in time or not granted, thus requiring earlier submission of a regular competing (Type 2) continuation application that will receive full peer review. These changes in criteria are necessitated by projected budget limitations and are intended to provide increased opportunity for new competing research grants. Individual MERIT awardees will be contacted individually by NCI staff, and no disruption of research activities is anticipated. INQUIRIES For additional information and questions, contact the NCI Program Director listed on the Notice of Award or: Marvin R. Kalt, Ph.D. Director, Division of Extramural Activities 6130 Executive Boulevard, Suite 600 - MSC 7405 Bethesda, MD 20892-7405 Telephone: (301) 496-5147 FAX: (301) 402-0956 Email: kaltm@dea.nci.nih.gov $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NIDA RESEARCH CENTER GRANT PROGRAM GUIDELINES NIH GUIDE, Volume 25, Number 4, February 16, 1996 P.T. 04; K.W. 1014006, 0404009 National Institute on Drug Abuse PURPOSE This notice is to inform the research community of the following modifications to the National Institute on Drug Abuse (NIDA) Research Center Grant Program Guidelines, which were announced in the NIH Guide, Vol. 24, No. 33, September 22, 1995. Mechanism of Support: NIDA has changed the components required under the P50 and P60 mechanisms from "provide support for a core and a minimum of three research projects" to "provide support for core(s) and related research projects." Period of Support: P20 grantees are not required to consult with the funding program division when applying for support as a P30, P50, or P60 center; however, all grantees are strongly encouraged to consult with the funding program division before submitting a competing renewal application. INQUIRIES The revised Research Center Grant Program Guidelines are available on NIDA's Home Page (http://www.nida.nih.gov/) and may be obtained from: Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** ANIMAL CARE AND USE: HOT ZONES, GRAY ZONES, AND GO SLOW ZONES NIH GUIDE, Volume 25, Number 3, February 9, 1996 P.T. 34; K.W. 0201011, 1014003 National Institutes of Health Public Responsibility in Medicine and Research Tufts University School of Veterinary Medicine The Office for Protection from Research Risks (OPRR), Public Responsibility in Medicine and Research (PRIM&R), and Tufts University School of Veterinary Medicine announce the annual conference on the care and use of laboratory animals in research. Attendees can expect to receive (1) the first comprehensive revision in a decade of the "Guide for the Care and Use of Laboratory Animals," and (2) a copy of the 1996 reprint of the Public Health Service Policy on Humane Care and Use of Laboratory Animals." Officials from OPRR, the U.S. Department of Agriculture, and the National Academy of Sciences will present briefings on these key documents. The conference will be held March 14-15 1996 at the Park Plaza Hotel, Boston, MA. Keynote speakers include Dr. Judith Vaitukaitis, Director, National Center for Research Resources; Dr. Bill Raub, Science Advisor for the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services; and Drs. Nancy and Gerald Jaax, central figures in the response and management of disease outbreak storied in "The Hot Zone." Among other forefront issues, the conference will address (1) the search for alternatives to painful procedures, and (2) the ethics, science, and risk of animal-to-human xenotransplantation. In addition to plenary addresses, panel discussions, and more than 24 workshops, the conference will include a Resource Room stocked with organizational resources and articles relevant to animal care and research, a Poster Session in which individuals who work in the areas of public and/or institutional education will display and discuss their programs, and a demonstration of computer, Internet, and other technical aids that can ease the administrative burden and enhance the ethical vigilance of the IACUC. There are a limited number of auditor-status scholarships for full- time students and others demonstrating need, and places for members of the press. INQUIRIES PRIM&R 132 Boylston Street Boston, MA 02116 Telephone: (617) 423-4112 FAX: (617) 423-1185 Email: primr@delphi.com $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NATIONAL GENE VECTOR LABORATORIES NIH GUIDE, Volume 25, Number 4, February 16, 1996 P.T. 34; K.W. 1002019, 0780005, 0745032 National Center for Research Resources National Cancer Institute National Heart, Lung, and Blood Institute National Institute of Diabetes and Digestive and Kidney Diseases The National Gene Vector Laboratories (NGVLs) provide shared resources to facilitate production of clinical grade vectors for human gene therapy research. The overall goals are to produce selected vectors and distribute them to qualified clinical investigators to conduct experimental gene therapy protocols for a wide variety of medical conditions. The NGVLs are now soliciting applications for production of clinical grade vectors. Priority for vector production by these facilities will be given to protocols that have received peer-reviewed grant support. These vectors must have completed preclinical testing. Preference will be given to NIH-sponsored research. Specifically, the NGVLs support biomedical research by providing investigators with the following customized services: PRODUCTION o After competitive review and approval, adenoviral, retroviral and nonviral vectors will be produced under Good Manufacturing Practices (GMP) conditions using either investigator- or NGVL-generated vector- producing cell lines or plasmids. o Vector batches will be documented to be free of adventitious viruses, bacteria and replication competent viruses. DISTRIBUTION o The clinical grade vectors will be distributed in quantities adequate for use in Phase I or II clinical trials to investigators whose clinical protocols have successfully completed competitive review by both the NGVL Scientific Review Board and Steering Committee. APPLICATION PROCEDURE o Interested investigators may contact Dr. Kenneth Cornetta (see INQUIRIES) to obtain application packages. o Applications will be reviewed by the NGVL Scientific Review Board and by the NGVL Steering Committee. o The application receipt dates for 1996 are April 16 and September 3. Thereafter, applications will be received annually in September. INQUIRIES Direct requests for applications and resource inquiries to: Kenneth Cornetta, M.D. Division of Hematology, Oncology Indiana University School of Medicine 875 W. Walnut Street, Room 442 Indianapolis, IN 46202-5121 Telephone: (317) 274-0843 FAX: (317) 274-4243 Email: Ken_Cornetta@iucc.iupui.edu Direct programmatic inquiries regarding this research resource to: Richard A. Knazek, M.D. Clinical Research National Center for Research Resources 6705 Rockledge Drive, Room 6128, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0792 FAX: (301) 480-3661 Email: RichardK@ep.ncrr.nih.gov The NGVLs are supported by cooperative agreement awards supported by the National Center for Research Resources with co-funding provided by the National Cancer Institute, the National Heart, Lung, and Blood Institute, and the National Institute of Diabetes and Digestive and Kidney Diseases. $$N4 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN DK-96-009 FULL-TEXT ************************************** SUPPORT OF MINORITIES IN DIABETES, DIGESTIVE AND KIDNEY DISEASE NIH GUIDE, Volume 25, Number 4, February 16, 1996 RFA AVAILABLE: DK-96-009 P.T. 34, FF; K.W. 0715075, 0715085, 0715133 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: March 14, 1996 Application Receipt Date: April 26, 1996 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) recognizes the need to increase the number of underrepresented minorities committed to scientific careers in research areas served by the NIDDK. This program will utilize the Small Research Grant (R03) mechanism of support and will provide up to $50,000 direct costs for up to two years. This solicitation is aimed primarily at recently trained M.D. and/or Ph.D. minority investigators. The program will enable the minority applicant to accept a tenure earning position, gain additional research experience and obtain preliminary data on which to base a subsequent research grant application in an area of diabetes, endocrinology, metabolism, digestive diseases and nutrition, kidney, urology, or hematology. 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, Support of Minorities in Diabetes, Digestive and Kidney Disease, is related to the priority area of increasing underrepresented minority health scientists. 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. Charles H. Rodgers, Ph.