[Federal Register Volume 69, Number 122 (Friday, June 25, 2004)]
[Notices]
[Pages 35651-35654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-14395]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Conference Grants to Support State Food Safety Task Force 
Meetings; Availability of Funds Grants; Request for Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) in collaboration with 
the Centers for Disease Control and Prevention (CDC) is announcing the 
availability of conference grant funding for meetings of State Food 
Safety and Food Security Task Forces. The original announcement of 
availability of funding for State Food Safety Task Force Meetings, 
published in the Federal Register of January 24, 2000 (65 FR 3720), is 
superseded by this announcement. This revised announcement provides new 
policies that apply to the State Food Safety and Food Security Task 
Force Meetings Conference Grant Program. FDA views this program as an 
ongoing program announcement, contingent on the availability of funds. 
FDA anticipates providing approximately $350,000 in direct costs only 
in support of this program in fiscal year (FY) 2004. It is anticipated 
that 50 awards will be made for up to $7,000 per award.

DATES: The application receipt date is August 9, 2004, for the first 
year and March 15 for each subsequent year this program is in effect.

ADDRESSES: Application forms are available from, and completed 
applications should be submitted to Cynthia M. Polit, Grants Management 
Specialist, Division of Contracts and Grants Management (HFA-531), Food 
and Drug Administration, 5600 Fishers Lane, rm. 2129, Rockville, MD 
20857, 301-827-7180, e-mail: [email protected]. Application forms PHS 
5161-1 are available via the internet at: http://www.psc.gov/forms 
(Revised 7/00). Applications handcarried or commercially delivered 
should be addressed to 5630 Fishers Lane (HFA-531), rm. 2129, 
Rockville, MD 20857. An application not received by FDA in time for 
orderly processing will be returned to the applicant without 
consideration. FDA cannot receive an application electronically.

FOR FURTHER INFORMATION CONTACT:
    Regarding the administrative and financial management aspects of 
this notice: Cynthia M. Polit (see ADDRESSES).
    Regarding the programmatic aspects of this notice: Stephen Toigo, 
Division of Federal-State Relations (DFSR), Office of Regulatory 
Affairs, Food and Drug Administration (HFC-150), 5600 Fishers Lane, rm. 
12-07, Rockville, MD 20857, 301-827-6906, or access the Internet at: 
http://www.fda.gov/ora/fed_state/default.htm.

SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA and CDC view State-based Food Safety and Food Security Task 
Forces as important mechanisms for promoting food safety, food security 
program coordination, and information exchanges within each State. 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 Security Task Force, as well as to States that are 
in the process of developing such a Task Force. State Food Safety Task 
Force meetings should foster communication and cooperation among State 
and local public health and food safety agencies and other interested 
parties. Under this grant announcement, States may be awarded grants 
for up to 3 years for a maximum of $7,000 per year in direct costs 
only, contingent on the availability of funds. Only one grant will be 
awarded per State per year.
    Before submission of an application, the State shall designate one 
State public health or food safety agency to lead, coordinate, and host 
the Food Safety and Food Security Task Force and its meetings. The 
formation of Food Safety and Food Security Task Force meetings shall 
not interfere with existing federal-state advisory mechanisms.
    Meetings covered by this notice will be supported under section 
1701-1706 (42 U.S.C. 300u-300u-5) of the Public Service Health (PHS) 
Act. FDA's Conference Grant Program is described in the Catalog of 
Federal Domestic Assistance, No. 93-103. Applicants are limited to one 
State government agency per State. Applications submitted under this 
program are subject to the requirements of Executive Order 12372.
    FDA urges applicants to submit workplans that address specific 
objectives of ``Healthy People 2010.'' Applicants may obtain a paper 
copy of the ``Healthy People 2010'' objectives, Volumes I and II, for 
$70 ($87.50 foreign) S/N 017-000-00550-9, by writing to the 
Superintendent of Documents, P.O. Box 371954,

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Pittsburgh, PA 15250-7954. Telephone orders can be placed to 202-512-
2250. The document is also available in CD-ROM format, S/N 017-001-
00549-5 for $19 ($23 foreign) as well as on the Internet at http://www.health.gov/healthypeople/. Internet viewers should proceed to 
``Publications.''

