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From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research, which have been published in the Federal Register of March 28, 1994 (FR 59 14508- 14513), and reprinted in the NIH Guide for Grants and Contracts of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below.  Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by April 3, 1995, a letter of intent that includes a de_script_ive _title_ of the proposed research, the proposed mechanism of support, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institution, 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 subsequent applications, the information that it contains allows NIDA 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: Director Office of Extramural Program Review, NIDA 5600 Fishers Lane, Room 10-42 Rockville, MD  20857 Telephone:  (301) 443-2755 FAX:  (301) 443-0538 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants.  These forms are available at most institutional offices of sponsored research, and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 240, Bethesda, MD 20892, telephone 301-594-7248. FIRST award (R29) applications must include at least three sealed letters of reference attached to the face page of the original application.  FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The RFA label in the PHS 398 must be affixed to the bottom of the original face page.  Failure to use the RFA label could result in delayed processing of the application such that it may not reach the review committee in time for review.  In addition, the RFA _title_ and number must be typed in Item 2a on the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD  20892** At the time of submission, two additional copies of the application must also be sent to: Director Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD  20857 Applications must be received by May 9, 1995.  If an application is received after that date will be held for the next regular receipt date and reviewed under standard circumstances.  However, it will not be considered as a response to this RFA.  The Division of Research Grants (DRG) will not accept any application in response to the RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application.  The DRG will not accept any application that is essentially the same as one already reviewed.  This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Division of Research Grants (DRG) and responsiveness by NIDA. Incomplete applications will be returned to the applicant without further consideration.  If the application is not responsive to the RFA, the applicant may be contacted to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific/technical merit by an appropriate peer review group convened by NIDA in accordance with the review criteria stated below.  As part of the initial merit review, a triage will be used by the initial review group in which applications will be determined to be competitive or non-competitive _base_d on their scientific merit relative to other applications received in response to this RFA.  Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria o  scientific, technical or medical significance and originality of proposed research; o  appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o  qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o  availability of the resources necessary to perform the research; o  appropriateness of the proposed budget and duration in relation to the proposed research; and o  Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA The anticipated date of award is September 30, 1995.  Applications recommended for further consideration by the NIDA Advisory Council will be considered for funding on the basis of overall scientific and technical merit of the application 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.  Special award criteria apply to R03 and R21 mechanisms.  Applicants should contact the program person listed under INQUIRIES. INQUIRIES Inquiries concerning this RFA are encouraged.  The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Harold W. Gordon, Ph.D. or Arthur Horton, Ph.D. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-38 Rockville, MD  20857 Telephone:  (301) 443-4877 Email:   This e-mail address is being protected from spam bots, you need JavaScript enabled to view it Direct inquiries regarding fiscal or grants management issues to: Chief, Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD  20857 Telephone:  (301) 443-6710 Email:   This e-mail address is being protected from spam bots, you need JavaScript enabled to view it The National Institute of Mental Health is not participating in this RFA, but continues to fund research in the area of basic human neuroscience through the unsolicited grant application process.  For more information contact: Dr. Israel Lederhendler Systems Neuroscience Program National Institute of Mental Health 5600 Fishers Lane, Room 11-102 Rockville, MD  20857 Telephone:  (301) 443-1576 FAX:  (301) 443-4822 AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance No. 93.279.  Awards are made under authorization of the Public Health Service Act, Section 301, and administered under PHS grants policies and Federal Regulations at _title_ 42 CFR 52 Grants for Research Projects, _title_ 45 CFR Part 74 & 92, Administration of Grants, and 45 CFR Part 46, Protection of Human Subjects.  _title_ 42 CFR Part 2, Confidentiality of Alcohol and Drug Abuse Patient Records may also be applicable to these awards.  This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and promote the non-use of all tobacco products.  This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.