To increase knowledge of basic brain and behavioral processes that underlie mental and behavioral disorders; to support epidemiological studies of biological and environmental risk factors; to translate basic and epidemiological research into the development of new diagnostics and interventions for preventing

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and treating mental disorders; to conduct clinical trials for testing the efficacy and effectiveness of interventions in controlled and real-world settings; and to conduct research to improve mental health service delivery and use.

Research supported by the National Institute of Mental Health may employ theoretical, laboratory, clinical, epidemiological, and field studies.

Studies may involve individuals with a mental disorder diagnosis, individuals with symptom levels that do not meet diagnostic thresholds, and healthy individuals of all ages.

Research also may involve animal, computational, and mathematical models appropriate to the system being investigated and the state of the field.

Areas eligible for research support are: basic and clinical neuroscience; genetics; geriatrics research; adult psychopathology; experimental therapeutics; developmental, behavioral, clinical, and epidemiological research relevant to mental disorders, behavioral disorders, and HIV/AIDS, in terms of the causes, prevention, treatment, and service delivery; basic (brain and behavior), clinical, and services research on the mental health problems of women, minorities, and rural populations; and research designed to eliminate mental health disparities.

In fiscal year 2007, NIMH made 94 SBIR/STTR awards totaling $28,655,126; no instrumentation awards were made in fiscal year 2007. NIMH funded 2,489 grants in fiscal year 2007, and an estimated 2,430 grants will be funded in fiscal year 2008. An estimated 2,371 grants will be funded in fiscal year 2009.

Uses and Use Restrictions

(1) Research project grants provide support for clearly defined projects by a named investigator in an area representing his/her specific interests and competencies.

(2) Exploratory/Development and Clinical Exploratory/Developmental Grants encourage the development of new research activities in categorical program areas; (3) Small Research Grants provide research support specifically limited in time and amount for studies in categorical program areas; (4) Collaborative Clinical Research Grants support evaluations of various methods of therapy and/or prevention; (5) Program Project and Center grants support large-scale, broad-based programs of research, usually interdisciplinary, consisting of several projects with a common focus; and (6) Cooperative Agreements support single or a group of related research activities with greater involvement of federal staff.

Standard small grants are limited to $50,000 direct costs for a period of 2 years or less, while other small grants are for less time and funds.

SBIR and STTR grants are awarded in two stages: Phase I grants are awarded to establish the technical merit and feasibility of a proposed research and development effort; only Phase I awardees are eligible to receive Phase II support.

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Eligibility Requirements

Applicant Eligibility

Public, private, profit, or nonprofit agencies (including State and local government agencies), eligible Federal agencies, universities, colleges, hospitals, and academic or research institutions may apply for research grants.

SBIR grants can be awarded only to domestic small businesses, and STTR grants can be awarded only to domestic small businesses which "partner" with a research institution in cooperative research and development.

For further definitions, requirements, and restrictions see the SBIR and STTR Omnibus Solicitations of the NIH, CDC, and FDA for SBIR and STTR Grant Applications.

Beneficiary Eligibility

Public, private, profit, or nonprofit organizations.

Credentials/Documentation

Costs will be determined in accordance with OMB Circular No. A-87 for State and local governments. For-profit organizations' costs will be determined in accordance with 48 CFR, Subpart 31.2 of the Federal Acquisition Regulations. For all other grantees, costs will be determined in accordance with HHS Regulations 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. Instructions for electronic submission may be found with the federal SF424 (R&R) form packages that are found in the SBIR/STTR funding opportunity announcements. Instructions are provided for SBIR Phase I and Phase II awards, respectively; as well as for STTR Phase I and Phase II awards, respectively.

Aplication and Award Process

Preapplication Coordination

Not applicable.

This program is excluded from coverage under E.O.

12372.

