[Federal Register Volume 67, Number 98 (Tuesday, May 21, 2002)]
[Notices]
[Pages 35823-35826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12665]


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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 (DFSR), is 
announcing the availability of grant funds for the support of an 
innovative food safety program. Approximately $350,000 will be 
available in fiscal year 2002. FDA anticipates making at least seven 
awards, not to exceed $50,000 (direct and indirect costs combined) per 
award per year. 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. 
These grants are not intended to fund or conduct food inspections.

DATES: Submit applications by July 22, 2002.

ADDRESSES: Application forms are available from, and completed 
applications should be submitted to Cynthia M. Polit, Grants Management 
Office (HFA-520), Food and Drug Administration, 5600 Fishers 
Lane, rm. 2129, Rockville, MD 20857, 301-827-7180, e-mail: 
[email protected]. Applications hand-carried or commercially delivered 
should be addressed to 5630 Fishers Lane, rm. 2129, Rockville, MD 
20857. Application forms PHS-5161-1 (7/00) are available 
via the Internet at http://www.psc.gov/forms (revised 7/00).

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: Paul M. Raynes, 
or Anne Hope Scott, Division of Federal-State Relations, Office of 
Regulatory Affairs (HFC-150), Food and Drug Administration, 5600 
Fishers Lane, rm. 12-07, Rockville, MD 20857, 
301-827-6906, e-mail: [email protected], on the Internet at 
http://www.fda.gov/ora/fed_state/default.htm.

SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA will support projects covered by this notice under title XVII 
of the Public Health Service Act (42 U.S.C. 1702). 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, local, and tribal governments.
    FDA urges applicants to submit work plans that address specific 
objectives of "Healthy People 2010." Applicants may obtain 
a hard copy of the "Healthy People 2010" objectives, 
volumes I and II, Conference Edition (B0074), for $22 per set, by 
writing to the Office of Disease Prevention and Health promotion 
(ODPHP) Communication Support Center, P.O. Box 37366, Washington, DC 
20013-7366. Each of the 28 chapters of "Healthy People 
2010" is priced at $2 per copy. Telephone orders can be placed to 
the center on 301-468-5690. The center also sells the 
complete Conference Edition in CD-ROM format (B0071) for $5. This 
publication is available as well on the Internet at http://www.health.gov/healthypeople/. Internet viewers should proceed to 
"Publications."
    The Public Health Service 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 FDA mission to protect 
and advance the physical and mental health of the American people.

II. Background

    ORA is the inspection component of the FDA and has some 1,100 
investigators and inspectors who cover the country's approximately 
95,000 FDA-regulated businesses. These investigators inspect more that 
15,000 facilities a year. In addition to the standard inspection 
program, they conduct special investigations, conduct food inspection 
recall audits, perform consumer complaint inspections, and collect 
samples of regulated product. FDA has relied on the States in assisting 
with the these activities through formal contracts, partnership 
agreements, and other informal arrangements. Under the Food Safety 
Initiative (FSI), the demands on both the agency and the States has 
increased. Procedures need to be reviewed and innovative changes made 
that will increase effectiveness and efficiency and conserve resources. 
ORA will support FSI by: (1) Effectively and efficiently ensuring 
compliance of regulatory products; and (2) providing high quality, 
science-based work that results in maximizing consumer protection.
    Under FSI, FDA is mandated to develop innovative food safety 
programs that would 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 7,000 
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 levels and have 
national implication 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. Examples of food 
safety projects are retail food (food manufacturers,

[[Page 35824]]

processors, wholesalers, and warehouses); egg safety program; milk 
safety program; shellfish safety program. Applications that address one 
of the food safety projects and 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 for FDA's draft "Recommended 
National Retail Food Regulatory Program Standards" (http://
vm.cfsan.fda.gov/ï¿½7Edms/ret-toc.html) (see review criteria).
    There are two key project areas identified for this effort:
1. Inspection
    Development of innovative regulatory inspection methods or 
techniques for the inspection process of various food establishments in 
order to improve effectiveness and efficiency. Innovative Regulatory 
Program Methodology projects must demonstrate an effect on factors that 
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 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). Other examples of 
projects in this area could include prevention and control of Listeria 
monocytogenes in retail and foodservice environments and projects that 
address shell egg safety, such as refrigeration, safe handling, or 
labeling. The goal of these projects should be to achieve efficient and 
effective compliance with regulations that affect factors that 
contribute to foodborne illness.
2. 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, local, 
and tribal levels must have national implication or application that 
can enhance Federal, State, and local food regulatory programs and are 
likely to reduce factors that cause foodborne illness. At the 
discretion of FDA, successful project formats will be made available to 
interested Federal, State, local, and tribal food safety regulatory 
agencies. No grant will be awarded for projects that do not support the 
FDA Food Code.

III. Reporting Requirements

    Semiannual progress reports as well as a final program progress 
report and a final financial status report (FSR) (SF-269) are 
required. An original FSR and two copies shall be submitted to FDA's 
Grants Management Officer 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 such 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 
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 duly 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 FDA, 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 Services 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 the SPOC 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 administrative contact 
(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 to accommodate or explain SPOC 
comments that are received after the 60 day cut-off.

