FEDERAL AGENCY:

NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES

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.

OBJECTIVES:

To foster research for the prevention, improved diagnosis, and treatment of non-malignant blood diseases such as Coolie's anemia, sickle cell disease, hemophilia, hemochromatosis, and disorders of hemostasis and thrombosis; to support research on hematopoietic stem cell biology and transplantation and on the use of transplantation to treat blood diseases; and to promote research in transfusion medicine for improving the availability, safety, and use of blood and blood products; and to develop new scientists for blood disease and resources research. Small Business Innovation Research (SBIR) program: To expand and improve the SBIR program; 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.

TYPES OF ASSISTANCE:

Project Grants. Place Cursor Here for Definition

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. 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.

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, 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 a research plan the 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. Grant forms PHS 6246-1 and PHS 6246-2 are used to apply for SBIR Phase I and Phase II, respectively. Grant forms PHS 6246-3 and PHS 6246-4 are used to apply for STTR Phase I and Phase II, respectively.

Pre-application Coordination:   Not applicable. This program is excluded from coverage under E.O. 12372.

Application Procedure:   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 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. Small Instrumentation Grants Program: Those invited to apply should prepare and submit applications on Form PHS 398 (revised May 1995). Only the face page, budget page, and checklist page are to be completed. Additional information required includes the number and dollar amount of the grant(s) that would benefit from the requested equipment, a brief description of each beneficiary project, and an explanation of how the equipment would benefit the project. This program is subject to the provisions of 45 CFR, Part 92 for State and local governments and OMB Circular No. A-110 for nonprofit organizations.

Award Procedure:   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. 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.

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 10 and May 10. Individual NRSA: April 5, August 5, and December 5. SBIR and STTR Grants: April 1, August 1, and December 1.

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 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 (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.

Obligations:   (Grants) FY 01 $327,632,000; FY 02 est $365,928,000; and FY 03 est $402,320,000.

Range and Average of Financial Assistance:  
Grants: $2,460 to $4,728,000; $453,716. SBIR Phase I-- $150,000, Phase II- $1,000,000; STTR Phase I- $150,000, Phase II- $1,000,000.

In fiscal year 2001, 770 research grants and 76 National Research Service Awards were made. The estimates for fiscal year 2002 are 829 research grants and 76 National Research Service Awards. The estimates for fiscal year 2003 are 899 research grants and 76 National Research Service Awards. In fiscal year 2001, for new and competing renewal awards 644 grant applications were received, and of these, 230 were awarded; 73 National Research Service Award applications were received and of these 26 were awarded. Small Business Innovation Research Awards: In fiscal year 2001, 20 Phase I and 15 Phase II awards were made.

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:   Not applicable.

Headquarters Office:   Dana A. Phares 6701 Rockledge Drive, Room 7176, Bethesda, Maryland 20892 Email: pharesda@nhlbi.nih.gov Phone: 301-435-0314

Web Site Address:  
https://www.nhlbi.nih.gov/

EXAMPLES OF FUNDED PROJECTS:

(1) A program project grant on the biology of human erythropoiesis to investigate the regulation of fetal hemoglobin synthesis, retroviral gene transfer in hematopoietic cells, membrane defects in the thalassemia's, assembly of red cell membrane proteins during erythroid development, and the structural and functional characterization of erythropoietin. (2) A multi-disciplinary program project grant on basic and clinical studies of coagulation proteins to study molecular structure and function relationships of coagulation proteins, especially fibrinogen, thrombin, and tissue factor, and to apply the results in clinical investigations principally relating to thrombohemorrhagic disorders, with the goal of developing second- generation fibrinolytic agents having superior pharmacological properties, and thus improved therapy for thrombotic vascular disease. (3) A program project grant on the structure, function, and genetics of coagulation factors directed toward understanding better the roles of clotting factors, particularly factors VIII and IX, in hemostasis and thrombosis, using biochemical, biophysical and immunogenetic methods. Gene cloning and monoclonal antibody production, in addition to classic protein chemical and enzyme kinetic studies, are being used to study an extensive, genetically well-characterized patient population with defects in factor IX. (4) A Small Business Innovation Research Award for genetic engineering of an improved factor VIII product. (5) An Institutional National Research Training Award in pediatric hematology with research and training in erythrocyte structure and function, coagulation, immunohematology, bone marrow transplantation, and transfusion medicine.

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.