From owner-sci-resources@net.bio.net Thu Sep 02 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 32, pt. 1, 3 September 1993 Message-ID: Date: 3 Sep 93 01:41:43 GMT Sender: kristoff@net.bio.net Lines: 1505 Approved: biosci-moderator@net.bio.net NOTE: The NIH Guide may be split into more than one mail message to avoid truncation during e-mail distribution. The first message always begins with the RFP/RFA summary sections followed by the appended texts of the full RFP/RFAs. ---------------------------------------------------------------------- $$XID NIHGUIDE 19930903 V22N32 P1O2 ************************************ X-comment: RFAs described: AG-94-002, CA-93-038, AI-93-019 NIH GUIDE - Vol. 22, No. 32 - September 3, 1993 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** PUBLICATION DATES FOR THE NIH GUIDE $$INDEX N2 ********************************************************** SMALL BUSINESS TECHNOLOGY TRANSFER PROGRAM National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** WITHDRAWAL OF INTERIM NIH GUIDELINES FOR THE SUPPORT AND CONDUCT OF THERAPEUTIC HUMAN FETAL TISSUE TRANSPLANTATION RESEARCH IN LIGHT OF SUPERSEDING PROVISIONS OF PUBLIC LAW 103-43, THE NATIONAL INSTITUTES OF HEALTH REVITALIZATION ACT OF 1993 National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N4 ********************************************************** HHS HUMAN RESEARCH SUBJECT PROTECTION REGULATIONS PERTAINING TO IN VITRO FERTILIZATION (IVF) OF HUMAN OVA MODIFIED BY THE NIH REVITALIZATION ACT National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N5 ********************************************************** CHANGES IN APPLICATION PROCEDURES FOR FELLOWSHIPS SUPPORTED BY THE MINORITY ACCESS TO RESEARCH PROGRAM National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** APPLICATIONS DEVELOPMENT PROGRAM (RFP NHLBI-HO-94-01) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R2 ********************************************************** CANCER PREVENTION AND CONTROL SURVEILLANCE MASTER AGREEMENT (MAA NCI-CN-35551-05) National Cancer Institute INDEX: CANCER $$INDEX R3 11/29/93 ************************************************* MENOPAUSE AND HEALTH IN AGING WOMEN (RFA AG-94-002) National Institute on Aging National Institute of Nursing Research Office of Research on Women's Health INDEX: AGING; NURSING RESEARCH, WOMEN'S HEALTH $$INDEX R4 12/07/93 ************************************************* IDENTIFICATION AND EVALUATION OF TISSUE MARKERS FOR PATHOLOGICAL CLASSIFICATION OF HUMAN GLIOMAS (RFA CA-93-038) National Cancer Institute INDEX: CANCER $$INDEX R5 01/21/94 ************************************************* NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS FOR THE TREATMENT OF OPPORTUNISTIC INFECTIONS ASSOCIATED WITH ACQUIRED IMMUNODEFICIENCY SYNDROME (NCDDG-OI): TUBERCULOSIS (RFA AI-93-019) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** DRUG ABUSE TREATMENT FOR WOMEN OF CHILDBEARING AGE AND THEIR CHILDREN (PA 93-106) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P2 ********************************************************** MEDICAL IMAGING DATABASES (PA-93-107) National Cancer Institute National Institute of Neurological Disorders and Stroke National Library of Medicine INDEX: CANCER; NEUROLOGICAL DISORDERS, STROKE; NATIONAL LIBRARY OF MEDICINE $$INDEX P3 ********************************************************** BEHAVIORAL RESEARCH IN SEXUALLY TRANSMITTED DISEASES (PA-93-108) National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute on Aging INDEX: ALLERGY, INFECTIOUS DISEASES; CHILD HEALTH, HUMAN DEVELOPMENT; AGING ERRATA $$INDEX E1 11/24/93 ************************************************* MULTICOMPONENT VACCINE DEVELOPMENT (RFA AI-93-017) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** THE NIH GUIDE FOR GRANTS AND CONTRACTS WILL NOT BE PUBLISHED ON SEPTEMBER 10, 1993. THE NEXT ISSUE WILL BE SEPTEMBER 17, 1993. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** SMALL BUSINESS TECHNOLOGY TRANSFER PROGRAM NIH GUIDE, Volume 22, Number 32, September 3, 1993 P.T. 34; K.W. 1016004 National Institutes of Health Application Receipt Date: December 1, 1993 The purpose of this announcement is to inform the public of a new set- aside funding opportunity that requires collaboration of small businesses with research institutions. Public Law 102-564, signed October 28, 1992, requires the National Institutes of Health (NIH), Public Health Service, Department of Health and Human Services, and certain other Federal agencies to reserve a specified amount of their extramural research or research and development (R&D) budgets for a Small Business Technology Transfer (STTR) program. The legislation is intended to: o stimulate and foster scientific, technical, and technological innovation through cooperative R&D carried out between small businesses and research institutions; o foster technology transfer between small businesses and research institutions; o increase private sector commercialization of innovations derived from Federal R&D; and o foster and encourage participation of socially and economically disadvantaged small businesses and women-owned small businesses in technological innovation. The STTR program is a three-year pilot program the begins in fiscal year (FY) 1994 and consists of the following three phases: PHASE I: The objective of this phase is to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort and the quality of performance of the small business concern, prior to providing further Federal support in Phase II. PHASE II: The objective of this phase is to continue the research or R&D efforts initiated in Phase I. Funding shall be based on the results of Phase I and the scientific and technical merit and commercial potential of the Phase II application. PHASE III: The objective of this phase, where appropriate, is for the small business concern to pursue with non-federal funds the commercialization of the results of the research or R&D funded in Phases I and II. The amount and period of support for STTR awards are as follows: PHASE I: Awards may not exceed $100,000 for direct costs, indirect costs, and negotiated fixed fee for a period normally not to exceed one year. PHASE II: Awards may not exceed $500,000 for direct costs, indirect costs, and negotiated fixed fee for a period normally not to exceed two years. A Phase I award must have been issued in order to apply for a Phase II award. (ONLY Phase I awards will be issued in FY 1994.) It is anticipated that approximately 40 STTR grants will be awarded by the NIH in FY 1994 from funds set aside for this purpose. The applicant organization must be the small business. As required by the legislation, at least 40 percent of the project is to be performed by the small business and at least 30 percent of the project is to be performed by the research institution. INQUIRIES Eligibility requirements, definitions, application procedures, review considerations, application forms and instructions, and other pertinent information are contained in the "Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR) Grant Applications," available from: Massachusetts Technological Laboratory, Inc. 13687 Baltimore Avenue Laurel, MD 20707 Telephone: (301) 206-9385 FAX: (301) 206-9722 The OMNIBUS SOLICITATION is for the single application receipt date of December 1, 1993, for grant awards to be made in FY 1994. Contact points for inquiries regarding each NIH awarding component's program interests concerning the STTR program are contained in the OMNIBUS SOLICITATION. $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** WITHDRAWAL OF INTERIM NIH GUIDELINES FOR THE SUPPORT AND CONDUCT OF THERAPEUTIC HUMAN FETAL TISSUE TRANSPLANTATION RESEARCH IN LIGHT OF SUPERSEDING PROVISIONS OF PUBLIC LAW 103-43, THE NATIONAL INSTITUTES OF HEALTH REVITALIZATION ACT OF 1993 NIH GUIDE, Volume 22, Number 32, September 3, 1993 P.T. 34; K.W. 0783005, 0755055, 0780005 National Institutes of Health SUMMARY: The National Institutes of Health (NIH) is announcing the withdrawal of its interim guidelines for the support and conduct of therapeutic human fetal tissue transplantation research because of the superseding provisions of P.L. 103-43, the National Institutes of Health Revitalization Act of 1993. A summary of pertinent provisions of the Act is provided below. Background On January 22, 1993, President Clinton issued a directive to the Secretary of Health and Human Services ending a five-year moratorium on Federal funding of therapeutic transplantation research that uses human fetal tissue derived from induced abortions. Secretary of Health and Human Services Donna E. Shalala notified the National Institutes of Health (NIH) of the President's action, and then formally revoked the moratorium on February 1, 1993. At the same time, the Secretary, through the Acting Assistant Secretary for Health, directed the NIH to develop interim guidelines based on the recommendations of the 1988 Human Fetal Tissue Transplantation Research Panel to ensure that Federal funding of human fetal tissue transplantation research does not encourage the choice of abortion. Accordingly, the NIH prepared, and transmitted to the Acting Assistant Secretary for Health, interim policy guidelines based on the recommendations of the 1988 Human Fetal Tissue Transplantation Research Panel and the Advisory Committee to the Director, NIH. Those interim guidelines were published in the NIH Guide for Grants and Contracts on March 19, 1993 (Vol. 22, No. 11). Action The NIH Interim Guidelines for the Support and Conduct of Therapeutic Human Fetal Tissue Transplantation Research are hereby withdrawn in light of the comprehensive and superseding provisions of P.L. 103-43, enacted June 10, 1993. Final guidelines will not be issued. Additional Information Attention is directed to section 498A of the Public Health Service Act (42 U.S.C. 289g-1) added by P.L. 103-43, the NIH Revitalization Act of 1993. The provisions of that section pertinent to research on transplantation of fetal tissue are summarized as follows: o Human fetal tissue means tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion, or after a stillbirth. o Human fetal tissue may be used regardless of whether the tissue is obtained pursuant to a spontaneous or induced abortion or pursuant to a stillbirth. o The Secretary of Health and Human Services may conduct or support research on the transplantation of human fetal tissue for therapeutic purposes. o The woman donating the human fetal tissue must sign a statement declaring that the tissue is being donated for therapeutic transplantation research, the donation is being made without any restriction regarding the identity of individuals who may be the recipients of transplantations of the tissue, and the donation is being made without her (the donor) having been informed of the identity of those individuals who may be the recipients. o The attending physician must sign a statement declaring that the tissue has been obtained in accord with the donor's signed statement and that full disclosure has been made to the donating woman of (1) the attending physician's interest, if any, in the research to be conducted with the tissue, and (2) any known medical risks to the donor or risks to her privacy that might be associated with the donation of the tissue and are in addition to the risks associated with the woman's medical care. In the case of tissue obtained pursuant to an induced abortion, the attending physician's statement must also declare that the consent of the woman for the abortion was obtained prior to requesting or obtaining consent for donation, the abortion was conducted in accord with applicable State Law, and no alteration of the timing, method, or procedures used to terminate the pregnancy was made solely for the purposes of obtaining the tissue. o The individual with the principal responsibility for conducting the research must sign a statement declaring that the individual is aware that the tissue is human fetal tissue donated for research purposes and may have been obtained pursuant to a spontaneous or induced abortion or pursuant to a stillbirth; that the principally responsible researcher has provided such information to other individuals with responsibilities regarding the research; that the principally responsible researcher will require, prior to obtaining the consent of a person to be a recipient of a transplantation of the tissue, written acknowledgment of receipt of the foregoing information by such recipient; and that the principally responsible researcher has had no part in any decisions as to the timing, method, or procedures used to terminate the pregnancy made solely for the purposes of the research. o Human fetal tissue may be used only if the head of the agency or other entity conducting the research involved certifies to the Secretary of Health and Human Services that the statements required herein will be available for audit by the Secretary [HHS]. o Research involving the transplantation of human fetal tissue for therapeutic purposes must be conducted in accord with applicable State law and the Secretary may not provide support for such research unless the applicant for assistance agrees to so conduct the research. The conduct of such research by the Secretary must be in accord with applicable State and local law. The