FOOD
AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
AUTHORIZATION:
Public
Health Service Act, Title III, Section 301(c), Public Law 78-410,
as amended; Radiation Control for Health Safety Act of 1968, Public
Law 90-602, 42 U.S.C. 241 and 263; 42 U.S.C. 300u, Title XVII; Small
Business Innovation Research Program Reauthorization Act of 1992,
as amended, Public Law 102-564 and 106-554.
To
assist profit-making organizations, public and other nonprofit institutions,
to establish, expand, and improve research, demonstration, education
and information dissemination activities; acquired immunodeficiency
syndrome (AIDS), biologics, blood and blood products, therapeutics,
vaccines and allergenic projects; drug hazards, human and veterinary
drugs, clinical trials on drugs and devices for orphan products
development; nutrition, sanitation and microbiological hazards;
medical devices and diagnostic products, radiation emitting devices
and materials; food safety and food additives. Small Business Innovation
Research (SBIR) Programs: to stimulate technological innovation;
to encourage the role of small business to meet Federal research
and development needs; to increase private sector commercialization
of innovations derived from Federal research and development; and
to foster and encourage participation by minority and disadvantaged
persons in technological innovation.
TYPES
OF ASSISTANCE:
Project Grants. Place Cursor Here for Definition
USES
AND USE RESTRICTIONS:
Research
grants are awarded to an eligible institution in the name of a principal
investigator for a discrete project representing the investigator's
interest and competence. Funds are to be used for salaries and wages,
equipment, supplies, travel, and other costs directly required to
carry out the research. Small Business Innovation Research (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. SBIR Phase II
grants for this program are for the competitive 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. All approved applications compete
for available SBIR set-aside funds on the basis of technical merit
and program relevance. Conference grants provide partial support
for domestic or scientific conferences.
ELIGIBILITY
REQUIREMENTS:
Applicant
Eligibility: Research grants, including application
for Orphan Product Developments, can be made to any public or private
nonprofit university, college, hospital, laboratory or other institution,
including State and local units of government. Commercial, nonprofit,
and faith-based organizations are also eligible. Small Business
Innovation Research (SBIR) grants can only be awarded to domestic
small businesses (entities that are independently owned and operated
for a 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 the award and during the
conduct of the proposed project. In both Phase I and Phase II, the
research must be performed in the United States and its possessions.
Beneficiary
Eligibility: Colleges, universities, profit-making
organizations, nonprofit institutions, hospitals, faith-based
and State and local governments.
Credentials/Documentation:
Research, including Orphan Product Development and conference
grant applicants must present a plan and furnish evidence that
scientific competence, facilities, and equipment are appropriate
to carry out the plan. For Small Business Innovation Research,
each applicant must present a research plan and furnish evidence
that scientific competence, experimental methods, facilities,
equipment, and supplies are appropriate to carry out the plan.
Furthermore, in Phase I, there should be an idea or concept with
commercial potential, and in Phase II there should be evidence
that commercialization of the research results is plausible. Costs
will be determined in accordance with OMB Circular No. A-87 for
State and local governments, for-profit organizations' with Subpart
31.2 of the Federal Acquisition Regulations (FAR), OMB Circular
No. A-21 for universities, and OMB Circular No. A-122 for nonprofit
organizations.
Pre-application
Coordination: Not applicable. This program is
excluded from coverage under Executive Order 12372.
Application
Procedure: Consultation of Program Staff is
available by contacting the Headquarters Office listed below.
The standard application forms, as furnished by FDA and required
by 45 CFR 74 and 92 must be used for this program. The applicant
must complete PHS Form 398 for new competing continuations or
supplemental research grants. SBIR must complete Forms PHS 6246-1
and 6426-2 for Phase I and Phase II applications, respectively.
State and local governments may use form PHS 5161-1 (rev 7-00).
All unsolicited applications, with the exception of those directed
to the Center for Veterinary Medicine, are submitted to the Center
for Scientific Review, National Institutes of Health, Suite 1040,
6701 Rockledge Drive MSC 7710, Bethesda, MD 20892. Unsolicited
applications directed to the Center for Veterinary Medicine will
be subject to Field Reader review or ad hoc panel reviews directed
by the Center. Applications in response to Federal Register Announcements
(solicited) shall be sent to the address listed below for Information
Contacts, Headquarters Office. All application kits may be obtained
from the FDA office listed below or from the CSR/NIH at the above
address. All applicants for solicited grant programs are cautioned
to follow the specific mailing instructions published in the RFA.
Award
Procedure: Research: All accepted research
grant applications, including Orphan Product Development and Small
Business and Innovative Research, receive a dual scientific review
for technical merit, a recommendation for approval by an appropriate
initial review group and a secondary review by a national advisory
council. All approved applications compete for available funds
on the basis of scientific merit and program emphasis. All applications
accepted under the Radiation Control for Health Safety Act of
1968, Public Law 90-602 and Small Scientific Conference grants,
are evaluated under objective review procedures and receive a
single initial review.
