Drug Abuse and Addiction Research Programs

To support biomedical, basic and clinical neuroscience, behavioral and social science, epidemiologic, health services and health disparity research to develop new knowledge and approaches related to the prevention, diagnosis, treatment, etiology, and consequences of addiction and drug abuse, including
credit: Nathan Rouse

HIV/AIDS.

To support research training and research scientist development.

To support dissemination of research findings.

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.

Examples of Funded Projects

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


Agency - Department of Health and Human Services

The Department of Health and Human Services is the Federal government's principal agency for protecting the health of all Americans and providing essential human services, especially to those who are least able to help themselves.




Program Accomplishments

In fiscal year 2007, 3,756 applications were received, 254 awards were issued. In fiscal year 2008 an estimated 3,482 applications are anticipated, 260 awards are anticipated. In fiscal year 2009, an estimated 3,569 applications are anticipated, 260 awards are anticipated.

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) research training grants including fellowships and institution training grants, career development grants and loan repayment grants; (5) 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

For research grants the following organizations/institutions are eligible to apply: Public/State Controlled Institutions of Higher Education; Private Institutions of Higher Education: Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and Alaska Native and Native Hawaiian Serving Institutions; Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education); Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education); Small Businesses; For-Profit Organizations (Other than Small Businesses); State Governments; Indian/Native American Tribal Governments (Federally Recognized); Indian/Native American Tribally Designated Organizations; County Governments; City or Township Governments; Special District Governments; Independent School Districts; Public Housing Authorities/Indian Housing Authorities; and Other(s): Eligible Agencies of the Federal Government, Faith-based or Community-based Organizations, U.S.

Territory or Possession, Indian/Native American Tribal Governments (Other than Federally Recognized), Regional Organizations, and Non-domestic (non-U.S.) Entities (Foreign Organizations).

Eligible Individuals: Any individual, or individuals (multiple PDs/PIs), with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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 and technical merit and program relevance by a scientific review group and a national advisory council.

Beneficiary Eligibility

Public or private profit and nonprofit sponsored organizations and individuals, minority groups, small businesses, health professionals, students, trainees, scientists and general public.

Credentials/Documentation

None.

Aplication and Award Process

Preapplication Coordination

Consultation/assistance is available from NIDA to aid in preparing the form.

This program is excluded from coverage under E.O.

12372.

Application Procedures

The National Institutes of Health is using www.grants.gov to accept electronic submission of applications. 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. 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 Procedures

Project grants recommended for approval by the appropriate National Advisory Council and approved for payment are awarded directly by NIDA to the applicant institution. All accepted, research projects, SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by the National Advisory Council. 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

Standard receipt dates for unsolicited applications: P01, R24, R25, T32-January 25, May 25, and September 25 for new, renewal, resubmission and revision. R01-February 5, June 5, and October 5 for new and March 5, July 5, and November 5 for renewal, resubmission and revision. K01, K02, K05, K08, K12, K23, K24, K25, K99/R01-February 12, June 12, and October 12 for new and March 12, July 12, and November 12 for renewal, resubmission and revision. R03, R21, R36-February 16, June 16, and October 16 for new and March 16, July 16, and November 16 for renewal, resubmission and revision. R15-February 25, June 25, and October 25 for new, renewal, resubmission and revision. New Investigator R01-March 20, July 20, and November 20 for resubmission (for applications involved in pilot only). SBIR/STTR: R44, R41, R42-April 5, August 5, and December 5 for new, renewal, resubmission and revision. F30, F31, F32-April 8, August 8, and December 8 for new, renewal and resubmission. R13-April 12, August 12, and December 12 for new, renewal, resubmission and revision. AIDS research-May 1, September 1, and January 2. For solicited applications, receipt dates are specified in the announcements.

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.

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 225 days.

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.

Obigations

(Grants) FY 07 $37,805,000; FY 08 est $38,771,000; and FY 09 est $38,771,000.

Range and Average of Financial Assistance

$35,000 to $1,133,000; $149,000.

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

None.

Headquarters Office

Program Contacts: Dr. David Shurtleff, Director, Division of Basic Neuroscience and Behavioral Research (Research on Basic Behavioral and Cognitive, Basic Chemistry and Biochemistry, Basic Pharmacological, Neurobiological, and Cellular, Basic Behavioral, and Molecular Biology and Genetic Research). Telephone: (301) 443-1887. Dr. Frank Vocci, Director, Division of Pharmacotherapies and Medical Consequences of Drug Abuse (Basic and Clinical Pharmaceutical, Medical Consequences of Drug abuse, Research on Treatment, AIDS, and Tuberculosis, Medication Development, Drug Delivery Systems and Clinical Trial Research). Telephone: (301) 443-6173. Dr. Wilson Compton, Director, Division of Epidemiology, Services and Prevention Research (Behavioral and Social Science Research, Incidence, Prevalence, Ethnographic, Survey Research, and Longitudinal Studies on Prevention, Vulnerability and Etiology, Health Services). Telephone: (301) 443-6504. Dr. Joseph Frascella, Director, Division of Clinical Neuroscience and Behavioral Research (Clinical Neurobiology of Addiction, Cognitive Neuroscience, Neurobiology of Treatment, Biological Etiology, Comorbidity, Neurobiology of HIV/AIDS, Neurobiology of Human Pain and Analgesia). Telephone: (301) 443-4877. Dr. Betty Tai, Director, Center for the Clinical Trials Network (Translate Drug Abuse Treatment Research Throughout the County; Research on Behavioral, Pharmacological, and Integrated Behavioral and Pharmacological Treatment Interventions of Therapeutic Effect in Rigorous Multisite Clinical Trials). Telephone: (301) 443-6697. Dr. Mimi Ghim, Ph.D., NIDA Deputy Coordinator of Research Training. Telephone: (301) 443-6071. SBIR Contact: Dr. Cathrine Sasek, Telephone: (301) 443-6071. Review Contact: Dr. Teresa Levitin, Office of Extramural Affairs. Telephone: (301) 443-2755. Grants Management Contact: Ms. Pam Fleming, Grants Management Officer. Telephone: (301) 443-6710. National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services, Neuroscience Building, 6001 Executive Boulevard, Bethesda, MD 20892. Dr. Levitin and Ms. Fleming are located in 6101 Executive Boulevard. 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; (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.



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