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 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:
$177,013 to $681,859; Average: $321,240. 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, 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:
Program Contacts: 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: 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: Mr. William Darby, 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.
Web Site Address: http://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.