Deadlines:
Contact Headquarters Office listed below for solicited research
application deadlines. Orphan Products Development Grant Applications
and other Research grant applications due dates are published
in the Federal Register and may vary from year to year. SBIR:
April 15, August 15 and December 15. Conference grant applications:
October 15, January 15, April 15, and July 15. Unsolicited and
SBIR applications are received and processed by the Center for
Scientific Review/ National Institutes of Health.
Range
of Approval/Disapproval Time: From 6 to 9
months for research grant applications. SBIR applications: Approximately
6 months. Conference applications: Approximately 3 months.
Appeals:
None.
Renewals:
Renewals are available. Procedures are the same as for new applications.
ASSISTANCE
CONSIDERATIONS:
Formula
and Matching Requirements: This program has
no statutory formula or matching requirements. Cost participation
is not required.
Length
and Time Phasing of Assistance: Normally,
awards are made for 1-year with additional support (up to 5 years)
depending on the recommendation of the dual review groups, successful
annual performance and availability of funds. Small Business Innovation
Research Phase I awards are generally for 6 months; Phase II awards
are generally for 2 years. Conference grant awards are for one
year.
POST
ASSISTANCE REQUIREMENTS:
Reports:
Annual program progress reports and financial status reports are
required for continuation at the end of each budget period. Final
program progress and financial status reports and an invention statement
on all projects must be submitted upon completion.
Audits:
In accordance with the provisions of OMB Circular No. A- 133 (Revised,
June 24, 1997), "Audits of States, Local Governments, and Non-Profit
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:
Progress reports, expenditures and other financial records must
be retained for 3 years from the day on which the grantee submits
the final financial status report for the report period.
Research and Conference Grants: In fiscal year 2001, approximately
165 new competitive applications were received and 83 new awards
were funded. Forty-nine continuation awards were also funded in
fiscal year 2001. It is anticipated that 110 new and approximately
120 continuation awards will be made in fiscal year 2002 and 130
new and 130 continuations in fiscal year 2003. SBIR: In fiscal year
2001, 2 new Phase I and 1 Phase II awards were made. It is anticipated
that three new Phase I and one Phase II continuation awards will
be made in fiscal year 2002; two Phase II continuations and one
new Phase I award is expected to be made in fiscal year 2003.
REGULATIONS,
GUIDELINES, AND LITERATURE:
42 CFR Part 52 - Grants for Research Project; 45 CFR Part 46 - Protection
of Human Subjects; 45 CFR Part 74 - Uniform Administrative Requirements
for Awards and Subawards to Institutions of Higher Education, Hospitals,
Other Nonprofit Organizations and Commercial Organizations; and
Certain Grants and Agreements with States, Local Governments and
Indian Tribal Governments; 45 CFR Part 92 - Uniform Administrative
Requirements for Grants and Cooperative Agreements to State and
Local Governments; the PHS Grants Policy Statement, DHHS Publication
No. (OASH) 94-50,000, (Rev.) April 1, 1994; and the Public Health
Omnibus Solicitation for Small Business Innovation Research.
INFORMATION
CONTACTS:
Regional
or Local Office: Not applicable.
Headquarters
Office: Program and Grants Management Contact:
Peggy L. Jones, Chief Grants Management Officer, Division of Contracts
and Procurement Management, Office of Facilities, Acquisition
and Central Services, Food and Drug Administration, Department
of Health and Human Services, HFA-520, Room 2129, 5630 Fishers
Lane, Rockville, MD 20857. Telephone: 301-827-7160; SBIR: 301-827-7182;
Fax 301-827-7101; Internet address: pjones1@oc.fda.gov.
Web
Site Address: http://www.fda.gov
EXAMPLES
OF FUNDED PROJECTS:
(1) Radiation Effects and Exposure Criteria; (2) Analytical Methodology
for Animal Drug Tissue in Milk; (3) Post Marketing Surveillance
of Adverse Drug Reactions; (4) International Program on Chemical
Safety; (5) ADI-PEG for Metastatic Melanoma; (6) Continuation of
the National Center for Food Safety and Technology; (7) Interferon
Gamma Treatment of Osteoporosis; and (8) SBIR: Phase I - Detection
of Campylobacteria in Foods, Phase II Point of Care Lead Instrument
and Sensor.
CRITERIA
FOR SELECTING PROPOSALS:
The major elements in evaluating proposals include the assessment
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 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.
For Small Business Innovation Research applications, the major elements
in evaluating Phase I grant applications include the assessment
of: (1) The technical merit of the proposed research; (2) the soundness
of the proposed design and methods; (3) the qualifications of the
proposed principal investigator, supporting staff, and consultants;
(4) the potential of the proposed research for technological innovation
and commercial application; (5) the appropriateness of the budget
requested; and (6) the adequacy and suitability of the facilities
and research environment. In review of Phase II applications, criteria
include those listed above, in addition to the following: (1) the
degree in which Phase I objectives were met and the feasibility
demonstrated; and (2) the adequacy of the Phase I objectives and
methodology for addressing the proposed research.
