From owner-sci-resources@net.bio.net Fri Aug 04 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-95-082 - V24(28) 08/04/95 Date: 4 Aug 1995 17:59:01 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 577 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3vufol$doi@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PAR95082 PAR-95-082 P1O1 ************************************* DEVELOPING AND IMPROVING INSTITUTIONAL ANIMAL RESOURCES NIH GUIDE, Volume 24, Number 28, August 4, 1995 PA NUMBER: PAR-95-082 P.T. 34; K.W. 1002002, 0710030, 0404000 National Center for Research Resources Application Receipt Dates: October 1, June 1 PURPOSE The National Center for Research Resources (NCRR) encourages the submission of individual animal resource improvement grant applications from biomedical research institutions. The major objective of this program is to upgrade animal facilities to support the conduct of PHS-supported biomedical and behavioral research. A related objective is to assist institutions in complying with the USDA Animal Welfare Act and DHHS policies related to the care and use of laboratory animals. Support is limited to alterations and renovations (A&R) to improve laboratory animal facilities, and the purchase of major equipment items for animal resources, diagnostic laboratories, transgenic animal resources, or similar associated activities. ELIGIBILITY REQUIREMENTS Any domestic public or private institution, organization, or association is eligible to apply for this grant if the institution has one or more research projects currently supported by the Public Health Service (PHS) that involve the use of laboratory animals. Institutions and commercial firms providing only services or products and without a clearly defined animal related research component are not eligible to apply. Also, this program will not support requests for equipment used for teaching purposes and for housing non-research animals. Applications from other Federal agencies or institutions (e.g., Department of Veterans Affairs) are limited to requests for equipment only. Applicants may not submit more than one application or apply for other NCRR support for developing and improving institutional animal resources in the same Federal fiscal year. For purposes of these guidelines, an "institution" is defined as the organizational component identified on page 1, item 11 of the PHS 398 (rev. 5/95), for which descriptive information is provided on pages 9-10 in the grant application form PHS 398 kit. Separate applications may be submitted from different colleges or schools on the same campus of a university within the same Federal fiscal year if they have different organizational component codes. If this is done, documentation from an appropriate institutional official, stating that the applications are part of a coordinated, campus-wide plan to improve the animal facilities, must be provided. The applicant institution is strongly encouraged to develop a single application for a campus-wide program with a single, centralized animal care program whenever possible or feasible. MECHANISM OF SUPPORT The mechanism available for the support of these improvement projects is the Grant for Repair, Renovation, and Modernization of Existing Research Facilities (G20). The total budget request for the improvement grant application and award is limited to $700,000 (direct costs), of which not more than $500,000 may be used for alterations and renovations (A&R) and not more than $200,000 may be used for moveable equipment. Matching funds from non-Federal sources are required, equal to or exceeding one-half of the total allowable costs (equipment and A&R) of the requested project ($1 Federal to $1 non-Federal). These matching funds must be applied to the specific project described in the application and cannot be met by citing other expenditures. Because the nature and scope of the projects proposed in response to this PA may vary, it is anticipated that the size of an award will vary also. Allowable Costs Items that may be requested under this grant mechanism include: o A&R to improve existing laboratory animal facilities, and allowable fees associated with the A&R project o Major resource equipment related to the improvement project, such as animal cage systems and cage washers o Equipment items, or an aggregate of identical equipment items, that have a total cost of at least $1,000. Items that are part of a system and require the purchase of small component parts (e.g., a rack and cages or microisolator units) may be requested and priced as a single item. A description of the individual components of such systems must be provided. o General purpose equipment items for centralized surgeries, diagnostic laboratories, transgenic animal facilities, and other similar associated activities when an integral part of the animal facility and available to all investigators o Basic equipment such as microscopes necessary for operation of the facility o Environmental monitoring systems. However, if such a system has multiple uses (e.g., the monitoring of research data or security), only those costs related to monitoring or providing for animal care (e.g., environmental monitoring) are allowable. Improvement grants are not intended to provide support for: o General operational support for the resource (e.g., funding for personnel, consumable supplies for routine animal care, or small equipment items) o Specialized research equipment or facilities for use by only a few investigators o New construction, including the completion of shell space o Equipment intended for teaching or non-research purposes o Office and research equipment, computers or data processing items o Physical security systems RESEARCH OBJECTIVES Animal resource improvement grants are awarded to assist biomedical research institutions in upgrading animal facilities and developing administratively centralized and uniformly effective programs of research animal care in support of PHS-funded research. Another major objective is to assist institutions in complying, and maintaining compliance, with provisions of the USDA Animal Welfare Act and DHHS policies related to the care and use of laboratory animals. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 5/95). Application forms may be obtained from the institution's office of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3034, MSC 7762, Bethesda, MD 20892-7762, telephone (301) 435-0714. There are two receipt dates per year of October 1 and June 1. Prospective applicants are encouraged to review the PHS Grants Policy Statement (rev. 4/94) sections dealing with alterations and renovations and equipment prior to completing the PHS 398 form. Applications must follow the instructions provided in the form PHS 398 kit, except for the following: Form Page 1: Item 2 - Check the box marked "YES" and type in the number and title of this program announcement. Item 5 - Check the box marked "No" at Item 5a. Item 5b - Not applicable. Form Page 2: Personnel - Only key personnel should be listed here even though salary support may not be requested. This must include the chief or consulting veterinarian. Form Page 4: Detailed Budget for Initial Budget Period Personnel Category - List only key individuals, and complete columns 1-4; salary support should not be requested. The total cost of the equipment and A&R needed should be entered in the rectangular space under the appropriate headings on the left. Equipment should be classified as movable or fixed, using the institution's own classification guidelines. Fixed equipment is considered as part of the A&R request. The right hand column should reflect only the PHS request. The Total Direct Costs (bottom right hand column total) should be the total request to the PHS. The total request for PHS support may not exceed $700,000. Of this total, the A&R request may not exceed $500,000, and the moveable equipment request may not exceed $200,000. Form Page 5 - Budget for Entire Proposed Project Period - Not applicable (do not complete this section). A cost estimate should be provided, and placed after Form Page 4. This estimate should detail: 1. For moveable equipment, the dollar request from NIH, amount to be funded from other sources, and total cost. 2. For eligible A&R costs, the dollar request from NIH, amount to be funded from other sources, and total cost. 3. For total project cost, the dollar request from NIH, amount to be funded from other sources, and total cost. For funding from other sources, indicate the source(s). For alterations and renovations requests, list separately the projected costs of: (a) Demolition; (b) General; (c) Plumbing; (d) HVAC; (e) Electrical; (f) Architect/Engineer Fee; (g) Other Costs (Specify); and (h) Fixed Equipment, with the total eligible A&R costs listed. If multiple sites are involved, the A&R and cost estimates should be described separately for each site. List the total net square feet of floor space to be renovated and the estimated cost per net sq. ft., excluding fixed equipment. Additional Form Pages Biographical Sketch Page - Provide a biographical sketch for all key personnel, strictly adhering to the two-page limitation for each. Other Support Page - Provide the information requested for all key personnel. Specific Instructions - Research Plan The following instructions should be used in lieu of the PHS 398 instructions for this section of the application; however, revised applications must include an introduction addressing criticisms and must highlight changes in the application as described in the instructions for PHS 398. The Research Plan section of the application (Items a-d) must strictly adhere to a limit of 25 pages. The outline suggested below should be followed in describing the program. All information critical to the review must be in the Research Plan, not in an appendix. 1. Specific Aims - Clearly present the aims of the animal resource improvement project and relate them to the short- and long-term goals of the institution's animal resource program, and the research needs of the institution. 2. Background and Significance - This section should address the overall animal care and use program and the need for improvements to meet current and future laboratory animal needs for biomedical research. Background Provide an overall description of the institution's animal care and use program. Provide relevant background information and describe the current status of the institution's animal resource facilities and program as they relate to biomedical research and research training. Describe the institution's overall involvement in animal-related research. This section should include a description of the following aspects of the animal resource: a. Administrative arrangements and structure of the animal resource. The lines of authority and responsibility for administering the institution's animal care and use program should be clearly presented. The role and composition of the IACUC and how compliance with relevant laws, policies, and guidelines is achieved should be included. b. Animal care procedures and the animal health program. This section should describe housing, caging, feeding, record keeping, sanitation, and other animal care practices; animal health program which includes clinical services, laboratory support, preventive medicine programs, and any relevant specialized procedures; veterinary oversight; vendor surveillance; conditioning programs; colony and environmental monitoring; and diagnostic capabilities in anatomic pathology, clinical chemistry, hematology, and microbiology. Data should be provided to characterize the extent of these activities, such as numbers of laboratory procedures for monitoring animal health, veterinary inspections for animal health, etc. If specialized equipment items are requested, the husbandry program to utilize this equipment should be outlined. c. Staffing. Outline the total staff and organization of the animal resource, both currently in place and as planned following the requested improvements. Briefly describe the qualifications of the animal care staff and the training opportunities available to them. d. Animal Program Data. Indicate the number of animals (by species) used or produced per year and the average daily census (by species) for each facility. Provide a brief description of all on-campus and off-campus animal facilities, including sites where experimental surgery is performed. Indicate who manages each facility. Indicate whether the institution is accredited by the American Association for Accreditation of Laboratory Animal Care (AAALAC). If equipment is requested for surgical or diagnostic facilities, the case load, species, types and numbers of surgeries or diagnostic tests must be documented. e. Animal Program Funding. Provide, for the most recently completed Federal fiscal year information on: (1) Investigators currently using the facility, including types of animals involved and level of usage; (2) the institution's total number and total direct costs of research projects using laboratory animals, indicating separately the number and costs of those funded from PHS and non-PHS sources; (3) for facilities for which improvement support is requested, list by facility name the number of research projects and total direct costs of the projects relevant to each. List all current financial support for the animal resource, including sources and amounts (e.g., recharge, core funding from the institution, etc.) and the annual operating budget (listed by major categories). Provide a copy of per diem and service charge schedules and indicate their method of determination (this information may be included in an Appendix). f. Previous and Future Improvements. Expenditures for capital improvements (facilities and equipment) during the past five years and future plans for meeting such needs should be described. Any previous support for improvement of the institution's animal facilities from the CMP, NCRR, NIH should be noted. The use of this support and its impact on the animal care program should be briefly described. g. Program Needs. List deficiencies in the animal care program that have been cited by the AAALAC, the Institutional Animal Care and Use Committee (IACUC) facility review reports, and the institution's PHS Animal Welfare Assurance Statement. Any problems in meeting the provisions of the Animal Welfare Act should also be addressed. Significance Describe the significance of the proposed resource improvement project to the institution's overall biomedical research programs, as well as to specific research projects that will be affected. If appropriate, the application should demonstrate both the need for the requested items and a sound plan for obtaining or maintaining the entire animal resource at required standards. 3. Progress Report/Preliminary Studies - Not applicable. 4. Research Design and Methods Clearly show how the proposed improvements will expand, improve or maintain existing research and research support activities. Brief descriptions of major research projects using the resource should be provided including source and amount of funding and level of animal usage. Future scientific needs to be addressed as part of the improvement should also be described. It is important to describe how the requested improvements will correct the deficiencies and problems described in the Background section. Demonstrate how the proposed facility improvement program fits into the institution's overall plan to meet or maintain PHS standards for animal care and use. If the project is part of an overall (larger) facility improvement plan, the application should describe the larger plan and how the project fits into that plan. Describe and provide detailed justifications for the requested equipment items. The manufacturer, model number, size, capacity, or design criteria, total unit cost and facility where it will be used should be included. Requests for surgical equipment must be justified by listing the number of investigators and PHS grant support received (can be provided in tabular form), the case load, and the types of surgical procedures performed. Failure to adequately justify each requested item will likely result in its deletion from the recommended budget. For any proposed A&R, a narrative summary (as outlined below), line drawings, and cost estimates must be provided. The following sample format is suggested: Narrative Summary (1) Relate the proposed renovations to projected animal populations (by species) and research projects that will use the facility; (2) list the functional components, including the size (dimensions) and square footage of each component (room, alcove, cubicle, etc.) that will be directly affected by the renovation project; (3) list engineering criteria applicable to each component (mechanical, electrical, and utilities). Include information such as the number of air changes per hour, electrical power, light levels, hot and cold water, steam, etc.; (4) list appropriate architectural criteria, such as width of corridors and doors, surface finishes, etc.; (5) list all fixed equipment items requested for the renovated area; and (6) list all movable equipment items requested for the renovated area. Line Drawings (1) Submit line drawings on 8-1/2" x 11" paper only. (DO NOT SUBMIT BLUEPRINTS.) These drawings will not be counted against the 25 page limit. All floor plans must be legible, with the scale clearly indicated. (2) The line drawings of the proposed renovation must be at a scale adequate to explain the project. The drawings should indicate size (dimensions), function, and net and gross square feet of space for each room. The total net and gross square feet of space to be renovated should also be given. (3) The plan should indicate the location of the proposed renovation area in the building. (4) Include the as-built drawings of the proposed renovation area and indicate any areas which will be demolished. (5) Changes or additions to existing mechanical and electrical systems should be clearly described in notes made directly on the plan or attached to the plan. (6) Indicate the type(s) of new finishes to be applied to room surfaces. Cost Estimates Detailed cost estimates must be included. Assurance to Provide Matching Funds A letter of assurance to provide matching funds and the projected source of those funds, signed by the responsible institutional official, must be provided by the applicant prior to the time an award is made. If such a letter is not included with the application, the applicant must include a letter of intent, also signed by the appropriate institutional official, to provide the necessary matching funds. The letter of assurance or the letter of intent should be placed as the final page of the application. The completed original application (signed original including appendices, if any) and three exact photocopies of the signed application and appendices must be submitted to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application (with appendices, if any) must be sent under separate cover to: Dr. Jill L. Carrington Office of Review National Center for Research Resources One Rockledge Centre, Room 6018 6705 Rockledge Drive MSC 7965 Bethesda, MD 20892-7965* email: jillc@ep.ncrr.nih.gov REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Division of Research Grants and responsiveness by NCRR. Those applications judged to be unresponsive, incomplete, or ineligible will be returned to the applicant. Applications that are complete and responsive will be reviewed for scientific and technical merit by the Scientific and Technical Review Board on Biomedical and Behavioral Research Facilities established for this purpose by the NCRR. The second level of review will be conducted by the National Advisory Research Resources Council. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Factors considered in the appraisal of an animal resource improvement project include: A. The Improvement Request 1. Research to be supported - The overall scope of the ongoing PHS-supported biomedical and behavioral research involving laboratory animals which will be affected by the proposed improvements will be considered. In addition, the resulting expanded or proposed future biomedical and behavioral research activities will be considered. 2. Need - The application should show how the grant support will meet current and future laboratory animal research needs, particularly for smaller or developing institutions, and how this will help the institution meet or maintain standards of the Animal Welfare Act and PHS policies concerning the care and use of laboratory animals. 3. Design Considerations - The proposed project will be judged for technical soundness, appropriateness and suitability of the proposed renovation project for addressing current and future needs of the institution. 4. Budget - the budget will be evaluated in relationship to the application's responsiveness to these guidelines, justification provided for each of the requested items, cost effectiveness, and the institution's perceived commitment to the animal care program. B. The Animal Care Program The scope of the animal care and use program to be enhanced by this facility improvement request should be carefully defined. For the purpose of this application, the animal care program should cover the entire applicant institution. 1. Animal Care - The quality of the animal husbandry program at the applicant institution will be assessed. The extent to which the project will enhance the welfare of animals maintained in the facility will be evaluated, including advances in the humane treatment of the animals due to husbandry changes allowed by the improvements. 2. Personnel - The technical and professional staff will be evaluated. The institution should have a sufficient number of professional staff with appropriate qualifications and experience to operate the animal resource in a competent manner. The facility should also have qualified non-professional staff and supporting services. 3. Administrative Arrangements - An evaluation will be made of the administrative arrangements for routine management of the animal resource. The institutional plan to assure a comprehensive and acceptable animal care and use program will be evaluated. The institution should have a record of commitment and a sound plan for financial support of the resource, through a recharge system, per diem charges, institutional support, etc. 4. Resources and environment - The suitability of the institutional setting for achieving the goals of the program will be considered. This will include an appraisal of the academic environment and the support for the animal resource by the administration and faculty. AWARD CRITERIA Applications will compete with all others in the G20 category for available funds. An institution must have current PHS funding for research involving laboratory animals to be eligible for an award. The following will also be considered when making funding decisions: o Merit of the proposed project as determined by peer review o Institutional assurance of non-federal matching funds o Availability of funds o Needs of the institution Evidence of continued PHS research funding will be verified prior to award. Award Conditions Following the actual award, funds for A&R will not be released until final architectural drawings, specifications, and updated cost estimates are approved by NCRR. No requests to initiate alterations or renovations will be entertained prior to receipt of the grant award from NIH and subsequent approval of working drawings and specifications by NIH staff. Renovations and equipment purchases must be initiated no later than twelve months after the start date of award. Awards will be made for one year and are not renewable. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Charles L. Coulter, Ph.D. Research Facilities Improvement Program National Center for Research Resources One Rockledge Centre, Room 6030 6705 Rockledge Drive MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0766 FAX: (301) 480-3770 Email: charlesc@ep.ncrr.nih.gov Questions regarding fiscal matters may be directed to: Mr. Paul Karadbil Office of Grants and Contracts Management National Center for Research Resources One Rockledge Centre, Room 6086 6705 Rockledge Drive MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0844 Email: paulk@ep.ncrr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.306, Laboratory Animal Sciences and Primate Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78.410, as amended; 42 USC 241) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Fri Aug 04 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-95-081 - V24(28) 08/04/95 Date: 4 Aug 1995 17:58:58 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 348 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3vufoi$doa@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PAR95081 PAR-95-081 P1O1 ************************************* CLINICAL RESEARCH SCHOLAR SUPPLEMENTS TO M01 GRANTS NIH GUIDE, Volume 24, Number 28, August 4, 1995 PA NUMBER: PAR-95-081 P.T. 04; K.W. 0785035, 1014006 National Center for Research Resources PURPOSE The National Center for Research Resources (NCRR) announces the Clinical Research Scholar (CRS) Program, a junior career development program, for physicians and dentists who have the interest and aptitude for careers in patient-oriented clinical research, but who have had limited formal clinical research training or career development. The CRS Program is intended to support the candidate for one year of course work and research activities to enhance the career development of the individual. The candidate should work closely with an appropriate mentor who is a clinical investigator supported by peer-reviewed grant(s). The mentor must work with the candidate in selecting appropriate course work to complement laboratory and patient-oriented clinical research. Applications to the CRS Program are to be submitted as competitive supplements to existing General Clinical Research Center (GCRC) grants (NIH Activity Code: M01). HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Clinical Research Scholar Supplements to M01 Grants, is related to all priority areas. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Only institutions with an existing GCRC grant funded by the NIH may submit applications for CRS supplemental awards. The candidate for the CRS supplemental award must have earned the M.D. or D.D.S. degree or equivalent and completed at least two years of residency training at the time of the award. The candidate must be a U.S. citizen or hold a permanent immigration visa. The candidate may not hold independent peer-reviewed grant support prior to or concurrently with funding of the CRS application. MECHANISM OF SUPPORT The CRS Program is to be supported by competitive supplements to GCRC grants (NIH Activity Code: M01). The one-year CRS award will provide salary support up to $42,500 and associated fringe benefits. The salary request must be commensurate with institutional salary policies for individuals with comparable experience. Funds for supplies, domestic travel to scientific meetings and other expenses may be requested up to a maximum total of $5,000 for the year. Applicable indirect costs will be provided. It is anticipated that approximately five to six CRS awards will be made annually. RESEARCH OBJECTIVES Background: In order to translate effectively unprecedented scientific discoveries into diagnostic and therapeutic tools benefiting patients of all ages, to further the development of medical sciences and to develop future leaders in patient-oriented clinical research, scientists with unusual interdisciplinary skills including those for molecular biology, biological chemistry, experimental design, and ethics are needed. The National Academy of Sciences and the Advisory Committee to the Director of the NIH have identified and stressed the urgent need to select and develop promising junior clinical scientists to become well-versed in the basic principles of patient-oriented research through a combination of courses and laboratory and clinical research. This new program offers support to address that need through work individualized to meet the career goals of the candidate. Program Description: The CRS Program requires at least 90 percent of time and effort for one year for participation in curriculum and related clinical research activities designed to enhance the patient-oriented clinical research skills of the participant. The courses should be relevant to diverse areas of patient-oriented clinical research and could include an array of topics, such as biostatistics, design of clinical trials, computer skills and bioethics. Courses relevant to more specific areas of clinical research of particular interest to the candidate may also be included. The Program must also include a supervised patient-oriented clinical research experience for the candidate. The application must detail how participation in the CRS Program will be integrated longitudinally into a more comprehensive program of activities intended to prepare the candidate for a career as an independent patient-oriented clinical investigator. A CRS candidate must be nominated by the GCRC Advisory Committee at the applicant institution on the basis of qualifications, interests, accomplishments, motivation, and potential for performing quality patient-oriented clinical research. Three sealed letters of reference for the CRS candidate must accompany the application. A mentor must be identified who will guide the career development of the candidate and provide the necessary resources for a research experience. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). The single annual receipt date for the CRS supplemental applications is October 1. The earliest start date of the award will be the following July 1. There is no restriction on the number of applications that may be submitted from the applicant institution for each October 1 receipt date. However, there must be sufficient time remaining in the competitive segment of the parent GCRC grant to accommodate the one year of this supplemental activity. 