[Federal Register Volume 68, Number 122 (Wednesday, June 25, 2003)]
[Notices]
[Pages 37847-37850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15964]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Food Safety and Security Research--Rapid Methods Development: 
Availability of Cooperative Agreements; Request for Applications; RFA-
FDA-CFSAN-03-1

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA), Center for Food Safety 
and Applied Nutrition (CFSAN) is announcing the availability of 
approximately $3 million in research funds for fiscal year (FY) 2003. 
These funds will be used to support collaborative research efforts 
between CFSAN and scientists, and to complement and accelerate ongoing 
research in four project areas in order to reduce the incidence of 
foodborne illness and to ensure the integrity of the nation's food 
supply (including food additives and dietary supplements) and 
cosmetics. All awards will be subject to the availability of FY 2003 
funds.

DATES: Submit applications by August 11, 2003.

ADDRESSES: Submit completed applications to: Rosemary Springer, Grants 
Management Specialist, Grants Management Staff (HFA-520), Division of 
Contracts and Procurement Management, Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-827-7182, e-mail: 
[email protected]. Hand-carried or commercially delivered 
applications should be sent to: Food and Drug Administration, 5630 
Fishers Lane, rm. 2129, Rockville, MD 20857.
    Application forms are available either from Rosemary Springer (see 
previous paragraph) or on the Internet at http://grants1.nih.gov/grants/funding/phs398/phs398.html. NOTE: Do not send applications to 
the Center for Scientific Research (CSR), National Institutes of Health 
(NIH). Applications mailed to CSR and not received by FDA in time for 
orderly processing will be returned to the applicant without 
consideration. Please note that FDA is unable to receive applications 
electronically.

FOR FURTHER INFORMATION CONTACT: 
    Regarding the administrative and financial management aspects of 
this notice: Rosemary Springer (see ADDRESSES section).
    Regarding the programmatic aspects of this notice: John W. Newland, 
Research Coordinator, Office of Science (HFS-006), Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 301-436-1915, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is committed to reducing the incidence of foodborne illness to 
the greatest extent feasible and to protecting the integrity of the 
nation's food supply. Research in food safety seeks to reduce the 
incidence of foodborne illness by improving our ability to detect, 
characterize, and quantitate foodborne pathogens, toxins and chemicals 
that could jeopardize the safety and security of the food supply, and 
to find new and improved ways to control these agents. Since 1998, 
CFSAN has supported multiyear cooperative agreements intended to help 
achieve the research goals of reducing the incidence of foodborne 
illness and ensuring the integrity of foods, including food additives 
and dietary supplements, and cosmetics. This extramural program 
supports novel collaborative research efforts between CFSAN and 
scientists, and leverages expertise not found within CFSAN to 
complement and accelerate ongoing research. Collaborations such as 
these provide information critical to food safety guidance and 
policymaking, help address the needs of CFSAN regulatory programs, 
stimulate fruitful interactions between FDA scientists and those within 
the greater research community, and benefit the American public.
    In continuation of this effort to help enhance the capabilities of 
the agency, CFSAN is announcing the availability of research funds for 
FY 2003 to support research in the following four categories: (1) 
Development of rapid analytical screening methods for the detection of 
pathogens that are not usually associated with food and foodborne 
illness at a contamination level of 100 to 10,000 microbial pathogens/
gram (g) of food without pregrowth or selective enrichment; (2) 
development of PCR-based methods for rapid confirmatory identification 
of pathogens that are not usually associated with food and foodborne 
illness; (3) development of rapid screening methods capable of 
detecting a broad range of nontraditional chemical and toxin 
adulterants; and (4) development of improved equipment, software, 
procedures, and/or methods for determining radionuclide contamination 
in foods.
    Approximately $3 million will be available in FY 2003. FDA 
anticipates making awards of $100,000 to $600,000 (direct plus indirect 
costs) per award. The research efforts supported by these agreements 
may be up to 3 years in duration, however the total budget amount will 
not exceed a one-time amount of $600,000 (direct plus indirect costs) 
per award. The project and budget periods of these awards will be the 
same. Any application received that exceeds the amount stated 
previously will not be considered responsive and will be returned to 
the applicant without being reviewed. The number of agreements funded 
will depend on the availability of Federal funds to support the 
projects and on the quality of the applications received. There is no

[[Page 37848]]

assurance that awards will be made in each of the four project 
categories.
    FDA will support the research studies covered by this notice under 
section 301 of the Public Health Service Act (42 U.S.C. 241). FDA's 
research program is described in the Catalog of Federal Domestic 
Assistance, No. 93.103.
    FDA is committed to achieving the health promotion and disease 
prevention objectives of ``Healthy People 2010,'' a national effort to 
reduce morbidity and mortality and to improve quality of life. 
Applicants may obtain a paper copy of the ``Healthy People 2010'' 
objectives, vols. I and II, for $70 per set, ($87.50 foreign) SN/017-
000-00550 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 ($23.50 foreign). This publication is also 
available on the Internet at http://health.gov/healthypeople under 
``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. Research Goals and Objectives