II. Background

    FDA's ORA is the inspection component of 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 previously mentioned 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.
    CDC is a non-regulatory Federal public health agency that works 
closely with FDA food safety regulatory and other agencies to prevent 
foodborne disease. CDC leads Federal efforts to gather data on 
foodborne illnesses, investigate foodborne illnesses and outbreaks, and 
monitor the effectiveness of prevention and control efforts. CDC also 
plays an ongoing role in identifying prevention strategies and building 
State and local health department epidemiology, laboratory, and 
environmental health capacity to support foodborne disease surveillance 
and outbreak response. CDC data assists in documenting whether food 
safety interventions are leading to reductions in the incidence of 
foodborne illness.
    Although the United States has one of the safest food supplies in 
the world, the public health burden of foodborne disease in the nation 
is substantial. Foodborne disease causes an estimated 76 million 
illnesses, 325,000 hospitalizations, and 5,000 deaths in the United 
States each year, and an estimated $6.9 billion in economic costs. New 
challenges continue to arise, including the globalization of the food 
supply and the emergence of new pathogens in foods.
    These facts reinforce the importance of this State Food Safety and 
Security Task Force program. The focus of these grant-sponsored 
meetings should be to discuss and resolve issues at the State and local 
levels relating to the following areas: (1) State/local agency roles 
and responsibilities; (2) capacity and resource needs; (3) Outbreak 
coordination and investigations; (4) information sharing and data 
collection; (5) uniform regulatory standards; (6) communications and 
education; (7) state/local laboratory operations and coordination; (8) 
adoption/implementation of FDA's Food Code; (9) uniform standards for 
foodborne illness and outbreak reporting investigation and response; 
and (10) state and local training needs for epidemiology, outbreak 
investigation, etc.

III. Project Goals, Definitions, and Examples

    The purpose of the Food Safety and Food Security Task Force 
meetings is to foster communication and cooperation within the States 
among State and local food safety regulatory agencies. The meetings 
should cover the following objectives: (1) Provide a forum for all the 
stakeholders of the food safety system--regulatory agencies, academia, 
industry, consumers, State legislators, and other interested parties; 
(2) assist in adopting or implementing FDA's Food Code; and (3) promote 
the integration of an efficient statewide food safety system that 
maximizes the protection of the public health through early detection 
and containment of foodborne illness.
    Conference grant funds will be awarded only for direct costs 
incurred to secure meeting facility rental expenses, supplies, 
publication costs, and in-state travel expenses for meeting attendees. 
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 at the meetings. Conference Grant funds may not be used for 
Federal employees to travel to these meetings.
    FDA's DFSR will provide meeting guidelines and organization 
documents as requested.
    FDA will consider funding meetings for up to 3 years. Funding after 
the first year will be at an amount that will be negotiated at the time 
of the initial competitive segment. Thus, the budgets for all 3 years 
of requested support must be fully justified in the original 
application.
    Continued funding of a noncompetitive segment is contingent upon 
satisfactory progress as determined annually by FDA procedures, the 
receipt of a noncompeting continuation application, and availability of 
federal funds. The noncompeting continuation will consist of a Standard 
Form 424 (SF424) face page, a financial status report, and conference 
proceedings for all conferences held the previous budget period. A 
decrease in the amount of the noncompetitive segment may occur if there 
is an unobligated balance from the prior year, in which case prior year 
funds can be used as an offset for the current year award.
    Following are the allowable costs: (1) Salaries in proportion to 
the time or effort spent directly on the conference, (2) rental of 
necessary equipment, (3) travel and per diem, (4) supplies needed to 
conduct the meeting, (5) conference services, (6) publication costs, 
(7) registration fees, and (8) speaker's fees.
    Nonallowable costs include but are not limited to: (1) Purchase of 
equipment; (2) transportation costs exceeding coach class fares; (3) 
entertainment; (4) tips; (5) bar charges; (6) personal telephone calls; 
(7) laundry charges; (8) travel or expenses other than local mileage 
for local participants; (9) organization dues; (10) honoraria or other 
payments for the purpose of conferring distinction or communicating 
respect, esteem, or admiration; (11) alterations or renovations; (12) 
indirect costs; and (13) travel or per diem costs for Federal 
employees.

IV. Reporting Requirements

    A final progress report of the meeting(s) or conference proceedings 
and a final financial status report (FSR) (SF-269) are required within 
90 days of the expiration date of the project period as noted on the 
Notice of Grant Award. An original and two copies of each report shall 
be submitted to FDA's Grants Management Office (see ADDRESSES). The 
following items should be included in the report of the meeting: (1) 
The grant number; (2) the title, date and place 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 planned sessions of the meeting; and (6) a 
summary of topics discussed, next steps and conclusions.
    An FSR and a progress report are also required no later than 90 
days after the close of the budget period. The progress

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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 
semiannually 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 and/or a site 
visit with appropriate officials of the recipient organization. The 
results of these monitoring activities will be recorded in the official 
file and may be available to the recipient upon request.

V. Mechanism of Support

A. Award Instrument

    Support for this program will be in the form of a grant. 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 (HHS) 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. Applicants (other than Federally recognized Indian tribal 
governments) should contact the State's Single Point of Contact (SPOC) 
as early as possible to alert them to the prospective application(s) 
and to receive any necessary instructions on the State's review 
process. A current listing of SPOCs is included in the application kit. 
The SPOC should send any State review process recommendations to FDA's 
Grants Management Office (see ADDRESSES). The due date for the State 
process recommendations is no later than 60 days after the deadline 
date for the receipt of applications. FDA does not guarantee 
availability to accommodate or explain SPOC comments that are received 
after the 60-day cutoff.

B. Eligibility

    These grants are available to State public health and food safety 
agencies. (See section V.A of this document.)