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-19J, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7716 FAX: (301) 480-3510 Email: rodgersc@ep.niddk.nih.gov $$R1 END ************************************************************ $$R2 BEGIN CA-96-006 FULL-TEXT ************************************** MINORITIES IN MEDICAL ONCOLOGY NIH GUIDE, Volume 25, Number 4, February 16, 1996 RFA AVAILABLE: CA-96-006 P.T. 34, FF; K.W. 0785140 National Cancer Institute Letter of Intent Receipt Date: March 14, 1996 Application receipt Date: May 14, 1996 PURPOSE The Comprehensive Minority Biomedical Program of the National Cancer Institute (NCI) announces the availability of minority medical oncology awards. The purpose of these awards is to encourage recently trained underrepresented minority clinicians to acquire clinical training and research experience in medical oncology, and to increase representation of minorities in medical oncology. There will be approximately nine new awards made at a direct cost level of $65,000 per year. The estimated total costs available for the first year support of the program is $750,000. 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), Minorities in Medical Oncology, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-0001-00474-0 or Summary Report: Stock No. 017-0001-00473-1) 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. Lester S. Gorelic, Ph.D. Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 628, MSC 7405 Bethesda, MD 20892-7405 Telephone: (301) 496-7344 FAX: (301) 402-4551 Email: gorelicl@dea.nci.nih.gov $$R2 END ************************************************************ $$R3 BEGIN CA-96-007 FULL-TEXT ************************************** MINORITY ENHANCEMENT AWARDS NIH GUIDE, Volume 25, Number 4, February 16, 1996 RFA AVAILABLE: CA-96-007 P.T. 34. FF; K.W. 0715035, 0745027, 0795003 National Cancer Institute Letter of Intent Receipt Date: March 20, 1996 Application Receipt Date: May 14, 1996 PURPOSE The Comprehensive Minority Biomedical Program (CMBP), Division of Extramural Activities (DEA), National Cancer Institute (NCI), invites research project grant (R01) applications from interested investigators with access to large or predominantly minority populations to promote minority group participation in cancer research with a special focus on cancer control research. Support provided by this initiative would broaden the operational base of each institution by: 1. Expanding cancer control and prevention efforts in early detection, prevention, screening, pre-treatment evaluation, treatment, continuation care, and rehabilitation; 2. Increasing the involvement of minority population primary care providers early in the course of clinical treatment research; 3. Promoting the involvement in treatment research at the institutional level with a focus on the development of treatment protocols for cancers that have a high incidence in minorities; 4. Supporting programs involving diet and nutrition cancer control research activities; 5. Coordinating the contributions of investigators from various relevant disciplines, psychology and nutrition; and 6. Promoting the inclusion of minority individuals at all levels in the conduct of the research with the increased recruitment of minority scientists into the research base of the institution as an expected outcome. Approximately $1,600,000 in total costs have been set aside for the first year to fund up to six applications. 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), Minority Enhancement Awards, 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. Lemuel Evans, Ph.D. Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 620 - MSC 7405 Bethesda, MD 20892-7405 Telephone: (301) 496-7344 FAX: (301) 402-4551 Email: evansl@dea.nci.nih.gov $$R3 END ************************************************************ $$R4 BEGIN NR-96-001 FULL-TEXT ************************************** SYMPTOM MANAGEMENT OF PERSONS INFECTED WITH HIV NIH GUIDE, Volume 25, Number 4, February 16, 1996 RFA AVAILABLE: NR-96-001 P.T. 34; K.W. 0715008, 0785130 National Institute of Nursing Research Letter of Intent Receipt Date: April 26, 1996 Application Receipt Date: May 15, 1996 PURPOSE The National Institute Of Nursing Research (NINR) invites research project grant (R01) applications to support research related to interventions to improve the care of individuals infected with HIV. The purpose of this initiative is to increase the quality of life of persons infected with HIV by decreasing the negative impact of physical and psychological symptoms associated with the disease, its complications or treatment. Approximately $1 million in total costs for the first year will be committed to fund applications submitted in response to this RFA. It is anticipated that three or four applications will be funded. 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), Symptom Management of Persons Infected with HIV, is related to the priority areas of HIV infection and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. June R. Lunney, Ph.D., R.N. Division of Extramural Programs National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-6908 FAX: (301) 480-8260 Email: JLunney@EP.NINR.NIH.GOV $$R4 END ************************************************************ $$R5 BEGIN AI-96-001 FULL-TEXT ************************************** PEDIATRIC AIDS CLINICAL TRIALS GROUPS NIH GUIDE, Volume 25, Number 4, February 16, 1996 RFA AVAILABLE: AI-96-001 P.T. 34; K.W. 0755015, 0715008, 0770005 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: March 27, 1996 Application Receipt Date: June 11, 1996 PURPOSE The Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) announces the availability of a Request for Applications (RFA) to establish a multisite Pediatric AIDS Clinical Trials Group (PACTG). The purpose of this RFA is to solicit applications from institutions interested in participating in a cooperative group to plan, direct, and conduct Phase I, II, and III clinical trials. These clinical trials will address high priority research questions on the treatment and prevention of human immunodeficiency virus (HIV) disease and its sequelae. The focus will be on: (1) treatment of primary HIV disease; (2) interventions designed to prevent perinatal transmission of HIV; and (3) prophylaxis and treatment of opportunistic infections. Modalities of intervention may include, but are not limited to (1) drugs or combinations; (2) active and/or passive immune based therapies; (3) immunomodulators; and (4) gene transfer techniques. The initiative targets: (1) HIV infected and perinatally exposed infants; (2) HIV infected children; (3) HIV infected pregnant women at risk of transmitting HIV to the infant; and (4) adolescents, when therapeutic research questions specific to this age group are identified. The PACTG will consist of: (1) one Coordinating and Operations Center (CORC); (2) 18-25 Pediatric AIDS Clinical Trials Units (PACTUS); and (3) one Statistical and Data Management Center (SDMC). Applicants applying for more than one award must submit a separate application for each category. The NIAID plans to fund one CORC, 18 to 25 PACTUs, and one SDMC. Approximately $30,000,000 total costs is expected to be available for the first year of support 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. This RFA, Pediatric AIDS Clinical Trials Group, relates to the priority area of pediatric HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Tina Johnson, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2B31, MSC 7620 Bethesda, MD 20892-7620 Telephone: (301) 496-8214 FAX: (301) 480-5703 Email: tj8y@nih.gov $$R5 END ************************************************************ $$R6 BEGIN HD-96-001 FULL-TEXT ************************************** COOPERATIVE CONTRACEPTIVE DEVELOPMENT RESEARCH CENTERS NIH GUIDE, Volume 25, Number 4, February 16, 1996 RFA AVAILABLE: HD-96-001 P.T. 34; K.W. 0750020, 0413002 National Institute of Child Health and Human Development Letter of Intent Receipt Date: April 1, 1996 Application Receipt Date: July 17, 1996 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications from investigators interested in participating with the NICHD under a Cooperative Agreement (U54) in an ongoing multicenter cooperative research program termed the Cooperative Contraceptive Development Research Centers program. This program is designed to expedite the development of new methods to regulate fertility. The aim of the program is to conduct a wide range of research leading to clinically useful products. It is anticipated that $4,080,000 (including indirect and direct costs) will be available for the first year of the entire program. These funds will support three Center awards. In addition to new applications received in response to this solicitation, up to three continuation (renewal) applications are expected to compete for these three Center awards. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Cooperative Contraceptive Development Research Centers program, is related to the priority area of family planning. 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. Nancy J. Alexander, Ph.D. Center for Population Research National Institute of Child Health and Human Development Building 6100, Suite 8B13G MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1661 FAX: (301) 480-1972 Email: AlexandN@hd01.nichd.nih.gov $$R6 END ************************************************************ $$P1 BEGIN PA-96-026 FULL-TEXT ************************************** MOLECULAR PHARMACOLOGY OF ANESTHETIC ACTION NIH GUIDE, Volume 25, Number 4, February 16, 1996 PA AVAILABLE: PA-96-026 P.T. 34; K.W. 0710100, 0785015, 0705048 National Institute of General Medical Sciences PURPOSE The National Institute of General Medical Sciences (NIGMS) is reannouncing its interest in receiving applications for the study of the molecular mechanisms of action of general and local anesthetics. This program announcement supersedes and replaces the previous announcement by this title published in the NIH Guide for Grants and Contracts, Vol. 17, No. 3, January 22, 1988. Support of this program will be through the individual research project grant (R01), program project grant (P01), and First Independent Research Support and Transition (FIRST) (R29) award. Investigators with ongoing R01, P01 or R37 (MERIT) awards who are expanding the scope of their work and have at least one year of support remaining from the anticipated date of award, may wish to consider applying for a competing supplemental award. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Alison E. Cole, Ph.D. Division of Pharmacology, Physiology, and Biological Chemistry National Institute of General Medical Sciences 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-1826 FAX: (301) 480-2802 Email: colea@gm1.nigms.nih.gov $$P1 END ************************************************************ $$P2 BEGIN PAS-96-027 FULL-TEXT ************************************* DEVELOPMENTAL AND GENETIC DEFECTS OF IMMUNITY NIH GUIDE, Volume 25, Number 4, February 16, 1996 PA AVAILABLE: PAS-96-027 P.T. 34; K.W. 0710070, 0775000, 1002019 National Institute of Child Health and Human Development The Jeffrey Modell Foundation Application Receipt Dates: June 1, October 1, 1996 and February 1, 1997 PURPOSE The National Institute of Child Health and Human Development (NICHD), in collaboration with the Jeffrey Modell Foundation (JMF), invites investigator-initiated research applications for basic studies to identify the genes and elucidate the molecular and genetic mechanisms that are responsible for the normal and defective development of the immune system. The estimated funds available for the total (direct and indirect) first-year costs of all awards made under this Program Announcement (PA) to applications assigned to NICHD will be $500,000 ($400,000 from the NICHD and $100,000 from the JMF). The NICHD and JMF plan to fund approximately two to three research project grants (R01) and/or First Independent Research Support and Transition (FIRST) (R29) awards for Fiscal Year 1997. 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, Developmental and Genetic Defects of Immunity, is related to the priority areas of maternal and infant health, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Allan Lock, D.V.M. Developmental Biology, Genetics and Teratology Branch National Institute of Child Health and Human Development Building 61E, Room 4B01 Bethesda, MD 20892-7510 Telephone: (301) 496-5541 FAX: (301) 402-4083 Email: LockA@HD01.NICHD.NIH.GOV $$P2 END ************************************************************ From owner-sci-resources@net.bio.net Sat Feb 17 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-025 - V25(03) 02/09/96 Date: 18 Feb 1996 14:31:14 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 530 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4g89bi$coj@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA96025 PA-96-025 P1O1 *************************************** NICHD SMALL GRANTS PROGRAM NIH GUIDE, Volume 25, Number 3, February 9, 1996 PA NUMBER: PA-96-025 P.T. 34; K.W. 1014006, 0413000, 0775013, 0710030, 0404000 National Institute of Child Health and Human Development PURPOSE The National Institute of Child Health and Human Development (NICHD) Small Grants Program provides limited financial support for new research projects relevant to the NICHD mission. Applications may be submitted by new or more established investigators for support of research in any scientific area relevant to the Institute's programs in the Center for Population Research, the Center for Research for Mothers and Children, and the National Center for Medical Rehabilitation Research. While proposals may involve a wide variety of biomedical, biobehavioral, or clinical disciplines, relevance to the mission of NICHD must be clear. 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, NICHD Small Grants Program, is related to the priority areas of Nutrition, Family Planning, Educational and Community-Based Programs, Unintentional Injuries, Maternal and Infant Health, Diabetes and Chronic Disabling Conditions, HIV Infection, Sexually Transmitted Diseases, and Immunization and Infectious Diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications for small research grants may be submitted by domestic public and private, for-profit and non-profit institutions such as university, college, hospital, or laboratory; units of State or local government; and authorized units of the Federal Government. Foreign institutions and organizations are not eligible. Racial and ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Small grant support is for new projects and may not be used to supplement research projects already being supported or to provide interim support of projects under review. Simultaneous submissions of both small and regular research grant applications on the same topic will not be accepted. Small grant support may not be requested for thesis or dissertation research. Only one small grant application from an individual principal investigator will be considered by NICHD during a given Council round, and only one revision of a previously reviewed small grant application may be submitted. Applications for studies aimed at problems outside the NICHD mission will be returned to the applicant without review. The Institute's programs and contact persons are listed under INQUIRIES below. Potential applicants are strongly encouraged to discuss their proposed work with the appropriate program contact prior to submission of an application. MECHANISM OF SUPPORT This program will use the small grant (R03) mechanism. Support may be requested for up to 2 years at $50,000 per year in direct costs, plus allowable indirect costs. These grants are not renewable. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff also can provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on 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 Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: girg@drgpo.drg.nih.gov. The following instructions are to be used in conjunction with the information accompanying application form PHS-398 (rev. 5/95). They refer only to selected items in the application form. All PHS-398 requirements should be adhered to, with the exception of those items affected by the following instructions; for example, the Research Plan is limited to 10 pages. Applications not conforming to the requested format will be returned to the applicant without review. Please note that some of the information to be omitted from the application at submission may be requested following review if the possibility of funding exists. Face Page Item 2, Response to Specific Program Announcement: Check the box marked YES. Enter PA-96-025 and NICHD Small Grants Program. Item 6, Dates of Proposed Period of Support: Up to a total of 2 years of support may be proposed. Detailed Budget for Initial Budget Period (Page 4) Do not complete or submit this page. Budget for Entire Proposed Period of Support (Page 5) Composite Budget Table: Enter total direct costs requested, up to a maximum of $50,000, for each year of support (up to two). Justification: Provide a narrative justification for each proposed personnel position, including role on the project and proposed level of effort Provide narrative justification for the additional resources requested for the conduct of the project. Biographical Sketch (Page 6) (Complete for each of the key personnel listed on Form Page 2.) Research and Professional Experience: List current position(s) and those previous positions directly relevant