    Proposed projects designed to fulfill the specific objectives of 
any one of the following requested projects will be considered for 
funding. Applications may address only one project and its objectives 
per application. However, applicants may submit more than one 
application for more than one project. In all of the following 
projects, CFSAN wants to promote the development of improved techniques 
for either the detection, control, or analysis of microbiological 
agents, toxins, and chemicals in food or cosmetics. None of the four 
projects should involve human research subjects. The projects and their 
objectives are as follows:

A. Project 1

    Develop food security rapid screening analytical methods capable of 
detecting 100 to 10,000 microbial pathogens/g of food, without 
pregrowth or selective enrichment and a total elapsed time of less than 
6 hours (sample preparation time included). These methods should be 
immunoassay-based techniques that require a minimum of laboratory-based 
equipment and are capable of being reproducibly and accurately executed 
by a trained, bachelor of science-level laboratory technician.

B. Project 2

    Develop PCR-based methods for the purpose of providing rapid, 
confirmatory identification of microbial pathogens that are usually not 
associated with food and foodborne illness. Methods must work directly 
in association with the food without pregrowth or selective enrichment, 
and they must provide a level of sensitivity of 100 organisms or less 
per g of food sample. The research approach should focus on providing 
complete protocols. The protocols must describe food sample preparation 
methods that are to be used in conjunction with the PCR-based 
identification protocols. Additionally, methods must be compatible with 
a wide variety of foods or broad food groups. Such groups may be 
artificially defined by a variety of food properties, such as origin, 
physical or chemical characteristics, or the method of preparation or 
manufacture.

C. Project 3

    Develop rapid screening methods capable of detecting a broad range 
of nontraditional chemical and toxin adulterants. These methods should 
be either kit-based or rely upon a minimum amount of instrumentation, 
to readily permit rapid deployment and field program use. Methods 
should rely upon a minimum amount of sample preparation and be usable 
with broad categories of food, such as high versus low fat content, 
high versus low water content, or high versus low protein or 
carbohydrate content. Sensitivities of proposed detection methods 
should target the acceptable daily intake or the tolerable daily intake 
for the specific target analytes.

D. Project 4

    Develop improved equipment, software, procedures, and/or methods 
for the determination of radionuclide contamination in foods. Of 
particular interest are reductions of analysis time, increases in 
portability, simplified procedures, and improved methodology for rapid 
determination of alpha- and beta-emitting radionuclides.

III. Mechanism of Support

A. Award Instrument

    Support for this program will be in the form of cooperative 
agreements. These cooperative agreements will be subject to all 
policies and requirements that govern the research grant programs of 
the PHS, including the provisions of 42 CFR part 52 and 45 CFR parts 74 
and 92. The regulations issued under Executive Order 12372 do not apply 
to this program. The NIH modular grant program does not apply to this 
FDA program.

B. Eligibility

    These cooperative agreements are available to any foreign or 
domestic, public or private nonprofit entity (including State and local 
units of government) and any foreign or domestic, for-profit entity. 
For-profit entities must commit to excluding fees or profit in their 
request for support to receive awards. Organizations described in 
section 501(c)(4) of the Internal Revenue Code of 1968 that engage in 
lobbying are not eligible to receive awards.

C. Length of Support

    Projects may take up to a maximum of 3 years for their completion. 
The amount of time that will be allocated for the completion of each 
individually approved and funded research project will be made 
commensurate with the research approach and methodology being proposed.

IV. Reporting Requirements

    Annual Financial Status Reports (FSRs) (SF-269) are required. An 
original FSR and two copies shall be submitted to FDA's Grants 
Management Officer (see ADDRESSES section) as indicated by the timeline 
noted in the Notice of Grant Award. Failure to file the FSR on time may 
be grounds for suspension or termination of the agreement. Program 
Progress Reports will be required quarterly and will be due 30 days 
following each quarter of the applicable budget period. The final 
quarterly report will serve as the annual report and will be due 90 
days after the budget expiration date. The recipient will be advised of 
the suggested format for the Program Progress Report at the time an 
award is made. In addition, the principal investigator will be required 
to present the progress of the study at an annual FDA extramural 
research review workshop in the Washington, DC metropolitan area. 
Travel costs for this requirement should be specifically requested by 
the applicant as part of the application. A final FSR, Program Progress 
Report, and Invention Statement must be submitted within 90 days after 
the expiration of the project period, as noted on the Notice of Grant 
Award.
    Program monitoring of recipients will be conducted on an ongoing 
basis, and written reports will be reviewed and evaluated at least 
quarterly by the Project Officer. Project monitoring may also be in the 
form of telephone conversations between the Project Officer/Grants 
Management Specialist

[[Page 37849]]

and the Principal Investigator and/or a site visit with appropriate 
officials of the recipient organization. A record of these monitoring 
activities will be made in an official file specific for each 
cooperative agreement and may be available to the recipient of the 
cooperative agreement upon request.