C. Length of Support

    It is anticipated that FDA will fund these grants at a level 
requested but not exceeding $7,000 total direct costs only for the 
first year. An additional 2 years of support up to approximately $7,000 
(direct costs only) each year will be available, depending upon fiscal 
year appropriations and successful performance.

D. Funding Plan

    Federal funds are currently available from FDA for this program. 
However, awards are subject to the condition that, in addition to FDA 
funds, augmenting funds are transferred to FDA from CDC to fully 
support this program. As the lead Federal agency, FDA intends to 
collect funds from CDC through an Interagency Agreement. An estimated 
amount of $100,000 is available in FY 2004 through the Interagency 
Agreement for a total of $350,000. 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 application with original signatures 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. Final 
funding decisions will be made by the Commissioner of Food and Drugs or 
his or her designee, in consultation with the CDC Director and his or 
her designee.
    Applicants are strongly encouraged to contact FDA to resolve any 
questions regarding criteria before the submission of their 
application. All technical or programmatic questions must be directed 
to the ORA program staff (see ADDRESSES). All administrative or 
financial questions must be directed to the Grants Management Staff 
(see ADDRESSES).
    Applications will be given an overall score and judged based on all 
of the following criteria: (1) The content/subject matter and how 
current and appropriate it is for the missions of FDA; (2) the 
conference plan and how thorough, reasonable, and appropriate it is for 
the intended audience; (3) the experience, training, and competence of 
the principal investigator/director and availability of support staff; 
(4) the adequacy of the facilities; and (5) the reasonableness of the 
proposed budget given the total conference plan, program, speakers, 
travel, and facilities.

VII. Submission Requirements

    The original and two copies of the completed grant application Form 
PHS-5161-1 (Revised 07/00) for State and local governments should be 
delivered to the Grants Management Office (see ADDRESSES). The 
application receipt date is August 9, 2004, for the first year and 
March 15 for each subsequent year this program is in effect. No 
supplemental material or addenda will be accepted after the receipt 
date.

VIII. Method of Application

A. Submission Instructions

    Applications will be accepted during working hours, 8 a.m. to 4:30 
p.m., Monday through Friday, on or before the established receipt date. 
Applications will be considered received on time if sent or mailed on 
or before the receipt date as evidenced by a legible U.S. Postal 
Service dated postmark or a legible date receipt from a commercial 
carrier, unless they arrive too late for orderly processing. Private 
metered postmarks shall not be acceptable as proof of timely mailing. 
Applications not received on time will not be considered for review and 
will be returned to the applicant. Applicants should note that the U.S. 
Postal Service does not uniformly provide dated postmarks. Before 
relying on this method, applicants should check with their local post 
office.
    Do not send applications to the National Institutes of Health's 
(NIH) Center for Scientific Review. Any application sent to NIH that is 
then forwarded to FDA and not received in time for orderly processing 
will be deemed unresponsive and returned to the applicant. FDA is 
unable to receive applications via the Internet.
    The outside of the mailing package and item 2 of the application 
face page should be labeled ``Response to Food Safety Task Force 
Conference Grant Program.'' You must submit only one application (an 
original and two copies) per package.

B. Format for Application

    When using Form PHS 5161-1 (Revised 07/00), all instructions for 
the enclosed SF424 should be followed using the nonconstruction 
application pages.
    Both the face page of the application and the outside of the 
mailing package should be labeled ``Response to Food Safety Task Force 
Conference Grant Program.'' Submit applications on SF424 and include 
the following: (1)

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Title, which has the term ``state food safety 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 known); 
(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. A 
properly formatted sample application for grants can be accessed on the 
Internet at: http://www.fda.gov/ora/fed_state/Innovative_Grants.html.
    Data included in the application, if restricted with the legend 
(see section X. of this document), may be entitled to confidential 
treatment as trade secret or confidential commercial information within 
the meaning of the Freedom of Information Act (FOIA) (5 U.S.C. 
552(b)(4)) and FDA's implementing regulations (21 CFR 20.61).
    Information collection requirements requested on PHS Form 5161-1 
were approved and issued under the Office of Management and Budget 
Circular A-102.

IX. Dun and Bradstreet Number (DUNS) Requirement

    As of October 1, 2003, applicants are now required to have a DUNS 
number to apply for a grant or cooperative agreement from the Federal 
government. 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. To obtain a DUNS number, call 1-866-705-5711. 
Be certain that you identify yourself as a Federal grant applicant when 
you contact Dun and Bradstreet.

X. Legend

    Unless disclosure is required by FOIA as amended (5 U.S.C. 552), as 
determined by the FOI officials of HHS or by a court, data contained in 
the portions of an application which have been specifically identified 
by page number, paragraph, etc., by the applicant as containing 
restricted and/or proprietary information shall not be used or 
disclosed except for evaluation purposes.

    Dated: June 18, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-14395 Filed 6-24-04; 8:45 am]
BILLING CODE 4160-01-S