[Federal Register Volume 64, Number 142 (Monday, July 26, 1999)]
[Notices]
[Pages 40380-40381]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18929]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Cooperative Agreement to Support the Joint Institute for Food
Safety and Applied Nutrition; Notice of Intent to Supplement
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing its
intention to noncompetitively supplement the cooperative agreement with
the University of Maryland, College Park (UMCP) for up to an estimated
$2 million per annum. These funds will provide additional support to
the UMCP's Joint Institute for Food Safety and Applied Nutrition
(JIFSAN) for the purpose of addressing emerging health issues and
crises that are related to food safety and applied nutrition and animal
health sciences, and expanding the current scope to include other
agency programs such as cosmetics.
DATES: Submit the application by August 25, 1999. If this date falls on
a weekend, it will be extended to Monday; if this date falls on a
holiday, it will be extended to the following workday.
ADDRESSES: An application is available from and should be submitted to:
Maura C. Stephanos, Office of Regulatory Affairs Support and Assistance
Management Branch (HFA-520), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-7183. If the application is hand
carried or commercially delivered, it should be addressed to Maura C.
Stephanos, 5630 Fishers Lane, rm. 2129, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Regarding the administrative and financial management aspects of
this notice: Maura C. Stephanos (address above).
Regarding the programmatic aspects: Elizabeth M. Calvey, Center for
Food Safety and Applied Nutrition (HFS-6), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, 202-205-4716.
SUPPLEMENTARY INFORMATION: This project is authorized under section 301
of the Public Health Service Act (the PHS Act) (42 U.S.C. 241). This
activity is generally described in the Catalog of Federal Domestic
Assistance at No. 93.103. The application will not be subject to review
as governed by Executive Order 12372, Intergovernmental Review of
Federal Program (45 CFR part 100).
I. Restricted Eligibility
In the Federal Register of May 22, 1997 (62 FR 28049), FDA
announced that a single source application for a cooperative agreement
to support the JIFSAN at the UMCP would be accepted. Supplemental
funding referenced herein will provide for the implementation and
enhancement of activities associated with the JIFSAN projects described
and authorized under the original award (FD-U-001418-01) dated
September 29, 1997.
II. Availability of Funds
FDA will provide supplemental funding up to an estimated $2
million per annum to the cooperative agreement, which is at a level
greater than the 25 percent of the original award currently provided
under agency policy. Supplemental funding will provide support of the
JIFSAN programs primarily through available Food Safety Initiative
funds and funds from other government agencies.
The original cooperative agreement was approved for 5 years of
funding and currently has 3 years of noncompetitive support remaining,
which is contingent upon the availability of fiscal year appropriations
and successful performance. FDA anticipates that supplemental funding
of the cooperative agreement will commence on or before September 30,
1999.
III. Background
JIFSAN was established between FDA and the UMCP in April 1996,
through a formal Memorandum of Understanding (MOU), to create a
partnership that allows for more efficient use of research resources,
thereby enhancing overall public health by expanding and improving food
safety and nutrition research as well as research in other program
areas that impact on public health policy. As the role of FDA research
scientists in regulatory activities increases (e.g., petition review,
rulemaking, enforcement compliance standards, hazard analysis critical
control point performance standards), it is vital that these same
scientists have ready access to very specialized research facilities
and expertise that are in close proximity to FDA's administrative
offices. The unique needs for research in support of regulatory
programs has been one of the key reasons for maintaining a strong FDA
research program. JIFSAN is a jointly administered, multi-disciplinary
research and outreach program. JIFSAN was established as part of FDA's
consolidation project affecting FDA's Center for Food Safety and
Applied Nutrition and Center for Veterinary Medicine. The primary focus
of JIFSAN is food safety and nutrition, specifically as related to risk
analysis, applied microbiology, natural toxins, chemical contaminants,
animal health sciences, and food composition and nutrition. JIFSAN also
encompasses other agency programs such as cosmetics, dietary
supplements, and food labeling.
IV. Purpose
Supplemental funding to FDA's current cooperative agreement will
provide the UMCP with the necessary resources to conduct further
research related to the goals of the National Food Safety Initiative
and to leverage additional resources for applied nutrition, animal
health science activities, and other agency programs. These resources
would: (1) Expand the expertise for public health research and risk
assessment initiatives, (2) support the Risk Assessment Consortium, and
(3) increase innovative public/private research and education
partnerships. Because international safety regulations must be founded
on science-based risk assessments, FDA's scientists must have a lead
role in their development.
Additionally, supplemental funding will provide resources to
identify gaps in risk analysis to: (1) Minimize/reduce uncertainty in
risk management decisions; (2) improve the quality of risk assessments
applied to agency
[[Page 40381]]
programs, principally but not limited to food safety and applied
nutrition (e.g., microbial pathogens, natural toxins, chemical
contaminants, and food composition and nutrition); and (3) enhance risk
communication, through outreach and public information programs, that
will help the mass media and consumers understand and act on public
health concerns. Innovative research and outreach efforts, made
possible by the supplemental funding, will complement existing efforts
under FDA's current cooperative agreement with the UMCP and will
provide public health officials with the appropriate knowledge to
formulate regulatory decisions and enhanced capabilities to communicate
with their stakeholders.
V. Substantive Involvement by FDA
All terms and conditions of the current award shall remain in full
force and effect for the supplemental awards.
VI. Review Procedure
The application submitted by the UMCP will undergo a
noncompetitive, dual peer review. The application will be reviewed for
scientific and technical merit by a panel of experts based on
applicable evaluation criteria. If the application is recommended for
approval it will then be presented to the National Advisory
Environmental Health Sciences Council.
VII. Reporting Requirement
All terms and conditions of the current award shall remain in full
force and effect for the supplemental awards.
VIII. Mechanism of Support
Support will be in the form of supplements to FDA's cooperative
agreement with the UMCP. This agreement will be subject to all policies
and requirements that govern the research grant program of the Public
Health Service, including provisions of 42 CFR part 52 and 45 CFR part
74.
Dated: July 15, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-18929 Filed 7-23-99; 8:45 am]
BILLING CODE 4160-01-F
