[Federal Register Volume 73, Number 126 (Monday, June 30, 2008)]
[Notices]
[Pages 36878-36880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-14735]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0357]


Food Protection Rapid Response Team and Program Infrastructure 
Improvement Prototype Project (U18); Availability of an Agreement of 
Limited Competition; Request for Applications: RFA Number: RFA FD08-007

I. Research Objectives

    The Food and Drug Administration (FDA), Office of Regulatory 
Affairs (ORA), Division of Federal-State Relations (DFSR) in 
collaboration with the Center for Food Safety and Applied Nutrition 
(CFSAN) and Center for Veterinary Medicine (CVM), is announcing the 
availability of an Agreement of Limited Competition. Only States with 
current FDA Food Safety contracts to provide funding to State agency 
food protection regulatory programs are eligible for a 3-year 
cooperative agreement to develop and sustain an all Food Hazards Rapid 
Response Team, encompassing both food and feed protection programs, 
through a process to further enhance and build the infrastructure of 
State food protection programs.
    The goal of FDA's ORA Cooperative Agreement Program is to enhance, 
complement, develop and improve State manufactured food protection 
regulatory and surveillance programs. This will be accomplished through 
the provision of funding for program assessment, additional equipment, 
supplies, funding for personnel, and training including Incident 
Command System (ICS), rapid response team development and coordination, 
and exercises of the response team. This will also require extensive 
cooperation and coordination with FDA District Offices to minimize 
duplication of inspections, an FDA contractor (the Western Institute 
for Food Safety and Security (WIFSS)) in the development of Rapid 
Response Teams (RRT), and other FDA program offices.
    These cooperative agreements are intended to develop, implement and 
exercise an all hazards food and foodborne illness RRT concept within 
the food protection program in conjunction with other food and feed 
agencies within State programs, other State RRTs, FDA District Offices, 
and State Emergency Operations Centers (EOC) to respond to all food 
hazard incidents in the farm-to-table continuum using expandable ICS 
protocols and structures as needed. The infrastructure necessary to 
develop and sustain an RRT is accomplished through the assessment and 
continuous improvement to the infrastructure and equivalency of the 
State food regulatory program using the FDA Manufactured Food 
Regulatory Program Standards (MFRPS). State food program enhancements 
will also include the incorporation of the FDA Food Protection Plan to 
implement a strategy of prevention, intervention and response to build 
safety into every step of the food supply chain. The cooperative 
agreements will provide funding for additional personnel, equipment, 
supplies and training to support activities related to the FDA MFRPS 
and the RRT concept.
    Under the cooperative agreement, the State would assess and 
implement a continuous program improvement/enhancement strategy 
(strategic plan) using the FDA MFRPS, and in addition, develop, train 
and implement a foodborne illness rapid response team that incorporates 
ICS concepts and conceptual elements outlined in this RFA. This 
standard applies to the surveillance, investigation, response and 
subsequent review of alleged food-related incidents and emergencies, 
either unintentional or deliberate that may result in illness, injury, 
and outbreaks.
    Post assessment, these funds should be used to enhance or establish 
systems to:
    1. Use epidemiological information supplied by local, State, or 
Federal agencies to detect incidents or outbreaks of foodborne illness 
or injury;
    2. Investigate reports of illness, injury, and suspected outbreaks;
    3. Correlate and analyze data;
    4. Disseminate public information effectively;
    5. Distribute outbreak reports and surveillance summaries to 
relevant agencies;
    6. Disseminate current guidance to industry on food defense;
    7. Provide guidance for immediate notification of law enforcement 
agencies when intentional food contamination or terrorism is suspected 
or threatened;
    8. Collaborate as necessary with FDA and other Federal authorities 
under conditions of increased threat of intentional contamination.
    The goal of developing and sustaining an RRT is in concert with 
long-term goals to enhance the food inspection and foodborne illness 
response programs, to increase the ability to inspect and obtain 
compliance for firms in their jurisdiction involved in the processing, 
manufacturing, distribution, transportation and warehousing of food, 
verify compliance with the State laws and regulations, good 
manufacturing practices, food defense, and other food protection 
requirements in support of the State program and the FDA Food 
Protection Plan (FPP), Action Plan for Import Safety (ISAP), and the 
Food and Drug Administration Amendments Act of 2007 (FDAAA).
    Funds could be used to increase State personnel to support the RRT, 
team coordinators, technical experts and epidemiologist team members. 
Funds could also be used for supplies, training, and equipment for 
inspections and rapid response including investigational, GPS 
interface, communication and laboratory. The goal of enhancing State 
food programs is to ensure that the necessary infrastructure is 
available to support an RRT along with the States regulatory and food 
protection responsibilities of inspections and oversight of food 
processing, manufacture, distribution, transportation and warehousing.
    These support project funds are intended to supplement, not 
replace, State funding for program improvement and activities. States 
funded under these cooperative agreements will be required to provide 
the previous years and subsequent years State funding to demonstrate 
that these funds have not replaced State allocations for the food 
protection program. The purpose of these cooperative agreements is the 
development and enhancement of existing State food regulatory programs 
in providing outbreak response capabilities. Funding will be provided 
for items such as: Supplies, lab equipment, surveillance, team 
development and exercise, sample collection, personnel, for the 
provision of training independently and with an FDA contract for RRT 
training, and meetings with FDA District response teams. Successful 
applications will be selected for funding to ensure a broad geographic 
distribution of the program. Size of the existing or new State/
territory/tribal program and number of facilities to be covered under 
the