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, 6701 Rockledge Drive, Room 3032 - MSC 7762, Bethesda, MD 20892-7762, telephone 301/435-0714. Applications must follow the instructions provided in the form PHS 398 kit except for the following: In Item 1 on the face page of the application, insert the name of the CRS candidate in the title, e.g., GCRC-CRS-Pat Brown, M.D. In Item 2, check the box marked "YES" and type the title and number of this program announcement. Under "Research Plan" Items a-d, substitute a narrative description of the following topics (not to exceed 15 pages): Candidate: o Include a signed statement from the CRS candidate describing his/her clinical research objectives and career goals. Mentor: o Provide a statement from the mentor detailing his/her role in oversight of the candidate's career development program. Information on the research qualifications of the mentor and previous experience as a research mentor must be provided. CRS Program: o Describe the process by which the CRS candidate was nominated by the institutional GCRC Advisory Committee. o Describe the proposed career development plan for the CRS candidate, taking into account his/her specific didactic and research needs and goals. The choice of courses for the CRS candidate must be specified with a brief description of their content and duration. Include a description of the plans for the CRS candidate upon completion of the year-long CRS Program. Research: o Provide a brief 4-5 page description of the patient-oriented clinical research project on which the CRS candidate will work, that includes: a. a summary of the project. b. a description of the research experience proposed for the CRS candidate. c. a description of how the research experience will promote the independent research capabilities of the CRS candidate. This research plan must be developed in consultation with the mentor. Attention must be paid to NIH policy on the inclusion of women and minorities as subjects in clinical research, as well as all six points listed under "Human Subjects" in the form PHS 398. Environment: o Describe the relevant resources of the sponsoring institution, including a description of any existing didactic multidisciplinary program or programs for the development of clinical investigators and resources for the conduct of clinical research. o Describe the record of the sponsoring institution in promoting the development of clinical researchers. Examples might include success in obtaining Clinical Associate Physician and/or Minority Clinical Associate Physician supplemental awards to M01 grants, relevant training grants, career development grants, or other programs to develop clinical researchers that are supported by the sponsoring institution, foundations or other sources. Provide, as part of the application, three sealed letters of recommendation addressing the CRS candidate's potential for a career as a clinical researcher. For applicants who are not U.S. citizens, the application must include evidence that the individual has been lawfully admitted as a permanent resident. The completed original application and three copies must be delivered to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Suite 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for courier/deliver service) At the time of submission, two additional copies must also be sent to: Clinical Research National Center for Research Resources National Institutes of Health 6705 Rockledge Drive, Room 6030 - MSC 7965 Bethesda, MD 20892-7965 REVIEW CONSIDERATIONS Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Office of Review, NCRR, in accordance with the standard NIH peer-review procedures. Following scientific-technical review, applications will receive a second-level review by the National Advisory Research Resources Council. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria o Qualifications and motivation of the CRS candidate to pursue a career in clinical research. o Qualifications of the mentor to oversee the career development plan of the candidate. o Quality and relevance of the proposed curriculum for enhancing the research skills of the CRS candidate. o Appropriateness of the proposed patient-oriented clinical research experience for enhancing the clinical research skills of the CRS candidate. o Appropriateness of the plans for the CRS candidate's career development upon completion of the CRS program. o Adequacy of existing resources of the sponsoring institution for the proposed didactic and clinical research experiences of the CRS candidate. o Record of the institution in promoting the development of clinical researchers. o Appropriateness of the budget for the proposed activities. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to NCRR. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Harriet L. Gordon, M.D. General Clinical Research Centers Program National Center for Research Resources One Rockledge Centre, Room 6030 6705 Rockledge Drive, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0790 Email: HarrietG@ep.ncrr.nih.gov Direct inquiries regarding fiscal matters to: Ms. Mary Niemiec Office of Grants and Contracts Management National Center for Research Resources One Rockledge Centre, Room 6086 6705 Rockledge Drive, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0844 Email: MaryN@ep.ncrr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.333. Awards are made under authorization of the Public Health Service Act, Title III, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Aug 04 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 28, pt. 1of1, 4 August 1995 Date: 4 Aug 1995 17:58:51 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 358 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3vufob$dnt@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950804 V24N28 P1O1 ************************************ X-comment: RFAs described: PAR-95-081, PAR-95-082 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/95.08.04 NIH GUIDE - Vol. 24, No. 28 - August 4, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N2 ********************************************************** REVISED PHS 2590 NONCOMPETING GRANT APPLICATION National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** CHANGES IN CAP AND MCAP SUPPLEMENTS TO M01 GRANTS National Center for Research Resources INDEX: RESEARCH RESOURCES NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX P1 ********************************************************** CLINICAL RESEARCH SCHOLAR SUPPLEMENTS TO M01 GRANTS (PAR-95-081) National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX P2 ********************************************************** DEVELOPING AND IMPROVING INSTITUTIONAL ANIMAL RESOURCES (PAR-95-082) National Center for Research Resources INDEX: RESEARCH RESOURCES THIS PUBLICATION IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE USING A PERSONAL COMPUTER (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435- 0692 FOR DETAILS. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTING EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. THE DIVISION OF RESEARCH GRANTS (DRG) HAS MOVED TO A NEW LOCATION. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 24, Number 28, August 4, 1995 P.T. 34; K.W. 1014004, 1014006 Department of Health and Human Services Notice is hereby given that the Office of Research Integrity (ORI) has made final findings of scientific misconduct in the following case: Jose R. Sotolongo, Jr., M.D., Mount Sinai Medical Center: On July 3, 1995, ORI found that Jose R. Sotolongo, Jr., M.D., formerly of Mount Sinai Medical Center in New York, committed scientific misconduct by falsifying research involving guanabenz treatment of spinal cord injured cats presented in a Public Health Service (PHS) grant application. Dr. Sotolongo has entered into a Voluntary Exclusion Agreement with ORI in which he has accepted ORI's finding and has agreed to exclude himself voluntarily, for the three year period beginning July 3, 1995, from: (1) applying for or receiving any Federal grant or contract funds; and, (2) serving in any advisory capacity to the PHS, including but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant. The above voluntary exclusion, however, shall not apply to Dr. Sotolongo's future training or practice of clinical medicine as a licensed practitioner unless that practice involves research or research training. No scientific publications were required to be corrected as part of this Agreement. INQUIRIES For further information, contact: Director Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** REVISED PHS 2590 NONCOMPETING GRANT APPLICATION NIH GUIDE, Volume 24, Number 28, August 4, 1995 P.T. 34; K.W. 1014006 National Institutes of Health The revised Public Health Service noncompeting grant application, PHS 2590, will be available in August. This revision, dated 5/95, supersedes all previous editions and contains additional information pertinent to research career awards and institutional training grants. The revised PHS 2590 application packet contains a booklet with instructions for preparing and submitting an application and sample forms. The instructional booklet should be retained for future preparation of applications. The form pages have been printed as a separate booklet. INQUIRIES To request two or more copies contact: Administrative Services Office Division of Research Grants National Institutes of Health 6701 Rockledge Drive MSC 7760 Bethesda, MD 20892-7760 Email: AMRG@DRGPO.DRG.NIH.GOV To request a one copy contact: Grants Information Office Division of Research Grants National Institutes of Health 6701 Rockledge Drive MSC 7762 Bethesda, MD 20892-7762 Email: GIRG@DRGPO.DRG.NIH.GOV To assist delivery, please include a complete mailing address, the number of copies requested, and an electronic mail address or telephone number. $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** CHANGES IN CAP AND MCAP SUPPLEMENTS TO M01 GRANTS NIH GUIDE, Volume 24, Number 28, August 4, 1995 P.T. 04; K.W. 0785035, 1014006 National Center for Research Resources The National Center for Research Resources (NCRR) announces changes effective immediately for the Clinical Associate Physician (CAP) and the Minority Clinical Associate Physician (MCAP) Supplements to General Clinical Research Center (GCRC) Grants (activity code: M01). These two competitive supplements were previously announced in the NIH Guide for Grants and Contracts, Vol. 19, No. 31, August 24, 1990, as PA-90-30 for CAP supplements and PA-90-29 for MCAP supplements. The changes for these awards are as follows: o Applications (both new and revised) for these two supplemental awards will be received on a single annual receipt date - October 1. o Awards will made effective the following July 1. o There will be no limitation on the number of CAP or MCAP applications that can be submitted from each funded GCRC. o There will be no limitation on the number of CAP or MCAP awards that may be concurrently funded at each GCRC. o Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. A table contrasting the old and new policies for CAP and MCAP supplements to M01 grants is presented below: Old Policy New Policy Annual Receipt Dates Feb 1, Oct 1, Jun 1 Oct 1 Annual Start Date(s) for Funding Dec 1, Jul 1, Apr 1 Jul 1 Number of Applications 1 CAP and 1 MCAP Unlimited Allowed Per Review Cycle for Each GCRC Number of Applications 3 CAPs and 3 MCAPs Unlimited That May Be Concurrently Funded at Each GCRC Review Process Triage Not Employed Triage INQUIRIES For further information, contact: Harriet Gordon, M.D. General Clinical Research Centers Program National Center for Research Resources One Rockledge Centre, Room 6030 6705 Rockledge Drive, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0790 FAX: (301) 480-3660 Email: HarrietG@ep.ncrr.nih.gov $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$P1 BEGIN PAR-95-081 FULL-TEXT ************************************* CLINICAL RESEARCH SCHOLAR SUPPLEMENTS TO M01 GRANTS NIH GUIDE, Volume 24, Number 28, August 4, 1995 PA AVAILABLE: PAR-95-081 P.T. 04; K.W. 0785035, 1014006 National Center for Research Resources PURPOSE The National Center for Research Resources (NCRR) announces the Clinical Research Scholar (CRS) Program, a junior career development program for physicians and dentists who have the interest and aptitude for careers in patient-oriented clinical research, but who have had limited formal clinical research training or career development. The CRS Program is intended to support the candidate for one year of course work and research activities to enhance the career development of the individual. The candidate should work closely with an appropriate mentor who is a clinical investigator supported by peer-reviewed grant(s). The mentor must work with the candidate in selecting appropriate course work to complement laboratory and patient-oriented clinical research. Applications to the CRS Program are to be submitted as competitive supplements to existing General Clinical Research Center (GCRC) grants (NIH Activity Code: M01). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Harriet L. Gordon, M.D. General Clinical Research Centers Program National Center for Research Resources 6705 Rockledge Drive, Room 6030, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0790 Email: HarrietG@ep.ncrr.nih.gov $$P1 END ************************************************************ $$P2 BEGIN PAR-95-082 FULL-TEXT ************************************* DEVELOPING AND IMPROVING INSTITUTIONAL ANIMAL RESOURCES NIH GUIDE, Volume 24, Number 28, August 4, 1995 PA AVAILABLE: PAR-95-082 P.T. 34; K.W. 1002002, 0710030, 0404000 National Center for Research Resources Application Receipt Dates: October 1, June 1 PURPOSE The National Center for Research Resources (NCRR) encourages the submission of individual animal resource improvement grant applications from biomedical research institutions. The major objective of this program is to upgrade animal facilities to support the PHS-supported biomedical and behavioral research. A related objective is to assist institutions in complying with the USDA Animal Welfare Act and DHHS policies related to the care and use of laboratory animals. Support is limited to alterations and renovations (A&R) to improve laboratory animal facilities, and the purchase of major equipment items for animal resources, diagnostic laboratories, transgenic animal resources, or similar associated activities. The mechanism available for the support of these improvement projects is the Grant for Repair, Renovation, and Modernization of Existing Research Facilities (G20). The total budget request for the improvement grant application and award is limited to $700,000 (direct costs), of which not more than $500,000 may be used for A&R and not more than $200,000 may be used for moveable equipment. Matching funds from non-Federal sources are required, equal to or exceeding one-half of the total allowable costs (equipment and A&R) of the requested project ($1 Federal to $1 non-Federal). These matching funds must be applied to the specific project described in the application and cannot be met by citing other expenditures. 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 by mail and email from the program contact listed below. Charles L. Coulter, Ph.D. Research Facilities Improvement Program National Center for Research Resources 6705 Rockledge Drive, Room 6030 MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0766 FAX: (301) 480-3770 Email: charlesc@ep.ncrr.nih.gov $$P2 END ************************************************************ From owner-sci-resources@net.bio.net Sun Aug 06 23:00:00 1995 Path: biosci!biosci!not-for-mail From: kathy@faseb.org (Kathy King) Newsgroups: bionet.announce,bionet.sci-resources Subject: ASCB 1996 Teacher Research Fellowships Date: 7 Aug 1995 14:23:47 -0700 Organization: FASEB Lines: 45 Sender: biohelp@net.bio.net Approved: bionews-moderator@net.bio.net Distribution: world Message-ID: <405504$68u@ns1.faseb.org> NNTP-Posting-Host: net.bio.net Xref: biosci bionet.announce:2365 bionet.sci-resources:1441 The American Society for Cell Biology Summer Teacher Research Fellowship Competition for Summer 1996 The program provides an opportunity for middle, junior high, or high school teachers to participate in basic biological research in the laboratory of an American Society for Cell Biology (ASCB) member. Duration: 8 weeks Stipend: $4000, plus $600 to attend the ASCB Teacher Fellows meeting at the National Association of Biology Teachers Annual Meeting Funding Sources: The American Society for Cell Biology and the RGK Foundation of Austin, Texas The ASCB offers these awards to introduce science teachers to contemporary questions in science and to a related research experience that together provide the science educator with a fresh perspective of biomedical research. The program exposes science educators to new information and techniques in biomedical research, which they are encouraged to disseminate to students and colleagues. Development of new laboratory teaching exercises is a required component of the program. Qualifications: Junior high school, middle school, or senior high school science teachers from any public or private school in the U.S.; female teachers, minority teachers, and teachers in schools with a high minority enrollment are especially encouraged to apply. Deadline for receipt of applications for the summer 1996 program is January 19, 1995 Awards will be announced in March, 1996. For an application packet and a list of potential mentors in your area or instructions on accessing the Summer Teacher Research Fellowship application form via internet (ftp, gopher, and WWW), contact Dorothy Doyle at the American Society for Cell Biology, 9650 Rockville Pike, Bethesda, MD 20814; tel: 301-530-7153; From owner-sci-resources@net.bio.net Sun Aug 06 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 6 August 1995 Date: 7 Aug 1995 15:02:52 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 102 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <4062ic$hhh@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Dir of Awards Title: NS 95-110a MIPS Division Fiscal Year 1994 Summary of Awards File size (bytes): STIS Filename: ns95110a.txt Also available: ns95110a.wp5 Title: NSF 95-110 MIPS Division Fiscal Year 1994 Summary of Awards File size (bytes): STIS Filename: nsf95110.txt Also available: nsf95110.wp5 Document Type: News Title: TIP50728 - Media Tipsheet July 28, 1995 File size (bytes): STIS Filename: tip50728.txt Document Type: Program Guideline Title: NSF 95-113 NSF Visiting Professorships for Women File size (bytes): STIS Filename: nsf95113.txt Also available: nsf95113.zip Title: NSF95-118 - Faculty Early Career Development (CAREER) Program File size (bytes): STIS Filename: nsf95118.txt Document Type: Recruit Title: Civilian Pay Technician (Office Automation) File size (bytes): STIS Filename: vgs95112.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 110165 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 110560 STIS Filename: phnorg.txt Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 53470 STIS Filename: sesvac.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve sesvac.txt, the text of your message should be as follows: get sesvac.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve sesvac.txt, you would enter: ftp> get sesvac.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Tue Aug 08 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: No NIH Guides 9/8 & 915 Date: 8 Aug 1995 17:04:06 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 4 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <408u1m$pok@net.bio.net> NNTP-Posting-Host: net.bio.net $$MAIL BEGIN ********************************************************** The NIH Guide for Grants and Contracts will not be published on September 8 and September 15, 1995. $$MAIL END************************************************************** From owner-sci-resources@net.bio.net Fri Aug 11 23:00:00 1995 Path: biosci!biosci!not-for-mail From: kcowing@aibs.org (Keith L. Cowing) Newsgroups: bionet.sci-resources Subject: CALL FOR PROPOSALS: Head and Spinal Cord Injury. $15 million available from U.S. Army Medical Research and Materiel Command Date: 11 Aug 1995 17:35:31 -0700 Organization: American Institute of Biological Sciences Lines: 34 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <40gt0j$jl8@net.bio.net> NNTP-Posting-Host: net.bio.net CALL FOR PROPOSALS Head and Spinal Cord Injury U.S. Army Medical Research and Materiel Command (USAMRMC). The FY 95 Appropriations Conference Report provided $15 million for support of Head and Spinal Cord injury research. In accordance with Federal Acquisition Regulations (FAR) and the law, research dollars awarded under this program must be contracted for use under the conditions of the FAR and consistent with the Broad Agency Announcement (BAA 95-1) of the USAMRMC. Full proposals must be received by 15 September 1995 (see BAA). Great emphasis will be placed on research proposals addressing aspects of life-saving, early, pre-hospital care, consistent with far-forward treatment of combat casualties. These proposals will be peer-reviewed, and funding decisions will be based on that peer review. Timing for final award of funds will be dependent upon the contracting process. The points of contact for information will be the USAMRMC Combat Casualty Care Research Program (COL William Wiesmann or MAJ Stephen Brutting; 301-619-7591), and the U.S. Army Medical Research Acquisition Activity (301-619-7431). NOTE: Due to the time-sensitive nature of this announcement, please forward this notice to appropriate individuals within your organization as quickly as possible. -- Keith L. Cowing - Manager of Planning and Operations American Institute of Biological Sciences 10700 Parkridge Blvd Suite 380 - Reston, VA, USA 22091 703-758-1212 voice - 703-758-1222 fax kcowing@aibs.org - gopher://aibs.org From owner-sci-resources@net.bio.net Fri Aug 11 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 29, pt. 1of1, 11 August 1995 Date: 11 Aug 1995 18:23:26 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 703 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <40gvqe$n8f@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950811 V24N29 P1O1 ************************************ X-comment: RFAs described: DA-96-001, AI-95-014 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/95.08.11 NIH GUIDE - Vol. 24, No. 29 - August 11, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N2 ********************************************************** BEHAVIORAL THERAPIES DEVELOPMENT PROGRAM (PA-94-078) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX N3 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION $$INDEX N4 ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** PLANT COLLECTION AND TAXONOMY (RFP NCI-CM-67244-30) National Cancer Institute INDEX: CANCER $$INDEX R2 11/14/95 ************************************************* BROADENING BASIC BEHAVIORAL SCIENCE RESEARCH IN DRUG ABUSE (RFA DA-96-001) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX R3 12/21/95 ************************************************* NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS FOR THE TREATMENT OF OPPORTUNISTIC INFECTIONS IN AIDS (RFA AI-95-014) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES THIS PUBLICATION IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE USING A PERSONAL COMPUTER (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435- 0692 FOR DETAILS. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. THE DIVISION OF RESEARCH GRANTS (DRG) HAS MOVED TO A NEW LOCATION. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 24, Number 29, August 11, 1995 P.T. 34; K.W. 1014004, 1014006 Department of Health and Human Services Notice is hereby given that the Office of Research Integrity (ORI) has made final findings of scientific misconduct in the following case: John J. Tomasula, Mount Sinai Medical Center: On June 29, 1995, ORI found that John J. Tomasula, formerly of the Mount Sinai Medical Center in New York, committed scientific misconduct by falsifying research involving guanabenz treatment of spinal cord injured cats reported in a Public Health Service (PHS) grant application. Additionally, ORI found that Mr. Tomasula had falsified his credentials on three PHS grant applications in which he claimed to have a Ph.D. degree from Northwestern University when, in fact, he had obtained a mail-order degree from Northwestern College of Allied Sciences in Oklahoma, an unaccredited, now-defunct "institution." Mr. Tomasula has entered into a Voluntary Exclusion Agreement with ORI in which he has accepted ORI's finding and has agreed to exclude himself voluntarily, for the three year period beginning June 29, 1995, from: (1) applying for or receiving any Federal grant or contract funds; and, (2) serving in any advisory capacity to the PHS, including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant. No scientific publications were required to be corrected as part of this Agreement. INQUIRIES For further information, contact: Director Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** BEHAVIORAL THERAPIES DEVELOPMENT PROGRAM NIH GUIDE, Volume 24, Number 29, August 11, 1995 PA NUMBER: PA-94-078 P.T. 34; K.W. 0404000, 0404009, 0404001, 0740020 National Institute on Drug Abuse PURPOSE This notice is an addendum to program announcement PA-94-078, which was published in the NIH Guide, Vol. 22, No. 26, July 15, 1994. The purpose of this addendum is to encourage research investigating the most advantageous integration of behavioral and pharmacotherapies to enhance the efficacy of both types of therapeutic interventions. Drug abuse and addiction are complex disorders with biological, cognitive, behavioral and psychosocial dimensions, and frequently co-occur with other mental disorders. While pharmacotherapy and behavioral therapy may both be useful for the treatment of the addictions, each may exert its effects through different mechanisms and influence different symptoms. It may also be that combination therapies are not simply complementary, but could be synergistic. Thus, integrated behavioral therapy-pharmacotherapy combinations may have better efficacy than either treatment alone. The National Institute on Drug Abuse (NIDA) is supporting the study of behavioral therapies (including, but not limited to, psychotherapy, behavior therapy, cognitive therapy, family therapy, skills training, and counseling approaches) that will potentially have a significant impact on reducing drug abuse and addiction and reducing AIDS risk behaviors. For those investigators applying for grants under the Behavioral Therapies Development Program, this notice is meant to supplement Program Announcement PA-94-078, which is still in effect and should be consulted in conjunction with this addendum. RESEARCH OBJECTIVES Behavioral therapies and pharmacotherapies (such as methadone, LAAM, buprenorphine, naltrexone, nicotine preparations, and clonidine) are available for the treatment of addiction to opioids and nicotine. Most treatment research has focused on either pharmacotherapy or behavioral therapy and few studies have explored the potential benefits of carefully specified combined therapies. The maintenance and detoxification of heroin addicts may be optimized by integration of behavioral therapies and pharmacotherapies such as opioid agonists, antagonists, or partial agonists. Differences in behavioral therapies may be required to address the unique needs of particular patient populations and/or the pharmacological differences of the medications. While no medications have as yet proven efficacious for the treatment of cocaine addiction, most studies have been conducted without or with minimal behavioral interventions. Integration of pharmacotherapies and behavioral therapies may enhance compliance with medication regimens, increase retention in treatment and help prevent relapse to drug abuse and addiction. Studies are sought on the integration of behavioral therapies and pharmacotherapies for the treatment of drug abuse and addiction in individuals who abuse and/or are addicted to drugs and in addicts with co-occurring mental and other illnesses, in order to determine when and how behavioral and pharmacological therapies can be integrated for optimal treatment outcome. Applicants are strongly encouraged to develop approaches for distinct drug abusing or addicted patient populations that are sensitive to cultural characteristics or unique needs of specific subgroups. Applications must be submitted on the grant application form PHS 398 (rev. 5/95 ) using the receipt dates in the form. INQUIRIES Direct inquiries regarding programmatic issues to: Dorynne Czechowicz, M.D. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-12 Rockville, MD 20857 Telephone: (301) 443-0107 $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 24, Number 29, August 11, 1995 P.T. 42; K.W. 0783005 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human subjects. The meetings should be of special interest to those persons currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all other Public Health Service agencies. The current schedule includes the following: DATES: September 18-19, 1995 TITLE: Contemporary Human Subject Issues in Academic Research LOCATION: The University of Mississippi, Oxford, MS SPONSORS: The University of Mississippi; Jackson State University REGISTRATION Mr. D. Russell Cooper OPRR Conference Registration c/o Center for Public Service and Continuing Studies The University of Mississippi P.O. Box 879 University, MS 38677 Telephone: (601) 232-7282 FAX: (601) 232-5138 REGISTRATION FEE: $95 ($115 after September 5) DESCRIPTION: The biomedical and behavioral research currently being conducted within academic institutions promises exciting advances in scientific knowledge, as well as unprecedented opportunities for the betterment of individual and societal life. Increasingly, however, these dramatic achievements and opportunities are accompanied by scientific, ethical, regulatory, and legal intricacies, and dilemmas. Within the academic community, understanding these rapidly changing complexities is central to the IRBs ability to protect the rights and welfare of human research subjects while supporting scientific endeavor and its potential benefits to humankind. This conference is designed to examine a broad range of contemporary scientific, ethical, regulatory, and legal issues relating to biomedical, social, behavioral, and anthropological research involving human subjects. Each of these issues will be discussed within the framework of the academic research environment, and presentations will focus on the unique challenges presented to IRBs, researchers, subjects, and administrators in academic institutions. Designed for both experienced and novice participants, the workshop will provide opportunities for greater depth and specificity on contemporary IRB issues. Along with sessions on examining common IRB issues - including liability, informed consent, and deception - the conference will feature special focus sessions on issues related to historical perspectives, issues in mental health, the establishment, structure, and management of IRBs, computerized management information systems for the IRB office, FDA regulations for clinical trials, guidelines on inclusion of minorities and women, research involving genetic/DNA testing, and research involving special populations, including American Indians children, and elderly research subjects. Sessions will feature issues particularly pertinent to historically black colleges and universities and institutions newer to the IRB process. Speakers will include representatives from OPRR and FDA, including Dr. Gary B. Ellis, Mr. Paul Goebel, Jr., and Dr. Gary Chadwick, and other Federal agencies such as the Congressional Office of Technology Assessment, the Office of Research on Women's Health at NIH, and the National Institute of Mental Health. Distinguished members of the academic and clinical research community will also include Dr. William L. Freeman of the Indian Health Service, Dr. Diane Brown from the University of California at Berkeley, Dr. Ernest D. Prentice of the University of Nebraska, and Dr. John Estrada of Meharry Medical College. The format will encourage audience participation and informal information exchanges, with ample question and answer opportunities throughout the program. DATES: November 13-14, 1995 TITLE: Symposium on International Research Concerns: Ethical Issues on the Protection of Human Subjects LOCATION: Marriott Hotel Inner Harbor, Baltimore, MD SPONSORS: Johns Hopkins University, Howard University REGISTRATION Ms. Donna M. Gebhardt, Program Coordinator Johns Hopkins University Office for Continuing Registration 720 Rutland Street Baltimore, MD 21205-2195 Telephone: (410) 955-6046 FAX: (410) 955-0807 REGISTRATION FEE: $175.00 PROGRAM INFORMATION Ms. Kate Prendergast (410) 955-2527 Ms. Joan Poling (410) 955-1608 Ms. Marian Secundy (202) 806-6300 DESCRIPTION: In this very contemporary conference, human subject protections in research will be explored by focusing on the cross cultural aspects from the national and international perspectives. While nations and their particular mores are recognized for their uniqueness, the theme of commonality will be stressed in relation to the ethical approach to the rights of individuals in research. Contributors from the international arena of research will present in-depth forums on topics such as Cross Cultural Issues on Informed Consent, The American Presence Abroad, Differences between Observational and Intervention Research and Research vs Care in the International Setting. All plenary sessions will be followed by individual panel discussions that will allow participants to further explore particular issues in grater