Application Procedures

Most applications must be prepared and submitted electronically. Most applicants use the SF 424 (Research & Related) for electronic submission. Information about the SF 424 form may be found on http://grants.nih.gov/grants/funding/424/index.htm, but application packages should be accessed through the appropriate funding opportunity announcement, found either on the NIH Guide to Grants and Contracts (http://grants1.nih.gov/grants/guide/index.html) or through the Grants.gov website (http://www.grants.gov/). Some institutions may submit the grant data directly (using what is called a system-to-system transfer). For further details, see grants.gov or eRA Commons. Application forms for SBIR and STTR grants may be obtained through the SBIR/STTR funding announcements posted on the NIH Guide to Grants and Contracts and the Grants.gov sites (see URLs listed above). All SBIR and STTR applications must be submitted electronically. The timeline for transition to electronic applications and the new forms may be found at: http://era.nih.gov/ElectronicReceipt/. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. Applications for the Resource-related Research Projects (R24) and Cooperative Agremment applications ("U" applications) must be prepared using the PHS 398 research grant application instructions and forms (Revised 9/2004 with an update on 4/2006). The PHS 398 is available at http://grants1.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Consultation on a proposed project may be obtained from the NIMH branch or office responsible for the research area of interest. Applications are reviewed by principally nonfederal consultants recruited nationwide from the mental health field. The amounts of the award and period of support are determined on the basis of merit of the project and the nature of the grant mechanism. Electronic applications are submitted through the Grants.gov website. Completed PHS 398 applications should be submitted to the National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Room 1040 - MSC 7710, Bethesda, MD 20892-7710 or Bethesda, MD 20817 (for express/courier service). This program is subject to the provisions of 45 CFR, Part 92 for State and local governments, OMB Circular No. A-110 for nonprofit organizations, cost principles of A-21 for educational institutions, and 42 CFR, Part 42.

Award Procedures

All applications for research grants, cooperative agreements, SBIR and STTR grants are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by the National Advisory Mental Health Council (excepting Small Grants). All competitive applications compete for available funds on the basis of scientific and technical merit, program relevance, and program balance. All SBIR and STTR applications receiving a priority score compete for 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

New R01 Applications: February 5, June 5, and October 5. Renewal, Resbumission, and Revision R01 Applications: March 5, July 5, and November 5. New R03, R21, R33, R21/R33, R34 and R36 Applications: February 16, July 16, and October 16. Renewal, Resbumission, and Revision R03, R21, R33, R21/R33, R34, and R36 Applications: March 16, July 16, and November 16. SBIR and STTR: April 5, August 5, and December 5. R13/U13 Applications: April 12, August 12, December 12. AIDS Applications: January 7, May 7, and September 7.

Authorization

Public Health Service Act, Title III, Section 301, Public Law 78-410, 42 U.S.C. 241, as amended; Small Business Research and Development Enhancement Act of 2000, Public Law 106-554.

Range of Approval/Disapproval Time

Applications: From 240 to 270 days from submission of application. SBIR/STTR applications: About 7- 1/2 months; Mental Health Education Programs and Various/Small Grants: From 5 to 6 months. Review of AIDS-related research is expedited.

Appeals

A principal investigator 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 homepage http://grants.nih.gov/grants/guide/notice-files/not97-232.html.

Renewals

Support is recommended for a specified project period, 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 new competing request. Small grants, exploratory, and dissertation grants are for 1-3 years (depending on program) and are not renewable.

Assistance Considerations

Formula and Matching Requirements

None.

Length and Time Phasing of Assistance

Varies, with a project periods ranging from 1 to 5 years. Funding commitments are made annually. SBIR: Generally, Phase I awards are for 6 months, and Phase II awards are for 2 years. STTR: Generally, Phase I awards are for 1 year and 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 for some programs.

In addition, immediate and full reporting of any inventions is required.

Audits

In accordance with the provisions of OMB Circular No. A-133, "Audits of States, Local Governments, and Nonprofit Organizations," nonfederal entities that expend $500,000 or more in its fiscal year in Federal awards shall have a single or program-specific audit conducted for that year in accordance with the provisions of this circular. Nonfederal entities that expend less than $500,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal government officials. Per the regulations, a for-profit (commercial) organization is subject to audit requirements for a non-Federal audit if, during its fiscal year, it expended $500,000 or more under HHS awards and at least one award is a HHS grant. For-profit organizations have two options regarding the type of audit that will satisfy the audit requirements either: (1) a financial related audit (as defined in the Government Auditing Standards, GPO Stock #020-000-00-265-4, http://www.gao.gov/govaud/ybk01.htm) of the HHS awards in accordance with Government Auditing Standards, or (2) an audit that meets the requirements contained in OMB Circular No. A-133(http://www.whitehouse.gov/OMB/circulars/a133/a133.html).

Records

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

Financial Information

Account Identification

75-0892-0-1-552.

Obigations

(Grants) FY 07 $965,030,435; FY 08 est $969,462,000; and FY 09 est $963,287,000.