to the application. List selected peer-reviewed publications directly relevant to the proposed project, with full citations. Provide information on research projects completed and/or research grants in which the investigator participated during the last 5 years which are relevant to the proposed project. For each project or grant listed, provide title, name of principal investigator, funding source, and role on project (if not principal investigator). Other Support (Page 7) Do not complete or submit this section. Research Plan Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 10 pages. Please note that a Progress Report is not needed; no competing continuation applications will be accepted for an R03. Appendix No appendix material may be submitted. Checklist New Applications: The Checklist should not be submitted. Revised Applications: Only the section of the Checklist pertaining to type of application should be completed. Submission Procedures: Submit a signed original of the application and four signed copies 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, one additional copy of the application must be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development Building 61E, Room 5E03 MSC-7510 6100 Executive Boulevard Bethesda MD 20892-7510 Rockville MD 20852-7510 (for express/courier service) REVIEW CONSIDERATIONS Upon receipt, applications will be evaluated by NICHD staff to determine whether they meet the eligibility requirements stated in this announcement. Applications that are judged not eligible will be returned to the applicant without review. Eligible applications will be evaluated for scientific and technical merit by a review committee of the NICHD Division of Scientific Review, in accordance with the standard NIH peer review procedures. Review Criteria o Scientific, technical, or clinical significance of the proposed research; o Innovativeness or promise of the research idea; o For pilot studies, the potential of the proposed study as a building block in the development of future research; o Basis or grounding of the project in the relevant literature; o Reasonableness and adequacy of the proposed approach/methodology; o Qualifications and research experience of the principal investigator and staff, particularly, but not exclusively, in the area of the proposed research; o Availability of the resources necessary to perform the proposed research; o Adequacy of the provisions for protection of human and/or animal subjects and the environment; o Adequacy of plans to address NIH policy on inclusion of women and minorities; o Reasonableness/appropriateness of the requested budget in relation to the proposed research. AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications assigned to NICHD. The following will be considered in making funding decisions: Scientific and technical merit of the application as determined by peer review; program priorities; consideration of the principal investigator's overall level of research support from all sources; and availability of funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. CENTER FOR POPULATION RESEARCH Contraceptive and Reproductive Evaluation Branch Steven Kaufman, M.D. Building 61E, Room 8B07 MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-4924 FAX: (301) 496-0962 E-Mail: KaufmanS@hd01.nichd.nih.gov The Contraceptive and Reproductive Evaluation (CARE) Branch encourages R03 applications of all kinds related to its mission: the discovery and dissemination of new knowledge concerning the safe and effective use of contraceptive and noncontraceptive drugs, devices, and surgical procedures affecting reproductive health. The CARE Branch is particularly interested in supporting applied research in these areas. Contraceptive Development Branch Lynn McCourt, R.N. Building 61E, Room 8B13 MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1661 FAX: (301) 496-0962 E-Mail: MccourtL@hd01.nichd.nih.gov The Contraceptive Development (CD) Branch supports basic and applied research and development, as well as clinical research, on novel methods of contraception and improvements on existing methods. The CD Branch is particularly interested in funding small grants for pilot studies of new forms of male contraception and innovative approaches to contraception which reduce the spread of sexually transmitted diseases. Demographic and Behavioral Sciences Branch Christine Bachrach, Ph.D. Building 61E, Room 8B13 MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1174 FAX: (301) 496-0962 E-Mail: BachracC@hd01.nichd.nih.gov The Demographic and Behavioral Sciences (DBS) Branch supports research related to population size, growth, and composition, including demographic and behavioral research on fertility; contraceptive and sexual behavior; behavioral aspects of AIDS and other sexually transmitted diseases; family demography; mortality, infant mortality and morbidity; immigration, migration and population movement; and population-environment interrelationships. The DBS Branch particularly encourages R03 applications to conduct feasibility studies of innovative ideas or methodologies, applications to support secondary analyses of existing data, and applications from new investigators. Reproductive Sciences Branch Koji Yoshinaga, Ph.D. Building 61E, Room 8B01 MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-6515 FAX: (301) 496-0962 E-Mail: YoshinaK@hd01.nichd.nih.gov The Reproductive Sciences (RS) Branch supports research in reproductive biology (male and female fertility/infertility) as announced in the NIH Guide for Grants and Contracts (Vol. 24, No. 31, August 25, 1995). The RS Branch is particularly interested in supporting small grants for pilot studies or feasibility studies to obtain preliminary data for preparation of fully developed, independent research grant applications. CENTER FOR RESEARCH FOR MOTHERS AND CHILDREN Developmental Biology, Genetics and Teratology Branch Allan Lock, D.V.M. Building 61E, Room 4B01 MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5541 FAX: (301) 402-4083 E-Mail: LockA@hd01.nichd.nih.gov The Developmental Biology, Genetics and Teratology (DBGT) Branch supports basic and clinical research on normal and abnormal development that relates to the causes and prevention of congenital and genetic defects. The major focus is on basic research using a variety of vertebrate and invertebrate model systems to elucidate the biochemical, molecular, genetic, and cellular mechanisms of gene expression, early embryonic development, limb development, chondrogenesis, myogenesis, neurologic development, teratogenesis, immunologic development, and maternal/fetal immunologic interaction. Priority will be accorded to small grants for research methodology/technology development, collection of preliminary data for the development of more comprehensive research projects, and innovative and high risk/high impact pilot feasibility studies. Endocrinology, Nutrition and Growth Branch Gilman Grave, M.D. Building 61E, Room 4B11 MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5593 FAX: (301) 402-2085 E-Mail: GraveG@hd01.nichd.nih.gov The Endocrinology, Nutrition and Growth (ENG) Branch supports research on nervous system development; biobehavioral development; somatic growth and development; developmental nutrition; diagnosis, treatment, and prevention of developmental abnormalities; and pre- and postnatal infection. The ENG Branch is interested in supporting R03 applications from investigators who have not previously held an NIH research grant (R01 or R29), particularly investigators who are receiving or have received NIH support through career development mechanisms such as K08 awards or New Program Development funds of the Child Health Research Centers. Human Learning and Behavior Branch Norman Krasnegor, Ph.D. Building 61E, Room 4B05 MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-6591 FAX: (301)402-2085 E-Mail: KrasnegN@hd01.nichd.nih.gov The Human Learning and Behavior (HLB) Branch supports research in behavioral pediatrics, risk taking, developmental psychobiology, learning and cognition (learning disability), speech, language and communication, social and emotional development, and AIDS. The Branch encourages studies designed to gather pilot data. Applications >From new investigators are particularly welcomed. Mental Retardation and Developmental Disabilities Branch Felix de la Cruz, M.D. Building 61E, Room 4B09 MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1383 FAX: (301) 496-3791 E-Mail: CruzF@hd01.nichd.nih.gov The Mental Retardation and Developmental Disabilities (MRDD) Branch supports research concerned with the prevention, treatment, and amelioration of mental retardation and related developmental disabilities. Its activities include the full range of