detail. Speakers will include: Dr. John Bryant, former Dean of the School of Public Health at Columbia University, and one of the authors of the CIOMS International Research Ethics Guidelines; Dr. Helene Gayle, Acting Director of the National Center for HIV/STD/TB Prevention at CDC; Dr. Gary B.Ellis, Director, Office for Protection from Research Risks, Office of Extramural Research, National Institutes of Health (OPRR, OER, NIH); F. William Dommel, Jr., J.D., OPRR, OER, NIH; Dr. Melody H. Lin, OPRR, OER, NIH; Dr. Joan P. Porter, OPRR, OER, NIH; Dr. Clifford C. Scharke, OPRR, OER, NIH; Dr. Kamal K. Mittal, OPRR, OER, NIH; Ms. Diane L. Aiken, OPRR, OER, NIH; Dr. Susan L. Crandall, OPRR, OER, NIH; Dr. Charles McCarthy, a scholar at the Kennedy Institute for Bioethics in Washington, DC; Dr. Carl Taylor of International Health at JHU; Dr. Segum Gbadegesian, Department of Philosophy at Howard University College of Medicine; Mr. Ronnie Lupo, the Chief of the White River Apache Tribe; and Dr. Ray Reid, who has spent considerable time working the field of Indian Health Care and Research. This symposium will identify issues of concern regarding the protection of human subjects in research when the location and the culture and mores are different; discuss and clarify the status of regulations and institutional requirements in governing the conduct of research being sensitive to cross cultural and international issues; heighten the awareness of the participants to the diversity of populations; and establish a network of investigators, administrators, IRB chairs and members, Federal representatives sensitive and knowledgeable in this area. INQUIRIES For further information regarding these workshops or future NIH/FDA National Human Subject Protections Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, Suite 3B01 Rockville, MD 20892-7507 Telephone: (301) 496-8101 x233 FAX: (301) 402-0527 $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS NIH GUIDE, Volume 24, Number 29, August 11, 1995 P.T. 42; K.W. 0201011, 1014003 National Institutes of Health The National Institutes of Health, Office of Extramural Research (OER), Office for Protection from Research Risks (OPRR) is continuing to cosponsor workshops on implementing the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Each of the workshops scheduled for Fiscal Year 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 information discussions. DATES: September 14-15, 1995 TOPIC: Internal Audits of the Animal Care and Use Program LOCATION Radisson Riverfront Hotel Two Tenth Street Augusta, GA 30910 Telephone: (706) 721-3967 FAX: (706) 721-4642 SPONSORS: National Institutes of Health; Medical College of Georgia; Albany State College REGISTRATION Ms. Katrinka Akeson Department of Continuing Education HM100 Medical College of Georgia Augusta, GA 300912 Telephone: (706) 721-3967 FAX: (706) 721-4642 FEE: $150.00 DESCRIPTION: The Workshop will address processes whereby Institutional Animal Care and Use Committees (IACUC) can effectively evaluate their institution's animal care and use program. The PHS Animal Welfare Policy and USDA Regulations state that at least once every six months the institution's program for humane care and use of animals is to be evaluated by the IACUC using the Guide and USDA Regulations (Title 9, Chapter 1, subchapter A-Animal Welfare) as a basis. Topics to be included in the Workshop include: A review of the program as described in the Guide; institutional policy issues such as the occupational health and safety program, personnel training, and the activities of the IACUC and how effectively does it meet its mandates. Other program issues to be included are veterinary care, the animal environment, and record reviews. Reports of the IACUC semiannual program and facility reviews will also be discussed. Approaches useful to IACUC's serving both small and large institutions will be included. INQUIRIES For further information concerning these workshops and future NIH/OER/OPRR Animal Welfare Education Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, Suite 3B01 Rockville, MD 20892-7507 Telephone: (301) 496-8101 ext. 233 FAX: (301) 402-0527 $$N4 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NCI-CM-67244-30 ****************************************** PLANT COLLECTION AND TAXONOMY NIH GUIDE, Volume 24, Number 29, August 11, 1995 RFP AVAILABLE: NCI-CM-67244-30 P.T. 34; K.W. 1002040 National Cancer Institute The National Cancer Institute (NCI), Division of Cancer Treatment (DCT), Development Therapeutics Program (DTP) anticipates the award of three cost-reimbursement contracts, for a base period of three years, with two one-year option years, beginning on or about September 1, 1996. The objective of this project is to establish contracts for the collection and taxonomy of plants from the following regions designated as follows: Task A: tropical Africa, with emphasis on Madagascar; Task B: Southeast Asia, with emphasis on Papua New Guinea; and Task C: the continental United States of America. The collections will be evaluated as sources of potential antineoplastic and anti-AIDS agents, with the ultimate goal being the discovery of novel structural types that can be developed for the selective treatment of cancer and AIDS in man. Successful offerors will be expected to provide qualified personnel, materials, and equipment for the collection, identification, storage, and shipping of plant samples (500 per year each from Africa and Southeast Asia and 1000 from the United States) to an NCI-designated extraction facility. Collections will comprise approximately 0.3-1.0kg (dry weight) of each sample and each plant will be identified as far as possible at the time of collection. Properly prepared voucher specimens for each plant will be collected for the purposes of unambiguous identification, and for permanent deposition of, at a minimum, two herbaria designated by NCI. The contractor will be expected to provide detailed documentation, including complete identification of each plant collected. The collection team should include a qualified plant taxonomist and personnel experienced in plant collection and identification, and having familiarity with the customs of the local populations. The Principal Investigator should be trained in botany or a related field and should have at least five years of experience in plant collection and identification. It is anticipated that re-collections of up to 10 plants per year in quantities of 10-50 kg will be required starting in the second year of the contract. The number of initial small scale collections will be reduced in proportion to the number and size of the large scale re-collections undertaken. Collections will include species from as wide a variety of families genera as possible. A list of genera with number of species collected in each genus since 1986 will be provided in order to aid in the determination of priorities in the collection program. In the case of trees and large shrubs, samples of plant parts may be collected and stored separately for individual evaluation, with each part being considered equivalent to plant sample. In addition, a list of countries in which collections have been performed and the number of samples collected in each country will be provided. The contractor will be responsible for obtaining all necessary permits including shipping and expert permits from foreign governments and agencies, for delivery of samples and voucher specimens to facilities in the United States. A "Letter of Collection" stating NCI's willingness to collaborate with local scientists and/or authorities in the discovery and development of novel drugs from plants collected will be provided to the contractor. The Government anticipates the award of one contract for each of the regions designated in Task A, B, and C. This is a recompetition of a group of contractors performing similar collections. The Request for Proposal (RFP) will be available on or about August 29, 1995. INQUIRIES A copy of the RFP may be obtained by written request from: Ms. Elsa B Carlton Research Contracts Branch National Cancer Institute Executive Plaza South, Room 603 6120 Executive Boulevard MSC 7220 Bethesda, MD 20892-7220 $$R1 END ************************************************************ $$R2 BEGIN DA-96-001 FULL-TEXT ************************************** BROADENING BASIC BEHAVIORAL SCIENCE RESEARCH IN DRUG ABUSE NIH GUIDE, Volume 24, Number 29, August 11, 1995 RFA AVAILABLE: DA-96-001 P.T. 34; K.W. 0404000, 0404009, 041005 National Institute on Drug Abuse Letter of Intent Receipt Date: October 13, 1995 Application Receipt Date: November 14, 1995 PURPOSE The purpose of this Request for Applications (RFA) is to broaden basic behavioral science research in drug abuse. A key feature of basic behavioral research is the use of laboratory and other comparably controlled procedures to elucidate underlying behavioral mechanisms or processes. As a primary goal, basic behavioral research establishes a scientific foundation for later application in treatment and prevention research. Several important research areas in behavioral sciences such as cognitive, motivational, and social processes as well as health behavior research have the potential to address questions of underlying behavioral mechanisms, determinants and correlates of drug abuse, as well as to better characterize the harmful sequelae of drug use and abuse. These and other basic behavioral science areas currently are underrepresented at NIDA. It is anticipated that approximately $2 million in FY 1996 will be available to fund six to seven new awards under this RFA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000,: a PHS-led national activity for setting priority areas. This RFA, Broadening Basic Behavioral Science Research in Drug Abuse, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Dr. Jaylan S. Turkkan Division of Basic Research National Institute on Drug Abuse 5600 Fishers Lane Room 10A-20 Rockville, MD 20857 Telephone: (301) 443-1263 FAX: (301) 594-6043 Email: jaylan@nih.gov $$R2 END ************************************************************ $$R3 BEGIN AI-95-014 FULL-TEXT ************************************** NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS FOR THE TREATMENT OF OPPORTUNISTIC INFECTIONS IN AIDS NIH GUIDE, Volume 24, Number 29, August 11, 1995 RFA AVAILABLE: AI-95-014 P.T. 34; K.W. 0715008, 0715125, 1002027, 0755025, 0710030 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: November 1, 1995 Application Receipt Date: December 21, 1995 PURPOSE The Opportunistic Infection Research Branch (OIRB) of the Treatment Research Program in the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), invites cooperative agreement applications on the discovery and rational design of new therapies with potential to treat and/or prevent infection caused by opportunistic infections (OIs) in individuals infected with HIV. The opportunistic pathogens emphasized in this RFA are Mycobacterium tuberculosis, Cryptosporidium parvum, and the Microsporidia (e.g., Enterocytozoon bieneusi, Septata intestinalis). Responsive applications will be directed toward discovery of selective drugs or molecular strategies that are lethal for these pathogens with minimal toxicity for the host. Investigators pursuing similar drug discovery for other AIDS-associated opportunistic infections (OIs) are strongly encouraged to contact program staff listed under INQUIRIES to discuss opportunities for support through other research support mechanisms. Applications that include collaborations, research projects, or core components from the private sector (e.g., pharmaceutical, chemical, or biotechnological companies) are strongly encouraged. It is anticipated that multidisciplinary approaches by scientists from a combination of academic, non-profit research, and commercial organizations, with the assistance of NIAID, will be necessary to effectively accelerate discovery of new therapeutics. The focus of this RFA is on targeted drug discovery research; random or large scale screening as well as clinical trials will not be supported under this RFA. It is anticipated that approximately $2.4 million will be available in FY 1996 to fund three to six new and/or recompeting applications. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, National Cooperative Drug Discovery Groups for the Treatment of Opportunistic Infections in AIDS, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Barbara Laughon, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C26 6003 Executive Boulevard Bethesda, MD 20892-7620 Telephone: (301) 402-2304 FAX: (301) 402-3171 Email: Barbara_Laughon@nih.gov $$R3 END ************************************************************ From owner-sci-resources@net.bio.net Fri Aug 11 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DA-96-001 - V24(29) 08/11/95 Date: 11 Aug 1995 18:23:40 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 370 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <40gvqs$n92@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DA96001 DA-96-001 P1O1 *************************************** BROADENING BASIC BEHAVIORAL SCIENCE RESEARCH IN DRUG ABUSE NIH GUIDE, Volume 24, Number 29, August 11, 1995 RFA: DA-96-001 P.T. 34; K.W. 0404000, 0404009, 041005 National Institute on Drug Abuse Letter of Intent Receipt Date: October 13, 1995 Application Receipt Date: November 14, 1995 PURPOSE The purpose of this Request for Applications (RFA) is to broaden basic behavioral science research in drug abuse. A key feature of basic behavioral research is the use of laboratory and other comparably controlled procedures to elucidate underlying behavioral mechanisms or processes. As a primary goal, basic behavioral research establishes a scientific foundation for later application in treatment and prevention research. Several important research areas in behavioral sciences such as cognitive, motivational, and social processes as well as health behavior research have the potential to address questions of underlying behavioral mechanisms, determinants and correlates of drug abuse, as well as to better characterize the harmful sequelae of drug use and abuse. These and other basic behavioral science areas currently are underrepresented at the National Institute on Drug Abuse (NIDA). 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, Broadening Basic Behavioral Science Research in Drug Abuse, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01). This solicitation is for applications for new (not competing renewal) awards only. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The anticipated award date is July 1, 1996. FUNDS AVAILABLE It is anticipated that approximately $2 million in FY 1996 will be available to support projects submitted under this RFA. Because the nature and scope of the research proposed in response to this RFA may vary, the size of an award will vary also. However, it is anticipated that approximately six to seven new awards will be made under this RFA. RESEARCH OBJECTIVES The primary objective of this RFA is to stimulate innovative basic behavioral approaches and paradigms that may advance the understanding of drug abuse. o To promote basic behavioral research relating to drug abuse that is conducted without necessarily including the use of abused drugs in the research protocols. o To encourage the development of behavioral protocols and models that do not use drugs in the initial development of the protocol, but have clear potential for further study with drugs. o To stimulate basic behavioral research clearly related to drug abuse, but using research volunteers other than drug users or addicts. This is particularly appropriate for protocols that do not involve the administration of drugs. o To develop and improve basic research models of behavioral change in drug abuse, HIV/AIDS, and other high-risk behaviors. Both laboratory studies and comparably controlled procedures that use behavioral measurements, that employ basic behavioral models or that study basic behavioral processes will be considered. Both human and animal research are encouraged. Additionally, applicants are encouraged to employ study designs that would permit assessment of gender differences. Targeted Areas in the Basic Behavioral Sciences: o Cognitive processes (learning and memory, language and information processing, perception, problem solving, concept formation, spatial ability, and animal cognition). o Social and personality factors (dominance hierarchies, social influence, social values, social attitudes and cognition, persuasion conformity and compliance, group and interpersonal processes, conflict and resolution, sex roles, sexual behavior; risk taking and HIV/AIDS). o Behavioral change models (self-control, self-management, incentive motivation theory, behavioral alternatives). o Developmental processes (cognitive, perceptual, motor and language development, psychosocial and personality development, lifespan studies). o Health-related behavioral processes (stress coping strategies, health decision models, placebo effects, self-medication, co-morbidity including sleep and eating disorders). o Biological bases of behavior (aggression, behavioral genetics, animal learning and behavior, physiology and behavior, stress, pain and analgesia, diurnal, circadian and ultradian rhythms). Examples of research topics responsive to this RFA may include, but are not restricted to, the following: o Cognitive dysfunctions associated with acute, casual, and chronic drug use, including memory deficits and higher-order dysfunctions. o Human and animal models of impulsivity and risk taking. o Basic behavioral factors leading to first use of drugs, and escalation to drug abuse and dependence, as well as spontaneous cessation of drug use. o The role of temporal factors (e.g., diurnal or circadian rhythms) in controlling normal, risky, or abnormal behavior. o The cognitive process by which drug-related information is encoded. o The motivational and learning processes underlying craving. o The role of social attachment, social interactions, and social influence on high risk or deviant behavior. o Mechanisms underlying the temporal patterning of drug use as a function of drug type (e.g., patterns of craving and binging). o Ecologically valid human and animal behavioral studies. o Co-morbidity (e.g., bipolar illness) as a factor in sensation seeking and risk-taking behavior. o Factors such as mood and emotion as modulators of interoceptive experiences. o Laboratory models of the development of and commonalities among excessive, persistent and highly motivated behaviors. o Aggression and drug abuse: for example, aggressor or victim status in modulating responsivity to drugs or susceptibility to drugs or drug cues, stress or drug-induced aggression, dominance-submissive animal paradigms. 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 13, 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 a subsequent application, the information that it contains allows NIDA staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research, and may be obtained from the Office of Grants Information, Division of Research Grants, NIH, 6701 Rockledge Drive, Room 3032 MSC 7762, Bethesda, MD 20892-7762, telephone (301) 435-0715. The RFA label in the PHS 398 application kit must be affixed to the bottom of the original face page. Failure to use the RFA label and to follow instructions 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 in Item 2 on the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight service) At the time of submission, two additional copies of the application must also be sent to: Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 Applications must be received by November 14, 1995. If an application is received after this date it will be held for the next regular receipt date and reviewed with all other unsolicited applications. However, it will not be considered as a response to this RFA. The Division of Research Grants (DRG) will not accept any application in response to the RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by NIDA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, the applicant may be contacted 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/technical merit by an appropriate peer review group convened by NIDA in accordance with the review criteria stated below. Review Criteria o scientific, technical or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and, o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will be considered for funding on the basis of overall scientific and technical merit of the proposal as determined by peer review, appropriateness of budget estimates, program needs and balance, policy considerations, adequacy of provisions for the protection of human and animal subjects, and availability of funds. In addition, criteria for awards will be based on the RESEARCH OBJECTIVES listed earlier. Schedule Letter of Intent Receipt Date: October 13, 1995 Application Receipt Date: November 14, 1995 Initial Review Date: February/March 1996 Advisory Council Date: May 1996 Earliest Start Date: July 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. Jaylan S. Turkkan Division of Basic Research National Institute on Drug Abuse 5600 Fishers Lane Room 10A-20 Rockville, MD 20857 Telephone: (301) 443-1263 FAX: (301) 594-6043 Email: jaylan@nih.gov Direct inquiries regarding fiscal or grants management issues to: Dr. Gary Fleming Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Email: GFLEMING@AOADA.SSW.DHHS.GOV AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Section 301, and administered under PHS grants policies and Federal Regulations at Title 42 CFR 52 "Grants for Research Projects," Title 45 CFR Part 74 & 92, "Administration of Grants," and 45 CFR Part 46, "Protection of Human Subjects." Title 42 CFR Part 2, "Confidentiality of Alcohol and Drug Abuse Patient Records" may also be applicable to these awards. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Aug 11 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-95-014 - V24(29) 08/11/95 Date: 11 Aug 1995 18:23:48 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1040 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <40gvr4$n9c@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AI95014 AI-95-014 P1O1 *************************************** NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS FOR THE TREATMENT OF OPPORTUNISTIC INFECTIONS IN AIDS NIH GUIDE, Volume 24, Number 29, August 11, 1995 RFA: AI-95-014 P.T. 34; K.W. 0715008, 0715125, 1002027, 0755025, 0710030 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: November 1, 1995 Application Receipt Date: December 21, 1995 PURPOSE The Opportunistic Infection Research Branch (OIRB) of the Treatment Research Program in the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), invites cooperative agreement applications on the discovery and rational design of new therapies with potential to treat and/or prevent infection caused by opportunistic infections (OIs) in individuals infected with HIV. The opportunistic pathogens emphasized in this RFA are Mycobacterium tuberculosis, Cryptosporidium parvum, and the Microsporidia (e.g., Enterocytozoon bieneusi, Septata intestinalis). Responsive applications will be directed toward discovery of selective drugs or molecular strategies that are lethal for these pathogens with minimal toxicity for the host. Investigators pursuing similar drug discovery for other AIDS-associated opportunistic infections (OIs) are strongly encouraged to contact program staff listed under INQUIRIES to discuss opportunities for support through other research support mechanisms. Applications that include collaborations, research projects or core components from the private sector (e.g., pharmaceutical, chemical, or biotechnological companies) are strongly encouraged. It is anticipated that multidisciplinary approaches by scientists from a combination of academic, non-profit research, and commercial organizations, with the assistance of NIAID, will be necessary to effectively accelerate discovery of new therapeutics. The focus of this RFA is on targeted drug discovery research; random or large scale screening as well as clinical trials will not be supported under this RFA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, National Cooperative Drug Discovery Groups for the Treatment of Opportunistic Infections in AIDS, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local government, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply as the primary institution, although domestic applications may contain international components (projects or cores). Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be the cooperative agreement (U01 or U19), an "assistance" mechanism in which substantial NIH scientific and/or programmatic involvement is anticipated. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Cooperative agreements may include a combination of academic, non-profit research, and commercial organizations; applications that include collaborations, research projects, or core components from industry are strongly encouraged. Awards are made to the institutions of each Principal Investigator, either as a U01 or U19 mechanism. U01 awards may consist of one or two collaborative projects. Essential elements of the U19 mechanism include: (1) a minimum of three inter-related research projects organized around a central theme; (2) collaborative efforts and interaction among independent projects and their investigators to achieve a common goal; and (3) common resources termed "cores," each of which must be utilized by at least two research projects within the group program (see also "APPLICATION PROCEDURES" in this RFA). Details of the responsibilities, relationships, and governance of a study funded under a cooperative agreement are discussed in the RFA under the section Terms and Conditions of Award. At this time, the NIAID is administratively limiting the duration of cooperative agreement awards to four years. The total project period proposed in applications may not exceed four years. The anticipated award date is August-September 1996. At this time, the NIAID has not determined whether or how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA reissuance will be $2.4 million. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of a cooperative agreement award will vary also. Individual research projects, whether they are single (as for U01s) or part of a multiple project proposal (two maximum for U01s, three or more for U19s), should be approximately in the budget range of $ 175,000 to 225,000 total costs for the first year. U01 applications with two projects should not exceed $450,000 in first year total costs. U19 applications received with budgets in excess of $800,000 first-year total costs will be returned without review. In Fiscal Year 1996, the NIAID plans to make a total of three to six awards from new and recompeting applications. This includes approximately one group for drug discovery against each of these high priority OIs: Mycobacterium, Cryptosporidium, and the microsporidia (e.g., Enterocytozoon, Septata). Although this program is provided for in the financial plans of the NIAID, awards pursuant to this RFA are contingent upon program priority and the availability of funds for this purpose. RESEARCH OBJECTIVES Background The principal causes of morbidity and mortality in AIDS are opportunistic infections (OIs). Although HIV causes AIDS and is responsible for the progressive immunological deterioration seen in this disease, the OIs account for the vast majority of all AIDS-related hospitalizations and deaths as well as diminishing quality of life. The intent of this project is to foster research in mycobacterial and diarrheal disease arenas that have not been adequately addressed by either the government or the private sector. Mycobacterial infections have become an increasing cause of morbidity among this population and has led to a public health imperative. Epidemiologic evidence has shown that disease progression of TB is much more rapid among individuals with AIDS compared to that in the general population. In addition, new TB cases are further complicated by the lack of an effective treatment for drug-resistant strains of M. tuberculosis. New therapies for treating TB have not emerged from the private sector. Currently, no effective therapies exist for Cryptosporidium parvum or the enteric Microsporida. Progressive weight loss and debilitation are often inevitable consequences of infection with these agents, and malnutrition has been recognized as a major cause of morbidity in this disease. Severe diarrhea and weight loss associated with intestinal damage and malabsorption are life-threatening in the acute phase; in the chronic state these agents are also responsible for poor absorption of medications, and a particularly devastating quality of life for the individuals affected. Available treatments for mycobacteria and the infectious causes of AIDS-related diarrhea do not have adequate potency to completely eradicate the infections. Further, HIV-mediated immunosuppression requires prolonged treatment schedules and prophylaxis regimens against recurrence of infections. The management of these infections is complicated by toxicity and adverse side effects of therapeutic agents, development of drug resistance, the occurrence of relapses, and simultaneous infections with other OIs. Due to the absence of support by the pharmaceutical industry, the high morbidity and mortality associated with these diseases requires government promotion of new drug discovery research. The NCDDG-OI program was launched in 1990 for the purpose of stimulating targeted drug discovery research, development and commercialization of therapeutic agents directed against AIDS-associated OIs. The program has supported over 20 cooperative agreements focusing on selected opportunistic pathogens, including Pneumocystis carinii, Toxoplasma gondii, Cryptococcus neoformans, Candida albicans, Histoplasma capsulatum, Cryptosporidium parvum, Mycobacterium avium, and M. tuberculosis. The goals of the NCDDG-OI program are: (1) the conceptualization, discovery and preclinical development of therapies designed to effectively treat OIs in individuals infected with HIV; (2) the conduct of biological, biochemical, and preclinical pharmacological studies leading to selection of potential therapies; and (3) the recommendation of therapies, entities or strategies for development in clinical trials. Objectives and Scope The purpose of this RFA is to solicit applications for research projects aimed at the discovery, rational design, and preliminary development of new therapies against the OIs associated with AIDS. Applications should reflect a comprehensive, multidisciplinary approach to the study of potential new therapies: this can be accomplished through collaborations in single project applications, or through multiple-project applications for Group awards. Original and innovative research is encouraged in areas such as the microbiology, molecular biology, chemistry, computer-assisted drug design, drug delivery vehicles, and animal models that will lead to the identification of new drug targets. Random or large scale screening as well as clinical trials will not be supported under this RFA. Examples of responsive studies to be supported by this RFA include, but are not limited to: 1. characterization and further development of molecular targets; 2. exploitation of biochemical and metabolic differences between pathogen and host to develop new therapeutics; 3. design and use of new assay systems for identification of active compounds; 4. development of innovative animal models and culture systems to test the therapeutic efficacy of compounds, particularly in an immunocompromised setting; 5. elucidation of mechanisms of drug resistance and strategies to overcome such resistance. All proposed studies should carefully consider issues of toxicity of the candidate compounds, in view of the ultimate potential for clinical application. SPECIAL REQUIREMENTS A. Minimum Requirements for NCDDG-OI Applications Applications may consist of a single project or two or more interrelated projects focusing on a unifying central theme. A minimum 20 percent effort by the Principal Investigator and each Project Leader should be devoted to the proposal, unless there are compelling arguments to the contrary. Investigator responsibilities and group organization is detailed in the following section. B. Definitions 1. NATIONAL COOPERATIVE DRUG DISCOVERY GROUP FOR THE TREATMENT OF OPPORTUNISTIC INFECTIONS (NCDDG-OI): In this RFA the terms NATIONAL COOPERATIVE DRUG DISCOVERY GROUP, NCDDG-OI, and "Group" are synonymous. Each group may consist of a number of scientific investigators from academic and/or non-profit research institutions as well as scientists from commercial organizations, performing research on interdependent projects. Award will be made to the Principal Investigator's institution as a cooperative agreement, either a U01 or U19 award mechanism. U01 awards may consist of one or two collaborative projects. A U19 award is for three or more independent laboratory research projects. Each group is intended to represent diverse scientific disciplines that join together under a Principal Investigator and function as a unit with a common goal. 2. NIAID NCDDG-OI PROGRAM DIRECTOR: A Senior Scientist of the NIAID extramural staff who coordinates NIAID's participation in the NCDDG-OI program, oversees the entire NCDDG-OI program, maintains the overall scientific balance in the NCDDG-OI program commensurate with new research and therapeutic findings and emerging research opportunities. The program director ensures that the NCDDG-OI program is consistent with NIAID's missions and goals. 