NATIONAL
INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES
AUTHORIZATION:
Public
Health Service Act, Sections 301, 405, 428, 431, 487, 491, 493,
495, and 498, as amended; Public Laws 78-410, 99- 158, 100-607,
and 106-554; 42 U.S.C. 241, 42 U.S.C. 285c-2; 42 U.S.C. 285c-5,
42 U.S.C. 288, as amended; Small Business Research and Development
Enhancement Act of 1992; Public Law 102-564.
To
encourage basic and clinical biomedical research and research training
for a greater understanding of diabetes and the underlying mechanisms
that cause diabetes and related complications. Fundamental and clinical
studies include the etiology, pathogenesis, prevention, diagnosis
and treatment of diabetes mellitus and its complications. In endocrine
research, to encourage biomedical research for a greater understanding
of the normal and abnormal function of the pituitary, thyroid, parathyroid,
adrenal, pineal, thymus glands, as well as the action of hormones,
hormone biosynthesis, secretion, metabolism, binding to protein
carriers and subsequent release, and the kinetics of binding. In
metabolic research, to encourage basic studies on fundamental metabolic
processes of diseases such as membrane structure, function, and
transport phenomena enzyme biosynthesis; and basic and clinical
studies on the etiology, pathogenesis, prevention, and treatment
of inherited metabolic disorders (such as cystic fibrosis) as an
example to support extramural basic laboratory research and clinical
investigations and provide postdoctoral biomedical research training
for individuals interested in careers in health sciences and fields
related to these programs. 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:
Research Grants provide
funds for salaries, equipment, supplies, travel, and other expenses
associated with scientific investigation relevant to program objectives.
National Research Service Awards (NRSAs) are made directly to individuals
for research training in specified biomedical shortage areas. In
addition, grants may be made to institutions to enable them to make
National Research Service Awards to individuals selected by them.
Each individual who receives a National Research Service Award is
obligated upon termination of the award to comply with certain service
and payback provisions. Small Business Innovation Research 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
that are likely to result in commercial products or processes. Only
Phase I awardees are eligible to receive 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:
Research grants: Individuals and public and private institutions,
both nonprofit and for-profit, who propose to establish, expand,
and improve research activities in health sciences and related fields.
National Research Service Awards: Individuals must be nominated
and sponsored by a public or nonprofit private institution having
staff and facilities appropriate to the proposed research training
program. All awardees must be citizens or have been admitted to
the United States for permanent residence. To be eligible, predoctoral
awardees must have completed the baccalaureate degree and postdoctoral
awardees must have a professional or scientific degree (M.D., Ph.D.,
D.D.S., D.O., D.V.M., Sc.D., D.Eng., or equivalent domestic or foreign
degree). Nonprofit domestic organizations may apply for the Institutional
National Research Service grant. Small Business Innovation Research
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. 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 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:
Research Grants: Although no degree of education is either specified
or required, nearly all successful applicants have doctoral degrees
in one of the sciences or professions. National Research Service
Awards: Predoctoral awardees must have completed the baccalaureate
degree and postdoctoral awardees must have a professional or scientific
degree.
Credentials/Documentation:
As required in application form. 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 Grants: Form PHS-398 (Rev. May 1995) with current instructions
is available from the Division of Extramural Outreach and Information,
National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910. Telephone: (301) 435-0714. E-mail: ASKNIH@odrockml.od.nih.gov.
Completed forms should be submitted to the Center for Scientific
Review, 6701 Rockledge Drive, MSC 7710, Federal Express should
use the Zip Code 20817-7710. The standard application forms, as
furnished by PHS and required by 45 CFR, Part 92, must be used
for this program by those applicants that are State or local units
of government. 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: Telephone:
(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:
Following review by the appropriate study section and council,
the successful applicant is notified by the National Institute
of Diabetes and Digestive and Kidney Diseases through a Notice
of Grant Award. 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 Applications: February 1, June 1, and October 1. Competing
renewal applications and supplements: March 1, July 1, and November
1. Individual NRSA applications: April 5, August 5, and December
5. Institutional NRSAs: January 10, May 10, and September 10.
Small Business Innovation Research (SBIR): April 1, August 1,
and December 1. Small Business Technology Transfer Program (STTR):
April 1, August 1, and December 1.
