From owner-sci-resources@net.bio.net Wed Mar 02 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Marvin.Stodolsky@mailgw.er.doe.gov Newsgroups: bionet.announce,bionet.sci-resources Subject: DOE Human Genome Program Announcement - Tech. Advances Date: 3 Mar 1994 10:44:00 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 151 Sender: kristoff@net.bio.net Approved: bionews-moderator@net.bio.net Distribution: bionet Message-ID: NNTP-Posting-Host: net.bio.net Xref: biosci bionet.announce:989 bionet.sci-resources:928 The US Department of Energy's 1994 competition for Research Financial Assistance within the Human Genome Program was announced in the Federal Register, 02/18/94 Vol. 59, No. 034, pages 30-32, Program Notices 94-12: Human Genome Program-Technological Advances. The full texts can also be accessed electronically through: anonymous ftp TO oerhp01.er.doe.gov for /genome/9412.txt anonymous ftp TO fedix.fie.com for files /DOE/DOENOTE.TXT or /DOE/DOENOTE.EXE. gopher TO fedix.fie.com telnet TO fedix.fie.com DOENOTE.EXE is the compressed version of DOENOTE.TXT which expands itself on DOS based systems. DOENOTE also contains several other DOE non-genome program notices. Some background information relevant to the Genome program is available by gopher at GOPHER.GDB.ORG ================================================================= Preapplications are due by April 15, 1994 and formal applications by July 14, 1994. Please note that the following addresses are ONLY for the short preapplications: US Mail Express Delivery Services ----------------- ------------------------- David A. Smith David A. Smith attn. Notice 94-12 attn. Notice 94-12 US Dept. of Energy US Dept. of Energy OHER, ER-72 GTN 19901 Germantown Rd. Washington, DC 20585 Germantown, MD 20874 The facsimile number is: (301) 903-8521. with secretary Joann Corcoran at telephone: (301) 903-6488. Internet address: genome@oerhp01.er.doe.gov Email submissions should use ASCII text format (please do NOT send LaTeX, TeX or Postscript files!). Materials for the formal applications will be returned with DOE responses to appropriate preapplications. ================================================================== Department of Energy Human Genome Program Announcement Program Notice 94-12: Human Genome Program-Technological Advances SUMMARY: The Office of Health and Environmental Research (OHER) of the Office of Energy Research (ER), U.S. Department of Energy (DOE), hereby announces its interest in receiving applications in support of the Human Genome Program. This Program is a coordinated, multidisciplinary, goal oriented, research effort aimed at improving technologies that will lead to a detailed understanding of the human genome at the molecular level. Several research goals are encompassed in this notice, with collaborative, multidisciplinary efforts specifically encouraged. Research will be supported for the development of: 1) integrated approaches to large-scale human genome sequencing that may include supportive mapping and automation; 2) cost-effective DNA sequencing systems that promise more than a 10-fold improvement in throughput; 3) software and resources for real-time analysis and annotation of data from high-speed DNA sequencing systems; (4) resources for facile entry and retrieval of data in community genome maps and DNA sequence databases, including coordinated entry or retrieval across multiple, complementary databases. PREAPPLICATIONS: Potential applicants are strongly encouraged to submit a brief preapplication that consists of two to three pages of narrative describing the research project objectives and methods of accomplishment. These will be reviewed relative to the scope and research needs of the DOE's Human Genome Program. Preapplications referencing Program Notice 94-12 should be received by April 15, 1994, and sent to Dr. David A. Smith, Office of Health and Environmental Research, ER-72 (GTN), Wash- ington, D.C. 20585. Telephone and FAX numbers are required parts of the preapplication and electronic mail addresses are desirable. A response to the preapplications discussing the potential program relevance of a formal application generally will be communicated within 30 days of receipt. FORMAL APPLICATION DATES: Formal applications submitted in response to this notice must be received by 4:30 p.m., E.D.T., July 14, 1994, to be accepted for merit review in September 1994, and to permit timely consideration for award in Fiscal Year 1995. ADDRESS: Formal applications referencing Program Notice 94-12 should be forwarded to: U.S. Department of Energy, Office of Energy Research, Acquisition and Assistance Management Division, ER-64 (GTN), Washington, D.C. 20585, ATTN: Program Notice 94-12. The following address must be used when submitting applications by U.S. Postal Service Express Mail or any commercial mail delivery service, or when handcarried by the applicant: U.S. Department of Energy, Office of Energy Research, Acquisition and Assistance Management Division, ER-64, 19901 Germantown Road, Germantown, MD 20874. SUPPLEMENTARY INFORMATION: It is anticipated that approximately $5,000,000 will be available for grant awards during FY 1995, 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 $79,000 per year up to $1,000,000 per year with terms from one to three years. Most awards are in the $200,000 to $400,000 per year range for three years. Similar award sizes are anticipated for new grants. Information on the development and submission of applications, eligibility, limitations, evaluation, selection process, and other policies and procedures may be found in the Application Guide for the Office of Energy Research Financial Assistance Program and 10 CFR Part 605. 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 (GTN), Washington, D.C. 20585. Telephone requests may be made by calling (301) 903-6488. 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" (51 FR 16958, May 7, 1986), 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 Human Genome Program. The OHER requires the timely sharing of resources and data. Applicants should, in their applications, discuss their plans for disseminating research data and materials that may include, where appropriate, putting cell lines, probes, sequence data, software, etc., into public repositories. 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 materials or submitting data to repositories are allowable; however, such requests must be adequately justified. Applicants should also provide timelines projecting progress toward achieving proposed goals. FOR FURTHER INFORMATION CONTACT: Dr. David A. Smith, Office of Health and Environmental Research, ER-72 (GTN), Office of Energy Research, U.S. Department of Energy, Washington, D.C. 20585, (301) 903-6488. FROM: The Federal Register, Friday, February 18, 1994, Vol. 59, No. 034, pages 30-32, 59 FR 8183 "Energy Research Financial Assistance Program Notice 94-12: Human Genome Program-Technological Advances" From owner-sci-resources@net.bio.net Wed Mar 02 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Marvin.Stodolsky@mailgw.er.doe.gov Newsgroups: bionet.announce,bionet.sci-resources Subject: DOE Human Genome Program Announcement - ELSI Date: 3 Mar 1994 10:44:05 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 174 Sender: kristoff@net.bio.net Approved: bionews-moderator@net.bio.net Distribution: bionet Message-ID: NNTP-Posting-Host: net.bio.net Xref: biosci bionet.announce:990 bionet.sci-resources:929 The US Department of Energy's 1994 competition for Research Financial Assistance within the Human Genome Program was announced in the Federal Register, 02/18/94 Vol. 59, No. 034, pages 32-34, Program Notices 94-13: Human Genome - Ethical, Legal, and Social Implications. The full texts can also be accessed electronically through: anonymous ftp TO oerhp01.er.doe.gov for /genome/9413.txt anonymous ftp TO fedix.fie.com for files /DOE/DOENOTE.TXT or /DOE/DOENOTE.EXE. gopher TO fedix.fie.com telnet TO fedix.fie.com DOENOTE.EXE is the compressed version of DOENOTE.TXT which expands itself on DOS based systems. DOENOTE also contains several other DOE non-genome program notices. Some background information relevant to the Genome program is available by gopher at GOPHER.GDB.ORG ================================================================= Preapplications are due by April 15, 1994 and formal applications by July 14, 1994. Related telephone queries should be made to Daniel W. Drell at 301/903-4742. Please note that the following addresses are ONLY for the short preapplications: US Mail Express Delivery Services ----------------- ------------------------- Daniel W. Drell Daniel W. Drell attn. Notice 94-12 attn. Notice 94-12 US Dept. of Energy US Dept. of Energy OHER, ER-72 GTN 19901 Germantown Rd. Washington, DC 20585 Germantown, MD 20874 The facsimile number is: (301) 903-8521. with secretary Joann Corcoran at telephone: (301) 903-6488. Internet address: Daniel.Drell@mailgw.er.doe.gov Email submissions should use ASCII text format (please do NOT send LaTeX, TeX or Postscript files!). Materials for the formal applications will be returned with responses to relevant preapplications. ============================================================= DOE HUMAN GENOME PROGRAM ANNOUNCEMENT Notice 94-13: Human Genome Program- Ethical, Legal, and Social Implications SUMMARY: The Office of Health and Environmental Research (OHER) of the Office of Energy Research (ER), U.S. Department of Energy (DOE), hereby announces its interest in receiving applications in support of the Ethical, Legal, and Social Implications (ELSI) subprogram of the Human Genome Program (HGP). The HGP is a coordinated, multidisciplinary, goal-oriented, research effort aimed at improving technologies that will lead to 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. The DOE especially encourages the submission of applications to conduct multidisciplinary, empirical research on privacy issues from the creation, use, maintenance, and disclosure of genetic information. This may include (but is not limited to) issues of ownership 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 exploration of issues associated with the ethical, legal, and social implications of the knowledge gained from the HGP. All applications should include, where appropriate, detailed discussion of human subjects protection issues; e.g., storage of, manipulation of, and access to data. Where survey techniques are proposed, 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. The DOE is also soliciting applications for the preparation and dissemination of educational materials in any appropriate medium that will enhance public understanding of both the scientific aspects and the ethical, legal, and social aspects of the HGP. In addition, the DOE is encouraging applications for the support of conferences focusing on specific issues or areas of concern related to the ethical, legal, and social implications of the HGP. Educational and conference applications should also demonstrate awareness of the relevant literature, and include detailed plans for the accomplishment of project goals, including, where appropriate, video productions. In the case of educational {pg 8185} activities, the DOE strongly recommends inclusion of assessments of effectiveness of the proposed activities. In the case of all conferences, a fairly detailed and complete roster of committed 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. PREAPPLICATIONS: Potential applicants are strongly encouraged to submit a brief preapplication that consists of two to three pages of narrative describing the research project objectives and methods of accomplishment. These will be reviewed relative to the scope and research needs of the DOE's Human Genome Program. Preapplications referencing Program Notice 94-13 should be received by April 15, 1994, and sent to Dr. Daniel W. Drell, Office of Health and Environmental Research, ER-72 (GTN), Washington, DC 20585. Telephone and FAX numbers are required parts of the preapplication, and electronic mail addresses are desirable. A response to the preapplications discussing the potential program relevance of a formal application generally will be communicated within 30 days of receipt. SUPPLEMENTAL INFORMATION It is anticipated that approximately $1,000,000 will be available for grant awards in this area during FY 1995, 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 $60,000 per year up to $500,000 per year with terms from one to three 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 the Application Guide for the Office of Energy Research Financial Assistance Program and 10 CFR part 605. 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 (GTN), Washington, DC 20585. Telephone requests may be made by calling (301) 903-6488. The dissemination of materials and research data in a timely manner is essential for progress towards the goals of the DOE Human Genome Program. 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. DATES: Formal applications submitted in response to this notice must be received by 4:30 p.m., e.d.t., July 14, 1994, to be accepted for merit review in September 1994, and to permit timely consideration for award in Fiscal Year 1995. ADDRESSES: Formal applications referencing Program Notice 94-13 should be forwarded to: U.S. Department of Energy, Office of Energy Research, Acquisition and Assistance Management Division, ER-64 (GTN), Washington, DC 20585, ATTN: Program Notice 94-13. The following address must be used when submitting applications by U.S. Postal Service Express Mail or any commercial mail delivery service, or when handcarried by the applicant: U.S. Department of Energy, Office of Energy Research, Acquisition and Assistance Management Division, ER-64, 19901 Germantown Road, Germantown, MD 20874. FOR FURTHER INFORMATION CONTACT: Dr. Daniel W. Drell, Office of Health and Environmental Research, ER-72 (GTN), Office of Energy Research, U.S. Department of Energy, Washington, DC 20585, (301) 903-6488. From: Federal Register, Friday, February 18, 1994, Vol. 59, No. 034, 59 FR 8184. "Energy Research Financial Assistance Program Notice 94-13: Human Genome Program-Ethical, Legal, and Social Implications" From owner-sci-resources@net.bio.net Thu Mar 10 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 6 March 1994 Date: 10 Mar 1994 18:31:46 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 160 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2lol6i$jju@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: NSF Bulletin March Vol 21; No. 7 File size (bytes): 38610 STIS Filename: bul9403 Document Type: Form Title: NSF Form 98A1 - Final Project Report File size (bytes): 994 STIS Filename: fm98a1 Also available: fm98a1.ps Title: NSF Form 98A2 - Final Project Report File size (bytes): 994 STIS Filename: fm98a2 Also available: fm98a2.ps Title: NSF Form 98A3 - Final Project Report File size (bytes): 994 STIS Filename: fm98a3 Also available: fm98a3.ps Title: NSF 94-3 - Grant Proposal Guide Forms Kit File size (bytes): 1277 STIS Filename: nsf943 Also available: nsf943.zip Document Type: Letter Title: Federal SBIR Conference - Houston, File size (bytes): 2091 STIS Filename: lsbi9401 Document Type: Press Release Title: PRELIMINARY CLUES ABOUT ELECTRICAL FIELDS' IMPACT ON CELLS File size (bytes): 2695 STIS Filename: pr943 Title: NSF-SUPPORTED RESEARCH RESULTS PRESENTED AT SAN DIEGO OCEAN SCIENCES MEETING File size (bytes): 7412 STIS Filename: pr945 Title: VERMONT TO RECEIVE THREE-YEAR EPSCoR AWARD TO STRENGTHEN RESEARCH EFFORTS File size (bytes): 3792 STIS Filename: pr946 Title: NSB GIVES GREEN LIGHT TO NSFNET'S NEXT STEPS- NEW ARCHITECTURE AND A CUTTING-EDGE NETWORK File size (bytes): 6425 STIS Filename: pr948 Document Type: Program Guideline Title: NSF 94-23 Combined Research-Curriculum Development Program File size (bytes): 17084 STIS Filename: nsf9423 Title: NSF 94-27--Management of Technological Innovation File size (bytes): 23351 STIS Filename: nsf9427 Title: NSF 94-30 Transformations to Quality Organizations File size (bytes): 23112 STIS Filename: nsf9430 Document Type: Recruit Title: Physical Science Administrator (Program Director) File size (bytes): 4834 STIS Filename: vex9415 Title: Cooperative Education Program (CO-OP) File size (bytes): 4044 STIS Filename: vgs9446 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 1084 STIS Filename: cmpublic Document Type: Letter Title: Current List of REU Sites File size (bytes): 54535 STIS Filename: reulist Title: Current List of REU Sites File size (bytes): 54535 STIS Filename: reulist Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 112839 STIS Filename: phnalpha Title: NSF Organizational Directory File size (bytes): 94725 STIS Filename: phnorg Document Type: Program Guideline Title: NSF 94-29 - Interagency Program Announcement File size (bytes): 14831 STIS Filename: nsf9429 ------------------------------------------------------------------------ ** 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 nsf9429, the text of your message should be as follows: get nsf9429 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9429, you would enter: ftp> get nsf9429 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 Mar 13 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 13 March 1994 Date: 14 Mar 1994 12:42:16 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 194 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2m2i78$rtf@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: Form Title: FM 1207A - GPG Cover Sheet for Proposal to NSF Form 1 of 2 File size (bytes): 773 STIS Filename: fm1207a Also available: fm1207a.ps Title: FM 1207B - GPG Cover Sheet for Proposal to NSF Form 2 of 2 File size (bytes): 773 STIS Filename: fm1207b Also available: fm1207b.ps Title: FM 1207C - GPG Instructions on Certification (1) File size (bytes): 7444 STIS Filename: fm1207c Title: FM 1207D - GPG Instructions for Certification (2) File size (bytes): 4546 STIS Filename: fm1207d Title: FM 1358 - GPG Project Summary File size (bytes): 743 STIS Filename: fm1358 Also available: fm1358.ps Title: FM 1359 - GPG Table of Contents File size (bytes): 745 STIS Filename: fm1359 Also available: fm1359.ps Title: FM 1360 - GPG Project Description File size (bytes): 747 STIS Filename: fm1360 Also available: fm1360.ps Title: FM 1361 - GPG Bibliography File size (bytes): 740 STIS Filename: fm1361 Also available: fm1361.ps Title: FM 1362 - GPG Biographical Sketch File size (bytes): 747 STIS Filename: fm1362 Also available: fm1362.ps Title: FM 1363 - GPG Facilities, Equipment & Other Resources Form File size (bytes): 772 STIS Filename: fm1363 Also available: fm1363.ps Title: PKUnZip Program (ShareWare owned by PKWare, INC) File size (bytes): 492 STIS Filename: pkunzip Also available: pkunzip.exe Title: PKUnZip Program (ShareWare owned by PKWare, INC) File size (bytes): 492 STIS Filename: pkunzip Also available: pkunzip.exe Document Type: General Publication Title: Graduate Research Fellowships - A Directory of Coordinating Officials File size (bytes): 69890 STIS Filename: nsf9424 Also available: nsf9424.wp5 Title: NSF 94-25 Directory of NSF-Supported UFE Projects File size (bytes): 125843 STIS Filename: nsf9425 Document Type: News Title: Tips 40114 Tip Sheet File size (bytes): 4608 STIS Filename: tip40114 Title: Tip40128 Tip Sheet File size (bytes): 10243 STIS Filename: tip40128 Title: TIP40214 Tip Sheet File size (bytes): 7303 STIS Filename: tip40214 Title: tip40225 Tip Sheets File size (bytes): 6302 STIS Filename: tip40225 Document Type: Press Release Title: NSF-SUPPORTED RESEARCHERS REPORT FINDINGS ON EVOLUTION OF CELLS File size (bytes): 4475 STIS Filename: pr9410 Title: RISING SEA LEVEL AND SUBSIDING COASTLINES- A NEW REPORT PROBES "THAT SINKING FEELING!" File size (bytes): 4890 STIS Filename: pr941 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Form Title: FM 1030 - GPG Summary Proposal Budget Form File size (bytes): 756 STIS Filename: fm1030 Also available: fm1030.ps Title: FM 1225 - GPG Information about PI's / PD's File size (bytes): 757 STIS Filename: fm1225 Also available: fm1225.ps Title: FM 1239 - GPG Current and Pending Support File size (bytes): 755 STIS Filename: fm1239 Also available: fm1239.ps Title: FM 1263 - NSF Grant Transfer Request Form File size (bytes): 755 STIS Filename: fm1263 Also available: fm1263.ps Title: FM 1328 - Annual NSF Grant Progress Report Form File size (bytes): 761 STIS Filename: fm1328 Also available: fm1328.ps Document Type: Phone Book Title: NSF Alphabetic Phone Directory File size (bytes): 113272 STIS Filename: phnalpha Title: NSF Organizational Phone Directory File size (bytes): 96684 STIS Filename: phnorg Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 31753 STIS Filename: sesvac ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve sesvac, the text of your message should be as follows: get sesvac Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve sesvac, you would enter: ftp> get sesvac WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Mon Mar 21 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 20 March 1993 Date: 21 Mar 1994 16:42:40 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 131 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2mleu0$c0p@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: Dir of Awards Title: NSF MINORITY GRADUATE FELLOWSHIP PROGRAM FOR FISCAL YEAR 1994 FELLOWSHIP AWARDS File size (bytes): 25930 STIS Filename: gf94mawd Also available: gf94mawd.dlm Title: NSF MINORITY GRADUATE FELLOWSHIP PROGRAM FOR FISCAL YEAR 1994 HONORABLE MENTIONS File size (bytes): 43633 STIS Filename: gf94mhm Also available: gf94mhm.dlm Title: NSF GRADUATE FELLOWSHIP PROGRAM FOR FISCAL YEAR 1994 FELLOWSHIP AWARDS File size (bytes): 159741 STIS Filename: gf94rawd Also available: gf94rawd.dlm Title: NSF GRADUATE FELLOWSHIP PROGRAM FOR FISCAL YEAR 1994 HONORABLE MENTIONS File size (bytes): 252266 STIS Filename: gf94rhm Also available: gf94rhm.dlm Document Type: Press Release Title: FEATURE- SECOND NATIONAL CONFERENCE ON SCIENCE EDUCATION REFORM SEEKS TO BUILD ON SUCCESSES File size (bytes): 9931 STIS Filename: pr9411 Title: NEW REPORT RELEASED-TEN-YEAR REVIEW OF THE NATIONAL SCIENCE FOUNDATION'S LONG-TERM ECOLOGICAL RESEARCH PROGRAM File size (bytes): 5080 STIS Filename: pr9412 Title: EARTHQUAKE HAZARDS IN SOUTHERN CALIFORNIA- IS A LARGER QUAKE ON THE WAY? File size (bytes): 5924 STIS Filename: pr9413 Title: FEATURE-LINGUISTS STRIVE TO DOCUMENT RAPIDLY DISAPPEARING LANGUAGES File size (bytes): 7337 STIS Filename: pr9414 Title: NSF-FUNDED SEARCH GATHERS COMPUTER TECHNOLOGY TO HELP TEACH LEARNING-DISABLED STUDENTS File size (bytes): 4148 STIS Filename: pr9415 Document Type: Recruit Title: Senior Advisor for Planning, Analysis and Policy File size (bytes): 8706 STIS Filename: vep9410 Title: Biologist (Science Assistant) File size (bytes): 3681 STIS Filename: vex9416 Document Type: STIS Title: NSF Organization Codes File size (bytes): 3522 STIS Filename: stisorgs ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 2522 STIS Filename: cmpublic Document Type: Dir of Awards Title: NSF 93-65 Engineering Directorate Directory of Awards File size (bytes): 876852 STIS Filename: nsf9365 Also available: nsf9365.ps nsf9365.wp5 ------------------------------------------------------------------------ ** 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 nsf9365, the text of your message should be as follows: get nsf9365 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9365, you would enter: ftp> get nsf9365 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 Mon Mar 21 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 11, pt. 1, 18 March 1994 Date: 22 Mar 1994 10:52:15 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1499 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2mneov$2r6@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940318 V23N11 P1O2 ************************************ X-comment: RFAs described: AI-94-010, RR/OD-94-004 NIH GUIDE - Vol. 23, No. 11 - March 18, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIH GUIDELINES ON THE INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** ELECTRONIC GRANT APPLICATIONS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** FINANCIAL MANAGEMENT WORKSHOP National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N4 ********************************************************** RESEARCH RESOURCES AT THE CARIBBEAN PRIMATE RESEARCH CENTER National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX N5 ********************************************************** GRANT WRITING WORKSHOP FOR NUTRITION FOR PA-94-033 National Cancer Institute INDEX: CANCER $$INDEX N6 ********************************************************** EXTENSION OF COOPERATIVE AGREEMENTS FOR THE MULTICENTER AIDS COHORT STUDY National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** EVALUATION OF ISCHEMIC HEART DISEASE IN WOMEN - CLINICAL CENTERS (RFP NHLBI-HC-94-13) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R2 06/15/94 ************************************************* MULTICENTER AIDS COHORT STUDY PATHOGENESIS RESEARCH LABORATORY (RFA AI-94-010) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R3 06/16/94 ************************************************* SCIENCE EDUCATION PARTNERSHIP AWARD (RFA RR/OD-94-004) National Center for Research Resources INDEX: RESEARCH RESOURCES ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** STUDIES ON ENVIRONMENTAL TOXICANTS AND THE IMMUNE SYSTEM (PA-94-049) National Institute of Environmental Health Sciences National Institute of Allergy and Infectious Diseases INDEX: ENVIRONMENTAL HEALTH SCIENCES; ALLERGY, INFECTIOUS DISEASES $$INDEX P2 ********************************************************** EXPLORATORY GRANTS TO STIMULATE CORRELATIVE LABORATORY STUDIES AND INNOVATIVE CLINICAL TRIALS (PA-94-050) National Cancer Institute INDEX: CANCER ERRATUM $$INDEX E1 ********************************************************** MORE FACULTY DEVELOPMENT AWARD (PAR-94-034) National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NIH GUIDELINES ON THE INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH NIH GUIDE, Volume 23, Number 10, March 11, 1994 P.T. 34; K.W. 1014006 National Institutes of Health The following is a reprint of the Notice of the NIH Guidelines that was published as a separate Part IV in the Federal Register of March 9, 1994 (59 FR 11146-11151). SUMMARY: The National Institutes of Health (NIH) is establishing guidelines on the inclusion of women and minorities and their subpopulations in research involving human subjects, including clinical trials, supported by the NIH, as required in the NIH Revitalization Act of 1993. EFFECTIVE DATE: March 9, 1994 ADDRESSES: Although these guidelines are effective on the date of publication, written comments can be sent to either the Office of Research on Women's Health, National Institutes of Health, Building 1, Room 203, Bethesda, MD 20892, or to the Office of Research on Minority Health, National Institutes of Health, Building 1, Room 255, Bethesda, MD 20892. During the first year of implementation, NIH will review the comments and experience with the guidelines in order to determine whether modifications to the guidelines are warranted. SUPPLEMENTAL INFORMATION: NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research I. INTRODUCTION This document sets forth guidelines on the inclusion of women and members of minority groups and their subpopulations in clinical research, including clinical trials, supported by the National Institutes of Health (NIH). For the purposes of this document, clinical research is defined as NIH-supported biomedical and behavioral research involving human subjects. These guidelines, implemented in accordance with section 492B of the Public Health Service Act, added by the NIH Revitalization Act of 1993, Public Law (PL) 103-43, supersede and strengthen the previous policies, NIH/ADAMHA Policy Concerning the Inclusion of Women in Study Populations, and ADAMHA/NIH Policy Concerning the Inclusion of Minorities in Study Populations, published in the NIH Guide for Grants and Contracts, Vol. 19, No. 31, August 24, 1990 and Vol. 19, No. 35, September 28, 1990. The 1993 guidelines continue the 1990 guidelines with three major additions. The new policy requires that, in addition to the continuing inclusion of women and members of minority groups in all NIH-supported biomedical and behavioral research involving human subjects, the NIH must: o ensure that women and members of minorities and their subpopulations are included in all human subject research; o for Phase III clinical trials, ensure that women and minorities and their subpopulations must be included such that valid analyses of differences in intervention effect can be accomplished; o not allow cost as an acceptable reason for excluding these groups; and, o initiate programs and support for outreach efforts to recruit these groups into clinical studies. Since a primary aim of research is to provide scientific evidence leading to a change in health policy or a standard of care, it is imperative to determine whether the intervention or therapy being studied affects women or men or members of minority groups and their subpopulations differently. To this end, the guidelines published here are intended to ensure that all future NIH-supported biomedical and behavioral research involving human subjects will be carried out in a manner sufficient to elicit information about individuals of both genders and the diverse racial and ethnic groups and, in the case of clinical trials, to examine differential effects on such groups. Increased attention, therefore, must be given to gender, race, and ethnicity in earlier stages of research to allow for informed decisions at the Phase III clinical trial stage. These guidelines reaffirm NIH's commitment to the fundamental principles of inclusion of women and racial and ethnic minority groups and their subpopulations in research. This policy should result in a variety of new research opportunities to address significant gaps in knowledge about health problems that affect women and racial/ethnic minorities and their subpopulations. The NIH recognizes that issues will arise with the implementation of these guidelines and thus welcomes comments. During the first year of implementation, NIH will review the comments, and consider modifications, within the scope of the statute, to the guidelines. II. BACKGROUND The NIH Revitalization Act of 1993, PL 103-43, signed by President Clinton on June 10, 1993, directs the NIH to establish guidelines for inclusion of women and minorities in clinical research. This guidance shall include guidelines regarding: (a) the circumstances under which the inclusion of women and minorities as subjects in projects of clinical research is inappropriate...; (b) the manner in which clinical trials are required to be designed and carried out ....; and (c) the operation of outreach programs... 492B(d)(1) The statute states that: In conducting or supporting clinical research for the purposes of this title, the Director of NIH shall ... ensure that - A. women are included as subjects in each project of such research; and B. members of minority groups are included in such research. 492B(a)(1) The statute further defines "clinical research" to include "clinical trials" and states that In the case of any clinical trial in which women or members of minority groups will be included as subjects, the Director of NIH shall ensure that the trial is designed and carried out in a manner sufficient to provide for valid analysis of whether the variables being studied in the trial affect women or members of minority groups, as the case may be, differently than other subjects in the trial. 492B(c) Specifically addressing the issue of minority groups, the statute states that The term "minority group" includes subpopulations of minority groups. The Director of NIH shall, through the guidelines established... define the terms "minority group" and "subpopulation" for the purposes of the preceding sentence. 492B(g)(2) The statute speaks specifically to outreach and states that The Director of NIH, in consultation with the Director of the Office of Research on Women's Health and the Director of the Office of Research on Minority Health, shall conduct or support outreach programs for the recruitment of women and members of minority groups as subjects in the projects of clinical research. 492B(a)(2) The statute includes a specific provision pertaining to the cost of clinical research and, in particular clinical trials. (A)(i) In the case of a clinical trial, the guidelines shall provide that the costs of such inclusion in the trial is (sic) not a permissible consideration in determining whether such inclusion is inappropriate. 492B(d)(2) (ii) In the case of other projects of clinical research, the guidelines shall provide that the costs of such inclusion in the project is (sic) not a permissible consideration in determining whether such inclusion is inappropriate unless the data regarding women or members of minority groups, respectively, that would be obtained in such project (in the event that such inclusion were required) have been or are being obtained through other means that provide data of comparable quality. 492B(d)(2) Exclusions to the requirement for inclusion of women and minorities are stated in the statute, as follows: The requirements established regarding women and members of minority groups shall not apply to the project of clinical research if the inclusion, as subjects in the project, of women and members of minority groups, respectively- (1) is inappropriate with respect to the health of the subjects; (2) is inappropriate with respect to the purpose of the research; or (3) is inappropriate under such other circumstances as the Director of NIH may designate. 492B(b) ...(B) In the case of a clinical trial, the guidelines may provide that such inclusion in the trial is not required if there is substantial scientific data demonstrating that there is no significant difference between- (i) the effects that the variables to be studied in the trial have on women or members of minority groups, respectively; and (ii) the effects that the variables have on the individuals who would serve as subjects in the trial in the event that such inclusion were not required. 492B(d)(2) III. POLICY A. 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 establishes to the satisfaction of the relevant Institute/Center Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Exclusion under other circumstances may be made by the Director, NIH, upon the recommendation of an Institute/Center Director based on a compelling rationale and justification. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. Women of childbearing potential should not be routinely excluded from participation in clinical research. All NIH-supported biomedical and behavioral research involving human subjects is defined as clinical research. This policy applies to research subjects of all ages. The inclusion of women and members of minority groups and their subpopulations must be addressed in developing a research design appropriate to the scientific objectives of the study. The research plan should describe the composition of the proposed study population in terms of gender and racial/ethnic group, and provide a rationale for selection of such subjects. Such a plan should contain a description of the proposed outreach programs for recruiting women and minorities as participants. B. Clinical Trials Under the statute, when a Phase III clinical trial (see Definitions, Section V-A) is proposed, evidence must be reviewed to show whether or not clinically important gender or race/ ethnicity differences in the intervention effect are to be expected. This evidence may include, but is not limited to, data derived from prior animal studies, clinical observations, metabolic studies, genetic studies, pharmacology studies, and observational, natural history, epidemiology and other relevant studies. As such, investigators must consider the following when planning a Phase III clinical trial for NIH support. o If the data from prior studies strongly indicate the existence of significant differences of clinical or public health importance in intervention effect among subgroups (gender and/or racial/ethnic subgroups), the primary question(s) to be addressed by the proposed Phase III trial and the design of that trial must specifically accommodate this. For example, if men and women are thought to respond differently to an intervention, then the Phase III trial must be designed to answer two separate primary questions, one for men and the other for women, with adequate sample size for each. o If the data from prior studies strongly support no significant differences of clinical or public health importance in intervention effect between subgroups, then gender or race/ethnicity will not be required as subject selection criteria. However, the inclusion of gender or racial/ethnic subgroups is still strongly encouraged. o If the data from prior studies neither support strongly nor negate strongly the existence of significant differences of clinical or public health importance in intervention effect between subgroups, then the Phase III trial will be required to include sufficient and appropriate entry of gender and racial/ethnic subgroups, so that valid analysis of the intervention effect in subgroups can be performed. However, the trial will not be required to provide high statistical power for each subgroup. Cost is not an acceptable reason for exclusion of women and minorities from clinical trials. C. Funding NIH funding components will not award any grant, cooperative agreement or contract or support any intramural project to be conducted or funded in Fiscal Year 1995 and thereafter which does not comply with this policy. For research awards that are covered by this policy, awardees will report annually on enrollment of women and men, and on the race and ethnicity of research participants. IV. IMPLEMENTATION A. Date of Implementation This policy applies to all applications/proposals and intramural projects to be submitted on and after June 1, 1994 (the date of full implementation) seeking Fiscal Year 1995 support. Projects funded prior to June 10, 1993, must still comply with the 1990 policy and report annually on enrollment of subjects using gender and racial/ethnic categories as required in the Application for Continuation of a Public Health Service Grant (PHS Form 2590), in contracts and in intramural projects. B. Transition Policy NIH-supported biomedical and behavioral research projects involving human subjects, with the exception of Phase III clinical trial projects as discussed below, that are awarded between June 10, 1993, the date of enactment, and September 30, 1994, the end of Fiscal Year 1994, shall be subject to the requirements of the 1990 policy and the annual reporting requirements on enrollment using gender and racial/ethnic categories. For all Phase III clinical trial projects proposed between June 10, 1993 and June 1, 1994, and those awarded between June 10, 1993 and September 30, 1994, Institute/Center staff will examine the applications/proposals, pending awards, awards and intramural projects to determine if the study was developed in a manner consistent with the new guidelines. If it is deemed inconsistent, NIH staff will contact investigators to discuss approaches to accommodate the new policy. Administrative actions may be needed to accommodate or revise the pending trials. Institutes/Centers may need to consider initiating a complementary activity to address any gender or minority representation concerns. The NIH Director will determine whether the Phase III clinical trial being considered during this transition is in compliance with this policy, whether acceptable modifications have been made, or whether the Institute/Center will initiate a complementary activity that addresses the gender or minority representation concerns. Pending awards will not be funded without this determination. Solicitations issued by the NIH and planned for release after the date of publication of the guidelines in the Federal Register will include the new requirements. C. Roles and Responsibilities While this policy applies to all applicants for NIH-supported biomedical and behavioral research involving human subjects, certain individuals and groups have special roles and responsibilities with regard to the adoption and implementation of these guidelines. The NIH staff will provide educational opportunities for the extramural and intramural community concerning this policy; monitor its implementation during the development, review, award and conduct of research; and manage the NIH research portfolio to address the policy. 1. Principal Investigators Principal investigators should assess the theoretical and/or scientific linkages between gender, race/ethnicity, and their topic of study. Following this assessment, the principal investigator and the applicant institution will address the policy in each application and proposal, providing the required information on inclusion of women and minorities and their subpopulations in research projects, and any required justifications for exceptions to the policy. Depending on the purpose of the study, NIH recognizes that a single study may not include all minority groups. 2. Institutional Review Boards (IRBs) As the IRBs implement the guidelines, described herein, for the inclusion of women and minorities and their subpopulations, they must also implement the regulations for the protection of human subjects as described in Title 45 CFR Part 46, "Protection of Human Subjects." They should take into account the Food and Drug Administration's "Guidelines for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs," Vol. 58 Federal Register 39406. 3. Peer Review Groups In conducting peer review for scientific and technical merit, appropriately constituted initial review groups (including study sections), technical evaluation groups, and intramural review panels will be instructed, as follows: o to evaluate the proposed plan for the inclusion of minorities and both genders for appropriate representation or to evaluate the proposed justification when representation is limited or absent, o to evaluate the proposed exclusion of minorities and women on the basis that a requirement for inclusion is inappropriate with respect to the health of the subjects, o to evaluate the proposed exclusion of minorities and women on the basis that a requirement for inclusion is inappropriate with respect to the purpose of the research, o to determine whether the design of clinical trials is adequate to measure differences when warranted, o to evaluate the plans for recruitment/outreach for study participants, and o to include these criteria as part of the scientific assessment and assigned score. 4. NIH Advisory Councils In addition to its current responsibilities for review of projects where the peer review groups have raised questions about the appropriate inclusion of women and minorities, the Advisory Council/Board of each Institute/Center shall prepare biennial reports, for inclusion in the overall NIH Director's biennial report, describing the manner in which the Institute/Center has complied with the provisions of the statute. 5. Institute/Center Directors Institute/Center Directors and their staff shall determine whether: a) the research involving human subjects, b) the Phase III clinical trials, and c) the exclusions meet the requirements of the statute and these guidelines. 6. NIH Director The NIH Director may approve, on a case-by-case basis, the exclusion of projects, as recommended by the Institute/Center Director, that may be inappropriate to include within the requirements of these guidelines on the basis of circumstances other than the health of the subjects, the purpose of the research, or costs. 7. Recruitment Outreach by Extramural and Intramural Investigators Investigators and their staff(s) are urged to develop appropriate and culturally sensitive outreach programs and activities commensurate with the goals of the study. The objective should be to actively recruit the most diverse study population consistent with the purposes of the research project. Indeed, the purpose should be to establish a relationship between the investigator(s) and staff(s) and populations and community(ies) of interest such that mutual benefit is derived for participants in the study. Investigator(s) and staff(s) should take precautionary measures to ensure that ethical concerns are clearly noted, such that there is minimal possibility of coercion or undue influence in the incentives or rewards offered in recruiting into or retaining participants in studies. It is also the responsibility of the IRBs to address these ethical concerns. Furthermore, while the statute focuses on recruitment outreach, NIH staff underscore the need to appropriately retain participants in clinical studies, and thus, the outreach programs and activities should address both recruitment and retention. To assist investigators and potential study participants, NIH staff have prepared a notebook, "NIH Outreach Notebook On the Inclusion of Women and Minorities in Biomedical and Behavioral Research." The notebook addresses both recruitment and retention of women and minorities in clinical studies, provides relevant references and case studies, and discusses ethical issues. It is not intended as a definitive text on this subject, but should assist investigators in their consideration of an appropriate plan for recruiting and retaining participants in clinical studies. The notebook is expected to be available early in 1994. 8. Educational Outreach by NIH to Inform the Professional Community NIH staff will present the new guidelines to investigators, IRB members, peer review groups, and Advisory Councils in a variety of public educational forums. 9. Applicability to Foreign Research Involving Human Subjects For foreign awards, the NIH policy on inclusion of women in research conducted outside the U.S. is the same as that for research conducted in the U.S. However, with regard to the population of the foreign country, the definition of the minority groups may be different than in the U.S. If there is scientific rationale for examining subpopulation group differences within the foreign population, investigators should consider designing their studies to accommodate these differences. V. DEFINITIONS Throughout the section of the statute pertaining to the inclusion of women and minorities, terms are used which require definition for the purpose of implementing these guidelines. These terms, drawn directly from the statute, are defined below. A. Clinical Trial For the purpose of these guidelines, a "clinical trial" is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or control intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non- pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included. B. Research Involving Human Subjects All NIH-supported biomedical and behavioral research involving human subjects is defined as clinical research under this policy. Under this policy, the definition of human subjects in Title 45 CFR Part 46, the Department of Health and Human Services regulations for the protection of human subjects applies: "Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information." These regulations specifically address the protection of human subjects from research risks. It should be noted that there are research areas (Exemptions 1-6) that are exempt from these regulations. However, under these guidelines, NIH-supported biomedical and behavioral research projects involving human subjects which are exempt from the human subjects regulations should still address the inclusion of women and minorities in their study design. Therefore, all biomedical and behavioral research projects involving human subjects will be evaluated for compliance with this policy. Research involving the collection or study of existing data, documents, records, pathological specimens, diagnostic specimens, or tissues which are individually identifiable also is included within the term "research involving human subjects." C. Valid Analysis The term "valid analysis" means an unbiased assessment. Such an assessment will, on average, yield the correct estimate of the difference in outcomes between two groups of subjects. Valid analysis can and should be conducted for both small and large studies. A valid analysis does not need to have a high statistical power for detecting a stated effect. The principal requirements for ensuring a valid analysis of the question of interest are: o allocation of study participants of both genders and from different racial/ethnic groups to the intervention and control groups by an unbiased process such as randomization, o unbiased evaluation of the outcome(s) of study participants, and o use of unbiased statistical analyses and proper methods of inference to estimate and compare the intervention effects among the gender and racial/ethnic groups. D. Significant Difference For purposes of this policy, a "significant difference" is a difference that is of clinical or public health importance, based on substantial scientific data. This definition differs from the commonly used "statistically significant difference," which refers to the event that, for a given set of data, the statistical test for a difference between the effects in two groups achieves statistical significance. Statistical significance depends upon the amount of information in the data set. With a very large amount of information, one could find a statistically significant, but clinically small difference that is of very little clinical importance. Conversely, with less information one could find a large difference of potential importance that is not statistically significant. E. Racial and Ethnic Categories 1. Minority Groups A minority group is a readily identifiable subset of the U.S. population which is distinguished by either racial, ethnic, and/or cultural heritage. The Office of Management and Budget (OMB) Directive No. 15 defines the minimum standard of basic racial and ethnic categories, which are used below. NIH has chosen to continue the use of these definitions because they allow comparisons to many national data bases, especially national health data bases. Therefore, the racial and ethnic categories described below should be used as basic guidance, cognizant of the distinction based on cultural heritage. American Indian or Alaskan Native: A person having origins in any of the original peoples of North America, and who maintains cultural identification through tribal affiliation or community recognition. Asian or Pacific Islander: A person having origins in any of the original peoples of the Far East, Southeast Asia, the Indian subcontinent, or the Pacific Islands. This area includes, for example, China, India, Japan, Korea, the Philippine Islands and Samoa. Black, not of Hispanic Origin: A person having origins in any of the black racial groups of Africa. Hispanic: A person of Mexican, Puerto Rican, Cuban, Central or South American or other Spanish culture or origin, regardless of race. 2. Majority Group White, not of Hispanic Origin: A person having origins in any of the original peoples of Europe, North Africa, or the Middle East. NIH recognizes the diversity of the U.S. population and that changing demographics are reflected in the changing racial and ethnic composition of the population. The terms "minority groups" and "minority subpopulations" are meant to be inclusive, rather than exclusive, of differing racial and ethnic categories. 