biomedical, behavioral, social, and family research on the etiology, pathophysiology, diagnosis, epidemiology, treatment, and assessment of MRDD. The MRDD Branch is interested in small grants of any type, including pilot projects, feasibility studies, applications from new investigators, and high risk/high impact research. Pediatric, Adolescent and Maternal AIDS Branch Anne Willoughby, M.D. Building 61E, Room 4B11 MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-7339 FAX: (301) 496-8678 E-Mail: WillougA@hd01.nichd.nih.gov The Pediatric, Adolescent and Maternal AIDS (PAMA) Branch will support small grants for the study of the natural history, epidemiology, pathogenesis, and treatment of infection with the human immunodeficiency virus (HIV) in women, pregnant women, fetuses, infants, children, and adolescents. The PAMA Branch is interested in small grants of any type, including pilot projects, feasibility studies, and high risk/high impact research. Pregnancy and Perinatology Branch Scott Andres, Ph.D. Building 61E, 4B03 MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5575 FAX: (301) 496-3790 E-Mail: AndresS@hd01.nichd.nih.gov The Pregnancy and Perinatology (PP) Branch is interested in supporting small grants of any type in the following scientific areas: high risk pregnancy; fetal pathophysiology; premature labor and birth; disorders of the newborn; and Sudden Infant Death syndrome. NATIONAL CENTER FOR MEDICAL REHABILITATION RESEARCH Applied Rehabilitation Medicine Research Branch Louis Quatrano, Ph.D. Building 61E, Room 2A03 MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 FAX: (301) 402-0832 E-Mail: QuatranL@hd01.nichd.nih.gov The Applied Rehabilitation Medicine Research (ARMR) Branch funds research that provides a scientific basis for the development of new treatments and technologies designed to improve the health of persons with disabilities. The ARMR small grant program is intended to provide support for pilot projects, testing of new techniques, and innovative or high risk projects which could provide a basis for more extended medical rehabilitation research. Basic Rehabilitation Medicine Research Branch Danuta Krotoski, Ph.D. Building 61E, Room 2A03 MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 FAX: (301)402-0832 E-Mail: KrotoskD@hd01.nichd.nih.gov The Basic Rehabilitation Medicine Research (BRMR) Branch supports basic and clinical research to provide a strong scientific basis on which to develop effective medical rehabilitation interventions. The BRMR Branch is interested in supporting pilot projects in the neurosciences, particularly neural plasticity and regeneration in the chronically injured nervous system, as well as studies in biomaterial development, fundamental and clinical studies on wound healing, and physiological and pharmacological interventions designed to improve mobility. The Branch also has a strong commitment to enhancing the health and quality of life of women and children with disabilities, and seeks small grant applications in these areas. Innovative, high-risk studies are encouraged. Direct inquiries regarding fiscal matters to: GRANTS MANAGEMENT BRANCH Maternal and Child Health Research Grants Management Section Douglas Shawver Building 61E, Room 8A17 MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (301) 402-0915 E-Mail: ShawverD@hd01.nichd.nih.gov Population Research Grants Management Section Melinda Nelson Building 61E, Room 8A17 MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5481 FAX: (301) 402-0915 E-Mail: NelsonM@hd01.nichd.nih.gov National Center for Medical Rehabilitation Research Section Mary Ellen Colvin Building 61E, Room 8A17 MSC-7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (301) 402-0915 E-Mail: ColvinM@hd01.nichd.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.3. 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 Sun Feb 18 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-96-007 - V25(04) 02/16/96 Date: 19 Feb 1996 14:41:30 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 400 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4gauaq$tl@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA96007 CA-96-007 P1O1 *************************************** MINORITY ENHANCEMENT AWARDS NIH GUIDE, Volume 25, Number 4, February 16, 1996 RFA: CA-96-007 P.T. 34, FF; K.W. 0715035, 0745027, 0795003 National Cancer Institute Letter of Intent Receipt Date: March 20, 1996 Application Receipt Date: May 14, 1996 PURPOSE The Comprehensive Minority Biomedical Program (CMBP), Division of Extramural Activities (DEA), National Cancer Institute (NCI), invites research grant applications from interested investigators with access to large or predominantly minority populations to promote minority group participation in cancer research with a special focus on cancer control research. Support provided by this initiative would broaden the operational base of each institution by: 1. Expanding cancer control and prevention efforts in early detection, prevention, screening, pre-treatment evaluation, treatment, continuation care, and rehabilitation; 2. Increasing the involvement of minority population primary care providers early in the course of clinical treatment research; 3. Promoting the involvement in treatment research at the institutional level with a focus on the development of treatment protocols for cancers that have a high incidence in minorities; 4. Supporting programs involving diet and nutrition cancer control research activities; 5. Coordinating the contributions of investigators from various relevant disciplines, psychology and nutrition; and 6. Promoting the inclusion of minority individuals at all levels in the conduct of the research with the increased recruitment of minority scientists into the research base of the institution as an expected outcome. 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), Minority Enhancement Awards, 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) 783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local government, and eligible agencies of the federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Institutions are eligible if they can demonstrate the following: 1. Broad research capabilities in cancer prevention, cancer control and cancer treatment as evidenced by significant research support in these areas. This would include past and current examples of ability to design and implement strong clinical trials research programs. 2. An organizational infrastructure that promotes and sustains a strong interdisciplinary, interactive cancer research environment which links basic research effectively to research in patient and population settings (e.g., NCI-designated Comprehensive Cancer Centers); the dissemination of information to minorities about cancer and its prevention; investigations of patient perspectives of cancer risks; the design and evaluation of interventions to minimize and control distress of minority patients with cancer; the development of pilot studies for minority clinical prevention trials; and psychosocial studies and perception of cancer risk in minorities. 3. Clear access to large numbers of minorities who are representative of the minority populations in the communities and/or regions associated with the institution. 4. Demonstrated capability to work with minority populations in a research setting within communities and/or regions. Applicants who do not adequately meet the above eligibility requirements of this initiative may have their applications returned. Thus, the NCI strongly encourages applicants to communicate with the appropriate NCI program official before submitting a letter of intent (see INQUIRIES section). MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed three years. The anticipated award date is September 30, 1996. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Funding in the amount of $1,600,000 in total costs has been set aside for the first year to specifically fund applications which are submitted in response to this RFA. It is anticipated that six awards will be made. This funding level is dependent on the receipt of sufficient number of applications of high scientific merit. The total project period for applications submitted in response to the present RFA may not exceed three years. The earliest feasible start date for the initial awards will be September 30, 1996. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The NCI is committed to reducing the cancer mortality disparity between disadvantaged populations, which include African Americans, Hispanics and Native Americans, and the general population. One approach to achieving this objective is through the NCI DEA CMBP, which is committed to providing support to institutions for increasing their efforts to broaden minority involvement in programs developing the latest and most effective measures in cancer prevention, cancer control, and clinical treatment research. One primary goal is the delivery of state-of-the-art cancer prevention and control as well as treatment modalities to underserved and minority populations. Cancer survival statistics verify that certain segments of the population, African Americans for example, have substantially lower cancer survival rates than that of American Whites with the same disease. By targeting minority populations with the highest mortality in different regions of the country, it is hoped that this initiative will have significant impact on minority population cancer survival. This initiative is to encourage institutions to develop research programs in cancer prevention, cancer control and cancer treatment that will specifically benefit minority populations. General research objectives within the scope of this initiative include, but are not limited to, studies of smoking behavior in minority youth; studies of communication strategies for presenting information to minorities about cancer and its prevention; investigations of patient perspectives of cancer risks; the design and evaluation of interventions to minimize and control distress of minority patients with cancer; the development of pilot studies for minority clinical prevention trials; and psychosocial studies and perception of cancer risk in minorities. Specific research strategies include: 1. Targeting and facilitating the involvement of minority populations in cancer control research. 2. Investigating the impact of cancer therapy and control advances on minorities in community medical practice settings 3. Increasing the involvement of minority primary health care providers and other specialists in treatment and other cancer control research, thereby providing both educational opportunities for health providers and facilitating exchange of information about current advances in cancer control research. 4. Increasing the number of underserved patients entered into clinical cancer treatment protocols. 5. Delivery of state-of-the-art cancer treatment to underserved minority populations. 6. Significantly impacting minority population cancer treatment and survival. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492 B 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. Investigators proposing research involving human subjects should read the "NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508- 14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit by March 20, 1996 a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NCI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Lemuel Evans, Ph.D. Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 620 - MSC 7405 Bethesda, MD 20892-7405 Telephone: (301) 496-7344 FAX: (301) 402-4551 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 Grants Information Office, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: girg@drgpo.drg.nih.gov; and from the NCI Information Office listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (U. S. Postal Service) Bethesda, MD 20817 (express/courier service) At the time of submission, two additional copies of the application must be sent to: Ms. Toby Freidberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Suite 636 6130 Executive Boulevard - MSC 7405 Bethesda, MD 20892-7405 (U. S. Postal Service) Rockville, MD 20852 (express/courier service) Applications must be received by May 14, 1996. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness by the NCI Program Staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. 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 NCI in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. REVIEW CRITERIA o Extent to which the proposed research plan addresses the goals and objectives of the RFA; o Scientific, technical, or medical significance and originality of proposed research; o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o Availability of the resources necessary to perform the research; and o Appropriateness of the proposed budget and duration in relation to the proposed research. o Adequacy of plans to include both genders and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA The earliest anticipated date of award is September 30, 1996. The following will be considered for making funding decisions: o quality of the proposed research project as determined by peer review o availability of funds o program balance among research areas o geographical distribution of awards INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Lemuel Evans, Ph.D. Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 620 6130 Executive Boulevard - MSC 7405 Bethesda, MD 20892-7405 Telephone: (301) 496-7344 FAX: (301) 402-4551 Email: evansl@dea.nci.nih.gov Direct inquiries regarding fiscal matters to: Ms. Joan Metcalfe Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard - MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, Extension 228 FAX: (301) 496-8601 Email: MetcalfJ@gab.nci.nih.gov AUTHORIZATION AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.3 99. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78- 410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR part 52 and 45 CFR part 74 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 Sun Feb 18 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 18 February 1996 Date: 19 Feb 1996 15:00:15 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 84 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4gavdv$2s4@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Program Guideline Title: NSF 96-45 NSF/EPA Partnership for Environmental Research File size (bytes): 49313 STIS Filename: nsf9645.txt Document Type: Report Title: Number 13--NSF OIG Semiannual Report to the Congress File size (bytes): STIS Filename: oig13.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 9599 STIS Filename: cmmtg.txt Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 113616 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 123950 STIS Filename: phnorg.txt Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 45889 STIS Filename: sesvac.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve sesvac.txt, the text of your message should be as follows: get sesvac.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve sesvac.txt, you would enter: ftp> get sesvac.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Sun Feb 18 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-96-001 - V25(04) 02/16/96 - P1/2 Date: 19 Feb 1996 14:55:06 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1499 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4gav4a$2d0@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AI96001 AI-96-001 P1O2 *************************************** PEDIATRIC AIDS CLINICAL TRIALS GROUP NIH GUIDE, Volume 25, Number 4, February 16, 1996 RFA: AI-96-001 P.T. 34; K.W. 0755015, 0715008, 0770005 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: March 27, 1996 Application Receipt Date: June 11, 1996 PURPOSE The Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) announces the availability of a Request for Applications (RFA) to establish a multisite Pediatric AIDS Clinical Trials Group (PACTG). The purpose of this RFA is to solicit applications from institutions interested in participating in a cooperative group to plan, direct, and conduct Phase I, II, and III clinical trials. These clinical trials will address high priority research questions on the treatment and prevention of human immunodeficiency virus (HIV) disease and its sequelae. The focus will be on: (1) treatment of primary HIV disease, (2) interventions designed to prevent perinatal transmission of HIV, and (3) prophylaxis and treatment of opportunistic infections. Modalities of intervention may include, but are not limited to: (1) drugs or combinations, (2) active and/or passive immune based therapies, (3) immunomodulators, and (4) gene transfer techniques. The initiative targets HIV infected and perinatally exposed infants, HIV infected children, HIV infected pregnant women at risk of transmitting HIV to the infant, and HIV infected adolescents, when therapeutic research questions specific for this age group are identified. 