From owner-sci-resources@net.bio.net Tue Apr 02 23:00:00 1996 Path: biosci!biosci!not-for-mail From: Mary Hilts Newsgroups: bionet.sci-resources Subject: SBIR Conference Date: 2 Apr 1996 17:23:19 -0800 Organization: Foresight Science & Technology Lines: 50 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <31617DA8.6919@foresnt.com> NNTP-Posting-Host: net.bio.net National Conference To Provide Access to Largest Source of Early-Stage Technology Financing in U.S. The federal government funds nearly $1 billion each year in early-stage R&D projects at small technology companies through its Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. These programs fund R&D projects that serve a government need and often have commercial applications, providing: up to $850,000 in pre-prototype R&D funding directly to small technology companies (or to individual entrepreneurs who form a company); and up to $850,000 in pre-prototype R&D funding to small companies working cooperatively with researchers at universities and other research institutions. Small companies retain the patent rights to any inventions they develop. Funding is awarded competitively, but the process is streamlined and user-friendly. To facilitate participation in these programs, the National Science Foundation, Department of Defense, the U.S. Small Business Administration, and seven other federal agencies are sponsoring a National SBIR Conference at the Dallas Airport Hyatt Regency in Dallas, Texas, April 29 through May 1, 1996. At the conference, small businesses and others will be able to meet individually with federal SBIR and STTR program managers and representatives from some of the nation=92s largest companies seeking partnerships with small companies. The conference will feature seminars conducted by national experts on topics ranging from starting and financing a small technology company to SBIR/STTR proposal preparation and federal procurement procedures. The Honorable Philip Lader, Administrator of the U.S. Small Business Administration, will be the keynote speaker. For information: Call the Conference Hotline at:(407)791-0720 Write to: NSBIR Conference Registration Office, c/o Foresight Science & Technology, P.O. Box 210065, West Palm Beach, FL 33421-0065 Log-on to the NSBIR Conference World Wide Web pages at www.seeport.com E-mail the Conference Listserver at list@seeport.com (On the first line of your message, type JOIN SBIR.) E-mail our conference registration specialist, teddy@seeport.com Faxback the conference brochure & registration form by dialing:(407)791-0098 From owner-sci-resources@net.bio.net Thu Apr 04 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-96-010 - V25(10) 03/29/96 Date: 4 Apr 1996 20:59:53 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 437 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4k29c9$mst@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA96010 CA-96-010 P1O1 *************************************** MECHANISMS OF GENOMIC INSTABILITY FROM THE EXPOSURE OF MAMMALIAN CELLS TO HIGH-LET IONIZING RADIATIONS NIH GUIDE, Volume 25, Number 10, March 29, 1996 RFA: CA-96-010 P.T. 34; K.W. 0725015, 1215018, 1002019, 1002008 National Cancer Institute National Aeronautics and Space Administration Letter of Intent Receipt Date: April 24, 1996 Application Receipt Date: June 14, 1996 PURPOSE The Division of Cancer Biology of the National Cancer Institute (NCI) and the Life and Biomedical Sciences and Applications Division of the National Aeronautics and Space Administration (NASA) invite research project grant (R01) applications from interested investigators for studies of the basic molecular mechanisms of long-term (heritable) genomic instability (GI) that is induced in mammalian (or suitable model eukaryotic) cells in organisms exposed to various forms of high-linear-energy-transfer (high-LET) radiation. The primary purpose and interest of both agencies in this Request for Applications (RFA) is to define and understand GI from chronic low-dose exposure of mammalian cells to high energy nuclei of high atomic number (referred to as HZE) particles (e.g., iron) and to high-energy protons, which are likely to be major sources of human exposure to high-LET radiation during extended space flight. It is also of interest to delineate the mechanistic basis for GI from chronic low-dose exposure of mammalian cells to low-energy neutrons or alpha particles (a surrogate for radioactive radon daughters) that are important sources of human exposure in environmental and certain occupational settings. In addition, both agencies have a continuing interest in the possible use of molecular changes that may accompany radiation-induced GI as biomarkers of human exposure to high-LET. 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, Mechanisms of Genomic Instability from the Exposure of Mammalian Cells to High-LET Ionizing Radiations, is related to the priority areas of biomedical and environmental health research. 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 institutions, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA is a one-time solicitation and will be supported through the National Institutes of Health (NIH) investigator-initiated research project grant (R01). The applicant will have the sole responsibility for planning, directing, and executing the proposed research. The total project period for an application submitted in response to this RFA may not exceed four years. At the end of the four-year RFA support period, competitive continuation applications will compete with all other unsolicited applications and be reviewed by a standing Division of Research Grants (DRG) Study Section. The anticipated average direct costs for an application in response to this RFA will be approximately $130,000, although applications with greater or lesser direct costs than this figure will be considered, depending on the nature of the proposed research. The anticipated date of award for the RFA is April 1, 1997. FUNDS AVAILABLE The intent of this research initiative is to fund approximately 10 individual research grants, with total program costs (direct plus indirect) not to exceed $2 million for the first year. It is planned that some portion of these funds (i.e., not to exceed $500,000) may be set-aside to procure beam-time and dosimetry support for HZE and high-energy proton studies at designated sites. Support for this RFA is provided in the financial plans of the NCI and NASA. However, award of grants responding to this RFA will be contingent on the availability of funds at the time the awards are made and also on the receipt of a sufficient number of grant applications of high scientific merit. RESEARCH OBJECTIVES Background A striking phenotypic characteristic of high-LET-induced GI in primary human or rodent cells is the long-term accumulation of genetic abnormalities (e.g., chromosomal aberrations) among progeny of irradiated cells. Most of the other changes associated with radiation-induced GI also involve genes (e.g., point and deletion mutations) or chromosomes; however, none has been studied to the same degree as have cytogenetic effects. Nevertheless, a number of studies that utilize a variety of biological systems and exposure conditions (e.g., primary and immortalized human and rodent cell lines, other eukaryotes, both high- and low-LET forms of ionizing radiation) suggest that radiation-induced GI may be characterized by: (1) eventual acquisition of a mutator phenotype by progeny cells, (2) extensive gene amplification (an early event) followed by generally increasing levels of genetic instability in duplicated sequences (e.g., insertions, deletions), (3) evidence for abnormally high rates of recombination during expression of GI, (4) possible non-random or "hotspot" associations of chromosomal instability and progressive expression of GI, and (5) evidence that the genetic instability associated with GI leads to neoplastic transformation in rodent cells. The mechanistic basis (or bases) for GI induced by either high- or low-LET radiations is unknown. However, it appears that a sizable fraction of mammalian cells that survive exposure to high-LET radiation can transmit the GI phenotype to their progeny. This comparatively high rate of GI induction among progeny of high-LET irradiated mammalian cells would appear to rule out a simple explanation for induction of GI based on radiation-induced forward mutations at individual loci. While all forms of ionizing radiation probably are capable of inducing GI, the limited studies with the high-LET radiations thus far examined suggest that they are far more potent than are low-LET gamma and x rays as inducers of GI. Single exposures of primary human or murine cells to comparatively low, non-killing doses of high-LET may be sufficient to induce significant expression of GI. By contrast, low-LET radiations appear to either not induce GI (e.g., most studies with primary mammalian cells) or to do so only after exposure to comparatively high doses of radiation (e.g., >1Gy). A fundamental question with respect to this RFA is whether the long-term expression of high-LET-induced GI ultimately results in elevated rates of mutagenesis and neoplastic transformation among progeny of irradiated primary human and rodent cell lines compared to background rates in non-irradiated cells. There is limited evidence that neutron-induced GI in progeny of primary murine mammary cells does, in fact, precede and then give rise to elevated rates of mutagenesis and neoplastic transformation compared to non-irradiated mammary cells otherwise treated in the same experimental way. There is little comparable information for most of the high-LET radiations of interest to this RFA; i.e., high-energy HZE particles, high-energy protons and alpha particles. In order to address the need for more basic information on the radiobiology of these forms of high-LET radiation, this RFA will permit a wide range of research activities, including, but not limited to, the following objectives: o Analysis of the role of the radiation-induced cell-cycle check points on the expression of GI; o The identification of DNA-sequences and specific genes that exhibit instability during the expression of GI, the analysis of the mutational changes that such DNA sequences undergo and their underlying generating mechanisms; o Molecular studies to determine if there is a cytogenetic mechanism(s) to account for both the progressive chromosomal and genetic instability observed in cells expressing radiation-induced GI; o Analysis of the role of recombination and DNA repair on the expression of radiation-induced GI; o Studies with preneoplastic cell lines, in vivo (implanted) and in vitro, to determine temporal and molecular relationships of radiation-induced GI to neoplastic transformation of non-immortalized cells; o The temporal and molecular relationships of radiation- induced GI to the acquisition and expression of a "mutator" phenotype among the progeny of irradiated cells. Beam time and dosimetry support for HZE and high-energy-proton studies supported by this RFA will be provided for qualified applicants at designated sources with high-LET radiation exposure capabilities (see below). Comparable exposure and dosimetry capabilities for alpha particles, neutrons or other sources of ionizing radiation must be provided for by the respondents. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Special instructions to applicants regarding implementation of NIH policies concerning inclusion of females and minorities in clinical research study populations are not applicable. Dosimetry and Beam Time for HZE Particles and High Energy Protons The National Aeronautics and Space Administration (NASA) conducts a ground-based program focused on mechanistic studies with the potential to enable extrapolation of scientific research results to human beings in space. In pursuit of this program, NASA has signed Memoranda of Agreement (MOA) with ground-based laboratories where energetic beams of protons and some atomic nuclei that constitute galactic cosmic rays (GCR) are available: (1) proton beams at the Loma Linda University Medical Center (protons with energies up to 250 MeV), and (2)the Alternating Synchrotron at Brookhaven National Laboratory (beams of iron and other heavy nuclei, with energies from 1 to 10 GeV/nucleon). Use of the Brookhaven facility has been negotiated by NASA in the framework of the Space Radiation Health Program, and successful respondents to this RFA will be considered to be part of the Space Radiation Health Program. Applicants should not budget separately for use of beam time and logistical support (e.g., dosimetry) for HZE studies carried out at this facility; funds for such beam time will be obtained from the set-aside monies indicated above, if necessary, or from other sources, if possible. Similar arrangements are intended for use of the beam time at Loma Linda University Medical Center for high-energy proton studies. It should be noted that no such agreements currently exist with other sources of radiation that may be relevant to this RFA (e.g., alpha particles, neutrons) and investigators requiring these sources should budget for their use. User facilities have been developed at Brookhaven for radiation-biology research, including cell cultures and small animals. Beams with energies as low as 1 GeV/nucleon have been extracted with beam spots up to 16 cm diameter, center to edge uniformity of 15%, and dose rates up to 11 Gy/min. A physics and dosimetry group is available at Brookhaven for investigators requiring their assistance. Use of the Brookhaven facilities will be coordinated by a laboratory-appointed panel and scheduled in accordance with available beam time and other laboratory resources. Applicants should not budget separately for use of the physics and dosimetry group as it is included in the set-aside funding for dosimetry and logistical support at BNL. It is expected that similar arrangements, taking advantage of existing in-house expertise, will be negotiated with Loma Linda University Medical Center, in the framework of the MOA with that institution. If exposures not available at Loma Linda or Brookhaven are needed for studies proposed in response to this RFA, applicants must indicate in their application how such exposures will be accomplished, provide evidence that the sources will be available for their use and indicate how the dosimetry and other physical characteristics of the radiation fields will be measured. LETTER OF INTENT Prospective applicants are asked to submit, by April 24, 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 that it contains allows NCI staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to either: Richard A. Pelroy, Ph.D. Division of Cancer Biology National Cancer Institute 6130 Executive Boulevard, Suite 530 - MSC 7391 Rockville, MD 20852-7391 Telephone: (301) 496-9326 FAX: (301) 496-1224 Email: pelroyd@epndce.nci.nih.gov, or Walter Schimmerling, Ph.D. NASA Space Radiation Health and Radiation Biology Programs NASA Headquarters/Code UL 300 E Street, S.W. Washington, DC 20546-001 Telephone: (202) 358-2205 FAX: (202) 358-4168 Email: wschimmerling@hq.nasa.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for this RFA. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov; and from the NCI and NASA staff listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the first page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier Service) At the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Suite 636 6130 Executive Boulevard - MSC 7405 Bethesda, MD 20892 Rockville, MD 20852 (express/courier service) Applications must be received by June 14, 1996. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review by a chartered study section unless the applicant withdraws the pending application. Also, DRG will not accept any application in response to this RFA 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 the DRG for completeness and by the NCI for responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, DRG staff may contact the applicant to determine whether to return the application to the applicant or submit it as is for review in competition with other unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer-review group convened by the NCI in accordance with NIH peer-review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally in the upper half of applications under review, will be discussed, assigned a priority score, and receive a second-level review by the National Cancer Advisory Board. Review Criteria o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of 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. AWARD CRITERIA Awards will be made on the basis of scientific merit, as determined by peer review, the degree that an application meets program priorities and the possible need to achieve programmatic balance to meet the overall objectives of the RFA. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquires regarding programmatic issues to: Richard A. Pelroy, Ph.D. Division of Cancer Biology National Cancer Institute 6130 Executive Boulevard, Suite 530 Rockville, MD 20852-7391 Telephone: (301) 496-9326 FAX: (301) 496-1224 Email: pelroyd@epndce.nci.nih.gov, or Walter Schimmerling, Ph.D. NASA Space Radiation Health and Radiation Biology Programs NASA Headquarters/Code UL 300 E Street, S.W. Washington, DC 20546-001 Telephone: (202) 358-2205 FAX: (202) 358-4168 Email: wschimmerling@hq.nasa.gov Direct inquiries regarding fiscal issues to: Ms. Marie N. Moyer Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 - MSC 7150 Bethesda, MD 20892 Telephone: (301) 496-7800, Ext 225 FAX: (301) 496-8601 Email: moyerm@gab.nci.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 Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and to 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 state of the American people. From owner-sci-resources@net.bio.net Thu Apr 04 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AA-96-002 - V25(10) 03/29/96 Date: 4 Apr 1996 20:59:20 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 336 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4k29b8$mr3@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AA96002 AA-96-002 P1O1 *************************************** ANTIBODIES AND ALCOHOL-RELATED BEHAVIOR NIH GUIDE, Volume 25, Number 10, March 29, 1996 RFA: AA-96-002 P.T. 34; K.W. 0404003, 0760050, 0760075 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: May 13, 1996 Application Receipt Date: June 13, 1996 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks research applications aimed at developing antibodies to proteins mediating alcohol-related behaviors. This Request for Applications (RFA) invites research applications that develop and utilize such antibodies to study the effects of ethanol on neurotransmitter receptor subtypes and second messenger proteins and on phosphorylation states involved in the actions of ethanol. Applications should develop and characterize highly specific antibodies to determine the distribution of the subunits in specific cell types, neural pathways, and brain regions known for their ethanol sensitivity. 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, Antibodies and Alcohol-Related Behavior, is related to the priority areas of alcohol abuse reduction and alcoholism treatment. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (Telephone: 202-512-1800). ELIGIBILITY Applications may be submitted by domestic and foreign, for-profit and non-profit, public and private organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Research support may be obtained through applications for a regular research project grant (R01) for up to five years. In FY 1995, the average total cost per year for new R01s funded by NIAAA was approximately $200,000. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. Program project grant applications (P01) will not be accepted for this RFA. Applicants may submit applications for Investigator-Initiated Interactive Research Project Grants (IRPGs). Interactive Research Project Grants require the coordinated submission of related research project grant (R01) and, to a limited extent FIRST Award (R29) applications from investigators who wish to collaborate on research, but do not require extensive shared physical resources. These applications must share a common theme and describe the objectives and scientific importance of the interchange of, for example, ideas, data, and materials among the collaborating investigators. A minimum of two independent investigators with related research objectives may submit concurrent, collaborative, cross-referenced individual R01 and R29 applications. Applicants may be from one or several institutions. Further information on these and other grant mechanisms may be obtained from the program staff listed under INQUIRIES. Further information on the IRPG mechanism is available in program announcement PA-96-001, NIH Guide for Grants and Contracts, Vol. 24, No. 35, October 6, 1995. FUNDS AVAILABLE It is estimated that up to $1.4 million will be available for approximately six to seven grants under this RFA in FY 1996. This level of support is dependent on the receipt of sufficient number of applications of high scientific merit. Although this program is provided for in the financial plan of NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. The earliest possible award date is September 30, 1996. RESEARCH OBJECTIVES Alcohol has the unique characteristic of being a very simple water- soluble molecule that interacts with specific hydrophobic domains of important proteins to alter their normal function. Such actions of alcohol on single molecules perturb the inter- and intracellular signaling systems containing those molecules and thereby exert diverse and profound effects on neural responses. As a result, ethanol is known to alter the activity of a variety of processes involved in synaptic transmission. Many studies indicate that ethanol acts directly on neurotransmitter receptors and second messenger proteins, thereby altering the normal neuronal activity. Proteins of interest include gamma-aminobutyric acid (GABA), glutamate (both the NMDA and AMPA types), serotonin, and dopamine receptors and cyclases, G-proteins, and protein kinases involved in signal transduction. Many of the proteins affected by ethanol are complex macromolecular proteins with numerous subtypes containing multiple subunits. Some protein assemblies are more sensitive to ethanol than others, such as observed for GABA and NMDA receptors. It is hypothesized that the subunit composition of the receptors in the brain is important in determining ethanol sensitivity. Unfortunately, sufficient probes are not available for studying all of the subunits and in sufficient quantities to make progress in determining the influence of each subunit in different regions of the brain. In addition, the phosphorylation state of the protein may be of crucial importance in the actions of ethanol on the protein. Knowing the specific receptor subtypes and phosphorylation states involved in ethanol actions, especially the distribution of the subunits and subtypes in specific nuclei, neural pathways, and brain regions known for their alcohol sensitivity, will provide a basis for rational medications development for treatment of ethanol-induced behaviors. Applications are encouraged to develop and produce antibodies as probes for identifying subunits of relevant ethanol-affected proteins in the brain that are not presently available or only in limited quantities. Applicants may undertake the development of specific antibodies or utilize antibodies obtained through subcontracts in exploring the properties of specified neuronal proteins. Applications should provide a means of producing the antibodies, as well as propose measures to ensure quality control, including specificity and cross-reactivity of the products. In addition, applicants are encouraged to develop monoclonal versions of the antibodies, to ensure batch-to-batch uniformity. SPECIAL REQUIREMENTS Since a purpose of this RFA is to provide unique sets of antibodies to NIAAA-funded researchers who are unable to obtain them for themselves, antibodies developed in this initiative should be made available to other investigators by an approved distribution plan in accordance with the "NIAAA Policy on Distribution of Unique Research Resources Produced with NIAAA Funding," and the PHS Policy Relating to Distribution of Unique Research Resources Produced with PHS Funding (NIH Guide, Volume 23, Number 26, July 15, 1994). Indication of the intent to comply with these policies will be considered in the Institute's award decisions. LETTER OF INTENT Prospective applicants are asked to submit, by May 13, 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 of 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 NIAAA staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: RFA-AA-96-002 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 409 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 FAX: (301) 443-6077 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained >From the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov; and from NIAAA staff listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Page limits and limits on size of type are strictly enforced. Non-conforming applications will be returned without being reviewed. Submit a signed, typewritten original of the application, including the checklist and three signed photo copies in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to: RFA AA-96-002 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 409 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) FAX: (301) 443-6077 Failure to forward the above two applications to NIAAA at the above address may delay consideration of an application such that it may not be received in time for FY 1996 funding consideration. Applications must be received by June 13, 1996. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, DRG staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAAA in accordance with the review criteria 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 applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. The second level of review will be provided by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria Criteria to be used in the scientific and technical merit review of the research grant applications will include the following: 1. The scientific, technical, or medical significance and originality of the proposed research. 2. The appropriateness and adequacy of the experimental approach and methodology, including adequacy of quality control methods, proposed to carry out the research. 3. The adequacy of the qualifications (including level of education and training) and relevant research experience of the principal investigator and key research personnel. 4. The availability of adequate facilities, general environment for the conduct of the proposed research, other resources, and collaborative arrangements necessary for the research. 5. The reasonableness of budget estimates and duration for the proposed research. 6. Where applicable, the adequacy of procedures to protect or minimize effects on animal subjects and the environment. AWARD CRITERIA Applications recommended for approval by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for funding on the basis of the overall scientific and technical merit of the application as determined by peer review, NIAAA programmatic needs and balance, adequacy of plans for sharing antibodies with other investigators, and the availability of funds. INQUIRIES Potential applicants are strongly encouraged to seek preapplication consultation, for which purpose they may contact the individuals listed below. Direct inquiries regarding the proposed research to: Walter A. Hunt, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4223 FAX: (301) 594-0673 Email: whunt@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Joseph Weeda Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4703 FAX: (301) 443-3891 Email: jweeda@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects;" Title 45 CFR Parts 74 and 92, "Administration of Grants;" and 45 CFR Part 46, "Protections of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Thu Apr 04 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DC-96-003 - V25(10) 03/29/96 Date: 4 Apr 1996 20:48:54 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 383 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4k28nm$lt8@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DC96003 DC-96-003 P1O1 *************************************** PHYSIOLOGIC AND MOLECULAR BASES OF TINNITUS NIH GUIDE, Volume 25, Number 10, March 29, 1996 RFA: DC-96-003 P.T. 34; K.W. 0715050, 0775005 National Institute on Deafness and Other Communication Disorders Letter of Intent Receipt Date: April 22, 1996 Application Receipt Date: May 22, 1996 PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) invites applications for the support of exploratory research addressing the physiologic and molecular bases of tinnitus. The goal of this Request For Applications (RFA) is to stimulate research on pathologic processes in the auditory system that produce tinnitus. 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 area. This RFA, Physiologic and Molecular Bases of Tinnitus, is related to the priority area of diabetes and 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 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Foreign institutions or institutions located in foreign countries are ineligible. Applications from minority individuals, women, and persons with disabilities are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) exploratory/developmental (R21) grant mechanism. This mechanism is designed to encourage the development of new research activities for which substantial preliminary data are not yet available. Although preliminary data as evidence of feasibility are not required, the applicant bears the responsibility for developing a sound research plan. The total project period for an application submitted in response to this RFA may not exceed two years. The R21 grant is not renewable, but future project continuation is possible through other grant mechanisms, such as the research project grant (R01), First Independent Research Support and Transition (FIRST) Award (R29) and the program project (P01). Continuations will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one-time solicitation, with an anticipated award date of December 1, 1996. The maximum funding levels and time frames of project support for the R21 awards indicated here are specific to this solicitation. FUNDS AVAILABLE The total funds available (direct and indirect costs) for the first year of support for successful responses to this RFA is $750,000, with maximum direct costs per grant per year of $100,000. The NIDCD anticipates making three to five awards under this solicitation. However, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Tinnitus, the subjective perception of sound in the absence of acoustic stimulation, is a condition that affects at least 18.5 million people in the United States. Tinnitus is an important national health problem, affecting many people to the point that normal occupational and social activities are precluded. It usually results from a disease of the auditory system that also produces hearing impairment. Tinnitus is a symptom that can result from pathologic conditions affecting various parts of the auditory system. Although the initial insult that produces tinnitus may be known, there is little, if any, evidence implicating specific physiologic or molecular mechanisms in the pathogenic process. Without information on specific pathophysiologic mechanisms, rational therapeutic strategies cannot be formulated. An NIDCD-sponsored workshop to define future directions for tinnitus research was held in March, 1995. Copies of the workshop report may be obtained by contacting the program officer listed under INQUIRIES. Recent advances in the physiology and molecular biology of the auditory system have provided insights into the function of the inner ear and the auditory portion of the central nervous system. For example, the characterization of the membrane properties of the sensory and neural elements within the organ of Corti has begun to provide an understanding of the molecular bases of auditory function. Molecular techniques have been used to identify specific cellular ion transport processes that contribute to auditory function, as well as many of the neurotransmitters at specific synapses throughout the auditory neural axis. There has been greater clarification of the relationship between the perception of stimulus variables and the neural codes for intensity, frequency, and temporal characteristics of sound. Working models of auditory perception have been produced which link contemporary psychoacoustic and physiologic research. Thus, progress in auditory system research has advanced this field to the point that concerted study of the problem of tinnitus is now possible. Research Goals and Scope There is a need to apply the results of recent research in the physiology and molecular biology of the auditory system to explore pathologic mechanisms that may induce tinnitus. Areas of research on the physiologic and molecular mechanisms of tinnitus that would be responsive to this RFA include, but are not limited to: o animal models of specific pathophysiologic conditions known to induce tinnitus; o genetic predisposition as a factor in differential responses to insults that produce tinnitus or tinnitus-like abnormal neural activity; o neural plasticity, or the ability of neuronal fields to alter their sensory input characteristics in response to insults or stress, as it relates to stimuli (e.g. noise) or lesions known to induce tinnitus or abnormal electrical activity in the auditory system; o the effects of aging on the auditory system as a factor that may predispose the development of tinnitus; o animal models of the physiologic basis for electrical stimulation to reduce tinnitus in cochlear implant patients; o the effects of tinnitus-inducing stimuli or lesions on the expression of neurotransmitters and their receptors in the auditory nervous system; o the mechanisms involved in noise-induced and ototoxicity-induced alterations in auditory function, including basilar membrane mechanics, effects on inner and outer hair cells, cochlear afferent and efferent neural activity, and the release of potentially neuromodulatory substances; and o the role of cochlear blood flow and cellular ion transport mechanisms, related to their effects on the generation or maintenance of tinnitus. SPECIAL REQUIREMENTS Principal Investigators of grants awarded under this RFA will be expected to attend an annual meeting to report their research progress. This meeting will be held on the NIH campus, Bethesda, MD, and funds should be included in the budget to cover the costs of attendance at this meeting for the Principal Investigator. 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 subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492 B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women and Minorities 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 on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (FR 59 14508-14513) to correct typesetting errors in the earlier publication, and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by April 22, 1996, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent application, the information that it contains allows NIDCD staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Marilyn Semmes, Ph.D. Scientific Review Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Suite-400C - MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 496-8683 FAX: (301) 402-6250 Email: Marilyn_Semmes@nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained >From the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The RFA label available in the PHS 398 (rev. 5/95) 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, 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 must be sent to: Marilyn Semmes, Ph.D. Scientific Review Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Suite 400C - MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 496-8683 Applications must be received by May 22, 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, nor will DRG accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and for responsiveness by NIDCD staff. Incomplete and/or nonresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDCD, in accordance with NIH peer review procedures. As part of the initial merit review, all accepted applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of all applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Deafness and Other Communication Disorders Advisory Council. Review Criteria A direct relevance to the elucidation of specific pathologic mechanisms that may produce tinnitus is mandatory for an application to be considered responsive to this announcement. However, preliminary data are not required. Additional review criteria include: o scientific, technical, or medical significance and originality of proposed research; o characterization as an innovative or high risk pilot project; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o probability the study will provide a basis for more extended research in the relevant area; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and o adequacy of 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 groups will also examine the provisions for the protection of human and animal subjects, and safety of the research environment. Note: Because of the high risk feasibility-testing nature of the applications support of salaries for student employees working on a dissertation is discouraged. AWARD CRITERIA The following will be considered as funding decisions are made: the scientific and technical merit reflected in the priority score assigned by the peer review group; programmatic priorities; and availability of funds. INQUIRIES Written, telephone, and email inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcomed. Direct inquiries regarding scientific and programmatic issues to: Kenneth A. Gruber, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Suite 400C - MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3458 FAX: (301) 402-6251 Email: Kenneth_Gruber@nih.gov Direct inquiries regarding fiscal matters to: Sharon Hunt Division of Extramural Activities National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Suite 400B - MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: Sharon_Hunt@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.173. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant 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 Apr 04 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HS-96-007 - V25(10) 03/29/96 Date: 4 Apr 1996 20:39:46 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 453 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4k286i$kgm@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HS96007 HS-96-007 P1O1 *************************************** COMPUTERIZED DECISION SUPPORT SYSTEMS FOR HEALTH PROVIDERS NIH GUIDE, Volume 25, Number 10, March 29, 1996 RFA: HS-96-007 P.T. 34; K.W. 0745047 Agency for Health Care Policy and Research Letter of Intent Receipt Date: May 7, 1996 Application Receipt Date: June 12, 1996 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications to conduct research on computerized decision support systems (CDSS) as a component of electronic medical record systems. The goal of this research is to assist providers' decisionmaking and to improve the cost- effective delivery of health services. This Request for Application (RFA) solicits applications to address one or more of the following elements for incorporating CDSS into electronic medical records: 1) Use of clinical practice guidelines in decision support systems while maintaining security and confidentiality of patient care data in different patient care settings, 2) The impact of CDSS on the effectiveness of the patient care process, patient outcomes of care, and/or cost impact on patient care, and 3) Identification and testing of factors that influence practitioner use of CDSS. Important factors surrounding the use of CDSS include: current restructuring within the health care system; a focus on a national information infrastructure (NII); progress toward establishing an electronic medical record; and the use of high performance computing and communication (HPCC) in health care. Of particular interest are studies involving the comparative effectiveness and/or cost and benefits of using CDSS within the changing health care system and the use of CDSS to disseminate practice guidelines and monitor their impact. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. AHCPR urges applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202-512-1800. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, non-profit organizations, public or private, including universities, clinics, units of State and local governments, non-profit firms, and non-profit foundations. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigator. MECHANISM OF SUPPORT This RFA will use the research project grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total requested project period may not exceed three years. This RFA is a one-time solicitation. The earliest anticipated award date is September 1, 1996. FUNDS AVAILABLE Dependent upon the availability of funds, AHCPR expects to award up to approximately $1.5 million in FY 1996 to support the first year of approximately 6-10 projects under this RFA. The number of awards is dependent on the number of high quality applications and their individual budget requirements; it is not the intent of AHCPR that the awards be equal in size. Funding beyond the initial budget period will depend upon annual progress reviews by AHCPR and the availability of funds. RESEARCH OBJECTIVES Background AHCPR, as of October 1994, became a participant in the government-wide High Performance Computing and Communication (HPCC) initiative, which is an effort designed to apply high-speed and high-performance computers to help solve the nation's problems in education, energy, weather, and health. As a result of this HPCC activity, AHCPR jointly sponsored with the National Library of Medicine (NLM) an RFA entitled "Applied Research Relevant to an Electronic Medical Record." Cooperative agreements funded under this RFA and other grants continue AHCPR's history of funding research in development of databases; accessing data and retrieval of information; advancement of expert systems, decision aids, and reminder systems; and assessment of quality of care. For the purpose of this RFA, computerized decision support systems (CDSS) are computer programs that use knowledge such as clinical practice guidelines and clinical research findings, to support practitioners' decisions with evidence-based information in a patient electronic medical record. Clinical practice guidelines are defined as systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical conditions. The studies supported by AHCPR that deal with CDSS typically involve a multidisciplinary team of researchers with clinical, informatics and methodological expertise, along with an understanding of the perspectives of providers, information behavior, health services research, and economics. Objectives and Scope The changing mix of payment mechanisms, benefit plans, and cost-containment strategies has widespread implications for CDSS in patient care. Of particular interest are studies involving the comparative effectiveness and/or cost and benefits of decision support systems within the changing health care system. This would include studies of applications across delivery settings and reimbursement systems; studies should consider the application of CDSS by clinicians in everyday practice, including primary care, and other office based practices. This would include the use of CDSS to disseminate practice guidelines and monitor their impact. Choice of condition and treatment options should be justified in terms of clinical and policy relevance. Topics of interest for decision support may include, but are not limited to, conditions addressed by AHCPR clinical practice guidelines. A list of guideline topics and order form may be obtained from Global Exchange, Inc. (See INQUIRIES) AHCPR desires to fund studies that focus on how to improve: 1) the outcomes of patient care, 2) the process of patient care, and 3) the cost effectiveness of care, or a combination of these. Studies addressing the following areas will receive highest program priority; however, this does not preclude applications focusing on other areas within the scope of the RFA. Studies may include: o Decision support models integrating clinical practice guidelines on networked systems which can be translated to products to improve quality of care and performance across institutional boundaries (e.g., primary care to hospitals to long-term care or home care settings). Maintenance of security and confidentiality of data requirements should be addressed. o The utility of these systems for generating performance data required by internal or external quality reporting and accountability systems, such as Health Plan Employer Data Information Set (HEDIS). o Decision support systems that are designed to facilitate prevention, early detection, diagnosis, treatment, and prescribing practices. These systems, when matched to medical review criteria and performance measures, allow assessment of improved quality of care, outcomes, and cost effectiveness. These decision support tools range from computer-generated reminders to adoption of clinical practice guidelines and treatment algorithms. o Evaluations of the medical effectiveness and economic impact (cost and benefits) of using CDSS. o Cost-utility studies that include user-friendly methods or measures for assessing patient preferences, values, and utilities, as well as improvements in provider productivity. o Identification and testing of factors that influence practitioner use of CDSS applications. o Dissemination strategies utilizing CDSS and their effect on awareness and use of information, with particular emphasis on comparing these strategies with more traditional dissemination mechanisms and processes to ascertain relative effectiveness and cost efficiency. Methods Applications must be explicit and detailed in describing databases, methods, data to be collected, instruments for data collection, and approaches to data analysis. The research plan must be justified in terms of potential for answering the proposed research question(s). AHCPR's decision support research initiative draws on a wide range of methods for applying existing medical knowledge into computerized systems. The description and rationale for choice of: hardware, software, protocols/guidelines, technology assessments, decision-analysis models, mathematical models, algorithms, logic rules, standards, vocabulary, and potential linkages to networks should be specified. The decision support systems should be existing working models or working systems. Data sources should allow for the detection, measurement, and/or control of: clinical content (based upon protocols), consensus statements, guidelines, or structured care processes; and translation of such content to algorithms for medical review criteria, performance measures, protocol algorithms, and logic rules, all within network systems. The study of sharing information across sites and standards, including content, data-exchange, and common vocabulary issues is encouraged. Proposed systems should be considered for linkage into large enterprise and national networks of aggregate knowledge sources. These systems should be capable of being accessed by multiple providers. Use of computer-generated and digital-video technology for assisting decisionmaking for health providers is welcome. Data sources should especially identify severity of illness, timeliness of diagnosis and treatment, utilization-based indicators of patient outcomes, comorbidities, relevant confounders, and costs of care when appropriate. Measures of short and long-term outcomes, as well as pre-treatment health status information, are highly valued components. SPECIAL REQUIREMENTS Confidentiality of Data Information obtained in the course of this study that identifies an individual or entity must be treated as confidential in accordance with section 903(c) of the Public Health Service Act. Applicants must describe in the Human Subjects section of the application procedures for ensuring the confidentiality of identifying information. The description of the procedure should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers will be safeguarded. Rights in Data AHCPR grantees may copyright or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHCPR funds. Such copyrights and patents are subject to a Federal Government license to use these products and materials for AHCPR purposes. AHCPR purposes may include, subject to statutory confidentiality protections, making research materials, data bases, and algorithms available for verification or replication by other researchers; and subject to AHCPR budget constraints, final products may be made available to the health care community and the public by AHCPR, or its agents, if such distribution would significantly increase access to a product and thereby produce public health benefits. Ordinarily, to accomplish distribution, AHCPR publishes research findings but relies on grantee efforts to market grant-supported products. In keeping with AHCPR's legislative mandates to make both research results and data available, copies of all products and materials developed under a grant supported in whole or in part by AHCPR funds are to be made available to AHCPR promptly and without restriction, upon request by AHCPR. