[Federal Register: June 2, 2003 (Volume 68, Number 105)]
[Notices]
[Page 32758-32761]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jn03-90]
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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) is announcing the
availability of grant funds for the support of an innovative food
safety program. The agency will have approximately $300,000 available
for this program in fiscal year (FY) 2003. FDA anticipates making at
least six 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 food inspections.
DATES: Submit applications by July 17, 2003.
ADDRESSES: Application kits 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,
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 20852. Application forms
PHS-5161-1 (7/00) are available via the Internet at http://www.psc.gov/forms
(revised 7/00). NOTE: Do not send applications to the Center for
Scientific Research (CSR), National Institutes of Health.
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,
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, e-mail: dfsr@ora.fda.gov.
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 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, 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.''
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.
II. Background
The Office of Regulatory Affairs (ORA) is the inspection component
of FDA and utilizes approximately 1,600 investigators and inspectors to
oversee the country's approximately 95,000 FDA-regulated businesses.
These investigators inspect more that 15,000 facilities a year. In
addition to their efforts under the standard inspection program, they
conduct special investigations and food inspection recall audits,
perform consumer complaint inspections, and collect samples of
regulated products. FDA has relied on the States in assisting with
these activities through formal contracts, partnership agreements, and
other arrangements. Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, the demands on both the agency
and the States have increased. Procedures need to be reviewed and
innovative changes made that will increase effectiveness and efficiency
and conserve resources. ORA will continue to support food safety
programs by: (1) Effectively and efficiently ensuring compliance of
regulatory products, and (2) providing high quality, science-based work
that results in maximizing consumer protection. Since it's inception in
FY 1999 this program has been extremely successful and generated
significant projects benefiting State and local governments, FDA, and
the general public. To view past awards view the ORA Web site at
www.fda.gov/ora/fed_state/Innovative_Grants.html.
In partnership with our State and local food safety agencies, FDA
will continue 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,
76 million Americans become ill each year from the food they consume,
and approximately 5,000 Americans a year, primarily the very young and
elderly, die as a result. The goal of our food safety programs 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 goal of this program is to complement, develop, or
improve State and local food safety programs that could be applied to
food safety
[[Page 32759]]
programs nationwide. Examples of food safety projects are the retail
food program; the egg, milk, and shellfish safety programs; and, State
food safety laboratories. 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 be used to fund
or conduct food inspections for food safety regulatory agencies. For
example, 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/[sim]dms/ret-toc.html) (see review criteria).
There are three key project areas identified for this effort:
1. Inspection
One key project area is the 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 5 Food Code Interventions
(management knowledge; employee health; hands as a vehicle of
contamination; time/temperature relationships; and consumer advisory),
or the 5 Centers for Disease Control and Prevention (CDC) 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
Another key project area is the 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.
3. State Laboratories
FDA recognizes that there are a number of new technologies and test
methods that may be applicable to chemical and/or microbiological food
analyses. FDA's regulation of a wide range of food commodities requires
the validation of new test methods in a variety of food matrices.
State/local food testing laboratory validation of test methods will
provide the Federal, State, and local food safety agencies with
invaluable information with respect to the methods' feasibility and
applicability. State laboratories should identify areas in food testing
(chemical and/or biological) that would enhance their program
activities and provide alternative analytical capabilities for Federal
and local food safety officials.
Requirements For State Laboratories Projects:
The applicant must include the following in the grant application:
1. The applicant must identify rapid test method/technique proposed
for validation study. Please note that this is NOT research; it is a
single lab validation of food test methods/techniques with already
existing data that warrants further investigation. Selection of test
method technology must fall under the following categories:
[sbull]AOAC official method with foods and food commodities that
have not been previously validated;
[sbull]Non-AOAC official method, i.e., State lab method;
[sbull]New technology or method with single lab validation for a
particular food and analyte (validation data must be submitted).
2. The applicant must include at least 4 food matrices for each
validation study. Food matrices selected should benefit State program
activities in addition to providing Federal and local agencies with
alternative analytical capabilities.