provisions of section 498B of the Public Health Service Act (42 U.S.C 289g-2), added by P.L. 103-43, the NIH Revitalization Act of 1993, are summarized as follows: o It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if the transfer affects interstate commerce. (Valuable consideration does not include reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue.) o It shall be unlawful for any person to solicit or knowingly acquire, receive, or accept a donation of human fetal tissue for the purpose of transplantation of such tissue into another person if the donation affects interstate commerce, the tissue will be or is obtained pursuant to an induced abortion, and (1) the donation will be or is made pursuant to a promise to the donating individual that the donated tissue will be transplanted into a recipient specified by such individual; (2) the donated tissue will be transplanted into a relative of the donating individual; or (3) the person who solicits or knowingly acquires, receives, or accepts the donation has provided valuable consideration for the costs associated with such abortion. (Valuable consideration does not include reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue.) o Any person who violates these provisions shall be (1) fined in accordance with Title 18 United States Code, except that the fine shall be not less than twice the amount of any valuable consideration received, (2) imprisoned for not more than 10 years, or (3) penalized as described in both (1) and (2). INQUIRIES Written comments may be mailed or delivered (between 9 a.m. and 5 p.m. weekdays). Comments received may be inspected at the same location during these hours. F. William Dommel, Jr., J.D. Senior Policy Advisor Office for Protection from Research Risks Building 31, Room 5B63 Bethesda, MD 20892 Telephone: (301) 496-7005 $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** HHS HUMAN RESEARCH SUBJECT PROTECTION REGULATIONS PERTAINING TO IN VITRO FERTILIZATION (IVF) OF HUMAN OVA MODIFIED BY THE NIH REVITALIZATION ACT NIH GUIDE, Volume 22, Number 32, September 3, 1993 P.T. 34; K.W. 0783005, 0755055, 0780005 National Institutes of Health The National Institutes of Health Revitalization Act of 1993 (P.L. 103- 43) nullified the provisions of section 204(d) of part 46 of title 45 of the Code of Federal Regulations (45 CFR 46.204(d)). The provisions- -which are now void--read: "No application or proposal involving human in vitro fertilization may be funded by the Department until the application or proposal has been reviewed by the Ethical Advisory Board and the Board has rendered advice as to its acceptability from an ethical standpoint." The practical effect of this nullification is that research applications and proposals involving in vitro fertilization (IVF) of human ova may be conducted or funded by HHS and its components without the prior review and advice of a national advisory body. IRB (Institutional Review Board) review and approval continues to be required in accord with 45 CFR 46.205. It is anticipated that applications and proposals involving certain types of human IVF research will still be subject to special review on a case-by-case basis, at the discretion of the Department and its components. INQUIRIES For further information, contact F. William Dommel, Jr., J.D. Senior Policy Advisor Office for Protection from Research Risks Building 31, Room 5B63 Bethesda, MD 20892 Telephone: (301) 496-7005 $$N4 END ************************************************************ $$N5 BEGIN ********************************************************** CHANGES IN APPLICATION PROCEDURES FOR FELLOWSHIPS SUPPORTED BY THE MINORITY ACCESS TO RESEARCH PROGRAM NIH GUIDE, Volume 22, Number 32, September 3, 1993 P.T. 34; K.W. 1014006 National Institute of General Medical Sciences The National Institute of General Medical Sciences (NIGMS) announces two changes in application procedures for fellowships supported by the Minority Access to Research Careers (MARC) Program. The NIGMS MARC Program provides MARC Predoctoral Fellowships, which support predoctoral research training for graduates of MARC Honors Undergraduate Research Training programs, and MARC Faculty Fellowships, which support research training at the pre- or postdoctoral level for faculty of institutions having a substantial enrollment of students from underrepresented ethnic minority groups. The first policy applies to applications for both types of MARC Fellowships, that is, both the Predoctoral and Faculty Fellowship programs. Applications for MARC fellowships will be accepted for the April 5 and December 5 receipt dates ONLY; the NIGMS will no longer accept MARC fellowship applications for the August 5 receipt date. The second policy applies to applications for PREDOCTORAL training support, including MARC Predoctoral Fellowships and those MARC Faculty Fellowships that seek support for PREDOCTORAL training; it DOES NOT apply to applicants seeking postdoctoral support in the MARC Faculty Fellowship Program. Beginning with the December 5, 1993 receipt date, all applicants for MARC predoctoral support must indicate that EITHER they are already enrolled in a Ph.D. or combined M.D./Ph.D. training program OR they have been accepted by and agreed to enroll in a Ph.D. or combined M.D./Ph.D. training program. The training program must be described in the application. Applications that lack this information at the time of the initial review will be deferred until this information is received. INQUIRIES Further information or clarification may be obtained from: NIGMS MARC Program Office National Institute of General Medical Sciences Westwood Building, Room 950 Bethesda, MD 20892 Telephone: (301) 594-7823 $$N5 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NHLBI-HO-94-01 ******************************************* APPLICATIONS DEVELOPMENT PROGRAM NIH GUIDE, Volume 22, Number 32, September 3, 1993 RFP AVAILABLE: NHLBI-HO-94-01 P.T. 34; K.W. 1004000, 1004017 National Heart, Lung, and Blood Institute The overall objective of this contract is to analyze, evaluate, design, program, test, implement, document, maintain, and enhance National Heart, Lung, and Blood Institute (NHLBI) mainframe and microcomputer applications and systems. Offerors will be required to present plans detailing the technical approaches, procedures, and time schedules for accomplishing these objectives. Nine new mainframe and microcomputer applications and systems will be developed. In order to develop these nine systems, the following five stages will be completed by the Contractor: (1) Analysis; (2) Evaluation; (3) Design/Specification, (4) Programming, and (5) Testing/Implementation. Fifteen mainframe and microcomputer applications and systems will be maintained and enhanced. Maintenance and enhancements will include, but are not limited to, the following: (1) enhancement of current utilities to meet new information requirements of users as well as those of the NHLBI; (2) assurance that the database is valid and accurate and is utilized as the official NHLBI database; (3) review and update of the system, sub-systems, reports, and user documentation as required; (4) addition of new sub-systems and utilities as requirements demand; and (5) maintenance and enhancement will be performed to accommodate changes made by the Division of Research Grants and the Division of Computer Research Technology, NHLBI reorganizations, end of fiscal year changes, interfaces to and with new internal and external systems, requests for new data elements or information based on user needs, new reporting and monitoring requirements, support of new scientific initiatives, and integration of new data sources and technology. It is anticipated that 14 full-time equivalents will be required for the successful completion of the study. This announcement is not a request for proposals (RFP). It is anticipated that RFP No. NHLBI-HO-94-01 will be available on or about September 20, 1993, with proposals due on November 10, 1993. INQUIRIES To receive a copy of the RFP, submit a written request along with three self-addressed mailing labels to: Joanne C. Deshler Division of Lung Diseases, Contracts Operations Branch National Heart, Lung, and Blood Institute Westwood Building, Room 654 Bethesda, Md 20892 This proposed program is a 100% set-aside for small business competition. Only responsible small business firms as defined in Part 19 of the Federal Acquisition Regulation are asked to respond to this synopsis. The Standard Industrial Classification (SIC) Code is 7379. $$R1 END ************************************************************ $$R2 BEGIN NCI-CN-35551-05 ****************************************** CANCER PREVENTION AND CONTROL SURVEILLANCE MASTER AGREEMENT NIH GUIDE, Volume 22, Number 32, September 3, 1993 MAA AVAILABLE: NCI-CN-35551-05 P.T. 34; K.W. 0715035, 0745027, 0795003 National Cancer Institute The National Cancer Institute, Division of Cancer Prevention and Control is soliciting proposals to provide information required for cancer control surveillance. The primary purpose is to conduct surveys and similar evaluation processes. The term "survey" is used to connote a full range of studies, including probability sample surveys and specialty studies requiring data abstraction. The Master Agreement Announcement (MAA) is tentatively scheduled for release on or about October 5, 1993. It is anticipated that multiple master agreements will be awarded pursuant to the MAA, each having a five year period of performance. Since MAs are unfunded, the obligation of funds will be accomplished solely through the award of master agreement orders (MAOs), issued under the terms of this MA. The MAOs will be issued on either a cost or fixed price basis. The Standard Industrial Code applicable to this procurement is 7379. The MA holder, upon award of a MAO, will coordinate and implement the requested survey(s), including data collection, processing and reporting for surveillance activities to be designed and developed by NCI alone or in collaboration with other organizations. INQUIRIES Copies of the MAA may be obtained by sending a written request, citing the MAA number to: No collect calls will be accepted. Mr. Gary Topper Research Contracts Branch, PCCS National Cancer Institute Executive Plaza South, Room 635 Bethesda, MD 20892 Telephone: (301) 496-8603 $$R2 END ************************************************************ $$R3 BEGIN AG-94-002 FULL-TEXT ************************************** MENOPAUSE AND HEALTH IN AGING WOMEN NIH GUIDE, Volume 22, Number 32, September 3, 1993 RFA AVAILABLE: AG-94-002 P.T. 34, II; K.W. 0710010, 0413002, 1002061 National Institute on Aging National Institute of Nursing Research Office of Research on Women's Health Letter of Intent Receipt Date: October 15, 1993 Application Receipt Date: November 29, 1993 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The National Institute on Aging (NIA), the National Institute of Nursing Research (NINR), and the Office of Research on Women's Health (ORWH) invite cooperative agreement applications for Clinical Sites to conduct prospective longitudinal studies of the natural history of menopause and the decline in ovarian function in women. The primary objective of this initiative is to characterize the chronology of the biological and psychosocial antecedents and sequelae of the menopausal transition and the effect of this transition on subsequent health and risk factors for age-related disease. Applications are also requested for a Central Laboratory to conduct standardized assays and for a Coordinating Center to coordinate the collection, management, and analysis of a common data set. 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, Menopause and Health in Aging Women, is related to the priority area of older adults and preventive services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Due to the need for close coordination and monitoring, no foreign or international components will be considered in this RFA. Applications from minorities and women are encouraged. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U01), an assistance mechanism (rather than an acquisition mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. 