3. NIAID SCIENTIFIC COORDINATOR: A Senior Scientist of the NIAID extramural staff who functions as a peer with the Principal Investigator and Project Leaders and who facilitates the partnership relationship between NIAID and each Group. The Scientific Coordinator is the immediate contact person to the Group and is assigned by the NCDDG-OI program director. 4. PRINCIPAL INVESTIGATOR: The person who assembles the NCDDG-OI application, who is responsible for the performance of the Group as a whole, and who submits the single application in response to this RFA. The Principal Investigator will coordinate Group activities scientifically and administratively and should be project leader of one of the Research Projects of the Group. A minimum 20 percent effort by the Principal Investigator should be devoted within the overall Group effort. The Principal Investigator's institution may establish and operate a Central Operations Office that funds Group members and is legally and fiscally accountable for the disposition of funds awarded. 5. PROJECT LEADER: The leader of one of the scientific research projects of the NCDDG-OI who is directly responsible for the scientific conduct of that project and also directly responsible to the Principal Investigator. A project leader is expected to commit a minimum of 20 percent effort to the project. 6. RESEARCH PROJECT: A discrete, specified project with a separate budget that relates to the unifying central theme and objectives of the NCDDG-OI. 7. SCIENTIFIC ADVISORS PANEL: U19 awards, i.e., groups consisting of three or more interrelated research projects, will have a panel comprised of two to three peers from the scientific community, whose mission is to provide the Principal Investigator with comprehensive review of the Group's activities and progress, consult on future goals and strategies, and recommend alternative directions, as appropriate. Selection and appointment of the Panel is the responsibility of the Principal Investigator. The composition of the designated Panel will be provided to the NIAID within the first year of funding; members of the Panel will not be affiliated with any of the institutions comprising the Group. The Principal Investigators budget should include travel funds for the Panel to attend one group meeting a year, starting from the second year. 8. SCIENTIFIC SUPPORT CORE COMPONENT: One or more cores may be proposed to provide facilities for equipment and/or services, which must be utilized by at least two research projects, in order to facilitate the research effort. The Core can be defined as a component with established techniques and assays that perform a service function resulting in an economy of effort and savings in the overall costs of the NCDDG-OI. The Core unit is to be described in the research plan of the projects and in adequate detail to enable the evaluation of its scientific and technical merit. C. Patent Coverage Because the discovery of innovative, effective drug therapies for OIs is the goal of this effort, and since active involvement by private sector laboratories is facilitated by the existence of adequate patent coverage, it is essential that applicants provide plans to ensure such coverage. Since several institutions may be involved, complex patent situations may arise. Each applicant Group must, therefore, provide a detailed description of the approach to be used for obtaining patent coverage and for licensing where appropriate, in particular where the invention may involve investigators from more than one institution. Each Group must provide a detailed description of the procedures to be followed for the resolution of legal problems that may develop (see "Application Procedures, Part D" in this RFA). Attention is drawn to the reporting requirements of 35 U.S.C. Parts 200-212 and 37 CFR Part 401 or FAR 55.227-11. Instructions were also published in the NIH Guide for Grants and Contracts, Vol. 19, No. 23, June 22, 1990. Note that non-profit organizations (including universities) and small business firms retain the rights to any patent resulting from Government contracts, grants or cooperative agreements. It is also noted that a Presidential memorandum of February 18, 1983 extended to all business concerns, regardless of size, the first option to the ownership of rights to inventions as provided in P.L. 96-517. As a result of this memorandum, the relationships among industrial organizations and other participants are simplified, since all Group members can now be full partners in the research and in any inventions resulting therefrom. The specific patenting arrangements among institutions may vary, and could include joint patent ownership, exclusive licensing arrangements, etc. Applicants are encouraged to develop an arrangement that is most suitable for their own particular circumstances. Federal regulation clause 37 CFR 401 and HHS Inventions regulations at 45 CFR Parts 6 and 8 require that NIH be informed of inventions and licensing occurring under NIH funded research. Invention and licensing reports must be submitted to Extramural Invention Reports Office, Office of Extramural Research, National Institutes of Health, Building 31, Room 5B62, 9000 Rockville Pike, Bethesda, MD 20892. D. Terms and Conditions of Award The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator as well as the institutional official at the time of award. The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 [Part 92 is applicable when State and local Governments are eligible to apply], and other HHS, PHS, and NIH grant administration policies The administrative and funding instrument used for this program is the Cooperative Agreement (U01 or U19), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. A U01 award consists of 1 or 2 collaborative projects. The U19 contains a minimum of three inter-related research projects organized around a central theme. A Core resource or facility must be utilized by at least two research projects. Under the Cooperative Agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the study will be shared among the awardees and the NIAID Scientific Coordinator. 1. Awardee Rights and Responsibilities Awardees will have primary responsibility for defining the details for the project within the guidelines of the RFA and for performing the scientific activity, and agree to accept close coordination, cooperation, and participation of NIAID staff in those aspects of scientific and technical management of the project as described under "NIAID Staff Responsibilities". Specifically, awardees have primary responsibilities as described below: Meetings and Scientific Advisors Panel Two Group meetings are required per year. The Principal Investigator and Project and Core Leaders will meet to review progress, plan and design research activities, and establish priorities within the Group. The Principal Investigator will be responsible for scheduling the time and place (generally at one of the performance sites), for notifying the Scientific Coordinator at least thirty days prior to the meeting date, and for preparing concise (2-3 pages) minutes or summaries of the Group meetings, which will be delivered to the members of the Group including the Scientific Coordinator within thirty days following the meeting. The NIAID Scientific Coordinator will participate but not chair Group meetings. One mandatory meeting of the entire NCDDG-OI program will be held each year at a site designated by NIAID during which all Principal Investigators and Project Leaders will attend and present significant findings in symposium format. Data presented at this meeting are selected by the individual presenters in consultation with their Principal Investigator, thus affording appropriate protection of proprietary or commercially sensitive information. Groups will designate Scientific Advisors Panels within the first year of funding. The Principal Investigator will convene a meeting or meetings of the Group with the Panel during the second and third years, which may be in conjunction with the required Group meetings. Funds to support Panel member travel should be included in the Principal Investigator's budget. The Panel will meet with the Group and advise the Principal Investigator on the Group's progress, future goals, strategies and new directions, as appropriate. The Panel will provide the Principal Investigator with a comprehensive written review (2-3 pages) of the Group's activity each year. Members of the Panel will not be affiliated with any of the institutions comprising the Group. Publications and Presentation of Findings Early publication of major findings is encouraged. The Principal Investigator will be responsible for the timely submission to the Scientific Coordinator of all abstracts, manuscripts, and reviews (co)authored by members of the Group and supported in part or in total under this Agreement. The Principal Investigator and Project Leader are requested to submit manuscripts to the Scientific Coordinator within three weeks of acceptance for publication so that an up-to-date summary of program accomplishments can be maintained. Publications or oral presentations of work done under this Agreement are the responsibility of the Principal Investigator and appropriate Project Leader. All publications (abstracts, peer reviewed manuscripts, reviews) and oral presentations of work supported in part or in total by the NCDDG-OI cooperative agreement should be acknowledged as part of the presentation and will include the mechanism, cooperative agreement number and Institute, for example, "This work was supported in whole (or in part) by the NCDDG-OI program, cooperative agreement number U01-or U19-AI-1234, NIAID." Progress Reports An annual Progress Report will be submitted with the Application for Continuation Grant, which must include significant experimental data obtained and a complete and cumulative list of all publications (abstracts, manuscripts, reviews) (co)authored by Group members and supported in part or in total under this Agreement. Each Progress Report should include a brief section outlining intra-Group interactions that have augmented activities, citing specific occurrences (e.g., compound X was synthesized under Project 1 and transferred to Project 2 for assays). Inter-Group collaboration with other NCDDG-OIs should be specified, where applicable. Interaction with the Scientific Coordinator and the NIAID during the reporting period should be described. Copies of publications or reprints should be appended. The Progress Report must also include basic information as instructed with PHS 2590 Noncompeting Continuation Application forms. Rights to Data While the NIAID Scientific Coordinator has a right of access to the data, the applicant will retain custody of and rights to the data. Information obtained from the data may be used by the Scientific Coordinator for the preparation of internal reports on the Group's activities. The NIAID Scientific Coordinator may assist the Groups by providing them with compounds for voluntary initial and confirmatory testing. In testing compounds supplied by the NIAID, the Groups agree to abide by any confidentiality agreement between the NIAID and a third party who may have supplied the compounds for testing through NIAID. 2. NIAID Staff Responsibilities The NIAID shall participate as a member of the Group and shall be represented by a Scientific Coordinator or the NCDDG-OI program director. The Scientific Coordinator shall be selected from the Division of Acquired Immunodeficiency Syndrome, or from the Division of Microbiology and Infectious Diseases, which are extramural programs of the NIAID. The NIAID Scientific Coordinator will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination such as participating in the design of Group activities, advising in the selection of sources or resources, coordinating or participating in collection and/or analysis of data, advising in management and technical performance, or participating in the preparation of publications. However, the role of NIAID will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus of the Group and that NIAID staff will be given the opportunity to offer input to this process. The manner of reaching this consensus and the final decision-making authority will rest with the Principal Investigator. The Scientific Coordinator may serve as a resource for information, laboratory testing, and biological supplies, when such resources are not a normal requirement of the Group's day-to-day research activities, but may be required on an occasional basis. The NIAID has a contract program for the preclinical development of compounds for the treatment of AIDS-associated opportunistic infections, including animal models. These resources are intended for initial studies and may not be available on a continual basis. Examples of potential assistance include: provision of reference compounds for standardization of test systems, facilitation of confirmatory testing at research sites including other NCDDG-OI Groups, limited testing in appropriate animal model(s), focused searches of NIAID's computer files of chemical structures and biological activity, chemical re-synthesis, analysis, formulation, and toxicology testing through existing pre-clinical development contracts (contingent upon NIAID's recommendation and prioritization), and networking with other NIH staff, NCDDGs, other collaborators, and other Government and non-Government researchers who may provide guidance, expertise or resources to facilitate development of therapies identified by the Group. The NIAID will retain the option to cross-file or independently file an application for investigational clinical trial; e.g., an Investigational New Drug (IND) application to the United States Food and Drug Administration of any invention resulting from these NIAID supported Cooperative Agreements. Reports of data generated by the Group or any of its members required for inclusion in INDs and Clinical Brochures and for cross-filing purposes will be submitted by the Principal Investigator to the Scientific Coordinator upon request. Such reports will be in final draft form and include background information, methods, results, and conclusions. They will be subject to approval and revision by the NIAID and may be augmented with test results from other Government sponsored projects prior to submission to the appropriate regulatory agency. The NIAID supports Phase I, Phase II and Phase III clinical trials through a variety of mechanisms. These clinical development resources are available to study promising therapies brought forward >From sources such as the NCDDG-OI program. The Government provides its consulting and testing services in the interest of expeditious pre-clinical and clinical development of experimental anti-infective agents. 3. Arbitration Process Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NIAID may be brought to arbitration. An arbitration panel will be composed of three members -- one Group designee, one NIAID designee, and a third designee with expertise in the relevant area and chosen by the other two. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 1. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from program staff at the address listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by November 1, 1995, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of this 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 NIAID staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the research grant application form PHS 398 (rev. 5/95). The application form may be obtained from the institution's office of sponsored research or its equivalent, and >From the Office of Grants Information, Division of Research Grants, National Institutes of Health, Room 3032, 6701 Rockledge Drive, MSC 7762, Bethesda, MD 20892-7762, telephone (301) 435-0714 (e-mail: GIRG@DRGPO.DRG.NIH.GOV). The RFA label available in the PHS 398 (rev.5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, for purposes of identification and processing, item 2 on the face page of the application must be marked "YES" and the RFA number and the words "NATIONAL COOPERATIVE DRUG DISCOVERY GROUP FOR TREATMENT OF OPPORTUNISTIC INFECTIONS IN AIDS (NCDDG-OI)" must be typed in. Applications must be received by December 21, 1995. Applications from multi-component consortia must contain a single face page, an overall budget page, and separate budget pages for each institution involved. Each consortium institution is allowed 25 pages for the research plan if different plans are proposed by the different member institutions. Because of the multi-institutional nature of and the special requirements in this RFA, additional instructions regarding format are contained in NIAID APPLICATION GUIDELINES FOR MULTIPROJECT RESEARCH AWARDS, which is available from the program staff listed under INQUIRIES. If a conflict exists between instructions as presented in the program policy guidelines and this RFA, this RFA takes precedence. Applications must address the requirements below as outlined in the section "SPECIAL REQUIREMENTS"; see also NIAID APPLICATION GUIDELINES FOR MULTIPROJECT RESEARCH AWARDS. A. Composition of the Program Overview Section of the application 1. It is suggested that applications provide a clear, concise plan in narrative and diagrammatic form that depicts the interrelationships among the members of the NCDDG-OI and the contribution of each to fulfillment of Group objectives that meets the scope of this RFA. 2. It is suggested that applications provide an organizational chart of the NCDDG-OI showing the name, organization, and scientific discipline of the investigators comprising the Group. 3. Applications are to provide a plan to ensure maintenance of close collaboration and effective communication among members of the Group. The application should include plans for scheduling Group meetings, notifying Group members including the NIAID Scientific Coordinator, and documenting and disseminating Group meeting proceedings. 4. Applications must include letters of commitment to the overall plan and acceptance of the participation of the NIAID Scientific Coordinator. 5. Applications are to provide a rationale for the drug discovery approach(es) proposed and discussion of the therapeutic approaches that may be derived from the research projects. 6. Applications should present the anticipated unique advantages to be expected from the Group operating within the proposed collaborative efforts, how the projects are mutually reinforcing, and how collectively they will further the stated goals of the proposed research. 7. Applications that are recompeting should describe accomplishments and progress made toward the scientific aims in the previous award. A rationale for new specific aims in the current applications should be provided that is based on knowledge gained in the course of the previous award. B. Organizational and Administrative Structure of the NCDDG-OI The application should describe in detail and by diagram the chain of responsibility for decision-making and administration beginning at the level of the Principal Investigator and including the different research Project Leaders and other investigators. Where in the chain of responsibility advisory groups will be used should be indicated and their role in establishing quality control of the research efforts should be described. C. Consortium Arrangements An application that includes research activity involving institutions other than the sponsoring organization is considered a consortium effort. It is imperative that care be taken in preparing any consortium application so that the programmatic, fiscal, and administrative considerations are fully explained. The policy governing consortia is described in the NIH Guide for grants and Contracts (Vol. 14, No. 7, June 21, 1985), which should be available at the sponsoring institution's office of sponsored research, or in the Office of Grants Information's publication entitled "Guidelines for Establishing and Operating Consortium Grants", January 1989, which may be obtained by calling (301) 435-0714. D. Patent Coverage Agreement 1. The application should provide a description of the Group's plan for assuring adequate patent coverage of new inventions that may arise as a result of Government funding of this U19 or U01. "Invention" is defined as a new drug or innovative treatment that is or may be patentable under Title 35 of the United States Code. A copy of the proposed patent plan among the institutions comprising the Group must be submitted with the application. This patent agreement, signed and dated by the organizational officials authorized to enter into patent arrangements for each Group member and member institution, must be delivered two weeks prior to submission of the application to Dr. Barbara Laughon at the address listed under INQUIRIES. 2. Should the Group wish to place all inventions and discoveries resulting from these studies within the public domain, a letter to that effect must be submitted to Dr. Laughon in lieu of the patent agreement prior to submission of the application. The letter must be co-signed by the Principal Investigator, Project Leaders, and each of the business officials representing the respective institutions. E. Individual Research Projects The strength of the complete application package will be judged mainly on the basis of the quality of each research project. Reviewers will expect each project to be described in the same detail as for a regular research grant application to enable the reviewers to judge the technical and scientific merit solely on the basis of the written applications. 2. Research projects that are re-competing should describe progress made toward previous scientific aims and a rationale for proposed changes in aims or scope. 3. The portion of the application for each component research project should be prepared in the same manner as an R01 application, following carefully the instructions found in the grant application form PHS 398 (rev. 5/95), and as modified in NIAID APPLICATION GUIDELINES FOR MULTIPROJECT RESEARCH AWARDS, SPECIFIC INSTRUCTIONS: INDIVIDUAL RESEARCH PROJECTS. F. Scientific Core Support 1. The application should describe the role and importance of the core as a resource to the Group as a whole and the specific service(s) such core support will provide and the projects it will serve. The facilities, techniques, and professional skills that the core will provide should be described. The role of the Core Leader and each of the key participants should be described. The portion of the application describing each scientific core should be prepared with the same level of detail as an R01 application in order for the technical merit and appropriateness of each core to be evaluated. 2. Cores on recompeting applications should provide a description of productivity and utilization by project investigators under the previous award. 3. Core support may be provided as consortia if performed at institutions different from that of the Principal Investigator. 4. The budget for each scientific core should be presented according to the instructions of the form PHS 398 (rev. 5/95); see also NIAID APPLICATION GUIDELINES FOR MULTIPROJECT RESEARCH AWARDS, SPECIFIC INSTRUCTIONS: CORES. Applications must be received by December 21, 1995. All components, subparts and sections of the application must be collated into the application, and the packages sent to the DRG and to the NIAID must each be complete in themselves. Applications that do not conform to the instructions contained in PHS 398 (rev. 5/95) application kit will be judged non-responsive and will be returned to the applicant. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-spaced photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight services) At the time of submission, two additional exact copies of the grant application and all five sets of appendix material must also be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. 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. Applications must be received by December 21, 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 a substantial revision of an application already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Review Method All applications will be judged on the basis of the scientific and technical merit of the proposed projects and the documented ability of the investigators to meet the RESEARCH OBJECTIVES of the RFA. U19 applications with first year total costs (direct and indirect) in excess of $800,000 will be returned without review. Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants (DRG) and for responsiveness by NIAID staff. Incomplete and/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 NIAID in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. For applications found non-competitive, summary statements will be very brief and will generally contain a one paragraph resume, based on reviewers' comments, indicating the major reason(s) for the findings. Those applications judged by the reviewers to be competitive for award will be further reviewed for scientific and technical merit by a review committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria The review criteria for this RFA are the same as those for unsolicited research project grant applications. In addition, applicants are expected to address the issues identified under special requirements as well as criteria specific to the objectives of this RFA. These criteria are: Scientific Considerations 1. The scientific and technical merit of the application as a whole as well as that of each individual research project and core components, for the realization of drug discovery objectives. Evaluations will be based on originality, novel and unique ideas, and the incorporation of state-of-the-art approaches and methodologies of the proposed project towards the attainment of the stated programmatic goals. Each project must be supportable on its own merit. 2. Relevance of the Group's objectives to the discovery of new entities and strategies for the treatment of opportunistic infections and the likelihood that innovative and potentially practical therapeutic strategies will be identified during the course of the proposed project. 3. For recompeting Groups, accomplishments and progress as defined by the scientific aims of each project and core of the previous award, including toxicity data supportive of eventual clinical utility. 4. The cohesiveness, multi-disciplinary and multifaceted scope of the application and the coordination and interdependence of the individual projects and core(s) to the common theme. 5. The justification for and the usefulness to the various research projects of the core facilities. The relationship of each core to the central focus of the overall project. Each core unit must provide essential facilities or service for two or more individual research projects. 6. The leadership, scientific ability, and administrative competence of the Principal Investigator for the development, implementation, and management of the research program; and the Principal Investigator's commitment to devote sufficient time and effort to the program. 7. The qualifications, experience, and commitment of the investigators responsible for the individual research projects (Project Leaders) or core(s) (Core Leaders) and their contribution to the program, including their ability to devote adequate time and effort to the Group. It is anticipated that, due to the complexity and time required to maintain a well- coordinated and productive research effort, a minimum 20 percent effort by the Principal Investigator (total Group effort) and each Project Leader should be devoted to the study, unless there are compelling arguments to the contrary. 8. Research training, experience and accomplishments of other participating investigators and support personnel in the Group in the research areas outlined in the RFA. 9. Provisions for the protection of human subjects and the humane care of animals; adequacy of biohazard containment facilities. 10. 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. Administrative Considerations 1. Academic environment and resources in which the research will be conducted, including the availability of space, equipment, human subjects, animals, or other resources as required, and the potential for interaction with scientists from other departments and/or participating institutions; 2. Documented commitment of Institutions represented by Group members; documented capability of the Principal Investigator's Institution to serve as the Central Operations Office for the Group; 3. Soundness of the administrative and organizational structure that facilitates attainment of the objective(s) of the program; 4. Institutional strength, stability, and commitment to research and to the program, including fiscal responsibility and management capability to assist the Principal Investigator and staff in following DHHS, PHS, and NIH policies; 5. Administrative planning and leadership capability to provide for internal quality control of on-going research, allocation of funds, day-to-day management, internal communications and cooperation among the investigators involved in the program, contractual agreements, and replacement of the Principal Investigator, if required, on an interim or permanent basis; 6. Documented commitment of the sponsoring institution to the cooperative agreement and willingness to accept the participation and assistance of NIAID staff (Scientific Coordinator); 7. Appropriateness of the budget and duration in relation to the proposed program. The initial review group can make recommendations regarding appropriateness of the applicant's specific aims to programmatic goals, deletion of projects or cores not essential to drug discovery, administrative oversight by program staff, and disaggregation of outstanding projects for consideration as individual research grants, in order to strengthen applications. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. The initial review group will review each project and core within the application individually, followed by scoring of the application as a whole. Council Review Stage The second level review will be conducted by the National Advisory Allergy and Infectious Diseases Council. Factors that will be considered in this review include: 1. Results of the initial scientific and technical merit review; 2. Significance to NIAID program goals in microbiology, infectious diseases, allergy, transplantation immunology, immunologic diseases, or AIDS; 3. National needs and NIAID program balance; 4. Policy and budgetary considerations. AWARD CRITERIA Award decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct requests for the RFA and inquiries regarding programmatic issues to: Barbara Laughon, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C26 6003 Executive Boulevard Bethesda, MD 20892-7620 Telephone: (301) 402-2304 FAX: (301) 402-3171 Email: Barbara_Laughon@nih.gov Direct inquiries regarding application preparation and review and address the letter of intent to: Dianne Tingley, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C07 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-2550 FAX: (301) 402-2638 Email: dianne_tingley@nih.gov Direct inquiries regarding fiscal matters to: Ms. Lesia Norwood Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B22 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: Lesia_Norwood@nih.gov Schedule Letter of Intent Receipt Date: November 1, 1995 Application Receipt Date: December 21, 1995 Scientific Review Date: March 1996 Advisory Council Date: June 1996 Anticipated Award Date: August-September 1996 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.855 Immunology, Allergic and Immunological Diseases Research and 93.856 Microbiology and Infectious Diseases Research. Grants are awarded under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grants policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of the Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Aug 14 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 13 August 1995 Date: 14 Aug 1995 19:15:47 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 143 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <40p00j$4vg@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 95-26 GRANT POLICY MANUAL File size (bytes): STIS Filename: nsf9526.txt Title: NSF 95-26s GRANT POLICY MANUAL (SUMMARY OF CHANGE) File size (bytes): STIS Filename: nsf9526s.txt Document Type: IAI Newsletter Title: IAIOES04 REPORT ON THE IAI WORKSHOP ON THE ON THE COMPARATIVE STUDIES OF OCEANIC, COASTAL AND ESTUARINE PROCESSES IN TEMPERATE ZONES File size (bytes): STIS Filename: iaioes04.txt Title: IAIOES05 REPORT ON THE IAI WORKSHOP ON HIGH LATITUDE PROCESSES File size (bytes): STIS Filename: iaioes05.txt Title: IAIOES06 REPORT ON THE IAI WORKSHOP OCEAN/LAND/ATMOSPHERE INTERACTIONS IN THE INTER-TROPICAL AMERICAS File size (bytes): STIS Filename: iaioes06.txt Title: IAIOES07 REPORT ON THE IAI WORKSHOP ON TROPICAL ECOSYSTEMS AND BIOGEOCHEMICAL CYCLES File size (bytes): STIS Filename: iaioes07.txt Title: IAIOES09 REPORT ON THE IAI WORKSHOP ON ENSO AND INTERANNUAL CLIMATE VARIABILITY File size (bytes): STIS Filename: iaioes08.txt Title: IAIOES09 REPORT ON THE IAI WORKSHOP ON THE COMPARATIVE STUDIES OF TEMPERATE TERRESTRIAL ECOSYSTEMS File size (bytes): STIS Filename: iaioes09.txt Title: IAIOES10 REPORT ON THE IAI WORKSHOP ON THE STUDY OF THE IMPACTS OF CLIMATE CHANGE ON BIODIVERSITY File size (bytes): STIS Filename: iaioes10.txt Title: IAIOES11 PROGRAMA CIENTIFICO INICIAL (ISP) File size (bytes): STIS Filename: iaioes11.txt Document Type: Press Release Title: EARLY EVENTS REVEALED IN THE FERTILIZATION OF AN EGG BY A SPERM File size (bytes): STIS Filename: pr9551.txt Title: PRIMARY EVENTS IN PHOTOSYNTHESIS REVEALED File size (bytes): STIS Filename: pr9552.txt Title: SPEECH MODEL MAY REVOLUTIONIZE COMPUTER SPEECH SYNTHESIS AND RECOGNITION File size (bytes): STIS Filename: pr9553.txt Document Type: Program Guideline Title: NSF 94-89 BASIC RESEARCH IN CONSERVATION AND RESTORATION BIOLOGY File size (bytes): STIS Filename: nsf9489.txt Document Type: Report Title: OIG12 Number 12--NSF OIG Semiannual Report to the Congress File size (bytes): STIS Filename: oig12.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alphabetical List File size (bytes): 108862 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Document Type: STIS Title: Document Types on STIS File size (bytes): 1843 STIS Filename: stistype.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve stistype.txt, the text of your message should be as follows: get stistype.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve stistype.txt, you would enter: ftp> get stistype.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Wed Aug 16 23:00:00 1995 Path: biosci!biosci!not-for-mail From: kcowing@aibs.org (Keith L. Cowing) Newsgroups: bionet.sci-resources Subject: UPDATE: Army Persian Gulf Illness Research Date: 17 Aug 1995 15:11:17 -0700 Organization: American Institute of Biological Sciences Lines: 84 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: NNTP-Posting-Host: net.bio.net Persian Gulf Illness Update IMPORTANT: All inquiries are to be directed to Mr. Craig D. Lebo @ (301) 619-2036, Fax (301) 619-2937, Email craig_lebo@ftdetrck-ccmail.army.mil. There is NO CHANGE in the due date for proposals which remains at 2:00 PM Eastern Daylight Time, 23 August 1995. Two Amendments have been issued by the Army for the following three Persian Gulf Illness CBD Announcements EPIDEMIOLOGICAL STUDIES PERSIAN GULF WAR ILLNESSES SOL DAMD17-95-#-0008 MCMR-RMA (PGI-1) PYRIDOSTIGMINE BROMIDE STUDIES PERSIAN GULF WAR ILLNESSES SOL DAMD17‹95‹#‹0009 MCMR‹RMA (PGI‹2) CLINICAL RESEARCH AND OTHER STUDIES PERSIAN GULF WAR ILLNESSES SOL DAMD17-95-#-0010 MCMR-RMA (PGI-3) +++++++++++++ DAMD17-95-#-0010 Amendment 0001 Defense Federal Acquisition Regulation Suplements, Subpart 235.70 is attached for your information. This subpart consists of 27 pages with Change 1 consisting of four pages. A. This request for proposals, dealing with Persian Gulf vererans' illnesses, is separated into two parts: federal and non-federal. For both federal and non-federal components, the independent proposal evaluation process will be conducted simultaneously. Evaluation of all proposals is based on the evaluation criteria states in this solicitation. Of the total program amount (about $8M), approximately 60% ($5M) is reserved for the exclusive participation of non-federal contractors. The remainder is available for both federal and non-federal entities. The total program is represented by all three solicitations DAMD17-95-#-0008, 0009, 0010. B. There is no change in the due date for proposals which remains at 2:00 PM Eastern Daylight Time, 23 August 1995. ++++++++++++ DAMD17-95-#-0010 Amendment 0002 1. Several inquiries have been received concerning proposal topics. Within the Persian Gulf Health Research domain several special interest areas exist: A. Proposals that document the prevalence of symptoms, illnesses, diseases, or adverse reproductive outcomes within the coalition forces (other that U.S.) and within indigenous populations in the Persian Gulf area, as well as U.S. Persian Gulf War participants, compared to appropriate control populations are of particular interest. Proposals that quantify any potential risk factors involving health outcomes associated the Persian Gulf deployment are also considered important. Proposals that effectively validate self-reported conditions and specifically address the issues of recall and selection bias are critical. B. Within the infectious disease area, proposals that concentrate on the ecology and epidemiology of Leishmania spp., on the development of an effective diagnostic or screening test(s) and treatment regimens for leishmaniasis are considered important. C. The highlighting of these two research areas does not exclude meritorious applications in any of the other areas of this solicitaion, but only serves to identify those areas of particular programmatic interest. 2. Points of Contact: Contracting and/or acquisitions details, funding allocation questions, questions concerning the independent scientific review process, information about timeline/production deliverable dates, etc. POC: Mr. Craig D. Lebo @ (301) 619-2036, Fax (301) 619-2937, Email craig_lebo@ftdetrck-ccmail.army.mil. -- Keith L. Cowing - Manager of Planning and Operations American Institute of Biological Sciences 10700 Parkridge Blvd Suite 380 - Reston, VA, USA 22091 703-758-1212 voice - 703-758-1222 fax kcowing@aibs.org - gopher://aibs.org From owner-sci-resources@net.bio.net Fri Aug 18 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-084 - V24(30) 08/18/95 Date: 18 Aug 1995 18:18:51 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 422 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <413e5r$fv7@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95084 PA-95-084 P1O1 *************************************** MOLECULAR EPIDEMIOLOGY OF PROSTATE CARCINOGENESIS NIH GUIDE, Volume 24, Number 30, August 18, 1995 PA NUMBER: PA-95-084 P.T. 34; K.W. 0705075, 0785055, 0715035, 0755030, 0760002 National Cancer Institute National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Environmental Health Sciences PURPOSE The Division of Cancer Etiology of the National Cancer Institute (NCI), the Division of Kidney, Urologic, and Hematologic Diseases of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the Division of Extramural Research and Training of the National Institute of Environmental Health Sciences (NIEHS) invite investigator-initiated research grant applications for molecular epidemiologic studies to further the understanding of prostate cancer etiology. The purpose of this initiative is to stimulate the use of biochemical and molecular markers for identifying and assessing risk factors that could lead to effective prevention strategies. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Molecular Epidemiology of Prostate Carcinogenesis, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202-512-1800. ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign institutions and organizations are not eligible for the First Independent Research Support and Transition (FIRST) awards (R29), but may participate in laboratory or clinical programs through subcontract or consortium arrangements. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) individual research project grants (R01) and FIRST (R29) awards. NCI-funded investigators with ongoing R01, Method to Extend Research in Time (MERIT) (R37), and Program Project (P01) awards who are expanding the scope of their work and have at least one year of support remaining from the anticipated date of award may apply for competing supplement (S1) awards for the duration of the ongoing grant. Because the nature and scope of the research proposed in response to this PA may vary, it is anticipated that the size of an award will also vary. For FIRST awards, the total direct cost award for the five-year period may not exceed $350,000; the direct cost award in any budget period may not exceed $100,000. Applications assigned to the NCI with direct costs exceeding $500,000 in any year, may be considered for an award as a cooperative agreement (U01) (refer to NIH Guide, Vol. 22, No. 43, November 26, 1993 and Vol. 22, No. 45, December 17, 1993). RESEARCH OBJECTIVES Background In the United States, prostate cancer has become the most frequently diagnosed neoplasm and the second leading cause of cancer mortality in men after lung cancer. The incidence rate of prostate cancer has continued to increase rapidly during the past two decades, especially in men more than 50 years old, and 165,000 new incident cases comprising 27 percent of male cancers were expected to be diagnosed in 1993. Prostate cancer develops more rapidly with advancing age than any other form of cancer, and since a larger proportion of the population is aging, its impact is a major public health concern. The etiology of prostate cancer is obscure. Clues may be derived >From descriptive epidemiology characterizing the steep slope of incidence in the elderly, variation in race-specific and international incidence patterns, and high prevalence of latent (histologically apparent and clinically silent) carcinoma. The most compelling hypothesis supports a hormonal etiology based on the androgen-dependency of the prostate gland for growth and function. Studies in animal models have demonstrated the role of androgens in the induction of prostate cancer. Moreover, in humans, men castrated before puberty do not develop prostate cancer, and prostate cancer has responded to estrogen therapy. Case-control studies of serum testosterone and other hormones thus far, however, have had inconsistent results, although it has been reported that populations with low levels of serum androgens have a lower incidence of prostate cancer. Although studies of familial aggregation and genetic analyses have indicated a heritable component in risk, the wide geographic variation in rates as well as migrant studies suggest a role for environmental factors, including diet and nutrition. African American men have the highest incidence and mortality rates in the world, two-fold higher than among U.S. whites and much higher than among African populations. The incidence varies widely around the world: a 50-fold difference exists between countries with the highest (blacks in Detroit, Michigan: 91.1 per 100,000) and lowest (Shanghai, China: 1.8 per 100,000) incidence rates of prostate cancer. In addition, immigrants from low-risk countries (e.g., China or Japan) experience an increased risk after migrating to a high-risk country (e.g., United States). Evidence from case-control and cohort studies has suggested that dietary fat may be associated with invasive prostate cancer while certain micronutrients such as vitamin D may be protective. The role of other environmental exposures (e.g., occupation, ionizing radiation, viruses) is inconclusive while the effects of lifestyle factors (e.g., smoking, alcohol consumption, sexual behavior, vasectomy) have yet to be clarified. The special characteristic of latent prostatic tumors, detected most often at autopsy and estimated to affect one third of all males older than 50 years, has remained an enigma in our understanding of the natural history and biology of invasive prostate cancer. Interestingly, there are no clear racial or geographic differences in the occurrence of small intraprostatic foci of latent cancer, whereas the prevalence of larger focal lesions parallels the variations in mortality rates. It has been hypothesized that environmental factors may affect the transition of latent to invasive cancer by acting as tumor promoters. Little is known about the molecular events and processes involved in the progressive transition to invasive cancer. To date, genetic alterations in chromosomes 5q, 8p, 10q, 16p, and 17p have been reported in relation to prostate carcinogenesis. Research Goals and Scope The purpose of this initiative is to stimulate innovative molecular epidemiologic research into the origins of prostate cancer, including the biological basis for the striking increase in prostate cancer incidence with age. Collaborations of several disciplines and research institutions are encouraged with utilization of shared laboratory and specimen resources whenever possible. Applications will be welcomed from investigators who are participating in ongoing collaborative organizations such as the George M. O'Brien Kidney and Urologic Research Centers, the Specialized Programs of Research Excellence in Prostate Cancer (SPORES), the NIEHS Environmental Health Sciences Centers and the General Clinical Research Centers (GCRCs). It is suggested that the collaborative organization be identified as the resource for conducting the proposed research, and a letter of agreement from the program director or principal investigator be included with the application. Proposals to expand an ongoing epidemiologic study by the addition of a laboratory component will be considered. Transitional molecular epidemiology studies characterizing and validating biomarkers while determining optimal biological specimens and the most suitable procedures for collection, processing, and storage are of particular interest. Selected measurements or biomarkers should be relevant to the processes of prostate carcinogenesis. Additionally, there is a need for demonstration of the utility of hormonal biomarkers with an evaluation of sensitivity, specificity, intra- and inter-individual variability. NCI, NIEHS, and NIDDK strongly encourage investigations in understudied populations and in study populations of contrasting risk. Projects will be evaluated on the basis of their potential for enhancing understanding of prostate cancer etiology. The initiative invites a range of epidemiologic and interdisciplinary investigations of prostate cancer including, but not limited to: o Epidemiologic studies to: - evaluate prostate cancer risk of lifestyle factors (e.g., smoking, alcohol intake), occupation (e.g., cadmium and zinc exposures, rubber industry, farming), environmental hazards (e.g., organochlorine compounds including DDT, PCBs, and dioxins or other pesticides), and dietary intake (e.g., fatty acids, vitamins A, D, and E) utilizing available biomarkers and sources of specimens (e.g., prostate tissue, prostatic fluid, blood components) whenever possible; - assess interactions of the above factors or their interrelationships with biochemical parameters (e.g., growth factors, prolactin, steroid receptors, androgen conjugates, 5-alpha-reductase isoenzymes); o Epidemiologic studies to identify risk factors (e.g., environmental, hormonal, viral exposure, sexually transmitted diseases, lifestyle, ethnicity) associated with benign prostatic hyperplasia or chronic prostatitis and to clarify their possible relationships to prostate cancer; o Population-based studies of the relationship between prostatic intraepithelial neoplasia, dysplasia, atypical hyperplasia, and invasive prostate cancer; o Analytic epidemiologic studies utilizing developed markers (e.g., biologic, biochemical, morphologic) to identify premalignant processes or risk factors (e.g., hormonal, environmental) that contribute to prostate carcinogenesis, including the transition from latent to invasive cancer; o Studies to further develop identified biomarkers (e.g., androgen receptor mutations, 5-alpha-reductase isoenzymes, epithelial cell receptors) for application in epidemiologic research by characterization and validation (in the laboratory and in humans) including consideration of biologic variables, e.g., age, genetic predisposition, ethnicity, nutritional status, hormonal profiles, preexisting disease and lifestyle; o Experimental laboratory or population-based studies to explore and elucidate the role of timing of environmental exposures during critical developmental and other time periods (e.g., fetal period, the window from birth to puberty, puberty, after castration or vasectomy) of the prostate gland relevant to future risk of carcinogenesis including, but not limited to: (a) cellular, genetic, and hormonal effects of environmental factors on normal and abnormal prostate growth and development, and (b) mechanism of how environmental exposures acting as initiating or promoting agents during time periods of interest affect the latency of prostate cancer; o Biochemical epidemiologic studies to: - validate and compare prostate tissue levels of hormones (e.g., androgens, estrogens), their metabolites and receptors with other sources of specimens such as blood components and prostatic fluid; - evaluate panels of circulating hormones (e.g., dihydrotestosterone [DHT] and its precursors, testosterone, DHEAS, DHEA, androstenedione and its metabolites such as DHT sulfate, DHT glucuronide, 3-alpha- diol glucuronide) in populations of varying risk, including men younger than 50 years old; o Molecular epidemiology studies to explore differences in genetic predisposition to prostate cancer due to variations in susceptibility genes, hormone metabolism, DNA repair activities, chromosome sensitivity to mutagens or other factors. INCLUSION OF MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that 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 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. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. 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, 6701 Rockledge Drive, Room 3032, MSC-7762, Bethesda, MD 20892-7762, telephone (301) 435-0714. The title and number of the program announcement must be typed in Section 2 on the face page of the application. 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 legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC-7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria o scientific, technical, or medical significance and originality of the proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the principal investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research. o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that IC. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged, particularly during the planning phase of the grant applications. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Kumiko Iwamoto Division of Cancer Etiology National Cancer Institute Executive Plaza North, Suite 535 Bethesda, MD 20892-7395 Telephone: (301) 496-9600 FAX: (301) 402-4279 Email: Jasonc@EPNDCE.NCI.NIH.GOV Dr. David Longfellow Chemical and Physical Carcinogenesis Branch National Cancer Institute Executive Plaza North, Suite 700 Bethesda, MD 20892 Telephone: (301) 496-5471 FAX: (301) 496-1040 Dr. Ralph L. Bain Urology Program National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AS-19B Bethesda, MD 20892 Telephone: (301) 594-7713 FAX: (301) 480-3510 Dr. Gwen W. Collman Chemical Exposures and Molecular Biology Branch National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-4980 FAX: (919) 541-2843 Direct inquiries regarding fiscal matters to: Theresa A. Mercogliano Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 243 FAX: (301) 496-8601 Email: Mercoglt@GAB.NCI.NIH.GOV Trude McCain Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AN-44J Bethesda, MD 20892 Telephone: (301) 594-8856 FAX: (301) 480-3504 David L. Mineo Grants Management Branch National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-7628 FAX: (919) 541-2860 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.393, 93.849, and 93.894. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under HHS policies and grant regulations. This program is not subject to intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of the facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. From owner-sci-resources@net.bio.net Fri Aug 18 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-083 - V24(30) 08/18/95 Date: 18 Aug 1995 18:18:46 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 489 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <413e5m$fuu@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95083 PA-95-083 P1O1 *************************************** WOMEN'S HIV RISK AND PROTECTIVE BEHAVIORS NIH GUIDE, Volume 24, Number 30, August 18, 1995 PA NUMBER: PA-95-083 P.T. 34; K.W. 0715008, 0411005, 0404000, 0745027 National Institute on Drug Abuse National Institute of Mental Health PURPOSE The purpose of this program announcement (PA) is to support basic social and behavioral research on women's HIV risk and/or protective behaviors combined with community-level intervention strategies aimed at understanding and preventing HIV/AIDS in women whose drug and sex practices put them at high risk of HIV infection, i.e., not-in- treatment injection drug users (IDUs), crack users, injecting and noninjecting sexual partners of male and/or female IDUs, and women who trade sex for drugs, money, or subsistence. Historically, these women have been omitted from research or have been difficult to reach and retain in research; as a result, the knowledge base is often limited to the male experience. Because of the increasing and disproportionate numbers of women acquiring HIV disease, this PA seeks to widen the research base on HIV risk behaviors and risk- taking contexts by focusing on women and including protective behaviors and contexts in addition to risks. The NIH Office of AIDS Research has approved monies to support research in several areas related to this announcement, including HIV in women and children and behavioral research in drug-abusing populations. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Women's HIV Risk and Protective Behaviors, is related to the priority areas of alcohol and other drugs and mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Awards made under this PA will use the investigator-initiated research project grant (R01) mechanism. Because the type and scope of proposed research responsive to this PA may vary, it is anticipated that the size and period of the award will vary also. RESEARCH OBJECTIVES Background By year end 1994, more than 58,000 U.S. women were reported with AIDS. In 1994, 41 percent of these cases resulted from injection drug use, and 15 percent resulted from heterosexual contact with an IDU (Centers for Disease Control (CDC) 1995). Indeed, women's drug- and sex-risks for HIV frequently co-occur. Women's drug use often involves membership in a network with HIV-infected individuals where direct and indirect sharing of injection equipment and/or sexual liaisons are transacted and where the social context (e.g., shooting gallery) affects the likelihood of transmitting HIV. Women's drug use may also lead to trading sex for drugs or money, especially when they smoke crack cocaine. Studies show that drug-dependent women are more likely than men to engage in high-risk sex and that women IDUs are more likely to acquire HIV sexually than men. Violence may be an additional risk factor, because women with abusive partners practice more HIV risk behaviors and are less likely to seek drug treatment, otherwise reduce risky behavior, or disclose their HIV status to their partners than nonabused women. Data on women's drug use and HIV serostatus are available from National Institute on Drug Abuse's (NIDA) Cooperative Agreement Research Program, which tested 2,975 women for HIV between July 1, 1992 and December 31, 1993. Of these, 10.6 percent were seropositive. By drug use category of the last 30 days, seropositivity occurred in 8.5 percent of women who injected drugs, in 13.4 percent of women who injected drugs and used crack cocaine, and in 9.9 percent of women who used crack but did not inject. While the last category -- crack only -- does not consider injection history, a connection between crack use and sexual transmission is emerging. A recent three-city study of young adults in the inner city found that crack smokers had significantly higher rates of HIV seropositivity (15.7 percent) than nonsmokers (5.2 percent), and seroprevalence was highest among women (Edlin et al., 1994). In addition, CDC data indicate that the fastest growing exposure categories of AIDS involve heterosexual contact. Heterosexual contact cases in women increased by 108 percent between 1989 and 1992, compared with increases of 43 percent among IDUs and 21 percent in homosexual/bisexual men (Haverkos, 1993). Women's unique HIV transmission contexts and behaviors, including the link between drug dependence and risky sex as well as the potential for vertical transmission to infants, have implications for the development of targeted, gender-specific risk reduction interventions, including programs for pregnant women. It is also important to note that HIV in this country has disproportionately affected African Americans and Hispanics. These groups constitute approximately 18 percent of the U.S. population, but 77 percent of AIDS cases in women in 1994 (rates for African American and Hispanic women were 16 and 7 times higher, respectively, than for white women). Similarly, a majority of perinatally-acquired pediatric AIDS cases were in African Americans and Hispanics (again, mothers' exposure categories were chiefly drug-related). Research Goals and Issues Given gender differences in life experiences, perceptions, social statuses, and HIV risk behaviors, there is reason to believe that HIV interventions and prevention messages must be tailored for women. The principal goals of this PA are to develop and implement gender- specific research strategies that address HIV prevention in groups of women whose behaviors and relationships place them at high risk of HIV infection. NIDA and the National Institute of Mental Health (NIMH) will support basic behavioral/social science research projects and/or evaluations of behavioral change strategies. These projects should build on and extend existing knowledge about HIV risks, prevention, and protective factors in women. For each proposed project, it is suggested that applicants review the relevant theoretical, empirical, and methodological literature; identify unresolved questions related to the determinants and contexts of drug use and HIV risk and protective behaviors in women who are not in treatment; develop and implement gender-related intervention strategies and measurement procedures; and present a plan for rigorous community-based research to address the outstanding questions. Because behavioral change is often multidimensional, it would be useful for applicants to propose measures covering a range of structural, social, and psychological factors and rely on qualitative as well as quantitative research strategies. Most importantly, applicants are encouraged to describe the unique contributions and/or integrative value of their proposed studies to understanding HIV prevention in women and to consider race/ethnicity factors in these studies. At least four themes are of interest. Basic research in field settings is needed on (1) the social and structural contexts of women's HIV risk behavior transactions and (2) determinants, mediators, and reinforcers of women's HIV risk and/or protective behaviors related to drug use, injection equipment, and sex. Community-based intervention research is needed to (3) develop gender-specific methodologies and instrumentation to recruit and retain women in research and measure their behaviors, and (4) develop and evaluate behavior change strategies aimed specifically at women. Overlap and integration of these themes are encouraged. Thematic issues can include but are not limited to: 1. The Social and Structural Contexts of Women's HIV-Related Behaviors and Transactions. Studies are encouraged that focus on social structures and social contexts of women's HIV-related behavior transactions as well as barriers and opportunities for change. Suggested themes include: o Gender-specific interpersonal contexts of HIV risk behaviors. Issues include gender-specific barriers in relationships (e.g., power differentials) with violent or nonviolent sexual partners and/or drug partners that affect women's HIV risk behaviors and the ability to decrease their risks. o Gender-specific economic contexts of HIV risks and barriers to change. Issues include trading sex for drugs, money, or subsistence, as well as economic pressure on sex trade workers to have unsafe sex. The economic context of living "on the streets" by runaway and homeless young women may also affect their risk of infection via drug or sex practices. o Structural contexts affecting access to prevention aids and behavior change. Macro contexts include community policy/programs affecting access to needles and condoms and/or law enforcement practices against drug use, sex trade, or illegal immigration, which may lead women to avoid contact with HIV prevention programs for fear of being identified, prosecuted, and/or losing custody of their children. Also important are medical care and drug abuse services system factors that may influence the delivery and effectiveness of HIV interventions (e.g., linkage of primary medical care, HIV prevention, drug abuse treatment, and treatment of comorbid mental disorders). o Membership/roles in social networks. Using qualitative and quantitative approaches to map linkages between individuals, issues involve nonrandom properties of networks, norms, and group dynamics that socially isolate and/or affect behavioral transactions across cultural, age, and gender groups. Suggested themes include: o Composition and stability of drug and sex networks o Nonrandom injection sequencing within networks of IDUs o Gender roles and the organization of drug procurement o Lesbian/gay IDU networks and bridges to other networks o Norms about needle hygiene and exchange of sex for drugs o Gangs/cliques/street youth and the initiation and extension of sexual activity and drug use 2. Determinants, Mediators, and Reinforcers of Women's HIV-Related Behaviors. NIDA and NIMH are interested in behavioral influences especially as they vary demographically and/or culturally. Suggested themes are: o Physical, sexual, and/or emotional abuse. Research is needed to address physical and/or sexual violence against women and the relationship of violence and abuse to high- risk behaviors and women's ability to adopt HIV risk- reduction practices. Young women in abusive home settings may be a critical group. o The effect of serostatus on women's HIV risk behaviors and behavior change. Issues include the role of HIV antibody testing and/or serostatus on behavior, motivation to change, and prevention efforts; also how fertility/motherhood issues interact with serostatus to affect behavior change. o The effect of pregnancy, childbearing, and childrearing on women's HIV risk behaviors and behavior change. Research is needed on whether these conditions affect the social isolation of women and their access/receptivity to HIV risk-reduction measures. o Women's reasoning/relational styles. Issues include women's unique psychosocial development and gender socialization and the resulting effect on the ability to implement risk reduction or interpret prevention messages. 