From owner-sci-resources@net.bio.net Mon Oct 03 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 2 October 1994 Date: 3 Oct 1994 19:59:06 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 174 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <36qgdq$sfh@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: News Title: TIP40923 Media Tipsheet September 23, 1994 File size (bytes): 5758 STIS Filename: tip40923 Document Type: Press Release Title: PR 94-50 THREE FEDERAL AGENCIES JOIN IN EFFORT TO INTEGRATE SCIENCE AND HUMANITIES STUDIES File size (bytes): 3609 STIS Filename: pr9450 Title: PR 94-51 RESEARCHERS SEEK BASIC KNOWLEDGE TO SUPPORT CONSERVATION AND RESTORATION File size (bytes): 12430 STIS Filename: pr9451 Title: PR 94-52 NSF ANNOUNCES AWARDS FOR DIGITAL LIBRARIES RESEARCH File size (bytes): 12541 STIS Filename: pr9452 Title: VICE PRESIDENT TO DEDICATE WORLD'S MOST POWERFUL MAGNETIC FACILITY File size (bytes): 2982 STIS Filename: pr9453 Title: PR 94-55 TECHNOLOGY TRANSFER ENCOURAGED IN NSF PROGRAM LINKING SMALL BUSINESSES TO UNIVERSITY RESEARCHERS File size (bytes): 5636 STIS Filename: pr9455 Title: READING THE "FINE PRINT" OF CLIMATE HISTORY IN GREENLAND"S ICE File size (bytes): 8482 STIS Filename: pr9456 Title: OCTOBER INAUGURATION FOR GIANT GEMINI "TWIN" TELESCOPES IN HAWAII AND CHILE File size (bytes): 3630 STIS Filename: pr9457 Document Type: Program Guideline Title: Presidential Faculty Fellows Awards File size (bytes): 25436 STIS Filename: nsf94134 Title: NSF 93-135 Faculty Early Career Development (CAREER) Program Program Characteristics FY 1995 (ALL) File size (bytes): 63653 STIS Filename: nsf94135 Title: NSF 94-144 -- Computational Approaches To Real Materials (CARM 95) File size (bytes): 11790 STIS Filename: nsf94144 Title: NSF 94-147 RESEARCH PLANNING GRANTS AND CAREER ADVANCEMENT AWARDS FOR MINORITY SCIENTISTS AND ENGINEERS File size (bytes): 43078 STIS Filename: nsf94147 Document Type: Recruit Title: Director, Division of Astronomical Sciences File size (bytes): 7991 STIS Filename: vep9414 Title: Astronomer (Program Director) File size (bytes): 4969 STIS Filename: vex9444 Title: Program Analyst File size (bytes): 5372 STIS Filename: vgs94126 Document Type: SRS Data Brief Title: DB 94-317 - 1992 R&D Spending by U.S. Firms Rises, NSF Survey Improved File size (bytes): 7878 STIS Filename: db94317 Also available: db94317.ps ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Bulletin Title: BUL 94-10 NSF October Bulletin Vol 22; No. 2 File size (bytes): 86662 STIS Filename: bul9410 Document Type: Press Release Title: PR 94-52 NSF ANNOUNCES AWARDS FOR DIGITAL LIBRARIES RESEARCH File size (bytes): 12541 STIS Filename: pr9452 Document Type: Program Guideline Title: NSF93-151--Postdoctoral Research Fellowships in Molecular Evolution File size (bytes): 33006 STIS Filename: nsf93151 Also available: nsf93151.doc Title: NSF 94-114 Postdoctoral Fellowships in Biosciences Related to the Environment File size (bytes): 27352 STIS Filename: nsf94114 Also available: nsf94114.doc Title: NSF 94-133 -- MINORITY POSTDOCTORAL RESEARCH FELLOWSHIPS AND SUPPORTING ACTIVITIES File size (bytes): 42691 STIS Filename: nsf94133 Also available: nsf94133.doc Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 64108 STIS Filename: sesvac ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve sesvac, the text of your message should be as follows: get sesvac Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve sesvac, you would enter: ftp> get sesvac WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Fri Oct 07 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-95-002 - V23(35) 10/07/94 Date: 7 Oct 1994 18:46:18 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 512 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <374tla$itq@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA95002 CA-95-002 P1O1 *************************************** OCCUPATIONAL EXPOSURE AND CANCER PREVENTION/CONTROL RESEARCH NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFA: CA-95-002 P.T. 34; K.W. 0725020, 0715035, 0745027 National Cancer Institute National Institute for Occupational Safety and Health Letter of Intent Receipt Date: January 10, 1995 Application Receipt Date: February 17, 1995 PURPOSE The Divisions of Cancer Etiology and Cancer Prevention and Control, National Cancer Institute (NCI) and the National Institute for Occupational Safety and Health (NIOSH) invite grant applications for innovative epidemiologic studies among populations occupationally exposed to potential carcinogenic substances. The purpose of this Request for Applications (RFA) is to promote cancer control research activities. Special emphasis is placed on investigating minority populations and women, who have not been studied adequately in the past, as well as small businesses, because of constraints in addressing their occupational health problems. 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, Occupational Exposure and Cancer Prevention/Control Research, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit institutions, public and private, such as colleges, universities, hospitals, research laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from or involving minority institutions, individuals, and women are encouraged. MECHANISM OF SUPPORT This RFA will be supported through NIH research project grants (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed four years. This RFA is a one-time solicitation. Competing continuation applications will compete with all other unsolicited applications and be reviewed by a Division of Research Grants study section. If NCI and NIOSH determine that there is a sufficient continuing program need, the NCI and NIOSH may announce a request for new and renewal applications. NIOSH has a long-standing interest in the identification, evaluation, and control of cancers caused by occupational exposures, and NIOSH will continue to accept cancer-related grant proposals under its regular grants program announcement. FUNDS AVAILABLE The funds for this RFA come from the NCI Cancer Control budget. Approximately $2.0 million per year in total costs for four years will be committed by the NCI to specifically fund applications submitted in response to this RFA. In addition, $300,000 per year in total costs will be committed by the NIOSH to fund at least one application. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will also vary. The expected number of awards is six to eight. Although this program is provided for in the financial plans of the NCI and NIOSH, the award of grants pursuant to this RFA is contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background The identification of occupational exposures that carry a long-term risk of disease or death is a major public health and scientific concern for the general population and especially minorities. Many well-known human carcinogens were first identified in the occupational environment on the basis of case reports by alert clinicians or pathologists. These discoveries were often serendipitous, requiring the recognition of a cluster of unusual or rare tumors in a medical practice that could be tied to an occupational exposure. Exposures and technologies in the workplace, however, are changing. Improvements in industrial hygiene and worker protection have reduced the risks of cancer in some groups. Nevertheless, exposures and risks at lower levels may remain. Many industries and occupations have reported cancer excess for which the causative agent or agents have yet to be identified. Research is needed on how occupational exposures interact with non-occupational exposures and with susceptibility factors. Occupational cancer among minority workers, inner city and rural populations is an understudied aspect of occupationally related cancer. Moreover, it has been estimated that about 5000 new chemicals are being introduced annually in the form of new commercial products, chemicals, foods, and drugs, and any potential risks are likely to be greatest and most easily detected in exposed workers. It is therefore necessary to continue evaluating the carcinogenic risks for various occupational groups. Epidemiologic studies of occupational groups are important not only to detect carcinogenic risks, but also to verify the effectiveness of reducing exposures, to define the agents responsible for the excess risk in occupations exposed to complex mixtures, and to assess how occupational agents interact with other cancer risk factors and demographic variables such as age at first exposure. It is important that information from occupational cancer studies be communicated to workers and regulatory agencies. The workers under study must be informed and educated about the potential risks associated with their employment and particular exposures. Information must also be disseminated to labor unions, industrial groups and other concerned organizations to inform workers and take necessary precautions. Improved procedures are needed to identify, trace and counsel workers who are members of specific occupational cohorts in which risks have been discovered or quantified. Modern molecular epidemiologic techniques my permit not only the direct or indirect identification of exposures to chemicals, but also the study of variations in host susceptibility that may be of genetic or environmental origin. Internal dose markers may provide an estimate of the biologically effective exposure received by an individual, or provide markers of preclinical disease response to exposure. The major goal of identifying occupational determinants of cancer is to introduce preventive measures. Occupational exposure can be controlled by the application of a number of well-known principles, including engineering techniques (substitution, isolation, and ventilation), work practices, and personal protective equipment. These principles may be applied at or near the hazard source, to the general workplace environment, or at the point of occupational exposure to individuals. Controls applied at the source of the hazard, including material substitution, process or equipment modification, isolation or automation, local ventilation, and work practices, are generally preferred and most effective in terms of both occupational and environmental concerns. Controls that may be applied to hazards that have escaped into the workplace environment include dilution ventilation, dust suppression, and housekeeping. Control measures may also be applied near individual workers, including the use of ventilated control rooms, isolation booths, supplied-air cabs, work practices, and personal protective equipment. The additional strategies for cancer control include: (l) regulation of carcinogens and appropriate substitution of agents in the work environment, (2) screening and early detection of occupationally-related cancer, (3) when appropriate, evaluation of chemopreventive agents that may inhibit the carcinogenic process, and (4) development of programs to reduce exposures (e.g., smoking) that may interact with occupational carcinogens to potentiate the risk of cancer. One area where an emphasis is needed is small businesses. The reason is that (1) the Occupational Safety and Health Administration (OSHA) is legislatively refrained from regularly inspecting businesses with 10 or fewer employees, with certain exceptions, and (2) data from NIOSH's National Occupational Exposure Survey showed that full-time health and safety services are rarely found in facilities having fewer than 50 employees. Thus, based on the OSHA constraints and NIOSH data, estimates have been made that up to 90 percent of all work sites, covering 40 percent of the total work force are not regularly inspected and do not have ready access to health and safety expertise. New research programs are needed to address the needs for health protection of workers in delivery of such materials and services in the field. Clearly a program is needed to identify potential hazards in small businesses, characterize the health and safety potential problems, develop cost-effective control recommendations and effectively transfer these recommendations to the small business sector. Research Scope and Goals The purpose of this RFA is to stimulate epidemiologic studies of cancer in the workplace and to enhance related cancer prevention and control efforts. Innovative approaches that include new diagnostic or exposure measurements are particularly encouraged. Applications that may have substantial impact on public health are encouraged. Projects should be proposed as traditional R01s. Applications that build upon ongoing research projects, utilizing already collected epidemiologic data or biospecimens, are encouraged. One important goal of this initiative is to assess the extent that occupational exposures contribute to cancer incidence and mortality among minority populations, underserved groups, and women, and to develop effective means of cancer control in these special populations. The initiative permits a wide range of epidemiologic investigations including studies directed towards modifying lifestyle behavior. Examples of areas of research that are considered to be responsive to this RFA include, but are not limited to: (1) Analytic epidemiologic studies to clarify the relation of specific occupational exposures to specific tumors, and if possible to evaluate the impact of changing exposures on time trends in cancer incidence. Once discovered, the information must be disseminated to workers in the study, and to regulatory agencies, management, unions, and other labor and industry associations. (2) Epidemiologic studies of occupational cancer that include molecular and biochemical components to more precisely identify previous exposures, intermediate outcomes or susceptibility states among particular groups of workers who are then targeted for cancer control interventions in the proposed research. Molecular epidemiologic studies could explore differences in predisposition to occupational cancer due to variations in metabolic patterns, DNA repair, formation of adducts, chromosome sensitivity to mutagens, or others, especially in minority populations and women, with appropriate cancer control interventions. The significance of biochemical or molecular analysis would be conveyed to the subjects along with suggested methods of reducing cancer risks. (3) Intervention studies with lifestyle changes, chemopreventive agents or cancer screening modalities involving population groups previously exposed to occupational carcinogens. (4) Intervention studies of engineering control, work practice modification, and use of protective equipment, with evaluation of success of interventions and assessment of applicability in other settings. (5) Cancer control intervention studies to address the impact of occupational exposures to carcinogens on the minority populations of the United States. (6) Cancer surveillance activities to utilize existing occupational data resources to identify occupational cancer risks among minority populations and women. (7) Educational interventions to inform populations-at-risk about the potential consequences of exposures to occupational carcinogens, especially as they relate to minorities and women. (8) Special research areas for small business might include the identification and characterization of potential hazards in small businesses, development of recommendations for cost effective engineering, administrative, and personal protective controls, communication of recommendations to small businesses; or education of small businesses and the public and industrial health community regarding hazards in small businesses and their control. (9) Engineering control research might include observational studies conducted in the workplace to document health hazard controls, to evaluate their performance, and to disseminate this information; investigative research to identify sources of worker exposure and subsequent development and demonstration of corrective measures. These later studies provide a much better understanding of the "etiology of occupational exposure" than previously has been possible using traditional workplace sampling. For example, it has been shown that in many cases, there are a few hazardous parts of the job that contribute most of the actual exposure. The seriousness of these exposure points was not at all apparent by observation. Intervention to control exposures at these specific hazardous points can then be much more focused, effective, supportable, and cheaper than attempts to reduce exposures without specific knowledge of the exposure profile. SPECIAL REQUIREMENTS Applicants should include, in the budget, funds for the principal investigator (and advisory board representative if a board exists) to attend an annual program meeting to be held in alternating locations of Bethesda, MD and Cincinnati, OH (or Morgantown, WV). Proposed studies must have components that provide cancer control activities, such as recommendations for substitute chemicals and for specific changes in work practices and engineering controls, informational and educational programs for workers, unions, and management, and dissemination of results to regulatory agencies, and other interested parties from labor and industry. 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-sponsored biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (59 FR 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 requested to submit, by January 10, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the names of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NCI and NIOSH staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Richard L. Bragg at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91) available at most institutional offices of sponsored research and from the Office of Grants Information. Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248. The format and instructions applicable to regular research grant applications must be followed. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator could be included with the application. The RFA label available in application form PHS 398 (rev. 9/91) must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the number and title of the RFA must be typed on line 2a of the face page of the application and YES must be checked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact, clear and single-sided photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, applicants must send two additional copies of the application to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard MSC 7405 Executive Plaza North, Room 636 Bethesda, MD 20892-7405 Failure to submit these copies may delay the review and subsequent possible consideration of an application for award in FY 1995. Applications must be received by February 17, 1995. If an application is received after that date, it will be returned without review. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI and NIOSH. Incomplete applications will be returned to the applicant without further consideration. If NCI and NIOSH staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. The second level of review by the National Cancer Advisory Board considers the special needs of the NCI and the priorities of the National Cancer Program. The second level of review by NIOSH will consider the number of workers affected by the hazard under study and the potential contribution to applied technical knowledge in the prevention of occupational cancers. Review criteria for RFAs are the same as those for unsolicited research grant applications: o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly but exclusively in the area of the proposed research; o availability of resources necessary to perform the research. o Adequacy of plans to include both genders and minorities and thier subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each scored application. AWARD CRITERIA The earliest anticipated date of award is September 29, 1995. Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o quality of the proposed project as determined by peer review; o reasonableness of the budget in comparison with other applications; o program balance among research areas. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Richard L. Bragg, Ph.D. Division of Cancer Prevention and Control National Cancer Institute 6130 Executive Boulevard MSC 7395 Executive Plaza North, Suite 240 Bethesda, MD 20892-7395 Telephone: (301) 496-8589 FAX: (301) 496-8675 A.R. Patel, Ph.D. Divisionof Cancer Etiology National Cancer Institute 6130 Executive Boulevard MSC 7395 Executive Plaza NOrth, Suite 535 Bethesda, MD 20892-7395 Telephone: (301) 496-9600 FAX: (301) 402-4279 Roy M. Fleming, Sc.D. National Institute of Occupational Safety and Health 1600 Clinton Road, NE Building l, Room 3053, Mail Stop D-30 Atlanta, GA 30333 Telephone: (404) 639-3343 FAX: (404) 639-2196 Email: rmf2@niood1.em.cdc.gov Direct inquiries regarding fiscal matters to: Ms. Cynthia Mead Grants Research Branch National Cancer Institute 6120 Executive Boulevard MSC 7395 Executive Plaza South, Suite 243 Bethesda, MD 20892-7395 Telephone: (301) 496-7800, Ext. 254 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.393 and 93.894. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-140, as amended by Public Law 99.158, 42 USC 241 and 285) and administered under HHS policies and grant regulations. This program is not subject to the intergovernment review requirements of Executive Order 12372 or Health System Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Oct 07 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DK-95-001 - V23(35) 10/07/94 Date: 7 Oct 1994 18:46:28 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 457 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <374tlk$iuu@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DK95001 DK-95-001 P1O1 *************************************** DIABETES RESEARCH AND TRAINING CENTER NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFA: DK-95-001 P.T. 04; K.W. 0715075, 0720005, 0710030 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 16, 1995 Application Receipt Date: March 16, 1995 PURPOSE The National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) supports six Diabetes Research and Training Centers (DRTCs). These Centers are part of an integrated program of diabetes-related research support within the NIDDK. Centers have provided a focus for increasing the efficiency and collaborative effort among groups of successful investigators at institutions with established comprehensive diabetes research bases. The NIDDK invites applications for funding of one DRTC grant to be competitively awarded in Fiscal Year 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 Request for Applications, (RFA), Diabetes Research and Training Centers, is related to the priority area of diabetes mellitus. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone (202) 783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit as Principal Investigators. Any institution with an outstanding, existing program of biomedical research in the area of diabetes may apply for a DRTC. In addition, existing Diabetes Endocrinology Research Centers (DERCs) may submit competing applications for conversion to DRTCs. Foreign institutions are not eligible to apply. MECHANISM OF SUPPORT This RFA is a one time solicitation. Support of this program will be through the National Institutes of Health (NIH) comprehensive center (P60) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. In addition to the requirements stated in this RFA, awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. FUNDS AVAILABLE The NIDDK anticipates awarding one DRTC Grant in Fiscal Year 1996 on a competitive basis. The receipt of one competing continuation application is anticipated, which will be in competition together with the other applications received in response to this RFA. The anticipated award will be contingent upon the availability of appropriated funds. Requests for support must be limited to no more than $1,250,000 in direct costs per year. Requests for support for Demonstration and Education (D&E) supplements to convert an existing DERC to a DRTC must be limited to $300,000 in direct costs. If awarded, the D&E supplement funding would be added to the level of the existing DERC budget. The $1,250,000 direct cost application limit would then apply to future DRTC competing renewals. The NIDDK has allocated $1,657,000 in total costs to support this RFA. Any application exceeding the direct cost amounts indicated will be returned to the applicant without review. RESEARCH OBJECTIVES The NIDDK-supported Diabetes Centers program is comprised of DERCs and DRTCs. The objective of the Diabetes Research Center is to bring together investigators from relevant disciplines in a manner which will enhance and extend the effectiveness of research and training being conducted in the field of diabetes and its complications. These Centers have provided a focus for increasing collaboration and cost effectiveness among groups of successful investigators at institutions with established comprehensive diabetes research bases. Both types of centers are based on the core concept. Cores are defined as shared resources that enhance productivity or in other ways benefit a group of investigators working in diabetes or diabetes-related areas to accomplish the stated goals of the Center. These centers also support a pilot and feasibility program and an enrichment program. The pilot and feasibility program provides modest support for new initiatives or feasibility research studies for new investigators or for established investigators in other research disciplines when their expertise may be applied to diabetes research. These include biomedical, epidemiologic, behavioral, and health care research as it pertains to the Center's mandate for the training of primarily health care professionals. The Center grant may also include limited funds for program enrichment such as seminars, visiting scientists, consultants, workshops, etc. While the above components are common to DERCs and DRTCs, DRTCs also include a substantial additional component, the Demonstration and Education (D&E) Division. The D&E Division: (1) carries out training programs for health care professionals, (2) is engaged in research in the translation of the outcomes of biomedical and behavioral science research into clinical care, and (3) develops, tests, and evaluates innovative methods and programs for translation activities. These features are described briefly in this RFA and in detail in the DRTC Guidelines. Each project or core within the D&E Division may not exceed 25 pages. A DERC is eligible to apply for conversion to the DRTC program. An existing DERC that elects to apply for such conversion in response to this RFA must follow the following procedures: (1) if the DERC will have at least one year of support remaining as of December 1, 1995 (the earliest funding date for applications submitted in response to this RFA), a competing supplement to the existing DERC may be submitted which includes only the components of a Demonstration and Education Division. In addition, information (limited to five pages) should be included describing how this D&E addition will interact with the existing DERC elements and enhance the comprehensive nature of the Center. A successful competition would result in the DERC being converted to a DRTC for the duration of that Center's current award. It would then be eligible to submit a DRTC proposal for its competing renewal. (2) If the DERC will have less than one year of support remaining after December 1, 1995, it must submit a full DRTC application. If funded the DRTC would have a five year award period. A DRTC must be an identifiable unit within a single university, medical center or a consortium of cooperating institutions, including an affiliated university. The overall goal of the DRTC is to bring together on a cooperative basis, clinical and basic science investigators and those involved in diabetes education and translation. As indicated above, the DRTCs are expected to encompass the following: (1) facilitate and strengthen basic and clinical research related to diabetes and its complications; (2) train health professionals about diabetes and its management. In addition, within the D&E Division of the DRTC: (3) develop a model demonstration facility to contribute to the above endeavors; and, (4) translate advances in the field of diabetes into improved care, especially, the translation of the intensive management shown to be effective by the Diabetes Control and Complications Trial (DCCT). The latter should focus on research to identify and overcome barriers to intensive diabetes management and treatment. All of these areas need not be developed to the same degree. A strong base of biomedical research is an essential prerequisite of a Center. Accordingly, a program of excellence in biomedical research in the area of diabetes and related metabolic and endocrine disorders in the form of NIH-funded research projects, program projects, or other peer-reviewed research must be in existence at the time of submission of a Center application. Close cooperation, communication, and collaboration among all involved personnel of all professional disciplines to enhance research progress are ultimate objectives. Applicants should request a copy of the DRTC guidelines and consult with NIDDK staff concerning plans for the development of the Center. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator should be included with the application. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) ad supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minority in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from program staff listed under INQUIIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by February 16, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid possible conflict of interests in the review. Prospective applicants may submit letters of intent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 APPLICATION PROCEDURES Applicants are strongly encouraged to request a copy of "Guidelines for Diabetes Research and Training Centers." These guidelines contain important suggestions and information on the format, content, and review of applications and review criteria. Prospective applicants may obtain guidelines from the program official listed under INQUIRIES. Applications are to be submitted on the form PHS 398 (rev. 9/91) available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, plus three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application must also be sent under separate cover to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Disgestive and Kidney Diseases 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Applications must be received by March 16, 1995. If an application is received after that date, it will be returned to the applicant. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications previously reviewed. Such applications must not only include an introduction addressing the previous critique but also be responsive to this RFA. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on the scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. It is essential that the written application be in a form to be reviewed on its own merit, since no site-visit is anticipated. Following this review, the applications will be given a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. The initial review group will review each application using the criteria stated below and detailed in the DRTC Guidelines: New and Competing DRTC Applications: 1. Biomedical Research o Scientific excellence of the Center's research base that must have a broad and central focus in diabetes and may extend to related research in metabolism and endocrinology. The relevance of the separately funded research to the DRTC objectives (see above) and the likelihood for meaningful collaboration among Center investigators must be demonstrated. o Potential of the cores for contribution to ongoing research, their appropriateness and relevance, their modes of operation and, suitability of facilities. Renewal applications must include the use, utility, quality control, cost effectiveness, and demonstrated progress of any developmental research in the shared resources. o For new applications, the pilot and feasibility program is judged on the basis of: (1) scientific merit of the studies as submitted and (2) the merit of the administrative process for selecting subsequent studies. In competitive renewal applications, emphasis is placed on the program as a whole, including past track record and management of the program. o Adequacy of plans to include both genders and minorities and their subgroups as apropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evalusted. 2. Research Training o Although the Center does not specifically support research training, demonstration of accomplishments and future plans related to the training of investigators necessary to conduct research in diabetes and related metabolic and endocrine disorders will be considered in assessing the potential to meet Center objectives. The integration of these efforts into the overall Center, including core facilities is of particular importance. 3. Demonstration and Education o The applicant's existing or planned activities to overcome barriers to translating research knowledge into improved diabetes health care will be evaluated on the basis of: (a) The novelty, feasibility, and quality of programs, materials, and publications that address overcoming barriers to translation of scientific advances into clinical practice. This should include program and/or curriculum development in the education of health care professionals (including students) both within and outside the DRTC. Completed programs and materials should be translatable to other settings and should have undergone some form of evaluation. (b) Organization and use of the Model Demonstration Unit which is a required component of the DRTC. The MDU should include as a central mission the development, testing, and demonstration of model diabetes care. Ideally it should span all the Center activities, including basic and clinical research, research training and training of health professionals. (c) For existing Centers, future plans for continuing ongoing activities and initiating new activities and their evaluation. (d) The approach, results, and general utility of any outreach projects, including: transferability to other settings, demonstrated effectiveness, and plans for take over by local groups and/or funding from other sources. (e) Overall coordination and cooperation within the D&E component among the cores of the DRTC and with other groups (voluntary health organizations, Federal agencies, and other diabetes-related efforts, etc.). (f) Consideration of the potential impact of the activity on the national diabetes effort. 4. Supplemental Demonstration and Education Unit Applications: o The supplement will be evaluated on the basis of the D&E criteria presented above. o The D&E supplement should carefully present the rationale for extending the currently funded DERC to include this new element. o The interfacing of the additional D&E element to the existing DERC. How does this extension impact on the overall activities of the Center? o The overall rating of the DERC plus D&E supplement for conversion to a DRTC will be based on the above stated D&E criteria in addition to the existing DERC framework. The latter will take into consideration the previous DERC Summary Statement. The DERC elements will not be re-reviewed. 5. Administration o The scientific and administrative leadership abilities of the DRTC Director and Associate Director and their commitment and ability to devote adequate time to the effective management of the DRTC program. o The appropriateness of the DERC budgets for the proposed and approved work to be done in core facilities, for pilot and feasibility studies, and for enrichment in relation to the total Center program. o Efficiency and effectiveness of use and/or planned use of enrichment funds. o Institutional commitment to the program, including lines of accountability regarding management of the DERC grant and a commitment to establish new positions as necessary. AWARD CRITERIA The anticipated date of the award is December 1, 1995. Applications will compete for available funds with all other applications submitted in response to this RFA and recommended by peer review. The following will be considered in making funding decisions: o Quality of the proposed Center as determined by peer review o Availability of funds INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Dr. Sanford A. Garfield Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 626 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7535 FAX: (301) 594-9011 Email: sandyg@dvsgate.niddk.nih.gov Direct inquiries regarding fiscal matters to: Ms. Linda Stecklein Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 653 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7543 Schedule Letter of Intent Receipt Date: February 16, 1995 Application Receipt Date: March 16, 1995 Initial Review Dates: June-July 1995 Second Level Review Dates: Sep-Oct 1995 Anticipated Award Date: December 1, 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Oct 07 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-001 - V23(35) 10/07/94 Date: 7 Oct 1994 18:46:01 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 243 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <374tkp$ir6@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95001 PA-95-001 P1O1 *************************************** FACTORS THAT DETERMINE THERAPEUTIC DRUG BIOAVAILABILITY NIH GUIDE, Volume 23, Number 35, September 30, 1994 PA NUMBER: PA-95-001 P.T. 34; K.W. 0740020, 0755025 National Institute of General Medical Sciences PURPOSE The purpose of this program announcement (PA) is to encourage basic research in the areas that are fundamental to understanding the factors that determine therapeutic drug bioavailability, with emphasis on the oral route of delivery. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and not-for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, eligible agencies of the Federal government, and small businesses. Applications from minority individuals and women are particularly encouraged. Foreign institutions are not eligible to receive First Independent Research Support and Transition (FIRST) awards (R29) or program project grants (P01). For-profit applicants for the Small Business Innovation Research (SBIR) program (R43, R44) and the Small Business Technology Transfer Research (STTR) program (R41, R42) must qualify as a small business concern in accordance with the definition given in the latest edition of the Omnibus Solicitation of the Public Health Service for Small Business Innovation (SBIR) Grant and Cooperative Agreement Applications, and the Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer Research (STTR) Applications. Additional eligibility requirements for SBIR and STTR applicants, including organizational, principal investigator, and performance site criteria are described in these Omnibus Solicitations. MECHANISMS OF SUPPORT Support of this program announcement will be through individual research project grants (R01), FIRST awards (R29), program project (P01) grants, and awards to small businesses under the Small Business Innovation Research (SBIR) program (R43, R44) and the Small Business Technology Transfer Research (STTR) program (R41, R42). Investigators with ongoing R01, R37 (Method to Extend Research in Time (MERIT)) and P01 awards who are expanding the scope of their work and would have at least one year of support remaining from the anticipated date of award may apply for competing supplement awards. RESEARCH OBJECTIVES Bioavailability represents an area of basic research that has received little emphasis to date. The economic consequences of problems with drug bioavailability are enormous. Many potential drug candidates have failed as a result of difficulties in penetrating barriers or not arriving or remaining in active form at the site of action. Drug candidates can be tested for their desired therapeutic activity, but it is not yet possible to predict whether or not a compound will have sufficient bioavailability to be useful and practical. The National Institute of General Medical Sciences (NIGMS) wants to encourage research in several different fundamental areas in order to optimize the bioavailability of newly designed therapeutic entities, and to develop strategies to predict how a drug candidate will perform based on its chemical structure. Because comprehensive understanding of the basic biology of how a drug gets to the site of action and overcomes the obstacles it encounters is currently quite limited, mechanistic research is encouraged in the areas that determine the physiological, pharmacological, biological, and chemical processes that contribute to drug absorption, metabolism, transport, or clearance. Overall, these studies may include, but are not limited to studies on: o integrating information useful for maximizing drug bioavailability at the drug design stage o generating strategies to predict the bioavailability of drug candidates intended for use in humans Basic research is encouraged in the areas of mechanisms determination, models validation, structure-activity relationships, formulations, methods development, and determining intra-/interindividual differences. Emphasis will be placed on, but not limited to, the oral route of drug delivery. Investigations that involve the interactions of physical and biological scientists (e.g., chemists, biologists, clinicians) are particularly encouraged. Liaisons between academic, industrial, and eligible government laboratories are also encouraged. Possible example research areas include: o investigation of the molecular mechanisms of active and passive transport processes of the gastrointestinal tract, liver, kidney, and lung, that determine drug absorption, metabolism, transport, or clearance o characterization of human metabolic enzymes, their isoforms and their heterogeneous distribution, that determine drug absorption, metabolism, transport, or clearance o identification of regional differences or site-specific processes within an organ system, that contribute to drug absorption, metabolism, transport, or clearance o investigation of interactions between the organ systems in humans, that contribute to drug absorption, metabolism, transport, or clearance o design and validation of predictive in vitro tests, based upon human information and comparison to existing established models o integrated modelling of all processes that in concert determine drug absorption, metabolism, transport, or clearance in humans o establishment of compound libraries to examine drug absorption, metabolism, transport, or clearance, that can be used to provide drug structural/functional predictive information o identification of pro-drug strategies that harness or circumvent carriers or enzymes of drug absorption, metabolism, transport, or clearance o identification of formulation approaches that take advantage of known routes for drug absorption, metabolism, transport, or clearance or devise new methods for delivery o development of analytical techniques with increased sensitivity, accuracy, speed, and simplicity for measuring drug absorption, metabolism, transport, or clearance o influence of age-based, sex-based, racially-based, disease-based, or other interindividual differences in drug absorption, metabolism, transport, or clearance o influence of polytherapy, food intake, nutritional status, or other intraindividual differences in drug absorption, metabolism, transport, or clearance APPLICATION PROCEDURES Applicants for research project grants (R01, R29), program project grants (P01), and supplemental awards are to use the regular grant application form PHS 398 (rev. 9/91). Application receipt dates are listed in the PHS 398. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Applications for the SBIR program will be accepted for the usual receipt dates: April 15, August 15, and December 15. Applications for the STTR program, phase I (R41) will be accepted for December 1, 1994. Applicants should consult future publications of the Omnibus Solicitation of the NIH for STTR Applications for additional receipt dates. Application kits are available from MTL, Inc., 13687 Baltimore Avenue, Laurel, MD 20707-5096, telephone (301) 206-9385; FAX (301) 206-9722; Internet a2y@cu.nih.gov. All individuals applying under this announcement must cite this program announcement by title and number. The application should clearly state how the scientific objectives of the proposed research will enhance the basic understanding of the factors that determine drug bioavailability in humans. On the face page of the application form PHS 398, item 2a, the word "YES" must be checked, and the title and number of this program announcement must be inserted in the space provided. FIRST applications must include the three sealed letters of reference attached to the face page of the original application, or the applications will be considered incomplete and will be returned to the applicant. The completed original application and five copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be assigned to an initial review group (IRG) and to a funding component (institute) based upon established Public Health Service referral guidelines. IRGs will review the applications for scientific and technical merit in accordance with the usual NIH peer review procedures. Following the IRG reviews, applications will receive a second level of review by the appropriate National Advisory Council. AWARD CRITERIA Applications will compete for funds with other approved applications. The following criteria will be considered when making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Significance of the proposed research to the aims of this program announcement o Program diversity and balance INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Rochelle M. Long, Ph.D. Pharmacology and Biorelated Chemistry Program National Institute of General Medical Sciences 45 Center Drive, Box 6200 Bethesda, MD 20892 Telephone: (301) 594-7808 FAX: (301) 594-7728 Email: LONG@GM1.NIGMS.NIH.GOV Direct inquiries regarding financial matters to: Ms. Toni Holland National Institute of General Medical Sciences 45 Center Drive, Box 6200 Bethesda, MD 20892 Telephone: (301) 594-7819 FAX: (301) 594-8891 Email: HOLLANDA@GM1.NIGMS.