[Federal Register Volume 73, Number 112 (Tuesday, June 10, 2008)]
[Notices]
[Pages 32715-32717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-13015]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Food Protection Task Force Conference
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of conference grant funding for meetings of State Food
Protection Task Forces. The original announcement of availability of
funding for State Food Safety Task Force Meetings, published in the
Federal Register June 25, 2004 (69 FR 35651) and February 4, 2005 (70
FR 6015) as revised on May 3, 2005 (70 FR 22889). This revised
announcement provides for a change in the name of the grant program to
align with the FDA Food Protection Plan and new policies that apply to
the State Food Protection Task Force Meetings conference Grant Program.
FDA anticipates providing approximately $160,000 in direct costs only
in support of this program in fiscal year (FY) 2008. It is anticipated
that 32 awards will be made for up to $5,000 per award.
FOR FURTHER INFORMATION CONTACT:
Regarding the administrative and financial management aspects of
this notice: Gladys M. Bohler, Grants Management Specialist at 301-827-
7168 or by e-mail at [email protected]
Regarding the programmatic aspects of this notice: Jennifer Gabb,
(DFSR), Office of Regulatory Affairs, FDA at 301-827-2899, e-mail:
[email protected] or access the Internet at: http://www.fda.gov/ora/fedlstate/default.htm.
Announcement Type: New limited competition Request for Applications
(RFA) (R13)
Request for Application Number: RFA-FD-08-06
Catalog of Federal Domestic Assistance Number(s): 93.103
Dates: The application receipt date is July 15, 2008.
Paper Applications will not be accepted. Applications may be
submitted on or after the opening date and must be successfully
received by Grants.gov no later than 5 p.m. local time (of the
applicant institution/organization) on the application submission/
receipt date(s). If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process
or not reviewed.
The required application, SF 424 (5161) can be completed and
submitted online. The package should be labeled, ``Response to RFA FD-
08-006.'' If you experience technical difficulties with your online
submission you should contact Gladys M. Bohler by telephone at 301-827-
7168 or by e-mail at [email protected].
Please visit Grants.gov to view the full version of this Request
for Applications. A full version of the RFA can also be found on the
Grants.gov Web site along with the application package. FDA urges
applicants to read the full version RFA in its entirety prior to
submitting application packets. A publishing of this announcement in
the Federal Register a copy of the full version RFA can also be
requested from the ORA and Grants Management contacts listed in the
following paragraphs.
Funding Opportunity Description
I. Background
The FDA's Office of Regulatory Affairs (ORA) is the inspection
component of the FDA and has 1,000 investigators and inspectors who
cover the approximately 95,000 FDA regulated businesses in the United
States and inspect more than 15,000 facilities a year. In addition to
the standard inspection program, FDA's investigators and inspectors
conduct special investigations, food inspection recall audits, and
perform consumer complaint inspections and sample collections.
In the past, FDA has relied on the States in assisting with the
previous duties through formal contracts, partnership agreements, and
other informal arrangements. The inspection demands on both the Agency
and the States are expected to increase. Accordingly, procedures need
to be reviewed and innovative changes made that will increase
effectiveness, efficiency, and conserve resources. Examples of support
include providing effective and efficient compliance of regulated
products and, providing high quality, science based work that maximizes
consumer protection.
II. Research Objectives
FDA views State based Food Protection Task Forces as an important
mechanism for providing food safety and food defense program
coordination, and information exchange within each State (``Food''
includes human food and animal feed and is defined in section 201 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 (f))). This
grant announcement is intended to encourage the development of a Task
Force within each State and to provide funding for Task Force meetings.
Conference grant funding is available to States that have an existing
Food Safety and Food Defense Task Force, as well as to States that are
in the process of developing a new Food Protection Task Force. State
Food Protection Task Force meetings should foster communication and
cooperation among State, local, and
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tribal food protection public health, agriculture, and regulatory
agencies.
Before submission of an application, the State shall designate one
public health or food safety agency to lead, coordinate, and host the
Food Protection and Food Security Task Force and its meetings. The
formation of Food Protection and Food Security Task Force meetings
shall not interfere with existing Federal-state advisory mechanisms.