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH STUDY POPULATIONS INVOLVING HUMAN SUBJECTS It is the policy of AHCPR that women and members of minority groups be included in all AHCPR-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. The NIH policy resulting from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) supersedes and strengthens NIH's previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which were in effect since 1990 and which AHCPR had adopted. The new NIH policy contains provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which has been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and printed in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. AHCPR follows the revised NIH Guidelines, as applicable. Investigators may obtain copies from those sources or from the AHCPR contractor, Global Exchange, Inc., listed under INQUIRIES. AHCPR program staff may also provide information concerning this policy (See INQUIRIES). LETTER OF INTENT Prospective applicants are asked to submit, by May 7, 1996, a letter of intent that includes the name, address, and telephone number of the proposed Principal Investigator and other key personnel; and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the consideration of any subsequent application, the information allows AHCPR to estimate the potential review workload and avoid conflicts of interest in the review. AHCPR will not provide responses to letters of intent. The letter of intent is to be sent to: Kathleen A. McCormick, Ph.D., R.N. Center for Information Technology Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 602 Rockville, MD 20852-4908 Email: kmccormi@po5.ahcpr.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. State and local government applicants may use form PHS-5161-1, Application for Federal Assistance (rev. 9/92), and follow those requirements for copy submission. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. AHCPR applicants are encouraged to obtain application materials from the AHCPR contractor: Global Exchange, Inc. (See INQUIRIES). The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the original application. Failure to do so could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Kathleen A. McCormick, Ph.D., R.N. Center for Information Technology Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 602 Rockville, MD 20852-4908 Applications submitted under this RFA must be received in the Division of Research Grants, NIH, by June 12, 1996. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with AHCPR peer review procedures. As part of the initial merit review, all applications will receive a written critique, and also may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. Recommendations of the peer review committee may be reviewed subsequently by AHCPR's National Advisory Council. General Review Criteria Review criteria for AHCPR grant applications are: significance and originality from a scientific and technical viewpoint; adequacy of the method(s); availability of data or proposed plan to collect data required for the project; qualifications and experience of the Principal Investigator and proposed staff; adequacy of the plan for organizing and carrying out the project and achieving outcome measures; reasonableness of the proposed budget; and adequacy of the facilities and resources available to the applicant. Special Review Criteria In addition to the general criteria above, the reviewers will assess the application's responsiveness to the RFA; generalizability of results; feasibility of answering the proposed research question(s) within the project period; and, the validity, specificity, and sensitivity of outcome(s) measures. Reviewers will also assess the applicant's description and rationale for choice of: hardware, software, protocols/guidelines, technology assessments, decision- analysis model, mathematical models, algorithms, logic rules, standards, vocabulary, and potential linkages to networks; and whether the decision support system is a working model or working system. AWARD CRITERIA Applications will compete for available funds with all other applications under this RFA. The following will be considered in making the funding decisions: quality of the proposed project as determined by peer review, program balance, and availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Copies of the RFA and related background materials are available from: Global Exchange, Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20814-3015 Telephone: (301) 656-3100 FAX: (301) 652-5264 Direct inquiries regarding programmatic issues, including information on the policy of inclusion of women and minorities in study populations, to: J. Michael Fitzmaurice, Ph.D. Center for Information Technology Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 602 Rockville, MD 20852-4908 Telephone: (301) 594-1483 Email: mfitzmau@po5.ahcpr.gov Direct inquiries regarding fiscal matters to: Carol Roache Grants Management Staff Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852-4908 Telephone: (301) 594-1447 FAX: (301) 594-3210 Email: croache@po7.ahcpr.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.226 and 93.180. Awards are made under authorization of Title IX of the Public Health Service Act (42 U.S.C. 299-299c-6) and Section 1142 of the Social Security Act (42 U.S.C. 1320b-12). Awards are administered under the PHS Grants Policy Statement and Federal regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, The Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Thu Apr 04 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 10, pt. 2of2, 29 March 1996 Date: 4 Apr 1996 20:39:10 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 77 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4k285e$kdf@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19960329 V25N10 P2O2 ************************************ States is a multi-cultural, multi-ethnic nation with wide diversity in the patterns, trends, and practices around alcohol use and abuse, much can be gained from research partnerships in this field. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Developmental Grants for Minority Collaborative Projects, is related to the priority areas of alcohol abuse reduction and alcoholism treatment. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Ernestine Vanderveen, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 Bethesda, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 Email: tvanderv@willco.niaaa.nih.gov $$P2 END ************************************************************ ERRATA $$E1 BEGIN R3 19960315 APPEND RFA HS-96-006 BOTH *********************** REFERRALS FROM PRIMARY TO SPECIALTY CARE NIH GUIDE, Volume 25, Number 10, March 29, 1996 RFA: HS-96-006 P.T. 34; K.W. 0730050, 0408006 Agency for Health Care Policy and Research The following correction is issued for the notice of availability of RFA HS-96-006, which was published in the NIH Guide for Grants and Contracts, Vol. 25, No. 8, March 15, 1996. In the Letter of Intent Receipt Date line delete the April 22, 1996 date and substitute May 3, 1996. INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. David Lanier, M.D. Center for Primary care Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 502 Rockville, MD 20852-4908 Telephone: (301) 594-1357 Email: dlanier@po3.ahcpr.gov $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Thu Apr 04 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 10, pt. 1of2, 29 March 1996 Date: 4 Apr 1996 20:37:42 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1499 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4k282m$kb7@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19960329 V25N10 P1O2 ************************************ X-comment: RFAS described: DC-96-003, HS-96-007, AA-96-002, CA-96-010, DK-96- X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.03.29 NIH GUIDE - Vol. 25, No. 10 - March 29, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N2 ********************************************************** JUST-IN-TIME PROCEDURES FOR FIRST AND CAREER AWARDS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** NCI-SPONSORED YEAR-ROUND SHANNON AWARD PROGRAM National Cancer Institute INDEX: CANCER $$INDEX N4 ********************************************************** AVAILABILITY OF PROGRAM PROJECT GUIDELINES National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** PRECLINICAL EVALUATION OF THERAPIES FOR MYCOBACTERIUM AVIUM INFECTION (RFP NIH-NIAID-DAIDS-97-01) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R2 ********************************************************** PRECLINICAL EVALUATION OF THERAPIES FOR MICROSPORIDIAL INFECTION (RFP NIH-NIAID-DAIDS-97-02) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R3 ********************************************************** PRECLINICAL EVALUATION OF THERAPIES FOR PNEUMOCYSTIS CARINII INFECTION (RFP NIH-NIAID-DAIDS-97-04 National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R4 ********************************************************** PRECLINICAL EVALUATION OF THERAPIES OF CRYPTOSPORIDIUM PARVUM (RFP NIH-NIAID-DAIDS-97-05) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R5 ********************************************************** MULTI-CHANNEL TRANSCUTANEOUS CORTICAL STIMULATION SYSTEM (RFP NIH-NINDS-96-08) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX R6 ********************************************************** STANDING BY FUNCTIONAL NEUROMUSCULAR STIMULATION (RFP NIH-NINDS-96-09) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX R7 05/22/96 ************************************************* PHYSIOLOGIC AND MOLECULAR BASES OF TINNITUS (RFA DC-96-003) National Institute on Deafness and Other Communication Disorders INDEX: DEAFNESS, OTHER COMMUNICATION DISORDERS $$INDEX R8 06/12/96 ************************************************* COMPUTERIZED DECISION SUPPORT SYSTEMS FOR HEALTH PROVIDERS (RFA HS-96-007) Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH $$INDEX R9 06/13/96 ************************************************* ANTIBODIES AND ALCOHOL-RELATED BEHAVIOR (RFA AA-96-002) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL, ABUSE, ALCOHOLISM $$INDEX R10 06/14/96 ************************************************ MECHANISMS OF GENOMIC INSTABILITY FROM THE EXPOSURE OF MAMMALIAN CELLS TO HIGH-LET IONIZING RADIATIONS (RFA CA-96-010) National Cancer Institute INDEX: CANCER $$INDEX R11 08/08/96 ************************************************ THE REGULATION OF PROSTATE GROWTH (RFA DK-96-005) National Institute of Diabetes and Digestive and Kidney Diseases; National Institute on Aging INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES; AGING $$INDEX P1 ********************************************************** CHEMICAL SENSES: NEUROTRANSMITTERS AND NEUROMODULATORS (PA-96-035) National Institute on Deafness and Other Communication Disorders; National Institute on Aging INDEX: DEAFNESS, OTHER COMMUNICATION DISORDERS; AGING $$INDEX P2 ********************************************************** DEVELOPMENTAL GRANTS FOR MINORITY COLLABORATIVE PROJECTS (PAR-96-036) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM ERRATA $$INDEX E1 ********************************************************** REFERRALS FROM PRIMARY TO SPECIALTY CARE (RFA HS-96-006) Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV NOTICES $$INDEX END ********************************************************* $$N1 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 25, Number 10, March 29, 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 cases: Gail L. Daubert, R.N., Northwestern University: Based on an investigation conducted by its Division of Research Investigations, ORI found that Gail Daubert, R.N., while serving as clinic coordinator for the Collaborative Ocular Melanoma Study (COMS) at Northwestern University, committed scientific misconduct by falsifying clinical trial data. The multicenter COMS involves research on the treatment of choroidal melanoma, a rare form of eye cancer. It is supported by the National Eye Institute. The study is still ongoing, and no results have been published. ORI found that Ms. Daubert falsified 211 data items, including falsely stating that a radiation oncologist had evaluated patients prior to randomization, falsely reporting laboratory blood test results were normal when they were abnormal, falsely reporting that dates for patient visits or procedures had been performed within the specified protocol window when the actual date was outside the protocol window, and falsely reporting that a COMS certified examiner had performed an evaluation or procedure when a non-certified examiner had performed the task. Ms. Daubert has entered into a Voluntary Exclusion Agreement with ORI in which she does not admit to any acts of scientific misconduct, but she has agreed to exclude herself voluntarily, for the three year period beginning March 4, 1996, from: (1) 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 and 48 C.F.R. Subparts 9.4 and 309.4 (Debarment Regulations); and (2) serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant. The above voluntary exclusion, however, shall not apply to Ms. Daubert's future training or practice of clinical medicine as a nurse, unless that practice involves research or research training, or to Ms. Daubert's participation in or eligibility for any Federal program relating to student loans, education grants, or educational assistance of any type or kind, for which she would otherwise be qualified to receive or be considered to receive (educational assistance), unless that educational assistance involves research or research training. Cathy Q. Lee, Massachusetts General Hospital: On February 28, 1996, ORI found that Cathy Q. Lee, Ph.D., Postdoctoral Fellow, Molecular Endocrinology Laboratory at the Massachusetts General Hospital, committed scientific misconduct by engaging in falsification and fabrication of research data incorporated in a manuscript prepared for submission (but not submitted) to the EMBO Journal (Lee, C.Q., Yun, Y., and Habener, J.F. "Transactivation of functions of cAMP- responsive transcription factor CREB-327 mediated by amphiphatic helical domains flanking the requisite serine-119 phosphorylated by protein kinase-A.") and by engaging in improper data selection and falsification of data published in the EMBO Journal (Lee, C.Q., Yun, Y., Hoeffler, J.P., and Habener, J.F. "Cyclic-AMP responsive transcriptional activation of CREB-327 involves interdependent phosphorylated subdomains." EMBO Journal 9:4455-4465, 1990.). This research was supported by a Public Health Service grant. Dr. Lee has entered into a Voluntary Exclusion Agreement with ORI in settlement of ORI's finding of scientific misconduct and has agreed: (1) to exclude herself voluntarily from any contracting or subcontracting with any agency of the United States Government and >From eligibility for, or involvement in, Federal nonprocurement transactions (e.g., grants and cooperative agreements) of the United States Government, as defined in 45 C.F.R. Part 76 and 48 C.F.R. Subparts 9.4 and 309.4 (Debarment Regulations) for a period of two years beginning on February 28, 1996; the above voluntary exclusion, however, shall not apply to Dr. Lee's future clinical laboratory training or practice, unless that training or practice involves research or research training; (2) that for a period of one year beginning immediately after the two year voluntary exclusion above, any institution that submits an application for PHS support for a research project on which the Respondent's participation is proposed or which uses the Respondent in any capacity on PHS supported research, must concurrently submit a plan for supervision of the Respondent's duties; the supervisory plan must be designed to ensure the scientific integrity of the Respondent's research contribution, and the institution must submit a copy of the supervisory plan to ORI; and (3) to exclude herself voluntarily from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for a period of three years beginning on February 28, 1996. A letter retracting the article entitled "Cyclic-AMP responsive transcriptional activation of CREB-327 involves interdependent phosphorylated subdomains" (EMBO Journal 9:4455-4465, 1990) has been published in the EMBO Journal (EMBO Journal 13:2736, 1994). 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 ********************************************************** JUST-IN-TIME PROCEDURES FOR FIRST AND CAREER AWARDS NIH GUIDE, Volume 25, Number 10, March 29, 1996 P.T. 34; K.W. 1014006 National Institutes of Health BACKGROUND "Just-in-Time" is an initiative of the National Institutes of Health (NIH) Extramural Reinvention Laboratory under the auspices of the National Performance Review and government-wide efforts to create a government that works better and costs less. JIT postpones the collection of certain information that currently must be included in all competing applications when submitted. The information for the applications with a likelihood of funding is submitted "just-in-time" for awards to be made. This delayed exchange of information significantly relieves the administrative burden for the 75 to 80 percent of applicants who will not receive an award. In addition, the information that is exchanged "just-in-time" for award will be current, rather than several months old as is currently the case (which often necessitates a request for updated information, e.g., for other support). In fiscal year (FY) 1995, four institutes (NICHD, NHLBI, NIAID, and NIA) issued requests for applications (RFAs) that incorporated JIT procedures and/or modified applications instructions for other support, the biographical sketch, the budget page, the research plan, and the checklist page (each of the RFAs did not include all of these components). The results of the pilot demonstrations convinced the NIH to expand implementation of "just-in-time" procedures. FY 1996 IMPLEMENTATION Beginning June 1, 1996, all unsolicited First Independent Research Support and Transition (FIRST) (R29) award and career award (K) applications must follow the JIT instructions below. All other requirements of the PHS 398 application remain in effect, as do the FIRST award and career award program guidelines. The program announcements for career awards were published in the NIH Guide, Vol. 24, No. 15, April 28, 1995. The FIRST award guidelines may be requested from Grants Information of the NIH Office of Extramural Outreach and Information Resources by email at ASKNIH@nih.gov or by phone on 301/435-0714. In addition, beginning in FY 1996, all NIH institutes and centers have been encouraged to incorporate JIT procedures routinely in RFAs. Thus, it is important for applicants planning to respond to RFAs to review those announcements carefully for special JIT instructions. JIT INSTRUCTIONS FOR CAREER AND FIRST AWARDS Budget Instructions - The total direct costs must be requested in accordance with the R29 and K program guidelines, following the budget instructions described below. Detailed Budget for 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. In some cases it may be requested prior to award. Budget for Entire Proposed Period of Support - Do not complete the categorical budget table on form page 5 in the PHS 398 (rev. 5/95). Only the requested total direct costs for each year and total direct costs for the entire proposed period of support should be shown. Begin the budget justification in the space provided, using continuation pages as needed. Budget Justification o List the name, role on project and percent effort for all project personnel (salaried or unsalaried) and provide a narrative justification for each person based on his/her role on the project and proposed level of effort. o Identify all consultants by name and organizational affiliation and describe the services to be performed. o Provide a narrative justification for any major budget items, other than personnel, that are requested for the conduct of the project that would be considered unusual for the scope of research. No specific costs for items or categories should be shown. o Indirect costs will be calculated at the time of the award using the institution's actual indirect cost rate. Applicants will be asked to identify the indirect cost exclusions prior to award. o If consortium/contractual costs are requested, provide the percentage of the subcontract total costs (direct and indirect) relative to the total direct costs of the overall project. The subcontract budget justification should be prepared following the instructions provided above. 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. o Complete the education block at the top of the form page; o List current position(s) and those previous positions directly relevant to the application; o List selected peer-reviewed publications directly relevant to the proposed project, with full citation; o Provide information on research projects completed and/or research grants participated in during the last five years that are relevant to the proposed project. Title, principal investigator, funding source, and role on project must be provided. Other Support - Do not complete the other support page (format page 7 of the PHS 398 (rev. 5/95)). Information on active support for key personnel will be requested prior to award. Checklist - Do not submit the checklist page. For amended and competing continuation applications, applicants must complete the block in the upper right corner of the face page to indicate the previous grant number. A completed checklist will be required prior to award. SUMMARY Beginning June 1, 1996, all unsolicited FIRST (R29) award and career (K series) award applications must follow the JIT procedures provided above. Failure to provide the requested information in the format required could result in the applications being returned as nonresponsive. For those applications with a likelihood of funding, NIH grants management staff will contact the institutional business official prior to award to request information about active other support, the checklist page, and in some cases, a detailed budget for the project. INQUIRIES Questions about these JIT procedures should be directed to the grants management staff in any of the NIH awarding institutes or centers. The published career and FIRST award guidelines provide a contact point in each Institute and Center that supports that grant activity. $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NCI-SPONSORED YEAR-ROUND SHANNON AWARD PROGRAM NIH GUIDE, Volume 25, Number 10, March 29, 1996 P.T. 34; K.W. 1014006, 0715035 National Cancer Institute The National Cancer Institute (NCI) announces that, with the permission of the Office of the Director, NIH, it has established an ongoing program to issue Shannon Awards (R55) on a three times yearly basis to supplement and expedite the annual NIH Shannon Award program, which is currently conducted as a single annual competition in the last quarter of each fiscal year. The NCI Shannon Award program will offer expedited funding for eligible applications that otherwise might wait up to nine months for the annual NIH Shannon competition, or for resubmission and review as full competing amended applications. Awardees will gain both immediate funding to begin important and innovative research projects; and, as has been the case for previous Shannon awards, are likely to have improved chances for obtaining subsequent research project grant (R01) support. The NCI Shannon Award program is conducted under the auspices of the authorities granted to the Director, NIH. Terms of award will be uniform with all other NIH Shannon Awards. R55 awards paid with NCI funds will be issued with the standard provisions of a 24-month single budget period at a maximum of $100,000 total cost, with indirect costs capped at a maximum of $20,000. Applicants do not submit requests for Shannon Awards. Instead, NCI program staff nominate for award previously reviewed eligible R01, R03, and R29 applications that are beyond the current NCI payline. After each of the three review cycles per year, Shannon Award nominations will be administratively reviewed by NCI according to standard review criteria, then submitted to the Office of Extramural Research, NIH, for expedited review and concurrence prior to funding. The NCI will use NCI funds to award R55 nominations that become eligible after each of the first two National Advisory Board rounds in each fiscal year. Such nominations cannot now be considered in a timely way, given the single annual summer date of the NIH-wide Shannon competition supported from the NIH Director's Discretionary Fund. The third round of the year will be submitted under the auspices of the current NIH-wide Shannon Award program. If the NIH is not able to hold a Shannon competition in a given year, NCI will extend its own program to all three application review rounds. The NCI is committed to offer funding for Shannon awards in numbers substantially higher than have previously been possible. It is anticipated that NCI will be able to commit approximately $3,000,000 to the NCI Shannon Award program in FY 96. NCI's continuation of this program in the future is contingent upon the availability of appropriated funds and applications of sufficient scientific merit. INQUIRIES For specific questions on this process, nominees may contact the NCI program director indicated on the original summary statement. General policy questions may be directed to: Marvin R. Kalt, Ph.D. Director, Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Suite 600 - MSC 7405 Bethesda, MD 20892-7405 Email: KALTM@DEA.NCI.NIH.GOV Inquiries of a fiscal/administrative nature may be directed to: Ms. Catherine Blount Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 262 $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** AVAILABILITY OF PROGRAM PROJECT GUIDELINES NIH GUIDE, Volume 25, Number 10, March 29, 1996 P.T. 34; K.W. 1014006, 0710030 National Institute of General Medical Sciences The National Institute of General Medical Sciences (NIGMS) announces the availability of updated guidelines for program project (P01) applications that are likely to be assigned to the NIGMS for review and funding. This is not an announcement of any new program or initiative. Rather, it articulates the more restricted circumstances under which NIGMS support of a program project grant is appropriate. Investigators anticipating submission of a program project grant application should request a copy of the guidelines, which explain NIGMS policies and procedures relating to the preparation, submission, and review of program project grant applications. INQUIRIES For further information, applicants are encouraged to contact the program staff listed below. Cell Biology and Biophysics Dr. James Cassatt Telephone: (301) 594-0828 Email: czj@cu.nih.gov Trauma and Burn Injury Research Dr. Scott Somers Telephone: (301) 594-5560 Email: somerss@gm1.nigms.nih.gov Genetics and Developmental Biology Dr. Judith H. Greenberg Telephone: (301) 594-0943 Email: greenbej@gm1.nigms.nih.gov Pharmacological Sciences Dr. Rochelle Long Telephone: (301) 594-1826 Email: longr@gm1.nigms.nih.gov Anesthesiology Dr. Alison Cole Telephone: (301) 594-1826 Email: colea@gm1.nigms.nih.gov Biorelated Chemistry Dr. Warren Jones Telephone: (301) 594-5938 Email: jonesw@gm1.nigms.nih.gov For general information, applicants may contact Dr. W. Sue Shafer Telephone: (301) 594-4499 Email: shafers@gm1.nigms.nih.gov For business management aspects, contact Ms. Carol Tippery Telephone: (301) 594-5135 Email: tipperyc@gm1.nigms.gov $$N4 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NIH-NIAID-DAIDS-97-01 ************************************ PRECLINICAL EVALUATION OF THERAPIES FOR MYCOBACTERIUM AVIUM INFECTION NIH GUIDE, Volume 25, Number 10, March 29, 1996 RFP AVAILABLE: NIH-NIAID-DAIDS-97-01 P.T. 34; K.W. 0745005, 0715125 National Institute of Allergy and Infectious Diseases The Opportunistic Infections Research Branch, Therapeutics Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID), NIH, has a requirement to develop therapies for the treatment of AIDS and associated opportunistic infections. The purpose of this RFP is to seek responsible offers to quantitatively evaluate therapeutic agents for efficacy against Mycobacterium avium in a standardized, validated mouse model test system. In vivo studies will include evaluation of therapies in combination and drug evaluations in prophylaxis protocols. Therapeutic agents will be evaluated for efficacy in standardized, reproducible, and validated in vitro culture and intracellular test systems. The offeror should have available a mouse testing system and in vitro systems (including relevant mycobacterial strains) suitable for evaluation of therapies with potential for treatment of Mycobacterium avium infections in people with AIDS. It is anticipated that one cost reimbursement, level-of-effort type contract will be awarded for a period of five years beginning on or about July 23, 1997. It is estimated that 1,450 percent total effort will be needed for this acquisition during the five-year period. RFP NIH-NIAID-DAIDS-97-01 will be available electronically on or about April 15, 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) To access the NIH Gopher: Point your gopher client to GOPHER.NIH.GOV PORT 70. (You should now be in the NIH Gopher.) Select "Grant and Research Information," then select "R&D Request for Proposals" (RFP). 2) NIH Home Page (via the World Wide Web): Access the NIH Home Page by using http://www.nih.gov. Once you are at the NIH Home Page, select "Grants and Contracts," then select "R&D Requests for Proposals (RFP)." INQUIRIES Responses to this RFP will be due on August 15, 1996. Any responsible offeror may submit a proposal that will be considered by the Government. This advertisement does not commit the Government to award a contract. Inquiries regarding this RFP may be directed to: Joyce U. Sagami Contract Management Branch National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3C07 - MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-7118 FAX: (301) 402-0972 Email: js73b@nih.gov No collect calls will be accepted. $$R1 END ************************************************************ $$R2 BEGIN NIH-NIAID-DAIDS-97-02 ************************************ PRECLINICAL EVALUATION OF THERAPIES FOR MICROSPORIDIAL INFECTION NIH GUIDE, Volume 25, Number 10, March 29, 1996 RFP AVAILABLE: NIH-NIAID-DAIDS-97-02 P.T. 34; K.W. 0745005, 0715125 National Institute of Allergy and Infectious Diseases The Opportunistic Infections Research Branch, Therapeutics Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID), NIH, has a requirement to develop therapies for the treatment of AIDS and associated opportunistic infections. The purpose of this RFP is: 1) to develop, standardize, and validate a murine model of microsporidiosis that is appropriate to testing new therapies, and 2) to develop, standardize, and validate an in vitro system to screen potential new drugs against microsporidial infection. The emphasis of the resulting contract will be to fill the gaps in knowledge and methodologies regarding research on Enterocytozoon bieneusi. Therefore, the primary in vivo and in vitro models should utilize E. bieneusi as the infectious agent. The Government anticipates that the first year will focus on development and validation of models. Evaluation of therapies will commence after the initial development period upon approval of the E. bieneusi models, and efforts to improve the models may continue in subsequent contract years. Additional, alternative, validated in vivo and in vitro models using other species of parasites in the phylum Microspora will also be conducted under certain conditions. Offerors must provide scientific justification for their selection of alternative series of Microspora for these studies. At the time of proposal, Offerors should propose a murine model and an in vitro model for standardization and validation under the contract using E. bieneusi; alternative models using other species of microsporidia should be justified in their selection, validated, and readily available at the time of proposal. It is anticipated that one cost reimbursement, level-of-effort type contract will be awarded for a period of five years beginning on or about July 15, 1997. It is estimated that 1,750% total effort will be needed for this acquisition during the five-year period. RFP NIH-NIAID-DAIDS-97-02 will be available electronically on or about April 15, 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) To access the NIH Gopher: Point your gopher client to GOPHER.NIH.GOV PORT 70. (You should now be in the NIH Gopher.) Select "Grant and Research Information," then select "R&D Request for Proposals" (RFP). 2) NIH Home Page (via the World Wide Web): Access the NIH Home Page by using http://www.nih.gov. Once you are at the NIH Home Page, select "Grants and Contracts," then select "R&D Requests for Proposals (RFP)." Responses to this RFP will be due on August 15, 1996. Any responsible offeror may submit a proposal which will be considered by the Government. This advertisement does not commit the Government to award a contract. INQUIRIES Inquiries regarding this RFP may be directed to: Phil Hastings Contract Management Branch National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3C07 - MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-0194 FAX: (301) 402-0972 Email: ph23k@nih.gov No collect calls will be accepted. $$R2 END ************************************************************ $$R3 BEGIN NIH-NIAID-DAIDS-97-04 ************************************ PRECLINICAL EVALUATION OF THERAPIES FOR PNEUMOCYSTIS CARINII INFECTION NIH GUIDE, Volume 25, Number 10, March 29, 1996 RFP AVAILABLE: NIH-NIAID-DAIDS-97-04 P.T. 34; K.W. 0745005, 0715125 National Institute of Allergy and Infectious Diseases The Opportunistic Infections Research Branch, Therapeutics Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID), NIH, has a requirement to develop therapies for the treatment of AIDS and associated opportunistic infections. The purpose of this RFP is to quantitatively evaluate therapeutic agents for efficacy against Pneumocystis carinii in a standardized, validated mouse model test system. In vivo studies will include evaluation of therapies in combination in the primary mouse model, drug evaluation in prophylaxis protocols in the primary mouse model, and evaluation of treatment therapies in a rat model. Therapeutic agents will be evaluated for efficacy in a standardized, reproducible and validated in vitro test system which employs intact organisms. The offeror should have available a mouse testing system and an in vitro system (including relevant Pneumocystis strains) suitable for the evaluation of therapies with potential for treatment of Pneumocystis carinii infections in people with AIDS. It is anticipated that one cost reimbursement, level-of-effort type contract will be awarded for a period of five years beginning on or about July 10, 1997. It is estimated that 1,400% total effort will be needed for this acquisition during the five-year period. RFP NIH-NIAID-DAIDS-97-04 will be available electronically on or about April 15, 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) To access the NIH Gopher: Point your gopher client to GOPHER.NIH.GOV PORT 70. (You should now be in the NIH Gopher.) Select "Grant and Research Information," then select "R&D Request for Proposals" (RFP). 2) NIH Home Page (via the World Wide Web): Access the NIH Home Page by using http://www.nih.gov. Once you are at the NIH Home Page, select "Grants and Contracts," then select "R&D Requests for Proposals (RFP)." Responses to this RFP will be due on August 15, 1996. Any responsible offeror may submit a proposal which will be considered by the Government. This advertisement does not commit the Government to award a contract. INQUIRIES Inquiries regarding this RFP may be directed to: Nancy Hershey Contract Management Branch National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3C07 - MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-0193 FAX: (301) 402-0972 Email: nh11x@nih.gov No collect calls will be accepted. $$R3 END ************************************************************ $$R4 BEGIN NIH-NIAID-DAIDS-97-05 ************************************ PRECLINICAL EVALUATION OF THERAPIES OF CRYPTOSPORIDIUM PARVUM NIH GUIDE, Volume 25, Number 10, March 29, 1996 RFP AVAILABLE: NIH-NIAID-DAIDS-97-05 P.T. 34; K.W. 0745005, 0715125 National Institute of Allergy and Infectious Diseases The NIAID, DAIDS, has a requirement to quantitatively evaluate therapeutic agents for efficacy against Cryptosporidium parvum infection in a standardized, validated immunocompromised mouse model test system. In vivo studies will include evaluation of therapies in combination in the primary mouse model; evaluation of therapies in a validated, standardized animal model for hepatobiliary disease; and evaluation of therapies using alternative strains of Cryptosporidium. Therapeutic agents will be evaluated for efficacy in a standardized, reproducible, and validated in vitro test system using intact organisms. The offeror should have available a primary mouse model of Cryptosporidium infection and an in vitro system (including relevant Cryptosporidium isolates) suitable for the evaluation of therapies with potential for treatment of Cryptosporidium infections in people with AIDS. It is anticipated that one cost reimbursement, level-of-effort type contract will be awarded for a period of five years beginning on or about July 23, 1997. It is estimated that 1,675% total effort will be needed for this acquisition during the five-year period. RFP NIH-NIAID-DAIDS-97-05 will be available electronically on or about April 15, 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) To access the NIH Gopher: Point your gopher client to GOPHER.NIH.GOV PORT 70. (You should now be in the NIH Gopher.) Select "Grant and Research Information," then select "R&D Request for Proposals" (RFP). 2) NIH Home Page (via the World Wide Web): Access the NIH Home Page by using http://www.nih.gov. Once you are at the NIH Home Page, select "Grants and Contracts," then select "R&D Requests for Proposals (RFP)." Responses to this RFP will be due on August 15, 1996. Any responsible offeror may submit a proposal which will be considered by the Government. This advertisement does not commit the Government to award a contract. INQUIRIES Inquiries regarding this RFP may be directed to: Bruce E. Anderson Contract Management Branch National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3C-07 - MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-8371 FAX: (301) 402-0972 Email: ba9i@nih.gov No collect calls will be accepted. $$R4 END ************************************************************ $$R5 BEGIN NIH-NINDS-96-08 ****************************************** MULTI-CHANNEL TRANSCUTANEOUS CORTICAL STIMULATION SYSTEM NIH GUIDE, Volume 25, Number 10, March 29, 1996 RFP AVAILABLE: NIH-NINDS-96-08 P.T. 34; K.W. 0740027, 0745047 National Institute of Neurological Disorders and Stroke The Neural Prosthesis Program (NPP) of the National Institute of Neurological Disorders and Stroke (NINDS) develops implanted devices that interface directly with the nervous system to replace or supplement function in neurologically disabled individuals. This includes visual prostheses for blind individuals based on electrical stimulation of the visual processing portions of the brain. A transcutaneous stimulation system consisting of an extracorporeal computer controlled transmitter and a group of implantable receiver-stimulator modules, each with 256 stimulus channel outputs, is needed. Research and development are required to assure that the implanted portion of this system will be small enough to fit safely and comfortably beneath the scalp and that the stimulus outputs are flexible enough to provide the range of stimulus parameters necessary for producing appropriate sensations of light by intracortical microstimulation. This transcutaneous transmission system will interface not only with discrete wire microelectrodes but also with silicon microstimulating microelectrodes presently being developed by other investigators in the NPP. The extracorporeal portion of the system will include a computer controlled transmitter for sending power and control signals across the skin to the implanted receiver-stimulator modules. Independently, and not as an agent of the government, the contractor shall exert its best efforts to design and fabricate a transcutaneous transmission system suitable for use in a human visual prosthesis. The contractor will not be required to furnish the microelectrodes nor perform any animal or human testing. Performance of this research project will require expertise in monolithic semiconductor circuit design, high density interconnects and implant packaging. It is anticipated that one award, on a cost-reimbursement basis, will be made for a period of three years. INQUIRIES This is not a Request for Proposals (RFP). RFP No. NIH-NINDS-96-08 will be issued on or about March 25, 1996 with responses due approximately 60 days thereafter. Interested organizations should request either a streamlined version or the entire RFP document. If no selection is made, a streamlined version of the RFP will be provided. The streamlined version includes only the Statement of Work, deliverable and reporting requirements, special requirements, and technical evaluation criteria. After examination of these documents, any organization interested in responding to the RFP must request the entire RFP either in writing or by FAX. Requests must cite the RFP number and supply this office with two self-addressed mailing labels. All responsible sources may submit a proposal that will be considered by the Government. Contracts Management Branch, DEA National Institute of Neurological Disorders and Stroke 7550 Wisconsin Avenue, , Room 910 - MSC 9190 Bethesda, MD 20892-9190 ATTN: RFP NIH-NINDS-96-08 FAX: (301) 402-4225 $$R5 END ************************************************************ $$R6 BEGIN NIH-NINDS-96-09 ****************************************** STANDING BY FUNCTIONAL NEUROMUSCULAR STIMULATION NIH GUIDE, Volume 25, Number 10, March 29, 1996 RFP AVAILABLE: NIH-NINDS-96-09 P.T. 34; K.W. 0745047 National Institute of Neurological Disorders and Stroke The Neural Prosthesis Program (NPP) of the National Institute of Neurological Disorders and Stroke (NINDS) supports research and development on systems to restore function in neurologically impaired individuals through functional neuromuscular stimulation (FNS). Clinical research supported by the NPP has resulted in functional upper extremity systems for quadriplegic individuals. This initiative will conduct research on a system for people afflicted with paraplegia that would allow them to independently rise and remain standing so that they can do activities that they cannot accomplish in a wheelchair. Specifically, the feasibility of developing a splint-free, low-energy standing system through FNS will be investigated. The goal is to develop a system that permits an individual to rise and stand for periods of at least 20 minutes and then sit again unassisted. Standing must be maintained without requiring exhausting muscular exertion or significant conscious attention to maintain balance. The system must also leave the hands and arms free for other tasks. It is anticipated that one award, on a cost-reimbursement basis, will be made for a period of three years. INQUIRIES This is not a Request for Proposals (RFP). RFP NIH-NINDS-96-09 will be issued on or about March 25, 1996 with responses due approximately 60 days thereafter. Interested organizations may request either a streamlined version or an entire RFP document. If no selection is made, a streamlined version of the RFP will be provided. This version includes only the Statement of Work, deliverable and reporting requirements, special requirements, and technical evaluation criteria. After examination of these documents, any organization interested in responding to the RFP must request the entire RFP either in writing or by FAX. Requests must cite the RFP number and supply this office with two self-addressed mailing labels. All responsible sources may submit a proposal that will be considered by the Government. Contracts Management Branch, DEA National Institute of Neurological Disorders and Stroke 7550 Wisconsin Avenue, Room 901 - MSC-9190 Bethesda, MD 20892-9190 ATTN: RFP NIH-NINDS-96-09 FAX: (301) 402-4225 $$R6 END ************************************************************ $$R7 BEGIN DC-96-003 FULL-TEXT ************************************** PHYSIOLOGIC AND MOLECULAR BASES OF TINNITUS NIH GUIDE, Volume 25, Number 10, March 29, 1996 RFA AVAILABLE: DC-96-003 P.T. 34; K.W. 0715050, 0775005 National Institute on Deafness and Other Communication Disorders Letter of Intent Receipt Date: April 22, 1996 Application Receipt Date: May 22, 1996 PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) invites applications for the support of research addressing the physiologic and molecular bases of tinnitus. The goal of this Request For Applications (RFA) is to stimulate research on pathologic processes in the auditory system that produce tinnitus. The NIDCD has set-aside approximately $750,000 to fund three to five exploratory/developmental (R21) 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 area. This RFA, Physiologic and Molecular Bases of Tinnitus, is related to the priority area of diabetes and 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 20402-9325 (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. Kenneth A. Gruber, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders Executive Plaza South, Suite-400C 6120 Executive Boulevard MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3458 FAX: (301) 402-6251 Email: Kenneth_Gruber@nih.gov $$R7 END ************************************************************ $$R8 BEGIN HS-96-007 FULL-TEXT ************************************** COMPUTERIZED DECISION SUPPORT SYSTEMS FOR HEALTH PROVIDERS NIH GUIDE, Volume 25, Number 10, March 29, 1996 RFA AVAILABLE: HS-96-007 P.T. 34; K.W. 1004017 Agency for Health Care Policy and Research Letter of Intent Receipt Date: May 7, 1996 Application Receipt Date: June 12, 1996 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications to conduct research on computerized decision support systems (CDSS) as a component of electronic medical record systems. The goal of this research is to assist providers' decisionmaking and to improve the cost-effective delivery of health services. This Request for Applications (RFA) solicits applications to address one or more of the following elements for incorporating CDSS into electronic medical records: (1) Use of clinical practice guidelines in decision support systems while maintaining security and confidentiality of patient care data in different patient care settings, (2) The impact of CDSS on the effectiveness of the patient care process, patient outcomes of care, and/or cost impact on patient care, and (3) Identification and testing of factors that influence practitioner use of CDSS. Important factors surrounding the use of CDSS include: current restructuring within the health care system; a focus on a national information infrastructure (NII); progress toward establishing an electronic medical record; and the use of high performance computing and communication (HPCC) in health care. Of particular interest are studies involving the comparative effectiveness and/or cost and benefits of using CDSS within the changing health care system and the use of CDSS to disseminate practice guidelines and monitor their impact. Dependent upon the availability of funds, AHCPR expects to award up to approximately $1.5 million in FY 1996 to support the first year of approximately 6 to 10 research project grants (R01) under this RFA. Funding beyond the initial budget period will depend upon annual progress reviews by AHCPR and the availability of funds. