FEDERAL AGENCY:

NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES

AUTHORIZATION:

Public Health Service Act, Sections 301, 405, 464L, 464N, and 464P, 42 U.S.C. 241, 42 U.S.C. 284, 42 U.S.C. 295, 42 U.S.C. 2850-2, and 42 U.S.C. 2850-4; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.

OBJECTIVES:

To support epidemiologic, basic, clinical, and applied research to develop new knowledge and approaches related to the prevention, treatment, etiology, and consequences of drug addiction, including HIV/AIDS. Small Business Innovation Research (SBIR) program: to expand and improve the SBIR program. The legislation is intended to expand and improve the SBIR programs to emphasize and increase private sector commercialization of technology developed through Federal SBIR research and development; increase small business participation in Federal research and development; and foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in the SBIR program. The legislation intends that the Small Business Technology Transfer (STTR) program stimulate and foster scientific and technological innovation through cooperative research and development carried out between small business concerns and research institutions; foster technology transfer between small business concerns and research institutions; to increase private sector commercialization of innovations derived from Federal research and development; and foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.

TYPES OF ASSISTANCE:

Project Grants. Place Cursor Here for Definition

USES AND USE RESTRICTIONS:

(1) Research project grants provide support for clearly defined projects or a small group of related research activities, and when appropriate, support of research conferences; (2) program project and center grants support large-scale, broad-based programs of research, usually interdisciplinary, consisting of several projects with a common focus; (3) small grants support newer, less experienced investigators; investigators at institutions without a well developed research tradition and resources; the testing of new methods or techniques; small-scale exploratory and pilot studies, or exploration of an unusual research opportunity; small grants provide research support of up to $50,000 direct costs per year for a period of up to 2 years; (4) SBIR Phase I grants (of approximately 6-months' duration) are to establish the technical merit and feasibility of a proposed research or research and development efforts to determine the quality of performance of the small business grantees. Phase II grants are for the continuation of the research initiated in Phase I and that are likely to result in commercially viable products or processes. Only Phase I awardees are eligible to apply for Phase II support; STTR Phase I grants (normally of 1-year duration) are to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort that has potential for commercial application and the quality of performance of the small business concerns. Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential of the Phase II application.

ELIGIBILITY REQUIREMENTS:

Applicant Eligibility:   Public or private profit and nonprofit agencies, foreign or domestic, including State, local or regional government agencies, universities, colleges, hospitals, and academic or research institutions may apply for research grants. SBIR grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed, and have no more than 500 employees). Primary employment (more than one-half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project. In both Phase I and Phase II, the research and/or development must be performed in the U.S. and its possessions. To be eligible, an SBIR grant application must be approved for scientific merit and program relevance by a scientific review group and by a national advisory council. STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed and have no more than 500 employees) which "partner" with a research institution in cooperative research and development. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.

Beneficiary Eligibility:   Public or private profit and nonprofit organizations.

Credentials/Documentation:   Costs will be determined in accordance with OMB Circular No. A-87 for State and local governments. For other grantees, costs will be determined in accordance with HHS Regulation 45 CFR, Part 74, Subpart Q. For SBIR and STTR grants, applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. Grant forms PHS 6246-1 and PHS 6246-2 are used to apply for SBIR Phase I and Phase II, respectively. Grant forms PHS 6246-3 and PHS 6246-4 are used to apply for STTR Phase I and Phase II, respectively.

Pre-application Coordination:   Not applicable. This program is excluded from coverage under E.O. 12372.

Application Procedure:   The standard application forms, as furnished by PHS and required by 45 CFR 92 for State and local governments, must be used for this program. Application kits containing the necessary forms and instructions, if not available at the applicant institution, may be obtained from the National Institutes of Health, Division of Extramural Outreach and Information Resources, Bethesda, MD. 20892. They are also available from the NIH web site at www.nih.gov. Information concerning NIDA and the types of research supported may be found at www.drugabuse.gov or www.nida.nih.gov. Consultation on a proposed project may also be obtained from NIDA. Applications are reviewed by primarily nonfederal consultants recruited nationwide. The amount of the award and period of support are determined on the basis of scientific merit of the project as well as financial and programmatic consideration. SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH's "Small Business Funding Opportunities" home page at http://www.nih.gov/grants/funding/sbir.htm on the World Wide Web. A limited number of hard copies of these publications are produced. Subject to availability, they may be obtained by contacting the NIH support services contractor: phone: (301) 206-9385; fax: (301) 206-9722; e-mail: a2y@cu.nih.gov. The Solicitations include submission procedures, review considerations, and grant application or contract proposal forms. SBIR and STTR grant applications should be submitted to the Center for Scientific Review, 6701 Rockledge Drive, Room 1040 - MSC 7710, Bethesda, MD 20892-7710.