3. The applicant must identify the microbiological or chemical test
method protocol, including laboratory equipment and personnel needed
for each validation study. Copies of the complete methods for the
validation study must be included.
4. The applicant must cite and incorporate into a protocol the
single-laboratory method validation guidelines (i.e., AOAC) for both
chemical and microbiological validations studies.
5. The applicant must also provide a scientific review of the
literature pertaining to the rapid test.
6. The applicant must agree to provide a written report on the
laboratory findings, including all the above materials and appropriate
documentation which will be reviewed by the FDA Division of Field
Science (DFS) before being recommended to other State/local food safety
agencies.
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.
FDA reserves a royalty-free, nonexclusive, and irrevocable license
to reproduce, publish or otherwise use, and to authorize others to use,
for Federal Government purposes: (1) The copyright in any work
developed under a grant, subgrant or contract under a grant or
subgrant; and (2) any rights of copyright to which a grantee,
subgrantee, or a contractor purchases ownership with grant support (45
CFR 92.34).
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.
The grantee must submit an original FSR and two copies 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
[[Page 32760]]
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 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 the FDA 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 cutoff.
B. Eligibility
This grant program is only available to State, local, and tribal
government food regulatory agencies. (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 the Request for
Applications (RFA) will first be reviewed by grants management and
program staffs for responsiveness. Responsiveness is defined as
submission of a complete application with original signatures on or
before the required submission date as listed above. 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 circumstances 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; (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. Applicants are
encouraged to check the list of projects that received funding in prior
years under this program on the Internet at http://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 FDA Commissioner
or his designee.
Applicants are strongly encouraged to contact FDA to resolve any
questions regarding criteria prior to the submission of their
applications. All questions of a technical or programmatic nature must
be directed to the ORA program staff (Paul Raynes) and all questions of
an administrative or financial nature must be directed to the grants
management staff (Cynthia Polit).
Applications will be given an overall score and judged based on all
of the following criteria:
[sbull] 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.
[sbull] Applications must provide in DETAIL, a sound rationale and
appropriate grant design to address the objectives of the RFA.
[sbull] The project MUST be generic enough in nature to be used by
other State, local, and tribal food regulatory agencies.
[sbull] Applications must include a detailed explanation of the
desired goals and outcomes of the project.
[sbull] For applications relating only to the Retail Food Program,
the outcome of the project should be applicable to the 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'' can be found on the Internet site
at http://vm.cfsan.fda.gov/[sim]dms/ret-toc.html or contact your local
FDA Regional Retail Food Specialist from the list provided in the
application packet.
[sbull] Applications must include a full description of the project
design, a detailed implementation plan, methods of execution, and a
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.
[sbull] Applications must address the adequacy of facilities,
equipment, databases and support services and the expertise of project
staff needed for the project.
[sbull] Applicants and applicant's subgrantees and subcontractors
must ensure 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. 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.
[sbull] Laboratory grant applications must meet all the
requirements in the key project areas: State laboratories (see section
II.A. 3 of this document).
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
17, 2003. 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-
[[Page 32761]]
FDA-ORA-03-Project I (Inspection)'' or ``RFA-FDA-ORA-03-Project II
(Education and Health Information Dissemination) or ``RFA-FDA-ORA-03-
Project III (State Laboratories).'' You must submit only one project
application (an original and two copies) per package.
VII. Method of Application
A. Submission Instructions
You must submit each application under separate cover. Do not
submit more than one application (original with 2 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
(CDR), 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 the Internet.
B. Format for Application
You must submit the application on Grant Application Form PHS 5161-
1 (Rev 7/00). All of the instructions for the enclosed Standard Form
424 (SF424) 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-03-
Project I (Inspection),'' or ``RFA-FDA-ORA-03-Project II (Education and
Health Information and Dissemination)'' or ``RFA-FDA-ORA-03-Project III
(State laboratories).''.
Data and information included in the application, if identified by
the applicant as trade secret will be given treatment as such to the
extent permitted by 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.
Dated: May 27, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-13594 Filed 5-30-03; 8:45 am]
BILLING CODE 4160-01-S