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. AHCPR urges applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202-512-1800. INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from Global Exchange at the address listed below. Global Exchange, Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20815-3015 Telephone (301) 656-3100 FAX: (301) 652-5264 $$R8 END ************************************************************ $$R9 BEGIN AA-96-002 FULL-TEXT ************************************** ANTIBODIES AND ALCOHOL-RELATED BEHAVIOR NIH GUIDE, Volume 25, Number 10, March 29, 1996 RFA AVAILABLE: AA-96-002 P.T. 34; K.W. 0404003, 0760050, 0760075 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: May 13, 1996 Application Receipt Date: June 13, 1996 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks research applications aimed at developing antibodies to proteins mediating alcohol-related behaviors. This Request for Applications (RFA) invites research applications that develop and utilize such antibodies to study the effects of ethanol on neurotransmitter receptor subtypes and second messenger proteins and on phosphorylation states involved in the actions of ethanol. Applications should develop and characterize highly specific antibodies to determine the distribution of the subunits in specific cell types, neural pathways, and brain regions known for their ethanol sensitivity. It is estimated that up to $1.4 million will be available for approximately six to seven research project grants (R01) under this RFA in FY 1996. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Antibodies and Alcohol-Related Behavior, is related to the priority areas of alcohol abuse reduction and alcoholism treatment. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The 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. Walter A. Hunt, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4223 FAX: (301) 594-0673 Email: whunt@willco.niaaa.nih.gov $$R9 END ************************************************************ $$R10 BEGIN CA-96-010 FULL-TEXT ************************************* MECHANISMS OF GENOMIC INSTABILITY FROM THE EXPOSURE OF MAMMALIAN CELLS TO HIGH-LET IONIZING RADIATIONS NIH GUIDE, Volume 25, Number 10, March 29, 1996 RFA AVAILABLE: CA-96-010 P.T. 34; K.W. 0725015, 1215018, 1002019, 1002008 National Cancer Institute National Aeronautics and Space Administration Letter of Intent Receipt Date: April 24, 1996 Application Receipt Date: June 14, 1996 PURPOSE The Division of Cancer Biology of the National Cancer Institute (NCI) and the Life and Biomedical Sciences and Applications Division of the National Aeronautics and Space Administration (NASA) invite research project grant (R01) applications from interested investigators for studies of the basic molecular mechanisms of long-term (heritable) genomic instability (GI) that is induced in mammalian (or suitable model eukaryotic) cells in organisms exposed to various forms of high-linear-energy-transfer (high-LET) radiation. The primary purpose and interest of both agencies in this Request for Applications (RFA) is to define and understand GI from chronic low-dose exposure of mammalian cells to high energy nuclei of high atomic number (referred to as HZE) particles (e.g., iron) and to high-energy protons, which are likely to be major sources of human exposure to high-LET radiation during extended space flight. It is also of interest to delineate the mechanistic basis for GI from chronic low-dose exposure of mammalian cells to low-energy neutrons or alpha particles (a surrogate for radioactive radon daughters) that are important sources of human exposure in environmental and certain occupational settings. In addition, both agencies have a continuing interest in the possible use of molecular changes that may accompany radiation-induced GI as biomarkers of human exposure to high-LET. This RFA will permit a wide range of research activities, including, but not limited to, the following objectives: o Analysis of the role of the radiation-induced cell-cycle check points on the expression of GI; o The identification of DNA-sequences and specific genes that exhibit instability during the expression of GI, the analysis of the mutational changes that such DNA sequences undergo and their underlying generating mechanisms; o Molecular studies to determine if there is a cytogenetic mechanism(s) to account for both the progressive chromosomal and genetic instability observed in cells expressing radiation-induced GI; o Analysis of the role of recombination and DNA repair on the expression of radiation-induced GI; o Studies with preneoplastic cell lines, in vivo (implanted) and in vitro, to determine temporal and molecular relationships of radiation-induced GI to neoplastic transformation of non-immortalized cells; o The temporal and molecular relationships of radiation-induced GI to the acquisition and expression of a "mutator" phenotype among the progeny of irradiated cells. It is anticipated that 10 awards will be made with a total set aside not to exceed $2 million for the first year to fund applications in response to this solicitation. 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, Mechanisms of Genomic Instability from the Exposure of Mammalian Cells to High-LET Ionizing Radiations, is related to the priority areas of biomedical and environmental health research. 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. Richard A. Pelroy, Ph.D. Division of Cancer Biology National Cancer Institute 6130 Executive Boulevard, Suite 530 - MSC 7391 Rockville, MD 20852-7391 Telephone: (301) 496-9326 FAX: (301) 496-1224 Email: pelroyd@epndce.nci.nih.gov, or Walter Schimmerling, Ph.D. NASA Space Radiation Health and Radiation Biology Programs NASA Headquarters/Code UL 300 E Street, S.W. Washington, DC 20546-001 Telephone: (202) 358-2205 FAX: (202) 358-4168 Email: wschimmerling@hq.nasa.gov $$R10 END *********************************************************** $$R11 BEGIN DK-96-005 FULL-TEXT ************************************* THE REGULATION OF PROSTATE GROWTH NIH GUIDE, Volume 25, Number 10, March 29, 1996 RFA AVAILABLE: DK-96-005 P.T. 34; K.W. 0705075, 0760020, 0705048 National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Aging Letter of Intent Receipt Date: July 15, 1996 Application Receipt Date: August 8, 1996 PURPOSE The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institute on Aging solicit research project grant (R01), First Independent Research Support and Transition (FIRST) (R29) award, and Interactive Research Project Grant (IRPG) applications for the support of basic research studies that use human tissue and cells to focus on the molecular mechanisms of the regulation of normal prostate growth, the factors involved in the re- initiation of normal growth in adult men, and abnormal, non-malignant prostate growth and disorders. The intent of this solicitation is to increase the diversity of approaches to the study of prostate growth regulation and related abnormalities by encouraging investigators >From diverse research areas to apply their expertise in this area. The maximum dollar request is limited to $160,000 in direct costs for the initial budget period for R01s and individual IRPGs. However, the lead IRPG may include a request for up to an additional $50,000 Direct Costs for shared resources. The anticipated award date will be April 1, 1997. For FY 1997, $2,500,000 will be committed by the NIDDK to fund applications submitted in response to this RFA. It is anticipated that 12 to 14 awards will be made. In addition, the NIA is committed to fund one to two applications. Applications to solely study malignant prostate growth and its regulation are not within the scope of this RFA; however, applications that use malignant tissue for comparative study with benign hyperplasia, chronic prostatitis, normal cells, or models are acceptable for application. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, The Regulation of Prostate Growth, is related to the priority area of disease and aging. 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. Ralph L. Bain, Ph.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301)-480-3510 Email: Ralph_Bain@nih.gov Frank Bellino, Ph.D. Biology of Aging Program National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892-9205 Telephone: (301) 496-6402 FAX: (301) 402-0010 Email: bellinof@gw.nia.nih.gov $$R11 END *********************************************************** $$P1 BEGIN PA-96-035 FULL-TEXT ************************************** CHEMICAL SENSES: NEUROTRANSMITTERS AND NEUROMODULATORS NIH GUIDE, Volume 25, Number 10, March 29, 1996 PA AVAILABLE: PA-96-035 P.T. 34; K.W. 0775017, 0760050, 0760075 National Institute on Deafness and Other Communication Disorders National Institute on Aging PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) and the National Institute on Aging (NIA) invite research project grant (R01) and First Independent Research Support and Transition (FIRST) (R29) award applications for the support of research fundamental to understanding the neurochemistry of pathways in the olfactory and gustatory systems throughout the life span. This research includes the identification and characterization of the neurotransmitters, neuromodulators, receptors, and secondary messengers throughout the chemosensory 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 Program Announcement, Chemical Senses: Neurotransmitters and Neuromodulators, is related to the priority areas of diabetes and chronic disabling conditions and special population objectives. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-11474-0 or Summary Report: Stock No. 017-001-11473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221), the NIH GOPHER (gopher.nih.gov), the NIH web site (http://www.nih.gov), and by mail and email from the program contact listed below. Jack Pearl, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C - MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3464 FAX: (301) 402-6251 Email: Jack_Pearl@nih.gov Judith A. Finkelstein, Ph.D. Neuroscience and Neuropsychology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3C307 - MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: FinkelsJ@gw.nia.nih.gov $$P1 END ************************************************************ $$P2 BEGIN PAR-96-036 FULL-TEXT ************************************* DEVELOPMENTAL GRANTS FOR MINORITY COLLABORATIVE PROJECTS NIH GUIDE, Volume 25, Number 10, March 29, 1996 PA AVAILABLE: PAR-96-036 P.T. 34, FF; K.W. 0404003, 0404000, 0710030 National Institute on Alcohol Abuse and Alcoholism PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking applications for exploratory/developmental (R21) grant applications for collaborative research projects to encourage new or strengthen existing cooperative relationships between established alcohol research scientists and scientists in minority and/or predominantly minority institutions. Awards under this program are intended to enhance and extend the alcohol research activities of minority scientists. It is expected that projects will be mutually beneficial to the collaborating scientists and to the advancement of research on alcoholism and alcohol abuse. Exploratory/developmental grants (R21) are intended to develop new research activities that could serve as the foundation for the development of more intensive and larger research studies. A grant supported under this program announcement will be limited to a two year effort and a maximum of $70,000 in direct costs per year. The issues related to alcohol abuse, alcoholism, and reduction of alcohol-related problems are complex. The NIAAA supports alcohol relevant basic and applied research involving a wide array of health science fields and related academic disciplines. Because the United From owner-sci-resources@net.bio.net Thu Apr 04 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DA-96-002 - V25(09) 03/22/96 Date: 4 Apr 1996 18:20:17 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 816 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4k2011$5md@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DA96002 DA-96-002 P1O1 *************************************** STRATEGIC PROGRAM FOR INNOVATIVE RESEARCH ON COCAINE ADDICTION PHARMACOTHERAPY NIH GUIDE, Volume 25, Number 9, March 22, 1996 RFA: DA-96-002 P.T. 34; K.W. 0404009, 0404001, 0745070, 0760050, 0760075 National Institute on Drug Abuse Letter of Intent Receipt Date: May 13, 1996 Application Receipt Date: June 13, 1996 PURPOSE This Request for Applications (RFA) will support innovative, integrated preclinical and clinical research to identify potential compounds and validate novel approaches that are safe and effective short-term (to reduce and stop cocaine use) and long-term (to prolong abstinence) pharmacotherapies for the treatment of cocaine addiction. A Strategic Program for Innovative Research on Cocaine Addiction Pharmacotherapy (SPIRCAP) can focus its therapeutic research activities on, for example, modulating specific receptor sites, (e.g., the dopamine transporter, D3 receptor, a serotonin receptor, etc,) or neurotransmitters that are believed to be involved in cocaine addiction, or on development of biologically based anti-cocaine medications, such as antibodies, enzymes, and catalytic antibodies, or other approaches with the potential for effective therapies. Studies supported by this RFA should have a truely novel or innovative approach. The SPIRCAP Program thus complements existing, more traditional, preclinical and clinical programs for the development of cocaine treatment medications, managed by the Medications Development Division of the National Institute on Drug Abuse (NIDA) (e.g., the Medications Development Research Centers (MDRC, P-50)), the medicinal chemistry synthesis contracts, and the preclinical medications testing contracts. Of greatest significance, each SPIRCAP will form a collaborative enterprise between preclinical and clinical scientists in the conceptualization and proof-of-concept of an identified therapeutic strategy. This will entail interactive research and information exchange between preclinical and clinical investigators in order to ensure effective development and refinement of the therapeutic concept. The Group must, therefore, possess the expertise necessary to (1) evaluate the proposed strategy in preclinical systems, and (2) conduct pilot clinical study(ies) using the proposed therapeutic approach. A SPIRCAP should be dedicated to the expedited transition of ground-breaking research from advanced preclinical findings to clinical application in developing an anti-cocaine medication. A SPIRCAP is encouraged to include investigators from academic, non-profit, and commercial (pharmaceutical, chemical, or biotechnological companies) organizations. 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, Strategic Program for Innovative Research on Cocaine Addiction Pharmacotherapy (SPIRCAP), is related to the priority areas of tobacco, alcohol, and other drugs, and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, private and public, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Awards will be made as cooperative agreements (U19s). The cooperative agreement is an assistance mechanism in which substantial NIDA programmatic involvement with the recipient during the performance of the planned activity is anticipated. The nature of NIDA staff participation is described in SPECIAL REQUIREMENTS - Terms and Conditions of Award. The awardee will be responsible for the planning direction, and execution of the proposed project and interrelated activities. All applications must consist of at least three interrelated projects conducted by at least three independent research laboratories, e.g., a preclinical laboratory, a clinical laboratory, and a laboratory from a pharmaceutical or biotechnology company. For the purpose of this RFA, two (or more) projects within a single company will not be considered independent. Similarly, two (or more) projects within the same academic department will not be considered independent. The involvement of laboratories from commercial (pharmaceutical, chemical, or biotechnological companies) organizations as part of the project is encouraged. This limitation on the number of independent projects from the same academic or private sector organization is intended to increase the diversity and multidisciplinary expertise available to the Group from other than the parent institution or organization. While no maximum number of projects is stipulated, it has been observed that when a multidisciplinary grant or award exceeds six component projects the program becomes less coordinated and more difficult to manage. This RFA is a one-time solicitation. If by the end of the third year of the award, the NIDA has not announced its intent to re-issue the RFA, awardees should contact NIDA program staff and consider submitting investigator-initiated (R01) applications which will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. All policies and requirements that govern the grant program of the U.S. Public Health Service (PHS) and the National Institutes of Health (NIH) apply. FUNDS AVAILABLE NIDA has set aside $2.0 million total costs for the first year of funding. This level of support is dependent on the receipt of a sufficient number and diversity of applications of high scientific merit. Two to three awards are anticipated for project periods up to four years. However, support beyond the second year of each SPIRCAP will be determined by NIDA staff based, in part, on the recommendations of an external ad hoc committee, convened to evaluate accomplishments and determine whether or not stated goals have been met. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of individual awards will vary also. Awards are subject to a first year limit of $1.0 million in total costs (direct plus indirect costs). Budget requests should be carefully justified and commensurate with the complexity of the project. Although this program is provided for in the financial plans of the NIDA, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Applications in excess of $1.0 million total cost will be returned without review, unless a waiver has been granted by the SPIRCAP Program Director, Dr. Betty Tai, in advance of submission. (address listed under INQUIRIES). RESEARCH OBJECTIVES Background The NIDA and the PHS are currently supporting comprehensive extramural and intramural projects aimed at the elucidation of processes susceptible to the action of cocaine and the mechanisms through which cocaine affects the fundamental brain processes, and for developing safe and effective behavioral and pharmacological therapies to treat cocaine addicts. Notwithstanding these efforts, no pharmacotherapeutic approaches yet been proven effective. To address this critical deficiency, NIDA has made the development of an anti-cocaine medication its number one priority. The sense of urgency is prompted by the fact that cocaine abuse and dependence affect all segments of our society with devastating personal, social, and public health consequences. National surveys indicate that more than 23 million Americans have used cocaine at some time in their lives and more than 1.3 million are current cocaine users. Cocaine use is associated with potentially life-threatening cardiovascular effects; sex-for-crack exchanges that are spreading the AIDS virus among both drug-abusing and non-drug-abusing populations; possible damage to the health and development of infants born to women who abuse cocaine during pregnancy; and violence and neighborhood disintegration related to the cocaine marketplace. In recent years, the scientific information base on the neurobiology of cocaine addiction has expanded and the number of technological breakthroughs has increased significantly. Advances in molecular biology, medicinal chemistry, immunology and neuroscience of cocaine addiction have been made: genes for the dopamine and serotonin receptors have been cloned, novel cocaine congeners of varying affinities and pharmacokinetics properties have been synthesized and evaluated, animal models that permit the study of behavioral features of cocaine addiction in the laboratory are available, relationship among protein function and regulation, brain structures, functions and behavioral end points, and how cocaine affects these relationships have been elucidated, basic brain mechanisms associated with addiction behavior have been studied by clinicians, imaging scientists and psychologists. However, application of developments to clinical and treatment activities has not been commensurate with this expansion. There is a need to apply these research advances to clinical research studies, an effort that requires interdependent research activities involving both preclinical and clinical investigators in the planning and implementation of studies whose ultimate goal is an effective pharmacotherapy for cocaine addiction. A concerted effort to mobilize the nation's combined basic and clinical scientific expertise through SPIRCAP can accelerate advances in the development of effective treatments for this brain disorder. The SPIRCAP Program is specifically designed to support research for the development of innovative hypothesis generating and proof-of-concept pharmacological intervention and strategy for the treatment of cocaine addiction. The theme of this program complements and balances present efforts pursued under existing NIDA programs, including the Medication Development Research Centers (MDRC), the various contracts managed by the Division's discovery programs for the synthesis, testing and screening of potential pharmacotherapeutics. Research Goals and Objectives of the SPIRCAP Program A. The principal goals of this RFA are to (1) bring together innovative, advanced preclinical research of sound scientific rationale and clinical proof-of concept of an identified therapeutic strategy for cocaine addiction; and (2) implement pilot clinical studies of a therapeutic strategy. In line with this objective, the SPIRCAP Program will support projects with a common thematic goal for which advanced preclinical data exist. These efforts are to be implemented through a concerted, interdependent Group effort by components comprising the SPIRCAP Group. A SPIRCAP can focus its preclinical and clinical research activities on strategies directed toward validating a "substitution" or "blocking" treatment concept or the development of cocaine antibodies or anti-idiotype based vaccines or other novel, innovative approaches. B. Applicants for SPIRCAP funding are expected to have an identified strategy - based on creative, solid scientific rationale and supported by advanced preclinical data - which is proposed for pilot clinical evaluation. Therapeutic strategies that require studies in humans as well as preclinical studies to refine the clinical approach are appropriate for funding under the SPIRCAP Program. Each SPIRCAP is a well-defined central research focus consistent with the research objectives of the Program as stated in the RFA. The following approaches are provided as examples and are not intended to be inclusive or restrictive: Strategies that substantiate or refute the concept of "substitution-agonist" and/or "antagonist" therapies. Much of the current approaches for the development of anti-cocaine medications are modeled after the success of opioid addiction pharmacotherapies (the methadone, LAAM and naltrexone) or the nicotine addiction pharmacotherapies (the nicotine patch, gum, etc.), however, the differences between these addictions warrant further validations of such concepts. Strategies that validate the utility of novel classes of compounds as potential anti-cocaine medications, e.g., dopamine D1 antagonists, SSRIs, or kappa opioid compounds. Strategies that validate the utility of an anti-craving medication to prevent relapse to cocaine addiction. Strategies for the development of catalytic antibodies and anti- idiotype based vaccines to treat cocaine addiction. Strategies that validate the utility of compounds which interrupt chronic cocaine use based on identified neurobiological and cellular mechanisms that may promote repeated cocaine use. Strategies that validate the utility of compounds that modifies cocaine sensitization or tolerance to treat cocaine addiction. C. Applications should address advanced preclinical refinements of the proposed strategy, evaluation and demonstration of therapeutic benefit in laboratory animals, if applicable, and implementation of pilot clinical studies. The cyclic flow of information between preclinical and clinical phases is critical for maximal refinement and optimization of the proposed clinical modality, clinical evaluation of the therapeutic concept, and ultimately, to accelerate transition to clinical treatment. D. Studies required for the IND-targeted preclinical development (formulation, toxicology) of proposed treatments are generally beyond the scope of this RFA, but such development through private venture capital is encouraged. Alternatively, a Group may request that the NIH assist in these developmental tasks using existing NIH/NIDA contract resources. The NIDA/MDD has the capacity for clinical evaluation of therapies for cocaine addiction in its VA interagency agreement. It is envisioned that extended clinical studies of treatments developed by a SPIRCAP group can be accommodated under the clinical trial mechanisms available through Medications Development Division. Queries about these programs may be directed to Dr. Betty Tai at the address listed under INQUIRIES. E. The Group's objectives and goals should be relevant to and compatible with the NIDA Program missions and directions as stated in this RFA. Applicants should describe their plans to accommodate the stated SPIRCAP Program requirements, criteria, and NIDA involvement. F. Applications that are not truely innovative or are covered by other NIDA programs are excluded from this RFA. G. Relevance to other NIDA programs: This RFA will support innovative, integrated preclinical and clinical studies to validate therapeutic concepts for cocaine addiction. Other MDD/NIDA initiatives involving only preclinical studies for novel intervention strategies address (1) preclinical animal models development; (2) early preclinical discovery of new drugs and therapeutic approaches for the treatment of cocaine addiction. SPIRCAP applicants must ensure that no overlap exists between the specific aims proposed under this RFA and those proposed under any of the other initiatives referenced above, if applicable. SPIRCAP applicants from an institution receiving government funds under General Clinical Research Center (GCRC), Medication Development Research Center (MDRC), should describe how these programs are integrated with the proposed studies, and ensure that no scientific and budget overlap exists with the SPIRCAP proposal. DEFINITIONS ADMINISTRATIVE CORE - An administrative facility that provides central operations and support for the overall management of the cooperative agreement and services shared by the Group as a whole. The Administrative Core should have a budget separate from that of the Principal Investigator's research project, but should be administered by the Principal Investigator's organization. The Administrative Core will have in its budget for each year travel expense to support its SPIRCAP Steering Committee members to attend scheduled Steering Committee meetings. The Administrative Core will be responsible for allocating required travel expenses to appropriate members of the Group. Only SPIRCAP-related travel will be supported under this RFA; travel funds to other domestic or foreign meetings is not provided under this RFA. (For additional details of required travel see SPECIAL REQUIREMENTS - TERMS AND CONDITIONS OF AWARD: A. and B.) COOPERATIVE AGREEMENT - An assistance mechanism in which substantial NIDA programmatic involvement is anticipated with the recipient organization during the performance of the planned activity. CORE COMPONENT - Laboratory facilities for equipment and services which are shared by two or more projects of the SPIRCAP. Examples of core components are: biochemical, cell-based, and immunological studies; animal model studies; pharmacology/toxicology studies; scale-up synthesis of the therapeutic agent. The core can be defined as a facility laboratory with established techniques and assays which performs a service function resulting in an economy of effort and savings in the overall costs of the Group. The core unit is to be described with the same detail as the research projects to enable evaluation of its scientific merit. CORE LEADER - The leader of one of the Scientific or Administrative Cores of the SPIRCAP. GROUP - see SPIRCAP, below. INVENTION - An innovative therapeutic approach that is or may be patentable under Title 35 of the United States Code. (SPIRCAP) STRATEGIC PROGRAM FOR INNOVATIVE RESEARCH ON COCAINE ADDICTION PHARMACOTHERAPY - In this RFA the terms STRATEGIC PROGRAM FOR INNOVATIVE RESEARCH ON COCAINE ADDICTION PHARMACOTHERAPY (SPIRCAP) and "Group" are synonymous. Each Group may consist of a number of scientific investigators from academic and/or non-profit research institutions as well as scientists from commercial organizations, performing research on interdependent projects whose central focus is development of effective clinical therapy for cocaine addiction. A CORE component cannot be used toward fulfillment of the three research projects requirement. NIDA SPIRCAP PROGRAM DIRECTOR - A Senior Scientist of the NIDA extramural staff who coordinates NIDA's participation in the SPIRCAP Program, oversees the operation of the entire SPIRCAP Program, maintains the program stewardship duties and who ensures that the SPIRCAP Program is consistent with the Medications Development program and NIDA missions and goals. NIDA SCIENTIFIC COORDINATORS - Scientists of the extramural staff of the Medications Development Program, NIDA, who function as collaborators with the Principal Investigators and Project Leaders and who facilitate the partnership relationship between NIDA and each Group. Two Scientific Coordinators from the Medications Development Program - one from the preclinical program area and one from the clinical program or other related program area - will be assigned to each Group by the SPIRCAP Program Director. The Scientific Coordinators are the immediate contact persons to the Group. PRINCIPAL INVESTIGATOR - The person who assembles the SPIRCAP, who is responsible for the performance of the Group as a whole and for that of each of the Project Leaders, and who is responsible for submitting the single application in response to this RFA. The Principal Investigator will coordinate Group activities scientifically and administratively and should preferably be project leader of one of the Research Projects of the Group. The awardee (Principal Investigator's) institution establishes and operates the Central Operations Office that funds Group members and is legally and fiscally accountable for the disposition of funds awarded. PROJECT LEADER - The leader of one of the scientific research projects of the SPIRCAP, who is responsible for the scientific conduct of that project. SPIRCAP GROUP STEERING COMMITTEES - Each SPIRCAP Group will form a Steering Committee (SC) which is the primary coordination center of the GROUP and will decide all major scientific/programmatic decisions. It will be composed of the Principal Investigator, the Project leaders of the Group, the Chief of NIDA MDD Regulatory Affairs Branch (non voting), the NIDA Scientific Coordinators (one >From the preclinical area and one from the clinical area), and other non voting consultants (e.g., Scientists, relevant FDA and/or DEA officials) as needed. Only one NIDA Scientific Coordinator will vote. The SC will have the following responsibilities and authorities: (1) develop a detailed plan and timetable to coordinate the various research activities among the GROUP's various research laboratories to ensure the preclinical concept/strategy will advance into clinical studies in a timely fashion. (2) Identify/allocate the essential and additional studies or resources (toxicology, formulation) required for the IND targeted preclinical medication development activities which are not the scope of the study. (3) formulate strategies to successfully interact with the FDA, and/or local IRBs, etc regarding the IND submission and quality control of the studies (GLP, GCP, GMP, etc). (4) develop policies on data sharing, on access to data and materials and on publication authorship. The SC will meet at least two but not to exceed four times a year and will tele-conference when requested. (For additional details on SC see SPECIAL REQUIREMENTS - TERMS AND CONDITIONS OF AWARD: B.) RESEARCH PROJECT - A discrete, specified, circumscribed project that must relate to the overall theme (refinement and proof-of- concept of high risk innovative pharmacological intervention and strategy for the treatment of cocaine addiction) of the SPIRCAP. SPECIAL REQUIREMENTS Terms and Conditions of Award NOTE: Failure to abide by any of the Terms of Award pertaining to awardee responsibilities stipulated in this Section may result in withholding of funds by the NIDA until compliance with the Terms is restored. A. Awardee Rights and Responsibilities Specifically, the Principal Investigator defines the details for the project within the guidelines of the RFA, retains primary authority and responsibility for the plan, conduct, analyze and publish results, interpretations and conclusions of their studies, and agrees to accept assistance in coordination, cooperation, and participation of NIDA staff in those areas of scientific and technical management identified under C. NIDA staff responsibilities. Awardee will participate on the SPIRCAP Steering Committee as described under Collaborative Responsibilities. Awardee will retain custody of primary rights to their data developed under the award, subject to rules formulated by the Steering Committee, and government rights of access consistent with current DHHS, PHS, and NIH policies. B. Collaborative Responsibilities Under the Cooperative Agreement, a partner relationship exists between the awardee and NIDA. In order to facilitate the collaborative effort between the awardee and the NIDA extramural staff, a Steering Committee for each SPIRCAP will be established. Each SPIRCAP Steering Committee will be composed of: 1. The Principal Investigator of the Group. 2. The Project leaders of all preclinical and clinical projects. 3. The Chief of the NIDA Regulatory Affairs Branch (or designee), 4. The NIDA preclinical and clinical Scientific Coordinators, 5. Additional non-voting consultants as needed NIDA will have one vote and will not be serving as the Chair of the Committee. Each SPIRCAP Steering Committee will have the authority and responsibility to: (1) develop a detailed plan and timetable that will ensure active and frequent interactions among the various research laboratories and NIDA staff to expedite the transition of preclinical concept/strategy into clinical studies; (2) identify and allocate all essential and additional studies or resources (toxicology, formulation) required for the IND targeted preclinical development that are not the scope of the study; (3) formulate strategies to interact with FDA, and/or local IRBs, regarding the IND submission and quality control of the study (GLP, GMP, GCP, etc); (4) develop policies on data sharing, on access to data and materials and on publication authorship. The steering committee will meet two to four times a year and tele-conference when requested by the Awardee or by NIDA staff. C. NIDA Staff Responsibilities: Nature of NIDA Participation Assistance via a Cooperative Agreement differs from the traditional research grant in that, in addition to the normal programmatic and administrative stewardship responsibilities, the awarding component (NIDA) anticipates substantial scientific and programmatic involvement during performance of the research program. NIDA will work with each Group and will be represented by two NIDA Scientific Coordinators, both members of the professional staff of the Medications Development Program: one coordinator will be from the Cocaine Treatment Discovery Program, and one coordinator will be from the Clinical Cocaine Treatment Program or other related Programs. NIDA SPIRCAP Scientific Coordinators will be voting members of the SPIRCAP Steering Committee but will not hold the position of chair. In light of the complex structure and research activities of the SPIRCAP and the medications development goal of the SPIRCAP, NIDA staff will provide technical assistance and advice in the area of pharmaceutical regulatory science and in the area of information management and project management to ensure effective and efficient progress of the study. Specifically, the responsibilities of NIDA staff are three fold: (1) By means of their project management and information management expertise to facilitate the effective communication among study laboratories to ensure expedited transition of ground-breaking research from advanced preclinical findings to applied clinical mode. (2) To provide pharmaceutical regulatory advice and support to the GROUP by serving as liaison with the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) regarding all relevant regulatory issues; serving as consultants for the GROUP to prepare IND submissions and to conduct studies that meet FDA standards (GLP, GMP, GCP) when needed. (3) To provide appropriate assistance, advice, and guidance in general by participating in the design of Group activities; advising in the selection of sources or resources; coordinating or participating in collection and/or analysis of data and participating in the preparation of publications but will not participate in the actual implementation of the preclinical and clinical studies. D. Patent Coverage Principal worldwide patent rights to an invention supported in whole or part with Federal funds usually vest with the grantee/contractor organization. Under existing regulations 37 CFR 401, grantee/contractor organization must promptly report all inventions disclosed to them by their investigators to NIH Extramural Technology Transfer Office. A grantee can elect to retain title to any subject invention, although such title is subject to an nonexclusive, nontransferable, irrevocable, paid-up license to the government to use, and license others to use, the invention for Government purposes. If the grantee does not elect to retain title, the Government may do so. Moreover, the Government retains march-in rights that require the patent holders to license others in certain circumstances such as when the licensee has not taken effective steps within a reasonable time to achieve practical application of an invention or to alleviate a health and safety need. E. Arbitration Process Inasmuch as certain activities require approval by NIDA staff during performance of this Cooperative Agreement - specifically, reports intended for inclusion in IND's and Clinical Brochures, redistribution of materials received from the Government, and dissemination of research findings resulting from the use of these materials - NIDA will establish an arbitration process to resolve any differences of opinion between the awardee and NIDA, on scientific and programmatic matters. An arbitration panel, composed of one Group designee, one NIDA designee, and a third designee with expertise in the relevant area and chosen by the other two, will be formed to review any scientific or programmatic issue that is significantly restricting progress. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. The special "TERMS AND CONDITIONS OF AWARD: " described in this Section are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH grant administration policies. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by May 13, 1996, a letter of intent that includes a descriptive title of the overall proposed research; the name, address, telephone number, and institution of the Principal Investigator; names of prospective Project Leaders, other key investigators, and their respective institutions; title, project leader, and institution for each component research project, and the number and title of the RFA in response to which the application may be submitted. Although the letter of intent is not required, is not binding, and is not a factor in the peer review of the application, the information it contains is helpful in planning for the review of applications. It allows NIDA staff to estimate the potential review workload and to avoid conflict of interest in the review process. The letter of intent is to be sent to: Director Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Rm 10-42 Rockville, MD 20857 Telephone: (301) 443-2755 APPLICATION PROCEDURES This RFA requires the submission of a single application for the proposed SPIRCAP. o The individual research projects comprising the SPIRCAP are subject to the same format and page limitations as a research project grant application. The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these cooperative agreements. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: girg@drgpo.drg.nih.gov. The title and number of this RFA must be typed in Item 2 on the face page of the application. o The special requirements of this RFA also necessitate certain modification. The Introductory Section should apply to the proposed SPIRCAP as a whole with respect to the overall theme, goals, objectives, and overall research plan. The Introductory Section, not to exceed three pages, should contain any additional information about the proposed Principal Investigator or his/her institution as evidence of capability to carry out the scientific and administrative duties required in this RFA and the functions of the Central Operations Office. 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, to ensure the identification of the application with this RFA the "YES" box must be marked in item 2 of the face page of the application form and the title and number of this RFA typed. Applications that are not received as a single package from the Principal Investigator and that do not conform to the instructions contained in PHS 398 (rev. 5/95) application kit will be judged non-responsive and will be returned to the applicant. The completed original, including the checklist, and three legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH, MSC-7762, 6701 ROCKLEDGE DRIVE, ROOM 1040 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight services) At the time of submission, two additional copies of the application must be sent to: Director Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Rm 10-42 Rockville, MD 20857 Telephone: (301) 443-2755 Applications must be received by June 13, 1996. If an application is received after this date, it will be returned to the applicant without review. If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications to be reviewed by different review committees. This restriction is superseded by an NIH policy permitting concurrent submission of a duplicate R01 and a component of a multi-project application. The NIH policy however, further stipulates that should both the R01 and the multi-project application be considered for funding, the R01 will be relinquished in favor of the multi-project application. REVIEW CONSIDERATIONS A. Review procedures Applications will be reviewed by the Division of Research Grants for completeness and by NIDA staff to determine administrative and programmatic responsiveness to this RFA; those judged to be non-responsive will be returned to the applicant without review. Applications with first year total costs (direct and indirect) in excess of $1.0 million will be returned without review unless the applicant has received a written waiver from the NIDA to exceed this amount (see FUNDS AVAILABLE, above). 