[Federal Register Volume 64, Number 94 (Monday, May 17, 1999)]
[Notices]
[Pages 26766-26769]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12287]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Innovative Food Safety Projects; Availability of Grants; Request 
for Applications

Agency: Food and Drug Administration, HHS.

Action: Notice.

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Summary: The Food and Drug Administration (FDA), Office of Regulatory 
Affairs (ORA), Division of Federal-State Relations, is announcing the 
availability of grant funds for the support of innovative food safety 
pilot programs. Approximately $300,000 will be available in fiscal year 
1999. FDA anticipates making six to eight awards, not to exceed $50,000 
(direct and indirect costs combined) per award. Support of these grants 
will be for 1 year. The number of grants funded will depend on the 
quality of the applications received and the availability of Federal 
funds to support the grant. This is a pilot grant program which, if 
successful, may lead to other grant programs in the future. These 
grants are not intended to fund or conduct food inspections.

DATES: Submit applications by July 1, 1999. If the closing date falls 
on a weekend or on a holiday, the date of submission will be extended 
to the following workday.

ADDRESSES: Application forms are available from, and completed 
applications should be submitted to Robert L. Robins, Chief Grants 
Management Officer, Division of Contracts and Procurement Management 
(HFA-520), Food and Drug Administration, 5600 Fishers Lane, rm. 2129, 
Rockville, MD 20857, 301-827-7185, e-mail ``[email protected]''. 
(Applications hand-carried or commercially delivered should be 
addressed to 5630 Fishers Lane, rm. 2129, Rockville, MD 20852.)

FOR FURTHER INFORMATION CONTACT:
    Regarding the administrative and financial management aspects of 
this notice: Robert L. Robins (address above).
    Regarding the programmatic aspects of this notice: Richard H. 
Barnes or Glenn Johnson, Division of Federal-State Relations, Office of 
Regulatory Affairs, Food and Drug Administration (HFC-150), 5600 
Fishers Lane, rm. 12-07, Rockville, MD 20857, 301-827-6906, Internet 
site: ``www.fda.gov/ora/fed_state''.

SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA will support projects covered by this notice under section 1701 
(300u) of the Public Health Service Act (42 U.S.C. 241). FDA's project 
program is described in the Catalog of Federal Domestic Assistance, No. 
93-245, and applicants are limited to food safety regulatory agencies 
of State and local governments. The Public Health Service (PHS) 
strongly encourages all award recipients to provide a smoke-free 
workplace and to discourage the use of all tobacco products. This is 
consistent with the PHS mission to protect and advance the physical and 
mental health of the American people.
    PHS urges applicants to submit work plans that address specific 
objectives of ``Healthy People 2000.'' Potential applicants may obtain 
a copy of ``Healthy People 2000'' (Full Report, stock No. 017-0010-
0474-0) through Superintendent of Documents, Government Printing 
Office,

[[Page 26767]]

Washington, DC 20402-9325, 202-512-1800.

II. Background

    ORA is the inspection component of FDA and has 1,000 investigators 
and inspectors who cover the country's approximately 95,000 FDA-
regulated businesses. These investigators and inspectors inspect more 
that 15,000 facilities a year. In addition to the standard inspection 
program, they conduct special investigations, food inspection recall 
audits, perform consumer complaint inspections and sample collections. 
In addition, FDA has relied on the States in assisting with the 
previously mentioned duties through formal contracts, partnership 
agreements, and other informal arrangements. Under the President's Food 
Safety Initiative (FSI), the demands on both the agency and the States 
will increase. Procedures need to be reviewed and innovative changes 
made that increase effectiveness and efficiency and conserve resources. 
ORA will support FSI by providing: (1) Effective and efficient 
compliance of regulated products; and (2) high quality, science-based 
work that maximizes consumer protection.
    Under FSI, FDA is developing innovative food safety programs that 
will be utilized nationally by State and local food safety regulatory 
agencies. Even though the American food supply is among the safest in 
the world, millions of Americans are stricken by illness each year 
caused by the food they consume, and some 9,000 Americans a year, 
primarily the very young and elderly, die as a result. The goal of FSI 
is to further reduce the incidence of foodborne disease to the greatest 
extent possible. Innovative food safety programs that are developed at 
the State and local level and have national implications could enhance 
programs that are developed at the Federal level.