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance number 93.859 (Pharmacology and Biorelated Chemistry). Awards will be made under the Public Health Service Act, Titles III and IV (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 287) and administered under PHS grants policies and Federal Regulations 42 CFR part 52 and 45 CFR Part 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Oct 07 23:00:00 1994 Path: biosci!biosci!not-for-mail From: peapud@rpi.edu (Diane Hope Peapus) Newsgroups: bionet.general,bionet.announce,comp.research.japan,bionet.sci-resources Subject: NSF Summer in Japan for grad students Date: 7 Oct 1994 18:40:16 -0700 Organization: Rensselaer Polytechnic Institute, Troy NY Lines: 115 Sender: biohelp@net.bio.net Approved: bionews-moderator@net.bio.net Distribution: usa Message-ID: <373par$ppf@usenet.rpi.edu> NNTP-Posting-Host: net.bio.net Xref: biosci bionet.general:11456 bionet.announce:1470 comp.research.japan:826 bionet.sci-resources:1122 Greetings: This as an announcement about a really good opportunity for anyone who is a grad student, or will be a grad student, and is interested in spending a summer doing research in Japan. The program allows you to find a Japanese "host", whose research is somewhat compatable to your own, or attempts to match you to a Japanese host in your general area, if you have no host of your own in mind. I went last year and collected data that will be used in my postdoc work, as well as collecting data for other people in my lab. Please feel free to distribute the announcement to anyone that you think will be interested. Anyone wanting additional info about what it was really like, is free to contact me at... diane@cwxtl.bioc.cwru.edu diane h peapus 216-368-8682 ______________________________________________________________ From: jcassidy@nsf.gov To: si90@nsf.gov, si91@nsf.gov, si92@nsf.gov, si93@nsf.gov, si94@nsf.gov Subject: Summer Institute 1995 Date: 6 Oct 94 10:47 EST Dear Alumni: The NSF Japan Program would appreciate it if you would please distribute the following email advertisement to any and all appropriate people, places, etc. Please encourage your colleagues, friends, and students to apply! We are still receiving about 120-130 applications a year and are selecting 60 people. The odds are good! Thanks, Janice Cassidy Japan Program/NSF --------------------------- TO: Interested applicants FROM: NSF Japan Program SUBJECT: 1995 Summer Institute in Japan -------------------------------------------- NSF and NIH announce an opportunity for graduate students.... ** the 1995 SUMMER INSTITUTE IN JAPAN *** for U.S. Graduate Students in Science and Engineering, Including Biomedical Science and Engineering. APPLICATION DEADLINE: December 1, 1994 Program's Goal: to provide U.S. graduate students first- hand experience in a Japanese research laboratory. Program Elements: ** Internship at a Japanese government, corporate or university laboratory in Tokyo or Tsukuba; ** Intensive Japanese language training; ** Lectures on Japanese science, history, culture, etc. Program Duration and Dates: 8 weeks; June 23 to August 19, 1995. Eligibility requirements: 1. U.S. citizens or permanent residents 2. Enrolled at a U.S. institution in a science or engineering Ph.D. program, Enrolled in an M.D. program and have an interest in biomedical research, or Enrolled in an engineering M.S. program of which one year has been completed by December 1, 1994. To download application materials: Send e-mail message to stisserv@nsf.gov (InterNet) or stisserv@nsf (BitNet) Ignore the subject line, but body of message should read as follows: Request: stis Topic: nsf94130 Request: end You will receive a copy of publication 94-130, the program announcement for the 1995 Summer Institute in Japan, by return e-mail. Further inquiries: Contact NSF's Japan Program staff at NSFJinfo@nsf.gov (InterNet) or NSFJinfo@nsf (BitNet) Tel: (703) 306-1701 Fax: (703) 306-0477 From owner-sci-resources@net.bio.net Fri Oct 07 23:00:00 1994 Path: biosci!biosci!not-for-mail From: pp000531@interramp.com Newsgroups: bionet.announce,bionet.sci-resources Subject: ANNOUNCE: National Technology Transfer Conference Date: 7 Oct 1994 18:39:39 -0700 Organization: PSI Public Usenet Link Lines: 279 Sender: biohelp@net.bio.net Approved: bionews-moderator@net.bio.net Distribution: world Message-ID: <3726hc$hqi@www.interramp.com> NNTP-Posting-Host: net.bio.net Xref: biosci bionet.announce:1468 bionet.sci-resources:1121 - Text following below describes the nature, purpose, program outline, and registration information for the fifth national technology transfer conference and exposition to be held this November in Washinton DC. - This is not a commercial advertisement but a news advisory of an upcoming multi-disciplinary science and technology meeting and exposition sponsored by US Government agencies and the Technology Utilization Foundation (a not-for-profit organization). Attendance at exhibits only is FREE; attendance at symposia and workshops involves registration fees. - Details contained herein are sufficient for registration by postal mail or by fax, however - a full, printed, paper registration package and program/exhibitor details can be obtained by sending an E-mail request (including your return [surface] postal mailing address) to pp000531@interramp.com who is acting on behalf of the Technology Utilization Foundation. The entity pp000531@interramp.com is Ted Morawski, MIS Director at NASA Tech Briefs, Suite 921, 41 East 42-nd Street, New York, NY. Voice tel. # 212-490-3999, Fax tel. # 212-986-7864. - More extensive descriptions of specific workshops, symposia, and exhibits are now constantly being uploaded and remain available on the Compuserve Ideas and Inventions forum (go ideas) in the Technology 2004 library which is solely devoted to this meeting and exposition. _______________________________________________________________ The Fifth National Technology Transfer Conference & Exposition November 8-10, 1994 Washington, DC Convention Center Sponsored by NASA, NASA Tech Briefs, and the Technology Utilization Foundation, in cooperation with the Federal Laboratory Consortium for Technology Transfer The federal government and its contractors will spend over $75 billion this year on research and development. Technology 2004 will show you how to tap into this tremendous resource and will introduce you to new funding and partnering opportunities. Technology 2004 will bring together the top technologists and tech transfer agents in US national laboratories, universities, and high-tech industry. It is designed to help companies to quickly and easily find innovative, ready-made ideas they can use to solve engineering problems, create new or improved products, and grow their businesses. How You Will Benefit: Practical, Informative Workshops Defense conversion...technology reinvestment, dual-use inventions. You've heard the buzzwords, but what do they mean for your company and your job? How can you take advantage of the federal government's multi-billion-dollar push to commercialize taxpayer-supported technologies and leverage the nation's R&D investment? Technology 2004 workshops will show you how to get started and what's in it for you. Symposia Spotlighting America's Best New Inventions Leading technologists from NASA, the departments of Defense and Energy, and other key agencies will unveil commercially-promising innovations and advanced processes in critical areas driving US and world growth markets. Discover how ideas developed for defense and space programs can be reapplied in commercial industries such as biotech, electronics, computing, transportation, and many more. The World's Largest Technology Transfer Exposition A "who's-who" of government labs, universities, and high-tech firms will demonstrate their latest inventions and products available for license or sale in the 80,000+ sq. ft. exhibits hall. It's the place to meet the technology vanguard, discuss your needs and capabilities you have to offer, and keep abreast of leading-edge developments across the techno-spectrum. Free Internet Training Sessions Daily demonstrations in the exhibits hall will help you to take advantage of the Internet - the worldwide web of computer networks that has been labeled "the on-ramp to the information superhighway." Learn about important resources on the net and how you can access them without spending a lot of time or money. Sessions will begin at 10:30 AM each day. Technology 2004 Program Tuesday, November 8 8:30 am - 10:00 am Plenary Session: Government-Industry Partnership Opportunities 10:30 am - 12:30 pm National Critical Technologies Concurrent Symposia: Advanced Manufacturing; Bio/Medical Technology; Computer-Aided Design; Materials Science; Power & Energy 2:00 pm - 4:00 pm Concurrent Symposia: Artificial Intelligence; Computers & Software; Electronics; Environmental Tech; Video/Imaging Exhibition Hours: 10:00 am - 5:00 pm Wednesday, November 9 8:30 am - 10:00 am Concurrent Workshops: Business Guide To Tech Transfer Resources; The Defense Technical Application Center (DTAC) Network; Small Business Innovation Research Grants 10:30 am - 12:30 pm National Critical Technologies Concurrent Symposia: Artificial Intelligence; Materials Science; Test & Measurement; Video/Imaging; Virtual Reality/Simulation 2:00 pm - 4:00 pm Concurrent Symposia: Computers & Software; Electronics; Environmental Tech; Materials Science; Test & Measurement 7:00 pm - 10:00 pm Technology Transfer Awards Dinner Exhibition Hours: 10:00 am - 5:00 pm Thursday, November 10 8:30 am - 10:00 am Concurrent Workshops: International Tech Transfer Forum; Licensing Government Patents; The Technology Reinvestment Project 10:30 am - 12:00 pm Concurrent Workshops: International Tech Transfer Forum (cont.); Cooperative Research & Development Agreements; The DOC Advanced Technology Program Exhibition Hours: 10:00 am - 3:00 pm Plus: The LaserTech '94 Photonics Technology Transfer Conference will be held concurrently with Technology 2004 on Wednesday, November 9 from 8:00 am to 4:30 pm. Complete registrants can attend the LaserTech '94 sessions, breakfast, and networking luncheon for an up-grade fee of $35.00. Preregister and $ave by 10/21 On-site Complete Registration $250 $295 (includes Technology 2004 symposia and exhibits, awards dinner, and a set of official proceedings) One-Day Registration $85 $100 Awards Dinner Only $50 $60 LaserTech '94 $35 $40 (upgrade for T2004 complete registrants; includes breakfast, lunch, and photonics symposia on 11/9) Exhibits Only - No Charge - Preregistrants will receive written confirmations via mail along with their name badges and inquiry cards. Badge holders, programs, and dinner tickets must be picked up in person at the Washington, DC Convention Center (900 Ninth St. NW) beginning at 12:00 pm on Monday, November 7. Special Hotel Rates Renaissance Hotel (headquarters) $125 single/double Grand Hyatt Washington $134 single/double Henley Park Hotel $100 single/$110 double Hotel Washington $99 single/double (govt. only) To make reservations, call the housing bureau at (800) 535-3336 or (202) 842-2930 and identify yourself as a Technology 2004 attendee. A $125 per room deposit is required. Travel Discounts Budget Rent-A-Car: Call (800) 772-3773 and refer to the Technology 2004 rate code #VNRD/TNGY. Valid Nov. 1-17. Amtrak: 10% discount. Call (800) USA-RAIL and refer to the Tech 2004 fare code #X-84E-927. Valid Nov. 6-12. USAir: Book your ticket on USAir to be entered into a drawing for two round-trip tickets good in the continental US, Canada, the Bahamas, and San Juan. 10% discount off unrestricted coach fares, and 5% off first class. Call (800) 334-8644, refer to gold file #35380094. Questions: E-mail pp000531@interramp.com Following below is a registration form that can be surface mailed or faxed, but a full printed package can also be obtained through e-mail request to pp000531@interramp.com (providing full surface-mail return address). Information requested on the registration form is not intended to disqualify anyone; it is meant to collect information regarding interest for purposes of feedback to government, industry, and the organizers. The feedback is needed for purposes of evaluation and improvement of this effort. The only restrictions are that attendance is limited to legal adults (unless prior arrangements of convenience are made), and that attendance is for legal purposes. Stuffy as it may sound in this day and age. _____________________________________________________________ TECHNOLOGY 2004 REGISTRATION FORM (DO NOT E-MAIL FOR SECURITY REASONS) Name: ___________________________________________________ Title: ____________________________________________________ Company: ________________________________________________ Address: _________________________________________________ City/St/Zip: ________________________________________________ Phone No.: __________________________________ Which of the following best describes your industry or service? (check one) A [ ] Electronics I [ ] Industrial Equipment B [ ] Computers J [ ] Manufacturing C [ ] Communications K [ ] Power/Energy D [ ] Transportation/Automotive L [ ] Biomedicine E [ ] Aerospace M [ ] University F [ ] Defense N [ ] Research Lab G [ ] Government O [ ] Other (specify below) H [ ] Materials/Chemicals ________________ Which of these products do you recommend, specify, or authorize the purchase of? (check all that apply) A [ ] Electronic Components & Systems B [ ] Software C [ ] Computers/Peripherals D [ ] CAD/CAE/CAM/CASE E [ ] Lasers/Optics F [ ] Materials G [ ] Mechanical Components H [ ] Positioning Equip./Motion Control I [ ] Test/Measurement Instruments J [ ] Sensors/Transducers K [ ] Data Acquisition L [ ] Video/Imaging Equipment M [ ] Industrial Controls/Systems N [ ] Communications Equipment O [ ] Laboratory Equipment Your principal job function is: (check one) A [ ] General & Corporate Management E [ ] Manufacturing/Production B [ ] Design & Development Engineering F [ ] Purchasing/Procurement C [ ] Engineering Services - Tests/Quality D [ ] Basic Research G [ ] Other (specify): ____________________________ Please register me for the following: A [ ] Complete Registration $250 B [ ] One-Day Symposia/Exhibits $ 85 check day: [ ] 11/8 [ ] 11/9 [ ] 11/10 C [ ] Awards Dinner Only $ 50 D [ ] LaserTech '94 upgrade fee $ 35 (D is for complete registrants only - you must have checked A above) E [ ] Exhibits Only - Free $ 0 TOTAL: $______ [ ] Check/MO enclosed (payable to Technology Utilization Foundation) [ ] Charge my: [ ] Mastercard [ ] VISA [ ] Am Ex Card No.: ____________________________ Expire Date: ______ Signature: _________________________________ Date: ____________ Registrations and Awards Dinner reservations are transferrable and may be cancelled until October 21, 1994. After that date no cancellations will be refunded. Return with payment to: Technology Utilization Foundation c/o Technology 2004, PO Box 614, Brookfield, IL 60513-0614 For fastest registration fax to: (708) 344-9482 From owner-sci-resources@net.bio.net Fri Oct 07 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA ES-94-009 - V23(35) 10/07/94 Date: 7 Oct 1994 18:46:11 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 310 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <374tl3$it7@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA ES94009 ES-94-009 P1O1 *************************************** MECHANISTICALLY-BASED ALTERNATIVE METHODS IN TOXICOLOGY NIH GUIDE, Volume 23, Number 35, September 30, 1994 RFA: ES-94-009 P.T. 34; K.W. 1007009 National Institute of Environmental Health Sciences Letter of Intent Receipt Date: November 15, 1994 Application Receipt Date: December 20, 1994 PURPOSE The National Institute of Environmental Health Sciences (NIEHS) invites applications to conduct research to develop mechanistically-based alternative methods and models for toxicology research and testing. Assessment of the potential adverse health effects of chemicals is currently accomplished largely by tests utilizing laboratory animals. While such traditional tests have provided information useful for human health risk assessment, improved test methods are needed that are more predictive, that provide information more supportive of quantitative risk assessment, can be achieved in a shorter time frame, and are more cost-effective. This RFA is issued to foster the development, validation, and use of improved testing and research methods that either do not require the use of animals, reduce the number of animals, or involve the use of alternatives such as non-mammalian species. This NIEHS initiative will facilitate the integration of recent advances in molecular and cellular biology and new research technologies into alternative toxicology testing methodologies that will provide improved human health hazard identification and improved dose-response relationships, thereby contributing to improved risk assessment. 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, Mechanistically-Based Alternative Methods in Toxicology, is related to the priority area of Environmental Health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state or local governments, and eligible agencies in the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research project grant (R01). Responsibility for planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period requested in and application may not exceed three years. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the entire program is $1.5 million. The expected number of awards is eight to ten. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Support will not be provided under this RFA for research activities focussed on clinical trials or the initiation of large-scope epidemiologic studies. RESEARCH OBJECTIVES The NIEHS proposes to expand research efforts to develop mechanistically-based alternative methods and test systems for toxicological research and testing. The development of alternative testing methods that incorporate new knowledge regarding the molecular and cellular mechanisms of toxicity will be encouraged, as well as the refinement of existing test methods/models by utilizing new scientific information and techniques such as characterization of the similarities and differences at the cellular and molecular level of test models with humans. Toxicological test methods and systems are encouraged in the priority areas of carcinogenicity, neurotoxicity, and developmental toxicity, but will be considered in any area of toxicity testing. Examples of alternative test methods and models that may be appropriate for development under each of these priority areas include: o Development of cell cultures or genetically engineered cell lines that can be used to characterize the biological activity and toxicity profiles of chemicals and classes of chemicals at the molecular and cellular level, and that are predictive of the toxic effects of chemicals in existing test species or humans. Such systems might incorporate reporter constructs that allow for the automated quantification of response. Note that cytotoxicity assays are not responsive to this RFA. o Development and utilization of transgenic animals that more closely model the human response to toxic substances and that can detect toxicant effects using fewer animals and shorter time frames. o Development and characterization of systems for toxicity testing that utilize non-mammalian or invertebrate species that are predictive of the toxic effects of chemicals in existing test species or humans. o Development and utilization of improved computer-based prediction and modeling systems for specific toxicologic endpoints. These might include physiologically-based pharmacokinetic (PBPK) models, toxicokinetic models, and biologically-based structure-activity relationship modeling/prediction system. These should include not only the design of the model, but also the design and implementation of the experiments to be conducted utilizing the model. It is anticipated that new methods/test systems worthy of further evaluation in detailed validation studies will result from the research supported by the RFA. Thus, applications submitted under this RFA must develop both a mechanistically based alternative model or test system (for example a tiered multiple system approach) and also provide sufficient evaluation to show its utility as a test/model. Thus, studies designed to simply explore the mechanism of action of a single toxicant in an alternative test/model will not be considered responsive to this RFA. SPECIAL REQUIREMENTS Applicants may request funds for one trip annually to the National Institute of Environmental Health Sciences for a meeting to discuss important new findings and a sharing of research progress. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by November 15, 1994, a letter of intent that includes the title of the proposed project, a short descriptive abstract, the name, address, and telephone number of the Principal Investigator, and RFA title and number. Although a letter of intent is not required, is not binding, and does not enter into the review of the subsequent application, the information that it contains is helpful in planning for the review of applications. It allows the NIEHS staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent: Dr. Ethel Jackson Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Building 17, Room 1717 104 TW Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-7826 FAX: (919) 541-2503 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7378. Applications must be received by December 20, 1994. If an application is received after that date, it will be returned to the applicant. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to Dr. Ethel Jackson at the address listed under LETTER OF INTENT. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIEHS staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIEHS in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. The second level of review will be provided by the National Advisory Environmental Health Sciences Council. Review criteria for RFAs are generally the same as those for unsolicited research grant applications. o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly but not exclusively in the area of the proposed research; o availability of resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research. The subject of this RFA may overlap interests of other Institutes, Centers and Divisions (ICDs). Applications will, therefore, be assigned according to extant Referral Guidelines. AWARD CRITERIA This anticipated date of award is July 1, 1994. The following will be considered in making funding decisions. o quality of proposed programs as determined by peer review, o availability of funds; and o program balance among research areas of the RFA. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Jerrold J. Heindel, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, 104 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-0781 FAX: (919) 541-2843 Email: Heindel_J@NIEHS.NIH.GOV Direct inquiries regarding fiscal matters to: Mr. David L. Mineo Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 104 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-1371 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.113 and 93.115. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 43 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun Oct 09 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 9 October 1994 Date: 10 Oct 1994 02:46:57 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 110 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <37b2ih$ccc@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: General Publication Title: NSF 94-2a Grant Proposal Guide - Appendix A File size (bytes): 14477 STIS Filename: nsf942a Also available: nsf942a.doc Title: NSF 94-2c Grant Proposal Guide - Appendix C File size (bytes): 2628 STIS Filename: nsf942c Also available: nsf942c.doc Document Type: News Title: Media Tipsheet October 7, 1994 File size (bytes): 3911 STIS Filename: tip41007 Document Type: Press Release Title: "SUPERSONIC ABRASIVE ICE-BLASTING," AN ENVIRONMENTALLY FRIENDLY METHOF OF REMOVING PAINT OR GREASE FROM SURFACES, DEVELOPED WITH NSF FUNDING File size (bytes): 6057 STIS Filename: pr9458 Document Type: Program Guideline Title: NSF 94-122 - Human Resource Development for Minorities in Science and Engineering File size (bytes): 164331 STIS Filename: nsf94122 Also available: nsf94122.ps Title: NSF 94-146 -- Doctoral Dissertation Improvement Grants In The Directorate For Biological Sciences File size (bytes): 11639 STIS Filename: nsf94146 Document Type: SRS Report Title: NSF 94-305--Science and Engineering Degrees- 1966-91 File size (bytes): 5328 STIS Filename: nsf94305 Also available: nsf94305.zip ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Program Guideline Title: NSF 94-147 -- RESEARCH PLANNING GRANTS AND CAREER ADVANCEMENT AWARDS FOR MINORITY SCIENTISTS AND ENGINEERS File size (bytes): 43070 STIS Filename: nsf94147 Document Type: SRS Report Title: NSF 93-309 -- Academic Science and Engineering- Graduate Enrollment and Support Fall -1991 File size (bytes): 37512 STIS Filename: nsf93309 Also available: nsf93309.zip ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf93309, the text of your message should be as follows: get nsf93309 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf93309, you would enter: ftp> get nsf93309 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Sun Oct 09 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 35, pt. 1of1, 7 October 1994 Date: 10 Oct 1994 03:26:41 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1147 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <37b4t1$e8r@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19941007 V23N35 P1O1 ************************************ X-comment: RFAS described: ES-95-002, CA-95-002, DK-95-001, HL-95-003, HL-95- 004, HL-95-005, HL-95-006, ES-94-009, PA-95-001 NIH GUIDE - Vol. 23, No. 35 - October 7, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION $$INDEX N2 ********************************************************** SUMMARY OF TECHNICAL REVIEWS AVAILABLE ON NIDA BBS National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX N3 ********************************************************** NIGMS MOVES TO NATCHER BUILDING, REORGANIZES National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** CLINICAL COORDINATING CENTER FOR ETIOLOGY OF SARCOIDOSIS: A CASE CONTROL STUDY (RFP NHLBI-HR-94-20) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R2 ********************************************************** TECHNICAL, ANALYTICAL AND SUPPORT SERVICES FOR THE NHLBI (RFP NHLBI-HO-94-33) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R3 ********************************************************** 1996-1997 NATIONAL SURVEY OF THE ORAL HEALTH OF U.S. SCHOOLCHILDREN (RFP NIH-NIDR-4-94-10R) National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX R4 01/13/95 ************************************************* ENVIRONMENTAL JUSTICE: PARTNERSHIPS FOR COMMUNICATION (RFA ES-95-002) National Institute of Environmental Health Sciences INDEX: ENVIRONMENTAL HEALTH SCIENCES $$INDEX R5 02/17/95 ************************************************* OCCUPATIONAL EXPOSURE AND CANCER PREVENTION/CONTROL RESEARCH (RFA CA-95-002) National Cancer Institute National Institute of Occupational Safety and Health INDEX: CANCER; OCCUPATIONAL SAFETY, HEALTH $$INDEX R6 03/16/95 ************************************************* DIABETES RESEARCH AND TRAINING CENTER (RFA DK-95-001) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY $$INDEX R7 03/29/95 ************************************************* BEHAVIORAL INTERVENTIONS FOR CONTROL OF TUBERCULOSIS (RFA HL-95-003) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R8 04/11/95 ************************************************* THE ETIOLOGY OF EXCESS CARDIOVASCULAR DISEASE IN DIABETES MELLITUS (RFA HL-95-004) National Heart, Lung and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R9 05/18/95 ************************************************* ISCHEMIC HEART DISEASE IN BLACKS (RFA HL-95-005) National Heart, Lung and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R10 12/08/95 ************************************************ SPECIALIZED CENTERS OF RESEARCH IN MOLECULAR MEDICINE AND ATHEROSCLEROSIS (RFA HL-95-006) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R11 12/20/94 ************************************************ MECHANISTICALLY-BASED ALTERNATIVE METHODS IN TOXICOLOGY (RFA ES-94-009) National Institute of Environmental Health Sciences INDEX; ENVIRONMENTAL HEALTH SCIENCES $$INDEX P1 ********************************************************** FACTORS THAT DETERMINE THERAPEUTIC DRUG BIOAVAILABILITY (PA-95-001) National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 23, Number 35, October 7, 1994 P.T. 42; K.W. 0783005 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human subjects. The meetings should be of special interest to those persons currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all other Public Health Service agencies. The current schedule includes: DATES: December 8-9, 1994 LOCATION Seven Hills Center San Francisco State University San Francisco, CA SPONSORS San Francisco State University, San Francisco, CA California State University, Los Angeles, CA REGISTRATION Darlene Yee, Ph.D. Chair, Committee for the Protection of Human Subjects Office of Research Sponsored Programs San Francisco State University 20 Tapia Drive San Francisco, CA 94132 Telephone: (415) 452-1908 FAX: (415) 338-6378 TITLE: Current Issues in Research Involving Human Subjects DESCRIPTION: Institutional Review Boards (IRBs) are charged with responsibilities for ethical review and oversight of the use of human subjects in research protocols. The primary principle governing the IRB's review and action is the protection of human subjects from risks while permitting the advancement of research. IRBs are faced today with complex concerns that require deep ethical and moral judgements, and they are challenged to act in an objective and timely fashion. Our workshop will focus on current issues in research involving human subjects: evolving concerns for protection of human subjects from research risks; FDA regulatory update; new guidelines on the inclusion of women and communities of color in clinical research; guidelines for human embryo research; ethics and philosophy of research with vulnerable populations such as children, the elderly, and those who are cognitively impaired and/or physically challenged; lessons learned from historical episodes in research; changing demographics of research in California; and emerging issues in research involving prisoners. The workshop formats will include facilitated forums, information exchanges, panel discussions, and active audience participation. We have assembled an outstanding faculty of distinguished experts to provide authoritative and provocative discussion of challenging issues in the field of human subjects research review. Participants will (1) learn how Federal regulations and community participation can protect human subjects in research, (2) become familiar with the issues involved in protecting the rights of vulnerable populations in research, (3) explore how regulations and community participation can collaborate to protect human subjects, (4) become more knowledgeable about policies, procedures, and expectations of an IRB, and (5) discuss the rights and responsibilities of researchers. INQUIRIES For further information regarding these workshops or future NIH/FDA National Human Subject Protections Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B-59 Rockville, MD 20892-2018 Telephone: (301) 496-8101 FAX: (301) 402-0527 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** SUMMARY OF TECHNICAL REVIEWS AVAILABLE ON NIDA BBS NIH GUIDE, Volume 23, Number 35, October 7, 1994 P.T. 16; K.W 0404009 National Institute on Drug Abuse Summaries of National Institute on Drug Abuse (NIDA) technical reviews are now available on NIDA's Bulletin Board System. Current summaries available include: 1. Cocaine Induced Neurotoxicity: Implications for Treatment 2. Qualitative Methods in Drug Abuse and HIV Research 3. Prevention Interventions with African American Populations 4. Laboratory Behavioral Studies of Vulnerability to Drug Abuse The NIDA bulletin board is a selection on the NIH Bulletin Board System and can be reached at 1-800-358-2221. Modem settings are 7 data bits, even parity and 1 stop bit. Logon initials FN5 and account FNF1 have been established for use by the public at no charge. INQUIRIES For additional information, contact Connie Latzko Information Resource Management Branch National Institute on Drug Abuse 5600 Fishers Lane Parklawn Building, Room 11A41 Rockville, MD 20857 Telephone: (301) 443-6910 Email: cl77g@nih.gov $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NIGMS MOVES TO NATCHER BUILDING, REORGANIZES NIH GUIDE, Volume 23, Number 35, October 7, 1994 P.T.34; K.W. 1014006 National Institute of General Medical Sciences On October 7, 1994, the staff of the National Institute of General Medical Sciences (NIGMS) moves to the new William H. Natcher Building on the main NIH campus. The mailing address is: (Name of staff member) NIGMS, NIH 45 Center Drive MSC 6200 Bethesda, MD 20892-6200 Telephone and FAX numbers are changing as well. Listed below are the new telephone numbers for key NIGMS staff members. For the telephone number of an NIGMS staff member who is not included on this list, call the person's old number (a recording will give the new number for several weeks) or call the NIGMS Office of Research Reports at (301) 496-7301. The following list also reflects the NIGMS' reorganization, effective October 1, 1994. The reorganization was undertaken to enhance the NIGMS' effectiveness and efficiency in supporting basic biomedical research and research training, as well as to align NIGMS' organizational structure and position titles with those of other NIH institutes. The most significant change is the rearrangement of four program branches--Cellular and Molecular Basis of Disease, Genetics, Biophysics and Physiological Sciences, and Pharmacology and Biorelated Chemistry--into three divisions: Cell Biology and Biophysics; Genetics and Developmental Biology; and Pharmacology, Physiology, and Biological Chemistry. In addition, the recently established Minority Opportunities in Research Programs Branch becomes the Division of Minority Opportunities in Research. The reorganization is not intended to reflect changes in NIGMS support for specific areas of science; in fact, the grant portfolios managed by individual program administrators will remain essentially the same. For additional information on the reorganization, contact the NIGMS Office of Research Reports at the above telephone number. Acting Director, Marvin Cassman, Ph.D. -- (301) 594-2172 Executive Officer, Martha Pine -- (301) 594-2755 Personnel Officer, Howard Chernoff -- (301) 594-2749 Equal Employment Opportunity Officer, Karen Basnight -- (301) 594-2751 Associate Director for Extramural Activities, W. Sue Shafer, Ph.D. -- (301) 594-4499 Chief, Grants Administration Branch, Carol Tippery -- (301) 594-5135 Assistant Director for Referral and Liaison, Anthony Rene, Ph.D. -- (301) 594-3833 Assistant Director for Research Training, John Norvell, Ph.D. -- (301) 594-0533 Director, Division of Cell Biology and Biophysics, James Cassatt, Ph.D. -- (301) 594-0828 Director, Division of Genetics and Developmental Biology, Judith Greenberg, Ph.D. -- (301) 594-0943 Director, Division of Minority Opportunities in Research, Clifton Poodry, Ph.D. -- (301) 594-3900 Acting Director, Division of Pharmacology, Physiology, and Biological Chemistry, Michael Rogers, Ph.D. -- (301) 594-3827 Chief, Office of Scientific Review, Helen Sunshine, Ph.D. -- (301) 594- 3663 $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NHLBI-HR-94-20 ******************************************* CLINICAL COORDINATING CENTER FOR ETIOLOGY OF SARCOIDOSIS: A CASE CONTROL STUDY NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFP AVAILABLE: NHLBI-HR-94-20 P.T. 34; K.W. 0755030, 0765034, 0755018 National Heart, Lung, and Blood Institute The overall objective of this program is to support a six year multi-center case-control study on the potential etiologic factors for sarcoidosis. This program will consist of up to twelve clinical centers which will recruit 840 sarcoidosis patients and 1680 control subjects for study over a four year period. The cases will also be followed to gain information on the natural history of this disease including risk factors for progression of disease. The protocol to be developed during Phase I (12 Months) will include a comprehensive clinical characterization of each participant and determination of markers of immune responsiveness. During Phase II (48 Months) the coordinating center will collect, manage and analyze the data from the clinical centers. In addition, the coordinating center will organize and manage the biological banking system in collaboration with the NHLBI-supported repository. The clinical coordinating center will: (1) assume leadership in areas of statistics and epidemiology for the study; (2) coordinate and manage meetings of the steering committee with direction from NHLBI; (3) participate in steering committee meetings and produce and distribute minutes of these meetings; (4) interact with the clinical centers in preparing the specific study protocol, reporting forms, and the manual of operations; (5) assist the Project Officer in preparing the agendas for periodic meetings of the Policy Board and make presentations at the Policy Board meetings; (6) standardize, print, and distribute reporting forms, the study protocol, and the manual of operations; (7) receive, collect, process, store, provide quality control and analyze data collected from the participating clinical centers; (8) prepare and distribute periodic technical and statistical reports to the participating clinical centers, the project officer, and the contracting officer. During Phase III (12 Months) the coordinating center will collaborate with the other study investigators and project officer in developing and writing manuscripts describing results of the study. Coordinating Center staff will collaborate fully in the development of the study protocol, monitor the clinical centers to ensure that data are reviewed for completeness and that quality control is maintained prior to processing, and conduct proper statistical analysis of the data. Under the direction of the Principal Investigator, these persons will monitor the clinical centers' activities to insure that: (1) data are forwarded in accordance with an established time schedule, (2) data are reviewed for accuracy and completeness, (3) quality control is maintained prior to and during processing of data, and (4) data is analyzed using appropriate statistical tests. This proposed program is a 100 percent set-aside for small business competition. Only responsible small business firms as defined in Part 19 of the Federal Acquisition Regulation are asked to respond to this synopsis. The Standard Industrial Classification (SIC) Code is 7379. This announcement is for a clinical coordinating center only. A separate Request for Proposals (RFP) for the clinical centers will be released. INQUIRIES RFP NHLBI-HR-94-20 is now available and proposals are due on or about November 1, 1994. Copies of the RFP may be obtained by submitting a written request along with three self-addressed mailing labels to: Pamela S. Randall Contracts Operations Branch National Heart, Lung, and Blood Institute Westwood Building, Room 654 Bethesda, MD 20892 $$R1 END ************************************************************ $$R2 BEGIN NHLBI-HO-94-33 ******************************************* TECHNICAL, ANALYTICAL AND SUPPORT SERVICES FOR THE NATIONAL HEART, LUNG, AND BLOOD INSTITUTE NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFP AVAILABLE: NHLBI-HO-94-33 P.T. 01; K.W. 0780000 National Heart, Lung, and Blood Institute The National Heart, Lung, and Blood Institute (NHLBI) will make available to interested offerors a request for proposal (RFP) to provide services in support of the National Heart, Blood Vessel, Lung, and Blood Diseases and Blood Resources Program. The NHLBI supports and/or sponsors a variety of task forces, conferences, and workshops and prepares numerous reports and technical documents. Many of these activities are related to assessment of the state of knowledge in a particular disease or problem area, identification of progress in that area, and formulating recommendations for future research. Support services are required to assist in conducting such activities and in preparing resulting reports and proceedings. There are three basic services to be provided. The first service is to provide administrative support to scientific working groups. This work will include the making of logistical arrangements for scientific meetings of technical experts; development, preparation, and distribution of technical and other support materials for meetings; documentation of meetings; and preparation of summary materials. The second major service is to provide documentation support to the NHLBI. This work will involve the preparation and reproduction of scientific documents and documentation support for preparation of reports and briefing materials including required editing. The third major service involves providing analytical support to the NHLBI. This task includes the compilation and interpretation of scientific and administrative data and the development of suitable graphs, tables and narratives. This task also involves the analysis and documentation of existing programs and support systems and will be followed by development and implementation of new or updated systems. The contract period of performance will be for five years. The project staff of the successful offeror must be available to meet with NHLBI program staff at the NIH in Bethesda, Maryland with as little as two hours advance notice. INQUIRIES This announcement is not an RFP. It is anticipated that RFP NHLBI-HO-94-33 is not available. Copies of the RFP may obtained by submitting a written request and three self-addressed mailing labels to: Douglas W. Frye Contracts Operations Branch, DEA National Heart, Lung, and Blood Institute Federal Building, Room 4C04 7550 Wisconsin Avenue, MSC 9070 Bethesda, MD 20892-9070 Telephone: (301) 496-6838 FAX: (301) 496-9501 To ensure timely receipt of requests for RFP No. NHLBI-HO-94-33, facsimile requests will be accepted. $$R2 END ************************************************************ $$R3 BEGIN NIH-NIDR-4-94-10R **************************************** 1996-1997 NATIONAL SURVEY OF THE ORAL HEALTH OF U.S. SCHOOLCHILDREN (OHSC III) NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFP AVAILABLE: NIH-NIDR-4-94-10R P.T. 34; K.W. 0404021, 0715148, 0785055 National Institute of Dental Research The National Institute of Dental Research (NIDR) has a requirement for the design and implementation of a nationwide oral epidemiologic survey of U.S. schoolchildren, grades K through 12. The survey will provide the database for a historical analysis of trends in dental caries and other oral health characteristics of U.S. schoolchildren. It will provide, for the first time, statistically reliable estimates of the oral health of Black and Hispanic schoolchildren in the United States. The objectives of this survey are to: (1) assess the relative frequency and sociodemographic distribution of certain oral diseases and disorders in U.S. schoolchildren, (2) over-sample selected minority schoolchildren to provide statistically reliable baseline national estimates of oral health for Black non-Hispanic and Hispanic schoolchildren, and (3) provide the database for the late nineties, needed to evaluate shorter- and longer-term trends in coronal caries and certain other oral diseases and disorders. INQUIRIES This is an announcement of an anticipated Request for Proposal (RFP). RFP No. NIH-NIDR-4-94-10R will be available approximately October 21, 1994, with a closing date tentatively set for December 16, 1994. Requests for the RFP must be submitted in writing, addressed to: Marion L. Blevins Contract Management Section National Institute of Dental Research Westwood Building, Room 533 Bethesda, MD 20892 $$R3 END ************************************************************ $$R4 BEGIN ES-95-002 FULL-TEXT ************************************** ENVIRONMENTAL JUSTICE: PARTNERSHIPS FOR COMMUNICATION NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFA AVAILABLE: ES-95-002 P.T. 34; K.W. 0725030, 0730050 National Institute of Environmental Health Sciences Letter of Intent Receipt Date: November 17, 1994 Application Receipt Date: January 13, 1995 PURPOSE The purpose of this program is to strengthen the NIEHS effort that supports research aimed at achieving environmental justice for socioeconomically disadvantaged and medically underserved populations in the United States. The main objective of this RFA is to establish methods for linking members of a community, who are directly affected by adverse environmental conditions, with researchers and health care providers. The estimated total funds available for the first year of support are anticipated to be $500,000. It is anticipated that one to three grants will be awarded depending upon the availability of funds for this purpose and the quality of the applications received. Awards are not renewable and supplements are not allowed. 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, Environmental Justice: Partnerships for Communication, is related to the priority area of environmental health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington DC 20402-9325 (telephone 202-783-3238). 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) and the NIH GOPHER via Internet, and in print from the program contact listed below. Allen Dearry, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 Research Triangle Park, NC 27709 Telephone: (919) 541-7825 / 4943 FAX: (919) 541-2843 EMAIL: DEARRY@NIEHS.NIH.GOV $$R4 END ************************************************************ $$R5 BEGIN CA-95-002 FULL-TEXT ************************************** OCCUPATIONAL EXPOSURE AND CANCER PREVENTION/CONTROL RESEARCH NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFA AVAILABLE: CA-95-002 P.T. 34; K.W. 0725020, 0715035, 0745027 National Cancer Institute National Institute of Occupational Safety and Health Letter of Intent Receipt Date: January 10, 1995 Application Receipt Date: February 17, 1995 PURPOSE The purpose of this Request for Applications (RFA) is to stimulate innovative epidemiologic studies aimed at promoting cancer control research activities. Approximately $2.0 million per year in total costs for four years will be committed by the National Cancer Institute (NCI) to specifically fund applications submitted in response to this RFA. In addition, $300,000 per year in total costs will be committed by the National Institute of Occupational Safety and Health (NIOSH) to fund at least one application. The expected number of awards is six to eight. 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, Occupational Exposure and Cancer Prevention/Control Research, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). 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) and the NIH GOPHER (gopher.nih.gov) and by mail and email from the program contacts listed below. Richard L. Bragg, Ph.D. Division of Cancer Prevention and Control National Cancer Institute 6130 Executive Boulevard MSC 7395 Executive Plaza North, Suite 240 Bethesda, MD 20892-7395 Telephone: (301) 496-8589 FAX: (301) 496-8675 Roy M. Fleming, Sc.D. National Institute of Occupational Safety and Health 1600 Clinton Road, NE Building l, Room 3053, Mail Stop D-30 Atlanta, GA 30333 Telephone: (404) 639-3343 FAX: (404) 639-2196 $$R5 END ************************************************************ $$R6 BEGIN DK-95-001 FULL-TEXT ************************************** DIABETES RESEARCH AND TRAINING CENTER NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFA AVAILABLE: DK-95-001 P.T. 04; K.W. 0715075, 0720005, 0710030 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 16, 1995 Application Receipt Date: March 16, 1995 PURPOSE The National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) supports six Diabetes Research and Training Centers (DRTCs). These Centers are part of an integrated program of diabetes-related research support within the NIDDK. Centers have provided a focus for increasing the efficiency and collaborative effort among groups of successful investigators at institutions with established comprehensive diabetes research bases. The NIDDK invites applications for funding of one DRTC grant to be competitively awarded in Fiscal Year 1996. Support of this program will be through the National Institutes of Health (NIH) comprehensive center (P60) award. The NIDDK anticipates awarding one DRTC Grant in Fiscal Year 1996 on a competitive basis. The receipt of one competing continuation application is anticipated, which will be in competition together with the other applications received in response to this announcement. The anticipated award will be for five years and will be contingent upon the availability of appropriated funds. Requests for support must be limited to no more than $1,250,000 in direct costs per year. Requests for support for Demonstration and Education (D&E) supplements to convert an existing DERC to a DRTC must be limited to $300,000 in direct costs. If awarded, the D&E supplement funding would be added to the level of the existing DERC budget. The $1,250,000 direct cost application limit would then apply to future DRTC competing renewals. The NIDDK has allocated $1,657,000 in total costs to support this RFA. Any application exceeding the direct cost amounts indicated will be returned to the applicant. 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, Diabetes Research and Training Centers, is related to the priority area of diabetes mellitus. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: (202) 783-3238). 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) and the NIH GOPHER via Internet, and in print from the program contact listed below. Dr. Sanford A. Garfield Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 626 45 Center DR MSC 6600 Bethesda, MD 20892 Telephone: (301) 594-7535 FAX: (301) 594-9011 $$R6 END ************************************************************ $$R7 BEGIN HL-95-003 FULL-TEXT ************************************** BEHAVIORAL INTERVENTIONS FOR CONTROL OF TUBERCULOSIS NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFA AVAILABLE: HL-95-003 P.T. 34; K.W. 0715165, 0745027, 0404000 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: February 15, 1995 Application Receipt Date: March 29, 1995 PURPOSE The purpose of this solicitation is to encourage research to develop, implement, and evaluate behavioral interventions for the control of tuberculosis. Plans that include the development, implementation, and evaluation of programs that can serve as models for other areas of the country will be given priority for consideration. This RFA solicits applications for the National Institutes of Health (NIH) individual research project grant (R01) support mechanism. The estimated funds (total costs) available for the first year of support for the entire program is $1.84 million. It is anticipated that no more than five awards will be issued under this program. Since a variety of approaches would represent valid responses to this RFA, it is anticipated that there will be a range of costs among individual grants awarded. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Behavioral Interventions for Control of Tuberculosis, is related to the priority area of immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). 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) and the NIH GOPHER via Internet, and in print from the program contact listed below. Mary S. Reilly, M.S. Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 640 Bethesda, MD 20892 Telephone: (301) 594-7466 FAX: (301) 594-7487 $$R7 END ************************************************************ $$R8 BEGIN HL-95-004 FULL-TEXT ************************************** THE ETIOLOGY OF EXCESS CARDIOVASCULAR DISEASE IN DIABETES MELLITUS NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFA AVAILABLE: HL-95-004 P.T. 34; K.W. 0715040, 0715075, 0755030, 0765033 National Heart, Lung and Blood Institute Letter of Intent Receipt Date: January 6, 1995 Application Receipt Date: April 11, 1995 PURPOSE The National Heart, Lung, and Blood Institute (NHLBI) and the Juvenile Diabetes Foundation International (JDFI), invite applications for program project grants for research on the etiology of cardiovascular diseases (CVD) associated with diabetes mellitus. This initiative will support investigators with outstanding programs of basic and human subjects research on one or more diabetes associated cardiovascular complications. In addition, these programs, with the encouragement of the NHLBI, will participate in a coordinated effort to evaluate the metabolic and environmental factors responsible for the pathogenesis of CVD in existing, defined population groups. A program project grant is for the support of a broadly-based multidisciplinary or multifaceted research program that has a specific major objective or central theme. Each program project application and award in response to this solicitation must have both basic research and human subjects components. Applications should be submitted to and will be reviewed by the NIH according to the usual NIH peer review procedures. Applications judged meritorious will be jointly funded by NHLBI and JDFI. To have an application reviewed and considered for funding by the JDFI, applicants must authorize the NHLBI in writing to provide a copy of their letter of intent, application, and NIH prepared summary statement of the initial review to the JDFI. Approximately $1.8 million in total costs will be provided for the first year of support for the entire program by NHLBI with an equivalent amount contributed by JDFI. Applicants may request up to $650,000 direct costs, not including indirect costs for collaborating institutions, in the first year with a maximum increase of no more than four percent in each additional year requested in the application. It is anticipated that three to five grants will be awarded under this program. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, The Etiology of Excess Cardiovascular Disease in Diabetes Mellitus, is related to the priority areas of heart disease and stroke, and 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 202-783-3238). 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) and the NIH GOPHER via Internet, and in print from the program contact listed below. David M. Robinson, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Federal Building, Room 416 7750 Wisconsin Avenue, MSC 9070 Bethesda, MD 20892-9070 Telephone: (301) 496-5656 FAX: (301) 402-3508 Email: drw@cu.nih.gov $$R8 END ************************************************************ $$R9 BEGIN HL-95-005 FULL-TEXT ************************************** ISCHEMIC HEART DISEASE IN BLACKS NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFA AVAILABLE: HL-95-005 P.T. 04, FC; K.W. 0715040, 0715075, 0710030 National Heart, Lung and Blood Institute Letter of Intent Receipt Date: November 30, 1994 Application Receipt Date: May 18, 1995 PURPOSE This Request for Applications (RFA) invites grant applications to enter into a single open competition for Specialized Centers of Research (SCOR) in Ischemic Heart Disease in Blacks. Applicants should select one of three themes, Sudden Cardiac Death, Microvascular Disease, or Diabetic Heart Disease as the focus of their applications. The goal of this initiative is to foster an interdisciplinary study of issues surrounding the expression of heart disease in Blacks. To this end, applicants must present an application that encompasses both basic and clinical science, including studies in Black patients. A SCOR provides the opportunity for investigators to engage in interdisciplinary and collaborative research that is focused on a specific disease or an area within a disease category. It is required that SCOR applications include studies of human subjects as well as basic studies clearly related to a disease area. The foundation of the clinical component should be strongly linked to the basic science projects; the basic science studies should be driven by the needs of the clinical projects. Thus, a SCOR has a central theme to which all research projects pertain. In addition, a SCOR may include CORE units to provide services to the various research projects and to support the organizational and administrative aspects of the program. In addition, to encourage women and underrepresented minority investigators to work within a SCOR project, to facilitate recruitment of new scientists to this area of research, and to foster cutting edge and innovative research directions, each SCOR program may support up to two investigators by utilizing up to $50,000 per year per investigator to fund pilot and feasibility projects. This will allow underrepresented minority investigators to acquire skills and data to make them more competitive in seeking independent research support (e.g., R01, R29). These funds will not be supplements, but rather specific dollars identified in the SCOR budget for this purpose. The recipients would be chosen based on a proposal written by a SCOR investigator and reviewed by an internal review committee at the parent institution. Approximately $4.8 million in total costs will be provided for the first year of support for the entire program. Applicants may request up to $1,080,000 direct costs, not including indirect costs for collaborating institutions, in the first year with a maximum increase of no more than four percent in each additional year requested in the application. It is anticipated that up to three grants will be awarded under this program. 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, Specialized Centers of Research in Ischemic Heart Disease in Blacks, is related to the priority areas of heart disease and stroke, and 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 202-783-3238). 