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 NIDA 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 priority score, and receive a second level review by the National Advisory Council of NIDA. B. Review Criteria Applicants are encouraged to submit and describe their own ideas about how best to meet the goals of the cooperative study and their specific objectives, and are expected to address issues identified under SPECIAL REQUIREMENTS of this RFA. The review group will assess the scientific and technical merit of the proposed study plans and related factors: o Relevance of proposed research to the goals of the RFA; o Significance and originality of the proposed research; o Appropriateness and adequacy of the proposed research approach, methodology, and plans to address special requirements; 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 Appropriateness of proposed methodology and demonstrated willingness to work as part of the cooperative study and with NIDA Collaborating Scientists; o Adequacy of provisions for the protection of human subjects; and o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the specific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA Applications recommended for further consideration by an appropriate Advisory Council will be considered for funding based on the following factors: o Overall scientific and technical merit of the proposal as determined by peer review; o Significance and originality of the proposed research; o Appropriateness of budget estimates; o Compatibility of research and data analytic approaches, administrative structures, and other features to make a successful cooperative study a reasonable likelihood; o Program priorities; and o Availability of funds. Schedule Letter of Intent Receipt Date: May 13,1996 Application Receipt Date: June 13, 1996 Scientific Review Date: August 1996 Council Meeting Date: September 1996 Earliest Award Date: September 30, 1996 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applications is welcome. Direct inquiries regarding programmatic issues to: Betty Tai, Ph.D. Medications Development Division National Institute on Drug Abuse Parklawn Building, Room 11A-55 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-3318/1428 FAX: (301) 443-2599 Email: BTAI@NIH.GOV Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.S. Grants Management Branch National Institute on Drug Abuse Parklawn Building, Room 8A-54 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-6710 Email: gfleming@aoada1.ssw.dhhs.gov AUTHORITY AND REGULATIONS This program is described in the catalog of Federal Domestic Assistance No. 93.279. Awards are 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 grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 122372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care of early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Thu Apr 04 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DK-96-005 - V25(10) 03/29/96 Date: 4 Apr 1996 21:00:23 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 459 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4k29d7$mu0@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DK96005 DK-96-005 P1O1 *************************************** THE REGULATION OF PROSTATE GROWTH NIH GUIDE, Volume 25, Number 10, March 29, 1996 RFA: DK-96-005 P.T. 34; K.W. 0705075, 0760020, 0705048 National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Aging Letter of Intent Receipt Date: July 15, 1996 Application Receipt Date: August 8, 1996 PURPOSE The Division of Kidney, Urologic, and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institute on Aging solicit research project grant (R01), First Independent Research Support and Transition (FIRST) (R29) award, and Interactive Research Project Grant (IRPG) applications for the support of basic research studies that use human tissue and cells to focus on the molecular mechanisms of the regulation of normal prostate growth, the factors involved in the re- initiation of normal growth in adult men, and abnormal, non-malignant prostate growth and disorders. The intent of this solicitation is to increase the diversity of approaches to the study of prostate growth regulation and related abnormalities by encouraging investigators >From diverse research areas to apply their expertise in this area. 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, The Regulation of Prostate Growth, is related to the priority area of disease and aging. 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. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as principal investigators. Competing renewal applications are not eligible for this solicitation. MECHANISM OF SUPPORT Support of this program will be through the NIH research project grant (R01), Investigator-Initiated Interactive Research Project Grant (IRPG) and FIRST (R29) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The total requested project period for applications submitted in response to this RFA may not exceed five years. FIRST Awards must be for five years and the total direct cost award for the five year period may not exceed $350,000. A maximum of three years can be requested for foreign awards. The maximum dollar request is limited to $160,000 in direct costs for the initial budget period for R01s and the individual IRPGs. However, the lead IRPG may include a request for up to an additional $50,000 Direct Costs for shared resources. (Special instructions for preparing applications for IRPGs must be requested from the program officials listed under INQUIRIES). The anticipated award date will be April 1, 1997. FUNDS AVAILABLE For FY 1997, $2,500,000 will be committed by the NIDDK to fund applications submitted in response to this RFA. It is anticipated that 12 to 14 awards will be made by the NIDDK. In addition, the NIA will fund up to two high quality applications related to molecular and cellular mechanisms of prostate growth in middle aged and older men. However, these funding level are dependent upon the receipt of a sufficient number of applications of high scientific merit. In order to help meet NIDDK and NIA goals or managing the costs of biomedical research, applicants must limit their requests to not more than $160,000 direct costs for the initial budget period. Although this program is provided for in the financial plans of the NIDDK and NIA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background: Normal and abnormal prostate growth contribute to two major prostate diseases: benign prostatic hyperplasia (BPH) and prostate cancer (PCa). Other prostate abnormalities result in the development of chronic prostatitis. The factors involved in the initiation and regulation of prostate growth have been inadequately characterized and many new factors remain to be described. There are also many other areas of prostate abnormality which are poorly investigated. Of particular importance are the immunologic mechanisms of the prostate and the interrelationship between benign prostate enlargement and urinary bladder abnormalities. A large amount of the current knowledge about these diseases has been extrapolated from research studies on animals and animal cell lines. The number of studies which focus on well characterized human tissue are very limited. If progress is to be made in effectively treating and preventing prostate disease, the basic molecular mechanisms which regulate prostate growth must be characterized in normal prostate tissue and in well characterized abnormal prostate tissue. Innovative molecular approaches to the study of cellular growth and immunology are being utilized effectively by investigators in fields as diverse as oncology, wound healing, morphogenesis, and pharmacogenetics. All too often these investigators focus on one specific organ system or disease problem and are not encouraged to apply their knowledge to a related phenomenon in a different tissue. Areas for investigation: The major emphasis of this RFA is the solicitation of new and innovative approaches to study of prostate growth and chronic prostate inflammation using well characterized human tissue. (Well characterized tissue is tissue for which both a pathological diagnosis, e.g. normal, prostatitis, hyperplasia, chronic prostatitis, and, if possible, the concurrent clinical parameters, are identified.) If animal tissue is used in the study design, it cannot be the major focus of the study but used as a mechanism to develop or amplify studies on human tissue. Topics that are be within the scope of this RFA include, but are not limited to: o research studies on prostate stem cells, o common regulatory factors found in various prostate diseases such as prostatitis, BPH and PCa, o the role of cytokines, interleukins, etc. in prostate growth regulation, o the regulation of prostate apoptosis, o cell/cell interactions and prostate growth o enzymatic factors involved in the regulation of prostate growth, o molecular genetics of prostate growth regulation, o the role of neuroendocrine cells and neuroendocrine factors in prostate growth regulation, o fetal imprinting and adult prostate growth regulation. o the effect of diabetes mellitus on prostate growth regulation. o comparison of growth regulation in tissues from persons of diverse ethnic/racial origins, o the molecular effects of prostate enlargement and/or outflow obstruction in gene expression in bladder and prostate, o the immune defense mechanisms of the human prostate and urethra, o effects of bacterial agents on the molecular immunology of the prostate, o exocrine, paracrine and other regulator mechanisms of prostate growth, o genetic differences in growth initiation in prostate tissue from persons of diverse ethnic origins. o age-related changes in prostate growth bioregulatory factors, and prostate cell sensitivity to these factors, o molecular, cellular, and genetic mechanisms that lead to initiation and sustenance of prostate growth in middle aged men. Applications solely to study malignant prostate growth and its regulation are not within the scope of this RFA. However, applications that use malignant tissue for comparative study with benign hyperplasia, chronic prostatitis, normal cells, or models are acceptable for application. Program project grant applications (P01) will not be accepted in response to this RFA. Special Requirements: NIDDK BPH Clinical Trial Investigators: Investigators funded by either the Pilot or Full-Scale NIDDK BPH Clinical Trial may utilize the tissue collected by the study and stored at the diagnostic center. Applicants must include with their application a letter from the NIDDK Project Officer stating that they are eligible to use this tissue bank. Applicants should include in their budget any special shipping or preparation costs which will be incurred by the diagnostic center and additional travel funds to the NIH for two research planning meetings during the first grant period. FIRST Award Applicants: Must adhere to the R29 Administrative Guidelines (revised February 1994) for eligibility, budget and period of award. FIRST Award applications (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award applications submitted without the required reference letters will be considered incomplete. Foreign Institutions are not eligible for FIRST Awards. 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. Because this solicitation is limited to prostate tissue, a statement regarding the inclusion of women in the study is not necessary. 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 may also obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by July 15, 1996, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, 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 NIDDK staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS 37-E - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES The research grant application form PHS-398 (rev. 5/95) is to be used in applying for these grants. 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 must be typed on line 2 of the face page of the application form and the YES box must be checked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At time of submission, two additional copies of the application must also be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS 37-E - MSC 6600 Bethesda, MD 20892-6600 Applications must be received by August 8, 1996. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications previously reviewed. Such applications must not only include an introduction addressing the previous critique but also be responsive to this RFA. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. Review criteria o scientific/technical merit criteria specific to the objectives of the RFA; o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively in the area of the proposed research; o availability of 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. o availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries which are not readily available in the United States or which provide augmentation of existing U.S. resources. o in addition, the reviewers will be asked to address the new and innovative character of the application; applicants should ensure that those factors are delineated in the application. AWARD CRITERIA The anticipated date of award is April 1, 1997. Funding decisions will be made based on the scientific and technical merit as reflected in the priority score, availability of funds, and programmatic priorities. Compliance with the intent and purpose of the RFA will also be considered in funding decisions. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcomed. Direct inquiries regarding programmatic issues to: Ralph L. Bain, Ph.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301)-480-3510 Email: Ralph_Bain@nih.gov Leroy M. Nyberg, Jr., Ph.D., M.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301)-480-3510 Email: Leroy_Nyberg@nih.gov Frank Bellino, Ph.D. Biology of Aging Program National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892-9205 Telephone: (301) 496-6402 FAX: (301) 402-0010 Email: bellinof@gw.nia.nih.gov Direct inquiries regarding fiscal and administrative matters to: Ms. Trude Hilliard Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8859 FAX: (301) 480-3504 Email: MccainT@ep.niddk.nih.gov Robert Pike Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 Bethesda, Md 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: pikeb@gw.nia.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849 (NIDDK) and 93.866 (NIA). 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 case, 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 Apr 04 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-96-036 - V25(10) 03/29/96 Date: 4 Apr 1996 21:02:19 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 330 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4k29gr$n1r@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PAR96036 PAR-96-036 P1O1 ************************************* DEVELOPMENTAL GRANTS FOR MINORITY COLLABORATIVE PROJECTS NIH GUIDE, Volume 25, Number 10, March 29, 1996 PA NUMBER: PAR-96-036 P.T. 34, FF; K.W. 0404003, 0404000, 0710030 National Institute on Alcohol Abuse and Alcoholism PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking applications for exploratory/developmental (R21) grant applications for collaborative research projects to encourage new or strengthen existing cooperative relationships between established alcohol research scientists and scientists in minority and/or predominantly minority institutions. Awards under this program are intended to enhance and extend the alcohol research activities of minority scientists. It is expected that projects will be mutually beneficial to the collaborating scientists and to the advancement of research on alcoholism and alcohol abuse. Exploratory/developmental grants (R21) are intended to develop new research activities that could serve as the foundation for the development of more intensive and larger research studies. Grants supported under this program announcement will be limited to a two-year effort and a maximum of $70,000 in direct costs per year. The issues related to alcohol abuse, alcoholism, and reduction of alcohol-related problems are complex. The NIAAA supports alcohol relevant basic and applied research involving a wide array of health science fields and related academic disciplines. Because the United States is a multi-cultural, multi-ethnic nation with wide diversity in the patterns, trends, and practices around alcohol use and abuse, much can be gained from research partnerships in this field. 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, Developmental Grants for Minority Collaborative Projects, is related to the priority areas of alcohol abuse reduction and alcoholism treatment. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications for exploratory/developmental (R21) research grants may be submitted by domestic non-profit and for-profit, public and private, institutions such as a university, college, hospital, laboratory, units of State and local government; and eligible agencies of the Federal government. One scientist must apply as principal investigator with a colleague from a laboratory or research site in the collaborating institution. It is recognized that scientific opportunities may arise that warrant a formal collaborative effort between the principal investigator and individuals from more than one institution. The collaborator must hold a position at a public or private non-profit institution that will allow him or her adequate time and provide appropriate facilities to conduct the proposed research. The linkages for collaborative efforts must be between institutions in the United States. Simultaneous submissions of both an exploratory/developmental and a regular research grant (R01) application on the same topic will not be accepted. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Research support mechanisms are limited to exploratory/developmental grants (R21) for up to $70,000 in direct costs per year for up to two years. Awards are made to the applicant institution to support a collaborative research project that will be performed, in part, at the collaborator's research site. Funds may be included to purchase supplies for the collaborator's laboratory and to support travel for the collaborators as justified by the needs of the research proposed. Annual awards will be made subject to continued availability of funds and progress achieved. FUNDS AVAILABLE While an award may be up to $70,000 in direct costs per year for two years, the NIAAA estimates that most of the awards will be smaller. It is estimated that in Fiscal Year 1997 approximately four awards will be made depending on the quality of applications, program priorities, and the availability of funds. Second year budgets should conform to current NIH cost-containment policy of a four percent increase for recurring costs. Support for subsequent years may be requested through the regular research grant programs of NIAAA. Although the financial plans of NIAAA provide for the support of this program, the award of grants pursuant to this program announcement is contingent upon the availability of funds for this program. RESEARCH OBJECTIVES The purpose of this program announcement is to encourage exploratory/developmental studies that will complement and enhance existing alcohol research efforts. The establishment of this program will provide opportunities for attracting additional scientists to the alcohol field. This program will establish a process for making the accumulated knowledge and experience of alcohol investigators available to colleagues in historically and predominantly minority institutions to address relevant issues and problems. The number of scientists who are identified as members of underrepresented minority groups and who are engaged in alcohol research is extremely small. Clearly there is a need to develop ways to assist and encourage minority scientists to become active in the conduct of studies that can advance the rapidly growing knowledge base in the alcohol field. It is anticipated that this program will provide support to enhance research capabilities in research oriented minority institutions; to collaboratively pilot test a hypothesis before a larger more complex project is developed; to develop new technology or methodologies to facilitate the study of appropriate research problems; and to create opportunities for collaborating scientists to acquire knowledge and skills that enable them to submit competitive research grant applications. The intent is to advance understanding, contribute meaningfully to the literature, and to significantly advance alcohol research efforts in minority institutions. Minority investigators may also apply directly for an exploratory/developmental grant from NIAAA. It is anticipated that collaborative efforts established through this program will: a) facilitate development of alcohol relevant epidemiologic, biomedical, behavioral, treatment, prevention, and policy research activities in minority institutions; b) provide opportunities to scientifically explore biological, behavioral and socio-cultural phenomena that may help to explain differing degrees of severity and disease progression of alcohol induced adverse effects observed among and within minority groups and subgroups; c) enhance development of talent, scientific expertise and resources capable of making unique contributions to the field; d) stimulate development of alcohol focused research training programs in schools of medicine and other doctoral degree programs in minority and predominantly minority institutions; and e) facilitate development of the foundation for the coordinated conduct of scientifically sound studies and interventions on a broad and inclusive basis that reflects the multi-ethnic, multi-cultural heterogeneity of the U.S. population. Applications may be made for support of research in any scientific area relevant to alcohol abuse. While applications may involve a wide variety of biomedical, biobehavioral, or clinical disciplines, relevance to the mission of the Institute must be clear. Applications for studies aimed at problems outside these areas will be returned without review. Areas of interest to NIAAA are described in program announcements that can be obtained on the Internet (http://www.niaaa.nih.gov) or >From the: National Clearinghouse for Alcohol and Drug Information P.O. Box 2345 6000 Executive Boulevard, Suite 402 Rockville, MD 20852 Telephone: (301) 468-2600 Potential applicants with questions concerning acceptability of the topic of their proposed study should contact NIAAA staff 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), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, 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 express/courier service) REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAAA in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. Review Criteria Criteria to be used in the scientific and technical merit review of exploratory/developmental (R21) applications will include the following: 1. The scientific, technical, health or medical significance, and originality of the proposed research. 2. The innovativeness or promise of the research proposed. 3. The degree to which the proposed collaboration presents opportunities for furthering research programs in minority institutions. 4. The potential of the proposed study as a building block in the development of future research. 5. The appropriateness and adequacy of the research design and methodology proposed to implement the research plan. 6. The adequacy of the qualifications (including level of education and training) and relevant research experience of the principal investigator, key personnel and the ability of the collaborator to undertake the research activities proposed in the project. 7. The availability of adequate facilities, general environment for the conduct of the proposed research and other resources and collaborative arrangements. 8. The appropriateness of budget estimates and time frame in relation to plans for the research. 9. 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 recommended for approval by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for funding on the basis of the overall scientific and technical merit of the proposal as determined by peer review, NIAAA program needs and balance, and the availability of funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding potential research to: Ernestine Vanderveen, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 Bethesda, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 Email: tvanderv@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Ms. Linda Hilley Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0915 FAX: (301) 443-3891 Email: lhilley@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 of Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care 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 Apr 04 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-96-002 - V25(11) 04/05/96 Date: 4 Apr 1996 21:10:30 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 398 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4k2a06$o4t@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HD96002 HD-96-002 P1O1 *************************************** HEALTH PROMOTION FOR WOMEN WITH PHYSICAL DISABILITIES NIH GUIDE, Volume 25, Number 11, April 5, 1996 RFA: HD-96-002 P.T. 34, II; K.W. 0745035, 0507004 National Institute of Child Health and Human Development Office of Research for Women's Health Letter of Intent Receipt Date: April 15, 1996 Application Receipt Date: May 16, 1996 PURPOSE The National Institute of Child Health and Human Development (NICHD) and the Office of Research on Women's Health (ORWH) invite applications for research project grants (R01s) that will develop and test the effectiveness of interventions that will lead to the improved health and well-being of women with physical disabilities. It is anticipated that studies resulting from this initiative will augment the knowledge needed to enable women with disabilities to achieve optimal health and, as a corollary, contribute to preventing or reducing the incidence or severity of secondary diseases or injuries. 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 Application (RFA), Health Promotion for Women With Physical Disabilities, is related to the priority area of chronic and disabling conditions and the goal to reduce health disparities among Americans. 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. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) mechanism. The total project period for an application submitted in response to the present RFA may not exceed three years and the total direct costs for the first year may not exceed $100,000 with a maximum of $350,000 for three years. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The anticipated award date is September 30, 1995. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all unsolicited investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Applications submitted in response to this RFA will compete for direct costs of approximately $600,000 that have been made available >From the NICHD and $100,000 from the ORWH for the first year of support for the program. It is expected that approximately seven awards will be made. The number of awards depends on the overall scientific merit of the applications, their relevance to the stated goal of the RFA, and the availability of funds. RESEARCH OBJECTIVES Background Currently, there are approximately 36 million women living with chronic physical impairments and disabilities in the United States. With improvements in medical care, individuals born with birth defects or experiencing serious injury are surviving and living longer. As a consequence, issues associated with the quality of life and reduction in the incidence of secondary conditions of persons with disabilities have become increasingly prominent. With enactment of the Americans with Disabilities Act, the need has been recognized for the development of effective interventions for promoting the health of persons with disabilities. Few such interventions have been validated systematically and research on health promotion practices that meet the particular needs of women with disabilities has been especially neglected. To identify the unique health needs of women with disabilities, the NIH sponsored a conference on "The Health of Women with Physical Disabilities" in May, 1994. The conference focused on four areas of women's health that served to establish a research agenda for improving health of women with disabilities. A common thread throughout the proceedings was the need to identify effective health promotion and wellness programs for women with disabilities and to evaluate the outcomes of these programs. Health has been defined by the World Health Organizations as being "a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity." Thus, health promotion programs should reflect a comprehensive approach to health that includes physiological functioning, emotional and social functioning, as well as life style behaviors. Such programs should emphasize self-responsibility, nutritional awareness, health related physical fitness and stress management. They must take into account that the health status of women with disabilities is not static, but dynamic, and that health programs should lead to enhanced useful functioning, the prevention of secondary disabling conditions, and an increased quality of life. Physically active life styles have been shown to be effective in reducing morbidity due to all causes in able-bodied populations. Prolonged exposure to stressors has been linked to suppression of the immune response and an increase in autoimmune disease. Known benefits of exercise for women include improved aerobic capacity, improved performance, weight control, modified aging responses, and possible prevention of osteoporosis. In addition, improvement in psychological health and quality of life are also reported. Low levels of fitness associated with physical inactivity have commonly been reported for general populations of individuals with physical disabilities. Further, women with disabilities contend with multiple stressors including major life changes and frequent daily hassles. The goal of this RFA is to encourage the development of health promotion programs for women with disabilities. Such programs can include the development and evaluation of specific interventions that will lead to increased fitness and well-being as well as stress reduction and health maintenance. Applications leading to improved methodology for assessing the effectiveness of these interventions are encouraged. Scope The following items provide examples of subject areas that are within the scope of the RFA. This list is not exhaustive and applicants are encouraged to communicate with program staff regarding the responsiveness of other topics that may be related to this RFA. o Develop comprehensive wellness programs that can provide women with opportunities to access fitness, nutrition, and stress reduction programs at one site, and evaluate their effectiveness in maintaining health and preventing secondary conditions. o Identify the barriers to greater participation in wellness programs by women with disabilities, either as a consequence of women's perceptions of the need for such programs or the attitudes of health care providers about the health maintenance and wellness of women with disabilities. Develop and evaluate interventions that will encourage greater utilization of such programs by women with disabilities. o Develop methodology for measuring the health promoting behaviors of women with disabilities. o Develop assessment tools for measuring the activity of women with disabilities. o Develop improved measures that differentiate the components of fitness and functioning, including strength, endurance, and flexibility. o Develop methods to promote the fitness of women with severely restricted mobility. o Examine the role of stress in fitness and well-being, examining its potential positive role as well as unwanted sequelae. For instance, can stress in women with severe motor impairments be utilized to improve cardiovascular fitness? o Characterize behaviors that integrate fitness strategies into other aspects of life, work, and family. o Characterize the positive impact of fitness and its effects on reducing secondary conditions, and other co-morbidity. o Evaluate the effectiveness of interventions over the life-span of women with disabilities, paying particular attention to differences in effectiveness based not only on age but also on duration after disability. 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 April 15, 1996, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, 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 NICHD staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Danuta Krotoski, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Building 6100, Room 2A03 6100 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 402-2242 FAX: (301) 402-0832 Email: krotoskd@hd01.nichd.nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained >From the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov; and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development Building 6100, Room 5E03H 6100 Executive Boulevard Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Applications must be received by May 16, 1996. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NICHD. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NICHD staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, a process may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non- competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Principal Investigators of applications judged to be non-competitive will receive summary statements containing reviewers' comments. Review Criteria o scientific, technical, or medical significance and originality of the proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o inclusion of women with disabilities as part of the research team, either as principal investigator, co-investigators, or consultants; 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 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 be selected based on scientific merit of the proposal, the availability of funds, inclusion of women with disabilities as investigators or co-investigators on the grants and its responsiveness to the RFA. 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: Danuta Krotoski, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Building 61E, Room 2A03 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 FAX: (301) 402-0832 Email: krotoskd@hd01.nichd.nih.gov Direct inquiries regarding fiscal matters to: Mary Ellen Colvin Grants Management Branch National Institute of Child Health and Human Development Building 61E, Room 8A07 Bethesda, MD 20892-7510 Telephone: (301) 493-1303 FAX: (301) 496-0915 Email: colvinm@hd01.nichd.nih AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.929-Medical Rehabilitation Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Thu Apr 04 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 11, pt. 1of1, 5 April 1996 Date: 4 Apr 1996 21:10:02 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 396 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4k29va$o3i@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19960405 V25N11 P1O1 ************************************ X-comment: RFAs described: HD-96-002, PA-96-037, PA-96-038 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.04.05 NIH GUIDE - Vol. 25, No. 11 - April 5, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIH GUIDE PUBLICATION DATES $$INDEX N2 ********************************************************** NEW EMAIL ADDRESS FOR THE GRANTS INFORMATION OFFICE National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** DURATION FOR NIAMS P30, P50, AND P60 GRANTS National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES $$INDEX N4 ********************************************************** NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS FOR THE TREATMENT OF HIV INFECTION (PA-95-047) National Institute of Allergy and Infectious Diseases National Institute of Mental Health National Institute of Neurological Disorders and Stroke INDEX: ALLERGY, INFECTIOUS DISEASES; MENTAL HEALTH; NEUROLOGICAL DISORDERS, STROKE NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 05/16/96 ************************************************* HEALTH PROMOTION FOR WOMEN WITH PHYSICAL DISABILITIES (RFA HD-96-002) National Institute of Child Health and Human Development Office of Research on Women's Health INDEX: CHILD HEALTH, HUMAN DEVELOPMENT; WOMEN'S HEALTH $$INDEX P1 ********************************************************** HEALTH RISK REDUCTION: COMMUNITY-BASED STRATEGIES (PA-96-037) National Institute of Nursing Research INDEX: NURSING RESEARCH $$INDEX P2 ********************************************************** THE SIGNIFICANCE OF SARCOPENIA IN OLD AGE (PA-96-038) National Institute on Aging National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: AGING; ARTHRITIS; MUSCULOSKELETAL, SKIN DISEASES THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 FAX: (301) 480-0525 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** THE NIH GUIDE FOR GRANTS AND CONTRACTS WILL NOT BE PUBLISHED ON APRIL 12, 1996. THE NEXT ISSUE OF THE NIH GUIDE WILL BE ON APRIL 19, 1996. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NEW EMAIL ADDRESS FOR THE GRANTS INFORMATION OFFICE NIH GUIDE, Volume 25, Number 11, April 5, 1996 P.T. 34; K.W. 1014006 National Institutes of Health The Grants Information Office, formerly with the Division of Research Grants and now a component of the Extramural Outreach and Information Resources Office, Office of Extramural Research, Office of the Director, NIH, has changed its email address. The new email address is: ASKNIH@ODROCKM1.OD.NIH.GOV. Use this address when requesting single copies of grant application materials or program guidelines and for general questions regarding extramural grant programs. The grants information telephone and FAX numbers remain unchanged. Grant applications and other printed materials may be requested on (301) 435-0714 or by FAX on (301) 480- 0525. $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** DURATION FOR NIAMS P30, P50, AND P60 GRANTS NIH GUIDE, Volume 25, Number 11, April 5, 1996 P.T. 34; K.W. 0710030, 1014006 National Institute of Arthritis and Musculoskeletal and Skin Diseases The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is beginning a study of how the center mechanisms (P30, P50, and P60) are used to further the missions of the NIAMS. To allow for a timely implementation of any recommendations that may arise from this study the NIAMS intends to award center grants for four years instead of five years. This applies to P30 applications for Skin Diseases Research Core Centers received June 19, 1996 (RFA AR-96-001), and P60 applications for Multipurpose Arthritis and Musculoskeletal Diseases Centers received June 1, 1996 and later. Any RFAs issued in FY 1996 and 1997 will reflect this change for NIAMS center grant applications. INQUIRIES For further information contact: Dr. Julia B. Freeman Director, Centers Program National Institute of Arthritis and Musculoskeletal and Skin Diseases 45 Center Drive MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-5052 FAX: (301) 480-4543 Email: Freemanj@ep.niams.nih.gov $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS FOR THE TREATMENT OF HIV INFECTION (NCDDG-HIV) NIH GUIDE, Volume 25, Number 11, April 5, 1996 PA NUMBER: PA-95-047 P.T. 34; K.W. 0715008, 0755025 National Institute of Allergy and Infectious Diseases National Institute of Mental Health National Institute of Neurological Disorders and Stroke Application Receipt Date: July 1, 1995 Application Receipt Date: June 1, 1996 Application Receipt Date: June 1, 1997 REMINDER: Program Project (P01) applications in response to the above referenced Program Announcement are due June 1, 1966. INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Nava Sarver, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C01 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-8197 FAX: (301) 402-3211 Email: ns18p@nih.gov $$N4 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN HD-96-002 FULL-TEXT ************************************** HEALTH PROMOTION FOR WOMEN WITH PHYSICAL DISABILITIES NIH GUIDE, Volume 25, Number 11, April 5, 1996 RFA AVAILABLE: HD-96-002 P.T. 34, II; K.W. 0745035, 0507004 National Institute of Child Health and Human Development Office of Research for Women's Health Letter of Intent Receipt Date: April 15, 1996 Application Receipt Date: May 16, 1996 PURPOSE The National Institute of Child Health and Human Development (NICHD) and the Office of Research on Women's Health (ORWH) invite research project grant (R01) applications that will develop and test the effectiveness of interventions that will lead to the improved health and well-being of women with physical disabilities. It is anticipated that studies resulting from this initiative will augment the knowledge needed to enable women with disabilities to achieve optimal health and, as a corollary, contribute to preventing or reducing the incidence or severity of secondary diseases or injuries. 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, Health Promotion for Women with Physical Disabilities, is related to the priority area of chronic and disabling conditions and the goal to reduce health disparities among Americans. 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 e-mail from the program contact listed below. Danuta Krotoski, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Building 61E, Room 2A03 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 FAX: (301) 402-0832 Email: krotoskd@hd01.nichd.nih.gov $$R1 END ************************************************************ $$P1 BEGIN PA-96-037 FULL-TEXT ************************************** HEALTH RISK REDUCTION: COMMUNITY-BASED STRATEGIES NIH GUIDE, Volume 25, Number 11, April 5, 1996 PA AVAILABLE: PA-96-037 P.T. 34; K.W. 0745035, 0411005, 0403004 National Institute of Nursing Research PURPOSE The National Institute of Nursing Research (NINR) is interested in facilitating investigator-initiated research into the clinical application of intervention strategies designed to reduce health risks at the community level. Community-based strategies targeting health problems of rural residents and of underserved minority groups are of particular interest to NINR. The mechanisms of support will be the National Institutes of Health (NIH) research project grant (R01) and First Independent Research Support and Transition (FIRST) (R29) award. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Health Risk Reduction: Community-Based Strategies, is related to all of the special populations targets. 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. Patricia Moritz Division of Extramural Programs National Institute of Nursing Research Building 45, Room 3AN-12 45 Center Drive MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-6906 FAX: (301) 480-8260 Email: pmoritz@ep.ninr.nih.gov $$P1 END ************************************************************ $$P2 BEGIN PA-96-038 FULL-TEXT ************************************** THE SIGNIFICANCE OF SARCOPENIA IN OLD AGE NIH GUIDE, Volume 25, Number 11, April 5, 1996 PA AVAILABLE: PA-96-038 P.T. 34; K.W. 0710010, 0715136, 0705050 National Institute on Aging National Institute of Arthritis and Musculoskeletal and Skin Diseases PURPOSE The National Institute on Aging (NIA) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invite research project grant (R01) and First Independent Research Support and Transition (FIRST) (R29) award applications to elucidate the metabolic/physiological and functional consequences of sarcopenia in old age. Sarcopenia is defined as the loss of skeletal muscle mass, quality and strength. 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, The Significance of Sarcopenia in Old Age, is related to the priority area of chronic diseases and disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). 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. Chhanda Dutta, Ph.D. Geriatrics Program National Institute on Aging Gateway Building, Suite 3E-327 Bethesda, MD 20892 Telephone: (301) 496-1033 FAX: (301)402-1784 Email: DuttaC@gw.nia.nih.gov Richard W. Lymn, Ph.D. Muscle Biology Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS49E, MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-5128 FAX: (301) 480-4543 Email: LYM@CU.NIH.GOV $$P2 END ************************************************************ From owner-sci-resources@net.bio.net Thu Apr 04 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-038 - V25(11) 04/05/96 Date: 4 Apr 1996 21:11:11 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 347 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4k2a1f$o6q@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA96038 PA-96-038 P1O1 *************************************** THE SIGNIFICANCE OF SARCOPENIA IN OLD AGE NIH GUIDE, Volume 25, Number 11, April 5, 1996 PA NUMBER: PA-96-038 P.T. 34; K.W. 0710010, 0715136, 0705050 National Institute on Aging National Institute of Arthritis and Musculoskeletal and Skin Diseases PURPOSE The National Institute on Aging (NIA) and the National Institute of Arthritis and Musculoskeletal Skin Diseases (NIAMS) invite research applications to elucidate the metabolic/physiological and functional consequences of sarcopenia in old age. Sarcopenia is defined as the loss of skeletal muscle mass, quality and strength. 