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. Applicants will be responsible for the planning, direction, and execution of their individual proposed project and for planning and participating in collaborative activities with other award recipients under this RFA. The total project period for applications submitted in response to this RFA may not exceed five years. The anticipated award date is July 1, 1994. FUNDS AVAILABLE It is expected that up to $2.3 million (total cost) for first year expenses will be available in Fiscal Year 1994 to fund five Clinical Sites plus a Coordinating Center and a Central Laboratory. Separate applications must be submitted if an institution seeks selection as both a Clinical Site, Coordinating Center and/or Central Laboratory. The requested total funding (direct plus indirect costs) for the first-year may not exceed $350,000 for Clinical Site applications, $250,000 for Coordinating Center applications and $300,000 for Central Laboratory applications. For the entire five years of the project, total (direct plus indirect) costs requested per application may not exceed $1.75 million for the individual research projects, $1.25 million for the Coordinating Center and $1.5 million for the Central Laboratory. Although this program will be provided for in the financial plans of the NIA and co-sponsors of this RFA, the award of grants pursuant to this RFA is contingent upon receipt of applications of high scientific merit and upon the availability of funds. RESEARCH OBJECTIVES The goal of this RFA is to stimulate comprehensive multidisciplinary research into the natural history of menopause and the role of the perimenopausal transition on woman's aging and subsequent susceptibility to disease. Because this initiative aims to generate epidemiologic studies in premenopausal women of the chronology and characteristics of the perimenopausal transition per se, and not to launch clinical intervention trials of hormone or other therapies, applications focused on testing treatment strategies will be considered not responsive to this RFA. Awardees are expected to recruit a cohort of premenopausal women to characterize the causes and consequences of the pre- to postmenopausal transition. Planned research should: o identify and utilize appropriate markers of ovarian aging (e.g., FSH, LH, or, preferably, other state-of-the art measures) and relate these markers to alterations in menstrual cycle characteristics as women approach and traverse menopause o elucidate factors that differentiate (1) symptomatic from asymptomatic women and (2) women most susceptible to long-term pathophysiological consequences of ovarian hormone deficiency from those who are protected; o collect and analyze data on demographics, health and social characteristics, race/ethnicity, reproductive history, pre-existing illness, physical activity and health practices. After addressing these general requirements, proposed studies should focus on a specific system or function(s) affected by, or of relevance to, menopause. Examples of topic areas of interest are in the RFA that must be requested from the program contacts listed under INQUIRIES. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to give special attention to the inclusion of minorities and women in study populations. For the purpose of this RFA, investigations are limited to studies of menopause, an event which occurs only in women. If minorities are not included in the study populations, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are strongly encouraged to submit, by October 15, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information allows NIH staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Sherry Sherman at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the PHS 398 (rev. 9/91) application form. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and from the NIH program administrators named below. The RFA label contained in the application kit must be affixed at the bottom of the face page of the application. Failure to use this label could delay processing of the application. In addition, the RFA title, number and type of application: "Clinical Site," "Coordinating Center," or "Central Laboratory" must be typed on line 2a of the face page of the application form and the YES box must be checked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Two copies of the application with appendices must also be sent to: Chief, Scientific Review Office National Institute on Aging Gateway Building, Suite 2C212 Bethesda, MD 20892 The deadline for receipt of applications is November 29, 1993. Materials will not be accepted after this date. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete and nonresponsive applications will be returned to the applicant without further consideration. Those applications that are complete and responsive will be evaluated for scientific/technical merit by an appropriate peer review group convened by the NIA. INQUIRIES The letter of intent and requests for the RFA may be addressed to: Dr. Sherry Sherman Geriatrics Program National Institute on Aging Gateway Building, Room 3E327 Bethesda, MD 20892 Telephone: (301) 496-1033 Programmatic inquiries related to social and behavioral research on menopause or of relevance to the National Institute of Nursing Research should be directed to: Dr. Marcia Ory Behavioral and Social Research Program National Institute on Aging Gateway Building, Room 2C234 Bethesda, MD 20892 Telephone: (301) 496-3136 Dr. Sharlene Weiss National Institute of Nursing Research Westwood Building, Room 757 Bethesda, MD 20894 Telephone: (301) 594-7496 Direct inquiries regarding fiscal matters to: Ms. Joanne Colbert Grants and Contracts Management Office National Institute on Aging Gateway Building, Room 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866 (Aging Research). Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations, 42 CFR Part 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372, or to the Health Systems Agency review. $$R3 END ************************************************************ $$R4 BEGIN CA-93-038 FULL-TEXT ************************************** IDENTIFICATION AND EVALUATION OF TISSUE MARKERS FOR PATHOLOGICAL CLASSIFICATION OF HUMAN GLIOMAS NIH GUIDE, Volume 22, Number 32, September 3, 1993 RFA AVAILABLE: CA-93-038 P.T. 34; K.W. 0760003, 0715035 National Cancer Institute Letter of Intent Receipt Date: October 6, 1993 Application Receipt Date: December 7, 1993 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Cancer Diagnosis Branch of the Division of Cancer Biology, Diagnosis and Centers, National Cancer Institute (NCI) invites applications for cooperative agreements from institutions to identify and evaluate tissue markers for improving the pathological classification of human gliomas. Precise pathologic diagnosis and/or classification of gliomas is often difficult. Since the incidence and mortality of brain tumors are increasing, and gliomas constitute the most common class of these important tumors, improved classification would be beneficial to clinicians making decisions about patient management. For the purposes of this RFA, gliomas are meant to include astrocytomas, mixed astrocytomas/oligodendrogliomas, and oligodendrogliomas. The purpose of the proposed awards is to extend and expand the ongoing inter-institutional studies the Glioma Marker Network to increase the availability of patient resources and enhance the technical capabilities of the Network to efficiently test clinical correlative hypotheses. The Network will carry out collaborative studies designed to continue the evaluation of a variety of glioma markers, identify additional promising markers, and correlate the markers with clinical parameters. The cooperative studies funded by this RFA will optimize the use of rare tissue resources. This RFA will also provide funding for coordinated management and statistical analyses of data collected by Network investigators. These studies will take advantage of the synergy resulting from collaborations among neuropathologists, clinicians, cancer biologists, and statisticians. 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, Identification and Evaluation of Tissue Markers for Pathological Classification of Human Gliomas, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applicant organizations must be located in the United States, Canada, or Mexico. Non-profit organizations and institutions, and government agencies are eligible to apply. For-profit organizations are also eligible. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to support the Glioma Network is the cooperative agreement (U01), an assistance mechanism in which substantial NCI program staff involvement with the recipient during performance of the planned activities is anticipated. Under the cooperative agreement, the NCI purpose is to support and/or stimulate the recipient's activities by collaborating and otherwise working jointly with the award recipient in a partner role. The awardees retain full responsibility for the planning and direction of the projects within the guidelines of the RFA and for performance of the proposed studies. There is no intent, real or implied, for NCI staff to direct awardee activities or limit the freedom of the funded investigators. The anticipated average amount of direct costs will be $125,000. This RFA is a one-time solicitation. However, if it is determined that there is sufficient continuing program need, the NCI will invite recipients of awards under this RFA to submit competitive continuation cooperative agreement applications for review according to the procedures described in REVIEW CONSIDERATIONS. FUNDS AVAILABLE The NCI anticipates making four to six new and/or competing awards for project periods up to four years and anticipates a total of $1,200,000 will be set aside for the initial year's funding. Because of the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the sizes of awards will vary also. Funding in response to this RFA is dependent on the receipt of a sufficient number of applications of high scientific merit. Although the program is provided for in the financial plans of the NCI, the award of cooperative agreements pursuant to this RFA is contingent on the availability of funds appropriated for fiscal year 1994. RESEARCH OBJECTIVES The objective of this RFA is to invite applications for cooperative agreements to extend and expand the Glioma Marker Network currently carrying out studies to identify and evaluate molecular markers for improving the pathological classification of human gliomas. Applicants should propose studies with hypotheses designed to evaluate tumor markers and to correlate markers with clinical parameters. Applications should discuss application of molecular genetic, cytogenetic, immunohistological, and/or biochemical techniques to studies of glial tumor markers that will be useful in tumor classification. Collaborations among neuropathologists, clinicians, cancer biologists, and statisticians are critical to these types of studies and are specifically encouraged. Applicants should address approaches to establishing correlations between tumor markers and clinical parameters. The hypotheses to be tested by the proposed studies should be clearly stated and the rationale for the study design and experimental techniques selected thoroughly discussed. Sufficient preliminary data should be provided to support the feasibility of the proposed studies. Applications should include a discussion of the statistical issues related to study design and data analysis. A goal of the RFA is to promote collaborative studies to optimize the use of rare tissue resources. The cooperative agreement mechanism was chosen to facilitate the coordinated management of tissue resources with associated clinical data and the statistical analyses of data generated in collaborative studies. Applicants should discuss their anticipated contribution to collaborative studies carried out by the Network. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women and minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are ask to submit, by October 6, 1993, a letter of intent that includes a descriptive title of the proposed project, the name, address, and telephone number of the Principal Investigator, the names of key personnel, any collaborating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it is requested in order to provide an indication of the number and scope of the applications to be reviewed. This information allows NCI staff to estimate potential workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. James W. Jacobson at the address listed under INQUIRIES. APPLICATION PROCEDURES The grant application form PHS 398 (rev. 9/91) is to be used for the cooperative agreement application. These forms are available from most offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892-4500, telephone 301/584-7248; and from the NCI Program Director named below. The RFA label available in the application form PHS 398 (rev. 9/91) must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time to be reviewed. The RFA number and title must be typed on line 2a of the face page of the application form as well. Applications must be received by December 7, 1993. Applications received after this date will be returned. REVIEW CONSIDERATIONS Review Procedures Upon receipt, applications will be reviewed (initially) by the Division of Research Grants for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the RFA is an NCI program staff function. An application judged non-responsive will be returned by the NCI, but may be resubmitted as an investigator-initiated regular research grant (R01) at the next receipt date. The application would require modification in accordance with the R01 guidelines. The new application would not be considered an application for a cooperative agreement, nor would it be considered a response to this RFA. If the number of applications is large compared to the number of awards to be made, the NCI may conduct a preliminary scientific peer review (triage) to determine their relative competitiveness by an NCI peer review group. The NIH will remove from further competition those applications that are judged to be noncompetitive and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive and responsive will be evaluated for technical merit, according to the review criteria stated in the RFA, by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review will be by the National Cancer Advisory Board. AWARD CRITERIA The anticipated date of award is September 1, 1994. Awards will be based on the peer reviewed priority score and programmatic priorities. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA, inquiries about whether or not specific activities would be responsive, and requests for the RFA are encouraged and may be directed to: James W. Jacobson, Ph.D. Division of Cancer Biology, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 513 6130 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-1591 FAX: (301) 402-1037 Direct inquires regarding fiscal and administrative matters to: Robert E. Hawkins, Jr. Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7800 Ext. 13 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.394, Cancer Detection and Diagnostic Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is no subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R4 END ************************************************************ $$R5 BEGIN AI-93-019 FULL-TEXT ************************************** NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS FOR THE TREATMENT OF OPPORTUNISTIC INFECTIONS ASSOCIATED WITH ACQUIRED IMMUNODEFICIENCY SYNDROME (NCDDG-OI): TUBERCULOSIS NIH GUIDE, Volume 22, Number 32, September 3, 1993 RFA AVAILABLE: AI-93-019 P.T. 34; K.W. 0715165, 0755060, 0715008 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: November 15, 1993 Application Receipt Date: January 21, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE It is the purpose of this RFA to invite Cooperative Agreement applications aimed at the discovery of new, more effective, selective, and diverse therapeutic agents to treat and prevent infection caused by Mycobacterium tuberculosis. Applications that include research projects or participation from the private sector (e.g., pharmaceutical, chemical, or biotechnological companies) are encouraged. Research in the following areas is needed to provide the foundation for improvements in therapeutics for tuberculosis, particularly in the setting of HIV infection: unique metabolic activities for drug targeting; biochemistry and molecular mechanisms of M. tuberculosis-host interactions; inhibitors of enzymatic and regulatory functions, and of biochemical pathways; mechanisms of overcoming drug resistance; and discovery and biochemical characterization of promising natural products or synthetic chemical compounds. These activities should be directed toward selective drug or strategy targeting that inhibits M. tuberculosis with minimal toxicity for the host. 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 the drug discovery process for treatment of tuberculosis. 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 Associated with Acquired Immunodeficiency Syndrome (NCDDG-OI) Including Tuberculosis, 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 "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, (telephone (202) 783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private organizations, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Awards will be made as Cooperative Agreements (U01s). The Cooperative Agreement funding mechanism differs from the traditional research grant in that the Government component (NIAID) awarding the Cooperative Agreement anticipates substantial programmatic involvement during performance. The nature of NIAID staff participation is described in the RFA. However, it is the Principal Investigator who defines his/her objectives in accord with his/her interests and perceptions of approaches to the treatment of AIDS-associated opportunistic infections. The applicant institution and the Principal Investigator will be responsible for the Group's application. Awards will be made to the applicant institution on behalf of the group as a whole and not to individual research projects within the Group. Respondents to this RFA may include new applications for a maximum period of four years support and competitive supplements to currently funded NCDDG-OI Groups for research focused on M. tuberculosis. This RFA is a one-time solicitation. Plans for continued support in this area are indefinite at this time. If by the end of the third year of the award, the NIAID has not announced its intent to re-issue the RFA, incumbents should contact NIAID program staff and consider submitting investigator-initiated (R01) applications which will compete with all investigator-initiated applications and be reviewed according to the customary NIH peer review procedures. FUNDS AVAILABLE It is estimated that no more than one or possibly two new Groups will be funded for drug discovery against M. tuberculosis as a result of this RFA. A maximum of $3.4 million (including direct and indirect costs) will be available over the four year period, including approximately $0.8 million (direct and indirect costs) during the first year. Awards and level of support are dependent on the receipt of a sufficient number of applications of high scientific merit. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of awards will vary also. Applications with budgets in excess of $800,000 total (direct and indirect) costs for the first year will be returned without review. Budget requests must be adequately justified and commensurate with the complexity of the project. Although this program is provided for in the financial plans of the NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES It is the intention of this RFA to encourage investigators to collaborate in new, multidisciplinary approaches to drug discovery against human tuberculosis. It is recognized that the ultimate objective of selective therapy against microbial infection requires a solid knowledge base of the biology, composition, physiology, molecular biology, and host interactions of infectious agents. The objective of this RFA is to stimulate original and innovative research of sound scientific rationale, requiring comprehensive team effort, that is likely to result in the discovery of agents effective against M. tuberculosis. Examples of research projects considered responsive to this RFA may include, but are not necessarily restricted to, the following: o Identification and development of drug evaluation assays for molecular targets, with selectivity for M. tuberculosis, such as recombination repair mechanisms, elongation factors, cell wall assembly, and others with potential for mycobactericidal consequences. o Identification of bacterial virulence determinants and development of drug evaluation assays for essential mycobacterial gene products, particularly biochemical activities expressed in vivo and associated with pathogenicity. o In vitro and in vivo testing of new chemical entities with potential for mycobactericidal activity within a framework of logical plans that examine structure-activity relationships and potential toxicities. o Development, validation, and implementation of drug evaluation systems capable of predicting cidal and sterilizing activity of new agents, or combinations of agents, against M. tuberculosis. o Studies on the effects of drugs on slow-growing M. tuberculosis, such as those found in granulomatous tubercular lesions, identification of drugs with extended lengths of biological activity, and development of methods to assess post-antibiotic effect on M. tuberculosis. o Development, validation, and implementation of improved models for in vivo drug evaluations, such as immunosuppressed animals, or mice with disrupted interferon-gamma genes or other immune effector genes. o Development and evaluation of biological entities, such as recombinant mycobacteriophage as drug or suicide gene delivery vehicles, and evaluation of these for efficacy and safety. o Identification and development of systems to predict emergence of resistance to established and newly identified antibiotics, and to evaluate new therapies for their ability to prevent or overcome resistance. SPECIAL REQUIREMENTS The applicant institution will provide a Central Operations Office for the Group, will be responsible for the performance of the entire Group, and will be accountable for the funds awarded. The participation of the Government through the NIAID extramural staff is intended to facilitate a concerted effort by all members of the Group by providing appropriate scientific input, by accessing appropriate databases, and by providing ancillary testing available under other mechanisms. The interaction of academic and non-profit research institutions with commercial organizations and the Government is strongly encouraged and is expected to favor expeditious discovery and development of agents active against human tuberculosis. An NCDDG-OI must be composed of two independent laboratory research projects and may consist of scientists from a combination of academic, non-profit research, and commercial organizations. For the purpose of this RFA, two projects within a single company or academic department will not be considered independent. This limitation on the number of independent projects from the same academic department or private sector company is intended to increase the diversity and multi-disciplinary expertise available to the Group. Each NCDDG-OI will be assembled by the Principal Investigator to form a multidisciplinary consortium that acts as a unit and represents the various skills needed to successfully design, synthesize, and evaluate, at the preclinical level, potential therapeutic agents useful in the treatment of opportunistic infections in AIDS patients. While it is anticipated that complete drug discovery and development of new therapies will not occur within the project period for all Groups, a rationale for the most likely utility of discoveries made within the NCDDG-OI must be included. Specifically excluded from the Group's activities are studies related to clinical evaluations. Projects or cores with proposed animal model development must be essential to targeted drug discovery and required to attain the objectives of the Group. Random or large scale screening of compounds will not be supported under this RFA. Each applicant Group must provide a detailed description of the approach to be used for obtaining patent coverage for discoveries and for licensing where appropriate, in particular where the invention may involve investigators from more than one institution. In addition, each Group must provide a detailed description of the procedures to be followed for the resolution of legal problems which may develop. The NIAID will not be a partner in any patents or royalties ensuing from this research. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of minorities and women in study populations. If women and minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by November 15, 1993, a letter of intent that includes a descriptive title of the proposed research, brief description of the proposed research, the name, address (including institution), and telephone number of the Principal Investigator, the identity of project leaders and titles of their projects, other key personnel and their institutions, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of the application, the information that it contains allows NIAID to estimate the potential workload for reviewers and to avoid possible conflict of interest in the review progress. The letter of intent is to be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. This form is available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248. Additional instructions for preparation of applications are provided in the RFA. Applications not received by January 21, 1994, will be considered non-responsive and returned to the applicant without review. REVIEW CONSIDERATIONS Applications will be reviewed by the Division of Research Grants (DRG) for completeness and by NIAID staff to determine responsiveness to this RFA. Incomplete and non- responsive applications will be returned to the applicant without further consideration or review. Those applications that are complete and responsive may be subjected to triage by an NIAID peer review group to determine their scientific merit relative to the other applications received in response to this RFA. The NIAID will remove from further competition those applications judged by a triage peer review group to be noncompetitive for award and will notify the applicant and the institutional business official. Those applications judged to be competitive for award will be further reviewed for scientific and technical merit by an appropriate NIAID review committee. Detailed review criteria are provided in the RFA. A second level of review will be provided by the NIAID Council. AWARD CRITERIA One or two awards are anticipated under this RFA. The primary criterion for award is the scientific and technical merit of the application as judged by peer reviewers and reflected in the priority score. Additional award criteria are the availability of funds, receipt of a sufficient number of scientifically meritorious applications that are responsive to this RFA, and overall programmatic relevance and priority. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify issues or questions from potential applicants are welcome. Requests for the RFA and inquiries regarding programmatic or scientific issues may be directed to: Barbara Laughon, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C35 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 402-2304 FAX: (301) 402-3211 Inquiries pertaining to review of applications may be directed to: Dianne Tingley, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C16 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-0818 FAX: (301) 402-2638 Inquiries regarding fiscal matters may be directed to: Ms. Jane Unsworth Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B22 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7075 FAX: (301) 480-3780 Schedule Letter of Intent Receipt Date: November 15, 1993 Application Receipt Date: January 21, 1994 Scientific Review Date: March 1994 Advisory Council Date: June 1994 Anticipated Award Date: July/August 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, 93.856 - Microbiology and Infectious Diseases Research and 93.855 - Immunology, Allergic and Immunological Diseases Research. Grants are awarded under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under the PHS grants policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of the Executive Order 12372 or Health Systems Agency Review. $$R5 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-93-106 ************************************************ DRUG ABUSE TREATMENT FOR WOMEN OF CHILDBEARING AGE AND THEIR CHILDREN NIH GUIDE, Volume 22, Number 32, September 3, 1993 PA NUMBER: PA-93-106 P.T. 34; K.W. 0404009 National Institute on Drug Abuse PURPOSE The purpose of this program announcement is to stimulate research to improve the effectiveness of drug abuse treatment for women of childbearing age and their offspring. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Drug Abuse Treatment for Women of Childbearing Age and Their Children, is related to the priority area of health promotion/alcohol and other drugs. A copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) may be obtained through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit, public and private organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT This program announcement will use the National Institutes of Health (NIH) individual research grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Support will be provided for a period of up to five years (renewable for subsequent periods) subject to From owner-sci-resources@net.bio.net Thu Sep 02 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 32, pt. 2, 3 September 1993 Message-ID: Date: 3 Sep 93 01:42:17 GMT Sender: kristoff@net.bio.net Lines: 1158 Approved: biosci-moderator@net.bio.net $$XID NIHGUIDE 19930903 V22N32 P2O2 ************************************ continued availability of funds and progress achieved. In fiscal year 1994, it is anticipated that $5 million will be available from the National Institute on Drug Abuse (NIDA) to fund approximately eight to nine grants under this announcement. Research projects requiring substantial programmatic support, such as the establishment of new comprehensive services or the addition of a substantial component to an existing program, are encouraged under this announcement. If required in support of research objectives, funds may be expended on drug abuse treatment costs, rental and operation of facilities, approved renovation and modification of facilities (subject to limits and conditions specified in the PHS grants policy), and other costs normally allowable under existing PHS grants policy. Funds may not be used for new construction or to replace existing treatment funding. RESEARCH OBJECTIVES Summary Research studies are sought to investigate effective and cost-effective drug abuse treatment for women and their children. Research is sought to: (1) improve outcomes of drug abuse treatment for women of childbearing age and their young children; (2) improve treatment recruitment, retention, and compliance; (3) improve interventions for women with co-existing mental disorders and to reduce family and social dysfunction; (4) improve the drug abuse treatment environment, delivery of services, and service linkages in order to facilitate recovery from drug abuse; and (5) understand and remove barriers to drug abuse treatment for women, particularly for pregnant women and women with children. Background This announcement builds on a NIDA program of research established with Requests for Applications 89-03 (Research Demonstration Grants on Drug Treatment ... For Pregnant Women) and 90-12 (Research Demonstration Applications on Drug Abuse Treatment for Women of Child-Bearing Age and their Offspring). Both new applicants and those investigators previously funded under the above-cited programs are eligible. The treatment needs of women often differ from those of men. Women who abuse drugs face a variety of barriers to treatment entry, engagement in treatment, and long-term recovery. Barriers to entry include a lack of economic resources, referral networks, women-oriented services, and conflicting child-related responsibilities. Engagement in treatment and consequent long-term recovery are hampered by the primarily male orientation of traditional models of drug treatment and aftercare; by women-specific problems such as low self-esteem, low employability, and a lack of appropriate services to treat social, psychiatric, and medical disorders. Women who are addicted are also more likely to engage in high-risk sexual behavior, such as sex in exchange for crack, that increases the risk of becoming pregnant as well as the risk of contracting infectious diseases such as HIV. Maternal drug abuse may complicate delivery of offspring and compromise the newborn child's chance of normal mental and physical development. Research on improved therapeutic programs and supportive services is needed to address drug abuse treatment and medical treatment needs of the mother and child before and after delivery. Research presently underway suggests a number of areas in which further investigation is needed. Applications focused on culturally appropriate treatment strategies and program models for women and children of special populations (i.e., programs designed to serve unique needs of specific racial/ethnic minorities), women in high-risk groups (e.g., engaged in prostitution), or under criminal justice supervision are of particular interest. Additional study is needed on methodological issues such as research design and the measurement of behavior change. Research may focus on outreach strategies to improve entry of women into drug abuse treatment, on removing barriers to treatment, and on making such treatment more attractive (e.g., by providing a range of health services, by adding child care to programs and/or allowing mothers to have their children live with them in residential treatment). Studies suggest that women may benefit from services such as assertiveness training, counseling to build self-esteem, social skills enhancements, social network interventions, treatment for depression, and counseling in family planning and birth control. Case management approaches to coordinate services and maintain the integrity of treatment plans can improve treatment outcomes. Other useful components include psychoeducational strategies and relapse prevention. Program Description Research is sought to improve the outcomes of treatment for women of childbearing age, including treatment for mothers and their young children; improve recruitment, retention, and compliance with treatment; investigate strategies to deal with comorbidity and family/social dysfunction; improve the drug abuse treatment program environment and the delivery of treatment services in order to facilitate recovery from drug abuse, and to investigate the impact of barriers to entry and engagement in drug abuse treatment that exist for women, particularly pregnant women and women with young children. Applicants are advised to review existing information relevant to the treatment of drug abusing women and their children, including pregnant and postpartum women. The NIDA will support studies to investigate the short- and long-term effectiveness of comprehensive drug abuse treatment for women and their young children based in a variety of settings (e.g., hospitals, outpatient clinics, residential facilities, home-based care). Areas of research interest include research to: o Improve treatment recruitment, retention, compliance, and outcomes for women, with and without children, and their children. o Evaluate the effectiveness of psychosocial interventions developed for women, or gender-specific modifications of existing therapeutic approaches. o Investigate the effectiveness and cost-effectiveness of drug abuse treatment, aftercare, and ancillary services for women, including pregnant women and women with young children, designed to address medical, mental health, social, vocational, educational, family, and related problem areas. o Improve linkages and reduce overlap between service providers and to enhance ancillary service support structures. o Investigate the roles of comorbidity, family/social dysfunction, marital discord, criminal behavior, low employability, homelessness, and other factors that predict relapse to illicit drug use, and identification of effective treatment strategies for dealing with these. o Improve treatment program environments for women, including overcoming barriers to implementation of effective treatment programs and improving treatment service delivery to help engagement in treatment and long-term recovery. o Reduce the impact of barriers to drug abuse treatment that exist for women, particularly for pregnant women or women with young children. The importance of a sound research plan and qualified research staff cannot be over-emphasized. It is recommended that investigators use the most rigorous methodology consistent with the purposes of the research. All applications should address issues of project feasibility and collaborative arrangements, study design, sampling procedures, implementation of the intervention, instrumentation and measurement, data collection, quality control, tracking of clients, followup, and data analysis, as appropriate. Investigators are encouraged to offer HIV testing and counseling in accordance with current guidelines to subjects identified during the course of the research as being at risk for HIV acquisition or transmission. In high-risk populations, investigators are encouraged to assess the effects of new interventions on the acquisition and transmission of infectious diseases, including HIV. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS Applications for clinical research grants and cooperative agreements that involve human subjects are required to include minorities and both genders in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis should be placed on the need for inclusion of minorities in studies of diseases, disorders, and conditions which disproportionately affect them. This policy applies to all research involving human subjects and human materials, and applies to males and females of all ages. If minorities are excluded or are inadequately represented in this research, particularly in proposed population-based studies, a clear compelling rationale for exclusion or inadequate representation should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., American Indians or Alaskan Natives, Asians or Pacific Islanders, Blacks, Hispanics). Investigators must provide the rationale for studies on single minority population groups. Applications for support of research involving human subjects must employ a study design with minority and/or gender representation (by age distribution, risk factors, incidence/prevalence, etc.) appropriate to the scientific objectives of the research. It is not an automatic requirement for the study design to provide statistical power to answer the questions posed for men and women and racial/ethnic groups separately; however, whenever there are scientific reasons to anticipate differences between men and women, and racial/ethnic groups, with regard to the hypothesis under investigation, applicants should include an evaluation of these gender and minority group differences in the proposed study. If adequate inclusion of one gender and/or minorities is impossible or inappropriate with respect to the purpose of the only study population available, there is a disproportionate representation of one gender or minority/majority group, the rationale for the study population must be well explained and justified. The NIH funding components will not make awards of grants, cooperative agreements or contracts that do not comply with this policy. For research awards which are covered by this policy, awardees will report annually on enrollment of women and men, and on the race and ethnicity of subjects. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Applicants who are currently supported under NIDA research demonstration program (R18) will be considered competing continuations (type 2) R01s and may submit their applications for the competing continuation receipt dates of November 1, March 1, or July 1. The receipt dates for applications for AIDS-related research are found in the PHS 398 instructions. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grant Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 240, Bethesda, MD 20892, telephone 301/594-7248. The title and number of the announcement must be typed in Item 2a on the face page of the application. The completed original and five permanent, legible copies of the PHS 398 form must be delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW PROCEDURES The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary DHHS grant programs. Applications received under this announcement will be assigned to an initial review group (IRG) in accordance with established PHS referral guidelines. The IRGs, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit in accordance with the standard NIH peer review procedures. Notification of the review recommendations will be sent to the applicant after the initial review. Applications will receive a second-level review by an appropriate Advisory Council, whose review may be based on policy considerations as well as scientific merit. Only applications recommended for further consideration by the Council may be considered for funding. AWARD CRITERIA Applications recommended for further consideration by an appropriate Advisory Council will be considered for funding on the basis of overall scientific, clinical 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 subjects, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Frank Tims, Ph.D. or Jack Blaine, M.D. Division of Clinical Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-30 Rockville, MD 20857 Telephone: (301) 443-4060 Direct inquiries regarding fiscal matters to: Chief, Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Section 301, and administered under PHS 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. $$P1 END ************************************************************ $$P2 BEGIN PA-93-107 ************************************************ MEDICAL IMAGING DATABASES NIH GUIDE, Volume 22, Number 32, September 3, 1993 PA NUMBER: PA-93-107 P.T. 34; K.W. 0735015, 1004008, 0706030 National Cancer Institute National Institute of Neurological Disorders and Stroke National Library of Medicine PURPOSE The National Cancer Institute (NCI) through the Diagnostic Imaging Research Branch (DIRB) of the Radiation Research Program, the National Library of Medicine (NLM), and the Division of Stroke and Trauma, National Institute of Neurological Disorders and Stroke (NINDS) are seeking grant applications that will address new medical imaging database designs that focus on non-textual paradigms. The goal of medical imaging databases is to provide a means for organizing a large mass of heterogeneous, changing, pictorial, and symbolic data into a structured environment that can be synthesized, classified, and presented in an organized efficient manner to facilitate optimal decision making in a health care environment. A properly organized imaging database can compensate for human memory limitations and provide an environment for improved patient care, research, and education. Development of an effective and useful medical imaging database must take place in an interdisciplinary environment, using the medical knowledge from radiologists, radiation and medical oncologists, neurologists and other specialties in collaboration with the database research community and the imaging expertise of the computer and Picture Archiving and Communications System (PACS) sciences. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Medical Imaging Databases, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit, public and private organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Foreign institutions are not eligible for First Independent Research Support and Transition Awards (R29). MECHANISM OF SUPPORT Applications considered appropriate responses to this announcement are the traditional research project grants (R01) and the First Independent Research Support and Transition (FIRST) award (R29). Although no funds are specifically set aside for funding grants submitted in response to this program announcement, the Radiation Research Program regards research in this area as high priority. Awards will be administered in accordance with PHS grants policy as described in the PHS Grants Policy Statement, DHHS, Publication No. (OASH) 90-50,000 revised October 1, 1990. Because of the nature and scope of the research proposed in response to this Program Announcement may vary, it is anticipated that the size of an award will vary also. RESEARCH OBJECTIVES Background Today, medical imaging database management and searches are largely performed by skilled human investigators. Although considerable progress has been achieved in recent years in the development of new strategies for rapid and efficient textual retrievals from text databases, very little effort has gone into the development of techniques for non-textual searches. Similarly, since medical images are poorly incorporated into the overall collection of data on cancer patients, there is very little attempt to cohesively gather information from images of different patients for correlation with other critical parameters of their disease. The wealth of information that is potentially accessible, but not available through any currently available technology, would contribute to new clinical knowledge about disease progression, prognostic indicators for outcome assessment in patients scheduled for treatment, and the ability to assess outcome in patients who have undergone treatment. Research Goals and Scope Although much research has already been done in the development of "next generation databases," more research is needed to address the complex issues of developing the tools for medical imaging databases in a clinical environment. The research goals of this Program Announcement include the following: 1. Development of a descriptive language for medical images that describes image features that define the oncologic content of images and develops a standardized vocabulary for the geometric description of the images; 2. Development and implementation of advanced query languages that use pictorial and symbolic-based object-oriented data modeling to support complex non-textual queries; 3. Development of new database models that incorporate the following features: a. index an imaging database using image features; b. support spatial relations for queries that can detect change, such as by shape and size, but are robust enough to adjust for deformations; c. develop object-oriented solutions that can handle levels of uncertainty in identifying objects with fuzzy boundaries; d. support temporal relations that reflect both the history of the patient, as is currently best known, as well as what was in the database at any given point in time; e. allow for the development of ad hoc and customized schema that evolve as the user gathers new data and knowledge by navigating through or perusing the database; f. solve integrity problems, such as resolving a situation when two databases contain contradictory information; g. carry out search and analysis processes that are both accurate and timely and allow for the interaction of a human investigator. 5. Development of tools that allow for the cohesive unification of data and information from hospital information systems, radiological information systems, image archives and imaging machines into one system for incorporation into the electronic medical record for incorporation into the electronic medical record. Research and implementations of database systems must proceed in interdisciplinary environments that successfully combine the expertise and knowledge from the medical community with that of the database and computer science disciplines. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for this program announcement and will be accepted at the standard application deadlines as indicated in the application kit. These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, 5333 Westbard Avenue, Bethesda, MD 20892, telephone (301-594-7248). The PA number and title must be typed on line 2a of the face page of the application form. The completed original application and five legible copies must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** All PHS and NIH grants policies will apply to applications received in response to this announcement. FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST (R29) award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by study sections, in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among the research areas of this announcement INQUIRIES Written and telephone inquiries concerning the objectives and scope of this PA and inquiries about whether or not specific proposed research would be responsive are encouraged and may be directed to: Dr. Sandra Zink Radiation Research Program National Cancer Institute Executive Plaza North, Suite 800 Bethesda, MD 20892 Telephone: (301) 496-9360 Dr. George N. Eaves Division of Stroke and Trauma National Institute of Neurological Disorders and Stroke Federal Building, Room 8A-13 Bethesda MD 20892-9905 Telephone: (301) 496-4226 Dr. Roger Dahlen Extramural Programs National Library of Medicine Building 38, Room 5S522 Bethesda, MD 20892 Telephone: (301) 496-4221 Direct inquiries regarding fiscal matters to: Barbara A. Fisher Grants Management Specialist National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 66 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.395, Cancer Treatment Research and Number 93.854, Biological Basis Research in the Neurosciences. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 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. $$P2 END ************************************************************ $$P3 BEGIN PA-93-108 ************************************************ BEHAVIORAL RESEARCH IN SEXUALLY TRANSMITTED DISEASES NIH GUIDE, Volume 22, Number 32, September 3, 1993 PA NUMBER: PA-93-108 P.T. 34; K.W. 0404000, 0715182, 0745027 National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute on Aging PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Child Health and Human Development (NICHD), and the National Institute on Aging (NIA) invite applications for intervention-oriented behavioral research on sexually transmitted diseases (STDs). The prevention and control of STDs relies on several strategies: blocking transmission, seeking early diagnosis and treatment, utilizing available vaccines, and altering risk-associated behaviors over the life course. Each strategy has a behavioral component that is critical to the success of STD prevention and control. Behavioral research to reduce the incidence, prevalence, and severity of STDs should include multidisciplinary efforts that incorporate the measurement of microbiologic and/or disease outcomes as well as behavioral outcomes. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Behavioral Research in Sexually Transmitted Diseases, is related to the priority area of sexually transmitted diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-10473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, non-profit and for-profit research institutions; public and private organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority and female investigators are encouraged. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) award (R29). MECHANISM OF SUPPORT This program announcement will use the National Institutes of Health (NIH) investigator-initiated research project grant (R01) and the FIRST Award (R29). