[Federal Register Volume 73, Number 142 (Wednesday, July 23, 2008)]
[Notices]
[Pages 42814-42816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-16818]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0362]


Directory of State and Local Officials and State Food Safety 
Resource Survey Support 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 a Sole Source to the Association of Food and Drug 
Officials (AFDO) to provide funding for a 3-year cooperative agreement 
award to support a Special Project Cooperative Agreement program. No 
other applications are solicited. This cooperative agreement is 
intended to have AFDO update and maintain the FDA Directory of State 
and Local Officials and to update the AFDO document ``State Food Safety 
Resource Survey (2000)'' by providing funding for additional personnel, 
equipment, and supplies to support activities related to these 
projects.

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].
    For issues regarding the programmatic or technical aspects of this 
notice: Jennifer Gabb, Division of Federal-State Relations (HFC-150), 
Office of Regulatory Affairs, Food and Drug Administration, 5600 
Fishers Lane, Rm. 12-07, Rockville, MD 20857, 301-827-2899, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

Announcement Type: New Cooperative Agreement (U18)
Request for Applications (RFA) Number: FD-08-011 Sole Source
Catalog of Federal Domestic Assistance Number: 93.103
    In 2007 and 2008, the Food and Drug Administration Amendments Act 
of 2007 (FDAAA), the Food Protection Plan, and the Import Strategic 
Action Plan addressed FDA's relationship with the States in food 
protection activities. In addition, the Food Protection Plan lays out 
new goals specific to protecting the food supply and responding to 
incidents in a rapid and coordinated manner.

A. Food Protection Plan 2007

    In May 2007, the Secretary of Health and Human Services and the 
Commissioner of Food and Drugs charged FDA with developing a 
comprehensive and integrated Food Protection Plan to keep the nation's 
food supply safe from both unintentional and deliberate contamination. 
Driven by science and modern information technology, the Food 
Protection Plan aims to identify potential hazards and counter them 
before they can do harm. A cornerstone of this forward-thinking effort 
is an increased focus on prevention.

B. Project Emphasis

    FDA's integrated approach within the Food Protection Plan 
encompasses three core elements: Prevention, intervention and response.
Core Element 1: Prevention
    The prevention element involves promoting increased corporate 
responsibility so that food problems do not occur in the first place. 
By comprehensively reviewing food supply vulnerabilities and developing 
and implementing risk reduction measures

[[Page 42815]]

with industry and other stakeholders, we can best address critical 
weaknesses.
Core Element 2: Intervention
    The intervention element focuses on risk-based inspections, 
sampling, and surveillance at high-risk points in the food supply 
chain. These interventions must verify that the preventive measures are 
being implemented and implemented correctly.
Core Element 3: Response
    The response element bolsters FDA's emergency response efforts by 
allowing for increased speed and efficiency. This element also includes 
the idea of better communication with other Federal, State, and local 
government agencies and industry during and after emergencies. Whether 
contamination is unintentional or deliberate, there is a need to 
respond quickly and to communicate clearly with consumers and other 
stakeholders. The communication should emphasize identifying products 
of concern as well as informing the public of what is safe to consume.

C. Food and Drug Administration Amendments Act of 2007

    Under the Food and Drug Administration Amendment Act of 2007 
(FDAAA), FDA is required to work with the states to improve food 
safety. Section 1004 of the FDAAA states:
    ``(a) IN GENERAL--The Secretary shall work with the States in 
undertaking activities and programs that assist in improving the safety 
of food, including fresh and processed produce, so that State food 
safety programs and activities conducted by the Secretary function in a 
coordinated and cost-effective manner. With the assistance provided 
under subsection (b), the Secretary shall encourage States to--
    (1) establish, continue, or strengthen State food safety programs, 
especially with respect to the regulation of retail commercial food 
establishments; and
    (2) establish procedures and requirements for ensuring that 
processed produce under the jurisdiction of State food safety programs 
is not unsafe for human consumption.''

