From owner-sci-resources@net.bio.net Sun Aug 04 23:00:00 1996 Path: biosci!biosci!not-for-mail From: Mary Hilts Newsgroups: bionet.sci-resources Subject: DoD Fast Track Date: 5 Aug 1996 15:25:13 -0700 Organization: Foresight Science & Technology Lines: 79 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <32023EBB.1D0F@foresnt.com> NNTP-Posting-Host: net.bio.net We (Foresight Science & Technology) are under contract with the DoD to assist them in finding candidates for their SBIR "Fast Track" program. Through this program funds are available for research and technology areas that fall within the DoD's mission. This task is awkward in this particular forum (newsgroups) in that it is not research exchange, yet it is not advertisement either. What I believe it could be categorized as is information exchange; "The DoD has R&D money available, your readers may be eligible, we are informing them of the availability of this funding". If you have any questions, please e-mail me, I appreciate your communication. Otherwise, please post the following. Mary Hilts, Internet support maryh@foresnt.com Foresight Science & Technology *************************************************** ************************ Defense Department offering up to 4X match on private sector investments in small high-technology companies. *************************************************** ************************ DoD's Small Business Innovation Research (SBIR) program will fund $450 million in early-stage R&D projects at small high-technology companies in 1996, in technology areas that fall within the broad DoD mission. Effective immediately, DoD will give its highest priority in making SBIR awards to small companies that are able to attract independent third-party investors -- such as venture capital firms, large companies, or "angel" investors. If selected for award, these small companies will receive uninterrupted DoD funding of up to $850,000 over a two-and-a-half year period. In practice, this means that an investor that offers to help fund an early-stage technology project at a small company can obtain a match of between $1 and $4 in DoD SBIR funds for every $1 the investor puts in. This new policy -- the SBIR "Fast Track" -- was approved for implementation by Under Secretary of Defense (Acquisition & Technology) Dr. Paul Kaminski in June, 1995. Its purpose is to significantly increase DoD's success in converting SBIR research into affordable, high-performance products which serve military and commercial customers. For more information: * call David Speser at (407) 791-0720 or e-mail david@foresnt.com * see the page entitled "DoD SBIR Fast Track" on the World Wide Web at http://www.seeport.com/SBIR/fasttrk.htm * contact our DoD Fast Track listserver by e-mailing list@seeport.com with the message "join DoD" on the first line of your e-mail. *************************************************** ****************** From owner-sci-resources@net.bio.net Sun Aug 04 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 3 August 1996 Date: 5 Aug 1996 16:15:14 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 96 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4u5va2$gi8@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending August 3, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Program Guideline Title: NSF 94-100 - University-Industry Cooperative Research Programs in the Mathematical Sciences File size (bytes): 36441 STIS Filename: nsf94100.txt Title: NSF 96-119 CISE Postdoctoral Research Associates in Computational Science and Engineering & Experimental Computer Science File size (bytes): 14404 STIS Filename: nsf96119.txt Document Type: Report Title: NSF 96-30 Graduate Education and Postdoctoral Training in the Mathematical and Physical Sciences File size (bytes): 20449 STIS Filename: nsf9630.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 113743 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 123609 STIS Filename: phnorg.txt Document Type: Program Guideline Title: NSF 94-100 - University-Industry Cooperative Research Programs in the Mathematical Sciences File size (bytes): 36441 STIS Filename: nsf94100.txt Title: NSF 95-111 Grant Opportunities for Academic Liaison with Industry(GOALI) File size (bytes): 23416 STIS Filename: nsf95111.txt Title: NSF 95-112 Grant Opportunities for Academic Liaison with Industry File size (bytes): 16989 STIS Filename: nsf95112.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf95112.txt, the text of your message should be as follows: get nsf95112.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf95112.txt, you would enter: ftp> get nsf95112.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Tue Aug 06 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 26, pt. 1of1, 2 August 1996 Date: 7 Aug 1996 16:33:41 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 369 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4ub94l$h78@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 25, No. 26 - August 2, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** JAPAN SOCIETY FOR THE PROMOTION OF SCIENCE FELLOWSHIPS Fogarty International Center INDEX: FOGARTY INTERNATIONAL CENTER $$INDEX N2 ********************************************************** INTERNATIONAL GRANTS FOR U.S. AND FORMER SOVIET UNION SCIENTISTS Fogarty International Center INDEX: FOGARTY INTERNATIONAL CENTER NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 12/18/96 ************************************************* STRUCTURAL BIOLOGY OF AIDS RELATED PROTEINS (RFA GM-96-012) National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES $$INDEX R2 03/12/97 ************************************************* MITOCHONDRIAL DNA MUTATIONS IN HEART, LUNG AND BLOOD DISEASES (RFA HL-96-013) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX P1 ********************************************************** INNOVATIVE DRUG DISCOVERY RESEARCH IN AIDS OPPORTUNISTIC INFECTIONS (PA-96-068) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** JAPAN SOCIETY FOR THE PROMOTION OF SCIENCE FELLOWSHIPS NIH GUIDE, Volume 25, Number 26, August 2, 1996 P.T. 22; K.W. 0710030, 0404000 Fogarty International Center Through arrangements made with the Fogarty International Center, the Japan Society for the Promotion of Science (JSPS) will award up to 30 short-term fellowships for U.S. researchers in the biomedical and behavioral sciences to pursue collaborative research visits to Japan for periods ranging from seven to sixty days. Applicants must be U.S. citizens or permanent residents and hold a doctoral degree or equivalent in the biomedical or behavioral sciences. Ph.D. and M.D. candidates who can demonstrate that their collaboration with Japanese colleagues holds exceptional professional promise also may apply. The deadline for receipt of applications is October 1. INQUIRIES Inquiries regarding this program may be directed to: Mr. Michael Snyder Program Officer for Japan Fogarty International Center Building 31, Room B2C11 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-4784 FAX: (301) 480-3414 Email: snyderm@nih.gov $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** INTERNATIONAL GRANTS FOR U.S. AND FORMER SOVIET UNION SCIENTISTS NIH GUIDE, Volume 25, Number 26, August 2, 1996 P.T. 34; K.W. 0710030 Fogarty International Center Through a program made possible by an award from the NIH, the U.S. Civilian Research and Development Foundation (CRDF) for the Newly Independent States of the Former Soviet Union (FSU) has announced a new competition for grants to support research projects between U.S. scientists and their counterparts in the FSU. Current NIH grantees and intramural scientists are invited to apply jointly with their counterparts in the FSU. Two-year cooperative grants of up to $80,000 will be awarded. All proposals will be evaluated through competitive peer review. The deadline for receipt of applications is February 15, 1997. INQUIRIES A detailed program announcement and application instructions are available from the U.S. Civilian Research and Development Foundation (CRDF) at http://www.crdf.inter.net; Email: information@crdf.org; telephone: (703) 526-9720; FAX: (703) 526-9721; and from: Ms. Karen Peterson Program Officer for Russia and the NIS Fogarty International Center Building 31, Room B2C11 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-4784 FAX: (301) 480-3414 Email: p9k@cu.nih.gov $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN GM-96-012 FULL-TEXT ************************************** STRUCTURAL BIOLOGY OF AIDS RELATED PROTEINS NIH GUIDE, Volume 25, Number 26, August 2, 1996 RFA AVAILABLE: GM-96-012 P.T. 34; K.W. 0715008, 0755025, 0760070 National Institute of General Medical Sciences Letter of Intent Receipt Date: November 18, 1996 Application Receipt Date: December 18, 1996 PURPOSE The National Institute of General Medical Sciences (NIGMS) reannounces its interest in receiving applications to apply modern methods of molecular structure determination and analysis in developing new approaches to structure-based drug design. The intent is to develop new approaches to the treatment of AIDS and associated opportunistic infections. The mechanism of support will be the program project grant (P01). The estimated funds (total costs) available for the first year of support for the entire program is $8,000,000. It is anticipated that six to ten new and competing applications will be funded. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Structural Biology of AIDS-Related Proteins, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. James C. Cassatt, Ph.D. Division of Cell Biology National Institute of General Medical Sciences 45 Center Drive, Room 2AS-19C - MSC 6200 Bethesda, MD 20892 Telephone: (301) 594-0828 FAX: (301) 480-2004 Email: czj@cu.nih.gov $$R1 END ************************************************************ $$R2 BEGIN HL-96-013 FULL-TEXT ************************************** MITOCHONDRIAL DNA MUTATIONS IN HEART, LUNG AND BLOOD DISEASES NIH GUIDE, Volume 25, Number 26, August 2, 1996 RFA AVAILABLE: HL-96-013 P.T. 34; K.W. 0760053, 0715040, 0715032, 0715165 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: January 24, 1997 Application Receipt Date: March 12, 1997 PURPOSE This initiative will foster research on molecular, cellular, genetic, and epidemiologic approaches to elucidate the role of mitochondrial DNA (mtDNA) mutations in heart, blood vessels, blood and lung diseases. Its goals are to define mechanisms by which mtDNA mutations cause tissue-specific, progressive diseases, and to elucidate the cause and effect relationships between alterations in this genome and pathological phenotypes. The ultimate purpose of this initiative is the development of effective strategies for prevention and treatment of cardiovascular, pulmonary, and hematologic disorders due to mitochondrial DNA mutations in humans. Although this Request for Applications (RFA) is sponsored by the National Heart, Lung, and Blood Institute (NHLBI), other Institutes and Centers of the NIH may also have an interest in mitochondrial research. Applications will be assigned to the most appropriate Institute/Center on the basis of established PHS referral guidelines. It is anticipated that for FY 1997, approximately $1,800,000 total costs will be available to support approximately six new research project grants (R01) under this Request for Applications (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, Mitochondrial DNA Mutations in Heart, Blood and Lung Diseases, is related to the priority areas of heart disease and stroke, diabetes and chronic disabling conditions, and environmental health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Dr. Isabella Liang Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 9142, MSC 7940 Bethesda, MD 20892-7940 Telephone: (301) 435-0520 FAX: (301) 480-1335 Email: liangi@gwgate.nhlbi.nih.gov $$R2 END ************************************************************ $$P1 BEGIN PA-96-068 FULL-TEXT ************************************** INNOVATIVE DRUG DISCOVERY RESEARCH IN AIDS OPPORTUNISTIC INFECTIONS NIH GUIDE, Volume 25, Number 26, August 2, 1996 PA AVAILABLE: PA-96-068 P.T. 34; K.W. 0715008, 0755025, 0765035, 0715125 National Institute of Allergy and Infectious Diseases PURPOSE The National Institute of Allergy and Infectious Diseases gives special consideration for funding to scientifically meritorious and appropriate applications in response to Program Announcements. Program Announcements identify areas of ongoing research emphasis for the NIAID. The Opportunistic Infections Research Branch (OIRB) of the Therapeutics Research Program in the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), invites applications for Innovative Drug Discovery Research in AIDS Opportunistic Infections. The purpose of this PA is to encourage investigator-initiated grant applications that involve creative and original research that emphasizes under-exploited facets of the basic biology, biochemistry, and pathophysiology of the opportunistic pathogens necessary to propel advances in improved therapies. The PA encourages applications for studies on the following AIDS-associated pathogens: human cytomegalovirus, JC virus, Mycobacterium avium, Pneumocystis carinii, Cryptosporidium parvum, the Microsporida, and Cryptococcus neoformans. Funding mechanisms to be used are research project grants (R01), First Independent Research Support and Transition (FIRST) (R29) awards, and Interactive Research Project Grants (IRPG). Applications in this area are also accepted for the SBIR and STTR programs. Research in the following areas will be considered responsive to this PA: discovery of efficacious new antibiotics; cellular and molecular biology of the pathogens leading to identification of new chemo- or immuno-therapeutic targets; pathogen physiology, biochemistry and metabolism relating to drug susceptibility and resistance; development of improved culture and animal model systems; identification of new drugs from natural products and synthetic chemical compounds; rapid, noninvasive diagnostic methods; and development of improved drug delivery systems. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Innovative Drug Discovery Research in AIDS Opportunistic Infections, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202/512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Chris Lambros, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2C40, MSC 7620 Bethesda, MD 20892-7620 Telephone: (301) 402-2304 FAX: (301) 402-3171 Email: chris_lambros@nih.gov $$P1 END ************************************************************ From owner-sci-resources@net.bio.net Tue Aug 06 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA GM-96-012 - V25(26) 08/02/96 Date: 7 Aug 1996 16:34:04 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 333 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4ub95c$h7v@net.bio.net> NNTP-Posting-Host: net.bio.net STRUCTURAL BIOLOGY OF AIDS RELATED PROTEINS NIH Guide, Volume 25, Number 26, August 2, 1996 RFA: GM-96-012 P.T. 34; K.W. 0715008, 0755025, 0760070 National Institute of General Medical Sciences Letter of Intent Receipt Date: November 18, 1996 Application Receipt Date: December 18, 1996 PURPOSE The National Institute of General Medical Sciences (NIGMS) reannounces its interest in receiving applications to apply modern methods of molecular structure determination and analysis in developing new approaches to structure-based drug design. The intent is to develop new approaches to the treatment of AIDS and associated opportunistic infections. 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), Structural Biology of AIDS Related Proteins, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanism of support will be the program project grant (P01). The circumstances under which NIGMS will support this RFA are the same as those described in the notice, "Support of Program Project Grants," published in the NIH Guide, Vol. 25, No. 10, March 29, 1996. It is expected that three or more investigators, all pursuing independent, interrelated projects, will be involved. One scientist must be designated by the applicant institution as the Principal Investigator and must bear the responsibility for the scientific and fiscal management of the program project grant. Most of the collaborating scientists should be independent investigators in accordance with the NIGMS program project notice cited above. Equipment and other core resources necessary for the accomplishment of the objectives of the program project grant may be requested. This RFA is one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE This RFA is a one-time solicitation, and represents a request for competing renewal applications funded under RFA GM-91-02 (STRUCTURAL BIOLOGY AS APPLIED TO THE PROBLEM OF TARGETED DRUG DESIGN, WITH POTENTIAL APPLICABILITY TO THE TREATMENT OF AIDS), and an opportunity for new groups to apply. The estimated funds (total costs) available for the first year of support for the entire program is $8,000,000. It is anticipated that six to ten applications will be funded. The level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. The total project period for applications submitted in response to this RFA may not exceed five years. The anticipated award date will be July 1, 1997. Although this program is provided for in the financial plans of NIGMS, the award of grants pursuant to this RFA is contingent on the availability of funds for this purpose. RESEARCH OBJECTIVES Background In 1987 the NIGMS initiated a program to support groups interested in developing the area of structure-based drug design with a specific emphasis on AIDS related systems. Since that time, considerable progress has been made through this program as well as elsewhere at NIH and in industry. The structures of several HIV proteins have been determined. These structures include the HIV, SIV and FIV proteases, the HIV reverse transcriptase, the zinc finger domains of the HIV nucleocapsid protein, and the catalytic domain of integrase. The first generation of HIV protease inhibitors have either been approved or are awaiting approval by the FDA. Other Although this progress has been significant, many areas require further investigation. For example, some targets, such as the membrane-bound gp120/gp41 complex, have not yielded to detailed structural determination. As another example, the development of drug resistance and complications raised by opportunistic infections present new challenges. Finally, despite the major advances that have been made in the speed with which structures can be determined and in our understanding of the theoretical basis of ligand binding to proteins, the limiting step in the process of drug design remains the lack of generalizable, efficient and reproducible approaches to the use of macromolecular structures to design lead compounds. Consequently, we are encouraging applications from research groups with an interest in developing the concepts and methodologies of structure-based drug design. Because of the progress that has been made in the determination of the structures of either AIDS-related proteins or proteins key to the survival of organisms that commonly cause opportunistic infections in people infected with HIV, it is expected that these will serve as a test bed for any new methodologies developed. Other possible targets that can be considered are biological macromolecules from the host that are involved in the uptake, transport, and integration of the viral genome. Furthermore, since drug resistance is now well-established as a major problem, the ability of potential inhibitors to withstand the effects of mutations of the target should be included in design principles. The central disciplines covered by this RFA are x-ray crystallography, NMR and molecular modeling augmented by expertise in organic synthesis, molecular enzymology, and virology. Groups with well-established expertise in this broad area but which have not previously been involved in AIDS research are encouraged to apply. SPECIAL REQUIREMENTS Informal interaction and exchange of information among all program groups is expected. All awardees are expected to participate in an annual conference. Because of the need for rapid communication of data, the three dimensional coordinates of structures determined as part of this program must be available in the Protein Data Bank at the time of publication. The National Institute of General Medical Sciences places a limit of $4 million in direct costs over five years that may be requested on all program project grants. Amounts over this total may be requested for major pieces of equipment, extensive organic synthesis, or other exceptional needs. Such exceptions must be discussed prior to submission with Dr. James Cassatt at the address listed under INQUIRIES. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by November 18, 1996, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application the information contained allows NIGMS staff to estimate the potential review workload and avoid conflicts of interest in establishing the review panel. The letter of intent is to be sent to Dr. James C. Cassatt at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS-398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research; from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov; and from the NIH Program Director listed under INQUIRIES. The RFA label available in the application kit must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the title of the application and the RFA number must be typed on line 2 of the face page of the application form. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies in one package to DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to Helen R. Sunshine, Ph.D. Office of Scientific Review Activities National Institute of General Medical Sciences 45 Center Drive, MSC-6200 Bethesda, MD 20892-6200 Applications must be received by December 18, 1996. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by DRG staff for completeness and by NIGMS for responsiveness. Incomplete and/or non-responsive applications will be returned to the applicant. It should not be assumed that a site visit will be conducted during the course of the review of any of these applications. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory General Medical Sciences Council. Review criteria for this RFA are the same as for individual research grants. In particular the following aspects will be stressed: o Quality and originality of the proposed research projects, and the qualifications of the individual project leaders; o Involvement of investigators having expertise in the appropriate scientific disciplines to provide the breadth needed for an integrated program; o Evidence of collaboration and interaction among all the groups named in the application; and o Experience and competence of the Principal Investigator in directing and overseeing a broad program of the type proposed. AWARD CRITERIA Awards will be made according to priority score availability of funds, and programmatic priorities. INQUIRIES Written and telephone inquiries concerning this RFA are strongly encouraged. Preapproval is required for all new applications that request over $500,000 direct cost in any given year as noted above. Inquiries regarding programmatic issues and requests for prior approval may be addressed to: James C. Cassatt, Ph.D. Division of Cell Biology National Institute of General Medical Sciences 45 Center Drive, MSC-6200 Bethesda, MD 10892 Telephone: (301) 594-0828 FAX: (301) 480-2004 Email: czj@cu.nih.gov For fiscal and administrative matters contact: Phyllis Finch National Institute of General Medical Sciences 45 Center Drive, MSC-6200 Bethesda, MD 20892 Telephone: (301) 594-5243 Email: finchp@gm1.nigms.nih.gov Schedule Letter of Intent Receipt Date: November 18, 1996 Applications Receipt Date: December 18, 1996 Initial Review: March-April 1996 Secondary Review: May 1996 Anticipated Award Date: July 1, 1996 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Assistance No. 93-821. 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 PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Aug 06 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-96-013 - V25(26) 08/02/96 Date: 7 Aug 1996 16:34:21 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 651 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4ub95t$h8e@net.bio.net> NNTP-Posting-Host: net.bio.net MITOCHONDRIAL DNA MUTATIONS IN HEART, LUNG AND BLOOD DISEASES NIH Guide, Volume 25, Number 26, August 2, 1996 RFA: HL-96-013 P.T. 34; K.W. 0760053, 0715040, 0715032, 0715165 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: January 24, 1997 Application Receipt Date: March 12, 1997 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THE FULL RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS AND MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE This initiative will foster research on molecular, cellular, genetic, and epidemiologic approaches to elucidate the role of mitochondrial DNA (mtDNA) mutations in heart, blood vessels, blood and lung diseases. Its goals are to define mechanisms by which mtDNA mutations cause tissue-specific, progressive diseases, and to elucidate the cause and effect relationships between alterations in this genome and pathological phenotypes. The ultimate purpose of this initiative is the development of effective strategies for prevention and treatment of cardiovascular, pulmonary, and hematologic disorders due to mitochondrial DNA mutations in humans. Although this Request for Applications (RFA) is sponsored by the National Heart, Lung, and Blood Institute (NHLBI), other Institutes and Centers of the NIH may also have an interest in mitochondrial research. Applications will be assigned to the most appropriate Institute/Center on the basis of established PHS referral guidelines. 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), Mitochondrial DNA Mutations in Heart, Blood and Lung Diseases, is related to the priority areas of heart disease and stroke, diabetes and chronic disabling conditions, and environmental health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under this RFA. Awards under this RFA to foreign institutions will be made only for research of very unusual merit, need, and promise, and in accordance with Public Health Service policy governing such awards. MECHANISM OF SUPPORT This RFA will use the NIH individual research project grant (R01) mechanism of support. Newly independent investigators who wish to apply are encouraged to consult with a program representative (see INQUIRIES below). Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. The "MODULAR GRANT" concept establishes specific modules (increments) in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The "JUST-IN-TIME" concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, applicant institutions, reviewers, and Institute staff. For this RFA, funds must be requested in $25,000 direct cost modules. Up to a maximum of seven modules ($175,000 direct costs) per year may be requested. A feature of the modular grant concept is that no escalation is provided for future years, and all anticipated expenses for all years of the project must be included within the number of modules being requested. Only limited budget information will be required and any budget adjustments made by the Initial Review Group will be in modules of $25,000. Instructions for completing the Biographical Sketch have also been modified. In addition, Other Support information and the application Checklist page are not required as part of the initial application. If there is a possibility for an award, necessary budget, Other Support, and Checklist information will be requested by NHLBI staff following the initial review. The APPLICATION PROCEDURES section of this RFA provides specific details of modifications to standard PHS 398 application kit instruction. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed four years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. It is anticipated that support for this program will begin in September 1997. Administrative adjustments in project period and/or amount may be required at the time of the award. FUNDS AVAILABLE It is anticipated that for fiscal year 1997, approximately $1,800,000 total costs will be available for the first year of support for this initiative. Award of grants pursuant to this RFA is contingent upon receipt of such funds for this purpose. It is anticipated that approximately six new grants will be awarded under this program. The specific number to be funded will, however, depend on the merit and scope of the applications received and on the availability of funds. Direct costs will be awarded in modules of $25,000, less any overlap or other necessary administrative adjustments. Indirect costs will be awarded based on the negotiated rates. RESEARCH OBJECTIVES Background There is now convincing evidence that proper functioning of human mitochondrial DNA (mtDNA) is critical to normal cellular metabolism and that mutations in mtDNA can result in severe disease phenotypes. Recently, a large number of mtDNA mutations have been catalogued and linked to human degenerative diseases. Mitochondrial defects may be inherited or acquired. Phenotypic abnormalities in individuals bearing genetic defects may be evident at birth or may not be apparent until middle age. Although it is clear that mutations in mtDNA can cause devastating symptoms affecting different organ systems, many clinically relevant questions concerning pathophysiology remain unanswered. Quantitative relationships between the abundance of mutated forms of mtDNA relative to normal mitochondrial genome and dysfunction of different cell types remain to be defined. In terms of cardiovascular diseases, evidence suggests that an accumulation of mutant forms of mtDNA in the myocardium frequently results in cardiac conduction block and sudden cardiac death. It is apparent that certain types of cardiac diseases may be caused by the mtDNA mutations, but the pathophysiological events that give rise to specific forms of heart disease in association with these mtDNA mutations still remain obscure. The current view is that abnormalities in mitochondrial structure and function, and mutations in mtDNA are associated with a large number of cardiac pathologies including ischemic heart disease, idiopathic dilated cardiomyopathy, hypertrophic cardiomyopathy, and cardiomyopathy of aging. However, strict causal relationships among abnormalities in mtDNA and/or abnormalities in mitochondrial biogenesis and these cardiac abnormalities are not fully elucidated. Resolution of this problem can come from study of animal models, which have not yet been developed. Such models will also provide the opportunity to test potential therapeutic strategies, including the development of mitochondrial gene therapy. Some studies suggest that abnormalities in mtDNA not only cause the rare but devastating syndromes that have been identified as mitochondrial diseases, but contribute to the pathophysiology of other widely prevalent diseases. A deficiency of mtDNA has been observed in HIV-infected patients treated with antiviral nucleoside analogues (ANA), and is proposed to contribute to myopathic symptoms in these individuals. Evidence suggests that short-term usage of ANA drugs is relatively safe; however, long term usage reveals that they can become toxic and affect oxidative phosphorylation, which appears to be attributable to a defect in mitochondrial replication. This defect resembles certain mitochondrial genetic diseases that have been associated with cardiomyopathy, mitochondrial myopathy, neuropathy, lactic acidosis, exocrine pancreas failure, pancreas failure, liver failure and bone marrow failure. It has been suggested that mitochondrial toxic ANAs may serve as experimental tools to clarify mtDNA replication. In the area of hematology, evidence for the association of mitochondrial DNA mutations and blood diseases is fragmentary. One exception is Pearson's syndrome, a progressive congenital disorder involving the hematopoietic system, exocrine pancreas, liver and kidneys. Within the blood, it is characterized by bone marrow failure, hypoproliferative sideroblastic anemia, and pancytopenia. It is associated with enzymatic deficiencies in some of the respiratory chain enzymes within blood cells that occur in conjunction with large-scale, single deletions of the mitochondrial genes encoding these enzymes. This is the first reported mitochondriopathy with a non-neuromuscular expression. The reported abnormalities of both erythroid and myeloid precursors in the arrow of Pearson's Syndrome patients suggests a potential role of mtDNA in hematopoiesis. Although Pearson's syndrome itself is relatively rare, it is certainly possible that other forms of sideroblastic or aplastic anemias may also be associated with acquired or inherited mtDNA mutations. Sideroblastic anemias in general have the unique characteristic of amorphous iron deposits in erythroblast mitochondria. The role of iron in mitochondria and the ineffective erythropoiesis in these anemias needs further study. Iron in red cell membranes has been reported in thalassemia and sickle cell disease. This iron deposition causes significant oxidation of membrane proteins in these disorders, but little has been reported on possible oxidative damage to mitochondria in the red blood cell precursors. In addition, little is known about possible mitochondrial damage in other diseases involving iron overload or in the blood of individuals undergoing chronic transfusion. Many dysfunctions of electron transport chain enzymes as well as mutant mtDNA have also been found in platelets and/or lymphocytes of patients with diseases associated with aging, including Parkinson's, Huntington's, and Alzheimer's diseases. Furthermore, this phenomenon has been reported in Down syndrome, which is characterized by an accelerated aging process. Some of these enzymatic dysfunctions have been linked to mutations in mitochondrial genes encoding these proteins. Most of these mutations have been discovered as a result of using blood cells because of their accessibility as a "diagnostic test" to screen for mutations that may also occur in tissues more directly involved in the disease, but are less accessible, such as brain tissue from Parkinson's Disease patients. It is quite possible that the function of the blood cells themselves may be affected by the mtDNA mutations. Elucidating how the bioenergetic defects in blood cells affect their own function may have implications for other diseases involving mtDNA mutations. The role of mutations in mtDNA in etiology and pathogenesis of lung disease is virtually unexplored. The lung might be particularly prone to mitochondrial DNA damage as a result of its oxidative environment, rapidly turning over epithelium, and constant exposure to environmental agents. The consequences on mtDNA of exposure of potential therapeutic agents such as nitric oxide are not understood. Damage or loss of specific mitochondrial genes associated with energy generation could potentially affect many aspects of pulmonary cell function, particularly under stressful conditions. Examples of lung cell functions that might be impaired include surfactant and extracellular matrix biosynthesis, cell repair processes, mucociliary transport, ion gradients, and neural control of airway smooth muscle function. Thus, one objective of future research should be to establish whether mtDNA damage occurs in the lung in association with disease states, and if so, to determine the role of mtDNA damage and repair in the etiology of lung disease. Although much of the evidence involving a link between mtDNA mutations and certain diseases is unequivocal, there is still a compelling need to determine the extent to which mtDNA mutations affect the natural history of heart, blood vessels, blood, and lung diseases. There have been few epidemiological studies of mitochondrial disorders and thus the extent of the problem in general populations is unknown. The attributable risk of myocardial, hypertensive, and other cardiovascular diseases due to mitochondrial gene mutations is also unknown. The lack of an easy screening test, other than the blood cell diagnostic test' mentioned above, which may miss certain types of mtDNA mutations, has hampered this research. However, maternal transmission of inherited mtDNA defects and the apparent mendelian pattern of inheritance for certain mtDNA deletions (implying nuclear gene involvement in mtDNA replication) suggests that pedigree studies could be informative. Family studies could be used to elucidate susceptibility markers and factors associated with phenotypic expression of mtDNA diseases. Preexisting population studies that have already collected DNA could assess mitochondrial DNA variation in a relatively cost-effective manner. Research Goals and Scope The following examples of potential research projects are given for illustrative purposes only and are not intended to define the scope of relevant topics. Investigators are expected to use their expert knowledge of the field in developing responses to this initiative o Establish animal and cellular models of mutant mtDNA relevant to heart, vascular, lung and blood disorders o Identify genes important for mtDNA replication or repair, segregation of mitochondrial genomes during cell division, and control of mtDNA copy numbers in cell types found in heart, vascular, lung and blood disorders o Develop methods to transfer exogenous genes into mammalian mitochondria or to complement mitochondrial gene defects by gene transfer to the nucleus of cardiovascular, lung and blood cells. o Establish mechanisms of damage in relationship to the etiology of the heart, vascular, lung and blood disease states in animals or humans o Elucidate mechanisms that promote mitochondrial DNA mutations in ischemic heart disease and hyperoxic lung disease. o Elucidate the role of mtDNA damage in early development of cardiovascular, lung and blood cells o Identify markers for susceptibility to mitochondrial diseases of heart, vascular, lung and blood and development of preventive strategies o Elucidate the reasons that some mitochondrial mutations and deletions give rise to clinically different heart, vascular, lung and blood disorders and some have no effect. o Elucidate quantitative relationships between mutant forms of mtDNA and heart and lung dysfunction. o Define the pathways for ATP synthesis and utilization changes in blood cells, cardiovascular, and lung tissues with defective mitochondrial genes. o Identify mtDNA determinants of heart, vascular, lung, and blood disease and risk factors. o Define the pathways for ATP synthesis and utilization changes in blood cells, cardiovascular and lung tissues with defective genes. SPECIAL REQUIREMENTS Upon initiation of the program, the NHLBI will sponsor periodic meetings to encourage exchange of information among investigators who participate in this program. In the budget for the grant application, applicants should request travel funds for a 1-day meeting each year, most likely to be held in Bethesda, Maryland. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by January 24, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH staff to estimate the potential review workload and avoid conflict of interest in the review. A faxed letter of intent may be used in place of a posted one. The letter of intent is to be sent to: Dr. C. James Scheirer Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7220, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0266 FAX: (301) 480-3541 Email: James_Scheirer@NIH.GOV APPLICATION PROCEDURES The research grant application form PHS-398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research; from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov; and from NHLBI program staff listed under INQUIRIES. The RFA label available in the application kit must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the title of the application and the RFA number must be typed on line 2 of the face page of the application form. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies in one package to DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) Submit an additional two copies of the application to Dr. Scheirer at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants; otherwise, the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Sample budgets and justification page will be provided upon request or following the submission of a letter of intent. BUDGET INSTRUCTIONS The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD Do not complete Form Page 4 of the PHS 398 (rev 5/95). It is not required nor will it be accepted at the time of application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT Do not complete the categorical budget tables on Form page 5 of the PHS 398 (rev. 5/95). Only the requested total direct costs line for each year must be completed based on the number of $25,000 modules being requested. Applicants may not request a change in the amount of each module. A maximum of seven modules ($175,000 direct costs) per year may be requested and each applicant may request up to four years of support for this RFA. Direct cost budgets will remain constant throughout the life of the project (i.e. the same number of modules requested for all budget periods). Any necessary escalation should be considered when determining the number of modules to be requested. However, in the event that the number of modules requested must change in any future year due to the nature of the research proposed, appropriate justification must be provided. Total Direct Costs for the Entire Proposed Project Period should be shown in the box provided. o BUDGET JUSTIFICATION Budget justifications should be provided under "Justifications" on Form Page 5 of the PHS 398. List the names, role on the project and proposed percent effort for all project personnel (salaried or unsalaried)and provide a narrative justification for each person based on his/her role on the project. Identify all consultants by name and organizational affiliation and describe the services to be performed. Provide a general narrative justification for individual categories (equipment, supplies, etc.) required to complete the work proposed. More detailed justifications should be provided for high cost items. Any large one-time purchases, such as large equipment requests, must be accommodated within these limits. o CONSORTIUM/CONTRACTUAL COSTS - If collaborations or subcontracts are involved that require transfer of funds from the grantee to other institutions, it is necessary to establish formal subcontract agreements with each collaborating institution. A letter of intent >From each collaborating institution should be submitted with the application. Only the percentage of the consortium/contractual TOTAL COSTS (direct and indirect) relative to the total DIRECT COSTS of the overall project needs to be stated at this time. The following example should be used to indicate the percentage cost of the consortium, "The consortium agreement represents 27% of overall $175,000 direct costs requested in the first year.". A budget justification for the consortium should be provided as described in the "Budget Justification" section above (no Form Page 5 required for the consortium). Please indicate whether the consortium will be in place for the entire project period and identify any future year changes in the percentage relative to the parent grant. If there is a possibility for an award, the applicant will be requested to identify actual direct and indirect costs for all years of the consortium. Please note that total subcontract costs need not be calculated in $25,000 modules. However, when subcontract funds are added to the parent grant budget, the total direct cost amount must be included in the number of $25,000 modules requested. o BIOGRAPHICAL SKETCH - A biographical sketch is required for all key personnel, following the modified instructions below. Do not exceed the two-page limit for each person. Complete the educational block at the top of the form page; List current position(s) and those previous positions directly relevant to the application; List selected peer-reviewed publications directly relevant to the proposed project, with full citation; The applicant has the option to provide information on research projects completed and/or research grants participated in during the last five years that are relevant to the proposed project. o OTHER SUPPORT - Do not complete the "Other Support" pages (Form Page 7). Selected other support information relevant to the proposed research may be included in the Biographical Sketch as indicated above. Complete Other Support information will be requested by NHLBI staff if there is a possibility for an award. o CHECKLIST - No "Checklist" page is required as part of the initial application. A completed Checklist will be requested by NHLBI staff if there is a possibility for an award. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Applications not conforming to these guidelines will be considered unresponsive to this RFA and will be returned without further review. Applications must be received by March 12, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already re-viewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer-review group convened by the NHLBI in accordance with NIH peer-review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Heart, Lung, and Blood Advisory Council. The personnel category will be reviewed for appropriate staffing based on the requested percent effort. The direct costs budget request will be reviewed for consistency with the proposed methods and specific aims. Any budgetary adjustments recommended by the reviewers will be in $25,000. The duration of support will be reviewed to determine if it is appropriate to ensure successful completion of the recommended scope of the project. Other review criteria will include: o scientific, technical or medical significance and originality of proposed research o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research o availability of the resources necessary to perform the research. o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: quality of the proposed project as determined by peer-review, availability of funds, and program priority. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Isabella Liang Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 9142, MSC 7940 Bethesda, MD 20892-7940 Telephone: (301) 435-0520 FAX: (301) 480-1335 Email: liangi@gwgate.nhlbi.nih.gov Dr. Carol Letendre Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 10162, MSC 7950 Bethesda, MD 20892-7950 Telephone: (301) 435-0080 FAX: (301) 480-0867 Email: letendrc@gwgate.nhlbi.nih.gov Dr. Dorothy Gail Division of Lung Diseases National Heart, Lung, and Blood Institute Two Rockledge Center, Suite 10100 6701 Rockledge Drive, MSC 7952 Bethesda, MD 20892-7952 Telephone: 301-435-0222 Fax: 301-480-3557 Email: gaild@gwgate.nhlbi.nih.gov Ms. Phyliss Sholinsky Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute Two Rockledge Center, Suite 8151 6701 Rockledge Drive, MSC 7934 Bethesda, MD 20892-7934 Telephone: 301-435-0701 Fax: 301-480-1667 Email: sholinsp@gwgate.nhlbi.nih.gov Direct inquiries regarding fiscal matters and requests for sample budgets to: Ms. Marie Willett Grants Operations Branch National Heart, Lung, and Blood Institute Two Rockledge Center, Suite 7128 6701 Rockledge Drive, MSC 7926 Bethesda, MD 20892-7926 Phone: 301-435-0144 Fax: 301-480-3310 E-mail: willettm@gwgate.nhlbi.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.837, 93.838, and 93.839. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants' policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Aug 06 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-068 - V25(26) 08/02/96 Date: 7 Aug 1996 16:34:35 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 375 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4ub96b$h91@net.bio.net> NNTP-Posting-Host: net.bio.net INNOVATIVE DRUG DISCOVERY RESEARCH IN AIDS OPPORTUNISTIC INFECTIONS NIH Guide, Volume 25, Number 26, August 2, 1996 PA NUMBER: PA-96-068 P.T. 34; K.W. 0715008, 0755025, 0765035, 0715125 National Institute of Allergy and Infectious Diseases Application Receipt Dates: January 2, May 1, September 1 PURPOSE The National Institute of Allergy and Infectious Diseases gives special consideration for funding to scientifically meritorious applications in response to Program Announcements. Program Announcements (PA) identify areas of ongoing research emphasis for the NIAID. The purpose of this PA is to seek research grant applications aimed at novel approaches to discovery and preclinical development of therapeutic agents and strategies against opportunistic infections (OIs) in people with AIDS. The intent of this Program Announcement is to encourage investigator-initiated grant applications that involve creative and original preclinical research that emphasizes under-exploited facets of the basic biology, biochemistry, and pathophysiology of the opportunistic pathogens necessary to propel advances in improved therapies. No clinical trials will be supported under this PA. Another Program Announcement, "Collaborations for Advanced Strategies in Opportunistic Infections," soliciting research projects that encompass laboratory research linked to proof-of-concept clinical studies will be announced at a later date. 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, Innovative Drug Discovery Research for Opportunistic Infections Associated with AIDS, is related to the priority area of human HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT Traditional research project grant (R01), FIRST award (R29), small research (R03) grant, and Interactive Research Project Grants (IRPG), awards may be submitted in response to this PA. Applications for R01 grants may request up to five years of support. Applications for R29 grants must request five years of support and are limited to $350,000 in direct costs over the entire project period. The NIAID uses R03 grants to support small highly innovative or pilot projects. Applicants for R03 grants may request up to $50,000 (direct costs) per year for a period not to exceed three years. Funds and time requested should be appropriate for the research proposed. Applicants for R03 grants must follow the special application guidelines and Terms and Conditions of Award for NIAID SMALL RESEARCH GRANTS, which appeared in the NIH Guide for Grants and Contracts, Vol. 25, No. 9, March 22, 1996. If an IRPG is proposed, it must consist of a minimum of two independent applications (see PA-96-001, NIH Guide for Grants and Contracts, Vol. 24, No. 35, October 6, 1995). An IRPG may consist of a combination of R01s and R29s or R01s only, but may not consist solely of R29 applications. An IRPG may also contain shared interactive resources (Cores), which must serve at least two of the research projects in order to facilitate achievement of the Group's common research goals. Collaborative arrangements involving more than one institution are especially encouraged, including participation of the pharmaceutical industry where appropriate. RESEARCH OBJECTIVES Background The principal causes of morbidity and mortality in AIDS are opportunistic infections (OIs). Although HIV is the primary cause of the progressive immunological deterioration seen in AIDS, the OIs account for the vast majority of all AIDS-related deaths as well as diminishing quality of life. Individuals infected with HIV are susceptible to a range of viral, bacterial, protozoal, and fungal infections. The pathologic consequences associated with OIs in AIDS are debilitating oral lesions, retinitis (cytomegalovirus), progressive multifocal leukoencephalopathy (JC virus),, disseminated nontuberculosis mycobacterial disease (M. avium), pulmonary disease (Pneumocystis carinii), protracted diarrhea (Cryptosporidium parvum, Enterocytozoon bieneusi), and meningitis (Cryptococcus neoformans). Whereas the available treatments for OIs have improved and prolonged the lives of people living with AIDS, the management of OIs in AIDS patients remains difficult and complicated due to toxicity and adverse side effects of therapeutic agents, long-term drug use leading to patient intolerance or drug resistance, frequent relapses, drug-drug interactions, and/or lack of standard treatments for newly emerging OIs (e.g., JC virus, C. parvum, E. bieneusi). New ideas and novel approaches are urgently needed to overcome the lack of therapeutic options available to people with AIDS-associated OIs. Research Objectives and Experimental Approaches The principal objective of this PA is to stimulate drug discovery through original and innovative research focused on key metabolic and pathophysiologic features between pathogen and host that will lead to the discovery and development of safe, better tolerated and effective new therapies for AIDS-associated OIs. Equally important is the need for rapid, non-invasive detection methods for early and specific diagnosis and for evaluation of responses to therapy. Research responsive to this PA includes studies to identify therapies and evaluation strategies for the following infectious agents: human cytomegalovirus (HCMV), JC virus, Mycobacterium avium, Pneumocystis carinii, Cryptosporidium parvum, the Microsporida, and Cryptococcus neoformans. Areas of study on these organisms include, but are not restricted to, the following: o discovery of efficacious new antibiotics for treatment and prevention of AIDS-associated disease; o basic cellular and molecular biology of the pathogens (virulence factors, genome structure, and gene expression) leading to identification of potential new chemo-or immuno-therapeutic targets; o pathogen physiology, biochemistry and metabolism leading to a better understanding of drug susceptibility and resistance; o development of improved in vitro (cell culture) and in vivo (animal model) systems for drug evaluations; o identification and evaluation of promising new drugs from natural products and synthetic chemical compounds, and elucidation of their mechanism of action; o early development and preclinical validation/standardization of rapid, non-invasive diagnostic methods for the specific and quantifiable detection of the infectious organism and for monitoring response to therapy; o development of improved delivery systems for therapeutic agents. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. Specific guidelines for R03 applications are provided in the notice, "NIAID Small Research Grants," NIH Guide, Vol. 25, No. 9, March 22, 1996; which is available from program staff listed under INQUIRIES. Specific guidelines for IRPG applications are provided in PA-96-001, NIH Guide, Vol. 24, No. 25, October 6, 1995. Specific guidelines for FIRST (R29) awards are provided in "First Award Guidelines (rev. 6/96). Applications for FIRST (R29) awards must include at least three sealed letters of reference attached to the face page of the original application. FIRST (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applications must be identified by checking "YES" on line 2 of the PHS face page, and the number and title of this program announcement must be typed in. Submit a signed, typewritten original of the application, including the Checklist, and five signed, exact photocopies in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) R03 applicants should submit an original typewritten application and three exact signed copies to the Division of Research Grants at the above address, and two copies to: Stanley Oaks, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C06 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7042 FAX: (301) 402-2638 Email: stanley_oaks@nih.gov Applicants from institutions that have a General clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. The Small Business Innovation Research Program (SBIR) and the Small Business Technology Transfer Research Program (STTR) also solicit applications in this research area. SBIR and STTR solicitation packages are available from: MTL, Inc. 13687 Baltimore Avenue Laurel, MD 20707-5096 Telephone: (301) 206-9385 FAX: (301) 206-9722 Email: a2y@cu.nih.gov The National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Dental Research (NIDR) also have interests in the basic biology, biochemistry, and pathophysiology of opportunistic pathogens; in particular, how these organisms interact with host lung cells and affect the respiratory system (NHLBI), or how they interact with tissues and defense mechanisms of the oral cavity (NIDR). Therefore, applications that are of mutual interest are likely to be given a secondary assignment to NHLBI or NIDR in accordance with the NIH referral guidelines. REVIEW CONSIDERATIONS R03 APPLICANTS ONLY: Review considerations and procedures are contained in the NIAID SMALL RESEARCH GRANTS notice which appeared in the NIH Guide for Grants and Contracts, Vol. 25, No. 9, March 22, 1996. Applications will be assigned on the basis of established PHS referral guidelines. Program staff will be responsible for determining whether an application is responsive to the goals of the PA. Applications will be reviewed for scientific and technical merit in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications may receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review will be discussed, assigned a priority score, and receive a second-level review by the appropriate national advisory council. Review Criteria o scientific, technical, or medical significance and originality of the proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o interactive nature of the component and overall program of the IRPG (where applicable); o qualifications and research experience of the Principal Investigator and staff, particularly but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications. The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance among research areas of the announcement, availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic (eligibility, responsiveness, and choice of funding mechanism) issues to: Chris Lambros, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2C40, MSC 7620 Bethesda, MD 20892-7620 Telephone: (301) 402-2304 FAX: (301) 402-3171 Email: chris_lambros@nih.gov R03 APPLICANTS ONLY: Direct inquiries regarding review issues and special instructions for application preparation to Dr. Stanley Oaks at the address listed under APPLICATION PROCEDURES. Direct inquiries regarding fiscal and administrative matters to: Ms. Jane W. Unsworth Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4B25, MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 402-6824 FAX: (301) 480-3780 Email: jane_unsworth@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance No. 93.856. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of the Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun Aug 11 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 27, pt. 1of1, 9 August 1996 Date: 12 Aug 1996 13:43:37 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 576 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4uo51p$3a4@net.bio.net> NNTP-Posting-Host: net.bio.net X-comment: RFAs described: HL-96-017, PA-96-069 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.08.09 NIH GUIDE - Vol. 25, No. 27 - August 9, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N2 ********************************************************** BEHAVIORAL THERAPIES DEVELOPMENT PROGRAM - ADDENDUM National Institute on Drug Abuse INDEX: National Institute on Drug Abuse $$INDEX N3 ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS National Institutes of Health INDEX: National Institutes of Health $$INDEX N4 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 04/24/97 ************************************************* ETIOLOGY OF CARDIOVASCULAR COMPLICATIONS IN HIV INFECTION (RFA HL-96- 017) National Heart, Lung and Blood Institute INDEX: NATIONAL HEART, LUNG AND BLOOD INSTITUTE $$INDEX P1 ********************************************************** COLLABORATIONS FOR ADVANCED STRATEGIES IN OPPORTUNISTIC INFECTIONS (PA-96-069) National Institute of Allergy and Infectious Diseases INDEX: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 25, Number 27, August 9, 1996 P.T. 34; K.W. 1014004, 1014006 Department of Health and Human Services Notice is hereby given that the Office of Research Integrity (ORI) has made final findings of scientific misconduct in the following case: Yahya Abdulahi, Ph.D., Clark Atlanta University: Based on its review of a report from the institution and ORI's own analysis, ORI found that Yahya Abdulahi, former Research Scientist, Department of Biology, Clark Atlanta University, committed scientific misconduct by plagiarizing words and concepts from a publication in the "Journal of Environmental Health" and by misrepresenting data in sections of a Public Health Service (PHS) grant application. Specifically, Dr. Abdulahi's grant application contains extensive and significant plagiarism in the "Description," "Background and Significance," "Experimental Design and Methods," and "Literature Cited" sections and contains plagiarism and misrepresentation of data in the "Preliminary Studies" section. Dr. Abdulahi's actions were serious in that (1) the plagiarism involved the use of extensive sections of a publication without attribution; (2) the materials, as plagiarized in the grant application, included misrepresented data; (3) the plagiarism included expropriation of the concept of the study in the publication; and (4) the plagiarism persisted throughout important portions of Dr. Abdulahi's grant application. Dr. Abdulahi has entered into a Voluntary Exclusion Agreement with ORI in which he has voluntarily agreed, for the three year period beginning July 16, 1996, to exclude himself from: (1) any contracting or subcontracting with any agency of the United States Government and from eligibility for, or involvement in, nonprocurement transactions (e.g., grants and cooperative agreements) of the United States Government as defined in 45 C.F.R. Part 76 (Debarment Regulations), and (2) serving in any advisory capacity to the Public Health Service (PHS), including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant. No publications were required to be corrected as part of this Agreement. INQUIRIES For further information, contact: Director, Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** BEHAVIORAL THERAPIES DEVELOPMENT PROGRAM - ADDENDUM NIH GUIDE, Volume 25, Number 27, August 9, 1996 PA NUMBER: PA 94-078 P.T. 34; K.W. 0415001, 0404009, 0404000 National Institute on Drug Abuse PURPOSE This notice is an addendum, Innovative Stage 1 Behavioral Therapy Development Research, to program announcement PA-94-078, published in the NIH Guide, Vol. 22, No. 26, July 15, 1994. The purpose of this addendum is to encourage Stage 1 research on the development of new and innovative behavioral interventions for the treatment of drug addiction and the prevention or reduction of HIV risk behaviors in drug abuse treatment populations. The translation of basic behavioral science research into creative new behavioral therapies for drug addicts is the ultimate goal of this program announcement. The National Institute on Drug Abuse (NIDA) is supporting the study of behavioral therapies (including, but not limited to, psychotherapy, behavior therapy, cognitive therapy, family therapy, skills training, and counseling approaches) that will potentially have a significant impact on reducing drug abuse and addiction and reducing HIV/AIDS risk behaviors. For those investigators applying for grants under the Behavioral Therapies Development Program, this notice is meant to supplement Program Announcement PA-94-078, which is still in effect and should be consulted in conjunction with this addendum. RESEARCH OBJECTIVES Behavioral interventions remain the most common, and sometimes the only, treatments administered to individuals with drug use disorders. Many of these interventions or therapies have been shown to have some efficacy in promoting initial abstinence from drugs, reducing relapse, decreasing total drug use, or decreasing HIV risk behaviors. Nonetheless, many questions remain about the best ways to intervene behaviorally in the treatment of addiction, and for some individuals, existing behavioral interventions may not be sufficient. Developments in basic behavioral science could have a positive impact upon the development of behavioral therapies. However, emerging scientific knowledge does not always get rapidly incorporated into the behavioral therapy development process. The objectives of this announcement are to encourage research, based upon emerging basic behavioral research findings, on the development of: (1) creative new therapies for drug use disorders and (2) innovative behavioral approaches to HIV risk reduction in drug abusing populations. This Stage 1 research ultimately involves the translation of ideas from basic behavioral science into clearly defined behavioral interventions/therapies for individuals with addictive disorders. Innovative research is needed that is not only based upon basic behavioral research, but also incorporates basic behavioral research into the Stage 1 effort. Such novel developmental therapy/intervention research may build upon research from the following (and other) areas of basic behavioral science: o Cognition and decision-making o Learning and motivation o Behavior analysis o Developmental psychology o Personality and individual differences o Social psychology Creative Stage 1 research that is theoretically-driven and solidly based in any area of basic behavioral science is sought. Applicants may propose behavioral therapy/intervention studies aimed at drug addiction treatment, HIV risk reduction in treatment populations, or both. All applications must be submitted on the grant application form PHS 398 (rev. 5/95) using the standard receipt dates described in the form. INQUIRIES Direct inquiries regarding this addendum and program announcement PA- 94-078 to: Lisa Onken, Ph.D. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-10 Rockville, MD 20857 Telephone: (301) 443-0107 Email: lo10n@nih.gov $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS NIH GUIDE, Volume 25, Number 27, August 9, 1996 P.T. 42; K.W. 0201011, 1014003 National Institutes of Health The National Institutes of Health (NIH), Office of Extramural Research (OER), Office for Protection from Research Risks (OPRR) is continuing to sponsor workshops on implementing the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Each of the workshops scheduled for Fiscal Year 1996 will focus on a specific theme. The workshops are open to institutional administrators, members of Institutional Animal Care and Use Committees, laboratory animal veterinarians, investigators and other institutional staff who have responsibility for high-quality management of sound institutional animal care and use programs. Ample opportunities will be provided to exchange ideas and interests through question and answer sessions and informal discussions. DATES: September 19-20, 1996 TOPIC: The 1996 Guide for the Care and Use of Laboratory Animals: The Era of Performance Based Standards LOCATION: Adams Park Hotel, 1550 Court Place, Denver, CO 80202, telephone (303) 893-3333, FAX (303) 623-0303 SPONSORS: University of Colorado Health Sciences Center, Denver, CO; University of Southern Colorado, Pueblo, CO CONTACT: Ms. Joann Bauer or Dr. James O. Stevens Continuing Medical Education Office University of Colorado Health Sciences Center 4200 East 9th Avenue, Campus Box C295 Denver, CO 80262 Telephone: (303) 372-9054 or (303) 270-4648 FAX: (303) 372-9065 REGISTRATION FEE: $175.00 INQUIRIES For further information concerning future NIH/OPRR Animal Welfare Education Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, Suite 3B01 - MSC 7507 Rockville, MD 20892-7507 Telephone: (301) 496-8101 x233 Email: RossD@od6100m1.od.nih.gov $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 25, Number 27, August 9, 1996 P.T. 42; K.W. 0783005 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human subjects. The meetings should be of special interest to those persons currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all other Public Health Service agencies. The current schedule includes the following: DATES: September 26-27, 1996 TITLE: Role of the IRB in Collaborative Research LOCATION: Jumer's Castle Lodge, Peoria, IL SPONSORS: University of Illinois College of Medicine at Peoria, Peoria, IL; Meharry Medical College, Nashville, TN REGISTRATION: Ms. Nancy Hibser IRB/OPRR/FDA/Conference University of Illinois College of Medicine at Peoria One Illini Drive P.O. Box 1649 Peoria, IL 61656-1649 Telephone: (309) 671-8437 FAX: (309) 671-8513 REGISTRATION FEE: $125 ($135 after September 16, 1996) DESCRIPTION: The biomedical and behavioral research currently being conducted within academic institutions promises exciting advances in scientific knowledge, as well as unprecedented opportunities for the betterment of individual and society life. Increasingly, however, these dramatic achievements and opportunities are accompanied by scientific, ethical, regulatory, and legal intricacies, and dilemmas. Within the academic community, understanding these rapidly changing complexities is central to the Institutional Review Board's (IRB) ability to protect the rights and welfare of human research subjects while supporting scientific endeavor and its potential benefits to humankind. This conference is designed to examine a broad range of contemporary scientific, ethical, regulatory, and legal issues relating to biomedical, social behavioral, and anthropological research involving human subjects. Each of these issues will be discussed within the framework of the academic research environment, and presentations will focus on the unique challenges presented to (IRBs). Designed for both experienced and novice participants, the workshop will provide opportunities for greater depth and specificity on contemporary IRB issues. Along with sessions examining common IRB issues - including liability, informed consent, and deception - the conference will feature special focus sessions on issues related to historical perspectives, issues in mental health, the establishment, structure, and management of IRBs, computerized management information systems for the IRB office, FDA regulations for clinical trials, guidelines on inclusion of minorities and women, research involving special population, including children and elderly research subjects. Guest speakers will include representatives from OPRR: Mr. F. William Dommel, Jr., J.D., Dr. Kammal K. Mittal, and Ms. Darlene M. Ross; FDA: Dr. Gary L. Chadwick, Mr. Paul Goebel, Jr., Dr. Michael Norcross; NIMH: Dr. Andrea Baruchin. Distinguished members of the academic and clinical research community will also be present, including: Dr. Patricia Finn, St. Jude Children's Hospital at Memphis; Dr. Ernest Prentice, University of Nebraska; and co-host Dr. John Estrada, Meharry Medical College. The format will encourage audience participation and informational exchanges, with question and answer sessions throughout the program. INQUIRIES For further information regarding these workshops or future NIH/FDA National Human Subject Protections Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, Suite 3B01 - MSC 7507 Rockville, MD 20892-7507 Telephone: (301) 496-8101 x233 FAX: (301) 402-0527 Email: RossD@od6100m1.od.nih.gov $$N4 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN HL-96-017 FULL-TEXT ************************************** ETIOLOGY OF CARDIOVASCULAR COMPLICATIONS IN HIV INFECTION NIH GUIDE, Volume 25, Number 27, August 9, 1996 RFA AVAILABLE: HL-96-017 P.T. 34; K.W. 0715040, 0715008, 0755030 National Heart, Lung and Blood Institute Letter of Intent Receipt Date: February 1, 1997 Application Receipt Date: April 24, 1997 PURPOSE This solicitation is intended to foster fundamental research into the mechanisms responsible for the cardiovascular dysfunction and disease that has been seen in HIV+ patients. Investigations may be conducted on cells, tissues or whole animals, including those that have been genetically altered. The purpose is to develop understanding of the role of virus, viral proteins, immune cells, cytokine production, growth factor expression and co-infection with other pathogens in the altered function and disease manifestations of the cardiovascular system. It is anticipated that in FY 97 approximately $1.5 million total cost will be available to support four to six research project grant (R01) applications. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Etiology of Cardiovascular Complication of HIV Infection, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000," (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Dr. Constance Weinstein Division of Heart and Vascular Diseases National Heart, Lung and Blood Institute 6701 Rockledge Drive, Suite 9044, MSC 7940 Bethesda MD 20892-7940 Telephone: (301) 435-0510 FAX: (301) 480-1335 Email: WEINSTEC@GWGATE.NHLBI.NIH.GOV $$R1 END ************************************************************ $$P1 BEGIN PA-96-069 FULL-TEXT ************************************** COLLABORATIONS FOR ADVANCED STRATEGIES IN OPPORTUNISTIC INFECTIONS NIH GUIDE, Volume 25, Number 27, August 9, 1996 PA AVAILABLE: PA-96-069 P.T. 34; K.W. 0715008, 0715125, 0785035, 0745020, 0745027 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Dates: September 16, 1996; August 1, 1997; August 2, 1998 Application Receipt Dates: October 25, 1996; September 1, 1997; September 1, 1998 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) gives special consideration for funding to scientifically meritorious applications that propose research that would meet the objectives and program priorities that have been described in a Program Announcement. Program Announcements identify areas of ongoing research emphasis for the NIAID. The Opportunistic Infection Research Branch (OIRB) of the Therapeutics Research Program in the Division of AIDS (DAIDS), NIAID, invites applications for Collaborations for Advanced Strategies in Opportunistic Infections (CASOI). The purpose of this Program Announcement (PA) is to expand the clinical knowledge of opportunistic infections in people with AIDS by expediting the translation of promising innovative preclinical findings into clinical research applications. This PA announces the interest of the NIAID in supporting focused collaborative research between preclinical and clinical scientists to test, refine, and improve diagnostic, pathogenic, or therapeutic concepts leading to innovative approaches for the prevention and management of opportunistic infections (OIs) in individuals infected with HIV. This type of collaborative research would be dedicated to the expedited development and use of advanced preclinical findings into clinical applications. The opportunistic pathogens emphasized in this PA are Mycobacterium avium, Cryptosporidium parvum, and cytomegalovirus. Because the NIAID would like to fund more research in this area, the NIAID announces the intent to give special funding consideration to applications for integrated, multidisciplinary, translational research activities that use molecular or cellular approaches to: o develop and clinically validate innovative methods for detection of opportunistic infection; o elucidate the mechanisms of the human host-pathogen relationship in opportunistic infections; o develop innovative approaches to measure response to treatment in HIV-infected individuals; and/or o develop innovative strategies for the prevention or treatment of opportunistic infection. Research projects that principally encompass preclinical laboratory research are not within the area of interest of this PA, but may be within the areas of programmatic emphasis described in PA-96-068, "Innovative Drug Discovery Research in AIDS Opportunistic Infections," published in the NIH Guide, Vol 25, No. 26, August 2, 1996. Applications that include collaborations with the private sector (e.g., pharmaceutical, chemical, or biotechnological companies) are strongly encouraged. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Collaborations for Advanced Strategies in Opportunistic Infections (CASOI), is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202/512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Barbara Laughon, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2C26 - MSC 7620 Bethesda, MD 20892-7620 Rockville, MD 20852 (for express/courier service) Telephone: (301) 402-2304 FAX: (301) 402-3171 Email: barbara_laughon@nih.gov $$P1 END ************************************************************ From owner-sci-resources@net.bio.net Sun Aug 11 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-96-017 - V25(27) 08/09/96 Date: 12 Aug 1996 13:43:54 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 625 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4uo52a$3av@net.bio.net> NNTP-Posting-Host: net.bio.net ETIOLOGY OF CARDIOVASCULAR COMPLICATIONS IN HIV INFECTION NIH GUIDE, Volume 25, Number 27, August 9, 1996 RFA: HL-96-017 P.T. 34; K.W. 0715040, 0715008, 0755030 National Heart, Lung and Blood Institute Letter of Intent Receipt Date: February 1, 1997 Application Receipt Date: April 24, 1997 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THE FULL RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS AND MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE This solicitation is intended to foster fundamental research into the mechanisms responsible for the cardiovascular dysfunction and disease that has been seen in HIV+ patients. Investigations may be conducted on cells, tissues or whole animals, including those that have been genetically altered. The purpose is to develop understanding of the role of virus, viral proteins, immune cells, cytokine production, growth factor expression and co-infection with other pathogens in the altered function and disease manifestations of the cardiovascular system. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000,"a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Etiology of Cardiovascular Complications in HIV Infection, is related to the priority area of HIV Infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No.017-001-00473-1) through the Superintendent of Documents,Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under the RFA. Awards under this RFA to foreign institutions will be made only for research of very unusual merit, need, and promise, and in accordance with Public Health Service policy governing such awards. Among the disciplines and expertise that may be appropriate for this research program are cell biology, molecular biology, biochemistry, genetics, immunology, pathology, virology and physiology. MECHANISM OF SUPPORT This RFA will use the NIH individual research project grant (R01) mechanism of support. However, specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, applicant institutions, reviewers and Institute staff. For this RFA, funds must be requested in $25,000 direct cost modules and a maximum of ten modules ($250,000 direct costs) per year may be requested. A feature of the modular grant concept is that no escalation is provided for future years, and all anticipated expenses for all years of the project must be included within the number of modules being requested. Only limited budget information will be required and any budget adjustments made by the Initial Review Group will be in modules of $25,000. Instructions for completing the Biographical Sketch have also been modified. In addition, Other Support information and the application Checklist page are not required aspart of the initial application. If there is a possibility for an award, necessary Budget, Other Support and Checklist information will be requested by NHLBI staff following the initial review. The APPLICATION PROCEDURES section of the RFA provides specific details of modifications to the standard PHS 398 application kit instructions. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. FUNDS AVAILABLE It is anticipated that for fiscal year 1997, approximately $1.5 million total costs will be available for the first year of support for this initiative. Award of grants pursuant to this RFA is contingent upon receipt of such funds for this purpose. It is anticipated that approximately four to six new grants will be awarded under this program. Applicants may request up to five years of support. The specific number to be funded will, however, depend on the merit and scope of the applications received and on the availability of funds. Direct costs will be awarded in modules of $25,000 less any overlap or other necessary administrative adjustments. Indirect costs will be awarded based on the negotiated rates. RESEARCH OBJECTIVES Background The incidence of HIV-infected patients suffering cardiac complications is unknown. Estimates vary considerably, depending upon geographical location, patient population and diagnostic procedures. Conservatively, it is estimated that about six percent to seven percent of HIV-infected adult patients have clinically significant heart disease, and a larger proportion, possibly as high as 18 percent, have clinically silent abnormalities. The two most common forms of HIV-related symptomatic cardiac disease are cardiomyopathy and pericardial effusion associated with cardiac tamponade. Left ventricular dysfunction occurs in all age groups including children and appears to increase when circulating CD4 cell counts are severely depressed. Left ventricular diastolic dysfunction has been reported in asymptomatic and symptomatic patients infected with HIV. HIV-infected intravenous drug users may develop severe cardiomyopathy and congestive heart failure with less CD4 cell depression than HIV patients who do not use drugs. Autopsy studies reveal a high prevalence of lymphocytic infiltrates in the hearts of AIDS patients, even though death may have been due to causes unrelated to cardiac disease, and some of these patients were not noted to have had symptomatic cardiac disease. In a meta-analysis of 402 cases, 46 percent were found to have histological evidence of myocarditis, yet a pathogenic viral, bacterial, or fungal agent was confirmed in only one out of five cases. There has been one report of significant coronary artery lesions in eight young HIV-infected patients who were found dead in unexplained circumstances. None of these patients had a family history of hypercholesterolemia, hypertension, or diabetes. The percentages of cardiac abnormalities are much higher in children infected with HIV. In one study of 81 patients, 64 percent were noted to have resting sinus tachycardia, and 11 percent sinus bradycardia. Dysrhythmias occurred in 35 percent, cardiorespiratory arrest occurred in 9 percent and 10 percent had chronic heart failure. In 12 percent, death was associated with marked cardiac dysfunction. Taking the Public Health Service estimate of 350,000 U.S. AIDS cases by the year 2000 and assuming a 6 percent rate of development of symptomatic heart disease in adults, a total of 21,000 HIV+ patients will require specialized cardiac care. The number will be very much larger worldwide. The susceptibility of cells within the heart to infection from HIV is undefined, as are possible mechanisms of indirect effects of HIV on the cardiovascular system. Research focused on the etiology and pathophysiology of cardiac disease in these patients could lead to improved treatment strategies and prevention of the onset of cardiovascular disease. Investigations of the etiology of cardiac complications in HIV-infected patients are confounded by a variety of factors, including drug use, the large number of self-prescribed medications, problems of nutrition, intercurrent illnesses, and of course, medications prescribed by the physician. For children with vertically transmitted HIV, the aforementioned factors may have affected the in utero environment. In addition, questions remain regarding: the effects of in utero infection; the possibility of increased susceptibility of immature and growing cells of the fetus and infant to HIV infection; and abnormal expression of growth factors and cytokines. For these reasons, it is proposed to study the effects of HIV on the cardiovascular system in animal models, in terms of a direct role and of an indirect role via expression of viral proteins, dysregulation of the immune system, cytokine expression and the pathogenicity of other infectious agents. In general, the role of viruses in the etiology of cardiac disease is poorly understood. Theories include injury as a result of viral infection of cardiac cells, apoptosis, myocytolysis as a consequence of a T-cell response to virus infected myocytes, autoimmune responses which target normal and infected myocytes, and cytokine and growth factor mediated dysfunction and injury. Susceptibility to inflammation may involve a genetic component. Similar speculations have been advanced for the occurrence of cardiac disease in HIV-infected patients. Thus, study of the role of HIV in cardiac complications might well lead to an overall advance in understanding the immunopathological mechanisms of cardiac injury resulting from infection by cardiotropic viruses and provide the basis for rational therapeutic strategies. One approach to understanding some of the mechanisms of dysfunction and disease of various organs and tissues seen in AIDS patients is to examine the role of various gene products by constructing transgenic mice, possibly with cardiotropic promoters. Several attempts have been made in organs and tissues other than heart, using various strains of mice, including SCID mice. This latter model may be useful in studying the role of immunodeficiency in the development of cardiac dysfunction and as an approach to cardiac disease in pediatric patients with HIV infection. Transgenic mice containing the complete HIV coding sequences fused to the mouse mammary tumor virus long terminal repeat have been generated. These mice produce gag and env HIV proteins in organs such as mammary gland, spleen and liver. In some transgenic lines, low levels of HIV proteins could also be detected in serum. The report states that animals sacrificed at 17 months of age were indistinguishable from non-transgenic mice on macroscopic and histologic examination. Thus, it would appear that cells from various tissues in the mouse are capable of replicating retroviruses and producing HIV proteins without causing disease. However, the heart was not among the tissues examined. Transgenic mice expressing the entire HIV genome under the control of the promoter for the human neurofilament NF-L gene exhibited neuropathological changes 7 to 12 months after birth. HIV was expressed in the neurons of these mice in contrast to the findings in humans where neurons are only rarely found to be infected with HIV. However, there were parallels between the hypoactivity of these mice and the psychomotor slowing and apathy seen in the early stages of AIDS dementia. These experiments suggest that disease may be caused not by the replication of the virus but by other related factors. Of more specific relevance is the transgenic mouse constructed to investigate the pathogenesis of HIV-associated nephropathy which occurs in about 10 percent of HIV-infected patients. The mice were made transgenic for a subgenomic proviral HIV construct, pNL4-3:d1443, which lacks the gag and pol genes and is therefore non-infectious. Abnormal renal histology was noted beginning at about 35 to 45 days of age. About 20 percent of these animals developed cardiac lesions at the base of the aortic valve, an adventitial process with macrophage and neutrophil infiltrates. Vasculitis involving the coronary arteries was also observed. The interesting aspect of this proviral construct was that its expression in heart tissue could not be detected by Northern analysis, although low level expression would only be detected by more sensitive methods. However, there was increased expression of atrial natriuretic factor, a molecular marker of myocyte hypertrophy, in the ventricles of these mice. One line of these transgenic mice carrying a subgenomic HIV proviral construct lacking the gag and pol genes was found to develop proliferative epidermal lesions with some similarities to those seen in HIV-infected patients. Dermal lesions similar to Kaposi's sarcoma were not seen in this model, in contrast to those seen in an HIV LTR-tat transgenic mouse. Thus, the proteins expressed by the genes appear to play an important role in pathogenesis of skin disorders in HIV-infected patients. There have been a few reports of the detection of HIV transcripts in endomyocardial biopsies of HIV-infected patients, but the significance of these findings is unclear since the transcripts have been detected in cardiac tissues of patients with and without known cardiac dysfunction. This leads to the speculation that viral proteins, immune mechanisms and cytokine and growth factor dysregulation might be implicated in the pathogenesis of cardiac dysfunction. It is possible that host genetic susceptibility may also play a role since it has been shown that, in mice infected with CVB3, macrophage inflammatory protein (MIP-l-alpha) is an absolute requirement for development of myocarditis. It is also possible that the constant, repeated cycles of viral replications lead to mutations with differential pathogenic effects which result in neurologic, kidney, or heart disease, or cancer. While some studies may be performed on cells, organs or whole animals, many will require the development and exploitation of transgenic animal models which could contribute to knowledge of the pathogenesis of cardiac complications in patients with HIV infection. However, because the presence of virus or viral proteins in a tissue does not necessarily induce dysfunction or disease and because cardiac dysfunction can occur in the absence of gross abnormalities it is important to evaluate these animals in terms of physiologic function and pathology of the cardiac disorders. Although not yet applied to the study of HIV-associated cardiac disorders, it has been demonstrated recently that microsurgical techniques can be used to study systolic and diastolic abnormalities that occur in transgenic mice. The use of such techniques has provided valuable mechanistic information regarding adrenergic signaling and calcium handling mechanisms that regulate ventricular function in vivo. These experiments suggest that similar approaches could be used to study relevant issues of ventricular dysfunction associated with HIV infection. Research Objectives and Scope The following items are provided as examples only. Applicants are urged to consider other projects within the scope of this solicitation based on their knowledge of the field and their expertise. Development of animal models is encouraged but preliminary data must be provided to indicate that the model will have relevance to the research requested. o Interaction of viral proteins with cardiovascular cells and the effects on cardiac function in HIV infection o Examination of circulating antibodies for cross-reactivity with cardiac tissue in HIV infection o Elucidation of the role of endothelium in the cardiovascular complications of HIV infection o Role of the immune system and cytokine production in the etiology of cardiac dysfunction in HIV infection o Evaluation of ventricular function and myocyte contractility in transgenic mice that exhibit neuropathologic changes in HIV-related studies o Investigations in cell culture and whole heart of the mechanisms whereby HIV infection perturbs the contractile function of the myocardium o Identification of the mechanisms whereby HIV mediates disorders of impulse generation, conduction and EC coupling o Investigations of the alterations of gene expression of cardiac contractile proteins, calcium regulatory proteins, and markers of ventricular hypertrophy such as ANF in HIV-related complications o The role of coinfection with other pathogens, such as cytomegalovirus, which have been implicated in HIV cardiomyopathy. SPECIAL REQUIREMENTS Upon initiation of the program, the NHLBI will sponsor periodic meetings to encourage exchange of information among investigators who participate in this program. Travel funds for a one day meeting each year, most likely to be held in Bethesda, Maryland should be included in the modules. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by February 1, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NHLBI 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. C. James Scheirer Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7220, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0266 FAX: (301) 480-3541 Email: James_Scheirer@NIH.GOV APPLICATION PROCEDURES The research grant application form PHS 398 (rev.5/95) is to be ujsed in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained >From the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The RFA label available in the application kit must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application and three signed, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to Dr. C. James Scheirer, at the same address given above in the section on LETTER OF INTENT. Sample budgets and justification page will be provided upon request or following the submission of a letter of intent. BUDGET INSTRUCTIONS The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD Do not complete Form Page 4 of the PHS 398 (rev 5/95). It is not required nor will it be accepted at the time of application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT Do not complete the categorical budget tables on Form page 5 of the PHS 398 (rev. 5/95). Only the requested total direct costs line for each year must be completed based on the number of $25,000 modules being requested. Applicants may not request a change in the amount of each module. A maximum of ten modules ($250,000 direct costs) per year may be requested and each applicant may request up to five years of support for this RFA. Direct cost budgets will remain constant throughout the life of the project (i.e., the same number of modules requested for all budget periods). Any necessary escalation should be considered when determining the number of modules to be requested. However, in the event that the number of modules requested must change in any future year due to the nature of the research proposed, appropriate justification must be provided. Total Direct Costs for the Entire Proposed Project Period should be shown in the box provided. o BUDGET JUSTIFICATION Budget justifications should be provided under "Justifications" on Form Page 5 of the PHS 398. List the names, role on the project and proposed percent effort for all project personnel (salaried or unsalaried) and provide a narrative justification for each person based on his/her role on the project. Identify all consultants by name and organizational affiliation and describe the services to be performed. Provide a general narrative justification for individual categories (equipment, supplies, etc.) required to complete the work proposed. More detailed justifications should be provided for high cost items. Any large one-time purchases, such as large equipment requests, must be accommodated within these limits. o CONSORTIUM/CONTRACTUAL COSTS - If collaborations or subcontracts are involved that require transfer of funds from the grantee to other institutions, it is necessary to establish formal subcontract agreements with each collaborating institution. A letter of intent >From each collaborating institution should be submitted with the application. Only the percentage of the consortium/contractual TOTAL COSTS (direct and indirect) relative to the total DIRECT COSTS of the overall project needs to be stated at this time. The following example should be used to indicate the percentage cost of the consortium, "The consortium agreement represents 27% of overall $175,000 direct costs requested in the first year.". A budget justification for the consortium should be provided as described in the "Budget Justification" section above (no Form Page 5 required for the consortium). Please indicate whether the consortium will be in place for the entire project period and identify any future year changes in the percentage relative to the parent grant. If there is a possibility for an award, the applicant will be requested to identify actual direct and indirect costs for all years of the consortium. Please note that total subcontract costs need not be calculated in $25,000 modules. However, when subcontract funds are added to the parent grant budget, the total direct cost amount must be included in the number of $25,000 modules requested. o BIOGRAPHICAL SKETCH - A biographical sketch is required for all key personnel, following the modified instructions below. Do not exceed the two-page limit for each person. Complete the educational block at the top of the form page; List current position(s) and those previous positions directly relevant to the application; List selected peer-reviewed publications directly relevant to the proposed project, with full citation; The applicant has the option to provide information on research projects completed and/or research grants participated in during the last five years that are relevant to the proposed project. o OTHER SUPPORT - Do not complete the "Other Support" pages (Form Page 7). Selected other support information relevant to the proposed research may be included in the Biographical Sketch as indicated above. Complete Other Support information will be requested by NHLBI staff if there is a possibility for an award. o CHECKLIST - No "Checklist" page is required as part of the initial application. A completed Checklist will be requested by NHLBI staff if there is a possibility for an award. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Applications not conforming to these guidelines will be considered unresponsive to this RFA and will be returned without further review. Applications must be received by April 24, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer-review group convened by the NHLBI in accordance with NIH peer-review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Heart, Lung, and Blood Advisory Council. The personnel category will be reviewed for appropriate staffing based on the requested percent effort. The direct costs budget request will be reviewed for consistency with the proposed methods and specific aims. Any budgetary adjustments recommended by the reviewers will be in $25,000 modules. The duration of support will be reviewed to determine if it is appropriate to ensure successful completion of the requested scope of the project. Other review criteria will include: o scientific, technical or medical significance and originality of proposed research o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research o availability of the resources necessary to perform the research. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: quality of the proposed project as determined by peer-review, availability of funds, and program priority. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Constance Weinstein Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 9044, MSC 7940 Bethesda, MD 20892-7940 Telephone: (301) 435-0510 FAX: (301) 480-1335 Email: WEINSTEC@GWGATE.NHLBI.NIH.GOV Direct inquiries regarding fiscal matters to: Mr. William Darby Grants Operations Branch National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 7128, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0177 FAX: (301) 480-3310 Email: DARBYW@GWGATE.NHLBI.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.837. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants' policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun Aug 11 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-069 - V25(27) 08/09/96 Date: 12 Aug 1996 13:44:08 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 617 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4uo52o$3bk@net.bio.net> NNTP-Posting-Host: net.bio.net COLLABORATIONS FOR ADVANCED STRATEGIES IN OPPORTUNISTIC INFECTIONS NIH GUIDE, Volume 25, Number 27, August 9, 1996 PA NUMBER: PA-96-069 P.T. 34; K.W. 0715008, 0715125, 0785035, 0745020, 0745027 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Dates: September 16, 1996; August 1, 1997; August 2, 1998 Application Receipt Dates: October 25, 1996; September 1, 1997; September 1, 1998 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) gives special consideration for funding to scientifically meritorious applications that propose research that would meet the objectives and program priorities that have been described in a Program Announcement. Program Announcements identify areas of ongoing research emphasis for the NIAID. The Opportunistic Infection Research Branch (OIRB) of the Therapeutics Research Program in the Division of AIDS (DAIDS), NIAID, invites applications for Collaborations for Advanced Strategies in Opportunistic Infections (CASOI). The purpose of this Program Announcement (PA) is to expand the clinical knowledge of opportunistic infections in people with AIDS by expediting the translation of promising innovative preclinical findings into clinical research applications. This PA announces the interest of the NIAID in supporting focused collaborative research between preclinical and clinical scientists to test, refine, and improve diagnostic, pathogenic, or therapeutic concepts leading to innovative approaches for the prevention and management of opportunistic infections (OIs) in individuals infected with HIV. This type of collaborative research would be dedicated to the expedited development and use of advanced preclinical findings into clinical applications. The opportunistic pathogens emphasized in this PA are Mycobacterium avium, Cryptosporidium parvum, and cytomegalovirus. Because the NIAID would like to fund more research in this area, the NIAID announces the intent to give special funding consideration to applications for integrated, multidisciplinary, translational research activities that use molecular or cellular approaches to: o develop and clinically validate innovative methods for detection of opportunistic infection; o elucidate the mechanisms of the human host-pathogen relationship in opportunistic infections; o develop innovative approaches to measure response to treatment in HIV-infected individuals; and/or o develop innovative strategies for the prevention or treatment of opportunistic infection. Research projects that principally encompass preclinical laboratory research are not within the area of interest of this PA, but may be within the areas of programmatic emphasis described in PA-96-068, "Innovative Drug Discovery Research in AIDS Opportunistic Infections," published in the NIH Guide, Vol 25, No. 26, August 2, 1996. Applications that include collaborations with the private sector (e.g., pharmaceutical, chemical, or biotechnological companies) are strongly encouraged. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Collaborations for Advanced Strategies in Opportunistic Infections (CASOI), is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202/512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local government, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT A request for up to five years of support in an application for a ~traditional~ research project grant (R01) will be considered if the proposed research would help meet the objectives of this PA. At this time, the NIAID has not determined whether or how this solicitation will be continued beyond the three annual receipt dates of this PA. Prior approval by NIAID program staff must be obtained before submitting an application that requests direct costs of $500,000 or more for any budgetary year (see APPLICATION PROCEDURES). RESEARCH OBJECTIVES Background HIV-infected persons experience progressive immunological deterioration and are subject to life-threatening disease caused by a variety of viruses, fungi, bacteria, and protozoa that, in the normal human host, are either nonpathogenic or cause only minor, limited infection. Such opportunistic infections (OIs) are a clinical hallmark of advanced HIV disease and are the primary cause of the morbidity and mortality associated with AIDS. Progress in the prevention, detection, and management of OIs is essential to improve the health status and quality of life of HIV- infected persons. Advances in this area, though, are limited by incomplete knowledge of the pathogenesis and clinical course during HIV infection, as well as inadequate knowledge about the HIV-induced immune defects that render infected persons unable to prevent or overcome diseases caused by these organisms. Therapeutic interventions are limited by inadequate information about the molecular or antigenic targets upon which the rational design of new therapies could be based. Finally, methods for diagnosis and treatment assessment are limited, complex, and expensive, which hinders the assessment and measurement of treatment responses in patients with several OIs. Advancing this knowledge base requires the collaboration of several disciplines such as clinical investigation, microbiology, immunology, molecular biology, pharmacology, and others. A coordinated multidisciplinary effort involving laboratory-based scientists and clinical investigators exploring focused questions should facilitate rapid advancement and lead to the development of innovative approaches to the diagnosis and treatment of these OIs. Such approaches may have a more than average risk-to-benefit ratio, but are likely to have greater potential for effective, long-term therapeutic returns. The Division of AIDS/NIAID supports a range of preclinical and clinical research in opportunistic infections: the National Cooperative Drug Discovery Group for the Treatment of Opportunistic Infections In AIDS, research project grants, screening contracts, animal model contracts, the AIDS Clinical Trials Group, and the Terry Beirn Community Program for Clinical Research in AIDS. While scientific exchange occurs among these disciplines and groups, funding opportunities for prospective multidisciplinary research are infrequent. The intent of this PA is to encourage research that bridges the gap between preclinical and clinical scientists, encouraging clinically focused collaborative research and allowing refinement and proof-of-concept of innovative strategies leading to effective clinical applications. Research Objectives and Scope This PA announces the interest of the NIAID in encouraging and supporting the advanced preclinical research and clinical proof-of- concept strategies needed to more effectively combat the opportunistic infections caused by human cytomegalovirus, Mycobacterium avium, or Cryptosporidium parvum. This PA encourages laboratory-based scientists and clinical investigators collaboratively to design and propose multi-component research that has a common thematic goal for which advanced preclinical data exist. This will entail iterative research and information exchange between preclinical and clinical studies in order to refine and improve matters such as the following: o molecular approaches to readily detect critical opportunistic infections in humans, o identification of human host factors contributing to infection (e.g., defects in immune response), and o methods of assessing response to treatment. If appropriate to the research aims of the applicant group, projects may include the implementation of proof-of-concept clinical trials of innovative therapeutic strategies. It is envisioned that feedback >From the patient care setting will validate hypotheses of pathogen- host relationships, direct refinement of quantitative assessment methodologies needed for advancement of care, or foster design of improved therapeutic strategies. Areas of special interest include, but are not limited to: A. Elucidation of immune responses to the infection occurring in HIV-infected individuals, such as specific humoral and cellular responses, and identification of features of immune dysregulation, such as cytokine abnormalities, humoral factors, and effector cell defects that promote infection. B. Elucidation of pathogenic mechanisms of the organism in HIV- infected individuals, and identification of molecular targets that can be exploited in innovative therapeutic approaches. C. Clinical evaluation of methods for early detection of infection and quantitative assessment of response to therapy in inaccessible infections (e.g., quantitative PCR, surrogate markers). D. Evaluation of innovative therapeutic strategies (e.g., immune- based therapies, gene-based approaches) and preliminary clinical testing, with modifications as necessary based on clinical research findings. Applicants are encouraged to focus on one infectious organism and to link several research objectives from basic research laboratories, clinical centers, and the private sector. All proposed studies should carefully consider the ultimate potential for clinical application. Examples of the types of projects to study the pathogens emphasized by this PA include, but are not limited to, the following: o Characterization of organism/infected cell interactions at various stages of HIV immunodeficiency for one of the targeted infections. o Evaluation of the role of cytokines and immune effector cells in the pathogenesis of infection caused by Cryptosporidium parvum in AIDS. o Advanced testing of convenient methods to quantify total parasite burden of Cryptosporidium parvum (in contrast to methods relying on cyst quantitation in stool samples). o Evaluation of drug delivery and distribution to intestinal and extra-intestinal sites for the treatment of Cryptosporidium parvum disease in HIV-infected persons. o Identification of immunological correlates of human CMV viral proliferation; development and testing of diagnostic or immunologic markers to facilitate identification of patients at high risk of CMV disease or to provide improved quantitative indicators of response to treatment. o Characterization of M. avium pathogenic mechanisms and associated control of gene expression in individuals with HIV-infection; identification of potential targets for innovative therapeutic approaches (e.g., gene-based therapies); evaluation of novel delivery systems to intracellular sites. o Identification of M. avium-specific defects in the response of HIV-infected hosts (e.g. T-cell and macrophage function, T cell- macrophage interaction); and identification of M. avium antigens associated with protective immune responses. SPECIAL REQUIREMENTS A. Terms and Conditions of Award The following terms and conditions will be incorporated into the Notice of Grant Award and provided to the Principal Investigator as well as the institutional official at the time of award. These terms and conditions are a reiteration of and in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 [Part 92 is applicable when State and local Governments are eligible to apply], and other HHS, PHS, and NIH grant administration policies. All clinical trials involving human subjects must be reviewed and approved by the Clinical Science Review Committee, DAIDS, NIAID prior to implementation. Clinical and laboratory leadership will be expected to attend an annual meeting with NIAID program staff in Bethesda, MD to review progress and share information among awardees. B. Patent Coverage Because the development and availability of innovative, effective strategies for the clinical management of OIs is the principal goal of this PA, and because active involvement by the private sector is facilitated by the existence of adequate patent coverage, it is essential that applicants provide plans to ensure such coverage. Since several institutions may be involved in this collaborative research, complex patent situations may arise. Each applicant must therefore provide a detailed description of (1) the approach to be used for obtaining patent coverage and for licensing where appropriate, in particular where the invention may involve investigators from more than one institution; and (2) the procedures to be followed for the resolution of legal problems that potentially may develop. Attention is drawn to the reporting requirements of 35 U.S.C. Parts 200-212 and 37 CFR Part 401 or FAR 55.227-11. Instructions were also published in the NIH Guide for Grants and Contracts, Vol. 19, No. 23, June 22, 1990. Note that non-profit organizations (including universities) and small business firms retain the rights to any patent resulting from Government contracts, grants or Cooperative Agreements. It is also noted that a Presidential memorandum of February 18, 1983 extended to all business concerns, regardless of size, the first option to the ownership of rights to inventions as provided in P.L. 96-517. As a result of this memorandum, the relationships among industrial organizations and other participants are simplified, since all members can now be full partners in the research and in any inventions resulting therefrom. The specific patenting arrangements among the institutions may vary, and could include joint patent ownership, exclusive licensing arrangements, etc. Applicants are encouraged to develop an arrangement that is most suitable for their own particular circumstances. The patent agreement among the collaborating institutions, signed and dated by the organizational officials authorized to enter into patent arrangements for each investigator and institution, must be delivered to Dr. Barbara Laughon prior to an award at the address listed under INQUIRIES. A copy of the proposed patent agreement may be submitted with the application. If the collaborators wish to place all inventions and discoveries resulting from these studies within the public domain, a letter to that effect must be submitted to Dr. Laughon in lieu of the patent agreement prior to award. The letter must be co-signed by the Principal Investigator, each investigator, and each of the business officials representing the respective institutions. Federal regulation clause 37-CFR-401 and HHS Inventions regulations at 45 CFR Parts 6 and 8 require that NIH be informed of inventions and licensing occurring under NIH funded research. Invention and licensing reports must be submitted to the Division of Extramural Invention and Technology Resources, Office of Extramural Research, NIH, 6701 Rockledge Drive, Room 3188, Bethesda, MD 20892. C. Federally Mandated Regulatory Requirements The CASOI must be in compliance with all Federal regulations and NIH policies that apply to the conduct of research involving human subjects. These include, but are not limited to, Title 21 CFR 50, 56, 312, and Title 45 CFR 46. The CASOI must be able to demonstrate that: (1) each institution conducting CASOI trials has a current, approved Assurance Number on file with the NIH Office for Protection >From Research Risks (OPRR); (2) each protocol and informed consent is approved by the responsible Institutional Review Board (IRB) prior to subject entry; (3) each investigator has supplied a completed (including curriculum vitae) FDA 1572 to Division of AIDS for each protocol conducted at each site; and (4) each subject (or legal representative) gives written informed consent prior to entry on study. The CASOI must assure timely reporting of all serious and unexpected toxicities and adverse experiences to the IND sponsor with concurrent notification to the NIAID Scientific Coordinator if the IND sponsor is other than Division of AIDS. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, and the number and title of this PA. The annual receipt dates for the letter of intent are shown at the top of this PA. 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 DRG and 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. Dianne Tingley at the address listed under INQUIRIES. APPLICATION PROCEDURES Applicants are strongly encouraged to call NIAID program staff with any questions regarding whether or not their proposed project is within the scope of the programmatic area of emphasis described in this PA. Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Applications kits are available at most institutional offices of sponsored research and through the NIH web site (http://www.nih.gov). If the application kit cannot be obtained >From either of those sources, contact ASKNIH, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. Because of the relatively broad and potentially complex nature of research encouraged, applications that include consortium/contractual arrangements should fully explain the programmatic research, fiscal, and administrative arrangements in section (h) of the research plan. The description of consortium arrangements should follow the outline in "Guidelines for Establishing and Operating Consortium Grants, January 1989," available from the individuals listed under INQUIRIES. 