B. Eligibility

    This grant program is only available to State, local, and tribal 
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. Responsiveness is defined as 
submission of a complete application with original signatures on or 
before the required submission date as listed previously in this 
document. If applications are found to be nonresponsive, they will be 
returned to the applicant without further consideration. An application 
will be considered nonresponsive if any of the following criteria are 
not met: (1) If it is received after the specified receipt date; (2) if 
the total dollar amount requested from FDA exceeds $50,000; (3) if all 
required original signatures are not on the face, assurance, or 
certification pages of the application; (4) if there is no original 
signature copy; (5) if it is illegible; (6) if the material presented 
is insufficient to permit an adequate review; (7) if the application 
demonstrates an inadequate understanding of the intent of the RFA; (8) 
if the application is determined to be essentially similar to projects 
that have been funded in the past; or (9) if for any reason the results 
of the project, including computer software, cannot be made available 
to other State, local, and tribal food regulatory agencies. All 
applicants are encouraged to check the

[[Page 35825]]

list of projects that received funding in prior years under this 
program on the Internet at www.fda.gov/ora/fed_state/Innovative_Grants.html.
    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. Applications will be 
considered for funding on the basis of their overall technical merit as 
determined through the review process. Other award criteria will 
include availability of funds and overall program balance in terms of 
geography. Final funding decisions will be made by the Commissioner of 
Food and Drugs or his 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 ORA's program staff (see ADDRESSES) 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. 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.
    2. Applications must provide in detail, a sound rationale and 
appropriate grant design to address the objectives of the RFA.
    3. The project must be generic enough in nature to be used by other 
State, local, and tribal food regulatory agencies.
    4. Applications must include a detailed explanation of the desired 
goals and outcomes of the project.
    5. Only for applications relating to the Retail Food Program, the 
outcomes of the project should be applicable to program improvement 
process for FDA's draft "Recommended National Retail Food 
Regulatory Program Standards." These standards will serve as a 
guide to the regulatory 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. The FDA draft "Recommended National 
Retail Food Regulatory Program Standards" are found on the 
Internet at http://vm.cfsan.fda.gov/ï¿½7Edms/ret-toc.html or contact 
your local FDA Regional Retail Food Specialist from the list provided 
in the application packet.
    6. Applications must include a full description of the project 
design, a detailed implementation plan, methods of execution, and 
timeline for completion. The application must include a detailed 
description of measures of effectiveness and a description of the 
source documents or data collection methods for establishing the 
baseline for measurement.
    7. Applications must address the adequacy of facilities, expertise 
of project staff, equipment, databases and support services needed for 
the project.
    8. Applicants and applicants' subgrantees and subcontractors must 
ensure compliance that any projects developed in whole or in part with 
Federal funds may be made available to other State, local, and tribal 
food regulatory agencies by FDA or its agents. Such copyrighted or 
copyrightable works shall be subject to a royalty-free, nonexclusive, 
and irrevocable license to the Federal Government to reproduce, 
publish, or otherwise use them, and to authorize others to do so for 
Federal Government purposes.

VI. Submission Requirements

    The original and two copies of the completed Grant Application Form 
PHS-5161-1 (Revised 7/00) for State and local governments, 
with copies of the appendices for each of the copies, should be 
delivered to Cynthia M. Polit (see ADDRESSES). The application receipt 
date is July 22, 2002. If the receipt date falls on a weekend, it will 
be extended to Monday; if the date falls on a holiday, it will be 
extended to the following workday. No supplemental or addendum material 
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-02-Project I (Inspection) or 
"RFA-FDA-ORA-02-Project II (Education and 
Health Information Dissemination)." Submit only one project 
application (an original and two copies) per package.

VII. Method of Application

A. Submission Instructions

    Each application must be submitted under separate cover. Do not 
submit more than one application (original with two copies) per 
envelope. 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 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. 
Instructions for completing the application are included in Form 
PHS-5161-1. FDA is unable to receive applications via 
Internet.

B. Format for Application

    Submission of the application must be on Grant Application Form PHS 
5161-1 (Rev 7/00). All instructions for the enclosed Standard 
Form 424 (SF-424) should be followed using the nonconstruction 
application pages. A properly formatted sample application for the 
grant can be accessed on the Internet at http://www.fda.gov/ora/fed_state/Innovative_Grants.html. Applications may be 
considered nonresponsive if not submitted in the proper order.
    The face page of the application should indicate 
"RFA-FDA-ORA-02-Project I 
(Inspection)," or 
"RFA-FDA-ORA-02-Project II (Education and 
Health Information and Dissemination)." 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 Management and 
Budget Circular A-102.

C. Legend

    Unless disclosure is required by FOIA as amended (5 U.S.C. 552), as 
determined by the freedom of information officials of Department of 
Health and Human Services or by a court, data contained in the portions 
of this application which have been specifically identified by page 
number and paragraph by the applicant as

[[Page 35826]]

containing restricted or proprietary information shall not be used or 
disclosed except for evaluation purposes.

    Dated: May 14, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-12665 Filed 5-20-02; 8:45 am]
BILLING CODE 4160-01-S