III. Project Goals
The purpose of the Food Protection Task Force meetings is to foster
communication and cooperation and collaboration within the States among
State local and tribal food protection public health, agriculture and
regulatory agencies. (For the purposes of this document and to be
consistent with the FDA Food Protection Plan: Food means human food and
animal feeds as defined in 21 U.S.C. 321(f). The meetings should: (1)
Provide a forum for all the stakeholders of the food protection
system--regulatory agencies, academia, industry, consumers, State
legislators, Boards of Health and Agriculture and other interested
parties; (2) assist in adopting or implementing the Food Code and other
food protection regulations; and (3) promote the integration of an
efficient statewide food protection/defense system that maximizes the
protection of the public health through prevention, intervention and
response including the early detection and containment of foodborne
illness. Each Task Force shall develop its own guidelines for work,
consensus decision making, size and format, at its initial meeting.
FDA's Division of Federal State Relations (DFSR) will provide meeting
guidelines and organization documents as requested.
Conference grant funds will be awarded only for the direct costs.
Each Task Force shall develop its own guidelines for work, consensus
decision making, size, and format at its initial meeting. Federal
agency representatives may be invited to be nonmember liaisons or
advisors to the task force and its meetings. Conference grant funds may
not be used for Federal employees to travel to or participate in these
meetings.
The following are the allowable and unallowable costs:
Allowable costs include but are not limited to: (1) Salary (in
proportion to the time or effort spent directly on the conference/
meeting); (2) facility and necessary equipment rental; (3) in-state
travel and per diem or subsistence allowances; (4) supplies needed for
conduct of the meeting (only if received for use during the budget
period); (5) conference services; (6) publication costs; (7)
registration fees; and (8) speakers' fees.
Non-allowable costs include but are not limited to: (1) Travel or
expenses other than local mileage for local participants; (2)
organization dues; (3) travel or per diem costs for Federal employees;
(4) purchase of equipment; (5) transportation costs exceeding U.S.
carrier coach class fares; (6) visas; (7) passports; (8) entertainment;
(9) tips; (10) bar charges; (11) personal telephone calls; (12) laundry
charges; (13) honoraria or other payments for the purpose of conferring
distinction or communicating respect, esteem or admiration; (14)
patient care; (15) alterations or renovations; and (16) facilities and
administrative costs/indirect costs.
Please also refer to the DHHS Grants Policy Statement for
additional information regarding costs http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.
IV. Reporting Requirements
A Financial Status Report (FSR) and Mid-Year Progress Reports are
required no later than 90 days after the end of a budget period. The
Mid-Year Progress Report should contain a description of a specific
plan for the next meeting, as well as all criteria listed in the
previous paragraph.
Program monitoring of recipients will be conducted on an ongoing
basis and written reports will be reviewed and evaluated at least semi-
annually by the project officer. Project monitoring may also be in the
form of telephone conversations between the project officer/grants
management specialist and the principal investigator.
When multiple years are awarded, awardees will be required to
submit the PHS Non-Competing Grant Progress Report (PHS 2590) annually
(http://grants.nih.gov/grants/funding/2590/2590.htm).
The PHS 2590 must be submitted at least 2 months prior to the next
budget period start date and should include a report of the previous
meeting supported by the current grant, as well as a full description
of the next planned meeting.
A final Progress Report of the meeting(s) (or Conference
Proceedings), and FSR SF-269 are required within 90 days of the
expiration date of the project period. An original and two copies of
each report shall be submitted to FDA's Grants Management staff
contact. The report of the meeting should include: (1) The grant
number; (2) the title, date and place of time of the meeting; (3) the
name of the person shown on the application as the conference director,
principal investigator, or program director; (4) the name of the
organization that conducted the meeting; (5) a list of individuals and
their institutional affiliations who participated as speakers or
facilitators in the formally planed sessions of the meeting; and, (6) a
summary of topics discussed, next steps and conclusions.
V. Mechanism of Support
A. Award Instrument
This funding opportunity will use the Conference/Scientific Meeting
(R13) grant award mechanism. Under the R13 mechanism, the applicant
will be solely responsible for planning, directing, and executing the
proposed project. Multiple year awards may be awarded to one
permanently sponsoring organization for conferences held annually or
biennially on a recurring topic. The total project period for an
application requesting support may not exceed 5 years.
This funding opportunity uses just-in-time budget concepts. It also
uses the non-modular budget format. Applicants must complete and submit
a detailed categorical budget in the SF424 application.
Meetings covered by this notice will be supported under section
1701-1706 of the Public Service (PHS) Act (42 U.S.C. 300u-300u-5).
FDA's Task Force Conference Grant program is described in the Catalog
of Federal Domestic Assistance No. 93-103. These grants will be subject
to all policies and requirements that govern the Conference Grant
Programs of the PHS, including the provisions of 42 CFR part 52 and 45
CFR parts 74 and 92. The regulations issued under Executive Order 12372
also apply to this program and are implemented through the Department
of Health and Human Service's regulations at 45 CFR part 100. Executive
Order 12372 sets up a system for State and local government review of
applications for Federal financial assistance.
