[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