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, Pediatric AIDS Clinical Trials Group, relates to the priority area of pediatric HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic institutions, public and private organizations (for-profit and non- profit), such as universities, colleges, hospitals, laboratories, units of State and local government, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Racial/ethnic minorities, women, and persons with disabilities are encouraged to apply. The PACTG will consist of: (1) ONE COORDINATING AND OPERATIONS CENTER (CORC), (2) 18-25 PEDIATRIC AIDS CLINICAL TRIALS UNITS (PACTUS), and (3) ONE STATISTICAL AND DATA MANAGEMENT CENTER (SDMC). Applicants applying for more than one award must submit a separate application for each category. Each applicant for a CORC award is responsible for identifying, in the body of the application, the SDMC with which it proposes to work and must coordinate the preparation of the application with them. Accordingly, each applicant for the SDMC award is expected to identify the CORC applicant with which it plans to work and must ensure that the applications are coordinated. Each applicant for a PACTU award must identify, in a cover letter and in the body of the application, the CORC with which it proposes to collaborate. PACTU applicants must be able to meet the minimum annual recruitment standards as described in this RFA under "C. APPLICATION PREPARATION; 2. Pediatric AIDS Clinical Trials Unit Application; Accrual Potential." Each CORC applicant should demonstrate the capability to develop and manage a comprehensive multicenter research program comprising a comprehensive research agenda, scientific and managerial leadership, laboratories to support the research agenda, organizational and governance structure, and an Operations Office. Upon the formation of the PACTG, the group will annually accrue 200 or more HIV positive (HIV+) children who have not been previously enrolled on PACTG protocols and 300 HIV+ pregnant women. This enrollment is exclusive of the subjects accrued to pediatric and perinatal clinical trials funded by the National Institute of Child Health and Human Development (NICHD). NICHD-funded institutions participate, at all levels, in the collaborating group of institutions comprising the PACTG. It is anticipated that the NICHD sites will contribute an additional 100 HIV+ children who have not been previously enrolled on PACTG protocols and an additional 150 HIV+ pregnant women. MECHANISM OF SUPPORT The administrative and funding instrument to be used for these awards will be the cooperative agreement (U01). The cooperative agreement is an assistance mechanism in which substantial NIAID scientific and programmatic involvement is anticipated during performance of the activity. Under the cooperative agreement, the NIAID's purpose is to support and encourage the recipients' activities by working jointly with the awardees in a partner role, but not to assume direction, prime responsibility, or dominance. Details of the responsibilities, relationships, and governance of the studies to be funded are described under the section entitled, SPECIAL REQUIREMENTS, "Terms and Conditions of Award." The total project period for each award may not exceed four years. The anticipated award date is March 1, 1997. It is anticipated that the award for the CORC will be approximately $ 5,000,000 to 8,000,000 total costs per year. The awards for the PACTUs will be approximately $ 18,000,000 to 21,000,000 total costs per year for 18-25 PACTUs; and the Statistical and Data Management Center award will be approximately $ 3,000,000 to 5,000,000 total costs per year. Because the nature and scope of the research proposed in response to this initiative may vary, it is anticipated that the size of individual awards will vary. This RFA is a renewal of the ongoing PACTG Program. Reissuance of this RFA is uncertain. If it is determined that there is sufficient programmatic need for continuing, the NIAID will invite applications for competitive renewal of this program. FUNDS AVAILABLE The NIAID plans to fund one CORC, 18 to 25 PACTUs, and one SDMC. Approximately $30,000,000 total costs is expected to be available for the first year of support under this RFA. The number of awards to be made is dependent on the receipt of a sufficient number of applications of high scientific merit and the availability of funds. Funding beyond the level awarded in the first year will be contingent upon the continued availability of funds for this purpose and the continued progress of the PACTG. RESEARCH OBJECTIVES A. Background HIV disease is now the seventh leading cause of death in the United States (U.S.) for children between one and fourteen years of age. Approximately 6500 HIV+ women deliver children annually in the U.S., and currently 1000-2000 of these children will be infected with HIV. The World Health Organization estimates that by the year 2000, approximately 10,000,000 children worldwide will have been infected with HIV, nearly all by perinatal transmission of the virus. The HIV epidemic in children follows the epidemic in women. It is a major health problem in urban centers where an increasing number of racial/ethnic minorities, women, and injection drug users are being infected. In addition, the epidemic is growing in rural areas where access to appropriate health care and research protocols is extremely difficult because of logistical problems. The goal of NIAID's research on pediatric HIV disease is to identify and support the development of improved interventions to prevent and treat HIV infection and its sequelae in infants, children, and adolescents. Considerable progress has been made in initial therapy of HIV disease with antiretrovirals, prophylaxis of Pneumocystis carinii pneumonia (PCP), and the dramatic reduction in the risk of perinatal transmission of HIV achieved by the administration of the ACTG Protocol 076 regimen. [Note: This regimen is the current standard of care, using zidovudine (ZDV) for the prevention of perinatal transmission.] Current antiretroviral regimens produce short-term improvements in quality of life, but little improvement in survival. The development of resistance results in current regimens becoming ineffective. Therapy for many common opportunistic infections requires the use of multiple drugs, many of which are toxic or only available for parenteral use. Many drugs in use or under investigation for adults are not available in a pediatric formulation, and the current available regimen for prevention of perinatal transmission is expensive, difficult to administer, and not completely effective. The relatively small number of newly infected HIV+ children in the U.S. imposes limitations on the design and conduct of clinical trials in this country. For example, a Phase III efficacy trial of antiretroviral agents might require 800 subjects, which is about one half the annual number of new pediatric cases projected by the Centers for Disease Control and Prevention. As the ACTG Protocol 076 and other preventive regimens become routinely used, this number could fall to approximately 600 new cases per year. Therefore, because of this possible decrease in numbers, pediatric clinical trials must be carefully designed and targeted to address high priority questions with the potential for major gains in therapeutic effect. Similarly, it is important to design these trials to obtain the maximum information about mechanisms of action and disease pathogenesis. Successful conduct of such trials requires the efforts of a large multicenter clinical trials organization. Limitations on the number of HIV+ pregnant women lead to similar conclusions with regard to trials designed to prevent perinatal transmission of HIV. B. Definitions Advanced Technology Laboratory (ATL) - The ATLs are central laboratories that enable the PACTG to implement state-of-the-art assays and technologies that are essential for the completion of the scientific agenda, as defined in the PACTG CORC Application. In addition to the performance of these assays for the group, these laboratories may investigate the feasibility, validity, and standardization of the assays and techniques. The ATLs are not intended to conduct basic research directed at finding new assays. Awards for ATLs will be made through the PACTG CORC and will provide support for protocol related studies only. Collaborating Institution - A collaborating institution of the PACTG may be either the CORC, the Statistical and Data Management Center, or a PACTU. Cooperative Agreement - A cooperative agreement is an assistance mechanism in which substantial NIAID programmatic involvement with the recipient is anticipated during performance of the planned activity. Coordinating and Operations Center (CORC) - The CORC is the central group, consisting of the Group leadership (Group Leader and Executive/Steering Committee) and Operations Office. This group coordinates all aspects of the PACTG and has oversight for the ATLs. Data and Safety Monitoring Board (DSMB) - The DSMB is an independent group of experts established by NIAID and charged with the responsibility of monitoring the progress of trials, the safety of participants, and the efficacy of treatments being tested. The