[Federal Register Volume 68, Number 105 (Monday, June 2, 2003)]
[Notices]
[Pages 32758-32761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13594]


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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: [email protected]. 
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: [email protected].

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

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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

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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-

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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