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
use available knowledge and technology to solve specific disease
problems of the lungs; to promote further studies on the structure
and function of the lung; and to achieve improvement in the prevention
and treatment of lung diseases. 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 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.
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, as well
as 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 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 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 applications may
be obtained from and submitted to the 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, 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. 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.
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 informs applicants of the results of the
review. If support is contemplated, staff initiates 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 Institute. A description of the NIH Peer
Review Appeal procedures is available on the NIH home page www.nih.gov/grants/guide/1997/97.11.21/n2.html.
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 Advisory Council may recommend
funding for periods 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. 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 $416,748,000; FY 02 est $467,817,000; and FY 03
est $505,467,000.
Range
and Average of Financial Assistance:
$37,500 to $857,480; Average: $328,953. 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, 1,132
research grants and 97 National Research Service Awards were made.
The estimates for fiscal year 2002 are 1,218 research grants and
97 National Research Service Awards. The estimates for fiscal year
2003 are 1,243 research grants and 97 National Research Service
Awards. In fiscal year 2001, for new and competing renewal awards:
891 grant applications were received, and of these, 318 were awarded;
84 National Research Service Award applications were received, and
of these, 30 were awarded. Small Business Innovation Research Awards:
In fiscal year 2001, 21 Phase I awards and 8 Phase II awards were
made.
REGULATIONS, GUIDELINES, AND
LITERATURE:
42 CFR 52; 42 CFR 66;
45 CFR 74; 45 CFR 92; "NIH Guide for Grants and Contracts, and Supplements";
PHS Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000,
(Rev.) April 1, 1994; 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 Lung Diseases, National
Heart, Lung, and Blood Institute, National Institutes of Health,
Public Health Service, Department of Health and Human Services,
Bethesda, MD 20892, Telephone (301) 435-0233. 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, Office of Program Policy and Procedures,
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.nih.gov
EXAMPLES OF FUNDED PROJECTS:
(1) An individual research
grant to investigate basic mechanisms of primary pulmonary hypertension,
a lethal disease that causes progressive obstruction of small pulmonary
arteries. This grant has established a national registry of familial
primary pulmonary hypertension that is providing the framework for
linkage analysis and the molecular search for basic mechanisms of
this disease. (2) A multi-project grant dealing with cellular and
molecular mechanisms underlying acute and chronic asthma. The focus
of this program is on the mechanisms causing asthma in humans. The
work includes laboratory projects, animal research, and human studies.
The work includes laboratory projects and animal research concentrated
on the cellular pathways of the asthmatic inflammatory process,
focused on the mast cell, a critical cell type in asthma. (3) A
grant for a Specialized Center of Research (SCOR) in the Pathobiology
of Fibrotic Lung Disease. The long term objective of this program
is to further understanding of the pathogenesis and treatment of
idiopathic interstitial pneumonias. The center hypothesis is: Local
alterations in the elaboration of effector molecules or in the expression
of receptors by inflammatory, epithelial, and mesenchymal cells
create an alveolar microenvironment that favors the fibroproliferative
response rather than normal repair. Such dysregulation determines
susceptibility to and expression of fibrotic lung disease. 4) An
Individual National Research Service Award to study the effect of
temperature on the medullary respiratory network, which controls
respiratory activity. Breathing is modulated as the result of change
in the internal and external environment and the behavioral state
of the human or animal. The research findings will be of importance
by virtue of the epidemiological linkage between environmental hyperthermia
and sudden infant death syndrome, and cardiorespiratory failure
during heat exhaustion and stroke. The fellow will train under the
guidance of an outstanding mentor with a strong record of training
scientists, and will develop research skills in important areas
of electrophysiology such as patch-clamp as well as gene-targeted
lesions. 5) A Small Business Innovative Research for development
of a new design for metered dose inhalers (MDIs), and testing of
a propellant to replace the chlorofluorocarbon (CFC) propellants
currently being phased out by the Federal Government due to their
high ozone-depletion potential. MDIs are in widespread use because
asthma is one of the most common and costly illnesses in the United
States, and drug formulation delivered via MDIs represent the primary
treatment method for asthma sufferes. With the phase-out of CFCs,
there is a need for a replacement that is safe, effective, and economical.
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
scientific, technical, or 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; (8)
The adequacy of plans to include both genders and minorities and
their subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will be evaluated;
and (9) 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.