3. Subpopulations Each minority group contains subpopulations which are delimited by geographic origins, national origins and/or cultural differences. It is recognized that there are different ways of defining and reporting racial and ethnic subpopulation data. The subpopulation to which an individual is assigned depends on self-reporting of specific racial and ethnic origin. Attention to subpopulations also applies to individuals of mixed racial and/or ethnic parentage. Researchers should be cognizant of the possibility that these racial/ethnic combinations may have biomedical and/or cultural implications related to the scientific question under study. F. Outreach Strategies These are outreach efforts by investigators and their staff(s) to appropriately recruit and retain populations of interest into research studies. Such efforts should represent a thoughtful and culturally sensitive plan of outreach and generally include involvement of other individuals and organizations relevant to the populations and communities of interest, e.g., family, religious organizations, community leaders and informal gatekeepers, and public and private institutions and organizations. The objective is to establish appropriate lines of communication and cooperation to build mutual trust and cooperation such that both the study and the participants benefit from such collaboration. G. Research Portfolio Each Institute and Center at the NIH has its own research portfolio, i.e., its "holdings" in research grants, cooperative agreements, contracts and intramural studies. The Institute or Center evaluates the research awards in its portfolio to identify those areas where there are knowledge gaps or which need special attention to advance the science involved. NIH may consider funding projects to achieve a research portfolio reflecting diverse study populations. With the implementation of this new policy, there will be a need to ensure that sufficient resources are provided within a program to allow for data to be developed for a smooth transition from basic research to Phase III clinical trials that meet the policy requirements. VI. DISCUSSION -- Issues in Scientific Plans and Study Designs A. Issues in Research Involving Human Subjects The biomedical and behavioral research process can be viewed as a stepwise process progressing from discovery of new knowledge through research in the laboratory, research involving animals, research involving human subjects, validation of interventions through clinical trials, and broad application to improve the health of the public. All NIH-supported biomedical and behavioral research involving human subjects is defined broadly in this guidance as clinical research. This is broader than the definition provided in the 1990 NIH Guidance and in many program announcements, requests for applications, and requests for proposals since 1990. The definition was broadened because of the need to obtain data about minorities and both genders early in the research process when hypotheses are being formulated, baseline data are being collected, and various measurement instruments and intervention strategies are being developed. Broad inclusion at these early stages of research provides valuable information for designing broadly based clinical trials, which are a subset of studies under the broad category of research studies. The policy on inclusion of minorities and both genders applies to all NIH-supported biomedical and behavioral research involving human subjects so that the maximum information may be obtained to understand the implications of the research findings on the gender or minority group. Investigators should consider the types of information concerning gender and minority groups which will be required when designing future Phase III clinical trials, and try to obtain it in their earlier stages of research involving human subjects. NIH recognizes that the understanding of health problems and conditions of different U.S. populations may require attention to socioeconomic differences involving occupation, education, and income gradients. B. Issues in Clinical Trials The statute requires appropriate representation of subjects of different gender and race/ethnicity in clinical trials so as to provide the opportunity for detecting major qualitative differences (if they exist) among gender and racial/ethnic subgroups and to identify more subtle differences that might, if warranted, be explored in further specifically targeted studies. Other interpretations may not serve as well the health needs of women, minorities, and all other constituencies. Preparatory to any Phase III clinical trial, certain data are typically obtained. Such data are necessary for the design of an appropriate Phase III trial and include observational clinical study data, basic laboratory (i.e., in vitro and animal) data, and clinical, physiologic, pharmacokinetic, or biochemical data from Phase I and Phase II studies. Genetic studies, behavioral studies, and observational, natural history, and epidemiological studies may also contribute data. It is essential that data be reviewed from prior studies on a diverse population, that is, in subjects of both genders and from different racial/ethnic groups. These data must be examined to determine if there are significant differences of clinical or public health importance observed between the subgroups. While data from prior studies relating to possible differences among intervention effects in different subgroups must be reviewed, evidence of this nature is likely to be less convincing than that deriving from the subgroup analyses that can be performed in usual- sized Phase III trials. This is because the evidence from preliminary studies is likely to be of a more indirect nature (e.g. based on surrogate endpoints), deriving from uncontrolled studies (e.g., non-randomized Phase II trials), and based on smaller numbers of subjects than in Phase III secondary analyses. For this reason, it is likely that data from preliminary studies will, in the majority of cases, neither clearly reveal significant differences of clinical or public health importance between subgroups of patients, nor strongly negate them. In these cases, Phase III trials should still have appropriate gender and racial/ethnic representation, but they would not need to have the large sample sizes necessary to provide a high statistical power for detecting differences in intervention effects among subgroups. Nevertheless, analyses of subgroup effects must be conducted and comparisons between the subgroups must be made. Depending on the results of these analyses, the results of other relevant research, and the results of meta-analyses of clinical trials, one might initiate subsequent trials to examine more fully these subgroup differences. C. Issues Concerning Appropriate Gender Representation The "population at risk" may refer to only one gender where the disease, disorders, or conditions are gender specific. In all other cases, there should be approximately equal numbers of both sexes in studies of populations or subpopulations at risk, unless different proportions are appropriate because of the known prevalence, incidence, morbidity, mortality rates, or expected intervention effect. D. Issues Concerning Appropriate Representation of Minority Groups and Subpopulations in All Research Involving Human Subjects Including Phase III Clinical Trials While the inclusion of minority subpopulations in research is a complex and challenging issue, it nonetheless provides the opportunity for researchers to collect data on subpopulations where knowledge gaps exist. Researchers must consider the inclusion of subpopulations in all stages of research design. In meeting this objective, they should be aware of concurrent research that addresses specific subpopulations, and consider potential collaborations which may result in complementary subpopulation data. At the present time, there are gaps in baseline and other types of data necessary for research involving certain minority groups and/or subpopulations of minority groups. In these areas, it would be appropriate for researchers to obtain such data, including baseline data, by studying a single minority group. It would also be appropriate for researchers to test survey instruments, recruitment procedures, and other methodologies used in the majority or other population(s) with the objective of assessing their feasibility, applicability, and cultural competence/relevance to a particular minority group or subpopulation. This testing may provide data on the validity of the methodologies across groups. Likewise, if an intervention has been tried in the majority population and not in certain minority groups, it would be appropriate to assess the intervention effect on a single minority group and compare the effect to that obtained in the majority population. These types of studies will advance scientific research and assist in closing knowledge gaps. A complex issue arises over how broad or narrow the division into different subgroups should be, given the purpose of the research. Division into many racial/ethnic subgroups is tempting in view of the cultural and biological differences that exist among these groups and the possibility that some of these differences may in fact impact in some way upon the scientific question. Alternatively, from a practical perspective, a limit has to be placed on the number of such subgroups that can realistically be studied in detail for each intervention that is researched. The investigator should clearly address the rationale for inclusion or exclusion of subgroups in terms of the purpose of the research. Emphasis should be placed upon inclusion of subpopulations in which the disease manifests itself or the intervention operates in an appreciably different way. Investigators should report the subpopulations included in the study. An important issue is the appropriate representation of minority groups in research, especially in geographical locations which may have limited numbers of racial/ethnic population groups available for study. The investigator must address this issue in terms of the purpose of the research, and other factors, such as the size of the study, relevant characteristics of the disease, disorder or condition, and the feasibility of making a collaboration or consortium or other arrangements to include minority groups. A justification is required if there is limited representation. Peer reviewers and NIH staff will consider the justification in their evaluations of the project. NIH interprets the statute in a manner that leads to feasible and real improvements in the representativeness of different racial/ethnic groups in research and places emphasis on research in those subpopulations that are disproportionately affected by certain diseases or disorders. VII. NIH CONTACTS FOR MORE INFORMATION The following senior extramural staff from the NIH Institutes and Centers may be contacted for further information about the policy and relevant Institute/Center programs: Dr. Marvin Kalt National Cancer Institute Executive Plaza North, Room 600A 6130 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-5147 Dr. Richard Mowery National Eye Institute Executive Plaza South, Room 350 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 496-5301 Dr. Lawrence Friedman National Heart, Lung and Blood Institute Federal Building, Room 212 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-2533 Dr. Miriam Kelty National Institute on Aging Gateway Building, Room 2C218 7201 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-9322 Dr. Cherry Lowman National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard Rockville, MD 20892 Tel: (301) 443-0796 Dr. George Counts National Institute of Allergy and Infectious Diseases Solar Building, Room 207P 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-8214 Dr. Michael Lockshin National Institute of Arthritis and Musculoskeletal and Skin Diseases Building 31, Room 4C32 Bethesda, MD 20892 Telephone: (301) 496-0802 Ms. Hildegard Topper National Institute of Child Health and Human Development Building 31, Room 2A03 Bethesda, MD 20892 Telephone: (301) 496-0104 Dr. Earleen Elkins National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 496-8683 Dr. Norman S. Braveman National Institute on Dental Research Westwood Building, Room 509 Bethesda, MD 20892 Telephone: (301) 594-7648 Dr. Walter Stolz National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 657 Bethesda, MD 20892 Telephone: (301) 594-7527 Ms. Eleanor Friedenberg National Institute on Drug Abuse Parklawn Building, Room 10-42 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-2755 Dr. Gwen Collman National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-4980 Dr. Lee Van Lenten National Institute of General Medical Sciences Westwood Building, Room 905 Bethesda, MD 20892 Telephone: (301) 594-7744 Dr. Dolores Parron National Institute of Mental Health Parklawn Building, Room 17C-14 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-2847 Dr. Constance Atwell National Institute of Neurological Disorders and Stroke Federal Building, Room 1016 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-9248 Dr. Mark Guyer National Center for Human Genome Research Building 38A, Room 605 Bethesda, MD 20892 Telephone: (301) 496-0844 Dr. Teresa Radebaugh National Center for Nursing Research Westwood Building, Room 754 Bethesda, MD 20892 Telephone: (301) 594-7590 Dr. Harriet Gordon National Center for Research Resources Westwood Building, Room 10A03 Bethesda, MD 20892 Telephone: (301) 594-7945 Dr. David Wolff Fogarty International Center Building 31, Room B2C39 Bethesda, MD 20892 Telephone: (301) 496-1653 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** ELECTRONIC GRANT APPLICATIONS NIH GUIDE, Volume 23, Number 11, March 18, 1994 P.T. 34; K.W. 1004017, 1014006 National Institutes of Health The National Institutes of Health plans to develop an automated means to acquire, process, and distribute electronic grant applications. As part of the process, technical specifications for the format and content of acceptable electronic applications will be published. The intention is to provide the opportunity for commercial developers, institutions, or others outside the NIH to develop software to prepare and submit electronic PHS grant applications. This notice is to invite those interested in this effort to identify themselves, so the NIH can keep them informed and solicit their input as the project proceeds. If interested, send name, E-mail address, postal address, and telephone number to: J.T. Lowrie Division of Research Grants Information Systems Branch Westwood Building, Room 120 Bethesda, MD 20892 $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** FINANCIAL MANAGEMENT WORKSHOP NIH GUIDE, Volume 23, Number 11, March 18, 1994 P.T. 34; K.W. 1014006 National Institutes of Health The Louisiana State University Medical Center, New Orleans, in conjunction with the National Institutes of Health (Division of Financial Management) is sponsoring a workshop to be held in New Orleans on May 2-3, 1994. The agenda for the workshop will include the following topics: o The System for the Electronic Transmittal of Financial Status reports (FSRs) o The Payment Management System/Federal Cash Transactions Report (PMS-272) o The NIH initiative on late FSRs o Shannon Awards o Indirect Costs INQUIRIES For further information and a registration form, contact: Ms. Darleen Galatas Louisiana State University Medical Center 433 Bolivar Street, Room 612 New Orleans, La 70112-2223 Telephone: (504) 568-3675 $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** RESEARCH RESOURCES AT THE CARIBBEAN PRIMATE RESEARCH CENTER NIH GUIDE, Volume 23, Number 11, March 18, 1994 P.T. 34; K.W. 1002002 National Center for Research Resources The Caribbean Primate Research Center (CPRC) operates three research facilities for behavioral, biomedical, and anthropological studies and dissertation research. Cayo Santiago: An island colony of approximately 1000 provisioned, free-ranging rhesus macaques ideal for both short- and long-term observational research. An annual capture also facilitates non- invasive biomedical investigations and surveys on a limited basis. Computerized demographic data are available on over 12 macaque generations. These include individual identifications, matriline, group affiliation, reproductive history, birth and death dates. Sabana Seca: A field station housing approximately 900 macaques, many derived from Cayo Santiago, in outdoor corrals, pens, and individual cages primarily for biomedical studies, breeding, and behavioral research that require frequent handling of animals. CPRC Skeletal Collection: A curated collection of over 2500 complete or nearly-complete skeletons of six species of nonhuman primates, mostly rhesus macaques and patas monkeys. The collection is ideal for studies of spontaneous and acquired joint and bone diseases, physical anthropology, growth and development, and bone remodeling. Available supporting data include basic demographic information, medical records and thoracic radiographs, a selection of cephalometric radiographs and reproductive history. Use is generally limited to non-destructive studies, but limited destructive sampling is permissible given sufficient justification. The Caribbean Primate Research Center is partially funded by NIH program project grant RR03640. INQUIRIES Investigators and students wishing to avail themselves of the CPRC's unique research resources should send a letter of intent and/or contact staff members. For an information packet, contact: Dr. Matt J. Kessler, Director Caribbean Primate Research Center University of Puerto Rico Medical Sciences Campus P.O. Box 1053 Sabana Seca, PR 00952-1053 (USA) FAX: (809) 795-6700 $$N4 END ************************************************************ $$N5 BEGIN ********************************************************** GRANT WRITING WORKSHOP FOR NUTRITION FOR PA-94-033 NIH GUIDE, Volume 23, Number 11, March 18, 1994 P.T. 34; K.W. 0710095, 1014006 National Cancer Institute A national workshop to discuss Program Announcement PA-94-033, "Culturally Sensitive Intervention Strategies for Promoting or Implementing Compliance with NCI Dietary Guidelines among African Americans," has been scheduled for Thursday, April 14 from 8:30am to 5:00pm on the NIH campus in Bethesda, MD, Building 31C, Conference Room 6. Topics related to grant writing will be discussed as they specifically relate to this program announcement. This one-day workshop will be of interest to both new and senior Principal Investigators. Discussion of issues related to community nutrition interventions in African Americans will be included. Topics for discussion include dietary change in African Americans; specific aims, background, and significance of the program announcement; research design and methods; budget preparation; grants review; and assurances and certifications. No registration fee will be charged. Time will be available for conference participants to meet informally with NIH representatives to discuss their individual ideas. This workshop is open to the public. Persons interested in attending the workshop will be expected to pay their own expenses. For persons who are unable to attend, a transcript of the meeting will be made available, and may be obtained by contacting Dr. Jacqueline Whitted at the address listed under INQUIRIES. Speakers will include several NCI and NIH staff involved in the management, review, and administration of this program announcement. INQUIRIES For further information, contact: Dr. Jacqueline Whitted Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 232 Bethesda, MD 20892 Telephone: (301) 496-8584 FAX: (301) 496-8675 DATE: April 14, 1994 LOCATION National Institutes of Health Building 31C, Conference Room 6 9000 Rockville Pike Bethesda, Maryland $$N5 END ************************************************************ $$N6 BEGIN ********************************************************** EXTENSION OF COOPERATIVE AGREEMENTS FOR THE MULTICENTER AIDS COHORT STUDY NIH GUIDE, Volume 23, Number 11, March 18, 1994 P.T. 34; K.W. 0715008, 0765033 National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID) has an active interest in the support of research projects addressing epidemiologic, etiologic, and pathogenetic patterns and trends in HIV infection and AIDS in various population groups. Studies are currently supported that focus on minorities, children, mothers and infants, women, and men. One group of these studies is the Multicenter AIDS Cohort Study (MACS), which was initiated in 1983 and is currently supported through cooperative agreements. Because the current awardees have unique access to the study cohorts, study data, and study specimens and have unique expertise with respect the integration of these elements, the NIAID intends to invite applications for competitive renewal of these studies through a competition limited to the current awardess only. One component of the current cooperative agreements (basic research using specimens from study cohorts) will not be included in any resultant awards; such studies will only be supported through open competitions. Although competition for this cooperative agreement study extension is limited, NIAID wishes to call attention to its ongoing interest in applications for prospective studies related to the etiology, pathogenesis, prevention, diagnosis, and treatment of HIV infection and its sequellae. INQUIRIES For further information contact: Lewis K. Schrager, M.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2B10 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-6177 $$N6 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NHLBI-HC-94-13 ******************************************* EVALUATION OF ISCHEMIC HEART DISEASE IN WOMEN - CLINICAL CENTERS NIH GUIDE, Volume 23, Number 11, March 18, 1994 RFP AVAILABLE: NHLBI-HC-94-13 P.T. 34, II; K.W. 0715040, 0745020 National Heart, Lung, and Blood Institute The National Heart, Lung, and Blood Institute (NHLBI) requires three to five clinical centers to evaluate innovative diagnostic methods that will improve the diagnostic reliability of cardiovascular testing in evaluation of ischemic heart disease in women. Innovative approaches proposed in evaluation of myocardial ischemia should include physiologic or functional measurements such as impaired metabolism, perfusion, or endothelial function as well as assessment of epicardial coronary arteries by angiography. Each clinical center will be fully independent and expected to fulfill all the requirements outlined in the Request for Proposals (RFP). The clinical centers will evaluate diagnostic methods and perform common study protocols, including angiography, on 100 participants annually for three years. The anticipated period of performance is from December 30, 1994 through December 29, 1998. INQUIRIES This is an announcement for an RFP. RFP No. NHLBI-HC-94-13 will be available on or about March 14, 1994 with proposals due May 31, 1994. Three to five awards are anticipated to be made in December 1994. Written requests must cite RFP No. NHLBI-HC-94-13 and include two, self-addressed mailing labels. Requests for copies of the RFP are to be sent to: Donna J. Neal Contracts Operations Branch National Heart, Lung, and Blood Institute Federal Building, Room 3C16 7550 Wisconsin Avenue Bethesda, MD 20892 $$R1 END ************************************************************ $$R2 BEGIN AI-94-010 FULL-TEXT ************************************** MULTICENTER AIDS COHORT STUDY PATHOGENESIS RESEARCH LABORATORY NIH GUIDE, Volume 23, Number 11, March 18, 1994 RFA AVAILABILE: AI-94-010 P.T. 34; K.W. 0715008, 0765033, 1002008, 0710070, 1002019, 1002045 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: April 1, 1994 Application Receipt Date: June 15, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES" BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Vaccine Trials and Epidemiology Branch (VTEB) of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID) administers major, prospective studies of HIV infection and disease in large, multicenter cohort studies, including the Multicenter AIDS Cohort Study (MACS). The purpose of this RFA is to fund a laboratory or a consortium of laboratories to study the immunologic, virologic, and other biologic determinants of disease progression, and factors which mitigate HIV-mediated immune system destruction among participants in the MACS. The work to be accomplished requires diverse expertise in HIV virology, immunology, genetics, and molecular biology that must be applied in a highly coordinated manner to adequately address the issues of interest. Proposed studies should utilize an interdisciplinary approach, with well-integrated research plans. 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, MACS Pathogenesis Research Laboratory(s), is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-10473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit research institutions, public and private organizations 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. Domestic applications may not include international components. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Awards will be made as Cooperative Agreements (U01s). Cooperative Agreements are grants awarded to institutions when it is desired to encourage investigator-initiated research in areas of special importance to the NIH. It is an "assistance" mechanism rather than an "acquisition" mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. The nature of NIAID staff participation is described in the RFA. Under the RFA, the Principal Investigator(s) assumes prime responsibility for the direction and completion of the research. This RFA solicitation represents a single competition with a specified deadline for receipt of applications. Reissuance of this RFA will be dependent on the state of science and findings at the completion of this cooperative agreement. Awards will be made for a twelve month budget period within a total project period not to exceed four years. The anticipated award date is April 1, 1995. Funding beyond the first and subsequent years of the award will be contingent upon satisfactory performance during the preceding years and upon the availability of funds for this purpose. FUNDS AVAILABLE Approximately $800,000 will be available for funding the total costs, both direct and indirect, for the initial year of awards made pursuant to this RFA. The NIAID anticipates making one or two awards as a result of this RFA. The issuance of the final award or awards will be dependent upon receipt of applications of high scientific merit that cover the range of scientific objectives in a comprehensive manner, and upon the availability of funds. RESEARCH OBJECTIVES The ongoing Multicenter AIDS Cohort Study (MACS), which includes four clinical centers and a data center, is supported by VTEB, CRP, DAIDS, NIAID. Studies of HIV-related malignancy in the MACS are co-funded by the NCI. The MACS was created in 1983 as a study of HIV infection in homosexual and bisexual men; over 5,500 men have been enrolled in the MACS since 1984. MACS study sites are located at Johns Hopkins University, Baltimore, MD; the University of Pittsburgh, Pittsburgh, PA; the Howard Brown Memorial Clinic/Northwestern University, Chicago, IL; and the University of California at Los Angeles in Los Angeles, CA. The Center for the Analysis of MACS Data (CAMACS) is located at Johns Hopkins University in Baltimore, MD. The NIAID intends to renew support for the MACS clinical sites and data center to follow and study selected MACS participants for clinical and laboratory outcomes and to collect specimens for pathogenesis research. The selected participants to be followed will include: (1) HIV-seropositive MACS participants, (2) HIV-seronegative MACS participants at high risk of HIV acquisition based on behavioral assessments, and (3) a limited number of seronegative men who are at lower risk of HIV infection. Blood specimens from MACS participants are obtained every six months, are processed and stored as frozen serum, plasma, and cells in the NIAID HIV Vaccine Trials and Epidemiology Specimen Repository, and will be made available to the MACS Pathogenesis Research Laboratory(s). Prospectively obtained samples of blood and other body fluids and tissues, such as semen and lymph nodes, for specific MACS pathogenesis protocols also may be made available, contingent on study feasibility, obtaining local IRB approval and necessary informed consent, and the agreement of the participants who comprise the MACS cohort. Applications are invited to conduct laboratory investigations on the pathogenesis of HIV infection using clinical specimens from the MACS and emphasizing close integration of the immunologic, virologic, and other biological investigations being planned. Preference will be given for studies of high scientific merit for which the cohort research approach, the use of the unique epidemiologic and clinical laboratory database of the MACS, and the stored MACS specimens from the NIAID HIV Vaccine Trials and Epidemiology Specimen Repository is essential. Each application must address the first of the following two areas of pathogenesis research. Applicants have the option of addressing the second area of pathogenesis research listed below: 1. The identification and characterization of the host immunologic factors and the virologic factors that correlate with the progression and/or non-progression of HIV disease in individuals who maintain high (e.g., above 500 CD4+ cells per microliter), stable CD4+ cell counts despite long periods of HIV infection; 2. The identification and characterization of the host immunologic factors and the virologic factors that correlate with the progression and/or non-progression of HIV disease in individuals who whose CD4+ cell counts decline to low levels (e.g., below 200 CD4+ cells per microliter) but who remain clinically stable for prolonged periods. SPECIAL REQUIREMENTS The MACS Pathogenesis Research Laboratory(s) will propose and conduct the relevant studies in collaboration with the MACS research infrastructure. The Principal Investigator(s) of the MACS Pathogenesis Research Laboratory(s) will be members of the MACS Pathogenesis Steering Committee, responsible for designing and implementing pathogenesis research in the MACS under this RFA. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are asked to submit, by April 1, 1994, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the Principal Investigator; the identities of other key personnel and participating institutions (if applicable); and the number and title of this RFA. The letter of intent does not commit the sender to submit an application, is not a requirement for submission of an application, and will not enter into the review of subsequent applications. Letters of intent are to be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these Cooperative Agreements. These forms are available at most institutional offices of sponsored research; the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the NIH Program Administrator listed under INQUIRIES. Additional instructions for preparation of applications are provided in the RFA. Applications not received by June 15, 1994 will be returned to the applicant without review. REVIEW CONSIDERATIONS From owner-sci-resources@net.bio.net Mon Mar 21 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-94-010 - V23(11) 03/18/94 Date: 22 Mar 1994 10:52:39 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 747 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2mnepn$2s5@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AI94010 AI-94-010 P1O1 *************************************** MULTICENTER AIDS COHORT STUDY PATHOGENESIS RESEARCH LABORATORY NIH GUIDE, Volume 23, Number 11, March 18, 1994 RFA: AI-94-010 P.T. 34; K.W. 0715008, 0765033, 1002008, 0710070, 1002019, 1002045 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: April 1, 1994 Application Receipt Date: June 15, 1994 PURPOSE The Vaccine Trials and Epidemiology Branch (VTEB) of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), administers major, prospective studies of HIV infection and disease in large, multicenter cohort studies. The largest and longest-running of these studies is the Multicenter AIDS Cohort Study (MACS). The MACS was created in 1983 as a study of HIV infection in homosexual and bisexual men; over 5,500 men have participated in the MACS since the initial 1984 enrollment. The National Cancer Institute co-funds MACS studies of malignancy in HIV infection. The purpose of this Request for Applications (RFA) is to fund a laboratory or a consortium of laboratories to study the immunologic, virologic, and other biologic determinants of disease progression and factors that mitigate HIV-mediated immune system destruction among participants in the MACS. The work to be accomplished requires diverse expertise in HIV virology, immunology, genetics, and molecular biology that must be applied in a highly coordinated manner to adequately address the issues of interest. Therefore, proposed studies should utilize an interdisciplinary approach in which the research plans are well integrated and are based on appropriate collaborations. 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, MACS Pathogenesis Research Laboratory, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-10473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit research institutions, public and private organizations 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. Domestic applications may not include international components. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Successful applicants funded under this RFA will be supported through a National Institutes of Health (NIH) Cooperative Agreement (U01). Cooperative agreements are grants awarded to institutions when it is desired to encourage investigator-initiated research in areas of special importance to the NIH. It is an "assistance" mechanism, rather than an "acquisition" mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH will support and/or stimulate the recipient's activity by working jointly with the awardee in a partner role; the NIH will not assume direction, prime responsibility, or a dominant role in the activity. The advantage of the cooperative agreement funding mechanism for this RFA is to ensure coordination of use of valuable research specimens and data derived from the MACS. This coordination is critical due to the finite and irreplaceable nature of the resource of MACS specimens, and the need to do diverse studies on the same samples. Details of the responsibilities, relationships, and governance of the study to be funded under this cooperative agreement are discussed later in this document under the section "Terms and Conditions of Award." The NIAID intends to award one or two Cooperative Agreements for laboratory studies on the pathogenesis of HIV/AIDS in MACS participants. A collaborative and innovative interdisciplinary approach to address the full spectrum of research objectives is essential. Therefore, applicants are encouraged to coordinate, through the use of consortium arrangements or subcontracts, integrated approaches with individuals or institutions having relevant and demonstrated ability in immunologic, virologic, genetic, and other molecular biologic techniques necessary to address the stated objectives. This RFA solicitation represents a single competition with a specified deadline for receipt of applications. The anticipated award date is April 1, 1995. Awards will be made for a twelve month budget period within a total project period not to exceed four years. Funding beyond the first and subsequent years of the award will be contingent upon satisfactory performance during the preceding years and upon the availability of funds for this purpose. Reissuance of this RFA will be dependent on the state of science and findings at the completion of the grant period. FUNDS AVAILABLE Approximately $800,000 will be available for funding the total costs, both direct and indirect, for the initial year of awards made pursuant to this RFA. The NIAID anticipates making one or two awards as a result of this RFA. The issuance of the final award or awards will be dependent upon receipt of applications of high scientific merit that cover the range of scientific objectives in a comprehensive fashion, and upon the availability of funds. RESEARCH OBJECTIVES Background The ongoing Multicenter AIDS Cohort Study (MACS), which includes four clinical centers and a data center, is supported by VTEB, CRP, DAIDS, NIAID. Studies of HIV-related malignancy in the MACS are co-funded by the NCI. MACS clinical centers are located at Johns Hopkins University, Baltimore, MD; the University of Pittsburgh, Pittsburgh, PA; the Howard Brown Memorial Clinic/Northwestern University, Chicago, IL; and the University of California at Los Angeles in Los Angeles, CA. The Center for the Analysis and Management of MACS Data (CAMACS) is located at Johns Hopkins University in Baltimore, MD. The MACS was created in 1983 as a study of HIV infection in homosexual and bisexual men; over 5,500 men have been enrolled in the MACS since 1984. The remarkable dedication of MACS participants and MACS site study staff has resulted in a high retention rate with a loss to follow-up of approximately 20 percent among HIV-infected men after ten years. Because of the continuing unique scientific contributions of this large prospective, multi-site cohort study, the NIAID intends to renew support for the MACS clinical centers and data center to follow and study selected MACS participants for clinical and laboratory outcomes and to collect specimens for pathogenesis research. The selected participants to be followed will include: (1) all HIV-seropositive men who were enrolled in the study as seroprevalent cases or who have seroconverted while in the study, (2) HIV-seronegative men at high risk of HIV acquisition based on behavioral assessments, and (3) a matched subset of HIV-seronegative men who are at lower risk of HIV infection. The NIAID currently plans to follow these MACS participants from the present time through at least 1999. The MACS research infrastructure offers a unique focus for study of HIV pathogenesis including: 1. A ten year prospective cohort study with well documented longitudinal clinical and laboratory outcomes data of HIV infection and disease. 2. A repository of clinical specimens of serum, plasma, and PBMCs that cover the natural history of HIV infection and disease. 3. Extensive clinical, epidemiologic, and statistical expertise within the MACS infrastructure that will be available to assist in the design and analysis of the laboratory studies. Approximately 1,800 men were found to be HIV-seropositive upon initial enrollment in 1984-1985; an additional 350 HIV- seropositive men were enrolled from 1987-1991. Over 450 of the seronegative men have seroconverted while being followed in the MACS. Approximately seventy men have displayed no CD4+ cell loss despite at least nine years of HIV infection (and without receipt of antiretroviral therapy). On the other end of the spectrum, at least twenty men have rapidly developed immunodeficiency disease, developing AIDS within three years of documented seroconversion. Other potentially important variants from the classical pattern of HIV-mediated CD4+ cell decline have been documented among HIV-infected MACS participants, including persons remaining clinically stable for long periods despite very low CD4+ cell counts. Additionally, the MACS follows at least 250 men who did not become infected with HIV despite a history of high-risk sexual behavior. MACS participants are followed at the clinical centers every six months, where they respond to a detailed health questionnaire, receive a physical examination, and have blood specimens taken. Blood specimens are processed and stored as frozen serum, plasma, and cells in the NIAID HIV Vaccine Trials and Epidemiology Specimen Repository. These stored specimens will be made available to the MACS Pathogenesis Research Laboratory. In addition, arrangements may be made with the MACS sites via the NIAID Program Officer to prospectively collect samples of blood and other body fluids and tissues, such as semen and lymph nodes, for specific MACS pathogenesis protocols, and to increase the frequency of follow-up for a small number of participants where necessary. Availability of these additional specimens and ability to increase follow-up frequency will be contingent on study feasibility, obtaining local IRB approval and necessary informed consent, and the agreement of the participants who comprise the MACS cohort. Further information regarding the MACS research infrastructure, cohort organization, sample sizes, MACS publications bibliography, specific characteristics of MACS participants (e.g., men who are rapid progressors, seroconverters, and slow progressors) and specific features of the stored specimens (e.g., numbers, types, prior experience with quality of stored cells) will be provided upon contacting the MACS Program Officer listed under INQUIRIES. Research Scope Additional study of host immunologic, virologic, genetic, and other determinants of HIV infection and disease progression is needed to gain a better understanding of the pathogenesis of HIV/AIDS. This information is crucial for the development of effective therapies for HIV/AIDS and design of vaccines against HIV infection. Accordingly, the NIAID is encouraging intensive broad-based laboratory studies including state-of-the-art and innovative approaches to the study of host and viral factors that contribute to the pathogenesis of HIV infection and disease. Applications are invited from investigators to conduct laboratory investigations on the pathogenesis of HIV infection using clinical specimens available from the MACS. The proposed studies should emphasize close integration of the immunologic, virologic, and other biological investigations being planned. Preference will be given for studies of high scientific merit for which the cohort research approach is essential, including effective utilization of the unique MACS database and the MACS-derived specimens stored at the NIAID HIV Vaccine Trials and Epidemiology Branch Specimen Repository. Each application must address the first of the following two areas of pathogenesis research. Applicants have the option of addressing the second area of pathogenesis research listed below: 1. The identification and characterization of the host immunologic factors and the virologic factors that correlate with the progression and/or non-progression of HIV disease in individuals who maintain high (e.g., above 500 CD4+ cells per microliter), stable CD4+ cell counts despite long periods of HIV infection; 2. The identification and characterization of the host immunologic factors and the virologic factors that correlate with the progression and/or non-progression of HIV disease in individuals whose CD4+ cell counts decline to low levels (e.g., below 200 CD4+ cells per microliter) but who remain clinically stable for prolonged periods. Highly innovative and creative approaches to studying the general areas covered in item (1) above (required) and item (2) above (optional), as well as related issues concerning the study of HIV pathogenesis in MACS participants, are encouraged. Examples of investigations sought through this RFA include, but are not limited to, those listed below: o Studies of humoral antibody responses (e.g., binding, neutralizing, enhancing, ADCC), cell-mediated responses (e.g., cytotoxic T cell activity), and nonspecific immune responses or immunoregulatory events (e.g., lymphokine secretion, natural killer cell activity, apoptosis) that may mediate or protect against immune system destruction or other HIV-related pathology, including characterization of the pattern of responses in the various stages of HIV infection and identification of the specific epitopes of HIV involved; o Studies of viral variables correlated with HIV pathogenesis (e.g., HIV phenotype, viral load, pattern of sequence variation during infection); o Studies of host and viral factors that may explain long-term clinical stability sometimes noted in subjects with low CD4+ cell counts; o Studies of other host factors that enhance viral replication, HIV pathogenesis, (e.g., studies of histopathology, immune dysregulation, genetic susceptibility, etc.) during the course of HIV infection from initial infection through development of disease. SPECIAL REQUIREMENTS A. Cooperation, Collaboration and Meetings The MACS Pathogenesis Research Laboratory(s) will propose and conduct the relevant pathogenesis studies in the areas of research listed above. As work progresses, the Principal Investigator(s) may seek input from the MACS clinical and data centers and the NIAID Program Officer regarding design and implementation of studies. Therefore, to be considered responsive to this RFA, an applicant must include a statement of willingness to work in close cooperation and collaboration with the MACS research infrastructure, whenever this is indicated. The Principal Investigator(s) of the MACS Pathogenesis Research Laboratory(s) will be members of the MACS Pathogenesis Steering Committee established under this RFA. The MACS Pathogenesis Steering Committee will be composed of the Principal Investigator(s) from the MACS Pathogenesis Research Laboratory(s), the Principal Investigators of the MACS clinical sites, the Principal Investigator from the MACS data center, and the NIAID Program Officer. Each member of the Steering Committee will have one vote. The chairperson, who will be someone other than the NIAID Program Officer, will be selected by the Steering Committee. Subcommittees will be established by the Steering Committee as it deems appropriate; the Program Officer will serve on subcommittees as he/she deems appropriate. Awardees will be required to accept and implement the protocols and procedures approved by the Steering Committee. The MACS Pathogenesis Steering Committee will be the primary organization responsible for the coordination of the activities of the MACS Pathogenesis Research Laboratory(s) with the MACS clinical centers and the MACS data center. The NIAID Program Officer will help facilitate coordination of pathogenesis research activities between the MACS Pathogenesis Research Laboratory(s), the MACS clinical centers, and the MACS data center. The MACS Pathogenesis Steering Committee will have monthly conference calls and will meet approximately three times yearly, either in the Washington, DC metropolitan area or in conjunction with national HIV/AIDS scientific meetings. Senior investigators of the MACS Pathogenesis Research Laboratory(s) are also expected to participate as members of the MACS Laboratory Research Working Group, created under this RFA. This group will include senior investigators in the MACS "core" laboratories performing routine laboratory and virology assays at the MACS clinical sites (described in greater detail under "Specimens", below), as well as a representative from the MACS data center. The LRWG will have regular conference calls and two annual meetings per year that usually will be held at one of the MACS clinical sites, or at the site(s) of the MACS Pathogenesis Research Laboratory(s). In addition, senior investigators from the MACS Pathogenesis Research Laboratory(s) will be expected to attend and present data at the Annual Research Meeting of the MACS, which is held in the Rockville, MD area. Applicants should include in their application a statement of their willingness to participate in the required meetings described above and should include funds for these meetings in their budget requests. Note that one of the Pathogenesis Steering Committee meetings and one of the LRWG meetings will be held in conjunction with the annual research meeting of the MACS. B. Specimens MACS specimens for the conduct of studies undertaken by the MACS Pathogenesis Research Laboratory(s) will be provided from the NIAID HIV Vaccine Trials and Epidemiology Specimen Repository. Fresh blood and body fluid specimens, and biopsy and necropsy tissue specimens, will be made available to the MACS Pathogenesis Research Laboratory(s) according to the needs of specific protocols. In special cases when specimens are no longer available from the NIAID HIV Vaccine Trials and Epidemiology Specimen Repository, (e.g., due to their prior usage), the NIAID Program Officer will facilitate the efforts of the MACS Pathogenesis Research Laboratory(s) in obtaining appropriate specimens from the MACS clinical centers. Applicants to this RFA should be aware that the MACS Pathogenesis Research Laboratory(s) will not have sole access to MACS specimens in the NIAID HIV Vaccine Trials and Epidemiology Specimen Repository. MACS specimens also will be made available by the NIAID to independent investigators upon review and approval of requests for specific research purposes. However, the release of MACS specimens for studies to be undertaken by the MACS Pathogenesis Research Laboratories will be based upon an expedited approval process, requiring NIAID Program Officer approval of specimen utilization. Use of MACS samples from the NIAID VTEB Repository will require review and approval by the DAIDS repository review process. The NIAID Program Officer will be responsible for ensuring that the efforts of the MACS Pathogenesis Research Laboratory(s) are compatible with those sponsored by other NIAID groups, particularly the contract anticipated to be awarded in 1994 for "Correlates of Immune Protection in AIDS." Applicants for this RFA also should note that core laboratory studies are conducted by the MACS clinical site laboratories, including quantitation of CD4+ and CD8+ T cell subsets on all MACS participants and HIV serology on all seronegative MACS participants. These data are included in the general MACS epidemiologic and clinical laboratory database and are available for research sponsored under this RFA, through collaboration with the MACS clinical sites and data center as facilitated by the NIAID Program Officer. A list of the specific assays and studies to be performed by the MACS core laboratories is available from the Program Officer listed under INQUIRIES. C. Reporting, Access to Data, and Publication of Research Findings The reporting requirements currently required of all awardees of traditional NIH research project grants will apply to the recipient(s) of this RFA. Program staff will have access to all study protocols and data generated under this cooperative agreement. Awardee(s) will retain rights to the data (see below). All data from the MACS Pathogenesis Research Laboratory(s) that require analysis with other MACS data will be submitted to the MACS data center as facilitated by the NIAID Program Officer. These laboratory data will remain the intellectual property of the awardee from which they originated, even following submission to the MACS data center and will not be used without the permission of the Principal Investigator of the specific MACS Pathogenesis Research Laboratory which generated these data. Data forms and software for transferring laboratory data to the MACS data center will be developed by the data center with the technical assistance of the grantee. Publications of results from MACS Pathogenesis Research Laboratory investigations must make appropriate acknowledgement of contributions made by MACS clinical and data centers. D. Terms and Conditions of Award Consistent with the concept of a cooperative agreement, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardee(s) and the NIAID Program Officer. 