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 (htt