[Federal Register Volume 73, Number 142 (Wednesday, July 23, 2008)]
[Notices]
[Pages 42816-42819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-16820]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0359]


Food Safety and Security Monitoring Project

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory 
Affairs (ORA), Division of Federal-State Relations (DFSR), is 
announcing the availability of cooperative agreements for equipment, 
supplies, personnel, training, and facility upgrades to Food Emergency

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Response Laboratory Network (FERN) chemistry laboratories of State, 
local, and tribal governments. The cooperative agreements are to enable 
the analyses of foods and food products in the event that redundancy 
and/or additional laboratory surge capacity is needed by FERN for 
analyses related to chemical terrorism. These grants are also intended 
to expand participation in networks to enhance Federal, State, local, 
and tribal food safety and security efforts.

DATES: Receipt Date: Applications are due within 30 days after the 
publication of the funding opportunity in the Federal Register.

FOR FURTHER INFORMATION CONTACT:
    For issues regarding the administrative and financial management 
aspects of this notice: Marc Pitts, Division of Acquisition Support and 
Grants, Food and Drug Administration, 5630 Fishers Lane, Rockville, MD 
20857, 301-827-7162, e-mail: [email protected];
    Regarding the programmatic aspects of this notice: Jennifer Gabb, 
Division of Federal-State Relations, Food and Drug Administration (HFC-
150), 5600 Fishers Lane, rm. 12-07, Rockville, MD 20857, 301-827-2899, 
e-mail: [email protected]; and
    For technical aspects of this notice: Dean Turco, Division of Field 
Science, Food and Drug Administration (HFC-140), 5600 Fishers Lane, rm. 
12-41, Rockville, MD 20857, 301-827-4097, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

Announcement Type: New Competing Cooperative Agreement (U18) under a 
Limited Competition
Request for Applications (RFA) Number: RFA-FD-08-009
Catalog of Federal Catalog of Federal Domestic Assistance Number: 
93.448
    ORA is the primary inspection and analysis component of FDA and has 
approximately 1,600 investigators, inspectors, and analysts who cover 
the country's approximately 95,000 FDA-regulated businesses. These 
investigators inspect more that 15,000 facilities per year and ORA 
laboratories analyze several thousand samples per year. ORA conducts 
special investigations, conducts food inspection recall audits, 
performs consumer complaint inspections, and collects samples of 
regulated products. Increasingly, ORA has been called upon to expand 
the testing program addressing the increasing threat to food safety and 
security through intentional chemical terrorism events. Toward these 
ends, ORA has developed a suite of chemical screening and analysis 
methodologies that are used to evaluate foods and food products in such 
situations. However, in the event of a large-scale emergent incident, 
analytical sample capacity in ORA field laboratories has a finite 
limit. Information from ongoing relationships with State partners 
indicates limited redundancy in State food testing laboratories, both 
in terms of analytical capabilities and analytical sample capacity. 
Several State food testing laboratories lack the specialized equipment 
to perform the analyses and/or the specific methodological expertise in 
the types of analyses performed for screening foods and food products 
involving chemical terrorism events.
    The events of September 11, 2001, reinforced the need to enhance 
the security of the U.S. food supply. Congress responded by passing the 
Public Health Security and Bioterrorism Preparedness and Response Act 
of 2002 (the Bioterrorism Act) (Public Law 107-188), which President 
George W. Bush signed into law on June 12, 2002. The Bioterrorism Act 
is divided into the following five titles:
    Title I--National Preparedness for Bioterrorism and Other Public 
Health Emergencies,
    Title II--Enhancing Controls on Dangerous Biological Agents and 
Toxins,
    Title III--Protecting Safety and Security of Food and Drug Supply,
    Title IV--Drinking Water Security and Safety, and
    Title V--Additional Provisions.
    Subtitle A of the Bioterrorism Act, Protection of Food Supply, 
section 312--Surveillance and Information Grants and Authorities, 
amends part B of Title III of the Public Health Service Act to 
authorize the Secretary of Health and Human Services (the Secretary) to 
award grants to States and tribes to expand participation in networks 
to enhance Federal, State, and local food safety efforts. This may 
include meeting the costs of establishing and maintaining the food 
safety surveillance, technical, and laboratory capacity needed for such 
participation.

