Cooperative Agreement to Establish and Support the Western Center for Food Safety (U01), 36875-36878 [E8-14749]
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Federal Register / Vol. 73, No. 126 / Monday, June 30, 2008 / Notices
the agreement and proposed order or to
modify in any way their terms.
By direction of the Commission.
Richard C. Donohue
Acting Secretary
[FR Doc. E8–14663 Filed 6–27–08: 8:45 am]
BILLING CODE 6750–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Meeting of the National Advisory
Council for Healthcare Research and
Quality
Agency for Healthcare Research
and Quality (AHRQ).
ACTION: Notice of public meeting.
AGENCY:
jlentini on PROD1PC65 with NOTICES
SUMMARY: In accordance with section
10(a) of the Federal Advisory Committee
Act, 5 U.S.C. app. 2 10(a), this notice
announces a meeting of the National
Advisory Council for Healthcare
Research and Quality.
DATES: The meeting will be held on
Friday, July 25, 2008, from 9 a.m. to 3
p.m.
ADDRESSES: The meeting will be held at
the Eisenberg Conference Center,
Agency for Healthcare Research and
Quality, 540 Gaither Road, Rockville,
Maryland 20850.
FOR FURTHER INFORMATION CONTACT:
Deborah Queenan, Coordinator of the
Advisory Council, at the Agency for
Healthcare Research and Quality, 540
Gaither Road, Rockville, Maryland
20850, (301) 427–1330. For press-related
information, please contact Karen
Migdail at (301) 427–1855.
If sign language interpretation or other
reasonable accommodation for a
disability is needed, please contact Mr.
Donald L. Inniss, Director, Office of
Equal Employment Opportunity
Program, Program Support Center, on
(301) 443–1144, no later than July 11,
2008. The agenda, roster, and minutes
are available from Ms. Bonnie Campbell,
Committee Management Officer, Agency
for Healthcare Research and Quality,
540 Gaither Road, Rockville, Maryland
20850. Ms. Campbell’s phone number is
(301) 427–1554.
SUPPLEMENTARY INFORMATION:
I. Purpose
The National Advisory Council for
Healthcare Research and Quality was
established in accordance with section
921 (now section 931) of the Public
Health Service Act (42 U.S.C. 299c). In
accordance with its statutory mandate,
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18:02 Jun 27, 2008
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the Council is to advise the Secretary of
the Department of Health and Human
Services and the Director, Agency for
Healthcare Research and Quality
(AHRQ), on matters related to actions of
AHRQ to enhance the quality, improve
the outcomes, and reduce the costs of
health care services; improve access to
such services through scientific
research; and promote improvements in
clinical practice and in the organization,
financing, and delivery of health care
services.
The Council is composed of members
of the public, appointed by the
Secretary, and Federal ex-officio
members.
II. Agenda
On Friday, July 25, the Council
meeting will convene at 9 a.m., with the
call to order by the Council Chair and
approval of previous Council minutes.
The AHRQ director will present her
update on current research, programs,
and initiatives. The agenda will include
a presentation on the National
Healthcare Quality and Disparities
Reports and a discussion on Employer
Engagement in healthcare. The final
agenda will be available on the AHRQ
Web site at https://www.ahrq.gov no later
than July 21, 2008.
Dated: June 18, 2008.
Carolyn M. Clancy,
Director.
[FR Doc. E8–14565 Filed 6–27–08; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0360]
Cooperative Agreement to Establish
and Support the Western Center for
Food Safety (U01)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
Request for Application (RFA) Number
RFA–FD–08–004 and its intention to
receive and consider a new sole source
application for the award of a
cooperative agreement in fiscal year
2008 (FY 2008) to establish and support
the Western Center for Food Safety
(WCFS). The WCFS will be located at
the Western Institute for Food Safety
and Security (WIFSS) on the University
of California, Davis (UCD) campus in
Davis, CA.
FOR FURTHER INFORMATION CONTACT:
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36875
Scientific/Programmatic Contact:
Steven Gendel, Center for Food
Safety and Applied Nutrition (HFS–
006), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740,
301–436–2290, e-mail:
steven.gendel@fda.hhs.gov.