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, The Significance of Sarcopenia in Old Age is related to the priority area of chronic diseases and disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No.017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC Program Director or Principal Investigator should be included with the application. MECHANISM OF SUPPORT This program will use the NIH investigator-initiated research project grant (R01) and FIRST (R29) award mechanisms. The total project period for an application submitted in response to this program may not exceed five years. Because the nature and scope of the research proposed in response to this program may vary, it is anticipated that the size of awards will vary as well. RESEARCH OBJECTIVES Background The Greek word "sarco" refers to flesh and "penia" indicates a deficiency. "Sarcopenia" is a generic term for the loss of skeletal muscle mass, quality, and strength that can lead to frailty in the elderly. Examples of skeletal muscle properties that contribute to its overall quality include, but are not limited to: contractility, fiber size and type, fatiguability, hormone responsiveness, glucose uptake/metabolism and capillary density. Sarcopenia is believed to be due predominantly to disuse atrophy of skeletal muscle fibers. However, age-associated changes in myofibrillar protein metabolism, nutritional status, neuromuscular function and in the production of, or tissue responsiveness to trophic factors, may also represent important underlying causes of sarcopenia. Currently the pathophysiology and the sequelae of sarcopenia are poorly understood and thus interventions to either prevent, retard or reverse this condition are extremely limited. To address these issues, the NIA convened a multidisciplinary group of clinical and basic investigators at the "Workshop on Sarcopenia" (held September 19-21, 1994) to (1) review the current knowledge base on the epidemiology, pathophysiology, public health impact and potential therapeutic approaches for sarcopenia and (2) identify promising avenues of future research in each of these areas. The proceedings and summary of the research recommendations from this workshop are published in the special issue "Workshop on Sarcopenia: Muscle Atrophy in Old Age" of the Journals of Gerontology (Vol. 50A) 1995. This PA seeks to promote the research priorities identified at the workshop that relate to advancing our understanding of the clinical manifestations of sarcopenia in the aging population. Even though a variety of studies have noted correlations between age- related changes in parameters of skeletal muscle quality (e.g., mass, fiber type composition, strength), with metabolic/physiological and functional impairments, a full appreciation of the consequences of sarcopenia and of the magnitude of the potential public health problem it poses remains to be ascertained. With respect to functional impairments, it is generally recognized that muscle weakness in the upper and lower extremities can contribute to gait problems, falls and ultimately to the loss of physical functional independence. Yet, very little is known about which age-related changes in specific muscle properties (e.g., mass, strength, torque development, fiber type distribution, fatigue characteristics, contractile properties) significantly affect physical function and performance of specific tasks (e.g., walking, maintaining balance, IADLs). Furthermore, the metabolic/physiological consequences of sarcopenia in the elderly remain to be systematically investigated. Assumptions have been made that age-related changes in muscle mass are associated with a reduced metabolic rate (leading to obesity and increased risk for chronic diseases) and in the development of non-insulin dependent diabetes mellitus in old age. The extent to which such metabolic changes can be attributed solely to age-related loss of muscle mass or to complex changes in body composition (e.g., increases in body fat) remains to be established. Controversy also exists over other putative morbid consequences of sarcopenia, which include osteoporosis (e.g., potential relationship between muscle weakness and decreased bone quality), increased susceptibility to fracture (independent of risk of falling), and altered thermoregulation (e.g., decreased thermogenic capacity of muscle due to reduced mass). Clarification through quantitative assessments of the interrelationship(s) between muscle mass/quality and the potential metabolic/physiological and functional consequences are essential steps towards the development of new approaches for clinical diagnosis, new insights into the underlying mechanisms and ultimately to the development of effective interventions for sarcopenia. Objectives The aims of this PA are to: (1) determine the clinical significance of sarcopenia in the elderly, by identifying the age-related changes in muscle quality that have morbid and functional implications and (2) establish quantitative relationships ("dose-effect" or threshold levels) between alterations in muscle quality and metabolic/physiologic impairment or functional abilities. Studies that will compare elderly populations with varying degrees of frailty, encompass a wide age range, including the "oldest old" and utilize multidisciplinary approaches to address these aims are especially encouraged. Topics of interest include, but are not limited to: o Epidemiologic approaches on the relationship between decreases in muscle mass/quality and decreases in functional abilities. o Characterization of potential gender and ethnic differences in the morbid and functional consequences of sarcopenia. o Studies that combine measures of age-related changes in muscle properties (e.g., mass, fiber type, capillary density) and muscle performance (e.g., force, power, torque, fatigue characteristics) within the same individuals, and then correlate such changes with metabolic and functional impairments. o Systematic evaluation of the key muscle groups involved in activities of daily living and the nature of the contribution(s) of the key muscle groups to successful task performance. o Characterization of age-related changes in skeletal muscle properties (e.g., strength, power, force, torque, range of motion, rate of force or torque development) responsible for deficits in functional status. o Establishing "dose-response" relationships between age-related changes in muscle properties (including biomechanical parameters) and gait, balance and functional status. o Determination of the relative contributions of age-associated changes in intrinsic contractile properties of muscle, the central and peripheral nervous systems to impairments in physical performance. o Characterization of metabolic/physiological changes due to decreased muscle mass or quality. o Role of age-related changes in fat free mass and skeletal muscle metabolism in the development of obesity and insulin resistance in the elderly. o Clarification of the effects of sarcopenia on bone density, risk for fractures and attenuation of impact forces of falls. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the 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. The title and number of this program announcement must be typed in Section 2 on the face page of the application. Applications for the FIRST (R29) award must include at least three sealed letters of reference attached to the face page of the original application. FIRST (R29) award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. Review Criteria o Scientific, technical, or medical significance and originality of the proposed research; o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o Qualifications and research experience of the Principal Investigator 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 Scored applications will compete for available funds with all other scored applications assigned to that Institute/Center. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review; o Availability of funds; and o Program balance among research areas of the program announcement. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Chhanda Dutta, Ph.D. Geriatrics Program National Institute on Aging Gateway Building, Suite 3E327 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-6761 FAX: (301) 402-1784 Email: DuttaC@gw.nia.nih.gov Richard W. Lymn, Ph.D. Muscle Biology Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS49E, MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-5128 FAX: (301) 480-4543 Email: LYM@CU.NIH.GOV Direct inquires regarding fiscal matters to: Mr. Joseph Ellis Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: EllisJ@gw.nia.nih.gov Joseph L. Brown Grants Management Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-43J, MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-3507 FAX: (301) 480-4543 Email: brownj@ep.niams.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.866 and 93.846. 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 Thu Apr 04 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-037 - V25(11) 04/05/96 Date: 4 Apr 1996 21:10:53 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 398 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4k2a0t$o61@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA96037 PA-96-037 P1O1 *************************************** HEALTH RISK REDUCTION: COMMUNITY-BASED STRATEGIES NIH GUIDE, Volume 25, Number 11, April 5, 1996 PA NUMBER: PA-96-037 P.T. 34; K.W. 0745035, 0411005, 0403004 National Institute of Nursing Research PURPOSE The National Institute of Nursing Research (NINR) is interested in facilitating investigator-initiated research into the clinical application of intervention strategies designed to reduce health risks at the community level. Community-based strategies targeting health problems of rural residents and of underserved minority groups are of particular interest to NINR. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Health Risk Reduction: Community-Based Strategies, is related to all of the special populations targets. 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 Research applications may be submitted by domestic and foreign, for- profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanisms of support will be the National Institutes of Health (NIH) research project grant (R01) and FIRST (R29) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. RESEARCH OBJECTIVES Background Major relocations and transitions are occurring in health care. New forms of health care delivery and financing are creating the need to review the efficacy and effectiveness of wellness and risk reduction protocols, clinical treatments and intervention strategies, and rehabilitation efforts, many of which were previously tested through carefully controlled studies in hospitals. The major emphasis today is on providing health care in the community, frequently to groups of patients rather than to individuals. There is little indication that this change will reverse itself. There is also little evidence that community-based health care strategies have been tested in a systematic and ongoing manner. The NINR convened a panel of scientific experts to examine the status of research on community-based health care models, with a particular focus on those that involve nursing strategies. The report of the panel is available from NINR (See Inquiries section below). The panel reviewed a variety of community-based models and intervention strategies, many of which have not been fully evaluated, nor tested for appropriateness. In general, however, the panel determined that community-based intervention strategies which directly involve community participation are more likely to be successful and to continue overtime than those relying solely on practitioner-patient relationships. Such an approach should enhance the chances that the risk reduction and health restoration activities will be maintained and their effect seen in the long term. The panel recommended that the perspective of primary health care be used as an organizing framework for community-based models. In the public health/community health context, primary health care includes primary, secondary, and tertiary prevention of health risks and disease onset and extension. Primary prevention includes health promotion and protection (such as immunizations of children and elders, nutrition counseling, and life style alterations) aimed at risky behaviors and at intervening before disease arises. Secondary prevention measures aim to prevent disease and disability through screening, early detection of risks, and prompt treatment of pre- symptomatic or early clinical disease (such as obesity, hypercholesterolemia education, and cardiac risk reduction strategies) of populations thought to be at-risk. Tertiary prevention measures seek to limit disease progression and the onset or extension of disabilities in persons in various stages of disease and rehabilitation (such as those with obstructive pulmonary disease, hypertension, coronary artery disease or diabetes mellitus). The lack of cultural specificity in the design of community-based programs is thought to be a potential major factor in the less frequent participation of certain groups, especially ethnic minorities. Several current studies indicate that identifying and incorporating unique cultural factors into intervention strategies may result in increased acceptability, use, and adherence. Other studies have identified intervention strategies that were efficacious but which had only limited continued use after the controlled circumstances of a specific study were withdrawn. Rural residents usually have more intimate knowledge of each other than is possible in more densely populated areas resulting in the potential for some residents avoiding care from fear of neighbors finding out they have a health problem even when the health problem may be unknowingly shared by a number of their neighbors. Community member participation in planning and designing intervention strategies may assist in resolving this phenomenon. There is evidence that certain population groups use health care services only in crises and may choose not to use preventative, restorative, or rehabilitative measures even when strongly advised to do so. For example, those with known HIV risk factors are strongly urged to use condoms or other safety measures, but many do not follow this advice. Those with chronic conditions frequently have medications prescribed to control their disease or its related symptoms, such as those taking medication for seizures or for hypertension, and who may or may not take the medication as instructed. After several types of surgery or after stroke, rehabilitative protocols such as exercises are prescribed to assist in restoring function or to increase various physiological capacities; however, there is great variation in patient adherence to these exercise protocols. There are indications that the explanation for this lack of use of prescribed or advised treatments and safety measures may be less the characteristics of the population groups themselves than the approaches and design of health care systems available to them. Our understanding is further clouded by a tendency to uniformly stereotype the health-related behaviors of all population groups when indeed they relate to only one or some part of the groups. An example is the over-generalization that all minority groups have poor pregnancy outcomes, when this is true for many African-Americans, but not for most Hispanic-Americans. Another example is the prescriptive telling to do treatments rather than a collaborative planning approach to treatment choices. It is not known to what extent the limited inclusion of cultural factors represents a barrier to health care participation in general or to the use of prevention strategies in particular. The inter- relationship of cultural factors and economic factors on the use and acceptability of health care among rural minority groups is also unclear. Some investigators have found that certain ethnic minority groups and rural residents use health care services differently than others, have illnesses diagnosed at a later stage than other groups, and seek care later in a disease process than others. Intervention studies with subsets of minority groups, such as certain rural Native Americans, migrant Hispanics, southern Black churchgoers, and rural pregnant women indicate that use of prevention strategies increases, involvement in prenatal care starts earlier, and chronic illness risk factors are modified when the clinical care is modified according to cultural expectations. Research Objectives and Scope Interest is in research targeted on identifying and reducing risk factors and disease occurrence at the community level. Individuals, families and other community groups as well as clinical practitioners and other providers may be included as foci of research questions. If questions are included about practitioners/providers in a study design, they should be secondary rather than the primary questions in the study. Contextual and system issues, such as environmental factors, specific aspects of community participation or ethnic group involvement, non-health care cultural, social and economic issues may be addressed as components of studies. The major purpose of this program announcement is to stimulate studies that directly test community-based intervention strategies and models. However, preliminary studies that will lead to such research are encouraged, if such work is necessary to achieve the central purpose. These studies may take the form of epidemiological inquiries, qualitative investigations such as ethnographies, or initial testing of intervention strategies on a smaller scale. Preliminary studies examining aspects of cultural sensitivity of intervention strategies or measures are also encouraged, if needed. Other methodological studies crucial to the successful conduct and analysis of community-level studies are also encouraged. Testing of strategies that may be unique in providing community level care, such as computer linkages and interactive television, may be tested if they are targeted to health problems or clinical conditions. The focus of research questions that could be addressed under this initiative include the examples noted in the narrative above and the questions noted here, but are not limited to these: o Do community-based health care models result in improved health of, or in health-related behavioral changes among community members? Do targeted, culturally relevant health care strategies change participation, timeliness of health seeking behaviors, frequency of crisis-oriented care seeking behaviors, appropriateness and acceptability of care, and o costs? o Are there unique requirements for community-based interventions or models in rural areas? How are they met? How can primary prevention as well as the restorative and rehabilitative interventions be implemented at the community level in rural areas? o What are the effects of health care strategies targeted to particular age groups of populations, such as pre-school and school- age children or middle age adults? Are they different when family and community participation are included in the planning, design, and implementation? Are differences seen when such strategies are targeted to those of different socioeconomic levels? Are they different when targeted to rural or minority populations? o Are there differences in health status, risk factors, clinical and cost outcomes between community-based programs and the more traditional individual patient-focused, episodic health care programs? Note: NINR is not interested in studies that propose cost analyses alone. 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 grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The title and number of the program announcement must be typed in Section 2 on the face page of the application. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The complete original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established 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 review procedures. Following scientific and technical review, the applications will receive second-level review by the appropriate national advisory council. Review Criteria o Scientific, technical, or clinical significance and originality of proposed research; o Appropriateness and adequacy of the experimental, quasi-experimental or qualitative 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 approved applications assigned to that institute or center. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. For general scientific questions and those related to secondary and tertiary prevention and/or chronic conditions, and for copies of the expert panel report on Community-Based Health Strategies contact: Dr. Patricia Moritz Email: pmoritz@ep.ninr.nih.gov For questions related to primary prevention and other health behavior strategies contact: Dr. J. Taylor Harden Email: tharden@ep.ninr.nih.gov For questions related to reproductive and infant health contact: Dr. Laura James Email: ljames@ep.ninr.nih.gov For questions related to cancer, HIV and other infectious diseases contact: Dr. June Lunney Email: jlunney@ep.ninr.nih.gov For questions related to cardiopulmonary health and trauma contact: Dr. Hilary Sigmon Email: hsigmon@ep.ninr.nih.gov For questions related to neurological conditions contact: Dr. Mary Leveck Email: mleveck@ep.ninr.nih.gov All of the above may be contacted at: Division of Extramural Programs National Institute of Nursing Research Building 45, Room 3AN-12 45 Center Drive MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-6906 FAX: (301) 480-8260 Direct inquiries regarding fiscal matters to: Jeff Carow Grants Management Office National Institute of Nursing Research Building 45, Room 3AN-32 6300 Center Drive MSC 6301 Bethesda, MD 20892-6301 Telephone: (301) 594-6869 FAX: (301) 480-8256 Email: jcarow@ep.ninr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361, Nursing Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The 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 Apr 04 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-035 - V25(10) 03/29/96 Date: 4 Apr 1996 21:08:08 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 327 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4k29ro$nsk@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA96035 PA-96-035 P1O1 *************************************** CHEMICAL SENSES: NEUROTRANSMITTERS AND NEUROMODULATORS NIH GUIDE, Volume 25, Number 10, March 29, 1996 PA NUMBER: PA-96-035 P.T. 34; K.W. 0775017, 0760050, 0760075 National Institute on Deafness and Other Communication Disorders National Institute on Aging PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) and the National Institute on Aging (NIA) invite grant applications for the support of research fundamental to understanding the neurochemistry of pathways in the olfactory and gustatory systems throughout the life span. This research includes the identification and characterization of the neurotransmitters, neuromodulators, receptors, and secondary messengers throughout the chemosensory 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 Program Announcement (PA), Chemical Senses: Neurotransmitters and Neuromodulators, is related to the priority areas of diabetes and chronic disabling conditions and special population objectives. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-11474-0 or Summary Report: Stock No. 017-001-11473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Foreign institutions or organizations in foreign countries are not eligible for First Independent Research Support Transitions (FIRST) (R29) awards. MECHANISM OF SUPPORT The support mechanisms for grants in this area will be the individual investigator-initiated research grant (R01) and the First Independent Research Support and Transition (FIRST) (R29) Award. RESEARCH OBJECTIVES The physiology and chemistry of the neural circuits of the olfactory and gustatory systems have been extensively studied, and certain chemically distinct synapses in these chemosensory systems have been identified. The relation of these findings to synaptic function and to central processing of chemosensory information is far from fully understood. There is evidence that the levels of neural activity within olfactory structures can influence the synthesis of transmitter and trophic substances and the strength of synaptic connections. It is not known how these changes alter the processing of olfactory information. Little is yet known about the transmitters and their receptors at the principal relays throughout the chemosensory pathways; the transmitters at the receptor cell-nerve interfaces in the chemosensory systems have not been unequivocally identified. The neurochemistry of the central olfactory system poses a challenging issue because of the wide variety of transmitter substances represented, particularly in the olfactory bulb. A better understanding of the mechanisms of neurotransmission in the chemosensory systems is possible through the application of contemporary tools such as biochemical and molecular probes, brain slice and organotypic culture preparations, transgenic animal models, electrophysiologic recording in anesthetized and in freely moving animals, and computational modeling. These important tools have had only limited use in studies of the neurochemistry of the chemosensory systems; their use in investigations of the transmitters and receptors of the chemosensory systems holds promise for the eventual development of effective prevention and treatment of chemosensory disorders. The National Institute on Deafness and Other Communication Disorders (NIDCD) and the National Institute on Aging (NIA) are interested in a broad range of mechanistic studies that will elucidate the neurochemistry of the pathways of the olfactory and gustatory systems over the life span. This research includes the identification and characterization of the neurotransmitters, neuromodulators, receptors, and second messengers throughout the chemosensory systems. Multidisciplinary studies of neurotransmitter and neuromodulatory mechanisms relevant to structure-function relations are encouraged as are collaborative efforts that lead to the integration of information >From levels spanning the molecular to the behavioral. Collaboration is encouraged among investigators, including molecular and cell biologists, pharmacologists, and other scientists who are using novel approaches to study the neurochemistry of sensory systems. Investigators are encouraged to address pivotal issues in the chemical senses in response to this Program Announcement and to utilize innovative methods and approaches to address them. Research issues, methods, and approaches in the chemical senses might include, but are not limited to, those below. Research issues o Identification and characterization of the transmitters at the receptor cell-nerve interface in the olfactory and gustatory systems. o Molecular properties of amino acid receptors in the chemosensory systems. o The role of transmitters in the regulation of neuronal growth, plasticity, and survival. o Neuron-glial communication. o The role of simple gases, such as carbon monoxide, in neurotransmission. o Functional significance of neurochemical and molecular diversity of subsets of neurons in the olfactory bulb. o Age-related changes in transmitter levels and transmitter-receptor relationships within the chemosensory systems. o Age-related mechanisms governing transmitter responses to injury of the chemosensory systems. o Ability of neurotoxins to affect the levels of transmitters and their receptors as a function of aging. o Mechanisms whereby an age-related change in one neuroactive substance can interact with and alter the levels of other neuroactive substances in the chemosensory systems. Methods and approaches: o Biochemical and molecular probes to identify and characterize the neurotransmitters and receptors involved in the central processing of chemosensory information. o Electrophysiologic and imaging techniques that are sufficiently sensitive to analyze neural circuit activity. o Confocal imaging and photolytic activation of compounds as dual probes of transmitter and synaptic function in brain slices. o Transgenic animals with altered transmitters and receptors. o Use of agonists and antagonists to investigate transmitter function. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (FR 59 14508-14513) to correct typesetting and errors in the earlier publication, and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The title and number of the program announcement must be typed in Section 2 on the face page of the application. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of all 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; and o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The Initial review group will also examine the provisions for the protection of human subjects and animal welfare and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other applications assigned to that Institute. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review and availability of funds. INQUIRIES Written and telephone inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Jack Pearl, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard - MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3464 FAX: (301) 402-6251 Email: Jack_Pearl@nih.gov Judith A. Finkelstein, Ph.D. Neuroscience and Neuropsychology of Aging Program National Institute on Aging Gateway Building, Suite 3C307 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: FinkelsJ@gw.nia.nih.gov Direct inquiries regarding fiscal matters to: Sharon Hunt Division of Extramural Activities National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-B 6120 Executive Boulevard - MSC 7180 BETHESDA, MD 20892-7180 Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: SH79F@nih.gov Joseph Ellis, Chief Office of Extramural Affairs 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 Nos. 93.173 and 93.866. 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 Apr 07 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 7 April 1996 Date: 8 Apr 1996 16:31:55 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 139 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4kc7lb$45u@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Dir of Awards Title: NSF 96-68 - FY 1995 Awards for Undergraduate Course and Curriculum Development File size (bytes): STIS Filename: nsf9668.txt Document Type: News Title: Media Tipsheet April 1, 1996 File size (bytes): STIS Filename: tip60401.txt Document Type: Press Release Title: NSF NAMES COOPERATIVE RESEARCH CENTERS FOR ARIZONA, ILLINOIS AND OHIO File size (bytes): STIS Filename: pr9613.txt Document Type: Program Guideline Title: NSF 96-71 - Dear Colleague Letter File size (bytes): STIS Filename: nsf9671.txt Document Type: Recruit Title: Assistant Director for Computer and Information Science and Engineering File size (bytes): STIS Filename: vep9600.txt Title: Biological Science Administrator (Assistant Program Manager) File size (bytes): STIS Filename: vex9614.txt Title: Mathematician (Program Director) File size (bytes): STIS Filename: vex9615.txt Title: Mathematician (Program Director) File size (bytes): STIS Filename: vex9616.txt Document Type: Report Title: NSF 96-61 Instructional Materials Development Program File size (bytes): STIS Filename: nsf9661.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Dir of Awards Title: NSF 96-54 The Advanced Technological Education (ATE) Program FY1995 Awards File size (bytes): 328 STIS Filename: nsf9654.txt Also available: nsf9654.doc Document Type: Letter Title: REULIST -- Current List of REU Sites File size (bytes): 89013 STIS Filename: reulist.txt Title: REULIST -- Current List of REU Sites File size (bytes): 89013 STIS Filename: reulist.txt Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 114212 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Alphabetical Telephone Directory File size (bytes): 114212 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 124413 STIS Filename: phnorg.txt Title: NSF Organization Telephone Directory File size (bytes): 124413 STIS Filename: phnorg.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg.txt, the text of your message should be as follows: get phnorg.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg.txt, you would enter: ftp> get phnorg.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Mon Apr 15 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 14 April 1996 Date: 15 Apr 1996 22:12:17 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 99 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4kva7h$b55@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Dir of Awards Title: NSF 96-56 FY 1995 Awards for Integrative Biology and Neuroscience File size (bytes): STIS Filename: nsf9656.txt Document Type: Program Guideline Title: NSF 96-71 - Dear Colleague Letter File size (bytes): STIS Filename: nsf9671.txt Title: NSF 96-74 Institution-wide Reform Of Undergraduate Education In Science, Mathematics, Engineering And Technology File size (bytes): STIS Filename: nsf9674.txt Title: NSF 96-75 Modeling and Simulation of Advanced Materials Process File size (bytes): Virtual Integrated Prototyping (VIP) Initiative for Thin Films STIS Filename: nsf9675.txt (NSF) Title: NSF 96-80 - CISE/EHR/ENG/MPS Collaborative Research on Learning Technologies File size (bytes): STIS Filename: nsf9680.txt Title: NSF 96-84 CEDAR Dear Colleague Letter File size (bytes): STIS Filename: nsf9684.txt Document Type: Recruit Title: Secretary (Office Automation) File size (bytes): STIS Filename: vgs9636.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Dir of Awards Title: 1996 Graduate Fellowship AWARDS File size (bytes): 128847 STIS Filename: gf96rawd.txt Also available: gf96rawd.dlm Title: 1996 Graduate Fellowship HONORABLE MENTIONS File size (bytes): 206411 STIS Filename: gf96rhm.txt Also available: gf96rhm.dlm ------------------------------------------------------------------------ ** 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 gf96rhm.txt, the text of your message should be as follows: get gf96rhm.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve gf96rhm.txt, you would enter: ftp> get gf96rhm.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 Apr 18 23:00:00 1996 Path: biosci!biosci!not-for-mail From: gwilliam@hgmp.mrc.ac.uk (Gary Williams) Newsgroups: bionet.sci-resources Subject: UK MRC Funding for SCWs Date: 19 Apr 1996 15:14:50 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 40 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4l938q$er2@net.bio.net> NNTP-Posting-Host: net.bio.net Notification of Revised UK Medical Research Council policy for funding ---------------------------------------------------------------------- Single Chromosome Workshops (SCWs) ---------------------------------- The UK Medical Research Council (MRC) has recently reviewed its policy for funding Single Chromosmoe Workshops, in the light of policies adopted by other agencies. - From 1 March 1996, each application to run a SCW in the UK will be peer reviewed in competition and only those workshops where a fully justified scientific case is made and accepted will be supported. - Requests for funding SCWs should be submitted as fully costed applications and should include a comprehensive list of potential participants, plus the costs of subsistence. - Requests for travel funds to attend SCWs overseas will be considered on a case-by-case basis. Normally only one participant per group will be considered, and they must be making a substantial contribution to the generation of the map. Retrospective travel claims will not be considered. Contact Address: Miss Lizanne Ryder Medical Research Council 20 Park Crescent London W1N 4AL UK Telephone: 0171 636 5422 ext 6281 e-mail: lizanne.ryder@hq.mrc.ac.uk From owner-sci-resources@net.bio.net Sun Apr 21 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 21 April 1996 Date: 22 Apr 1996 16:24:32 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 182 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4lh4fg$qre@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: BUL 96-05 NSF May 1996 Bulletin V-23; No.9 File size (bytes): STIS Filename: bul9605.txt Document Type: Dir of Awards Title: NSF 96-82 Teacher Preparation And Nsf Collaboratives For Excellence In Teacher Preparation Fy 95 Awards File size (bytes): STIS Filename: nsf9682.txt Document Type: Grant Conditions Title: FDP-NSF Specific Requirements File size (bytes): STIS Filename: fdp96.txt Document Type: News Title: Media Tipsheet April 12, 1996 File size (bytes): STIS Filename: tip60412.txt Document Type: Press Release Title: NEW REPORT LINKS EMERGING TECHNOLOGIES TO THE BIOSCIENCES File size (bytes): STIS Filename: pr9614.txt Document Type: Program Guideline Title: NSF 96-67 SMALL BUSINESS INNOVATION RESEARCH (SBIR) File size (bytes): STIS Filename: nsf9667.txt Also available: nsf9667.pdf Title: NSF 96-77 - Directory of NSF-Supported Undergraduate Faculty Enhancement Projects File size (bytes): Workshops and Short Courses for Undergraduate Faculty-Summer 1996, Academic Year 1996-1997 STIS Filename: nsf9677.txt (NSF) Title: NSF 96-78 - Coastal Ocean Processes (CoOP), Coastal Studies in the Great Lakes File size (bytes): STIS Filename: nsf9678.txt Title: NSF 96-87 Recognition Awards for the Integration of Research and Education Solicitation File size (bytes): STIS Filename: nsf9687.txt Document Type: Recruit Title: Associate Program Manager File size (bytes): STIS Filename: vex9617.txt Title: Computer Specialist File size (bytes): STIS Filename: vgs9638.txt Document Type: Report Title: NSF 96-83 - Activities in Support of Two-Year College Science, Mathematics, Engineering, and Technology Education - FY 1995 Highlights File size (bytes): STIS Filename: nsf9683.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Grant Conditions Title: FDP-NIH Specific Requirements File size (bytes): 7489 STIS Filename: fdpnih.txt Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 113982 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Alphabetical Telephone Directory File size (bytes): 113982 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 124942 STIS Filename: phnorg.txt Title: NSF Organization Telephone Directory File size (bytes): 124942 STIS Filename: phnorg.txt Document Type: Program Guideline Title: NSF 96-80 - CISE/EHR/ENG/MPS Collaborative Research on Learning Technologies File size (bytes): 23321 STIS Filename: nsf9680.txt Title: NSF 96-80 - CISE/EHR/ENG/MPS Collaborative Research on Learning Technologies File size (bytes): 23321 STIS Filename: nsf9680.txt Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 52193 STIS Filename: sesvac.txt Document Type: STIS Title: Document Types on STIS File size (bytes): 2738 STIS Filename: stistype.txt Title: Document Types on STIS File size (bytes): 2738 STIS Filename: stistype.txt Title: Document Types on STIS File size (bytes): 2738 STIS Filename: stistype.txt Title: Document Types on STIS File size (bytes): 2738 STIS Filename: stistype.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve stistype.txt, the text of your message should be as follows: get stistype.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve stistype.txt, you would enter: ftp> get stistype.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Wed Apr 24 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-96-039 - V25(12) 04/19/96 Date: 24 Apr 1996 17:48:17 -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: <4lmi4h$2dn@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PAR96039 PAR-96-039 P1O1 ************************************* NCRR MINORITY INITIATIVE: K-12 TEACHERS AND HIGH SCHOOL STUDENTS NIH GUIDE, Volume 25, Number 12, April 19, 1996 PA NUMBER: PAR-96-039 P.T. 34, FF; K.W. 0720005, 0710030, 0404000 National Center for Research Resources Application Receipt Dates: June 17, 1996; thereafter, February 1 and June 1 annually PURPOSE As part of its continuing commitment to strengthen the quality of precollege health science education, the National Center for Research Resources (NCRR) encourages the submission of applications for a program aimed at increasing the pool of underrepresented minority high school students who are interested in pursuing, and academically prepared to pursue, careers in biomedical and/or behavioral research and the health professions. The program includes both K-12 inservice and preservice teachers and underrepresented minority high school students. The "NCRR Minority Initiative: K-12 Teachers and High School Students" replaces the S03 "Minority High School Student Research Apprentice Program" (MHSSRAP), which made its last awards in 1995. The main component of this program is the provision of structured science research experiences for both teachers and underrepresented minority high school students -- usually during the summer -- in the laboratories, and under the direction, of active biomedical and/or behavioral researchers. Individualized research experiences and other activities are intended to: (1) allow teachers to keep pace with the explosive growth of scientific knowledge in health-related areas, enable them to develop new discovery-oriented educational strategies, and transfer this new knowledge to their students; and (2) provide students with a personalized, hands-on exposure to health-related research that stimulates their research interest and encourages decisions towards careers in the health sciences. A long-range goal of the program is to establish and/or strengthen partnerships between biomedical research institutions and K-12 schools by developing mentoring ties among teachers, underrepresented minority students, and biomedical and/or behavioral researchers, that will result in creating more pathways for underrepresented minority students to establish careers in the health sciences. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), "NCRR Minority Initiative: K-12 Teachers and High School Students," is related to many of the areas discussed in this publication. 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, and high schools, may not apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as program directors. For the purpose of this announcement, "underrepresented minorities" 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 and/or behavioral research. Individuals who have been found to be underrepresented in biomedical and/or behavioral research nationally include Black Americans, Hispanic Americans, Native Americans, and Pacific Islanders. "Students" are defined as those who are enrolled in high school during the current academic year, or who have just graduated from high school. "Inservice teachers" include elementary, middle, junior, and senior high school science teachers. In order to maximize the program's impact on underrepresented minority students, teachers must be members of an underrepresented minority group or teach a significant number of underrepresented minority students. "Preservice teachers" are those teachers in training and enrolled in preservice education programs who have expressed an interest in teaching life sciences at the K-12 level with a focus on underrepresented minority students. MECHANISM OF SUPPORT Awards under this Program Announcement will use the education project (R25) grant mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this Program Announcement may not exceed three years. Because of the wide range in the size and type of institutions that may apply, it is anticipated that the sizes of the awards may also vary. Applications must request support for both students and teachers, with a minimum of eight students per year unless justification is provided. Indirect costs, other than those awarded to State or local government agencies, will be reimbursed at eight percent of total allowable direct costs. State and local government agencies will receive reimbursement at their full indirect cost rate. Allowable costs Funds for personnel costs may only be requested for eligible students and teachers and must be paid as salaries and wages for work performed; stipends are not allowable costs under this program. Applicant organizations must establish the rate of salary and fringe benefit compensation to be provided for students and teachers employed on the grant activity; however a maximum of $2,000 per student, $3,000 per preservice teacher and $5,000 per inservice teacher may be requested for salary and fringe benefits for a summer experience. Part-time experiences during the academic year would be reimbursed at the same hourly rate. Students' salaries should be based on the prevailing scale for comparable type work, but should not be less than the Federal minimum hourly wage. Funds to defray other costs such as supplies can be requested as a lump sum of up to $250 per participant per year. RESEARCH OBJECTIVES Background Relative to their representation in the general population, minority Americans are severely underrepresented in scientific and health fields at every level, from the professional workforce -- physicians, dentists, research scientists -- through all levels of the educational system. Although there are a number of factors for this underrepresentation, it is generally agreed that the long-term resolution of this problem centers at improving science education of underrepresented minority youths at the early stages of the educational process. With the rapid pace of technological innovations and the increasing number of occupations that require a knowledge of scientific principles, as well as the predicted increase in the minority population, it is imperative that precollege education further enhance the capacity and capability of underrepresented minority youth to become more productive and competitive in tomorrow's work force. The primary objectives of this program are to improve the quality of precollege science education and to increase the pool of underrepresented minorities interested and academically prepared to enter college and pursue a career in the biomedical/behavioral sciences. Program Characteristics The Program Director will be responsible for the selection and recruitment of students, teachers, and mentors, as well as for the overall direction of the program. The Program Director must be a biomedical and/or behavioral scientist, or an experienced science educator, employed by the applicant organization. The program has two major activities. The first is for underrepresented minority high school students; the second is for K-12 inservice and preservice teachers. While the proposed program should be best suited to an institution's own strengths and characteristics, at a minimum, each program should include: o a description of the proposed overall program plan (specific research projects should not be described); o the research environment (ongoing research activity, availability of equipment, facilities, resources); o methods and criteria for student, teacher, and mentor recruitment and selection; o methods to assign students and teachers to mentors; o the general characteristics and length of the research experiences; o special enrichment activities available to students and teachers; o prior accomplishments of the institution in precollege education; o the impact of other precollege programs, if any, for the proposed program; and o the level of institutional commitment to precollege programs and partnerships. Criteria for selection of mentors must include commitment to improving the quality of precollege science education, and the ability and time to work with high school students and teachers to instill an understanding of research and the technical skills needed. Mentors must have active biomedical and/or behavioral research support and/or a recent publication history in biomedical and/or behavioral research (research support can include NIH or other Federal agency support or private or institutional grants). An evaluation component must be included as part of the application. Methods, formative in nature, should be devised to evaluate whether or not the program is making progress in meeting its goals (e.g., information could be collected to learn if the program is helping teachers integrate new concepts in health sciences into the classrooms). Student participants should be assessed to determine if it has increased their awareness and/or interest in the health sciences. To the extent possible, the progress of students should be tracked to determine if they attended and/or graduated from college and, if so, their major academic area of concentration. Specific characteristics regarding the student and teacher activities are as follows: Student Activities The most important aspect of this program is the research laboratory experience. In this program, high school students, no more than two students to one mentor, work in an active research laboratory, usually for approximately six to eight weeks in the summer. It is expected that the applicant will set forth a plan that will provide: o an individualized, hands-on, mentored laboratory research experience with attainable goals, that introduces the students to some of the latest concepts in biomedical science; o mentoring and career guidance by biomedical and/or behavioral scientists; and, o an opportunity for students to participate in various laboratory activities and to acquaint them with the environment and resources of the institution. A program of special summer scientific enrichment activities must be proposed. Such activities may include, but are not limited to: programs on research opportunities and careers within the health sciences, bioethical issues in biomedical and/or behavioral research, or implications of the human genome effort. A final forum should be held where students present their research results. Students are expected to devote sufficient effort to research and related activities during the period of support to gain insight into the process of scientific discovery. In order to maximize the long-term effects of the research experience, follow-up activities such as seminars, workshops or Saturday study groups may occur during the academic year if the students are located within reasonable distance of the research institution. Mentors should also try to visit students' schools to meet with teachers, recruit future candidates for the program, and help build effective partnerships between the research institutions and secondary schools. Recruitment and selection criteria for students should include the student's motivation, ability, scholastic aptitude, and accomplishments. In addition, consideration should be given to science teachers' recommendations. Teacher Activities K-12 teachers are the key individuals in increasing the pool of scientifically skilled underrepresented minority high school students. However, many preservice teaching programs do not require a hands-on laboratory experience; many elementary school teachers have had no opportunity for training in science; and middle, junior, and senior high school teachers can benefit from exposure to the latest scientific concepts. To address these deficiencies, the proposed program should provide inservice and preservice teachers with an intensive hands-on mentored laboratory research experience of four weeks or more that: o exposes them to contemporary concepts in the health sciences; o introduces them to modern laboratory techniques, including computers; o enables them, in collaboration with their research mentor, to prepare new discovery-based lesson plans; and, Unless the teachers' schools are geographically remote, the teacher programs must include follow-up components in which the participants discuss their experiences in implementing new scientific activities into the classroom. An important aspect of the program is to develop continuing partnership relationships between teachers and mentors to improve the teaching of life sciences at the precollege level and to stimulate students' interest in health science careers. Recruitment and selection criteria for inservice teachers should include experience and teaching responsibilities, level of interest in participating in a research program, expected impact on their teaching programs, ability to stimulate underrepresented minority students to pursue scientific careers, and future plans for continued interaction with the research institution. Recruitment and selection criteria for preservice teachers should include the commitment to participate in a research program, and the expressed interest to teach life sciences at the K-12 level with a focus on underrepresented minority students. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available in most institutional offices of sponsored research and may be requested from the Office of Extramural Outreach and Information Resources, Office of Extramural Research, National Institutes of Health, 6701 Rockledge Drive, Room 6207, MSC 7910, Bethesda, MD 20892-7910, telephone 301-435-0714, fax 301-480-0525, Email: asknih@odrockm1.od.nih.gov. Applications must follow the instructions provided in the Form PHS 398 except for the following: Face Page-AA Item 2. Check "Yes" and list the number and title of this Program Announcement. Item 4. Human Subjects - Check "No." Item 5. Vertebrate Animals - Check "No." Item 6. The project period start date should be no earlier than April 1 for applications submitted for the June 1 deadline, or December 1 for applications submitted for the February 1 deadline. The length of the project period may not exceed three years. Form Page 4-DD - Detailed Budget for Initial Budget Period Personnel Category - Follow the instructions provided in the PHS 398 regarding the Principal Investigator/Program Director. Students and teachers must be treated as employees (not trainees) at the grantee organization during the period of their grant-supported research experience. Use successive lines in the Personnel category to indicate the number of positions being requested for students, preservice, and inservice teachers. For each of these classifications, provide the requested information for all columns in the Personnel category. If students and/or teachers will be working during the academic year as well as the summer, use separate lines to display the summer and academic year information, following the instructions provided on page 11 of the PHS 398 kit. Since the student and teacher work experiences may be measured by the grantee in weekly or monthly employment terms, applicants may reflect the columnar information in such a manner. Following the Personnel category columns, an example might be: Name: 8 students - summer; Role on project: lab worker; Type Appt: 8 wks; % Effort on proj.: 40 hrs/wk; Inst. base salary: $/hr. Calculate and enter the salary, fringe benefits, and total dollars requested information. Continuing the example, the next line might reflect: 2 students - academic year, 1 wk, 20 hrs/wk, etc. Other Expenses - Up to $250 per student and teacher participant may be requested as a lump sum to defray costs such as supplies required for their research experiences. Form Page 5-EE - Budget for Entire Proposed Period of Support Follow instructions provided on page 14 of the Form PHS 398. Justification - Applicants must clearly describe and provide sufficient detail regarding the support requested for students, preservice, and inservice teachers to permit the reviewers to evaluate the requested costs compared to the proposed length of the research experience. A suitable example would separately describe the number and types of student and teacher positions being requested for summer and, if applicable, academic year activity, and would include for each the number of hours/week, total number of weeks of the experience, and the rate of compensation. Applicants should also explain any increases or decreases over the initial budget period, e.g., if students and/or teachers are expected to return for a portion of a succeeding period and will require salary and other support during this period. Again, provide sufficient detail to permit the reviewers to evaluate the proposed request. Additional Form Pages Biographical Sketch (Form Page 6-FF) - Provide a biographical sketch for the Program Director and each proposed mentor, strictly adhering to the 2 page limitation for each. Other Support (Format Page 7-GG) - Provide the information requested for the Program Director and each proposed mentor. Resources (form Page 8-HH) - Follow the Form PHS 398 instructions. Specific Instructions - Research Plan Introduction (Revised applications only). Revised applications must follow the additional requirements set out on page 15 of the Form PHS 398 instructions. This section of the application may not exceed 3 pages. The following instructions should be used in lieu of the Form PHS 398 instructions for this section of the application. The Research Plan section of the application must strictly adhere to a limit of 15 pages, excluding a maximum of three letters of institutional support, and item 2.e. below. Include sufficient information to facilitate an effective review; be specific, informative, and avoid redundancy. The outline suggested below should be followed in describing the program. A. Background 1. If the applicant institution has had precollege programs in the past, they should describe the history of the programs, the type and size of the programs (number of students and teachers), and any program accomplishments including tracking data for the students, if available. Information may be provided in tabular form. 2. A progress report is required for Competing Continuation applications. Provide: a. the beginning and ending dates for the period covered since the project was last reviewed competitively; b. accomplishments since the project's last competitive review; c. a description of any differences between the program proposed in the previous application and the program proposed below, and an explanation of the reasons for any changes; d. a description of what has been done to evaluate whether or not the project has made progress in meeting its goals, and/or how well the program has functioned; and a discussion of changes that have been made, or are being considered, as a result of evaluation findings; and, e. a report on the gender, race, and ethnicity of student and teacher participants, using a format similar to the Annual Report Format on page 30 of the Form PHS 398 instructions. Provide separate reports for students, inservice teachers, and preservice teachers. These reports do not count in the 15 page limit. B. Proposed Program The description of the program must include, at a minimum, the following information: 1. a description of the proposed program; 2. a description of the research environment and how it relates to the proposed program (e.g., ongoing research activity, availability of equipment, facilities, and resources); 3. methods and criteria for student, teacher, and mentor recruitment and selection; 4. methods to assign students and teachers to mentors (specific research projects should not be described, but a description of the general scientific skills to be learned should be included); 5. the general characteristics and length of the proposed student, preservice, and inservice teacher research laboratory experiences, and how they will differ; 6. special enrichment activities available to the students and teachers; and, 7. plans for formative evaluation of the program. C. Institutional Supporting Data Include a minimum of one and a maximum of three letters of institutional support. The letter(s) should be from a highly placed institutional official, at the level of Dean or above (or similar high level administrative official), who is in a position to commit the institutional resources necessary to assure effective conduct of the program. Appendix - No appendix material will be allowed. The signed, typewritten original of the application, including the Checklist, and three exact photocopies of the signed application, in one package, must be submitted 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: Office of Review National Center for Research Resources 6705 Rockledge Drive, Suite 6018, MSC 7965 Bethesda, MD 28092-7965 Bethesda, MD 20817 (for express/courier service) Timetable 1996 Only: Application Receipt Date: June 17, 1996 (New projects only) Council Review: February 1997 Earliest Award Start Date: April 1, 1997 Annually beginning in 1997: New, Competing Continuation, and Revised applications will be considered on the schedule noted below. No Competing Supplemental applications will be considered. Application Receipt: February 1 (New projects); March 1 (Competing Continuations and Revised projects) Initial Review: June-July Council: September Earliest award: December 1 Application Receipt: June 1 (New projects); July 1 (Competing Continuations and Revised projects) Initial Review: October-November Council: February Earliest award: April 1 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCRR. Late, incomplete or nonresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to this Program Announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCRR in accordance with NIH peer review procedures, using the review criteria 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 applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Research Resources Council. REVIEW CRITERIA o quality of the overall scientific and educational content of the proposed program including research laboratory and special enrichment activities; o appropriateness of the plans considering the size, strengths, and characteristics of the institution; o the qualifications of the Program Director and the proposed mentors; o the quality of the method of recruitment, selection and assignment of students, teachers, and mentors; o the quality of the institution's plans for a formative evaluation of the program; o the extent of the institutional commitment to providing a quality research experience and to precollege education partnerships; o the extent of prior accomplishments in precollege education; o and, for competing continuations, the quality of accomplishments since the project's last competitive review. The second level of review will be provided by the National Advisory Research Resources Council. AWARD CRITERIA The following will be considered when making funding decisions: the quality of the proposed application as determined by peer review, availability of funds, program balance among the types of institutions, and geographic distribution of the awards. 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: Mr. Martin B. Blumsack Research Infrastructure Area National Center for Research Resources One Rockledge Centre, Suite 6030 6705 Rockledge Drive - MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-1303 Email: ncrr_k12@nih.gov Direct inquiries regarding fiscal matters to: Ms. Mary V. Niemiec Office of Grants and Contracts Management National Center for Research Resources One Rockledge Centre, Suite 6086 6705 Rockledge Drive - MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0844 Email: maryn@ep.ncrr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance No.93.922. Awards will be made under authorization of the Public Health Service Act, Title III, Part A (Public Law 78-410, as amended, 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed Apr 24 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-040 - V25(12) 04/19/96 Date: 24 Apr 1996 17:48:45 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 280 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4lmi5d$2g8@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA96040 PA-96-040 P1O1 *************************************** EXPLORATORY GRANTS FOR CORRELATIVE LABORATORY STUDIES AND CLINICAL TRIALS NIH GUIDE, Volume 25, Number 12, April 19, 1996 PA NUMBER: PA-96-040 P.T. 34; K.W. 0715035, 0755015, 0745070 National Cancer Institute PURPOSE The Division of Cancer Treatment Diagnosis and Centers (DCTDC) of the National Cancer Institute (NCI) invites research grant applications >From interested investigators to conduct innovative therapeutic clinical trials or new correlative laboratory studies using patient specimens from therapeutic clinical studies. The exploratory/developmental (R21) grant mechanism is utilized for pilot projects or feasibility studies to support creative, novel, high risk/high payoff research that may produce innovative advances in science. The objective of this Program Announcement (PA) is to encourage applications from individuals who are interested in testing novel or conceptually creative ideas that are scientifically sound and may advance progress in human health. This PA supersedes PA-94- 050, Exploratory Grants to Stimulate Correlative Laboratory Studies and Innovative Clinical Trials, which was published in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. The exploratory grant program provides limited funds (maximum of $100,000 direct costs per year not including indirect costs of any collaborating institutions) for short-term (up to two years) research projects. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Exploratory Grants for Correlative Laboratory Studies and Clinical Trials, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications may be from a single institution or may include arrangements with one or more institutions (e.g., consortia, clinical trials cooperative group) if appropriate. Applications from minority individuals, women, and new investigators are encouraged. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) exploratory/developmental grant (R21) mechanism. Applicants will be responsible for the planning, direction, and execution of the proposed project. All PHS and NIH grants policies will apply to applications received and awards made in response to this program announcement. Applicants may request up to $100,000 per year in direct costs, not including indirect costs for collaborating institutions, if any. The total project period for applications submitted in response to this PA may not exceed two years. These grants are non-renewable and continuation of projects developed under this program will be through the traditional unsolicited investigator initiated grant program. RESEARCH OBJECTIVES Background The NCI supports an extensive network of clinical and laboratory research studies related to cancer therapy through grants and cooperative agreements. At present, there is no mechanism targeted to stimulate the communication of promising and potentially relevant innovative developments between the laboratory and the clinical setting. It has been difficult for investigators to obtain complementary funding through either the traditional basic research project grant (R01) mechanism or through the cooperative agreement (U10) mechanism for either: (1) innovative clinical trials that take advantage of new developments in the laboratory or (2) novel correlative laboratory studies to existing clinical trials. The small grants (R03) mechanism partially addressed these problems but the limited funds ($50,000 direct cost cap) prevented larger innovative clinical studies from being pursued. These clinical studies would not be developed fully enough for a standard R01 and would therefore be considered high risk. It is expected that these R21 grants will serve as a basis for planning future clinical research project grant applications (R01) or NCI cooperative clinical trial group studies. Because the exploratory grant mechanism is designed to support innovative ideas, preliminary data as evidence of feasibility are not required. However, the applicant does have the responsibility for developing a sound research plan. Originality of the approach and potential significance of the proposed research are major considerations in the evaluation. Research Goals and Scope The major goal of this initiative is to promote translational and clinical research through the support of two types of studies: (1) new therapeutic clinical trials or (2) new correlative studies relevant to therapeutic clinical trials. Applications should be focused on integrating clinical goals with laboratory research areas. This PA envisions funding new therapeutic clinical trials that move new treatment strategies more rapidly from the laboratory into the clinic. These clinical studies must involve human subjects, be designed to ultimately improve cancer treatment, and be based on a strong rationale. Furthermore, the underlying hypothesis should be supported by preclinical data. The proposed clinical protocol should be included in the Appendix of the application. This PA has a second research goal of funding new correlative laboratory studies that are relevant to therapeutic clinical trials. The clinical correlates must have a future clinical application such as development of new treatment strategies or identification of patient subsets for specific treatment therapies. Examples of correlative studies include, but are not limited to, analysis of prognostic markers, cytogenetic studies, pharmacokinetic studies, studies of drug resistance, and analyses of immune response. The laboratory assays must utilize patient specimens from ongoing clinical trials or specimen banks. Where applicable, evidence of statistical support should be included to ensure proper correlation of assay parameters with clinical outcome. 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 4928 of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The title and number of the program announcement must be typed in line 2 on the face page of the application and the YES box must be marked. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator must be included with the application. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by an appropriate peer review group convened by NIH, in accordance with the standard NIH peer review procedures. The second level of review will be provided by a National Advisory Council or Board. Review criteria that will be used to assess the scientific merit of an application are: o Scientific merit and originality of the proposed research o Potential significance of the proposed research o Soundness of the experimental design o Qualifications, relevant experience, and commitment of the investigator(s) o 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 The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each approved application. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o Quality of the proposed research as determined by peer review o Program balance among research areas o Responsiveness to the goals and objectives of the PA INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Ms. Diane Bronzert or Dr. Roy S. Wu Division of Cancer Treatment Diagnosis and Centers National Cancer Institute Executive Plaza North, Room 734 6130 Executive Boulevard MSC 7432 Bethesda, MD 20892-7432 Telephone: (301) 496-8866 FAX: (301) 480-4663 Email: BRONZERD@DCT.NCI.NIH.GOV or WUR@DCT.NCI.NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Eileen Natoli Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, ext. 256 FAX: (301) 496-8601 Email: NATOLIE@GAB.NCI.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.395, Cancer Treatment Research. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended, Public Law 99-158, 42 USC 241 and 285) and administered under HHS grants policies. 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 routing 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 Wed Apr 24 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AR-96-002 - V25(12) 04/19/96 Date: 24 Apr 1996 17:47:26 -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: <4lmi2u$27p@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AR96002 AR-96-002 P1O1 *************************************** SPECIALIZED CENTERS OF RESEARCH (SCORs) IN OSTEOPOROSIS, RHEUMATOID ARTHRITIS AND SCLERODERMA NIH Guide, Volume 25, Number 12, April 19, 1996 RFA: AR-96-002 P.T. 34; K.W. 07155031, 07005050, 0715010, 0715185, 0715170 National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: November 1, 1996 Application Receipt Date: February 12, 1997 PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invites applications for Specialized Centers of Research (SCORs) in the following disease areas: osteoporosis, rheumatoid arthritis, and scleroderma. A SCOR should foster a coordinated research effort that strongly emphasizes basic disciplines, but also involves significant interaction between basic research and clinical investigations. A SCOR is envisioned as a national resource associated with one or more major medical complexes and dedicated to working with the NIAMS in furthering the research effort to translate basic research to clinical application. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Specialized Center of Research (SCOR), is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by 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. An established clinical and research program in the disease area should be present. Foreign organizations are not eligible. International collaborations in domestic applications will only be accepted if the resources are clearly shown to be unavailable in the United States. Applications >From racial/ethnic minority individuals and women and persons with disabilities are encouraged. MECHANISM OF SUPPORT Support of this program will be through the NIH specialized center (P50) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. This RFA is a one-time solicitation for these disease areas. A separate RFA (AR-96-003) is directed to osteoarthritis and systemic lupus erythematosus. The total requested project period for an application submitted in response to this RFA may not exceed four years. The anticipated award dates are September 1997 through April 1998. FUNDS AVAILABLE The NIAMS intends to fund up to nine SCORs in FY 1997 and 1998 in the scientific areas covered by this RFA and RFA AR-96-003. Funding is subject to the availability of resources and receipt of sufficiently meritorious applications. Nine competing continuation applications are anticipated in response to these RFAs. The anticipated awards are for four years and are subject to the availability of appropriated funds. The estimated funds (total costs) available for the first year of support of these centers are $10 million per year. The direct costs requested cannot exceed $750,000 (excluding indirect costs of subcontracts) each year. RESEARCH OBJECTIVES The objective of the SCOR program is to expedite development and application of new knowledge to a disease area, to learn more about the etiology of these diseases, and to foster improved approaches to treatment and/or prevention. A SCOR consists of at least three individual, but interrelated, research projects, each with high scientific merit and clear research objectives and, in the aggregate, devoted to a specific major health area. Each SCOR should provide a multidisciplinary approach utilizing both laboratory and clinical research to focus on a particular health problem and provide for a mutually supportive interaction between basic scientists and clinical investigators. Clinical research is defined as patient oriented clinical research conducted with human subjects, or on material of human origin (such as tissue specimens and cognitive phenomena) for which an investigator or colleague directly interacts with human subjects in an outpatient or inpatient setting to clarify a problem in human physiology, pathophysiology, or disease. Although research programs will vary at each institution according to local expertise, interests, and resources, each SCOR should have a central theme related to the disease area to which individual projects relate and which serves as an integrating force. Emphasis in proposed projects should be on development of innovative approaches, elaboration of new and significant hypotheses, and generation of improved strategies for approaching current issues relating to the disease area addressed. Funding may also be requested for one or more core resources. A core is defined as a resource shared by multiple investigators that enhances research productivity and increases the functional capacity of the SCOR. Ongoing projects may be absorbed into the SCOR if their original funding source is relinquished. Support for large clinical trials or for applications that contain exclusively clinical or exclusively basic studies will not be provided within this SCOR program. Applicants from institutions which 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. Details of the interactions of the SCOR staff with the GCRC staff and research personnel may be provided in a statement describing the collaborative linkages being developed. A letter of agreement from the GCRC Program Director must be included with the application. SPECIAL REQUIREMENTS The director and co-director should budget for an annual one-day meeting in Bethesda, MD with NIAMS staff. The director should be prepared to devote at least 15 percent effort as the director and 20 percent effort as a project PI. Each project and core PI should be prepared to devote at least 20 percent effort. To be funded, a SCOR must include at least three highly meritorious projects approved for four years. One of these must have the SCOR director as the principal investigator, and the highly meritorious projects must include both basic and clinical research. 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 1, 1996, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIAMS staff to estimate the potential review workload and to avoid conflict of interest in the selection of reviewers. The letter of intent is to be sent to Dr. Julia B. Freeman 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 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. Special guidelines have been developed for the SCOR program in NIAMS. These guidelines should be used in assembling the application. See INQUIRIES for obtaining a copy of these guidelines. 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, "Specialized Center of Research (SCOR) in [add disease]", and number, "AR-96-002" must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies of the application 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, send two additional copies of the application to: Review Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS.25U - MSC 6500 Bethesda, MD 20892-6500 Bethesda, MD 20814 (for express/courier service) Applications must be received by February 12, 1997. If an application is received after the specified 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 for SCORs will be first screened for completeness by DRG and responsiveness by NIAMS program staff. Incomplete applications will be returned to the application without further consideration. In addition, if program staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAMS in accordance with the 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 application 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 Council for NIAMS. If the project from the SCOR director is not recommended for further consideration during the review for scientific merit, the entire SCOR application will not be reviewed further. If all the clinical research projects in a SCOR application are not recommended for further consideration, the SCOR application will not be further reviewed. Major factors to be considered in evaluation of applications will include: 1. How the proposed SCOR combines basic and clinical research into the scientific goals and research theme; 2. If a competing continuation application, the quality and significance of the progress made in the previous funding period; 3. Scientific merit of each proposed project, including originality and feasibility of the project and adequacy of the experimental design; 4. Scientific merit of combining the component parts into a SCOR; 5. Technical merit and justification of each core unit; 6. Competence of the investigators to accomplish the proposed research goals, their commitment, and the time they will devote to the research program; 7. Adequacy of facilities to perform the proposed research, including laboratory and clinical facilities, instrumentation, and data management systems, when needed; 8. Adequacy of plans for interaction among investigators, and the integration of the various projects and core units; 9. Qualifications, experience and commitment of the SCOR Director and his/her ability to devote time and effort to provide effective leadership; 10. Scientific and administrative structure, including internal and external procedures for monitoring and evaluating the proposed research and for providing ongoing quality control and scientific review; 11. Institutional commitment to the program, and the appropriateness of resources and policies for the administration of a SCOR; 12. 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 appropriateness of the budget for the proposed program and its individual components will be considered independently of the factors indicated above. AWARD CRITERIA The anticipated award dates will be as early as September 1, 1997, and as late as April 1, 1998. The primary factors determining the award will be the priority score, the overall balance of meritorious projects (clinical and basic research) within the application relative to the disease area, and the availability of funds. Since the NIAMS is interested in funding only the best research, individual projects or cores of lesser quality may not be funded, even if approved, under the "umbrella" of the SCOR mechanism. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues and letters of intent may be directed to: Dr. Julia B. Freeman Centers Program, EP National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS.19F - MSC 6500 Bethesda, MD 20892-6500 Bethesda, MD 20814 (for express/courier service) Telephone: (301) 594-5052 FAX: (301) 480-4543 Email: freemanj@ep.niams.nih.gov Copies of the guidelines for the SCOR program may be obtained from: NIAMS Clearinghouse 1 AMS Circle Bethesda, MD 20892-3675 Telephone: (301) 495-4484 FAX: (301) 587-4352 Direct inquiries regarding fiscal matters to: Sally A. Nichols Grants Management Officer National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building Room 5AS.49F - MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-3535 FAX: (301) 480-5450 Email: nicholss@ep.niams.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 410, 78th Congress, as amended, 42 USC 241) and administered under PHS grant policies and Federal regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to 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 Wed Apr 24 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA TW-96-001 - V25(12) 04/19/96 Date: 24 Apr 1996 17:46:51 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 663 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4lmi1r$24j@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA TW96001 TW-96-001 P1O1 *************************************** INTERNATIONAL TRAINING AND RESEARCH IN EMERGING INFECTIOUS DISEASES NIH GUIDE, Volume 25, Number 12, April 19, 1996 RFA: TW-96-001 P.T. 34; K.W. 0715125, 0720005, 0404000 Fogarty International Center National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: September 15, 1996 Application Receipt Date: January 15, 1997 PURPOSE A comprehensive strategy to address global emerging and re-emerging infectious diseases (ERID) should include international training and biomedical and behavioral research. This strategy will strengthen the capacity of scientists to understand and respond to outbreaks of infectious diseases more effectively. The definition of ERID is "new, re-emerging or drug-resistant infections whose incidence in humans has increased within the past two decades or whose incidence threatens to increase in the near future" (Institute of Medicine, 1992). The objectives of the International Training and Research in Emerging Infectious Diseases (ITREID) Program are to: o Train laboratory scientists, clinicians, epidemiologists, social scientists, and public health workers in developing countries and the United States in emerging and re-emerging infectious disease research, control and prevention strategies and their implementation and evaluation; this will increase global infrastructure and capacity for dealing with ERID. o Assist scientists from developing countries to contribute to global emerging infectious diseases research efforts and advance knowledge in support of national and international ERID policies. o Encourage and facilitate international collaboration on ERID research, including the conduct of advanced in-country research. o As a result of the above, enhance domestic infectious diseases research programs and improve the protection of the United States population from ERID by early detection and response to epidemics internationally and nationally. 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), International Training and Research in Emerging Infectious Diseases, is related to the priority area of emerging diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS The grantee institution must be a U.S. non-profit private or public institution capable of meeting the objectives in the RFA. Applicant investigators (or co-investigators) must be either a U.S. Principal Investigator of at least one relevant NIH-sponsored research project grant (R-series) or a Project Director of an NIH-sponsored center grant, program project grant or cooperative agreement (P and U series) related to infectious diseases. For example, an award under the NIAID International Collaborations in Infectious Diseases Research Program would satisfy the eligibility requirements. On submission of an application, at least eighteen months of active research support must remain on the listed parent grant(s) so that the parent grant will be funded during at least one year of the proposed new grant award period. The following mechanisms alone do not meet the eligibility requirements: Center Core Grants (P30), Shannon Awards (R55), and Small Grants (R03). Investigators may request five years of support in anticipation that a renewal application for the parent grant(s) will be submitted and awarded. Under certain circumstances, another award, such as an NIH research contract will be considered as meeting the eligibility requirements. Though an existing international relationship would be desirable to meet the eligibility requirements, this is not absolutely necessary. The application must demonstrate that the award is relevant to and will enhance the activities of the NIH-supported parent grant(s), and benefit the research needs and interests of the host countries, and of participating scientists and health professionals. Within allowable limits, research collaborations can include other industrialized nations in addition to the U.S. Questions about eligibility and partnerships with colleagues and institutions in the U.S. and overseas should be referred to the program staff listed under INQUIRIES. Only one application will be allowed under this program >From each U.S. institution. MECHANISM OF SUPPORT This RFA will use the international training grants in epidemiology (D43) mechanism. The application should describe both training and research objectives to be pursued in the United States and in the cooperating developing nation(s) of Africa, Asia and the Pacific region, the Middle East and Latin America including the Caribbean. Applications may incorporate cooperative activities with scientists >From one or several developing countries or regions, based on the training and research objectives of the program. However, applicants are encouraged to focus their efforts on a limited number of countries. Types Of Training: Public health related training and research programs for foreign scientists and health professionals may include the following elements: o Participation in training of health workers in the diagnosis, patient management, control, and prevention of disease and in activities in support of field research; o Predoctoral training in research related to emerging infectious diseases; academic courses (which may lead to a degree) will be undertaken in the U.S. in disciplines which may include: laboratory, epidemiologic and social science research as described above; research projects may be undertaken either at the U.S. host institution or preferentially, in the trainee's home country; o Postdoctoral training in laboratory procedures and research projects and techniques related to emerging infectious diseases research, to be conducted at the host U.S. institutions or in the trainee's home country; o Participation in advanced in-country research training conducted by U.S. faculty in the host country and also short-term in-country training for foreign scientists and health professionals in the host country; and As part of the application, the applicant institution must describe recruitment and selection procedures for the foreign pre- and post-doctoral scientists. Major Research Themes The areas of research addressed by this ITREID program would include the following major research themes. These are exclusive of HIV/AIDS international training and research areas that are addressed by other granting mechanisms, particularly the FIC/NIH AIDS International Training and Research Program and the NIAID/NIH HIV Network (HIVNET) program: o Emerging and re-emerging viruses particularly hemorrhagic fevers occurring in the geographic areas emphasized above; including Ebola virus and other filoviruses, dengue, yellow fever, Lassa fever and other arena viruses, o Parasitic infections; including malaria and leishmaniasis; o Bacterial diseases; including cholera, plague, meningitis, tuberculosis, leptospirosis, lyme disease, group A streptococcus, diphtheria, pertussis, and shigella. o Other viral diseases of local, national and international importance; including, but not limited to, Hantaviruses, rotavirus, rabies,. o Cross cutting themes such as microbial resistance to drugs Special recommendations for infectious diseases training and research would address the following categories; these are examples, and programs are not limited to these topics. Training Categories A. Epidemiologic research o The clinical presentation, transmission patterns and risk factors for transmitting and/or becoming infected with infectious diseases o The natural history of infectious diseases o The development and testing for effectiveness of intervention strategies for limiting the spread of new diseases and preventing and controlling resurgent diseases o Studies to identify patterns and host factors associated with the development of drug resistance o New epidemiologic and statistical methods, including the development of predictive models for the occurrence and spread of epidemics and the use of geographical information systems o Improvement of surveillance tools, including computer programs for reporting and data management o Environmental and ecologic factors that influence the population biology of insects, rodent vectors and other animal (or unknown) vectors. B. Laboratory research o Fundamental aspects of microbial physiology, genetics, and biochemistry o Pathogenesis and pathology o Human immune response o Development and standardization of diagnostic tests o Development of drugs o Development of vaccines o Development of vector control interventions o Methods for monitoring drug resistance o Cellular and molecular factors that accelerate the development of drug resistance and methods for limiting those factors o Environmental and climatic factors that influence temperature, the quality and distribution of water and the population biology of insect and rodent vectors C. Social science research: o Human behavior and demographics as they relate to the causes and control of infectious diseases, including the development of drug resistance o Economic assessments of the cost-effectiveness of different surveillance and response strategies Training Programs would: o Strengthen interdisciplinary training programs and scientific exchanges within the United States in the area of infectious diseases and emerging infections; o Enhance and increase international research capacity and training programs in infectious diseases; o Encourage networking among international research and public health communities that support surveillance and response actions for emerging diseases; and o Support the World Health Organization initiative to improve detection, response to and understanding of ERID. Allowable Costs Eligible costs include: travel and subsistence related to research and training conducted at a foreign site; support for short and long-term training of pre- and postdoctoral scientists and health professionals from developing nations; provision of research supplies and materials to the foreign site in support of joint activities; and limited support for relevant activities with institutions in industrialized nations that would provide scientific contributions. The following cost categories are eligible for reimbursement under this program. The stipends and allowances are maximums and applicants are encouraged to design the most cost-effective programs: For foreign scientists from developing nations: - Living allowance (stipend) comparable to scientist's professional level and compatible with established NIH guidelines, but not to exceed $45,000 per annum while undergoing training or conducting research in the U.S.; - Stipend, if necessary and justified, to cover the added time for scientists to conduct in-country research if not paid for by the home institution at a level comparable to that received by similar professionals in-country, but also not to exceed $45,000 per annum; - Tuition and fees at the U.S. university; - Round trip economy class air fare between the U.S. and home country (via U.S. air carrier); - Allowance for the grantee institution of up to $600 monthly per scientist to cover health insurance, travel to scientific meetings, and incidental research expenses; - Additional research support of up to $15,000 per person to support training-related research or advanced research training in the developing country (the program director is expected to ensure that projects submitted for this funding are peer reviewed by the U.S. institution); For U.S. scientists affiliated with grantee institution: - Economy class travel (via U.S. carrier) and per diem for the program director and U.S. faculty colleagues to provide guidance to trainees conducting related field studies or advanced research training in their home countries; - Economy class travel (via U.S. carrier) and per diem for U.S. faculty presenting short-term courses in the foreign country; - Longer-term support (travel, per diem and pro-rated salary, up to 10 percent of annual salary or $10,000, whichever is less) to enable U.S. faculty to conduct advanced research training activities in-country; For administrative expenses: - Administrative expenses at the U.S. institution (secretarial expenses, etc.) not to exceed 10 percent of the direct costs of this award. These expenses must be exclusively for this training and research proposal. It is expected that the portion of salary for the program director for the purpose of administering this award will be provided for under the parent grant(s) associated with this proposal; For related activities with other industrialized nations: - Support for travel and subsistence of U.S. or foreign investigator(s), and the exchange of data, materials and supplies, not to exceed 10 percent of direct costs of this award unless prior approval is secured from the FIC. As a condition of this special expenditure, the applicant must indicate that some form of cost-sharing will be provided by the counterpart institution in an industrialized nation. Requests for an administrative supplemental budget will be considered for increases of up to 20 percent of funded levels in a given budget year. These funds may be requested to meet special needs and take advantage of unusual opportunities. Such requests will be reviewed by FIC program staff in consultation with NIAID and support will depend upon availability of funds. The grantee institution may request an indirect cost allowance based on 8 percent of the total allowable direct costs, exclusive of tuition and related fees and expenditures for equipment. Applicants should assume a budget increase of four percent per year for each succeeding year. The anticipated date of award will be before September 30, 1997. FUNDS AVAILABLE An estimated total of $500,000 is available for this program. International Training and Research in Emerging Infectious Diseases awards (D-43) will be available to U.S. investigators at a funding level not to exceed $150,000 per year in total costs (direct and indirect) for the first year, for a maximum of five years. It is anticipated that three to four awards will be made, with an estimated total of $500,000 available for the entire program in the first year, with no single award exceeding $150,000 (in total costs). RESEARCH OBJECTIVES Outbreaks of newly identified infectious diseases in humans and animals have occurred with increasing frequency worldwide over the past two decades. During the same period there has been a re-emergence of infectious diseases that had been in abeyance, for which control and prevention measures have become ineffective. The reasons for the emergence of infectious diseases are complex and are tied to biologic properties of the organisms, behavior of human populations, and environmental changes. As a global community becomes a reality, the dangers of disease importation to all countries, linked mainly to immigration (legal and illegal) and international air travel, have increased. The objectives of the research supported by the International Training and Research in Emerging Infectious Diseases Program (ITREID) grants are consistent with those championed by the National Academy of Sciences, Institute of Medicine Report "Emerging Infections: Microbial Threats to Health in the United States" (1992), and the Report of the National Science and Technology Council, Committee on International Science, Engineering, and Technology, Working Group on Emerging and Re-emerging Infectious Diseases, "Infectious Disease-A Global Health Threat" (1995). The geographic emphasis of this program will be primarily on developing countries in Africa, Asia and the Pacific Region, the Middle East, and Latin America including the Caribbean, but may also include other areas when well justified; for example, projects in the former Soviet Union and Eastern European regions will be considered. SPECIAL REQUIREMENTS Before any funds may be expended on in-country research, the grantee institution must show evidence of formal approval from responsible authorities at the collaborating institution and the host government. These approvals should be included in the application. As part of proposed training programs, the applicants must describe the training in the responsible conduct of research, consistent with NIH policy (NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992) to be part of the program. An award will not be made unless such a description is included in the proposal. Protection of Human Subjects and Laboratory Animals: Applicable provisions for the protection of human research subjects and laboratory animals in research and training activities must be met in both domestic and foreign settings. Title 45 CFR, Part 46, provides guidelines concerning Department of Health and Human Services regulations for the protection of human subjects and the Public Health Service Policy on Humane Care and Use of Laboratory Animals. These are available from the Office for Protection from Research Risks, National Institutes of Health, 6100 Executive Boulevard, Rockville, Maryland 20852. 