D. Import Safety Action Plan

    The Import Safety Action Plan (ISAP) acknowledges the value of 
mutual leveraging of State and Federal resources and recommends 
consideration of cooperative agreements to increase information 
sharing. Specifically, the ISAP provides the following recommendations:
Federal-State Rapid Response
Recommendation 12--Maximize Federal-State Collaboration
    The roles of and the resources used by the Federal Government and 
the States in import safety are complementary. States possess 
legislative authority and resources to respond to unsafe imported 
products within their jurisdiction. The Federal Government can take 
steps to interdict unsafe imported goods at ports of entry. Should an 
unsafe product enter domestic commerce, federal departments and 
agencies often work with State authorities to track it down, seize it, 
notify the public if it has already been purchased by consumers, and 
impose appropriate penalties on domestic entities who violate U.S. law. 
Also, both the Federal Government and States may have access to 
information relevant to protecting consumers that the other does not 
possess. For example, Federal departments and agencies may have 
relevant information about the foreign source of the imported product 
and about the importer. This information can help State officials track 
down an unsafe imported product within their jurisdiction. On the other 
hand, State officials may identify an unsafe imported product during 
transport or at the point of sale, if the product does get into the 
country, and can tip off Federal officials to prevent future shipments 
from entering domestic commerce.
    Several Federal departments and agencies already collaborate 
closely with State authorities to protect consumers. For example, FDA 
has contracts and cooperative agreements with State Governments to 
share information, conduct joint inspections, and collaborate on 
laboratory analyses. Greater mutual leveraging of State and Federal 
resources can further enhance consumer protection.
    Recommendation 12.1 states: ``Consider cooperative agreements 
between the federal inspection agencies and their state counterparts 
for greater information-sharing.'' Such cooperative agreements would 
not infringe on the statutory authorities of Federal or State 
regulators and would encourage a coordinated effort that would result 
in a more rapid and effective response. Establishing clear procedures 
and points of contact for information sharing and joint enforcement 
efforts can further enhance the effectiveness of Federal-State actions 
to limit exposure and potential harm to consumers if an unsafe imported 
product enters domestic commerce.

II. Award Information

Mechanism of Support

    Support will be in the form of a Sole Source cooperative agreement 
U18 Mechanism. Substantive 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.

III. Eligibility Information

A. Eligible Applicants

    ORA is offering this sole source cooperative agreement to AFDO to 
improve and update the Directory of State and Local Officials (current 
version is from 2004) to provide information for Rapid Response and 
information sharing. AFDO will also update the data in the AFDO State 
Food Safety Resource Survey including recall and foodborne illness 
investigation information to identify and to support Risk Management 
and information sharing. Assistance will be provided only to the AFDO. 
No other applications are solicited.

B. Applicability

    AFDO is uniquely qualified for this cooperative agreement. AFDO 
(http://www.afdo.org/) conducted a nationwide survey of State and local 
food safety programs in 2000 and, with the National Center for Food 
Protection and Defense, has been an active partner in the FoodSHIELD 
project (http://www.afdo.org/afdo/upload/061025-FoodSHIELD%20Brochure.pdf, http://www.foodshield.org/), during which 
AFDO has collected contact information of State and local jurisdictions 
comparable to the FDA Directory of State and Local Officials (http://www.fda.gov/ora/fed_state/directorytable.htm). AFDO is the 
organization qualified for conducting this work because:
     AFDO is the only national organization that represents the 
State and local food protection regulatory agencies. AFDO's principal 
purpose is to act as a leader and a resource to State and local 
regulatory agencies in developing strategies to resolve and promote 
public health and consumer protection related to the regulation of 
foods, drugs, medical devices, and consumer products. Regular members 
are officials of State and local regulatory agencies that administer 
these programs in conjunction and collaboration with FDA.
     AFDO has always focused on the administration of the 
nation's food

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protection programs. Thus, unlike other organizations, AFDO has a 
unique perspective on the infrastructure, capacity, strengths, and 
needs of State and local food protection programs.
     AFDO has successful experience in carrying out national 
efforts that focus on the needs of State and local regulatory agencies. 
FDA has used the data from the initial AFDO State Food Safety Resource 
Survey, AFDO model codes, and training programs such as the Seafood 
HACCP training program certified through AFDO. AFDO has also developed 
the AFDO Recall Manual and many other training programs and initiatives 
with the Centers for Disease Control, the U.S. Department of 
Agriculture, and others in meat and poultry processing at retail. AFDO 
also has industry associate members.