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. Applicants from an institution receiving government funds under Center for AIDS Research (CFAR), AIDS Clinical Trial Unit (ACTU), AIDS Vaccine Evaluation Unit (AVEU), DATRI, and CPCRA programs, should describe how these programs are integrated with the proposed studies, if applicable, and ensure that no scientific and budget overlap exists with the proposed project. The National Institute of Dental Research (NIDR) also has an interest in the basic biology, biochemistry, pathophysiology, diagnosis, prevention and treatment of opportunistic pathogens; in particular, how these organisms interact with host tissues and defense mechanisms in the oral cavity. Applications that are of mutual interest to NIAID and NIDR are likely to be given a secondary assignment to NIDR in accordance with the NIH referral guidelines. The NIH Policy Update on Acceptance for Review of Unsolicited Applications that Request More Than $500,000 Direct Cost for Any One Year applies to applications in response to this Program Announcement. The Policy update was published in the NIH Guide, Vol. 25, No. 14, May 3, 1996, and is effective June 1, 1996. An application that proposes research within the programmatic areas described by this PA must be identified by "YES" and the number and title of this program announcement in section 2 of the face page of the application. This will facilitate the assignment of the application by the Referral Office. However, the fundamental factor upon which the assignment will be based is the content of the proposed research. The completed original and four legible, single-sided copies of the application and four sets of the appendices must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) At the same time, one complete copy of the application and appendices must be sent or delivered to: Dianne Tingley, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C07 6003 Executive Boulevard Bethesda, MD 20892-7610 Rockville, MD 20852 (for express/courier service) REVIEW CONSIDERATIONS Review Procedures Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants (DRG). Incomplete applications will be returned to the applicant without further consideration. Applications that are complete will be assigned, based on the content of the proposed research, the PHS Referral Guidelines, and the elaboration of those guidelines set forth by this PA. Applications for research topics that are not within the areas described by this PA will be assigned and reviewed according to standard procedures. Applications that propose research that is within the scope described by this PA will be assigned to a peer review group convened by DRG and NIAID. Each application will be evaluated for scientific and technical merit by in accordance with the review criteria for research project grant applications. These criteria and an elaboration of the meaning thereof in the context if this area of interest are stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. The assignment for funding consideration and the second level of review for applications that propose research within the areas of emphasis described by this PA will be the National Institute of Allergy and Infectious Diseases. Review Criteria o scientific, technical, or medical significance and originality of the proposed research, specifically including relevance of study objectives to advancing the prevention, diagnosis, or treatment of opportunistic infections in HIV infected persons and the likelihood that innovative and potentially practical strategies will be identified during the course of the proposed project; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research, specifically including assessment of the clinical and basic components in terms of the incorporation of state-of-the-art approaches and methodologies of the proposed project towards the attainment of the stated programmatic goals; cohesiveness, multi-disciplinary and multifaceted scope of the application and the coordination and interdependence of all proposed components to the common theme; o qualifications and research experience of the Principal Investigator and collaborators, particularly, but not exclusively, in the area of the proposed research, as well as the leadership, and administrative competence of the Principal Investigator for the development, implementation, and management of the research program, and the Principal Investigator's commitment to devote sufficient time and effort to the project; and the qualifications, experience, and commitment of all other investigators, including their ability to devote adequate time and effort to the project; o availability of the resources necessary to perform the research, particularly the soundness of the administrative and organizational structure that facilitates attainment of the project objectives, including the administrative planning and leadership capability to provide for internal quality control of on-going research, allocation of funds, day-to-day management, internal communications and cooperation among the investigators involved in the project. o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. Concerns expressed by the initial review group about any of these factors may influence the recommendation of the National Advisory Allergy and Infectious Diseases Council. AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications. The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance among research areas of the announcement, and availability of funds. The National Institute of Allergy and Infectious Diseases gives special consideration for funding to scientifically meritorious applications that propose research in the areas of programatic emphasis described in PAs issued by the NIAID. 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: Barbara Laughon, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2C26 - MSC 7620 Bethesda, MD 20892-7620 Rockville, MD 20852 (for express/courier service) Telephone: (301) 402-2304 FAX: (301) 402-3171 Email: barbara_laughon@nih.gov Direct inquiries regarding fiscal and administrative matters to: Ms. Jane Unsworth Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4B22 - MSC 7610 Bethesda, MD 20892-7610 Rockville, MD 20852 (for express/courier service) Telephone: (301) 402-6824 FAX: (301) 480-3780 Email: jane_unsworth@nih.gov Direct inquiries regarding application preparation and review, the letter of intent and ONE copy of the completed application to: Dianne Tingley, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4C07 - MSC 7610 Bethesda, MD 20892-7610 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-2550 FAX: (301) 402-2638 Email: dt15g@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.855, Immunology, Allergic and Immunological Diseases Research, and 93.856, Microbiology and Infectious Diseases Research. Grants are awarded under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grants policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of the Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun Aug 11 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 10 August 1996 Date: 12 Aug 1996 14:03:29 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 92 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4uo671$5bb@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending August 10, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Press Release Title: SCIENTISTS STUDY UNDERSEA VOLCANO DURING EARTHQUAKE (SWARM) File size (bytes): 3389 STIS Filename: pr9639.txt Title: NSF AWARDS $16.8 MILLION TO STUDY HUMAN DIMENSIONS OF GLOBAL CHANGE File size (bytes): 4272 STIS Filename: pr9640.txt Document Type: Program Guideline Title: NSF 96-118 - SHEBA - Surface HEat Budget of the Arctic Ocean, Phase 2 File size (bytes): 24671 STIS Filename: nsf96118.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 113968 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 125372 STIS Filename: phnorg.txt Document Type: Press Release Title: NSF AWARDS $16.8 MILLION TO STUDY HUMAN DIMENSIONS OF GLOBAL CHANGE File size (bytes): 4272 STIS Filename: pr9640.txt Document Type: Program Guideline Title: NSF 96-115 Faculty Early Career Development (CAREER) Program Guidelines File size (bytes): 31539 STIS Filename: nsf96115.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf96115.txt, the text of your message should be as follows: get nsf96115.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf96115.txt, you would enter: ftp> get nsf96115.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Thu Aug 15 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 28, pt. 1of1, 16 August 1996 Date: 15 Aug 1996 17:44:40 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 587 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4v0g9o$eph@net.bio.net> NNTP-Posting-Host: net.bio.net X-comment: RFAs described: AG-97-001, PA-96-070 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.08.16 NIH GUIDE - Vol. 25, No. 28 - August 16, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIH GUIDE PUBLICATION DATES $$INDEX N2 ********************************************************** RECEIPT DATE FOR ENVIRONMENTAL HEALTH SCIENCES CORE CENTER GRANTS PROGRAM National Institute of Environmental Health Sciences INDEX: ENVIRONMENTAL HEALTH SCIENCES $$INDEX N3 ********************************************************** EXTENSION OF COOPERATIVE AGREEMENTS: WOMEN AND INFANTS TRANSMISSION STUDY National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute of Drug Abuse INDEX: ALLERGY, INFECTIOUS DISEASES; CHILD HEALTH, HUMAN DEVELOPMENT; DRUG ABUSE $$INDEX N4 ********************************************************** REMINDERS FROM THE REFERRAL OFFICE, DIVISION OF RESEARCH GRANTS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N5 ********************************************************** REVISED GUIDE FOR THE CARE AND USE OF LABORATORY ANIMALS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** NATIONAL EPIDERMOLYSIS BULLOSA REGISTRY (RFP NIH-NIAMS-97-1) National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES $$INDEX R2 ********************************************************** NIDCD HEREDITARY HEARING IMPAIRMENT RESOURCE REGISTRY (RFP NIH-DC-96-03) National Institute on Deafness and Other Communication Disorders INDEX: DEAFNESS, OTHER COMMUNICATION DISORDERS $$INDEX R3 12/10/96 ************************************************* MINORITY DISSERTATION RESEARCH GRANTS IN AGING (RFA AG-97-001) National Institute on Aging INDEX: AGING $$INDEX P1 ********************************************************** CHRONIC FATIGUE SYNDROME PATHOPHYSIOLOGY (PA-96-070) National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Mental Health National Heart, Lung, and Blood Institute National Institute of Environmental Health Sciences National Institute of Nursing Research National Institute of Diabetes and Digestive and Kidney Diseases Office of Research on Women's Health INDEX: ALLERGY, INFECTIOUS DISEASES; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; MENTAL HEALTH; HEART, LUNG, BLOOD; ENVIRONMENTAL HEALTH SCIENCES; NURSING RESEARCH; DIABETES, DIGESTIVE, KIDNEY DISEASES THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** THE NIH GUIDE FOR GRANTS AND CONTRACTS WILL NOT BE PUBLISHED ON AUGUST 23, 1996. THE NEXT ISSUE WILL BE ON AUGUST 30, 1996 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** RECEIPT DATE FOR ENVIRONMENTAL HEALTH SCIENCES CORE CENTER GRANTS PROGRAM NIH GUIDE, Volume 25, Number 28, August 16, 1996 P.T. 34; K.W. 1014006, 0725000 National Institute of Environmental Health Sciences This Notice is to remind potential applicants that the receipt date for applications for the National Institute of Environmental Health Sciences (NIEHS) Core Center Grants Program is February 1 each year. NIEHS Core Center Grants provide support for an administrative structure, scientific leadership, and shared equipment to multidisciplinary groups of productive scientists with programs in environmental health. Direct research support is NOT provided by the grant, except for limited funds for pilot projects. The NIEHS currently supports nineteen Environmental Health Sciences (EHS) and five Marine and Freshwater Biomedical Sciences (MFBS) Centers. Because of limitations on the number of centers that can be supported and the special nature of the program, potential applicants are strongly urged to contact NIEHS staff to discuss the scope, content, size, and timing of any applications for this program. Applications received for the February 1, 1997 receipt date will compete with two extant EHS Core Centers for funding early in Fiscal Year 1998. Applications having a research program focused on environmentally related health problems of underserved and/or economically disadvantaged populations are particularly encouraged. INQUIRIES Guidelines for this program, including fiscal limitations, review criteria, and additional information are available from: Dr. Allen Dearry Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, 104 Alexander Drive, MD 3 04 Research Triangle Park, NC 27709 Telephone: (919) 541 4500 FAX: (919) 541 2843 Email: dearry@niehs.nih.gov $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** EXTENSION OF COOPERATIVE AGREEMENTS: WOMEN AND INFANTS TRANSMISSION STUDY NIH GUIDE, Volume 25, Number 28, August 16, 1996 P.T. 34, AA, II; K.W. 0715008, 0715125, 0785055, 0745020 National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute of Drug Abuse The National Institute of Allergy and Infectious Diseases (NIAID) has an active interest in the support of research projects addressing epidemiologic, etiologic, and pathogenetic patterns and trends in HIV infection and AIDS in various population groups. Studies are currently supported that focus on minorities, children, mothers and infants, women, and men. One group of these studies is the Women and Infants Transmission Study (WITS), which was initiated in 1988 and is currently supported through cooperative agreements. In addition to the NIAID, the National Institute of Child Health and Human Development (NICHD) and the National Institute of Drug Abuse (NIDA) support awards in WITS. Because the current awardees have unique access to the study cohorts, study data, and study specimens and have unique expertise with respect to the integration of these elements, the NIAID, NICHD, and NIDA intend to invite applications for competitive renewal of these studies through a competition limited to the current awardees only. Although competition for this cooperative agreement study extension is limited, NIAID wishes to call attention to its ongoing interest in applications for prospective studies related to the etiology, pathogenesis, prevention, diagnosis, and treatment of HIV infection and its sequelae. INQUIRIES For further information contact: Mary Glenn Fowler, M.D., M.P.H Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2A09 Bethesda, MD 20892 Telephone: (301) 496-6177 FAX: (301) 402-1506 Email: mf25c@nih.gov $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** REMINDERS FROM THE REFERRAL OFFICE, DIVISION OF RESEARCH GRANTS NIH GUIDE, Volume 25, Number 28, August 16, 1996 P.T. 34; K.W. 1014006 National Institutes of Health The Referral Office reminds applicants of specific requirements for applications for the following types of award: INTERACTIVE RESEARCH PROJECT GRANTS (PA-96-001, NIH Guide, Vol. 24, No. 35, October 6, 1995) All component applications for a set of Interactive Research Project Grants (IRPG) are to be submitted in one package. The receipt dates for investigator-initiated applications for a set of IRPGs are October 15, February 15, and June 15. These are the receipt dates, even if some or all of the component applications are revised (amended) or for competing continuation awards. Applications for IRPG support of AIDS and AIDS-related research have receipt dates of September 1, January 2, and May 1. FELLOWSHIPS (F-series) (NIH Guide, Vol. 23, No. 15, April 15, 1994 and Vol. 25, No. 2, February 2, 1996) Effective with the December 5, 1996 receipt date, all applications for fellowships must be submitted on the 8/95 revision of PHS 416-1. RESEARCH CAREER AWARDS (K-series) (PA-95-049, PA-95-050, PA-95-051, PA-95-052, PA-95-053, PA-95-054, NIH Guide, Vol. 24, No. 15, April 28, 1995) Line 2 of the face page of an application (PHS 398, rev. 5/95) for a Research Career Award (K-series) must be filled is as follows: "Yes" should be checked, followed by the appropriate K-series number and title. INQUIRIES For additional information about preparing an application for any of the awards above, contact a program official listed in the appropriate Program Announcement. $$N4 END ************************************************************ $$N5 BEGIN ********************************************************** REVISED GUIDE FOR THE CARE AND USE OF LABORATORY ANIMALS NIH GUIDE, Volume 25, Number 28, August 16, 1996 P.T. 34; K.W. 0201011, 1014003 National Institutes of Health The Institute of Laboratory Animal Resources (ILAR) of the National Academy of Sciences has published the 1996 revision of the Guide for the Care and Use of Laboratory Animals. This is the sixth revision of the Guide for the Care and Use of Laboratory Animals since the original was first published in 1963. The purpose of this publication is to assist institutions in caring for and using animals in ways judged to be scientifically, technically, and humanely appropriate, and to assist investigators in fulfilling their obligation to plan and conduct animal experiments in accord with the highest scientific, humane, and ethical principles. The recommendations of the Guide for the Care and Use of Laboratory Animals are based on published data, scientific principles, expert opinion, and experience with methods and practices that have proven to be consistent with high-quality, humane animal care and use. The 1996 edition includes extensive references and differs from previous editions by an increasing emphasis on performance goals as opposed to engineering standards. This edition of the Guide for the Care and Use of Laboratory Animals was financially supported by NIH, the U.S. Department of Agriculture, and the Department of Veterans Affairs. It is published by the National Academy Press. The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals requires that institutions receiving PHS support for activities involving animals base their programs of animal care and use on the Guide for the Care and Use of Laboratory Animals and comply, as applicable, with the Animal Welfare Act and other Federal statutes and regulations relating to animals. PHS-assured institutions are encouraged to begin implementing the 1996 revision of the Guide for the Care and Use of Laboratory Animals as soon as possible. By July 31, 1997, all PHS-assured institutions are expected to have conducted at least one semiannual program and facility evaluation, complete with reasonable and specific plans and schedules for corrections of deficiencies where appropriate, using the 1996 Guide for the Care and Use of Laboratory Animals as the basis for evaluation. Copies of the Guide for the Care and Use of Laboratory Animals are available from the Office for Protection from Research Risks (OPRR) at (301) 496-7163, ext. 226; ILAR (202) 334-2590; and the National Center for Research Resources, NIH (301) 435-0744. It is also available on the world wide web at http://www2.nas.edu/ilarhome/. INQUIRIES For additional information contact: Sue Machado Division of Animal Welfare Office for Protection from Research Risks 6100 Executive Boulevard, Suite 3B01, MSC 7507 Rockville, MD 20892-7507 Telephone: (301) 496-7163, ext. 234 FAX: (301) 402-2803 $$N5 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NIH-NIAMS-97-1 ******************************************* NATIONAL EPIDERMOLYSIS BULLOSA REGISTRY NIH GUIDE, Volume 25, Number 28, August 16, 1996 RFP AVAILABLE: NIH-NIAMS-97-1 P.T. 34; K.W. 0780030 National Institute of Arthritis and Musculoskeletal and Skin Diseases The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is seeking proposals for the continuation of a National Epidermolysis Bullosa Registry. The Registry will be aimed at searching for the basic defect, improving methods of diagnosis, and developing effective methods in treatment and prevention and shall be continued to: a. Develop a roster of well-characterized patients with the different forms of Epidermolysis Bullosa (EB). Selected patients will be requested to contribute specimens and to be followed as part of diagnostic, research, and in some cases, therapeutic protocols. b. Determine with accuracy and precision the incidence and prevalence of disease by clinical genetic type in a sufficiently broad geographic region to permit extrapolation of data to the United States as a whole. c. Increase information on genetics, particularly family patterns or sporadic occurrence of disease, including penetrance and severity d. Assess disease distribution geographically, to search for clusters and patterns and assess the societal and economic impact of the disease e. Develop a pool of patients of the same genetic type for a wide variety of studies on pathogenesis and genetics of EB, including support for the banking of appropriate tissue specimens. f. Foster and support well-designed and well-executed clinical trials of new therapeutic interventions in carefully selected groups of patients with one or another form of EB. INQUIRIES The Government anticipates awarding one cost-reimbursement contract as a result of this solicitation. RFP NIH-NIAMS-97-1 will be available on or about August 15, 1996 and proposals will be due on or about October 15, 1996. This advertisement does not commit the Government to award a contract. To receive a copy of the RFP, this office with two self-addressed mailing labels. Requests for the RFP will be filled on a first-come first-served basis, until the supply is exhausted. Written requests must be submitted to: Eileen Webster-Cissel Contracts Management Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases 45 Center Drive, Room 5AS13A, MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-2543 FAX: (301) 480-4543 $$R1 END ************************************************************ $$R2 BEGIN NIH-DC-96-03 ********************************************* NIDCD HEREDITARY HEARING IMPAIRMENT RESOURCE REGISTRY NIH GUIDE, Volume 25, Number 28, August 16, 1996 RFP AVAILABLE: NIH-DC-96-03 P.T. 34; K.W. 0780030 National Institute on Deafness and Other Communication Disorders The National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health, has a requirement to continue and further develop the NIDCD Hereditary Hearing Impairment Resource Registry, which serves as a national resource for the biomedical research community engaged in the study of the genetics of hereditary hearing impairment. The Contractor will continue the direct enlistment of individuals and families in whom hearing impairment appears and who are willing to participate in genetic studies related to the etiology of auditory impairments. The Contractor will continue to contact health care providers (e.g., otolaryngologists, audiologists) who are in contact with individuals with hearing impairment, to enlist their assistance in providing information regarding enrollment and participation in the Registry to their patients. The Contractor will continue the collection and maintenance of clinical information on participants; including specified medical, audiological, demographic, and epidemiological variables. In addition, the Contractor will continue to encourage the pursuit of research on the genetic bases of hereditary hearing impairment by disseminating pertinent information to primary care physicians, otolaryngologists, audiologists, medical and molecular geneticists, and other biomedical scientists and health care professionals. Collaboration in the study of hereditary hearing impairment will be encouraged and facilitated. This acquisition is the recompetition of contract number N01-DC-3-2134, currently being performed by Father Flanagan's Boys' Home. A three-year cost-reimbursement type contract is anticipated. The solicitation is scheduled to be issued on or about August 16, 1996. Proposals will be due 45 days after the date of issuance of the solicitation. All responsible sources may submit a proposal that will be considered by the Government. INQUIRIES Copies of the solicitation can be obtained by sending a written request to: John P. DeCenzo Division of Research Contracts National Institutes of Health 6100 Executive Boulevard, Room 6E01 - MSC 7540 Bethesda, MD 20892-7540 FAX: (301) 402-0178 Email: jd93o@nih.gov $$R2 END ************************************************************ $$R3 BEGIN AG-97-001 FULL-TEXT ************************************** MINORITY DISSERTATION RESEARCH GRANTS IN AGING NIH GUIDE, Volume 25, Number 28, August 16, 1996 RFA AVAILABLE: AG-97-001 P.T. 34, FF; K.W. 0710010, 0710030 National Institute on Aging Application Receipt Date: December 10, 1996 PURPOSE Small grants (R03) to support doctoral dissertation research will be available for minority doctoral candidates. Grant support is designed to aid the research of new minority investigators and to encourage minority individuals from a variety of academic disciplines and programs to study problems in aging. It is anticipated that $300,000 will be available to fund between 10 to 12 grants. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Minority Dissertation Research Grants in Aging, is related to several priority areas applicable to aging. Potential candidates for the awards may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Dr. Robin A. Barr Office of Extramural Affairs National Institute on Aging 7201 Wisconsin Avenue, Suite 2C218, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9322 Email: rb42h@nih.gov $$R3 END ************************************************************ $$P1 BEGIN PA-96-070 FULL-TEXT ************************************** CHRONIC FATIGUE SYNDROME PATHOPHYSIOLOGY NIH GUIDE, Volume 25, Number 28, August 16, 1996 PA AVAILABLE: PA-96-070 P.T. 34; K.W. 0715043, 0710030 National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Mental Health National Heart, Lung, and Blood Institute National Institute of Environmental Health Sciences National Institute of Nursing Research National Institute of Diabetes and Digestive and Kidney Diseases Office of Research on Women's Health PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Mental Health (NIMH), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Environmental Health Sciences (NIEHS), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Nursing Research (NINR), and the Office of Research on Women's Health (ORWH) invite investigator-initiated research project grant applications (R01, R03, and R29) to support research on the pathophysiology of chronic fatigue syndrome (CFS). Applications that address new hypotheses and research gap areas or are small studies that explore new ideas, 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 program announcement, Chronic Fatigue Syndrome Pathophysiology, is related to the priority area of chronic disabling diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Catherine Laughlin, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3A14 - MSC 7630 Bethesda, MD 20892-7630 Telephone: (301) 496-7453 FAX: (301) 496-8030 Email: CL28R@nih.gov $$P1 END ************************************************************ From owner-sci-resources@net.bio.net Thu Aug 15 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AG-97-001 - V25(28) 08/16/96 Date: 15 Aug 1996 17:44:53 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 396 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4v0ga5$eq8@net.bio.net> NNTP-Posting-Host: net.bio.net MINORITY DISSERTATION RESEARCH GRANTS IN AGING NIH GUIDE, Volume 25, Number 28, August 16, 1996 RFA: AG-97-001 P.T. 34, FF; K.W. 0710010, 0710030 National Institute on Aging Application Receipt Date: December 10, 1996 PURPOSE Small grants to support doctoral dissertation research will be available for minority doctoral candidates. Grant support is designed to aid the research of new minority investigators and to encourage minority individuals from a variety of academic disciplines and programs to study problems in aging. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Minority Dissertation Research Grants in Aging, is related to several priority areas applicable to aging. Potential candidates for the awards may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS For the purpose of this RFA, underrepresented minority students and investigators are defined as individuals belonging to a particular ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical or behavioral research. Awards will be limited to citizens or non-citizen nationals of the United States or to individuals who have been lawfully admitted for permanent residence (i.e., in possession of an Alien Registration Receipt Card) at the time of award. In awarding grants for dissertation support, the National Institute on Aging (NIA) will give priority to projects involving African American (Black), Hispanic American, Native American and Alaskan Natives, and Pacific Islander or other ethnic or racial group members who have been found to be underrepresented in biomedical or behavioral research nationally. The doctoral candidate must have a dissertation topic approved by the named committee. This information must be verified in a letter of certification from the thesis chairperson and submitted with the grant application (see APPLICATION PROCEDURES). Research topics must be on aging-related issues and fit within one or more of the areas described below for each individual program (see RESEARCH OBJECTIVES). The applicant organization must be a domestic institution supporting doctoral level training, such as a university or college. The performance site may be foreign or domestic. MECHANISM OF SUPPORT The mechanism of support is the NIH small grant (R03). Grants may be made for up to two years. Grants to support dissertation research will provide no more than $30,000 in total direct costs, and no more than $25,000 in direct costs in any one year. FUNDS AVAILABLE The NIA anticipates funding between 10 and 12 grants with a total cost of up to $300,000. These grants are not eligible for competitive renewal. RESEARCH OBJECTIVES This research initiative is to provide minority students assistance to complete their dissertation research on an aging-related topic and thereby increase the pool of minority researchers in aging. The description of the four extramural programs below is provided to help potential applicants determine whether their topic may be appropriate for this initiative. Questions on the relevance of a particular topic can be addressed to the program contact listed under INQUIRIES. Biology of Aging Program This program supports studies that focus on diseases associated with increasing age and the basic mechanisms involved in aging processes. The overall objectives of the program are related to understanding normal functions and alterations in them that can be induced by interaction with the environment and disease processes as aging proceeds. The program interests are in molecular and cellular biology, genetics, immunology, basic nutrition, and endocrinology. Behavioral and Social Research Program This program supports research on social and psychological aging processes and the place of older people in society and its social institutions. The emphasis is on promoting health, effective functioning, productivity, and independence throughout the middle and later years. Areas of special interest include health and behavior; cognitive functioning; long term care; work, retirement and productivity; family and intergenerational relationships; aging demographics; aging among minorities, women, oldest old, and rural populations and the aging of adults who are retarded. Neuroscience and Neuropsychology of Aging Program This program supports research on the structure and function of the aging nervous system and the behavioral manifestations of the aging brain. Areas of special interest include age-related changes in the nervous system, especially as these affect sensory processes, learning, cognition, memory and sleep. The study of Alzheimer's disease and other disorders associated with the aging nervous system, including the causes, diagnosis, epidemiology, treatment and management of such disorders is of special interest. Geriatrics Program This program supports research on clinical issues and problems that occur predominantly among middle-aged and older persons or that are associated with increased morbidity and mortality in older people. Areas of interest include cardiovascular and pulmonary diseases, infectious diseases, osteoporosis, digestive diseases, rehabilitation, menopause and physical function and performance in older persons. SPECIAL REQUIREMENTS Additional Material. In addition to the completed PHS 398 form described under APPLICATION PROCEDURES, applicants must also submit: o A letter from the faculty committee or university official directly responsible for supervising the development and progress of the dissertation research. The letter must be countersigned by a representative of the graduate school of the sponsoring institution. The letter must: (a) fully identify the members of the committee and certify their approval of the dissertation topic, (b) certify that the candidate is a member of an ethnic minority group underrepresented in biomedical or behavioral science (see ELIGIBILITY REQUIREMENTS) (c) certify that the author of the letter has read the application and that it reflects the work to be completed in the dissertation, and (d) note that the university official or faculty committee expects the doctoral candidate to proceed with the approved project proposal with or without NIA support. o A transcript of the investigator's graduate school record o Biography of mentor, limited to 2 pages (use the Biographical Sketch page in form PHS 398) o Statement of the investigator's career goals to be placed under "Background" (see the Research Plan instructions in PHS 398) Although not required, identification of the investigator's particular minority group would be helpful so that NIA may continue to monitor and improve the effectiveness of this program. Grant Conditions. The following conditions apply to dissertation grants: o The doctoral candidate must be the designated Principal Investigator on the grant and the doctoral candidate must be the only individual on the grant for whom salary support is requested. o The principal investigator's salary may not exceed $12,000 per twelve months. o Work on the funded project must be initiated within three months after the date of the award. o An awardee may be invited to participate in a meeting or presentation with other NIA dissertation awardees. o The dissertation constitutes the final report of the grant. Two copies of the dissertation must be submitted. The dissertation must be officially accepted by the faculty committee or university official responsible for the candidate's dissertation and must be signed by the responsible officials. o Investigators may request support for up to 24 months. An application that requests support beyond this time will be returned. o Grantees who are approved for two years of support must submit a satisfactory progress report no later than 10 months after the start of the first year of the grant. This report should contain a brief summary of the work completed to date together with copies of any publications supported wholly or in part by the dissertation grant. An applicant who receives support for dissertation research under a grant from the NIA may not at the same time receive support under a predoctoral or fellowship grant awarded by any other Federal agency, nor be supported under any other research project grant. Allowable Costs. Expenses usually allowed under PHS research grants will be covered by the NIA dissertation research grants, but may not exceed $30,000 for the project. Allowable costs include the investigator's salary (not to exceed $12,000 per 12 months); direct research project expenses such as travel to one scientific meeting per year (limited to $1000 per year), data processing, supplies, and dissertation costs. Any level of effort that is less than full time by the candidate must be fully justified. No tuition is allowed. It is expected that most equipment needed for the research will be available at the site or laboratory in which the dissertation is to be performed. Therefore, any requests for equipment must be specially justified. Indirect costs are limited to eight percent of requested direct costs, less equipment. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number (Minority Dissertation Research Grants in Aging, AG-97-001) must be typed on line 2 of the face page of the application form and the YES box must be marked. Instructions for completing the applications are found in the PHS 398 form. These instructions must be followed except that under C. Specific Instructions - Research Plan, no more than 10 pages may be used for items 1 to 4 (instead of 25 pages as stated in the standard instructions). Applications that exceed the 10 page limit for this section will be returned. Submit a signed original of the application (with the supporting letter and graduate school transcript), including the Checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight service) At the time of submission, two additional copies of the application (with the supporting letter and the graduate school transcript) must be sent to: Chief, Scientific Review Office National Institute on Aging Gateway Building, Suite 2C212 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 ATTN: Minority Dissertation Complete applications must be received by December 10, 1996. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIA in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score. Review Criteria o scientific, technical, or medical significance and originality of the proposed research; o appropriateness and adequacy of the literature review, experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator (the student); o qualifications, research and training experience of the mentor, particularly, but not exclusively, in the proposed area of research; o quality and availability of research resources needed to complete the dissertation; o appropriateness of the proposed budget and duration in relation to the proposed research; o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA The anticipated date of award is March, 1997. Final funding decisions are based on the recommendations of the reviewers, the relevance of the project to NIA priorities, and the availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Interested investigators are strongly encouraged to contact program staff who can provide clarifying information about material described in this RFA. The investigator will then be referred to the relevant program to discuss the suitability of the research topic. Direct inquiries regarding programmatic issues to: Dr. Robin A. Barr Office of Extramural Affairs National Institute on Aging Gateway Building, Suite 2C218 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9322 FAX: (301) 402-2945 Email: rb42h@nih.gov Direct inquiries relating to fiscal matters to: Mr. Joseph Ellis Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: EllisJ@gw.nia.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.366. Awards are made under authorization of the Public Health Service Act Title IV, Part A (Public Law 79-410, as amended by Public Law 99-158, 42 DSC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Thu Aug 15 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-070 - V25(28) 08/16/96 Date: 15 Aug 1996 17:45:07 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 475 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4v0gaj$ets@net.bio.net> NNTP-Posting-Host: net.bio.net CHRONIC FATIGUE SYNDROME PATHOPHYSIOLOGY NIH GUIDE, Volume 25, Number 28, August 16, 1996 PA NUMBER: PA-96-070 P.T. 34; K.W. 0715043, 0710030 National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Mental Health National Heart, Lung, and Blood Institute National Institute of Environmental Health Sciences National Institute of Nursing Research National Institute of Diabetes and Digestive and Kidney Diseases Office for Research on Women's Health PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Mental Health (NIMH), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Environmental Health Sciences (NIEHS), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Nursing Research (NINR), and the Office for Research on Women's Health (ORWH) invite submission of investigator-initiated research grant applications to support research on the pathophysiology of chronic fatigue syndrome (CFS). Applications are encouraged that address new hypotheses and research gap areas or that are small studies that explore new ideas. 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, Chronic Fatigue Syndrome Pathophysiology, is related to the priority area of chronic disabling diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) award (R29). MECHANISM OF SUPPORT Traditional research project grant (R01) and FIRST award (R29) applications may be submitted in response to this program announcement. The R01 mechanism can be used to support small studies. Funds and time requested should be appropriate for the research proposed. Several Institutes use specialized mechanisms such as the small research grant (R03); if you believe that your project is appropriate for such a mechanism, consult the individuals listed in the INQUIRIES section. RESEARCH OBJECTIVES Background Chronic fatigue syndrome (CFS) is a multisystem syndrome characterized by months of debilitating fatigue frequently associated with myalgia, headache, sore throat, low grade fever, cognitive complaints, gastrointestinal symptoms, and tender lymph nodes. The cause(s) and pathogenic mechanism(s) of the illness remain unknown. The range of symptoms and comparisons of CFS patients with healthy persons and with other chronically ill persons suggest subtle perturbations in multiple physiological pathways. However, no single marker or physiological alteration has been identified that can be used to diagnose the syndrome. CFS is diagnosed three to four times more frequently in women than in men and about 10 times more often in white Americans than in other American population groups. Research Objectives and Experimental Approaches Well-designed studies are needed to provide a better understanding of CFS pathogenesis with the goal of developing diagnostic and intervention strategies. Studies should include appropriate sample sizes and test biologically rational hypotheses. Selection criteria and procedures for CFS cases and comparison groups should be carefully delineated and appropriate for the hypothesis under study. Factors which may explain or have an impact on CFS pathogenesis and areas needing additional research include, but are not limited to: o low levels of cortisol and corticotropin-releasing hormone in CFS patients in the absence of documented adrenal-hypothalamic axis dysfunction attributable to other causes o overlapping symptomatology with neurally-mediated hypotension o role of cardiovascular regulatory centers in the brain stem, hypothalamus, and higher cortical regions in the loss of the normal control of blood pressure, heart rate, and contractility in CFS patients. o dysfunctions in the baroreceptor, ventricular mechanoreceptor, and other cardiovascular reflex pathways in the chronic fatigue syndrome and in acute and chronic episodes of hypotension and syncope observed in CFS patients. o development of novel cardiovascular pharmacological and non-pharmacological interventions for treatment of CFS patients. o development of novel and objective cardiovascular markers for the diagnosis of CFS. o interaction of cytokines with physiological systems other than the immune system as effectors of CFS pathogenesis o increased frequency of sleep disturbances (hypersomnia or insomnia) o overlapping symptomatology with fibromyalgia o role of neuroendocrine and neuroimmune functions in CFS pathogenesis o hormonal effects, including in pregnancy, on illness severity and/or symptomatic improvement o low tolerance to physical exertion manifested by prolonged generalized fatigue after very moderate exercise o potential role of viruses or other infectious agents as markers of disease pathogenesis or as co-factors in pathophysiological processes. o lymphocyte patterns suggestive of immune activation (e.g., alterations in T-cell subsets number and function, altered cytokine levels and function) o increased frequency of psychiatric diagnoses in CFS patients (except those that would exclude an individual from the CFS case definition) o increased frequency of atopy in CFS patients compared with the U.S. population as a whole o role of environmental agents as etiological or pathophysiological factors o gender specific factors in etiology and disease progression o highly active lifestyle prior to onset of CFS o epidemiology, natural history and pathophysiology of CFS in less studied populations such as children, adolescents, minorities, men o demographic risk factors (gender, age, race, socioeconomic class) Applications for small studies that explore new ideas are also encouraged and could provide the basis for submission of a subsequent larger grant application. Study Design and Methodological Issues Multidisciplinary studies and collaboration among investigators with expertise in appropriate disciplines are encouraged. When investigators are at different institutions, individual R01 applications may include consortium arrangements. Collaborative arrangements with on-going studies that provide patient populations, specimens and data are encouraged. Such arrangements should be clearly delineated in the application. The methodologies and personnel involved in statistical/epidemiological analyses should be described in the application and evident in the study design. The hypothesis(es) to be tested should be clearly stated. The constructs and measurements to be used operationally to obtain statistically and biologically meaningful results should be clearly defined and enumerated. The value of studies of patients or their specimens will be directly related to the care exercised in selection and initial characterization of cases and controls. A detailed description of case recruitment procedures, the criteria to be used for case definition and the manner in which the criteria are to be applied must be included. Similar care should be given to descriptions of enrollment of comparison groups. Investigators are encouraged to use the CFS case definition as presented in Fukuda, et. al., Annals of Internal Medicine: 121, 953-9, 1994. If other case definitions are proposed, they should be clearly defined and the rationale for their choice clearly delineated. Applications to estimate the frequency of physiological or behavioral variables or responses, or to address other quantitative aspects in relevant populations should pay particular attention to sample sizes required to attain the degree of precision sought or needed for statistically and biologically meaningful results. The reliability and validity of markers chosen for measurement should be demonstrated. Applications attempting to examine interrelationships among two or more separate factors are encouraged to the extent that the types and numbers of subjects are sufficient for such comparisons. The measurement of many markers, including immunological, virological, physiological and psychological markers, are dependent on the measurement system chosen and its execution. Thus, it is very important that applicants clearly define the methodologies to be used, the rationale for choosing that methodology and for validating results as well as methods of collection, processing, and storage of samples and data. When conflicting results have been reported in the literature, applicants should provide possible explanations for such variability and indicate how their approach might resolve the issue. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact persons listed below. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted on the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. Each application must be identified by checking "YES" on line 2 of the PHS face page, and the number and title of this program announcement must be typed in section 2. The completed original and five legible, single-sided copies of the application must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight service) FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST (R29) award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific/technical review, the applications will receive secondary review by the appropriate national advisory council. Review Criteria o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications assigned to an Institute or Center. The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance among research areas of the announcement, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Catherine Laughlin, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3A16 - MSC 7630 Bethesda, MD 20892-7630 Telephone: (301) 496-7453 FAX: (301) 402-0659 Email: c128r@nih.gov Susana A. Serrate-Sztein, Ph.D. Arthritis Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS37G Bethesda, MD 20892 Telephone: (301) 594-5032 FAX: (301) 480-4543 Email: szteins@ep.niams.nih.gov Fred Altman, Ph.D. Basic Prevention and Behavioral Medicine Research Branch National Institute of Mental Health Parklawn Building, Room 10-104 Rockville, MD 20857 Telephone: (301) 443-4337 FAX: (301) 443-4045 Email: fa2w@nih.gov Paul Velletri, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung and Blood Institute 6701 Rockledge Drive, Suite 10193 - MSC 7956 Bethesda, MD 20892-7956 Telephone: (301) 435-0560 FAX: (301) 480-2849 Email: p4v@cu.nih.gov June Lunney, Ph.D. RN Division of Extramural Programs National Institute of Nursing Research Building 45, Room 3AN12 Bethesda, MD 20892-6300 Telephone: (301) 594-6908 FAX: (301)480-8260 Email: Jlunney@ep.ninr.nih.gov Philip F. Smith, Ph.D. Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8816 FAX: (301) 480-3503 Email: phil_smith@nih.gov Annette G. Kirshner, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences 104 Alexander Drive, Box 12233, MD 3-03 Research Triangle Park, NC 27709 Telephone: (919) 541-0488 FAX: (919) 541-2843 Email: kirshner@niehs.nih.gov Direct inquiries regarding fiscal matters to: Ms. Victoria Putprush Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4B35 - MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: vp8g@nih.gov Ms. Carol Fitzpatrick Grants Management Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases 45 Center Drive, Room 5AS-43K - MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-3535 FAX: (301) 480-5450 Email: fitzpatc@ep.niams.nih.gov Mr. Bruce Ringler Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C08 Rockville, MD 20857 Telephone: (301) 443-3065 FAX: (301) 443-6885 Email: bringler%nimh@ngmsmtp.samhsa.gov Mr. Jeff Carow Grants Management Office National Institute of Nursing Research Building 45, Room 3AN32 Bethesda, MD 20892-6100 Telephone: (301) 594-5974 FAX: (301) 480-8256 Email: Jcarow@ep.ninr.nih.gov Ms. Donita Marconi Division of Extamural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8860 Email: dm150h@nih.gov Mr. David L. Mineo Division of Extramural Research and Training National Institute of Environmental Health Sciences 104 Alexander Drive, Box 12233, MD 2-01 Research Triangle Park, NC 27709 Telephone: (919) 541-1373 FAX: (919) 541-2860 Email: mineo@niehs.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.856, Microbiology and Infectious Disease Research; No. 93.846, Arthritis, Musculoskeletal, and Skin Diseases Research; No.93.837, Heart and Vascular Diseases Research; No. 93.361, Nursing Research; No. 93.242, Mental Health Research; No. 93.847 Diabetes, Endocrinology, and Metabolic Diseases Research; and Nos. 93.113, 93.115 Environmental Health Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant and contract recipients to provide a smoke-free work place and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun Aug 18 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 17 August 1996 Date: 18 Aug 1996 22:29:36 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 112 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4v8u40$lon@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending August 17, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: International Document Title: INT 96-19 - JAPAN'S TECHNICAL COOPERATION WITH ASIAN COUNTRIES File size (bytes): 4472 STIS Filename: int9619.txt Title: INT 96-20 - Growth of Epitaxial Thin Films by Molecular Beam Epitaxy File size (bytes): 3050 STIS Filename: int9620.txt Document Type: News Title: TIP60809 -- Media Tipsheet August 9, 1996 File size (bytes): 5048 STIS Filename: tip60809.txt Document Type: Press Release Title: BASIC COLLEGE SCIENCE COURSES 'FILTER OUT' MOST STUDENTS File size (bytes): 3524 STIS Filename: pr9642.txt Title: TEACHERS CAPTURE THE EXCITEMENT OF MARTIAN METEORITE WITH SCIENCE 'TOOLKIT' File size (bytes): 4834 STIS Filename: pr9643.txt Title: THE NEXT GENERATION INTERNET File size (bytes): NSF ANNOUNCES AWARDS FOR NEW HIGH PERFORMANCE CONNECTIONS STIS Filename: pr9644.txt (NSF) Title: THE NEXT GENERATION INTERNET File size (bytes): ANOTHER STEP IN THE SUCCESSFUL TRANSITION TO THE COMMERCIAL INTERNET STIS Filename: pr9645.txt (NSF) Document Type: Recruit Title: Computer Scientist (Program Director) File size (bytes): 7382 STIS Filename: vex9626.txt Title: Computer Scientist (Program Director) File size (bytes): 9401 STIS Filename: vex9627.txt Title: Attorney-Advisor (General) File size (bytes): 7004 STIS Filename: vex9628.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 5348 STIS Filename: cmmtg.txt Document Type: Recruit Title: Computer Scientist (Program Director) File size (bytes): 7382 STIS Filename: vex9626.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve vex9626.txt, the text of your message should be as follows: get vex9626.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve vex9626.txt, you would enter: ftp> get vex9626.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Tue Aug 20 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: BIOSCI/bionet miniFAQ & Fundraiser Date: 21 Aug 1996 14:22:55 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 240 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <199608200900.CAA06361@net.bio.net> NNTP-Posting-Host: net.bio.net (LAST REVISION: 30-JUL-95) This BIOSCI "miniFAQ" is designed to answer the questions that come up the *most frequently*. The main BIOSCI FAQ (Frequently Asked Questions) is accessible on the World Wide Web at URL http://www.bio.net/. If you can not find an answer to your question in this or other documentation, the BIOSCI technical support staff answers e-mail queries sent to biosci-help@net.bio.net We can only answer questions about the use of the newsgroups and mailing lists. We unfortunately do not have the staff to do Internet information searches or answer scientific questions. Please post those to the appropriate BIOSCI/bionet newsgroups. Contents: -------- 0) BIOSCI NEEDS YOUR SUPPORT!! 1) Using the WWW to access the BIOSCI/bionet newsgroups. 2) What to do about "spams," i.e., junk mail, ads, etc. 3) Examples of subscribing and unsubscribing to the mailing lists. 4) The BIOSCI user address and research interest directory. 0) BIOSCI NEEDS YOUR SUPPORT!! ------------------------------ BIOSCI's government funding has been expended, and we are now operating solely from advertising revenue that we have raised from our Web site at http://www.bio.net/. We need just a few minutes of your time to help us serve you. You can do two important things which will take very little time for you individually and will immensely help us continue to help you. First, please use our WWW system at http://www.bio.net/ to access the archives. You can post or reply to messages via your Web browser as described in item #1 below. Your usage helps attract sponsors. If you contact any of our sponsors, please be sure to thank them for supporting BIOSCI. It is critical for them to get this feedback if they are to continue their sponsorship for the long term. Second, if you work for a company or organization that provides products or services of interest to the biology community, please pass this message on to your marketing or marketing communications department or other appropriate group. Please ask them to help support BIOSCI by sponsoring our Web site and explain the uses and benefits of the system to the biology community. If they are interested, they can then contact us for further information at our tech support address, biosci-help@net.bio.net. 1) Using the WWW to access the BIOSCI/bionet newsgroups. -------------------------------------------------------- As of 10 December 1995, all BIOSCI/bionet full newsgroups are accessible through the World Wide Web (WWW) at URL http://www.bio.net. One can read and reply publicly or privately to both recent postings and archived messages through one's Web browser if it is configured properly to send e-mail. Each newsgroup is equipped with its own WAIS index. The main BIOSCI home page also has access to the BIO-JOURNALS Table of Contents database WAIS index and the BIOSCI user address database described in another item further below. 2) What to do about "spams," i.e., junk mail, ads, etc. ------------------------------------------------------- BIOSCI is a set of parallel USENET newsgroups (the "bionet" groups), mailing lists, and a hypermail archive at URL http://www.bio.net/. The same postings are distributed on all media (except for a small number of mailing-list-only groups at net.bio.net). Unfortunately it is becoming a despicable practice on the Internet (by a few people out to make a fast buck) to do automated mass postings to thousands of newsgroups and mailing lists. These attempts to grab free advertising are refered to as "spams" in the usual, somewhat boneheaded, net terminology. USENET is more susceptible to this practice, and many spams originate on the USENET groups and then are passed on to the mailing lists. However, spammers also get lists of mailing addresses and hit these too, so neither medium is immune. What should you do personally if you get junk mail? --------------------------------------------------- Just delete it and move on without reading it further. Filing a protest is becoming increasingly useless because spammers are often disguising the addresses where the messages are sent from. Unless you really understand Internet mail systems, your attempt at protest by sending replies to the message will often end up being sent to the address of an innocent person that the spammer is victimizing. What can BIOSCI/bionet do to protect its newsgroups? ---------------------------------------------------- The only solution currently available is to moderate the newsgroup. If this newsgroup is already moderated, then you are in good shape. Moderation protects the USENET distribution from about 95% of the spams that are being sent to date and protects the mailing lists completely. Moderation means, however, that someone has to take the time to review each message before it goes out. We have set up software here that simply allows the moderator to forward to an address at net.bio.net messages that (s)he wishes to have distributed. This takes no more time than that needed to read the message and pass it on, say about 1 min. per message. Most newsgroups currently have a discussion leader who is responsible for their newsgroup. The discussions leaders and their e-mail addresses are listed in the BIOSCI Information Sheet which is available on the Web at http://www.bio.net/. If a newsgroup is being hit with too many junk postings, please contact the discussion leader for that group and see if there is interest in moderating the group. Please do not assume that by simply posting a complaint to the newsgroup itself, anyone on the BIOSCI staff will act on your complaint. With close to 100 newsgroups to run, the BIOSCI staff has to rely on the discussion leaders of each newsgroup to report problems directly to us at biosci-help@net.bio.net. We will moderate any of our newsgroups if the discussion leader tells us that the readership of the group wishes to do so and if a moderator is willing to do the work. For most BIOSCI/bionet groups, this entails only a few minutes of work each day. Moderating a newsgroup will resolve probably 95% of the junk postings on the USENET distribution. Unfortunately there are easy ways for determined spammers to override the moderation mechanism on USENET, but we can protect our e-mail subscribers from unwanted postings if the newsgroup is moderated. You can also access our newsgroups over the WWW at URL http://www.bio.net. While this Web interface will not stop spammers from trying to post to the groups, this will give you yet another way, besides using USENET news, to keep the junk out of your personal mail files. For those of you with local USENET news systems, the Web interface will also give you faster access to new newsgroups and recent postings. 