To foster research and research training on the pathophysiology, diagnosis, treatment, and prevention of non-malignant blood diseases, including anemias, sickle cell disease, thalassemia; leukocyte biology, pre-malignant processes such as myelodysplasia and myeloproliferative disorders; hemophilia and

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other abnormalities of hemostasis and thrombosis; and immune dysfunction.

Funding encompasses a broad spectrum of hematologic inquiry, ranging from stem cell biology to medical management of blood diseases and to assuring the adequacy and safety of the nation's blood supply.

Programs also support the development of novel cell-based therapies to bring the expertise of transfusion medicine and stem cell technology to the repair and regeneration of human tissues and organs.

Small Business Innovation Research (SBIR) program: To stimulate technological innovation; 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 through cooperative research 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, 795 research grants and 68 National Research Service Awards were made. The estimates for fiscal year 2008 are 795 research grants and 68 National Research Service Awards. The estimates for fiscal year 2009 are 795 research grants and 68 National Research Service Awards. In fiscal year 2007, for new and competing renewal awards 1055 grant applications were received, and of these, 211 were awarded; 84 National Research Service Award applications were received and of these 19 were awarded. Small Business Innovation Research/Technology Tranfer Awards: In fiscal year 2007, 20 Phase I and 10 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.

National Research Service Awards (NRSAs) are made directly to individuals for research training.

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.

These awards are made to small businesses working in collaboration with academic institutions.

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.

While the intent of the SBIR/STTR programs is commercialization (Phase III), no SBIR/STTR funds are allowed for commercialization activities such as patents; market and sales; market research; business development/product development/market plans; legal fees, travel and other costs including labor relating to license agreements and partnerships.

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Eligibility Requirements

Applicant Eligibility

Any nonprofit organization engaged in biomedical research and 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, or owned by another small business that itself is independently owned and operated for profit, are not dominant in the field in which research is proposed, and have no more than 500 employees including affiliates).

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.

SBIR projects must be performed at least 67% by the applicant small business in Phase I and at least 50% of the project in Phase II.

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. Only domestic for-profit small business firms may apply for SBIR and STTR programs.

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 a research plan 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. SBIR and STTR applicants must use the SF424 Research and Related (R&R) application for electronic submission through Grants.gov. Electronic submission of SNAP Progress Reports (eSNAP) apply for non-competing continuations (e.g., second year of Phase II).

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 award applications may be obtained from and submitted to: Office of Research Manpower, 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 www.nih.gov/grants/funding/sbir.htm on the World Wide Web. The Solicitation includes submission procedures, review considerations, and links to grant application or contract proposal forms. SBIR and STTR grant applications must be submitted electronically using the SF424 Research and Related (R&R) forms to Grants.gov. For questions about submission please call the GRANTSINFO office at Phone: (301) 435-0714 or send an E-mail: grantsinfo@nih.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. Fellowship applications have a secondary review by the staff of the Institute. Staff informs applicants of the results of the review. If support is contemplated, staff initiates preparations 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. Eligibilility criteria must be verified prior to the competing award as stated in the SBIR/STTR Funding Opportunity Announcement and annual OMNIBUS SOLICITIATION.

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. 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 1, August 1, and December 1.

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 Research and Development Enhancement Act of 1992, Public Law 102-564.

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.

Renewals

Renewals require application and review 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 ranging 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 from grantees are required 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, "Audits of States, Local Governments, and Nonprofit Organizations," non-Federal 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

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 $409,262,576; FY 08 est $409,262,576; and FY 09 est $409,262,576.

Range and Average of Financial Assistance

$97,396 to $999,972; $427,867. Small Business Innovation Research/Small Business Technology Awards: 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 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: Dr. Susan Shurin, Acting Director, Division of Blood Diseases and Resources, National Heart, Lung, and Blood Institute, National Institutes of Health, Public Health Service, Department of Health and Human Services, Bethesda, MD 20892. Telephone: (301) 435-0080. Small Business Innovation Research Program: Ms. Susan Pucie, Senior Program Analyst, Division of Blood Diseases and Resources, National Heart, Lung, and Blood Institute, National Institutes of Health, Public Health Service, Department of Health and Human Services, Bethesda, MD 20892. Telephone: (301) 435-0079. Grants Management Contact: Ms. Suzanne White, Grants Management Officer, Grants Operations Branch, 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) 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 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.