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 (59 FR 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 28, 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 September 15, 1996, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, 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 as well as to provide important information to prospective applicants. The letter of intent is to be sent to: Dr. Joel Breman Division of International Training and Research Fogarty International Center National Institutes of Health Building 31, Room B2C39 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained >From the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov; and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for overnight/courier service) At the time of submission, two additional copies of the application must be sent to: Mr. Allan W. Czarra Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3C28 Rockville, MD 20852 Applications must be received by January 15, 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 Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the FIC, NIAID and other collaborating institutions. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, the application will be returned to the applicant without review. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by a peer review group convened by the NIAID in accordance with the review criteria 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 applications under review, will be discussed, assigned a priority score, and receive a second level review by the FIC Advisory Board. Review criteria include those generally applicable to research training programs and research: o Past training and research record for both the program and designated preceptors in terms of the rate at which former trainees establish independent and productive research careers; o Past training and research record in terms of the success of former trainees in obtaining individual awards such as fellowships, career awards and research grants for further development; o Objectives, design and direction of the training and research program; o Training environment including the institutional commitment, the quality of the facilities and the availability of research support; o Caliber of preceptors as researchers including the institutional commitment, the quality of the facilities, and the availability of research support; o Recruitment and selection plans for appointees and the availability of high quality candidates; o The record of the research training program in retaining health professional postdoctoral trainees for at least two years in research training or other research activities; and o When appropriate, the concomitant training of health-professional postdoctorates (e.g. , individuals with the M.D., D.O., D.D.S.) with basic science postdoctorates (e.g., individuals with a Ph.D., Sc.D.) will receive special consideration. Where specific research protocols are proposed, additional review criteria, applicable to research grants, will be as follows: 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. Additional factors to be considered in the scientific evaluation of each application include the likelihood that the applicant institution can meet the objectives stated in this RFA and specifically: o The expected public health and scientific contributions of the proposed activity; o The strength of the research program in health sciences related to the proposed research and training; o Quality of teaching and research facilities and resources of the U.S. institution, as well as the cooperating institution(s) in other countries including documentation of previous international collaboration with developing country scientists and institutions; o Previous training experience at the pre- and postdoctoral levels and success in maintaining collaboration with former trainees; o Demonstrated capacity or potential to provide advanced in-country research or technical training; and o Demonstrated capacity or potential to conduct future emerging diseases related research projects with collaborating scientists and institutions from developing nations. AWARD CRITERIA The most important factor to be considered in making funding decisions will be the quality of the proposed project as determined by peer review. In addition, FIC, in consultation with NIAID and other ICDs and collaborators will make every effort to ensure a reasonable balance of basic, clinical and epidemiologic research training, as well as a geographic distribution among developing nations of Asia and the Pacific region, Africa, the Middle East and Latin America including the Caribbean. The number and amount of the awards made under this program will depend upon the availability of funds; cost-effectiveness of activities will be one of the factors considered in making funding decisions. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome and prospective applicants are strongly encouraged to discuss their proposals with program staff prior to submission. Inquiries regarding programmatic issues to: Dr. Joel Breman Division of International Training and Research Fogarty International Center National Institutes of Health 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-2056 Email: jbreman@nih.gov Inquiries regarding fiscal matters to: Ms. Silvia Mandes Division of International Training and Research Fogarty International Center National Institutes of Health 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: mandess@ficod.fic.nih.gov AUTHORITY AND REGULATIONS 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 to 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 Wed Apr 24 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 12, pt. 1of2, 19 April 1996 Date: 24 Apr 1996 17:46:10 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1498 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4lmi0i$216@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19960419 V25N12 P1O2 ************************************ X-comment: RFAS described: DA-96-005, LM-96-002, DA-97-001, CA-96-012, HG-96- X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.04.19 A-96-034, PAR-96-039, PA-96-040, PAR-96-041 NIH GUIDE - Vol. 25, No. 12 - April 19, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** SYMPOSIUM ON THE PAST, PRESENT, AND FUTURE OF PEER REVIEW National Institutes of Health Division of Research Grants INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** PROGRAM ANNOUNCEMENTS AND RESEARCH EMPHASIS AREAS National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX N3 ********************************************************** NCRR RESEARCH PROGRAM PROJECT GRANTS IN COMPARATIVE MEDICINE National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX N4 ********************************************************** NCRR COMPARATIVE MEDICINE RESEARCH AND RESOURCE GRANT SUPPORT National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX N5 ********************************************************** NIDA RESEARCH CENTER GRANT PROGRAM GUIDELINES National Institute on Drug Abuse INDEX: DRUG ABUSE NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** CONTRACEPTIVE EFFICACY TESTING (SS-NICHD-96-01) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R2 ********************************************************** PRODUCTION AND BIOSAFETY TESTING OF A RETROVIRAL VECTOR SUPERNATANT FOR GENE THERAPY OF FABRY DISEASE (RFP NIH-NINDS-96-06) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX R3 06/18/96 ************************************************* BEHAVIORAL SCIENCE TRACK AWARDS FOR RAPID TRANSITION (RFA DA-96-005) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX R4 06/19/96 ************************************************* MEDICAL INFORMATICS RESEARCH TRAINING PROGRAMS (RFA LM-96-002) National Library of Medicine INDEX: NATIONAL LIBRARY OF MEDICINE $$INDEX R5 07/24/96 ************************************************* CRAVING IN DRUG ABUSE AND ADDICTION (RFA DA-97-001) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX R6 07/30/96 ************************************************* MULTI-INSTITUTIONAL COOPERATIVE AGREEMENTS FOR CLINICAL EVALUATION OF MAGNETIC RESONANCE IMAGING IN BREAST CANCER (RFA CA-96-012) National Cancer Institute INDEX: CANCER $$INDEX R7 09/06/96 ************************************************* LARGE SCALE FUNCTIONAL ANALYSIS OF THE YEAST GENOME (RFA HG-96-001) National Center for Human Genome Research National Cancer Institute INDEX: HUMAN GENOME RESEARCH; CANCER $$INDEX R8 09/18/96 ************************************************* CLAUDE D. PEPPER OLDER AMERICANS INDEPENDENCE CENTERS (RFA AG-96-003) National Institute on Aging INDEX: AGING $$INDEX R9 12/11/96 ************************************************* ALCOHOL RESEARCH CENTER GRANTS (RFA AA-96-003) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX R10 01/15/97 ************************************************ INTERNATIONAL TRAINING AND RESEARCH IN EMERGING INFECTIOUS DISEASES (RFA TW-96-001) Fogarty International Center National Institute of Allergy and Infectious Diseases INDEX: FOGARTY INTERNATIONAL CENTERS; ALLERGY, INFECTIOUS DISEASES $$INDEX R11 02/12/97 ************************************************ SPECIALIZED CENTERS OF RESEARCH IN OSTEOPOROSIS, RHEUMATOID ARTHRITIS, AND SCLERODERMA (RFA AR-96-002) National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES $$INDEX P1 ********************************************************** AGING WOMEN AND BREAST CANCER (PA-96-034) National Institute on Aging National Cancer Institute National Institute of Nursing Research National Institute of Mental Health INDEX: AGING; CANCER; NURSING RESEARCH; MENTAL HEALTH $$INDEX P2 ********************************************************** NCRR MINORITY INITIATIVE: K-12 TEACHERS AND HIGH SCHOOL STUDENTS (PAR-96-039) National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX P3 ********************************************************** EXPLORATORY GRANTS FOR CORRELATIVE LABORATORY STUDIES AND CLINICAL TRIALS (PA-96-040) National Cancer Institute INDEX: CANCER $$INDEX P4 ********************************************************** MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD IN AGING (PAR-96-041) National Institute on Aging INDEX: AGING THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************** NOTICES $$N1 BEGIN ********************************************************** SYMPOSIUM ON THE PAST, PRESENT, AND FUTURE OF PEER REVIEW NIH GUIDE, Volume 25, Number 12, April 19, 1996 P.T. 42; K.W. 1014006, 1014004 National Institutes of Health Division of Research Grants 1996 is the 50th anniversary of the founding of the Division of Research Grants. The National Institutes of Health and the Division of Research Grants are marking this occasion with a symposium on the Past, Present, and Future of Peer Review. This symposium will be held Thursday, June 20 at the Natcher Conference Center on the Bethesda campus of NIH. The symposium will start at 8:30 a.m. and conclude with a reception at the Natcher Center in the late afternoon. this is an opportunity for colleagues, friends, and others to discuss fifty years of excellence in peer review and its impact on biomedical research. The agenda and registration information are available on the DRG home page - http://www.drg.nih.gov - or by requesting information from the address listed under INQUIRIES. There is no fee for the symposium, but advance registration is required. The registration deadline is May 31, 1996. The Natcher facility is fully accessible in compliance with the Americans with Disabilities Act. INQUIRIES Suzanne E. Fisher, Ph.D. Division of Research Grants National Institutes of Health Rockledge Building, Room 2030 6701 Rockledge Drive, MSC 7720 Bethesda, MD 20892-7720 Telephone: (301) 435-0715 FAX: (301) 480-1987 Email: fys@drgpo.drg.nih.gov $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** PROGRAM ANNOUNCEMENTS AND RESEARCH EMPHASIS AREAS NIH GUIDE, Volume 25, Number 12, April 19, 1996 P.T. 34; K.W. 0710030, 1014006 National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID) is increasing the use of Program Announcements (PAs) to inform the scientific community of its current areas of research emphasis. Research emphasis areas warrant expanded support based on scientific need and opportunity, public health importance, and/or legislative mandate. These emphasis areas are developed jointly with the scientific, medical, and public health communities and with the concurrence of the National Advisory Allergy and Infectious Diseases Council. In addition, fewer Requests for Applications (RFAs) will be issued. As a result, more funds will be devoted to support of investigator-initiated research projects. Program Announcements offer the advantages of multiple receipt dates with fewer administrative requirements for applicants. A specific amount of funds will not be set-aside for award of grants under each PA. This is being done for two reasons: (1) NIAID does not know what its appropriations (budget) will be in Fiscal Years 1997 and beyond; and (2) NIAID cannot accurately predict the number of applications that will be submitted in response to each PA or the scientific merit of those applications. Scientifically meritorious applications determined by NIAID to be responsive to our Program Announcements will be given special consideration for funding including the award of grants beyond the established NIAID percentile or priority score paylines. Each NIAID Program Announcement identifies staff contacts who can answer questions from potential applicants concerning their eligibility to apply and the types of research responsive to the purpose and scope of the Program Announcement. POTENTIAL APPLICANTS ARE STRONGLY ENCOURAGED TO CONTACT NIAID STAFF BEFORE PREPARATION OF A GRANT APPLICATION. This action results from recommendations of the National Advisory Allergy and Infectious Diseases Council and advice from broad cross- sections of the scientific community. INQUIRIES NIAID's Program Announcements are published in the NIH Guide for Grants and Contracts and are available via the Internet through the NIH Home Page at http://www.nih.gov. NIAID's Program Announcements are also available from NIAID staff and from the NIAID Division of Extramural Activities at: Office of the Director Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 3C20 Bethesda, MD 20892-7610 Telephone: (301) 496-7291 FAX: (301) 402-0369 Email: ac20a@nih.gov $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NCRR RESEARCH PROGRAM PROJECT GRANTS IN COMPARATIVE MEDICINE NIH GUIDE, Volume 25, Number 12, April 19, 1996 P.T. 34; K.W. 1014006 National Center for Research Resources This notice is to inform the research community that Comparative Medicine, National Center for Research Resources (NCRR), will no longer accept Research Program Project (P01) applications effective with the October 1, 1996 receipt date. Any eligible responsive application currently being prepared for the June 1, 1996 deadline will be accepted, peer-reviewed, and considered for funding based on its scientific merit and programmatic relevance to Comparative Medicine and to the mission of NCRR. All currently funded P01 grants will be honored through the completion of their respective competitive segments. However, subsequent competitive renewal applications for continuation of the program project grant will not be accepted. INQUIRIES For further information, contact: Dr. Leo A. Whitehair Director, Comparative Medicine National Center for Research Resources One Rockledge Centre, Suite 6030 6705 Rockledge Drive, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0744 Email: LeoW@EP.NCRR.NIH.GOV $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NCRR COMPARATIVE MEDICINE RESEARCH AND RESOURCE GRANT SUPPORT NIH GUIDE, Volume 25, Number 12, April 19, 1996 P.T. 34; K.W. 1002002, 0755020 National Center for Research Resources With the recent reorganization of the National Center for Research Resources (NCRR) extramural programs that resulted in the Biological Models and Materials Research Program becoming a part of the Comparative Medicine area, the Comparative Medicine area is publishing this notice to restate its interests regarding the support of nonhuman primate resources, other special colonies of laboratory animals, and research and resource-related research projects for the development of animal (mammalian and nonmammalian) models. Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Material Resource Grants (P40) are used to provide support for special colonies of laboratory animals, including nonhuman primates, as well as for other resources such as cultures (cells, tissues, and organs) and genetic stocks that serve the biomedical research community at large. These resource centers must have three basic characteristics: (1) the resource must have a research component to generate new information which is relevant to the resource; (2) the resource must serve the needs of investigators in a variety of biomedical research areas where work is sponsored by NIH categorical Institutes; and (3) the resource must be available to investigators on a local, regional and national basis. Special colonies of research animals are defined as those animals that are valuable to biomedical research, but are not generally available because of problems of breeding, maintenance or procurement. Support for such colonies is usually limited to those used for a variety of research projects which span the interests of two or more categorical Institutes of the NIH. Grants for Regional Primate Research Centers (P51) support distinct organizational and structural components affiliated with major host academic institutions to provide the necessary specialized facilities, personnel, equipment, breeding colonies of nonhuman primates, and other core support needed by qualified investigators (local, regional, and national) to conduct independent and collaborative multi-categorical research programs. Regional Primate Research Centers (RPRC) were established to allow biomedical research to be carried out effectively using various species of nonhuman primates. Competition for a RPRC is open to extramural institutions that meet the required qualifications. To qualify, an applicant institution must already have in place the necessary infrastructure, including a well-established facility with a very strong ongoing research program supported by research grants from NIH and other funding agencies, specialized professional and support personnel, as well as an appropriate number and diversity of nonhuman primate species to compete for regional primate research center funding. Investigator-initiated research projects (R01 and R29) provide for the exploration and development of new models (including mammalian, nonmammalian, and mathematical and computer approaches) or for research to expand the usefulness of established model systems. Resource-related research projects (R24)provide for activities intended to enhance the capability of Comparative Medicine resources or that may lead to the development of a resource. All applications must be submitted on grant application form PHS 398 (rev. 5/95). Applications for projects under the R01, R24, R29, P40, and P51 mechanisms are accepted at the standard Division of Research Grants (DRG) receipt dates as published in the PHS 398 instructions. Since there are special instructions or guidelines for the preparation of resource center (P40 and P51) applications, prospective applicants are urged to consult with the Comparative Medicine Staff listed under INQUIRIES below. INQUIRIES For further information regarding this notice or to request special guidelines or instructions for NCRR Comparative Medicine resource center activities, contact: Dr. Leo A. Whitehair Director, Comparative Medicine National Center for Research Resources One Rockledge Centre, Suite 6030 6705 Rockledge Drive, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0744 Email: LeoW@EP.NCRR.NIH.GOV $$N4 END ************************************************************ $$N5 BEGIN ********************************************************** NIDA RESEARCH CENTER GRANT PROGRAM GUIDELINES NIH Guide, Volume 25, Number 12, April 19, 1996 P.T. 04; K.W. 0404009, 1014006 National Institute on Drug Abuse Review Procedures for NIDA Center Grant Applications The purpose of this notice is to inform the research community of the procedures the National Institute on Drug Abuse (NIDA) will follow in the review of center applications. See also NIDA Research Center Grant Program Guidelines, December 1995 and a subsequent amendment published in the NIH Guide, Vol. 25, No. 4, February 16, 1996. Duration of the review cycle: The review of center applications will consist of a three phase process, which will take two rounds of review to complete. Initially, an application will be reviewed by a center committee primarily for "centerness". This assessment will include considerations such as scientific significance, thematic integration, synergy of approach, extent of unique contributions, quality of leadership and other factors cited in the above mentioned guidelines. If the application does not meet the criteria for "centerness", the review will be concluded and the application will not be recommended for further consideration. If the application meets the "centerness" criteria, it will be further evaluated for its scientific merit by a group of appropriate substantive experts. The results of the scientific evaluation will be submitted to the center committee at their next regularly scheduled meeting. A final priority score, if appropriate, will be assigned by the center committee. Schedule for June 1 Applications: For applications submitted for the June 1, 1996 receipt date, the "centerness" review will be scheduled during the months of October or November. The scientific merit review will be completed at the February/March 1997 meeting of the center committee. Applications that are scored at this meeting will be presented to the May meeting of the NIDA Advisory Council. Schedule for October 1 Applications: For applications submitted for the October 1, 1996 receipt date, the "centerness" review will occur during the months of February or March 1997 followed by an evaluation of the scientific merit for successful applications and a subsequent final review by the center committee in June or July 1997. The scored applications will be presented to the September 1997 meeting of the NIDA Advisory Council. P20 and P30 Applications: For P20 and P30 applications, the process may be abbreviated depending upon the results of the initial review by the center committee. It is conceivable that an additional evaluation of scientific merit or a site visit by a separate panel of experts may not be necessary for some applications of limited scope and the center committee may be able to take final action within one round of review. Concurrent Submission of Center Components as R01 Applications: If components of a center application are concurrently submitted for review or submitted at another time such that the center application is either pending review or awaiting a funding decision, no final action will be taken on any scored component R01s until a final decision is made about the center application. INQUIRIES Office of Extramural Programs Research National Institute on Drug Abuse Parklawn Building, Room 10-42 Rockville, MD 20857 Telephone: (301) 443-2755 Email: jp862@nih.gov $$N5 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN SS-NICHD-96-01 ******************************************* CONTRACEPTIVE EFFICACY TESTING NIH GUIDE, Volume 25, Number 12, April 19, 1996 SOURCES SOUGHT: SS-NICHD-96-01 P.T. 34; K.W. 0750020, 0750005 National Institute of Child Health and Human Development The Contraceptive Development Branch of the Center for Population Research, National Institute of Child Health and Human Development (NICHD), is establishing a Contraceptive Clinical Trials Network to evaluate new devices and drugs and is planning to initiate contraceptive efficacy testing of synthetic, new material, condoms in August 1996. Interested companies with condoms appropriate for this testing must submit documentation that supports that they have the capability to produce 3000 synthetic, new material condoms under Good Manufacturing Practices and are planning to market these condoms. Additionally, documentation must support that these synthetic, new material condoms: (1) currently have a cleared FDA premarket notification or (2) have undergone sufficient in vitro and clinical testing to have an FDA investigational device exemption (21CFR part 812) for contraceptive efficacy testing. An original and four copies of the requested documentation must be submitted, by May 10, 1996, to: Paul J. Duska Contracts Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Suite 7A07 Bethesda, MD 20892 $$R1 END ************************************************************ $$R2 BEGIN NIH-NINDS-96-06 ****************************************** PRODUCTION AND BIOSAFETY TESTING OF A RETROVIRAL VECTOR SUPERNATANT FOR GENE THERAPY OF FABRY DISEASE NIH GUIDE, Volume 25, Number 12, April 19, 1996 RFP AVAILABLE: NIH-NINDS-96-06 P.T. 34; K.W. 0780005, 0715138 National Institute of Neurological Disorders and Stroke The National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH),will solicit proposals for the production of 30 liters (10 liters each year) of high-titer retroviral supernatant solutions under GMP conditions, biosafety testing, and delivery for the transduction of stem and progenitor cells for patients with Fabry disease. Offerors are required to have a facility that has been inspected by the FDA and is in compliance with established current Good Manufacturing Practices (GMP) and current Good Laboratory Practices (GLP). Offerors must have personnel on staff with established experience in the production of retroviruses under GMP conditions. It is anticipated that one contract will be awarded for a maximum period of three years. Payment will be on a cost-reimbursement type basis. INQUIRIES This is not a Request for Proposals. Request for Proposals (RFP) No. NIH-NINDS-96-06 was issued on April 15, 1996 with responses due approximately forty-five days thereafter. All responsible sources may submit a proposal that will be considered by the Government. Requests for the RFP must cite the RFP number and include two self-addressed mailing labels. Written or FAX requests may be submitted to: Raina Cervantes Contracts Management Branch National Institute of Neurological Disorders and Stroke 7550 Wisconsin Avenue, Room 901 - MSC 9190 Bethesda, MD 20892-9190 FAX: (301) 402-4225 ATTN: RFP NIH-NINDS-96-06 $$R2 END ************************************************************ $$R3 BEGIN DA-96-005 FULL-TEXT ************************************** BEHAVIORAL SCIENCE TRACK AWARDS FOR RAPID TRANSITION NIH GUIDE, Volume 25, Number 12, April 19, 1996 RFA AVAILABLE: DA-96-005 P.T. 34; K.W. 0404009, 0404000, 0404001 National Institute on Drug Abuse Letter of Intent Receipt Date: May 17, 1996 Application Receipt Date: June 18, 1996 PURPOSE The purpose of this RFA is to underscore NIDA's commitment and interest in expanding the scope of basic behavioral sciences research in drug abuse. NIDA supports both animal and human basic research to elucidate underlying behavioral mechanisms, determinants and correlates of drug abuse (both licit and illicit), and to characterize the harmful sequelae of drug abuse and addiction. NIDA invites newly independent investigators to submit applications for small-scale, exploratory (i.e., pilot) research projects related to NIDA's basic behavioral sciences mission. The Behavioral Science Track Award for Rapid Transition (B/START) will provide rapid review and funding decisions of applications. Basic science (mostly laboratory) applications are encouraged in cognitive and perceptual processes, social processes and motivational factors in drug abuse. Given the role that drug abuse plays in HIV/AIDS transmission, studies applying basic behavioral science models and methods to address this issue are especially encouraged. It is anticipated that up to $400,000 for FY 1996 will be available to support up to eight small grant (R03) projects submitted under this RFA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Behavioral Science Track Awards for Rapid Transition, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The 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. Jaylan S. Turkkan, Ph.D. Division of Basic Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-20 Rockville, MD 20857 Telephone: (301) 443-1263 Email: jaylan@nih.gov $$R3 END ************************************************************ $$R4 BEGIN LM-96-002 FULL-TEXT ************************************** MEDICAL INFORMATICS RESEARCH TRAINING PROGRAMS NIH GUIDE, Volume 25, Number 12, April 19, 1996 RFA AVAILABLE: LM-96-002 P.T. 44; K.W. 0710078 National Library of Medicine Letter of Intent Receipt Date: June 3, 1996 Application Receipt Date: June 19, 1996 PURPOSE The National Library of Medicine invites continuing education training (T15) grant applications in a single competition for support of predoctoral and postdoctoral training programs in medical informatics research. Applications may be for the creation of new training centers or for the renewal of existing NLM-supported training programs. Approximately $4,000,000 is expected to be available to award up to ten training grants. Acceptable applications must clearly indicate that the primary intent of the program preparation is for a career in medical informatics research. It is expected that the core of training will emphasize the synthesis, organization, retrieval, and effective management of knowledge. The curricula should be interdisciplinary. Trainees must be citizens or non-citizen nationals of the United States or have been lawfully admitted for permanent residence at the time of appointment. Individuals on temporary or student visas are not eligible. INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Roger W. Dahlen, Ph.D. Biomedical Information Support Branch National Library of Medicine Building 38A, Room 5S522 Bethesda, MD 20894 Telephone: (301) 496-4221 Email: dahlen@lhc.nlm.nih.gov $$R4 END ************************************************************ $$R5 BEGIN DA-97-001 FULL-TEXT ************************************** CRAVING IN DRUG ABUSE AND ADDICTION NIH GUIDE, Volume 25, Number 12, April 19, 1996 RFA AVAILABLE: DA-97-001 P.T. 34; K.W. 0404001, 0404009 National Institute on Drug Abuse Letter of Intent Receipt Date: June 24, 1996 Application Receipt Date: July 24, 1996 PURPOSE The National Institute on Drug Abuse (NIDA) is seeking research applications to study the nature, determinants and consequences of drug craving as well as potential interventions on drug craving. The objective of this RFA is to encourage the investigation of craving to further our understanding of and treatment for drug abuse and addiction. This RFA will us the research project grant (R01), First Independent Research Support and Transition (FIRST) (R29) award, exploratory/developmental grant (R21), and small grant (R03). It is anticipated that up to $2 million in FY 1997 will be available to support approximately six to seven new awards under this RFA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Craving In Drug Abuse and Addiction, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The 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. Jaylan S. Turkkan (basic research) or Dr. Jack Blaine (treatment research) National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-12 Rockville, MD 20857 Telephone: (301) 443-1263 or (301) 443-0107 Email: jaylan@nih.gov or jblaine@aoada.ssw.dhhs.gov $$R5 END ************************************************************ $$R6 BEGIN CA-96-012 FULL-TEXT ************************************** MULTI-INSTITUTIONAL COOPERATIVE AGREEMENTS FOR CLINICAL EVALUATION OF MAGNETIC RESONANCE IMAGING IN BREAST CANCER NIH GUIDE, Volume 25, Number 12, April 19, 1996 RFA AVAILABLE: CA-96-012 P.T. 34; K.W. 0715036, 0706030, 0735015 National Cancer Institute Letter of Intent Receipt Date: May 15, 1996 Application Receipt Date: July 30, 1996 PURPOSE The Radiation Research Program (RRP) of the Division of Cancer Treatment , Diagnosis and Centers (DCTDC) of the National Cancer Institute (NCI), invites applications for a cooperative agreement (U01) to study the role of Magnetic Resonance Imaging (MRI) in improved detection and staging of breast cancer. The NCI is seeking scientists from academic, non profit and for-profit research organizations who will interact with other members of a Cooperative Consortium (called a Consortium throughout this RFA), and with RRP in a concerted way to evaluate and optimize new approaches to breast cancer diagnosis. One Consortium, consisting of multiple institutions and called "Multi-Institutional Cooperative Agreements for Clinical Evaluation of MRI in Breast Cancer", will be funded by the NCI. The purpose of this RFA is to facilitate the clinical evaluation of sensitivity, specificity and local staging accuracy of breast MRI (BMRI) compared to conventional radiologic approaches in about 3,000 women with abnormal x-ray mammograms and/or abnormal physical examination (e.g. palpable mass). The MRI data in detection and staging of breast cancer may be compared to that of ultrasound (US) and other imaging modalities. Histopathologic correlation of and/or follow up imaging studies will be required for all patients. A sufficient number of patients must be available in each participating institution for successful completion of the proposed clinical trial. Each participating institution must have experience with clinical studies in BMRI (at least 100 previous examinations) and must demonstrate the plan for histopathologic evaluation and/or follow up of MRI-detected lesions. It is anticipated that the two awards will be made at approximately $1,500,000 total costs per year for four years. 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), "Multi-Institutional Consortium For Clinical Evaluation of Magnetic Resonance Imaging In Breast Cancer", is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Dr. Carl Mansfield Division of Cancer Treatment, Diagnosis, and Centers National Cancer Institute 6130 Executive Boulevard, Suite 800 - MSC 7440 Bethesda, MD 20892-7440 Telephone: (301) 496-6111 FAX: (301) 480-5785 Email: mansfieldc@dtpepn.nci.nih.gov $$R6 END ************************************************************ $$R7 BEGIN HG-96-001 FULL-TEXT ************************************** LARGE SCALE FUNCTIONAL ANALYSIS OF THE YEAST GENOME NIH GUIDE, Volume 25, Number 12, April 19, 1996 RFA AVAILABLE: HG-96-001 P.T. 34; K.W. 1002058, 0755045 National Center for Human Genome Research National Cancer Institute Letter of Intent Receipt Date: August 9, 1996 Application Receipt Date: September 6, 1996 THIS REQUEST FOR APPLICATIONS (RFA) USES THE "JUST-IN-TIME" CONCEPT. THE FULL RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS AND MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The availability of this Request for Applications (RFA) is being announced. The DNA sequence of the Saccharomyces cerevisiae genome will be completed in the very near future. The availability of the entire yeast DNA sequence will provide experimental and computational biologists with an incomparable resource for systematic and comprehensive analyses of the genetic basis of biological function including, for example, analyses of gene function, the regulation of gene expression, the interactions between functional and structural elements, and the biological consequences of genomic organization. This RFA calls for research projects that will enrich the yeast sequence with biological information in rapid and comprehensive, and efficient ways and/or take advantage of the complete DNA sequence of S. cerevisiae in new, global approaches to the study of biological phenomena important for human health and disease, including cancer. These studies should be based on technologies that are efficient, cost-effective and scalable to the entire yeast genome, and that use and/or add value to the complete DNA sequence. Applications to develop new technologies that could be applied to the yeast genome in a timely manner will also be considered. It is anticipated that these studies will provide functional information, resources and infrastructure that will serve as a platform for more in-depth, specific studies in the future. It is anticipated that approximately $ 2.5 million (total costs) will be available for this initiative in fiscal year 1997. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Large-Scale Functional Analysis of the Yeast Genome, is related to several priority areas, including cancer, heart disease and stroke, diabetes and chronic disability conditions, maternal and infant health, and others. 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. Elise Feingold, Ph.D. Mapping Technology Branch National Center for Human Genome Research 38 Library Drive, Room 614 - MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: elise_feingold@nih.gov Cheryl Marks, Ph.D. Division of Cancer Biology National Cancer Institute Executive Plaza North, Room 505 Bethesda, MD 20892-7385 Telephone: (301) 496-7028 FAX: (301) 402-1037 Email: cheryl_marks@nih.gov $$R7 END ************************************************************ $$R8 BEGIN AG-96-003 FULL-TEXT ************************************** CLAUDE D. PEPPER OLDER AMERICANS INDEPENDENCE CENTERS NIH GUIDE, Volume 25, Number 12, April 19, 1996 RFA AVAILABLE: AG-96-003 P.T. 04; K.W. 0710010, 0785035, 0745027, 0745070 National Institute on Aging Letter of Intent Receipt Date: July 10, 1996 Application Receipt Date: September 18, 1996 PURPOSE The National Institute on Aging (NIA) invites applications for support of Claude D. Pepper Older Americans Independence Centers (OAICs). The purpose of these centers is to increase independence in older Americans. OAICs will provide support for research to develop and test clinical interventions, and core laboratories in the basic sciences. OAICs will also train individuals in research approaches to develop and test methods of maintaining and increasing independence, and enhance expertise in aging research through the provision of training in the relevant fundamental scientific disciplines. They will conduct demonstration projects and information dissemination concerning the applications of such research. Centers should promote linkages between mechanistic and outcome research and thereby foster the capacity of new investigators to develop better clinical treatments and preventive approaches. It is recognized that the balance between support devoted to intervention studies and fundamental science will differ among Centers to take advantage of areas of strength in geriatric and gerontologic research available at different institutions. In those instances where applications request significant core resources to enhance ongoing projects, the number and quality of externally funded peer-reviewed studies will be of special importance. Older Americans Independence Centers will be supported through the comprehensive center grant (P60) mechanism. First year budgets may not exceed $1.6 million (direct plus indirect costs). Budget increments for subsequent years generally will be limited to no more than one percent. Awards are made initially for no less than five years and may be renewed competitively for five-year periods. Although it is anticipated that up to $3.2 million will be directed to the support of competing OAICs in Fiscal Year 1997 and $1.6 million in Fiscal Year 1998, and that two awards will be made in Fiscal Year 1997 and one award in Fiscal Year 1998 from the applications received in response to this RFA, issuance of an Older Americans Independence Center award is contingent upon the receipt of scientifically meritorious applications and allocation of appropriated funds for this purpose. 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, Claude D. Pepper Older Americans Independence Centers, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Stanley L. Slater, M.D. Geriatrics Program National Institute on Aging Gateway Building, Room 3E-327 Bethesda, MD 20892 Telephone: (301) 496-6761 FAX: (301) 402-1784 Email: SlaterS@GW.NIA.NIH.GOV $$R8 END ************************************************************ $$R9 BEGIN AA-96-003 FULL-TEXT ************************************** ALCOHOL RESEARCH CENTER GRANTS NIH GUIDE, Volume 25, Number 12, April 19, 1996 RFA AVAILABLE: AA-96-003 P.T. 34; K.W. 0404003, 0710030, 0745020, 0745027, 0745070, 0730050 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: November 1, 1996 Application Receipt Date: December 11, 1996 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) provides grant support for Alcohol Research Centers to conduct interdisciplinary research on alcoholism and alcohol abuse. The specialized center (P50) grants program is interrelated with and complementary to all other research support mechanisms and scientific activities that comprise the NIAAA programs of research on the nature, causes, and consequences of alcohol abuse and alcoholism, including diagnosis, treatment, prevention, and health services research related to prevention and treatment of alcoholism. The NIAAA currently supports 14 Centers and anticipates that the level of support for this program will not expand during this competition. Support for seven of the current five-year Center grant awards will expire in late 1997. Research within each of these seven Centers is organized around a central theme: genetic determinants of alcohol ingestion, neurobiology of alcohol in central nervous system effects, genetic approaches to alcohol neuropharmacology, alcohol effects on the cell, alcohol and pregnancy outcome, environmental factors in alcohol problem prevention and etiology in treatment of alcohol dependence. Applications for new Centers in these and other research areas will be accepted with applications from currently funded Centers seeking renewal support. 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, Alcohol Research Center Grants, is related to the priority area of alcohol abuse and alcoholism reduction. 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. Ernestine Vanderveen, Ph.D. Centers Program National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 - MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1273 FAX: (301) 594-0673 Email: tvander@willco.niaaa.nih.gov $$R9 END ************************************************************ $$R10 BEGIN TW-96-001 FULL-TEXT ************************************* INTERNATIONAL TRAINING AND RESEARCH IN EMERGING INFECTIOUS DISEASES NIH GUIDE, Volume 25, Number 12, April 19, 1996 RFA AVAILABLE: TW-96-001 P.T. 34; K.W. 0715125, 0720005, 0404000 Fogarty International Center National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: September 15, 1996 Application Receipt Date: January 15, 1997 PURPOSE A comprehensive strategy to address global emerging and re-emerging infectious diseases (ERID) should include international training and biomedical and behavioral research. This strategy will strengthen the capacity of scientists to understand and respond to outbreaks of infectious diseases more effectively. This Request for Applications (RFA) will use the international training grants in epidemiology (D43). It is anticipate that approximately $500,000 will be available to fund three to four awards. The definition of ERID is "new, re-emerging or drug-resistant infections whose incidence in humans has increased within the past two decades or whose incidence threatens to increase in the near future" (Institute of Medicine, 1992). The objectives of the International Training and Research in Emerging Infectious Diseases (ITREID) Program are to: (1) Train laboratory scientists, clinicians, epidemiologists, social scientists, and public health workers in developing countries and the United States in emerging and re-emerging infectious disease research, control and prevention strategies and their implementation and evaluation; this will increase global infrastructure and capacity for dealing with ERID; (2) Assist scientists from developing countries to contribute to global emerging infectious diseases research efforts and advance knowledge in support of national and international ERID policies; (3) Encourage and facilitate international collaboration on ERID research, including the conduct of advanced in-country research; and (4) As a result of the above, enhance domestic infectious diseases research programs and improve the protection of the United States population from ERID by early detection and response to epidemics internationally and nationally. 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, International Training and Research in Emerging Infectious Diseases, is related to the priority area of emerging diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The 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. Joel Breman Division of International Training and Research Fogarty International Center 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-2056 Email: jbreman@nih.gov $$R10 END *********************************************************** $$R11 BEGIN AR-96-002 FULL-TEXT ************************************* SPECIALIZED CENTERS OF RESEARCH IN OSTEOPOROSIS, RHEUMATOID ARTHRITIS, AND SCLERODERMA NIH GUIDE, Volume 25, Number 12, April 19, 1996 RFA AVAILABLE: AR-96-002 P.T. 34; K.W. 0715031, 0705050, 0715010, 0715185, 0715170 National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: November 1, 1996 Application Receipt Date: February 12, 1997 PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invites applications for Specialized Centers of Research (SCORs) (P50) in the following disease areas: osteoporosis, rheumatoid arthritis, and scleroderma. A SCOR should foster a coordinated research effort that strongly emphasizes basic disciplines, but also involves significant interaction between basic research and clinical investigations. A SCOR is envisioned as a national resource associated with one or more major medical complexes and dedicated to working with the NIAMS in furthering the research effort to translate basic research to clinical application. The NIAMS intends to fund up to nine SCORs in FY 1997 and 1998 in the scientific area covered by this Request for Applications (RFA). Funding is subject to the availability of resources and receipt of sufficiently meritorious applications. Nine competing continuation applications are anticipated in response to these RFAs. The anticipated awards are for four years and are subject to the availability of appropriated funds. The estimated funds (total costs) available for the first year of support of these centers are $10 million per year. The direct costs requested cannot exceed $750,000 (excluding indirect costs of subcontracts) each year. 