3. Gender-Specific Methodological and Measurement Studies. NIDA and NIMH encourage the development of methodologies and measures sensitive to women, especially multidimensional outcome measures of behavior change. Suggested themes include: o Innovative strategies, sampling, and tracking plans to identify, access, recruit, engage, intervene with, retain, and follow up women at highest risk for HIV. These women, particularly when in abusive relationships, are often hard to reach, tend to drop out, and are lost to followup. o Development of instruments and scales with proven validity and reliability among women. Design specificity to different racial/ethnic populations is especially desired. o New techniques or technologies for accruing data efficiently and economically. Investigators are encouraged to develop innovative strategies to deliver research findings to the field in a timely fashion. 4. Gender-Specific Behavior Change Interventions. NIDA and NIMH wish to support theoretically based interventions as well as interventions based on what is learned in basic research: o Studies are needed to evaluate what works, for whom it works, under what circumstances it works, and how long it works, taking into account the levels of risk engaged in as well as the episodic nature of HIV risk behaviors/behavior change and need for intermittent reinforcement. o Prevention messages. Studies are sought that address how women's behavior change is related to the structure, context, duration, and content of education and prevention messages, specifically, which media and messages have the most impact or cumulative impact (e.g., news reports, talk shows, movies, personal experiences, community messages in churches, clinics, or social agencies). o Studies of strategies to link HIV behavior change interventions for women to health care services and to drug abuse treatment, and vice versa (i.e., linkage of health care and drug treatment services to HIV behavior change interventions). o Woman-controlled technologies, such as the female condom or microbicides. Issues include whether these technologies are viable options for women at high risk of HIV; perceptions surrounding the technologies; reasons for and barriers facing their use; and optimal approaches to educate women (and men). o Other studies are encouraged that focus on individual gender- related attributes and/or the interaction of gender with race/ethnicity and the impact of these attributes and statuses on HIV risk behaviors and behavior change. NIDA Policy on HIV Counseling and Testing Researchers funded by NIDA, who are conducting research in community outreach settings, clinics, hospital settings, or clinical laboratories, and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk-reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing services. Persons at risk for HIV infection include injection drug users, crack cocaine users, and sexually active drug users and their sexual partners. Health Services Research Priorities Historically, NIDA's research agenda has included a health services research component; more recently, NIDA has placed increased importance on health services research, especially related to cost and financing as well as organizational aspects of drug abuse treatment/prevention. Therefore, applicants are encouraged to address one or more issues on: costs, cost effectiveness, access and utilization of services, financing, characteristics and matching, and organization and management. Only 25 percent of the NIDA grant budget may be used for services. These services must be directly related to the research study. Therefore, applicants who choose to address health services issues are strongly encouraged to form linkages and agreements with community service agencies. 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 also obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning this policy. Confidentiality. The Public Health Service (PHS) has a formal policy concerning Certificates of Confidentiality and communicable disease reporting. In brief, the policy reflects the expectation that research projects will cooperate with State and local health departments to assure that the purposes of reporting are accomplished, and the expectation that health departments will develop relationships with research projects that assist their mission without thwarting the research goals. A description of the policy as well as Instructions for Applicants can be obtained after award. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard AIDS receipt dates indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3032 - MSC 7762, Bethesda, MD 20892-7762, telephone 301-435-0714. The title and number of this PA must be typed in Item 2 on the face page of the application. The completed original and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC-7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for courier/overnight service) REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria o scientific or technical significance and originality of the proposed research; o appropriateness and adequacy of the research approach and methodology proposed to carry out the research; o qualifications and research experience of the principal investigator and staff; o availability of resources necessary to the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, and safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Susan Coyle, Ph.D. Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-42 Rockville, MD 20857 Telephone: (301) 443-6720 FAX: (301) 443-2636 Email: SCOYLE@AOADA.SSW.DHHS.GOV Willo Pequegnat, Ph.D. Office on AIDS National Institute of Mental Health 5600 Fishers Lane, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: WPEQUEGN@A0AMH2.SSW.DHHS.GOV Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8-A-54 Rockville, MD 20857 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: GFLEMING@AOADA2.SSW.DHHS.GOV Diana S. Trunnell Assistant Chief Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-3065 FAX: (301) 443-6885 Email: DT21a@NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279 and 93.242. Awards are authorized under the Public Health Service Act, Section 301 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. Grants will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (DHHS Publication No. (OASH) 82-50-000 GPO 0017-020-0090-1 (rev. 4/94). The PHS strongly encourages all grant recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education,library, day care, health care of early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Aug 18 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 30, pt. 1of1, 18 August 1995 Date: 18 Aug 1995 18:18:41 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 588 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <413e5h$fup@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950818 V24N30 P1O1 ************************************ X-comment: RFAs described: HD-95-017, PA-95-083, PA-95-084 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/95.08.18 NIH GUIDE - Vol. 24, No. 30 - August 18, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** SUMMARY REPORT ON CONFERENCE AND WORKSHOP ON ACADEMIC RESEARCH ENHANCEMENT AWARD PROGRAM National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** SYNTHESIS OF CONGENERS AND PRODRUGS (RFP NCI-CM-67246-74) National Cancer Institute INDEX: CANCER $$INDEX R2 ********************************************************** MATERNAL IMMUNIZATION FOR THE PREVENTION OF INFECTIOUS DISEASES IN NEONATES AND INFANTS (RFP NIH-NIAID-DMID-96-11) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R3 ********************************************************** NON-HUMAN PRIMATE MODELS FOR EVALUATION OF AIDS THERAPIES (RFP NIH- NIAID-DAIDS-96-15) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R4 05/15/95 ************************************************* SPECIALIZED RESEARCH CENTER PROGRAMS OR CENTER CORE GRANTS TO SUPPORT RESEARCH IN REPRODUCTION (RFA HD-95-017) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX P1 ********************************************************** WOMEN'S HIV RISK AND PROTECTIVE BEHAVIORS (PA-95-083) National Institute on Drug Abuse National Institute of Mental Health INDEX: DRUG ABUSE; MENTAL HEALTH $$INDEX P2 ********************************************************** MOLECULAR EPIDEMIOLOGY OF PROSTATE CARCINOGENESIS (PA-95-084) National Cancer Institute National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Environmental Health Sciences INDEX: CANCER; DIABETES, DIGESTIVE, KIDNEY DISEASES, ENVIRONMENTAL HEALTH SCIENCES THIS PUBLICATION IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE USING A PERSONAL COMPUTER (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435- 0692 FOR DETAILS. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. THE DIVISION OF RESEARCH GRANTS (DRG) HAS MOVED TO A NEW LOCATION. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** SUMMARY REPORT ON CONFERENCE AND WORKSHOP ON ACADEMIC RESEARCH ENHANCEMENT AWARD PROGRAM NIH GUIDE, Volume 24, Number 30, August 18, 1995 P.T. 34; K.W. 1014006 National Institutes of Health This notice announces the availability of a summary report on the conference and workshop on the Academic Research Enhancement Award (AREA) program of the National Institutes of Health (NIH) that was held in Indianapolis, IN in April 1995. The host and one of the sponsors of the conference was Ball State University, Muncie, IN; the other sponsors were the American Association of State Colleges and Universities and the NIH. Two hundred and seventeen participants attended the conference, representing 111 institutions from 25 states. INQUIRIES Copies of the summary report (and recommendations) on the AREA conference and workshop may be obtained from: Dr. Dorothy Adalis Office of Academic Research and Sponsored Programs Ball State University Muncie, IN 47306 Telephone: (317) 285-1600 FAX: (317) 285-1624 Email: 00d0adalis@bsuvc.bsu.edu In addition, a Book of Abstracts of research projects funded under the NIH AREA program was prepared to coincide with the conference. The Book was compiled from responses submitted by principal investigators of the results of their research effort under AREA grants and is presented as a sample of research productivity that may serve as a catalyst for the continued success of the AREA program. Copies of the AREA Book of Abstracts may be obtained from: Office of Grants Information Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 3032 - MSC 7762 Bethesda, MD 20892-7762 Telephone: (301) 435-0714 FAX: (301) 480-3963 Email: girg@drgpo.drg.nih.gov $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NCI-CM-67246-74 ****************************************** SYNTHESIS OF CONGENERS AND PRODRUGS NIH GUIDE, Volume 24, Number 30, August 18, 1995 RFP AVAILABLE: NCI-CM-67246-74 P.T. National Cancer Institute The Drug Synthesis and Chemistry Branch (DS&CB), Developmental Therapeutics Program (DTP), Division of Cancer Treatment (DCT) of the National Cancer Institute (NCI) is seeking contractors with expertise in chemical synthesis and drug design to synthesize a variety of compounds for evaluation as potential anti-cancer and anti-HIV agents. The assigned objectives of this project are to design and synthesize the following: (a) congeners of lead compounds having confirmed activity to enhance activity or potency; (b) prodrugs with structural modifications that may provide altered pharmacokinetics, altered drug transport, improved bio-availability through increased water solubility or increased chemical stability; (c) other altered structures that possess elements of both congener and prodrug; and (d) compounds related to natural products, e.g., alkaloids, heterocycles, nucleosides, peptides and the like. Each contractor must have available a fully operational facility including all necessary equipment and instrumentation for all aspects of the contract. The nature of this project requires that the following restriction be applied: "The NCI signs legally binding agreements with certain suppliers (often pharmaceutical or chemical companies) which state that all information on compounds submitted by the supplier will be held confidential." The successful offeror will be expected to synthetically modify such commercially confidential (discreet) materials. Thus, pharmaceutical or chemical companies could obtain valuable data on new lead compounds. Therefore, in order to honor the confidentiality agreement with the original supplier, the NCI believes that the compounds cannot be sent to potential competitors of the supplier, and thus pharmaceutical and chemical companies must be excluded from the competition. The intent of the exclusion is to prevent companies who market chemicals or drugs on the open market >From gaining undue competitive advantage by access to privileged inside information. The exclusion does not apply to companies and/or laboratories whose synthesis activities are performed on a specific order from another party. It is understood that such companies do not sell drugs or chemicals on the open market and are thus not in a position to profit from access to privileged information from NCI. It is anticipated that 6,032 hours per award per year will be required for this project. This is a recompetition of contracts currently held by the Purdue Research Foundation (N01-CM-17512), Research Foundation of the State University of New York at Buffalo (N01-CM-17569), Georgia Tech Research Foundation (N01-CM-17570) and (N01-CM-47012), and University of Tennessee (N01-CM-47038). It is anticipated that four cost-reimbursement contracts will be awarded for a period of three years, with two one-year options, beginning on or about August 1, 1996. INQUIRIES Requests for RFP No. NCI-CM-67246-74 may be directed to: Odessa Henderson Research Contracts Branch National Cancer Institute 6120 Executive Boulevard, Suite 603 Rockville, MD 20892 Telephone: (301) 496-8620 No collect calls will be accepted. $$R1 END ************************************************************ $$R2 BEGIN NIH-NIAID-DMID-96-11 ************************************* MATERNAL IMMUNIZATION FOR THE PREVENTION OF INFECTIOUS DISEASES IN NEONATES AND INFANTS NIH GUIDE, Volume 24, Number 30, August 18, 1995 RFP AVAILABLE: NIH-NIAID-DMID-96-11 P.T. National Institute of Allergy and Infectious Diseases The Respiratory Diseases Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID) has a requirement for a Maternal Immunization Group (MIG). This MIG will conduct Phase I and Phase II maternal immunization clinical trials to evaluate candidate vaccines for infectious diseases in neonates and infants. The Contractor must have demonstrated experience in the clinical evaluation of vaccines, and have demonstrated capacity to organize and administer a clinical study. It is anticipated that one cost-reimbursement, level-of-effort contract will be awarded for a period of five years. Request for Proposals (RFP) NIH-NIAID-DMID-96-11 will be available electronically on or about August 23, 1995 and may be accessed through either the NIH Gopher, NIH Grant Line, or the NIH Home Page by using the following electronic mail addresses and instructions: 1. To access the NIH Gopher: Point your gopher client to GOPHER.NIH.GOV PORT 70 (you should now be in the NIH Gopher). Select "Grant & Research Information", then select "R&D Requests for Proposals (RFP)." 2. To access the NIH Grant Line (via modem): Configure your terminal emulator as: 1200 or 2400 baud, even parity, 7 data bits, 1 stop bit, Half Duplex. Using the procedure specified in your communication software, dial 301-402-2221. When you get a response indicating that you have been connected, then type ,GEN1 (the comma is mandatory) and press ENTER; you will be prompted by the NIH system for "INITIALS?". Type BB5 and press ENTER. You will then be prompted for "Account?". Type CCS2 and press ENTER. 3. NIH Home Page (via the World Wide Web): Access the NIH Home Page by using http://www.nih.gov. Once you are in the NIH Home Page, select "Grants & Contracts", then select "R&D Requests for Proposals (RFP)." INQUIRIES The RFP for this procurement has been revised to include only the Work Statement, deliverable and reporting requirements, special requirements and mandatory qualification, if any, the Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Following proposal submission and the initial review process, offerors comprising the competitive range will be requested to provide additional documentation to the Contracting Officer. Responses to this RFP will be due on January 12, 1996. Any responsible offeror may submit a proposal that will be considered by the Government. This advertisement does not commit the Government to award a contract. Inquiries regarding this RFP may be directed to: Sara M. Southard Contracts Management Branch National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3C07 Bethesda, MD 20892 Telephone: (301) 402-6289 FAX: (301) 480-5253 Email: ss63e@nih.gov $$R2 END ************************************************************ $$R3 BEGIN NIH-NIAID-DAIDS-96-15 ************************************ NON-HUMAN PRIMATE MODELS FOR EVALUATION OF AIDS THERAPIES NIH GUIDE, Volume 24, Number 30, August 18, 1995 RFP AVAILABLE: NIH-NIAID-DAIDS-96-15 P.T. National Institute of Allergy and Infectious Diseases The Targeted Interventions Branch, Basic Sciences Program, Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID) has a requirement for evaluating therapeutic approaches and drug-based inhibitors of sexual transmission for HIV/AIDS in non- human primate models of lentivirus infection. Evaluation encompasses the determination of efficacy, toxicity, and when needed, limited pharmacokinetics in models of (1) acute and chronic infection and (2) sexual transmission. Therapies to be tested alone and in combination include antiviral agents (drugs and biologics), immune-based strategies, and gene-based therapies. Examples of lentivirus models appropriate for this RFP include HIV-1, HIV-2, pathogenic SHIV, or other relevant lentivirus that induces disease in a non-human primate animal model. Excluded from this competition are small animal models of lentivirus infection. These capabilities will be used by the Division of AIDS, NIAID, in its efforts to develop intervention and prevention strategies for HIV/AIDS. It is anticipated that two cost-reimbursement, level-of-effort type contracts will be awarded for a period of five years beginning on or about July 9, 1996. However, the Government reserves the right to limit the number of awards based on the merit of the technical proposals received. The electronic version of Request for Proposals (RFP) NIH-NIAID- DAIDS-96-15 is available through the NIH GOPHER and Internet using the following electronic mail addresses and instructions: 1. To access the NIH Gopher: Point your gopher client to GOPHER@NIH.GOV PORT 70. (You should now be in the NIH Gopher.) Select "Grant and Research Information," then select "R&D Request for Proposals (RFP)." 2. To access the NIH Grant Line (Internet): Configure your terminal emulator as: 1200 or 2400 baud, even parity, 7 data bits, 1 stop bit, Half Duplex. Using the procedure specified in your communication software, dial 301-402-2221. When you get a response indicating that you have been connected, then type ,GEN1 (The comma is mandatory) and press ENTER; you will be prompted by the NIH system for "INITIALS?". Type BB5 and press ENTER. You will then be prompted for "Account?". Type CCS2 and press ENTER. INQUIRIES The RFP for this procurement has been revised to include only the Statement of Work, deliverable and reporting requirements, the Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Following proposal submission and the initial review process, offerors comprising the competitive range will be requested to provide additional documentation to the Contracting Officer. Responses to this RFP will be due on October 12, 1995. Any responsible offeror may submit a proposal that will be considered by the Government. This advertisement does not commit the Government to award a contract. Inquiries regarding this RFP may be directed to: Joyce U. Sagami Contracts Management Branch National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3C07 Bethesda, MD 20892 Telephone: (301) 496-7118 FAX: (301) 402-0972 Email: js73b@nih.gov No collect calls will be accepted. $$R3 END ************************************************************ $$R4 BEGIN HD-95-017 FULL-TEXT ************************************** SPECIALIZED RESEARCH CENTER PROGRAMS OR CENTER CORE GRANTS TO SUPPORT RESEARCH IN REPRODUCTION NIH GUIDE, Volume 24, Number 30, August 18, 1995 RFA AVAILABLE: HD-95-017 P.T. 04; K.W. 0413002, 0710030 National Institute of Child Health and Human Development Letter of Intent Receipt Date: January 10, 1996 Application Receipt Date: May 15, 1996 PURPOSE The National Institute of Child Health and Human Development (NICHD) provides funding for a limited number of research centers in the reproductive sciences. These centers are broadly based investigative endeavors encompassing research of a biomedical nature. They are supported by the Reproductive Sciences Branch (RSB) of the Center for Population Research through Center Core Grants (P30) and Specialized Research Center Grants (P50). These centers form a national network that fosters communication, innovation, and high quality reproductive research. Reproductive Sciences Research Centers provide a stimulating, multidisciplinary environment that attracts and nurtures both established and promising investigators. Each Center works closely with NICHD staff in participating in a Center Network and in carrying out its objectives in a manner consistent with the goals and mission of the NICHD. Each award will be for a five-year period, and it is anticipated that $3.8 million will be available to fund up to four new or competing renewal awards in fiscal year 1997. Applications for new P30 Center Core Grants will not be considered for this round of competition. 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 Research Center Programs or Center Core Grants to Support Research in Reproduction, is related to the area of family planning. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington DC 20402-9325 (telephone 202/512-1800). INQUIRIES The RFA, which describes the eligibility requirements, 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), NIH GOPHER (gopher.nih.gov), and by mail and E-Mail from the program contact listed below. Louis V. DePaolo, Ph.D. Center for Population Research National Institute of Child Health and Human Development Building 6100, Room 8B01 Bethesda, MD 20892-7510 Telephone: (301) 496-6515 FAX: (301) 496-0962 Email: depaolol@hd01.nichd.nih.gov $$R4 END ************************************************************ $$P1 BEGIN PA-95-083 FULL-TEXT ************************************** WOMEN'S HIV RISK AND PROTECTIVE BEHAVIORS NIH GUIDE, Volume 24, Number 30, August 18, 1995 PA AVAILABLE: PA-95-083 P.T. 34; K.W. 0715008, 0411005, 0404000, 0745027 National Institute on Drug Abuse National Institute of Mental Health PURPOSE The purpose of this program announcement (PA) is to support basic social and behavioral research on women's HIV risk and/or protective behaviors combined with community-level intervention strategies aimed at understanding and preventing HIV/AIDS in women whose drug and sex practices put them at high risk of HIV infection, i.e., not-in- treatment injection drug users (IDUs), crack users, injecting and noninjecting sexual partners of male and/or female IDUs, and women who trade sex for drugs, money, or subsistence. Historically, these women have been omitted from research or have been difficult to reach and retain in research; as a result, the knowledge base is often limited to the male experience. Because of the increasing and disproportionate numbers of women acquiring HIV disease, this PA seeks to widen the research base on HIV risk behaviors and risk- taking contexts by focusing on women and including protective behaviors and contexts in addition to risks. Awards made under this PA will use the investigator-initiated research project grant (R01) mechanism. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Women's HIV Risk and Protective Behaviors, is related to the priority areas of alcohol and other drugs and mental health and mental disorders. 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 Superintendent of Documents, Government Printing Office, Washington DC 20402 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Susan Coyle, Ph.D. Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-42 Rockville, MD 20857 Telephone: (301) 443-6720 FAX: (301) 443-2636 Email: SCOYLE@AOADA.SSW.DHHS.GOV Willo Pequegnat, Ph.D. Office on AIDS National Institute of Mental Health 5600 Fishers Lane, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: WPEQUEGN@A0AMH2.SSW.DHHS.GOV $$P1 END ************************************************************ $$P2 BEGIN PA-95-084 FULL-TEXT ************************************** MOLECULAR EPIDEMIOLOGY OF PROSTATE CARCINOGENESIS NIH GUIDE, Volume 24, Number 30, August 18, 1995 PA AVAILABLE: PA-95-084 P.T. 34; K.W. 0705075, 0785055, 0715035, 0755030, 0760002 National Cancer Institute National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Environmental Health Sciences PURPOSE The Division of Cancer Etiology of the National Cancer Institute (NCI), the Division of Kidney, Urologic, and Hematologic Diseases of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the Division of Extramural Research and Training of the National Institute of Environmental Health Sciences (NIEHS) invite investigator-initiated research grant applications for molecular epidemiologic studies to further the understanding of prostate cancer etiology. A major emphasis of this PA is to stimulate the use of biochemical and molecular markers for identifying and assessing risk factors of prostate cancer that could lead to effective prevention strategies. Support of this program will be through the National Institutes of Health (NIH) individual research project grants (R01) and First Independent Research Support and Transition (FIRST) (R29) awards. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Molecular Epidemiology of Prostate Carcinogenesis, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221), the NIH GOPHER (gopher.nih.gov), and by mail from the program contact listed below. Dr. Kumiko Iwamoto Division of Cancer Etiology National Cancer Institute Building Executive Plaza North, Room 535 Bethesda, MD 20892-7395 Telephone: (301) 496-9600 FAX: (301) 402-4279 Email: Jasonc@EPNDCE.NCI.NIH.GOV $$P2 END ************************************************************ From owner-sci-resources@net.bio.net Tue Aug 22 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-95-017 - V24(30) 08/18/95 Date: 22 Aug 1995 21:42:30 -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: <41ebjm$e0n@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HD95017 HD-95-017 P1O1 *************************************** SPECIALIZED RESEARCH CENTER PROGRAMS OR CENTER CORE GRANTS TO SUPPORT RESEARCH IN REPRODUCTION NIH GUIDE, Volume 24, Number 30, August 18, 1995 RFA: HD-95-017 P.T. 04; K.W. 0413002, 0710030 National Institute of Child Health and Human Development Letter of Intent Receipt Date: January 10, 1996 Application Receipt Date: May 15, 1996 PURPOSE The National Institute of Child Health and Human Development (NICHD) provides funding for a limited number of research centers in the reproductive sciences. These centers are broadly based investigative endeavors encompassing research of a biomedical nature. They are supported through Center Core Grants (P30) and Specialized Research Center Grants (P50). These centers form a national network that fosters communication, innovation, and high quality research. Reproductive Sciences Research Centers provide a stimulating, multidisciplinary environment that attracts and nurtures both established and promising investigators. Each Center works closely with the NICHD staff in participating in a Center Network and in carrying out its objectives in a manner consistent with the goals and mission of the NICHD. Background The Reproductive Sciences Branch (RSB) of the Center for Population Research (CPR) of the NICHD supports basic and clinical research on reproduction that relies on a variety of approaches in biomedical sciences. Among the grant mechanisms used to provide research support, the RSB uses: (1) Specialized Research Center Grants (P50s), which support integrated groups of research projects and supporting core service facilities. The research activities included in such project grants must comprise, by definition, a multidisciplinary approach to biomedical problems addressing the research objectives announced in this Request for Applications (RFA). These research programs may have more than one theme, focus, or emphasis, but all of the subprojects involved must be responsive to one or more of the specific research areas of reproduction supported by the RSB. (2) Center Core Grants (P30s), which support Center Core facilities designed to enhance existing federally supported research projects within the purview of the RSB, CPR, NICHD. Such center awards require a critical mass of individual awards for which coordinated technical support would be cost-effective to the NIH. Core Grants provide no funds for the direct support of research projects other than for new program development; however, by making cost-effective resources and facilities available, they enhance the productivity of existing projects that are either integrated in a specialized research area or organized within a central theme of research that addresses the research objectives announced in this RFA. At present, the RSB supports a fixed number of centers with a commitment of five years of support that is competitively renewable for additional five-year periods. An annual competition is held to guide the NICHD's award decisions for funding new or renewal Center Grant applications in the next fiscal year. In fiscal year 1997, awards to one P50 Center and three P30 Centers end, and it is expected that up to four new or renewal competing awards will be made. It is anticipated that the existing Centers will submit renewal applications. New groups of investigators interested in submitting a P50 Center application, in addition to the current awardees, are invited to compete for the awards available in FY 1997. Applications for new P30 Center Core Grants will not be considered for this round of competition. 