1. Awardee Rights and Responsibilities The Principal Investigator(s) of the MACS Pathogenesis Research Laboratory(s) under this RFA will be responsible for the overall conduct of the studies performed at the Principal Investigator's institution or at the subcontracting laboratories within a proposed consortium. This responsibility includes the production of high quality data and the analysis and publication of the research results. 2. NIAID Rights and Responsibilities The NIAID will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants, as described below: The NIAID will assist the Principal Investigator(s) of the MACS Pathogenesis Research Laboratory(s) selected under this RFA through a Program Officer who will be designated by the Chief, VTEB, CRP, DAIDS. The role of NIAID Program Officer will be to facilitate and not to direct the activities of the laboratory investigators funded through this cooperative agreement. The NIAID Program Officer will support and facilitate the performance of research efforts of the laboratory or laboratories selected under this RFA in the following ways: a. by providing ongoing assistance and coordination in overall research planning, data gathering methodologies, analysis, and reporting; b. by providing the assistance of the MACS data center to support the awardee or awardees in areas including statistical and data collection, analysis, and publication; c. by ensuring that coordination of communication and facilitation of information exchange occurs between the laboratory or laboratories selected under this RFA and the MACS clinical sites, the MACS "core" laboratories, the MACS clinical centers, and the MACS data center; d. by releasing relevant MACS specimens from the NIAID HIV Vaccine Trials and Epidemiology Specimen Repository. 3. Collaborative Responsibilities The Principal Investigator(s) of the MACS Pathogenesis Research Laboratory(s) will be responsible for the scientific conduct of these studies. The NIAID Program Officer will be responsible for facilitating these collaborations. The Principal Investigator(s) of the MACS Pathogenesis Research Laboratory(s) will be members of the MACS Pathogenesis Steering Committee established under this RFA. The MACS Pathogenesis Steering Committee will be composed of the Principal Investigator(s) from the MACS Pathogenesis Research Laboratory(s), the Principal Investigators from the MACS clinical sites, the Principal Investigator from the MACS data center, and the NIAID Program Officer. Awardees will be required to accept and implement the protocols and procedures approved by the Steering Committee. Senior investigators of the MACS Pathogenesis Research Laboratory(s) are also expected to participate as members of the MACS Laboratory Research Working Group, created under this RFA. This group will include senior investigators in the MACS "core" laboratories performing routine laboratory and virology assays at the MACS clinical sites, as well as a representative from the MACS data center. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters within the scope of the award, between award recipients and NIAID, may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the MACS Pathogenesis Steering Committee (or by the individual awardee in the event of an individual disagreement), a second member selected by the NIAID, and a third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS Ordinarily, for projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. However, the MACS is a study of homosexual and bisexual men, including men of minority racial and ethnic background. Hence, a specific justification for the absence of women in this study need not be provided. Seven hundred and fifty men of minority background were enrolled in the MACS from 1984-1985. An additional 432 minority men were enrolled in the MACS from 1987-1991 in a targeted effort to enroll men from minority backgrounds in the study. Five hundred and seventy one men of minority background continue to be followed in the MACS; 299 of these men are HIV-seropositive. Applicants are encouraged to include proposals for research projects that best utilize the relatively limited specimens available from minority MACS participants. Biohazard and Biosafety Procedures Applicants should ensure and document that adequate procedures are in place for avoidance of biohazards and enhancing of biosafety. The following reference is available from the Occupational Safety and Health Branch, NIH Division of Safety, telephone 301-496-2960: Richmond JY, McKinney RW, eds. Biosafety in Microbiological and Biomedical Laboratories, 1993. Washington, DC: US Department of Health and Human Services, Public Health Service. HHS Publication no. (CDC) 93-8395. LETTER OF INTENT Prospective applicants are asked to submit, by April 1, 1994, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the Principal Investigator; the identities of other key personnel and participating institutions (if applicable), and the number and title of this RFA. The letter of intent does not commit the sender to submit an application, is not a requirement for submission of an application, and will not enter into the review of subsequent applications. The information contained in the letter will be used to allow NIAID staff to estimate the number and scope of applications to be reviewed, and help avoid conflict of interest in the review process. Letters of intent are to be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these cooperative agreements. These forms are available at most institutional offices of sponsored research; the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594- 7250; and from the NIH Program Administrator listed under INQUIRIES. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Because of the inherent complexity of the research to be performed, applicants will be permitted to utilize up to 35 pages when submitting their research plans in sections 1-4 of the Research Plan in form PHS 398. Applicant institutions are reminded that adequate protection for human subjects in research is an essential requirement of the NIH. The investigators in the laboratory(s) or laboratory consortium(ia) supported under this grant will be utilizing specimens obtained from human subjects in an NIAID-sponsored clinical study, making this concern applicable to the primary grant recipient as well as the subcontractees. As a condition of award, not as a condition of application, applicants are required to demonstrate approval of the research plan by an Institutional Review Board (IRB) or an equivalent oversight body. Applicants will be notified if additional information is required on this matter. Submit a signed, typewritten original of the application, and three signed, exact, single-space photocopies, in one package, to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional exact copies of the grant application and all five sets of appendix material must also be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. Applications must be received by June 15, 1994. An application not received by this date 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 also will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS A. Review Method Upon receipt, applications will be reviewed by the DRG for completeness and by NIAID staff for responsiveness to the RFA. Incomplete or non-responsive applications will be returned to the applicant without further consideration. To be considered responsive to this RFA, applications must address research goal (1) set forth under the section "Research Scope"; researchers have the option of responding to research goal (2). A decision not to respond to research goal (2) will not reflect negatively on any application received. Those applications judged to be complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIAID. This initial review may include a triage; the NIAID will withdraw from further consideration applications judged to be noncompetitive and will notify the Principal Investigator and the official signing for the applicant's organization. Those applications judged to be competitive will be evaluated further for scientific and technical merit by the usual peer review procedures. Each application will receive a priority score based upon review criteria listed below. The second level of review will be provided by the NIAID Council in February 1995. B. Review Criteria Factors to be considered in the evaluation of each application will be similar to those used in review of traditional research grant applications. Major factors to be considered in the evaluation of applications will include: 1. Scientific merit of the proposed projects, including innovation and originality of hypotheses, feasibility of the scientific approach, and development plans, status, and validity of the laboratory methods to be applied; adequacy of the experimental design and relevance to understanding HIV pathogenesis via effective utilization of the unique resources offered by the MACS. 2. Competence of the investigators to accomplish the proposed research goals, including their prior experience in collaborative research efforts and the time they will devote to this initiative. 3. Adequacy of facilities for the performance of the proposed research. 4. Evidence of integration and coordination among the laboratory disciplines within a given laboratory or consortium. 5. Experience of the sponsoring organization or institution in comparable laboratory research efforts. 6. Evidence of adequate quality assurance of laboratory assays. The presentation should include discussions of sensitivity, specificity, and reproducibility of proposed assays, or how these will be studied if the proposed assays are in the early developmental phases. The presentation should also describe appropriate positive and negative controls to be used in each assay. External performance evaluation procedures that will be done on panels of well characterized specimens should be described. To ensure objectivity in laboratory assays, the NIAID HIV Vaccine Trials and Epidemiology Specimen Repository will provide blinded specimens on instruction by NIAID staff. 7. Appropriateness of the plan to collaborate with MACS epidemiologic, clinical, and biostatistical investigators through the MACS Pathogenesis Steering Committee and the MACS Laboratory Research Working Group. 8. Appropriateness of the budget for the proposed research studies. AWARD CRITERIA It is anticipated that one or two MACS Pathogenesis Research Laboratories will be selected under a cooperative agreement through this RFA. While not a requirement for selection, it is anticipated that applicants will develop a consortium with other laboratories to complement the research activities intended under this RFA. The number of awards and the specific amount to be awarded will depend on the merit and scope of the applications received and on the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcomed. Direct inquiries regarding programmatic or scientific issues to: Lewis K. Schrager, M.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2B-10 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-6177 Direct inquiries regarding review issues, address the letter of intent to, and mail two copies of the application and five sets of appendices to: Dr. Dianne Tingley Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C01 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-0818 Questions regarding administrative policy and fiscal matters may be addressed to: Ms. Ann Devine Grants Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 4B22 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7075 Schedule Letter of Intent Receipt Date: April 1, 1994 Application Receipt Date: June 15, 1994 Anticipated Award Date: April 1, 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.85 "Microbiology and Infectious Disease Research" and No. 93.855 "Immunology," "Allergic and Immunologic Diseases Research." Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Mon Mar 21 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA RR/OD-94-004 - V23(11) 03/18/94 Date: 22 Mar 1994 10:52:32 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 452 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2mnepg$2rr@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA ROD94004 RR/OD-94-004 P1O1 *********************************** SCIENCE EDUCATION PARTNERSHIP AWARD NIH GUIDE, Volume 23, Number 11, March 18, 1994 RFA: RR/OD-94-004 P.T. 34; K.W. 0502000 National Center for Research Resources Letter of Intent Receipt Date: April 15, 1994 Application Receipt Date: June 16, 1994 PURPOSE The main objective of the Science Education Partnership Award (SEPA) Program is to encourage active biomedical/behavioral scientists to work in partnerships with educators and other organizations to improve the student (K-12) and public understanding of the health sciences. In Fiscal Year 1991 the former Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) and the National Institutes of Health (NIH) issued a joint Request for Applications (RFA) AD-91-01 and OD-91-01 for the Science Education Partnership Award (SEPA) Program. Twenty-four pilot programs were funded under this RFA to determine the feasibility of scientists, educators, media experts, and community leaders working together in partnerships to increase the scientific literacy of Americans. This RFA solicits applications to further develop existing model pilot science education partnership programs aimed at improving health-science education at the K-12 level and/or the science literacy of the general public in human health. The intent of this RFA is to support finalization of such programs, their evaluation and the development of effective strategies for disseminating them in a manner which will produce a significant impact on the quality of health science education. 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, Science Education Partnership Award, is related to all priority areas. 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 Organizations with a scientific or educational mission are eligible to submit applications. Such groups include colleges and universities; state and local education agencies; professional societies; museums; research laboratories; media producers; private foundations and industries; and other public and private education-related organizations, for-profit and non-profit. Foreign institutions are not eligible. Only programs that have demonstrated strong cooperative efforts/partnerships between the scientific and educational communities will be considered responsive. Applications to develop new model programs will not be accepted. The existing pilot model programs in science education must have been developed during the last five years and must possess all the following elements to be considered responsive to this RFA: (1) substantive scientific content in human health (2) established and productive partnerships between educators and scientists with demonstrated expertise in biomedical or behavioral research (3) well-designed program assessments and evaluations (4) potential for significant impact on quality of health-science education MECHANISM OF SUPPORT This RFA will use the education projects (R25) mechanism and is a one-time solicitation. Applicants will be responsible for the planning, direction, and execution of the proposed programs. The total project period for applications submitted in response to this RFA may not exceed three years. The anticipated award date is September 30, 1994. Because of the wide range of programs expected to be proposed, it is anticipated that the size of an award may vary also. The total project period proposed may range from one to three years. Annual direct costs requested are expected to range from approximately $50,000 to $250,000. Indirect costs will be paid at the lesser of eight percent of the modified total direct costs or the negotiated rate of the grantee institution. FUNDS AVAILABLE The NIH expects that through the National Center for Research Resources (NCRR) and the Office of Science Education Policy, Office of the Director, NIH, $1,750,000 will be available during FY 1994 to support this initiative, subject to the receipt of a sufficient number of meritorious applications. It is anticipated that approximately ten to fifteen awards will be made. The award of grants pursuant to this RFA is contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background In order for the National Institutes of Health to fulfill its mission, it is necessary for adequate numbers of students to enter and remain in mathematics and science education tracks so that there will be a sufficient supply of scientists, engineers, and technicians to meet the nation's future workforce needs. The NIH is also dependent on a scientifically literate public that understands the behaviors that increase the risk of disease and the necessity for basic research to make progress toward improving health. To help address these issues, the NIH has initiated a number of science education programs for students, teachers, and the general public. The original SEPA program seeded the development of a variety of model programs in the health-related life sciences. The programs funded were designed to convey the scientific process in a way which makes science fun and interesting for the students and which captured their enthusiasm for science. Programs aimed at the general population were directed to increasing their knowledge of scientific terms, concepts and reasoning, and their ability to understand scientific policy issues. To gain maximum benefit from the program, priority was given to projects that were innovative and had the potential to be replicated for widespread use. The model programs focused on biomedical science areas such as molecular biology, genetics, and immunology, and on behavioral science areas such as brain and behavior and their reaction to the addictive and mental disorders. Other aspects of health science such as the responsible use of animals in science, programs which supported health promotion and disease prevention, and programs supporting science education for the special needs of underrepresented groups were included. While the SEPA projects represented new activities which focused on health-related science, coordination with other science education programs such as those funded by the National Science Foundation, the Department of Energy, and the Department of Education were encouraged. Program Description This RFA is meant to (a) support the finalization of those model pilot programs that need additional time to evolve and mature into finished products and (b) provide funding for developing effective strategies for the dissemination of well-tested programs so that they can reach a larger audience and have a significant impact on scientific literacy in the biomedical/behavioral sciences. Only those programs that have been subjected to evaluations for corrective feedback should be considered for replication. Methods to adapt such model programs for dissemination on a regional or national scale are desired. Use of advanced technologies that incorporate modern pedagogical approaches are highly encouraged (for example, technology based curricula and interactive computer strategies for enhancing both student and teacher learning). Detailed dissemination plans are required. Leverage of NIH support to secure other sources of funding may be warranted to insure wide-range dissemination of effective projects. Whether the pilot program falls in category (a) or (b), the research plan must describe the program accomplishments and plans for continuation of the project (see APPLICATION PROCEDURES). SPECIAL REQUIREMENTS Principal Investigator meetings will be convened to foster collaboration, discuss new emerging national standards, coordinate dissemination, share evaluation methodologies and outcomes and avoid unnecessary duplication of efforts. Travel funds for this activity should therefore be included in the budget request of the application; a statement regarding willingness to participate in this activity should also be included in the application. General Requirements Publications or audiovisual materials costing over $25,000 each may be produced with project funds only if prior written approval is obtained from the funding agency. Two copies of the finished product must be supplied along with the annual or final progress report. Any products derived from the project activity must be publicized and must be freely available in the public domain. Any project funded under the SEPA may not be used to endorse or publicize any profit-making activities. An annual progress report must be filed with the Grants Management Officer of the awarding agency, and a final report is due within 90 days of the end of the project period. Reports should summarize the goals, methods, and results of the activity undertaken. It should also be accompanied by at least two copies of any materials intended for dissemination developed as part of the SEPA project. Grant funds may be used for expenses clearly related and necessary to conduct research projects, including both direct costs that can be specifically identified with the project and allowable indirect costs of the institution. Expenses must be itemized and justified for each year of the proposed project. The general requirements cited above represent only a portion of applicable Public Health Service policy under which SEPA awards will be administered. All awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000 (rev. October 1, 1990). All SEPA program awardees should have access to a copy of this document. LETTER OF INTENT Prospective applicants are asked to submit, by April 15, 1994, a letter of intent that includes a descriptive title of the proposed program, the name, address, and telephone number of the Principal Investigator, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information contained is helpful in planning for the review of applications. It allows NCRR staff to estimate the potential review workload and avoid possible conflict of interest in the review. The letter of intent is to be sent to: Dr. Marjorie A. Tingle Biomedical Research Support Program National Center for Research Resources Westwood Building, Room 848 Bethesda, MD 20892 APPLICATION PROCEDURES Applications are to be submitted using form PHS 398 (rev. 9/91). These forms are available in most institutional offices of sponsored research and may be requested from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Applications must follow the instructions provided in the PHS 398 form except for the following: Form Page 1 - Item 2a. - Identify the number and the title of this RFA and check the box marked "YES." Item 2b. - Type "R25" in 2b. Items 4 and 5 on the face page must be completed. Where appropriate, Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) approval must be obtained for each research project for which NIH support is requested. Item 6. The project period begin date should be 09-30-94. The length of the project period may not exceed three years. Research Plan In general, this part of the application should be used to provide information sufficient to allow the reviewers to assess the project in terms of the stated review criteria below. Progress/Accomplishments o Describe the accomplishments of the existing pilot program. Include a description of the educational approach, the scientific content of the program, and the type and extent of the educational and scientific partnerships and collaborations. o Provide a description of the educational material produced. Do not include the actual printed material, videotapes, etc. in the Research Plan. These materials should be referred to in the Research Plan as Exhibit 1, 2, etc. and included as an appendix to the application. o Present information on the evaluation of the program. Do not include copies of evaluation materials, e.g., questionnaires, in the Research Plan; include these materials in the appendix. o Describe, if appropriate, dissemination efforts. Proposed Plan The proposed plan should: o Describe the plans for continuation of the pilot program. o Describe the proposed educational approach and scientific content. o Describe how the plan would contribute to the enhancement of scientific literacy in the biomedical/behavioral sciences. o Describe dissemination strategies and scope of the plan, including efforts aimed at underrepresented groups including both minorities and women. o Describe the evaluation plan and discuss potential limitations of the plan. o Describe the plans for continuation of the program following termination of NIH support. Appendix Material Copies of the educational and evaluations materials developed should be labeled sequentially as Exhibit 1, 2, etc., and included as an appendix to the application. Prior to the time of submission, applicants are urged to contact Dr. Sestili at the address listed below concerning the submission of appendix material. In addition, pay particular attention to the address noted below to which all copies of appendix material are to be sent. The RFA label in the PHS 398 kit 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. The signed, typewritten original of the application, Checklist, and three exact photocopies of the signed application, excluding appendix material must be submitted to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application and five copies of all appendix material must be sent to: Dr. Mary Ann Sestili Office of Review National Center for Research Resources Westwood Building, Room 10A16 Bethesda, MD 20892 Telephone: (301) 594-7902 Applications must be submitted by June 16, 1994. Applications submitted after this date will be returned to the applicant. REVIEW CONSIDERATIONS Applications will be reviewed by Division of Research Grants (DRG) staff for completeness and by NCRR staff to determine administrative and programmatic responsiveness to this RFA. Those applications judged to be incomplete or nonresponsive will be returned to the applicant without review. Those applications considered complete and responsive may be subjected to a triage review by an NCRR peer review group to determine their scientific merit relative to the other applications submitted in response to this RFA. The NIH will withdraw from competition those applications judged by the triage peer review group to be noncompetitive for award and will so notify the applicant investigator and the institutional business official. Those applicants judged to be competitive for award will be reviewed for scientific and technical merit by an appropriate as hoc review committee(s) to be convened by the Office of Review, NCRR. The second level of review will be conducted by the National Advisory Research Resources Council in September 1994. Potential applicants are strongly encouraged to consider carefully the specific review criteria listed in the RFA before submitting an application or contacting staff. Review Criteria Past accomplishments This criterion assesses the various past program achievements, presence of substantive health-related scientific content in the project, strength of the existing partnership arrangements, especially with the biomedical community or NIH funded investigators, outcomes of formative and/or summative evaluations, program impact, and dissemination efforts, if appropriate. Proposed program o Merit of the proposed educational approach and the presence of substantive health-related scientific content in the proposed program and ties with the NIH funded community. o Overall quality, feasibility, and adequacy of the design of the program to achieve its specific aims and long term objectives. o Quality of the program leadership in terms of past record of achievements and qualifications to implement future plans as proposed. o Extent of educational and scientific partnerships and collaborations; evidence of commitment from critical partners. o Relevance and impact of the proposed program on the enhancement of scientific literacy in the biomedical and/or behavioral sciences. o Potential impact of reaching a broad population, including underrepresented groups. o Merit of the program's evaluation plans. This criterion addresses the effectiveness of the proposed methodologies and the data collection strategies. o Accessibility, feasibility, scope, and cost effectiveness of dissemination strategies. o Plans to sustain the program after the period of grant support ends. AWARD CRITERIA The following will be considered when making funding decisions: the merit of the application, availability of funds, program balance among various types of projects, and geographic distribution of the awards. Consideration will be given to reaching minority and/or female populations. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquires regarding programmatic issues to: Dr. Marjorie A. Tingle or Dr. Abraham Levy Biomedical Research Support Program National Center for Research Resources Westwood Building, Room 848 Bethesda, MD 20892 Telephone: (301) 594-7947 Direct inquiries regarding fiscal matters to: Ms. Mary V. Niemiec Office of Grants and Contracts Management National Center for Research Resources Westwood Building, Room 849 Bethesda, MD 20892 Telephone: (301) 594-7955 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93-922. Awards will be made under authorization of the Public Health Service Act, Title III, Part A (Public Law 78-410, as amended, 42 USC 241) 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. From owner-sci-resources@net.bio.net Mon Mar 21 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 11, pt. 2, 18 March 1994 Date: 22 Mar 1994 10:52:25 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 965 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2mnep9$2rh@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940318 V23N11 P2O2 ************************************ Upon receipt, applications will be reviewed by the Division of Research Grants for completeness and by NIAID staff for responsiveness to the RFA. Incomplete or non-responsive applications will be returned to the applicant without further consideration. Those applications judged to be complete and responsive may be subjected to triage by an NIAID peer review group to determine their scientific merit relative to the other applications received in response to this RFA. The NIAID will withdraw from further consideration applications judged to be noncompetitive and will promptly notify the Principal Investigator and the official signing for the applicant's organization. Those applications judged to be competitive will be evaluated further for scientific and technical merit by the usual peer review procedures. Detailed review criteria are provided in the RFA. The second level of review will be provided by the NIAID Council in February 1995. AWARD CRITERIA It is anticipated that one or two MACS Pathogenesis Research Laboratories will be selected under a Cooperative Agreement through this RFA. While not a requirement for selection, it is anticipated that applicants will develop a consortium with other laboratories complement the research activities intended under this RFA. The number of awards and the specific amount to be awarded will depend on the merit and scope of the applications received and on the availability of funds. INQUIRIES It is essential that prospective applicants obtain a copy of the RFA before preparing an application. Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcomed. Direct requests for the RFA and inquiries regarding programmatic or scientific issues to: Lewis K. Schrager, M.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2B10 Bethesda, MD 20892 Telephone: (301) 496-6177 Letters of intent, and inquiries pertaining to review of applications may be directed to: Dr. Dianne Tingley Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C01 Bethesda, MD 20892 Telephone: (301) 496-0818 Questions regarding administrative policy and fiscal matters may be addressed to: Ms. Ann Devine Grants Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 4B22 Bethesda, MD 20892 Telephone: (301) 496-7075 Schedule Letter of Intent Receipt Date: April 1, 1994 Application Receipt Date: June 15, 1994 Anticipated Award Date: April 1, 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.85 "Microbiology and Infectious Disease Research" and No. 93.855 "Immunology," "Allergic and Immunologic Diseases Research." Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R2 END ************************************************************ $$R3 BEGIN RR/OD-94-004 FULL-TEXT *********************************** SCIENCE EDUCATION PARTNERSHIP AWARD NIH GUIDE, Volume 23, Number 11, March 18, 1994 RFA AVAILABLE: RR/OD-94-004 P.T. 34; K.W. 0502000 National Center for Research Resources Letter of Intent Receipt Date: April 15, 1994 Application Receipt Date: June 16, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The main objective of the Science Education Partnership Award (SEPA) Program is to encourage active biomedical/behavioral scientists to work in partnerships with educators and other organizations to improve the student (K-12) and public understanding of the health sciences. In Fiscal Year 1991 the former Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) and the National Institutes of Health (NIH) issued a joint RFA AD-91-01 and OD-91-01 for the Science Education Partnership Award (SEPA) Program. Twenty-four pilot programs were funded under this RFA to determine the feasibility of scientists, educators, media experts, and community leaders to work together in partnerships to increase the scientific literacy of Americans. This RFA solicits applications to further develop existing model pilot science education partnership programs aimed at improving health-science education at the K-12 level and/or the science literacy of the general public in human health. The intent of this RFA is to support finalization of such programs, their evaluation, and the development of effective strategies for disseminating them in a manner that will produce a significant impact on the quality of health science education. 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, Science Education Partnership Award (SEPA), is related to all priority areas. 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 Organizations with a scientific or educational mission are eligible to submit applications. Such groups include colleges and universities; state and local education agencies; professional societies; museums; research laboratories; media producers; private foundations and industries; and other public and private education-related organizations, for-profit and non-profit. Foreign institutions are not eligible. Only programs that have demonstrated strong cooperative efforts/partnerships between the scientific and educational communities will be considered responsive. Applications to develop new model programs will not be accepted. The existing pilot model programs in science education must have been developed during the last five years and must possess all the following elements to be considered responsive to this RFA: (1) substantive scientific content in human health (2) established and productive partnerships between educators and scientists with demonstrated expertise in biomedical or behavioral research (3) well-designed program assessments and evaluations (4) potential for significant impact on quality of health-science education MECHANISM OF SUPPORT This RFA will use the education projects (R25) mechanism and is a one-time solicitation. Applicants will be responsible for the planning, direction, and execution of the proposed programs. The total project period for applications submitted in response to this RFA may not exceed three years. The anticipated award date is September 30, 1994. Because of the wide range of programs expected to be proposed, it is anticipated that the size of an award may vary also. FUNDS AVAILABLE The NIH expects that through the National Center for Research Resources (NCRR) and the Office of Science Education Policy, Office of the Director, NIH, $1,750,000 will be available during FY 1994 to support this initiative, subject to the receipt of a sufficient number of meritorious applications. It is anticipated that approximately ten to fifteen awards will be made. The total project period proposed may range from one to three years. Annual direct costs requested are expected to range from approximately $50,000 to $250,000. Indirect costs will be paid at the lesser of eight percent of the modified total direct costs or the negotiated rate of the grantee institution. The award of grants pursuant to this RFA is contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES This RFA is meant to: (a) support the finalization of those model pilot programs that need additional time to evolve and mature into finished products and (b) provide funding for developing effective strategies for the dissemination of well-tested programs so that they can reach a larger audience and have a significant impact on scientific literacy in the biomedical/behavioral sciences. Only those programs that have been subjected to evaluations for corrective feedback should be considered for replication. Methods to adapt such model programs for dissemination on a regional or national scale are desired. Use of advanced technologies that incorporate modern pedagogical approaches are highly encouraged (for example, technology based curricula and interactive computer strategies for enhancing both student and teacher learning). Detailed dissemination plans are required. Leverage of NIH support to secure other sources of funding may be warranted to insure wide-range dissemination of effective projects. LETTER OF INTENT Prospective applicants are asked to submit, by April 15,1994, a letter of intent that includes a descriptive title of the proposed program, the name, address, and telephone number of the Principal Investigator, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information contained is helpful in planning for the review of applications. It allows NCRR staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to Dr. Marjorie A. Tingle at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted using form PHS 398 (rev. 9/91). These forms are available in most institutional offices of sponsored research and may be requested from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Applicants must request the RFA, which contains essential information for completion of the PHS 398 form. The signed, typewritten original of the application, Checklist, and three exact photocopies of the signed application, excluding appendix material must be submitted to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application and five copies of all appendix material must be sent to: Dr. Mary Ann Sestili Office of Review National Center for Research Resources Westwood Building, Room 10A16 Bethesda, MD 20892 Telephone: (301) 594-7902 Applications must be submitted by June 16, 1994. Applications submitted after this date will be returned to the applicant. REVIEW CONSIDERATIONS Applications will be reviewed by Division of Research Grants (DRG) staff for completeness and by NCRR staff to determine administrative and programmatic responsiveness to this RFA. Those applications judged to be incomplete or nonresponsive will be returned to the applicant without review. Those applications considered complete and responsive may be subjected to a triage review by an NCRR peer review group to determine their scientific merit relative to the other applications submitted in response to this RFA. The NIH will withdraw from competition those applications judged by the triage peer review group to be noncompetitive for award and will so notify the applicant investigator and the institutional business official. Those applicants judged to be competitive for award will be reviewed for scientific and technical merit by an appropriate as hoc review committee(s) to be convened by the Office of Review, NCRR. The second level of review will be conducted by the National Advisory Research Resources Council in September 1994. AWARD CRITERIA The following will be considered when making funding decisions: the merit of the application, availability of funds, program balance among various types of projects, and geographic distribution of the awards. Consideration will be given to reaching minority and/or female populations. INQUIRIES Written and telephone requests for the RFA and inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct requests for the RFA, inquires regarding programmatic issues, and address the letter of intent to: Dr. Marjorie A. Tingle or Dr. Abraham Levy Biomedical Research Support Program National Center for Research Resources Westwood Building, Room 848 Bethesda, MD 20892 Telephone: (301) 594-7947 Direct inquiries regarding fiscal matters to: Ms. Mary V. Niemiec Office of Grants and Contracts Management National Center for Research Resources Westwood Building, Room 849 Bethesda, MD 20892 Telephone: (301) 594-7955 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93-922. Awards will be made under authorization of the Public Health Service Act, Title III, Part A (Public Law 78-410, as amended, 42 USC 241) 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. $$R3 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-94-049 ************************************************ STUDIES ON ENVIRONMENTAL TOXICANTS AND THE IMMUNE SYSTEM NIH GUIDE, Volume 23, Number 11, March 18, 1994 PA NUMBER: PA-94-049 P.T. 34; K.W. 0705040, 1007003 National Institute of Environmental Health Sciences National Institute of Allergy and Infectious Diseases PURPOSE The National Institute of Environmental Health Sciences (NIEHS) and the National Institute of Allergy and Infectious Diseases (NIAID) announce their interest in receiving individual research grant applications for support of studies on the interactions between environmental substances and their effects on immune function, which last appeared in the NIH Guide, Vol. 20, No. 23, June 14, 1991, Page 5. The objective is to promote research at the molecular and cellular level to better understand mechanisms of environmentally-induced aberrations within the immune system in order to gain insight into approaches to mitigate the effects of such agents. These agents are substances that may be present in the natural environment or have been added by human activities and are known to or are suspected of inducing illnesses that affect or involve the immune systems. The NIAID is the principal agency that supports fundamental research concerned with the structure and function of the immune system in health and disease. The acquisition of new and deeper knowledge about the immune system is requisite to the development of improved procedures for prevention, diagnosis and treatment of immunological diseases and of diseases having a major immunological component. The interest of the NIAID in environmental toxicology is predicated on the strong likelihood that the analysis of interactions between noxious substances in the environment and the immune system can provide insight, from a largely-ignored perspective, on some of the typical functions of the immune system, the adaptability and plasticity of the immune system, and the susceptibility of the immune system to abnormalities induced by chemical and physical insult. The NIEHS is the principal Federal funding agency for support of basic research on environmental factors that contribute to human health problems and disease. Major emphasis by NIEHS is placed upon research examining those physical and chemical substances resulting from industrial progress. However, there also are many natural environmental substances which have been found to have deleterious effects on human health and are within the purview of the NIEHS mission. Many of these substances cause human health problems by disrupting normal immune function which can lead to a disease state. 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, Studies on Environmental Toxicants and the Immune System, 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 "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 or local governments, and eligible agencies in the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) individual research grant (R01) and FIRST (R29) award. Responsibility for planning, direction, and execution of the proposed project will be solely that of the applicant. RESEARCH OBJECTIVES The effects of environmental toxicants may be divided into three broad categories: suppression/inhibition of immunological competence; initiation or triggering of autoimmunity; and stimulation of allergic/hypersensitivity reactions. Although the NIEHS and NIAID have overlapping interests with respect to each of these categories of effect, it is reasonable to state that the interests of NIEHS center on the effects of chemical/physical agents that suppress or reduce the capacity of the immune system. The interests of NIAID are more focussed on the actions of chemical/physical agents that precipitate or lead to autoimmune and allergic disorders. NIEHS's interests are to identify and characterize the mechanisms of action of substances that affect the immune system and to determine the magnitude and consequences of exposure to such substances. NIAID is concerned with understanding the immuno-physiological processes that are affected by environmental agents and elucidating the pathogenesis of the disorders that they cause. Both Institutes are interested in approaches that may mitigate the noxious effects of environmental agents and in the development of improved animal and in vitro models for studying the effects of noxious substances. Research Goals and Scope These applications should emphasize mechanisms rather than mere descriptions of processes. They should utilize state-of-the-art immunology, biochemistry, and molecular biology in such investigations. The following are examples of projects/topics that would be of interest but are not meant to present the full range of possibilities: o Determine the mechanisms by which toxicants affect individual components of the immune system; e.g., on cellular components such as antigen-processing cells (APC), B- lymphocytes and T-lymphocytes. o Identification of the actual immunogenic components (fragments, molecular conjugates, etc.) and epitopes of toxicants that trigger allergic/hypersensitive responses or autoimmunity, and detailed analyses of their processing by APC and presentation to T- and B-cells. o Development of in vitro systems for systematic quantitative analyses and mechanisms of action of toxicants on individual cellular components of the immune system: APC, B-cells and T-cells. o Comprehensive studies on toxicant-induced allergic/hypersensitive responses designed to reveal the roles of components such as T-cells, APC, IgE-producing B- cells, IgE molecules, leukocytes and mediator substances in the development and manifestation of those responses. o Development of approaches to prevent or reduce the undesirable effects of toxicants on the immune system; e.g., appropriate pre-immunization ("vaccination") against toxicants or preparation of monoclonal antibodies capable of nullifying the effects of toxicants. o Evaluation of the effects of "natural" levels of toxins on the immune system. o Studies on the genetics of susceptibility and resistance to the effects of toxic substances. o Studies on the genetic control of susceptibility and resistance to those effects of toxicants that lead to autoimmune or allergic disorders. o Studies on the pharmacologic control of susceptibility of the immune system to toxic substances. o Studies on dual effects of toxic agents such as simultaneous inactivation of certain components of the immune system and activation of other components. o Studies on toxicant-triggered expression of stress proteins (e.g., heat-shock proteins) and special receptors such as those for aromatic hydrocarbons controlled by the "Ah" genetic locus and found in leukocytes; and the roles of such protein in the effects of toxicants on immune functions. o Studies on aberrations in the elaboration and functions of cytokines and cytokine receptors induced by toxicants. o Synergistic actions of physical/chemical agents either with each other (e.g., a chemical and UV-B or two chemicals) or with other agents such as viruses or oncogenes. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151) 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. (NOTE: When the proposed study or studies in the RFA or PA involves a gender specific study or a single or limited number of minority population groups, this should also be stated to inform potential applicants and reviewers.) 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, use alternative species such as nonmammals or invertebrates, reduce the number of animals required, and incorporate refinements to procedures that will result in the elimination or further minimization of pain and distress to animals. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91), which is available in the office of sponsored research at most academic and research institutions and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. To identify the application as a response to this program announcement, check "YES" in Item 2a on the face page of the application and enter the program announcement title number. Applications will be accepted in accordance with the usual receipt dates for new research grant applications; i.e., February 1, June 1, and October 1. The earliest possible award dates will be approximately nine months after the respective receipt dates. Applications received too late for one cycle of review will be held until the next receipt date. 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. Applications will be received by the NIH Division of Research Grants (DRG) and referred to an appropriate study section for scientific and technical merit review. Institute assignment decisions will be governed by normal programmatic considerations as specified in the NIH Referral Guidelines. The original and five copies of the application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS The review criteria customarily employed by the NIH for regular research grant applications will prevail. Following the initial scientific review, the applications will be evaluated by the appropriate National Advisory Council. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that ICD. The following will be considered 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 he announcement INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Eugene M. Zimmerman Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A24 Bethesda, MD 20892 Telephone: (301) 496-8973 FAX: (301) 402-2571 Dr. Jerry A. Robinson Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-7724 FAX: (919) 541-2843 To better ensure appropriate Program and Institute assignment, applicants may submit a letter of intent and/or a copy of the application face page to the Program Administrator, NIAID or NIEHS. Direct inquiries regarding fiscal matters to: David L. Mineo Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-1373 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Numbers 93.112, Characterization of Environmental Health Hazards; 93.113, Biological Response to Environmental Health Hazards; and 93.855, Allergy, Immunology and Transplantation Research. Awards are made under the authority of Section 487, Public Health Service Act as amended (42 USC 288) and administered under PHS grants policies and Title 42 of the Code of Federal Regulations, Part 66. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P1 END ************************************************************ $$P2 BEGIN PA-94-050 ************************************************ EXPLORATORY GRANTS TO STIMULATE CORRELATIVE LABORATORY STUDIES AND INNOVATIVE CLINICAL TRIALS NIH GUIDE, Volume 23, Number 11, March 18, 1994 PA NUMBER: PA-94-050 P.T. 34; K.W. 0715035, 0755015, 0745005 National Cancer Institute Application Receipt Dates: June 1, October 1, and February 1 PURPOSE The Division of Cancer Treatment (DCT) of the National Cancer Institute (NCI) invites research grant applications from interested investigators for tightly focused innovative laboratory studies that are related to clinical trials and/or for innovative clinical trials that take advantage of new developments in the laboratory. The exploratory/developmental grant mechanism is utilized for pilot projects or feasibility studies to support creative, novel, high risk/high payoff research that may produce innovative advances in science. The objective of this Program Announcement (PA) is to encourage applications from individuals who are interested in testing novel or conceptually creative ideas that are scientifically sound and may advance progress in human health. This PA supersedes the PA, Exploratory/Developmental Grants in Cancer Therapy (PA-92-66), that was published in the NIH Guide for Grants and Contracts, Vol. 21, No. 13, April 3, 1992. The exploratory grant program provides limited funds (maximum of $100,000 direct costs per year not including indirect costs of any collaborating institutions) for short-term (up to two years) research projects. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Exploratory Grants To Stimulate Correlative Laboratory Studies and Innovative Clinical Trials, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications may be from a single institution or may include arrangements with one or more institutions (e.g., consortia, clinical trials cooperative group) if appropriate. Applications from minority individuals, women, and new investigators are encouraged. MECHANISM OF SUPPORT Support of the program will be through the National Institutes of Health (NIH) exploratory/developmental grant (R21) mechanism. Applicants will be responsible for the planning, direction, and execution of the proposed project. All PHS and NIH grants policies will apply to applications received and awards made in response to this program announcement. Applicants may request up to $100,000 per year in direct costs, not including indirect costs for collaborating institutions, if any. The total project period for applications submitted in response to the present PA may not exceed two years. These grants are non-renewable and continuation of projects developed under this program will be through the traditional unsolicited grant program. RESEARCH OBJECTIVES Background The NCI supports an extensive network of clinical and laboratory research studies related to cancer therapy through contracts, grants, and cooperative agreements. At present, there is no mechanism targeted to stimulate the communication of promising and potentially relevant innovative developments between the laboratory and the clinical setting. It has been difficult for investigators to obtain complementary funding through either the traditional basic research project grant (R01) mechanism or through the cooperative agreement (U10) mechanism for either: (1) innovative clinical trials that take advantage of new developments in the laboratory or (2) novel correlative laboratory studies to existing clinical trials. The small grants (R03) mechanism partially addressed these problems but the limited funds ($50,000 direct cost cap) prevented larger innovative clinical studies from being pursued. These clinical studies would not be developed fully enough for a standard R01 and would therefore be considered high risk. It is expected that these R21 grants will serve as a basis for planning future clinical research project grant applications (R01) or NCI cooperative clinical trial group studies. Because the exploratory grant mechanism is designed to support innovative ideas, preliminary data as evidence of feasibility are not required. However, the applicant does have the responsibility for developing a sound research plan. Originality of the approach and potential significance of the proposed research are major considerations in the evaluation. Research Goals and Scope The major goal of this initiative is to promote translational and clinical research that may lead to improved treatment results and clinical outcomes. To accomplish this goal, two types of studies will be supported: (1) the development of new therapeutic clinical trials or (2) new correlative studies relevant to clinical trials. Applications should be focused on integrating clinical goals with laboratory research areas. This PA envisions funding new therapeutic clinical trials that move new treatment strategies more rapidly from the laboratory into the clinic. These clinical studies must involve human subjects, be designed to ultimately improve cancer treatment, and be based on a strong rationale. Furthermore, the underlying hypothesis should be supported by preclinical data. The proposed clinical protocol should be included in the Appendix of the application. This PA has a second research goal of funding new correlative laboratory studies that are relevant to therapeutic clinical trials. The therapeutic correlates must have a future clinical application such as development of new treatment strategies or identification of patient subsets for specific treatment therapies. This PA does not support research investigations on diagnostic markers or clinical correlates which will have no impact on the clinical treatment of patients. The laboratory assays must utilize patient specimens from clinical trials. Where applicable, evidence of statistical support should be included to ensure proper correlation of assay parameters with clinical outcome. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151) 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. (NOTE: When the proposed study or studies in the RFA or PA involves a gender specific study or a single or limited number of minority population groups, this should also be stated to inform potential applicants and reviewers.) APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The title and number of the announcement must be typed in line 2a on the face page of the application. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator must be included with the application. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by an appropriate peer review group convened by NIH, in accordance with the standard NIH peer review procedures. The second level of review will be provided by a National Advisory Council or Board. Review criteria that will be used to assess the scientific merit of an application are: o Importance, timeliness and clinical merit of the proposed clinical trials o Relevance of the proposed laboratory studies to the clinical trials o Scientific merit and originality of the proposed research o Potential significance of the proposed research o Soundness of the experimental design o Qualifications, relevant experience, and commitment of the investigator(s) o Resources and environment The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each approved application. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o Quality of the proposed research as determined by peer review o Availability of funds o Program balance among research areas 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: Dr. Roy S. Wu or Ms. Diane Bronzert Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 Direct inquiries regarding fiscal matters to: Ms. Eileen Natoli Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 256 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.393, 93.394, 93.395, 93.396, and 93.399. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P2 END ************************************************************ ERRATUM $$E1 BEGIN P2 19940218 APPEND PAR-94-034 BOTH ************************** MORE FACULTY DEVELOPMENT AWARD NIH GUIDE, Volume 23, Number 11, March 18, 1994 PAR NUMBER: PAR-94-034 P.T. 14; K.W. 0710030 National Institute of General Medical Sciences Application Receipt Dates: February 1, June 1, and October 1 The program announcement of the MORE Faculty Development Award (PAR-94-034) was published in the NIH Guide for Grants and Contracts, Vol. 23, No. 7, February 18, 1994. The heading for this announcement lists the application receipt dates as February 1, June 1, and October 1. However, under AWARD CRITERIA, the review schedule gave incorrect receipt dates of March 1, July 1, and November 1. The correct review schedule is: Application Receipt Dates: Feb 1 Jun 1 Oct 1 Initial Review: Jun/Jul Oct/Nov Feb/Mar Secondary Review: Aug Jan May Earliest Start Date: Sep Feb Jun INQUIRIES Questions concerning programmatic issues may be directed to: Dr. Yvonne Maddox Minority Access to Research Careers Program National Institute of General Medical Sciences Westwood Building, Room 950 Bethesda, MD 20892 Telephone: (301) 594-7823 $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Mon Mar 28 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 9, 4 March 1994 Date: 28 Mar 1994 18:23:36 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1390 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2n83f8$ih8@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940304 V23N09 P1O1 ************************************ X-comment: RFAs described: ES-94-006 NIH GUIDE - Vol. 23, No. 9 - March 4, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** EXTENSION OF COOPERATIVE AGREEMENT: THE NICHD STUDY OF EARLY CHILD CARE National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX N2 ********************************************************** THE NIH GUIDE FOR GRANTS AND CONTRACTS: INTENT TO MODIFY National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 05/20/94 ************************************************* MINORITY SCIENTIST AWARD AT MINORITY INSTITUTIONS (RFA ES-94-006) National Institute of Environmental Health Sciences INDEX: ENVIRONMENTAL HEALTH SCIENCES ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** SUPPLEMENTS TO PROMOTE REENTRY INTO BIOMEDICAL AND BIOBEHAVIORAL RESEARCH CAREERS (PA-94-043) National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX P2 ********************************************************** ACADEMIC AWARD IN ENVIRONMENTAL/OCCUPATIONAL MEDICINE (PAR-94-041) National Institute of Environmental Health Sciences INDEX: ENVIRONMENTAL HEALTH SCIENCES $$INDEX P3 ********************************************************** FELLOWSHIP AND CAREER AWARDS IN SICKLE CELL DISEASE RESEARCH (PAR-94- 042) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD ERRATUM $$INDEX E1 ********************************************************** MORE FACULTY DEVELOPMENT AWARD (PAR-94-034) National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES $$INDEX E2 ********************************************************** IDIOPATHIC MALE INFERTILITY (RFA HD-94-015) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** EXTENSION OF COOPERATIVE AGREEMENT: THE NICHD STUDY OF EARLY CHILD CARE NIH GUIDE, Volume 23, Number 9, March 4, 1994 P.T. 34; K.W. 0404004, 1014006 National Institute of Child Health and Human Development The National Institute of Child Health and Human Development (NICHD) has an active interest in the support of research on the development of children who have been placed in child care arrangements during their infancy. In 1988, NICHD issued a request for cooperative agreement applications (RFA) titled "Effects of non-parental infant day care on child development." The data collection for the study that ensued will terminate at the end of 1994 and NICHD intends to extend this cooperative agreement for an additional five years for the purpose of longer follow-up studies of the same cohort of children. It also intends to limit the competition to the participating research sites and to expert investigators who have access to the study participants and to data derived therefrom. The study will continue to be conducted as a collaboration between awardees and NICHD scientific program staff. The NICHD staff will have substantial programmatic involvement in designing and coordinating the research protocol, monitoring its progress, making data analyses plans and writing scientific papers. The NICHD scientific program staff member will also continue to be responsible for the overall coordination of the project.INQUIRIES Additional information may be obtained from: Sarah L. Friedman, Ph.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development Building 61E, Room 4B05 Bethesda, MD 20892 Telephone: (301) 496-6591 FAX: (301) 402-2085 Bitnet: SF2@NIHCU AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.856. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** THE NIH GUIDE FOR GRANTS AND CONTRACTS: INTENT TO MODIFY NIH GUIDE, Volume 23, Number 9, March 4, 1994 P.T. 34; K.W. 1014006, 1004017 National Institutes of Health PURPOSE The National Institutes of Health intends to modify the NIH Guide for Grants and Contracts on August 1, 1994. The format of Request for Applications (RFAs) and Program Announcements (PAs) will not be changed, but increased emphasis on electronic access of those documents will be implemented. The purpose of the changes is to improve the timeliness and accuracy of information dissemination and reduce production costs. BACKGROUND The printed edition of the weekly NIH Guide for Grants and Contracts now includes notices, PAs, Notices of Availability (NA) of RFAs, and NAs of Requests for Proposals (RFP) and is mailed to approximately 34,000 subscribers. Although first class postal service is used, copies of the printed version may not be received until a week or more following publication. Currently, a delimited, electronic edition of the NIH Guide, which includes RFAs in addition to NA/RFAs, is sent via a BITNET LIST to 530 sites, primarily university offices of sponsored research. The NIH Guide is also available on a public access electronic bulletin board and on the NIH GOPHER on the Internet. Through these sources, the NIH Guide, including the full text of RFAs and PAs, is available nationwide within a day of publication. INTENDED MODIFICATIONS Content of the NIH Guide The printed edition of the NIH Guide will contain notices and brief NA/RFAs and NA/PAs. The NAs will include a brief summary of the purpose of the RFA or PA; the application receipt date, anticipated number of awards, and funds available for RFAs; and information about how to obtain a copy of the RFA or PA. The electronic edition will include the contents of the printed edition and the complete text of PAs and RFAs. Access to the NIH Guide PAs and RFAs will be available in print and via email from the NIH contacts listed in each NA in the printed edition. The NIH will send one copy of the printed edition of the NIH Guide to each major component of each Institution, primarily to the Offices of Sponsored Research or the equivalent, and institutions not on the list of institutional contacts maintained by the NIH may request subscriptions. The current subscription list for the printed edition will be terminated. The electronic edition of the NIH Guide, including the RFAs and PAs, will be available to individuals via a LISTSERV subscription list, the NIH Grant Line electronic bulletin board, and the NIH Gopher Server. Current subscribers to the printed edition are encouraged to establish a preferred route to the electronic edition of the NIH Guide as soon as possible and cancel subscriptions to the printed edition. ELECTRONIC ACCESS TO THE NIH GUIDE FOR GRANTS AND CONTRACTS LISTSERV Distribution On the day of publication, a delimited electronic edition of the NIH Guide for Grants and Contracts is distributed to list members. The delimiters are characters that mark the beginning and end of each item. Several institutions have found this useful for topical searching, archiving, and intra-institutional distribution. At this time, individuals and institutions may join the list. To join, send an E-mail message to Q2C@NIHCU.bitnet or via the Internet to Q2C@CU.NIH.GOV requesting inclusion on the list. NIH Grant Line Bulletin Board The NIH Grant Line includes information about NIH extramural programs, including the NIH Guide for Grants and Contracts. A new feature on the NIH Grant Line allows the rapid transmission of files via Bitnet or Internet to a Bitnet or Internet address instead of downloading via a modem. 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 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. NIH Gopher The NIH Gopher contains information about the NIH, including the NIH Guide to Grants and Contracts, and has text searching capability. One can tunnel to the NIH Gopher, if one has access to a system with Gopher. Local computer support staff should be consulted for additional information. INQUIRIES For additional information or comment on the intended modifications, direct inquiries to: Claudia Blair, Ph.D. Director, Institutional Affairs Office National Institutes of Health Building 1, Room 328 Bethesda, MD 20892 Telephone: (301) 496-5366 FAX: (301) 402-2831 email: ubl@nihcu.bitnet or ubl@cu.nih.gov For additional information about the NIH Grant Line Bulletin Board, direct inquiries to: John C. James, Ph.D. Assistant Director for Special Projects Division of Research Grants Westwood Building, Room 109 Bethesda, MD 20892 Telephone: (301) 594-7270 FAX: (301) 594-7384 $$N2 END ************************************************************ $$R1 BEGIN ES-94-006 FULL-TEXT ************************************** NOTICES OF AVAILABILITY (RFPs AND RFAs) MINORITY SCIENTIST AWARD AT MINORITY INSTITUTIONS NIH GUIDE, Volume 23, Number 9, March 4, 1994 RFA AVAILABLE: ES-94-006 P.T. 34, FF; K.W. 0725005 National Institute of Environmental Health Sciences Application Receipt Date: May 20, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE Human health and human disease result from three interactive elements: Environmental factors, genetic susceptibility, and age. The mission of the National Institute of Environmental Health Sciences (NIEHS) is to reduce the burden of human illness and dysfunction from environmental causes by further understanding each of these elements and how they interrelate. The ultimate goal of the NIEHS activities is to define and understand the mechanism of action of environmental agents on human health, and to transfer this knowledge to the public benefit. The NIEHS invites minority faculty members at historically black colleges and universities and other predominantly minority colleges, universities and health professional schools to submit applications for support of activities directed at the development of investigators at such schools in areas relevant to environmental health sciences. The intent of the award is to provide an underrepresented minority faculty member with increased access to research opportunities through collaborative arrangements with funded environmental health scientists. 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, Minority Scientist Award at Minority Institutions, 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 "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 A minority school is defined as a medical or nonmedical college, university or equivalent school in which students of minority ethnic groups including African Americans, Hispanics, American Indians, and Asian or Pacific Islanders comprise a significant proportion of the school enrollment. Candidates for this award are full-time underrepresented minority faculty members at a minority institution who (1) are members of an underrepresented minority group; (2) are citizens of the United States, noncitizen nationals, or permanent residents at the time of application; (3) have an M.D., Ph.D. degree or equivalent in a biomedical or behavioral science; (4) wish to develop research capabilities in environmental health sciences research; and (5) have the background and potential to become an independent biomedical investigator. A minimum of 70 percent effort annually must be committed to the award. Each candidate must also identify and complete arrangements with a mentor, preferably at a majority or minority institution within reasonable commuting distance, approximately 100 miles, who is recognized as an accomplished, independently funded investigator in the research area proposed, and who will provide guidance for the awardee's development and research plan. Preference will be given for applications with a mentor who is an NIEHS-supported researcher. NIEHS staff is willing to assist prospective applicants in identifying appropriate NIEHS grantees. The plans for an intensive training period should be developed with the mentor. The commitment of the mentor and his/her institution to both summer and academic year training must be evidenced by letters of support to be included in the application. A commitment from the mentor's department head must be included in the application. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) Minority Scientist Award at Minority Institutions (K14). Applicants will be responsible for the planning, direction, and execution of the proposed project. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000 (rev. October 1, 1990). Awards are nonrenewable and nontransferable from one awardee to another. Funding beyond the first year of the grant is contingent on satisfactory progress during the preceding year. In addition, funding for the fourth and fifth years is dependent upon the submission of applications for traditional NIH grant support (R01, R29, R15) or other grant programs not specifically targeted to minority institutions. Awards should be requested for a period of five years. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for this RFA are anticipated to be $250,000. It is expected that two to three awards will be possible. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. RESEARCH OBJECTIVES This program is designed to support environmental health sciences related research career development of minority faculty at minority institutions at the M.D., Ph.D. or equivalent level who have the interest and capabilities of doing state-of-the-art research in this area. The objective of this RFA is to broaden the experience of faculty members at minority schools, to increase the pool of biomedical and behavioral investigators in environmental health sciences research, and to inform undergraduate students, most of whom will be minority individuals, about research opportunities in environmental health sciences. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Applications must be received by May 20, 1994. If an application is received after that date, it will be returned to the applicant. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies, to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete and non-responsive applications will be returned to the applicant without further consideration. Applications may be triaged on the basis of relative competitiveness. Those applications judged to be competitive will undergo further merit review by an appropriate review group convened by the Scientific Review Branch, NIEHS. The second level review by the National Advisory Environmental Health Sciences Council considers the special needs of the NIEHS and the priorities of the NIEHS Program. The review factors that will be used in the evaluation of applications for this RFA are listed below. o The overall merit of the candidate's plan for research and the development of research skills. o The background and potential of the proposed candidate for development into an independent biomedical investigator. o The candidate's commitment to a research career. o The ability of both the minority institution and the training center to provide facilities, resources, and opportunities necessary for the candidate's research development. o The commitment of the home institution to the faculty candidate's research and development o The arrangement between the applicant and mentor for the conduct of the research. o The qualifications, ability, and plans of the mentor who will provide the candidate with the guidance necessary for career development in research. Recognition of the mentor as reflected by receipt of support from national peer reviewed funding sources. o The schedule and plans for the submission of traditional NIH grant applications. o The seminar plan. INQUIRIES The NIEHS welcomes the opportunity to clarify any issues or questions from potential applicants. Written and telephone inquiries concerning this RFA are encouraged. However, potential applicants are expected to have reviewed the material in the RFA before contacting the NIEHS. To receive a copy of the RFA, contact the NIEHS either by FAX at (919) 541-2843 or Voice Mail at (919) 541-3319. Include the complete mailing address and telephone number. Direct mail requests for a copy of the RFA to: Michael J. Galvin, Jr., Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 (North Campus) Research Triangle Park, NC 27709 Direct inquiries regarding fiscal matters to: Ms. Carolyn Winters Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 2-01 (North Campus) Research Triangle Park, NC 27709 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. $$R1 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-94-043 ************************************************ SUPPLEMENTS TO PROMOTE REENTRY INTO BIOMEDICAL AND BIOBEHAVIORAL RESEARCH CAREERS NIH GUIDE, Volume 23, Number 9, March 4, 1994 PA NUMBER: PA-94-043 P.T. 34; K.W. 0710030 National Institute of Mental Health PURPOSE The National Institute of Mental Health (NIMH), National Institutes of Health (NIH), announces a program for administrative supplements to research grants to support individuals with high potential to reenter an active research career after taking time off to care for children or parents or to attend to other family responsibilities. The aim of these supplements is to encourage fully trained individuals to reenter research careers within the missions of all the program areas of NIMH. This program will provide administrative supplements to existing NIMH research grants for the purpose of supporting full-time or part-time research by these individuals in a program geared to bring their existing research skills and knowledge up to date. The NIMH recognizes the need to increase the number of women and minorities in basic, behavioral, and clinical science research careers. Among the reasons for the low representation of women may be the fact that women bear a majority of the responsibilities surrounding child and family care. To address this issue, this program is designed to offer opportunities to individuals, especially women, who have interrupted their research careers to care for children or parents or to attend to other family responsibilities. The objective of the program is for those who receive support to reestablish careers in mental health-related 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, Supplements to Promote Reentry into Biomedical and Biobehavioral Research Careers, is related to the priority area of women's health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Grants and Cooperative Agreements: Only the following active NIMH award mechanisms at domestic institutions are eligible for the Supplement to Promote Reentry into Biomedical and Biobehavioral Research Careers: R01, R10, R18, R24, R37, P01, P50, U01, U10. Principal Investigators on such awards are invited to submit a request for an administrative supplement to the awarding component of the parent grant to support an eligible candidate interested in reestablishing a research career. The parent grant must have at least two years of support remaining at the time of the proposed beginning date of the supplemental funding. The rationale for this policy is to assure ample opportunity for the candidate to develop further her or his research skills. A maximum of three years supplemental support can be awarded under this program. Usually, a parent grant would support only one administrative supplement (Research Supplements for Underrepresented Minorities, Research Supplements to Promote the Recruitment of Individuals with Disabilities into Biomedical Research Careers, or Research Supplement to Promote Reentry into Biomedical and Biobehavioral Research Careers). Grants most likely to support more than a single administrative supplement are multicomponent awards. Candidates Candidates must have a doctoral degree, such as M.D., D.D.S., Ph.D., D.V.M., or equivalent, and at least two years of post-doctoral research experience and must have had sufficient prior research experience to qualify for a faculty appointment at the assistant professor or equivalent level. Candidates who have begun the reentry process through a fellowship or similar mechanism are not eligible for this program. The duration of the career interruption must be for at least two years. Examples of qualifying interruptions would include starting and/or raising a family; an incapacitating illness or injury of the candidate, the spouse, partner, or a member of the immediate family; relocation to accommodate a spouse, partner, or other close family member; pursuit of non-research endeavors that would permit earlier retirement of debt incurred in obtaining a doctoral degree; and military service. The program is not intended to support graduate or postdoctoral training and is not intended to support career changes from non-research to research careers for individuals without prior research training. At the time of application, a candidate may not be engaged in paid research activities for more than 10 hours per week. MECHANISM OF SUPPORT In all cases, the proposed research must be directly related to the approved ongoing research of the parent grant or cooperative agreement. The individual supported under this supplemental award, hereafter called the reentry candidate, must be afforded the opportunity to act as a full participant in the research project and must be given an opportunity to update and enhance her or his research capabilities. This will allow the candidate to establish a career as an independent, competitive research investigator. Supplemental awards will be consistent with the goals of strengthening the existing research program and with the overall programmatic balance and priorities of the funding program of the NIMH. Awards will be made according to the policies and provisions stated in this announcement and in the PHS Grants Policy Statement (rev. 10/90). Administrative supplements (S1) provided under this program may be for either part-time or full-time support for the candidate, and all supported time is to be spent updating and enhancing research skills. Proposed part-time appointments may not be less than 20 hours per week. Supplemental awards may be made for up to three years and may not exceed $50,000 in direct costs per year. A maximum of $40,000 may be requested for the combination of full time salary and fringe benefits for the reentry candidate. Proposed part-time appointments may not be for less than 20 hours per week (continuous) and must be pro-rated accordingly. The amount of salary requested must be consistent with the policies of the grantee institution for individuals occupying similar positions (up to our maximum annual limits) and must relate to the percent of effort and number of months requested for the supplement. An additional amount up to $10,000 may be requested for supplies, domestic travel, and publication costs relevant to the proposed research. Equipment may not be purchased as a part of this supplement without justification and specific prior approval of the NIMH. The decision to fund a supplement will take six to eight weeks from the time the necessary information is received. 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 can not extend beyond the current competitive segment of the parent grant. FUNDS AVAILABLE It is expected that approximately $150,000 will be available from NIMH to support three Reentry Administrative Supplements during Fiscal Year 1994. APPLICATION PROCEDURES A request for a supplement may be made at any time during the funding year, providing there will be two full years of funding remaining for the parent grant at the time of funding. In making requests, the grantee institution, on behalf of the Principal Investigators, should submit the request for supplemental funds directly to the program official of NIMH responsible for the parent grant. Principal Investigators should obtain the address for submission from the NIMH program administrator for the parent grant. Applications should not be sent to the Division of Research Grants address provided on grant application form PHS 398 (rev. 9/91). The request for a supplemental award must include the following: 1. A complete face page (with appropriate signatures) from grant application form PHS 398 (rev. 9/91), including the title and grant number of the parent grant and "Reentry Supplement" on line 1 2. A brief, three- or 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 proposed for the candidate c. How the supplement will expand and foster the independent research capabilities of the candidate d. How the proposed research relates to the specific research goals and objectives of the parent grant e. A description of the scope and nature of the mentoring relationship between the Principal Investigator and the candidate 3. A brief description, prepared by the candidate, that includes: a. research objectives and career goals b. length of and reason for career hiatus c. description of how the candidate has kept current in her/his field d. identification of steps taken toward reentry, (if any, such as attending scientific meetings) 4. A biographical sketch of the candidate that includes: a. curriculum vitae b. social security number c. citizenship status d. publications e. other evidence of scientific achievement. 5. A proposed budget entered on budget pages from the grant application form PHS 398 (rev. 9/91), related to the percent effort for the research proposed for the reentry candidate during the first and future budget period(s) (The amount requested for the supplement must coincide with the current period of support. Thus, if the initial budget period requested is less than 12 months, the budget must be prorated accordingly.) 6. Documentation, if applicable, that the proposed research is approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) of the grantee institution 7. Under unusual circumstances where the applicant and mentor would be at a site other than the grantee institution, an appropriately signed letter from the institution where the research is to be conducted must also be submitted. The request must be signed by the Principal Investigator, the reentry candidate, and the appropriate institution business official. REVIEW CONSIDERATIONS The program staff of the particular awarding component will review requests for supplements using the following general criteria: o the qualifications of the reentry candidate, including career goals, prior research training, research potential, and any relevant experience o the plan for the proposed research experience in the supplemental request and its relationship to the parent grant o evidence from the Principal Investigator that the experience will enhance the research potential, knowledge, and/or skills of the reentry candidate o evidence from the Principal Investigator that the activities of the reentry candidate are an integral part of the project o evidence of excellence of prior research training and experience of the reentry candidate o evidence of effort by the reentry candidate to initiate the reentry process, such as attending scientific meetings, keeping current with journals o evidence that proposed research will achieve the stated objectives of the reentry supplements In noncompeting continuation applications, the progress report for the reentry supplement should be clearly delineated from the progress report for the parent grant. The progress report should include information about the research activities supported by the supplement, even if support for future years is not requested. Since these applications will undergo administrative review, summary statements will not be produced. This is consistent with NIH practice for other similar programs, such as those referenced in the ELIGIBILITY REQUIREMENTS section of this program announcement. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Reentry candidates who have not yet made contact with a Principal Investigator will be referred to the program official whose Division or program is specific to their research interest. Direct inquiries regarding programmatic issues to: Deborah Dauphinais, M.D. Office for Special Populations National Institute of Mental Health 5600 Fishers Lane, Room 17C-14 Rockville, MD 20857 Telephone: (301) 443-3724 To discuss business aspects of the parent grant or the supplement, Principal Investigators may contact their grants management official. For other information concerning grants management issues, applicants may contact: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 5600 Fisher Lane, Room 7C-15 Rockville, MD 20857 Telephone: (301) 443-3065 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.242. 93.281, and 93.282. The statutory authorities for these supplements are Sections 301, 487, and 518 of the Public Health Service Act. (42 U.S.C. 241, 288, and 290cc-11), as amended. Federal regulations at 42 CFR Part 52, "Grants for Research Projects" and 45 CFR Part 74, "Administration of Awards," are applicable to these awards. Grants must be administered in accordance with the Public Health Grants Policy Statement. $$P1 END ************************************************************ $$P2 BEGIN PAR-94-041 *********************************************** ACADEMIC AWARD IN ENVIRONMENTAL/OCCUPATIONAL MEDICINE NIH GUIDE, Volume 23, Number 9, March 4, 1994 PAR NUMBER: PAR-94-041 P.T. 34; K.W. 0725007, 0725020 National Institute of Environmental Health Sciences PURPOSE The National Institute of Environmental Health Sciences (NIEHS) announces its fifth national competition for Environmental/Occupational Medicine Academic Awards (E/OMAA), which last appeared in the NIH Guide, Vol. 22, No. 14, April 9, 1993. The award will have the dual purpose of improving the quality of environmental/occupational medicine curricula and fostering graduate research careers in environmental/occupational medicine. For the purposes of the E/OMAA, the term environmental/occupational medicine refers to the area of medicine concerned with the development of knowledge and the application of knowledge directed at the diagnosis, treatment, and prevention of adverse human health effects from environmental/occupational exposures to toxic agents. This includes adverse health effects in infants, children, and adults who are at risk of developing such health problems and the reduction of preventable complications or disability in persons of all ages who have already developed such diseases. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement, Academic Award in Environmental/Occupational Medicine, 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 "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 Only schools of medicine or osteopathy in the United States and its possessions or territories are eligible to compete for Environmental/Occupational Medicine Academic Award for a project period that does not exceed five years and, if successful, to receive the Award once only. MECHANISM OF SUPPORT Mechanism of support for this activity will be for the research career program (academic) (K07) award. RESEARCH OBJECTIVES The NIEHS initiated the E/OMAA Program to provide a stimulus for development of an environmental/occupational medicine curriculum in those schools that do not have one and to strengthen and improve the environmental/occupational medicine curriculum in schools that do. Awards provide support to applicant faculty members for their educational development and for implementation or expansion of the curriculum in environmental/occupational medicine. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Application deadline date is June 1, 1994. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248 (one copy), and 301/594-7378 (for multiple copies). The title and number of the program announcement must be typed in Section 2a on the face page of the application. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for technical merit by a special study section convened by the NIEHS in accordance with the standard NIH peer review procedures. Following technical review, the applications will receive a second level review by the National Advisory Environmental Health Sciences Council. AWARD CRITERIA Applications will compete for available funds with all other approved applications in the Career (K) category assigned to the NIEHS. Applications will be evaluated for evidence of commitment by both the sponsoring institution and the sponsoring department or division to the accomplishment of the objectives of the award, as well as the qualification, interest, and commitment of the candidate to undertake the responsibility for implementing a high quality environmental/occupational medicine curriculum. Additional criteria are included in the program guidelines available from NIEHS program staff. INQUIRIES Program Guidelines for the E/OMAA award are available. 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: Annette G. Kirshner, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-03 (North Campus) Research Triangle Park, NC 27709 Telephone: (919) 541-0488 Direct inquiries regarding fiscal matters to: David L. Mineo Division of Extramural Research and Training National Institute of Environmental Health Sciences National Institutes of Health P.O. Box 12233, North Campus Research Triangle Park, NC 27709 Telephone: (919) 541-1373 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.894. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P2 END ************************************************************ $$P3 BEGIN PAR-94-042 *********************************************** FELLOWSHIP AND CAREER AWARDS IN SICKLE CELL DISEASE RESEARCH NIH GUIDE, Volume 23, Number 9, March 4, 1994 PAR NUMBER: PAR-94-042 P.T. 22; K.W. 0715032 National Heart, Lung, and Blood Institute PURPOSE The objective of this program announcement is to encourage the submission of applications for Fellowship and Clinical Investigator Development Awards in Sickle Cell Disease research in order to support the training and professional development of individuals who can serve the expanding research, teaching, and clinical requirements in the area of sickle cell disease. This program announcement emphasizes the need for increased research training and career development in this area and encourages individuals at varying levels of experience to submit applications for support by using three existing research training and career development mechanisms that are sponsored by the NHLBI. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Fellowship and Clinical Investigator Development Awards in Sickle Cell Disease Research, is related to the priority areas of clinical prevention services, chronic disabling conditions, and maternal and infant health. Potential applicants may obtain a copy of "Health 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 202-782-3238). 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. Only domestic institutions are eligible for K awards. At the time of application for a fellowship or K award, individuals must be either citizens or noncitizen nationals of the United States or have been lawfully admitted to the United States for permanent residence. An individual lawfully admitted for permanent residence must submit with the application a notarized statement indicating possession of the alien Registration Receipt Card (1-151 or 1-551). Individuals on temporary or student visas are not eligible.MECHANISM OF SUPPORT The mechanisms of support available for this program announcement are the NRSA Individual Fellowship (F32), NRSA Senior Fellowship (F33) and the Clinical Investigator Development Award (CIDA) (K08). The three support mechanisms for Fellowship and Clinical Investigator Development Awards in Sickle Cell Disease provide a wide range of training and career development opportunities to obtain research experience in sickle cell disease. A brief description of these mechanisms is listed below. NSRA Individual Fellowship Award (F32) Provides support for individuals at the postdoctoral level who wish to gain experience in biomedical and behavioral research related to sickle cell disease. Upon completion of this training, individuals are encouraged to consider other mechanisms to support further research experience. NRSA for Senior Fellows (F33) Provides support to experienced scientists who have at least seven years of relevant postdoctoral research or professional experience and wish to make major changes in the direction of their scientific careers, or enhance and enlarge their capabilities to conduct biomedical and behavioral research on problems related to sickle cell disease. Clinical Investigator Development Award (K08) Provides support to physicians with varying levels of research experience to prepare them for research careers as independent investigators. Candidates' development programs are based on scholastic background, previous research experience, past achievements, and identified skills needed to become an independent scientist. The objective is to develop clinical investigators whose basic and clinical research interests are grounded in the advanced methods and experimental approaches needed to solve problems in sickle cell disease. Detailed guidelines for each of the support mechanisms can be obtained from most institutional offices of sponsored research; the Office of Grants Information, Division of Research Grants, National Institutes of Health, telephone (301) 594-7248; and Dr. Fann Harding, Division of Blood Diseases and Resources, telephone (301) 496-1817. RESEARCH OBJECTIVES Background Sickle cell anemia is a major health problem characterized by recurrent episodes of pain called "crises," a chronic anemia related to accelerated destruction of red blood cells, increased susceptibility to certain infections, and acute and chronic damage to various organs. This blood disorder results from the presence of genes for sickle hemoglobin inherited from both parents. In the United States, sickle cell anemia is predominantly, but not exclusively, found in persons of African ancestry. The prevalence of sickle cell anemia within this group is about 1 in 500 at birth, affecting more than 50,000 individuals in this country. This disorder is also found in Greeks, Southern Italians, Eti-Turks, Arabs, Egyptians, Southern Iranians and Asiatic Indians at incidence rates often equal to or greater than that found in African-Americans. In addition, sickle cell hemoglobin also occurs in combination with other abnormal hemoglobins and thalassemia, bringing the total number of individuals affected with various forms of sickle cell disease to over 70,000 in the United States. Thus, sickle cell anemia and related hemoglobinopathies are among the most common genetic blood disorders seen in this country. During the past two decades, there has been a quantum leap in basic and clinical research leading to significant advances at the molecular and cellular levels. This progress embraces a number of important research areas, including the molecular structure of the sickle hemoglobin fiber, kinetics of polymerization, adherence of sickle cells to vascular endothelium, alterations in blood flow, regulation, and control of globin gene expression, development of animal models, abnormalities of the red cell membrane, and identification of genetic modifiers. At the clinical level, there appears to be a new era of therapeutic optimism, especially with agents that increase fetal hemoglobin, which are now undergoing clinical trials. Patients are living longer and more productive lives. Mortality from infection, the major cause of early death in infants and young children, has been significantly reduced with early identification of newborns with sickle cell disease and adding prophylactic penicillin to the management regimen. In spite of this progress to date, an effective therapy remains elusive. These major advances in basic and clinical understanding of sickle cell disease provide an unprecedented opportunity for further improvements in patient management. In addition, the enormous health and economic impact of sickle cell disease, estimated to be more than $705 million per year, argues strongly for increased attention to this disorder. A particular emphasis is placed on training due to the paucity of qualified investigators to carry out basic and clinical research as well as patient care in sickle cell disease. This need was reaffirmed by the NHLBI Sickle Cell Task Force convened to investigate the significant decline noted in investigator-initiated research in sickle cell disease. Although the Task Force was unable to ascribe the decline to any single factor, it made several recommendations to remedy this problem. These recommendations included the initiation of strategies to augment the availability of training and career development programs devoted to sickle cell disease. This Program Announcement is a direct response to that recommendation. The "Sickle Cell Task Force Report on Investigator-Initiated Research" was published in May, 1993. Areas of Interest The integration of a broad range of disciplines is required to further elucidate the basic pathophysiology of the disease and achieve the goals of treatment, prevention, and management. Thus, sickle cell disease is an especially exciting research area, encompassing a wide spectrum of scientific interactions with important behavioral and humanistic components. Potential research areas include cell biology, biochemistry, genetics, molecular biology, physiology, and psychology. Individual programs that offer research training and career development opportunities in all areas related to sickle cell disease are encouraged. The past training of candidates applying for these programs may have been in the basic sciences or in the clinical disciplines. If candidates do not possess skills in research design and biostatistics, the applicant should consider including these areas in his/her training or career development plan. Candidates submitting applications in response to this program announcement should focus on topics exemplified by those listed below. These topics are examples only and should not be viewed as inclusive. Applicants are encouraged to consider other related topics and innovative approaches. o Basic research projects that lead to a better understanding of the pathophysiology and clinical manifestations of sickle cell disease. o Basic and applied research projects that lead to the development of effective therapeutic approaches for the treatment of sickle cell disease. o Clinical research projects that will improve the identification of patients at risk for severe disease and the development of methods and therapies to prevent sequelae. o Studies that deal with the psychosocial and behavioral aspects of sickle cell disease. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans, Blacks, and Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications for NRSA Individual Fellowships (F32) and Senior Fellowships (F33) are to be submitted on the grant application form PHS 416-1 (rev. 10/91) and will be accepted at the standard application deadlines as indicated in the application kit. Applications for Clinical Investigator Development Awards (K08) are to be submitted on PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. The title and number of the program announcement must be typed in Section 2a on the face page of the application. The completed original application, for a Clinical Investigator Development Award, and three legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications for NRSA Fellowships will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH. Applications for Clinical Investigator Development Awards, assigned to the NHLBI, will be reviewed by the appropriate initial review group managed by the Division of Extramural Affairs, NHLBI. All reviews will be conducted in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. The review criteria are set forth in the guidelines for each support mechanism. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the ICD. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review. o Availability of funds o Program balance among research areas of the announcement. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Fann Harding, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute Federal Building, Room 5A08 Bethesda, MD 20892 Telephone: (301) 496-1817 For fiscal and administrative matters, contact: Ms. Jane R. Davis Blood Division Grants Management Section National Heart, Lung, and Blood Institute Westwood Building, Room 4A15 Bethesda, MD 20892 Telephone: (301) 594-7436 AUTHORITY AND REGULATIONS The programs of the Division of Blood Diseases and Resources of the National Heart, Lung, and Blood Institute are identified in the Catalog of Federal Domestic Assistance, number 93.839. Awards will be made under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grant policies and Federal regulations, most specifically 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372, or to Health Systems Agency review. $$P3 END ************************************************************ $$E1 BEGIN P2 19940218 APPEND PAR-94-034 BOTH ************************** ERRATUM MORE FACULTY DEVELOPMENT AWARD NIH GUIDE, Volume 23, Number 9, March 4, 1994 PAR NUMBER: PAR-94-034 P.T. 14; K.W. 0710030 National Institute of General Medical Sciences Application Receipt Dates: February 1, June 1, and October 1 The program announcement of the MORE Faculty Development Award (PAR-94-034) was published in the NIH Guide for Grants and Contracts, Vol. 23, No. 7, February 18, 1994. The following paragraph concerning reference letters should be added to the announcement. Letters of Reference At least three sealed letters of reference must accompany the application. The references should address the candidate's qualifications and the potential impact of this award on the candidate's research and teaching potential. A list of individuals submitting reference letters must be included at the end of the research plan. Provide the name, title and institutional affiliation for each individual. $$E1 END ************************************************************ $$E2 BEGIN R3 19940225 APPEND RFA HD-94-015 BOTH *********************** IDIOPATHIC MALE INFERTILITY NIH GUIDE, Volume 23, Number 9, March 4, 1994 RFA: HD-94-015 P.T. 34; K.W. 0413002, 0705075 National Institute of Child Health and Human Development Letter of Intent Receipt Date: April 8, 1994 Application Receipt Date: May 18, 1994 The Request for Applications (RFA) HD-94-015, published in the NIH Guide for Grants and Contracts, Vol. 23, No. 8, February 25, 1994, contained an incorrect date for earliest possible award. The correct date is April, 1, 1995, not December 1, 1994 as published. The dates for receipt for letters of intent and applications are unchanged. $$E2 END ************************************************************ From owner-sci-resources@net.bio.net Mon Mar 28 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 12, pt. 2, 25 March 1994 Date: 28 Mar 1994 18:10:21 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 842 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2n82md$hks@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940325 V23N12 P2O2 ************************************ RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Institute of Child Health and Human Development (NICHD) invites research grant applications for the support of basic and applied research to evaluate the affect of intravaginal products, treatments and spermicides on vaginal physiology. An important part of the mission of the NICHD is to gain new knowledge about human reproduction, especially those that may lead to new approaches to contraception. This RFA is intended to address that charge. 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, Vaginal Physiology: Interaction with Intravaginal Products, is related to the priority area of primary prevention of sexual spread of HIV infection with the use of topical microbicides and contraceptives. 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 20402-9352 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit organizations, public and private. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Minority individuals, persons with disabilities, and women are encouraged to apply. MECHANISM OF SUPPORT This RFA will use the NIH individual research project grant (R01) and FIRST (R29) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed five years. The earliest expected award date is March 1, 1995. 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. 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 also vary. FUNDS AVAILABLE It is expected that up to five new applications will be funded, within the total cost limit of $1,000,000 available for the first year. This level of support is dependent on the receipt of sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NICHD, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES For the purpose of this RFA, research subject areas would include, but not be limited to, the following: o Identify the physical and chemical interactions throughout the menstrual cycle that occur between vaginal bacteria and the underlying epithelium. One approach is to consider the nutrients microorganisms need and to evaluate how the vaginal microenvironment supplies these requirements. These include nutritional substrates, need for appropriate physical environment (temperature, pH, hydration and oxygen tension) and the ability to survive in the presence of antibacterial factors produced by the host or other microbial species. o Delineate characteristics of normal vaginal physiology such as the amount of vaginal fluid released in the vagina during sexual excitement or how fast the vaginal epithelium is exfoliated and replaced. o Assess the value of artificial colonization with bacteria such as lactobacilli as a mechanism to resist disease. o Delineate endocrinologic or biological factors that may affect host susceptibility or infectiousness to HIV in vaginal and cervical mucosal tissues: e.g., time of the menstrual cycle, pregnancy, menopause, or exogenous hormones. Define the role of antiviral defense mechanisms in HIV transmission, e.g., low pH, lysozyme, hydrogen peroxide, and lactoferrin in vaginal fluids. o Determine how spermicides, douches, and topical or systemic agents (antibiotics, antifungals, etc.) affect the vaginal environment. Does use of any topical spermicides or microbicides reduce the infectiousness of seropositive women? o Determine how different formulations affect a product's activity in the vagina in terms of time required for activation, effect of pH on activity, or interaction with cervical mucus. o Determine what characteristics are desirable in a formulation of a topical drug including interaction with the vaginal environment, time to onset of activity, and limits on frequency of application. Note: The use of sexually transmitted diseases or human immunodeficiency virus infection as a model is not within the scope of this RFA. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are strongly encouraged, but not required, to submit, by May 31, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NICHD staff to estimate the potential review workload and to avoid conflict of interest circumstances in the review process. The letter of intent is to be sent to Dr. Pamela Stratton at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Applications must be received by July 27, 1994. If an application is received after that date, it will be returned to the applicant. 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, it will be returned to the applicant, who may then submit it to DRG for review in competition with unsolicited applications at the next available review cycle. Responsive applications may be triaged by a peer review group to determine their relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applicant judged to be competitive will undergo further evaluation for scientific merit in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the National Advisory Child Health and Human Development (NACHHD) Council. Review criteria for RFAs are generally the same as those for unsolicited research grant applications. For studies in HIV-infected women, documented collaboration with ongoing epidemiologic studies of HIV-infected women, including but not limited to the Women and Infants Transmission Study (WITS), the Women's Interagency HIV Study, and the HIV Epidemiologic Research Study (HERS). For studies of any other cohort of women, documented collaboration with gynecologists or other clinicians who have access to the number and type of women who are proposed to be studied. AWARD CRITERIA The earliest anticipated date of award is March 1, 1995. Funding decisions will be based on peer review and NACHHD Council recommendation, program relevance, and availability of funds. In some cases, if the proposed research has relevance to any other Institute of the National Institutes of Health such as the National Institute of Allergy and Infectious Diseases, the application may be dually assigned to, and considered for funding by, the other institute. Any such assignment will be made independently of peer review procedures. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are encouraged. Direct requests for the RFA, inquiries regarding scientific issues, and address the letter of intent to: Pamela Stratton, M.D. Contraceptive Development Branch National Institute of Child Health and Human Development Building 6100, Room 8B13 Bethesda, MD 20892 Telephone: (301) 496-1661 FAX: (301) 496-0962 Direct inquires regarding fiscal matters to: Melinda Nelson Office of Grants and Contracts National Institute of Child Health and Human Development Building 6100, Room 8A17 Bethesda, MD 20892 Telephone: (301) 496-5481 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.864, Population Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12374 or health Systems Agency review. $$R7 END ************************************************************ $$R8 BEGIN AI-94-014 FULL-TEXT ************************************** NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS FOR THE TREATMENT OF OPPORTUNISTIC INFECTIONS ASSOCIATED AND TUBERCULOSIS IN AIDS NIH GUIDE, Volume 23, Number 12, March 25, 1994 RFA AVAILABLE: AI-94-014 P.T. National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: July 15, 1994 Application Receipt Date: August 11, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES", BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Developmental Therapeutics Branch (DTB) of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), invites applications from a combination of academic, non-profit research, and commercial organizations focused on the discovery and rational design of new therapies with potential to treat and/or prevent specific opportunistic infections (OIs) in individuals infected with HIV. Opportunistic pathogens targeted in this RFA are human cytomegalovirus (HCMV), Mycobacterium tuberculosis, Mycobacterium avium, Pneumocystis carinii, Cryptosporidium parvum, Toxoplasma gondii, the microsporidia (e.g., Enterocytozoon bieneusi, Septata intestinalis), and Cryptococcus neoformans. Research activities should be directed toward discovery of selective drugs or molecular strategies that are lethal to the pathogen with minimal toxicity for the host. Applications that include research projects or core components from the private sector are encouraged. No clinical trials will be supported 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, National Cooperative Drug Discovery Groups for the Treatment of Opportunistic Infections Associated with AIDS (NCDDG-OI) including Tuberculosis, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private organizations such as universities, colleges, hospitals, laboratories, units of State or local government, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be the cooperative agreement (U19), an "assistance" mechanism in which substantial NIH scientific and/or programmatic involvement is anticipated. Essential elements of the U19 mechanism include: (1) a minimum of three inter-related research projects organized around a central theme; (2) collaborative efforts and interaction among independent projects and their investigators to achieve a common goal; and (3) "Core" resources or facilities, each of which is expected to be utilized by at least two research projects. Details of the responsibilities, relationships, and governance of a study funded under cooperative agreement(s) are discussed in the RFA under the section Terms and Conditions of Award. The total project period for applications may not exceed four years. The anticipated award date is April/May 1995. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA reissuance will be $5.6 million. Applications received with budgets in excess of $700,000 first-year total costs will be returned without review. In Fiscal Year 1995, the NIAID plans to fund at least one group each for drug discovery against these high priority OIs: HCMV, Mycobacterium tuberculosis, Mycobacterium avium, Pneumocystis carinii, Cryptosporidium parvum, Toxoplasma gondii, the microsporidia (e.g., Enterocytozoon bieneusi, Septata intestinalis), and Cryptococcus neoformans. RESEARCH OBJECTIVES The purpose of this RFA is to foster multi-disciplinary research projects aimed at the discovery and rational design of new therapies against the OIs associated with AIDS. The objective of this RFA is to stimulate drug discovery through original and innovative research focused on the microbiology, molecular biology, chemistry, computer-assisted drug design, drug delivery vehicles, and animal models that will lead to the identification of new drug targets. Research objectives in this RFA reissuance include, but are not necessarily limited to: o the discovery and development of effective therapies to treat high priority opportunistic infections associated with AIDS; o identification and characterization of new molecular targets for exploitation toward selective virucidal, mycobactericidal, parasiticidal, and fungicidal therapeutic agents; o establishment and utilization of in vitro assays for selected molecular targets to identify compounds and biologicals; o refinement of novel and innovative animal models to evaluate the therapeutic potential of new compounds and to compare efficacy in normal and immunocompromised models; o development of improved methodologies or surrogate markers for assessing therapeutic efficacy in animal models; o elucidation of mechanisms of drug resistance and study of strategies to overcome such resistance. SPECIAL REQUIREMENTS All applications must consist of at least three interrelated projects conducted by at least three independent laboratories focusing on a unifying central theme. For the purpose of encouraging new collaborations under this RFA, two (or more) projects within a single company will not be considered independent. Similarly, two (or more) projects within the same academic department will not be considered independent. Random or large scale screening as well as clinical trials will not be supported under this RFA. A minimum 10 percent (time) effort by the Principal Investigator and each Project Leader should be devoted to the study, unless there are compelling arguments to the contrary. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are asked to submit, by July 15, 1994, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, the number and title of this RFA, and a list of the key investigators and their institution(s) and projects. The letter of intent is to be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the research grant application form PHS 398 (rev. 9/91). For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the RFA number and the words "NATIONAL COOPERATIVE DRUG DISCOVERY GROUP FOR TREATMENT OF OPPORTUNISTIC INFECTIONS (NCDDG-OI)" must be typed in. Applications must be received by August 11, 1994. These application forms may be obtained from the institution's office of sponsored research or its equivalent, and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. REVIEW CONSIDERATIONS All applications will be judged on the basis of the scientific and technical merit of the proposed projects and the documented ability of the investigators to meet the RESEARCH OBJECTIVES of the RFA. Applications with first year total costs (direct and indirect) in excess of $700,000 will be returned without review. Applications that are complete and responsive may be subjected to a triage by a peer review group to determine their scientific merit relative to other applications received. The NIAID will withdraw from competition those applications judged to be noncompetitive for award and will notify the Principal Investigator and institutional business official. AWARD CRITERIA Award criteria will be made on the basis of scientific and technical merit as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct requests for the RFA and inquiries regarding programmatic issues to: Barbara Laughon, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C35 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 402-2304 FAX: (301) 401-3211 Direct inquiries regarding application preparation and review and address the letter of intent to: Dianne Tingley, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C16 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-0818 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Ms. Jane Unsworth Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B22 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7075 FAX: (301) 480-3780 Schedule Letter of Intent Receipt Date: July 15, 1994 Application Receipt Date: August 11, 1994 Scientific Review Date: November 1994 Advisory Council Date: February 1995 Anticipated Award Date: April/May 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.856 - Microbiology and Infectious Diseases Research and No. 93.855 - Immunology, Allergic and Immunologic Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Parts 52 and 45 CFR Part 74 [and Part 92 when applicable for State and Local governments]. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R8 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-94-051 ************************************************ RESEARCH ON CLINICAL BIOETHICAL DILEMMAS NIH GUIDE, Volume 23, Number 12, March 25, 1994 PA NUMBER: PA-94-051 P.T. National Institute of Nursing Research PURPOSE The National Institute of Nursing Research (NINR) invites applications for grants to support research that will extend current knowledge about clinical bioethical dilemmas (and possible resolutions) that are faced by individuals and families. The goal of this program announcement is to generate research that will contribute knowledge of the ethical implications and actions arising from diagnostic and treatment strategies, in order to support those making decisions that impact their health and well-being and strengthen the quality and appropriateness of decisions made by family members. 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, Research on Clinical Bioethical Dilemmas, cross cuts all priority areas and relates directly to the responsibilities shared by individuals, families and practitioners for successfully implementing the priority areas. 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, public and private, organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Topics studied by foreign applications must have direct relevance to U.S. populations. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) award (R29). Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The mechanisms of support will be the National Institutes of Health individual research grant (R01) and FIRST award (R29). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Though the length of individual studies will vary, support will be provided for a period of up to five years, based on availability of funds and sufficient scientific progress. Applicants must plan for five years of support for the R29 award. Costs of individuals projects will vary. The average direct cost of an R01 award in FY 1993 was $186,000. Direct costs for R29 awards are capped at $100,000 in any one year and $350,000 across all years. RESEARCH OBJECTIVES Rapidly occurring advancements in science and health care technology are generating new ethical issues with increasing frequency. The availability of health and illness related information is outpacing knowledge about the best strategies for assisting those who must use this information. Therefore, there is a growing need for strategies and frameworks that can be used by health care professionals to organize and present clinical information in a way that is usefully supportive of the decision-making process that is required of patients and/or their families. These frameworks, when based on empirical studies of bioethical issues, should enable the determination of the best approaches for organizing information, deciding strategies, and facilitating individuals and their families in making clinical decisions. In the absence of such organizing frameworks, it is possible that when unstructured information is provided, it may actually work against the patient's needs and interests. The NINR sponsored an interdisciplinary clinical bioethics workshop in 1989 as a means of exploring the research opportunities in bioethics and clinical practice. Proceedings from this workshop are available from NINR program staff listed under INQUIRIES. As a result of the recommendations made by workshop participants, NINR funded a small grants program from 1989 to 1991 focused on bioethics and clinical decision making research. The program was designed to support pilot and feasibility studies. This current Program Announcement builds on and expands that earlier research program on clinical bioethical issues. Preserving a patient's individual autonomy has been a goal of national and institutional policies, as exemplified by "The Patient Self Determination Act," which was designed to involve patients actively in determining how much care they desire in order to maintain their life. From a policy perspective, involving patients directly in decisions about their own health and clinical care needs has both quality of life and economic imperatives. Advance directives are the means to formalize individual patients decisions about their future clinical care needs. Whether or not such advanced directives are useful and effective and actually protect an individual's autonomy still needs to be determined. It is commonly assumed that knowledge is good, that knowing a diagnosis is better than not knowing. But if the new diagnostic capabilities only predict risk of developing diseases, will having this knowledge potentially cause more harm than good? Will the quality of life be diminished by having the information when nothing can be done to reduce the risk factors or have an impact on the outcome? A central question concerns the optimum way to support people making decisions about therapeutic options when the long term effects of the treatments are not known. These issues become all the more challenging and complex when there is diminished autonomy due to development, such as with minors, or when understanding may be compromised, such as with some mental illnesses, certain disabilities, or mental retardation. The NINR welcomes applications that propose empirical approaches to these ethical issues and dilemmas. Although it is expected that investigators will propose study designs that are appropriate to the research question being asked, it should be noted that both qualitative, quantitative, or combined approaches could be used. Some examples of specific areas that may be pursued include, but are not limited to, the following: 1. Health-Related Decision Making Involving New Clinical Technologies. This area involves questions on how individuals make choices for their personal health when accepting or rejecting new diagnostic and therapeutic technologies, especially when some are still considered experimental. Factors such as psychological, sociocultural, economic, and quality of life issues that influence these decisions need to be examined. Determining which informational, educational, and counseling strategies are most effective in supporting autonomous decision making needs study. What is the influence of choices or the lack of choices when making these decisions? How do individuals respond and what factors are considered when decisions are being made about diagnostic tests that have greater or lesser degrees of uncertainty, sensitivity, or specificity? How do patients and families make decisions about new treatments such as surgical innovations or gene therapies? Do individuals and families consider costs when making these decisions for themselves; for others? 2. Patient Involvement in Clinical Decision Making. This area involves individuals who are receiving ongoing clinical care. The continuing evaluation of the appropriateness, efficacy, efficiency, and effectiveness of treatment and clinical intervention strategies, and the development of clinical practice standards or guidelines, are expected to influence how decisions about clinical care are made and how that care is provided. In addition, it is planned that such information will be made available to patients and their families in a form they can understand to assist them when making decisions about diagnostic, treatment and intervention strategies. Such patient-focused information will include information about clinical effectiveness, potential impact of treatments and intervention strategies on quality of life and cost data. To what extent is this new information available to and used by patients and their families? How patients and their families receive such information and how they respond to it is unknown. How decisions are made in light of this new clinical information needs to be determined. What factors related to psychological, sociocultural, economic and quality of life issues influence these decisions? How best can they be explored? Which informational, educational, or counseling strategies would be most effective in supporting autonomous decision making? Do such clinical factors as symptom intensity influence the outcome of decision making? To what extent? Are patients and their family members now more involved in clinical decision making? Do they make different decisions? To what extent do fiscal issues influence decisions, if at all? 3. Informed Consent in a Pluralistic Society. This area includes examining issues surrounding the informed consent process. Some questions that could be considered include: What factors influence decisions when "informed decisions" are made? Are individuals truly knowledgeable and well informed when they sign consent forms for clinical treatments? What ethnocultural influences play a role in informed decision making? What actually takes place when family members, or non-related members, of an ethnolinguistic group translate information about health status, or obtain consent for procedures or treatments? Who should be involved in obtaining consent when autonomy is diminished? What are the issues and best approaches to informed decision making for the developmentally disabled, children, adolescents, or adults with special needs? 4. Organ and Tissue Donation and Receipt. With increasing availability of transplantation and the ongoing need for organs and tissue, various strategies are used to obtain them. The influence of these strategies on individuals and families have not been fully explored. The aftermath of making a decision to donate either by an individual or a family member needs to be more fully understood. It has been recognized that there are cultural and ethnic differences in responding to organ and tissue donation, this results in some groups having little opportunity for receipt of a donation. These differences need to be examined. In addition, the need for transplantation, for example, of bone marrow, occurs during serious, life threatening illness. What factors influence decisions under these circumstances? Do these factors change over time or in association with complications, such as those occurring after transplantation? What strategies are used to assist patients and families in the decision making process, during treatment, and after treatment? How specific and how much information is provided? 5. Privacy and Confidentiality. This area involves examining such issues as how best to protect the privacy of individuals, who now have access to information about themselves or about other members of their families, that has been previously unavailable. What factors are involved in protecting the confidentiality of information about an individual when it may be important and relevant to other members of the family or community? Increasing amounts of information are available about individuals and their health status in clinical databases and other potentially accessible sources. What strategies are effective in protecting individual privacy under these circumstances? STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151) 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. (NOTE: When the proposed study or studies in the RFA or PA involves a gender specific study or a single or limited number of minority population groups, this should also be stated to inform potential applicants and reviewers.) APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. The receipt dates for applications for AIDS-related research are also found in the PHS 398 (rev. 9/91) instructions. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The title and number of the program announcement must be typed in Section 2a on the face page of the application. Applicants for FIRST awards should note that three letters of reference must be submitted with the application. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892**" REVIEW CONSIDERATIONS Applications received under this program announcement will be assigned to an initial review group on the basis of established Public Health Service referral guidelines. The IRG will review the applications for scientific and technical merit in accordance with the standard NIH peer review procedures. Applications recommended for further consideration will receive a second-level review by the appropriate national advisory council. Only applications recommended by the Council/Board may be considered for funding. AWARD CRITERIA Applications recommended for further consideration will be considered for available funds on the basis of the scientific and technical quality of the proposed project determined by peer review, program needs and balance, policy considerations, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. To receive a copy of "Bioethics and Clinical Practice: Examining Research Outcomes and Methods," direct inquiries to: Office of Information and Legislative Affairs National Institute of Nursing Research Building 31, Room 5B13 Bethesda, MD 20892 Telephone: (301) 496-0207 Direct inquiries regarding scientific programmatic issues to: Dr. Patricia Moritz Nursing Systems Branch National Institute of Nursing Research Westwood Building, Room 738 Bethesda, MD 20892 Telephone: (301) 594-7493 Direct inquiries regarding fiscal matters to: Ms. Sally A. Nichols Grants Management Office National Institute of Nursing Research Westwood Building, Room 748 Bethesda, MD 20892 Telephone: (301) 594-7498 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361, Nursing Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the american people. $$P1 END ************************************************************ From owner-sci-resources@net.bio.net Mon Mar 28 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 12, pt. 1, 25 March 1994 Date: 28 Mar 1994 18:10:14 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1499 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2n82m6$hkn@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940325 V23N12 P1O2 ************************************ X-comment: RFAS described: HD-94-020, HD-94-016, AI-94-019, HD-94-017, HD-94- 018, AI-94-014 NIH GUIDE - Vol. 23, No. 12 - March 25, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINAL FINDINGS OF SCIENTIFIC MISCONDUCT Public Health Service INDEX: PUBLIC HEALTH SERVICE $$INDEX N2 ********************************************************** VOLUNTARY PROVISION OF INFORMATION ON BIOMARKERS AND INTERMEDIATE ENDPOINTS IN PREVENTION TRIALS National Cancer Institute INDEX: CANCER $$INDEX N3 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOP National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** EXPIRED BREATH ANALYSIS IN CHEMICAL TOXICITY ASSESSMENT (RFP NIH-ES-94-27) National Institute of Environmental Health Sciences INDEX: ENVIRONMENTAL HEALTH SCIENCES $$INDEX R2 ********************************************************** DETAILED DRUG EVALUATION OF TREATMENT STRATEGIES FOR CHEMOTHERAPEUTIC AGENTS (RFP NCI-CM-57207-30) National Cancer Institute INDEX: CANCER $$INDEX R3 07/15/94 ************************************************* MENTAL RETARDATION RESEARCH CENTERS (RFA HD-94-020) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R4 07/19/94 ************************************************* COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORK (RFA HD-94-016) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R5 07/21/94 ************************************************* TROPICAL DISEASE RESEARCH UNITS (RFA AI-94-019) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R6 07/27/94 ************************************************* VAGINAL IMMUNOLOGY: INTERACTION WITH INTRAVAGINAL PRODUCTS (RFA HD-94-017) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R7 07/27/94 ************************************************* VAGINAL PHYSIOLOGY: INTERACTION WITH INTRAVAGINAL PRODUCTS (RFA HD-94-018) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R8 08/11/94 ************************************************* NCDDG FOR THE TREATMENT OF OPPORTUNISTIC INFECTIONS ASSOCIATED WITH TUBERCULOSIS IN AIDS (RFA AI-94-014) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** RESEARCH ON CLINICAL BIOETHICAL DILEMMAS (PA-94-051) National Institute of Nursing Research INDEX: NURSING This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. THE PUBLIC HEALTH SERVICE STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** FINAL FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 23, Number 12, March 25, 1994 P.T. Public Health Service Notice is hereby given that on February 25, 1994 a Research Integrity Adjudications Panel of the Departmental Appeals Board issued a ruling upholding scientific misconduct findings of the Office of Research Integrity (ORI) in the following case: John C. Hiserodt, M.D., Ph.D., University of Pittsburgh. An inquiry conducted by the university and an investigation conducted by the Office of Research Integrity found that Dr. Hiserodt deliberately and knowingly falsified four figures and one table in two research grant applications submitted to the National Institutes of Health, and deliberately and knowingly fabricated a laboratory notebook to cover- up the falsifications in the grant applications. In reporting research results on antigen recognition by natural killer cells, Dr. Hiserodt falsely reported that a purportedly unique protein had a molecular weight of 48 kilodaltons by altering photographs of autoradiograms, falsely reported that this protein had been found in human cells, falsely reported the results of a gene sequence in response to questions raised by NIH grant reviewers about his experimental findings, and fabricated a laboratory notebook to cover- up the falsified research when questions about it were raised by investigating officials. Dr. Hiserodt has been debarred from receiving Federal grant or contract funds for a period of five years beginning March 9, 1994. In addition, any institution receiving PHS research support involving Dr. Hiserodt must monitor the accuracy of his research for an additional two-year period following the five-year debarment (for a total period of seven years) beginning March 9, 1999. He has also been prohibited from serving on PHS Advisory Committees or review groups for seven years beginning February 25, 1994. Dr. Hiserodt is also required to request correction of the article "The Expression and Functional Involvement of Laminin-like Molecules in Non-MHC Restricted Cytotoxicity by Human Leu-19+/CD3-Natural Killer Lymphocytes," Journal of Immunology, Vol. 141, 3318-23, 1988, to indicate that Figure 2 in the article may not be relied upon. INQUIRIES The Office of Research Integrity will continue to publish findings of scientific misconduct as further cases are closed. For further information, contact: Director Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** VOLUNTARY PROVISION OF INFORMATION ON BIOMARKERS AND INTERMEDIATE ENDPOINTS IN PREVENTION TRIALS NIH GUIDE, Volume 23, Number 12, March 25, 1994 P.T. National Cancer Institute The National Cancer Institute (NCI) announces the establishment of a biomarker registry comprised of information that may be useful to investigators when biomarkers are being considered as intermediate endpoints or as outcome measures in prevention trials. In an effort to collect information on biomarkers, the NCI seeks cooperation from the extramural scientific community on a voluntary basis. Information may be submitted by anyone currently engaged in biomarker research. The following characteristics of biomarkers are of interest: 1. Biological Characteristics: The description should include, but is not limited to, the spontaneous biological rate of progression and/or regression, site-specificity, histology, chromosomal aberrations, epigenetic changes, mutations, histologic correlation, and the phase, i.e., whether the marker in question occurs at an early, intermediate, or late stage of the carcinogenesis process. 2. Outcome Association: Provide information on population, subjects, sites, intermediate endpoints, and the rate of regression of intermediate endpoints in a given time frame in response to the intervention (e.g., 50 percent regression in two months). In the case of chemoprevention trials, also provide the name of the chemopreventive agent, dose (including toxicity data), preclinical efficacy, preclinical safety, clinical safety, and the clinical efficacy, if known. 3. Epidemiological Characteristics: Provide information on (1) types of marker: (a) biomarkers of susceptibility, (b) biomarkers of exposure, (c) biomarkers of biological effects, (d) biomarkers of disease cancer; (2) source of variability: sampling variability, inter- and intra-individual variability, inter- and intra- observational variability, and time-dependent variability; (3) study design: case-control, prospective cohort, or randomized trial. Provide the material for the choice of the endpoint and sample size in your study. INQUIRIES For further information, contact Barnett S. Kramer or Sudhir Srivastava Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 305 Bethesda, MD 20892 Telephone: (301) 496-8544 FAX: (301) 496-8667 $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOP NIH GUIDE, Volume 23, Number 12, March 25, 1994 P.T. 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 27-28, 1994 LOCATION Magovern Conference Center, Allegheny General Hospital, Pittsburgh, PA SPONSORS Allegheny-Singer Research Institute, Pittsburgh, PA Delaware State College, Dover, DE REGISTRATION Ms. Kathleen Hrdlicka Continuing Medical Education Allegheny General Hospital 320 E. North Avenue Pittsburgh, PA 15212 Telephone: (412) 359-4952 TITLE: Contemporary Issues in Human Subject Protection DESCRIPTION: The protection of human subjects is the fundamental responsibility of institutional review boards. Today there are many challenges facing IRBs and research investigators in accomplishing this objective. This Workshop will focus on current legal, ethical, and media issues related to human subjects participating in research. Emphasis will be directed at risk assessment (including mechanisms to minimize risk), research fundamentals, regulatory updates, and a special session will address the impact of the media on biomedical research. The format for the Workshop will include large and small group didactic presentations and panel discussions providing a forum for audience participation. DATES: July 11, 12, 13, 1994 LOCATION Mall of American Grand Hotel, Bloomington, MN SPONSORS University of Minnesota of Minneapolis, Minneapolis, MN American Indian Health Care Association, St. Paul, MN Indian Health Service, Albuquerque, NM CONTACT Office of Continuing Medical Education University of Minnesota Radisson Hotel Metrodome, Suite 107 615 Washington Avenue, SE Minneapolis, MN 55414 Telephone: (612) 626-7600 or (800) 776-8636 TITLE: Contemporary Issues on Existing and New Research Guidelines on Women and Minority Groups: Special Emphasis on American Indians DESCRIPTION: The Conference will examine existing NIH research guidelines, and discuss contemporary issues in the research environment. There will be IRB training; conference participants will be in small mock IRBs to review three protocols, with facilitation by experienced IRB staff. The Conference will examine how protecting American Indian individuals and communities by IRBs and community participation: (1) increases research benefit, (2) decreases research risk, and (3) improves quality of the research. Because Native (American Indian and Canadian First Nation) people are covered by the new NIH guidelines about inclusion of women and minorities in research, the Conference will also examine that policy in depth. The focus on Native communities and volunteers will illuminate how the new Guidelines, current IRB regulations, and community involvement fit together in practice. INQUIRIES For further information regarding these workshops or future NIH/FDA National Human Subject Protections Workshops, contact: Ms. Darlene M. Ross Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B63 Bethesda, MD 20892 Telephone: (301) 496-8101 $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NIH-ES-94-27 ********************************************* EXPIRED BREATH ANALYSIS IN CHEMICAL TOXICITY ASSESSMENT NIH GUIDE, Volume 23, Number 12, March 25, 1994 RFP AVAILABLE: NIH-ES-94-27 P.T. National Institute of Environmental Health Sciences The National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), is soliciting proposals from offerors that have the capabilities and facilities for the following: Phase 1 -- Using the methodology developed under the contract N01-ES-05290 "Expired Breath Analysis in Chemical Toxicity Assessment," the contractor design of a series of experiments to determine changes in the relative production rate (normalized to CO2 production) of the various breath components in male or female F344 rats exposed to various chemical treatments. These treatments will include specific inhibitors or inducers of as many cytochrome P450 isoforms as can be evaluated in the rat, including forms of the enzymes involved in steroid metabolism. The contractor will propose experiments to study the effect of modulation of tissue glutathione levels in relation to changes in expired breath components; Phase 2 will consist of one of two selected tasks. The Government estimates that the project will require approximately 1.5 professional person-years per contract year. The estimated period of performance is three years. INQUIRIES Release of the RFP is anticipated on or about March 21, 1994 with proposals due May 2, 1994. All responsible sources may submit a proposal that will be considered by the Agency. Requests must reference RFP No. NIH-ES-94-27 and must be directed to: Howard Hill Contracts and Procurement Management Branch National Institute of Environmental Health Sciences 79 T.W. Alexander Drive, Building 4401 Research Commons P.O. Box 12874 Research Triangle Park, NC 27709 Telephone: (919) 541-4971 FAX: (919) 541-2712 $$R1 END ************************************************************ $$R2 BEGIN NCI-CM-57207-30 ****************************************** DETAILED DRUG EVALUATION OF TREATMENT STRATEGIES FOR CHEMOTHERAPEUTIC AGENTS NIH GUIDE, Volume 23, Number 12, March 25, 1994 RFP AVAILABLE: NCI-CM-57207-30 P.T. National Cancer Institute The Developmental Therapeutics Program (DTP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI) is seeking a contractor to evaluate compounds for anticancer activity in experimental in vivo tumor models. Studies will focus on agents identified by the Program's disease-oriented in vitro drug screen and will employ human tumors growing in immune-deficient (e.g., athymic, SCID) mice. Experiments will be designed and conducted to optimize drug activity and evaluate the drug's therapeutic potential. Some in vivo studies may involve murine tumors growing in pathogen-free immune-competent rodents, and some cell culture support will be required for propagation of selected human tumors. Results from the project will be interrelated with pharmacokinetic, toxicologic, biochemical and immunologic information to devise and recommend treatment strategies for clinical trials and will be included in investigational New Drug Applications. Compounds to be studied will be selected and assigned by the Government. As compounds of a commercially confidential nature may be evaluated, pharmaceutical and chemical companies will be excluded from the competition. Also, since structural formulae of confidential materials may be provided by the Government on occasion, the organization must be willing to sign a confidentiality of information statement. The organization will provide facilities for handling pathogen-free immune-competent and immune-deficient rodents and utilize methods to protect the facilities from pathogenic organisms. The contract also shall provide facilities/equipment for frozen storage of tumors, tumor transplantation, drug preparation, and treatment, facilities/equipment for the handling of potentially carcinogenic or hazardous materials; facilities/equipment for propagation and testing human and murine tumor lines in vitro. The Principal Investigator should have an M.D.; D.V.M.; or Ph.D. in one of the relevant biological sciences (or equivalent experience), managerial experience, and experience in either managing an in vivo screening program utilizing small animals or evaluating the efficacy or toxicity of antitumor agents, should understand the principles of cancer chemotherapy, and devote approximately 25 percent of his/her time to the project. It is anticipated that one incrementally funded contract will be awarded for a base period of three years, with two one year options. The contract will be written on a level-of-effort basis, specifying that the contractor is to furnish 64,000 labor hours over five years. RFP No. NCI-CM-57207-30 will be available on or about March 31, 1994. Responses will be due May 20, 1994. INQUIRIES Copies of the RFP may be obtained by sending a written request to: Ms. Elsa B. Carlton Research Contracts Branch National Cancer Institute Executive Plaza South, Room 603 Bethesda, MD 20892 Telephone: (301) 496-8620 No collect calls will be accepted. $$R2 END ************************************************************ $$R3 BEGIN HD-94-020 FULL-TEXT ************************************** MENTAL RETARDATION RESEARCH CENTERS NIH GUIDE, Volume 23, Number 12, March 25, 1994 RFA AVAILABLE: HD-94-020 P.T. National Institute of Child Health and Human Development Letter of Intent Receipt Date: May 15, 1994 Application Receipt Date: July 15, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Institute of Child Health and Human Development (NICHD), through the Mental Retardation and Developmental Disabilities (MRDD) Branch, Center for Research for Mothers and Children (CRMC), invites research center core grant applications to develop new knowledge in the field of prevention, treatment, and amelioration of mental retardation and developmental disabilities. Four centers may be supported in response to this RFA. The primary objective of the NICHD Mental Retardation Research Centers (MRRCs) is to provide support and facilities for a cohesive, interdisciplinary program of research and research training in mental retardation and related aspects of human development. The NICHD has supported MRRCs through the provision of core grants, which facilitate program coordination and support central research core facilities. Funds for the research projects using these core units come from independent sources including Federal, State, and private organizations. This RFA seeks applications from existing MRRCs and from other institutions that have a comparable concentration of research in mental retardation. A major goal of the MRDD Branch's research program is to prevent and/or ameliorate mental retardation. In general, the degree of impairment associated with mental retardation varies in relation to the cause. Moderate and more severe mental retardation often results from problems that produce profound alterations in brain development and/or function. Diminished intellectual and adaptive capacity can often be traced to defective genes, teratogenic agents, infections, nutritional deficits, accidents, diseases and other disorders causing brain damage. A larger proportion of cases of mental retardation is related to environmental conditions and disorders of unknown etiology. These complex problems require integrated multidisciplinary approaches involving biomedical and behavioral sciences in a variety of settings. The purpose of a Mental Retardation Research Center is to provide a research environment that facilitates interdisciplinary collaboration among investigators who are working in areas of relevance to the prevention and amelioration of mental retardation. Such research will cover a broad spectrum of scientific approaches ranging from laboratory research on fundamental processes of abnormal development to clinical and educational research in which persons with mental retardation are studied. It is thought that major solutions to the problems of mental retardation may be found as a result of multidisciplinary collaboration involving a variety of approaches in the MRRCs. As a result of the administrative and scientific organization within an MRRC and across the network of MRRCs, opportunities for breakthroughs will be enhanced. 