Range of Approval/Disapproval
Time: Research grants: From 6 to 9 months.
SBIR/STTR applications: About 7-1/2 months. National Research
Service Awards: From 6 to 9 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:
Research grants: Renewals by competitive application and review.
National Research Service Individual Awards: may be made for 1,
2, or 3 years. No individual may receive NIH fellowship support
at the postdoctoral level for more than 3 years.
ASSISTANCE CONSIDERATIONS:
Formula and Matching
Requirements: This program has no statutory
formula or matching requirements.
Length and Time Phasing
of Assistance: Research grant awards may be
recommended for up to 5 years. Awards usually are made for 12-month
budget periods. 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:
Research grants: Annual and terminal progress reports, annual reports
of inventions, financial status reports, and annual certification
with respect to research involving human subjects are required.
National Research Service Awards: Reports are required after termination
of National Research Service Awards to ascertain compliance with
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
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. National Research Service
Awards: Documentation of expenditures and other fiscal records
must be kept readily available for examination by authorized government
personnel, and must be maintained for 3 years following the submission
of the annual financial status report for that year.
FINANCIAL INFORMATION:
Account Identification:
75-0884-0-1-552.
Obligations:
(Grants) FY 01 $454,135,000; FY 02 est $510,390,000; and FY 03
est $553,893,000. (NRSAs) FY 01 $16,513,000; FY 02 est $20,787,000;
and FY 03 est $21,618,000.
Range
and Average of Financial Assistance:
Research Grants: $16,600 to $2,098,000; Average: $180,100.
National Research Service Awards: $3,000 to $263,700; $61,600.
SBIR: Phase I awards approximately $50,000; Phase II awards not
to exceed $500,000.
Research Grants: In fiscal
year 2001, 1,389 awards were made; in fiscal year 2002, 1,474 awards
are estimated, and in fiscal year 2003, 1,599 awards are estimated.
National Research Service Awards: in fiscal year 2001, 145 awards
and 438 trainees were made; in fiscal year 2002, 138 awards and
445 trainees are estimated, and in fiscal year 2003, 138 awards
and 415 trainees are estimated. Small Business Innovation Research
Awards: In fiscal year 2001, 44 awards were made; in fiscal year
2002, 55 awards are estimated, and in fiscal year 2003, 54 awards
are estimated.
REGULATIONS, GUIDELINES, AND
LITERATURE:
Research Grants: 42 CFR
52; 42 CFR 66; 45 CFR 74. 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 Contact: Research Grants: Dr. Judith Fradkin, Director,
Division of Diabetes, Endocrinology, and Metabolic Diseases, National
Institute of Diabetes and Digestive and Kidney Diseases, National
Institutes of Health, 31 Center Drive, MSC 2560, Bethesda, MD
20892-2560. Telephone: (301) 496-7348. Small Business Innovation
Research Grants Contact: Mr. George Tucker, Acting Chief Grants
Management Officer, Division of Extramural Activities, National
Institute of Diabetes and Digestive and Kidney Diseases, National
Institutes of Health, Democracy Plaza 2, Room 633, 6707 Democracy
Plaza Blvd, Bethesda, MD 20892. Telephone: (301) 594-8853. Grants
Management Contact: Mr. George Tucker, Acting Chief Grants Management
Officer, Division of Extramural Activities, National Institute
of Diabetes and Digestive and Kidney Diseases, National Institutes
of Health, Democracy Plaza 2, Room 633, 6707 Democracy Plaza Blvd.,
Bethesda, MD 20892. Telephone: (301) 594-8853. Use the same numbers
for FTS.
Web Site Address: http://www.niddk.nih.gov
EXAMPLES OF FUNDED PROJECTS:
(1) Genetic Control of
Diabetes Pathogenesis; (2) Factors Involved in Insulin Homeostasis;
(3) Mode of Action of Steroid Hormones; (4) Regulation of Lipogenesis
and VLDL Synthesis/Assembly; and (5) Endocrine Sweat Gland Function
and Cystic Fibrosis. Small Business Innovation Research grants:
Implantable Glucose Sensor.
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.