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 Research Center Programs or Center Core Grants to Support Research in Reproduction, is related to the area of family planning. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). ELIGIBILITY REQUIREMENTS Domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, and units of State or local governments are eligible to apply for these centers. Applications prepared for this competition may not propose multi- institutional consortium arrangements. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as Principal Investigators. Applications eligible for award consideration include those for a new P50 Center or a renewal of a P30 or P50 Center. Applications for a new P30 Center are not eligible for award consideration and, if received, will be returned to the applicant unreviewed. MECHANISM OF SUPPORT The support mechanisms for these programs are the P50 Specialized Reproductive Sciences Research Center Grant and the P30 Reproductive Sciences Research Center Core Grant. The applications should be prepared in a manner consistent with the policy and instructional details of this RFA and the general guidelines presented in the publications entitled either P50 SPECIALIZED RESEARCH CENTER GRANT GUIDELINES or P30 CENTER CORE GRANT GUIDELINES that are available >From the NICHD offices listed below. The current policies and requirements that govern the research grant programs of NIH will prevail (Code of Federal Regulations, Title 42, Part 52 and Title 45, Part 75). The total project period for applications submitted to this RFA is five years. FUNDS AVAILABLE Although this solicitation is included in the fiscal plans for FY 1997, support for these center grants is contingent upon the receipt of funds for these purposes. The number of grants to be awarded is also contingent upon a sufficient number of applications receiving high enough levels of merit to be considered for an award. It is expected that up to four awards will be made as a result of this RFA within the expected total costs limit of $3.8M available for the first year. SPECIAL REQUIREMENTS Specialized Research Center Grants (P50) In order to receive funding, an individual domestic institution's application for a P50 Center Grant must have three or more related, integrated, and high quality research subprojects that provide a multidisciplinary, yet thematic, approach to the problems to be investigated. These research subprojects may be accompanied by an appropriate number and type of core facilities, as described below, for providing cost-effective technical support. For new P50 Center applications, at least one of the subprojects must be a clinical research program. Furthermore, it is strongly encouraged that at least one basic science subproject be in a similar scientific area as a clinical subproject in order to provide a setting for translation of basic science knowledge to the clinic. The inclusion of basic and clinical research in a P50 Center should also enhance the interaction between basic and clinical scientists, thereby enriching the research environment in the Center. Although existing P50 Centers will not be required to propose a clinical research subproject in the applications for competing renewals, they are strongly encouraged to do so. The concurrent submission of an R01 or R29 research project application to do essentially the same research as that proposed in a subproject of a P50 Center application is permissible within the context of NIH policy. As a general policy, preference in selection for funding by NICHD will be given to the subprojects of the P50 Center in order to maintain the integrity of the program and the validity of its merit assessment. The coincident R01 or R29 application(s) usually will be expected to be withdrawn or relinquished. P50 subprojects must address one or more of the biomedical topics announced in this RFA to be eligible for funding. Center Core Grants (P30) A domestic institution's application for a reproductive sciences research Center Core Grant (P30) must be predicated on the existence of a comprehensive research base in the reproductive sciences. This research base must be comprised of a minimum of ten specifically relevant NIH-funded projects of which at least five are administered by RSB, CPR. Regardless of funding source, all projects must directly address one or more of the biomedical topics announced in this RFA to be eligible for inclusion in the center, and all must be active on April 1, 1997. The eligibility for funding a core in a P30 Center is determined by the demonstrated need of a minimal number of three relevant NIH (or other federally peer-reviewed and funded) research grants from the research base in the application. At least two of the user projects justifying the proposed Core must be NICHD-funded grants. P30 Center grant funds support only active users of the core facilities and services from the research base (projects) proposed in the Center grant application, and only serve programs of scientific research relevant to the mission of the RSB, CPR. Core facilities eligible for support under this announcement are organized activities directly providing reagents, assays, sophisticated technical services and technical expertise in areas required by multiple projects of a center. Such Core facilities neither directly conduct project type research nor serve as a funding source for non-Center technical services available elsewhere at the institution. It is expected that such Core facilities will be organized to provide training only for eligible users and only to the extent necessary to utilize the Core effectively. The general guideline request for information demonstrating research training program history and availability pertains to discussing the overall richness of the environment of the Center's setting and should not be confused with Core service needs per se. In addition to requesting funds for the core facilities, a P30 Center application can also request funds for a New Program Development (NPD) component. To be considered for funding, the principal investigator of an NPD should be either a new investigator or an early career stage investigator seeking to conduct research in a new area which is significantly different from their past research focus. If an NPD is requested, it must be a subproject description with a research plan formatted in the usual NIH research project style. Sufficient detail should be provided to allow a full peer-review evaluation of its merits. Budget New Specialized Research Center Grant (P50) applications may not request more than $600,000 in direct costs for the first year. Renewal applications from existing P30 or P50 Centers may not request initial year direct costs exceeding 120 percent of the Council recommended direct costs for the final year of the preceding project period. Budgets of new and renewal applications will be stringently reviewed within these guidelines. Unless prior written approval of the NICHD has been obtained, applications with requests exceeding these guidelines will be administratively withdrawn by the NICHD and returned to the applicant. Applicants must request travel funds for the Principal Investigator to attend an annual meeting of the directors of P50s and P30s. RESEARCH OBJECTIVES The ultimate goals of biomedical research in the reproductive sciences are to develop new knowledge leading to clinical applications that will enable men and women to control their fertility with methods that are safe, effective, inexpensive, reversible, and acceptable to various population groups, and to overcome problems of infertility and reproductive disorders. Domestic U.S. Reproductive Sciences centers designated as "Specialized Reproductive Sciences Research Centers" (P50s) and as "Reproductive Sciences Research Centers" (P30s) are awarded funds for the support of comprehensive reproductive research programs of high quality that focus on topics deemed to be of high priority and significance because of their critically important relationship to the mission of the RSB, CPR. This RFA is specifically designed to stimulate the reproductive sciences research community to organize or to maintain reproductive sciences research centers of outstanding quality that, serving as national research resources, form a network that fosters communication, innovation, and high quality reproductive research. Applications are encouraged for the biomedical topics listed below: 1. Reproductive medicine: Fertility and infertility aspects, including assisted reproductive technologies 2. Regulatory mechanisms governing gametogenesis, including intracellular processes controlling mitosis and meiosis and germ cell-somatic cell interactions which support gametogenesis 3. Ovarian follicular development, especially intraovarian mechanisms regulating follicular selection and atresia 4. Reproductive neuroendocrinology, particularly molecular and cellular control of hypothalamic and pituitary hormone secretion and pulsatility 5. Mechanisms of action of reproductive hormones, particularly at the cellular and molecular level, and how cytokines and growth factors affect reproductive hormone actions 6. Studies on fertilization, preimplantation embryo genetics and development or implantation 7. Mechanisms regulating fertility- or infertility-related genital tract functions 8. Immunological mechanisms regulating fertility Applications submitted in response to this RFA may not request subprojects in P50 Centers or Core facilities access in P30 Centers for projects whose main research focus is in the area of reproductive oncology, reproductive toxicology or reproductive epidemiology. These topic areas are outside the purview of research areas supported by RSB, CPR, and, therefore, will be deemed nonresponsive to this RFA. Since elimination of such subprojects (P50) or grants (P30) >From a center application can jeopardize the funding status of the center application, prospective applicants preparing either a new or competing center grant application are encouraged to discuss such programmatic issues with the program staff cited under INQUIRIES in this RFA. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is 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 Population, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Interested applicants may consult with the RSB staff contact regarding reproductive sciences center grants (P50s and P30s). Prospective applicants are asked to submit, by January 10, 1996, a letter of intent that includes a descriptive title of the proposed research, the names of relevant key investigators, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NICHD staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Louis V. DePaolo at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. 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, 6701 Rockledge Drive, Room 3032, MSC 7762, Bethesda, MD 20892-7762, telephone 301/435-0714 and from the program administrator listed under INQUIRIES. It is especially important that applicants obtain and follow the supplemental NICHD guidelines for preparing the application. These guidelines address special organizational aspects that benefit from certain tabulations in addition to the usual instructions. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development Building 6100, Room 5E03 Bethesda, MD 20892-7510 Applications must be received by May 15, 1996. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by NICHD. Incomplete and/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 NICHD in accordance with the review criteria detailed in the P50 SPECIALIZED RESEARCH CENTER GUIDELINES AND P30 CENTER CORE GRANT GUIDELINES (available >From the NICHD program staff listed under INQUIRIES). Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Child Health and Human Development Council (NACHHD). Applications submitted in response to this RFA may receive a site visit as part of the review process. However, applicants should assure that their applications are complete and can stand on their own. AWARD CRITERIA The anticipated date of award is April 1, 1997. Funding decisions will be based on the recommendations of the peer review group and the NACHHD, program relevance, and the availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Louis V. DePaolo, Ph.D. Center for Population Research National Institute of Child Health and Human Development Building 6100, Room 8B01 Bethesda, MD 20892-7510 Telephone: (301) 496-6515 FAX: (301) 496-0962 Email: depaolol@hd01.nichd.nih.gov For information on budget and fiscal matters, contact: Ms. Melinda Nelson Office of Grants and Contracts National Institute of Child Health and Human Development Building 6100, Room 8A17K Bethesda, MD 20892-7510 Telephone: (301) 496-5481 FAX: (301) 402-0915 Email: nelsonm@hd01.nichd.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.864, Population Research. Awards are made under authorization of the PHS Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Aug 22 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 20 August 1995 Date: 22 Aug 1995 21:42:34 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 134 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <41ebjq$e12@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: BUL-9509 Sept 1995 Bulletin, Vol. 23; No.1 File size (bytes): STIS Filename: bul9509.txt Document Type: General Publication Title: NSF 95-27 Grant Proposal Guide File size (bytes): STIS Filename: nsf9527.txt Title: NSF 95-28 Grant Proposal Guide (FORMS KIT) File size (bytes): STIS Filename: nsf9528.txt Also available: nsf9528.doc Document Type: IAI Newsletter Title: IAIISPS - PROGRAMA CIENTIFICO INICIAL (ISP) File size (bytes): STIS Filename: iaiisps.txt Document Type: Press Release Title: REVIEW TO EXPLORE HOW CURRENT INNOVATIONS CAN REINFORCE UNDERGRADUATE SCIENCE EDUCATION File size (bytes): STIS Filename: pr9554.txt Title: NEW UNDERGRADUATE SCIENCE EDUCATION AWARDS AIM REFORM INSTITUTION-WIDE File size (bytes): STIS Filename: pr9555.txt Title: KENYAN FOSSILS POINT TO NEW SPECIES OF HUMAN ANCESTOR File size (bytes): STIS Filename: pr9556.txt Document Type: Program Guideline Title: NSF 95-125 - CISE Infrastructure Research Program File size (bytes): 36268 STIS Filename: nsf95125.txt Title: NSF 95-127 Comprehensive Reform Of Science, Mathematics, Engineering, And Technology Education File size (bytes): STIS Filename: nsf95127.txt Title: NSF 95-128--CISE Postdoctoral Research Associates in Computational Science and Engineering and Experimental Computer Science File size (bytes): STIS Filename: nsf95128.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 8182 STIS Filename: cmmtg.txt Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 108484 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Directory File size (bytes): 105023 STIS Filename: phnorg.txt Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 43146 STIS Filename: sesvac.txt Document Type: Report Title: NSF 95-65 Restructuring Engineering Education File size (bytes): A Focus on Change STIS Filename: nsf9565.txt (NSF) ------------------------------------------------------------------------ ** 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 nsf9565.txt, the text of your message should be as follows: get nsf9565.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9565.txt, you would enter: ftp> get nsf9565.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Sun Aug 27 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 31, pt. 1of1, 25 August 1995 Date: 28 Aug 1995 12:52:38 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 686 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <41t6q6$mis@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950825 V24N31 P1O1 ************************************ X-comment: RFAs described: PA-95-085 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/95.08.25 NIH GUIDE - Vol. 24, No. 31 - August 25, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT AREAS OF HIGH PROGRAM RELEVANCE National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX N2 ********************************************************** EXTRAMURAL ASSOCIATES RESEARCH DEVELOPMENT AWARD (RFA OD-96-001) National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** NEW ENGLAND SBIR/STTR WORKSHOP National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX P1 ********************************************************** RESEARCH ON ATHEROSCLEROSIS LESIONS USING HUMAN TISSUES COLLECTED IN PDAY/RFEHA (PA-95-085) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD THIS PUBLICATION IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE USING A PERSONAL COMPUTER (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435- 0692 FOR DETAILS. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. THE DIVISION OF RESEARCH GRANTS (DRG) HAS MOVED TO A NEW LOCATION. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT AREAS OF HIGH PROGRAM RELEVANCE NIH GUIDE, Volume 24, Number 31, August 25, 1995 P.T. 34; K.W. 0413002, 0775020, 0775013 National Institute of Child Health and Human Development PURPOSE The purpose of this notice is to reannounce the broad programs of the National Institute of Child Health and Human Development (NICHD) and to highlight priority research areas therein that for the next two years, the NICHD will consider of high program relevance. Background information, details of the process, and a description of these areas are given below. Background The NICHD has primary responsibility for supporting basic, clinical, and applied research and research training in maternal and child health; human development; reproductive biology and fertility regulation; population dynamics; developmental biology and teratology; clinical nutrition; perinatal and infant morbidity and mortality; human learning and behavior; mental retardation and developmental disabilities; pediatric, adolescent, and maternal AIDS; and medical rehabilitation. Although the NICHD will continue to fund those projects that are deemed to be scientifically excellent and innovative within the full scope of its mission, this notice highlights areas of particularly high program relevance to achieve the following goals: o Given fiscal constraints, formal identification of areas of high program relevance will enable the NICHD to encourage submission of applications on these topics and foster emerging areas of science. Establishing and publishing priorities, to be used as part of a select-pay process, will help the NICHD meet program needs and take advantage of scientific opportunities, while still ensuring that high quality applications are funded. o Support of research and special consideration in funding in the areas of high program relevance, along with studies that are innovative or high-risk/high payoff, maintain critical ongoing research efforts, or are conducted by new investigators, will ensure that broader opportunities exist for meritorious research to be funded. o It is anticipated that this process will reduce the need to publish Requests for Applications (RFAs) and Program Announcements. This notice reflects the commitment of the NICHD to inform the scientific community and the public of areas identified as high priority or of high program relevance and to indicate that any decision to fund a grant out of percentile order will be based on scientific merit and program goals. PROCESS All applications that are ranked highly by initial peer review will ordinarily be paid in percentile rank order, up to the point where the NICHD obligates 75 percent of the funds available for each National Advisory Child Health and Human Development Council (NACHDC) round. From the point where 75 percent of the funds are expended to the 20th percentile is the "discretionary zone" (DZ). The staff will recommend paying selected grants from the DX with the remaining 25 percent of funds with the advice of the NACHDC. The areas of high program relevance listed below will be used as the first criterion guiding any decision to pay grants that are in the DZ. These high priority areas will be used as a guide for FY 1996 and FY 1997. Priorities and procedures will be revised, as appropriate, at the end of that time. Areas of High Program Relevance The following areas of high program relevance are organized according to the three extramural research centers of the NICHD. Center for Research for Mothers and Children Pregnancy: Research is needed to better understand how several factors, both external and internal to the maternal-fetal unit, affect pregnancy outcomes and maternal well being, especially in different ethnic and racial populations. Within this broad area, the priorities are: o High Risk Pregnancy - including studies of factors responsible for maintaining pregnancy and initiating labor. o Therapeutics During Pregnancy - particularly research to develop and evaluate maternal therapies targeted to ensure optimal pregnancy outcomes. o Maternal-Fetal-Placental Unit - particularly studies to investigate the anatomic and physiologic role of the placenta in the well-being of both the mother and fetus and the pathogenesis of intrauterine growth retardation. o Vertical Transmission of Infections - especially research to elucidate the mechanisms by which infectious agents, including HIV, are transmitted to the fetus/neonate. Priority would extend to studies that develop and evaluate therapies that prevent or interrupt this transmission. Growth and Development: The NICHD supports basic and clinical research to better understand many facets of normal and abnormal growth and development. Special consideration will be given to studies in areas that represent opportunities for understanding various aspects of growth, maturation, and adaptation, ranging from genetic/molecular interactions to the development of the whole organism. The selected areas are: o Early Development and Fetal Growth - particularly studies on signal transduction and identification of regulatory factors that are responsible for defining intra- and intercellular interactions, pattern formation, organogenesis, and tissue differentiation. Brain and Nervous System Development - particularly research on the cellular, molecular, genetic, and physiological aspects of central nervous system (CNS) development; and cognition, motor function, and behavior of the child. Also of interest is the impact of insults during gestation on CNS development. Nutrition and Growth - particularly studies of optimal nutrition during the fetal and neonatal periods, with emphasis on the preterm infant, delineation of the biological role of human milk, and the impact of various nutritional factors on physical, cognitive, and behavioral development. Prevention, Diagnosis, and Treatment of Developmental Abnormalities: The NICHD is interested in developing and evaluating modern technologies that assess the cause and pathogenesis of developmental abnormalities and provide the basis for developing novel strategies to treat and prevent these conditions. Two specific areas of interest are: Prenatal/Perinatal/Infant/Early Childhood Screening, Diagnosis, Assessment and Therapy - including research to develop (1) methodologies that can assess fetal well being, genetic disorders, gestational or neonatal infections, behavioral abnormalities, and congenital anomalies; and (2) new behavioral, genetic, nutritional, pharmacological, and surgical therapies. o Antecedents of Adult Disease - particularly studies to understand the interaction of environment and genotype in the developing human, as predictors of adult well-being. Behavioral Development: A variety of mortality and morbidity statistics for children and youth highlight the need to develop effective, theory-based, behavioral prevention and intervention strategies. The areas with high program relevance are: Biobehavioral Interactions - including studies on the interactions between biological (i.e., genes, hormones, CNS) and behavioral processes. o Risk Taking and Compliance - including studies on the psychological and behavioral factors associated with risk taking and compliance/adherence, particularly during middle childhood and adolescence. One major interest area is unintentional injuries. o Factors Influencing Normal and Aberrant Learning, Perception and Cognition - particularly studies that investigate the genetic, biological, and behavioral mechanisms involved in learning. o Destructive Behavior - including studies on the underlying neuropathology and behavioral antecedents of maladaptive behaviors (e.g., those that are self-injurious, repetitive and aggressive), and on their diagnosis, treatment and management. o Race and Ethnicity - particularly studies to clarify the relationships between minority status and social, emotional and cognitive development in children and their families. Center for Population Research Reproductive Biology: New knowledge is needed to provide innovative contraceptive leads, improve means of alleviating infertility, and enhance the effectiveness and pregnancy outcomes of assisted reproductive technologies. Selected research topics are targeted to the unique features of the male and female reproductive systems. o Male fertility/infertility - particularly studies that address the (1) molecular, genetic, hormonal, and intracellular factors affecting spermatogenesis; (2) pathophysiology of male infertility, including studies on how the male genome contributes to gonadal, fertilization, or implantation failure; and (3) diagnosis and treatment of male infertility. o Female fertility/infertility - particularly studies that address (1) molecular, genetic, and hormonal events controlling oocyte and follicular development; (2) fertilization, preimplantation genetics and development, and cell-to-cell interactions regulating implantation; and (3) cervical factor infertility, uterine dysfunctions associated with infertility, the relation of endometriosis to infertility, and the treatment of benign gynecologic diseases. Epidemiology and Evaluation of Infertility: As research improves the ability to treat millions of individuals with infertility, studies are needed to better understand ways to prevent the condition and evaluate the potential long-term impact of related treatments. Selected research is needed in two areas: o Prevalence and Risk Factors - including studies on the (1) prevalence of infertility and reduced fertility; and (2) risk factors for these conditions (e.g., occupational, environmental, and medical factors, including such conditions as leiomyomata or endometriosis). o Treatments: Efficacy/Adverse Outcomes - particularly epidemiologic studies to (1) determine the efficacy and adverse effects of infertility treatments on men, women, and their offspring, and (2) establish the mechanisms and rates of occurrence of adverse effects and evaluate ways to reduce their incidence. Development and Evaluation of Contraceptives: The widespread use of long-acting contraceptives, such as Depo-Provera or other injectable progestins, raises important scientific issues. In addition, given that at any point in time most women in the U.S. wish to prevent pregnancy and that rates of heterosexual transmission of HIV and new HIV cases among women are increasing, it is critical that new and improved contraceptive methods be developed and evaluated that prevent both pregnancy and transmission of disease. o The Impact of Depo-Provera - particularly studies on the causes and treatment of the side effects of Depo-Provera (e.g., bone loss, weight gain, bleeding problems, and extended infertility after discontinuing use). o Vaginal Physiology and Immunology - particularly studies on the influence of intravaginal contraceptive products on the vaginal ecosystem and the relationship of these factors to disease transmission. o Comparative Protection/Risk of Various Methods - including studies to (1) clinically evaluate currently available spermicides or to epidemiologically assess their protective value for HIV infection; (2) develop and evaluate new topical spermicides/microbicides for contraceptive efficacy and relative protection against disease; (3) define the degree of protection or increased risk for HIV infection associated with using other contraceptive methods and the mechanisms by which these effects are achieved. Special emphasis is placed on hormonal contraceptives and how they affect the acquisition and progression of HIV infection. Behavioral Studies of Pregnancy and Family Formation: U.S. rates of teen pregnancy and childbearing are among the highest in the industrialized world; over two-thirds of births to teens and nearly one-third of all births in this country now occur outside of marriage. To strengthen the research base to address these closely related issues, U.S. or comparative studies are needed in three areas: o Men's Behavior - particularly research on the influence of gender roles and relationships, male and couple influences on fertility- related behavior, and male involvement in parenting. o Determinants/Consequences of Non-Marital Childbearing - including research on marriage and cohabitation and the factors underlying the changing relationship of marital status to fertility behavior. o Prevention - particularly behavioral research on factors that contribute to improved contraceptive use and the prevention of unintended pregnancy. Immigration: Meeting the challenge created by the flow of immigrants across U.S. borders requires improved demographic information about population movement, its causes, and its consequences. Areas of high program relevance are: o Measurement Issues - including studies to develop improved methods to better measure and analyze U.S. immigration and emigration trends. o Immigration Processes and Their Impact - including research on the (1) processes through which migrants attach and adapt to the population; (2) selectivity of immigrants in terms of health, socioeconomic status, and resilience; (3) intergenerational transmission of skills and resources; and (4) impact of international migration on the health and well-being of both immigrant and native- born individuals, families, communities, and populations. National Center for Medical Rehabilitation Research Medical Rehabilitation Outcomes Research: Research is needed to strengthen scientific evidence about the outcomes of therapeutic practices relevant to the rehabilitation and health care of people with disabilities. Special consideration will be given to the following areas: o Assessing Outcomes - particularly studies that (1) assess outcomes valued by consumers, providers, and payers of medical rehabilitation services; and (2) design and evaluate flexible methods for weighing the findings of specific outcome studies. o Models and Measures - particularly studies that 1) develop and validate theory-based models, classification systems, and measures of rehabilitative interventions; and (2) develop measures of social, physical, and attitudinal environments that may influence the medical rehabilitation outcomes of individuals. Habilitation of Infants and Children with Early-Onset Physical Disabilities: Improved interventions must be developed and evaluated that promote independence, gender identity, and self-esteem in children with early-onset physical disabilities. Two areas of special interest are: o Behavioral Adaptation - particularly studies to assess the behavioral characteristics of both children and caregivers that are associated with successful adaptation to physical disability over the developmental period. o