To develop a sound fundamental knowledge base which can be applied to the development of improved methods of treatment and more effective strategies for preventing alcoholism and alcohol-related problems.

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) supports research in a broad

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range of disciplines and subject areas related to biomedical and genetic factors, psychological and environmental factors, alcohol-related problems and medical disorders, health services research, and prevention and treatment research.

Small Business Innovation Research (SBIR) program: to increase private sector commercialization of innovations derived from Federal research and development; to increase small business participation in Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.

Small Business Technology Transfer (STTR) program: To stimulate and foster scientific and technological innovation and technology transfer through cooperative research and development carried out between small business concerns and research institutions; to increase private sector commercialization of innovations derived from Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.

None.

Uses and Use Restrictions

(1) Research Project Grants provide support for clearly defined projects or a small group of related activities, and when appropriate, support of conferences; (2) Program Project Grants are for large-scale, broad-based programs of research, usually interdisciplinary, consisting of several projects with a common focus; (3) Small Grants are for small-scale exploratory and pilot studies or exploration of an unusual research opportunity; Small Grants are limited to $50,000 for direct costs for a period of up to 2 years; and (4) Exploratory/Developmental Grants are limited for a period of up to 2 years, and a maximum of $275,000 for direct costs for the entire 2- year period.

Funds may be used only for expenses directly related to the approved research project.

SBIR Phase I grants (of approximately 6- months' duration) are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or processes.

Phase II grants are for the continuation of the research initiated in Phase I, and that are likely to result in commercial products or processes.

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.

Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential of Phase II application.

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Eligibility Requirements

Applicant Eligibility

Public or private profit and nonprofit agencies, including State, local, or regional government agencies, universities, colleges, hospitals, 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 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.

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, profit and nonprofit private organizations.

Credentials/Documentation

Costs will be determined in accordance with OMB Circular No. A-87 for State and local governments. For-profit grantees' costs will be determined in accordance with Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined in accordance with HHS Regulation 45 CFR Part 74, Subpart C, Section 74.27. 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.

Aplication and Award Process

Preapplication Coordination

Not applicable.

This program is excluded from coverage under E.O.

12372.

Application Procedures

The standard application forms, as furnished by PHS, must be used by grant applicants. Application kits, containing the necessary forms and instructions, if not available at the applicant institution, may be obtained from the NIAAA. Consultation on proposed projects is also available. Preapplication consultation with NIAAA staff is required before submission of a Program Project grant application or any unsolicited new grant application requesting $500,000 or more direct costs in any one year. Applications are reviewed by nonfederal consultants recruited nationwide. The amount of the award and period of support are determined on the basis of the merit of the project. This program is subject to the provisions of 45 CFR Part 92 for State and local governments and OMB Circular No. A-110 for nonprofit organizations. SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH's "Small Business Funding Opportunities" home page at 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: Telephone: (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 Procedures

Research Grants in support of projects recommended for approval by the National Advisory Council on Alcohol Abuse and Alcoholism and approved for payment are awarded directly by the NIAAA 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. SBIR: April 15, August 15, and December 15. STTR: December 1, only. AIDS related research applications January 2, May 1, and September 1.

Authorization

Public Health Service Act, as amended, Sections 301 and 464H, Public Law 78-410, 42 U.S.C. 241, and 42 U.S.C. 290Gb; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.

Range of Approval/Disapproval Time

From 240 to 270 days from submission of application for grant support. SBIR/STTR applications about 7-1/2 months. AIDS related research applications about 6 months.

Appeals

A principal investigator may appeal 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 Appeals procedures is available on the NIH home page www.nih.gov/grants/guide/1997/97.11.21/n2.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 renewal of support for a new project period. An application for renewal is processed as a competing request. Small Grants and Exploratory/Developmental Grants are not renewable, but grantees may apply for research project grants on the same topics.

Assistance Considerations

Formula and Matching Requirements

None.

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. Within the project period, continuation applications must be submitted on a non-competing basis for each year of approved support. Small Grants are limited to 2 years or less and are not renewable. Exploratory/Developmental Grants are limited to 3 years or less and are not renewable. Payments will be made either on a Monthly Cash Request System or under an Electronic Transfer System. Necessary instructions for the appropriate type of payment will be issued shortly after an award is made. 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 continuation 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; (4) Immediate and full reporting of any inventions.

Audits

Audits are to be carried out in accordance with the provisions set forth in 45 CFR Part 74, Subpart C, Section 74.26 and in OMB Circular No. A-133, as appropriate. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal officials.

Records

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

Financial Information

Account Identification

75-0894-0-1-552.

Obigations

(Research Projects) FY 07 $260,567,000; FY 08 est $260,630,000; and FY 09 est not reported.

Range and Average of Financial Assistance

$40,000 to $1,515,000; $359,000.

Regulations, Guidelines, and Literature

42 CFR 52. Guidelines are included in application kits. PHS Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, (Rev.) April 1, 1994. Specific program announcements are available electronically from the NIAAA World Wide Web Home Page on the Internet at http://www.niaaa.nih.gov or from the NIH Home Page under Institutes and Offices. Grants will be available under the authority of and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 USC 241; 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

The Headquarters Office (National Institute on Alcohol Abuse and Alcoholism) is responsible for the administration of these programs.

Headquarters Office

Program Contacts: Dr. Antonio Noronha, Director, Division of Neuroscience and Behavior: Telephone: (301) 443-7722. Dr. Ralph Hingson, Director, Division of Epidemiology and Prevention Research: (301) 443-1274. Dr. Mark Willenbring, Director, Division of Treatment and Recovery Research: (301) 443-1208. Dr. Samir Zakhari, Division of Metabolism and Health Effects: (301) 443-0799. National Institute on Alcohol Abuse and Alcoholism, NIH, Department of Health and Human Services, 5635 Fishers Lane, Bethesda, MD 20892-9304. Grants Management Contact: Judy Fox, Grants Management Officer, National Institute on Alcohol Abuse and Alcoholism, NIH, Department of Health and Human Services, 5635 Fishers Lane, Room 3023, Bethesda, MD 20892-9304. Telephone: (301) 443-4704. Use the same numbers for FTS.

Criteria for Selecting Proposals

The following considerations will be used in determining projects to be funded: (1) Scientific and technical merit of the proposal; (2) program balance; and (3) relevance to NIAAA priorities and public health issues. 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 of 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 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 technological innovation, originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget requested for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) 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.