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, 36878-36880 [E8-14735]
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Federal Register / Vol. 73, No. 126 / Monday, June 30, 2008 / Notices
C. Other Information
Awardees will be required to submit
the Non-Competing Continuation Grant
Progress Report (PHS 2590) annually
and financial statements, as required in
the HHS GPS.
Dated: June 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–14749 Filed 6–27–08; 8:45 am]
BILLING CODE 4160–01–S
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
jlentini on PROD1PC65 with NOTICES
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
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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 foodrelated 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
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Fmt 4703
Sfmt 4703
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
E:\FR\FM\30JNN1.SGM
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Federal Register / Vol. 73, No. 126 / Monday, June 30, 2008 / Notices
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.
jlentini on PROD1PC65 with NOTICES
II. Authority and Regulations
This request for applications (RFA) is
subject to intergovernmental review
E.O. 12372. See https://
www.whitehouse.gov/omb/grants/
spoc.html. This program is described in
the Catalog of Federal Domestic
Assistance (93.103) at https://
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 https://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 https://
www.grants.gov and/or https://
web.ora.fda.gov/dfsr/detail.jsp?id=66.
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.
VerDate Aug<31>2005
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Jkt 214001
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
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36879
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 https://
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 https://www.grants.gov and
the FDA/ORA Website for application
materials: https://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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Federal Register / Vol. 73, No. 126 / Monday, June 30, 2008 / Notices
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:
jlentini on PROD1PC65 with NOTICES
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, email: Jennifer.gabb@fda.hhs.gov or
access the Internet at https://
www.fda.gov/ora/fedState/default.htm.
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Jkt 214001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0352]
Prescription Drug User Fee Act IV
Information Technology Plan
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the information
technology (IT) Plan entitled
‘‘Prescription Drug User Fee Act
(PDUFA) IV Information Technology
Plan’’ to achieve the objectives defined
in the PDUFA Performance Goals. This
plan is intended to provide regulated
industry and other stakeholders with
information on FDA’s vision and plan
for improving the automation of
business processes and maintaining
information systems that support the
review process of human drug
applications.
Submit written or electronic
comments on the plan at any time.
These comments will be considered as
the agency makes annual adjustments to
the plan each fiscal year.
ADDRESSES: Submit written requests for
single copies of the IT plan to the Office
of the Chief Information Officer (HFA–
080), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD
20857. Send one self-addressed
adhesive label to assist that office in
processing your requests. Submit
written comments on the IT plan to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments
to https://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the plan.
DATES:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Suzanne Mitri, Office of the Chief
Information Officer, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–255–6700.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
the IT plan entitled ‘‘Prescription Drug
User Fee Act (PDUFA) IV Information
Technology Plan.’’ This plan is intended
to provide regulated industry and other
stakeholders with information on FDA’s
vision and plan for improving the
automation of business processes and
maintaining information systems that
support the process for the review of
human drug applications to achieve the
objectives defined in section XIV,
Information Technology Goals, of the
PDUFA Performance Goals (https://
www.fda.gov/oc/pdufa4/
pdufa4goals.html).
On September 27, 2007, President
Bush signed into law the Food and Drug
Administration Amendments Act of
2007, which includes the
reauthorization and expansion of
PDUFA. The reauthorization of PDUFA
will significantly broaden and upgrade
the agency’s drug safety program,
increase resources for review of
television drug advertising, and
facilitate more efficient development of
safe and effective new medications for
the American public. The
reauthorization also includes IT Goals
that are divided into four subsections:
Objectives, Communications and
Technical Interactions, Standards and
IT Plan, and Metrics and Measures. In
addition, there are IT Goals associated
with the upgrade of the agency’s drug
safety program in section VIII,
Enhancement and Modernization of the
FDA Drug Safety System of the PDUFA
Performance Goals.
The objectives of the PDUFA IV IT
Goals are to move FDA towards the
long-term goal of an automated
standards-based information technology
environment for the exchange, review,
and management of information
supporting the process for the review of
human drug applications throughout the
product life cycle. As part of this
process, FDA has developed and will
periodically update the 5-year IT plan.
II. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
E:\FR\FM\30JNN1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 126 (Monday, June 30, 2008)]
[Notices]
[Pages 36878-36880]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14735]
-----------------------------------------------------------------------
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
[[Page 36879]]
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 https://www.whitehouse.gov/omb/grants/spoc.html.
This program is described in the Catalog of Federal Domestic Assistance
(93.103) at https://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
https://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 https://www.grants.gov and/or https://
web.ora.fda.gov/dfsr/detail.jsp?id=66.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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: 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 https://
www.grants.gov and the FDA/ORA Website for application materials:
https://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
https://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