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) and the NIH GOPHER via Internet, and in print from the program contact listed below. Dr. Patrice Desvigne-Nickens Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Federal Building, Room 3C06 7550 Wisconsin Avenue MSC 9050 Bethesda, MD 20892-9050 Telephone: (301) 496-1081 FAX: (301) 480-6282 $$R9 END ************************************************************ $$R10 BEGIN HL-95-006 FULL-TEXT ************************************* SPECIALIZED CENTERS OF RESEARCH IN MOLECULAR MEDICINE AND ATHEROSCLEROSIS NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFA AVAILABLE: HL-95-006 P.T. 04; K.W. 0715040, 1002008, 0765035, 0755020, 0745032 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: October 9, 1995 Application Receipt Date: December 8, 1995 PURPOSE The objectives of this new cycle of Specialized Centers of Research (SCORs) are to focus on studies on the pathobiology of the atherosclerotic lesion at the level of the arterial wall. Such studies may include investigations of the mechanisms for lesion susceptibility and initiation; the mechanisms of lesion progression, complication, and regression; and the interactions of the vessel wall with systemic factors promoting atherogenesis. The new program emphasizes a shift away from studies with an exclusive focus on the structure and function of lipids and lipoproteins. The means for acquiring this new knowledge would involve exploitation of new techniques and strategies of molecular medicine such as gene transfer and gene mapping and identification, three-dimensional structural biology, vascular imaging, genetically modified animal models, and gene therapy, which can yield information that heretofore was inaccessible. All these techniques are complemented by clinical research disciplines as appropriate. Applicants may request up to $1,170,000 direct costs, not including indirect costs for collaborating institutions, in the first year, with a maximum increase of no more than four percent in each future year requested in the application. It is anticipated to support seven SCOR grants for a five year project period at an estimated first year total cost of $12.285 million. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Specialized Centers of Research in Molecular Medicine and Atherosclerosis, is related to the priority area of heart disease and stroke. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). 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) and the NIH GOPHER via Internet, and in print from the program contact listed below. Dr. Momtaz K. Wassef Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Federal Building, Room 4A12 7550 Wisconsin Avenue MSC 9050 Bethesda, MD 20892-9070 Telephone: (301) 496-1978 FAX: (301) 480-9882 $$R10 END *********************************************************** $$R11 BEGIN ES-94-009 FULL-TEXT ************************************* MECHANISTICALLY-BASED ALTERNATIVE METHODS IN TOXICOLOGY NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFA AVAILABLE: ES-94-009 P.T. 34; K.W. 1007009 National Institute of Environmental Health Sciences Letter of Intent Receipt Date: November 15, 1994 Application Receipt Date: December 20, 1994 PURPOSE The National Institute of Environmental Health Sciences (NIEHS) invites applications to conduct research to develop mechanistically-based alternative methods and models for toxicology research and testing. Assessment of the potential adverse health effects of chemicals is currently accomplished largely by tests utilizing laboratory animals. While such traditional tests have provided information useful for human health risk assessment, improved test methods are needed that are more predictive, that provide information more supportive of quantitative risk assessment, can be achieved in a shorter time frame, and are more cost-effective. This RFA is issued to foster the development, validation, and use of improved testing and research methods that either do not require the use of animals, reduce the number of animals, or involve the use of alternatives such as non-mammalian species. This NIEHS initiative will facilitate the integration of recent advances in molecular and cellular biology and new research technologies into alternative toxicology testing methodologies that will provide improved human health hazard identification and improved dose-response relationships, thereby contributing to improved risk assessment. The estimated funds (total costs) available for the first year of support for the entire program is $1.5 million. The expected number of awards is eight to ten. 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, Mechanistically-Based Alternative Methods in Toxicology, is related to the priority area of Environmental Health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington DC 20402-9325 (telephone 202-783-3238). 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) and the NIH GOPHER (Internet) and by mail and email from the program contact listed below. Jerrold J. Heindel, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, 104 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-0781 FAX: (919) 541-2843 Email: Heindel_J@NIEHS.NIH.GOV $$R11 END *********************************************************** $$P1 BEGIN PA-95-001 FULL-TEXT ************************************** FACTORS THAT DETERMINE THERAPEUTIC DRUG BIOAVAILABILITY NIH GUIDE, Volume 23, Number 35, October 7, 1994 PA AVAILABLE: PA-95-001 P.T. 34; K.W. 0740020, 0755025 National Institute of General Medical Sciences PURPOSE The purpose of this program announcement (PA) is to encourage basic research in the areas that are fundamental to understanding the factors that determine therapeutic drug bioavailability, with emphasis on the oral route of delivery. Support of this program announcement will be through individual research project grants (R01), FIRST awards (R29), program project (P01) grants, and awards to small businesses under the Small Business Innovation Research (SBIR) program (R43, R44) and the Small Business Technology Transfer Research (STTR) program (R41, R42). INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Rochelle M. Long, Ph.D. Pharmacology and Biorelated Chemistry Program National Institute of General Medical Sciences 45 Center Drive, Box 6200 Bethesda, MD 20892 Telephone: (301) 594-7808 FAX: (301) 594-7728 Direct inquiries regarding financial matters to: Ms. Toni Holland National Institute of General Medical Sciences 45 Center Drive, Box 6200 Bethesda, MD 20892 Telephone: (301) 594-7819 FAX: (301) 594-8891 $$P1 END ************************************************************ From owner-sci-resources@net.bio.net Sun Oct 09 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-95-003 - V23(35) 10/07/94 Date: 10 Oct 1994 03:26:49 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 546 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <37b4t9$e9f@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL95003 HL-95-003 P1O1 *************************************** BEHAVIORAL INTERVENTIONS FOR CONTROL OF TUBERCULOSIS NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFA: HL-95-003 P.T. 34; K.W. 0715165, 0745027, 0404000 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: February 15, 1995 Application Receipt Date: March 29, 1995 PURPOSE The purpose of this solicitation is to encourage research to develop, implement, and evaluate behavioral interventions for the control of tuberculosis. Plans that include the development, implementation, and evaluation of programs that can serve as models for other areas of the country will be given priority for consideration. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Behavioral Interventions for Control of Tuberculosis, is related to the priority area of immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS 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 and local governments and eligible agencies of the Federal government. Applications from minority individuals, women, and new investigators are encouraged. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under this RFA. Awards under this RFA to foreign institutions will be made only for research of very unusual merit, need and promise, and in accordance with Public Health Service policy governing such awards. This solicitation may be of interest to investigators from a broad range of disciplines, including pulmonary medicine, infectious disease medicine, behavioral sciences, public health, biostatistics, and health education. Multidisciplinary approaches will be needed to meet the goals of the research. Applicants must demonstrate access to target and comparison or control populations, and expertise within the research team to conduct research that is sensitive to socio-cultural elements of the study population. MECHANISM OF SUPPORT The support mechanism for this program will be the National Institutes of Health (NIH), individual research grant (R01). While multidisciplinary approaches are encouraged, it is not the intent of this RFA to solicit applications for large studies encompassing a variety of individual subprojects, i.e., program projects. If collaborative arrangements through subcontracts with other institutions are planned, consult the program staff listed under INQUIRIES. Since the emphasis of this program is on behavioral interventions, it is recommended that applicants refer to "The Guidelines for Demonstration and Education Research Grants" (revised 9/87, with 2/93 supplement), which are available from the program administrator, listed under INQUIRIES. Upon initiation of the program, the NHLBI will sponsor periodic meetings to encourage exchange of information among investigators who participate in this program. In the budget for the grant application, applicants should request travel funds for a two-day meeting each year, most likely to held in Bethesda, Maryland. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings and cooperate with other researchers in this program. Applicants are expected to furnish their own estimates of time required to achieve the objectives of the proposed research; however, the award period for this activity must not exceed five years. Because a variety of approaches would represent valid responses to this RFA, it is anticipated that there will be a range of costs among individual grants awarded. This RFA is a one-time solicitation. Future unsolicited competing continuation applications may be submitted for peer review and competition for support through the regular grant program of the National Institutes of Health (NIH). It is anticipated that support for this program will begin in September 1995. Administrative adjustments in project period and/or amount may be required at the time of the award. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a case, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. The National Institute of Nursing Research (NINR) also has interest in behavioral interventions for tuberculosis control. Therefore, applications that are of mutual interest are likely to be given a secondary assignment to NINR in accordance with the NIH referral guidelines. FUNDS AVAILABLE Although financial plans for fiscal year 1995 include approximately $1,840,000 for the total cost of the program for the first year, award of grants pursuant to this RFA is contingent upon receipt of funds for this purpose. It is anticipated that no more than five awards will be issued under this program. The specific number to be funded will, however, depend on the merit and scope of the applications received and the availability of funds. RESEARCH OBJECTIVES Background Tuberculosis was on the decline from the 1950s until the mid 1980s; however, the United States is now experiencing a resurgence of tuberculosis. In 1992, approximately 27,000 new cases were reported, an increase of approximately 20 percent from 1985 to 1992. Not only are tuberculosis cases on the increase, but a serious aspect of the problem is the recent occurrence of outbreaks of multidrug resistant (MDR) tuberculosis, which poses an urgent public health problem and require rapid intervention. Tuberculosis is an infectious diseases caused by Mycobacterium tuberculosis, which is spread almost exclusively by airborne transmission. While the disease can affect any site in the body, it most often affects the lungs. Persons with a pulmonary tuberculosis cough and produce tiny droplet nuclei that contain tuberculosis bacteria that can remain suspended in the air for prolonged periods of time. Persons breathing the air containing these droplet nuclei can become infected with tuberculosis. Those who become infected with the tuberculosis bacillus remain infected for years. Those who have a healthy immune system usually do not become ill, however, antituberculosis drugs are often necessary in order to eliminate the infection. Persons with latent tuberculosis infection, as this condition is called, are asymptomatic and cannot spread tuberculosis to others. Generally, a positive tuberculosis skin test is the only evidence of infection. An estimated 10-15 million persons in this country are infected with M. tuberculosis. About 10 percent of the otherwise healthy persons who have latent tuberculosis infection will become ill with active tuberculosis at some time during their lives. Control programs involve two major components. First, and of highest priority, is to detect persons with active tuberculosis and treat them with effective antituberculosis drugs, which prevents death from tuberculosis and stops the transmission of infection to others persons. Treatment of active tuberculosis involves taking multiple antituberculosis drugs daily or several times weekly for at least six months. Failure to take the medications for the full treatment period may mean that the disease is not cured and may recur. If sufficient medications are not prescribed early and taken regularly, the tuberculosis organisms can become resistant to the drugs and the drug resistant tuberculosis then may be transmitted to other persons. Drug resistant disease is difficult and expensive to treat, and in some cases cannot be treated with available medications. The second major goal of control efforts is the detection and treatment of persons who do not have active tuberculosis, but who have latent tuberculosis infection. These people may be at high risk of developing active tuberculosis. The only approved treatment modality for preventive therapy requires treatment daily or twice weekly for minimum of six months and many patients do not complete a full course of therapy. Tuberculosis control poses special problems for a number of groups. One of these is the HIV infected, among whom the risk of tuberculosis is considerably greater than in the general population. Because of the breakdown of the immune system in HIV positive persons, the traditional tuberculin skin test may be unreliable and existence of other pulmonary infections in such persons may complicate the diagnosis, making it difficult to distinguish tuberculosis on chest X-rays. Failure to diagnose tuberculosis rapidly in HIV infected persons has led to higher mortality rates and more rapid transmission among that population. Penal institutions pose another special problem for tuberculosis control. Not only has the population in these institutions doubled, causing severe overcrowding and general decline in living conditions, but inmates generally come from lower socio-economic strata, tend to have poor health status, and are at higher risk for AIDS and tuberculosis as well as other medical conditions. The incidence of tuberculosis among incarcerated persons in 1984 and 1985 has been estimated at more than three times the rate in the general population. The existence of HIV positive inmates, the constant transferring of persons, lack of adequate health services and infrastructures, inadequate communication of medical information, and poor ventilation and overcrowding have contributed to making the transmission of tuberculosis a major medical problem. Not only is transmission of tuberculosis among prisoners a health problem for prisons, but also for the communities into which inmates are released. The disenfranchised are also being particularly hard hit by the resurgence of tuberculosis. The poor, the homeless, and drug users are among the most likely to contract and transmit tuberculosis. The influx of immigrants and refugees from countries with high tuberculosis rates also poses problems in control. Finding and coordinating treatments for individuals without a fixed address, such as migrants, is difficult, but assuring adherence to treatment plans is even more so. Recent outbreaks of multidrug resistant tuberculosis in large city hospitals have indicated the special needs to control tuberculosis in hospitals, nursing homes, and similar facilities. When tuberculosis was a common problem a generation ago, most health care providers had experience in treating the disease. Indeed a survey by the Centers for Disease Control in 1992 indicated that many physicians may not be aware of recommended treatment for tuberculosis. Thus, there is a need to educate and/or to reeducate physicians and other health care providers in modern tuberculosis control methods. In addition, public and patient programs are needed to increase the awareness of the problem among the general population, to promote early diagnosis and treatment, and to encourage adherence to therapy. The future of tuberculosis control will require more effective programs to identify and adequately treat active tuberculosis cases and to identify and prevent tuberculosis among those who have latent tuberculosis infection. Adherence to medical treatment, for example, remains a major problem in both groups. Behavioral interventions should contribute to solving the problems. Objectives and Scope The objective of this initiative is to seek ways of controlling the spread of tuberculosis through behavioral interventions. Studies responsive to this solicitation may focus on a community at large or upon specific population groups such as immigrants, migrants, institutionalized groups, HIV positive individuals, and ethnic minority populations or a combination of groups. As a component of an overall program, physicians and other health care providers as well as patients and their families may also be the target of research efforts. Systems approaches to detection, diagnosis, treatment, and control may be tested. Programs that mobilize community resources to increase access to care, integrate patient education into medical care, educate health professionals about tuberculosis control including patients needs and concerns, provide follow up as patients move among settings (e.g., from long term institutions to community), and increase patient adherence with treatment regimens are encouraged. Examples of questions that could be answered by studies developed through this solicitation include, but are not limited to, the following: o What interventions are effective in bringing persons with tuberculosis into treatment programs early? Are different interventions needed for different age, ethnic, or other special population groups or for differing levels of awareness or concern? o How can provider adherence to environmental controls in hospitals, penal institutions, nursing homes, and/or other sites contribute to reducing the spread of tuberculosis? What are the barriers to adherence with infection control and how can they be overcome? o What interventions result in patient adherence to treatment regimens? What interventions result in persons who have latent tuberculosis infection taking preventive therapy? o How can physicians and other health care providers best be trained to diagnose and treat tuberculosis early? What interventions change provider practice behaviors? o How can interpersonal communications be improved between health care providers and patients with tuberculosis? How can communications within and outside the health care organization contribute to community control programs? o How can significant barriers to tuberculosis control be overcome? o What patient education interventions are most effective? o What roles can families, employers, lay advocates, volunteers, and others play in helping to insure patient adherence to treatment regimens? How can these groups contribute effectively to local public health services? How can target populations be involved in educational and control efforts? o How can patients be assessed for the need for directly observed therapy? Are different sequences or combinations of services more effective in achieving adherence? What are options to supervised therapy to improve adherence? o What is the role of incentives? Which are most effective for what specific purposes? o What predictors (e.g., cultural, social, and personal factors) can be used to identify the factors associated with poor adherence and the development of multidrug resistant tuberculosis? o What are the relationships between interventions and medical outcomes? o What interventions result in improved collaborative efforts between private health care providers, health departments, and other health and community organizations, etc. that ultimately improve control of tuberculosis in the community? Innovative interventions involving patients and their families, use of community resources, special approaches (e.g., combination inpatient/outpatient centers; community coalitions or consortia), and program strategies based upon the cultural characteristics of the population are encouraged. Applications from minority scientists and minority institutions are especially encouraged. There is an interest in obtaining model programs that can be readily adapted for use in several sections of the country. Research designs should include the following elements: o a specified, well-defined population; o reliable and valid assessment of tuberculosis and provisions for monitoring changes, including laboratory services; o an appropriate theoretical basis for the intervention(s); o sufficient population to provide for a control or comparison group and to permit evaluation of the efficacy of the program; o availability of required medical care services and resources, including process data on quality of services; o evidence that the cultural and social characteristics of the study population have been taken into account in the study design and implementation of the program; o measurements of behavior change (e.g. adherence measures) related to control of tuberculosis. Assessment of other factors such as knowledge about tuberculosis, quality of life, use of medical care services, and cost effectiveness are also encouraged. o ability to obtain follow up data on patients for two years after intervention(s) to assess the efficacy of the interventions over time; SPECIAL REQUIREMENTS Although the research design may build from an existing tuberculosis control programs, the studies should test hypotheses specifically related to the targeted population and assess innovative approaches to interventions. Funding requests for support of existing tuberculosis control programs without a research component would not be considered responsive to this solicitation. Investigations of the effectiveness of clinical therapies also will be excluded. Interdisciplinary approaches that include medicine, behavioral science, and education are strongly encouraged. If collaborative arrangements through subcontracts with other institutions are planned, consult the NHLBI Grants Operations Branch (301) 594-7420 regarding procedures. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 28, 1994, Volume 23, Number 11. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by February 15, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NHLBI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. C. James Scheirer, at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Use the conventional format for research project grant applications and ensure the points identified in the section REVIEW CONSIDERATIONS are fulfilled. To identify the application as a response to this RFA, check "YES" on item 2a of page 1 of the application and enter the title "Behavioral Interventions for Control of Tuberculosis" HL-95-003. The RFA label found in form PHS 398 application kit must be affixed to the bottom of the face page of the original completed application form PHS 398. 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. Send or deliver the completed application and three signed photocopies in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Send two additional copies of the application to the Chief, Centers and Special Projects Review Section at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants. Otherwise the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by March 29, 1995. If an application is received after this date, it will be returned to the applicant without review. The 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 the DRG and responsiveness to this RFA by the NHLBI. Incomplete applications will be returned without further consideration. If an application is judged unresponsive, the applicant will be contacted and given an opportunity to withdraw the application or to have it considered for the regular, investigator-initiated grant program of the NIH. Applications judged to be responsive will be reviewed for scientific and technical merit by an initial review group, which will be convened by the Division of Extramural Affairs, NHLBI, solely to review these applications. Applications should be prepared so that they can be reviewed without the necessity of interaction between applicants and reviewers since no site visit or reverse site visit will be part of the technical merit review. At this initial review a preliminary evaluation will determine the scientific merit relative to the other applications received in response to this RFA (triage); the NIH will withdraw from further consideration applications judged to be noncompetitive and promptly notify the principal investigator and the official signing for the applicant organization. Those applications judged to be competitive will be further evaluated for scientific/technical merit by the usual peer review procedures. Review Criteria. The factors to be considered in the evaluation of scientific merit of each application will be similar to those used in the review of traditional research project grant applications including the novelty, originality, and feasibility of the approach; the training, experience, and research competence of the investigator(s); the adequacy of the experimental design; the suitability of the facilities; the appropriateness of the requested budget to the work proposed; and the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. AWARD CRITERIA The anticipated date of award is September 1995. In addition to the scientific merit of the applications, awards will be based on responsiveness to the RFA and the availability of resources. In order to more evenly distribute administrative workload and reduce the number of awards with July 1 or September 30 start dates, the NHLBI will award ten months of time and money for the first competing budget period of this project. This action results in a project period of 46 months rather than 48 months. Investigators should plan their research projects and budgets within these timeframes. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Mary S. Reilly, M.S. Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 640 Bethesda, MD 20892 Telephone: (301) 594-7466 FAX: (301) 594-7487 Direct inquiries regarding review matters and address the letter of intent to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 557 Bethesda, MD 20892 Telephone: (301) 594-7478 FAX: (301) 594-7407 Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A17 Bethesda, MD 20892 Telephone: (301) 594-7420 FAX: (301) 594-7492 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.838. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to review by a Health Systems Agency. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of American people. From owner-sci-resources@net.bio.net Sun Oct 09 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-95-004 - V23(35) 10/07/94 Date: 10 Oct 1994 03:27:11 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 861 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <37b4tv$eai@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL95004 HL-95-004 P1O1 *************************************** THE ETIOLOGY OF EXCESS CARDIOVASCULAR DISEASE IN DIABETES MELLITUS NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFA: HL-95-004 P.T. 34; K.W. 0715040, 0715075, 0755030, 0765033 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: January 6, 1995 Application Receipt Date: April 11, 1995 PURPOSE The National Heart, Lung, and Blood Institute (NHLBI) and the Juvenile Diabetes Foundation International (JDFI), invite applications for program project grants for research on the etiology of cardiovascular diseases (CVD) associated with diabetes mellitus. This initiative will support investigators with outstanding programs of basic and human subjects research on one or more diabetes associated cardiovascular complications. In addition, these programs, with the encouragement of the NHLBI, will participate in a coordinated effort to evaluate the metabolic and environmental factors responsible for the pathogenesis of CVD in existing, defined population groups. A program project grant is for the support of a broadly-based multidisciplinary or multifaceted research program that has a specific major objective or central theme. Each program project application and award in response to this solicitation must have both basic research and human subjects components. Applications should be submitted to and will be reviewed by the National Institutes of Health (NIH) according to the usual NIH peer review procedures. Applications judged meritorious will be jointly funded by NHLBI and JDFI. To have an application reviewed and considered for funding by the JDFI, applicants must authorize the NHLBI in writing to provide a copy of their letter of intent, application, and NIH prepared summary statement of the initial review to the JDFI. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, The Etiology of Excess Cardiovascular Disease in Diabetes Mellitus, is related to the priority areas of heart disease and stroke, and 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by for-profit and non-profit domestic institutions, public and private, such as universities, colleges, hospitals, laboratories, units of State and local government and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. While program project awards cannot be made to foreign institutions, a subproject of high scientific merit may be eligible for support. Exclusions This RFA is intended to support program project grants that have both a basic research and human population component. Therefore, applications that include only basic or only clinical research will not be responsive to this announcement. This solicitation is intended to redress the inadequate information on the etiology of excess cardiovascular disease in patients with diabetes mellitus and applications that do not focus on this aspect of diabetes and cardiovascular disease will not be considered. Large population studies or large clinical trials will be considered unresponsive to this RFA. Program Project awards are not made to foreign institutions. Under exceptional circumstances, a foreign component critical to a project may be included as a part of that application. MECHANISM OF SUPPORT It is the intention of NHLBI and JDFI to stimulate collaboration among investigators with different but complimentary areas of expertise. This research will be supported by the NIH program project research grant mechanism (P01). Responsibility for planning the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed 58 months. A program project grant is for the support of a broadly-based multidisciplinary or multifaceted research program that has a specific major objective or central theme. The award may support research components and core functions. Collectively, these components should demonstrate essential elements of unity and interdependence and result in a greater contribution to program goals than if each activity were pursued individually. Each applicant will be expected to propose studies containing both basic and human subjects based research components with concentration on one or more major risk factors as they relate to the increased risk of CVD in diabetic patients. Efforts will be made by the NHLBI to facilitate collaboration both during development of applications and after the program is established. The principal investigator should be an established research scientist with the expertise and experience to provide scientific leadership, ensure quality control, and effectively administer and integrate all components of the program. A minimum time commitment of 25 percent is expected for this individual. The principal investigator must also be the project leader of one of the component research projects. If, through peer review, this project is not recommended for further consideration, the overall Program Project application will not be considered further. If this project is judged by peer review to be of low scientific merit, it will markedly reduce the overall scientific merit ranking assigned to the entire application by the review committee. Project leaders must agree to commit at least 20 percent effort to each project for which they are responsible. Applications must be prepared and awards will be made according to NHLBI Program Project policies. NHLBI Guidelines for the preparation of Program Project Grant applications may be obtained from Dr. C.James Scheirer at the address listed under LETTER OF INTENT. Approximately 50 percent of the total costs of each grant will be funded by the NHLBI and the same amount by the JDFI. Funding rules, including the determination of allowable indirect costs, will take into consideration those of each sponsor. Post award administration will be according to current policies and requirements that govern the research grant programs of the NIH and the JDFI as appropriate. Consortium Arrangements If a grant application includes research activities that involve institutions other than the grantee institution, the program is considered a consortium effort. Such activities may be included in a program project grant application, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. The published policy governing consortia is available in the office of sponsored research of institutions that are eligible to receive Federal grants-in-aid. Consult the latest published policy governing consortia before developing the application. If clarification of the policy is needed, contact William Darby, (301) 594-7458. Applicants for program project grants should clearly describe the interactions of the participants and the integration of the consortium project(s) with those of the parent institution, because synergism and cohesiveness can be diminished when projects are located outside the group at the parent institution. Indirect costs paid as part of a consortium agreement are excluded from the limit on the amount of direct costs that can be requested. In order to more evenly distribute administrative workload and reduce the number of awards with July 1 or September 30 start dates, the NHLBI will award ten months of time and money for the first competing budget period of this project. This action results in a project period of 58 months rather than 60 months. Investigators should plan their research projects and budgets within these timeframes. Although multidisciplinary approaches are required, it is not the intent of this RFA to solicit applications for large clinical trials or large epidemiological studies. In general, funds will not be provided to purchase and install expensive new equipment. Support will be provided for up to 58 months. Continued funding will be contingent on satisfactory completion of proposed investigations. In addition to a continuing series of reports on results of individual investigations, an overall report will be produced at the conclusion of the program. FUNDS AVAILABLE Approximately $1.8 million in total costs will be provided for the first year of support for the program by NHLBI with an equivalent amount provided by JDFI. Applicants may request up to $650,000 direct costs, not including indirect costs for collaborating institutions, in the first year with a maximum increase of no more than four percent in each additional year requested in the application. Funding rules, including the determination of allowable indirect costs, will take into consideration those of each sponsor. It is anticipated that three to five grants will be awarded under this program. Although this program is provided for in the financial plan of the NHLBI, award of grants pursuant to this RFA is contingent upon receipt of funds for this purpose. Administrative adjustments in project period and/or amount of support may be required at the time of the award. Equipment is included in the budget limitation. However, requests for special equipment that cause an application to exceed this limit may be permitted on a case-by-case basis following staff consultation. Such equipment requires strong justification. Final decisions will depend on the nature of the justification and the availability of funds. RESEARCH OBJECTIVES Background Additional investigations of the etiology of macrovascular complications of diabetes mellitus are needed. Such studies should include populations, clinical research and basic research and involve experts in both diabetes and cardiovascular diseases. JDFI has embarked on a major long term capital fund raising campaign to establish programs of excellence in diabetes research. Diabetes mellitus is a complex metabolic disorder that affects not only glucose metabolism but several other metabolic processes. Some of these effects are acute and appear related to concentrations of glucose and/or insulin. Other effects develop over many years and are related to other metabolic derangements of diabetes or are of uncertain etiology. Recent advances in understanding the process of atherogenesis and the pathogenesis of chronic diabetic complications indicate that diabetes may accelerate atherosclerosis and the development of clinical cardiovascular disease through several mechanisms. The association between overt diabetes mellitus and excess risk of cardiovascular disease (CVD) has been documented in diabetic populations throughout the world but the pathogenic mechanisms for the relationship are only partially understood. Among diabetic patients, both the incidence and mortality rates from myocardial infarction are increased, as are the risks of recurrent infarction, congestive heart failure, cerebrovascular disease, and peripheral vascular disease. The increased risk of CVD associated with diabetes appears to be greater in women than in men. In general, about 50 percent of excess heart disease in diabetics is attributed to associated abnormalities in other known CVD risk factors but levels of these factors may be in part determined by the degree of diabetic control. Milder abnormalities of glucose tolerance are also associated with an increased risk of cardiovascular disease, but glucose level in this group generally has not been an independent CVD risk factor. In these patients, an underlying multiple risk factor syndrome may be a major contributor to accelerated macrovascular disease. Approximately 12 to 14 million Americans have diabetes and up to an additional 18 million are estimated to have impaired glucose tolerance, or glucose levels between diabetes and normoglycemia. Cardiovascular disease is the cause of death in 60 to 75 percent of this combined group. Insulin dependent diabetes mellitus (IDDM) is a leading cause of premature cardiovascular disease. Non-insulin dependent diabetes (NIDDM) is a significant risk factor for cardiovascular disease in middle and older ages. As the U.S. population ages, the importance of glucose intolerance as a risk factor for CVD will increase since its prevalence increases markedly with age, reaching over 50 percent in those above age 65 years. Moreover, with improved methods of glucose control, the anticipated decline in chronic microvascular complications of diabetes may be offset by an increase in the rates of major cardiovascular complications. It is not clear whether the pathogenesis of excess CVD is the same in IDDM and NIDDM. It is also important to recognize that improved glucose control in diabetic patients may not by itself be sufficient to eliminate the excess risk of diabetic cardiovascular complications. Although recent data from the Diabetes Control and Complication Trial (DCCT) suggest a reduction in cardiovascular events in the group achieving near normoglycemia, the numbers of CVD events in this generally young cohort are small. Preliminary results from a pilot study of intensive treatment of hyperglycemia in Type II diabetic veterans fail to suggest any short term benefit of improved glucose control, showing fewer cardiovascular events in the conventional than in the intensive treatment group. No relative reduction in CVD was observed in the variable dose insulin treated group of the University Group Diabetes Program that achieved the best degree of glucose control. These observations may be particularly relevant to the Type II diabetic patient with the multiple cardiovascular risk factor syndrome (Syndrome X of Reaven) where control of hyperglycemia only partially ameliorates the other CVD risk factor abnormalities. Finally, the relative benefits of glucose control and other CVD risk factor control may vary depending upon the race and gender of the patient and whether or not atherosclerotic disease is already advanced. Thus, the treatment most appropriate to prevent long term macrovascular complications in a young Type I diabetic with labile hyperglycemia may not be best for an elderly Type II diabetic with mild hyperglycemia. More information is needed in all of these areas to design better and more specific treatment and prevention regimens. Available data on hyperglycemia and insulin levels as risk factors for CVD have numerous limitations. Many of the frequently cited studies are old and utilized techniques of risk factor and disease measurement that are crude by today's standards. Until recently, most population studies of diabetes have included only rudimentary measures of vascular disease. Many studies of CVD and associated risk factors measured diabetes crudely and, in others, particularly several large clinical trials, diabetics were excluded. Among several early studies that indicated a risk for CVD associated with hyperglycemia, it is now probable that at least part of the risk can be explained by subsequently identified risk factors that were not measured at the time of the studies, such as hyperinsulinemia, elevated insulin resistance, abnormalities in coagulation factors, platelet function, or lipoprotein particle size or composition. In fact, two of the frequently cited studies indicating elevated insulin level is an independent risk factor for CVD did not measure HDL-cholesterol. The relative importance of hyperglycemia, hyperinsulinemia, and elevated insulin resistance as factors in the excess CVD of diabetes has not been assessed in prospective studies. Relative to studies on other major CVD risk factors such as hypertension and hypercholesterolemia, evaluations of the role of glucose intolerance and its related abnormalities as causes of CVD have been limited. The multiple complex metabolic abnormalities associated with diabetes and their potential interactions with risk factors for atherosclerosis make collaboration between investigators with differing expertise essential. While diabetes increases the risk of CVD in all populations studied, the observed CVD event rates vary widely, suggesting that important environmental and probably genetic factors may modify the adverse effects of hyperglycemia. Collaboration between experts in cardiovascular disease and diabetes and among basic researchers, clinical investigators, and epidemiologists will be essential to maximize progress in understanding the causes of cardiovascular disease among diabetic patients and to develop new therapeutic approaches for preventing this major chronic complication. Objectives The primary objective of this initiative is to understand how the presence of diabetes increases the risk of cardiovascular disease. To accelerate this understanding, this initiative will bring together basic, clinical, and population based investigators to develop a research program to address this question at the laboratory, clinical, and population levels. While the control of hyperglycemia is clearly associated with a reduction in the development of microvascular complications of diabetes, its role in the prevention of the macrovascular complications of diabetes is less certain. As a consequence, optimal interventions to prevent these two major categories of complications may differ. Proposed studies should focus on how diabetes increases the risk of macrovascular disease and the relative importance of hyperglycemia compared to other cardiovascular disease risk factors associated with glucose intolerance in the pathogenesis of the macrovascular disease in diabetic patients. Key questions include: o Does hyperglycemia directly cause the macrovascular disease? o Does hyperglycemia increase the risk of macrovascular disease primarily by altering other CVD risk factors? o Is the excess risk of CVD in diabetics largely independent of the level of glucose? o Does hyperglycemia have differing importance as a CVD risk factor in Type I (insulin dependent) compared to Type II (non-insulin dependent) diabetic patients? o Is the observed variation in rates of cardiovascular complications among diabetic patients in different populations secondary to genetic and/or environmental factors? Answers to these questions will be important in formulating recommendations for therapy of diabetic patients and, potentially, for the design of a future clinical trial to prevent diabetes associated CVD. Investigators selected for participation in this program will be expected both to direct innovative research at their individual institutions and to collaborate with other members of the study group in order to apply this information to human populations. This initiative will support a broad program to understand the etiology of the accelerated macrovascular disease found in diabetic patients. It will not necessarily support investigations in all relevant areas but attempt to select and to promote collaboration among the most promising applicant groups. Applicants will be selected for participation based upon the overall evaluation of the importance and innovative aspects of their proposed program and their plans for evaluating these findings in defined populations. Specifically, this initiative may support research in several areas, for example: o To evaluate the roles of hyperglycemia, glycosylation of proteins, and advanced glycosylation end products (AGEs) in the development of diabetic macrovascular disease. o To evaluate the role of hypertension and its interactions with other risk factors in the development of diabetic macrovascular disease. o To evaluate the role of modifications of lipids and lipoproteins (oxidation and glycosylation) with the development of diabetic macrovascular disease o To evaluate the role of altered coagulation factors, abnormalities in platelet function, and alterations in blood viscosity in the development of diabetic macrovascular disease. o To evaluate the role of hyperinsulinemia and/or insulin resistance in the development of diabetic macrovascular disease. o To evaluate the role of vascular wall factors in the development of vascular disease in the presence of hyperglycemia. o To evaluate the role of the co-occurrence or "clustering" of CVD risk factor abnormalities including hypertension, dyslipidemia, hyperglycemia, and obesity in the development of diabetic macrovascular disease. o To evaluate the role of genetic and environmental factors in the variation in prevalence of diabetic macrovascular disease among racial and ethnic groups. A unique aspect of this initiative is the recognition that much relevant work on the pathogenesis of atherosclerosis has been conducted that has not yet been related to the link between diabetes and atherosclerosis. A goal of this initiative is to establish collaborations among groups who have been pursuing separate paths. For example, extensive work on lipid oxidation has taken place, the importance of this process in diabetes has been recognized, but research to assess its importance in diabetic vascular disease is limited. Similarly, extensive work has been done on insulin and insulin resistance. The potential importance of these factors in the multiple CVD risk factor syndrome and in atherosclerosis has been recognized, but research to assess their atherogenicity in the diabetic is limited. Many additional examples were evident in the presentations at the 1992 Workshop on Diabetes and Mechanisms of Atherogenesis (Getz, 1993). Advances in basic research during the past decade have greatly improved understanding of the metabolic abnormalities of diabetes and the process of atherogenesis. Further work may lead to unique ways of preventing or treating the atherosclerosis associated with diabetes. Because of this, a major portion of this initiative will be devoted to advancing fundamental knowledge of the atherosclerotic process in diabetics and to clarifying whether the same processes are responsible for the excess risk in all diabetic patients. A key question is whether the process in diabetic patients is the same or different from that in nondiabetics. Multiple research opportunities were identified in the workshop mentioned above (Getz, 1993). Many are interrelated. Several areas appear appropriate for emphasis: Dyslipidemias and diabetes: Prevalence rates of cardiovascular disease are low among diabetic patients in populations with low levels of total and LDL cholesterol. Multiple studies have shown alterations in the levels and composition of lipid particles in diabetic subjects. In addition to the long recognized abnormalities such as elevated triglyceride and lowered HDL-cholesterol levels, numerous other abnormalities including changes in lipoprotein particle size and composition, protein glycosylation and oxidation of lipoproteins have recently been reported. While the basic lipid changes have been found in all populations studied, their magnitude varies considerably, both within groups and within individual diabetic patients, suggesting the effects of diabetes can be substantially modified by environmental or underlying genetic factors. The reasons some individuals and groups appear to be protected are unknown and represent a promising area for further investigations. Lipid metabolism is also an area where differences occur between Type I and Type II diabetic patients with more adverse alterations generally found in Type II diabetic patients. Hypertension and diabetes: Hypertension is more common in diabetic patients than in age-matched normoglycemics and its presence increases the risk of both micro- and macrovascular complications of diabetes. Many questions need further exploration in this area including the origins of the excess hypertension. The relationship of elevated blood pressure to subclinical renal disease and to the multiple CVD risk factor syndrome are promising areas for further investigation. In addition, recent studies have suggested that the choice of drugs to treat hypertension may be important in postponing both micro- and macrovascular complications of diabetes. The role of renal dysfunction and the significance of microalbuminuria as a predictor of both micro- and macrovascular disease needs to be evaluated. Hemostasis and diabetes: Multiple abnormalities in the coagulation system of diabetics have been identified. Abnormalities include changes in level and structure of coagulation factors, alterations in platelet function, and alterations in blood and plasma viscosity. Many of the studies are small and the techniques used for measurement were sometimes controversial. The associations among coagulation factors and other recognized CVD risk factors require clarification. This is one of the least explored areas of diabetes associated CVD risk but potentially very important and much work remains to be done. Hyperglycemia, insulinemia, and insulin sensitivity and diabetes: These risk factors have generally been the province of diabetologists studying the development of diabetes but recent reports have suggested they may be independent cardiovascular disease risk factors. Critical questions center around the absolute and relative importance of each of these factors in the acceleration of atherosclerosis. If hyperglycemia is "atherogenic", then improved blood glucose levels should lead to a decrease in the risk of CVD. In contrast, if hyperinsulinemia is "atherogenic," improvement of blood glucose levels by intensive insulin treatment may reduce the risk of microvascular disease (as demonstrated in the DCCT) but might increase the risk of macrovascular disease. Treatment regimens may have different effects in Type I and Type II diabetic patients. Vascular biology: The past decade has produced major advances in our understanding of atherogenesis at the cellular and molecular level. It is now recognized that the vascular endothelium is a complex organ that senses its environment and responds in numerous ways to injury and to recognized CVD risk factors. Independently, major advances have occurred in understanding how diabetes produces modifications at the cellular and molecular level. Much less is known about how these diabetic modifications may interact with other atherogenic factors in the local environment of the vessel wall to initiate and propagate atherosclerotic plaques in diabetic patients. In fact, it is not known whether atherosclerosis in diabetics is simply a more rapidly progressing common atherosclerotic plaque or whether differences exist in its composition and in the pattern of cellular responses and gene expression. An area of particular opportunity is the study of the regulation of growth factor and cytokine expression by mildly oxidized low density lipoprotein and advanced glycosylation end products (AGEs). Genetic and Environmental Factors: Rates of diabetic macrovascular complications vary widely in different populations. For example, some American Indian tribes, despite extraordinary rates of diabetes, appear relatively protected against cardiovascular complications. Some potential explanations for these differences have been outlined above. Clarifying the effects of genetic and environmental factors on risk factor levels (and/or composition) and on the susceptibility of the vascular wall to atherosclerosis is of critical importance for the design of future preventive measures. In addition to improving understanding of the basic processes that lead to excess macrovascular disease in diabetic patients, a major goal of this initiative is to apply this information to human studies. This initiative will also provide support for limited clinical and population studies that can either enhance understanding of the pathophysiology of cardiovascular complications of diabetes or provide information important for developing new therapeutic interventions. Because of their cost, support for establishing new epidemiologic studies of populations or clinical trials to test reduction of disease risk cannot be provided through this initiative. The NHLBI has already established several large populations to study risk factors for cardiovascular disease. Many of these studies have collected information on glucose tolerance and historical information on diagnosis and treatment of diabetes. They include extensive characterization of CVD risk factors and assessments of clinical and subclinical cardiovascular disease, making it possible to describe risk factor patterns prior to their alteration by drug therapy or clinical disease. In addition, these studies include men and women and representatives of multiple racial and ethnic groups, providing an opportunity to look at the contrast in risk of cardiovascular complications among different diabetic groups. Overall, they represent a valuable resource for studies of cardiovascular complications in Type II diabetic patients. Other important populations have been identified and characterized with support from other funding sources. Some include substantial numbers of Type I diabetic patients. Investigators applying for support from this initiative are strongly encouraged to propose collaborative efforts with existing population studies since this will be the most efficient way to develop a clinical component. Investigators are free to propose other clinical components, especially if they offer unique advantages. To obtain further information on NHLBI supported population studies, contact Dr. Peter Savage at the address listed under INQUIRIES. It is anticipated that each program project will have several discrete subprojects conducted by multiple investigators under the overall direction of the Principal Investigator. Each application should include laboratory investigations and also include a clinical and/or population component. Studies initiated in one of these components should lead to application in the others. For example, lipid abnormalities described in a population study could be studied further in the laboratory using cell or animal models then translated into small clinical trials of drug efficacy. Other examples could involve investigations of the effects of hyperinsulinemia or elevated insulin resistance which include studies of their effect on the isolated vascular wall lesion, induction of hyperinsulinemia in animal models, pharmacologic alteration of levels of insulin resistance in small clinical studies, and assessment of the relative importance of insulin and insulin resistance on other risk factors in population studies containing several racial or ethnic groups. Such examples are not meant to suggest specific studies but to indicate the spectrum of research and type of collaboration which this initiative is designed to support. In most cases, human subjects will be selected from an existing population on the basis of previously measured evidence of clinical or subclinical disease or risk factor profiles. In many cases such studies may be conducted on stored samples. For more complex tests requiring extensive subject participation or collection of additional samples, care must be taken to not interfere with the ongoing study. Existing policies in current multicenter population studies for approval and reporting of ancillary studies will apply. NHLBI Project Scientists will expedite the collaborative aspects of study design and will facilitate joint research with existing NHLBI funded studies, as appropriate. SPECIAL REQUIREMENTS To facilitate development of applications, NHLBI and JDFI will sponsor a pre-application information meeting to provide interested investigators with background information about relevant ongoing studies using defined human populations and with an opportunity to meet with individuals involved with this research. Possibilities for interdisciplinary efforts will be discussed and individual investigators will be able to explore ways to apply laboratory findings to clinical or population samples. Potential investigators for this initiative will be encouraged to contact the respective NHLBI Project Scientist to determine if proposed clinical measurements could be conducted on a sample from one or more of the existing populations. Potential applicants are encouraged to attend but no NIH funds will be provided to attend this meeting. Upon initiation of this program, the NHLBI and JDFI plan to sponsor a meeting to encourage the exchange of information among investigators, to foster collaborative efforts among program grantees, and to identify resources that would enhance the productivity of several grantees. In many cases, combining proposed measures in highly characterized population subgroups may provide the most information. Where appropriate, additional joint protocols will be developed. After this planning phase, collaborative investigations will be conducted. Subsequent meetings will take place approximately yearly. For this purpose, requests for travel funds for a two-day meeting (two in year 01 and one per year thereafter) should be included in the budget section of the application (assume meeting will be held in Bethesda, MD). Applicants should include a statement in their applications indicating their willingness to participate in such meetings and to cooperate with other researchers at other interdisciplinary research program sites. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by January 6, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the principal investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. The letter of intent is to be sent to: Dr. C.James Scheirer, Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 553 A Bethesda, MD 20892 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248. Applicants must follow the instructions provided in the RFA. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, to identify the application as a response to this RFA, check "YES," enter the title, "Etiology of Excess Cardiovascular Disease in Diabetes Mellitus," and the RFA number HL-95-004 on Line 2a of the face page of the application. Send or deliver a signed, typewritten original of the application, including the checklist, and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Send two additional copies of the application to Dr. James Scheirer, at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants, otherwise the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by April 11, 1995. If an application is received after that date, it will be returned to the applicant. 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, or 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. Letter of Authorization Applicants must submit a brief letter to the NHLBI indicating that they will allow their applications to be considered for funding by the JDFI. All materials relating to the application will be promptly forwarded to the JDFI by NHLBI. The summary statements for such applications will be shared with the JDFI at the time of their availability. Letters of authorization should be prepared by the Principal Investigator and co-signed by the official signing for the applicant institution. This letter may be combined with the LETTER OF INTENT or may be submitted directly to Dr. Savage or Dr. Robinson at the address listed INQUIRIES. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness by the NHLBI. Incomplete applications will be returned to the applicant without further consideration. If NHLBI staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer group convened by the NHLBI in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be notified. Neither site visits nor reverse site visits are planned as a part of the review process, therefore each application should be complete on submission. Following the initial review group consideration, secondary review of applications will be conducted by the National Heart, Lung and Blood Advisory Council and the Juvenile Diabetes Foundation International Scientific Advisory Board. The criteria for review of applications will be those used regularly for the review of program project grant applications by the NHLBI. A complete and detailed description of these criteria is contained in "Program Project Grant: Preparation of the Application", NHLBI, US DHHS, August 1992, a copy of which may be obtained from Dr Scheirer at the address listed under LETTER OF INTENT. Awardees will be selected on the basis of the priority score of their individual applications, subproject scores, and the ability of that proposal to contribute to a comprehensive investigation of diabetic cardiovascular disease. Review criteria for this RFA are generally the same as those for unsolicited interdisciplinary research grant applications: o the scientific merit of each proposed project in the application, including originality, feasibility of the approach, and adequacy of the experimental design; o the integration of the clinical and fundamental research into a coherent enterprise with adequate plans for interaction and communication of information and concepts among the collaborating investigators; o if applicable, the technical merit and justification of each core unit; o the qualifications, experience, and commitment of the Program Project Principal Investigator and his/her ability to devote adequate time and effort to provide effective leadership; o the competence of the subproject investigators to accomplish the proposed research goals, their commitment, and the time they will devote to the program; o the adequacy of facilities to perform the proposed research including the laboratory and clinical facilities, access to subjects, instrumentation, and data management systems when needed; o the scientific and administrative structure of the program, including adequate internal and external arrangements and procedures for monitoring and evaluating the proposed research and for providing ongoing quality control and scientific review; o the institutional commitment to the program and the appropriateness of the institutional resources and policies for the administration of a research program of the type proposed; and o the appropriateness of the budget for the proposed program. o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA Applications must fulfill all the eligibility and responsiveness criteria in order to be considered for funding. Since a variety of approaches would represent valid responses to this RFA, it is anticipated that there will be a range of costs among individual grants awarded. The most important criterion in selecting awardees will be the scientific merit as reflected in the priority score. However, factors such as program balance and available funds may enter into selection from among meritorious applications. Application must be received by April 11, 1995. An application not received by this date will be considered ineligible. Schedule Letter of Intent Receipt Date: January 6, 1995 Application Receipt Date: April 11, 1995 Initial Review: June/July 1995 Review by NHLB Advisory Council: September 1995 Review by JDFI Advisory Board: September 1995 Anticipated Award Date: September 30, 1995 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Peter J. Savage, M.D. Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute Federal Building, Room 300 7750 Wisconsin Avenue, MSC 9070 Bethesda, MD 20892-9070 Telephone: (301) 496-4333 FAX: (301) 480-5298 Email: sav@cu.nih.gov David M. Robinson, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Federal Building, Room 416 7750 Wisconsin Avenue, MSC 9070 Bethesda, MD 20892-9070 Telephone: (301) 496-5656 FAX: (301) 402-3508 Email: drw@cu.nih.gov Inquiries regarding fiscal and administrative matters may be directed to: Mr. William Darby Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A11 Bethesda, MD 20892 Telephone: (301) 594-7458 FAX: (301) 594-7492 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance number 93.387, Heart and Vascular Diseases. Awards are made under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grants policies and Federal regulations, most specifically 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372, or to Health Systems Agency Review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun Oct 09 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-95-006 - V23(35) 10/07/94 Date: 10 Oct 1994 03:27:03 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 772 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <37b4tn$ea9@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL95006 HL-95-006 P1O1 *************************************** SPECIALIZED CENTERS OF RESEARCH IN MOLECULAR MEDICINE AND ATHEROSCLEROSIS NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFA: HL-95-006 P.T. 04; K.W. 0715040, 1002008, 0765035, 0755020, 0745032 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: October 9, 1995 Application Receipt Date: December 8, 1995 PURPOSE This solicitation invites new grant applications to enter into a single open competition for Specialized Centers of Research (SCOR) in Molecular Medicine and Atherosclerosis. The goals of the program are to advance the understanding of the etiology and pathobiology of the atherosclerotic lesion at the molecular level through the modern methods and approaches of molecular medicine. Molecular medicine represents a paradigm shift to more systematic targeting and design of clinical interventions based upon detailed and sophisticated molecular information. It embraces strategies aimed at understanding the molecular basis of disease, and at studying how the structure and activity of living cells are controlled by molecules such as DNA and proteins. A SCOR provides the opportunity for investigators to engage in interdisciplinary and collaborative research that is focused on a specific disease or an area within a disease category. It is required that SCOR applications include studies of human subjects and/or human materials as well as basic studies clearly related to a disease area. The foundation of the clinical component should be strongly linked to the basic science projects; the basic science studies should be driven by the needs of the clinical projects. Thus, a SCOR has a central theme to which all research projects pertain. In addition, a SCOR may include core units to provide services to the various research projects and to support the organizational and administrative aspects of the program. Previous generations of the SCOR in Arteriosclerosis have contributed significantly to the understanding of the basic mechanisms responsible for the development of atherosclerosis, and clarified the role of major risk factors such as blood cholesterol and specific lipoproteins and apoproteins in atherogenesis. The objectives of this new cycle of SCORs are to focus on studies on the pathobiology of the atherosclerotic lesion specially at the level of the arterial wall. Such studies may include investigations of the mechanisms for lesion susceptibility and initiation; the mechanisms of lesion progression, complication, and regression; and the interactions of the vessel wall with lipoproteins and other systemic factors promoting atherogenesis. The new program emphasizes a shift away from studies with an exclusive focus on the structure and function of lipids and lipoproteins. The means for acquiring this new knowledge would involve exploitation of new techniques and strategies of molecular medicine such as gene transfer and gene mapping and identification, three-dimensional structural biology, vascular imaging, genetically modified animal models, and gene therapy, which can yield information that heretofore was inaccessible. All these techniques are complemented by clinical research disciplines as appropriate. Coronary Heart Disease (CHD) accounts for the largest share of deaths from diseases of the heart. CHD rates are particularly high in blacks, perhaps due to the higher prevalence of major CHD risk factors such as hypertension, diabetes and obesity. Differences in the nature of the atherosclerotic process leading to CHD in blacks may also be a contributory factor. The National Heart, Lung, and Blood Institute (NHLBI) wishes to encourage research into the pathogenesis of the atherosclerotic lesion in blacks as part of this SCOR program. To chart a course for future research, the NHLBI convened a working group, which released a report in March 1994 on RESEARCH IN CORONARY HEART DISEASE IN BLACKS. This report provides specific recommendations for future research in black populations. The NHLBI wishes to strongly encourage research into the pathogenesis of the atherosclerotic lesion in women, Blacks and other minorities as part of this SCOR program and recommends that this report, in particular, be consulted. In addition, to encourage women and underrepresented minority investigators to work within a SCOR project, to facilitate recruitment of new scientists to this area of research, and to foster cutting edge and innovative research directions, each SCOR program may support up to two investigators by utilizing up to $50,000 per year per investigator to fund pilot and feasibility projects. This will allow underrepresented minority investigators to acquire the skills and data to become more competitive in seeking independent research support (e.g., R01, R29). These funds will not be supplements, but rather specific dollars identified in the SCOR budget and restricted to be used for this purpose. The recipients would be chosen based on a proposal written by a SCOR investigator and reviewed by an internal review committee at the parent institution. 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, Specialized Centers of Research in Molecular Medicine and Atherosclerosis, is related to the priority area of heart disease and stroke. Potential applicants may obtain a copy of Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by for-profit and non-profit domestic institutions, public and private, such as universities, colleges, hospitals, laboratories, units of State and local goverrnments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Awards will not be made to foreign institutions. However, under exceptional circumstances, a foreign component critical to a project may be included as a part of that project. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) specialized center of research (P50) grant mechanism. Responsibility for planning the proposed project will be solely that of the applicant. The total project period of applications submitted in response to the present RFA may not exceed five years. The anticipated date of award is December 1, 1996. Upon initiation of the program, there will be required communications between SCORs, usually in the setting of a biennial combined meeting of SCOR participants. Applicants should request travel funds for this purpose in fiscal years 1997, 1999, and 2001 of the budget. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. The principal investigator should be an established research scientist with the ability to ensure quality control and the experience to administer effectively and integrate all components of the program. A minimum time commitment of 25 percent is expected for this individual. The principal investigator must also be the project leader of one of the component research projects. If, through peer review, this project is not recommended for further consideration, the overall SCOR application will not be considered further. If this project is judged by peer review to be of low scientific merit, it will markedly reduce the overall scientific merit ranking assigned to the entire application by the review committee. Project leaders must agree to commit at least 20 percent effort to each project for which they are responsible. This RFA is intended to support Specialized Centers of Research grants. Therefore, applications that include only basic or only clinical research will not be responsive to this RFA. In addition, clinical research projects focused on large epidemiological studies or large clinical trials will be considered unresponsive to this RFA. This new SCOR program focuses on studies of the atherosclerotic lesion at the level of the arterial wall. Thus, studies with exclusive focus on the structure and function of lipoproteins will be considered unresponsive to this RFA. Applicants should be aware that applications for supplemental funds will be accepted only under unusual and well defined circumstances. For example, the NHLBI may provide supplements to Centers to continue a project not funded for the entire project period. NHLBI staff should be consulted prior to submission of an application. Supplemental grants for these purposes will not be awarded for the first 18 months or the last 12 months of a total project period. Length of SCOR Programs Each NHLBI SCOR program be limited to ten years of support. Exceptions to this policy will be made only if a thorough evaluation of needs and opportunities, conducted by a committee composed of non-federal experts, determines that there are extraordinarily important reasons to continue a specific SCOR program. Under this policy, a given SCOR grant is awarded for a five-year project period following an open competition. Only one five-year competing renewal is permitted, for a total of ten years of support, unless the SCOR program is recommended for extension. The NHLBI comprehensive evaluation of the SCOR program in Molecular Medicine and Atherosclerosis will be conducted during the second project period according to the following timetable. Announcement SCOR competition FY 1995 Project Period (First Competition) FY 1997 to FY 2001 Program Re-announcement FY 1999 Project Period (Second Competition) FY 2002 to FY 2006 Letters to SCOR Directors regarding SCOR evaluation Plans FY 2004 (mid-way through year 02 of 2nd project period) SCOR Evaluation Meeting FY 2004 (Late in year 02 of project period) Notification of SCOR Directors of NHLBI decision FY 2004 (mid-way through year 03 of 2nd project period) The NHLBI does not limit the number of SCOR applications in a given SCOR program from one institution provided there is a different SCOR principal investigator for each application and each application is self-contained and independent of the other(s). This does not preclude cooperation planned or possible among participants of SCORs after awards are made. Scientific overlap among applications will not be accepted. If more than one application is envisioned from an institution, the institution is encouraged to discuss its plans with the NHLBI SCOR program administrator. Consortium Arrangements If a grant application includes research activities that involve institutions other than the grantee institution, the program is considered a consortium effort. Such activities may be included in a SCOR grant application, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. The published policy governing consortia is available in the business offices of institutions that are eligible to receive Federal grants-in- aid. Consult the latest published policy governing consortia before developing the application. If clarification of the policy is needed, contact Mr. William Darby, Section Chief, Grants Operation Branch, NHLBI, (301)594-7458. Applicants should exercise great diligence in preserving the interactions of the participants and the integration of the consortium project(s) with those of the parent institution, because synergism and cohesiveness can be diminished when projects are located outside the group at the parent institution. Indirect costs paid as part of a consortium agreement are excluded from the limit on the amount of direct costs that can be requested. FUNDS AVAILABLE Applicants may request up to $1,170,000 direct costs, not including indirect costs for collaborating institutions, in the first year, with a maximum increase of no more than four percent in each future year requested in the application. It is anticipated that seven SCOR grants, for a five year project period, at an estimated first year total cost of $12.285 million, will be supported. Award of grants pursuant to this RFA is contingent upon receipt of funds for this purpose. Designated funding levels are subject to change at any time prior to final award, due to unforeseen budgetary, administrative, and/or scientific developments. Equipment is included in the budget limitation. However, requests for expensive special equipment that cause an application to exceed this limit may be permitted on a case-by-case basis following staff consultation. Such equipment requires justification. Final decisions will depend on the nature of the justification and the availability of funds. RESEARCH OBJECTIVES Background Atherosclerosis underlies most coronary heart disease, a major cause of death (500,000 per year) and disability, as well as much peripheral vascular disease, many cases of stroke, and several other diseases. Atherosclerosis is a multifactorial process with a complex and incompletely understood etiology. An interdisciplinary approach integrating basic sciences with the clinical aspects of the disease is required to study this disorder, and the NHLBI adopted the SCOR mechanism in 1971 for that purpose. Since their inception, the SCORs in Arteriosclerosis have promoted multidisciplinary research on the relationships of hyperlipidemia, hypertension, thrombosis, diabetes, smoking, and other systemic risk factors to the etiology and pathogenesis of atherosclerosis. The SCORs have advanced our understanding of the structure and function of lipoproteins and apolipoproteins at the systemic and cellular levels and their role in atherogenesis. The program contributed greatly to the development of the concept of the oxidative modification hypothesis for atherosclerosis, and demonstrated that cholesterol lowering in Familial Hypercholesterolemia retarded the progression and promoted the regression of human coronary atherosclerotic lesions. The SCORs pioneered research on nutrition, lesion dynamics, and the relationship of hemodynamics to atherogenesis, and led to the establishment of nonhuman primate resources. The SCORs made important contributions to the pediatric aspects of atherosclerosis, and conducted behavioral and psychosocial research, and demonstration and education projects. Many of these studies have advanced sufficiently so as to no longer warrant a "special" program and are now supported by other mechanisms. Despite the significant progress achieved, however, there remain many unresolved questions in atherosclerosis research that are well suited for the comprehensive and multidisciplinary nature of the SCOR mechanism. The past accomplishments of the SCOR/A program and the potential for continued advances in understanding and averting atherosclerosis and coronary artery disease through an integrated program of clinical and basic research are the basis for continuation of this avenue of support. Atherosclerosis research is evolving; a shift of emphasis has gradually occurred from a predominant interest in the role of lipids and lipoproteins, towards defining the role of the arterial wall and its interactions with systemic factors. This shift has led to a change in the direction of the current solicitation. Significant progress has been made in elucidating the structure and function of lipoproteins and apoproteins, the generation of useful animal models for nutrition and metabolic studies, and the definition of factors influencing localization of atherosclerotic lesions. Other ongoing activities over the last decade have considerably expanded insight into relevant processes in the arterial wall. An explicit pathogenesis is emerging and the development of new modes of intervention to show the progression of the disease is now possible. However, much of the pathobiology involving the arterial wall is incompletely defined, and this is believed to be especially important in the clinical expression of atherosclerosis. Critical Areas of Research Opportunity To optimize the impact of the new SCOR program in the next decade, emphasis needs to be placed on the pathobiology of the arterial wall that results in the initiation, progression, complication, and regression of atherosclerosis. Studies on systemic factors promoting atherogenesis and its complications acting at the level of the vessel wall also need to be addressed. To delineate the mechanisms responsible for atherosclerosis and its complications in humans, sophisticated, state-of-the-art methodologies and approaches of molecular medicine such as gene regulation, gene transfer, three-dimensional structural biology, vascular imaging techniques, gene mapping and identification, and genetically modified animal models are required, as well as the more standard research approaches. Because of the interdisciplinary nature of the research, collaboration among investigators of varied expertise within the same or different institution is strongly encouraged. Specifically, Networking (i.e., shared biologic and information resources, reagents, patients, genetically altered animals, and the like), will be established to prevent duplication of efforts and to maximize benefits in the most cost-efficient manner possible. The following are examples of methods, approaches, and areas of opportunities for research into lesion susceptibility and initiation; progression, complication, and regression of atherosclerotic lesions; and systemic factors promoting atherogenesis and its complications acting at the level of the arterial wall. The list is not to be regarded as complete or exclusive and other research proposed by applicants that meet the objectives of this program will be considered by the NHLBI. It includes examples of several questions pertaining to blacks. Mechanisms Involved in Lesion Susceptibility and Initiation Hemodynamic factors influence the localization of the atherosclerotic lesion. The role of sheer stress in affecting the site of early lesions is controversial in view of the demonstrated existence of selective ion channels that may signal changes in the local hemodynamic environment in vascular cells. In addition, there exists a newly discovered Shear Stress Response Element and DNA binding proteins in the promoter regions of certain genes that encode growth factors or adhesion molecules that are thought to play a role in lesion initiation. This type of work provides a framework for novel molecular approaches to the study of atherosclerotic lesion initiation that promise to provide insight into the critical links among well-defined risk factors, hemodynamics, and locally altered arterial wall biology. Another important gap in our knowledge of lesion initiation in humans relates to the formation of the arterial intima and the heterogeneity of smooth muscle and endothelial cells in the human arterial wall. New concepts of vascular developmental biology and molecular tools for distinguishing subpopulations of arterial cells are currently emerging. An opportunity thus exists to approach key issues in the initiation of human atherogenesis that previously have remained elusive. The effects of the well established risk factors on CHD events in the population at large have been shown to apply also to blacks, and most studies show that hypertension, glucose intolerance, and obesity may contribute disproportionately to CHD in black populations. The contribution of these risk factors to lesion initiation and acceleration would shed light on devising approaches for interventions targeted to black populations. Mechanisms Involved in Lesion Progression, Complication, and Regression Recent clinical and pathological data show that, in human coronary atherosclerosis, rupture of the plaque, rather than gradual closure, underlies many acute myocardial infarctions and episodes of unstable angina, and that non-occlusive plaque rupture may constitute an important mode of episodic lesion progression. Arterial calcification is a prominent feature of coronary atherosclerosis and correlates with increased risk of myocardial infarction and may play an important role in plaque rupture. Calcification of the arterial wall has been shown to result from the expression of the same genes that are involved in bone formation. When calcium and vitamin D are prescribed to prevent osteoporosis, the potential for enhancing arterial calcification exists. Further research into the molecular mechanisms of arterial calcification may yield new insights into the aging of the vasculature and present new targets for clinical intervention. Normal hemostasis and vascular patency are maintained by a dynamic equilibrium between the fibrinolytic and coagulation systems. Endothelial cells play a central role in hemostatic regulation by producing components of the coagulation and the fibrinolytic systems and inhibitors of platelet aggregation. Hence, several issues implicating the hemostatic system in atherogenesis merit consideration. These may include interactions of the coagulation factors with blood lipids and their impact on the function of the endothelial cells and blood cells; mechanisms regulating the interaction of the blood components with the vascular endothelium in thrombosis and atherogenesis; factors regulating endothelial functions such as macromolecular transport, abnormal permeability, and endothelial cell relaxing factor; and mechanisms controlling arterial endothelial thrombo-resistance processes. Potential specific areas of new research might include studies of apoptosis of cells within plaques, matrix accretion and dissolution, studies on the origin of the calcifying cells of the arterial wall, regulation of prothrombotic factors such as tissue factor within complex lesions, and formation of plaques in microvessels which are sources of intraplaque hemorrhage. Emerging vascular imaging modalities provide a major opportunity to probe, in vivo, the nontraditional mechanisms of plaque progression and complication. Human tissue, such as that obtained at atherectomy from black and white male and female patients, can be utilized to shed light on the alterations in cellular and molecular regulatory mechanisms, as well as on possible differences among races. The use of these technologies may provide information on the structure of the intima, media, and adventitia of coronary arteries, which may elaborate on the vascular remodeling and compensatory responses to atheroma. Such observations may provide insight into how profiles of risk factors in blacks and whites influence these pathophysiological mechanisms. Plaque rupture and acute thrombosis have been identified as major substrates for acute coronary syndromes in the general population. However, it is not known whether current concepts about lipid content and structure of the fibrous cap of atheroma are directly applicable to blacks, or whether these characteristics have a more pronounced influence on the development of acute coronary syndromes owing to the high prevalence of hypertension, thrombotic diathesis and high levels of lipoprotein (a) [Lp(a)] in blacks. As stenotic but stable plaques seldom cause lethal clinical manifestations, a biological approach to understanding the mechanisms of plaque destabilization should suggest novel therapies aimed at reversing this process, a target newly envisioned in cardiovascular therapeutics. One potential avenue to this end could involve local gene therapy using newly developed vectors and endovascular delivery systems. Systemic Factors Promoting Atherogenesis and its Complications Acting at the Level of the Arterial Wall Many systemic factors associated with atherosclerosis have been identified. However, understanding how these risk factors interact with vascular cells has lagged. One high priority area in this regard involves the complex interactions of insulin resistance, dyslipidemia, hypertension, and central obesity with coronary heart disease. These risk factors are particularly prevalent in the black population where studies of these complex interactions and their association with race would be desirable. The advent of genetically altered animals such as mice provides a new avenue to explore the integrative metabolic and local arterial wall aspects of such systemic factors that promote atherogenesis. For example, an area of interest that could be used to probe the link of systemic factors with atherosclerotic lesions would be the generation of compound mutants of insulin-resistant mice with apo-E- or LDL receptor-deficient animals on different diets. Once established, such newly created animal models could be used for systematic evaluation of the effect of dietary and other environmental variables on atherogenesis. Likewise, such compound mutant animal strains could be used to test potential preventive and therapeutic measures. Various compound mutant animals could be applied to advantage to probe polygenic risk factors that promote atherogenesis (e.g., crosses with animals over-expressing or with gene knockouts involving growth factors, cytokines, coagulation factors, and apolipoproteins). Molecular Medicine Methods and Approaches Responses to this RFA should apply modern methods and approaches of molecular medicine to studies of the pathogenesis of atherosclerosis in the arterial wall and should emphasize the molecular and cellular bases of atherogenesis and the molecular genetics of atherosclerosis. The methodology to be used may include, among others, the following approaches: Genetics/Gene Manipulation The power to map and identify genes responsible for disease, the capability of delivering exogenous genes to cells and organs, and the ability to manipulate gene expression and regulation all provide opportunities to investigate the role of various factors on vessel wall biology. Examples of methods and approaches include: o Methods to Prevent Specific Gene Expression (e.g., antisense) o Understanding Gene Expression in the Developing Animal. o Gene Transfer and Therapy. o Generation of Genetically Altered Animals. o Gene Mapping and Identification. Structural Biology Elucidation of the fine structure of the key enzymes, receptors, growth factors, cytokines, etc., at the three-dimensional level is an important step toward understanding their mechanisms of action on the vessel wall and designing agonists or antagonists to perturb their activity. Examples of the methodology to be used include: o X-Ray Crystallography o NMR o New Electron and Laser Microscopy Techniques Vascular Imaging Techniques The imaging of arterial lesions can be used to investigate the pathophysiological basis for the development and progression/ regression of atherosclerosis and to predict the impact of intervention on progression/ regression. The use of improved methods for invasive and noninvasive imaging of lesions, especially plaque rupture and acute occlusion, is a high priority. Examples of the methods that can be used include: o Quantitative Angiography o B-Mode Ultrasound o Intravascular Ultrasound o NMR Basic and Clinical Research The overall concept of a SCOR program focuses on scientific issues related to diseases relevant to the mission of the NHLBI. It is essential, therefore, that all applications include both basic and clinical research projects. In the ideal SCOR, the clinical research derives from, or is otherwise intimately linked to, the basic research proposed by the investigators. Interactions between basic and clinical scientists are expected to strengthen the research, enhance transfer of fundamental research findings to the clinical setting, and identify new research directions. Plans for transfer of findings from basic to clinical studies should be described. Each SCOR grant application and award must include research involving human/patient subjects. Support may be provided for human biomedical and behavior studies of etiology, pathogenesis, prevention and prevention strategies, diagnostic approaches, and treatment of diseases, disorders or conditions. Small population-based studies, where the research can be completed within five years, may also be proposed. In addition, basic research projects must be included that relate to the clinical focus. A SCOR may also contain one or more core units that support the research projects. Special instructions pertaining to the regulations regarding inclusion of human subjects in research are detailed under the section STUDY POPULATION. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by October 9, 1995 a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the principal investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. The letter of intent is to be sent to: Dr. C. James Scheirer Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 553 A Bethesda, MD 20892-9070 Upon receipt of the letter of intent, applicants will be contacted by program staff to discuss their proposed applications and to provide guidance to applicants not familiar with the SCOR concept. APPLICATION PROCEDURES The research grant application for PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892-9070, telephone 301/594-7248. Applicants must follow the instructions provided in the supplement to the RFA. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, to identify the application as a response to this RFA, check "YES," enter the title "Specialized Center of Research in Molecular Medicine and Atherosclerosis," and the RFA number HL-95-006 on Line 2a of the face page of the application. Send or deliver a signed, typewritten original of the application, including the checklist, and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892-9070** Send two additional copies of the application to Dr. C. James Scheirer, Chief, Review Branch, Centers and Special Projects Section at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants, otherwise the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by December 8, 1995. If an application is received after that date, it will be returned to the applicant. 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, or 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 NHLBI. Incomplete applications will be returned to the applicant without further consideration. If NHLBI staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsible to the RFA will be evaluated for scientific and technical merit by an appropriate peer group convened by the NHLBI in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be notified. Neither site visits nor reverse site visits are planned as a part of the review process, therefore each application should be complete on submission. Review criteria for RFAs are generally the same as those for unsolicited interdisciplinary research grant applications. o the scientific merit of each proposed project in the application, including originality, feasibility of the approach, and adequacy of the experimental design; o the integration of the clinical and fundamental research into a coherent enterprise with adequate plans for interaction and communication of information and concepts among the collaborating investigators; o the technical merit and justification of each core unit; o the qualifications, experience, and commitment of the SCOR Director and his/her ability to devote adequate time and effort to provide effective leadership; o the competence of the investigators to accomplish the proposed research goals, their commitment, and the time they will devote to the program; o the adequacy of facilities to perform the proposed research including the laboratory and clinical facilities, access to subjects, instrumentation, and data management systems when needed; o the scientific and administrative structure of the program, including adequate internal and external arrangements and procedures for monitoring and evaluating the proposed research and for providing ongoing quality control and scientific review; o the institutional commitment to the program and the appropriateness of the institutional resources and policies for the administration of a research program of the type proposed; and o the appropriateness of the budget for the proposed program. o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA Applications must fulfill all eligibility criteria in order to be considered for funding. Since a variety of approaches would represent valid responses to this RFA, it is anticipated that there will be a range of costs among individual grants awarded. The most important criterion in selecting awardees will be the scientific merit as reflected in the priority score. However, factors such as program balance and available funds may enter into selection from among meritorious applications. Schedule Letter of Intent Receipt Date: October 9, 1995 Application Receipt Date: December 8, 1995 Review by NHLBI Advisory Council: September 1996 Anticipated Award Date: December 1, 1996 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Momtaz K. Wassef Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Federal Building, Room 4A12 7550 Wisconsin Avenue MSC 9050 Bethesda, MD 20892-9070 Telephone: (301) 496-1978 FAX: (301) 480-9882 Email: momtaz_wassef%nihhfed1.bitnet@cu.nih.gov Inquiries regarding fiscal and administrative matters may be directed to: Mr. William Darby Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A11 Bethesda, MD 20892-9070 Telephone: (301) 594-7458 FAX: (301) 594-7492 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.837, Heart and Vascular Diseases. Awards will be made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirement of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Sun Oct 09 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA ES-95-002 - V23(35) 10/07/94 Date: 10 Oct 1994 03:26:56 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 593 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <37b4tg$e9r@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA ES95002 ES-95-002 P1O1 *************************************** ENVIRONMENTAL JUSTICE: PARTNERSHIPS FOR COMMUNICATION NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFA: ES-95-002 P.T. 34; K.W. 0725030, 0730050 National Institute of Environmental Health Sciences Letter of Intent Receipt Date: November 17, 1994 Application Receipt Date: January 13, 1995 PURPOSE The purpose of this program is to strengthen the NIEHS effort that supports research aimed at achieving environmental justice for socioeconomically disadvantaged and medically underserved populations in the United States. One goal of the Institute is to stimulate investigative efforts that attempt to address questions related to the influence of economic and social factors on the health status of individuals exposed to environmental toxicants. This component of the NIEHS research program in environmental justice is designed to stimulate community outreach, training, and education efforts which will become the catalyst for reducing exposure to environmental pollutants in underserved populations. The main objective of this RFA is to establish methods for linking members of a community, who are directly affected by adverse environmental conditions, with researchers and health care providers. This will ensure that: o the community is aware of basic environmental health concepts, issues, and resources; o the community has a role in identifying and defining problems and risks related to environmental exposures; o the community is included in the dialogue shaping potential future research approaches to the problem; and o the community actively participates with researchers and health care providers in developing responses and setting priorities for intervention strategies. The aim of this program is to facilitate the process of developing the trust needed for establishment of effective partnerships among individuals who are adversely impacted by an environmental hazard in a socioeconomically disadvantaged community, researchers in environmental health, and health care providers. 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, Environmental Justice: Partnerships for Communication, is related to the priority area of environmental health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001- 00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, both public and private including predominantly minority institutions, individually or as joint efforts of minority institutions and majority institutions. Usually, only one award under this RFA will be funded at an institution. While a single institution must be the applicant, a multi-institutional arrangement (consortium) is possible. Such consortia, entailing active participation by more than one organization, are encouraged if there is clear evidence of close interaction and responsible partnership among the participants. It is important to note that, because of the wide range of environmental health problems to be addressed and the diversity of affected communities, applications must include at least one of each of the following: o A research scientist in environmental health sciences (such as those at NIEHS Environmental Health Sciences Centers). o A primary health care provider directly involved in a community affected by an environmental pollutant. This individual must have a record of providing health care to the participating community. He/she could, but need not necessarily, be affiliated with a county or state public health department. o A member of a community organization in an area having an underserved population that is adversely affected by an environmental pollutant. This individual must be someone who lives in or works directly and regularly with the participating community. At least one member of each of these three required personnel groups must have an active and meaningful role in both development of the application and conduct of the proposed project. These personnel should be listed on page 2 of the PHS 398 application, and a biographical sketch should be provided for each. Applications lacking the required personnel will not be considered. The role of each member of these three personnel groups in developing the application and carrying out the project must be clearly identified and fully described. There should be an equitable distribution of responsibilities as well as of requested financial resources among the three personnel groups. The NIEHS has a significant commitment to the support of programs designed to increase the number of underrepresented minority and female scientists participating in biomedical and behavioral research. Therefore, applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Education Grant (R25). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed four years, and projects are not renewable. This RFA is a one time solicitation. FUNDS AVAILABLE The estimated total funds available for the first year of support for the entire program are anticipated to be $500,000. The maximum award will be $150,000 in direct costs per year. Indirect costs will be paid at the approved indirect cost rate for the applicant organization less appropriate exclusions. It is anticipated that one to three grants will be awarded depending upon the availability of funds for this purpose and the quality of the applications received. Awards are not renewable and supplements are not allowed. RESEARCH OBJECTIVES Background Americans want to live long and healthy lives, and the majority of them achieve that goal. In general, however, people who are economically disadvantaged and/or who live or work in areas and occupations where conditions impart greater exposure to hazardous substances are less likely to do so. At every stage of life, these persons suffer disproportionate levels of morbidity and mortality. Evidence suggests that certain groups, especially minorities and low-income communities, bear an uneven share of hazardous environmental exposures. Socioeconomically disadvantaged people suffer the lowest life expectancy and highest adverse health consequences of inadequate access to high-quality health care. Additionally, they most often experience the highest degree of exposure to environmental agents and frequently have the least information available as to the health consequences of exposure to these agents. Environmental justice refers to the need to remedy the perceived unequal burden borne by socioeconomically disadvantaged persons in terms of residential exposure to greater than acceptable levels of environmental pollution, occupational exposure to hazardous substances, and fewer civic benefits such as sewage and water treatment. Geographic location plays an important role in environmental exposure of socioeconomically disadvantaged persons. Inner city poor often live in homes with high lead levels. They may also be exposed to higher levels of air pollution. Toxic wastes sites are more frequent in rural, low socioeconomic counties in the US. Nuclear facilities and chemical plants are often located in rural areas. Exposure to pesticides is another example where rural, socioeconomically disadvantaged populations are at a greater than average risk. Disadvantaged neighborhoods may rely on well water which may be polluted with toxic chemicals. In addition, medical care is often inadequate or unavailable to a significant proportion of the socioeconomically disadvantaged and minority people in America today. Lead poisoning and the cognitive and developmental damage associated with exposure to lead occur disproportionately among minorities. High blood pressure and prostate cancer are very common among African-Americans. Low birth weight babies and other problems during pregnancy are common among groups of women who do not have access to good prenatal care. Some of these conditions or other diseases may have an environmental component in their etiology. The lack of resources for early identification of the effects of toxic agents may lead to an increased disease burden in people who are economically least able to cope with it. Recent Progress and Opportunities Some work has been done to investigate the effects of pesticides in agricultural workers, of polychlorinated biphenyls in children in rural areas, and of lead exposure in socioeconomically disadvantaged urban children. The effect of low versus high air pollutant exposure on pulmonary function has been extensively studied. Evidence from the NHANES study has shown that, for comparable levels of exposure, different racial groups have different levels of blood lead. Some evidence is also available that suggests the toxic effects of some agents such as lead can be mitigated by good nutrition. Many of these studies have engaged underserved populations, but none have focused on such problems from the perspective of identifying issues of highest impact on and priority to these populations. Thus, progress has been minimal in most areas due to the lack of well-developed studies targeting socioeconomically disadvantaged populations. More effort must be put into defining disadvantaged populations having high levels of exposure to various types of environmental hazards in residential or occupational settings. Comprehensive outcomes to these exposures must be defined and measured. Prevention and treatment strategies for these effects must also be generated. Prominent among the goals of the NIEHS is support of research aimed at achieving environmental justice for all populations. It is equally important to bring minority populations into the mainstream of biomedical research as scientists, health care providers, and allied health service professionals. Both of these goals have a clear benefit to the health of the nation and provide a means of addressing a potential labor shortage in the twenty-first century. As one aspect of this effort, the Institute is requesting submission of applications that focus on establishing new avenues of communication among those living or working in a community impacted by an environmentally related health problem and the researchers and health care providers attempting to recognize and ameliorate such problems. Objectives and Scope One component of the mission of NIEHS is to promote research aimed at achieving environmental justice by identifying and addressing disproportionately high and adverse effects of environmental agents on human health in low income and minority populations. The main objective of this program is to establish methods for linking members of a community, who are directly affected by adverse environmental conditions, with researchers and health care providers. Development of community-based strategies to address environmental health problems requires approaches that are not typically familiar to the research and medical communities. Customary approaches to risk assessment and management often neglect the knowledge and experience of at-risk populations and the sociocultural context of environmental hazards. The distinctive needs of individual communities and their inhabitants are only rarely considered in identifying environmental health problems and devising appropriate disease and pollution prevention tactics. Underserved populations are often diverse, fragmented, and isolated, making it difficult to obtain their input and to integrate their concerns in decision- making processes. Assays of the health effects of environmental pollution, as well as regulations based on such assays, are often performed with little or no input from the affected community. The purpose of this program is to institute mechanisms to bridge this communication gap. Applicants are therefore expected to create equitable partnerships among researchers in environmental health, health care providers, and representatives of low-income or minority communities affected by environmental health problems. Types of activities which may be proposed include, but are not limited to: o Develop efficacious methods for risk communication in minority and low-income communities unfavorably impacted by environmental hazards. o Develop community-based, culturally sensitive educational programs to mitigate adverse health effects from environmental toxicants in minority and low-income communities. o Carry out community-based training to increase environmental health literacy, i.e., increase awareness of the public, in such neighborhoods. o Train and educate neighborhood health care professionals in the diagnosis and treatment of disorders having an etiology related to exposure to hazardous substances, i.e., increase awareness of health care providers. These providers should have a direct role in assisting a community affected by exposure to an environmental hazard. NIEHS wishes to encourage a broad, comprehensive approach to this problem. Applicants are encouraged to consider proposing some combination of the above activities. The following factors must be included in applications submitted in response to this RFA: o A means of establishing effective input from an underserved community affected by an environmental toxicant. For example, applicants may consider creating a community-based advisory board or steering committee to facilitate outreach, planning, and evaluation efforts. This input could be obtained directly from members of a community affected by an environmental toxicant as well as from representatives of such groups as community and neighborhood associations, churches, public housing resident councils, community health centers, local public health service departments, and minority educational institutions. o An objective assessment process designed to identify priority areas in environmental health as perceived by community members, to develop a consensus among community members as to plausible approaches, to build upon existing expertise and knowledge within the community, and to detect any potential constraints in implementing the project. o Development of appropriate education/communication modules. Proposed projects should provide for dissemination of relevant information within the community as well as a means for the community to have a voice that reaches researchers and health care providers. There should be an effective flow of information among all participants. o Feedback and evaluation of the project's effectiveness. A procedure should be established to assess the usefulness of the project's education/communication activities. o Recommendations for future activities, beyond the period of NIEHS funding, to assure continued participation of community members in research and service programs addressing environmental injustices. Each of the above elements is essential to fulfill the education, communication, and outreach aims of this RFA. Applications lacking any of the above components will not be considered. It is important to note that award of a grant under this RFA by the NIEHS does not imply a commitment to future funding of any programs planned with the support of such a grant. Separate applications must be submitted for such programs and such applications will be evaluated on the basis of their own merits. SPECIAL REQUIREMENTS To encourage applicants to share information gained via these grants, a member of each of the three types of required personnel on each project will be asked to attend an annual meeting at NIEHS. Applicants should include such travel in their budget requests. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14586-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are requested to submit, by November 17, 1994, a letter of intent that includes a descriptive title of the proposed project, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. The letter of intent influences neither review nor funding decisions, but it is helpful to NIEHS staff in planning the review process, e.g., in estimating workload and avoiding conflict of interest. Letters of intent are to be directed to: Ethel B. Jackson, D.D.S. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 17-09 104 T.W. Alexander Drive Research Triangle Park, NC 27709 APPLICATION PROCEDURES Applicants are to use standard form PHS 398 (rev 9/91), which is available from most institutional offices of sponsored research from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248). The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In order to assure proper identification of the application, item 2a of the application form must be filled in as follows: Check the box indicated as "YES" enter the RFA number as ES-95-002 and the title as "Environmental Justice: Partnerships for Communication." Each application must be presented in the format used for an NIH research grant. Submit a signed, typewritten original of the application, including the Checklist and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must be sent to: Ethel Jackson, D.D.S. Division of Extramural Research & Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 17-09 104 T.W. Alexander Drive Research Triangle Park, NC 27709 Applications must be received by January 13, 1995. 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. Applicants who are submitting revised applications based on criticisms in summary statements received in response to the previous announcement of this RFA, ES-94-005, are urged to read the appropriate instructions on pages 19-20 of the PHS 398 and to contact program staff listed under INQUIRIES. All human and animal welfare as well as misconduct assurances must be complete for a application to be reviewed. All follow-up assurances and approvals submitted as pending must be received within 60 days of the application receipt deadline as the application will not be reviewed. The following is the schedule planned for this initiative. It should be noted that this schedule may be changed without notification due to factors that were unanticipated at the time of the announcement. Please contact the program official listed below regarding any changes in the schedule. Letter of Intent Receipt Date: November 17, 1994 Application Receipt Date: January 13, 1995 Initial Scientific Review: March 1995 Advisory Council Review: May 1995 Anticipated Date of Award: July 1, 1995 REVIEW CONSIDERATIONS Review will be carried out by the Scientific Review Branch, Division of Extramural Research and Training. Applications will be screened by staff for completeness and responsiveness to the RFA. Those that are incomplete or nonresponsive will be returned to the applicant without review. Complete and responsive applications will be reviewed by either the Environmental Health Sciences Review Committee or a special review committee impaneled by the Scientific Review Branch. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or noncompetitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be noncompetitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. The second level of review will be provided by the National Advisory Environmental Health Sciences Council. The review factors listed below will be used in evaluation of applications for this RFA: o Scientific, technical, and/or medical significance and merit of the proposed project as determined by such factors as its content, originality, and feasibility. o Evidence of access to, interaction with, and input from a minority, low-income, or underserved community, whose members' health is adversely impacted by an environmental toxicant. There should be evidence of effective involvement of such a community in development of the application as well as in conduct of the project. o Capacity of the project to: 1. Identify key environmental hazards that affect the health and quality of life of people who live in or around communities thought to be at risk. 2. Establish a focus for information exchange related to environmental health problems in socioeconomically disadvantaged communities. 3. Enhance awareness of environmental health problems among members of the public and/or health care providers living or working in minority or low-income communities. 4. Have a direct impact on the health or quality of life of individuals in affected communities, e.g., by diminishing exposure to environmental toxicants. o Appropriateness and adequacy of the approach and methodology proposed to accomplish the project's objectives. Effectiveness of the proposed plan in reaching the target audience. For example, many socioeconomically disadvantaged persons tend not to obtain information from the written word. Low- or no-literacy, as well as bilingual, materials may need to be generated. o Qualifications and experience of the principal investigator and staff, particularly but not exclusively in areas relevant to the mission of NIEHS. Personnel should demonstrate knowledge of the needs of their target audience. Applications must include, at a minimum, a researcher in environmental health sciences, a health care provider, and a member of a community organization in an area having an underserved population that is adversely affected by an environmental pollutant. There should be evidence of effective cooperation and interaction among these staff members in development of the application as well as in execution of the project. There should be an equitable distribution of responsibilities among the three types of required personnel. o Strength of institutional commitment as evidenced by provision of appropriate resources, services, technical support, and allocation of space. o Availability of resources necessary to carry out the project. o Appropriateness of the proposed budget and duration in relation to the project's objectives. Consistent with an equitable distribution of responsibilities, there should likewise be an equitable distribution of requested financial support among the three types of required personnel. o Plans for evaluation of factors contributing to the project's effectiveness. Evaluations should include a measure of the impact of the project on community members' knowledge and awareness of issues and resources related to environmental health sciences. AWARD CRITERIA The anticipated date of award is July 1, 1995. The following will be considered in making funding decisions: o Quality of the proposed applications as determined by peer review. o Responsiveness to the goals of this RFA and the mission of the NIEHS. o Availability of funds. Although this program is provided for in the financial plans of the NIEHS, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the award will be contingent upon satisfactory progress during the preceding year and upon availability of funds. INQUIRIES Inquiries concerngin this RFA ar encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Allen Dearry, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-02 Research Triangle Park, NC 27709 Telephone: (919) 541-7825 / 4943 FAX: (919) 541-2843 E-mail: DEARRY@NIEHS.NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Carolyn Winters Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 2-01 Research Triangle Park, NC 27709 Telephone: (919) 541-7623 FAX: (919) 541-2860 E-mail: WINTERS@NIEHS.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.113, 93.114, and 93.115. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 100-607) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. The program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun Oct 09 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-95-005 - V23(35) 10/07/94 Date: 10 Oct 1994 03:27:19 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 891 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <37b4u7$eb2@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL95005 HL-95-005 P1O1 *************************************** ISCHEMIC HEART DISEASE IN BLACKS NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFA: HL-95-005 P.T. 04, FC; K.W. 0715040, 0715075, 0710030 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: November 30, 1994 Application Receipt Date: May 18, 1995 PURPOSE This solicitation invites grant applications to enter into a single open competition for Specialized Centers of Research (SCOR) in Ischemic Heart Disease in Blacks. Applicants should select one of three themes, Sudden Cardiac Death, Microvascular Disease, or Diabetic Heart Disease as the focusof their applications. The goal of this initiative is to foster an interdisciplinary study of issues surrounding the expression of heart disease in Blacks. To this end, applicants must present an application that encompasses both basic and clinical science, including studies in Black patients. The goal of the program is to advance understanding of the expression of heart disease in this population through exploitation of modern methods and approaches to molecular biology, cellular and organ physiology, and clinical practice. A SCOR provides the opportunity for investigators to engage in interdisciplinary and collaborative research that is focused on a specific disease or an area within a disease category. It is required that SCOR applications include studies of human subjects as well as basic studies clearly related to a disease area. The foundation of the clinical component should be strongly linked to the basic science projects; the basic science studies should be driven by the needs of the clinical projects. Thus, a SCOR has a central theme to which all research projects pertain. In addition, a SCOR may include CORE units to provide services to the various research projects and to support the organizational and administrative aspects of the program. 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, Specialized Centers of Research in Ischemic Heart Disease in Blacks, is related to the priority areas of heart disease and stroke, and 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by for-profit and non-profit domestic institutions, public and private, such as universities, colleges, hospitals, and laboratories, units of State and local governments, and eligible agencies of the Federal government. Applicants must provide evidence that there is an adequate resource of eligible Black subjects to meet proposed recruitment goals. In addition applicants should provide detailed plans of recruitment and retention strategies for study subjects so that liklihood of meeting recruitment targets can be assessed. Awards will not be made to foreign institutions. However, under exceptional circumstances, a foreign component critical to a project may be included as a part of that project. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) specialized center of research grant mechanism (P50). Responsibility for planning the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated date of award is September 1995. Although multidisciplinary approaches are required, it is not the intent of this RFA to solicit applications for large clinical trials or large epidemiological studies. In general, funds will not be provided for the purchase and installation of expensive, new equipment. The principal investigator should be an established research scientist with the ability to ensure quality control and the experience to administer effectively and integrate all components of the program. A minimum time commitment of 25 percent is expected for this individual. The principal investigator must also be the project leader of one of the component research projects. If, through peer review, this project is not recommended for further consideration, the overall SCOR application will not be considered further. If this project is judged by peer review to be of low scientific merit, it will markedly reduce the overall scientific merit ranking assigned to the entire application by the review committee. Project leaders must agree to commit at least 20 percent effort to each project for which they are responsible. Upon initiation of the program, the Division of Heart and Vascular Diseases will sponsor periodic meetings to encourage exchange of information among investigators who participate in this program, and to stimulate collaboration. Applicants should request travel funds for a one-day meeting each year, most likely to be held in Bethesda, Maryland. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. This RFA is intended to support Specialized Centers of Research grants. Therefore, applications that include only basic or only clinical research will not be responsive to this RFA. This solicitation is intended to redress the inadequate data base of studies in Blacks. Therefore, only clinical studies in Blacks will be responsive to this RFA. In addition, clinical research projects focused on large studies or large clinical trials will be considered unresponsive to this RFA. Consortium Arrangements If a grant application includes research activities that involve institutions other than the grantee institution, the program is considered a consortium effort. Such activities may be included in a SCOR grant application, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. The published policy governing consortia is available in the business offices of institutions that are eligible to receive Federal grants-in-aid. Consult the latest published policy governing consortia before developing the application. If clarification of the policy is needed, contact William Darby, (301) 594-7458. Applicants of SCOR grants should exercise great diligence in preserving the interactions of the participants and the integration of the consortium project(s) with those of the parent institution, because synergism and cohesiveness can be diminished when projects are located outside the group at the parent institution. Indirect costs paid as part of a consortium agreement are excluded from the limit on the amount of direct costs that can be requested. FUNDS AVAILABLE Approximately $4.8 million in total costs will be provided for the first year of support for the entire program. Applicants may request up to $1,080,000 direct costs, not including indirect costs for collaborating institutions, in the first year with a maximum increase of no more than four percent in each additional year requested in the application. It is anticipated that up to three grants will be awarded under this program. Although this program is provided for in the financial plan of the NHLBI, award of grants pursuant to this RFA is contingent upon receipt of funds for this purpose. Administrative adjustments in project period and/or amount of support may be required at the time of the award. Equipment is included in the budget limitation. However, requests for special equipment that cause an application to exceed this limit may be permitted on a case-by-case basis following staff consultation. Such equipment requires strong justification. Final decisions will depend on the nature of the justification and the availability of funds. RESEARCH OBJECTIVESS Background Ischemic Heart Disease (IHD) and heart muscle disease is the leading cause of mortality in the United States, and is particularly important to study in Blacks due to their disproportionately high death rates. Other minority groups (Hispanics, Asian/pacific Islanders and American Indians) have lower death rates than Whites. To chart a course for future research, the NHLBI convened a working group which released its report in March 1994 on RESEARCH IN CORONARY HEART DISEASE IN BLACKS. This report provides specific recommendations for future research in Black populations. The NHLBI strongly encourages research into the pathogenesis of diseases in Blacks, and recommends that this report be consulted. Scientific IHD or myocardial damage secondary to ischemia has been a major focus in cardiovascular research in this country. Although death due to IHD is a leading cause of death for both White and Black populations in this country and is a major contributor to the excess deaths among Blacks 20 to 64 years old, studies in Blacks are minimal compared to those available in White populations. Racial disparities in the clinical expression, risk factor prevalence and outcomes for IHD have been reported. The significance of these differences remains uncertain. The lower prevalence of coronary atherosclerosis observed in several studies, despite high prevalence of risk factors and poorer outcomes, suggests that mechanisms of myocardial damage other than obstructive coronary atherosclerosis may be of particular importance in this population. Advances in cellular biology, vascular biology and molecular genetics offer an unprecedented opportunity for exploring the relative influences of genetic, physiological, and environmental factors in the pathogenesis of complex diseases such as IHD which affect Blacks disproportionately. Understanding the clinical expression and pathologic mechanisms of myocardial damage in Blacks may provide more precise interventions to prevent or halt disease progression for this population as well as the general population at risk. This initiative seeks to foster an innovative research approach to understanding IHD in Blacks by studying each of three topic areas: sudden cardiac death, diabetic heart disease, and the coronary microcirculation. Sudden Cardiac Death The Black population has a higher rate of out-of-hospital SCD than the White population. The difference, though, does not depend on the quality of the emergency medical care provided to the two groups. Black patients with an AMI also have a higher morbidity and mortality rate than White counterparts; there is speculation that the disparity is due to a host of factors ranging from reduced utilization of medical services to increased susceptibility to lethal arrhythmias. The poorer prognosis after myocardial infarction has been associated with a greater incidence of ventricular hypertrophy and arterial hypertension in this minority population. Apart from socioeconomic issues, there is a fundamental concern that racial differences in biological mechanisms may contribute to the higher prevalence of SCD among Blacks. Important distinctions in the specific substrates for the genesis of arrhythmias have yet to be fully elucidated, but offer the promise of more effective therapy for all patients. It is well accepted that LVH increases the risk of SCD. Studies have shown that left ventricular wall thickness is greater in Blacks than in Whites when data are normalized for differences in blood pressure. Approximately 80 percent of Blacks with ischemic heart disease also have hypertension. The combination of hypertrophy and hypertension complicates interpretation of the electrocardiogram (ECG), resulting in a higher number of false positive exercise stress tests used for the diagnosis of IHD. Thus, there is a need to improve the accuracy of cardiac stress testing in Blacks suspected of hypertrophy, with or without hypertension. At present there are gaps in understanding how the hypertrophied myocardium predisposes an individual to a greater risk of a serious arrhythmia. It is known, for instance, that the added physical load imposed on a myocyte can activate stretch-dependent ion channels that lead to calcium (Ca++) overload. Blacks are hypothesized to have a greater responsiveness of stretch-dependent channels, but no electrophysiologic evidence has linked this finding with a greater prevalence of arrhythmias in this population. Moreover, it is unknown whether differences in the kinetics of the L-type Ca++ current or the transient outward current (Ito) might exacerbate Ca++ overload. Since animal models of the aging heart have been shown to be less tolerant of Ca++ overload, and thus more susceptible to ventricular fibrillation, it would be intriguing to determine if any alteration in Ca++ handling correlates with the aging process. The role of connexins in impulse propagation through gap junctions is well established. Alterations in connexin density or distribution may be differentially affected during the development of hypertrophy, thereby increasing the risk of reentrant or nonsustained ventricular tachycardia. Other basic electrical properties of the cardiac cell membrane may play a decisive role in the development of serious arrhythmias. The surface charge on the membrane can be altered by oxygen free radicals generated during hypoxic or ischemic stress. Such stress is more common in individuals with LVH, suggesting that free radical damage may also be more prevalent. Regular physical exercise is known to increase the production of free radical scavenger enzymes. Some studies have reported that Blacks tend to be more sedentary than Whites, but it remains to be determined whether exercise would exert a beneficial effect on free radical scavenging in the former population and thereby reduce the incidence of serious arrhythmias. Other factors influencing the extent of free radical damage in the heart, such as estrogen replacement, may also be important in the development of substrates for arrhythmia production. Hypertensive patients who have a low renin production were found to have a digitalis-like compound that inhibits the Na+/K+ ATPase pump. In the heart, such inhibition of the electrogenic Na+/K+ pump leads to partial depolarization of cardiac tissue, possibly forming a substrate for impulse conduction abnormalities. Regional heterogeneity in the magnitude of depolarization, especially in the presence of ventricular hypertrophy, may exacerbate conditions for arrhythmia production associated with SCD. Electrocardiographic variants in R wave amplitude, ST segment voltage, and T wave morphology have long been considered normal in the Black population. Given the higher rates of SCD and post-MI morbidity, it may be instructive to determine whether, in fact, such variants are non-pathologic or a harbinger of cardiac disorders. Understanding the basis for such population-related variants may help explain the basis of angina-like pain in the absence of angiographic evidence of coronary atherosclerosis. At present, tests like the exercise ECG are of limited value in the diagnosis of such patients, especially Black women. Blacks may be more sensitive than other populations to certain provocative stimuli. For example, indirect evidence suggests that this population is more sensitive to the effects of nicotine on triggering increased platelet aggregation, vasomotor reactivity, or arrhythmogenesis. Quantifying this difference can lead to improvements in diagnosis and prediction of those at increased risk of SCD or post-MI arrhythmias. Moreover, research may derive clinically normative standards for measurements of the signal averaged ECG, nonlinear analysis of rate and rhythm, and other tests that would be especially useful when applied to Black cohorts. Proposed Research Sudden Cardiac Death o Identification of the electrophysiological mechanisms responsible for arrhythmias in hypertrophied myocardial cells o Assessment of the structural and functional changes in gap junctions and connexins associated with myocardial hypertrophy o Determination of the sensitivity of hypertrophied cardiac myocytes to calcium overload; correlate any changes with the aging process o Assessment of the significance of normal variants in the surface ECG with the early development of ventricular hypertrophy and the prognostic value of such variants for the risk of serious arrhythmias o Utilization of basic and clinical research studies to define the relative contribution of the autonomic nervous system and receptor activation to the development and risk of SCD o Determination of the extent to which physical exercise, or other behavior modifications, reduces the risk of SCD or post-MI arrhythmias in Blacks o Utilization of state-of-the-art techniques like signal averaged ECG or nonlinear analysis, to determine the relative risk among Black males and females following the onset of angina-like pain, or following MI; assessment of the predictive value of such technology o Determination of the sensitivity of Blacks for development of arrhythmias in response to stressors like acute exercise, psychological stress, exposure to nicotine, or ingestion of alcohol Microvascular Disease Dysfunction of the cardiac microcirculation has been reported in patients who suffer chest pain and have electrocardiographic evidence of ischemia despite normal or near normal angiograms. Of Blacks presenting with angina-like chest pain, nearly half have been reported to have normal coronary angiograms. Furthermore, Blacks have higher morbidity and mortality from cardiovascular disease than White Americans, despite the high rates of angiographically normal or minimally diseased epicardial coronary arteries. Studies of predominantly or purely Black populations, the major proportion of whom were hypertensive, have demonstrated that left ventricular mass is a strong predictor of all cause mortality independent of the number of obstructed coronary arteries. Hypertrophied heart muscle has an increased coronary flow demand, yet studies have shown that the maximum blood flow that can be achieved is subnormal in both humans and animal models. Furthermore patients with hypertension without hypertrophy have also been shown to have abnormalities of coronary flow. These abnormalities have been attributed to impairment of vasodilatory reserve in the resistance vessels of the microcirculation. They appear to be more common in younger, more severely hypertensive patient populations, including women and Blacks. Other investigations have suggested a relationship between left ventricular hypertrophy, coronary atherosclerosis, extracoronary atherosclerosis and arterial hypertrophy. Thus, treatment of hypertension alone may not be adequate to reduce the increased risk of death. Much needs to be understood about the mechanisms underlying the vascular changes brought about by hypertension and hypertrophy of the heart. Research is needed to improve the diagnosis of microvascular disease and to translate knowledge of the etiology of the disease at the molecular, cellular and physiologic levels into new therapeutic modalities. Commonly used tests for screening for IHD are stress thallium-201 myocardial perfusion imaging for patients who can exercise and dipyridamole-induced vasodilation in conjunction with thallium imaging or echocardiography for patients who cannot exercise. Currently there is no ideal, clinically applicable technique for directly measuring microcirculation in the myocardium. Thus, there are opportunities to develop methods for better assessment of the microcirculation. Several methods offer promise as for example X-ray CT, SPECT, quantitative echocardiography, and metabolic based techniques such as PET and NMR. An approach that would enable non-invasive assessment of microvascular function concerns the possibility that microvascular function in the forearm might reflect function in the heart. Leukocyte and/or platelet plugging following an ischemic episode were once thought to account for impaired perfusion. However, it is now thought that changes in the structure of capillary walls and changes in the structure and function of endothelial cells are largely responsible for inadequate myocardial perfusion. Recently published findings confirm this view. Endomyocardial biopsies of Japanese patients with normal coronary arteries and angina were examined by light and electron microscopy. Mild myocardial hypertrophy and marked perivascular fibrosis around small arteries and arterioles were observed. Luminal narrowing due to a medial thickening was also seen. Electron microscopy revealed that the nuclei of endothelial cells tended to be swollen and the chromatin marginalized. In the media smooth muscle cell proliferation and deformation was observed reflecting the medial thickening seen in light microscopy. The generality of these findings needs to be defined by biopsy or autopsy studies. Furthermore the mechanisms underlying these changes have yet to be explored fully in Blacks and offer a fruitful field for basic research. Many factors have the potential to modulate vascular tone in both the physiologic and pathophysiologic setting, to remodel the structure of the vessel wall, and alter the function of vascular cells. These include hypoxia, oxygen free radicals, altered neural and hormonal influences, changes in secretion of autocrine and paracrine factors, and genetic predisposition. This latter possibility is based on a study showing that salt sensitive and salt insensitive rats differ in their predisposition to hypertension and microvascular injury in the remnant kidney model. Rats, pigs, and dogs have been used as animal models to study intramyocardial circulation to validate imaging techniques, to examine postmortem pathology, to elucidate the pathophysiology of microvascular tone, and to study the effectiveness of pharmacologic preparations in promoting microvascular dilation. For example, intramyocardial flow can be assessed using fluorescent or radioactive microsphere techniques, as well as PET and NMR scanning. Thus, the effects of hypertension, high blood cholesterol and diabetes on intracardiac flow can be assessed. These methods can also be used to evaluate, by direct observation, drug regimens with respect to their ability to improve vasodilator reserve. Pig (and human) cardiac microvessels can be used to examine their reactivity profile with respect to endothelin, arachidonic acid metabolites, catecholamines, and other vasoactive substances; to characterize vascular ion channels which modulate vascular smooth muscle in microvessels; and to elucidate biochemical pathways by which endogenous vasoactive factors exert their influence. The animal models will also provide the opportunity to observe whether angiogenesis occurs during hypertrophy and whether the angiogenic potential can be manipulated to improve microcirculation in the hypertrophied heart. Microvascular cells can now be isolated from ventricular tissue of adult rats and their function can be studied in vitro alone and in co-culture with ventricular myocytes. These studies have revealed the existence of cell-cell signalling between microvascular endothelium and ventricular myocytes. As stated by Kramer et al (Circulation 1992; 85:350) in a recent review, "There is growing evidence to support the existence of a dynamic interaction in vivo between cardiac myocytes and adjacent microvascular endothelial cells in the regulation of both cardiac myocyte and possibly endothelial cell phenotype and function." These authors speculate that endothelins may be only one of several endogenous cytokines or autocoids that are released by the cardiac microvascular and/or endocardial endothelium and transported vectorially to adjacent myocytes that could modify cardiac contractile state, perhaps in response to changes in microvascular blood flow. Similarly, cardiac myocytes themselves could release cytokines that could directly affect endothelial cell proliferation or angiogenesis and indirectly elicit or modify the release of endothelium-derived cytokines and autocoids. Thus, in addition to modifying function, endothelial cell-cardiac myocyte interactions may also be of importance in the dynamic events that lead to myocardial wall remodeling and angiogenesis during hypertrophic growth and in the response to cardiac injury. As an example of this, endothelin, which is secreted by endothelial cells and numerous nonendothelial tissue sources, is a potent vasoconstrictor and inotropic factor. It has mitogenic effects in vascular smooth muscle and certain other cell types, and affects expression of proto-oncogenes such as c- fos, c-jun and erg-1 and atrial natriuretic peptide. Thus, the powerful tools of molecular biology and state-of-the-art cellular physiology could be brought to bear on the problem of microvascular disease. Microvascular Disease o Diagnostic studies to evaluate patients with suspected microvascular disease to compare a forearm test of microcirculation with results in the heart o Development and testing of new and improved diagnostic procedures for microvascular disease o Evaluation of treatment for hypertension coupled with treatment to prevent remodelling, e.g., Angiotension Converting Enzyme (ACE) inhibitors o Study of a possible genetic predisposition to microvascular disease in response to hypertension in Blacks o Animal model studies of the progression of microvascular dysfunction and remodelling in hypertension and cardiac hypertrophy o Assessment of experimental therapies for prevention and treatment of microvascular dysfunction in animal models o Elucidation of the underlying mechanisms initiating and sustaining cardiac hypertrophy in response to hypertension o Elucidation of the changes in gene expression that initiate and sustain microvascular remodelling in response to hypertension and cardiac hypertrophy o Investigation of the role of altered ventricular function and myocyte structure in mediating changes in the microvasculature o Examination of the possibility that angiogenesis could be stimulated in the hypertrophied heart to improve myocardial perfusion. Diabetic Heart Disease Diabetes is currently the third leading cause of death in the US and affects approximately five percent of the population. There is a greater prevalence of diabetes among Blacks than among Whites. Over 50 percent of deaths among diabetic patients result from cardiovascular complications. Diabetic cardiomyopathy is a significant cause of heart failure in diabetic subjects and occurs more frequently in those with microvascular complications and/or hypertension. The pathologic significance of diabetic cardiomyopathy is not limited to coronary atherosclerosis. For example, the high mortality of myocardial infarction among diabetics may reflect in part, preexistent myocardial dysfunction from diabetic cardiomyopathy. There is a two- and five-fold increase in the incidence of congestive heart failure in diabetic men and women, respectively, as compared to non-diabetic subjects. The clinical significance of diabetic cardiomyopathy may be even greater in Blacks because there is a high prevalence of hypertension in this population. Furthermore, subgroups at particularly high risk of developing diabetic cardiomyopathy include women and obese subjects. Obesity is a significant problem in Blacks; one out of every three young adult Black women is considered obese. More clinical work in the area of diabetic cardiomyopathy is clearly needed including: (1) the evaluation of its natural history by serial, noninvasive evaluation of myocardial size and function in a variety of diabetic subgroups; and (2) study of the effects of tight control of hyperglycemia and normalization of blood pressure on cardiac function. Comparison of different antihypertensive agents in the hypertensive diabetic population would be of particular interest. Despite the importance of diabetic cardiomyopathy as a major cause of morbidity and mortality in diabetic Blacks, the fundamental pathophysiology of the process is still poorly understood. Further work is required to understand the basic molecular and cellular processes responsible for the pathophysiology of diabetic cardiomyopathy and coronary heart disease and to discover new interventions that effectively reverse, halt, or prevent disease progression. Diabetes is a heterogeneous disease. Clinically, it has been classified into insulin-dependent diabetes mellitus (IDDM) and noninsulin- dependent diabetes mellitus (NIDDM). IDDM is the less prevalent form of the disease and is characterized by severe insulinopenia, hyperglycemia and occasional bouts of ketoacidosis. By contrast, NIDDM is a disease of insulin resistance and hyperglycemia. IDDM is closely correlated with autoimmune injury of the pancreas associated with genetic markers associated with the human leukocyte antigen (HLA) system. There is also strong evidence that genetic susceptibility plays a role in the development of NIDDM, which is often found in obese subjects. People with NIDDM are twice as likely to die from heart disease as are members of the non-diabetic population. NIDDM is not uniformly distributed among ethnic groups, there is a clustering prevalence among certain ethnic/racial groups such as Blacks, suggesting the likely contribution of genetic factors to the expression of this disease. The candidate genes involved are presently unknown. Diabetic cardiomyopathy has been characterized as myocardial failure independent of atherosclerotic coronary artery disease, valvular disease or hypertension. Noninvasive studies of diabetic subjects have shown disorders in systolic and diastolic function, which may progress to overt congestive heart failure. The pathogenesis of this disorder is still uncertain. Common histopathologic abnormalities include small vessel disease, interstitial fibrosis and myocardial hypertrophy. Improved understanding of the pathophysiology of diabetic cardiomyopathy requires study of experimental animals with either genetically or drug induced diabetes. A wide variety of studies in several animal species have shown a host of alterations in the structure and function of the myocyte, the interstitium and the coronary vasculature. More work is needed in order to understand the fundamental mechanisms that account for: (1) the wide range of adaptive (and reversible) changes in myocyte function including alterations in myosin, regulatory proteins, calcium transport systems (sarcolemmal, sarcoplasmic reticular and mitochondrial) and catecholamine turnover and catecholamine responsiveness; (2) the possible role of altered myocardial energetics in diabetics as a stimulus to these adaptations should be considered; (3) irreversible changes in myocardial structure including cell loss, replacement fibrosis and interstitial role of small vessel disease including alterations in vascular interstitial fibrosis, and (4) the possible roles of increased vascular permeability and the formation of advanced glycosylation products. Much of what is know about the pathogenesis of diabetic complications has been gleaned from studies using animal models. Most studies have utilized chemically-induced diabetic rodent models or the BB (Biobreeding) rat, whose diabetes is of autoimmune origin. In addition, a number of transgenic mouse models have been developed which mimic some of the effects of IDDM. Although NIDDM is the most prevalent form of diabetes, less information is available on the cardiomyopathy linked to it. Most studies examining this condition have employed a chemical model of NIDDM produced by treating neonatal rats with the pancreatic toxin, streptozotocin. While the cardiomyopathy that develops in the IDDM and NIDDM animal models share certain properties, they differ in some important ways, most notably in signal transduction mechanisms, calcium transport, energy metabolism and diastolic function. One of the most important contractile defects of the NIDDM cardiomyopathy, but not the disease linked to IDDM, is the reduction in diastolic compliance and resulting reductions in left ventricular and diastolic volume and stroke volume. While the chemically induced model of NIDDM exhibits most of the characteristics of NIDDM, including insulin resistance, modest hyperglycemia, severe glucose intolerance and normal fasting insulin plasma content, it only mimics a subset of NIDDM subjects which are lean. Identification of an animal model which appropriately mimics the human condition of NIDDM in obese persons has been problematic. While there are a number of animal models that carry a genetic predisposition to develop obese NIDDM, it is common for these species to develop abnormalities independent of diabetes. Hyperinsulinemia is an independent risk factor for hypertension, therefore, coexistence of diabetes and hypertension is common. Hypertension in the diabetic subject markedly increases the risk of heart disease, accelerates the course of cardiomyopathy, and potentiates the severity of the disease. Some models combining hypertension and diabetes have been described, but only a few studies have examined cardiomyopathy which develops in these models. The mechanism by which hypertension potentiates the severity of the heart muscle disease is still poorly understood. Diabetic Heart Disease o Determination of the mechanisms underlying altered gene expression of structure and contractile proteins in diabetic cardiomyopathy o Elucidation of the genetic factors that are responsible for the expression of diabetic cardiomyopathy in Blacks o Elucidation of the cellular and molecular mechanisms underlying the alterations in intracellular Ca++ homeostasis and trans-sarcolemmal receptor signals during the development of diabetic cardiomyopathy o Determination of the changes in myocyte function including alterations in myosin, regulatory proteins, calcium transport systems, altered myocardial energetics, and catecholamine responsiveness in diabetics o Elucidation of the role of growth factors and cytokines in both cellular dysfunction and structural changes including cell death, replacement fibrosis, and interstitial fibrosis (including vascular mechanisms and neurohumoral factors) in diabetic subjects o Elucidation of the role of coexistent conditions such as hypertension in the potentiation of diabetic-induced myocardial disease o Elucidation of the relative pathogenic significance of the multiple factors that may alter myocardial performance in diabetic patients o Elucidation of the role of metabolic control on myocardial abnormalities and on the primary prevention or reversal of myocardial dysfunction. Basic and Clinical Research The overall concept of a SCOR program focuses on scientific issues related to diseases relevant to the mission of the NHLBI. It is essential, therefore, that all applications include both basic and clinical research projects. In the ideal SCOR, the clinical research derives from, or is otherwise intimately linked to the basic research proposed by the investigators. Interactions between basic and clinical scientists are expected to strengthen the research, enhance transfer of fundamental research findings to the clinical setting, and identify new research directions. Plans for transfer of findings from basic to clinical studies should be described. Each SCOR grant application and award must include research involving human/patient subjects. Support may be provided for human biomedical and behavior studies of prevention and prevention strategies, diagnostic approaches, and treatment of diseases, disorders or conditions. Small population-based studies, where the research can be completed within five years, may also be proposed. In addition, basic research projects must be included that relate to the clinical focus. A SCOR may also contain one or more core units that support the research projects. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by November 30, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the principal investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. The letter of intent is to be sent to: Dr. James Scheirer, Chief Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 553 A Bethesda, MD 20892 Upon receipt of the letter of intent, applicants will be contacted by program staff to discuss their proposed applications and to provide guidance to applicants not familiar with the SCOR concept. APPLICATION PROCEDURES The research grant application for PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248. Applicants must follow the instructions provided in the supplement to the RFA. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, to identify the application as a response to this RFA, check "YES," enter the title, "Specialized Centers of Research in Ischemic Heart Disease in Blacks" and the RFA number HL-95-005 on Line 2a of the face page of the application. Send or deliver a signed, typewritten original of the application, including the checklist, and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Send two additional copies of the application to Dr. James Scheirer, Chief, Review Branch, Centers and Special Projects Section at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants, otherwise the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by May 18, 1995. If an application is received after that date, it will be returned to the applicant. 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, or 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 NHLBI. Incomplete applications will be returned to the applicant without further consideration. If NHLBI staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer group convened by the NHLBI in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and will be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be notified. Neither site visits nor reverse site visits are planned as a part of the review process, therefore each application should be complete on submission. Review criteria for this RFA are generally the same as those for unsolicited interdisciplinary research grant applications. o the scientific merit of each proposed project in the application, including originality, feasibility of the approach, and adequacy of the experimental design; o the integration of the clinical and fundamental research into a coherent enterprise with adequate plans for interaction and communication of information and concepts among the collaborating investigators; o the technical merit and justification of each core unit; o the qualifications, experience, and commitment of the SCOR Director and his/her ability to devote adequate time and effort to provide effective leadership; o the competence of the project investigators to accomplish the proposed research goals, their commitment, and the time they will devote to the program; o the adequacy of facilities to perform the proposed research including the laboratory and clinical facilities, access to subjects, instrumentation, and data management systems when needed; o the scientific and administrative structure of the program, including adequate internal and external arrangements and procedures for monitoring and evaluating the proposed research and for providing ongoing quality control and scientific review; o the institutional commitment to the program and the appropriateness of the institutional resources and policies for the administration of a research program of the type proposed; and o the appropriateness of the budget for the proposed program. o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA Applications must fulfill all the eligibility and responsiveness criteria in order to be considered for funding. Since a variety of approaches would represent valid responses to this announcement, it is anticipated that there will be a range of costs among individual grants awarded. The most important criterion in selecting awardees will be the scientific merit as reflected in the priority score. However, factors such as program balance and available funds may enter into selection from among meritorious applications. The anticipated date of award is September 1995. Schedule Letter of Intent Receipt Date: November 30, 1994 Application Receipt Date: May 18, 1995 Review by NHLB Advisory Council: September 1995 Anticipated Award Date: September 1995 INQUIRIES Inquiries concerning this RFA are encouraged. the opportunity to clarify any issues or questions from potential applicants is welcome. Dr. Patrice Desvigne-Nickens Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Federal Building, Room 3C06 7550 Wisconsin Avenue MSC 9070 Bethesda, MD 20892-9050 Telephone: (301) 496-1081 FAX: (301) 480-6282 Email: patrice_nickens%nihhfed1.bitnet@cu.nih.gov Inquiries regarding fiscal and administrative matters may be directed to: Mr. William Darby Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A11 Bethesda, MD 20892 Telephone: (301) 594-7458 FAX: (301) 594-7492 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance number 93.387, Heart and Vascular Diseases. Awards are made under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grants policies and Federal regulations, most specifically 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372, or to Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Thu Oct 13 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-95-010 - V23(36) 10/14/94 Date: 13 Oct 1994 19:27:08 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 512 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <37kq9s$bti@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL95010 HL-95-010 P1O1 *************************************** COAGULATION, PLATELETS AND THROMBOSIS IN SICKLE DISEASE PATHOPHYSIOLOGY NIH GUIDE, Volume 23, Number 36, October 14, 1994 RFA: HL-95-010 National Heart, Lung, and Blood Institute P.T. 34; K.W. 0715032, 0715040, 0765033 Letter of Intent Receipt Date: December 20, 1994 Application Receipt Date: January 24, 1995 PURPOSE The Division of Blood Diseases and Resources (DBDR) of the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), invites research grant applications to support basic research on the role of hemostasis and thrombosis in the pathophysiology of sickle cell disease vasculopathy. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Coagulation, Platelets and Thrombosis in Sickle Cell Disease Pathophysiology, is related to the priority areas of clinical prevention services, chronic disabling conditions, and maternal and infant health. The goal of this program is basic research leading to approaches that ameliorate the long term debilitating effects of this disease. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-782-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state or local governments, and eligible agencies of the federal government. Awards in response to this RFA will be made to foreign institutions only for research of very unusual merit, need, and promise, and in accordance with PHS policy governing such awards. Applications from minority individuals and women are encouraged. Foreign institutions are not eligible for FIRST (R29) awards. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research project grant (R01) and FIRST award (R29) and is a one-time solicitation. Applicants, who will plan and execute their own research programs, are requested to furnish their own estimates of the time required to achieve the objectives of the proposed research project. Up to 46 months of support may be requested for R01 applications, but 58 months of support must be requested for R29 applications. At the end of the official award period, renewal applications may be submitted for peer review and competition for support through the regular grant program of the NHLBI. It is anticipated that support for the present program will begin July 1, 1995. Administrative adjustments in project period/or amount of support may be required at the time of the award. Since a variety of approaches would represent valid responses to this RFA, it is anticipated that there will be a range of costs among individual grants awarded. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded in connection with this RFA. FUNDS AVAILABLE It is anticipated that for fiscal year 1995, $1,500,000 will be available for this initiative. It should be noted that award of grants pursuant to this RFA is contingent upon receipt of such funds for this purpose. It is anticipated that about six new grants will be awarded under this program. The specific number to be funded will, however, depend on the merit and scope of the applications received and on the availability of funds. If collaborative arrangements involve sub-contracts with other institutions, the NHLBI Grants Operations Branch (telephone: (301) 594-7436) should be consulted regarding procedures to be followed. RESEARCH OBJECTIVES Vascular occlusive events account for much of the morbidity and mortality associated with sickle cell disease. Despite significant advances in clinical observation and experimental investigation, however, the pathogenesis of these vaso- occlusive events remains ill-defined and the subject of much speculation. Factors contributory to the initiation of vaso-occlusion may include rheological abnormalities related to sickling, abnormal adhesiveness of sickle red cells to endothelium, dehydration and poor deformability of sickle red cells, various vascular factors, and activation of hemostatic systems. Despite various observations that are consistent with a pathogenetic role for hemostasis and thrombosis in sickle vaso-occlusive events, the incompleteness of existing data leaves important but unanswered hypotheses regarding this neglected area of sickle disease pathophysiology. Further understanding of the role of thrombosis and/or hemostatic activation in sickle cell disease pathophysiology is likely to facilitate the rational design of therapeutic trials and approaches and to thereby improve clinical care of affected individuals. Clinical Involvement Cerebrovascular disease contributes significant morbidity in up to 17 percent of patients with sickle cell anemia, with stroke resulting from thrombosis usually developing at sites of underlying intimal hyperplasia. Suggestive, albeit inconclusive, evidence suggests that thrombosis may contribute to the acute chest syndrome and pulmonary hypertension in sickle cell disease. Whether this disease includes an increased risk for venous thrombosis and thromboembolism has not been resolved. The possibility that thrombosis and/or hemostatic activation contributes to other manifestations such as the acute painful vaso-occlusive crisis has not been excluded. Limited trials have failed to find benefit in prophylactic aspirin, although this approach could leave thrombin-induced platelet activation unimpeded. Very small trials have claimed lack of benefit from warfarin therapy but discernible benefit from long-term subcutaneous heparin. There have been no studies of antiplatelet or anticoagulant agents in the primary or secondary prevention of stroke in sickle cell disease, nor has the efficacy of thrombolytic agents been tested. Pathophysiology Insofar as thrombotic complications occur in sickle cell disease, they may be uniquely widespread in their anatomical distribution, with abnormal clotting occurring in the venous (e.g., thrombosis with pulmonary embolus), arterial (e.g., stroke), and microvascular (e.g., painful vaso-occlusive crisis) circulations. Such heterogeneity of clinical phenomena is distinctly unusual (i.e., in inherited hypercoagulable states such as protein S or C deficiency) and conceivably could derive from participation of multiple hemostatic disturbances. Virchow's triad (altered blood flow, disturbed vascular integrity, and alterations in the blood) encompasses our understanding of the pathogenesis of thrombosis, irrespective of the anatomical vascular bed in question. Therefore, it is reasonable to consider the potential role of hemostasis and thrombosis in sickle cell disease in terms of the components of Virchow's triad. Blood flow augments mass transport of blood borne elements beyond that resulting from diffusion alone and may thereby influence the thrombotic process. In a normal laminar flow situation, the effective concentration of platelets is increased several fold towards the periphery of a normal vessel. This cellular distribution is a function of both red cell concentration and wall shear rate. Flow models have been employed to study a combination of normal red blood cells and platelets, but nothing is known about sickle erythrocytes and their interaction with platelets in such models. The complex interplay of abnormalities in erythrocyte deformability, membrane characteristics, vascular factors (e.g., flow rate, vessel diameter and reactivity, and so on), and tendency to adhere to the vascular endothelium has not been directly studied in the context of the genesis of thrombosis. The disturbance in normal laminar blood flow in sickle vessels might directly influence endothelial cell function; for example, it has been previously demonstrated that shear stresses regulate the synthesis and expression of prostacyclin, tissue plasminogen activator, and von Willerbrand factor by endothelial cells. Studies have also shown that platelets exposed to physiological shear forces ex vivo (in viscometers) aggregate without the addition of exogenous agonists, a phenomenon not seen in standard platelet aggregation assays. Further studies specifically examining shear stresses in interrelationships between sickle red cells, platelets, endothelial cells, and coagulation factors may enhance our understanding of this disease. Normal vascular endothelium plays an important role in resisting thrombosis. It is likely that endothelial cell dysfunction (and possibly denudation) contributes significantly to the thrombotic manifestations of sickle cell disease. Increased numbers of circulating endothelial cells have been observed during crisis, and elevated levels of prostacyclin metabolites have been variably observed in sickle plasmas, possibly suggesting that endothelial injury occurs in vivo. Vascular intimal hyperplasia of large cerebral arteries, sometimes with superimposed thrombosis, is thought to be the most frequent cause of stroke in sickle cell disease. It is now possible with a combination of magnetic resonance imaging and angiography to demonstrate the presence of vascular intimal lesions in the cerebral vascular circulation of children with sickle cell disease. In order to extend our knowledge of the role of altered vascular integrity in some of the other complications of sickle cell disease, further histopathological and clinical-pathological data are necessary to define the frequency and significance of intimal hyperplasia in other vascular beds. This in turn raises the question of the pathogenesis of this vascular lesion and whether it may derive from endothelial injury caused by adherent sickle erythrocytes or molestation of the endothelium by pathologic or biologic modifiers that impact upon its anticoagulant/procoagulant balance. For example, elevated levels of tumor necrosis factor, IL1 and endotoxin have been noted in sickle plasmas, although the temporal relationship of such changes to clinical or vascular events is undefined. The state of endothelial activation or integrity, either in general or in relationship to specific clinical events, is wholly undefined in sickle cell disease. Numerous clinical studies have documented that the coagulation system is in a state of activation in "steady state" sickle disease as well as during painful crisis. In particular it seems clear that ongoing thrombin generation and fibrinolysis occurs in these patients (e.g., as evidenced by increased prothrombin F 1.2 fragment, fibrinopeptide A, thrombin/antithrombin complexes, and D-dimer), even in steady state; whether this change is in relationship to acute vaso-occlusive crisis is less clear. D-dimer levels are reported to be commonly elevated in sickle patients with leg ulcers, aseptic necrosis, or stroke. Diminished levels of anti-thrombotic substances (proteins S and C and antithrombin III) are often observed in sickle patients. Since plasmatic coagulation is initiated by tissue factor in vivo, it is significant that recent observation of accelerated Factor VII turnover has provided indirect evidence for abnormal tissue factor expression in sickle disease patients. Direct demonstration of tissue factor expression, verification of its location (e.g., monocytes versus endothelium), and identification of stimulants underlying its apparent expression in sickle cell disease have not been attempted. The extent to which hemostatic changes are contributed to in vivo by abnormality of the sickle cell membrane (in which negatively charged phospholipids are available to enhance coagulation reactions) or the circulating red cell membrane spicular fragments in sickle plasma is essentially unknown. Other studies have provided suggestive evidence for platelet activation (e.g., elevated plasma -thromboglobulin, decreased platelet thrombospondin, and preliminary observation of abnormal expression of platelet activation antigens) even in steady state sickle patients, but unambiguous proof of this using modern, optimal platelet collection methodology has not been provided. The precise reason for apparent platelet activation in these patients has not been established, nor have the circumstances of its occurrence. In particular, the degree to which platelet abnormalities change relative to specific clinical events is not defined, nor is the relationship, if any, between platelet activation and thrombin generation. The recent demonstration that platelet-derived thrombospondin could be a major factor in adhesion of sickle red cells to endothelium identifies one potential link between the hemostatic systems and vascular occlusion in this disease. The extent to which platelet release products impact upon the endothelium and vessel wall in sickle disease has not been defined. This RFA is intended to stimulate research on the role of hemostasis and thrombosis in the pathophysiology of sickle cell disease. Examples of research areas that would be responsive to this RFA are given below. This list is intended to provide guidance as to areas suitable for study; it is not intended to be all inclusive. Investigators are encouraged to consider other topics relevant to this program. o Investigation of endothelial function/dysfunction as it pertains to the anticoagulant/procoagulant balance of the endothelial surface in sickle patients. What is the state of endothelial activation in sickle cell patients? Does endothelial dysfunction contribute to the coagulopathy and vasculopathy of sickle cell disease? Do other known factors peculiar to sickle disease (e.g., red cell adhesivity, elevation of certain acute phase reactants) impact upon endothelial cell hemostatic function? o Investigation of the reason(s) for coagulation abnormalities in sickle cell disease. What causes apparent activation of tissue factor? Where and under what circumstances is it expressed? Does the abnormal sickle red cell membrane or the presence of circulating spicular fragments contribute to in vivo hemostatic abnormalities? What explains apparent deficiencies of antithrombotic proteins in these patients? o Investigation of the extent to which hemostatic abnormalities contribute to sickle vascular disease. What vascular events do (and which do not) involve hemostatic abnormalities in their primary pathogenesis? For which events does hemostatic activation and/or thrombosis play an important secondary role? Does coagulopathy in sickle disease precede or follow vasculopathy? o Investigation of platelet physiology in sickle cell disease. What is the extent of platelet activation in sickle patients? Under what circumstances does it occur, and what triggers it? Is there any relationship between platelet activation and specific vascular events? o Investigation of the biochemical distinction (or similarity) between acute painful crisis and inter-critical periods. Does the "steady-state" really exist vis a vis hemostatic systems? What are the precise hemostatic differences between apparent steady state and acute painful crisis? Do any hemostatic abnormalities play a different role in vaso- occlusive events other than the acute painful episode? Can detailed longitudinal studies of hemostatic systems elucidate cause from effect, risk factor from primary trigger, acute from chronic? o Can pharmacologic manipulation of hemostasis impact favorably upon any vaso-occlusive manifestations of sickle cell disease? The primary intent of this RFA is to solicit basic rather than clinical studies. However, in recognition of the fact that the long term goal of such work is to develop successful therapeutic approaches, inclusion of some clinical investigation as a necessary and integral part of a basic scientific program would be considered to be responsive to this RFA. SPECIAL REQUIREMENTS Upon initiation of the program, the NHLBI will sponsor annual meetings to encourage the exchange of information among investigators who participate in this program. Applicants should request additional travel funds for one meeting each year to be held in Bethesda, Maryland. Applicants should also include a statement in the applications indicating their willingness to participate in such meetings. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators also may obtain copies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by December 20, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 553 Bethesda, MD 20892 Telephone: (301) 594-7478 FAX: (301) 594-7407 Internet: James_Scheirer@NIH.GOV APPLICATION PROCEDURES Applications are to be submitted on the research grant application form PHS 398 (rev. 9/91). This form is available in an applicant institution's office of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Use the conventional format for research grant applications and ensure that the points identified in the section on REVIEW CONSIDERATIONS are fulfilled. FIRST applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of references will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. To identify the application as a response to this RFA, check "YES" on Item 2a of page 1 of the application and enter the title and RFA number: COAGULATION IN SICKLE CELL DISEASE RFA HL-95-010. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Send or deliver the completed application and three signed, exact photocopies of it to the following, making sure that the original application with the RFA label attached is on top: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Send an additional two copies of the application to the Chief, Centers and Special Projects Review at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants. Otherwise the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by January 24, 1995. 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 the DRG and responsiveness by the NHLBI. Incomplete applications will be returned to the applicant without further consideration. If NHLBI staff determine that the application is not responsive to the RFA, it 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 NHLBI in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. Applications should be prepared so that they can be reviewed without the necessity of interaction between the applicants and the reviewers, since no site visit or reverse site visit will be part of the technical review. Review Criteria The factors to be considered in the evaluation of scientific merit of each application will be similar to those used in the review of traditional research grant applications, including the novelty, originality, and feasibility of the approach; the training, experience and research competence of the investigator(s); the adequacy of the experimental design; the suitability of the facilities; the appropriateness of the requested budget to the work proposed, and adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. AWARD CRITERIA The anticipated date of award is July 1, 1995. Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs and balance, and the availability of funds. In order to more evenly distribute administrative workload and reduce the number of awards with July 1 or September 30 start dates, the NHLBI will award ten months of time and money for the first competing budget period of this project. This action results in a project period of 46 months rather than 48 months. Investigators should plan their research projects and budgets within these timeframes. Awards in response to this RFA will be made to foreign institutions only for research of very unusual merit, need, and promise, and in accordance with PHS policy governing such awards. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Junius G. Adams, III Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute Federal Building, Room 508 7550 Wisconsin Avenue MSC 9090 Bethesda, MD 20892-9090 Telephone: (301) 496-6931 FAX: (301) 402-4843 Internet: Junius_Adams@NIH.GOV For fiscal and administrative matters, contact: Ms. Jane R. Davis Blood Division Grants Management Section National Heart, Lung, and Blood Institute Westwood Building, Room 4A11 Bethesda, MD 20892 Telephone: (301) 594-7436 FAX: (301) 594-7492 Internet: Jane_Davis@NIH.GOV AUTHORITY AND REGUALTIONS The programs of the Division of Blood Diseases and Resources, NHLBI, are described in the Catalog of Federal Domestic Assistance number 93.839. Awards will be made under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grants policies and Federal regulations, most specifically 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372, or to Health Systems Agency Review. From owner-sci-resources@net.bio.net Thu Oct 13 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-95-007 - V23(36) 10/14/94 Date: 13 Oct 1994 19:27:04 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 416 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <37kq9o$bt9@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL95007 HL-95-007 P1O1 *************************************** THROMBOTIC THROMBOCYTOPENIC PURPURA AND HIV NIH GUIDE, Volume 23, Number 36, October 14, 1994 RFA: HL-95-007 P.T. 34; K.W. 0715032, 0715008, 0765033 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 16, 1994 Application Receipt Date: February 16, 1995 PURPOSE The objectives of this initiative are to (1) support studies on the pathogenesis of thrombotic thrombocytopenic purpura (TTP) and (2) stimulate development of new approaches for determining predisposition, early diagnosis and treatment of TTP associated with HIV infection. The goal of this program is to understand the pathogenesis of TTP and the development of better therapy for TTP patients with HIV. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Application (RFA), Thrombotic Thrombocytopenic Purpura and HIV, is related to the priority areas of heart disease and stroke, and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-782-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state or local governments, and eligible agencies of the federal government. Awards in response to this RFA will be made to foreign institutions only for research of very unusual merit, need, and promise, and in accordance with PHS policy governing such awards. Applications from minority individuals and women are encouraged. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research project grant (R01) and FIRST (R29) awards and is a one-time solicitation. Applicants, who will plan and execute their own research programs, are requested to furnish their own estimates of the time required to achieve the objectives of the proposed research project. Up to five years of support may be requested. At the end of the official award period, renewal applications may be submitted for peer review and competition for support through the regular grant program of the NHLBI. It is anticipated that support for the present program will begin in July 1995. Administrative adjustments in project period/or amount of support may be required at the time of the award. Since a variety of approaches would represent valid responses to this RFA, it is anticipated that there will be a range of costs among individual grants awarded. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded in connection with this RFA. FUNDS AVAILABLE It is anticipated that for fiscal year 1995, $2,000,000 (total costs) will be available for this initiative. It should be noted that award of grants pursuant to this RFA is contingent upon receipt of such funds for this purpose. Designated funding levels are subject to change at any time prior to final award, due to unforeseen budgetary, administrative, and/or scientific development. It is anticipated that about seven new grants will be awarded under this program. The specific amount to be funded will, however, depend on the merit and scope of the applications received and on the availability of funds. If collaborative arrangements involve sub-contracts with other institutions, the NHLBI Grants Operations Branch (tel: 301- 594-7436) should be consulted regarding procedures to be followed. RESEARCH OBJECTIVES Thrombotic thrombocytopenic purpura (TTP) is characterized by thrombocytopenia, hemolytic anemia, fluctuating neurological signs, renal dysfunction, fever, and other signs of organ failure. Histologically, there are widespread micro-thrombi and reactive endothelial proliferation. Thrombi consist of masses of platelets and entrapping erythrocytes and fibrin. The etiology and mechanism of this disorder is unclear and past studies dealing with etiology and treatment of the disorder have been flawed or inconclusive. TTP occurs in a very heterogenous group of persons and has been associated with cancer, pregnancy, collagen vascular disorders, bacterial infection, and most recently HIV-1 infection. It is unclear if all cases of TTP arise by a similar mechanism to produce the same constellation of symptoms or if each represents a different disorder with similar clinical manifestations. It has been reported that plasma obtained from patients with TTP contains a platelet aggregatory factor. Moreover, calpain, a calcium-dependent protease, is thought to be present in the serum of individuals with active TTP, but not normal controls or persons with the disease in remission. vWF proteolyzed by calpain binds to activated platelets and causes platelet aggregation. Other investigators also documented 170 kD and 150 kD fragments after treating vWF with calpain. Of interest is the fact that normal plasma prevented calpain-associated abnormal fragmentation of vWF. Recently, very large vWF multimers, that disappeared during relapses of the disease, have been isolated from the plasma of individuals with TTP. These large vWF multimers are absent in normal plasma and probably reflect the endothelial damage that occurs during the course of the disease, resulting in the secretion of unusually large vWF multimers from Weibel-Palade bodies during the episode of TTP. These findings suggest that an abnormal calpain-like protease activity in TTP plasma might cause abnormal fragmentation of these unusually large vWF multimers. Other investigators have demonstrated decreased prostacyclin generation from the blood vessel walls of individuals with this disorder, as well as in their first degree relatives without the disease. The hemolytic anemia in this disorder is thought to be caused by the mechanical trauma that red cells sustain as they pass through abnormal blood vessels. Other investigators believe that platelets obtained from individuals with TTP promote hemolysis of normal red cells when they are incubated together in vitro. There has been significant progress in the basic understanding of the cell biology of both platelets and endothelial cells, the two components that appear to be intimately involved in the pathophysiology of TTP. The technology and probes necessary to determine the activation status of these cells are now routinely available in a number of laboratories. Similarly, progress has been made in understanding the structure-function of von Willebrand factor, a plasma protein that may play a key role in the development of TTP. It thus appears to be timely to apply this knowledge and the available tools to determine the etiology of TTP, which is being increasingly reported in the HIV-positive population. Plasmapheresis was developed as a therapeutic modality after it was observed that individuals with TTP receiving repeated whole blood transfusion underwent a remission. Subsequently, marked improvement was noted in some patients within hours following plasma exchange. Alternatively, some investigators have noted a response to plasma exchange in patients who have previously failed to respond to fresh frozen plasma. This has fueled the debate about whether the clinical manifestations of TTP result from a missing plasma factor that inhibits aggregation (which is replaced during plasma infusion) or a platelet aggregatory factor that is not normally present in plasma (which is removed during plasmapheresis). A recent controlled trial of plasma exchange versus plasma infusion in patient with TTP of all origins, except HIV infection, demonstrated the superiority of plasma exchange, although proponents of plasma infusion argue that plasma exchange merely allows a greater volume of plasma to be infused. The role of steroids, splenectomy, vincristine, and anti-platelet agents in the treatment of this disorder is controversial. Most studies using these agents also used many other different treatments and it is not clear what part of the clinical response could be attributed to these agents. In a disease that was considered uniformly fatal before 1968, it is clear that the prognosis for thrombotic thrombocytopenic purpura appears to have improved greatly in recent years. This decreased mortality may result from more effective therapy, earlier or better diagnosis of milder cases, or a change in the natural history of the disease. Certainly there have been a number of cases with apparent indolent course reported in the literature. The effectiveness of various therapies may differ with the underlying disease. Examples of promising research topics include: Controlled clinical studies addressing the effective treatment of TTP and its etiology are clearly warranted. This initiative will support research designed to determine the most effective treatment of TTP related to HIV infection as well as to examine the factors which lead to its expression. The aim of this initiative is to encourage basic research that will increase the understanding of the pathophysiology of TTP in all patients. Special emphasis will be placed on the determination of safe and effective treatment for this disorder in HIV-positive persons. Because of the relatively small numbers of persons afflicted with TTP, collaborative arrangements among centers are encouraged. The following are examples of research areas for this initiative. o Elucidation of the pathogenesis of TTP o Studies on the mechanism of platelet activation in vivo with emphasis on the platelet surface o Elucidation of the influence of HIV infection on the development of TTP o Studies to determine the optimal treatment of TTP in HIV infected persons o Development of animal models of TTP and evaluation of specific agents (antibodies, peptides) that could be beneficial in the treatment of TTP o Investigation of the relationship between TTP and HIV and CMV viremia, and other markers of immune function o Studies of the status of the endothelium in patients with active TTP o Critical studies of possible abnormalities in plasma from patients with TTP, e.g., large vWf multimers, platelet aggregators and inhibitors, proteolytic enzymes and methods of their inhibition SPECIAL REQUIREMENTS Upon initiation of the program, the NHLBI will sponsor annual meetings to encourage the exchange of information among investigators who participate in this program. Applicants should request additional travel funds for one meeting each year to be held in Bethesda, Maryland. Applicants should also include a statement in the applications indicating their willingness to participate in such meetings. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in study populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators also may obtain copies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by December 16, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 553 Bethesda, MD 20892 Telephone: (301) 594-7478 FAX: (301) 594-7407 Internet: James_Scheirer@NIH.GOV APPLICATION PROCEDURES Applications are to be submitted on the research grant application form PHS 398 (rev. 9/91). This form is available in most institutional offices of sponsored research from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Use the conventional format for research grant applications and ensure that the points identified in the section on REVIEW CONSIDERATIONS are fulfilled. To identify the application as a response to this RFA, check "YES" on Item 2a of page 1 of the application and enter the title and RFA number: Thrombotic Thrombocytopenic Purpura and HIV: HL-95-007. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Send or deliver the completed application and three signed, exact photocopies to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Send an additional two copies of the application to the Chief, Centers and Special Projects Review Section at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants. Otherwise the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by February 16, 1995. 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 the DRG and responsiveness by the NHLBI. Incomplete applications will be returned to the applicant without further consideration. If NHLBI staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Affairs, NHLBI in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be notified. Applications should be prepared so that they can be reviewed without the necessity of interaction between applicants and reviewers since no site visit or reverse site visit will be part of the technical merit review. Review Criteria The factors to be considered in the evaluation of scientific merit of each application will be similar to those used in the review of traditional research grant applications, including the novelty, originality, and feasibility of the approach; the training, experience and research competence of the investigator(s); the adequacy of the experimental design; the suitability of the facilities; the appropriateness of the requested budget to the work proposed; and adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from ptential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Pankaj Ganguly Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute Federal Building, Room 5C14 Bethesda, MD 20892 Telephone: (301) 402-2237 FAX: (301) 496-9940 Internet: Pankaj_Ganguly@NIH.GOV For fiscal and administrative matters, contact: Ms. Jane R. Davis Grants Operation Branch National Heart, Lung, and Blood Institute Westwood Building, Room 4A15 Bethesda, MD 20892 Telephone: (301) 594-7436 FAX: (301) 594-7492 Internet: Jane_Davis@NIH.GOV AUTHORITY AND REGULATIONS The programs of the Division of Blood Diseases and Resources, NHLBI, are described in the Catalog of Federal Domestic Assistance No 93.839. Awards will be made under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grant policies and Federal regulations, most specifically 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372, or to Health Systems Agency Review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Thu Oct 13 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 36, pt. 1of1, 13 October 1994 Date: 13 Oct 1994 19:26:47 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 678 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <37kq97$bsm@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19941014 V23N36 P1O1 ************************************ X-comment: RFAs described: HL-95-010, HL-95-007, PAR-95-002 NIH GUIDE - Vol. 23, No. 36 - October 14, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** ENHANCING FAMILY CAREGIVING FOR ALZHEIMER'S DISEASE AND RELATED DISORDERS (RFA AG-94-003) National Institutes on Aging INDEX: AGING $$INDEX N2 ********************************************************** NIH SOUTHWEST REGIONAL SEMINAR IN PROGRAM FUNDING AND GRANTS ADMINISTRATION National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N4 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** ASSESSING THE OUTCOMES OF ALLOPLASTIC TEMPOROMANDIBULAR JOINT IMPLANTS (RFP NIH-NIDR-3-94-9R) National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX R2 01/24/95 ************************************************* COAGULATION, PLATELETS AND THROMBOSIS IN SICKLE DISEASE PATHOPHYSIOLOGY (RFA HL-95-010) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R3 02/16/95 ************************************************* THROMBOTIC THROMBOCYTOPENIC PURPURA AND HIV (RFA HL-95-007) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX P1 ********************************************************** NATIONAL RESEARCH SERVICE AWARD--INSTITUTIONAL GRANTS POLICY AND GUIDELINES (PAR-95-002) Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH THIS PUBLICATION IS AVAILABLE ELECTRONICALLY TO INSTITUTIONS VIA BITNET OR INTERNET AND IS ALSO ON THE NIH GOPHER. ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE USING A PERSONAL COMPUTER (DATA LINE 301/402-2221). CONTACT DR. JOHN JAMES AT 301/594-7270 FOR DETAILS. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. **THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD BUILDING IS: 5333 Westbard Avenue Bethesda, MD 20816 $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** ENHANCING FAMILY CAREGIVING FOR ALZHEIMER'S DISEASE AND RELATED DISORDERS NIH GUIDE, Volume 23, Number 36, October 14, 1994 RFA: AG-94-003 P.T. 34; K.W. 0715180, 0730052 National Institutes on Aging Letter of Intent Receipt Date: October 1, 1994 Application Receipt Date: November 29, 1994 PLEASE NOTE SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO RFA AG-94-003 "ENHANCING FAMILY CAREGIVING FOR ALZHEIMER'S DISEASE AND RELATED DISORDERS," PUBLISHED IN THE NIH GUIDE FOR GRANTS AND CONTRACTS, VOL. 23, NO. 30, AUGUST 12, 1994. The National Institutes of Health (NIH) has been designated a "reinvention laboratory" by the Public Health Service (PHS). One NIH reinvention objective is to simplify and improve each stage in the grant process: application, review, award, and administration. An experiment is being conducted to determine how to reduce the administrative burden in applying for an NIH grant without compromising the information needed by the initial scientific peer review group to assess the scientific merit of the application and the reasonableness of the proposed budget. Applicants must request specific "JUST-IN-TIME" instructions for sections of the PHS 398 (rev. 9/91) application form, which should be completed differently than usual. Some sections are modified and others in the application should not be completed for the submission of the application, but will be requested if the application receives a score in the range for possible funding. For all other items in the application, follow the usual instructions on pages 9-32 of the PHS 398 booklet. INQUIRIES "JUST-IN-TIME" instructions may be obtained from the National Institute on Aging, Behavioral and Social Research Program by faxing your request of (301) 402-0051. You may also leave your request on the grants voice mailbox (301/496-3136). Be sure to leave your name, mailing address, telephone, and FAX number. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NIH SOUTHWEST REGIONAL SEMINAR IN PROGRAM FUNDING AND GRANTS ADMINISTRATION NIH GUIDE, Volume 23, Number 36, October 14, 1994 P.T. 34; K.W. 1014006 National Institutes of Health A regional seminar covering topics related to program funding and grants administration at the National Institutes of Health has been scheduled for November 17-18, 1994, in Albuquerque, New Mexico. The seminar, hosted by the Offices of Research Administration and Continuing Medical Education at the University of New Mexico, is intended to attract faculty and research administrators from the southwest region of the United States, although those interested from other regions are also invited and welcome. Staff from small and minority colleges, for-profit research organizations, hospitals, universities, and medical centers are encouraged to attend. This two-day seminar will have a dual focus of interest to both academic researchers and new and senior research administrators. Discussions of current issues that affect NIH funding and grants administration will be featured to give seminar participants a comprehensive view of NIH-sponsored research. There will be time available to network with colleagues and meet informally with NIH representatives to discuss topics of special interest. The faculty will include Geoffrey Grant, Joellen Harper, and Sue Ohata from the Office of Policy for Extramural Research Administration; Wayne Berry, Division of Financial Management; Faye Calhoun, Ph.D., Division of Research Grants; Joseph Ellis, NIA; Marvin Kalt, Ph.D, NCI; Mary Kirker, NIAID; Yvonne Maddox, Ph.D., NIGMS; and Carol Tippery, NIGMS. SEMINAR LOGISTICS Seminar Leader: Geoffrey Grant, Acting Director Office of Policy for Extramural Research Administration (OPERA) Seminar Coordinator (NIH): Joellen Harper, Grants Policy Office, OPERA, 301/496-5967 Seminar Coordinator (University of New Mexico): Dorrie Murray, Office of Continuing Medical Education, University of New Mexico, 505/277-3942 Dates: Thursday and Friday, November 17-18, 1994 Location Ramada Hotel Classic 6815 Menaul N.E. Albuquerque, NM 87110 Telephone: (505) 881-0000 or 800/252-7772 Participants need to make hotel reservations directly and should reference the regional seminar when you call. Reservations made by October 16, 1994, are guaranteed the special room rate of $68 (single) or $78 (double). Cost: $125 early-bird registration ($150 after November 3) Registration and Inquiries: Advance registration is required. You are encouraged to register early, as space is limited. To receive the draft program and registration materials, call 505/277-3942, or send a fax that provides your name, institution, address, telephone number, and anticipated number of registrants to 505/277-8604. FUTURE SEMINARS At this time, the dates and locations for regional seminars to be held in 1995 and beyond have not yet been finalized. If you have any questions about hosting a regional seminar, contact Ms. Joellen Harper in the NIH Grants Policy Office on 301/496-5967. $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS NIH GUIDE, Volume 23, Number 36, October 14, 1994 P.T. 42; K.W. 0201011, 1014003 National Institutes of Health The National Institutes of Health, Office for Protection from Research Risks is continuing to sponsor workshops on implementing the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Each of the workshops scheduled for Fiscal Year 1994 and 1995 will focus on a specific theme. The workshops are open to institutional administrators, members of Institutional Animal Care and Use Committees, laboratory animal veterinarians, investigators and other institutional staff who have responsibility for high-quality management of sound institutional animal care and use programs. Ample opportunities will be provided to exchange ideas and interests through question and answer sessions and informal discussions. DATES: December 1-2, 1994 TOPIC: New Frontiers in Surgery LOCATION Sheraton Charleston 170 Lockwood Drive Charleston, SC 29403 Telephone: (803) 723-3000 FAX: (803) 723-3000 SPONSOR Medical University of South Carolina REGISTRATION M. Michael Swindle, D.V.M. MUSC/Comparative Medicine 171 Ashley Avenue Charleston, SC 29425-2211 Telephone: (803) 792-3625 FAX: (803) 792-9067 FEE: $150.00 (Before Nov 15, 1994) $175.00 (After Nov 15, 1994) DESCRIPTION: The Workshop will address ethics, protocol review and technical and training aspects related to new surgical and interventional technologies. Topics to be discussed in the program include xenographic procedures, fetal intervention, transgenic technologies, and use of biomaterials in orthopedic surgery. DATES: January 12-13, 1995 TOPIC: Considerations For Use of Wild Vertebrates in Research LOCATION Westward Look Resort 245 Ina Road Tucson, AZ 85704 Telephone: (602) 297-1151 or 1-800-722-2500 FAX: (602) 297-9023 SPONSORS Northern Arizona University University of Arizona Health Science Center REGISTRATION Dr. Terry May Director of Research Administration Northern Arizona University P.O. Box 4130 Flagstaff, AZ 86011-4130 Telephone: (602) 523-6788 FAX: (602) 523-1075 E Mail: tam1@nauvax.ucc.nau.edu Dr. Susan Sanders, Director University of Arizona Animal Care 2205 E. Speedway Boulevard Tucson, AZ 85719 Telephone: (602) 621-3454 FAX: (602) 621-3355 FEE: $175 - Full Workshop $70 - Daily Registration as Space Available DESCRIPTION: This Workshop will focus on three general themes related to the inclusion of native vertebrates in research: (1) Federal and institutional policies and procedures as they relate to the responsibilities of the Institutional Animal Care and Use Committee (IACUC) in considering research on both captive and free-living wild vertebrates; (2) standards for the husbandry and housing of captive wild vertebrates; and (3) occupational health considerations with an emphasis on rodent-borne hantavirus. DATES: March 12-14, 1995 TOPIC: Animal Care and Research: Challenges and Changes for the Institutional Animal Care and Use Committee LOCATION San Diego Princess 1404 West Vacation Road San Diego, CA 92109-7994 Telephone: (619) 274-4630 or (1-800) 344-2626 FAX: (619) 581-5929 SPONSORS Tufts University School of Veterinary Medicine Public Responsibility in Medicine and Research REGISTRATION Ms. Danielle Demko Public Responsibility in Medicine and Research 132 Boylston Street Boston, MA 02116 Telephone: (617) 423-4112 FAX: (617) 423-1185 FEE: $300 DESCRIPTION: The Workshop will focus on revisions to the Institutional Animal Care and Use Committee Guidebook; assessment and reduction of pain and distress in animal research; occupational health risks ad biohazards; and a host of other regulatory and administrative issues that are central to the successful operation of laboratory animal care and research programs. Immediately preceding the Tufts University School of Veterinary Medicine/NIH/OPRR Workshop, Applied Research Ethics National Association (ARENA) will sponsor its annual animal issues meeting on Sunday, March 12, also at the San Diego Princess. INQUIRIES For further information concerning these workshops and future NIH/OPRR Animal Welfare Education Workshops, contact: Mrs. Roberta Sonneborn Office of Protection from Research Risks National Institutes of Health Building 31, Room 5B63 Bethesda, MD 20892-2180 Telephone: (301) 496-7163 FAX: (301) 402-2803 $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 23, Number 36, October 14, 1994 P.T. 42; K.W. 0783005 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human subjects. The meetings should be of special interest to those persons currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all other Public Health Service agencies. The current schedule includes: DATES: December 8-9, 1994 LOCATION Seven Hills Center San Francisco State University San Francisco, CA SPONSORS San Francisco State University, San Francisco, CA California State University, Los Angeles, CA REGISTRATION Darlene Yee, Ph.D. Chair, Committee for the Protection of Human Subjects Office of Research Sponsored Programs San Francisco State University 20 Tapia Drive San Francisco, CA 94132 Telephone: (415) 452-1908 FAX: (415) 338-6378 TITLE: Current Issues in Research Involving Human Subjects DESCRIPTION: Institutional Review Boards (IRBs) are charged with responsibilities for ethical review and oversight of the use of human subjects in research protocols. The primary principle governing the IRB's review and action is the protection of human subjects from risks while permitting the advancement of research. IRBs are faced today with complex concerns that require deep ethical and moral judgements, and they are challenged to act in an objective and timely fashion. Our workshop will focus on current issues in research involving human subjects: evolving concerns for protection of human subjects from research risks; FDA regulatory update; new guidelines on the inclusion of women and communities of color in clinical research; guidelines for human embryo research; ethics and philosophy of research with vulnerable populations such as children, the elderly, and those who are cognitively impaired and/or physically challenged; lessons learned from historical episodes in research; changing demographics of research in California; and emerging issues in research involving prisoners. The workshop formats will include facilitated forums, information exchanges, panel discussions, and active audience participation. We have assembled an outstanding faculty of distinguished experts to provide authoritative and provocative discussion of challenging issues in the field of human subjects research review. Participants will (1) learn how Federal regulations and community participation can protect human subjects in research, (2) become familiar with the issues involved in protecting the rights of vulnerable populations in research, (3) explore how regulations and community participation can collaborate to protect human subjects, (4) become more knowledgeable about policies, procedures, and expectations of an IRB, and (5) discuss the rights and responsibilities of researchers. INQUIRIES For further information regarding these workshops or future NIH/FDA National Human Subject Protections Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B-59 Rockville, MD 20892-2018 Telephone: (301) 496-8101 FAX: (301) 402-0527 $$N4 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NIH-NIDR-3-94-9R ***************************************** ASSESSING THE OUTCOMES OF ALLOPLASTIC TEMPOROMANDIBULAR JOINT IMPLANTS NIH GUIDE, Volume 23, Number 36, October 14, 1994 RFP AVAILABLE: NIH-NIDR-3-94-9R P.T. 34; K.W. 0740027, 0765035, 0715148 National Institute of Dental Research The National Institute of Dental Research (NIDR) has a requirement for a one-year study to assess patients' biochemical, molecular, and cellular responses to alloplastic jaw joint implants (i.e., composed of either teflon-proplast or silastic). The pathophysiology of rejection of alloplastic jaw joint implants will be investigated according to: (a) the particular type of implant material, i.e., teflon-proplast or silastic, and (b) the TMD sub-group classification of the patient's condition prior to implantation, i.e., disc derangement, arthritis (arthralgia, osteoarthritis of the TMJ, osteoarthrosis of the TMJ), or muscle disorder (e.g., myofascial pain). INQUIRIES RFP NIH-NIDR-3-94-9R will be available on or about October 28, 1994, with proposals due on or about December 16, 1994. It is anticipated that one award will be made as a result of this solicitation. Verbal requests for the RFP will not be accepted; requests must be submitted in writing, addressed to: Marilyn R. Zuckerman Contracts Management Office National Institute of Dental Research Westwood Building, Room 533 Bethesda, MD 20892 $$R1 END ************************************************************ $$R2 BEGIN HL-95-010 FULL-TEXT ************************************** COAGULATION, PLATELETS AND THROMBOSIS IN SICKLE DISEASE PATHOPHYSIOLOGY NIH GUIDE, Volume 23, Number 36, October 14, 1994 RFA AVAILABLE: HL-95-010 P.T. 34; K.W. 0715032, 0715040, 0765033 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 20, 1994 Application Receipt Date: January 24, 1995 PURPOSE The Division of Blood Diseases and Resources (DBDR) of the National Heart, Lung, and Blood Institute (NHLBI) National Institutes of Health (NIH), invites research grant applications to support basic research on the role of hemostasis and thrombosis in the pathophysiology of sickle cell disease vasculopathy. The goal of this program is basic research leading to approaches that ameliorate the long term debilitating effects of this disease. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Coagulation, Platelets, and Thrombosis in Sickle Cell Disease Pathophysiology, is related to the priority areas of clinical prevention services, chronic disabling conditions, and maternal and infant health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-782-3238). 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) and the NIH GOPHER (gopher.nih.gov), and in print from the program contact listed below. Dr. Junius G. Adams, III Division of Blood Diseases and Resources National Heart, lung, and Blood Institute Federal Building, Room 508 7550 Wisconsin Avenue MSC 9090 Bethesda, MD 20892-2090 Telephone: (301) 406-6931 FAX: (301) 402-4843 Email: ja33m@nih.gov $$R2 END ************************************************************ $$R3 BEGIN HL-95-007 FULL-TEXT ************************************** THROMBOTIC THROMBOCYTOPENIC PURPURA AND HIV NIH GUIDE, Volume 23, Number 36, October 14, 1994 RFA AVAILABLE: HL-95-007 P.T. 34; K.W. 0715032, 0715008, 0765033 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 16, 1994 Application Receipt Date: February 16, 1995 PURPOSE The Thrombosis and Hemostasis Scientific Research Group, Blood Resources Program, of the Division of Blood Diseases and Resources, National Heart, Lung, and Blood Institute (NHLBI), announces the availability of a Request for Application (RFA) encouraging studies on the pathogenesis of thrombotic thrombocytopenic purpura (TTP) and development of new approaches for determining predisposition, early diagnosis and treatment of TTP associated with HIV infection. The goal of this program is basic research on TTP and treatment of TTP associated with HIV infection. This RFA will use the NIH individual research project grant (R01) and FIRST (R29) award. It is anticipated that for fiscal year 1995, $2,000,000 (total costs) will be available, to fund approximately seven new grants, for this initiative. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Thrombotic Thrombocytopenic Purpura and HIV, is related to the priority areas of heart disease and stroke, and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-782-3238). 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) and the NIH GOPHER (gopher.nih.gov), and in print from the program contact listed below. Dr. Pankaj Ganguly Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute Federal Building, Room 5C14 Bethesda, MD 20892 Telephone: (301) 402-2237 FAX: (301) 496-1622 Internet: Pankaj_Ganguly@NIH.GOV $$R3 END ************************************************************ $$P1 BEGIN PAR-95-002 FULL-TEXT ************************************* NATIONAL RESEARCH SERVICE AWARD--INSTITUTIONAL GRANTS POLICY AND GUIDELINES NIH GUIDE, Volume 23, Number 36, October 14, 1994 PA AVAILABLE: PAR-95-002 P.T. 44; K.W. 0720005, 0730050 Agency for Health Care Policy and Research PURPOSE The Agency for Health Care Policy and Research (AHCPR) awards National Research Service Award (NRSA) institutional training grants (T32) to eligible institutions to develop or enhance research training opportunities for qualified individuals selected by the institution who have demonstrated an interest in health services research and who seek to prepare for careers in the systematic examination of the organization, provision, and financing of health care services. The purpose of the NRSA program is to help ensure that adequate numbers of highly trained individuals are available to carry out the Nation's health services research agenda. NRSA institutional training grants assist domestic institutions in supporting predoctoral and postdoctoral academic training. The awards allow trainees to gain one or more years of experience in applying research methods to the evaluation of health services. The AHCPR does not support short-term training. INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and in print from the program contact listed below. DonnaRae Castillo, NRSA Project Officer Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 400 Rockville, MD 20852 Telephone: (301) 594-1362 Email: dcastill@po7.ahcpr.gov $$P1 END ************************************************************ From owner-sci-resources@net.bio.net Thu Oct 13 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-95-002 - V23(36) 10/14/94 Date: 13 Oct 1994 19:27:12 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 603 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <37kqa0$btt@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PAR95002 PAR-95-002 P1O1 ************************************* NATIONAL RESEARCH SERVICE AWARD--INSTITUTIONAL GRANTS POLICY AND GUIDELINES NIH GUIDE, Volume 23, Number 36, October 14, 1994 PA NUMBER: PAR-95-002 P.T. 44; K.W. 0720005, 0730050 Agency for Health Care Policy and Research PURPOSE The Agency for Health Care Policy and Research (AHCPR) awards National Research Service Award (NRSA) institutional training grants (T32) to eligible institutions to develop or enhance research training opportunities for qualified individuals selected by the institution who have demonstrated an interest in health services research and who seek to prepare for careers in the systematic examination of the organization, provision, and financing of health care services. The purpose of the NRSA program is to help ensure that adequate numbers of highly trained individuals are available to carry out the Nation's health services research agenda. NRSA institutional training grants assist domestic institutions in supporting predoctoral and postdoctoral academic training. The awards allow trainees to gain one or more years of experience in applying research methods to the evaluation of health services. The AHCPR does not support short-term training. ELIGIBILITY Applicant Institutions Domestic non-profit private and public institutions may apply for grants to support doctoral and postdoctoral health services research training programs. The applicant institution must have the staff and facilities required for the proposed program. The training program director at the institution will be responsible for the selection and appointment of trainees and for the overall direction of the program. Institutions may apply for support for predoctoral students, postdoctoral students, or a combination. Applicants should include a rationale for their proposed choice of supporting the level(s) of students requested. An applicant may request as many postdoctoral or predoctoral positions as the proposed program can adequately accommodate; but the number of positions awarded will be determined by the review process, program needs, and availability of funds. Trainees Trainees appointed to the proposed training program must have the opportunity to carry out supervised health services research with the primary objective of extending their research skills and knowledge in preparation for a health services research career. Prospective trainees must be U.S. citizens or noncitizen nationals or permanent residents of the United States in possession of an Alien Registration Receipt Card I-551 or I-151, or other legal verification of such status at the time of appointment. Individuals on temporary or student visas are not eligible. A postdoctoral student, as of the beginning date of the NRSA appointment, must have a Ph.D., M.D., Dr.P.H., Sc.D, D.N.Sc. or other doctoral degree, or an equivalent degree from any accredited domestic or foreign institution. (Persons holding the J.D. as the sole advanced degree are not considered postdoctoral for purposes of NRSA appointments.) Certification by an authorized official of the degree-granting institution that all requirements for the doctoral degree have been met is acceptable. Predoctoral trainees must have received a baccalaureate degree as of the beginning date of the NRSA appointment and must be enrolled in a program leading to a Ph.D., Dr.P.H., or equivalent doctoral degree. Individuals working toward a medical or dental degree who wish to interrupt their studies to engage in full-time research training for a year or more before completing their health professional degree are eligible for NRSA support with approval from AHCPR. MECHANISM OF SUPPORT The mechanism of support will be the National Research Service Award (NRSA) institutional training grant (T32). RESEARCH OBJECTIVES Areas of Training AHCPR-sponsored NRSA Awards emphasize multidisciplinary health services research training. Training should provide individuals with rigorous academic and health services research experiences. At the conclusion of the training program, trainees should have the conceptual and methodological foundation for investigating some or all of the following health care areas: o Determinants of successful health care market reform, including incentives for selection of efficient plans by health care purchasers and effective management by health care providers; o Cost-effectiveness and cost-benefit analysis, including allocation of health care resources and its relationship to health status; o Analysis of service delivery, resource use, and costs of care for persons with HIV-related illnesses; o Primary care issues, including relationships between the structure and organization of service delivery, and access to and costs and outcomes of care; o Evaluation of managed care and other alternative approaches to organizing, financing, and reimbursing health care services; o Alternative delivery systems, providers, and practice patterns in long-term care including home and community-based care; o Medical treatment effectiveness issues, including evaluation of outcomes associated with the use of clinical practice guidelines; o Availability, accessibility, effectiveness, and quality of care for underserved populations such as low-income groups and minorities; o Rural health issues, including primary care access, service delivery, technology diffusion, and supply of health professionals; o Medical malpractice and liability; o Appropriateness and effectiveness, including cost effectiveness, of alternative treatments and technologies; o Factors affecting dissemination and assimilation of health and clinical information to practitioners and patients; o The development of measures, methods, and technologies to support quality assurance and foster quality improvement in health care; and o Application of medical informatics to developing and improving expert systems for clinical diagnosis and treatment selection. Levels and Types of Training Permitted NRSA grants may not be used to support studies leading to the M.D. or other similar professional degrees, or to support residencies, that is, postgraduate training for health professionals providing health care directly to patients where the majority of their time is spent in nonresearch clinical training. However, if a specified period of full-time research training is creditable toward specialty or subspecialty board certification, the NRSA may support such research training if the trainee intends to pursue a research career. Trainees are required to pursue their research training on a full-time basis. Because of the close relationship between teaching and research in the academic environment, trainees are permitted, with the approval of AHCPR, to teach if it can significantly contribute to their academic training. Teaching by trainees may not take up more than 10 percent of work time during the year or exceed four hours each week. Research trainees who are clinicians are expected to devote full time to the proposed research training. Clinical duties are permitted for up to 10 percent time (4 hours per week) within the training program only if they relate to the training itself. Trainees appointed to the program are expected to carry out supervised health services research with the primary objective of extending their quantitative research skills and substantive knowledge in preparation for a career in health services research. Duration of Support Institutional grants are made for competitive segments of five years and are renewable; individual trainee appointments should be made in increments of 12 months. Support for additional years is dependent on satisfactory progress and continued availability of funds. No individual trainee may receive more than five years of aggregate NRSA support at the predoctoral level and three years of aggregate NRSA support at the postdoctoral level, including any combination of support from institutional training grants and individual fellowship awards, except under certain circumstances. Any exception to this policy requires a waiver from AHCPR. Institutional training grants are a desirable mechanism for postdoctoral training of physicians and other health professionals whose doctoral training has usually involved limited health services research experience. For such individuals, it is highly recommended that they agree to engage in at least two years of research training or comparable experiences at the time of appointment regardless of whether or not the NRSA training is part of a research degree program. Payback Provisions All postdoctoral trainees must sign an agreement to fulfill the NRSA payback requirements when they are initially appointed to a training grant (or receive an individual fellowship). Officials of the applicant organization responsible for recruitment of trainees should familiarize themselves with the terms of the service requirements and explain them carefully to prospective training candidates before an appointment at the institution is offered. The NIH Revitalization Act of 1993 substantially modifies the existing service payback requirements for individuals supported under NRSA programs. Beginning with new appointments (or reappointments) made as of June 10, 1993, the following new guidelines apply: o Predoctoral trainees will not be required to sign the Payback Agreement Form (PHS Form 6031) and will not incur a service payback obligation. o Postdoctoral trainees in the first 12 months of postdoctoral NRSA support will incur one month of obligation for each month of support. o Postdoctoral trainees in the 13th and subsequent months of NRSA support will not sign the Payback Agreement Form and will not incur a service payback obligation. o The 13th and each subsequent month of postdoctoral NRSA support will be considered acceptable payback service; therefore, individuals who are appointed to their initial NRSA postdoctoral period on or after June 10, 1993, and continue under that award for two years will have fulfilled their first year obligation by the end of the second year. Service payback obligations can be repaid after the period of training by engaging in health services related research and/or teaching for at least 20 hours per week averaged over a full year. Recipients must undertake the obligated service on a continuous basis within two years after termination of NRSA support. The period for undertaking payback service may be delayed for temporary disability, for completion of residency requirements, or for completion of the requirements for a graduate degree. Requests for an extension must be made in writing to AHCPR and must specify the need for additional time and the length of the required extension. Recipients of NRSA support are responsible for informing AHCPR of changes in their status or address. Individuals who fail to fulfill their obligation through service must pay back the total amount of NRSA funds paid to them for the obligation period plus interest at a rate determined by the Secretary of the Treasury. Financial payback must be completed within three years beginning on the date the United States becomes entitled to recover such amount. Under certain conditions, the Secretary of Health and Human Services may extend the period for starting service or for repayment, permit breaks in the period of service or repayment, or otherwise waive or suspend the payback obligation of an individual. Stipends and Other Trainee Support Stipends National Research Service Awards provide funds in the form of stipends to predoctoral and postdoctoral trainees. A stipend is provided as an allowance for trainees to help defray living expenses during the research training experience. It is not provided as a condition of employment with either the Federal Government or the institution. Trainees may not receive stipends for periods during which they are not enrolled in the training program. For predoctoral trainees at all levels of experience, the stipend level (effective October 1, 1993) is $10,808 per year. For postdoctoral trainees, the stipend for the first year of support is determined by the number of full years of relevant postdoctoral experience at the time of appointment. Relevant experience may include research experience (including industrial), teaching, internship, residency, clinical practice, or other time spent in full-time studies in a health-related field beyond that of the qualifying doctoral degree. The stipend for each additional year of NRSA support is the next level on the stipend scale and does not change mid-year. No departure from the established stipend schedule may be negotiated by the institution with the trainee. Current postdoctoral stipend levels, effective October 1, 1993, are as follows: Full years of relevant experience Stipend Less than 1 $19,608 1 20,700 2 25,600 3 26,900 4 28,200 5 29,500 6 30,800 7 or more 32,300 Supplementation and Compensation Stipend Supplementation: NRSA stipends may be supplemented by an institution from non-Federal funds. Federal funds may be used for stipend supplementation only if specifically authorized under the terms of the program from which the supplemental funds are derived. Supplementation, when provided, must be without obligation to the trainee. Compensation: Trainees may be permitted to receive compensation for work in some other position (for example, teaching or laboratory assistance) when the trainee is in an employee-employer relationship, the payments are for services rendered, and the situation otherwise meets conditions for student compensation as specified in the PHS Grants Policy Statement. Compensation may not be paid from a research grant that supports the trainee's dissertation or the same research as that of the training program. Compensation for services must occur on a limited, part-time basis apart from the normal full-time training activities that require a minimum of 40 hours per week. Educational loans: An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation. Under no circumstances may the conditions of either stipend supplementation or student compensation for coincidental employment detract from or prolong the research training. Further information on stipend supplementation and compensation is available in "National Research Service Awards -- Guidelines for Individual Awards - Institutional Grants," NIH Guide for Grants and Contracts (special edition), Volume 13, Number 1, January 6, 1984. Tax Liability of Stipends Section 117 of the Internal Revenue Code applies to the tax treatment of all scholarships and fellowships. Under that section, degree candidates may exclude from gross income, as reported for tax purposes, any amounts used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at the educational institution. Nondegree candidates are required to report all stipends and monies paid on their behalf for course tuition and required fees as gross income. The taxability of stipends in no way alters the relationship between NRSA trainees and their institutions. NRSA stipends are not now, and have never been, considered as salaries. Trainees supported under a National Research Service Award are not in an employer-employee relationship with AHCPR or with the institution in which they are pursuing research training, nor are they considered to be self-employed. NRSA stipends are not subject to employment or self-employment tax (FICA). It must be emphasized that the interpretation and implementation of tax laws are the domain of the Internal Revenue Service (IRS) and the courts. AHCPR is not in a position to advise students or institutions about their tax liability. Individuals should consult their local IRS office for information on their tax obligations. Other Training Costs Tuition and fees, including medical insurance for the trainee, are allowable trainee costs if such charges are required of all persons in a similar training status at the institution, regardless of their source of support; family medical insurance is not an appropriate charge to the NRSA grant. Tuition for postdoctoral trainees not enrolled in a degree program is limited to that required for specific courses in support of the approved training program; tuition for other courses must be justified. Annual increments in tuition and fee costs beyond the first year of the award may not exceed 6 percent for equivalent numbers of trainees. Trainee travel, such as attendance at domestic scientific meetings determined by the institution as necessary to the research training, is an allowable expense. Institutional costs of $1,500 per year for each predoctoral trainee and $2,500 per year for each postdoctoral trainee may be requested to defray the cost of other expenses related to the training program. Salaries of the program director and faculty are not reimbursed. The institution will receive indirect costs based on eight percent of total allowable direct costs (exclusive of tuition, fees, and health insurance) or their actual indirect cost rate, whichever is less. Applications from State and local government agencies may request full indirect cost reimbursement. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used. (State and local government agencies may use form PHS 5161 and follow those requirements for copy submission.) This revision includes special instructions for institutional NRSA research training grants. Applicants are reminded that the 25-page limit on the narrative section must be observed. Insert the title of this PA (National Research Service Award -- Institutional Grants) and PA number on line 2a of the application face page. These forms are available at most institutional offices of sponsored research; the Office of Grant Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248. Application material for AHCPR NRSA institutional grants is also available from Global Exchange, Inc., 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3015, telephone 301-656-3100. The first application receipt date for this program announcement is January 10, 1995. Applications received on that date will be for awards to begin no earlier than December 1, 1995. Thereafter, AHCPR will accept applications only on January 10th annually for awards to begin no earlier than the following December. Applications must be received at the Division of Research Grants, NIH, by January 10th each year. Late applications will be returned to the applicant. The completed, signed, original application and three legible copies of the form PHS 398 must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Two information copies must be submitted simultaneously to: Director, Scientific Review Branch Agency for Health Care Policy Research 2101 East Jefferson Street, Suite 602 Rockville, MD 20852 Failure to provide these information copies will result in the return of the application to the applicant. REVIEW CONSIDERATIONS Applications will be reviewed for technical and educational merit by an AHCPR peer review group. They may also be reviewed by the National Advisory Council for Health Care Policy, Research, and Evaluation for applicability to AHCPR's overall research and training goals. Review Criteria The peer review group will consider the following criteria in its review: o Qualifications and responsibilities of the program director; o Organizational structure of the proposed training program, including delineation of administrative responsibilities for planning, oversight, and evaluation; o Qualifications of the program's faculty, including ongoing health services research support and ability to serve as effective mentors for trainees; o Objectives and design of the proposed training program and the probability of achieving stated goals; o Substantive content of the proposed program and its relevance to current health care concerns, including descriptions of courses offered; o Documentation of availability of qualified candidates and program's plans for recruitment and selection of trainees, including minority trainees; o Institutional commitment to providing a quality training environment, including availability of space and facilities, curriculum time, and research support; o Demonstration of cooperation by any collaborating facilities, institutions, or departments in providing experience and research training sites for trainees and documentation of mechanisms for integration of trainees into ongoing health services research; o Proposed methods for monitoring and evaluating performance of trainees and of the overall program, including tracking of graduates after completion of training and record of trainees in obtaining individual research awards or fellowships following training and in establishing careers in health services research; o Record of the training program in retaining health professional postdoctoral trainees for more than 1 year of research training; and o Reasonableness of the proposed budget, including number and levels of trainees, in relation to the research training. Also see "Modification of Existing Review Criteria for NRSA Institutional Research Training Grants," NIH Guide for Grants and Contracts, Volume 21, Number 11, March 20, 1992. Additional Review Considerations Minority Recruitment Plan: The AHCPR remains committed to increasing the participation of individuals from minority groups under- represented in health services research. All competing applications must include a plan to recruit individuals from minority groups underrepresented in health services research; review of any application received without such a plan will be deferred until it is provided. Additional information on this requirement was published in the NIH Guide for Grants and Contracts, Volume 22, Number 25, July 16, 1993. Competing renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented minority groups during the previous award period. Information on the types of successful and unsuccessful recruitment strategies should be included. The report should provide information on the ethnic/racial distribution of predoctoral and postdoctoral students in the department(s) relevant to the training program, individuals who applied for research training, individuals who were offered admission, and individuals who were appointed to the grant. For appointees to the grant, the report should include information about the duration of their training and whether those trainees finished the training program. After the overall technical and educational merit of an application has been assessed, reviewers will examine the minority recruitment plan and any record of recruitment and retention efforts. The recruitment components of each application will be judged as either acceptable or unacceptable. The findings of the review committee on the plan for attracting minority individuals will be presented in an administrative note in the summary statement. Funding of any application with a plan for recruiting underrepresented minorities that is judged unacceptable by the review committee will be withheld until a revised plan that addresses the deficiencies is received and determined to be acceptable by AHCPR. Information on the recruitment and retention of underrepresented minority trainees appointed during the previous budget period must also be provided in progress reports included in noncompeting continuation applications. Training in the Responsible Conduct of Research: Every predoctoral and postdoctoral trainee supported by a NRSA institutional training grant must receive instruction in the responsible conduct of research. Notice of this requirement was published in the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992, and republished in the NIH Guide, Volume 23, Number 23, June 17, 1994. Applications must include a description of the program to provide formal and informal instruction in scientific integrity and the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. Although the exact content of the plan is left to the individual training program, all programs are strongly encouraged to consider instruction in the following ares: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human subjects, and data management. Plans should include a rationale for the proposed instruction as well as the subject matter, format, and frequency, degree of faculty participation, and trainee attendance. Program reports on the type of instruction provided, topics covered, and other information such as trainee attendance and faculty participation must be included in future competing and noncompeting applications. The plan to provide instruction in the responsible conduct of research will be assessed on the appropriateness and breadth of topics; instructional format and materials; amount, nature, and quality of faculty participation; and frequency and duration of the training. Plans will be rated as acceptable or unacceptable by the initial review group. The plan and acceptability will be described in an administrative note in the summary statement. The plan to provide instruction in the responsible conduct of research will not be considered in the assignment of a priority score to the application. Regardless of priority score, applications with unacceptable plans will be considered incomplete, and awards will not be made until a revised and adequate plan is provided and determined to be acceptable by AHCPR. AWARD CRITERIA Funding decisions will be based on peer review, Advisory Council recommendations when applicable, the need for research personnel in specified program areas, balance among types of research training supported by AHCPR, and the availability of funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: DonnaRae Castillo NRSA Project Officer Agency for Health Care Policy Research 2101 East Jefferson Street, Suite 400 Rockville, MD 20852 Telephone: (301) 594-1362 Email: dcastill@po7.ahcpr.gov Direct fiscal and administrative inquiries to: Ralph Sloat Grants Management Officer Agency for Health Care Policy Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1447 AUTHORITY AND REGULATIONS NRSA institutional research training grants are made under authority of Section 487 of the Public Health Service (PHS) Act as amended (42 USC 288). Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program. The program is described under Catalog of Federal Domestic Assistance No. 93.225. This program is not subject to the intergovernmental review requirements of Executive Order 12372. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun Oct 16 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 16 October 1994 Date: 17 Oct 1994 14:49:44 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 91 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <37urho$6q4@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. 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From owner-sci-resources@net.bio.net Mon Oct 17 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 25 September 1994 Date: 18 Oct 1994 13:32:44 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 116 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <381bdc$db7@net.bio.net> NNTP-Posting-Host: net.bio.net ------------------------------------------------------------------ NOTE: This message was originally mailed on September 25, 1994, but was not delivered due to configuration problems here at NSF. ------------------------------------------------------------------ This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: BUL 94-10 NSF October Bulletin Vol 22; No. 2 File size (bytes): 86180 STIS Filename: bul9410 Document Type: Program Guideline Title: NSF 94-135A Faculty Early Career Development (CAREER) Program Program Characteristics FY 1995 (BIO) File size (bytes): 8592 STIS Filename: ns94135a Title: NSF 94-135B Faculty Early Career Development (CAREER) Program Program Characteristics FY 1995 (CISE) File size (bytes): 7902 STIS Filename: ns94135b Title: NSF 94-135C Faculty Early Career Development (CAREER) Program Program Characteristics FY 1995 (EHR) File size (bytes): 8966 STIS Filename: ns94135c Title: NSF 94-135D Faculty Early Career Development (CAREER) Program Program Characteristics FY 1995 (ENG) File size (bytes): 11267 STIS Filename: ns94135d Title: NSF 94-135E Faculty Early Career Development (CAREER) Program Program Characteristics FY 1995 (GEO) File size (bytes): 8894 STIS Filename: ns94135e Title: NSF 94-135F Faculty Early Career Development (CAREER) Program Program Characteristics FY 1995 (MPS) File size (bytes): 9176 STIS Filename: ns94135f Title: NSF 94-135G Faculty Early Career Development (CAREER) Program Program Characteristics FY 1995 (SBE) File size (bytes): 10095 STIS Filename: ns94135g Title: NSF 94-132 Group Infrastructure Grants File size (bytes): 15326 STIS Filename: nsf94132 Title: NSF 94-133 -- MINORITY POSTDOCTORAL RESEARCH FELLOWSHIPS AND SUPPORTING ACTIVITIES File size (bytes): 42073 STIS Filename: nsf94133 Also available: nsf94133.doc ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Program Guideline Title: NSF 94-135A Faculty Early Career Development (CAREER) Program Program Characteristics FY 1995 (BIO) File size (bytes): 8592 STIS Filename: ns94135a ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve ns94135a, the text of your message should be as follows: get ns94135a Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve ns94135a, you would enter: ftp> get ns94135a WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Wed Oct 19 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-95-005 - V23(37) 10/21/94 Date: 20 Oct 1994 15:59:52 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 815 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <386sp8$sab@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HD95005 HD-95-005 P1O1 *************************************** LEARNING DISABILITIES: MULTIDISCIPLINARY RESEARCH CENTERS NIH GUIDE, Volume 23, Number 37, October 21, 1994 RFA: HD-95-005 P.T. 04, AA; K.W. 0720010, 0755030, 0745027, 0507004, 0785055, 0710030 National Institute of Child Health and Human Development National Institute of Neurological Disorders and Stroke Application Receipt Date: February 14, 1995 PURPOSE The Human Learning and Behavior Branch (HLB) of the Center for Research for Mothers and Children (CRMC) of the National Institute of Child Health and Human Development (NICHD) and the Developmental Neurology Branch (DNB) of the Division of Convulsive, Developmental, and Neuromuscular Disorders (DCDND) of the National Institute of Neurological Disorders and Stroke (NINDS) invite research grant applications to develop new knowledge in the areas of definition, classification, epidemiology, prevention (and preventive strategies), early intervention, etiology, diagnosis, and treatment of children who display learning disabilities (LD) in component oral language abilities (phonology, morphology, semantics, syntax, pragmatics), reading (word attack skills, word recognition skills, reading comprehension), written expression abilities (spelling, composition), and mathematics (basic calculation skills, mathematical reasoning), and combinations and relationships among them (e.g., combined deficits in phonology, word attack skills, spelling behavior and mathematics). An emphasis should also be placed on identifying the distinctions and interrelationships (comorbidities) between well defined types of learning disabilities and other well defined disorders to include disorders of attention, oppositional/conduct disorders, genetic disorders affecting learning (e.g., Fragile X syndrome, Asperger's syndrome, etc.). In addition, of significant interest are longitudinal studies of treatment effectiveness with children with LD who are well defined in terms of age, gender, ethnicity, SES, primary LD, comorbid LD, severity of disability, intensity and duration of any previous intervention(s), familial and/or genetic findings, intellectual status, cognitive-linguistic status, neuropsychological status, neurophysiological status, educational status, and social/behavioral competencies. Specialized research center grant applications should propose, for the purposes of this request for applications (RFA), an integrated and synergistic research program that includes, at a minimum: (1) studies of basic biological (neurobiological and genetic) factors relevant to the etiology, developmental course, and outcomes of LD; (2) cognitive-information processing, neuropsychological, and behavioral factors relevant to the phenotypic expression of different types of LD at different developmental periods and the predictive capability of these factors for purposes of early intervention and treatment; and, (3) factors related to response to treatment. Up to four Specialized Research Centers may be supported in response to this RFA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Learning Disabilities: Multidisciplinary Research Centers, specifically addresses those priorities that are concerned with the developmental problems in children that are related to developmental and learning problems in children, and particularly those that require psychosocial interventions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001- 00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic public and private, non- profit and for-profit organizations such as universities, colleges, hospitals, schools, laboratories, units of State and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Specialized Research Center Grant (P50). Policies that govern the grant-in-aid award programs covered by the PHS will apply. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this RFA may not exceed five years. FUNDS AVAILABLE The NICHD has set aside 2.1 million dollars for direct costs for the first year of support and the NINDS has set aside 0.7 million dollars. It is anticipated that up to four awards will be made. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plan of the Institutes, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background The NICHD and the NINDS have had a long-standing interest in the study of learning disabilities and disorders that adversely affect the development of listening, speaking, reading, writing and mathematics abilities in approximately 15 to 20 percent of children in the United States. Since its inception in 1963, the NICHD has funded research to delineate the basic biological and behavioral mechanisms that underlie specific deficits in attention, perception, language, cognition, and academic skills, particularly reading. In January 1987, a National Conference on Learning Disabilities, co- sponsored by the Interagency Committee on Learning Disabilities (of which the NICHD was designated as the lead agency and of which the NINDS was a member) and the Foundation for Children with Learning Disabilities was held on the NIH campus. The proceedings of this conference were combined with other sources to provide a comprehensive document titled "Learning Disabilities: A Report to the U.S. Congress" (1987). A major recommendation included in this report called for a systematic effort to conduct research to develop a valid and reliable definition and classification system that could provide a theoretical, conceptual, and empirical framework for the identification of different types of learning disabilities, as well as the identification of distinctions and interrelationships (comorbidities) between types of LD and other childhood disorders including general academic underachievement, disorders of attention, mental retardation, and emotional disturbance. In addition, the "Report to Congress" called for a systematic effort to develop rigorous research strategies and intervention trials to examine the responses of children with LD to different forms of treatment. Based on the 1987 "Report to Congress" recommendations, NICHD funded three Multidisciplinary Learning Disability Research Centers (LDRCs) in 1988 to initiate studies on the definition, classification and etiology of LD and related disorders. NINDS was at this time funding the Center for the Study of the Neurological Basis of Language, which serves as a model for these recommendations. The three NICHD centers joined several NICHD Program Projects that focussed on the specific study of dyslexia. In 1993, two additional research programs were funded to study the effects of treatment interventions on children with language-based reading deficits. Studies conducted at the LDRCs and Program Projects over the past five years have yielded discoveries in several domains, and these are summarized below according to research targets. Classification/Definition o The definition and classification of LD, dyslexia, and disorders of attention (i.e., attention deficit hyperactivity disorder (ADHD)) should be accomplished within a longitudinal developmental framework that does not require adherence to a priori assumptions reflected in current definitions. The development of valid definitions requires that studies be conducted with representative groups of children over time that document, with robust measurements and measurement models, how differences among children emerge, change, respond to treatment, and influence further development. In developing definitions, a critical emphasis must be placed on the identification of valid inclusionary criteria. o Current exclusionary definitions of LD in reading appear to be invalid if discrepancy criteria are used. Reading disabled (RD) children with and without a discrepancy between IQ and reading achievement do not differ in the information processing subskills (e.g., phonological and orthographic processing) that are critical to the reading of single words. Likewise, genetic and neurophysiological studies have not indicated differential etiologies for RD children with and without IQ achievement discrepancies. It remains to be seen whether or not discrepancies between IQ and achievement constitute valid markers in the areas of oral language, written expression, mathematics, or whether or not discrepancies are worthwhile predictors of response to treatment/interventions. Reading and Language-Related Processes o LDRC longitudinal, epidemiological studies show that RD (dyslexia) affect at least 10 million children, or approximately 1 child in 5. o While public schools identify approximately four times as many boys as girls as RD, LDRC and Program Project longitudinal and epidemiological studies show that as many girls manifest RD as boys. What is not as well understood are the factors that predispose boys to a higher rate of identification. Questions related to severity, classroom behavior, teacher expectations and perceptions, and the influence of comorbidities need to be addressed. o RD reflects a persistent deficit rather than a developmental lag in linguistic (phonological) skills and basic reading skills. LDRC longitudinal studies show that of the children who are diagnosed RD in the third grade, 74 percent remain disabled in the ninth grade. Given these findings, several questions remain. For example, what are the characteristics of those children who are no longer diagnosed RD? Was their disability less severe in contrast to children with persistent RD? Were particular treatment/interventions more effective with the compensated RD children than with those children who remained RD? Do compensated RD children show differences in neurophysiological, linguistic, cognitive, and behavioral features? What are the best predictors of outcome? Do predictors change as a function of type of intervention/treatment? o Children with RD differ from one another and from other non- disabled readers along a continuous distribution, and do not cluster to form a bimodal distribution or a distinctive "hump" at the tail of the normal distribution. Given that RD occurs along a continuum, it will be important to understand in future studies which "cut-off points" are most valid and useful for establishing levels of severity for diagnostic and treatment planning purposes. Treatment/ intervention studies would be helpful in this regard. o The ability to read and comprehend depends upon rapid and automatic recognition and decoding of single words, and slow and inaccurate decoding are the best predictors of difficulties in reading comprehension. While this finding has been replicated across the LDRCs and other projects, an identification of the multiple cognitive and linguistic sources that are required for comprehension and their relative importance to comprehension is not fully understood. More detailed and comprehensive studies are needed in this area. o The ability to decode single words accurately and fluently is dependent upon the ability to segment words and syllables into abstract constituent sound units (phonemes). Converging evidence from all the LDRCs and other projects show that deficits in phonological awareness reflect the core deficit in RD or dyslexia. In future studies, it will be critical to determine whether the phonological deficit reflects a specific linguistic deficiency that interferes with the development of reading in and of itself, or whether deficits in phonology actually reflect deficiencies at lower levels of processing (e.g., rapid temporal processing of information irrespective of modality). It is also critical to establish the neurobiological underpinnings of the phonological deficit and temporal processing deficiencies, if in fact, the latter are strongly implicated in the developmental reading process. o In addition, some LDRC data and studies from other sources continue to find that orthographic processing influences how reading develops in children. Given this consistent finding, research is needed to fully define and identify the role of orthographic processing in both single-word reading and comprehension, as well as to identify and delineate other visual processing factors that may contribute to the developmental reading process. Neurobiological, cognitive, and treatment studies would be instrumental in this regard. o At this time, the best single predictor of RD from kindergarten and first grade test performance is phoneme segmentation ability. However it remains to be determined whether other phonological skills are equally robust, or whether combinations of tasks are most efficacious. Attention o The reviews of the literature conducted by the LDRCs and Program Projects indicate that a precise classification system and definition of disorders of attention is not yet available. A classification methodology that assesses BOTH internal and external validity of dimensional AND categorical models must be applied to the task. Thus, any findings discussed with respect to ADD or ADHD must be interpreted with the type of caution that should accompany any ill- defined construct. o Disorders of attention and RD often coexist, but the two disorders appear distinct and separable with respect to the effects of ADD on cognitive tasks. For example, it has been found that ADD children perform poorly on rote verbal learning and memory tasks, but relatively well on naming and phonological awareness tasks. The converse appears to be the case for children with RD. Clearly, research is needed to understand whether differential neurobiological and genetic mechanisms underlie disorders of attention versus other types of learning disabilities. It will also be critical to understand whether comorbidity between RD and disorders of attention predispose a child to particular treatment-response patterns. o Disorders of attention, which occur more frequently among males, exacerbate the severity and cognitive morbidity of RD. Thus, level of severity may be one reason that more males than females are identified as RD. Again, neurobiological and genetic research will be critical to understanding the gender difference for ADD and ADHD, and treatment studies will be critical in determining the types of interventions necessary to remediate severe RD with ADD/ADHD. Genetics o A multiple regression analytic procedure has been developed by the Colorado LDRC that allows for the analysis of the genetic etiology of deviant scores as well as individual differences in language/reading functions. This is a unique and highly flexible methodology that can be extended to assess a wide range of possible main effects and interactions and to test for differential genetic and environmental influences. o Twin studies have found strong evidence for a genetic etiology of reading disability, with deficits in phonological awareness reflecting the greatest degree of heritability. There is also behavioral genetic evidence for degrees of heritability for orthographic processing, but this genetic relationship is not well understood. o Preliminary data suggest that