To foster research and prevention, education, and control activities related to heart and vascular diseases and to develop young scientist investigators in these areas.

Small Business Innovation Research (SBIR) program: To increase private sector commercialization of innovations derived from Federal

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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 through cooperative research and development carried out between small business concerns and research institutions; to foster technology transfer 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.

In fiscal year 2007, 2,930 research grants and National Research Service Awards were made. The estimates of fiscal year 2008 are 2671 research grants and 259 National Research Service awards. The estimates for fiscal year 2009 are 2,671 research grants and 259 National Research Service Awards. In fiscal year 2007, for new and competing renewal awards: 4,070 grant applications were received, and of these, 814 were awarded; 304 National Research Service Award applications were received, and of these, 72 were awarded. Small Business innovation Research Awards/Small Technology Transfer Research Awards: In fiscal year 2007, 34 Phase I awards, and 16 Phase II awards were made.

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.

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

Institutional NRSA awards may be made to eligible institutions to enable them to appoint individuals selected by the institution.

Certain service and payback provisions may apply to postdoctoral individuals upon termination of the award or termination of the appointment.

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 research initiated in Phase I that is likely to result in commercial products or processes.

Only Phase I awardees are eligible to apply for Phase II support.

Some Phase II awardees may be eligible to apply for funds to continue research for up to three years beyond the original Phase II award.

Eligible projects involve assessment and improvement of drugs or devices or propose to conduct preclinical studies of drugs or devices that ultimately require: 1) clinical evaluation and/or 2) approval of a Federal regulatory agency.

The product being developed must be one for which Federal regulatory approval (e.g., FDA) is a required step toward commercialization.

Prospective applicants are strongly encouraged to contact NIH staff to determine eligibility.

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

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.

Any nonprofit organization engaged in biomedical research and institutions or companies organized for profit may apply for almost any kind of grant.

Only domestic, non-profit, private or public institutions may apply for NRSA Institutional Research Training Grants.

An individual may apply for an NRSA or, in some cases, for a research grant if adequate facilities 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 being 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.

or 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) that formally collaborate with a university or other non-profit 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.

Beneficiary Eligibility

Research project grants and cooperative agreements, training and career development grants, and SBIR and STTR grants.

Credentials/Documentation

Individual NRSAs and Institutional NRSA trainees 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 possess 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 organization costs are determined in accordance with Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined in accordance with DHHS Regulations 45 CFR, Part 74, Subpart Q. For SBIR and STTR grants, the applicant organization (small business concern) must present, in a research plan, an idea that has potential for commercialization and must furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. The grant application form SF424 (R&R) is used to apply for all SBIR and STTR grants.

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 and Institutional NRSA award applications may be obtained from and submitted to: Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892. 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 for State and local governments, 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 http://grants.nih.gov/grants/oer.htm . The Solicitation includes submission procedures, review considerations, and grant application or contract proposal forms. SBIR and STTR grant applications should be submitted electronically submitted through the federal portal of Grants.gov.

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 inform applicants of the results of the review. If support is contemplated, staff initiate 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 5, June 5, and October 5 (or as specified in Request for Applications (RFA) announcements). Renewals and Supplementals: March 5, July 5, and November 5. Institutional NRSAs: January 25 (new, resubmission, amended, and renewal applications) and September 25 (resubmission and amended applications). Individual NRSA: April 8, August 8, and December 8. SBIR and STTR Grants: April 5, August 5, and December 5.

Authorization

Public Health Service Act, Section 301, 422 and 487, as amended, Public Laws 78-410 and 99-158, 42 U.S.C. 241, 42 U.S.C. 285, and 42 U.S.C. 288, as amended; Small Business Reauthorization Act of 2000, Public Law 106-554.

Range of Approval/Disapproval Time

Regular Grants: From 7 to 9 months. SBIR/STTR Grants: About 9 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 National Heart, Lung, and Blood Institute.

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 National Heart, Lung, and Blood Advisory Council may recommend funding for periods typically ranging from one to five years. Funding commitments are made annually. Usually, SBIR Phase I awards are for six months and Phase II for two years, and STTR Phase I awards are for one year and Phase II are for two years.

Post Assistance Requirements

Reports

Annual reports on progress and expenditures are required.

Final reports are required within 120 days of termination.

Reports are required after termination of NRSAs 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 Nonprofit 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 $1,556,459,000; FY 08 est $1,556,459,000; and FY 09 est $1,556,459,000.

Range and Average of Financial Assistance

Grants: $16,600 to $4,444,879; $441,745. SBIR/STTR: Phase I - $100,000; Phase II - up to $750,000.

Regulations, Guidelines, and Literature

42 CFR 52; 42 CFR 66; 45 CFR 74; "NIH Guide for Grants and Contracts, and Supplements"; 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

None.

Headquarters Office

Program Contact: Director, Division of Heart and Vascular Diseases, National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, MD 20892. Telephone: (301) 435-0466. SBIR Program: Deputy Director, Division of Extramural Affairs, National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, MD 20892. Telephone: (301) 435-0266. Grants Management Contact: Grants Management Officer, Grants Operations Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, MD 20892. Telephone: (301) 435-0166. Use the same numbers for FTS.

Criteria for Selecting Proposals

The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2)the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. 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 importance of the problem the proposed research will address; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation of the proposed research; (5) the potential of the proposed research for commercial application; (6) the appropriateness of the budget requested; (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. 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.