
[Federal Register: August 30, 2010 (Volume 75, Number 167)]
[Notices]               
[Page 52957-52958]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30au10-73]                         

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: timothy.mcgrath@fda.hhs.gov; 
or Camille R. Peake, Food and Drug Administration, 5630 Fishers Lane, 
rm. 2105, Rockville, MD 20857, 301-827-7168, FAX: 301-827-7101, email: 
Camille.Peake@fda.hhs.gov.


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]
BILLING CODE 4160-01-S