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, SCORs in Osteoporosis, Rheumatoid Arthritis, and Scleroderma, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nigh.gov), and the NIH Website (http:/www.nih.gov), and by mail and email from the program contact listed below. Dr. Julia B. Freeman Centers Program, EP National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS.19F - MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-5052 Email: freemanj@ep.niams.nih.gov Copies of the guidelines for the SCOR program may be obtained from: NIAMS Clearinghouse 1 AMS Circle Bethesda, MD 20892-3675 Telephone: (301) 495-4484 FAX: (301) 587-4352 $$R11 END *********************************************************** $$P1 BEGIN PA-96-034 FULL-TEXT ************************************** AGING WOMEN AND BREAST CANCER NIH GUIDE, Volume 25, Number 12, April 19, 1996 PA AVAILABLE: PA-96-034 P.T. 34, II; 0710010, 0715036, 0785055, 0404000, 0785035 National Institute on Aging National Cancer Institute National Institute of Nursing Research National Institute of Mental Health PURPOSE The National Institute on Aging (NIA), the National Cancer Institute (NCI), the National Institute of Nursing Research (NINR), and the National Institute of Mental Health (NIMH) invite research project grant (R01) and First Independent Research Support and Transition (FIRST) (R29) award applications that focus on the unique problems of older women with breast cancer. Breast cancer affecting elderly women is a major health problem for cancer control. The purpose of this broad-based program announcement (PA) is to inform the scientific community of the interests of NIA, NCI, NINR, and NIMH, and to expand the knowledge base on breast cancer in older women through studies in the fields of biology, clinical medicine, epidemiology, and the behavioral and social sciences. 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, Aging Women and Breast Cancer, is related to the priority areas of age-related objectives for older adults and cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The 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. Rosemary Yancik, Ph.D. Geriatrics Program National Institute on Aging Building 31, Room 5C05 Bethesda, MD 20892 Telephone: (301) 496-5278 FAX: (301) 496-2793 Email: YancikR@31.nia.nih.gov Claudette G. Varicchio, DSN, RN, OCN, FAAN Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Suite 300 Bethesda, MD 20892 Telephone: (301) 496-8541 FAX: (301) 496-8667 Email: Varricci@dopcepn.nci.nih.gov June R. Lunney, Ph.D., R.N. Scientific Program Administrator 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 Enid Light, Ph.D. Mental Disorders of the Aging Research Branch National Institute of Mental Health Parklawn Building, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-1185 FAX: (301) 594-6784 Email: ELight@nih.gov $$P1 END ************************************************************ $$P2 BEGIN PAR-96-039 FULL-TEXT ************************************* NCRR MINORITY INITIATIVE: K-12 TEACHERS AND HIGH SCHOOL STUDENTS NIH GUIDE, Volume 25, Number 12, April 19, 1996 PA AVAILABLE: PAR-96-039 P.T. 34, FF; K.W. 0720005, 0710030, 0404000 National Center for Research Resources Application Receipt Dates: June 17, 1996; thereafter, February 1, and June 1 annually PURPOSE As part of its continuing commitment to strengthen the quality of precollege health science education, the National Center for Research Resources (NCRR) announces the availability of a program announcement (PA) aimed at increasing the pool of underrepresented minority high school students who are interested in pursuing, and academically prepared to pursue, careers in biomedical and/or behavioral research and the health professions. The program includes both K-12 inservice and preservice teachers and underrepresented minority high school students. The "NCRR Minority Initiative: K-12 Teachers and High School Students" replaces the S03 "Minority High School Student Research Apprentice Program" (MHSSRAP), which made its last awards in 1995. Awards under this PA will use the education project (R25) grant mechanism. 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, NCRR Minority Initiative: K-12 Teachers and High School Students, is related to many of the areas discussed in this publication. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221), the NIH GOPHER (gopher.nih.gov,) the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Mr. Martin B. Blumsack Research Infrastructure Area National Center for Research Resources One Rockledge Centre, Suite 6030 6705 Rockledge Drive - MSC 7965 Bethesda, MD 20892-7965 Telephone: (301)435-1303 Email: ncrr_k12@nih.gov $$P2 END ************************************************************ $$P3 BEGIN PA-96-040 FULL-TEXT ************************************** EXPLORATORY GRANTS FOR CORRELATIVE LABORATORY STUDIES AND CLINICAL TRIALS NIH GUIDE, Volume 25, Number 12, April 19, 1996 PA AVAILABLE: PA-96-040 P.T. 34; K.W. 0715035, 0755015, 0745070 National Cancer Institute PURPOSE The Division of Cancer Treatment Diagnosis and Centers (DCTDC) of the National Cancer Institute (NCI) invites research grant applications >From interested investigators to conduct innovative therapeutic clinical trials or new correlative laboratory studies using patient specimens from therapeutic clinical studies. The exploratory/ developmental (R21) grant mechanism is utilized for pilot projects or feasibility studies to support creative, novel, high risk/high payoff research that may produce innovative advances in science. The objective of this Program Announcement (PA) is to encourage applications from individuals who are interested in testing novel or conceptually creative ideas that are scientifically sound and may advance progress in human health. This PA supersedes PA-94-050, Exploratory Grants to Stimulate Correlative Laboratory Studies and Innovative Clinical Trials, which was published in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. The exploratory grant program provides limited funds (maximum of $100,000 direct costs per year not including indirect costs of any collaborating institutions) for short-term (up to two years) research projects. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Exploratory Grants for Correlative Laboratory Studies and Clinical Trials, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or 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. Ms. Diane Bronzert or Dr. Roy S. Wu Division of Cancer Treatment Diagnosis and Centers National Cancer Institute 6130 Executive Boulevard, Room 734 - MSC 7432 Bethesda, MD 20892-7432 Telephone: (301) 496-8866 FAX: (301) 480-4663 Email: BRONZERD@DCT.NCI.NIH.GOV or WUR@DCT.NCI.NIH.GOV $$P3 END ************************************************************ $$P4 BEGIN PAR-96-041 FULL-TEXT ************************************* MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD IN AGING NIH GUIDE, Volume 25, Number 12, April 19, 1996 PA AVAILABLE: PAR-96-041 P.T. 34; K.W. 0710030, 0710010 National Institute on Aging PURPOSE The Mentored Research Scientist Development Award in Aging (MRSDAA) (K01) is for: (1) Research scientists who have established careers in biomedical, behavioral or social research and wish to change career direction towards aging research; (2) more junior researchers with training in aging research who need an additional period of mentored research experience prior to becoming fully independent; or (3) researchers with training and experience in some aspect of aging research who wish to gain complementary training to expand their research interests in aging. This program announcement identifies the areas of research that the National Institute on Aging (NIA) will support under this mechanism and further specifies, for investigators interested in aging research, the NIH program announcement PA-95-049 Mentored Research Scientist Development Award (NIH Guide, Vol. 24, No. 15, April 28, 1995) From owner-sci-resources@net.bio.net Wed Apr 24 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-034 - V25(12) 04/19/96 Date: 24 Apr 1996 17:47:53 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 545 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4lmi3p$2ar@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA96034 PA-96-034 P1O1 *************************************** AGING WOMEN AND BREAST CANCER NIH GUIDE, Volume 25, Number 12, April 19, 1996 PA NUMBER: PA-96-034 P.T. 34; K.W. 0710010, 0715036, 0785055, 0404000, 0785035 National Institute on Aging National Cancer Institute National Institute of Nursing Research National Institute of Mental Health PURPOSE The National Institute on Aging (NIA), the National Cancer Institute (NCI), the National Institute of Nursing Research (NINR), and the National Institute of Mental Health (NIMH) invite research applications to focus on the unique problems of older women with breast cancer. Breast cancer affecting elderly women is a major health problem. The purpose of this broad-based program announcement is to expand the knowledge base on breast cancer in older women through studies in the fields of biology, clinical medicine, epidemiology, and the behavioral and social sciences. 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, Aging Women and Breast Cancer, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for the research program project or First Independent Research Support and Transition (FIRST) awards (R29). Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The mechanisms of support will be the investigator-initiated research project grant (R01) and FIRST award (R29). RESEARCH OBJECTIVES Background Of the 182,000 breast cancer patients diagnosed in 1994, 91,000 were women 65 years or older (American Cancer Society, 1994). As national incidence and mortality data show, aging is an important risk factor for breast cancer. Age- adjusted rates reported by the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program reveal that women 65 years or older have an incidence rate of 444.7 per 100,000 population as compared to 72.8 per 100,000 for women under 65 years of age. The peak breast cancer incidence rate of 483.9 per 100,000 is in the age group 75-79 years. The breast cancer mortality rate for women under 65 years of age is 16.6 per 100,000 as compared to the rate for women 65 years and older which is 125.8 per 100,000. The peak mortality rate is 191.0 per 100,000 for women 85 years and older (SEER, 1994). This population-based epidemiologic evidence demonstrates the disproportionate number of older-aged women afflicted with breast cancer. Yet, there is insufficient information on biological mechanisms affecting the onset and progression of cancer in older women, recommended treatment, response of older women to cancer risks and symptoms, individual and family coping with breast cancer, and survival outcome (including quality of life). The dearth of data on these issues makes it difficult to provide answers to the many questions that arise about breast cancer in older women. The problems of breast cancer and its association with advanced age have not been adequately addressed. Breast cancer prevention, early detection, and management in older women may be complicated by the presence of other diseases, age-associated problems, and risk factors. No comprehensive guidelines for prevention, diagnosis, pretreatment evaluation, or treatment have been formulated which take into account the multiple health problems and recurrent medical, economic, and social needs of women age 65 and older who survive breast cancer or are newly diagnosed with the disease. Although older women are less likely to engage in cancer prevention practices such as mammography screening, little research has promoted the development of strategies to improve either patient or physician behavior to encourage communication about cancer prevention. Sufficient data on the treatment of elderly women with breast cancer are not available from clinical trials. With the changing age and ethnic profiles in the United States which project an expansion of the aged female population in coming decades, there is an even greater need to address the problems of breast cancer control for older women. The targeted areas of research relevant to this multidisciplinary solicitation are identified below. Biology --- Age-related factors in carcinogenesis. Applicants are encouraged to focus on biological factors that contribute to the increased incidence of breast cancer in older women and/or affect treatment outcome. The following examples are illustrative, but not exclusive: o The control of repair and cell death "programs," and how that relates to cell senescence, aging and cancer (e.g., research on BPH, caloric restriction, lymphocyte selection, cell loss); o Any age-related biological factors that affect the initiation, promotion, or treatment of cancer, including protein or gene therapy (e.g., research on control of telomerase expression, oxidative damage, mitochondrial function); o Age-related differences in invasion and metastases of breast cancer in older women; o Cell senescence in breast tissue, and age-related changes in gene expression affecting predisposition to cell immortalization; o Age-related differences in drug sensitivity and metabolism; o Age-related changes in sensitivity to systemic and local hormones, growth factors, and cytokines on breast cell proliferation and carcinogenesis; o Age-related changes in secretion of hormones, growth factors, and cytokines by breast tissue which act in a paracrine manner to alter the secretion of growth-promoting factors from nearby adipose and stromal tissues. Of major interest to the NIMH are: o Age-related differences in stress, pain, and mood which contribute to the functional impairment of neuroendocrine, neuroimmunology, and neurotransmitter systems. Clinical Medicine --- The full range of prevention and treatment issues that involve screening, early detection, diagnosis, perioperative and/or postoperative management, adverse physical influences on surgical outcome, and influence of age on physician/surgeon treatment decisions for operative risk. Research questions centering on these processes may be addressed individually or combined. While related issues designated by the applicant will be considered, the following topics are of major interest to the NIA, NCI, and NINR: o Testing new interventions or treatment strategies, in older women especially, in the presence of patients' comorbid conditions to reduce age-associated complications or lessen age-associated reduction in treatment efficacy (as measured by treatment outcomes such as quality of life, functional status, and/or survival experience); o Age-associated and ethnicity-associated differences in breast cancer treatment efficacy and effectiveness for such outcomes as survival rates, treatment complications, side effects of treatment, and functional status; o Factors responsible for differences in treatment received (e.g, stage at diagnosis, presence of comorbid conditions, age selection bias by physicians) and the effects of interactions among such factors; o Special features of aging and/or symptoms of illness in old age that influence the treatment and care of older-aged breast cancer patients and relate to treatment differences or modifications made because of old age; o Assessment of the effectiveness of different treatments relative to the stage of disease and characteristics of old age (e.g., poor repair mechanisms, functional loss, greater susceptibility to toxicity of treatment); o Evaluation of tolerance and response to standard or experimental adjuvant chemotherapy regimens or multimodality breast cancer treatment interventions, controlling for physiologic parameters and other factors; o Effects of age-associated, cultural, and life-style changes on sensitivity, specificity, prognostic value, and predictive value for treatment responsiveness, of breast cancer screening and diagnostic techniques (e.g., mammography, MRI, gross and histopathologic breast and lymph node biopsy measures, receptor assays). Testing new methods and technologies to reduce age-associated problems in diagnosis and prognosis; o Barriers to recruitment of older women to breast cancer clinical trials (e.g., comorbid conditions, physical frailty, lack of transportation). The NIMH encourages: o Studies designed to examine the impact of mental health interventions on the treatment outcomes and treatment costs for comorbid breast cancer in older women, with a focus on special populations (e.g., oldest-old, nursing home populations, minorities, older women diagnosed with genetic markers); o Exploration of the interaction of aging, the pharmacodynamics and pharmacokinetics of medications (e.g., anti-estrogen therapeutics and other types of chemotherapy) used to treat breast cancer, on mood and other measures of mental status in older women. Epidemiology --- Studies in the context of aging and/or old age that (1) investigate risk factors in cancer etiology, (2) evaluate methods of prevention, (3) elucidate the pattern of breast cancer as an illness for patients, and (4) improve clinical effectiveness of the diagnostic and management processes for older-aged women breast cancer patients. Studies may focus on the etiology of breast cancer in combination with data from other disciplines such as genetics and molecular epidemiology, or on issues in epidemiology and clinical practice that represent pressing clinical problems. o Relationships and interactions of aging and age to breast cancer risk (e.g., relative prominence of various physiologic and etiologic risk factors at different ages, factors affecting risk and age of onset of breast cancer in high-risk individuals); o Improved methods to identify high risk older women through development of new techniques to distinguish premalignant changes >From nonmalignant age-associated changes in breast tissue; o Development of epidemiologic approaches addressing the possible role of related changes such as hormonal status, both endogenous and exogenous (exercise, education, nutrition, and immune function) as risk factors for breast cancer in women; o Prospective studies on the early detection, diagnosis, and treatment of aged breast cancer patients; o Analyses of existing databases applicable and relevant to addressing treatment of older women breast cancer patients. Emphasis on older ethnic populations is encouraged; o Effects of previous and/or concurrent illnesses on breast cancer treatment recommendations; o Occurrence of second breast cancer primaries: synchronous (two or more cancers present at the same time) and/or metachronous (first cancer followed by a second tumor at a later date); o Validation of new methodologies to identify high-risk older women; o Molecular epidemiology and epidemiologic studies of age- related biological factors that affect the onset, progression, metastatic behavior, and mortality outcome of breast cancer in older women; Behavioral and Social Sciences --- Special concerns include health behaviors and beliefs about aging and breast cancer, interactions between health professionals and older people, effects of breast cancer on psychosocial and physical functioning, sociodemographic factors related to breast cancer prevention in older women, long-term care for older women with breast cancer, and the complex interactions among aging, breast cancer and psychosocial disease, and gender influences. Research is also needed on older people's attitudes toward breast cancer and aging; age differences in current cancer- related behaviors (e.g., willingness to obtain or prescribe a mammogram); strategies for encouraging doctor-patient interactions and treatment decisions; and the effects of living with cancer in later life. Researchers are invited to make age comparisons and to look at aging processes across the life course. Specific behavioral and social research issues of interest are listed. Related issues will be considered. o How age (e.g., aging processes or age-related attitudes or behaviors) affects the diagnosis, treatment and care of persons with breast cancer; o How age interacts with race, ethnicity, and socioeconomic status (SES) to affect attitudes and behavior and consequent diagnosis, treatment, and care; o Strategies for promoting behavioral change by older women and their health care providers to increase preventive health behaviors, and how to implement such changes on community-wide basis over long periods of time (e.g., institutional and financial incentives as in coverage for mammograms); o Social and behavioral processes and interventions in symptom recognition of breast cancer, as well as interpretation and action for cancer-related symptoms in older women; o Doctor/older patient interactions and their influence on breast cancer-related behaviors. Strategies for improving cancer related communications, adherence to medical and life-style recommendations, and encouraging appropriate health utilization and functional outcomes; o Behavioral and social factors affecting cancer treatment decisions (e.g., joint influence of age, SES, and race/ethnicity as well as patient preferences, payer source, coverage); o Self-management interventions for coping with breast cancer, such as increasing self- efficacy regarding cancer treatment and employing pain management strategies; o Relationship of community and area level factors (e.g. location and availability of preventive diagnosis and treatment services) independent of, or in interaction with, sociodemographic and psychosocial characteristics of older women that affect diagnosis, treatment, self-care, and family caregiving; o Consequences of cancer in older women for household arrangements and the provision of resources by family and social network members; o Strategies to reduce caregiver burden and how caregiving is influenced by age, family and household structure and composition, and the economic and social burdens caregiving imposes. The NIMH invites applications on: o Clarification of the relationships and interactions of aging, biologic and psychosocial factors which contribute to the comorbidity of breast cancer and mental disorders in older women (e.g., late onset depression, early onset depression with recurrent episodes, schizophrenia, etc.) and how these factors contribute to the course, diagnosis and treatment of both illnesses. DEFINITION OF "OLD AGE" OR "ELDERLY" FOR THIS PROGRAM ANNOUNCEMENT This PA focuses in particular on women aged 65 years and older because the highest cancer incidence and mortality rates are found in this age group. Also, women in their mid- seventies and older are generally those most severely affected by breast cancer and are already quite likely to have preexisting chronic conditions. However, the definition of "old age" or "elderly" is flexible and dependent on investigator- defined parameters. Applicants are expected to identify what is meant by "old" in the context of their research. Age comparisons with younger women are appropriate and may be included. 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 may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The title and number of the program announcement must be typed in line 2 on the face page of the application. Applications for the FIRST award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. 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, SUITE 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) Receipt dates for new Research Project Grants and FIRST Awards applications are February 1, June 1, and October 1 of each year. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH (or by the review group of the relevant Institute, Center, or Division), in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria o Scientific, technical, or medical significance and originality of proposed research; o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o Availability of the resources necessary to perform the research; o Appropriateness of the proposed budget and duration in relation to the proposed research; o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that IC. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Rosemary Yancik, Ph.D. Cancer Section, Geriatrics Program National Institute on Aging Building 31, Room 5C05 Bethesda, MD 20892 Telephone: (301) 496-5278 FAX: (301) 496-2793 Email: YancikR@31.nia.nih.gov Claudette G. Varricchio, DSN, RN, OCN, FAAN Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Suite 300 Bethesda, MD 20892 Telephone: (301) 496-8541 FAX: (301) 496-8667 Email: Varricci@dopcepn.nci.nih.gov June R. Lunney, Ph.D., R.N. Scientific Program Administrator 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 Enid Light, Ph.D. Mental Disorders of the Aging Research Branch National Institute of Mental Health Parklawn Building, Room 18-105 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-1185 FAX: (301) 594-6784 Email: ELight@nih.gov Direct inquiries regarding fiscal matters to: Mr. Joseph Ellis Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: EllisJ@gw.nia.nih.gov Robert E. Hawkins, Jr. Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800 Ext. 213 FAX: (301) 496-8601 Email: HawkinsR@gab.nci.nih.gov Mr. Jeff Carow Grants Management Office National Institute of Nursing Research Building 45, Room 3AN-32 Bethesda, MD 20892-6301 Telephone: (301) 594-5974 FAX: (301) 480-8256 Email: JCarow@ep.ninr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866, Aging Research, No. 93.399, Cancer Control Research, No. 93.393, Cancer Cause and Prevention Research, No. 93.396, Cancer Biology Research, No 93.399, Cancer Treatment Research, No. 93.361, Nursing Research, and No. 93.242, Mental Health Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed Apr 24 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-96-041 - V25(12) 04/19/96 Date: 24 Apr 1996 17:49:14 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 740 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <4lmi6a$2i4@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PAR96041 PAR-96-041 P1O1 ************************************* MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD IN AGING NIH GUIDE, Volume 25, Number 12, April 19, 1996 PA NUMBER: PAR-96-041 P.T. 34; K.W. 0710030, 0710010 National Institute on Aging PURPOSE The Mentored Research Scientist Development Award in Aging (MRSDAA) is for: (1) Research scientists who have established careers in biomedical, behavioral or social research and wish to change career direction towards aging research; (2) more junior researchers with training in aging research who need an additional period of mentored research experience prior to becoming fully independent; or (3) researchers with training and experience in some aspect of aging research who wish to gain complementary training to expand their research interests in aging. This program announcement identifies the areas of research that the National Institute on Aging (NIA) will support under this mechanism and further specifies, for investigators interested in aging research, the NIH program announcement PA-95-049 Mentored Research Scientist Development Award (NIH Guide, Volume 24, No. 15, April 28, 1995) The award provides an intensive, supervised career development experience in some aspect of aging research. The proposed experience should be in a research area new to the applicant and/or one in which an additional supervised research experience will demonstrably enhance the candidate's scientific career. For example the award may be used to provide relatively junior candidates expanded or complementary training in their major field of study. Alternatively the award may be used by more senior candidates to introduce them to a new field of research, for example to provide biologists training in the demography of aging (or vice versa), or to provide cardiovascular researchers thorough training in geriatric research. A candidate must justify the need for a three, four, or five year period of mentored research experience and must be able to provide a convincing case that the proposed period of support will substantially enhance his/her career and/or will allow the pursuit of a novel or promising approach to a particular research problem. In general shorter (i.e., three year) awards are more suitable for senior researchers. Candidates who have interrupted their careers because of illness or pressing family care commitments may apply if they can clearly demonstrate the potential for productive independent research and the need for an additional period of mentored research experience in order to accomplish an effective scientific reentry. Similarly, faculty members at institutions with a substantial minority enrollment, who wish to enhance their research skills through a supervised research experience at a research center, may also apply, if they agree to return to, and remain at, their parent institution for at least two years after completing the award. This Mentored Research Scientist Development Award in Aging Research replaces the existing NIA Special Emphasis Research Career Awards (SERCA). Individuals who were eligible to apply for any one of these awards are now eligible to apply for this new award. Therefore, this Program Announcement (PA) supersedes all previous NIA SERCA program announcements. 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, Mentored Research Scientist Development Award in Aging, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS The candidate must have a research or a health-professional doctorate or its equivalent and should have demonstrated the capacity, or have shown the potential, for highly productive independent research after the doctorate prior to applying for this award. The candidate must identify a mentor with extensive research experience, and must be willing to spend a minimum of 75 percent of full-time professional effort conducting research and research career development activities for the period of the award. Applications may be submitted on behalf of candidates by domestic, non-Federal organizations, public or private, such as medical, dental, or nursing schools or other institutions of higher education. Minorities and women and individuals with disabilities are encouraged to apply. Candidates must be U.S. citizens or noncitizen nationals, or must have been lawfully admitted for permanent residence. Individuals on temporary or student visas are not eligible. Candidates may have been principal investigators on PHS research grants and may have been supported by a research career award in the past, provided the proposed research experience is a fundamentally new field of study or there has been a significant hiatus in their research career because of family or other personal obligations. Current principal investigators on PHS research grants are not eligible. MECHANISM OF SUPPORT Awards in response to this PA will use the K01 mechanism. Planning, direction, and execution of the program will be the responsibility of the candidate and her/his mentor on behalf of the applicant institution. The project period may be for three, four, or five years and will depend upon the number of years of prior research experience and the need for additional experiences to achieve independence. Awards are not renewable. PROGRAM OBJECTIVES Research Areas The National Institute on Aging has identified the following research areas as requiring substantial further investment of human resources in order to develop the fields. For that reason NIA is targeting this award to these areas. Individuals interested in pursuing other areas of aging research should contact the staff listed at the end of this announcement. Cardiovascular Aging. The aim is to expand the community of researchers trained in the cardiovascular aging field and focusing on age-related changes (structure/function) of the cardiovascular, pulmonary, hematologic, and renal systems and the importance of these changes to age-related pathologies, pathophysiologies, dysfunctions, and diseases in mature and older persons. Emphasis should be placed on biologically relevant studies in older persons and may also include relevant investigations in animals. Skeletal aging and age-related skeletal disease. The objective is to increase the numbers of qualified researchers interested in human skeletal aging and age-related skeletal disease using interdisciplinary approaches and expertise from the areas of bone biology, bone densitometry, biomechanics, orthopedics, histomorphometry, endocrinology, geriatrics and epidemiology. Emphasis should be placed on biologically relevant studies in middle-aged and older women and men. Research on the causes and effects of menopause. The aim is to increase research expertise in the areas of aging and reproductive endocrinology and physiology and in other systems, areas and disciplines pertinent to the pathophysiology associated with female reproductive aging. Relevant other areas and systems include the skeletal and cardiovascular systems and nutrition. Relevant other disciplines include behavioral science, epidemiology, and clinical, cellular and molecular studies pertinent to menopause-related issues. Topics of interest include: role of the ovary and ovarian hormones across the menopausal transition; pathophysiology and treatment of clinical disturbances and conditions associated with the perimenopausal condition; physiological effects of menopause in various systems; effects of menopause-related endocrine changes on the development of cancer, cardiovascular disease, osteoporosis and other chronic diseases of aging; effects of hormonal and alternative, nonhormonal, therapies on specific age- and menopause-related conditions and pathologies (e.g., hot flashes, sleep disturbance, osteoporosis, Type II diabetes, alterations in body composition, etc.); and social and behavioral aspects of menopause and interrelationships with biomedical processes. A more extensive list of topics has been identified in a paper reporting the recommendations from an NIH workshop on menopause. (Monjan, AA, Bellino FL, Ory, MG, Sherman, S, Weiss, S. Research Recommendations. Experimental Gerontology, 29: 525-528; 1994) and in the program announcement: Biology of the Menopause: Change of Ovarian Function (NIH Guide, PA-95-006, vol. 23, no. 40, November 18, 1994). Growth of the aging prostate. Researchers are encouraged to work with a mentor to gain experience in the molecular and cellular mechanisms involved in the age-dependent increase in prostate growth in older men using appropriate animal models and human prostate cell/tissue specimens. For sample topics applicants should consult the program announcement: Prostate Growth in Older Men: Age-dependent Mechanisms (NIH Guide, PA-93-052, vol. 22, no. 6, February 12, 1993). Nutrition and metabolism. Particular needs to expand human research resources on this topic can be grouped into two major areas: (1) molecular and cellular effects of nutritional and metabolic factors acting over the life span on longevity, health, and diseases of late life; and (2) mechanistic studies of effects of age-related changes on nutritional requirements. Sample topics include: mechanisms responsible for life span extension and retardation of disease by caloric restriction; long term effects of caloric intake, obesity, and inadequate to excess intake of specific macro- and micro-nutrients on longevity and maintenance of health in late life; nutrient modulation of cellular maintenance and repair, cell receptor expression and function, cell-cell signaling, signal transduction pathways, transport mechanisms, and control of proliferation and senescence; contribution of metabolic byproducts such as free radicals or glycosylated proteins to age-related processes and pathologies through their effects on cellular or tissue constituents and functions; age-related changes in nutrient digestion, absorption, and metabolism; and effects of physiologic changes with age on nutritional requirements and intermediary metabolism. Free radical metabolism and aging. Applications are encouraged from investigators with experience in free radical metabolism/oxidative damage or in experimental gerontology to work with a mentor who has interests and experience in both of these areas. For sample topics applicants should consult the program announcement: Oxidative Damage, Antioxidant Defense and Aging (NIH Guide, PA 93-017, vol 21, no. 41 November 13, 1992) Demography and Economics of Aging. Population aging raises questions about the future size, composition, and characteristics of the older population. The demography of aging emphasizes research on the changing social and demographic structure of society; the economics of aging focuses on the economic consequences of population and individual aging. Illustrative topics of interest in the demography and economics of aging include: forecasting outcomes such as life and active life expectancy and health care usage; the medical demography of late life chronic diseases including dementia; early life determinants of late life health; the oldest old (age 85 and over); integration of demographic topics with those of epidemiology, population genetics and nutrition; the emerging fields of bio- and experimental demography; immigration; the micro and macro dynamics of intergenerational transfers; studies of the impact of changing benefit programs such as Medicare and Social Security on the elderly including micro- and macro-simulation studies; international comparisons; understanding the role of education and economic status on late-life health status; the determinants and consequences of savings and retirement patterns on health and wellbeing; studies that integrate economic, demographic and psychosocial models of the life course; and the development of new theoretical paradigms and models that link these fields and questions. Psychosocial Geriatrics Research: Health Behaviors and Aging. Additional researchers are needed who are trained in the study of health behaviors and aging. Topics of particular interest include: Health-related behaviors and attitudes that can affect health and functioning as people grow older, and how these behaviors and attitudes develop under varying social, emotional and cognitive conditions; how they relate to health promotion and disease prevention, care, treatment, and rehabilitation or death; and how they can be modified as relevant new scientific knowledge is developed. Research on the full range of health and illness behaviors is relevant to this announcement, including self care, informal or lay care, and formal care. Also of interest are studies on the nature, determinants and consequences of doctor-patient interactions which have been shown to have a strong influence on health-related behaviors. For more sample topics applicants should consult the program announcement: Psychosocial Geriatrics Research: Health Behaviors and Aging (NIH Guide, PA 93-064, vol. 22, no. 11 March 19, 1993) Rehabilitation and Aging: Biomedical, Psychosocial, and Cognitive Perspectives. Researchers are encouraged to expand their training and experience with research on rehabilitation interventions targeted at older persons who have a wide range of physical and cognitive disabilities resulting either from disuse, disorders, or injuries of the musculoskeletal, cardiovascular, cognitive, or other physiological systems. More well-trained researchers are needed on biomedical, social, cognitive, and behavioral aspects of rehabilitation as well as the combined applications of geriatric, psychosocial, and cognitive strategies. Development and assessment of methods of memory rehabilitation both as related to cognitive changes associated with the aging process, as well as a result of specific diseases are of special interest. Also of special interest are methods for delaying deterioration and promoting function in Alzheimer's Disease. Researchers trained in methodological research are also needed, especially focusing on developing standardized methods for assessing functional aspects of aging (e.g., cognitive, biomedical, and psychosocial). Sensory, and motor disorders of aging. The ability to receive (sensory) and to act (motor) appropriately upon information declines with age. Investigators with research experience in the traditional sensory fields, i.e., vision, audition, chemosensation and somatosensation, are encouraged to apply their expertise to problems related to the aging population. Research to understand changes with aging in brain/behavior relationships, multisensory processes and sensory-motor coordination are of particular interest. Studies of age-associated deficits should utilize contemporary research techniques, including, but not limited to, neurophysiology, psychophysics, molecular biology and imaging. Sleep disruptions and disorders among older adults. In light of the widespread occurrence of chronic sleep disorders and disruptions among older adults there is a vital need for more basic and clinical researchers interested and trained in the problems of sleep among older people. Applications are encouraged from individuals with research experience in the allied fields of biological or behavioral sciences who need to have the appropriate training and research experiences to design and conduct interdisciplinary research related to the problems of sleep and aging. Environment The institution must have a well-established research and/or clinical career development program(s) in the proposed field of study and qualified faculty to serve as mentors. The institution must be able to demonstrate a commitment to the development of the candidate as a productive, independent investigator. And, the candidate, mentor and institution must be able to describe a career development program that will maximize the use of relevant research and educational resources. Program The award provides three to five consecutive 12 month appointments. At least 75 percent of the recipient's full-time professional effort must be devoted to the program and the remainder devoted to other research-related and/or teaching pursuits consistent with the objectives of the award. The candidate must develop knowledge in the basic sciences and research skills relevant to his or her career goals. The candidate may find it appropriate to include relevant didactic and laboratory or field research experiences. Mentor The recipient must receive appropriate mentoring throughout the three to five year program. Where feasible, women and minority mentors should be involved as role models. Allowable Costs: 1. Salary: The NIA will provide salary and fringe benefits for the K award recipient, based on the institution's salary scale for faculty at an equivalent experience level. The amount allowed varies by the length of the award. Up to $60,000 per year (plus commensurate fringe benefits) is allowed for three year awards. For longer awards, up to $60,000 is allowed on any three years of the award, and $50,000 is allowed on the remaining year or years. The institution may supplement the NIA contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case, may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the MRSDAA. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary requested must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. 2. Research Development Support: The NIA will provide up to $20,000 per year for the following expenses: (a) tuition, fees, and books related to career development; (b) research expenses, such as supplies, equipment, and technical personnel; (c) travel to research meetings or training; (d) statistical services including personnel and computer time. 3. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed. 4. Indirect costs: Indirect costs will be reimbursed at eight percent of modified total direct costs, or at the actual indirect cost rate, whichever is less. Evaluation In carrying out its stewardship of human resource related programs, the NIA or NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. Other Income Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution. The funds may be used for health-related research purposes. The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks must be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment. Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of an MRSDAA career award must receive prior written approval of the NIA. Special Leave Leave to another institution, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval of the NIA is required. To obtain prior approval, the award recipient must submit a letter to the NIA describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIA and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Parental leave will be granted consistent with the policies of the NIH and the grantee institution. Termination or Change of Institution When a grantee institution plans to terminate an award, the NIA must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. If the individual is moving to another eligible institution, career award support may be continued provided: A new career award application is submitted by the new institution; The period of support requested is no more than the time remaining within the existing award period; and The new application is submitted far enough in advance of the requested effective date to allow the necessary time for review. NIA may require a review by an initial review group and/or the appropriate National Advisory Council or Board. Alternatively, review may be carried out by staff within NIA, depending upon the circumstances. The Director of the NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution and career award recipient in writing of this determination, the reasons therefor, the effective date, and the right to appeal the decision. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 5/95) and will be accepted on or before the receipt deadlines 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. The title and number of the program announcement must be typed in item 2 on the face page of the application. The application must address the following issues: Candidate o Establish the candidate's commitment to a career in aging research o Establish the candidate's potential to develop into a successful independent investigator. o Summarize the candidate's immediate and long-term career objectives, explaining how the award will contribute to their attainment. o Letters of recommendation. Three sealed letters of recommendation addressing the candidate's potential for a research career in aging must be included as part of the application Career Development Plan o Describe the career development plan, incorporating consideration of the candidate's goals and prior experience. It should describe a systematic plan to obtain the necessary background and research experience to launch or reinitiate an independent research career in aging. o Candidates must describe plans to receive instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction as well as the amount and nature of faculty participation. No award will be made if an application lacks this component. Research Plan o The candidate and mentor together must describe the research plan as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. Mentor's Statement o The application must include information on the