[Federal Register Volume 66, Number 98 (Monday, May 21, 2001)]
[Notices]
[Pages 27980-27983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12626]


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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

[[Page 27981]]

announcing the availability of grant funds for the support of an 
innovative food safety program. Approximately $200,000 will be 
available in fiscal year 2001. FDA anticipates making at least four 
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 5, 2001.

ADDRESSES: Application forms are available from, and completed 
applications should be submitted to Cynthia M. Polit, Grants Management 
Office, Food and Drug Administration (HFA-520), 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 (address and telephone number given 
above).
    Regarding the programmatic aspects of this notice: Paul M. Raynes 
or Anne Hope Scott, Division of Federal-State Relations (HFC-150), 
Office of Regulatory Affairs, Food and Drug Administration, 5600 
Fishers Lane, rm. 12-07, Rockville, MD 20857, 301-827-6906. Internet 
site: http://www.fda.gov/ora/fed_state/default.htm.

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. FDA 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.
    FDA urges applicants to submit work plans that address specific 
objectives of ``Healthy People 2010.'' Potential applicants may obtain 
a copy of ``Healthy People 2010'' (full report, stock No. 017-001-
00547-9) through Superintendent of Documents, Government Printing 
Office, Washington, DC 20402-9325, 202-512-1800.

II. Background

    ORA is the inspection component of FDA and has some 1,100 
investigators and inspectors who cover the country's approximately 
95,000 FDA-regulated businesses. These investigators inspect more than 
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. 
FDA has relied on the States in assisting with the above duties through 
formal contracts, partnership agreements, and other informal 
arrangements. Under the 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 will increase effectiveness 
and efficiency and conserve resources. ORA will support FSI by 
providing: (1) Effective and efficient compliance of regulatory 
products, and (2) 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. 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 for FDA's draft entitled 
``Recommended National Retail Food Regulatory Program Standards'' 
(http://vm.cfsan.fda.gov/~dms/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 
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 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 food service 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 impact contributing factors 
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 and 
local levels must have national implication or application

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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. 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 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 (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 SPOCs is included in the application kit. The SPOC should 
send any State review process recommendations to FDA's administrative 
contact (address listed above). The due date for the State process 
recommendations is no later than 60days 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 and local government 
food regulatory agencies and federally recognized Indian tribal 
governments. (See SPOC requirements stated in section IV. A of this 
document.)

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. 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 
exceeds $50,000; (3) if all required signatures are not on the face 
page or assurance 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; or (7) if the application 
demonstrates an inadequate understanding of the intent of the RFA.
    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. 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 his/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 ORA's 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://
vm.cfsan.fda.gov/~dms/ret-toc.html) only: The outcomes of the project 
should be applicable to program improvement process for FDA's draft 
entitled ``Recommended National Retail Food Regulatory Program 
Standards'' (http://vm.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 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. FDA's draft entitled 
``Recommended National Retail Food Regulatory Program Standards'' is 
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.
    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 in detail, a sound rationale and 
appropriate grant design to address the objectives of RFA and the 
project must be reproducible within the national regulatory framework.
    4. Applications must include a detailed explanation of the desired 
goals and outcomes of the project.
    5. 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.
    6. Applications must address the adequacy of facilities, expertise 
of project staff, equipment, databases, 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 7/00) for State and local governments, with copies 
of the

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appendices for each of the copies, should be delivered to Cynthia M. 
Polit (address above). The application receipt date is July 5, 2001. If 
the receipt date falls on a weekend, or if the date falls on a holiday, 
the date of submission 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-01-Project I'' or 
``RFA-FDA-ORA-01-Project II.'' 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 (with 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 that is 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 (revised 7/00). 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-01-
Project I,'' or ``RFA-FDA-ORA-01-Project II.''
    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 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 15, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-12626 Filed 5-18-01; 8:45 am]
BILLING CODE 4160-01-S