Project Emphasis

    The goal of ORA's cooperative agreement program is to complement, 
develop, and improve State, local, and tribal food safety and security 
testing programs. This will be accomplished through the provision of 
equipment, supplies, personnel, facility upgrades, training in current 
food testing methodologies, participation in proficiency testing to 
establish additional reliable laboratory sample analysis capacity, 
analysis of surveillance samples, and in cooperation with FDA, 
participation in method enhancement activities designed to extend 
analytical capabilities. In the event of a large-scale chemical 
terrorism event affecting foods or food products, the recipient may be 
required to perform selected chemical analyses of domestic and imported 
food samples collected and supplied to the laboratory by FDA or other 
government agencies through FDA. These samples may consist of, but are 
not limited to, the following: Vegetables and fruits (fresh and 
packaged), juices (concentrate and diluted), grains and grain products, 
seafood and other fish products, milk and other dairy products, infant 
formula, baby foods, bottled water, condiments, and alcoholic products 
(beer, wine, scotch).

II. Award Information

Mechanism of Support

    All grant application projects that are developed at State, local, 
and tribal levels must have national implication or application that 
can enhance Federal food safety and security programs. At the 
discretion of FDA, successful project formats will be made available to 
interested Federal, State, local, and tribal government FERN 
laboratories.
    There are four key project areas identified for this effort that 
must be addressed:
    1. The use of gas chromatography/mass spectrometry analysis for the 
screening and identification of poisons, toxic substances, and unknown 
compounds in foods;
    2. The use of liquid chromatography/mass spectrometry analysis for 
the screening and identification of poisons, toxic substances, and 
unknown compounds in foods;
    3. The use of inductively coupled plasma/mass spectrometry analysis 
for the screening and identification of heavy metals and toxic elements 
in foods; and
    4. The use of enzyme-linked immunosorbent assay and other antibody-
based analyses for the screening and identification of unknown toxins 
in foods.
    FDA will support the projects covered by this document under the 
authority of section 312 of the Bioterrorism Act. This program is 
described in the Catalog of Federal Domestic Assistance under number 
93.448.
    Support will be in the form of a cooperative agreement. Substantive

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involvement by the awarding agency is inherent in the cooperative 
agreement award. Accordingly, FDA will have substantial involvement in 
the program activities of the project funded by the cooperative 
agreement. Substantive involvement includes, but is not limited to, the 
following: (1) How often samples will be sent, (2) directions on how 
tests should be executed, (3) onsite monitoring, (4) supply of 
equipment, (5) FDA training on processes, and (6) enhancement and 
extension of analytical methodology.
    FDA will provide specific procedures and protocols for the four 
project areas to be used for the analysis of toxic chemicals and toxins 
in food.
    FDA will provide guidance on the specific foods to be collected for 
analysis by the successful applicant. FDA will purchase and have all 
needed major equipment for the four project areas delivered to the 
awardee's laboratory. The equipment purchased will remain the property 
of FDA until such time as it is released as surplus property.
    Only proposed projects designed to address all four project areas 
will be considered for funding. Applicants may also apply for only 
facility upgrades, personnel, training, method extension, and 
surveillance sample analysis if they have the necessary equipment and 
it will be available for these projects. These grants are not to fund 
or conduct food inspections for food safety regulatory agencies.
    It should be emphasized that in all of the projects, there is a 
particular desire to promote a continuing, reliable capability and 
capacity for laboratory sample analyses of foods and food products for 
the rapid detection and identification of toxic chemicals or toxins. 
With this in mind, it is desirable that sample analyses will be 
completed no later than 2 weeks after receipt, and the results will be 
reported to FERN. The format and reporting media will be established by 
FERN. Shorter timeframes may be sought for special testing such as 
proficiency tests or special assignments.

III. Eligibility Information

A. Eligible Applicants

    This cooperative agreement program is only available to State, 
local, and tribal government FERN laboratories that currently are not 
funded under this cooperative agreement and is authorized by section 
312 of the Bioterrorism Act. All grant application projects that are 
developed at State, local, and tribal levels must have national 
implication or application that can enhance Federal food safety and 
security programs. At the discretion of FDA, successful project formats 
will be made available to interested Federal, State, local, and tribal 
government FERN laboratories.

B. Cost Sharing or Matching

    Cost sharing is not required.