3) Examples of subscribing and unsubscribing to the mailing lists. ------------------------------------------------------------------ PLEASE NOTE: The BIOSCI management does NOT act on subscription/unsubscription requests that are posted improperly to the newsgroups and mailing lists. People who do this only bother everyone on the lists to no avail. Please be sure to follow the proper procedures below. Gory details are in the BIOSCI Information sheets on the Web at http://www.bio.net. Below we give an example utilizing the METHODS-AND-REAGENTS list at both of our two BIOSCI sites: Users in the Americas and Pacific Rim countries who use the BIOSCI ------------------------------------------------------------------ node at computer net.bio.net: ---------------------------- A) Determine the "listname" which is the <=8 character mail address ^^^^^^^^^^^^^ for the group. These can be found in the BIOSCI Info. Sheet. For the METHODS-AND-REAGENTS group the mailing address is methods@net.bio.net. The listname is the portion of the address to the left of the @ sign, i.e., "methods". The listname is used with the "subscribe" and "unsubscribe" commands illustrated below. B) Mail all commands in the body of a mail message addressed to biosci-server@net.bio.net. Do NOT send commands to the newsgroup posting addresses! Leave the Subject: line blank, any text on it will be ignored. C) In the body of your message put one or more of the following commands with an "end" command on the last line, e.g., subscribe methods unsubscribe methods end Do NOT put your e-mail address or other text on these lines. The server only allows you to cancel your subscription if the address on your mail header matches the address on our mailing list. Please ask for help at biosci-help@net.bio.net if your address has changed, e.g., if you know you are on the list but the server tells you that you are not a member. Users in Europe, Africa, and Central Asia who use the BIOSCI node at -------------------------------------------------------------------- computer daresbury.ac.uk (also known as dl.ac.uk): ------------------------------------------------- To subscribe and unsubscribe to/from the BIOSCI lists, you need to specify the full USENET newsgroup name with "bionet-news." prepended. The USENET newsgroup names are listed in the BIOSCI Information sheet on the Web at http://www.bio.net/. For the METHODS-AND-REAGENTS list the USENET newsgroup name is bionet.molbio.methds-reagnts, thus the appropriate commands are sub bionet-news.bionet.molbio.methds-reagnts unsub bionet-news.bionet.molbio.methds-reagnts These commands are included in a message addressed to mxt@dl.ac.uk, NOT to the newsgroup mailing addresses. As usual, include the text in the body of the message as text on the Subject: line is ignored. To unsubscribe from all the lists at the UK node, use unsub bionet-news Please note that if the address in the list is different than the one in your mail message header, you will not be able to unsubscribe by this method. If you have problems, please mail biosci@daresbury.ac.uk. 4) The BIOSCI user address and research interest directory. ----------------------------------------------------------- Please take this opportunity to add your name, address, and research interest information to the BIOSCI User Address Database if you have not already done so. You can fill out the address form directly through our Web page at URL http://www.bio.net/adrform.html. The address database is reindexed nightly for WWW access (the URL is http://www.bio.net/). If you are not directly on the Internet but can reach it by e-mail, please use our waismail server to access the user directory. waismail use is described above. You can also request a user address form by e-mail from biosci-help@net.bio.net. Please check your database entry from time-to-time to see if your address information is still up-to-date. Because of our limited personnel resources, we ask that you resubmit a *complete* form to revise your entry; we only replace complete entries and do not have resources to edit old forms. Sincerely, Dave Kristofferson BIOSCI/bionet Manager biosci-help@net.bio.net From owner-sci-resources@net.bio.net Sun Aug 25 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 24 August 1996 Date: 26 Aug 1996 15:56:48 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 105 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4vta3g$peb@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending August 24, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: BUL 96-09 -- NSF September 1996 Bulletin V-24; No. 1 File size (bytes): 62809 STIS Filename: bul9609.txt Document Type: Graduate Fellowships Title: NSF 96-122 NSF 96-122 NSF Graduate Fellowship Program File size (bytes): 35806 STIS Filename: nsf96122.txt Document Type: International Document Title: INT 96-21 Discrete Particle Simulation of Fluidized Beds File size (bytes): 9258 STIS Filename: int9621.txt Title: INT 96-22 Studies of Metal/Ceramic Interfaces File size (bytes): 2901 STIS Filename: int9622.txt Document Type: News Title: Media Tipsheet August 16, 1996 File size (bytes): 6021 STIS Filename: tip60816.txt Document Type: Press Release Title: HIGH-TECH RADAR SEES THROUGH COLORADO 'WEATHER TRICKS' File size (bytes): 3796 STIS Filename: pr9641.txt Document Type: Recruit Title: Secretary (Office Automation) File size (bytes): 7381 STIS Filename: vgs9653.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Grant Conditions Title: (ARI) ACADEMIC RESEARCH INFRASTRUCTURE PROGRAM FACILITIES MODERNIZATION File size (bytes): 19335 STIS Filename: ari.txt Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 113966 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 125371 STIS Filename: phnorg.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg.txt, the text of your message should be as follows: get phnorg.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg.txt, you would enter: ftp> get phnorg.txt If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Fri Aug 30 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 29, pt. 1of1, 30 August 1996 Date: 30 Aug 1996 17:06:46 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 687 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <507vmm$krf@net.bio.net> NNTP-Posting-Host: net.bio.net X-comment: RFAs described: HL-96-015, PA-96-071 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.08.30 NIH GUIDE - Vol. 25, No. 29 - August 30, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** QUESTIONS AND ANSWERS ON IMPLEMENTATION OF THE NIH PROCEDURES FOR HANDLING NON-ELECTION OF TITLE TO PATENTABLE BIOLOGICAL MATERIALS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** CHRONIC FATIGUE SYNDROME PATHOPHYSIOLOGY - ADDENDUM (PA-96-070) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX N3 ********************************************************** AVAILABILITY OF PUBLIC USE DATA DISK National Institute on Drug Abuse INDEX: DRUG ABUSE NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** RESOURCE FOR COLLECTION AND EVALUATION OF HUMAN TISSUE AND CELLS FROM DONORS WITH EPIDEMIOLOGY PROFILES (RFP N01-BC-71006-21) National Cancer Institute INDEX: CANCER $$INDEX R2 ********************************************************** SEXUALLY TRANSMITTED DISEASES CLINICAL TRIALS UNIT (RFP NIH-NIAID- DMID-97-07) National Institute of Allergy and Infectious Disease INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R3 ********************************************************** LARGE SCALE AUTOMATED DNA SEQUENCING OF HUMAN GENES INVOLVED IN NEUROLOGICAL DISORDERS (RFP NIH-NINDS-96-13) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX R4 03/13/97 ************************************************* MOLECULAR BIOLOGY AND GENETICS OF SLEEP AND SLEEP DISORDERS (RFA HL-96-015) National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Child Health and Human Development INDEX: HEART, LUNG, BLOOD; MENTAL HEALTH; CHILD HEALTH; HUMAN DEVELOPMENT $$INDEX P1 ********************************************************** DNA DAMAGE AND REPAIR IN CENTRAL NERVOUS SYSTEM INJURY (PA-96-071) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** QUESTIONS AND ANSWERS ON IMPLEMENTATION OF THE NIH PROCEDURES FOR HANDLING NON-ELECTION OF TITLE TO PATENTABLE BIOLOGICAL MATERIALS NIH GUIDE, Volume 25, Number 29, August 30, 1996 P.T. 34; K.W. 1014006 National Institutes of Health A. Purpose: This notice is in response to frequently asked questions concerning the new procedure for handling non-election of title for patentable biological materials made with National Institutes of Health (NIH) funding that appeared in the NIH Guide, Vol. 25, No. 16, May 17, 1996. It is intended to help clarify the expectations of the NIH and what grantee/contractor organizations need to do to meet these expectations. B. Q&As 1) Which biological materials are subject to these Procedures? Only biological materials that meet the definition of "Subject Inventions" as included in the regulations implementing the Bayh-Dole Act need to be reported. That definition is as follows: "any invention or discovery which is or may be patentable or otherwise protectable under Title 35 of the United States Code, or any novel variety of plant which is or may be protectable under the Plant Variety Protection Act (7 U.S.C. 2321 et seq.)...conceived or first actually reduced to practice in the performance of work under any contract, grant, or cooperative agreement [with NIH]." It is expected that grantee institutions will follow the same decision-making process for determining whether a disclosure of a biological material qualifies as a "subject invention" as they follow for disclosures of other types of inventions or discoveries. In other words, if the institution determines that the biological material would normally not be reported to NIH as a "subject invention," it would not be covered by these Procedures. In such cases institutions should document these decisions in their files. 2) What does NIH mean by the requirement to "address continuing availability of the material to the nonprofit research community" when granting an exclusive license for internal use by a for-profit entity? Perhaps the simplest way to meet NIH's expectations regarding "continuing availability" is to reserve the right, as part of the exclusive license agreement, for the licensor (the grantee institution) to make the materials available for non-commercial research purposes to nonprofit organizations. Of course, the licensor/grantee institution would need to arrange with the originating laboratory to provide the materials to appropriate researchers at nonprofit organizations so long as supplies of the material are available or can be reasonably produced. Consistent with the Public Health Service policy relating to the distribution of unique research resources, these materials should be provided either without cost or at cost. Clearly this obligation cannot extend forever, but should continue for a reasonable period while the materials are useful to the research of other scholars. If the grantee institution expects to have difficulty with the preservation of a supply of the material, it might require the licensee to provide a sample of the material to the licensor institution in the event the institution's supply is depleted and cannot be easily replicated. In that way the grantee institution could continue to provide the material to researchers at nonprofit organizations. Another alternative would be to require the licensee to provide the materials to a reasonable number of appropriate researchers at nonprofit organizations -- perhaps under material transfer agreements between the licensee and the recipient organization. 3) When does an exclusive license need to "provide for conversion to nonexclusive status or termination of the licensee's rights upon failure to comply with the terms addressing continuing availability?~ If the licensor (grantee institution) has retained the right to make the materials available to other nonprofit organizations, such a provision is generally unnecessary. However, if the only source for the materials is via the licensee (i.e., if the licensee is responsible for providing the materials to other researchers), then such a clause would be required. 4) What is meant by the requirement to provide for "independent maintenance of the material?~ NIH is concerned that if the sole source of the materials is an exclusive licensee and that licensee fails to meet its obligations as to availability, then the materials may become totally unavailable to the research community. Thus, the grantee institution should make efforts to obtain the commitment of the originating laboratory to maintain the materials for a reasonable period. Clearly such a commitment cannot be unlimited since that laboratory might close, the supply of material could be accidentally destroyed or could be depleted and recreating the material (due to cost or manpower constraints) may not be feasible. Depositing the material at a national repository would also meet the requirement. However, it is recognized that there is a cost involved and that an exclusive licensee would undoubtedly require that the licensor insure that access to samples from the repository be limited to researchers at nonprofit institutions conducting noncommercial research. 5) Will the government pay the costs of supplying material to government researchers? What happens if there are no further supplies? If there are costs involved in preparing the materials and/or in shipping and handling, the university and NIH need to reach an agreement regarding them. NIH expects that grantee institutions and the originating laboratories will make reasonable and good faith efforts to supply requested materials to government researchers. Nonetheless, NIH recognizes that occasionally supplies may cease to be available. 6) What happens if NIH utilizes its right "to distribute the material" because of the failure of the grantee institution to follow these procedures? Since NIH's concern is that the materials are available to the nonprofit research community, it would restrict its distribution to that community. An easy way to ensure that NIH retains its right, would be for the university to include in its license agreement a provision that the license is subject to these NIH procedures. 7) Does the grantee institution still need to sign an agreement with NIH for each unpatented biological material it reports to NIH? No. Grantee organizations are no longer required to sign a terms and conditions agreement for each patentable biological material they wish to commercially license, but not patent. For those reporting electronically, NIH only requires that you report your decision in EDISON under "Institution Invention Status" within "New Inventions" in the main menu. Others who are reporting with paper should submit a letter informing NIH of the decision to license commercially, but not patent. A confirmatory license to the government must be sent to NIH whether you report in writing or electronically. INQUIRIES For additional information on this notice, contact: Ms. Sue Ohata Division of Extramural Inventions and Technology Resources National Institutes of Health 6701 Rockledge Drive, MSC 7750 Bethesda, MD 20892-7750 Telephone: (301) 435-1986 FAX: (301) 480-0272 Email: Sue_Ohata@nih-gov $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** CHRONIC FATIGUE SYNDROME PATHOPHYSIOLOGY - ADDENDUM NIH GUIDE, Volume 25, Number 29, August 30, 1996 PA NUMBER: PA-96-070 P.T. 34; K.W. 0715043, 0710030 National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Mental Health National Heart, Lung, and Blood Institute National Institute of Environmental Health Sciences National Institute of Nursing Research National Institute of Diabetes and Digestive and Kidney Diseases Office of Research on Women's Health This notice is an addendum to PA-96-070, which was published in the NIH Guide, Vol. 25, No. 28, August 16, 1996. Within "Research Objectives and Experimental Approaches" the following two topics are added to factors that may explain or have an impact on CFS pathogenesis and areas need additional research: o association of altered sleep/wake physiology and the frequency of sleep disorders/disturbances in CFS, including sleep related periodic limb movements and sleep apnea o relationship between CFS and disordered circadian functions INQUIRIES Direct inquiries regarding this addendum to: Paul Velletri, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung and Blood Institute 6701 Rockledge Drive, Suite 10193 - MSC 7956 Bethesda, MD 20892-7956 Telephone: (301) 435-0560 FAX: (301) 480-2849 Email: p4v@cu.nih.gov $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** AVAILABILITY OF PUBLIC USE DATA DISK NIH GUIDE, Volume 25, Number 29, August 30, 1996 P.T. 34; K.W. 0755018, 0780018 National Institute on Drug Abuse PURPOSE The National Institute on Drug Abuse (NIDA) announces the availability of the public use data disk and documentation (one 3 + inch DOS diskette, 1.44M high density; file format: ASCII text; documentation not provided separately) for the Washington, D.C. Metropolitan Area Drug Study (DC*MADS): Drug Use Among Women Delivering Livebirths in D.C. Hospitals, 1992. To order, write the National Technical Information Service (NTIS) at 5285 Port Royal Road, Springfield, VA 22161 or call direct at 703-487-4650; order #PB96-502109GEI; $97 + $6.00 S&H; fax orders to 703-321-8547. INQUIRIES Direct questions to: Elizabeth Lambert, Ph.D. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-53 Rockville, MD 20857 Telephone: (301) 443-6720 Email: el46i@nih.gov $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN N01-BC-71006-21 ****************************************** RESOURCE FOR COLLECTION AND EVALUATION OF HUMAN TISSUE AND CELLS FROM DONORS WITH EPIDEMIOLOGY PROFILES NIH GUIDE, Volume 25, Number 29, August 30, 1996 RFP AVAILABLE: N01-BC-71006-21 P.T. 34; K.W. 0780015, 0780020, 0785055 National Cancer Institute The Laboratory of Human Carcinogenesis (LHC), Division of Basic Sciences (DBS), National Cancer Institute (NCI), National Institutes of Health (NIH), is recompeting a four-year tissue-collection contract. Proposals are now being solicited from qualified firms to provide the necessary resources for the collection of viable surgical, biopsy and autopsy specimens from a variety of human tissues and cells (lung, bronchus, colon, liver, pancreas) and other biological specimens (pleural effusions, blood and urine) from donors with epidemiological profiles prepared in specifically designed patient questionnaires which include the relevant medical records. The incumbent contractor is The University of Maryland at Baltimore (Contract N01-BC-33010), which is scheduled to expire March 30, 1997. The LHC subjects the tissues and cells to in vitro adaptability and carcinogenesis, biochemical characterizations and assays of chemical and oncogene-induced alterations of macromolecules, innovative methods for determining populations at risk for certain carcinogens by biochemical epidemiology survey. Relevant studies are extenuated by the application of xenotransplantation techniques for definitive assay of chemically stimulated tumorigenesis. Offerors must demonstrate, in their technical proposal, their ability to facilitate delivery of the nonfrozen viable tissues to the NCI in Bethesda, Maryland within two hours of collection as a mandatory qualification criteria of this solicitation. Failure to demonstrate this element at the time of original submission will result in the offeror~s elimination from further consideration. This contract will be awarded as a multiple-year, cost-reimbursement, level-of-effort (term) type contract with a required level-of-effort for all four years of 50,284 person hours (an estimated 12,571 hours per year) and incremental funding will be used. t is anticipated that the RFP NIH- NCI-N01-BC-71006-21 will be available electronically on or about September 9, 1996, and may be accessed through either the NIH Gopher or the NIH Home Page by using the following electronic mail addresses and instructions: 1) The NIH Gopher address is GOPHER.NIH.GOV PORT 70. Select ~Grant & Research Information~ then select "R&D Requests for Proposals (RFP)". 2) The NIH Home Page (via World Wide Web) address is http://www.nih.gov. Select "Grants & Contracts". Select "R&D Requests for Proposals (RFP)". INQUIRIES Proposals will be due 45 days following the actual date of RFP issuance. The NCI will consider proposals from all responsible sources. The RFP for this acquisition has been revised to include only the Work Statement, deliverables and reporting requirements, special requirements and mandatory qualifications (if any), Technical Evaluation Criteria and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Organizations unable to access this RFP electronically may request a copy in writing from: Barbara A. Shadrick Research Contracts Branch National Cancer Institute 6120 Executive Boulevard, Room 620 - MSC 7224 Bethesda, MD 20892-7224 Telephone: (301) 496-8611 Email: SHADRICB@RCB.NCI.NIH.GOV $$R1 END ************************************************************ $$R2 BEGIN NIH-NIAID-DMID-97-07 ************************************* SEXUALLY TRANSMITTED DISEASES CLINICAL TRIALS UNIT NIH GUIDE, Volume 25, Number 29, August 30, 1996 RFP AVAILABLE: NIH-NIAID-DMID-97-07 P.T. 34; K.W. 0715182, 0755015 National Institute of Allergy and Infectious Disease The Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases has a requirement for one Sexually Transmitted Diseases Clinical Trials Unit (STD CTU). This STD CTU will conduct clinical studies, Phase I and Phase II, to evaluate biomedical and behavioral interventions to prevent and control STDs. It is anticipated that one cost-reimbursement, completion type contract will be awarded for a period of five years. RFP NIH-NIAID-DMID-97-07 will be available electronically on or about August 26, 1996, and may be accessed through either the NIH Home Page or the NIH Gopher by using the following electronic mail addresses and instructions: 1. NIH Home Page (via the World Wide Web): Access the NIH Home Page by using http://www.nih.gov. Once you are at the NIH Home Page, select "Grants & Contracts", then select "Funding Opportunities," then select "R&D Requests for Proposals (RFP)." 2. To access the NIH Gopher: Point your gopher client to gopher.nih.gov PORT 70 (you should now be in the NIH Gopher). Select "Grants & Research Information," then select "R&D Requests for Proposals (RFP)." INQUIRIES The RFP includes only the Work Statement, deliverable and reporting requirements, special requirements and mandatory qualification, if any, the Technical Evaluation Criteria, and proposal preparation instructions. All information required to submit an offer is contained in the electronic RFP package. Responses to this RFP will be due on January 15, 1997. Any responsible offeror may submit a proposal that will be considered by the Government. This advertisement does not commit the Government to award a contract. Offerors who intent to submit a proposal in response to this RFP should notify: Sara Southard Contracts Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C04 Rockville, MD 20892 Telephone: (301) 496-6289 Email: ss63e@nih.gov $$R2 END ************************************************************ $$R3 BEGIN NIH-NINDS-96-13 ****************************************** LARGE SCALE AUTOMATED DNA SEQUENCING OF HUMAN GENES INVOLVED IN NEUROLOGICAL DISORDERS NIH GUIDE, Volume 25, Number 29, August 30, 1996 RFP AVAILABLE: NIH-NINDS-96-13 P.T. 34; K.W. 0755045, 0715138 National Institute of Neurological Disorders and Stroke The NINDS has a requirement for the continued development of highly reproducible rapid DNA template production and purification procedures that provide DNA of sufficient purity for highly accurate automated DNA sequence analysis and significantly improve techniques currently used for genotyping and positional cloning. Additional requirements include screening and amplification of clones from lambda, cosmid, or YAC libraries and biological samples. Libraries of plasmid subclones are to be made from the larger clones. Genetic typing with highly informative PCR based markers shall also be required. Work under the proposed contract will support the objectives of the NINDS Core DNA Facility. The NINDS Facility provides rapid DNA sequencing and other types of DNA analysis to NINDS scientists for use in Basic Neuroscience and Clinical Neurogenetics projects. The Contractor will be required to provide approximately 5,000 purified DNA template preparations/year by generating nested deletions in clones of interest; perform genotyping in the amount of approximately 300 markers per 200 DNA samples/year; and perform screening of approximately 10 libraries. The sources of DNA shall be provided by the Government. The NINDS DNA Facility will be responsible for evaluation of materials and results. Prospective offerors must have staff with expertise and experience in molecular biology, nucleic acid biochemistry, computer analysis and robotics; and operational experience in large scale DNA isolation and analysis techniques, basic microbiological techniques, use of DNA modifying enzymes, bacterial transformation, DNA hybridization and use of polymerase chain reaction (PCR). This is a recompetition or work currently being performed under Contract NO1-NS-4-2305, with Genome Therapeutics Corporation, Waltham, MA. The Government anticipates awarding one contract with a performance period of five years. RFP No. NIH-NINDS-96-13 will be issued on or about September 6, 1996, with a tentative closing date for receipt of proposals of October 31, 1996. INQUIRIES All responsible sources are encouraged to submit a proposal that will be considered by the NINDS. To receive a copy of the RFP, submit a written request and two self-addressed mailing labels to: Kirkland L. Davis Contracts Management Branch National Institute of Neurological Disorders and Stroke 7550 Wisconsin Avenue, Room 901 - MSC 9190 Bethesda, MD 20892-9190 ATTN: RFP No. NIH-NINDS-96-13 $$R3 END ************************************************************ $$R4 BEGIN HL-96-015 FULL-TEXT ************************************** MOLECULAR BIOLOGY AND GENETICS OF SLEEP AND SLEEP DISORDERS NIH GUIDE, Volume 25, Number 29, August 30, 1996 RFA AVAILABLE: HL-96-015 P.T. 34; K.W. 0715187, 1002008, 1002019 National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Child Health and Human Development Letter of Intent Receipt Date: January 6, 1997 Application Receipt Date: March 13, 1997 PURPOSE The purpose of this initiative is to advance our understanding of the molecular and genetic basis of sleep and sleep disorders. Research project grant (R01) applications that bring together expertise in sleep, chronobiology, molecular biology, and genetics are encouraged. Specifically, the program is designed to stimulate studies on basic molecular correlates of sleep, cellular mechanisms responsible for restorative processes during sleep, the interactions between sleep and circadian systems controlling sleep and wakefulness at a molecular level, the genetic basis of sleep disorders, and the molecular neurobiology of sleep. Studies are also needed to identify specific sleep regulating molecules and their receptors. An essential requirement of this RFA is that the framework for proposed studies include molecular or genetic approaches. It is anticipated that for FY 1997, approximately $2,000,000 from the NHLBI, $800,000 >From NIMH, and $400,000 from NICHD will be available to fund between 12 to 15 awards for the first year of this initiative. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This request for applications (RFA), Molecular Biology and Genetics of Sleep and Sleep Disorders, is related to the priority areas of heart disease and stroke, chronic disabling conditions, mental health and disorders, maternal and infant health, and clinical prevention services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. James P. Kiley, Ph.D. National Center on Sleep Disorders Research National Heart, Lung, Blood Institute 6701 Rockledge Drive, Suite 7024, MSC-7920 Bethesda, MD 20892-7920 Telephone: (301) 435-0199 FAX: (301) 480-3451 Email: kileyj@nih.gov Israel I. Lederhendler, Ph.D. Coordinator for Sleep Research National Institute of Mental Health 5600 Fishers Lane, Room 11-102 Rockville, MD 20857 Telephone: (301) 443-1576 FAX: (301) 443-4822 Email: ilu@helix.nih.gov Marian Willinger, Ph.D. Pregnancy and Perinatology Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B03 Bethesda, MD 20892 Telephone: (301) 496-5575 Email: willingm@hd01.nichd.nih.gov $$R4 END ************************************************************ $$P1 BEGIN PA-96-071 FULL-TEXT ************************************** DNA DAMAGE AND REPAIR IN CENTRAL NERVOUS SYSTEM INJURY NIH GUIDE, Volume 25, Number 29, August 30, 1996 PA AVAILABLE: PA-96-071 P.T. 34; K.W. 0705055, 0715027, 0765040 National Institute of Neurological Disorders and Stroke PURPOSE The National Institute of Neurological Disorders and Stroke (NINDS), invites applications for support of research that will increase our knowledge of the genetic, molecular, cellular, and physiological mechanisms of DNA injury and repair mechanisms in the nervous system after ischemic and traumatic injury, and in neurodegenerative disorders. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, DNA Damage and Repair in CNS Injury, is related to the priority areas of heart disease and stroke and unintentional injuries. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Dr. Thomas P. Jacobs Division of Stroke and Trauma National Institute of Neurological Disorders and Stroke Federal Building, Room 8A13 Bethesda, MD 20892 Telephone: (301) 496-4226 FAX: (301) 480-1080 Email: TJ12G@NIH.GOV $$P1 END ************************************************************ From owner-sci-resources@net.bio.net Fri Aug 30 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-96-015 - V25(29) 08/30/96 Date: 30 Aug 1996 17:07:14 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 583 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <507vni$ksd@net.bio.net> NNTP-Posting-Host: net.bio.net MOLECULAR BIOLOGY AND GENETICS OF SLEEP AND SLEEP DISORDERS NIH GUIDE, Volume 25, Number 29, August 30, 1996 RFA: HL-96-015 P.T. 34; K.W. 0715187, 1002008, 1002019 National Heart, Lung, and Blood Institute National Institute on Mental Health National Institute on Child Health and Human Development Letter of Intent Receipt Date: January 6, 1997 Application Receipt Date: March 13, 1997 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS AND INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS AND MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The purpose of this initiative is to advance our understanding of the molecular and genetic basis of sleep and sleep disorders. Specifically, the program is designed to stimulate studies on basic molecular correlates of sleep, cellular mechanisms responsible for restorative processes during sleep, the interactions between sleep and circadian systems controlling sleep and wakefulness at a molecular level, the genetic basis of sleep disorders, and the molecular neurobiology of sleep and sleep disorders. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This request for applications (RFA), Molecular Biology and Genetics of Sleep and Sleep Disorders, is related to the priority areas of heart disease and stroke, chronic disabling conditions, mental health and disorders, maternal and infant health, and clinical prevention services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Foreign institutions may not apply. However, subcontracts to foreign institutions maybe allowed if justified. Ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Collaborations and consortia promoting the cross-fertilization of ideas are strongly encouraged. In such cases, each participant's contribution should be identified and well-integrated into the overall experimental design. MECHANISM OF SUPPORT This RFA will use the NIH individual research project grant (R01) mechanism of support. Awards will be made and managed by the National Heart, Lung, and Blood Institute (NHLBI) and/or the National Institute of Mental Health (NIMH) and/or the National Institute on Child Health and Human Development (NICHD). Policies that govern the research grants programs of the NIH will prevail. However, specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, applicant institutions, reviewers, and Institute staff. For this RFA, funds must be requested in $25,000 direct cost modules and a maximum of 9 modules ($225,000 direct costs) per year may be requested. A feature of the modular grant concept is that no escalation is provided for future years, and all anticipated expenses for all years of the project must be included within the number of modules being requested. Only limited budget information will be required and any budget adjustments made by the Initial Review Group will be in modules of $25,000. Instructions for completing the Biographical Sketch have also been modified. In addition, Other Support information and the application Checklist page are not required as part of the initial application. If there is a possibility for an award, necessary budget, Other Support and Checklist information will be requested by staff at NHLBI and/or NIMH and/or NICHD following the initial review. The APPLICATION PROCEDURES section of this RFA provides specific details of these modifications to standard PHS 398 application kit instructions. This RFA is a one time solicitation. Future unsolicited competing continuation applications will compete with all investigator initiated applications and be reviewed according to customary peer review procedures. FUNDS AVAILABLE It is anticipated that during fiscal year 1997, support will be available for total costs of approximately $2,000,000 from the NHLBI, $800,000 from NIMH, and $400,000 from NICHD for the first year of this initiative. Award of grants pursuant to this RFA is contingent upon receipt of such funds for this purpose. It is anticipated that approximately 12 to 15 grants will be awarded under this program. Applicants may request up to four years of support. The specific number to be funded will, however, depend on the merit and scope of the applications received and on the availability of funds. Direct costs will be awarded in modules of $25,000, less any overlap or other necessary administrative adjustments. Indirect costs will be awarded based on the negotiated rates. RESEARCH OBJECTIVES Background Sleep related problems represent a significant health concern for millions of Americans and all age groups. The impact of sleep disturbances on society includes reduced productivity, lowered cognitive performance, increased likelihood of accidents, decreased quality of life, and higher risk of morbidity and mortality. Sleep disturbances are important markers of affective disorders and possibly are a contributing factor in the pathogenesis of Sudden Infant Death Syndrome. Although recent scientific progress has provided a strong foundation for advancing our basic scientific understanding of this important clinical problem, neurobiological mechanisms underlying normal and disordered sleep remain largely unknown. Physiological, metabolic, and behavioral processes during sleep contribute to the normal function and maturation of the nervous system. Improved understanding of how sleep modifies the nervous system at a molecular level is critical to develop new approaches for the primary prevention and treatment of sleep disorders. Research Scope Little is currently known about the molecular events involved in sleep regulation or the restorative processes that occur in neurons and/or glia during sleep. Consequently, there are a number of directions that could be pursued by applicants responding to this RFA. The topics that follow serve as examples and are not a comprehensive or exclusive list of the areas supported by this initiative. Applicants are encouraged to propose other topics consistent with the goals of this program. An essential requirement of this RFA is that the framework for proposed studies include molecular or genetic approaches. A current hypothesis is that sleep-promoting compounds accumulate during wakefulness and are dissipated during sleep. Although a number of candidate compounds have been proposed, the study of these compounds needs to be extended to a molecular level. For instance, we need to know whether molecular events leading to the formation of sleep promoting molecules or their receptors are regulated by the sleep/wake cycle and how this regulation is achieved in relevant brain regions. Defining the basic role of sleep in health and disease represents a significant, unmet biological challenge. One theory is that sleep has a restorative role such as replenishing the energy stores of glia or contributing to the reorganization of synaptic connections. Molecular studies to test these hypotheses are strongly encouraged. A related question is whether molecular changes in brain function accompany sleep deprivation. Sleep deprivation may have long-term effects through changes in gene expression (e.g. IL-1beta, TNF, and prostaglandins) and neuronal plasticity. Where are these genes regulated (cell type, location) and what signals account for changes in transcriptional regulation? Studies are also needed to identify the role of specific sleep regulating molecules that provoke the development of major affective disorders or are linked to cardiorespiratory or thermoregulatory function. Animal models are needed to study the development and maintenance of neuronal circuitry controlling sleep (e.g. synaptogenesis, neural plasticity) using molecular techniques. The mouse provides an especially useful vehicle for studying homeostatic control of sleep because techniques are available to precisely manipulate gene expression in this species. The role of specific genes in sleep disorders could be investigated using knock-out, knock-in, and other recently developed transgenic techniques in mouse models. Current definitions of sleep are based primarily on criteria derived >From the mammalian electroencephalogram and hence limit the study of sleep to mammalian species. However, the genome of nonmammalian species (e.g., Drosophila, C. Elegans) is more easily manipulated and presents the opportunity to develop model systems in which the basic control mechanisms governing activity cycles and their effects on neurobiological processes can be investigated. The development of new approaches enabling the neurobiological significance of sleep to be studied in nonmammalian species is encouraged. There are significant changes to the sleep process that occur across the life span. The neurobiological basis for such changes and especially the role of sleep regulating molecules in development and aging requires investigation. Animal models containing specific gene deletions may have unique value for studying the molecular basis for altered patterns of sleep and rhythmicity associated with development or traumatic experiences. Studies are also needed to determine whether neurodegenerative mechanisms (e.g., apoptosis) or molecular defects in neuroendocrine regulation are factors in the pathogenesis of sleep disorders with age. Genetic factors are implicated in many sleep disorders, e.g., narcolepsy, restless legs syndrome (RLS) and obstructive sleep apnea (OSA). Narcolepsy is associated with an HLA subtype and close relatives of individuals with narcolepsy have a much greater risk of having the disorder. Studies are needed in human narcolepsy to advance our understanding of fundamental sleep mechanisms and open new areas of investigation. Narcolepsy in a canine model of the disorder is transmitted as a single autosomal recessive trait. However, genetic studies in the canine model have been hampered by the lack of information on the canine genome. On the other hand, a large base of genetic information is available in mice. The development of a mouse model of narcolepsy would advance markedly studies of this disease and create new opportunities to investigate the genetic basis for sleep disorders. In this regard, genetic factors are also thought to contribute significantly to restless leg syndrome (RLS) and obstructive sleep apnea (OSA) since multiple family members are frequently affected when one of these disorders is present. In the case of OSA, familial risk seems to be associated with certain facial bony structures suggesting that the genes determining that structure are involved. A close familial association may also exist with respect to primary insomnia. Studies contributing a more precise definition of the genetic basis for these and other sleep disorders including elements associated with behavioral and mental disorders and genetic disorders affecting arousal and cardiorespiratory or thermoregulatory function during sleep and infancy will be responsive. SPECIAL REQUIREMENTS The primary focus of proposed studies must be on the molecular or genetic basis of sleep and sleep disorders. Studies of the circadian system must be tightly coupled to mechanisms of sleep control. Psychobiological, neurophysiological, anatomical, or polysomnographic studies which do not include molecular or genetic approaches to understanding sleep will be considered unresponsive to this RFA. Pharmacological studies that investigate the efficacy of sleep promoting agents but not the underlying molecular mechanisms will also not be acceptable. Studies proposing the use of nonmammalian species should clearly establish the relationship of these models to the goals set forth in this RFA. Applicants are encouraged to contact the program officials listed under INQUIRIES for further information. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (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 policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994, (F 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies of the policy from these sources or >From the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by January 6, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel, participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIH staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be faxed or sent to Dr. C. James Scheirer, at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. 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, to identify the application as a response to this RFA, check "YES" in item 2 of page 1 of the application and enter the title "Molecular Biology and Genetics of Sleep and Sleep Disorders, HL-96-015". The following modifications are made to the standard PHS 398 application instructions: BUDGET INSTRUCTIONS The total direct costs must be requested in accordance with the program guidelines and modifications made to the standard PHS 398 application instructions as described below: o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398 (rev 5/95). It is not required nor will it be accepted at the time of application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget tables on Form page 5 of the PHS 398 (rev. 5/95). Only the requested total direct costs line for each year must be completed based on the number of $25,000 modules being requested. Applicants may not request a change in the amount of each module. A maximum of 9 modules ($225,000 direct costs) per year may be requested and each applicant may request up to four years of support for this RFA. Direct cost budget remain constant throughout the life of the project (i.e., the same number of modules requested for all budget periods). Any necessary escalation should be considered when determining the number of modules to be requested. However, in the event that the number of modules requested must change in any future year due to the nature of the research proposed, appropriate justification must be provided. Total Direct Costs for the Entire Proposed Project Period should be shown in the box provided. o BUDGET JUSTIFICATION - Budget justifications should be provided under "Justifications" on Form Page 5 of the PHS 398. - List the names, role on the project and proposed percent effort for all project personnel (salaried or unsalaried) and provide a narrative justification for each person based on his/her role on the project. - Identify all consultants by name and organizational affiliation and describe the services to be performed. -Provide a general narrative justification for individual categories (equipment, supplies, etc.) required to complete the work proposed. More detailed justifications should be provided for high cost items. Any large one-time purchases, such as large equipment requests, must be accommodated within these limits. o CONSORTIUM/CONTRACTUAL COSTS - If collaborations or subcontracts are involved that require transfer of funds from the grantee to other institutions, it is necessary to establish formal subcontract agreements with each collaborating institution. A letter of intent >From each collaborating institution should be submitted with the application. Only the percentage of the consortium/contractual TOTAL COSTS (direct and indirect) relative to the total DIRECT COSTS of the overall project needs to be stated at this time. The following example should be used to indicate the percentage cost of the consortium, "The consortium agreement represents 27% of overall $175,000 direct costs requested in the first year". A budget justification for the consortium should be provided as described in the "Budget Justification" section above (no Form Page 5 required for the consortium). Please indicate whether the consortium will be in place for the entire project period and identify any future year changes in the percentage relative to the parent grant. If there is a possibility for an award, the applicant will be requested to identify actual direct and indirect costs for all years of the consortium. Please note that total subcontract costs need not be calculated in $25,000 modules. However, when subcontract funds are added to the parent grant budget, the total direct cost amount must be included in the number of $25,000 modules requested. o BIOGRAPHICAL SKETCH - Biographical sketches are required for key personnel, following the modified instructions below. Do not exceed the two-page limit for each person. - Complete the educational block at the top of the form page; - List current position(s) and those previous positions directly relevant to the application; - List selected peer-reviewed publications directly relevant to the proposed project, with full citation; - The applicant has the option to provide information on research projects completed and/or research grants participated in during the last five years that are relevant to the proposed project. o OTHER SUPPORT - Do not complete the "Other Support" pages (Form Page 7). Selected other support information relevant to the proposed research may be included in the Biographical Sketch as indicated above. Complete Other Support information will be requested by the staff of NHLBI or collaborating Institutes if there is a possibility for an award. o CHECKLIST - No "Checklist" page is required as part of the initial application. A completed Checklist will be requested by the staff of NHLBI or collaborating Institutes if there is a possibility for an award. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Applications not conforming to these guidelines will be considered unresponsive to this RFA and will be returned without further review. Submit a signed, typewritten original of the application and three signed, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to Dr. C. James Scheirer, at the address listed under INQUIRIES. Applications must be received by March 13, 1997. If an application is received after this date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will also not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. o A sample budget is available upon request from Mr. Raymond Zimmerman at the number listed under INQUIRIES. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness to this RFA by the collaborating institutes. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Affairs, NHLBI. As part of the initial merit review, all applications will receive a written critique and undergo a review in which only those applications deemed to have the highest scientific merit of the applications under review (usually two to three times the number of applications that the NHLBI and participating Institutes anticipate being able to fund under the program) will be discussed, assigned a priority score, and receive a second level review by the National Heart, Lung, and Blood Advisory Council and the Advisory Council of NIMH and/or NICHD. The following criteria will be considered when assessing the scientific and technical merit of a research grant application: o Scientific, technical, or medical significance and originality of proposed research. o Appropriateness and adequacy of the experimental approach and methodology. o Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research. Applications that couple basic sleep with molecular biology or genetics expertise are strongly encouraged. o Availability of the resources necessary to perform the research. The personnel category will be reviewed for appropriate staffing based on the requested percent effort. The direct costs budget request will be reviewed for consistency with the proposed methods and specific aims. Any budgetary adjustments recommended by the reviewers will be in $25,000 modules. The duration of support will be reviewed to determine if it is appropriate to ensure successful completion of the requested scope of the project. AWARD CRITERIA The anticipated date of award is September 30, 1997. Factors that will be taken into consideration in making awards include the scientific merit of the proposed program as evidenced by the priority score and the availability of funds. Subject to the availability of necessary funds and consonant with the priorities of this RFA, the NHLBI, NIMH, and/or NICHD will provide funds for a project period up to four years. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: James P. Kiley, Ph.D. National Center on Sleep Disorders Research National Heart, Lung, Blood Institute 6701 Rockledge Drive, Suite 7024, MSC-7920 Bethesda, MD 20892-7920 Telephone: (301) 435-0199 FAX: (301) 480-3451 Email: Kileyj@nih.gov Israel I. Lederhendler, Ph.D. Coordinator for Sleep Research National Institute of Mental Health 5600 Fishers Lane, Room 11-102 Rockville, MD 20857 Telephone: (301) 443-1576 FAX: (301) 443-4822 Email: ilu@helix.nih.gov Marian Willinger, Ph.D. Pregnancy and Perinatology Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B03 Bethesda, MD 20892 Telephone: (301) 496-5575 Email: willingm@hd01.nichd.nih.gov Direct inquiries regarding review matters to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7220, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0266 FAX: (301) 480-3541 Email: ScheireJ@nih.gov Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7154 Bethesda, MD 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310 Email: ZimmermR@nih.gov Diana Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-3065 Email: dt21a@nih.gov Douglas Shawver Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17 Bethesda, MD 20892 Telephone: (301) 496-1303 Email: shawverd@hd01.nichd.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Grants are made under the authorization of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended by Public Law 99-158, 42 US 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is subject to the intergovernmental review requirements of Executive Order 12372 or to a review by a Health Systems Agency. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Aug 30 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-071 - V25(29) 08/30/96 Date: 30 Aug 1996 17:07:35 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 313 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <507vo7$ktc@net.bio.net> NNTP-Posting-Host: net.bio.net DNA DAMAGE AND REPAIR IN CENTRAL NERVOUS SYSTEM INJURY NIH GUIDE, Volume 25, Number 29, August 30, 1996 PA NUMBER: PA-96-071 P.T. 34; K.W. 0705055, 0715027, 0765040 National Institute of Neurological Disorders and Stroke PURPOSE The National Institute of Neurological Disorders and Stroke (NINDS), invites applications for support of research that will increase our knowledge of the genetic, molecular, cellular, and physiological mechanisms of DNA injury and repair mechanisms in the nervous system after ischemic and traumatic injury, and in neurodegenerative disorders. 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, DNA Damage and Repair in CNS Injury, is related to the priority areas of heart disease and stroke and unintentional injuries. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign institutions, for-profit and non-profit organizations, public or private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards and program project (P01) grants. Applications from minority institutions, minority individuals, and women are particularly encouraged. MECHANISM OF SUPPORT The mechanisms of support for grants in this area will be the investigator-initiated research project grant (R01), FIRST (R29) award, and program project grant (P01). The principal investigator will plan, direct, and, along with any co-investigators, perform the research. Applicants planning to submit a new (Type 1) investigator-initiated grant application requesting $500,000 or more in direct costs for any year must contact NINDS program staff before submitting the application. A cover letter that identifies the program staff member who agrees to accept the assigned application must be sent with the application. RESEARCH OBJECTIVES Background: The basis of current knowledge and concepts of DNA damage and repair are largely derived from non-neuronal cells/tissues and non-mammalian research. Therefore, a significant gap of knowledge exists concerning the fundamental biochemical processes that may lead to DNA damage and repair in the brain, and the physiological relevance of such processes. There is evidence of DNA damage in experimental stroke and trauma, and neurodegenerative processes have been attributed to impairment in DNA repair mechanisms. Thus, DNA damage is a likely factor in promoting CNS pathophysiology, and DNA repair may be an important mechanism for maintenance of normal physiological function. DNA damage and repair are vibrant areas of research with broad implications for understanding pathology in human disease and injury. The application of the science of DNA injury and repair may yield new and important information on mechanisms of neuronal damage, and provide opportunities for the development of novel and effective therapies to reduce CNS injury in stroke, trauma, and neurodegenerative disorders. The NINDS supports many basic and applied science programs focused on understanding the biology of neurons and glia. It is anticipated that further progress in basic neurobiology will provide insight into the inordinately complex molecular and cellular processes involved in CNS ischemic and traumatic injury and repair. Therefore, the intent of this announcement is to encourage investigator-initiated applications to study the mechanisms of DNA damage and repair in cerebral ischemia and CNS trauma. Research Goals and Scope: Examples of investigator-initiated research grant applications for basic, applied, and clinical studies related to the understanding of DNA damage and repair mechanisms in the CNS, may include, but should not necessarily be limited to: o Investigate the mechanisms of DNA damage and repair in neurons, since our knowledge base, thus far, has been largely derived from non-neuronal tissue (dividing cells); o Clarify the causal relationships between DNA damage and pathological CNS responses to stroke and CNS trauma and neurodegenerative disorders; o Explore the role of ICE, Bcl-2, p53, DNA pol b, bax and related genes and gene families in DNA damage and repair in CNS injury and neurodegenerative disorders; o Define critical events in pathological cascades resulting from DNA damage such as trigger points or points at which reversible and irreversible damage occurs; o Identify genomic locations of DNA damage and repair in neurons for an accurate assessment of the biological importance of these lesions; o Assess the differences between potentially deficient transcription-coupled repair and global repair mechanisms in selective regions after CNS injury; o Identify genes, enzymes, and receptors associated with DNA repair in neurons; o Assess the effects of DNA injury on the expression of trophic factors involved in either development or regeneration after CNS injury; o Identify the contribution of extracellular (e.g. NMDA, NO, pH, Ca++) and intracellular (e.g. mitochondrial dysfunction, deacylation of phospholipids) mechanisms to DNA damage and apoptosis in neurons; o Investigate the role of DNA injury and repair as mechanisms underlying selective vulnerability, penumbra, pre-conditioning, delayed cell death, and reperfusion injury in the CNS; o Examine the role of the DNA repair enzymes in cerebral injury from stroke and trauma using transgenic animals with various defects of nucleotide excision repair; o Assess the extent to which DNA damage and defective repair in utero may compromise normal fetal development of the CNS; o Investigate the role of DNA repair mechanisms and responses of the cerebral blood vessel wall cells following CNS ischemia and trauma. Cerebrovascular responses are virtually unexplored and could provide insight into the role of angiogenesis in CNS cell and tissue survival; o Identify methods to measure DNA damage non-invasively in the brain (e.g., SPECT, MRI). Applicants are encouraged to develop and use new or refined methodologies, instrumentation, and procedures that will reveal mechanistic details of the CNS injury and reparative processes. Basic, applied, or clinical studies to improve DNA damage and repair control, prevent molecular pathophysiological changes, or restrain cell death are welcome. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) according to the instructions included in the application package. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The title and number of the program announcement must be typed in Section 2 on the face page of the application. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE ROOM 1040 MSC 7710 BETHESDA MD 20892-7710 BETHESDA MD 20817 (for courier service) A number of other Institutes, Centers and Divisions (ICD) at the NIH may be interested in the general subject of this program announcement. For example, the NINDS and the NIA have mutual interest in understanding chronic neurodegenerative disorders such as Alzheimer's Disease. Applications submitted in response to this PA that propose to do research in scientific areas that overlap ICD interests will receive a funding component assignment in accord with existing referral guidelines and procedures established by the Division of Research Grants, NIH. REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA The standard review criteria will be used to assess the scientific merit of applications. Applications will compete for available funds with all other applications. The following will be considered when making funding decisions: o quality of the proposed projects as determined by peer review; o availability of funds; and o program balance among research areas. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Dr. Thomas P. Jacobs Division of Stroke and Trauma National Institute of Neurological Disorders and Stroke Federal Building, Room 8A13 Bethesda, MD 20892 Telephone: (301) 496-4226 FAX: (301) 480-1080 Email: TJ12G@NIH.GOV Dr. Mary Ellen Cheung Division of Stroke and Trauma National Institute of Neurological Disorders and Stroke Federal Building, Room 8A13 Bethesda, MD 20892 Telephone: (301) 496-4226 FAX: (301) 480-1080 Email: MM108W@NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Kathleen Howe Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 Bethesda, MD 20892 Telephone: (301) 496-9231 FAX: (301) 402-0219 Email: KH52X@NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance, Number 93.853, Clinical Research Related to Neurological Disorders, and 93.854, Biological Basis Research in the Neurosciences. Grants will be awarded under the authority of the Public Health Service Act, Title IV, Section 301 (Public Law 78-410, as amended: 42 USC 241) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR 74. This program is not subject to Health Services Agency Review of the intergovernmental review requirements of Executive Order 12372. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.