Range and Average of Financial Assistance

$30,000 to $2,297,271; $387,718.

Regulations, Guidelines, and Literature

42 CFR 52. NIH Grant Policy Statement (Revised 12/2003). Grants will be available under the authority if and administered in accordance with the PHS Grants Policy Statement and federal regulations at 42 CFR 52 and 42 U.S.C. 241; Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Applications; and Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer Grant Applications.

Information Contacts

Regional or Local Office

Not applicable.

Headquarters Office

Dr. Ellen Stover, Director, Division of AIDS and Health and Behavior Research (Branch/Centers: Health and Behaivor Research; Health and Behavior Research Training and Career Development; Health and Behavior Small Business Innovation Research and Small Business Technology Transfer). Center for Mental Health Research on AIDS: Branches: HIV Pathogenesis, Neuropsychiatric and Treatment; Primary Prevention; Secondary Prevention and Translation; Other Programs: AIDS Research Centers; AIDS Small Business Innovation Research and Small Business Technology Transfer; AIDS Research Training; AIDS Fellowship Program. Telephone: (301) 443-9700. Dr. Wayne Goodman, Director, Division of Adult Translational Research and Treatment Development (Branches: Adult Psychopathology and Psychosocial Intervention Research; Clinical Neuroscience Research; Geriatrics Research; Experimental Therapeutics. Other Programs: Traumatic Stress Disorders; Research Training and Career Development; Small Business Innovation Research and Small Business Technology Transfer); Telephone (301) 443-9700. Dr. Linda Brady, Director, Division of Neuroscience and Basic Behavioral Science (Branches: Molecular, Cellular, and Genomic Neuroscience Research; Behavioral Science and Integrative Neuroscience Research; Genomics Research. Other Programs: Office of Research Training and Career Development; Office of Cross-cutting Science and Scientific Technology, including the Human Brain Project; Small Business Innovation Research; Small Business Technology Transfer, Molecular Libraries and Imaging Roadmap); Telephone (301) 443-3563. Dr. Mary Ellen Oliveri, Director, Division of Developmental Translational Research (Branches: Neurodevelopmental Disorders; Psychosocial Stress and Related Disorders, Affective and Regulatory Disorders. Other Programs: Autism STAART Centers; Child Abuse and Neglect; Research Training and Career Development; Small Business Innovation Research and Small Business Technology Transfer); Telephone: (301) 443-5944. Dr. Phil Wang, Director, Division of Services and Intervention Research (Branches: Services Research and Clinical Epidemiology; Adult Treatment and Preventive Intervention Research; Child and Adolescent Treatment and Preventive Intervention Research. Other Programs: Office of Research Training and Career Development; Small Business Innovation Research and Small Business Technology Transfer. Other Units: Clinical Trials Operations and Biostatistics Unit); Telephone (301) 443-6233. Dr. Jane Steinberg, Director, Division of Extramural Activities; Telephone (301) 443-3367. (Branches: Extramural Review Branch; Grants Management Branch. Other units: Special Projects; Extramural Policy; Staff Development). Office of the Director, NIMH: Dr. Della Hann, Director, Office of Science Policy, Planning, and Communications; Telephone: (301) 443-4335. Dr. Karen Babich, Director, Office of Global Mental Health; Telephone: (301) 443-7725. Ms. Gemma Weiblinger, Director, Office of Constituency Relations and Public Liaison; Telephone: (301) 443-3673. Dr. Robert Heinssen, Director, Office of Prevention; Telephone: (301) 435-0371. Dr. Ellen Stover, Director, Office on AIDS; Telephone: (301) 443-9700. Dr. Ernest Marquez, Director, Office for Special Populations, and Director, Office of Rural Mental Health Research; Telephone: (301) 443-2847. SBIR/STTR: Dr. Michael Huerta; Telephone: (301) 443-3563. Grants Management Contact: Ms. Rebecca Claycamp, Chief Grants Management Officer, National Institute of Mental Health, NIH, Department of Health and Human Services, 6001 Executive Blvd., Room 6115, MSC 9605, Bethesda, MD 20892-9605; Telephone: (301) 443-2811. Use the same numbers for FTS.

Criteria for Selecting Proposals

The following consideration will be used in determining projects to be funded: (1) Technical merit of the proposed project as determined by peer review; (2) Availability of funds; and (3) Relevance to program priorities.