IV. Application and Submission

A. Application Information

    In order to apply electronically, the applicant must complete the 
following steps:
Step 1: Obtain a Dun & Bradstreet Number (DUNS Number)
    Same day. Your organization will need to obtain a DUNS Number. If 
your organization doesn't already have one, go to the Dun & Bradstreet 
Web site at http://fedgov.dnb.com/webform.
Step 2: Register with the Central Contractor Registry (CCR)
    Two days or up to 1 to 2 weeks. Ensure that your organization is 
registered with the CCR at http://www.ccr.gov. If your organization is 
not already registered, an authorizing official of your organization 
must register. You will not be able to move on to Step 3 until this 
step is completed.
Step 3: Obtain Username and Password
    Same day. Create a username and password with Operational Research 
Consultants (ORC), the Grants.gov credential service provider. Use your 
organization's DUNS Number to access the ORC Website at http://apply07.grants.gov/apply/OrcRegister.
Step 4: Grants.gov Registration
    Same day. Register with Grants.gov at https://apply07.grants.gov/apply/GrantsgovRegister to open an account using the username and 
password you received from ORC.
Step 5: Authorized Organization Representative (AOR) Authorization
    Time depends on responsiveness of your E-Business Point of Contact 
(E-Biz POC). The E-Biz POC at your organization must respond to the 
registration e-mail from Grants.gov and login at Grants.gov to 
authorize you as an AOR. Please note that there can be more than one 
AOR for your organization. In some cases the E-Biz POC is also the AOR 
for an organization.
Step 6: Track AOR Status
    At any time, you can track your AOR status at the Applicant home 
page of Grants.gov in ``Quick Links'' by logging in with your username 
and password (https://apply07.grants.gov/apply/ApplicantLoginGetID).
    FDA is accepting new applications for this program electronically 
via Grants.gov. Applicants must apply electronically by visiting the 
Web site http://www.grants.gov and following instructions under ``APPLY 
FOR GRANTS.'' The required application SF424, which is part of the PHS 
5161-1 form, can be completed and submitted online by selecting Step 1: 
``Download a Grant Application Package,'' then by entering the funding 
opportunity number ``RFA-FD-08-009.'' The ``Selected Grant Applications 
For Download'' page will provide you with the Additional Resources 
downloads for Adobe Reader and PureEdge Viewer as well as the download 
to the ``Instructions & Application'' hyperlink.

B. Content and Form of Application

1. Content of Application
    The SF424 PHS-5161 has several components. Some components are 
required, others are optional. The forms package associated with this 
request for application (http://www.Grants.gov/Apply) includes all 
applicable components. If you experience technical difficulties with 
your online submission you should contact either Marc Pitts (see FOR 
FURTHER INFORMATION CONTACT) or the Grants.gov Customer Support Center 
by e-mail at [email protected] or by phone at 1-800-518-4726.
2. Format for Application
    All applications must be submitted electronically through 
Grants.gov. Paper applications will not be accepted. The application 
must be an SF424-PHS-5161. The narrative portion, excluding appendices, 
of the application may not exceed 100 pages in length and must be 
single-spaced in 12-point font. The appendices should also not exceed 
100 pages in length (separate from the narrative portion of the 
application).
    Information collection requirements requested on Form (SF-424) PHS 
5161-1, expiration date of January 31, 2009, have been sent by the 
Public Health Service (PHS) to the Office of Management and Budget 
(OMB) and have been approved and assigned OMB control number OS-4040-
0004.

C. Submission Dates and Times

    The application receipt date is 30 days after the publication of 
the funding opportunity in the Federal Register. Applications will be 
accepted from 8 a.m. to 4:30 p.m., Monday through Friday, until the 
receipt date. Applications submitted electronically must be received by 
close of business on

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the receipt date. No addendum material will be accepted after the 
receipt date.

D. Intergovernmental Review

    The regulations issued under Executive Order 12372, 
Intergovernmental Review of Department of Health and Human Services 
Programs and Activities (45 CFR part 100), apply to the Food Safety and 
Security Monitoring Project. Applicants (other than federally 
recognized Indian tribal governments) should contact the State's Single 
Point of Contact (SPOC) as early as possible to alert the SPOC to the 
prospective application(s) and to receive any necessary instructions on 
the State's review process. A current listing of SPOCs is included in 
the application kit or at http://www.whitehouse.gov/omb/grants/spoc.html. (FDA has verified the Web site address, but FDA is not 
responsible for subsequent changes to the Web site after this document 
publishes in the Federal Register.) The SPOC should send any State 
review process recommendations to the FDA administrative contact (see 
FOR FURTHER INFORMATION CONTACT). The due date for the State process 
recommendations is no later than 60 days after the application receipt 
date. FDA does not guarantee accommodation or explaination of SPOC 
comments that are received after the 60-day cutoff.

E. Funding Restrictions

    These grants are not to fund or conduct food inspections for food 
safety regulatory agencies. They may not be utilized for new building 
construction, however, remodeling of existing facilities is allowed, 
provided that remodeling costs do not exceed 25 percent of the grant 
award amount.

    Dated: July 7, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-16820 Filed 7-22-08; 8:45 am]
BILLING CODE 4160-01-S