2010-21480. 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.

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: [e-mail]; or Camille R. Peake, Food and Drug Administration, 5630 Fishers Lane, rm. 2105, Rockville, MD 20857, 301-827-7168, FAX: [phone], email: [e-mail].

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.