[Federal Register: May 21, 2001 (Volume 66, Number 98)]
[Notices]
[Page 27980-27983]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my01-90]
 
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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: cpolit@oc.fda.gov.
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
 
[[Page 27982]]
 
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
 
[[Page 27983]]
 
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