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.
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 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 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.
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 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. 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.
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, 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 "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 NRSAs 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 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 DHHS 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. 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 to 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. 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 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 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 the 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 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.
Obligations:
(Grants) FY 01 $1,017,035,000; FY 02 est $1,134,864,000; and FY
03 est $1,237,286,000.
Range
and Average of Financial Assistance:
Grants: $13,558 to $1,970,369; Average: $349,022. Small
Business Innovation Research/Small Business Technology Awards:
Phase I - $100,000; Phase II - up to $500,000 for STTR and up
to $750,000 for SBIR.
In fiscal year 2001, 2,712
research grants, and 302 NRSAs were made. For new and competing
renewal awards: 2,129 grant applications were received 760 were
awarded; 289 NRSA applications were received, 103 were awarded.
The estimates for fiscal year 2002 are 2,918 research grants and
302 NRSAs. The estimates for fiscal year 2003 are 2,972 research
grants and 302 NRSA. Small Business Innovation Research Awards:
In fiscal year 2001, 64 Phase I awards and 32 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 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: Not applicable.
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: Ms. Marie Willett, Acting Grants Management
Officer, Grants Operations Branch, Office of Program Policy and
Procedures, National Heart, Lung, and Blood Institute, National
Institutes of Health, Department of Health and Human Services,
Bethesda, MD 20892. Telephone: (301) 435-0144. Use the same numbers
for FTS.
Web Site Address: http://www.nih.gov
EXAMPLES OF FUNDED PROJECTS:
(1) A research project
grant to determine the accuracy of three different technologies
for assessing carotid artery narrowing due to atherosclerosis, which
could facilitate selection of those patients best suited for surgery
to improve blood flow to the brain. (2) A program project grant
to investigate the basic biology of how arterial wall cells interact
with blood cell types to predispose toward blood clots forming in
arteries containing plaque build-up. (3) A Specialized Center Of
Research (SCOR) grant in heart failure whereby genetic analysis
is augmenting family and molecular screening studies to identify
genetic defects that contribute to the kinds of enlargement of the
heart that can lead to heart failure. (4) An institutional NRSA
to provide a training program in hypertension research. (5) An SBIR
grant (phase I) to produce a novel cryosurgical cardiac catheter.
(6) An STTR grant (phase I) to devise a noninvasive test using computer-assisted
analysis of electrocardiograms to better identify heart patients
at risk of sudden cardiac death. (7) A Cooperative Agreement award
that is part of a network of grants comprising the Family High Blood
Pressure Program, which is evaluating genetic variation as expressed
by blood pressure level and presence of hypertension in blacks,
Mexican Hispanics and non-Hispanic Whites.
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.