C. Award Amount

    The total amount of funding available for fiscal years 2008 through 
2010 is $250,000. This cooperative agreement will award up to $250,000 
in total (direct plus indirect) costs for a 3-year cooperative 
agreement.

D. Length of Support

    The length of support for this project will be 3 years.

E. Cost Sharing or Matching

    Cost sharing is not required.

IV. Application and Submission

A. Application Information

    Applications must be prepared using the most current SF424 
(Research and Related) (also referred to as the ``SF424 (R&R)'', which 
is part of the Public Health Service, PHS 5161-1 form. Applications 
must have a Dun and Bradstreet Data Universal Numbering System (DUNS) 
number as the universal identifier when applying for Federal grants or 
cooperative agreements. The DUNS number can be obtained by calling 866-
705-5711 or through the Web site at http://www.dnb.com/us/. (FDA has 
verified the Web site addresses throughout this document, but we are 
not responsible for any subsequent changes to the Web sites after this 
document publishes in the Federal Register.)
    Applications must be prepared using the forms found in the SF424 
R&R instructions for preparing a nonmodular research grant application. 
Submit a signed, typewritten original of the paper application, 
including the checklist, three signed photocopies, and appendix 
material in one package to: Marc Pitts (see FOR FURTHER INFORMATION 
CONTACT).
    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.
    Information collection requirements requested on Form (SF-424) PHS 
5161-1, expiration date of January 31, 2009, have been sent by the PHS 
to the Office of Management and Budget (OMB) and have been approved and 
assigned OMB control number OS-4040-0004.

B. 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. e.s.t., Monday through Friday, until 
the established receipt date. Applications submitted electronically 
must be received by the close of business on the established receipt 
date. No addendum material will be accepted after the established 
receipt date.

C. Intergovernmental Review

    The regulations issued under Executive Order 12372, 
Intergovernmental Review of Federal Programs (45 CFR part 100) apply. 
Applicants (other than federally recognized 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 located at http//www.whitehouse.gov/omb/grants/spoc.html. 
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 explanation of SPOC comments that are received after 
the 60-day cutoff.

D. Funding Restrictions

    This cooperative agreement is not to fund annual, regional, or 
State meetings of AFDO, travel for other than project employees, 
equipment other than consumables or as outlined in the application, or 
any remodeling or capital improvement to office location or space.

E. Central Contractor Registration

    Applicants must register with the Central Contractor Registration 
(CCR) database. This database is a government-wide warehouse of 
commercial and financial information for all organizations conducting 
business with the Federal Government. Registration with CCR is a 
mandatory requirement and is consistent with the government-wide 
management reform to create a citizen-centered Web presence and to 
build e-gov infrastructures in and across agencies to establish a 
``single face to industry.'' The preferred method for completing a 
registration is through the World Wide Web at http://www.ccr.gov. This 
Web site provides a CCR handbook with detailed information on data you 
will need prior to beginning the online preregistration, as well as 
steps to walk you through the registration process. You must have a 
DUNS number to begin your registration. The CCR registration process 
can also be found under the ``Organization Registration'' page of 
Grants.gov at http://www.grants.gov/applicants/organization_registration.jsp.

F. Copyright Material

    Applicant and applicants' subgrantees and subcontractors must 
ensure that any projects developed in whole or in part with Federal 
funds may be made available to other State, territorial, local, and 
tribal regulatory agencies by FDA or its agents. Any copyrighted or 
copyrightable works shall be subject to a royalty-free, nonexclusive, 
and irrevocable license to the Federal Government to reproduce, 
publish, or otherwise use them, and to authorize others to do so for 
Federal Government purposes.

    Dated: July 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-16818 Filed 7-22-08; 8:45 am]
BILLING CODE 4160-01-S