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The maximum duration of support for a given project period is five years. Investigators interested in collaborative and interactive research efforts around the central theme of behavioral research for the prevention and control of STDs may consider submission of interactive research project grants (IRPGs). Such investigators should first contact NIH program staff listed under INQUIRIES for advice on this mechanism and the method of application. RESEARCH OBJECTIVES Background In November 1989 and April 1990, the NIAID convened two interdisciplinary conferences on integrated behavioral research for the prevention and control of STDs to develop an intervention-oriented behavioral research agenda. The reports of these conferences are found in Appendix 1 of Research Issues in Human Behavior and Sexually Transmitted Diseases in the AIDS Era, Washington, DC: American Society for Microbiology, 1991, available from the publisher. The research objectives of this program announcement are based on the recommendations of those conferences. Magnitude and Impact of STDs Despite control efforts to prevent the spread of STDs, including human immunodeficiency virus (HIV) infection, both bacterial and viral STDs remain epidemic in many areas of the United States. Current estimates predict that there will be 10 to 13 million new cases of STDs this year, not including HIV infection. Associated costs are likely to exceed $5 billion. Complications of STDs include infertility, ectopic pregnancy, anogenital cancer, fetal wastage, low birth weight, and congenital/perinatal infection. Furthermore, recent studies indicate that ulcerative diseases as well as the more prevalent non-ulcerative STDs increase the risk of HIV transmission at least three- to five-fold. The long-term sequelae of STDs cause significant morbidity and mortality, and women and their infected infants bear much of the associated disease burden. Additionally, STDs disproportionately affect the health of several minority populations and a significant proportion of adolescents in the United States. Both the incidence of STDs and their long-term, potentially fatal sequelae are consistently higher among black and Hispanic Americans than among white Americans. Over 60 percent of all STD cases occur in people less than 25 years of age, and 3 million teenagers are infected with an STD each year. Transmission Dynamics The persistence, spread, and progression of STDs are related not only to biological factors but also to behavioral and social factors. According to May and Anderson's model on transmission dynamics, the reproductive rate of infection or the average number of sexually transmitted infections generated by an infected person is a function of (1) transmission probability, (2 contact rates, and (3) duration of infectiousness. In addition to biological factors, transmission probability is affected by the type and frequency of sexual behavior and the extent to which each behavior facilitates transmission. Contact rates are a function of the absolute number of partners as well as the characteristics of sexual partners encountered over a specified period of time. Duration of infectiousness, or the period of time during which an individual remains infectious, is determined by recognition of symptoms or risk and health-seeking behaviors, which lead to diagnosis and treatment. Behavioral interventions to prevent the acquisition, spread, and progression of STDs are associated with all three elements of May and Anderson's model. Decreasing transmission probability requires changing individuals' behaviors, including decreasing or eliminating sexual behaviors known to facilitate STD transmission and increasing condom use behavior. Decreasing contact rates calls for reduction in the number of sexual partners. Decreasing the period of infectiousness can be accomplished through symptom recognition, risk awareness, and increased health-seeking behavior as well as use of effective vaccines. STD Prevention and Control Strategies The ultimate outcome of behavioral research activities will be the design, implementation, and evaluation of interventions to decrease behaviors associated with STD risk and to increase health-seeking behaviors. The sequential research steps needed to build effective interventions are: 1. basic research to define antecedents associated with specific behaviors (including beliefs, perceptions, and motivations); 2. development of hypotheses derived from basic research concerning new approaches to STD prevention, treatment, and control; 3. pilot tests of intervention components on small, well defined samples; 4. experimental or quasi-experimental tests of complete interventions (formed from several components evaluated in pilot tests) to detect behavioral and microbiological effects. It should be noted that some of the behavioral research that has been conducted for HIV/AIDS prevention may augment or accelerate basic research or hypothesis development related to other STDs. For example, frequency of unprotected intercourse, number of sexual partners, and asymptomatic infection similarly affect the transmission dynamics of all STDs, including HIV infection. However, antecedents of preventive action may differ for STDs that are fatal (e.g., HIV infection), compared to those that incur long term consequences (e.g., pelvic inflammatory disease or genital herpes), or those that present only as an acute disease without long term sequelae (e.g., treatable bacterial STDs). Moreover, the factors that affect duration of infectiousness are different for HIV and many STDs. Infectiousness may be limited by curative therapy for bacterial STDs, and there is an available vaccine for one viral STD (hepatitis B). While the scientific areas covered in the following research objectives are very broad, it is not expected that any single application will cover the range of scientific areas described below. Applicants are encouraged to focus their investigations. A. Decrease Transmission Probability and Contact Rates The goal of research to decrease transmission probability and contact rates is to reduce risk of exposure to and acquisition of STDs through: (1) postponing coital debut; (2) reducing frequency of sexual practices associated with higher rates of transmission; (3) reducing numbers of sexual partners; and (4) increasing use of barrier contraceptives (e.g., condoms). While other NIH programs support research on these behaviors for HIV prevention (see addendum section), research targeted by this program announcement focuses on the reduction of the incidence, prevalence, and severity of STDs other than HIV and should include microbiologic and/or disease outcomes as well as behavioral outcomes. 1. Individual Factors: To change behaviors that put people at risk for STDs or their sequelae, individuals must recognize that there is a problem in their environment that is both serious and personally relevant; be motivated to act; and have the relevant knowledge, skills, and tools to undertake recommended action. Specific areas for research include, but are not limited to: o identification of antecedents and determinants of behaviors relevant to STD risk reduction in different populations (i.e., does the threat of PID and its sequelae motivate women to take preventive action against STDs); o ascertainment of optimal content, format, and venues for delivering information about acquisition and transmission of STDs and the serious consequences associated with these infections (i.e., what misperceptions about STDs are related to sexual risk taking, how is information concerning STDs conveyed through formal and informal networks of communication, and how can these networks be used to deliver programs that will result in a decrease in incident disease); o identification of skills needed to prevent STD transmission and optimal mechanisms to impart those skills (i.e., what is the best way to increase consistent condom use among individuals with genital herpes who may be asymptomatic but shedding virus). 2. Environmental Factors: In addition, impediments in the social environment must be identified and removed or diminished if individual behavioral change to reduce risk of STDs is to be initiated and sustained. Thus, research may focus on the individual as the target of the intervention or larger social structures. Specific areas of STD-related research on environmental factors may include: o determination of key norms that govern behaviors associated with STD transmission and development of strategies to modify them (i.e., what are the norms governing sexual intercourse during treatment for a bacterial STD, how do they vary by subpopulation, and what intervention strategies would be effective to modify them); o increase the adoption and diffusion of new and existing technologies to prevent STDs, such as barrier methods, that are compatible with human skills, dispositions, and perceptions related to STDs, including those technologies that can be controlled exclusively by women (i.e., what characteristics of vaginal suppositories enhance or discourage use among women, and which should be considered in the development of new topical microbicides to prevent STDs). On the basis of the findings of this research, STD interventions that target either individuals, groups, or the social environment will then be designed, implemented, and evaluated. B. Decrease the Duration of Infectiousness The goal of research in this area is to decrease the infectious period through increasing health-seeking behaviors leading to early diagnosis and treatment of STDs. 1. Diagnosis and Treatment: Behavioral research is needed to increase appropriate use of diagnostic tests. Given the high prevalence of asymptomatic disease, effective strategies should encourage individuals to seek STD screening on the basis of recognition of risk-related behavior rather than symptoms, which may not be present or recognized. For treatment to be effective, the patient must comply with the prescribed regimen. Optimal treatment for STDs includes taking medication, abstaining from sex during treatment (i.e., until the infection is no longer transmissible), referring partners for screening, and returning for follow-up screening or care after treatment, as necessary. Examples of research areas of interest include, but are not limited to, the following, and all should include both behavioral and microbiologic outcomes: o identification of antecedents and determinants of health-seeking behaviors that lead to STD diagnostic screening and medication compliance; o determination of level of current knowledge about benefits associated with screening, early treatment and medication compliance, and identification of misperceptions and other barriers to use; determination of optimal content, format, and venues for information delivery about screening and treatment; o development of behavioral instruments accompanied by microbiologic or disease measures that can (1) identify women at risk for repeat infection, (2) distinguish women with infection limited to the lower genital tract from those at risk for progression to upper genital tract infection, and (3) distinguish women with upper tract infection from those at risk for chronic sequelae; o determination of characteristics of health care provider-patient interaction that support and sustain diagnostic screening and compliance with treatment; o identification of barriers (from the perspective of both the patient and the health care provider) to appropriate use of screening and treatment; and o ascertainment of the impact of product characteristics (e.g., programmed timers to prompt pill taking) on medication compliance. 2. Vaccination: It is likely that vaccines for several STDs will be available by the end of this decade. To make full use of these powerful tools there is a critical need to dissect and understand the behavioral aspect of vaccine acceptance and compliance. Poor acceptance of the hepatitis B vaccine underscores this need. Immunization for hepatitis B has been available since 1982, yet the overall impact on incidence has been negligible. Rates of infection remain high even among high risk groups (i.e., homosexual men). Lack of use and poor compliance with the hepatitis B vaccine regimen underscore the need for research on the complex processes by which an individual arrives at a decision to either accept or decline immunization. This information will be essential in the development of clinical trial protocols and will be critical in increasing the likelihood of use of approved STD vaccines. Examples of research areas of interest include, but are not limited to: o identification of antecedents, determinants, and motivators of vaccine acceptance and compliance; o measurement of current knowledge about benefits associated with STD vaccine acceptance and identification of misperceptions and other barriers to use; o determination of optimal content, format, and venues for information delivery about vaccine availability; and o determination of characteristics of patient-provider interaction that support and sustain vaccine acceptance and compliance. Research to decrease the duration of infectiousness should produce detailed and specific information concerning increased use of diagnosis as well as acceptance of and compliance with treatment and vaccination. These findings will point to elements of interventions that are appropriate for pilot testing. Promising elements can then be folded into more complete interventions, which will be implemented and evaluated in experimental trials. Study Design Considerations In requiring investigators to measure both behavioral and disease or microbiologic outcomes, investigators will need to establish linkages to clinical settings where diagnostic capabilities are present. Treatment becomes an issue (1) if signs or symptoms make disease apparent, or (2) if infection is detected upon screening. In either case, consideration must be given to providing treatment. In addition, intervention research that results in significant benefit to cases should make provisions to provide a similar program to subjects who served as controls. However, other appropriate research designs may go beyond the clinical setting. For example, investigators may wish to consider epidemiologic research or add a component to an ongoing epidemiologic study (i.e., piggybacking an STD component on an existing survey that includes the collection of biologic samples). Epidemiologic research that expands beyond traditional demographic factors to include STD-related behaviors and infection status is integral and complementary to intervention-oriented research. Traditionally, epidemiologic surveys have focused on demographic and ecologic risk factors, such as age, race, sex, and population density. While these may be important indices of risk, they are not amenable to change. It is equally important that epidemiologic research monitor behaviors that may have a demonstrated relationship to STDs and are theoretically changeable. In this way, epidemiologic findings will identify which behaviors are important to consider in constructing pilot programs. Additional areas for research include, but are not limited to: o epidemiologic studies focused on factors associated with transmission probability and contact rates such as age of coital debut, number of partners, as well as factors influencing selection of partners from high risk populations; and o epidemiologic studies to identify sexual and other behaviors that increase risk of transmission or disease progression (e.g., douching or dry sex). Within the context of the research objectives of this program announcement, submission of applications that focus on methodologic research to improve data collected on sexual behaviors, creating valid and reliable indices of important outcome variables, and to probe factors that affect the quality of these data are encouraged. Clinical Assessment and Study Population As stated earlier, applicants are required to assess change in relevant behaviors and status of infection. Therefore, proposed projects must have ties to clinical facilities to characterize subjects with respect to sexually transmitted pathogens including, but not limited to, Chlamydia trachomatis, Neisseria gonorrhoeae, Treponema pallidum, human papillomavirus (HPV), herpes simplex virus type 2 (HSV-2), and human immunodeficiency virus (HIV). Although populations at risk for STDs are also at risk for HIV, studies that focus exclusively on HIV are not included under this program announcement. Certain populations continue to be at greater risk of STD acquisition, transmission, and progression, and they share a disproportionate burden of related disease; applicants are encouraged to investigate research questions in ethnic, racial, gender, and age groups as well as social environments in which risk is greatest. Special emphasis is placed on inner-city minorities, women, and adolescents. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 under Research Plan items 1-4 and item 5-Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations [i.e., Native Americans (including American Indians or Alaskan Natives), Asian and Pacific Islanders, Blacks, Hispanics]. The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicants must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted on the standard application deadlines for investigator-initiated applications: February 1, June 1, and October 1. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449 Bethesda, MD 20892, telephone 301-594-7248. The title and number of the announcement must be typed in Item 2a on the face page of the application and the "YES" box marked. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CRITERIA Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by relevant study sections of the Division of Research Grants, NIH in accordance with standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council or board. INQUIRIES The opportunity to clarify issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Heather Miller, Ph.D. Sexually Transmitted Diseases Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3A-26 Bethesda, MD 20892 Telephone: (301) 402-0443 FAX: (301) 402-1456 Arthur A. Campbell Center for Population Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B07 Bethesda, MD 20892 Telephone: (301) 496-1101 FAX: (301) 496-0962 Marcia Ory, Ph.D., M.P.H. Behavioral and Social Research Program National Institute on Aging Gateway Building, Room 2C234 7201 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-3136 FAX: (301) 402-0051 Direct inquiries regarding fiscal matters to: Mr. Todd Ball Grants Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 4B-22 Bethesda, MD 20892 Telephone: (301) 496-7075 Ms. Melinda B. Nelson Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17 Bethesda, MD 20892 Telephone: (301) 496-5481 Ms. Vicki Maurer Grants and Contracts Management Office National Institute on Aging Gateway Building, Room 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 13.856 "Microbiology and Infectious Disease Research". Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. ADDENDUM The National Institute of Mental Health (NIMH) Office of AIDS Programs supports research to better understand, assess, and treat the neuropsychiatric, behavioral, and psychosocial aspects of HIV infection and AIDS. Preventing or changing high risk behaviors and maintaining low risk behaviors are the only available strategies to prevent the further spread of HIV infection. The NIMH supports both preintervention and intervention studies in its behavioral and psychosocial program which includes identification of determinants of high-risk sexual and drug-using behaviors; determinants of maintaining low-risk behaviors, especially for hard-to-reach and special populations; the social contexts in which risk-taking behaviors occur; the impact of affective states (e.g., depression, anxiety, social isolation) on risk behavior; the affects of cognitive impairment on adherence to risk-reduction guidelines; the design, testing, and evaluation of theory-driven behavioral interventions designed to prevent and reduce high-risk behaviors for HIV infection and maintain low-risk behaviors in children, adolescents, and adults; research on interventions targeted to populations for which current research data are not available; the promotion of help-seeking behaviors such as counseling, social support, and early intervention services; adherence to medical treatment for HIV infection among different populations; and the psychological and psychosocial impact of HIV and AIDS upon individuals, families, and communities. For more information, contact: Ellen Stover, Ph.D., Director, Office of AIDS Programs, National Institute of Mental Health, Parklawn Building, Room 10-75, 5600 Fishers Lane, Rockville, MD 20857, telephone (301) 443-7281. $$P3 END ************************************************************ ERRATUM $$E1 BEGIN R3 19930806 APPEND RFA AI-93-017 BOTH *********************** MULTICOMPONENT VACCINE DEVELOPMENT NIH GUIDE, Volume 22, Number 32, September 3, 1993 RFA: AI-93-017 P.T. 34; K.W. 0740075, 1002045, 0710070 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: October 1, 1993 Application Receipt Date: November 24, 1993 The following change is made to RFA AI-93-017, published in the NIH Guide for Grants and Contracts, Vol. 22, No. 28, August 6, 1993: INQUIRIES The FAX number for Dr. David L. Klein should be: (301) 496-8030. $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Thu Sep 02 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 32, pt. 3, 3 September 1993 Message-ID: Date: 3 Sep 93 01:43:01 GMT Sender: kristoff@net.bio.net Lines: 1420 Approved: biosci-moderator@net.bio.net $$XID RFA AI93019 AI-93-019 P1O1 *************************************** NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS FOR THE TREATMENT OF OPPORTUNISTIC INFECTIONS ASSOCIATED WITH ACQUIRED IMMUNODEFICIENCY SYNDROME (NCDDG-OI): TUBERCULOSIS NIH GUIDE, Volume 22, Number 32, September 3, 1993 RFA: AI-93-019 P.T. 34; K.W. 0715165, 0755060, 0715008 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: November 15, 1993 Application Receipt Date: January 21, 1994 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) invites applications for the establishment of National Cooperative Drug Discovery Groups for the Treatment of Opportunistic Infections Associated with Acquired Immunodeficiency Syndrome (NCDDG-OI) focusing on tuberculosis. It is the purpose of this Request for Applications (RFA) to invite applications focused on the discovery of new, more effective, selective, and diverse therapeutic agents to treat and prevent infection caused by Mycobacterium tuberculosis. Research in the following areas is needed to provide the foundation for improvements in therapeutics for tuberculosis (TB), particularly in the setting of HIV infection: unique metabolic activities for drug targeting; biochemistry and molecular mechanisms of M. tuberculosis-host interactions; inhibitors of enzymatic and regulatory functions and biochemical pathways; mechanisms of overcoming drug resistance; and identification of natural products or synthetic chemical compounds with promise for development as TB therapies. Research activities should be directed toward discovery of selective drugs or molecular strategies that are lethal for M. tuberculosis with minimal toxicity for the host. It is anticipated that multidisciplinary approaches by scientists from a combination of academic, non-profit research, and commercial organizations, with the assistance of the NIAID, will be necessary to effectively accelerate discovery of new therapeutics. Applications that include research projects or core components from the private sector (e.g., pharmaceutical, chemical, or biotechnological companies) are encouraged. M. tuberculosis is the single opportunistic infection targeted in this RFA because of the compelling public health emergency and the need for additional therapies to overcome multi-drug resistant infections. Investigators pursuing similar drug discovery for other AIDS-associated opportunistic infections (OIs) are strongly encouraged to apply through other research support mechanisms. 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 Associated with Acquired Immunodeficiency Syndrome (NCDDG-OI), 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 "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private organizations, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Awards will be made as Cooperative Agreements (U01s). The Cooperative Agreement is an assistance mechanism, rather than an acquisition mechanism, in which substantial NIAID programmatic involvement is anticipated. The NIAID will support and/or stimulate research activity by collaborating and otherwise working jointly with the award recipient in a partner role, but is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of studies funded under a cooperative agreement are discussed later under SPECIAL REQUIREMENTS. In applying for a cooperative agreement, the Principal Investigator defines his/her objectives in accord with his/her interests and perceptions of approaches to the discovery of new treatments against tuberculosis. The applicant institution and the Principal Investigator will be responsible for the Group's application. Awards will be made to the Principal Investigator's institution on behalf of the Group as a whole and not to individual research projects within the Group. Respondents to this RFA may include new applications for a maximum period of four years support and competitive supplements to currently funded NCDDG-OI Groups for research focused on M. tuberculosis. Because the varied talents and commitment required for effective drug discovery will be from diverse disciplines and may be located at geographically disparate locations, it is anticipated that Project Leaders within a Group may be associated with different institutions. Each application must include two projects from independent laboratories. For the purpose of encouraging new collaborations under this RFA, projects within a single private company will not be considered independent. Similarly, two projects within the same academic department will not be considered independent. The Group will be led by a Principal Investigator who will also lead a scientific project. The applicant institution of the Principal Investigator will provide a Central Operations Office for the Group (usually as part of the Principal Investigator's research project), will be responsible for the performance of the entire Group, and will be accountable for the funds awarded. This RFA is a one-time solicitation. Plans for continued support in this area are indefinite at this time. If by the end of the third year of the award, the NIAID has not announced its intent to re-issue the RFA, incumbents should contact NIAID program staff and consider submitting investigator-initiated (R01) applications that will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. Under the Cooperative Agreement, a negotiated partner relationship exists between the recipient of the award and the NIAID in which the Group is responsive to the requirements and conditions set forth in this RFA. The interaction of academic and non-profit research institutions with commercial organizations and the Government is encouraged and is expected to favor expeditious discovery and preclinical development of agents active against tuberculosis and to facilitate their subsequent development for clinical trials. All policies and requirements that govern the grant program of the U.S. Public Health Service and the National Institutes of Health (NIH) apply. FUNDS AVAILABLE At the present time, it is estimated that no more than one to two new Groups will be funded for drug discovery against M. tuberculosis as a result of this RFA. Approximately $3.4 million (including direct and indirect costs) will be available over the four year period, including approximately $0.8 million (direct and indirect) during the first year. Any application received with a budget in excess of $0.8 million total costs (direct and indirect) for the first year will be returned without review. Awards and level of support are dependent on the receipt of a sufficient number of applications of high scientific merit. Because the nature and scope of the research proposed in response to th