Financial or Grants Management
Contact: Gladys M. Bohler, Division
of Acquisition Support and Grants
(HFA–500), Food and Drug
Administration, 5630 Fishers Lane,
rm. 2105, Rockville, MD 20857,
301–827–7168, FAX: 301–827–
7101, e-mail: gladys.melendezbohler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
A. Background
FDA intends to establish a
cooperative agreement to create the
WCFS to address these issues through
the development of approaches and data
critical to understanding the risks
associated with the interface between
production agriculture and food
protection. Such knowledge is critical to
the development of scientifically
validated ‘‘best practices’’ for mitigating
those risks at the production (versus
processing) level. In establishing this
cooperative agreement, FDA recognizes
the importance of agricultural practices
in the Western states, an increasingly
important food producing region for
fruits, vegetables, specialty crops, and
dairy products; and a key point of entry
for imported foods. The development of
an integrated collaborative food
protection research/education/outreach
program in this region will benefit both
consumers and producers nationwide.
B. Program Research Goals
A proposal is being solicited to
establish and operate a collaborative
center that is designed to meet the
objectives of the RFA. The proposal
should include information on both the
structure and administration of the
center and the approaches that will be
used to establish robust and sustainable
regional, national, and international
research and outreach collaborations
(including collaborations with the
agency’s other Centers of Excellence;
other Centers at UCD, such as the Center
for Produce Safety; and other
components of the University of
California system), as well as strategies
for cultivating additional base support
for the center.
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Federal Register / Vol. 73, No. 126 / Monday, June 30, 2008 / Notices
1. Concept
FDA faces an increasing number of
critical and complex food protection
and public health challenges. FDA
believes that these challenges can be
addressed most efficiently by expanding
the available science base through
collaborative partnerships. Collaborative
partnerships stimulate the integration of
applied research, education, and
outreach programs to enhance food
protection and public health and
address new and emerging issues.
Collaborative partnerships provide
opportunities to leverage resources and
to stimulate interest among academics
in solving pressing national food
protection challenges. Accordingly,
access to scientists and facilities
associated with agriculture within the
Western United States increases FDA’s
understanding of the unique challenges
and practices that must be considered
when developing risk management
measures that are pertinent to
agricultural production in this region.
2. Project Emphasis
The collaborative partnership with
WCFS will focus on the interface
between food protection and the
agricultural production of commodities
such as produce and dairy foods. This
will include studies in areas such as
pre- and post-harvest practices and
environmental contamination (both
from point sources and from distributed
sources, e.g., perchlorate in ground
water) for both domestic and imported
commodities. WCFS will address ‘‘realworld’’ problems (such as the
development of technologies and
practices for food safety-related
sampling of fresh produce or the impact
of field practices on subsequent
processing) and develop knowledge
leading to practical solutions and
approaches that are both feasible and
protective of public health. WCFS will
also generate and analyze data needed
to provide a scientific basis for
optimizing the interactions between
potentially competing national
concerns, e.g., safety of food production
environments versus the protection of
wildlife habitats in agricultural
communities. The education and
outreach components of the partnership
will ensure that this knowledge is
available for, and useful to, all
stakeholders.
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3. Summary of Objectives
The cooperative research, education,
and outreach programs developed
through the WCFS will address
scientific issues related to the interface
between food protection and agriculture
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for commodities such as produce, dairy
foods, and seafood. These programs will
include partnerships with academia,
industry, non-governmental
organizations, and international
organizations. These partnerships will
also promote and sustain collaborative
domestic and international outreach and
education.
The objectives of this cooperative
agreement are to:
1. Carry out multidisciplinary applied
research projects that address ‘‘real
world’’ issues related to food protection,
agricultural practices, and the impact of
agricultural practices on subsequent
food processing associated with FDAregulated products;
2. Develop and implement outreach
and communication programs with
stakeholders to identify research needs
and to facilitate utilization of the
knowledge produced by the research
program; and
3. Develop and implement education
programs that address food protection
problems and increase awareness of the
role of science in food protection.