A. Project Goals, Definitions, and Examples

    The specific objective of this program will be to complement, 
develop or improve State and local food safety programs that would have 
applicability to food safety programs nationwide. Applications that 
fulfill the following specific project objectives will be considered 
for funding. Each application must address only one project. Applicants 
may apply for more than one project area, but must submit a separate 
application for each project. These grants are not to fund or conduct 
food inspections for food safety regulatory agencies. Applications 
relating to the Retail Food Program area should be applicable to 
program improvement processes consistent with FDA's draft entitled 
``Recommended National Retail Food Regulatory Program Standards'' 
(``http://www.cfsan.fda.gov/dms/ret-toc.html'') (see review 
criteria).
    There are four key project areas identified for this effort:
 1. Inspection
    Development of innovative regulatory inspection methods or 
techniques for the inspection of various food establishments in order 
to improve effectiveness and efficiency. Innovative Regulatory Program 
Methodology projects must demonstrate an effect on factors which 
contribute to foodborne illness in all, or a segment of, food industry 
programs. For example, projects could address key elements from the 
draft entitled ``Recommended National Retail Food Regulatory Program 
Standards,'' such as the five major Food Code Interventions (management 
knowledge; employee health; hands as a vehicle of contamination; time/
temperature relationships; and consumer advisory), or the five Centers 
for Disease Control and Prevention risk factors (improper holding 
temperature; inadequate cooking; contaminated equipment; unsafe source; 
and poor personal hygiene).
 2. Regulation and Compliance
    Development of new procedures for industry that would enhance the 
efficiency and effectiveness of Federal, State, and local compliance 
actions. Examples of projects in this area could include innovative 
regulation and compliance strategies for State and local food safety 
regulatory agencies. The goal of these projects should be to achieve 
efficient and effective compliance with regulations that impact 
contributing factors to foodborne illness.
 3. Information Systems
    Development of systems for collection, storage, and retrieval of 
data on projects that support food safety regulatory State or local 
programs. These systems should utilize readily available ``off the 
shelf'' technology systems that could be used by food safety regulatory 
agencies of any size.
 4. Education and Health Information Dissemination
    Development of innovative education projects and materials for 
State and local food safety regulatory officials that foster 
consistency and uniform application of State and local food 
regulations. These education projects and/or materials must be 
reproducible by other State and local food safety regulatory agencies. 
These projects may incorporate concurrent education of both State and 
local food safety regulatory agencies and the food industry.

B. Applicability

    All grant application projects that are developed at State and 
local levels must have national implication or application that can 
enhance Federal, State, and local food regulatory programs and reduce 
factors that cause foodborne illness. At the discretion of FDA, 
successful project formats will be made available to interested 
Federal, State, and local food safety regulatory agencies.

III. Reporting Requirements

    Quarterly progress reports as well as a Final Program Progress 
Report and a Financial Status Report (FSR) (SF-269) are required. An 
original FSR and two copies shall be submitted to FDA's Chief Grants 
Management Officer (address above), within 90 days of the expiration 
date of the grant. The Final Program Progress Report must provide full 
written documentation of the project, copies of any results, as 
described in the grant application, and an analysis and evaluation of 
the results of the project. The documentation must be in a form and 
contain sufficient detail that other State and local food safety 
regulatory agencies could reproduce the final project.
    Program monitoring of recipients will be conducted on an ongoing 
basis and written reports will be reviewed and evaluated at least 
quarterly 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.

IV. 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 
project grant programs of 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 
Department of Health and Human

[[Page 26768]]

Services (DHHS) 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 SPOC's is included in 
the application kit. The SPOC should send any State review process 
recommendations to FDA's Chief Grants Management Officer (address 
listed above). 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 to accommodate or explain SPOC 
comments that are received after the 60 day cut-off.

B. Eligibility

    These grants are available to State and local government food 
regulatory agencies (see SPOC requirements stated previously).

C. Length of Support

    The length of support will be for 1 year from date of award.