at least one type of reading disability can be linked to the HLA region of Chromosome 6 reflecting a possible association with autoimmune disorders. Recent evidence obtained from twins and siblings with severe deficits in reading performance show strong support for a Quantitative Trait Locus on Chromosome 6. Neurobiology (Neuroanatomy, Neurophysiology, Neuroimaging) o Several types of brain pathology, including microdysgenesis (ectopias), cell loss, hippocampal anomalies, congenital hydrocephalus, and abnormalities of the corpus callosum have been reported in a number of strains of immune-defective mice. There is a similarity between the brain lesions seen in the animal models and in the brains of individuals with dyslexia. o Data suggest that the microdysgenesis in the cortex of affected animals is developmental in origin and begins prior to the end of neuronal migration. Comparable pathology occurring after the completion of neuronal migration leads to cell loss and myelinated gliosis - a finding also obtained in dyslexic brain samples. o At the macroscopic level, atypical neural organization in dyslexic individuals is suggested by an absence of the normal left-greater- than- right asymmetry in the region of the temporal planum. This observation requires substantial continued investigation using well controlled structural neuroimaging procedures. o Converging evidence derived from anatomical microstructure studies, gross morphology studies, and neuroimaging studies carried out at the LDRCs and the LD Program Projects suggests that the phenotypic expression in dyslexia is related to anomalous organization of brain structures and processing systems within the posterior left hemisphere. Substantial structural and functional neuroimaging remain to be done with children with dyslexia to obtain a valid signature for this hypothesized neurophysiological difference. Treatment/Intervention o Disabled readers do not readily acquire the alphabetic code when learning to read, apparently due to deficiencies in the processing of phonological information. Further, some data suggest that explicit instruction in phonological concepts and their relationship to early reading skills is more efficacious than interventions that rely on contextual or meaning-based approaches. o Of substantial importance is the need to extend these preliminary treatment/intervention studies to identify specific child x treatment interactions at early stages of development, and to further investigate how positive or negative responses to different forms of intervention are reflected in brain development and neural and cognitive information processing. Such aptitude x treatment studies are clearly needed for all types of LD (reading, oral language, mathematics, written expression). Focus The major focus of this RFA is to build upon the findings derived from the studies conducted at the LDRCs, the LD Program Projects, and other research programs in and outside of North America, and to confirm, refute, and extend these findings with an eye toward generating new knowledge relevant to the definition and classification of all types of LD, their epidemiology, their developmental course, their etiologies, their response to treatments, and their outcomes, as well as the factors that explain different outcomes. Given the significant advances in neuroimaging technology, particularly in the development and application of non-invasive functional Magnetic Resonance Imaging technology to the study of brain development and information processing in children, an emphasis on investigating the neurobiology of different types of LD will be critical. Moreover, such non-invasive neurobiological studies should be designed so that questions related to the etiologies and developmental courses of different types of LD (with and without comorbidities) can be examined in detail. Of particular interest is the effect that different forms of well-defined treatment/ interventions have on brain development and neural processing. It should be noted that current knowledge related to the etiologies, developmental courses, and diagnostic characteristics of children with LD who display primary deficits in written expression, reading comprehension, and mathematics is less developed than that which is now known about aspects of oral language (e.g., phonology) and basic reading development. As such, there exists a need to initiate studies of these types of LD, particularly with reference to establishing reliable and valid definitions and classification systems. Research Population: The selection of the research population should be based upon the need to conduct integrated prospective, developmental, longitudinal investigations incorporating neurobiological, cognitive/behavioral, and early (and later) treatment/intervention studies with children who manifest LD in one or more of several domains to include oral language, basic reading skills, reading comprehension, written expression, and mathematics development. Within this context, longitudinal studies may be initiated with preschool and kindergarten children, with the children being followed as they enter and proceed through the early grades. Cross-sectional studies of LD children of ages ranging across the elementary and middle school age-span should also be considered, but such studies must be related meaningfully to the questions being asked within the longitudinal studies. It is expected that not all children within the research population will manifest the entire range of oral language, written language, and mathematics deficits detailed above. In fact, there will likely be subgroups and subtypes of children with significantly different patterns of academic deficits, different patterns of comorbidity, levels of severity, and different psychological/cognitive processing deficits. As such, applicants should consider research protocols that are capable of identifying well defined subgroups and subtypes that exist within the sample. Investigators should also consider casting the sampling net wide enough to insure a representative number of subtypes and contrast groups within the study population. For example, of interest are subtypes of LD children of varying intellectual abilities, with primary deficits in one or more academic domains who display no comorbid deficits, a single comorbid deficit, or a combination of comorbid deficits in attention, behavior, and social competencies, etc. Subject Selection Criteria: The samples for study must be rigorously defined so that complete replication in another site can be accomplished. Within this context, applicants should provide clearly documented and operationalized definitions for their subject selection criteria. These definitions and criteria must be specified in an a priori manner. The selection of "school-identified" or "clinic-identified learning disabled children is strongly discouraged unless the diagnostic characteristics in these cases match the applicant's a priori established selection criteria. Likewise, criteria for selection of contrast group(s) must be specified in a priori. All children selected for study must be defined with reference to age, gender, grade level, length of time in special education placement, type of current special education placement, previous special education placement(s) to include intensity and duration, ethnicity, socioeconomic status, primary learning disability, comorbid disabilities, severity of disability, familial and/or genetic findings, physical/neurological findings, intellectual status, cognitive linguistic status, neurophysiological/ neuropsychological status, levels of academic achievement in oral language, reading, mathematics, and written language, and presence or absence of attention deficit disorder. Measurement Criteria: Standardized tests, laboratory tasks, observational measures, and other assessment procedures (e.g., dynamic assessment procedures) must be selected on the basis of known reliability and validity and appropriateness for the population under study. If reliability and validity characteristics are not yet known for a particular assessment or measurement procedure, the application should contain specific plans for establishing these features. The valid measurement of change over time is critical to the research called for in this RFA since the study of developmental course and treatment effectiveness are of primary concern. As such, applicants should be aware of and utilize robust procedures for separating treatment effects from the effects of development in general. The use of growth curve models and longitudinal data are encouraged as is the collection of sufficient data prior to the onset of any experimental condition or treatment(s) to allow estimation of pre-and post-treatment growth curves. Measurement should also be carried out across multiple time points. Rationale and Research Questions A critical public health task that continues to confront the field of learning disabilities is the development of a set of operational definitions and a classification system for different types of LD that will provide the scientific context for their treatment and for the identification of distinctions and interrelationships (comorbidities) between the types, and other well defined disorders to include disorders of attention, oppositional/conduct disorders, and genetic disorders affecting learning. There exists a compelling need to apply state-of-the-art classification methodology to achieve this goal, and to externally validate emerging definitions and classification models via the conduct of neurobiological/neuroimaging studies, cognitive studies, and treatment/intervention studies. To this end, examples of research questions and areas that need to be addressed are provided below. These examples are illustrative and not restrictive. 1. IQ-Achievement discrepancies have not been found to be meaningful in differentiating between discrepant and non-discrepant poor readers with deficits in single word reading. Does this same finding hold true for children who manifest LD in reading comprehension? written expression?, mathematics? Do IQ-Achievement discrepancies predict response to treatment/intervention? Are they related to LD children's self-esteem and self-concept? Are they related to teacher and parent expectations? 2. Are there more appropriate psychometric means to assess the concept of "unexpected underachievement" that is central to most existing definitions of LD and to the construct of LD? If so, do children who demonstrate "unexpected underachievement" differ from children whose achievement is predicted to be subaverage on measures of linguistic performance, neuropsychological abilities, neurophysiological functioning, genetic factors, response to instruction, etc. 3. Are there demonstrable differences between children with different types of LD (e.g., reading vs. mathematics, vs. written language) with respect to brain structure and function as assessed by non-invasive neuroimaging technology? Does level of severity influence any differences? Do comorbidities influence any differences? 4. Are there demonstrable differences between children with different types of LD with respect to cognitive and information processing characteristics? Does level of severity and/or comorbidities influence any differences? 5. Can neurobiological and genetic information obtained during the early course of development (e.g., preschool/kindergarten years) be useful in predicting the onset, course, and level of severity of different types of LD? Can neurobiological and genetic information help to predict response to different forms of treatment? 6. Given that disabilities in single word reading, and possibly other types of LD, occur along a continuous distribution, what methods, procedures, and/or strategies can be used to identify precise levels of severity and the treatment intensity necessary to remediate the deficit(s)? This issue and its resolution is critical to accurate identification and efficacious treatment/education of LD children in schools. 7. Is outcome for different types of LD related to severity? comorbidity? gender? IQ? SES? neurobiological factors? genetic factors? type, intensity, and amount of treatment? onset of treatment (early vs. late)? 8. How do deficits in information processing abilities (e.g., phonological processing, listening comprehension, visual perception, orthographic processing and memory, spatial and temporal processing) relate to neurobiological data obtained via non-invasive structural and functional neuroimaging studies, and to behavioral, genetic and linkage studies? How do such deficits interact with well defined treatment/interventions to develop specific skills, concepts, and strategies in different academic areas? 9. Deficits in the development of phonological abilities have been strongly linked to failure in developing basic reading skills. Do phonological deficits constitute the core deficit in reading, or is the ability to process information rapidly, regardless of modality, the major underlying factor in reading disability? 10. What is the most robust definition and classification system for disorders of attention? Should a categorical model be employed? Should a dimensional model be employed? Should a combination of models be used? 11. Do different types of deficits in attention correspond reliably to different neurophysiological signatures as measured by functional MRI or other non-invasive functional neuroimaging modalities? If so, does the signature differ with age? severity? gender? degree of comorbidity? IQ? 12. Are there neurobiological or genetic factors that can explain the greater frequency of attention disorders in males than females? 13. Are different deficits in component oral language skills (e.g., phonology, semantics, syntax) related to different reading, written language, and mathematics disabilities? 14. Is there differential treatment response by gender? By SES? By comorbidity? By degree of neurobiological involvement? 15. How can treatment success and efficacy best be measured? How are growth curves best assessed? Are static or dynamic measures best suited for the monitoring of treatment effects? 16. Are positive responses to treatment for component oral language, written language or mathematics deficits accompanied by changes in neurophysiological, neuropsychological, affective, social, and attentional status? INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS The research subjects will range in age from four to 12 years. Investigators are encouraged to study male and female children varying in their racial and socio-economic background. It is the policy of NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43 and supersedes and strengthens the previous policies Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91). This application form is available in the office of sponsored research at most academic and research institutions and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westwood Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. The receipt deadline for applications prepared in response to this RFA is February 14, 1995. Late applications will not be accepted. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title, "Learning Disabilities: Multidisciplinary Research Centers" and the number must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed typewritten original of the application, including the checklist, and three signed photocopies in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two copies of the application must be sent under separate cover to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03 Bethesda, MD 20892 Applications must be received by February 14, 1995. 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 the same as one already reviewed. This does not preclude the submission of substantial revisions of an application already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by NICHD and NINDS staff. Incomplete or non- responsive 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 Institutes in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Those applications judged to be competitive will be further evaluated for technical and scientific merit by a peer review panel convened for this purpose by the Division of Scientific Review, NICHD. Review criteria for evaluating the applications will be those normally used by reviewers as specified in the NICHD P50 Guidelines. The review criteria for the overall program are: o significance of the research program proposed by the center to the initiative on learning disabilities; o scope and breadth of the center's programs, the component research projects, and core units; o suitability of the center's central theme and provisions for coordinating the research projects and core units; o multidisciplinary scope of the center and provisions for coordinating the research projects and cores; and o leadership ability and scientific stature of the center director and his/her ability to meet the program's demands of time and effort. The review criteria for the component research projects and core units are: o scientific merit of each component research project and the relation of the project to the center's overall theme; o cost effectiveness and quality control of core units; o the quality and productivity of research projects using the core facilities. (each core should be used by at least three research projects); o the appropriateness of the research projects' use of core services; o qualifications, experience, and the commitment of the investigator's responsible for the component research projects and core units; o participation of a suitable number of responsible, experienced investigators; o appropriateness of the budgetary requests; o accomplishments and progress to date of the component research projects and core units, particularly for competing continuation (renewal) and supplemental applications; o as appropriate, the adequacy of the means proposed for protecting against risks to human subjects, animals, and/or the environment; o academic and physical environment as it bears on patients, space, and equipment, and on the potential for interaction with scientists from other departments and institutes; o arrangements for internal quality control of ongoing research, the allocation of funds, day-to-day management, contractual agreements, and internal communication and cooperation among the investigators in the center's program; o presence of an administrative and organizational structure conducive to attaining the center's objectives; and o institutional commitment. o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA The earliest anticipated date of award is December, 1995. Scientific merit, technical proficiency, and availability of funds as described in the application, will be the predominant criteria for funding. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic and scientific issues to: G. Reid Lyon, Ph.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Building, Room 4B05 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-6591 FAX: (301) 402-2085 EMAIL: LYONR@HD01.NICHD.NIH.GOV Sarah H. Broman, Ph.D. Division of Convulsive, Developmental, and Neuromuscular Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 8C06 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-5821 FAX: (301) 402-0887 EMAIL: sb73f@nih.gov Direct inquiries regarding fiscal and administrative matters to: E. Douglas Shawver Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Building, Room 8A17 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-1303 Angeline Wilson Grants Management Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-9231 AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance No. 93.365, Research for Mothers and Children. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42, USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. Awards are also made under authorization of PHS Act, Title V, Part B. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or health System Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed Oct 19 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA GM-95-002 - V23(37) 10/21/94 Date: 20 Oct 1994 15:59:34 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 490 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <386som$s9d@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA GM95002 GM-95-002 P1O1 *************************************** INITIATIVE FOR MINORITY STUDENTS: BRIDGES TO THE DOCTORAL DEGREE NIH GUIDE, Volume 23, Number 37, October 21, 1994 RFA: GM-95-002 P.T. 44, FF; K.W. 0725005, 0710030 National Institute of General Medical Sciences Letter of Intent Receipt Date: November 18, 1994 Application Receipt Date: January 20, 1995 PURPOSE The National Institute of General Medical Sciences (NIGMS) and the Office of Research on Minority Health (ORMH), National Institutes of Health (NIH), announce two research initiatives directed at increasing the number of underrepresented minorities entering careers in biomedical research. The programs target two different underrepresented minority student populations: those in colleges and universities offering only Master of Science (M.S.) degree programs in biomedically-related sciences and those in two-year junior or community colleges. These have been identified as two key transition points for students considering careers in biomedical research. This is the third year of this program, which seeks to encourage the development of new and innovative programs and the expansion of existing programs to improve the academic competitiveness of underrepresented minority students and facilitate their transition into the next stage towards careers in biomedical research. This Request for Applications (RFA) solicits new applications for a partnership program involving institutions awarding the M.S. degree as the terminal degree and universities awarding the Ph.D. degree. A separate RFA (GM-95-001) describes a program targeting the transition from two-year colleges awarding the Associate's degree to institutions awarding the Baccalaureate degree. Previous applicants of unfunded Bridges applications are encouraged to submit revised applications that respond to the concerns of the National Advisory General Medical Sciences Council. ELIGIBILITY REQUIREMENTS General Applications may be submitted by domestic, private and public, educational institutions. State or local systems of higher education (also hereinafter referred to as institutions) may submit applications as well. An institution may be involved as a partner institution in more than one Bridges Program, but can be the applicant institution for only one Bridges to the Baccalaureate Degree and one Bridges to the Doctoral Degree Program. Institutions with NIGMS Bridge Program (R25) awards made effective on September 1, 1993 may submit competing continuation applications for three years of continued support (see RFA GM-95-003) since those initial awards will be ending in 1995. Institutions with NIGMS Doctoral Bridges Program (R25) grants funded on September 1, 1994 are not eligible to apply for this RFA (GM-95-002) or RFA GM 95-003. An institution or system of higher education may submit ONLY ONE application for this RFA. Institutions that submit an application in response to this RFA may also apply for support for a Bridges to the Baccalaureate Degree program (RFA GM-95-001), if they meet the eligibility requirements. However, a separate application for each RFA is required. Institutions submitting their own applications may participate in programs with other applicant institutions so long as these interactions are consistent with institutional resources and their unified institutional plans described in BOTH applications (see UNIFIED PLAN under SPECIAL REQUIREMENTS). Institutions participating in more than one application should provide a justification for each. Programs developed or modified under this initiative must be specifically designed to target underrepresented minority graduate students majoring in the sciences. For purposes of this RFA, underrepresented minority students are individuals belonging to a particular ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical or behavioral research. Nationally, individuals who have been found to be underrepresented in biomedical or behavioral research include, but are not limited to, African Americans, Hispanic Americans, Native Americans and Pacific Islanders. The term "science" is used in this RFA to mean the natural, physical, and behavioral sciences and mathematics relevant to biomedical research. Applications must include a partnership between an institution that offers the M.S. degree ("MS Institution") as the only post-graduate degree in the sciences within the participating departments AND has a significant enrollment of underrepresented minorities, and one research university providing Ph.D.-degree programs in areas relevant to the biomedical sciences. All applications must involve a partnership of at least two colleges or universities, but may involve a consortium of several institutions, and may include several institutions within a single state system. One participating institution must be designated as the applicant institution, must name the program director and must submit the application. Each participating institution must name one individual to act as its program coordinator. Applications must include a description of the collaborative arrangement with all participating institutions. Institutions offering both the M.S. and Ph.D. degrees may not use funds from this program for graduates of their own M.S. degree programs to enter their own Ph.D. degree programs, even if the student is moving from one department, school, or college to another. The program seeks to promote and enhance partnerships BETWEEN institutions. For additional requirements see: SPECIAL REQUIREMENTS MECHANISM OF SUPPORT General Awards under this RFA will use the institutional education project (R25) grant. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this RFA may not exceed two years. Requested direct costs are not to exceed $300,000 for the two-year period. Indirect costs will be paid at eight percent of the direct costs, minus appropriate exclusions, or actual indirect costs, whichever is less. A budget for each year should be provided. This RFA is a one-time solicitation. Future unsolicited competing applications will not be accepted. Allowable Costs If appropriate, the budget request may be divided into two phases: a planning phase with its attendant budget for the minor adjustment and/or refinement of the partnership program; and an implementation phase with its attendant budget. The planning phase costs should be minimal and not exceed a period of one year (not intended to serve as a substitute for the complete and detailed plan required to be in the application). Faculty release time for planning and implementation of the program and faculty travel related to program development may be requested. The implementation phase may include the costs of administering and coordinating the partnership program within and between each of the participants. Requests for equipment, supplies, travel, and other expenses should be limited to those necessary for program development and should be carefully and specifically justified. Student remuneration (limited to underrepresented minorities matriculated at the MS partner institution(s)) through salary/wages and/or other forms of compensation paid in lieu of wages for participation in research experiences may be requested. Tuition remission (or other forms of compensation paid in lieu of wages) expenditures are allowable provided the following conditions are met: o the student is performing necessary work, o there is an employer-employee relationship between the student and the institution, o the total compensation is reasonable for the work performed, and o it is the institution's practice to provide compensation for all students in similar circumstances, regardless of the source of support for the activity. In summary, allowable costs include, but are not limited to: tuition remission, supplies, equipment, travel, other expenses, salary, wages, and fringe benefits for students and faculty. Unallowable Costs Stipends, housing, food, tuition (unless as stated above), and fees are not allowable costs under this program. FUNDS AVAILABLE An estimated total of $9 million will be available in Fiscal Year 1995 to support awards made in response to this solicitation, GM-95-001, and applications for competing continuations, GM-95-003. NIH staff anticipate making a combined total of 20 to 40 new and competing continuation awards for these RFAs using multi-year funding, depending on the receipt of a sufficient number of highly meritorious applications and availability of appropriated funds. RESEARCH OBJECTIVES Background This program seeks to promote the initiation and development of new transitional programs, as well as the expansion and enhancement of existing programs between those institutions with departments offering only the Master's degree as the graduate academic degree in the sciences, and that have significant enrollments of underrepresented minority students, and research universities with Ph.D. degree programs. The objective is to facilitate the transition of underrepresented minority graduate students into Ph.D. programs after obtaining their M.S. degree. Students receiving their M.S. degree in one field of science may pursue a Ph.D. in a different area so long as it is in a discipline related to the biomedical sciences. Collaborative agreements should take the form that best fits the needs and situations of the institutions involved. The challenge for the project director, with the help of the participating partners, is to design a new partnership program, or enhance an existing program, that will focus attention and adequate resources to the MS Institution(s) to enhance the academic competitiveness of their graduate degree programs and graduates in the sciences. Additional Information The "Bridge" programs must be designed with special attention to the needs and special requirements of the underrepresented minority graduate students enrolled in the M.S. degree program. They may include, but are not limited to, the following elements: o providing research opportunities for M.S. students at the Ph.D. institution or in private industrial laboratories (students may receive compensation for these activities); o establishing a mentoring program for M.S. students with faculty at the Ph.D. institution; o strengthening the research capability of the MS Institution (e.g., by faculty research collaborations, joint seminar programs, etc.); o enhancing the curriculum of the MS Institution (special courses, seminars, etc.); o enabling and encouraging students from either institution to take classes at the other institution; o guaranteeing acceptance into the participating Ph.D. program(s) for students completing the M.S. program; o academic counseling for M.S. students, with a particular focus on encouraging students to pursue research careers in the biomedical sciences. o nontraditional or other professional degree-granting institutions should describe those modifications or additions to their programs that would encourage and facilitate Bridge students to enter research careers. It is an expectation of NIGMS and ORMH that students who enter Ph.D. programs as a result of this enhancement program will receive support, if needed, while progressing satisfactorily in Ph.D. research training programs. Applicants should describe the type(s) of institutional support that would be available to such students. SPECIAL REQUIREMENTS Applicants should describe the proposed transition program in detail and explain how its design will meet the goals of this initiative. Applicants should describe the criteria to be used in the selection and retention of the student participants for this program; applicants should also describe the criteria for selecting participating faculty. Applicants with an existing transition program should describe that program and explain how it would be altered to meet the goals of this initiative. Applicant should describe the methods and facilities available for tracking student participants, and criteria to be used for program evaluation. Unified Plan To avoid duplication of effort each institution should develop a unified plan (which may include the biomedically relevant physical, natural and behavioral sciences and mathematics) to facilitate the transfer of its students from the M.S. degree program to the Ph.D. degree program at another institution. Applicants should describe how this proposal fits in with the institution's overall transition plan. If an institution is involved in more than one Bridge Program, the applicant or the institution's program coordinator must describe how the various Bridge Programs interact and are consistent with the institution's unified plan. Other Training Programs Colleges with any NIH funding such as the Minority Access to Research Careers (MARC), Minority Biomedical Research Support Program (MBRS), National Research Service Award (NRSA) training grants, and/or project grants, or other sources of funds such as National Science Foundation grants or Howard Hughes Medical Institute grants, should define the relationship between those programs and this transition program. They should delineate how this enhancement program will influence their partnerships with the other participants and the manner in which underrepresented minority students in the transition program will interact with these other sources of support. Consortium Agreements Each applicant institution should delineate appropriate agreements and consortium arrangements with other institutions consistent with its own unified institutional plan. The following statement, accompanied by signatures of the appropriate administrative officials from EACH of the collaborating institutions, must be included as part of the application: "THE APPROPRIATE PROGRAMMATIC AND ADMINISTRATIVE PERSONNEL OF EACH INSTITUTION INVOLVED IN THIS GRANT APPLICATION ARE AWARE OF THE NIH CONSORTIUM GRANT POLICY AND ARE PREPARED TO ESTABLISH THE NECESSARY INTER-INSTITUTIONAL AGREEMENT(S) CONSISTENT WITH THAT POLICY." In addition, letters, signed by the appropriate institutional official and program coordinator, acknowledging participation in the program are required from each participating institution. Reporting Requirements A progress report will be required at the end of the planning phase (if any) or at the end of the first year, whichever is shorter. A final report will be required 90 days after the termination date of the award and must include information for each student participant and the benefits derived from the partnership program. For applicants submitting competing renewals the progress report in the competing application may satisfy this requirement. Student Population and Career Tracking The nature and extent of underrepresented minority student participation must be thoroughly delineated. The applicant should also describe the MS Institution's success in training its students in the sciences, including information on the numbers of minority students receiving the M.S. degree and data on subsequent careers or education of their graduates. The applicant should describe a system by which it would monitor and track the students participating in this program, including their future careers, in order to evaluate the success of the program. The applicant should maintain data to be able to demonstrate the benefits of this program on retention rates, graduation rates, transfer rates to the next higher degree program, and graduation rates from the next higher degree programs. These data should be compared to those of the non-minority students and the minority students that were not in the bridges program. LETTER OF INTENT Prospective applicants are requested to submit, by November 18, 1994, a letter of intent that includes a descriptive title of the proposed plan, the name, address, and telephone number of the program director, the identities of other key personnel and participating institutions, and the number and title of the RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIH staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Rivera at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and from the NIGMS program administrator listed under INQUIRIES. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title must be typed on line 2A of the face page form, the "YES" box must be marked, and "R25" typed in 2B. Submit a signed, typewritten original of the application, including the Checklist, and three photocopies of the signed application in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to Dr. Americo Rivera, Jr. at the address listed under INQUIRIES. Applications must be received by January 20, 1995. Applications arriving after that date will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Division of Research Grants (DRG) and responsiveness by the NIGMS. Incomplete and/or unresponsive applications will be returned to the applicant without further consideration. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific and technical merit by appropriate peer review groups. The second level of review will be provided by the National Advisory General Medical Sciences Council. Review Criteria o qualifications and experience of the Principal Investigator and staff to carry out the proposed program; o appropriateness of the plans to develop the transition program to meet the goals of the solicitation; o appropriateness of the existing program, if appropriate, and of plans to modify that program; o availability of significant numbers of underrepresented minority students in the participating science department(s) who are interested in studying further in biomedical and health-related fields; o evidence of underrepresented minority students progressing to higher education in the sciences; o appropriateness of the system to track future course of program participants and monitor the effectiveness of the program; o budget and cost-effectiveness of the project including appropriateness to the scope of the program, benefit to the students, number of students involved, appropriateness of the of resources allocated to MS institution(s), and responsible and prudent senior personnel costs; o evidence of institutional commitment, for each institution, and strength of the collaborative efforts between institutions to foster professional development of underrepresented minority faculty and to train underrepresented minority students in the biomedical sciences; o appropriateness of the administrative plan for managing the proposed program, including adequacy of space and other institutional resources. o appropriateness of applicant's plan for the evaluation of the impact the Bridges program has made (before and after) on the institutions and the underrepresented minority students and faculty. AWARD CRITERIA The anticipated date of award is September 30, 1995. Award decisions will be based on the technical merit of the applications, the geographical distribution of the awardee institutions, and diversity of underrepresented minority student participants. Awards will be made only to institutions with financial management systems and management capabilities that are acceptable under PHS policy. Awards will be administered under the PHS Grants Policy Statement. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Americo Rivera, Jr., Ph.D. National Institute of General Medical Sciences Room 2AS-13H 45 Center Drive MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-0533 FAX: (301) 480-2004 Internet: RiveraA@GM1.NIGMS.NIH.GOV Direct inquiries regarding fiscal matters to: Ms Annette Hanopole National Institute of General Medical Sciences Room 2AN-50J 45 Center Drive MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-3928 FAX: (301) 480-3423 Internet: HanopolA@GM1.NIGMS.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.960, Special Minority Initiatives Program. Awards are authorized by sections 301 and 405 of the Public Health Service Act, as amended, and administered under PHS grants policies and Federal Regulations 45 CFR Part 74 or 45 CFR Part 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed Oct 19 23:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 37, pt. 1of1, 21 October 1994 Date: 20 Oct 1994 15:59:26 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 660 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <386soe$s92@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19941021 V23N37 P1O1 ************************************ X-comment: RFAs described: GM-95-001, GM-95-002, HD-95-005, PA-95-003 NIH GUIDE - Vol. 23, No. 37 - October 21, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** TRIAGE AND STREAMLINED SUMMARY STATEMENT FORMAT TO BE USED BY THE NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX N2 ********************************************************** TRIAGE AND STREAMLINED SUMMARY STATEMENT FORMAT TO BE USED BY THE NATIONAL INSTITUTE ON DRUG ABUSE National Institute on Drug Abuse INDEX: DRUG ABUSE NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** AN INVESTIGATION OF ORAL HARD TISSUE STATUS IN RELATION TO SKELETAL BONE MINERAL DENSITY MEASURES AND OSTEOPOROSIS (RFP NIH-NIDR-1-95-1R) National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX R2 ********************************************************** ENHANCING RECOVERY IN CORONARY HEART DISEASE (ENRICHD] PATIENTS - CLINICAL COORDINATING CENTER (RFP NHLBI-HC-94-29) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R3 ********************************************************** CLINICAL TRIAL TO EVALUATE THE PREVENTION OF EVENTS WITH ANGIOTENSIN CONVERTING ENZYME INHIBITOR THERAPY (RFP NHLBI-HC-94-31) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R4 01/20/95 ************************************************* INITIATIVE FOR MINORITY STUDENTS: BRIDGES TO THE BACCALAUREATE DEGREE (RFA GM-95-001) National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES $$INDEX R5 01/20/95 ************************************************* INITIATIVE FOR MINORITY STUDENTS: BRIDGES TO THE DOCTORAL DEGREE (RFA GM-95-002) National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES $$INDEX R6 02/14/95 ************************************************* LEARNING DISABILITIES: MULTIDISCIPLINARY RESEARCH CENTERS (RFA HD-95-005) National Institute of Child Health and Human Development National Institute of Neurological Disorders and Stroke INDEX: CHILD HEALTH, HUMAN DEVELOPMENT; NEUROLOGICAL DISORDERS, STROKE $$INDEX P1 ********************************************************** CLINICAL TRIALS USING TIPS PROCEDURE FOR PORTAL HYPERTENSION (PA-95- 003) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES ERRATA $$INDEX E1 ********************************************************** NATIONAL RESEARCH SERVICE AWARD -- INSTITUTIONAL GRANTS POLICY AND GUIDELINES (PAR-95-002) Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH THIS PUBLICATION IS AVAILABLE ELECTRONICALLY TO INSTITUTIONS VIA BITNET OR INTERNET AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE USING A PERSONAL COMPUTER (DATA LINE 301/402-2221). CONTACT DR. JOHN JAMES AT 301/594-7270 FOR DETAILS. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************* TRIAGE AND STREAMLINED SUMMARY STATEMENT FORMAT TO BE USED BY THE NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM NIH GUIDE, Volume 23, Number 37, October 21, 1994 P.T. 34; K.W. 1014006 National Institute on Alcohol Abuse and Alcoholism Beginning with the review of applications submitted for the October 1, 1994 receipt date, all National Institute on Alcohol Abuse and Alcoholism (NIAAA) standing review committees will triage investigator initiated research project grant applications (R01s and R29s). Reviewers will be instructed to designate approximately half of the applications as "noncompetitive" for support. For this purpose, "noncompetitive" means that, with respect to scientific and technical merit, the application is judged to be in the lower half of research project grant applications usually reviewed by the review committee. Applications determined to be "noncompetitive" will not receive full discussion at the review committee meeting, will not receive a priority score, and will not routinely be further reviewed by a national advisory council or board. A decision to not fully discuss an application requires unanimous agreement of the review committee. The summary statement for an application determined to be "noncompetitive" will consist of the customary administrative information and will now include the reviewers' verbatim critiques. The summary statement for a competitive application that receives full discussion and a score will include, in addition to the reviewers' critiques and the administrative information, a "Resume and Summary of Discussion," which synopsizes the review committee's discussion of the application. Subsequent to the study section meeting, all applicants will continue to receive the snap-out mailer that advises them of the outcome of the initial review. INQUIRIES Extramural Project Review Branch Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 409 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4375 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** TRIAGE AND STREAMLINED SUMMARY STATEMENT FORMAT TO BE USED BY THE NATIONAL INSTITUTE ON DRUG ABUSE NIH GUIDE, Volume 23, Number 37, October 21, 1994 P.T. 34; K.W. 1014006 National Institute on Drug Abuse Beginning with the review of applications submitted for the October 1, 1994 receipt date, all National Institute on Drug Abuse (NIDA) initial review groups/study sections will triage investigator- initiated research project grant applications (R01, R03, R29 and P01). Reviewers will be instructed to designate approximately half of the applications as "noncompetitive" for support. A designation of "noncompetitive requires unanimous agreement of the study section. For this purpose, "noncompetitive" means that, with respect to scientific and technical merit, the applications are judged to be in the lower half of research project applications usually reviewed by that study section. Applications determined to be "noncompetitive" will not receive full discussion at the study section meeting, will not receive a priority score, and will not routinely be further reviewed by the national advisory councils/boards. The summary statement for an application determined to be "noncompetitive" will consist of the customary administrative information and the reviewers' verbatim critiques. The summary statement for a competitive application that receives full discussion and a score will include, in addition to the reviewers' critiques and the administrative information, a "Resume and Summary of Discussion," which synopsizes the study section's discussion of the application. Subsequent to the study section meeting, all applicants will continue to receive the snap-out mailer that advises them of the outcome of the initial review. INQUIRIES Office of Extramural Program Review National Institute on Drug Abuse Parklawn Building, Room 10-42 Rockville, MD 20857 Telephone: (301) 443-2755 $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NIH-NIDR-1-95-1R ***************************************** AN INVESTIGATION OF ORAL HARD TISSUE STATUS IN RELATION TO SKELETAL BONE MINERAL DENSITY MEASURES AND OSTEOPOROSIS NIH GUIDE, Volume 23, Number 37, October 21, 1994 RFP AVAILABLE: NIH-NIDR-1-95-1R P.T. 34; K.W. 0715031 National Institute of Dental Research The National Institute of Dental Research (NIDR) has a requirement for a study to develop, implement, and evaluate the results of a descriptive study of tooth and oral bone status for a subsample of women enrolled in the observational component of the Women's Health Initiative (WHI) and to correlate these measures with skeletal bone density assessments. The proposed research will focus on collecting oral data by means of detailed oral examinations, standardized radiographs, and questionnaires. These data will be used to describe changes in oral bone mass and quality with age and the relation to skeletal bone status in health and disease. Offerors must have access to women at designated Bone Density Centers and provide demonstrated concurrence of the Bone Density Center's principal investigator and the WHI project office. This is an announcement for an anticipated Request for Proposal (RFP). RFP NIH-NIDR-1-95-1R will be available approximately November 4, 1994, with a closing date tentatively set for December 16, 1994. INQUIRIES Requests for the RFP must be submitted in writing, to: Marion L. Blevins Contract Management Section National Institute of Dental Research Westwood Building, Room 533 Bethesda, MD 20892 $$R1 END ************************************************************ $$R2 BEGIN NHLBI-HC-94-29 ******************************************* ENHANCING RECOVERY IN CORONARY HEART DISEASE (ENRICHD] PATIENTS - CLINICAL COORDINATING CENTER NIH GUIDE, Volume 23, Number 37, October 21, 1994 RFP AVAILABLE: NHLBI-HC-94-29 P.T. 04; K.W. 0715040, 0755015, 0715072, 0755018 National Heart, Lung, and Blood Institute The National Heart, Lung, and Blood Institute (NHLBI) is soliciting proposals from organizations to serve as a clinical coordinating center in a multicenter trial to determine the effects of psychosocial interventions on morbidity and mortality in coronary heart disease (CHD) patients. The primary objective of this multicenter trial is to evaluate the effects of psychosocial interventions on the cardiac-related morbidity and mortality of myocardial infarct (MI) patients at high psychosocial risk. High psychosocial risk is defined as the presence of depression and/or social isolation. The study design will compare a psychosocial intervention group, in which patients are provided with social support and psychological treatment designed to decrease social isolation and depression, with a health education control and a standard medical care group, using a combined endpoint of CHD death plus reinfarction. Secondary endpoints include health-related quality of life; adherence to medications and health-promoting behaviors; and ischemic events, measured by ambulatory electrocardiogram and exercise tolerance testing. To accomplish its objective, this program proposes to award approximately eight clinical units for patient accession, intervention, and data collection and one clinical coordinating center for study coordination and data management. It is anticipated that a total of 3,000 patients will be enrolled. This is an announcement for a Request For Proposals (RFP). RFP NHLBI-HC-94-29 is now available and proposals are due November 18, 1994. One award is anticipated by the Government. The period of performance for the clinical coordinating center is anticipated for eight years beginning in August 1995. INQUIRIES Written requests for this solicitation must include three self- addressed mailing labels and cite RFP NHLBI-HC-94-29. Verbal requests must be confirmed in writing or by FAX. Requests for the solicitation are to be addressed to: Cheryl A. Jennings Contracts Operations Branch National Heart, Lung, and Blood Institute Federal Building, Room 3C16 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-1326 FAX: (301) 496-0075 $$R2 END ************************************************************ $$R3 BEGIN NHLBI-HC-94-31 ******************************************* CLINICAL TRIAL TO EVALUATE THE PREVENTION OF EVENTS WITH ANGIOTENSIN CONVERTING ENZYME INHIBITOR THERAPY NIH GUIDE, Volume 23, Number 37, October 21, 1994 RFP AVAILABLE: NHLBI-HC-94-31 P.T. 34; K.W. 0715040, 0760013, 0760035, 0755015 National Heart, Lung, and Blood Institute The National Heart, Lung, and Blood Institute (NHLBI) is soliciting proposals for a clinical trial center to determine whether or not the addition of an angiotensin converting enzyme (ACE) inhibitor to standard therapy in patients with known coronary artery disease and preserved left ventricular function will prevent cardiovascular mortality and reduce the risk of experiencing a myocardial infarction. Other secondary endpoints will also be studied. A minimum of 14,000 patients will be enrolled. The anticipated period of performance is eight years beginning on or about August 1, 1995. The Request for Proposal (RFP) NHLBI-HC-94-31 will be released on or about October 17, 1994 with proposals due on December 5, 1994. One award is anticipated from this RFP. INQUIRIES Requests must be in writing, cite RFP NHLBI-HC-94-31, and be addressed to: Ms. Peggy Mills ECA Contract Section National Heat, Lung, and Blood Institute Federal Building, Room 200 7550 Wisconsin Avenue Bethesda, MD 20892 $$R3 END ************************************************************ $$R4 BEGIN GM-95-001 FULL-TEXT **********************************