D. Delineation of Substantive
Involvement
A cooperative agreement involves
substantial FDA programmatic
involvement with the awardees is
anticipated during the performance of
the activities. Under the cooperative
agreement, FDA’s purpose is to support
and stimulate the recipients’ activities
by involvement in and otherwise
working jointly with the award
recipients in a partnership role; it is not
to assume direction, prime
responsibility, or a dominant role in the
activities. Consistent with this concept,
the dominant role and prime
responsibility resides with the awardees
for the project as a whole, although
specific tasks and activities may be
shared among the awardees and FDA.
Additional information on the role and
responsibility of the grantee and FDA
can be found in the full text
announcement of the FOA posted on
FDA’s Center for Food Safety and
Applied Nutrition (CFSAN) Web site:
https://www.cfsan.fda.gov/list.html.
II. Award Information
A. Eligible Institutions/Organizations
Competition is limited to the
University of California. FDA believes
that establishing the WCFS at WIFSS is
appropriate because WIFSS is uniquely
qualified to fulfill the objectives of the
proposed cooperative agreement. It is an
established partnership between
academia, state and Federal agencies,
and private industry focused on
enhancing food protection using a
variety of approaches that include basic
and applied research; communication
and connectivity with public and
private partners; outreach programs that
extend from farm to fork; and modern
information management. WIFSS’s
location at the UCD facilitates
interaction with numerous Centers and
Departments within the School of
Veterinary Medicine, School of
Medicine, College of Agricultural and
Environmental Sciences, and College of
Engineering. The existing administrative
structure at WIFSS can be readily
leveraged for developing new food
protection programs and fostering new
partnerships. Existing collaborations
with agricultural producers will
promote the conduct of on-farm, pre-,
and post-harvest food protection
research. Such field-scale research is
critical both for understanding how
agricultural practice impacts food safety
and for ensuring that new technologies
are practical and effective.
Collaboration between the public and
the private sectors has proven to be an
efficient means for both FDA and
A. Award Instrument/Mechanism of
Support
This Funding Opportunity
Announcement (FOA) will use the
cooperative agreement award
mechanism (U01). Support will be in
the form of a cooperative agreement.
Accordingly, FDA will have substantial
involvement in the program activities of
the project. FDA will support the
collaboration covered by this notice
under the authority of section 301 of the
Public Health Service (PHS) Act (42
U.S.C. 241).
B. Award Amount and Length of
Support
The estimated amount of support in
FY 2008 will be for up to $1.5 million
(direct plus indirect costs), with the
possibility of 4 additional years of
support for up to $2.6 million, subject
to the availability of funds. This award
will improve public health by creating
an applied research, education, and
outreach program related to the
interface between food protection (i.e.,
food safety and food defense) and
agriculture.
C. Funding Plan
The estimated amount of support in
FY 2008 will be for up to $1.5 million
(direct plus indirect costs), with the
possibility of 4 additional years of
support for up to $2.6 million, subject
to the availability of funds.
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III. Eligibility Information
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Federal Register / Vol. 73, No. 126 / Monday, June 30, 2008 / Notices
academia to remain current with
scientific and technical advances
associated with FDA-regulated products
(e.g., foods, animal drugs and feed
additives). The degree to which FDA
nurtures, develops, and builds on these
collaborations directly affects FDA’s
ability to enhance public health. The
information and expertise that will be
obtained through this partnership
between FDA and WIFSS can be
leveraged by all segments of the food
protection and nutrition community, as
well as by public health organizations,
other Federal agencies, and academic
institutions in the performance of their
roles.
B. Cost Sharing
This cooperative agreement program
requires that the applicant substantially
share in the project costs if an award is
made, including, but not limited to,
partial salary support for administrative
staff and in-kind support (e.g., faculty
salaries and facilities costs).
IV. Application and Submission
A. Form and Content of Applications
Applications must be prepared using
the most current PHS 398 research grant
application instructions and forms.
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 https://www.dnb.com/us/.1
The DUNS number should be entered
on line 11 of the face page of the PHS
398 form.
The PHS 398 application instructions
are available at https://grants.nih.gov/
grants/funding/phs398/phs398.html in
an interactive format. Applicants must
use the currently approved version of
the PHS 398. For further assistance,
contact Gladys M. Bohler, 301–827–
7168, e-mail: gladys.melendezbohler@fda.hhs.gov. Hearing Impaired—
Telecommunications for the hearing
impaired are available at: TTY 301–451–
0088.
jlentini on PROD1PC65 with NOTICES
B. Address to Submit Application
Applications must be prepared using
the forms found in the PHS 398
instructions for preparing a nonmodular research grant application.
