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