[Federal Register Volume 75, Number 167 (Monday, August 30, 2010)]
[Notices]
[Pages 52957-52958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21480]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0445]
Supplemental Funding Under the Food and Drug Administration's
Food Emergency Response Laboratory Network Microbiological Cooperative
Agreement Program (U18) PAR-09-215; Request for Supplemental
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of intent to provide supplemental funding to the
existing cooperative agreement (U18), PAR-09-215, with the Food and
Drug Administration and a request for supplemental applications.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of supplemental grant funds for the support of Food
Emergency Response Laboratory Network (FERN) Microbiological
Laboratories. The goal of these FERN Microbiological Laboratories
supplements is a minor program expansion to enhance the lab
capabilities to handle human pathogenic bacteria in animal feed.
DATES: Important dates are as follows:
1. The supplemental application due date is August 30, 2010.
2. The anticipated start date is September 2010.
3. The opening date is August 30, 2010.
4. The expiration date is September 6, 2010.
[[Page 52958]]
FOR FURTHER INFORMATION CONTACT: Tim McGrath, Office of Regulatory
Affairs, Food and Drug Administration, 5600 Fishers Lane, rm. 12-41,
Rockville, MD 20857, 301-827-1028, email: [email protected];
or Camille R. Peake, Food and Drug Administration, 5630 Fishers Lane,
rm. 2105, Rockville, MD 20857, 301-827-7168, FAX: 301-827-7101, email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
For more information on the original funding opportunity
announcement (FOA) for the FERN Microbiological Laboratories, please
refer to the full FOA located at http://grants.nih.gov/grants/guide/pa-files/PAR-09-215.html. The program is further described in the Catalog
of Federal Domestic Assistance under 93.103.
A. Background
This Federal Register announcement issued by FDA under the FERN
Microbiological Cooperative Agreement Program Grant mechanism (U18) is
to solicit applications from existing FERN Microbiology Laboratories to
enhance current Cooperative Agreement Program (CAP) capabilities. The
FERN cooperative agreements are to enable the analyses of foods and
food products in the event that laboratory surge capacity is needed by
FERN and FDA for analyses related to microbiological contamination,
either through intentional or unintentional means. The supplemental
grant funds will enable analyses of human pathogenic bacteria found in
animal feed, for samples collected by Federal, State, or local
agencies. Numbers of samples and scheduling of samples will be done by
the FERN National Program Office (NPO) in coordination with State/local
lab authorities.
These supplemental grant funds will also be utilized to enhance
animal feed analysis results through the usage of standardized methods,
equipment platforms (provided by the grant), analytical worksheets, and
electronic reporting. The supplemental funds will also provide training
and proficiency testing for each method/platform. Minimal quality
management systems will be initiated for each lab, based on existing
systems in place in each lab and consultations between the FERN NPO and
each lab management group.
Each laboratory shall develop its own consensus decisionmaking,
size, and format. Federal agency representatives may be invited to be
nonmember liaisons or advisors to the laboratory and its meetings.
Supplemental funds may not be used for Federal employees to travel to
or participate in these meetings.
B. Research Objectives
Selected FDA FERN Microbiological Cooperative Agreement
Laboratories (CAP labs) will participate in a special Cooperative
Agreement program to enhance their ability to handle human pathogenic
bacteria in animal feed. This additional program will be compatible
with other FERN Cooperative Agreement work that the selected
laboratories will be performing. This special program will involve
screening and detection studies for selected pathogens (Listeria,
Salmonella, Escherichia coli O157:H7 and generic E. coli). The isolates
will be tested using methods agreed upon in consultation with the
Center for Veterinary Medicine's (CVM) Office of Research, most of
which are already being used to isolate these organisms from human
foods. The selected labs will participate in FERN food defense/food
safety assignments. The participation in this cooperative agreement
will expand the ability of FERN to screen for potential foodborne
pathogens in these feed matrices. In addition, this project will
provide CVM with information needed to assess future testing needs.
C. Eligibility Information
These supplemental grant funds are only available to existing grant
recipients from State, local, and tribal government FERN laboratories
and are authorized by section 312 of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188)
(42 U.S.C. 247b-20). This program is described in the Catalog of
Federal Assistance under number 93.448. All projects developed with
these funds at State, local, and tribal levels must have national
implication or application that can enhance Federal food and feed
safety and security programs.
D. Requirements
Laboratories will be selected based on the following criteria:
If it's an existing FDA FERN Microbiological Cooperative
Agreement Laboratory;
If it has routine microbiological capabilities as
demonstrated through established, ongoing State testing programs,
preferably those involving animal feed testing;
If it participates in FERN Food Safety/Food Defense
surveillance assignments;
If it participates in FERN proficiency testing; and
If it has a geographically balanced distribution of the
selected laboratories.
II. Award Information/Funds Available
A. Award Amount
FDA anticipates providing approximately $50,000 total costs (direct
costs only) in support of this supplemental program in fiscal year
2010. It is estimated that up to six microbiological laboratories will
be supplemented at the level requested, but not exceeding $50,000 total
costs (direct costs only) for a 1-year minor program expansion.
B. Length of Support
The initial award will be for a 1-year performance period and any
additional funding related to this supplement will be dependant on
successful performance and fiscal appropriations.
III. Paper Application and Submission Information
To submit an application in response to this supplemental notice,
applicants should download the PHS-398 form at http://grants.nih.gov/grants/funding/phs398/phs398.html.
Submit the paper application to:
Camille R. Peake, Food and Drug Administration, 5630 Fishers Lane,
rm. 2105, Rockville, MD 20857, 301-827-7168; and
Jenny Gabb, Office of Regulatory Affairs (HFC-150), Food and Drug
Administration, 5600 Fishers Lane, rm. 12-07, Rockville, MD 20857, 301-
827-8299.
Dated: August 24, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-21480 Filed 8-27-10; 8:45 am]
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