In fiscal year 2006, 126 research grants, and 8 National Research Service Awards were made. In fiscal year 2006, for new and competing renewal awards: 130 sleep grant applications were received, and of these, 24 were awarded; 6 Small Business Innovation Research Phase I awards, and 2 Phase II awards were made in fiscal year 2006.

Uses and Use Restrictions

Grants may support salaries, equipment, supplies, travel, and patient hospitalization as required to perform the research effort.

Restrictions or limitations are imposed against the use of funds for entertainment, foreign travel, general-purpose equipment, alterations and renovations, and other items not regularly required for the performance of research.

National Research Service Awards (NRSAs) are made directly to individuals for research training in specified biomedical shortage areas.

Grants may be made to institutions to enable them to make NRSAs to individuals selected by them.

Certain service and payback provisions apply to individuals upon termination of the award.

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 process.

Phase II grants are for the continuation of the research initiated in Phase I and which are likely to result in commercial 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.

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

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Eligibility Requirements

Applicant Eligibility

Any nonprofit organization engaged in biomedical research, as well as institutions or companies organized for profit, may apply for grants with the exception of NRSAs.

An individual may apply for a NRSA or, in some cases, may qualify for a research grant if adequate facilities in which to perform the research are available.

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 that 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

Any nonprofit or for-profit organization, company or institution engaged in biomedical research.

Credentials/Documentation

Applicants for individual National Research Service Awards must be citizens of the United States or have been admitted for permanent residency; must hold a doctoral degree (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D. Eng., or equivalent domestic or foreign degree); and must designate a desire for training in one of the health or health-related areas specified by the National Institutes of Health. Each applicant must be sponsored by an accredited public or private nonprofit institution engaged in such training. Costs will be determined in accordance with OMB Circular No. A-87 for State and local governments. For-profit organizations' costs are determined in accordance with Subpart 31.2 of the Federal Acquisition Regulations. For 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. Effective for the December 1, 2005 submission date and beyond, all SBIR and STTR Phase I, Phase II, and Fast-Track grant applications must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 (R&R) forms and Application Instruction Guide. Complete SBIR and STTR application instructions, including requirements for electronic submission, can be found at http://grants.nih.gov/grants/funding/sbir.htm.

Aplication and Award Process

Preapplication Coordination

Not applicable.

This program is excluded from coverage under E.O.

12372.

Application Procedures

Research grant applications are submitted on designated forms to the Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892. Forms for individual NRSA applications may be obtained from and submitted to the Division of Extramural Outreach and Information Resources, Office of Extramural Research, National Institutes of Health, 6701 Rockledge Drive, Room 6207, MSC 7910, Bethesda, MD 20892. Telephone: (301) 435-0714. Fax: (301) 480-0525. E-mail: asknih@od.nih.gov. For some special grant programs, applicants may be advised to submit directly to the Review Branch, Division of Extramural Affairs, National Heart, Lung, and Blood Institute, Bethesda, MD 20892. The standard application forms, as furnished by PHS and required by 45 CFR, Part 92, must be used for this program. 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: 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

All accepted applications are evaluated by an appropriate initial review group (study section). All grant applications receive a final secondary review by the National Heart, Lung, and Blood Advisory Council. Staff informs applicants of the results of the review. If support is contemplated, staff initiates preparation of awards for grants. 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

New Research Grants: February 1, June 1, and October 1 (or as specified in Request for Applications (RFA) announcements). Renewals and Supplementals: March 1, July 1, and November 1. Individual NRSAs: April 5, August 5, and December 10. Individual NRSA: January 10, May 10, and September 10. SBIR/STTR Grants: April 1, August 1, and December 1.

Authorization

NIH Reauthorization Act of 1993, Public Health Service Act, Section 503: Subpart 2, Part C, Title IV, Section 424, 42 U.S.C. 285b et seq.

Range of Approval/Disapproval Time

Regular Grants: From 7 to 9 months. SBIR/STTR Grants: 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 grants information page http://www.grants.nih.gov/grants/guide/notice-files/not97-232.html.

Renewals

Renewal applications are reviewed in the same manner as new applications.

Assistance Considerations

Formula and Matching Requirements

This program has no statutory formula or matching requirements.

Length and Time Phasing of Assistance

The Advisory Council may recommend funding for periods from 1 to 5 years. Funding commitments are made annually. 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

Annual reports on progress and expenditures.

Final reports are required within 120 days of termination.

Reports are required after termination of National Research Service Awards to ascertain compliance with the service and payback provisions.

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 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.

Records

Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the last financial status report for the report period.

Financial Information

Account Identification

75-0872-0-1-552.

Obigations

(Grants) FY 07 $52,938,299; FY 08 est $52,938,299; and FY 09 est not reported.

Range and Average of Financial Assistance

$13,316 to $1,585,118; $401,255; Small Business Innovation Research/Small Business Technology Awards: Phase I - $100,000; Phase II - up to $750,000 for STTR and up to $750,000 for SBIR.

Regulations, Guidelines, and Literature

42 CFR 52; 42 CFR 66; 45 CFR 74; 45 CFR 92; "NIH Guide for Grants and Contracts, and Supplements"; PHS Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000, (Rev.) April 1, 1994; 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 U.S.C. 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

None.

Headquarters Office

Program Contacts: Director, National Center on Sleep Disorders Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Public Health Service, Department of Health and Human Services, Bethesda, MD 20892. Telephone: (301) 435- 0199. James MacKenzie, Administrative Officer. Telephone: (301) 435-6373. Small Business Innovation Research Program: Deputy Director, Division of Extramural Affairs, National Heart, Lung, and Blood Institute, National Institutes of Health, Public Health Service, Department of Health and Human Services, Bethesda, MD 20892. Telephone: (301) 435-0266. Grants Management Contact: Ms. Suzanne White, Grants Management Officer, Grants Operations Branch, Office of Program Policy and Procedures, National Heart, Lung and Blood Institute, National Institutes of Health, Public Health Service, Department of Health and Human Services, Bethesda, MD 20892. Telephone: (301) 435-0144. Use the same numbers for FTS.

Criteria for Selecting Proposals

The major elements in evaluating proposals include assessments of: (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? (2) Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? (4) Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Complete review criteria can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-002.html. 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 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. Complete SBIR review criteria can be found at http://grants1.nih.gov/grants/funding/sbirsttr_ReviewCriteria.htm.