Submit a signed, typewritten original of
the paper application, including the
1 (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.)
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16:15 Jun 27, 2008
Jkt 214001
checklist, three signed photocopies, and
appendix material in one package to:
Gladys M. Bohler, Grants Management
Specialist, Division of Acquisition
Support and Grants (HFA–500), Food
and Drug Administration, 5630 Fishers
Lane, rm. 2105, Rockville, MD 20857,
301–827–7168, e-mail: gladys.melendezbohler@fda.hhs.
C. Key Dates
The application is due within 30 days
after publication of the Funding
Opportunity Announcement in the
Federal Register. On-time submission
requires that the application be
successfully submitted to https://
www.grants.gov no later than 5 p.m.
local time (of the applicant institution/
organization).
D. Other Submission Requirements
The total project period for an
application submitted in response to
this funding opportunity may not
exceed 5 years.
Applicant may submit only one
application. Resubmission applications
are not permitted in response to this
FOA. Renewal applications are not
permitted in response to this FOA.
Consent forms, assent forms, and any
other information given to a subject are
part of the grant application and must
be provided, even if in a draft form. The
applicant is referred to the Department
of Health and Human Services (HHS)
regulations at 45 CFR 46.116 and 21
CFR 50.25 for details.
Awardee(s) must agree to the
‘‘Cooperative Agreement Terms and
Conditions of Award’’ in section VI.2.A.
of the full text of the FOA posted on the
CFSAN Web site: (https://
www.cfsan.fda.gov).
V. Application Review
Applications that are complete and
responsive to the FOA will be evaluated
for scientific and technical merit by an
appropriate peer review group convened
by FDA, CFSAN, and in accordance
with FDA peer review procedures, using
the review criteria stated in the
following paragraph.
As part of the scientific peer review,
a responsive complete application will:
(1) Undergo a review process to
determine their scientific and technical
merit; (2) be assigned a priority score;
(3) receive a written critique; and (4)
receive a second level of review by the
National Institutes of Health, National
Cancer Institute National Cancer
Advisory Board.
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36877
VI. Award Administrative Information
A. Reporting
Substantive involvement by the
awarding agency is inherent in the
cooperative agreement award.
Accordingly, FDA will have substantial
involvement in the program funded by
the cooperative agreement. Substantive
involvement includes, but is not limited
to, the following:
1. FDA will have prior approval of the
appointment of all key administrative
and scientific personnel proposed by
the grantee.
2. FDA will be directly involved in
the guidance and development of the
program.
3. FDA scientists will participate,
with the grantee, in determining and
carrying out scientific and technical
activities. Collaboration will also
include data analysis, interpretation of
findings and, where appropriate, coauthorship of publications.
4. The original and two copies of the
annual Financial Status Report (FSR)
(SF–269) must be sent to FDA’s Grants
Management Specialist within 90 days
of each budget period end date.
5. A final progress report, invention
statement, and Financial Status Report
are required when an award is
relinquished when a recipient changes
institutions or when an award is
terminated and/or at the end of the
project period.
B. Administrative Requirements
This agreement will be subject to all
policies and requirements that govern
the research grant programs of the PHS,
including provisions of 42 CFR part 52
and 45 CFR Parts 74 and 92. All grants
are subject to the terms and conditions,
cost principles, and other
considerations described in the HHS
Grants Policy Statement (GPS), dated
January 2007, which supersedes in its
entirety the PHS GPS, dated April 1,
1994, and addendum dated January 24,
1995.
An award is subject to the
requirements of the HHS GPS that are
applicable based on the recipient type
and the purpose of this award. This
includes any requirements in Parts I and
II of the HHS GPS (available at https://
www.hhs.gov/grantsnet/adminis/gpd/
index.htm) that apply to an award.
Although consistent with the HHS
GPS, any applicable statutory or
regulatory requirements, including 45
CFR parts 74 or 92, directly apply to this
award apart from any coverage in the
HHS GPS.