DSMB also makes recommendations to NIAID concerning continuation, termination or modification of the trials based on observed beneficial or adverse effects of any of the interventions under study. This panel is funded separately by NIAID. Division of AIDS (DAIDS) - The Division within the NIAID that has the primary responsibility for basic and clinical research on HIV/AIDS. Executive/Steering Committee - The Executive/Steering Committee, established and chaired by the Group Leader, represents the main governing body of the PACTG. This committee will be responsible for the conduct and overall activities of the PACTG. (Refer to "SPECIAL REQUIREMENTS; B. Awardee Rights and Responsibilities" in the RFA.) Group Leader - The Group Leader is responsible for the leadership and coordination of all PACTG activities both scientifically and administratively, and serves as the Principal Investigator for the CORC award. The Group Leader may also be associated with a PACTU. NICHD Site - NICHD sites are funded by the National Institute of Child Health and Human Development to conduct AIDS clinical trials research in children and pregnant women. These institutions participate, at all levels, in the collaborating group of institutions comprising the PACTG. The NICHD sites and investigators are selected, funded, monitored, and evaluated by NICHD or its contractor. Operations Office - The Operations Office is a unit within the CORC that will take responsibility for coordinating PACTG administrative activities. Participant Subunit - A subunit is an institution supported under the fiscal and managerial umbrella of a PACTU. Subunits may be established to support the scientific agenda and/or accrual goals. All subunits are subject to the same policies and procedures mandated by Federal regulations, DAIDS and NIAID policies, and the bylaws of the PACTG. Pediatric AIDS Clinical Trials Group (PACTG) - The PACTG is a collaborative network of institutions comprised of the CORC, PACTUs, and the SDMC. This group conducts all phases of clinical trials and laboratory studies. The PACTG consists of experienced investigators in multiple disciplines (e.g., pediatrics, infectious diseases, virology, immunology, clinical pharmacology, neurology, neuropsychology, obstetrics and gynecology, and biostatistics). Clinical investigators and sites supported by the NICHD will participate in the PACTG under an agreement between NICHD and NIAID. Pediatric AIDS Clinical Trials Unit (PACTU) - A PACTU is a clinical site that is a member of the collaborating group of institutions comprising the PACTG. A PACTU may be organized as a main clinical site or a main site and several subunits under the leadership of one Principal Investigator. Statistical and Data Management Center (SDMC) - The SDMC is the component of the PACTG that is responsible to the Group leadership for the statistical aspects of study design and analysis and management of the PACTG database. Therapeutics Research Program (TRP) - The TRP is a program within the DAIDS that is responsible for the scientific, administrative, and operational management of clinical therapeutic research programs funded by the Division. C. Research Goals and Scope The primary goals of the PACTG are to evaluate in Phase I, II, and III clinical trials: 1) innovative interventions for the prevention of perinatal transmission of HIV, and 2) innovative therapeutic strategies and interventions for HIV infection and its complications in infants and children. The structure for the group, as defined in this RFA, is intended to strengthen coordination between the PACTG research agenda and understanding in the basic sciences in order to increase understanding of the pathogenesis and complications of pediatric HIV disease and perinatal transmission. This structure will also allow the PACTG to exploit the most recent developments in the biology of HIV and its transmission, and to develop more effective treatments and interventions while enhancing knowledge of the pathogenesis of HIV disease, its complications, and its transmission. The NIAID HIV/AIDS Research Agenda comprehensively documents the Institute's major scientific programs, priorities, and plans in the following scientific areas: pathogenesis, epidemiology and natural history, therapeutics research and development, vaccine research and development, and pediatric disease. The agenda forms the basis for NIAID's scientific planning, program management and evaluation, and communications about the scope and nature of NIAID's efforts in HIV research. The PACTG will play a crucial role in helping to fulfill the goals and priorities delineated in the Pediatric Section of the NIAID's HIV/AIDS Research Agenda. For this reason, it is important that the PACTG identify (by gender and minority status for individuals who choose to be identified) its leadership, advisory boards, and committees. The PACTG will focus on those parts of the Pediatric Section related to the treatment and prevention of pediatric HIV and its complications. Copies of the Pediatric Section of the NIAID HIV/AIDS Research Agenda are available from program staff listed under INQUIRIES. The Group Leadership will identify the highest priority research questions from the major therapeutic areas, and develop a comprehensive clinical trials agenda consistent with the NIAID HIV/AIDS Pediatric Research Agenda. The PACTG will be responsible for developing a prioritized plan to address the research questions in the NIAID HIV/AIDS Research Agenda. Specific areas of the NIAID HIV/AIDS Research Agenda are summarized below: Prevention of Perinatal Transmission of HIV - Nearly all new cases of pediatric HIV infection are due to perinatal transmission. The ZDV regimen developed by the PACTG in ACTG Protocol 076 has demonstrated that perinatal transmission of HIV can be significantly reduced. Additional ongoing trials are investigating the use of HIV hyperimmune globulin (HIVIG) and other agents. Because the ZDV regimen from ACTG Protocol 076 is complex, costly, and likely to be ineffective in patients with resistant HIV, there is a need to develop shorter, more effective, and less expensive regimens. Insights into the mechanisms and biology of perinatal transmission of HIV are emerging from ongoing natural history studies and will be developed as ACTG Protocol 076 comes to a close. These insights should permit the rational design of new regimens. These regimens may involve more effective combinations of antiretroviral agents, passive and/or active immunotherapy, and obstetrical interventions or combinations of the above. Specific goals should include the following: 1. Development of new antiretroviral agents, or combinations of agents, and other modalities for prevention of perinatal transmission (including all necessary Phase I and Phase II trials) in pregnant women and infants for the rational design of efficacy regimens. Recognizing the international nature of the problem, and the limited capacity in the U.S. for the conduct of multiple efficacy trials, the PACTG might undertake research in Phase I and II trials to initially evaluate regimens which could undergo further evaluation in overseas trials funded through other mechanisms by NIAID or other domestic and foreign agencies. 2. Design and conduct efficacy trials of promising regimens for the prevention of perinatal transmission with the goal of improving upon currently available treatments by simplifying them or increasing efficacy. Increased efficacy, low cost, low potential toxicity, and the potential for worldwide use are desirable characteristics of new regimens. 3. Design clinical intervention trials in perinatal transmission to provide as much information as possible regarding the biology of transmission as well as the reasons for success or failure of the intervention being studied. 4. When appropriate, conduct long-term follow-up studies of infants born to mothers who participated in perinatal transmission trials to evaluate potential long term adverse consequences of the therapies. Similarly, conduct appropriate studies in women who participated in perinatal transmission trials to evaluate consequences of the therapies. 5. Determine, if possible, clinical and laboratory markers useful for deciding what regimen, if any, is appropriate for pregnant women who are HIV+. This will require careful thought when designing future efficacy trials. Primary Therapy of HIV Disease in Pediatrics - Considerable progress has been made in the development of antiretroviral drugs for the primary therapy of HIV disease in children. ZDV, ddI, ddC, and d4T have all been extensively evaluated in children. Combinations of agents designed to improve efficacy and impair development of resistance are underway. As new agents become available, it is vital t