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cooperative agreement will also be a determining factor. States with 
current food safety Inspection contracts from FDA can maintain these 
contracts at the discretion of the State and FDA. However, the 
facilities and work covered under the contract cannot be counted 
towards fulfillment of the cooperative agreement and must remain 
distinct and separate from the cooperative agreement. These cooperative 
agreements are not to fund licensed medicated feed or routine feed 
safety good manufacturing practice (GMP) inspections, or retail food or 
foodservice inspections.
    Because the nature and scope of the proposed research will vary 
from application to application, it is anticipated that the size and 
duration of each award will also vary. Although the financial plans of 
the FDA provide support for this program, awards under this funding 
opportunity are contingent upon the availability of funds and the 
receipt of a sufficient number of meritorious applications.

II. Authority and Regulations

    This request for applications (RFA) is subject to intergovernmental 
review E.O. 12372. See http://www.whitehouse.gov/omb/grants/spoc.html. 
This program is described in the Catalog of Federal Domestic Assistance 
(93.103) at http://www.cfda.gov/\1\ and it is subject to the 
intergovernmental review requirements of Executive Order 12372. Awards 
are made under the Bioterrorism Act, Subtitle A of Title III-Protection 
of Food Supply, Section 31--Grants to States for Inspections, amends 
the Federal Food, Drug, and Cosmetic (act) by adding section 909 to 
authorize the Secretary of Health and Human Services to award grants to 
States, territories, and Indian tribes that undertake examinations, 
inspections, and investigations, and related activities under Section 
702 of the act. All awards are subject to the terms and conditions, 
cost principles, and other considerations described in the NIH Grants 
Policy Statement. The FDA Grants Policy Statement can be found at 
http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.
    See Section VIII, Other Information--Required Federal Citations, 
under the full text of the RFA for policies related to this 
announcement found in http://www.grants.gov and/or http://web.ora.fda.gov/dfsr/detail.jsp?id=66.
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    \1\ FDA has verified the non-FDA 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.
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III. Mechanism of Support

A. Background

    This funding opportunity will use the cooperative agreement award 
mechanism(s) (U18).
    The Project Director/Principal Investigator (PD/PI) will be solely 
responsible for planning, directing, and executing the proposed 
project.
    This funding opportunity will use a cooperative agreement award 
mechanism. In the cooperative agreement mechanism, the PD/PI retains 
the primary responsibility and dominant role for planning, directing, 
and executing the proposed project, with FDA staff being substantially 
involved as a partner with the principal investigator, as described 
under the Section VI. 2. Administrative Requirements of the full RFA, 
under ``Cooperative Agreement Terms and Conditions of Award''.
    Funding for an additional 3 years of noncompetitive support is 
contingent on cooperative agreement performance, program progress and 
the availability of funds.

B. Funds Available and Anticipated Number of Awards

    The total amount of funding available in fiscal year (FY) 2008 is 
$3 million.
    It is anticipated that FDA will make up to six awards in FY 2008. 
The number of projects funded will depend on the quality of the 
applications received and is subject to availability of Federal funds 
to support the projects. In addition, if a cooperative agreement is 
awarded, grantees will be informed if any additional documentation 
should be needed to support their award. Funds may be requested in the 
budget to travel to FDA for meetings with program staff about the 
progress of the project. The project office will have continuous 
interaction with the grantee through inspection field audits, 
collection of quarterly progress reports, and provision of training, 
joint inspections, and compliance, program standards audits, rapid 
response team exercises and coordination and others as needed in the 
development of the self assessment, strategic improvement plan and its 
implementation. There may be other regular meetings with grantees to 
assist in fulfilling the requirements of the cooperative agreement.