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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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16:15 Jun 27, 2008
Jkt 214001
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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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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Agencies
[Federal Register Volume 73, Number 126 (Monday, June 30, 2008)]
[Notices]
[Pages 36875-36878]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14749]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0360]
Cooperative Agreement to Establish and Support the Western Center
for Food Safety (U01)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a Request
for Application (RFA) Number RFA-FD-08-004 and its intention to receive
and consider a new sole source application for the award of a
cooperative agreement in fiscal year 2008 (FY 2008) to establish and
support the Western Center for Food Safety (WCFS). The WCFS will be
located at the Western Institute for Food Safety and Security (WIFSS)
on the University of California, Davis (UCD) campus in Davis, CA.
FOR FURTHER INFORMATION CONTACT:
Scientific/Programmatic Contact: Steven Gendel, Center for Food
Safety and Applied Nutrition (HFS-006), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2290, e-mail:
steven.gendel@fda.hhs.gov.
Financial or Grants Management Contact: Gladys M. Bohler, Division
of Acquisition Support and Grants (HFA-500), Food and Drug
Administration, 5630 Fishers Lane, rm. 2105, Rockville, MD 20857, 301-
827-7168, FAX: 301-827-7101, e-mail: gladys.melendez-
bohler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
A. Background
FDA intends to establish a cooperative agreement to create the WCFS
to address these issues through the development of approaches and data
critical to understanding the risks associated with the interface
between production agriculture and food protection. Such knowledge is
critical to the development of scientifically validated ``best
practices'' for mitigating those risks at the production (versus
processing) level. In establishing this cooperative agreement, FDA
recognizes the importance of agricultural practices in the Western
states, an increasingly important food producing region for fruits,
vegetables, specialty crops, and dairy products; and a key point of
entry for imported foods. The development of an integrated
collaborative food protection research/education/outreach program in
this region will benefit both consumers and producers nationwide.
B. Program Research Goals
A proposal is being solicited to establish and operate a
collaborative center that is designed to meet the objectives of the
RFA. The proposal should include information on both the structure and
administration of the center and the approaches that will be used to
establish robust and sustainable regional, national, and international
research and outreach collaborations (including collaborations with the
agency's other Centers of Excellence; other Centers at UCD, such as the
Center for Produce Safety; and other components of the University of
California system), as well as strategies for cultivating additional
base support for the center.
[[Page 36876]]
1. Concept
FDA faces an increasing number of critical and complex food
protection and public health challenges. FDA believes that these
challenges can be addressed most efficiently by expanding the available
science base through collaborative partnerships. Collaborative
partnerships stimulate the integration of applied research, education,
and outreach programs to enhance food protection and public health and
address new and emerging issues. Collaborative partnerships provide
opportunities to leverage resources and to stimulate interest among
academics in solving pressing national food protection challenges.
Accordingly, access to scientists and facilities associated with
agriculture within the Western United States increases FDA's
understanding of the unique challenges and practices that must be
considered when developing risk management measures that are pertinent
to agricultural production in this region.
2. Project Emphasis
The collaborative partnership with WCFS will focus on the interface
between food protection and the agricultural production of commodities
such as produce and dairy foods. This will include studies in areas
such as pre- and post-harvest practices and environmental contamination
(both from point sources and from distributed sources, e.g.,
perchlorate in ground water) for both domestic and imported
commodities. WCFS will address ``real-world'' problems (such as the
development of technologies and practices for food safety-related
sampling of fresh produce or the impact of field practices on
subsequent processing) and develop knowledge leading to practical
solutions and approaches that are both feasible and protective of
public health. WCFS will also generate and analyze data needed to
provide a scientific basis for optimizing the interactions between
potentially competing national concerns, e.g., safety of food
production environments versus the protection of wildlife habitats in
agricultural communities. The education and outreach components of the
partnership will ensure that this knowledge is available for, and
useful to, all stakeholders.
3. Summary of Objectives
The cooperative research, education, and outreach programs
developed through the WCFS will address scientific issues related to
the interface between food protection and agriculture for commodities
such as produce, dairy foods, and seafood. These programs will include
partnerships with academia, industry, non-governmental organizations,
and international organizations. These partnerships will also promote
and sustain collaborative domestic and international outreach and
education.