B. Eligibility
These grants are available to State public health, agriculture and
food protection agencies that have an existing Food Safety and Food
Defense Task Force, as well as to States that are in the process of
developing a new Food Protection Task Force. Only one grant will be
awarded per State per year. States are urged to collaborate between
agencies to submit a single application.
C. Length of Support
It is anticipated that FDA will fund these grants at a level
requested but not
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exceeding $5,000 total direct costs only for the first year. An
additional 4 years of support, up to $5,000 (direct costs only) each
year may be available, depending upon fiscal year appropriations and
successful performance of the conference.
D. Funding Plan
Continued funding for future year, noncompetitive segments, will be
contingent upon satisfactory progress as determined annually by the
FDA, the receipt of a PHS 2590 application, the approval of yearly task
force reports, and the availability of Federal funds. An estimated
amount of $160,000 is available in FY 2008. The number of grants funded
will depend on the quality of the applications received, their
relevance to FDA's mission, priorities, and the availability of funds.
VI. Review Procedure and Criteria
All applications submitted in response to this request for
applications (RFA) will first be reviewed for responsiveness by grants
management and program staff. Responsiveness is defined as submission
of a complete on or before the required submission date as listed in
the previous paragraphs. If applications are found to be nonresponsive,
they will be returned to the applicant without further consideration.
Responsive applications will be reviewed and evaluated for
scientific and technical merit by an ad hoc panel of experts. The
following will be considered in making funding decisions: (1)
Scientific merit of the proposed conference/scientific meeting as
determined by the evaluation process; (2) availability of funds; and
(3) relevance of program priorities. Final funding decisions will be
made by the Commissioner of Food and Drugs or his or her designee.
Applicants are strongly encouraged to contact FDA Program staff to
resolve any questions regarding criteria before the submission of their
application.
VII. Submission Requirements
FDA is accepting new applications for this program electronically
via www.grants.gov. To download the SF424 (5161) Application forms for
this Funding Opportunity Announcement (FOA) link to http://www.grants.gov/Apply and follow the directions provided on that site. A
one-time registration is required for institutions at: Grants.gov
(http://www.grants.gov/GetStarted). The application receipt date is
July 15, 2008.
Your organization will need to obtain a Data Universal Number
System (DUNS) number as part of the Grants.gov registration process.
The DUNS number is a 9-digit identification number, which uniquely
identifies business entities. Obtaining a DUNS number is easy and there
is no charge. The D&B number can be obtained by calling 866-705-5711 or
through the Web site at http://www.dnb.com/us.
The applicant must also register in the Central Contractor
Registration (CCR) database in order to be able to submit the
application. Information about the CCR is available at http://www.grants.gov/applicants/get_registered.jsp.
VIII. Method of Application
A. Submission Instructions
The SF424 (5161) application has several components. Some
components are required, others are optional. The forms package
associated with this FOA in Grants.gov/APPLY includes all applicable
components, required, and optional.
B. Format for Application
A completed application in response to this FOA includes the data
in the following components:
The face page of the application should indicate ``Response to Food
Protection Task Force Conference Grant Program RFA FD 08-006''.
Applications should include the following: (1) A title which has
the term ``state food protection task force meetings'', ``conference'',
``council'', ``workshop'', ``alliance'' or other similar description to
assist in the identification of the request; (2) location of the
conference; (3) expected number of registrants and type of audience
expected with their credentials; (4) dates of conference(s); (5)
conference format and projected agenda(s), including list of principal
areas or topics to be addressed; (6) physical facilities required for
the conduct of the meeting; (7) justification of the conference(s),
including the problems it intends to clarify and any developments it
may stimulate; (8) brief biographical sketches of individuals
responsible for planning the conference(s) and details concerning
adequate support staff; (9) information about all related conferences
held on this subject during the last 3 years (if available); (10)
details of proposed per diem/subsistence rates, transportation,
printing, supplies and facility rental costs; and (11) the necessary
checklist and assurances pages provided in each application package.
IX. Freedom of Information
Data included in the application which have been specifically
identified by the applicant as containing restricted and/or proprietary
information may be entitled to confidential treatment as trade secret
or confidential commercial information within the meaning of the
Freedom of Information Act, (5 U.S.C. 552(b)(4), and FDA's implementing
regulations (21 CFR 20.61).
Dated: June 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-13015 Filed 6-9-08; 8:45 am]
BILLING CODE 4160-01-S