[Federal Register: June 30, 2008 (Volume 73, Number 126)]
[Notices]
[Page 36878-36880]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jn08-80]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.whitehouse.gov/omb/grants/spoc.html.
This program is described in the Catalog of Federal Domestic Assistance
(93.103) at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.grants.gov and/or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://web.ora.fda.gov/dfsr/detail.jsp?id=66.
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-0088. See
Section IV.1 in the full text of the RFA available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.grants.gov and the FDA/ORA Website for application materials:
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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.
[[Page 36880]]
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: Jennifer.gabb@fda.hhs.gov or access the Internet at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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: gladys.melendez@fda.hhs.gov.
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