The objectives of this cooperative agreement are to:
1. Carry out multidisciplinary applied research projects that
address ``real world'' issues related to food protection, agricultural
practices, and the impact of agricultural practices on subsequent food
processing associated with FDA-regulated products;
2. Develop and implement outreach and communication programs with
stakeholders to identify research needs and to facilitate utilization
of the knowledge produced by the research program; and
3. Develop and implement education programs that address food
protection problems and increase awareness of the role of science in
food protection.
II. Award Information
A. Award Instrument/Mechanism of Support
This Funding Opportunity Announcement (FOA) will use the
cooperative agreement award mechanism (U01). Support will be in the
form of a cooperative agreement. Accordingly, FDA will have substantial
involvement in the program activities of the project. FDA will support
the collaboration covered by this notice under the authority of section
301 of the Public Health Service (PHS) Act (42 U.S.C. 241).
B. Award Amount and Length of Support
The estimated amount of support in FY 2008 will be for up to $1.5
million (direct plus indirect costs), with the possibility of 4
additional years of support for up to $2.6 million, subject to the
availability of funds. This award will improve public health by
creating an applied research, education, and outreach program related
to the interface between food protection (i.e., food safety and food
defense) and agriculture.
C. Funding Plan
The estimated amount of support in FY 2008 will be for up to $1.5
million (direct plus indirect costs), with the possibility of 4
additional years of support for up to $2.6 million, subject to the
availability of funds.
D. Delineation of Substantive Involvement
A cooperative agreement involves substantial FDA programmatic
involvement with the awardees is anticipated during the performance of
the activities. Under the cooperative agreement, FDA's purpose is to
support and stimulate the recipients' activities by involvement in and
otherwise working jointly with the award recipients in a partnership
role; it is not to assume direction, prime responsibility, or a
dominant role in the activities. Consistent with this concept, the
dominant role and prime responsibility resides with the awardees for
the project as a whole, although specific tasks and activities may be
shared among the awardees and FDA. Additional information on the role
and responsibility of the grantee and FDA can be found in the full text
announcement of the FOA posted on FDA's Center for Food Safety and
Applied Nutrition (CFSAN) Web site: https://www.cfsan.fda.gov/list.html.
III. Eligibility Information
A. Eligible Institutions/Organizations
Competition is limited to the University of California. FDA
believes that establishing the WCFS at WIFSS is appropriate because
WIFSS is uniquely qualified to fulfill the objectives of the proposed
cooperative agreement. It is an established partnership between
academia, state and Federal agencies, and private industry focused on
enhancing food protection using a variety of approaches that include
basic and applied research; communication and connectivity with public
and private partners; outreach programs that extend from farm to fork;
and modern information management. WIFSS's location at the UCD
facilitates interaction with numerous Centers and Departments within
the School of Veterinary Medicine, School of Medicine, College of
Agricultural and Environmental Sciences, and College of Engineering.
The existing administrative structure at WIFSS can be readily leveraged
for developing new food protection programs and fostering new
partnerships. Existing collaborations with agricultural producers will
promote the conduct of on-farm, pre-, and post-harvest food protection
research. Such field-scale research is critical both for understanding
how agricultural practice impacts food safety and for ensuring that new
technologies are practical and effective.
Collaboration between the public and the private sectors has proven
to be an efficient means for both FDA and
[[Page 36877]]
academia to remain current with scientific and technical advances
associated with FDA-regulated products (e.g., foods, animal drugs and
feed additives). The degree to which FDA nurtures, develops, and builds
on these collaborations directly affects FDA's ability to enhance
public health. The information and expertise that will be obtained
through this partnership between FDA and WIFSS can be leveraged by all
segments of the food protection and nutrition community, as well as by
public health organizations, other Federal agencies, and academic
institutions in the performance of their roles.
B. Cost Sharing
This cooperative agreement program requires that the applicant
substantially share in the project costs if an award is made,
including, but not limited to, partial salary support for
administrative staff and in-kind support (e.g., faculty salaries and
facilities costs).
IV. Application and Submission
A. Form and Content of Applications
Applications must be prepared using the most current PHS 398
research grant application instructions and forms. 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 https://www.dnb.com/us/.\1\ The DUNS
number should be entered on line 11 of the face page of the PHS 398
form.