V. Review Procedure and Criteria

    All applications submitted in response to this request for 
application (RFA) will first be reviewed by grants management and 
program staff for responsiveness. 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 in the 
subject field of the specific application. Responsive applications will 
also be subject to a second level of review by a National Advisory 
Council for concurrence with the recommendations made by the first 
level reviewers. Final funding decisions will be made by the 
Commissioner of Food and Drugs or her designee.
    Applicants are strongly encouraged to contact FDA to resolve any 
questions regarding criteria prior to the submission of their 
application. All questions of a technical or programmatic nature must 
be directed to the ORA program staff (address above) and all questions 
of an administrative or financial nature must be directed to the grants 
management staff (address above). Applications will be given an overall 
score and judged based on all of the following criteria:
     1. Applications relating to the Retail Food Program ( ``http://
www.cfsan.fda.gov/dms/ret-toc.html'') only: The outcomes of 
the project should be consistent with the program improvement process 
described in FDA's draft entitled ``Recommended National Retail Food 
Regulatory Program Standards'' (http://www.cfsan.fda.gov/
dms/ret-toc.html''). These standards will serve as a guide 
to regulatory retail food program managers for the design and 
management of a retail food program. The standards apply to the 
operation, management, and promotion of a regulatory retail food 
program focused on the reduction of risk factors known and suspected to 
cause foodborne illness and integration of the five major Food Code 
interventions listed in section II.A.1 of this document. The FDA draft 
entitled ``Recommended National Retail Food Regulatory Program 
Standards'' and the 1999 Food Code are found on the Internet site at 
``http://www.cfsan.fda.gov/dms/ret-toc.html'' or contact 
your local FDA Regional Retail Food Specialist from the list provided 
in the application packet about obtaining copies.
     2. Application budgets must remain within the $50,000 cap for 
combined direct and indirect costs. Applications exceeding this dollar 
amount will be returned as nonresponsive.
     3. Applications must provide a sound rationale and appropriate 
grant design to address the objectives of the RFA and the project must 
be reproducible within the national regulatory framework.
     4. Applications must include an explanation of the desired goals 
of the pilot project.
     5. Applications must include a full description of the project 
design, implementation plan, methods of execution, and timeline for 
completion. The application must include a full description of measures 
of effectiveness and a description of the source documents or data 
collection methods for establishing the baseline for measurement.
     6. Applications must address the adequacy of facilities, expertise 
of project staff, equipment, data bases, and support services needed 
for the project.

VI. Submission Requirements

    The original and two copies of the completed Grant Application Form 
PHS-5161-1 (revised May 1996) for State and local governments, with 
copies of the appendices for each of the copies, should be delivered to 
Robert L. Robins (address above). The application receipt date is July 
1, 1999. If the receipt date falls on a weekend or on a holiday, it 
will be extended to the following workday. No supplemental material or 
addenda will be accepted after the receipt date.
    The outside of the mailing package and item 2 of the application 
face page should be labeled ``Response to RFA-FDA-ORA-99-Project I, 
Project II, Project III or Project IV.''

VII. 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 Center for Scientific Research, 
National Institutes of Health (NIH). Any application that is sent to 
NIH, that is then forwarded to FDA and not received in time for orderly 
processing, will be deemed nonresponsive and returned to the applicant. 
Instructions for completing the application are included in Form PHS-
5161-1. FDA is unable to receive applications via the Internet.

B. Format for Application

    Submission of the application must be on Grant Application Form 
PHS-5161-1 (revised May 1996). All instructions for the enclosed 
Standard Form 424 (SF-424) should be followed using the nonconstruction 
application pages.
    The face page of the application should indicate ``RFA-FDA-ORA-99-
Project I, Project II, Project III or Project IV.''
    Data included in the application, if restricted with the legend 
specified below, 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 Office of

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Management and Budget Circular A-102.

C. Legend

    Unless disclosure is required by the FOIA as amended (5 U.S.C. 
552), as determined by the freedom of information officials of DHHS or 
by a court, data contained in the portions of this 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: May 10, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-12287 Filed 5-14-99; 8:45 am]
BILLING CODE 4160-01-F