Secondary Impairments - particularly studies to develop and evaluate interventions that prevent secondary impairments and disabilities among children with early-onset physical disabilities. Health of Women with Physical Disabilities: Because the effectiveness of most interventions for meeting the unique health needs of women with chronic impairments or disabilities has not been established, the following research areas of special interest have been identified: o Reproductive Health - particularly studies that (1) assess the obstetrical management and family planning needs of women with disabilities; (2) investigate access to, and the effectiveness of, current contraceptive methods, and (3) develop new contraceptive methods for women with various chronically disabling impairments. o Stress and Abuse - particularly studies that identify and characterize the (1) types of stressors experienced by women with physical disabilities; (2) relationships that exist between stressors and women's perception of stress, their coping responses, and their physiological and neurohumoral stress responses; and (3) factors that predispose females of all ages with disabilities to becoming victims of abuse. Studies to develop interventions that will prevent abuse or mitigate its effects are also encouraged. Rehabilitation of Persons with Chronic Disorders of the Central Nervous System: Currently, most research focuses on clinical interventions during the acute phases of central nervous system injuries, rather than on interventions to restore useful functioning later, in the chronic phases of injury. Thus, additional research is needed to develop and evaluate the effectiveness of biomedical interventions that promote the functional reorganization and respecification of the chronically injured central nervous system to improve functioning that is useful in daily life. Chronic Pain as a Secondary Condition: Little evidence exists concerning the effectiveness of therapeutic practices that are currently used to manage chronic pain of persons with various physically disabling conditions. Thus, studies are needed to determine the relative contributions of biological, psychological, behavioral, and environmental factors to (a) the course of pain, (b) pain dysfunction, (c) expressive behavior, and (d) responses to treatment by persons with various physical disabilities. Prosthetics and Orthotics: Systematic research is needed to determine how best to develop, evaluate, and prescribe orthoses and prostheses that will be fully and appropriately used by people in their daily lives. Research is needed in two areas: o Factors Influencing the Use and Outcomes of Orthoses and Prostheses - particularly studies that (1) formulate and test theories of aided ambulation; 2) develop biomaterials for the human/device interface and joint components that replicate human movement; (3) encourage practices that promote the behavioral adaption to and the optimal use of assistive technology; and (4) evaluate the contributions of biological, psychological, behavioral, environmental, and design factors that promote optimal use of prostheses and orthoses. o Neuroprostheses - particularly outcome studies of neuroprostheses for enhancing limb movement, pulmonary functioning, and bowel or bladder control that consider personal priorities and life styles. Biomaterials to Restore Useful Functioning to People with Physical Disabilities: Advances in developing biocompatible materials and in characterizing their tissue interactions provide a foundation for developing novel materials that can be used for several purposes. To build on these advances, research is needed in two areas: o Coating Materials - particularly studies to develop coating materials that can be used on implanted devices such as indwelling catheters or electrodes to render them biocompatible and to reduce infection. o Scaffolding for Tissues - including developmental studies to modify natural products that can serve as scaffolding to support the regeneration of neurons, cartilage and bone, skin, and other tissues. INQUIRIES Inquiries regarding this announcement are encouraged. The NICHD welcomes the opportunity to clarify any issues or questions from potential applicants. The acronym "AHPP96" should be placed on line of 2 of an unsolicited application if the applicant thinks that the topic of the application is within an area of high program priority as defined in this notice. However, applications will be assigned according to PHS Referral Guidelines and formal determination of high program priority will be made by NICHD staff. Direct inquiries regarding the priorities of the Center for Research for Mothers and Children to: Sumner J. Yaffe, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B05, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5097 FAX: (301) 402-2085 Email: YAFFES@HD01.NICHD.NIH.GOV Direct inquiries regarding the priorities of the Center for Population Research to: Florence P. Haseltine, M.D. Center for Population Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1101 FAX: (301) 496-0962 Email: HASELTIF@HD01.NICHD.NIH.GOV Direct inquiries regarding the priorities of the National Center for Medical Rehabilitation Research to: Marcus Fuhrer, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 2A03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 FAX: (301) 402-0832 Email: FUHRERM@HD01.NICHD.NIH.GOV $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** EXTRAMURAL ASSOCIATES RESEARCH DEVELOPMENT AWARD NIH GUIDE, Volume 24, Number 31, August 25, 1995 RFA AVAILABLE: OD-96-001 P.T. 14, FF; K.W. 1014006, 1014002 National Institutes of Health Application Receipt Date: January 19, 1996 PURPOSE The Extramural Associates (EA) Program is soliciting applications >From academic institutions with significant minority student enrollment, and from women's colleges for participation in the January or June 1997 sessions of the EA Program. In addition, the award will enable the participating institution to establish or enhance an office of sponsored research and to provide for other research infrastructure needs through the recently established Extramural Associates Research Development Award (EARDA). ELIGIBILITY Eligibility is limited to those domestic academic institutions that have a significant enrollment comprised of minorities (i.e., African Americans, Hispanics, Asians, Native Americans), or are women's colleges, and who wish to nominate a faculty member who has not participated in the NIH Extramural Associates Program since 1993. INQUIRIES Further information may be obtained from: Dr. Matthew A. Kinnard Office of Extramural Programs National Institutes of Health Building 31, Room 5B38 Bethesda, MD 20892-2182 Telephone: (301) 496-9728 FAX: (301) 496-7060 Email: KINNARDM@NIHOD31.NIH.GOV $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NEW ENGLAND SBIR/STTR WORKSHOP NIH GUIDE, Volume 24, Number 31, August 25, 1995 P.T. 42; K.W. 0710030, 1014006 National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID) is sponsoring a New England Workshop to help investigators and organizations take advantage of the Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) grant programs at the National Institutes of Health (NIH). In 1996, NIH is expected to have more than $200 million available for SBIR/STTR support in all areas of NIH-supported biomedical research. The New England Workshop is being co-sponsored with the Massachusetts Biotechnology Council and the Center for AIDS Research at the Dana Farber Cancer Center. Although applications for SBIR/STTR funding must originate in independently owned U.S. companies with fewer than 500 employees, researchers at non-profit institutions can benefit by collaborating with these firms. For example, investigators can profit through consulting fees, research funds for their laboratories, placement of graduates and postdoctoral fellows, and, if successful, a share of the profits from the commercial venture. Biotechnology companies can benefit from the expertise of academic investigators in identifying important areas of research and in writing grant proposals and from the development of new collaborations for pursuing research. The New England Workshop will facilitate SBIR/STTR partnerships. Academic investigators are invited to submit a one-page summary that describes their ideas that might have commercial value. Company representatives also are invited to identify their research areas of interest in a similar write-up. To foster partnership and collaborations, a compendium of these statements will be distributed to the Workshop participants. Participants will also have the opportunity ask questions during simultaneous roundtable discussion groups with representatives from NIH, academic investigators, venture capital firms, technology transfer and sponsored research specialists, accounting and legal firms, and other support services. INQUIRIES The one-day New England Workshop will take place at the Sheraton Boston Hotel & Towers on Wednesday, October 11, from 8:00 am to 5:00 pm. Registration is $50 in August, $75 in September and $100 on-site after September. For more information and registration forms, contact: Ms. Leisa Coles-Winters The CDM Group, Inc. 5530 Wisconsin Avenue, Suite 1660 Chevy Chase MD 20815 Telephone: (301) 654-6740 FAX: (301) 656-4012 For comments and suggestions, contact: Dr. Gregory Milman Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C06 Bethesda, MD 20892 Telephone: (301) 496-8378 FAX: (301) 402-3211 Email: GM16S@NIH.GOV $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$P1 BEGIN PA-95-085 FULL-TEXT ************************************** RESEARCH ON ATHEROSCLEROSIS LESIONS USING HUMAN TISSUES COLLECTED IN PDAY/RFEHA NIH GUIDE, Volume 24, Number 31, August 25, 1995 PA AVAILABLE: PA-95-085 P.T. 34; K.W. 0715040, 0780020 National Heart, Lung, and Blood Institute PURPOSE The Division of Heart and Vascular Diseases, National Heart, Lung, and Blood Institute (NHLBI) announces a program to support research on atherosclerosis lesions utilizing human tissues collected in the Pathobiological Determinants of Atherosclerosis in Youth/Risk Factors in Early Human Atherogenesis (PDAY/RFEHA) program. These specimens are suitable for use to investigate cellular and molecular factors that may be implicated in the initiation and progression of atherosclerotic lesions. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Research on Atherosclerosis Lesions Using Human Tissues Collected in PDAY/RFEHA, 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 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and by mail and email from the program contact listed below. Momtaz Wassef, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Two Rockledge Center, Suite 10193 6701 Rockledge Drive Bethesda, MD 20892-7956 Telephone: (301)435-0550 FAX: (301) 480-2858 Email: MOMTAZ_WASSEF@NIH.GOV $$P1 END ************************************************************ From owner-sci-resources@net.bio.net Sun Aug 27 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 27 August 1995 Date: 28 Aug 1995 12:52:29 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 133 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <41t6pt$mib@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: Form1030 - Individual Form MS Word for Windows 6.0 Version File size (bytes): STIS Filename: form1030.txt Also available: form1030.doc Title: Form1207 - Individual Form MS Word for Windows 6.0 Version File size (bytes): STIS Filename: form1207.txt Also available: form1207.doc Title: Form1225 - Individual Form MS Word for Windows 6.0 Version File size (bytes): STIS Filename: form1225.txt Also available: form1225.doc Title: Form1239 - Individual Form MS Word for Windows 6.0 Version File size (bytes): STIS Filename: form1239.txt Also available: form1239.doc Title: Form1328 - Individual Form MS Word for Windows 6.0 Version File size (bytes): STIS Filename: form1328.txt Also available: form1328.doc Title: Form1358 - Individual Form MS Word for Windows 6.0 Version File size (bytes): STIS Filename: form1358.txt Also available: form1358.doc Title: Form1359 - Individual Form MS Word for Windows 6.0 Version File size (bytes): STIS Filename: form1359.txt Also available: form1359.doc Title: Form1360 - Individual Form MS Word for Windows 6.0 Version File size (bytes): STIS Filename: form1360.txt Also available: form1360.doc Title: Form1361 - Individual Form MS Word for Windows 6.0 Version File size (bytes): STIS Filename: form1361.txt Also available: form1361.doc Title: Form1362 - Individual Form MS Word for Windows 6.0 Version File size (bytes): STIS Filename: form1362.txt Also available: form1362.doc Title: Form1363 - Individual Form MS Word for Windows 6.0 Version File size (bytes): STIS Filename: form1363.txt Also available: form1363.doc Title: Form98a - Individual Form MS Word for Windows 6.0 Version File size (bytes): STIS Filename: form98a.txt Also available: form98a.doc Title: FormCert - Individual Form MS Word for Windows 6.0 Version File size (bytes): STIS Filename: formcert.txt Also available: formcert.doc Document Type: Program Guideline Title: NSF 95-137 - Active Tectonics-Research Opportunities in Tectonically Active Systems of the Earth's Continental Crust File size (bytes): STIS Filename: nsf95137.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: General Publication Title: NSF 95-26 GRANT POLICY MANUAL File size (bytes): 333351 STIS Filename: nsf9526.txt Title: NSF 95-26s GRANT POLICY MANUAL (SUMMARY OF CHANGE) File size (bytes): 19555 STIS Filename: nsf9526s.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf9526s.txt, the text of your message should be as follows: get nsf9526s.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9526s.txt, you would enter: ftp> get nsf9526s.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Sun Aug 27 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: UNSUBSCRIBING, BIOSCI ARCHIVES, ADDRESS DATABASE & BIOSCI FAQ Date: 28 Aug 1995 11:23:16 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 347 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <41t1ik$hkf@net.bio.net> NNTP-Posting-Host: net.bio.net Four important items follow: How to cancel e-mail subscriptions to BIOSCI newsgroups, BIOSCI archive searching, the BIOSCI FAQ, and the BIOSCI User Address Directory form. If you have not yet listed yourself in our BIOSCI user directory, please take a few minutes to complete and return the form below. If your personal information has changed since you listed yourself, please send us a complete new updated form. We can not make manual revisions to existing entries. Sincerely, Dave Kristofferson BIOSCI/bionet Manager biosci-help@net.bio.net **** How to cancel a BIOSCI e-mail subscription **** If you want to cancel your e-mail subscription to this group, PLEASE DO NOT POST YOUR UNSUBSCRIBE REQUEST TO THE NEWSGROUP ADDRESS (NOR REPLY TO A MESSAGE POSTED TO THE NEWSGROUP)!!! This would send your request to all of the readers of the newsgroup, but it might still not be seen by the BIOSCI staff - thus you would annoy many people and possibly not accomplish your goal anyway. IF YOU ARE LOCATED IN THE AMERICAS OR PACIFIC RIM COUNTRIES, please send a message to biosci@net.bio.net Instructions on how to subscribe/unsubscribe will be returned automatically, so the contents of your message do not matter. IF YOU ARE LOCATED IN EUROPE, AFRICA OR CENTRAL ASIA, please send a message to MXT@dl.ac.uk containing the word help in the body of the message to retrieve e-mail server instructions. Any text placed on the Subject: line of your message will be ignored, so be sure to put the "help" command in the body of the message. If you need personal assistance, a BIOSCI staff member can be contacted at either of the following addresses. Please contact the address designated for your location. Support Address Location --------------- -------- biosci@daresbury.ac.uk Europe, Africa, and Central Asia biosci-help@net.bio.net Americas and the Pacific Rim **** SEARCHING BIOSCI ARCHIVES **** The easiest way to search the BIOSCI archives is to use Mosaic or another World Wide Web browser and connect to the BIOSCI WWW home page at URL http://www.bio.net/. Select the hypertext link to the BIOSCI archives. This gives you read access to all newsgroup messages and the ability to search the indexes described below. You can also use gopher software and connect over the Internet to net.bio.net, the U.S. BIOSCI computer. We maintain three indexes which are searchable from the main gopher menu on net.bio.net: (1) an index of all BIOSCI postings; (2) an index of individual journal article references from the Table of Contents postings on the BIO-JOURNALS newsgroup; and (3) an index of BIOSCI users including regular mail and e-mail addresses, phone/FAX numbers, research interests, and newsgroup participation. E-mail users can search the BIOSCI archives by using our waismail e-mail server. For instructions send the message help to waismail@net.bio.net. Leave the Subject: line blank (anything entered on the Subject: line is ignored). WAIS software can also be used to search the archives as described in the BIOSCI FAQ (see below). Finally, the BIOSCI archive files are accessible by anonymous FTP to net.bio.net [134.172.2.69] in the directory pub/BIOSCI. **** BIOSCI FREQUENTLY ASKED QUESTIONS (FAQ) SHEET **** New users of BIOSCI/bionet may want to read the "Frequently Asked Questions" or "FAQ" sheet for BIOSCI. The FAQ provides details on how to participate in these forums and fix problems that you might encounter in using the newsgroups. The FAQ and other BIOSCI documentation is available through our WWW home page at URL http://www.bio.net/. It is also available for anonymous FTP from net.bio.net [134.172.2.69] in pub/BIOSCI/doc/biosci.FAQ or for retrieval by gopher to net.bio.net, port 70. It may also be requested by sending the command info faq in the body of an e-mail message to the Internet address biosci-server@net.bio.net. Please do not enter the info faq command on the Subject: line of your message since the e-mail server ignores text on the Subject: line. The FAQ is also posted on the first of each month to the newsgroup BIONEWS/bionet.announce immediately following the posting of the BIOSCI information sheet. **** BIOSCI USER ADDRESS DIRECTORY **** Please take this opportunity to add your name and address information to the BIOSCI User Address Database if you have not already done so. Below is the address form that we would like each reader of the BIOSCI/bionet newsgroups to complete and return if you would like to be listed in our database. The database serves as a directory that enables biologists, who are currently using (or even just reading) the BIOSCI newsgroups, to look up e-mail addresses and other information about our users. The address database is reindexed nightly for WAIS, waismail, gopher, and WWW access (the URL is http://www.bio.net). If you have access to gopher, connect to net.bio.net to search the database. If you have access to WAIS, please use our WAIS source biologists-addresses.src. If you are not on the Internet, please use our waismail server (send the word "help" to waismail@net.bio.net to get instructions; any text on the Subject: line of your message will be ignored, so put the help command in the body of the mail message.). Please carefully follow the instructions for completing the form below and return it to either of the following two addresses (whichever is more convenient for you). Thanks in advance for taking the time to complete and return the form. Addresses for returning forms Location Network ----------------------------- -------- ------- biovote@net.bio.net U.S.A. Internet/BITNET biovote@daresbury.ac.uk U.K. JANET MAKING SURE THAT YOUR INFORMATION IS CURRENT This notice will be mailed bimonthly to each newsgroup. You should check your database entry from time-to-time to see if your address information is still up-to-date. Using Gopher to complete the form --------------------------------- If you don't want to use a text editor, you can also use Dan Jacobson's gopher site to fill out the address database form as follows. Otherwise skip this section on gopher and proceed to the instructions for filling out the form below. > To add yourself to the database just point your > gopher client at merlot.gdb.org and select the following: > > --> 14. Searching For Biologists/ > > --> 9. E-mail Addresses of Biosci-Bionet Users/ > > --> 1. Add (or Correct) Your Address to the BIOSCI User Address > Data.. > > > And fill out the form. or Rob Harper's gopher site in Europe as follows: > Europeans can point their gopher client at gopher.csc.fi and add their > information to the database. All entries will be mailed directly to > Dave for incorporation in a wais source. > > The path to the questionare is as follows. > > > 6. Information in English/ > > 5. Scientific and other topics/ > > 1. Finnish EMBnet BioBox/ > > 9. FAQ Files/ > > 5. Bionauts Address Database (questionaire) > IMPORTANT INSTRUCTIONS - PLEASE READ CAREFULLY Please enter all responses after the : on each line, leaving one (1) blank space after the : (i.e., before the start of your text). Please do NOT extend your responses past the end of each line (80 characters). PLEASE DO NOT alter any of the field identifiers such as "first name: ". If you have nothing to enter after a field identifier, PLEASE LEAVE IT - do not delete it even if there is no data on the line in question. Several lines are provided at the end of the form for comments, but, please adhere to the line length restriction. On the date: line, please enter the date in the DD-MM-YY format, e.g., 15-05-93 for 15 May 1993. This line will tell others when the information was last updated. Please be sure to include the 0's for single digit days or months, e.g., 15-05-93, not 15-5-93. Note that the "e-mail network: " line below is for specifying, e.g., "Internet," "BITNET," "EARN," "JANET," or whatever other network that your computer may be on. If you are uncertain about any field, please feel free to leave it blank, but please DO NOT DELETE the field identifier from the form! In the first field below, "New information or Update ...", please enter "N" if this is the first time that you have registered in the directory or "U" if you are correcting a listing that you sent to us previously. The comment: lines may be used for anything that you like but PLEASE DO NOT DELETE THEM FROM THE FORM OR ALTER THEM. One suggested use is to list the names of the newsgroups in which you participate. Please use the MAILING LIST name (see below - the latest version of the list can be requested from biosci@net.bio.net) instead of the USENET name even if you don't participate by e-mail. WAIS might get confused by the periods in the USENET names. This allows one to retrieve via WAIS or waismail the list of participants in a particular group. For example: comment: ARABIDOPSIS PLANT-BIOLOGY BIONEWS On the comment: lines use these names below ---- NOT the USENET names below MAILING LIST NAME USENET Newsgroup Name ----------------- --------------------- ACEDB-SOFT bionet.software.acedb AGEING bionet.molbio.ageing AGROFORESTRY bionet.agroforestry ARABIDOPSIS bionet.genome.arabidopsis ASCB bionet.prof-society.ascb BIOCAN bionet.prof-society.cfbs BIOFORUM bionet.general BIO-INFORMATION-THEORY bionet.info-theory BIONAUTS bionet.users.addresses BIONEWS bionet.announce BIO-JOURNALS bionet.journals.contents BIO-MATRIX bionet.molbio.bio-matrix BIOPHYSICAL-SOCIETY bionet.prof-society.biophysics BIOPHYSICS bionet.biophysics BIO-SOFTWARE bionet.software BIOTHERMOKINETICS bionet.metabolic-reg BIO-WWW bionet.software.www CARDIOVASCULAR-RESEARCH bionet.biology.cardiovascular CELEGANS bionet.celegans CELL-BIOLOGY bionet.cellbiol CHLAMYDOMONAS bionet.chlamydomonas CHROMOSOMES bionet.genome.chromosomes COMPUTATIONAL-BIOLOGY bionet.biology.computational CSM bionet.prof-society.csm CYTONET bionet.cellbiol.cytonet DROSOPHILA bionet.drosophila EMBL-DATABANK bionet.molbio.embldatabank EMF-BIO bionet.emf-bio EMPLOYMENT bionet.jobs EMPLOYMENT-WANTED bionet.jobs.wanted FASEB bionet.prof-society.faseb GDB bionet.molbio.gdb GENBANK-BB bionet.molbio.genbank GENETIC-LINKAGE bionet.molbio.gene-linkage GRASSES-SCIENCE bionet.biology.grasses HIV-MOLECULAR-BIOLOGY bionet.molbio.hiv HUMAN-GENOME-PROGRAM bionet.molbio.genome-program IMMUNOLOGY bionet.immunology INFO-GCG bionet.software.gcg JOURNAL-NOTES bionet.journals.note METHODS-AND-REAGENTS bionet.molbio.methds-reagnts MICROBIOLOGY bionet.microbiology MOLECULAR-EVOLUTION bionet.molbio.evolution MOLECULAR-MODELLING bionet.molec-model MOLLUSC-MOLECULAR-NEWS bionet.molbio.molluscs MYCOLOGY bionet.mycology NEUROSCIENCE bionet.neuroscience N2-FIXATION bionet.biology.n2-fixation PARASITOLOGY bionet.parasitology PHOTOSYNTHESIS bionet.photosynthesis PLANT-BIOLOGY bionet.plants POPULATION-BIOLOGY bionet.population-bio PROTEIN-ANALYSIS bionet.molbio.proteins PROTEIN-CRYSTALLOGRAPHY bionet.xtallography PROTISTA bionet.protista RAPD bionet.molbio.rapd SCIENCE-RESOURCES bionet.sci-resources STADEN bionet.software.staden STRUCTURAL-NMR bionet.structural-nmr TROPICAL-BIOLOGY bionet.biology.tropical URODELES bionet.organisms.urodeles VIROLOGY bionet.virology WOMEN-IN-BIOLOGY bionet.women-in-bio YEAST bionet.molbio.yeast ZBRAFISH bionet.organisms.zebrafish Listing newsgroups on the comment: line is optional, of course. Thanks again for your cooperation! --------------- please cut here and return portion below --------------- New information or Update to old record (enter N or U): date (DD-MM-YY): first name: middle initial: family name: job title: e-mail address: e-mail network: phone number: FAX number: institution: address1: address2: address3: city: state/province: country: postal code: research interest: research interest: comment: comment: comment: comment: comment: From owner-sci-resources@net.bio.net Sun Aug 27 23:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-085 - V24(31) 08/25/95 Date: 28 Aug 1995 12:52:54 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 258 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <41t6qm$mjj@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95085 PA-95-085 P1O1 *************************************** RESEARCH ON ATHEROSCLEROSIS LESIONS USING HUMAN TISSUES COLLECTED IN PDAY/RFEHA NIH GUIDE, Volume 24, Number 31, August 25, 1995 PA NUMBER: PA-95-085 P.T. 34; K.W. 0715040, 0780020 National Heart, Lung, and Blood Institute PURPOSE The Division of Heart and Vascular Diseases, National Heart, Lung, and Blood Institute (NHLBI) announces a program to support research on atherosclerosis lesions utilizing human tissues collected in the Pathobiological Determinants of Atherosclerosis in Youth/Risk Factors in Early Human Atherogenesis (PDAY/RFEHA) program. These specimens are suitable for use to investigate cellular and molecular factors that may be implicated in the initiation and progression of atherosclerotic lesions. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Research on Atherosclerosis Lesions Using Human Tissues Collected in PDAY/RFEHA, 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 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT Research support mechanisms include traditional research project grants (R01) and FIRST (R29) awards. Traditional research project grants (R01) provide support for up to five years. Applications for FIRST (R29) awards must request support for five years and are limited to $350,000 in direct costs over the entire project period. RESEARCH OBJECTIVES The NHLBI sponsored a multi-center study (PDAY/RFEHA) to document the natural history of atherosclerosis, its relationship to risk factors, and the pathobiology of lesion development in humans. From over 3,000 autopsy cases, there are samples collected from the thoracic and abdominal aortas, right and left anterior descending, and left circumflex coronary arteries in addition to samples of serum, liver, spleen, kidney, heart and adipose tissue. The samples collected are all from individuals who suffered sudden traumatic deaths ages 15 to 34, who had no indication of chronic disease. They are approximately 75 percent male, almost equally divided between black and white races, and are fairly evenly distributed among the four age cells of five years each from 15 to 34. Samples were collected by standardized techniques and the tissues have been prepared and stored in a variety of manners (i.e., frozen at -80x, OCT and glutaraldehyde-fixed). Most of these cases have demographic data on age, race, and sex. There are also risk factor data on smoking, hyperlipidemia, hypertension, diabetes, and obesity. Arteries have been evaluated for lesions (extent and stage of complexity) and correlated with available risk factors and demographic data. In addition, a number of genotypes related to apoproteins have been determined and correlated with the risk factors. More statistical analyses and correlations are currently under way to confirm that atherosclerosis starts at an early age, and that the recognized risk factors for coronary heart disease are associated with lesion development in the arteries of young subjects. However, because of the vast potential wealth of information that could be obtained, these tissues should provide a special opportunity to initiate studies on the origin and progression of the atherosclerotic lesion in humans. This program announcement provides the opportunity to perform state-of-the-art cellular and molecular biological research on PDAY/RFEHA specimens. Investigators are expected to utilize selected material from the PDAY/RFEHA samples for their proposed basic research projects. Thus, the type and quantity of tissue needed to perform the proposed research should be specified. The tissues are centrally housed at Louisiana State University Medical Center in New Orleans and will be provided to investigators (Jack Strong, M.D., Phone 504/568-6033). A Scientific Advisory Committee with representation from NHLBI, non-PDAY and PDAY Steering Committee will be convened to ensure that specimens will be provided according to Study Section recommendations. For other interested investigators, who already have non-NIH independent support, this committee will also assess the scientific merits and feasibility of their requests, which will not be reviewed by the NIH peer review system. In the event that an investigator requires extra samples, the Committee will be responsible for approving the request. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3032, MSC 7762, Bethesda, MD 20892, telephone 301/435-0714. The title and number of the program announcement must be typed in Section 2 on the face page of the application. Applications for the FIRST award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST award (R29) applications submitted without the required number of reference letters will be considered incomplete and returned without review. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific and technical review, the applications will receive a second-level review by the appropriate national advisory council. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria o scientific, technical or medical significance and originality of proposed research, o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issue or questions from potential applicants is welcome. Direct inquiries regarding programmatic issue to: Momtaz Wassef, Ph.D Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Two Rockledge Center, Suite 10193 6701 Rockledge Drive Bethesda, MD 20892-7956 Telephone: (301)435-0550 FAX: (301) 480-2858 Email: MOMTAZ_WASSEF@NIH.GOV Direct inquiries regarding fiscal matters to: William W. Darby Grants Operations Branch National Heart, Lung, and Blood Institute Two Rockledge Center Suite 7128 6701 Rockledge Drive Bethesda, MD 20892-7128 Telephone: (301)435-0177 FAX: (301)480-3310 Email: WILLIAM_DARBY@NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.837. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants' policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.