---------------------------------------------------------------------------
\1\ (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.)
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The PHS 398 application instructions are available at https://
grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. Applicants must use the currently approved version of the PHS
398. For further assistance, contact Gladys M. Bohler, 301-827-7168, e-
mail: gladys.melendez-bohler@fda.hhs.gov. Hearing Impaired--
Telecommunications for the hearing impaired are available at: TTY 301-
451-0088.
B. Address to Submit Application
Applications must be prepared using the forms found in the PHS 398
instructions for preparing a non-modular 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: Gladys M. Bohler, Grants Management
Specialist, Division of Acquisition Support and Grants (HFA-500), Food
and Drug Administration, 5630 Fishers Lane, rm. 2105, Rockville, MD
20857, 301-827-7168, e-mail: gladys.melendez-bohler@fda.hhs.
C. Key Dates
The application is due within 30 days after publication of the
Funding Opportunity Announcement in the Federal Register. On-time
submission requires that the application be successfully submitted to
https://www.grants.gov no later than 5 p.m. local time (of the applicant
institution/organization).
D. Other Submission Requirements
The total project period for an application submitted in response
to this funding opportunity may not exceed 5 years.
Applicant may submit only one application. Resubmission
applications are not permitted in response to this FOA. Renewal
applications are not permitted in response to this FOA.
Consent forms, assent forms, and any other information given to a
subject are part of the grant application and must be provided, even if
in a draft form. The applicant is referred to the Department of Health
and Human Services (HHS) regulations at 45 CFR 46.116 and 21 CFR 50.25
for details.
Awardee(s) must agree to the ``Cooperative Agreement Terms and
Conditions of Award'' in section VI.2.A. of the full text of the FOA
posted on the CFSAN Web site: (https://www.cfsan.fda.gov).
V. Application Review
Applications that are complete and responsive to the FOA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by FDA, CFSAN, and in accordance with FDA peer
review procedures, using the review criteria stated in the following
paragraph.
As part of the scientific peer review, a responsive complete
application will: (1) Undergo a review process to determine their
scientific and technical merit; (2) be assigned a priority score; (3)
receive a written critique; and (4) receive a second level of review by
the National Institutes of Health, National Cancer Institute National
Cancer Advisory Board.
VI. Award Administrative Information
A. Reporting
Substantive involvement by the awarding agency is inherent in the
cooperative agreement award. Accordingly, FDA will have substantial
involvement in the program funded by the cooperative agreement.
Substantive involvement includes, but is not limited to, the following:
1. FDA will have prior approval of the appointment of all key
administrative and scientific personnel proposed by the grantee.
2. FDA will be directly involved in the guidance and development of
the program.
3. FDA scientists will participate, with the grantee, in
determining and carrying out scientific and technical activities.
Collaboration will also include data analysis, interpretation of
findings and, where appropriate, co-authorship of publications.
4. The original and two copies of the annual Financial Status
Report (FSR) (SF-269) must be sent to FDA's Grants Management
Specialist within 90 days of each budget period end date.
5. A final progress report, invention statement, and Financial
Status Report are required when an award is relinquished when a
recipient changes institutions or when an award is terminated and/or at
the end of the project period.
B. Administrative Requirements
This agreement will be subject to all policies and requirements
that govern the research grant programs of the PHS, including
provisions of 42 CFR part 52 and 45 CFR Parts 74 and 92. All grants are
subject to the terms and conditions, cost principles, and other
considerations described in the HHS Grants Policy Statement (GPS),
dated January 2007, which supersedes in its entirety the PHS GPS, dated
April 1, 1994, and addendum dated January 24, 1995.
An award is subject to the requirements of the HHS GPS that are
applicable based on the recipient type and the purpose of this award.
This includes any requirements in Parts I and II of the HHS GPS
(available at https://www.hhs.gov/grantsnet/adminis/gpd/index.htm) that
apply to an award.
Although consistent with the HHS GPS, any applicable statutory or
regulatory requirements, including 45 CFR parts 74 or 92, directly
apply to this award apart from any coverage in the HHS GPS.
[[Page 36878]]
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