C. Budget and Project Period

    The length of support is 3 years and the applicants must apply for 
3 years of currently projected funding. The applicants must provide 3 
years worth of budgets and program objectives. The initial competitive 
review and award process will provide all awardees with 1 year of 
funding. The second year and third years of funding of noncompetitive 
continuation of support will depend on performance during the preceding 
year and availability of Federal funds. Cooperative agreements will be 
awarded up to $500,000 in total (direct plus indirect) costs per year 
for up to 3 years and can be modified, depending on the availability of 
funds and review of prior year's accomplishments.

IV. Eligible Institutions/Organizations

    This cooperative agreement program is only available to State food 
safety agencies and their manufactured food regulatory programs that 
currently have an FDA food safety inspection contract. All cooperative 
agreement prototype projects that are developed at State agency level 
must have existing food safety inspection and surveillance programs 
under contract to FDA for food safety inspections.

V. Applications

A. Number of Applicants:

    Applicants may submit more than one application, provided they are 
scientifically distinct. Resubmission applications are not permitted in 
response to this Funding Opportunity Announcement (FOA). Renewal 
applications are not permitted in response to this FOA.

B. Application Materials:

    The PHS 424/5161-1 application instructions are available at http://www.hhs.gov/forms/PHS-5161-1.pdf. Applicants must use the currently 
approved version of the PHS424. For further assistance contact 
GrantsInfo, Telephone: 301-435-0714, Email: [email protected].
    Telecommunications for the hearing impaired: TTY 301-451-0088. See 
Section IV.1 in the full text of the RFA available at http://www.grants.gov and the FDA/ORA Website for application materials: 
http://web.ora.fda.gov/dfsr/detail.jsp?id=66.
    The title and number of this funding opportunity must be included 
on the face page of the application.
    The applicant will be judged on, and must specifically address, the 
following in the cooperative agreement application:
    1. Program goals as stated in the RFA
    2. Demonstrate the availability of adequately trained food program 
staff including field staff, supervisory staff and support staff and 
the criteria to hire and/or train personnel to conduct food program 
activities including assessment and implementation.

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    3. Demonstrate the availability of adequately trained personnel to 
support the activities required under this cooperative agreement and 
agency commitment and support for this project including the 
development of the RRT.
    4. Provide a detailed description of the current food regulatory 
program including types of inspections performed, and types and numbers 
of food establishments in the State inventory. Provide an indication of 
how many of each of these facilities would be covered each year under 
this agreement.
    5. Provide a properly detailed budget (one for each of 3 years) 
that is intended to develop the RRT and enhance the food protection 
program in the State. Included will be the previous and current years 
State funding for the program including program staffing and costs.
    6. Demonstrate the ability to satisfy the reporting requirements 
outlined in section VI.3.A of the full RFA notice.
    7. Provide current funding level certification for their food 
safety program from State funding appropriations.
    8. Outline detailed methodology for program assessment improvement 
or program development to accomplish the work.
    9. Provide justification for hiring new staff, hiring 
qualifications, their training needs and any new equipment.
    10. It is noted that the grantee should provide a clearly detailed 
description on how the State food program will follow procedures for 
notifying FDA of violative facilities for enforcement under FDA 
jurisdiction.

C. Dates

    The application receipt date is August 15, 2008.

VI. Agency Contacts:

    We encourage your inquiries concerning this funding opportunity and 
welcome the opportunity to answer questions from potential applicants. 
Inquiries may fall into two areas: Scientific/research, and financial 
or grants management issues:

A. Scientific/Research Contacts

    Jennifer Gabb, Project Officer, Division of Federal-State Relations 
(HFC-150), Office of Regulatory Affairs, Food and Drug Administration, 
5600 Fishers Lane, rm. 12-07, Rockville, MD 20857, telephone: 301-827-
2899, e-mail: [email protected] or access the Internet at 
http://www.fda.gov/ora/fedState/default.htm.

B. Financial or Grants Management Contacts

    Gladys M. Bohler, Grants Management Specialist, Division of 
Acquisition Support and Grants, Food and Drug Administration, 5630 
Fishers Lane, rm. 2105, Rockville, MD 20857,telephone: 301-827-7168, e-
mail: [email protected].

    Dated: June 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14735 Filed 6-27-08; 8:45 am]
BILLING CODE 4160-01-S