Award Procedure:   Research grants in support of projects recommended for approval by the appropriate National Advisory Council and approved for payment are awarded directly by NIDA to the applicant institution. All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score compete for available SBIR/STTR set-aside funds on the basis of scientific and technical merit and commercial potential of the proposed research, program relevance, and program balance among the areas of research.

Deadlines:   February 1, June 1, and October 1, for R01, R03, R13, R21, P01, P30, 50, and 60. January 2, May 1, and September 1 for AIDS research. SBIR: April 1, August 1, and December 1. STTR: April 1, August 1, and December 1.

Range of Approval/Disapproval Time:   From 240 to 270 days from submission of grant application. For AIDS applications the range will not exceed 180 days from cited receipt dates. SBIR/STTR applications: About 7-1/2 months.

Appeals:   A principal investigator (P.I.) may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute. A description of the NIH Peer Review Appeal procedures is available on the NIH home page www.nih.gov/grants/guide/notice-files/not97-232.html.

Renewals:   Support is recommended for a specified project period, usually not in excess of 5 years. Prior to termination of a project period, the grantee may apply for additional support via competing continuation application unless otherwise restricted. Small grants are limited to up to 2 years. Exploratory/developmental grants are limited to 3 years.

ASSISTANCE CONSIDERATIONS:

Formula and Matching Requirements:   This program has no statutory formula or matching requirements.

Length and Time Phasing of Assistance:   Varies, but a project period is generally limited to 5 years or less. Grantee may apply for renewal of support on a competing basis unless otherwise restricted. Within the project period, continuation applications must be submitted on a non-competing basis for each year of approved support. Small grant support is limited to no more than 2 years. SBIR: Normally, Phase I awards are for 6 months; normally, Phase II awards are for 2 years. STTR: Normally, Phase I awards are for 1 year; normally, Phase II awards are for 2 years.

POST ASSISTANCE REQUIREMENTS:

Reports:   Reports must be submitted as follows: 1) Interim progress reports annually as part of a non-competing application for previously recommended support; (2) terminal progress report within 90 days after end of project support; (3) annual financial status report within 90 days after termination of annual grant; and (4) immediate and full reporting of any inventions.

Audits:   In accordance with the provisions of OMB Circular No. A- 133, (Revised, June 24, 1997), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that expend financial assistance of $300,000 or more in Federal Awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $300,000 a year in Federal awards are exempt from Federal audit requirements for the year, except as noted in Circular No. A-133. For nongovernmental grant recipients, audits are to be carried out in accordance with the provisions set forth in OMB Circular No. A- 133. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal officials.

Records:   Records must be retained for at least 3 years; records shall be retained beyond the 3-year period if audit findings have not been resolved.

FINANCIAL INFORMATION:

Account Identification:   75-0897-0-1-552.

Obligations:   (Grants) FY 01 $604,692,000; FY 02 est $673,994,000, and FY 03 est $729,438,000.

Range and Average of Financial Assistance:  
Range-$4,078 to $5,013,000; Average-$403,000.

In fiscal year 2001, 1,688 grants were issued. In fiscal year 2002, an estimated 1,802 grants are anticipated, and in fiscal year 2003, an estimated 1,849 grants are anticipated.

REGULATIONS, GUIDELINES, AND LITERATURE:

42 CFR 52; Guidelines are included in applications kits. PHS Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000, (Rev.) April 1998. Grants will be available under the authority of and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR Part 52 and 42 CFR Part 52a; Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant and Cooperative Agreement Applications. Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR) Grant Applications.

INFORMATION CONTACTS:

Regional or Local Office:   Not applicable.

Headquarters Office:   Camilla L. Holland 6001 Executive Blvd., Rm. 4241, Bethesda, Maryland 20892 Email: chollan1@nida.nih.gov Phone: 3014351384

Web Site Address:  
http://www.drugabuse.gov/

EXAMPLES OF FUNDED PROJECTS:

(1) Kinetics of Morphine and its Derivatives; (2) Epidemiology of drug abuse among minority populations; (3) Studies of AIDS among IV Drug Abusers; (4) Studies of Narcotic- Induced Respiratory Depression; (5) Endorphins: Metabolism, Release, and Tolerance; (6) Biological and Behavior Mechanisms of Addictive and Compulsive Behavior; and (7) Maternal/Paternal Effects of Drugs of Abuse.

CRITERIA FOR SELECTING PROPOSALS:

The following considerations will be used in determining projects to be funded: (1) Scientific and technical merit; (2) the feasibility of the research; (3) potential contribution to the national drug abuse problem; and (4) relevance to NIDA priorities. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technology.