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, Mental Retardation Research Centers, is related to several priority areas including nutrition, alcohol and other drugs, mental health and mental disorders, environmental health, maternal and fetal health, HIV infection, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-011-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, and units of State or local governments. As stated in the NICHD Center Guidelines, the NICHD will not support more than one center grant in a given department or specialty unit. MECHANISM OF SUPPORT Mental Retardation Research Center grants will be supported through the center core grant (P30) mechanism. The application should be prepared in a manner consistent with the general guidelines presented in the publication, P30 CENTER CORE GRANT GUIDELINES, which are available from the NICHD office listed under INQUIRIES. Awards will be made for a period of five years. To be eligible for award as an MRRC, the Center must provide core support for a minimum of 10 projects funded from non-university sources. The total direct costs requested for the first year of a new Center Core Grant (P30) should not exceed $500,000. Renewal applications from existing P30 Centers may request initial year direct costs up to, but not exceeding, 120 percent of the Notice of Grant Award level of direct costs for the final year of the preceding project period, or $500,000 direct cost, whichever is greater. Budgets of applications for new and renewal support will be stringently reviewed within these guidelines. Applications with budget requests exceeding these guidelines will be returned to the applicant without review. FUNDS AVAILABLE This is the seventh in a series of annual announcements. Plans are to make four awards in fiscal year 1995. The estimated funds available for the first year of support for the entire program is $3.3 million total costs. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the nichd, awards pursuant to this RFA are also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES MRRC Core Grants are intended to bring together in a center a variety of disciplines to work on the common problems of mental retardation. Consequently, applications for Mental Retardation Center Core Grants (P30) should include investigators studying a range of topics in basic and clinical or applied research. Applicants are encouraged, but are not required, to include both biomedical and behavioral components from among, but not limited to, the following topics: 1. Developmental neurobiological studies relevant to MRDD. 2. Inborn errors of metabolism relevant to MRDD. 3. Genetic/cytogenetic disorders associated with MRDD. 4. Molecular biology; development of animal models. 5. Toxicology and physical environmental factors in the etiology, treatment and prevention of MRDD. 6. Intellectual, behavioral, physical and the intergenerational effects of malnutrition. 7. Developmental pharmacology and psychopharmacology. 8. Infectious diseases in the etiology, prevention and treatment of MRDD. 9. Diagnosis: identification of, and early intervention for, infants and children at risk to develop MRDD. 10. Perinatal problems associated with MRDD. 11. Psychobiological processes in MRDD. 12. Psychological processes in MRDD. 13. Behavioral analysis of individuals with MRDD. 14. Family and community studies. 15. Language and communication studies. 16. Learning disabilities, dyslexia, and attention deficit disorder. 17. Behavior in residential, educational, and occupational settings. 18. Socioeconomic status, ethnicity, and ecological processes. 19. Epidemiology of MRDD. 20. Behavior and life-styles that could affect mortality and morbidity. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are asked to submit, by May 15, 1994, a letter of intent that includes a descriptive title, the name, address, and telephone number of the principal investigator, the names of other key personnel and participating institutions, the core unit directors and principal investigators of the research projects that would use the core units, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in evaluating relevance to MRDD and in planning for the review of applications. The letter of intent is to be sent to Dr. Felix F. de la Cruz at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted using PHS 398 (rev. 9/91). Application kits containing this form and the necessary instructions are available in most institutional offices of sponsored research and may be obtained from the Office of Grant Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The NICHD recommends that the application be developed in consultation with the MRDD Program staff, CRMC, who will provide whatever guidance is possible and appropriate in relation to both scientific and administrative issues. The completed application must be submitted to the Division of Research Grants by July 15, 1994. REVIEW CONSIDERATIONS Applications received in response to this RFA will be reviewed with each other on a nationwide competitive basis. The initial review for scientific merit will be carried out by the NICHD Mental Retardation Research Committee (MRRC) at its March 1995 meeting. Because a site visit is not a prerequisite for MRRC consideration, each application should be thorough and complete enough to stand on its own. The second-level review will be made by the National Advisory Child Health and Human Development Council at its June 1995 meeting. The earliest possible funding will be August 1995. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA, inquiries regarding programmatic issues, and address the letter of intent to: Felix F. de la Cruz, M.D., M.P.H. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B-09 Bethesda, MD 20892 Telephone: (301) 496-1383 Direct inquiries regarding fiscal matters to: Mr. Edgar D. Shawver Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A-17 Bethesda, MD 20892 Telephone: (301) 496-1303 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 13.865 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. $$R3 END ************************************************************ $$R4 BEGIN HD-94-016 FULL-TEXT ************************************** COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORK NIH GUIDE, Volume 23, Number 12, March 25, 1994 RFA AVAILABLE: HD-94-016 P.T. National Institute of Child Health and Human Development Letter of Intent Receipt Date: May 1, 1994 Application Receipt Date: July 19, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate, with the assistance of NICHD under cooperative agreements, in an ongoing multicenter cooperative program designed to conduct clinical studies investigating problems in adult reproductive medicine. 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, Cooperative Multicenter Reproductive Medicine Network, 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 "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private. Minority individuals, persons with disabilities, and women are encouraged to apply. The need for continuous and active communication among sites dictates that only institutions in the United States will be eligible for participation. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U10), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreements are discussed in the RFA under "Terms and Conditions." Cooperative agreements are assistance mechanisms and are subject to the same administrative requirements as grants. The special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS, PHS, and NIH grant regulations, policies and procedures at 45 CFR Part 74 and 92, and other HHS, PHS, and NIH grant administration policies. The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated award date is April 1, 1995. At this time, the NICHD has not determined whether this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE It is anticipated that one award for the Data Coordinating Center and eight awards for Clinical Sites will be made, with an estimated total of $1,800,000 (including direct and indirect costs) for the entire program in the first year. Up to five competing continuation awards and at least four new awards are expected. Although this program is provided for in the financial plan of the NICHD, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES There are a number of unresolved questions in reproductive medicine that would lend themselves to cooperative study. The following should by no means be viewed as exclusive, and are intended only as examples: o In vitro fertilization: Patient selection, comparison of treatment protocols to optimize live birth rates. o Endometriosis: Controlled trials of diagnostic methods and treatments. o Polycystic ovarian syndrome: Definition, subgroups, response to therapies. o Leiomyomata: Controlled trials of diagnostic methods and treatments. o Varicocele: Effect on fertility, benefits of surgery. o Male infertility: Diagnosis and treatment directed at the male. The Network will include approximately eight clinical sites or "Reproductive Medicine Units" (RMUs) and a Data Coordinating Center (DCC). There will be two domains within the Network: Infertility/Andrology, and Gynecology. "Infertility" is intended to encompass male factor, female factor, and unknown cause. It is anticipated that initial Network activity would encompass one protocol from each domain, with one RMU acting as lead unit for each protocol. The RMUs will recruit, evaluate and treat the participants in either or both of the clinical studies. The Data Coordinating Center will have primary responsibility for data collection and management for each trial. A Steering Committee will consist of the principal investigators, the NICHD Research Coordinator, and a chairperson designated by the Steering Committee. The Steering Committee will develop by consensus the protocols to be carried out under these cooperative agreements, and supervise the conduct of the studies. A Data Safety and Monitoring Committee convened by the NICHD will have responsibility for reviewing proposed clinical protocols, and for making a recommendation to the NICHD whether to accept, modify, or decline such proposed studies. SPECIAL REQUIREMENTS The NICHD invites applications both from current members of the Network (competing renewal applications) and from prospective members (new applications). Minimum requirements for applicants are described in detail in the RFA (see INQUIRIES). Before requesting the RFA, potential RMU applicants should note that they must have a history of previous successful clinical research and expertise in research design, biostatistics, and the use of clinical protocols. They must also be able to demonstrate ability to enroll sufficient numbers of patients for meaningful studies and excellence in collecting and maintaining clinical data. Potential DCC applicants must have demonstrated prior experience as a Coordinating Center in multicenter studies. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are asked to submit, by May 1, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NICHD staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Donna L. Vogel at the address listed under INQUIRIES. APPLICATION PROCEDURES All applicants must document their ability to meet or exceed the minimum requirements as set out in the SPECIAL REQUIREMENTS section for RMU or DCC applications in the RFA. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these awards. These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248. Applications must be received by July 19, 1994. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness by NIH staff. Incomplete applications will be returned to the applicant without further consideration. Any application that does not meet the minimum requirements of this RFA will be considered unresponsive to the RFA and returned to the applicant. Applications may receive a preliminary scientific peer review (triage) by an NICHD peer review group to determine their relative competitiveness. The NIH will withdraw from further competition those applications judged to be noncompetitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further evaluation for scientific merit by an appropriate peer review group convened by the NICHD, according to the criteria listed in the RFA, including: qualifications, experience, and commitment of Key Personnel; protocols and procedures; and facilities and management. The second level of review will be provided by the National Advisory Child Health and Human Development (NACHHD) Council. AWARD CRITERIA The anticipated date of award is April 1, 1995. Applications recommended by the NACHHD Council will be considered for award based on scientific and technical merit, program balance, and availability of funds. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA, inquiries regarding programmatic issues, and address the letter of intent to: Donna L. Vogel, M.D., Ph.D. Reproductive Sciences Branch National Institute of Child Health and Human Development Building 61E, Room 8B01 Bethesda, MD 20892 Telephone: (301) 496-6515 FAX: (301) 496-0962 Direct inquiries regarding fiscal matters to: Ms. Melinda Nelson Office of Grants and Contracts National Institute of Child Health and Human Development Building 61E, Room 8B17 Bethesda, MD 20892 Telephone: (301) 496-5481 FAX: (301) 402-0915 AUTHORITY AND REGULATIONS This Program is described in the Catalog of Federal Domestic Assistance number 13.864, Population Research. Awards will be made under the authority of the Public Health Service Act, Title X, Section 1004 (Public Law 92-572, as amended; 42 USC 241) and Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241). These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Part 74, and other HHS, PHS, and NIH grant administration policies. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R4 END ************************************************************ $$R5 BEGIN AI-94-019 FULL-TEXT ************************************** TROPICAL DISEASE RESEARCH UNITS NIH GUIDE, Volume 23, Number 12, March 25, 1994 RFA AVAILABLE: AI-94-019 P.T. National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: May 23, 1994 Application Receipt Date: July 21, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Parasitology and Tropical Diseases Branch, Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID) invites applications for program project grants to conduct multidisciplinary research leading to the development and evaluation of new strategies to prevent and control diseases caused by protozoan and helminth parasites. Programs will focus on one of the following areas: (1) development of vaccines for infection and disease; (2) discovery of drug targets and development of new chemotherapeutic agents for treating and preventing parasitic infections; or (3) development of new approaches for interruption of the parasite life cycle at the level of the invertebrate (vector) host. 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, Tropical Disease Research Units, is related to the priority areas of 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 202-783-3238). ELIGIBILITY REQUIREMENTS Only domestic organizations are eligible to apply for program project (P01) grants. Applications may be submitted by domestic for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The mechanism of support will be the program project (P01) grant. This is a mechanism for the support of a broadly based multidisciplinary research program that has a well-defined central research focus or objective. An important feature of the program project is that the interrelationships of the individual scientifically meritorious projects will result in a greater contribution to the overall program goals than if each project were pursued individually. The program project grant consists of a minimum of three interrelated individual research projects that contribute to the program objective. The program project grant also can provide support for certain common resources termed cores. Such resources should be utilized by two or more projects within the program project. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years. These P01 applications may not request budgets in excess of $500,000 direct costs in the first year and may not request more than four percent annual inflationary increases for future years. FUNDS AVAILABLE The estimated minimum total funds (direct and indirect costs) available for the first year of this program will be $2.4 million. In fiscal year 1995, the NIAID plans to fund at approximately three to four program projects related to this award. RESEARCH OBJECTIVES Background Parasitic diseases continue to represent tremendous public health problems, especially for people living in the tropics where parasites are responsible for deaths and impaired growth and development of children and debilitating, chronic diseases among adults. Additionally, parasitic infections have been increasingly recognized as responsible for diseases in the United States and other industrialized countries. Of special interest is the occurrence of severe disease in individuals who acquired an infection congenitally or as a result of immunosuppression. This RFA represents a continuation of the Tropical Disease Research Units (TDRU) program, which was designed to stimulate advanced biomedical research on five parasitic diseases (filariasis, leishmaniasis, malaria, schistosomiasis, and trypanosomiasis). Recent advances in our understanding of the basic biology of these parasites and of host-parasite interactions have created unique opportunities for discovering and evaluating new means of controlling the mortality and morbidity associated with parasitic infections. The NIAID recognizes that substantial advances have been made in the understanding of other parasitic diseases that also represent significant global public health concerns. Thus, for the purposes of this recompetition, the NIAID will expand the scope of the TDRU program to encompass all medically important human parasitic diseases. TDRUs will provide a resource for concerted efforts for the development and preclinical testing of new intervention strategies for parasitic diseases. Scope of Research The NIAID wishes to support multidisciplinary, state-of-the-art biomedical research units to serve as foci for innovative research on medically important parasites or their vectors, leading to new intervention strategies to control the public health impact of diseases caused by protozoa and helminths. For the purpose of this RFA, intervention strategies to be considered are: (1) vaccines to prevent infection and/or disease; (2) chemotherapeutic agents to prevent and/or treat infection; and (3) methods to control invertebrate vectors or interrupt the parasite's life cycle in the vector. The entire program project grant, consisting of three or more projects as well as cores, must address the development of one of these intervention strategies. While limited to a single intervention strategy, the program project may focus, however, on one or more parasitic infections. Each application must provide an experimental plan which details the methods that will be used to validate the utility of the chosen approach. Programs may involve collaboration among investigators at several institutions. Consortium arrangements should follow the NIH Guide outline in "Guidelines for Establishing and Operating Consortium Grants, January 1989." These are available from the individuals listed under INQUIRIES. SPECIAL REQUIREMENTS Institutions receiving TDRU awards are considered as Centers in the NIAID International Centers for Tropical Disease Research network and TDRU program directors are designated as Center Directors in this network. The application should budget appropriate funds to allow the TDRU program director to attend the annual meeting of the network, which is generally held in Bethesda in the Spring. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are asked to submit, by May 23, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. The letter of intent is not required. It allows NIAID staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Preble at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892. Applicants for Program Project Grants should read the information brochure "NIAID Program Project and Multiproject Cooperative Agreements" available from Michael Gottlieb at address listed under INQUIRIES. REVIEW CONSIDERATIONS Applications will be reviewed by Division of Research Grants (DRG) staff for completeness and by NIAID staff to determine administrative and programmatic responsiveness to this RFA. Those judged to be incomplete or nonresponsive will be returned to the applicant without review. Those considered complete and responsive may be subjected to a triage review by an NIAID peer review group to determine their scientific merit relative to the other applications. The NIAID will withdraw from competition those applications judged by the triage peer review group to be noncompetitive for award and will so notify the applicant investigator and the institutional business official. Those applications judged to be competitive for award will be reviewed for scientific and technical merit by a Review Committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the NIAID Council. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify issues or questions from potential applicants is welcome. Requests for the RFA and the brochure entitled "NIAID Program Project and Multiproject Cooperative Agreements" as well as inquiries regarding programmatic issues may be directed to: Dr. Michael Gottlieb Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A03 Bethesda, MD 20892 Telephone: (301) 496-7115 FAX: (301) 402-0804 E-Mail: mg35s@nih.gov Direct inquiries regarding the review of applications and address the letter of intent to: Dr. Olivia Preble Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C19 Bethesda, MD 20892 Telephone: (301) 496-8208 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Ms. Leslie Marsden Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B29 Bethesda, MD 20892 Telephone: (301) 496-7075 Schedule Letter of Intent Receipt Date: May 23, 1994 Application Receipt Date: July 21, 1994 Scientific Review Date: November 1994 Advisory Council Date: February 1995 Earliest Date of Award: May 1995 AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301 (c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citation is Sec. 93.856, Microbiology and Infectious Diseases Research. Awards will be administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. $$R5 END ************************************************************ $$R6 BEGIN HD-94-017 FULL-TEXT ************************************** VAGINAL IMMUNOLOGY: INTERACTION WITH INTRAVAGINAL PRODUCTS NIH GUIDE, Volume 23, Number 12, March 25, 1994 RFA AVAILABLE: HD-94-017 P.T. National Institute of Child Health and Human Development Letter of Intent Receipt Date: May 31, 1994 Application Receipt Date: July 27, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Institute of Child Health and Human Development (NICHD) invites research grant applications for the support of basic and applied research to evaluate the affect of intravaginal products, treatments and spermicides on vaginal immunology. An important part of the mission of the NICHD is to gain new knowledge about human reproduction, especially those that may lead to new approaches to contraception. This RFA is intended to address that charge. 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, Vaginal Immunology: Interaction with Intravaginal Products, is related to the priority area of primary prevention of sexual spread of HIV infection with the use of topical microbicides and contraceptives. 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 20402-9352 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit organizations, public and private. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Minority individuals, persons with disabilities, and women are encouraged to apply. MECHANISM OF SUPPORT This RFA will use the NIH individual research project grant (R01) and FIRST (R29) award as the support mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed five years. The earliest expected award date is March 1, 1995. 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. 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 also vary. FUNDS AVAILABLE It is expected that up to five new applications will be funded, within the total cost limit of $1,000,000 available for the first year. This level of support is dependent on the receipt of sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NICHD, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES For the purpose of this RFA, research subject areas would include, but not be limited to, the following: o Delineate how endocrinologic and biological factors such as exogenous hormones (oral contraceptives, time of the menstrual cycle, pregnancy, and menopause affect the mucosal immune response in the reproductive tract and alter an HIV-negative woman's susceptibility to HIV infection or an HIV-positive woman's infectiousness. o Delineate characteristics influencing the concentration and activation of lymphoid cells in the vagina when exposed to semen. lactobacilli on the local immune responses as a mechanism to resist disease. o Determine how and whether spermicides, douches, and topical agents (antibiotics, antifungals etc) affect the vaginal/cervical secretory or cell-mediated immune responses. o Determine what characteristics are desirable in a formulation of a topical drug to maintain or enhance mucosal cell-mediated or secretory immune responses. NOTE: The use of STDs as a model to understand vaginal immunology is outside the scope of this RFA. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines On the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are strongly encouraged, but not required, to submit, by May 31, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NICHD staff to estimate the potential review workload and to avoid conflict of interest circumstances in the review process. The letter of intent is to be sent to Dr. Pamela Stratton at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Applications must be received by July 27, 1994. If an application is received after that date, it will be returned to the applicant. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, it will be returned to the applicant, who may then submit it to DRG for review in competition with unsolicited applications at the next available review cycle. Responsive applications may be triaged by a peer review group to determine their relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further evaluation for scientific merit in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the National Advisory Child Health and Human Development (NACHHD) Council. Review criteria for RFAs are generally the same as those for unsolicited research grant applications. For studies in HIV-infected women, documented collaboration with ongoing epidemiologic studies of HIV-infected women, including but not limited to the Women and Infants Transmission Study (WITS), the Women's Interagency HIV Study, and the HIV Epidemiologic Research Study (HERS). For studies of any other cohort of women, documented collaboration with gynecologists or other clinicians who have access to the number and type of women who are proposed to be studied. AWARD CRITERIA The anticipated date of earliest award is February 1, 1995. Funding decisions will be based on peer review and NACHHD Council recommendation, program relevance, and availability of funds. In some cases, if the proposed research has relevance to other Institutes of the National Institutes of Health, the application may be dually assigned to, and considered for funding by, the NIAID. Any such assignment will be made independently of peer review procedures. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are encouraged. Direct requests for the RFA, inquiries regarding scientific issues, and address the letter of intent to: Pamela Stratton, M.D. Contraceptive Development Branch National Institute of Child Health and Human Development Building 6100, Room 8B13 Bethesda, MD 20892 Telephone: (301) 496-1661 FAX: (301) 496-0962 Direct inquiries regarding fiscal matters to: Melinda Nelson Office of Grants and Contracts National Institute of Child Health and Human Development Building 6100, Room 8A17 Bethesda, MD 20892 Telephone: (301) 496-5481 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.864, Population Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12374 or health Systems Agency review. $$R6 END ************************************************************ $$R7 BEGIN HD-94-018 FULL-TEXT ************************************** VAGINAL PHYSIOLOGY: INTERACTION WITH INTRAVAGINAL PRODUCTS NIH GUIDE, Volume 23, Number 12, March 25, 1994 RFA AVAILABLE: HD-94-018 P.T. National Institute of Child Health and Human Development Letter of Intent Receipt Date: May 31, 1994 Application Receipt Date: July 27, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE From owner-sci-resources@net.bio.net Mon Mar 28 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA ES-94-006 - V23(09) 03/04/94 Date: 28 Mar 1994 18:23:41 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 386 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2n83fd$ihe@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA ES94006 ES-94-006 P1O1 *************************************** MINORITY SCIENTIST AWARD AT MINORITY INSTITUTIONS NIH GUIDE, Volume 23, Number 9, March 4, 1994 RFA: ES-94-006 P.T. 34, FF; K.W. 0725005 National Institute of Environmental Health Sciences Application Receipt Date: May 20, 1994 PURPOSE Human health and human disease result from three interactive elements: environmental factors, genetic susceptibility, and age. The mission of the National Institute of Environmental Health Sciences (NIEHS) is to reduce the burden of human illness and dysfunction from environmental causes by further understanding each of these elements and how they interrelate. The NIEHS achieves its mission through a multidisciplinary biomedical research program, prevention and intervention efforts, and a communication strategy that encompasses training, education, technology transfer, and community outreach. The ultimate goal of the NIEHS activities is to define and understand the mechanism of action of environmental agents on human health and transfer this knowledge to the public benefit. The NIEHS invites minority faculty members at historically black colleges and universities and other predominantly minority colleges, universities, and health professional schools to submit applications for support of activities directed at the development of investigators at such schools in areas relevant to environmental health sciences. The intent of the award is to provide an underrepresented minority faculty member with increased access to research opportunities through collaborative arrangements with funded environmental health scientists, usually at institutions within a 100-mile radius of the applicant organization. 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 Scientist Award at Minority Institutions, 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 "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 A minority school is defined as a medical or nonmedical college, university, or equivalent school in which students of minority ethnic groups including African Americans, Hispanics, American Indians, and Asian or Pacific Islanders comprise a significant proportion of the school enrollment and that has a commitment to the special encouragement of minority faculty, students and investigators. Candidates for this award are faculty members who (1) are members of an underrepresented minority group; (2) are citizens of the United States, noncitizen nationals or permanent residents at the time of application; (3) have an M.D., Ph.D. degree or equivalent in a biomedical or behavioral science; (4) wish to develop research capabilities in environmental health sciences research; and (5) have the background and potential to become an independent biomedical investigator. A minimum of 70 percent effort annually must be committed to the award. Applicants may not apply for, or accept, other PHS research grant support or its equivalent at the time of submission of the Minority Scientist Award at Minority Institutions, nor may they apply at the same time for any other type of academic award. However, they may apply for, and accept research grant support subsequent to award of the Minority Scientist Award at Minority Institutions. Each candidate must also identify and complete arrangements with a nearby mentor, preferably at a majority or minority institution within reasonable commuting distance, approximately 100 miles. The mentor should be recognized as an accomplished NIEHS-funded investigator, in the research area proposed, who will provide guidance for the awardee's development and research plan. NIEHS staff is willing to assist prospective applicants in identifying appropriate NIEHS grantees. If no NIEHS-supported grantee can be identified, other NIH-supported grantees may be suitable as mentors. However, the applicant should discuss this with NIEHS staff to determine if the mentor is appropriate for this program. Plans for an intensive training period should be developed with the mentor. The commitment of the mentor and his/her institution to both the summer and academic year training must be evidenced by letters of support to be included in the application. A commitment from the mentor's department head must be included in the application. MECHANISM OF SUPPORT Support of this program will be through the NIEHS Minority Scientist Award at Minority Institutions (K14). Applicants will be responsible for the planning, direction, and execution of the proposed project. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000 (rev. October 1, 1990). Awards are nonrenewable and nontransferable from one awardee to another. Funding beyond the first year of the grant is contingent upon satisfactory progress during the preceding year. Future program interest in this initiative will be announced through the NIH Program Announcement mechanism. Awards must be requested for a period of five years. Allowable costs include: Salary: The salary of the candidate may be requested up to $50,000, plus fringe benefits, per annum for the time and effort committed to the activities of the award. A minimum of 70 percent effort annually must be committed to the award. Research Support: A maximum of $60,000 for year 01 and $35,000 per year in succeeding years for the categories listed below: Equipment: Specialized research equipment essential to the proposed program; in accordance with PHS policy, title to such equipment will vest with the grantee institution. Supplies: Consumable supplies essential to the proposed program. Other: Personnel, publication costs, computer costs, or other costs necessary for the research program. Travel: Domestic travel for the awardee that is essential to the proposed program. Travel expenses for up to two active researchers from outside the institution as consultants/seminar speaker(s). Tuition and Fees: If essential to the awardee's individual research development program. Indirect Costs: Will be provided for at a rate of eight percent of the total direct costs of each award, exclusive of tuition, fees, and expenditures for equipment. Categorical amounts cited above notwithstanding, the total award may not exceed $110,000 in direct costs per year ($135,000 in the first year). FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for this RFA are anticipated to be $250,000. It is expected that two to three awards will be possible. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. RESEARCH OBJECTIVES This program is designed to support environmental health sciences related research career development of minority faculty at minority institutions at the M.D., Ph.D., or equivalent level who have the interest and capabilities of doing state-of-the-art research in this area. The objective of this RFA is to develop the research skills and capacity of faculty members at minority schools, increase the pool of biomedical and behavioral investigators in environmental health sciences research, improve the research facilities at minority institutions, and have undergraduate students, most of whom will be minority individuals, become more cognizant of research opportunities in environmental health sciences. Since the objective of this program is to develop the faculty research capacity, the inclusion of undergraduate students on the project is not required. However, if appropriate, the participation of an undergraduate student is allowable. SPECIAL REQUIREMENTS The applicant should request funds for one trip annually to the National Institute of Environmental Health Sciences for a grantee meeting. The applicant must include plans for a seminar program for undergraduate students. Each year the applicant should include his/her own research and two active researchers from outside the institution as seminar speakers. Although the specific features of the seminar program are the responsibility of the applicant, it is expected that this would be a regularly occurring seminar program and provide undergraduate students an opportunity to learn about and explore environmental health sciences issues and opportunities. The NIEHS expects that this award will result in the submission of manuscripts for publication and presentations of the research at national forums by the awardee. In addition, the applicant must include a plan for the submission of a grant application to a program not targeted to minority institutions. Since the objective of this award is the development of the research capacity, funding for the fourth and fifth year of the award will be contingent upon the submission of a NIH grant application. Although the specific research to be proposed in such a grant application will be uncertain at the time of this application, the applicant should be planning to obtain future research support via traditional research grants. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear, compelling rationale should be provided. The composition of the proposed study populations must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7378 (for multiple copies) (301) 496-7248 (for one copy). Applications must be received by May 20, 1994. If an application is received after that date, it will be returned to the applicant. The RFA label provided in the PHS 398 (rev 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies, to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** To expedite review, two copies must also be sent to: Ethel Jackson, D.D.S. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 104 Alexander Drive, Building 17, North Campus Research Triangle Park, NC 27709 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete and non-responsive applications will be returned to the applicant without further consideration. Applications may be triaged on the basis of relative competitiveness. Those applications judged to be competitive will undergo further merit review by an appropriate review group convened by the Scientific Review Branch, NIEHS. The second level review by the National Advisory Environmental Health Sciences Council considers the special needs of the NIEHS and the priorities of the NIEHS Program. The factors that will be used by the review group in the evaluation of applications for this RFA are listed below. o The overall merit of the candidate's plan for research and the development of research skills. o The background and potential of the proposed candidate for development into an independent biomedical investigator. o The candidate's commitment to a research career. o The ability of both the minority institution and the training center to provide facilities, resources, and opportunities necessary for the candidate's research development. o The commitment of the home institution to the faculty candidate's research and development must clearly be presented in the application, including statements from the sponsor and the department chairman. o The qualifications, ability, and plans of the mentor who will provide the candidate with the guidance necessary for career development in research. Recognition of the mentor as reflected by receipt of support from national peer reviewed funding sources. o The seminar plan. AWARD CRITERIA The anticipated date of award is September 30, 1994. INQUIRIES The NIEHS welcomes the opportunity to clarify any issues or questions from potential applicants. Written and telephone inquiries concerning this RFA are encouraged. Direct inquiries concerning the RFA to: Michael J. Galvin, Jr., Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 (North Campus) Research Triangle Park, NC 27709 Telephone: (919) 541-7825 Direct inquiries regarding fiscal matters to: Ms. Carolyn Winters Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 2-01 (North Campus) Research Triangle Park, NC 27709 Telephone: (919) 541-7823 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. From owner-sci-resources@net.bio.net Mon Mar 28 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-94-020 - V23(12) 03/25/94 Date: 28 Mar 1994 18:10:25 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 517 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2n82mh$hl6@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HD94020 HD-94-020 P1O1 *************************************** MENTAL RETARDATION RESEARCH CENTERS NIH GUIDE, Volume 23, Number 12, March 25, 1994 RFA: HD-94-020 P.T. National Institute of Child Health and Human Development Letter of Intent Receipt Date: May 15, 1994 Application Receipt Date: July 15, 1994 PURPOSE The National Institute of Child Health and Human Development (NICHD), through the Mental Retardation and Developmental Disabilities Branch (MRDD), Center for Research for Mothers and Children (CRMC), invites research center core grant applications as part of the NICHD Mental Retardation Research Program to develop new knowledge in the field of diagnosis, prevention, treatment, and amelioration of mental retardation and developmental disabilities. Four centers may be supported in response to this RFA. A Mental Retardation Research Center (MRRC) is a center to facilitate, through organization and operation, a program of biomedical and/or behavioral research related to mental retardation. Mental Retardation Research Center core grants support multidisciplinary research in areas that may lead to diagnosis, prevention, treatment, and/or amelioration of mental retardation and developmental disabilities. These grants fund core support services, administration, and development of a limited number of new research programs. The primary objective of the NICHD Mental Retardation Research Centers is to provide support and facilities for a cohesive, interdisciplinary program of research and research training in mental retardation and related aspects of human development. Public Law 88-164, Title I, Part A authorized construction of mental retardation research centers. NICHD has provided partial support for a limited number of these centers through the provision of core grants (P30), which facilitate program coordination and support central research facilities. Funds for the research projects using these core facilities come from independent sources including Federal, State, and private organizations. This Request for Applications (RFA) seeks applications, not only from these constructed centers, but also from other comparable institutions that meet the qualifications for a program of mental retardation research. A major goal of the MRDD Branch's Mental Retardation Research Centers is to prevent and/or ameliorate mental retardation. The degree of impairment associated with mental retardation varies in relation to the cause. Moderate and more severe mental retardation often results from problems that produce profound alterations in brain development and/or function. Diminished intellectual and adaptive capacity can often be traced to defective genes, teratogenic agents, toxic substances, infections, nutritional deficits, accidents, diseases, and other disorders causing brain damage. A larger proportion of cases of mental retardation is related to environmental conditions and disorders of unknown etiology. These complex problems require integrated, multidisciplinary approaches involving biomedical and behavioral sciences in a variety of settings. More than 400 mental retardation syndromes have been identified, and new ones are being discovered. Each requires fundamental research into the underlying processes, as well as studies designed to meet the unique needs of the afflicted children. Therefore, one of the missions of the MRDD Branch is to support research on the etiology, pathophysiology, epidemiology, diagnosis and evaluation, prevention, and amelioration of mental retardation. The purpose of a Mental Retardation Research Center is to provide a research environment that facilitates interdisciplinary collaboration among investigators who are working in areas of relevance to the prevention and amelioration of mental retardation. Such research will cover a broad spectrum of scientific approaches ranging from laboratory research on fundamental processes of normal and abnormal development to clinical and behavioral research in which persons with mental retardation are studied. It is thought that major solutions to the problems of mental retardation may be found as a result of multidisciplinary collaboration involving a variety of approaches in the Mental Retardation Research Centers. As a result of the administrative and scientific organization within an MRRC and across the network of MRRCs, opportunities for breakthroughs will be enhanced. 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, Mental Retardation Research Centers, is related to several priority areas including nutrition, alcohol and other drugs, mental health and mental disorders, environmental health, maternal and fetal health, HIV infection, immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-011-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, and units of State or local governments. As stated in the NICHD Center Guidelines, the NICHD will not support more than one center grant (P30 or P50) in a given department or specialty unit. MECHANISM OF SUPPORT Mental Retardation Research Center grants will be supported through the center core grant (P30) mechanism. The application should be prepared in a manner consistent with the general guidelines presented in the publication titled P30 CENTER CORE GRANT GUIDELINES, which is available from the MRDD Branch office listed below. Awards will be made for a period of five years. To be eligible for award as an MRRC, the Center must provide core support for a minimum of 10 projects funded from non-university sources. The total direct costs requested for the first year of a new Center Core Grant (P30) should not exceed $500,000. Renewal applications from existing P30 Centers may request initial year direct costs up to, but not exceeding, 120 percent of the Notice of Grant Award level of direct costs for the final year of the preceding project period, or $500,000 direct costs, whichever is greater. Budget increments for subsequent years generally will be limited to four percent. Budgets of new and renewal applications will be stringently reviewed within these guidelines. Applications with budget requests exceeding these guidelines will be administratively withdrawn by NICHD and returned to the applicant. FUNDS AVAILABLE This is the seventh in a series of annual announcements. Plans are to make four awards in fiscal year 1995. The estimated funds available for the first year of support for the entire program is $3.3 million total costs. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NICHD, awards pursuant to this RFA are also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Mental Retardation Research Center Core Grants are intended to bring together in a center scientists from a variety of disciplines to work on the common problems of mental retardation. Consequently, applications for Mental Retardation Center Core Grants (P30) should include investigators studying a range of topics in basic and clinical or applied research. Applicants are encouraged, but are not required, to include both biomedical and behavioral components among the topics addressed within their center. Center grant applications must include, but are not limited, among these topics at least five of the following: 1. Developmental neurobiological studies relevant to MRDD: neurophysiological, neuroanatomical, neurochemical, neuropharmacological. 2. Inborn errors of metabolism relevant to MRDD, including mitochondrial disorders: pathophysiology, recombinant DNA technology, screening, applied clinical and experimental studies, including treatment. 3. Genetic/cytogenetic disorders associated with MRDD: research on prenatal diagnosis, particularly non-invasive methods during the early stages of pregnancy on prevalent genetic causes of mental retardation such as Down syndrome or Fragile X syndrome; research on rare genetic disorders associated with mental retardation; genomic imprinting. 4. Molecular biology: gene localization, structure, function and organization; gene mapping; gene therapy; and development of animal models. 5. Toxicology and physical environmental factors in the etiology, treatment and prevention of MRDD including lead, mercury, and alcohol; developmental and behavioral teratology; subclinical levels of toxic agents and their effects on morphological and behavioral changes associated with mental retardation. 6. Effects of malnutrition (protein, calorie, micronutrients) on intellectual, behavioral, social and physical development and the intergenerational effects of malnutrition. 7. Developmental pharmacology and psychopharmacology: medication used with MRDD populations. 8. Infectious diseases in the etiology, prevention and treatment of MRDD; neurological, neuropathological, behavioral and intellectual consequences of AIDS in children. 9. Diagnosis: development and application of biomedical and behavioral methods and measures; identification of children and infants at risk for MRDD. Early interventions for infants at risk to develop MRDD: research into the process of early intervention strategies. 10. Predictive and developmental studies of perinatal problems associated with MRDD: developmental studies of low birth weight, small for gestational age, preterm and neonatally sick infants; hypoxic or ischemic insults. 11. Psychobiological processes in MRDD of conditions such as autism and Rett syndrome using methods of behavioral genetics, embryology and teratology, developmental neuroscience and psychophysiology. 12. Psychological processes in MRDD: studies of cognitive and information processing; attention and perception; sensory and motor development; family, social and affective behavior; and, motivation and personality. 13. Behavioral analyses: manipulations of interaction between behavior and environments of individuals with MRDD to reduce problem behaviors, facilitate vocational training, improve social and self-help skills, and increase acquisition of adaptive behaviors. 14. Family and community studies: parent-child and family interactions; sexual behaviors; family structure and demographic variables, including ethnic minority families with members with MRDD; family and community factors influencing developmental outcomes and adjustment; community resources; caregiver behavior; and social support networks. 15. Language and communication of MRDD populations: studies on development of alternative communication systems; ontogeny of linguistic processes. 16. Learning disabilities, dyslexia, and attention deficit disorder. 17. Residential, educational, and occupational settings throughout the life- span: effects on behavior and adjustment of MRDD individuals; learning and social behavior in educational settings; adaptation to residential environments; aberrant behavior, including stereotypies, destructive behavior, and self-injury. 18. Socioeconomic status, ethnicity, and ecological processes: interaction of MRDD individuals in multiple settings (naturalistic observation); ethnographic research; life history reporting; systematic observation of specific activities. 19. Epidemiology of MRDD: analytic and case-control studies of etiology; prevalence; follow-up of outcomes. 20. Behavior and life-styles that could affect mortality and morbidity. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151) 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. (NOTE: When the proposed study or studies in the RFA or PA involves a gender specific study or a single or limited number of minority population groups, this should also be stated to inform potential applicants and reviewers.) LETTER OF INTENT Prospective applicants are asked to submit, by May 15, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the names of other key personnel and participating institutions, the core unit directors and principal investigators of the research projects that would use the core units, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in evaluating relevance to MRDD and in planning for the review of applications. The letter of intent is to be sent to: Felix F. de la Cruz, M.D., M.P.H. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B-09 Bethesda, MD 20892 Telephone: (301) 496-1383 APPLICATION PROCEDURES Applications are to be submitted using PHS 398 (rev. 9/91). Application kits containing this form and the necessary instructions are available in most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the NIH program administrator listed under INQUIRIES. The NICHD recommends that the application be developed in consultation with the MRDD Program staff, who will provide whatever guidance is possible and appropriate in relation to both scientific and administrative issues. Applicants for P30 Mental Retardation Research Center grants should propose a program with a theme relevant to the mission of the MRDD Branch as outlined above. The program should consist of at least 10 externally funded research projects grouped according to relevant topics. These projects must be of high quality, providing a multidisciplinary approach to the problem(s) being investigated. Each project is to be summarized in accordance with the NICHD P30 Center Core Grant Guidelines. The MRRC Director should be a scientist or science administrator who can provide effective administrative and scientific leadership. The Director will be responsible for the organization and operation of the MRRC and for communication with the NICHD on scientific and operational matters. Scientific personnel and institutional resources capable of providing a strong research base in the fields specified must be available. In addition, the institution and pertinent departments are expected to show a strong commitment to the center's support. Such commitment may be provided as dedicated space, salary support for investigators, dedicated equipment, or other financial support for the proposed MRRC. Each core unit proposed for funding under the MRRC grant must be utilized by at least three federally funded research projects, at least one of which is funded by the MRDD Branch of NICHD, exclusive of research contracts, training grants, interagency agreements, and NIH-supplemental projects funded by other agencies. Program staff will make exceptions to this requirement in instances where research relevant to MRDD is assigned elsewhere within NICHD. Subprojects within a program project (P0l) will be considered as individual projects comparable to an R0l. A detailed description of each core unit proposed as part of the center must be provided with detailed budget and budget justification. A scientist must be named as responsible for each core unit proposed. The description of the core units proposed should include a rationale to show how they will support the research effort in a cost effective manner. Facilities must be available for the primary needs of the MRRC Program and require no more than modest alteration and/or renovation. Funds for new construction will not be provided. Promoting interdisciplinary collaboration among scientists working within a Center is a major goal of the MRRC Program. Each MRRC applicant should submit a plan, as part of the application, to ensure continuing interaction among participating scientists from different disciplines. Another goal of the MRRC Program is to attract scientists to the field of mental retardation research. Therefore, where appropriate, the applicant may request "New Program Development" funds for direct research support of one or more projects, not to exceed a total of $50,000 per year or 10 percent of total direct cost, whichever is less. Such funds might serve to attract new investigators to the Center, to develop a new area or program of research, or to facilitate the development of newly trained investigators' research programs. New Program Development projects should be comparable to R0l research applications in their detail and development. Each such project can provide support for only two years for any one investigator. It is a major goal of the NICHD to promote active collaboration among MRRCs. To accomplish this goal, the successful applicants will be encouraged to participate in the collaborative efforts of established MRRC programs. Some consideration should be given, in planning the program, to potential collaborative studies and projects that might be proposed for the MRRC network. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Applications must be identified by checking the YES box in item number 2a on the face page of the application. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, a copy of the covering letter and two additional copies of the application must also be sent to: Acting Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E-03 Bethesda, MD 20892 Applications must be received by July 15, 1994. If an application is received after that date, it will be returned to the applicant. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness to the RFA. Incomplete and/or nonresponsive applications will be returned to the applicant without further consideration. Applications may be triaged by a peer review group on the basis of relative competitiveness. If so, the NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Applications judged to be competitive will undergo further scientific merit review by the NICHD Mental Retardation Research Committee at its March 1995 meeting, in accordance with the criteria stated below. Because a site visit is not a prerequisite for MRRC consideration, each application should be thorough and complete enough to stand on its own. The second-level review will be made by the National Advisory Child Health and Human Development Council at its June 1995 meeting. The anticipated date of award is August 1, 1995. Review Criteria Criteria for the initial review of applications include: o scientific, technical, or medical significance of the application; o qualifications and research experience of the Principal Investigator and scientific collaborators; o scientific and administrative leadership of the Principal Investigator; o quality of proposed core facilities; o availability and quality of resources and research environment; o quality and relevance to mental retardation of research projects that will be using the core facilities; o plans for interdisciplinary/multidisciplinary collaboration; o cost-effectiveness of the proposed MRRC; o institutional commitment; o appropriateness of the proposed budget; o adequacy of plans for the protection of human subjects; o adequacy of plans to protect against or minimize adverse effects on animals; o inclusion of women and minority subjects in research. AWARD CRITERIA In addition to the scientific and technical merit of the application, other factors will be considered in making the awards. Among these are: o centers addressing research areas of high programmatic interest to the MRDD Branch, the CRMC, and NICHD; and research areas targeted by Congress; o availability and quality of resources, especially institutional commitment; o access to unique populations; o potential to increase productivity and quality of research within the center, and stimulate interdisciplinary/multidisciplinary collaborations; o providing unique resources for the use of other Centers, and the greater research community; and o cost-effectiveness of the core facilities. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Inquiries regarding programmatic issues may be directed to: Felix F. de la Cruz, M.D., M.P.H. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B-09 Bethesda, MD 20892 Telephone: (301) 496-1383 Inquiries regarding fiscal matters may be directed to: Mr. Edgar D. Shawver Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A-17 Bethesda, MD 20892 Telephone: (301) 496-1303 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865 Research for Mothers and Children. Awards will be made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Mon Mar 28 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-94-045 - V23(10) 03/11/94 Date: 28 Mar 1994 18:19:02 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 522 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2n836m$ibh@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA94045 PA-94-045 P1O1 *************************************** NEW AND IMPROVED TECHNOLOGIES FOR GENOMIC RESEARCH AND ANALYSIS NIH GUIDE, Volume 23, Number 10, March 11, 1994 PA NUMBER: PA-94-045 P.T. 34; K.W. 1215018, 0755045 National Center for Human Genome Research PURPOSE [This program announcement supersedes the previous announcement that was published in the NIH Guide to Grants and Contracts, Vol. 21, No. 9, Part 2 of 2 parts, March 6, 1992.] The National Center for Human Genome Research (NCHGR) invites applications to support research that will significantly advance progress toward achieving the extended scientific goals of the Human Genome Program (HGP). These goals are described in the article, "A New Five-Year Plan for the U.S. Human Genome Project" (Science, vol. 262, p. 43-46), which covers the years 1994-1998. Because of the need to increase the rate and efficiency and to lower the cost of mapping and sequencing, the main focus of this program announcement is to solicit projects directed to the development of new or the significant improvement of current methods, strategies and technologies for mapping, sequencing, informatics and gene identification. ELIGIBILITY REQUIREMENTS Domestic and foreign universities, medical colleges, hospitals, corporations, and other public, private, or for-profit research institutions, including state and local government units, are eligible. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applications from minorities, women, and individuals with disabilities are especially encouraged. MECHANISM OF SUPPORT Support for this program will be through research grants, including research project grants (R01) and FIRST (R29) awards. BACKGROUND The National Institutes of Health (NIH) is currently engaged, along with several other federal, private, and international organizations, in a 15-year research program designed to characterize the human genome and the genomes of selected model organisms. This research program, the Human Genome Project (HGP), has the following interrelated goals: 1. the construction of high-resolution genetic linkage maps; 2. the development of detailed physical maps; 3. the determination of the complete nucleotide sequence of the human genome and the genomes of selected organisms; 4. the development of efficient methods of identifying genes and for placement of known genes on physical maps or sequenced DNA; 5. the development of the capability to collect, store, distribute and analyze the data and materials produced; 6. the development of appropriate new technologies to achieve these goals; and 7. the identification of major issues related to the ethical, legal and social implications (ELSI) of genome research, and the development of policy options to address them. The products of the Human Genome Project will include information and material resources, as well as new technologies, that will be available to the entire research community to facilitate further research leading to the prevention, diagnosis, and therapy of disease, as well as to further understanding of human biology. In 1990, the NCHGR and the Department of Energy (DOE) jointly published a plan that set out specific goals to be achieved in the first five-year phase of the U.S. human genome program. Anticipating the attainment of much of the initial set of goals, the NCHGR and DOE recently published the above-referenced new five-year plan extending the goals for the U.S. Human Genome Project. In particular, the new plan recognizes the need for further substantial improvements in technology in all areas of genomic research if the goals are to be reached, particularly in the area of sequencing technology. The objectives of this program announcement are to encourage investigators who have creative and innovative ideas to participate in the HGP and to solicit research projects that address the scientific goals of the HGP, particularly those that address the development of new, or improvement of existing, technology that will facilitate and accelerate achievement of both the short- and long- term scientific goals of the Human Genome Program in the most expeditious and cost-saving manner. RESEARCH OBJECTIVES Technologies for Improving Physical Maps An STS map of the human genome at a resolution of 100 kilobases remains an important goal of the U.S. human genome project. Such a map will be extremely useful for isolating and characterizing individual genes and other DNA regions of interest. An appropriate physical map will also be a pre-requisite for large-scale DNA sequencing. With respect to both uses, the quality of the map, i.e., the degree to which it faithfully represents genomic DNA, is critical. In order to achieve a fully connected, high quality physical map of the human genome, research projects in the following areas are encouraged: 1. Efficient and rapid methods to isolate and map additional STSs to achieve a resolution of 100 kilobases. The incorporation of STSs with added value (e.g., representing expressed sequences) is encouraged to the extent that it is consistent with the objective of efficiently identifying STSs and incorporating them into the map; 2. Development of methods to accurately measure physical distances between markers on cloned and genomic DNA; 3. Development of new vector systems for mapping and sequencing; 4. Construction of clone libraries in which the DNA inserts are large, stable, free of artifacts, and faithfully represent genomic DNA; 5. Development of methods or strategies to assemble contigs of cloned DNA rapidly and accurately; and 6. Development of methods and strategies to solve the problem of closure. Advanced Sequencing Technologies The goal of the HGP is not only to complete the sequence of the human genome within the projected 15 years, but to do so with technology that will make it possible to sequence large regions of DNA, such as other genomes, rapidly and inexpensively. Achieving this goal will require the development and testing of significantly improved sequencing technology within the next several years. Increasing the overall rate of DNA sequence accumulation at least two-fold per year for the next several years will be necessary to reach the HGP's sequencing objectives. Currently, the maximum rate of sequencing of large contiguous sections of DNA by the community is approximately two megabases per year; the newly stated goal is to increase that rate to 50 Mb per year by 1998. Research projects are encouraged in the following areas: 1. Development of new approaches to DNA sequencing that offer substantial increases in the rate and cost-effectiveness of sequencing of complex genomes; 2. Significant improvement in current DNA sequencing technologies for large-scale application, with an emphasis on improving cost- effectiveness, exportability (capability of being readily adopted by additional laboratories), and assessment of the accuracy of determined sequence; 3. Development of highly automated systems for DNA sequencing, with emphasis on the integration of all process steps from preparation of DNA through sequence assembly, finishing and correcting. Only applications that aim to develop new technology or to significantly improve current technology should be submitted in response to this Program Announcement. Applications for routine sequencing will not be supported. Applications to develop sequencing capacities on the order of one to a few megabases per year should be submitted in response to the program announcement, "Genome Science and Technology Centers (GESTEC)," NIH Guide to Grants and Contracts, Vol. 23, No. 10, March 11, 1994. Technologies for Refining Genetic Linkage Maps Several current efforts, both genome-wide and chromosome-specific, are expected to allow the timely completion of the 2 to 5 centimorgan human genetic linkage map that was called for in the initial five- year plan. The extended five-year goal for linkage mapping calls for further improvement of genetic mapping technologies, such as the development of methods for rapid genotyping, and the development of new, easier-to-use markers. To facilitate the refinement of the genetic linkage map, to maximize its usefulness and to develop technology for high throughput genotyping, applications are encouraged in the following areas: 1. Development of new DNA-based markers that can readily be incorporated into existing maps and that are amenable to automated analysis; special attention should be given to map closure, the development of methods and strategies to develop DNA-based markers to fill in gaps between markers that are greater than 5 centimorgans apart; 2. Development of novel, marker-independent mapping technologies to facilitate accurate and rapid analysis of whole genomes or megabase regions of genomes; and 3. Development of high-throughput genotyping technologies that are accurate, rapid, efficient, and cost-effective. New Technologies for Gene Identification One of the long-range objectives of the Human Genome Program is to identify all coding sequences, genes and other functional elements in genomic DNA. Given that physical maps are being rapidly assembled and that the rate of accumulation of large-scale sequence data is increasing, there is a critical need for robust, high-throughput, and cost-effective methods and strategies to identify and map functional elements in the genome. Demonstration projects in the following areas are encouraged: 1. Development of methods for rapidly identifying and efficiently mapping all coding regions, genes and other functional elements in genomic and cloned DNA on the order of several megabases or greater in size. 2. Development of new methods of generating and efficiently mapping high quality, full-length cDNAs and constructing representative cDNA libraries. Informatics The Human Genome Program will generate mapping and sequencing data from many laboratories. While some computer tools and information systems for handling these types of data exist, there is a continuing need to develop and improve appropriate computer tools and information systems for the collection, storage, retrieval and distribution of mapping and sequencing data. In addition to the development of databases, it will be necessary to develop new methods and tools for the analysis and interpretation of genome maps and DNA sequences. Research projects are encouraged in the following general areas: 1. Development of effective database management systems to support large-scale mapping and DNA sequencing projects -- such projects should be undertaken in the context of actual mapping and sequencing efforts; 2. Creation of database and/or software tools that provide easy access to up-to-date physical and genetic mapping and DNA sequencing information and allow linkage or integration of these specific data sets; 3. Development of analytical tools that can be used in the assembly, analysis, and interpretation of genomic data; and 4. Development of technology to accelerate the collection, storage, retrieval, analysis and distribution of mapping and sequencing data. Because of the need to provide many of these resources to the larger scientific community, applications may request funds for distribution of software and database designs and for maintenance and user- support. Such requests must be adequately justified in the application. These research topics supplement those described in the program announcement, "Genome Informatics Program," which was published in the NIH Guide to Grants and Contracts, Vol. 21, No. 12, March 27, 1992. Model Organisms The mapping and sequencing of the genomes of model organisms are central to the goals of the HGP. In the initial five-year plan, the mapping and sequencing of the genomes of E. coli, S. cerevisiae, C. elegans, D. melanogaster, and the laboratory mouse were identified as goals of the model organism component of the U.S. HGP for two reasons. Because of the conservation of gene information, a comprehensive analysis of the genomes of these organisms will contribute significantly to our understanding of the human genome. Model systems are also useful in the development of new analytical technologies applicable to the analysis of the human genome. Sufficient progress has been made so that the physical maps of the four non-mammalian systems are essentially complete or close to completion. The sequencing of the DNAs of those organisms is under way and the extended goals call for the completion of the E. coli and S. cerevisiae sequences by or before 1998, for the C. elegans sequence to be approaching completion by 1998, and for the D. melanogaster sequence to be approaching completion by 2000. Applications that propose to contribute to the sequencing of the genomes of any of these organisms must address the way in which a new project would interact with or take into account any existing sequencing programs with similar objectives. Similarly, an application that proposed to contribute to the physical map of the mouse genome must address the way in which it would interact with existing mapping programs. As for sequencing mouse DNA, the extended goals for the HGP emphasize the usefulness of parallel sequencing of homologous regions of mouse and human DNA. Applicants may also propose to study model systems other than those listed. The choice of organism, however, must be justified as contributing significantly to achieving the overall objectives of the HGP, must have technology development as the primary focus, and must be applicable to the analysis of the human genome. Additional Considerations In planning research projects, applicants are strongly encouraged to consider the following: Interdisciplinary Research. The problems that must be solved in genomic analysis may require technically demanding solutions. Accordingly, interdisciplinary approaches are particularly appropriate. The NCHGR strongly encourages interdisciplinary collaborations, which may involve biologists from various sub- disciplines, as well non-biologists, such as chemists, physicists, mathematicians, information scientists and engineers. Sharing of Materials and Data. The sharing of materials and data in a timely manner is essential for optimal progress towards the goals of the HGP, for avoiding unnecessary duplication, and for facilitating application of genome resources in other areas of biomedical research. Public Health Service (PHS) policy requires that investigators make the results and accomplishments of funded activities publicly available. The advisors of the NIH and the DOE genome programs have also developed a set of "NIH-DOE Guidelines for Access to Mapping and Sequencing Data and Material Resources" that address the special needs of the HGP. The guidelines call for materials and information from HGP-supported projects to be made available within six months from the time the data or materials are generated; more rapid sharing is encouraged. The guidelines are available from the NCHGR staff listed below. Applications submitted in response to this program announcement should include plans for sharing data and materials, for example by depositing cell lines, probes, sequence data, etc. into appropriate repositories. Where appropriate, grantees may work with the private sector in making unique resources, such as cloned libraries and probe screening services, available to the larger biomedical research community at reasonable cost. The plans for sharing will be reviewed for adequacy by NIH staff and the National Advisory Council on Human Genome Research prior to award of a grant and the proposed sharing plan will be made a condition of the award. Investigators may request funds to defray the costs of sharing materials or submitting data to repositories in their applications. Such requests must be adequately justified. Instrumentation. Proposals for instrument development are expected to address the issues of access to any instruments developed through this program. In projects where automation, robotics and/or software development are key components, investigators should specifically address the issues of (1) exportability to other laboratories, (2) access of other investigators to unique instruments, and (3) integration of individual components into systems. Additional Considerations. In order to achieve the goals of the HGP, applications that propose to develop new approaches and strategies to mapping and sequencing problems, as well as those that propose creative, novel, high-risk/high-payoff strategies are highly encouraged. All researchers applying for support should (l) address how the proposed research will help accomplish the current five-year goals as well as the long-range goals; (2) discuss incorporation of new approaches and/or technology into any mapping or sequencing strategy; (3) approach the problem in a comprehensive manner, irrespective of the size of the project; and (4) propose adequate plans for managing data, interacting and collaborating with the rest of the scientific community working on similar or related objectives, and making data and resources publicly available in a timely manner. APPLICATION PROCEDURES Applications submitted in response to this program announcement will be reviewed in accordance with the usual NIH peer review procedures. Applications are to be submitted on the grant application form PHS 398 (Rev. 9/91). Submission dates for new applications are February 1, June 1, and October 1; competing continuation applications and amended applications are accepted on March 1, July 1, and November 1. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. The title and number of this program announcement must be typed in Item 2a on the face page of the application. Applicants for R29 awards must include in the application three letters of reference and a letter or memorandum from an appropriate department head or dean. The completed original application and five legible copies must be delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will first be reviewed for scientific and technical merit by an appropriate study section in the Division of Research Grants. Following the initial scientific review, applications will receive a second-level review by the appropriate National Advisory Council or Board. o Review criteria that will be used to assess the scientific merit of an application are: o Significance and originality of the research and methodological approaches; o Feasibility of the research and adequacy of the experimental design; o Training, experience, research competence, and commitment of the investigator(s); o Adequacy of the facilities and resources; and o Appropriateness of the requested budget for the work proposed. AWARD CRITERIA Applications assigned to the NCHGR will compete for available funds with all other approved applications assigned to the NCHGR. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review and potential for developing technology or strategies that will accelerate progress in mapping and sequencing the human genome; o Value of the proposed research for achieving the research goals of the NCHGR, while maintaining programmatic balance in the NCHGR grant portfolio; o Adequacy of any plans proposed for managing data and sharing data, resources and technology in a timely manner; and o Availability of funds. In addition to the above award criteria, applications from foreign institutions must present special opportunities for research accomplishments that are not readily available in the United States. INQUIRIES The program staff and grants management officer welcome the opportunity to discuss the program interests and PHS grant policy, respectively, with prospective applicants and current grantees. Telephone, electronic and/or written inquiries are strongly encouraged. Specific questions regarding the following programmatic areas should be directed to: Technology development for physical mapping and gene identification: Dr. Bettie Graham, Chief, Mapping Technology Branch Internet: Bettie_Graham@occshost.nlm.nih.gov Dr. Elise Feingold, Program Director, Mapping Technology Branch Internet: Elise_Feingold@occshost.nlm.nih.gov Large-scale sequencing and mapping of the mouse and human genomes: Dr. Jane L. Peterson, Chief, Mammalian Genomics Branch Internet: Jane_Peterson@occshost.nlm.nih.gov Dr. Jeffery Schloss, Program Director, Mammalian Genomics Branch Internet: Jeffery_Schloss@occshost.nlm.nih.gov Sequencing technology development; large-scale mapping and sequencing of non-mammalian genomes: Dr. Robert Strausberg, Acting Chief, Sequencing Technology Branch Internet: Robert_Strausberg_@occshost.nlm.nih.gov Dr. Carol Dahl, Program Director, Sequencing Technology Branch Internet: Carol_Dahl@occshost.nlm.nih.gov Informatics: Dr. David Benton, Assistant to the Director for Informatics Internet: David_Benton@occshost.nlm.nih.gov The address and telephone number for the staff listed above are: National Center for Human Genome Research Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-7531 FAX: (301) 480-2770 Inquiries about grants management/policy issues may be directed to: Ms. Jean Cahill Grants and Contracts Management Branch National Center for Human Genome Research Building 38A, Room 613 Bethesda, MD 20892 Telephone: (301) 402-0733 Related NCHGR Program Announcements Information about other NCHGR grant programs can be found in the following program announcements: Pilot/High Risk Projects. NIH Guide for Grants and Contracts, Vol. 23, No. 10, March 11, 1994. Genome Science and Technology Centers (P01 and P50 mechanisms). NIH Guide for Grants and Contracts, Vol. 23, No. 10, March 11, 1994. Ethical, Legal and Social Implications Projects. NIH Guide for Grants and Contracts, Vol. 19, No. 4, 1990. Training. NIH Guide for Grants and Contracts, Vol. 20, No. 46, December 12, 1991. Research Career Development. NIH Guide for Grants and Contracts, Vol. 20, No. 34, Part 1, September 13, 1991. Supplements for Minorities and Individuals with Disabilities. NIH Guide for Grants and Contracts, Vol. 21, No. 3, January 24, 1992. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.172. Awards will be made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirement of Executive Order 12372 or to Health Systems Agency review. From owner-sci-resources@net.bio.net Mon Mar 28 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-94-013 - V23(10) 03/11/94 Date: 28 Mar 1994 18:18:58 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 558 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2n836i$ib4@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AI94013 AI-94-013 P1O1 *************************************** RESEARCH ON TOPICAL MICROBICIDES FOR PREVENTION OF STDS/HIV INFECTION NIH GUIDE, Volume 23, Number 10, March 11, 1994 RFA: AI-94-013 P.T. 34; K.W. 0715182, 0745027, 1002027, 0710070, 1002004 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: May 13, 1994 Application Receipt Date: July 13, 1994 PURPOSE The Sexually Transmitted Diseases Branch of the Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), invites research grant applications for program projects to conduct research necessary for the development of topical microbicides for intravaginal use to prevent sexually transmitted diseases (STDs), including Human Immunodeficiency Virus (HIV) infection. The NIAID wishes to expand research in this area through the conduct of multi-disciplinary research in microbiology, immunology, reproductive biology, reproductive toxicology, and cell biology. Basic and applied research that will lead to effective strategies for intravaginal protection against STDs, including HIV infection, are encouraged. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request For Applications (RFA), Research on Topical Microbicides for Prevention of STDs/HIV, is related to the priority areas of sexually transmitted diseases and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-10473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic, for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The mechanism of support will be the Program Project grant (P01). Multidisciplinary approaches that involve collaborative efforts among investigators in microbiology, immunology, reproductive biology, reproductive toxicology, and cell biology specialties are strongly encouraged. The total project period for applications submitted in response to this RFA may not exceed four years. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA will be $1,500,000. In Fiscal Year 1995, the NIAID plans to fund approximately two program projects. Applications may not request budgets in excess of $750,000 total costs in the first year or more than four percent annual inflationary increases for future years. An application with a first year requested amount in excess of $750,000 total direct cost will require written approval by senior a NIAID official via the program officer for acceptance of the application for processing. The usual PHS policies governing grants administration and management will apply. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAID, awards pursuant to this RFA 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. RESEARCH OBJECTIVES Background The HIV pandemic has focused attention on sexually transmitted diseases (STDs), both because HIV infection is a fatal STD and because other STDs are implicated as risk factors for sexual transmission of HIV. Current global estimates indicate that 14 million people are infected with HIV, the cause of Acquired Immunodeficiency Syndrome (AIDS). The majority of these infections were acquired through sexual intercourse. Unless effective prevention measures to stop sexual transmission of HIV are implemented, the number of AIDS cases will continue to grow. Separate from the HIV epidemic, STDs cause significant morbidity and mortality and contribute greatly to increasing health care costs. In the United States in 1993, an estimated 12 million new cases of STDs occurred, 64 percent of which were in people less then 24 years old, including three million in teenagers. In 1993, cost estimates associated with these infections exceeded six billion dollars. Furthermore, STDs disproportionately affect the female, the fetus, and the newborn. Gonococcal and chlamydial infections cause pelvic inflammatory disease, infertility, and ectopic pregnancy. Several common STDs adversely affect pregnancy and result in spontaneous abortion, stillbirth, chorioamnionitis, premature rupture of membranes, preterm delivery, and postpartum endometritis. Neonatal infections include gonococcal conjunctivitis, which may lead to blindness; chlamydial pneumonia, which may lead to chronic respiratory disease; congenital syphilis and herpes encephalitis. Moreover, genital infections due to human papillomavirus are causally associated with cervical cancer, one of the most common cancers in women throughout the world. It is now clear that the risk of becoming infected or infecting others with HIV is substantially increased if one has an STD such as chancroid, genital herpes, syphilis, trichomoniasis, gonorrhea, or chlamydial infection. Over 75 studies on the role of STDs in HIV transmission have been conducted. In 15, STD effects could be assessed independently of sexual behavior effects; both ulcerative and non-ulcerative STDs increased risk of HIV transmission. Although the individual risk of HIV transmission associated with genital ulcer diseases appears to be higher than the discharge diseases (up to ten-fold compared to three to five fold), the high prevalence of discharge diseases results in a much higher population attributable risk. Furthermore, data from over 80 reports on the natural history of STDs in HIV infected people suggest that, at a community level, HIV infection may increase the prevalence of some STDs (e.g. genital ulcers). If co-infection with HIV prolongs or augments the infectiousness of individuals with STDs, and if the same STDs increase risk of HIV acquisition, these infections may greatly amplify one another. This "epidemiological synergy" may be fueling the explosive growth of the HIV pandemic in some populations (reviewed by Wasserheit, 1991). Based on the recommendations from four international conferences, a consensus has emerged that safe, effective, female-controlled chemical barriers that will block transmission are needed to prevent sexually transmitted HIV infection as well as other STDs. Currently available mechanical and chemical barriers have many limitations. Although the male condom, if used consistently and correctly, is a very effective barrier against transmission of HIV and the discharge diseases, it requires the active cooperation of the male partner and, therefore, cannot be independently implemented at the discretion of the female partner. Although the female condom only requires partner consent, virtually nothing is known about its efficacy in preventing bacterial and viral STDs. Spermicides have in vitro activity against most sexually transmitted pathogens including HIV; however, well designed clinical studies demonstrating, unequivocally, that spermicides prevent STDs/HIV infection have not been done. Furthermore, several studies have revealed that spermicides can cause mucosal erosions and ulcers; whether these lesions might increase risk of transmission of HIV infection is presently unknown. In addition to the inherent limitations of these existing methods, there are many situations in which personal, social, or cultural barriers interfere with a woman's ability to successfully negotiate and implement the use of barriers that could decrease risk of infection. Specifically, the need for a method that can be implemented by women is grounded in the high prevalence of: (1) non-consensual sex, (2) sex without condom use, and (3) risky behaviors that occur without partner knowledge. Just as oral contraceptives dramatically enhanced the ability of women to avoid unwanted pregnancy, effective female-controlled topical microbicides are urgently needed to enhance the ability of women to avoid sexually transmitted infections. Furthermore, chemical barriers that inactivate pathogens in vaginal/cervical secretions, as well as in the ejaculate could reduce female-to-male as well as male-to-female transmission. Topical microbicides are defined herein as preparations for intravaginal use that are microbicidal (virucidal and/or bactericidal); these products will prevent sexually transmitted infections. The ideal microbicide should have the following characteristics: colorless, odorless, tasteless (physically "invisible"), stable, easy to store, fast acting for appropriate duration, effective pre- and post-coitus, inexpensive, available without a prescription, and safe for use at least one to two times daily. Candidate classes of microbicidal compounds include, but are not limited to, detergents, chemicals such as iodophores, carbohydrates, antibodies, defensins, and pyocins. Ideally topical microbicides would not be inherently spermicidal but could be formulated with or without spermicidal activity. Non-contraceptive microbicides would be extremely useful for women who wish to become pregnant, or for those women who use one of the many safe, effective methods for contraception that either have no protective effect against infection or, arguably, exacerbate risk of infection. Indeed, a person's contraceptive choices may change over a lifetime. However, no matter what an individual's current contraceptive preference, if they are sexually active, they will desire/require protection from sexually transmitted infections. Scope of Research A fundamental objective of the NIAID's STD/HIV research programs is to develop topical microbicides effective in preventing and controlling sexually transmitted infections. Whereas it is recognized that safe, spermicidal-microbicides are important outcomes in the search for female-controlled barrier methods to prevent HIV infection and STDs, the development of spermicides which are not microbicidal is not an objective of NIAID. Arguably the most productive approach to identifying safe, effective molecular strategies for blocking the early steps in the infectious process is based on multi-disciplinary efforts including, but not limited to, microbiology, immunology, reproductive biology, reproductive toxicology, and cell biology. Applicants are strongly encouraged to include microbiology and two additional disciplines in the program project. A wide range of basic and applied research questions must be answered in order to meet this programmatic objective. Research issues and areas of high priority to the NIAID and to this RFA include, but are not limited to, the following: Diseases of interest Applicants are encouraged to address the following sexually transmitted diseases of high scientific priority to the NIAID: o HIV infection o Chlamydial infection o Gonorrhea o Trichomoniasis o Genital Ulcer Diseases, including syphilis, genital herpes (herpes simplex virus 1 and 2) and chancroid o Human papillomavirus infection The goal, as envisioned, is to develop topical microbicides with activity against a combination of pathogens including viral, bacterial and protozoan. With respect to HIV prevention, it is theoretically possible that microbicides may be used to prevent HIV infection primarily or secondarily. For example, a microbicide might be virucidal and prevent HIV infection through direct viral neutralization. Another plausible outcome is development of a safe microbicide that was bactericidal but did not inactivate enveloped viruses such as HIV . Given the role of the discharge STDs in increasing risk of HIV transmission, a microbicide with this specificity would prevent gonorrhea and chlamydial infection directly and HIV infection secondarily. For these reasons, research on two sexually transmitted diseases, preferably one viral and one bacterial, is highly recommended. Early steps in infectious processes Studies delineating the chronology and biology of the early steps in the host/pathogen interaction including, but not limited to, the role of inflammation in altering kinetics and infectious dose and the role of cell-free versus cell-associated pathogens in the transmission of disease are encouraged. Microbicide evaluation Of interest are in vitro (using established tissue culture systems), ex vivo (using primary human cells eg. vaginal and cervical epithelium or sperm) and pre-clinical characterization of bactericidal and virucidal activity of currently available spermicidal products, new topical microbicides and inactive ingredients (carriers) in existing or new products. Biology of the reproductive tract It is critical to identify and characterize the "endogenous" anatomical, physiological, hormonal, immunological and microbiological factors of the female reproductive tract that play a role in resistance and susceptibility to infection including, but not limited to, vaginal pH, mucus, estrogen and other hormones, cervical ectopy and normal flora including lactobacilli. Reproductive toxicology Using materials from human subjects (i.e., cell or organ cultures) or established model systems, studies on the effects of topical microbicides on the normal vaginal environment, including but not limited to, alteration of vaginal pH, mucus, surface receptors, normal flora (e.g., lactobacilli and yeast), and induction of inflammatory processes are encouraged. Studies on characterization of spermicidal, teratogenic, mutagenic, or carcinogenic properties of topical microbicides are also of interest. Appropriate models for studying the reproductive toxicology of topical microbicides might include, but are not limited to, those that measure vaginal/cervical irritation/inflammation, or effects on sperm, or on embryogenesis. If animal models are included, these should be well-established models, e.g., those developed for characterizing adverse effects of spermicidal contraceptives. Projects may involve collaboration among investigators at several institutions. Consortium arrangements should follow "Guidelines for Establishing and Operating Consortium Grants, January 1989", available from the individuals listed under INQUIRIES. Project Leaders and Program Directors should budget for an annual one-day progress review meeting at a site to be designated (either in Bethesda or in association with a relevant national meeting). STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not support applications that do not comply. LETTER OF INTENT Prospective applicants are asked to submit, by May 13, 1994, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Program Director, and the number and title of this RFA. Prospective applicants are also asked to submit a list of the project leaders and other key investigators and their institution(s). Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Olivia Preble at the address listed under INQUIRIES. APPLICATION PROCEDURES In preparing the application, the applicant should bear in mind the research objectives of this RFA. P01 applications should be prepared using the guidance and instructions provided in "NIAID Program Project Grants and Multiproject Cooperative Agreements (rev. 02/94)," which may be requested from Dr. Olivia Preble at the address listed under INQUIRIES. Failure to follow these instructions may result in delays in the review or in an incomplete application. Applications are to be submitted on form PHS 398 (rev. 9/91), the standard application form for research grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. Applicants must adhere to the format and requirements specified in the PHS 398 application kit. For purposes of identification and processing, mark "YES" in item 2a on the face page of the application and type in the RFA number AI-94-013 and the title "RESEARCH ON TOPICAL MICROBICIDES FOR PREVENTION OF STDS/HIV." The RFA label available in the form PHS 398 must be affixed to the bottom of the face page of the original 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. The signed, typewritten original of the application, including the Checklist, and three exact single-sided copies must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies and all five sets of appendices must also be sent to Dr. Olivia Preble at the address listed under INQUIRIES. To ensure their review, applications must be received by both the Division of Research Grants and Dr. Olivia Preble by July 13, 1994. Applications not received by the receipt date will be returned to the applicant without review. If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of essentially identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Review Procedures Applications will be reviewed by Division of Research Grants (DRG) staff for completeness and by NIAID staff to determine administrative and programmatic responsiveness to this RFA. Those judged to be incomplete or non-responsive will be returned to the applicant without review. Those considered complete and responsive may be subjected to a triage review by an NIAID peer review group, to determine their scientific merit relative to the other applications submitted in response to this RFA. The NIAID will withdraw from competition those applications judged by the triage peer review group to be noncompetitive for award and will so notify the applicant investigator and the institutional business official. Those applications judged to be competitive for award will be further reviewed for scientific and technical merit by a Review Committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria The review criteria for P01 grant applications are the review criteria for large, multi-component, interdisciplinary program projects as outlined in the document entitled NIAID PROGRAM PROJECT GRANTS AND MULTIPROJECT COOPERATIVE AGREEMENTS (rev. February 1994). The application must include a justification for the appropriateness of the proposed studies for the P01 grant mechanism. The distinguishing features of a program project grant include: o A unifying well-defined goal or problem area of research to which each project relates and contributes, thereby producing a research environment that allows each research effort to share the creative strengths of others. o A program director who possesses recognized scientific and administrative competence; she/he should show a substantial commitment of time and effort to the program and exercise leadership in its quality control. o Each research project should, as assessed by peer review, stand on its own independent scientific merit, as well as complement other projects whenever feasible. o These multiple projects require the participation of established investigators in several disciplines, or investigators with special expertise in several areas of one discipline. All investigators should contribute to and share in the responsibilities of fulfilling the program objective. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC Program Director or Principal Investigator could be included with the applications. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program priorities and balance, and the availability of funds. The totality of the awarded projects will reflect the programmatic objectives described above. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Requests for the document entitled "NIAID PROGRAM PROJECT GRANTS AND MULTIPROJECT COOPERATIVE AGREEMENTS" (rev. 2/94) as well as inquiries regarding programmatic issues may be directed to: Dr. Penelope J. Hitchcock Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A-21 Bethesda, MD 20892 Telephone: (301) 402-0443 FAX: (301) 402-1456 Email: penny@exec.niaid.pc.niaid.nih.gov Direct inquiries regarding review issues, address the letter of intent, and mail two copies of the application and all five sets of appendices to: Dr. Olivia Preble Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C20 Bethesda, MD 20892 Telephone: (301) 496-8208 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Ms. Sharie Bernard Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B32 Bethesda, MD 20892 Telephone: (301) 496-7075 Schedule Letter of Intent Receipt Date: May 13, 1994 Application Receipt Date: July 13, 1994 Scientific Review Date: October 1994 Advisory Council Date: February 1995 Earliest Date of Award: April 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.856 - Microbiology and Infectious Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Mon Mar 28 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 10, pt. 2, 11 March 1994 Date: 28 Mar 1994 18:18:53 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1300 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2n836d$iar@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940311 V23N10 P2O2 ************************************ will be used for programs that support a minimum of three components with a well-defined central research focus. The term of support for GESTEC projects is normally three to five years. RESEARCH OBJECTIVES The National Institutes of Health (NIH) is currently engaged, along with several other federal, private, and international organizations, in a 15-year research program designed to characterize the human genome and the genomes of selected model organisms. The product of the Human Genome Project will be a set of information and material resources available to the entire research community that will facilitate further research leading to the prevention, diagnosis, and therapy of disease, as well as a further understanding of human biology. The NCHGR and DOE recently published the above-referenced new five- year plan extending the initial goals for the U.S. Human Genome Project. At the same time, the NCHGR has established a reformulated centers program, the Genome Science and Technology Centers (GESTEC) program. This announcement solicits applications for new and continuing research that proposes to address the needs outlined in the new five-year plan, leading toward complete sequencing of the human genome and the genomes of selected model organisms. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Although it is not required or binding, applicants are strongly urged to contact NCHGR staff by telephone or by letter of intent. This will enable staff to provide clarification of programmatic and budgetary issues regarding these often-complicated applications and will also assist review staff in planning the review workload. This communication will be most useful if it is submitted at least three months before the receipt date on which the application is to be submitted. It need include only the names of the principal investigator and principal collaborators, a descriptive title of the proposed application and identification of the organization(s) involved. This information will not be part of the material that will be peer reviewed and should be directed to the NCHGR program staff listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the application deadlines as indicated in the application kit. Application kits are available from most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The title and number of the program announcement must be typed in Section 2a 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 Westwood Building, Room 240 Bethesda, MD 20892** Additionally, two copies of the full application must be sent to: Office of Scientific Review National Center for Human Genome Research Building 38A, Room 604 Bethesda, MD 20892 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by DRG staff for completeness and, for those applications assigned to the NCHGR, by NCHGR staff for appropriateness with respect to expressed NCHGR programmatic interests. Incomplete or inappropriate applications will be returned to the applicant without further consideration. The regular NIH receipt dates for center grant and program project applications and renewals are as follows: February 1, June 1, and October 1. Applications will be evaluated for scientific merit by the Genome Research Review Committee (GRRC) or an appropriate review committee constituted for the purpose of evaluating GESTEC grant applications. Site visits are frequently conducted as part of the review process, but are not routine. Therefore, applicants should present a complete and well-justified written proposal and not depend on a site visit to amplify the application. Review criteria will include the following: (1) significance and originality of the research and methodological approaches; (2) feasibility of the research and adequacy of the experimental design; (3) training, experience, research competence and commitment of the investigator(s); (4) adequacy of the facilities and resources; and (5) provisions for the protection of human subjects, the humane care of animals and biosafety conditions. Subsequent to evaluation by the initial review group, applications will be reviewed by the appropriate National Advisory Council or Board. AWARD CRITERIA For applications assigned to the NCHGR, the following will be considered in making funding decisions: (1) quality of the proposed project as determined by peer review; (2) value of the proposed research and of the proposed technology development for achieving the goals of the Human Genome Project; (3) adequacy of the proposed management structure; (4) nature and extent of the outreach program, including the adequacy of any plans proposed for sharing and distributing data and resources in a timely manner; (5) balance among projects within the NCHGR's grant portfolio; and (6) availability of funds. INQUIRIES Written and telephone inquiries are strongly encouraged. The program announcement and GESTEC grant application guidelines should be requested before preparing the grant application. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding the GESTEC program may be directed to: Jane L. Peterson, Ph.D. Mammalian Genomics Branch National Center for Human Genome Research Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-7531 Internet: Jane_Peterson@occshost.nlm.nih.gov Inquiries regarding fiscal matters may be directed to: Ms. Jean Cahill Grants and Contracts Management Branch National Center for Human Genome Research Building 38A, Room 613 Bethesda, MD 20892 Telephone: (301) 402-0733 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.172. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P1 END ************************************************************ $$P2 BEGIN PA-94-045 FULL-TEXT ************************************** NEW AND IMPROVED TECHNOLOGIES FOR GENOMIC RESEARCH AND ANALYSIS NIH GUIDE, Volume 23, Number 10, March 11, 1994 PA AVAILABLE: PA-94-045 P.T. 34; K.W. 1215018, 0755045 National Center for Human Genome Research THIS IS A NOTICE OF AVAILABILITY OF A PROGRAM ANNOUNCEMENT (PA). IT IS ONLY AN ABSTRACT OF THE PA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE PA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE PA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE [This program announcement supersedes the previous announcement that was published in the NIH Guide to Grants and Contracts, Vol. 21, No. 9, Part 2 of 2 parts, March 6, 1992.] The National Center for Human Genome Research (NCHGR) invites applications to support research that will significantly advance progress toward achieving the extended scientific goals of the Human Genome Program (HGP). These goals are described in the article, "A New Five-Year Plan for the U.S. Human Genome Project" (Science, vol. 262, p. 43-46), which covers the years 1994-1998. Because of the need to increase the rate and efficiency and to lower the cost of mapping and sequencing, the main focus of this program announcement is to solicit projects directed to the development of new or the significant improvement of current methods, strategies and technologies for mapping, sequencing, informatics and gene identification. ELIGIBILITY REQUIREMENTS Domestic and foreign universities, medical colleges, hospitals, corporations, and other public, private, or for-profit research institutions, including state and local government units, are eligible. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applications from minorities, women, and individuals with disabilities are especially encouraged. MECHANISM OF SUPPORT Support for this program will be through research grants, including research project grants (R01) and FIRST (R29) awards. RESEARCH OBJECTIVES Research projects in the following areas are encouraged: o Technologies for improving physical maps; o Advanced DNA sequencing technologies; o Technologies for refining genetic linkage maps, development of methods for rapid genotyping, and the development of new, easier-to- use genetic markers; o New technologies for gene identification; and o Informatics, including the development and improvement of appropriate computer tools and information systems for the collection, storage, retrieval and distribution of mapping and sequencing data, as well as the development of new methods and tools for the analysis and interpretation of genome maps and DNA sequences. Initially, the mapping and sequencing of the genomes of E. coli, S. cerevisiae, C. elegans, D. melanogaster, and the laboratory mouse were taken as goals of the U.S. HGP. Applicants may also propose to study model systems other than those listed. The choice of organism, however, must be justified as contributing significantly to achieving the overall objectives of the HGP, must have technology development as the primary focus, and must be applicable to the analysis of the human genome. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Submission dates for new applications are February 1, June 1, and October 1; competing continuation applications and amended applications are accepted on March 1, July 1, and November 1. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. The completed original application and five legible copies must be delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will first be reviewed for scientific and technical merit by an appropriate study section in the Division of Research Grants. Following the initial scientific review, applications will receive a second-level review by the appropriate National Advisory Council or Board. Review criteria that will be used to assess the scientific merit of an application are: (1) Significance and originality of the research and methodological approaches; (2) Feasibility of the research and adequacy of the experimental design; (3) Training, experience, research competence, and commitment of the investigator(s); (4) Adequacy of the facilities and resources; and (5) Appropriateness of the requested budget for the work proposed. AWARD CRITERIA Applications assigned to the NCHGR will compete for available funds with all other approved applications assigned to the NCHGR. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review and potential for developing technology or strategies that will accelerate progress in mapping and sequencing the human genome; o Value of the proposed research for achieving the research goals of the NCHGR, while maintaining programmatic balance in the NCHGR grant portfolio; o Adequacy of any plans proposed for managing data and sharing data, resources and technology in a timely manner; and o Availability of funds. In addition to the above award criteria, applications from foreign institutions must present special opportunities for research accomplishments that are not readily available in the United States. INQUIRIES Written, telephone, and electronic requests for the complete program announcement and the opportunity to clarify any issues on questions from potential applicants are welcomed. Direct requests for the program announcement and inquiries regarding programmatic issues to: Bettie J. Graham, Ph.D. Mapping Technology Branch National Center for Human Genome Research Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-7531 FAX: (301) 480-2770 Internet: Bettie_Graham@occshost.nlm.nih.gov Direct inquiries regarding fiscal matters to: Ms. Jean Cahill Grants and Contracts Management Branch National Center for Human Genome Research Building 38A, Room 613 Bethesda, MD 20892 Telephone: (301) 402-0733 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.172. Awards will be made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirement of Executive Order 12372 or to Health Systems Agency review. $$P2 END ************************************************************ $$P3 BEGIN PAR-94-046 *********************************************** PILOT PROJECTS OR FEASIBILITY STUDIES FOR GENOMIC ANALYSIS NIH GUIDE, Volume 23, Number 10, March 11, 1994 PAR NUMBER: PAR-94-046 P.T. 34; K.W. 1215018, 0755045 National Center for Human Genome Research PURPOSE [This program announcement supersedes the previous announcement that was published in the NIH Guide for Grants and Contracts, Vol. 19, No. 28, July 27, 1990.] The National Center for Human Genome Research (NCHGR) invites applications for pilot projects/feasibility studies that have the potential for significantly advancing progress toward achieving the extended scientific goals of the Human Genome Program as recently described in Science. Vol. 262, 43-46, 1993. The purpose of this program announcement is to encourage applications from individuals who are interested in developing novel, creative approaches that will provide significant advances in the areas of physical map annotation, DNA sequencing, high-throughput genotyping, gene identification and informatics, but which are not yet fully developed enough to successfully compete for a standard R01 grant. ELIGIBILITY REQUIREMENTS Domestic universities, medical colleges, hospitals, corporations, and other public, private, or for-profit research institutions, including state and local government units, are eligible. Applications from minorities, women, and individuals with disabilities are especially encouraged. MECHANISM OF SUPPORT This program will be supported through the exploratory/developmental grants (R21) mechanism. Applicants may request up to two years of support. Projects will be limited to $100,000 (direct cost per annum). These grants will not be renewable; continuation of projects developed under this program will be through the research grant program. RESEARCH OBJECTIVES Background The National Institutes of Health (NIH) is currently engaged, along with several other federal, private, and international organizations, in a 15-year research program designed to characterize the human genome and the genomes of selected model organisms. This research program, the Human Genome Project (HGP), has the following interrelated goals: (1) the construction of high-resolution genetic linkage maps; (2) the development of detailed physical maps; (3) the determination of the complete nucleotide sequence of the human genome and the genome of selected organisms; (4) the development of efficient methods of identifying genes and for placement of known genes on physical maps or sequenced DNA; (5) the development of the capability to collect, store, distribute and analyze the data and materials produced; (6) the development of appropriate new technologies to achieve these goals; and (7) the identification of major issues related to the ethical, legal and social implications (ELSI) of genome research, and the development of policy options to address them. The products of the HGP will include information and material resources, as well as new technologies, available to the entire research community that will facilitate further research leading to the prevention, diagnosis, and therapy of disease, as well as to further understanding of human biology. Significant progress has been made toward meeting the initial five- year goals of the HGP (as described in the document "Understanding Our Genetic Inheritance - The U.S. Human Genome Project: The First Five Years FY 1991-1995). Meeting the set of extended goals of the HGP and completing the HGP, however, will require still further increases in efficiency and cost-effectiveness of mapping and sequencing techniques. Achieving such increases will undoubtedly benefit from the development of new approaches. Pilot projects can be a valuable means of promoting the development of novel or conceptually creative ideas that are scientifically sound and may significantly advance progress toward the scientific goals of the Human Genome Program, but which may not be developed fully enough to warrant support with a standard R01 grant. Objectives Applications for pilot projects or feasibility studies are encouraged in, but not limited to, the following areas: o development of new technologies for improving STS-based physical maps at a resolution of 100 kilobases; o development of new methods for DNA sequencing that are capable of significantly reducing the cost and/or increasing the throughput of sequencing; o development of high-throughput genotyping technologies that are accurate, rapid, efficient and cost-effective; o development of new technologies for rapidly and cost-effectively identifying and mapping genes and coding regions in genomic DNA; o development of computer tools, information systems, and strategies for collecting, storing, retrieving, analyzing, interpreting and distributing large amounts of mapping and sequencing data. The purpose of this initiative is to identify high-risk/high payoff projects that, if successful, could lead to significant increases in the rate of data generation, significant decreases in the cost of genomic research, or significant new insights. The NCHGR encourages applications from scientists who have not traditionally been funded by the NCHGR, such as chemists, engineers, physicists, and information scientists, as well as from molecular biologists and other biologists. Applicants must clearly identify the biological problem for which the technology is being developed, and must indicate plans for demonstrating or testing the utility of the technology. Applicants whose expertise is primarily non-biological and who are interested in addressing problems of genome analysis with new, non-biological tools are especially encouraged to interact closely with biologists. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Submission dates for new applications are February 1, June 1, and October 1; competing continuation applications and amended applications are accepted on March 1, July 1, and November 1. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The title and number of this program announcement must be typed in Item 2a on the face page of the application. The completed original application and five legible copies must be delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will first be reviewed for scientific and technical merit by an appropriate study section in the Division of Research Grants. Following the initial scientific review, applications will receive a second-level review by the National Advisory Council for Human Genome research. The following review criteria will be used to assess the scientific merit of an application: o Significance and originality of the research and methodological approaches; o Feasibility of the research and adequacy of the experimental design; o Training, experience, research competence, and commitment of the investigator(s); o Adequacy of the facilities and resources; and o Appropriateness of the requested budget for the work proposed. Because this program is designed to support innovative ideas, preliminary data are not required. However, the applicant does have the responsibility for developing a sound research plan and for presenting any other information that can be considered as evidence of feasibility. AWARD CRITERIA Applications assigned to the NCHGR will compete for available funds with all other approved applications assigned to the NCHGR. The following will be considered in making funding decisions: o Innovativeness of the proposed project as determined by peer review; o The potential for developing technology or strategies that will accelerate progress toward achieving the research goals of the National Center for Human Genome Research; and o Availability of funds. INQUIRIES The program staff and grants management officer welcome the opportunity to discuss program interests and PHS grant policy, respectively, with prospective applicants and current grantees. Telephone, electronic and/or written inquiries are strongly encouraged. Specific questions regarding programmatic areas may be directed to: Bettie J. Graham, Ph.D. Mapping Technology Branch National Center for Human Genome Research Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-7531 FAX: (301) 480-2770 Internet: Bettie_Graham@occshost.nlm.nih.gov Inquiries about fiscal matters may be directed to: Ms. Jean Cahill Grants and Contracts Management Branch National Center for Human Genome Research Building 38A, Room 613 Bethesda, MD 20892 Telephone: (301) 402-0733 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.172. Awards will be made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirement of Executive Order 12372 or to Health Systems Agency review. $$P3 END ************************************************************ $$P4 BEGIN PA-94-047 ************************************************ DRUG ABUSE HEALTH SERVICES RESEARCH NIH GUIDE, Volume 23, Number 10, March 11, 1994 PA NUMBER: PA-94-047 P.T. 34; K.W. 0404009, 0730050 National Institute on Drug Abuse PURPOSE The purpose of this Program Announcement is to encourage applications for a new program emphasis on health services research in the field of drug abuse. 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 Health Services Research, 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by for-profit and non-profit public and private organizations such as universities, colleges, hospitals, units of State or local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT This program announcement will use the National Institutes of Health (NIH) individual research grant (R01), interactive research project grant (IRPG) (see NIH Guide, Vol 22, No. 16, April 23, 1993), small grant (R03), and FIRST award (R29). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Support will be provided for a period of up to five years (renewable for subsequent periods) subject to continued availability of funds and progress achieved. RESEARCH OBJECTIVES The ADAMHA Reorganization Act (Public Law 102-321) directed the National Institute on Drug Abuse (NIDA) to expand its program of health services research. Health services research is defined as research endeavors that study the organization, financing, and management of health services and their impact on the quality, cost, access to, and outcomes of care (Section 409). Subsequent legislative clarification included research to study the effectiveness of primary and secondary prevention activities. Research on the efficacy of services to prevent, diagnose, or treat medical conditions is excluded (Public Law 103-43), and investigators contemplating such studies should consult other relevant NIDA announcements. NIDA's health services research program includes interdisciplinary study of the structure, processes, and outcomes of the delivery of health services. Factors that influence the availability, accessibility, and utilization of health services and the efficiency and effectiveness of these services are studied within established service delivery settings and at a system-wide level. Research is sought on how services are organized, financed, delivered, and utilized as well as how effective these services are in addressing health issues and related concerns. This Program Announcement invites research grant applications in four major areas of health services research: (1) primary and secondary prevention activities; (2) HIV prevention services for drug abusers and their sexual partners, both in and out of health care settings; (3) health services for drug abusers in primary care settings, and linkages between primary care and drug abuse treatment programs/systems; and (4) drug abuse treatment services research at system, program, and client levels. Illustrative general or cross-cutting health services research areas include: o Assessment of need for services and factors influencing utilization of services; o Effectiveness and efficiency of alternative organizational and manpower configurations; o Client/patient, provider, and community/environmental characteristics that affect service delivery and outcome; o Financing and economic research on programs, practices, policies, and outcomes; o Assessment, matching and referral of patients to improve services and outcomes; o Impact of specific policies or cost/utilization control strategies on outreach, service delivery, retention, and effectiveness; and o Methodological development in research designs, analytic techniques, and measurement, including development of standards and criteria. Applications that focus on research within any of the four major areas or that cut across areas are encouraged. Topics not mentioned are not necessarily excluded from consideration under this Program Announcement. Applicants are advised to review existing information relevant to drug abuse health services research and to design studies using the most rigorous methodological and analytic designs feasible. Timely reporting of findings is emphasized. Applicants should be willing to participate in research coordination efforts to maximize the utility of the research, including review and dissemination activities. If investigators are studying populations that are at risk for HIV, they are encouraged to explicitly address AIDS-related issues in their applications. Investigators are encouraged to offer HIV testing and counseling in accordance with current guidelines to subjects identified during the course of the research as being at risk for HIV acquisition or transmission. In high-risk populations, investigators are encouraged to assess the effects of new interventions on the acquisition and transmission of infectious diseases, including HIV. Due to the growing AIDS problem in this country, special consideration will be given to applications that focus on AIDS-related issues such as services to reduce AIDS risk behaviors, services for high-risk subgroups such as prostitutes or injection drug users, or measures of program effect on AIDS risk behaviors (e.g., needle sharing, unprotected sex). Drug Abuse Prevention. The intent of health services prevention research is to assess the effectiveness and cost effectiveness of preventive interventions in reducing drug-related problems. Research is needed to improve the quality of prevention services, to expand access to prevention services to all populations, particularly minorities, and to lower costs of health care by reducing the extent of drug use and its adverse medical, psychological, and social consequences. In addition to intervention studies in health care settings, prevention services research may occur in a variety of other settings (e.g., worksites, schools, and local communities) and may focus on financing, organization, management, enforcement, and utilization of prevention services as well as their effectiveness. Illustrative drug abuse prevention services research areas include: o Qualitative and quantitative assessment of the impact of program service delivery at the community, State, regional, or national level; o Outreach research to assess strategies to expand prevention services to underserved populations and geographic areas, such as rural communities and inner cities; o Research on methods for diffusion of innovative clinical practices and management techniques to improve prevention services and lower costs; o Research on consumer choice, prevention program selection, and service retention resulting from innovative practices; and o Research to integrate drug abuse prevention with interventions directed at other related behavioral and societal problems such as violence, unwed pregnancy, school dropouts, and domestic abuse. HIV Prevention. Behavior change remains the only strategy available to prevent HIV infection. To date, research has focused on the implementation and testing of interventions designed to reduce drug-using and sexual behaviors that place the individual at high risk for HIV infection or transmission. Little research attention has been given to the need, demand, utilization, effectiveness, and cost effectiveness of HIV prevention and outreach in various settings and with specific subgroups. Further research is needed to develop and refine service delivery models for outreach to the population at risk of HIV infection. Results of community-based research indicate that over 40 percent of injecting drug users contacted, including many long-term users of illicit drugs, have never enrolled in drug abuse treatment. Given the threat of HIV/AIDS to drug abusers and their sexual partners, research is needed to develop and refine risk reduction intervention strategies and methods of referral to medical and drug treatment to intervene with these high-risk populations. Illustrative HIV prevention services research areas include: o Improving the effectiveness and cost effectiveness of HIV outreach and prevention services on reducing risk behaviors; o Delivery of HIV prevention and outreach services in nontraditional settings (e.g., in the community; in criminal justice settings), and barriers to delivery; o Delivery of HIV prevention interventions to non-treatment as well as treatment populations and for specific subgroups at risk, including criminal justice-involved, HIV+, adolescent, and those with chronic medical conditions (e.g., tuberculosis) or psychiatric problems; o Improving identification, liaison, and linkages with external resources, and managing information and access to service networks; o Development of valid and reliable measures of high-risk behaviors, of behavior change, of alternative HIV antibody testing and reporting strategies, and of measures to assess client need and match services to need. Primary Care for Drug Abusers. Individuals dependent upon illicit drugs often have limited access to primary medical care, resulting in overuse of expensive emergency treatment. The social costs of drug abuse are multiplied by poor rates of compliance with treatment for tuberculosis and other diseases. Health services research in primary care is needed to determine the effects of organizational and financing arrangements on access to primary care, on research to improve primary care/drug abuse treatment linkages, and to provide training opportunities for prevention, treatment, and primary care providers. Illustrative research areas in primary care for drug abusers include: o Health services research on programs combining drug abuse and primary care, including cross-training for primary care providers and drug abuse treatment providers; o Studies to improve how health care and other organizations receive, assimilate, and adopt or respond to knowledge (e.g., new treatment strategies; clinical records information) bearing on treatment of drug abusers; o Studies to enhance early identification of drug abuse and associated medical problems (e.g., HIV infection and its consequences, tuberculosis, hepatitis B, sexually transmitted diseases) in non-drug abuse treatment settings, such as STD clinics or educational settings; and o Research to enhance client/patient engagement in and compliance with medical treatment programs. Drug Abuse Treatment. Research is needed on treatment services and service delivery systems, on the influence of financing and health care coverage, and on the impact of these factors upon treatment outcomes. In the context of limited treatment resources, a need exists to determine the relative costs and benefits of providing augmented treatment services or improving drug abuse treatment service delivery systems. The intent of treatment services research is to assess the impact of health services and the effects of organizational and financing arrangements on the quality and outcomes of care provided to patients with drug abuse as well as medical and other problems related to drug abuse. Illustrative drug abuse treatment services research areas include: o Effects of financing, reimbursement, regulatory strategies, and insurance strategies, including the impact of differences in public and private financing and coverage, on access, quality, outcomes of care, and subsequent utilization of health care services; o Long-term aspects of drug abuse treatment utilization and recovery processes; o Client and program factors that influence treatment-seeking behavior, retention, compliance, effectiveness, and relapse, including program factors that influence change in AIDS risk behaviors, and factors related to engaging and retaining HIV+ drug users in treatment; and o Facility- or system-level studies to investigate the organization, management, financing, and quality of treatment and ancillary services in relation to client characteristics, treatment content, and outcome. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and both genders in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale for exclusion or inadequate representation should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objective of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of the United States racial/ethnic minority populations (i.e., American Indian or Alaskan Natives, Asians or Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. The receipt dates for applications for AIDS-related research are found in the PHS 398 instructions. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 240, Bethesda, MD 20892, telephone 301-594-7248. The title and number of the announcement must be typed in Item 2a on the face page of the application. FIRST award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original and five permanent, legible copies of the PHS 398 form must be delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary DHHS grant programs. Applications received under this announcement will be assigned to an initial review group (IRG) in accordance with established PHS referral guidelines. The IRGs, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit in accordance with the standard NIH peer review procedures. Notification of the review recommendations will be sent to the applicant after the initial review. Applications recommended for further consideration will receive a second-level review by an appropriate Advisory Council, whose review may be based on policy considerations as well as scientific merit. Only applications recommended for further consideration by the Council may be considered for funding. Small grant (R03) applications do not receive a second level review. AWARD CRITERIA Applications recommended for further consideration by a National Advisory Council will be considered for funding on the basis of overall scientific and technical merit of the application as determined by peer review, appropriateness of budget estimates, program needs and balance, policy considerations, adequacy of provisions for the protection of human subjects, and availability of funds. Special consideration will be given to applications that directly deal with AIDS-related issues. 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: Frank M. Tims, Ph.D. Treatment Services Research Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-30 Rockville, MD 20857 Telephone: (301) 443-4060 Direct inquiries regarding fiscal matters to: Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Section 301, and administered under PHS policies and Federal Regulations at Title 42 CFR 52 "Grants for Research Projects," Title 45 CFR Part 74 & 92, "Administration of Grants" and 45 CFR Part 46, "Protection of Human Subjects." Title 42 CFR Part 2, "Confidentiality of Alcohol and Drug Abuse Patient Records" may also be applicable to these awards. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P4 END ************************************************************ $$P5 BEGIN PAR-94-048 *********************************************** SMALL GRANTS FOR THERAPEUTIC CLINICAL TRIALS OF MALIGNANCIES NIH GUIDE, Volume 23, Number 10, March 11, 1994 PAR NUMBER: PAR-94-048 P.T. 34; K.W. 0745005, 0745062, 0785210 National Cancer Institute Application Receipt Dates: June 1, October 1, February 1 PURPOSE The Division of Cancer Treatment (DCT), National Cancer Institute (NCI) announces a program to encourage the submission of small grant applications for new pilot, phase I, or phase II therapeutic clinical trials of malignancies that take advantage of recent laboratory developments. New and experienced investigators in relevant fields and disciplines (clinical, surgical, and radiation oncology) may apply for small grants to test new treatment strategies or do pilot studies. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Small Grants for Therapeutic Clinical Trials, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Applications may be from a single institution or several institutions (collaborating institutions, consortia, clinical trials cooperative groups), if appropriate. New and experienced investigators are encouraged to apply. Applications from minority and women individuals encouraged. MECHANISM OF SUPPORT Support of the program will be through the National Institutes of Health (NIH) small grants (R03) mechanism. The small grants research program provides limited funds (maximum of $50,000 direct costs per year) for short-term (up to two years) research projects. These grants are non-renewable and continuation of projects developed under this program will be through the regular grant program. Applicants will be responsible for the planning, direction, and execution of the proposed project. Applications submitted in response to this Program Announcement (PA) will compete for funds with all other R03 grant applications assigned to the NCI. The award of grants in response to this PA is also contingent upon the availability of funds. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. RESEARCH OBJECTIVES Background The NCI supports an extensive network of clinical and laboratory research studies related to cancer therapy through contracts, grants, and cooperative agreements. At present, there is no mechanism targeted to stimulate the communication of promising and potentially relevant new developments between the laboratory and the clinical setting. There is a need for a mechanism to fund short-term studies and obtain preliminary clinical data rapidly. It is expected that these R03 grants will serve as a basis for planning future clinical research grant applications (R01) or NCI cooperative clinical trial group studies. The small grants (R03) mechanism provides research support specifically limited in time and amount for studies in categorical program areas (see Research Goals and Scope). Small grants provide flexibility for initiating preliminary, short-term studies and are non-renewable. Furthermore, the time interval from application to funding is shortened under the R03 mechanism, thus allowing new ideas to be investigated or pursued in a more expeditious manner. The Cancer Therapy Evaluation Program, DCT, NCI has targeted the use of the small grants mechanism to support single or several institutions to perform therapeutic clinical trials to test new ideas. Support is needed to encourage new as well as experienced investigators to apply new treatment approaches. Research Goals and Scope The aim of this initiative is to support pilot, phase I, or phase II therapeutic clinical trials of malignancies to move new treatment strategies more rapidly from the laboratory into the clinic. Clinical studies must involve human subjects and be therapeutic in design. The clinical studies must be based on a strong rationale and preclinical data should support the underlying hypotheses. The research plan should be focused on the clinical trial proposed. New clinical therapeutic trials employing drugs, biologics, radiation, or surgery whether used as a single agent/modality or in combination are appropriate. Laboratory studies may also be proposed to conduct pharmacokinetic, pharmacodynamic, and other important correlative studies in the cancer patients receiving therapy. The laboratory studies should be in support of the clinical trial, such that their conduct leads to a greater understanding of the relationship between drug administration and biological changes in patients. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator must be included with the application. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign consortium participants, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Applications must be received by the following receipt dates: June 1, October 1, and February 1 of 1994 and 1995. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The title and number of this Program Announcement must be typed in line 2a on the face page of the application. Submit a signed, typewritten original of the application, including the Checklist, and four signed, exact photocopies, in one package: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, one additional copy of the application must also be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636A 6130 Executive Boulevard Bethesda, MD 20892 The application must meet the requirements listed below. The Research Plan of the application is limited to 16 pages total. A suggested page limitation is as follows: o Specific Aims - one page o Background, Significance, and Preliminary Studies - five pages o Research Design and Methods - 10 pages Following the research plan, include the discussion of Human Subjects and the literature cited. Human subjects approval and IRB approval of clinical protocols must be obtained prior to review. Documentation for the composition of the proposed study population in terms of gender and racial/ethnic group together with a rationale for its choice must be included in the Human Subjects section. The clinical protocol must be included in the Appendix. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by an appropriate review group at the Division of Extramural Activities, National Cancer Institute. Foreign grant applications will also be reviewed by the National Cancer Advisory Board. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the NCI. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Ms. Diane Bronzert or Dr. Roy Wu Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 Direct inquiries regarding fiscal matters to: Ms. Eileen Natoli Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 56 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.395, Cancer Treatment Research. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended, Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations at 42 CFR Part 52 and 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P5 END ************************************************************ From owner-sci-resources@net.bio.net Mon Mar 28 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: Old NIH Guide Postings Coming Date: 28 Mar 1994 18:03:01 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 12 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2n828l$h9i@net.bio.net> NNTP-Posting-Host: net.bio.net This week I am getting caught up on both bionet.sci-resources and bionet.journals.contents postings. Some of the issues of the NIH Guide that will be coming down the pipe shortly are from a couple of weeks to a couple of months old, but I'm inserting them into news to keep our archive service complete. Sincerely, Dave Kristofferson BIOSCI/bionet Manager biosci-help@net.bio.net From owner-sci-resources@net.bio.net Mon Mar 28 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 27 March 1994 Date: 28 Mar 1994 18:00:43 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 94 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2n824b$h70@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: Dir of Awards Title: NSF 93-48 Microelectronic Information Processing Systems Summary of Awards Fiscal Year 1993 File size (bytes): 439 STIS Filename: nsf9348 Also available: nsf9348.wp5 Document Type: General Publication Title: NSF 94-42 Division of Integrative Biology and Neuroscince File size (bytes): 14851 STIS Filename: nsf9442 Document Type: Press Release Title: FRUITFLY CIRCADIAN RHYTHMS FOUND TO BE RELATED TO NEWLY DISCOVERED "CLOCK" GENE File size (bytes): 4084 STIS Filename: pr9416 Document Type: Program Guideline Title: NSF 94-52 Metacenter Regional Alliances File size (bytes): 15666 STIS Filename: nsf9452 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 3939 STIS Filename: cmpublic Document Type: Letter Title: NSF 94-7 CISE NEWSLETTER File size (bytes): 14422 STIS Filename: nsf947 Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 29060 STIS Filename: sesvac ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve sesvac, the text of your message should be as follows: get sesvac Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve sesvac, you would enter: ftp> get sesvac WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Mon Mar 28 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-94-010 - V23(10) 03/11/94 Date: 28 Mar 1994 18:21:00 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 554 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2n83ac$if2@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA94010 CA-94-010 P1O1 *************************************** CLINICAL/METABOLIC STUDIES IN NUTRITION AND BREAST CANCER PREVENTION NIH GUIDE, Volume 23, Number 10, March 11, 1994 RFA: CA-94-010 P.T. 34; K.W. 0715036, 0745027, 0710095, 0765020 National Cancer Institute Letter of Intent Receipt Date: April 12, 1994 Application Receipt Date: June 9, 1994 PURPOSE The Division of Cancer Prevention and Control, National Cancer Institute (NCI), invites Interactive Research Project Grants (IRPGs) (see NIH Guide, Vol. 22, No. 16, April 23, 1994), to encourage and facilitate formal interdisciplinary collaborations through the coordinated submission of related research project applications that share a common research focus relevant to the development and conduct of clinical/metabolic studies for nutrition and breast cancer prevention research and do not require extensive shared physical resources or core functions. Complex questions in nutrition and breast cancer prevention research often require investigative efforts that extend beyond the level practicable in a single project or that require a variety of technical approaches beyond the means of a single investigator. The perceived merit of individual research project applications sometimes may be limited by the lack of a comprehensive, interdisciplinary, approach or by limitations in resident technical expertise. Many areas of nutrition and breast cancer investigations are under-represented in grant applications either because they cannot effectively be exploited without a collaborative effort or local opportunities for such interactions are not available. The objectives of this RFA for Interactive Research Project Grants (IRPGs) are to (1) increase the investigator-initiated pool of quality applications employing clinical/metabolic studies in human nutrition and breast cancer research and (2) stimulate an intermediate level of interdisciplinary collaborative efforts to build stronger research bridges between nutritional science and the disciplines that relate closely to basic and clinical research for the development, application and evaluation of new approaches to nutrition and breast cancer prevention research utilizing clinical/metabolic studies. A minimum of two independent investigators with related research objectives will be encouraged to submit concurrent, collaborative, cross-referenced individual research project grant applications that share a common research focus. The overall goals are to encourage and stimul