V. Delineation of Substantive Involvement

    Inherent in the cooperative agreement award is substantive 
involvement by the awarding agency. Accordingly, FDA will have 
substantive involvement in the programmatic activities of all the 
projects funded under this notice and request for applications (RFA). 
Substantive involvement may include, but is not limited to, the 
following:
    1. FDA will provide guidance and direction with regard to the 
scientific approach and methodology that may be used by the 
investigator;
    2. FDA will participate with the recipient in determining and 
executing any: (1) Methodological approaches to be used, (2) procedures 
and techniques to be performed, (3) sampling plans proposed, (4) 
interpretation of results, and (5) microorganisms and commodities to be 
used; and
    3. FDA will collaborate with the recipient and have final approval 
on the experimental protocols. This collaboration may include protocol 
design, data analysis, interpretation of findings, coauthorship of 
publications, and the development and filing of patents.

VI. Review Procedure and Criteria

    An application must: (1) Be received by the specified due date; (2) 
be submitted in accordance with sections III.B ``Eligibility,'' VII. 
``Submission Requirements,'' and VIII.A ``Submission Instructions'' of 
this document; (3) not exceed the recommended funding amount stated in 
section I of this document; (4) address only one of the four project 
categories identified in this notice and RFA; and (5) bear the original 
signatures of both the Principal Investigator and the institution's/
organization's authorized official. If an application does not comply 
with these requirements it will be returned to the applicant without 
further consideration.
    Applications meeting the previous requirements will be reviewed, 
evaluated, and scored for scientific and technical merit by a panel of 
experts in the subject field of the specific application.
    Applications will be evaluated and scored on the following 
criteria:
    1. Soundness of the scientific rationale for the proposed study, 
appropriateness of the study design, and the study's ability to address 
all of the objectives of the RFA and thereby protect the health of the 
American consumer;
    2. Availability and adequacy of resources (laboratory facilities, 
equipment, and support services, e.g., biostatistics computational 
support, databases, etc.) to perform and achieve the expected results;
    3. Qualifications, research experience and training of the 
principal investigator and other proposed staff to carry out their 
expected roles under the project; and
    4. Whether the budget requested is realistic and reasonable in 
terms of the scope, aims and duration of the proposed project, 
including whether it is within budget guidelines, and whether all costs 
have been adequately justified and fully documented.
    Funding recommendations are subject to review by a National 
Advisory Council for concurrence with the recommendations made. Final 
funding decisions will be made by the Commissioner of Food and Drugs or 
his designee.
    Applicants must clearly state in their application the project 
category for which they are applying. There is no assurance that awards 
will be made in each of the four project categories. If a project 
category is funded, funding will start with the highest ranked 
application within that project category, and any additional awards 
within that project category will be made based on the next highest 
ranked application. All questions of a technical or scientific nature 
should be directed to the CFSAN program staff, and all questions of an 
administrative or financial nature should be directed to the Grants 
Management Staff. (See the FOR FURTHER INFORMATION CONTACT section of 
this document.)

VII. Submission Requirements

    The original and two copies of the completed Grant Application Form 
PHS 398 (Rev. 4/98 or Rev. 5/01) or the original and two copies of PHS 
5161-1 (Rev. 7/00) for State and local governments (no appendices) 
should be delivered to Rosemary Springer (see ADDRESSES). State and 
local governments may choose to use the PHS 398 application form in 
lieu of PHS 5161-1. 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 CFSAN-03-1[ ]'' (insert Project  1, 2, 3, or 4 within the 
brackets).

VIII. Method of Application

A. Submission Instructions

    Applications will be accepted during normal business 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 CSR, NIH. Any 
application that is sent to NIH, and is then forwarded to FDA and not 
received in time for orderly processing will be deemed not responsive 
and returned to the applicant. Applications must be submitted via mail 
or hand delivery as stated previously. FDA is unable to receive 
applications electronically. Applicants are advised that FDA does not 
adhere to the page limitations or the type size and line spacing 
requirements imposed by the NIH on its applications. NOTE: Applicants 
must limit the Research Plan sections of their applications to 10 pages 
and that no appendices should be included with the applications.

B. Format for Application

    Submission of the application must be on Grant Application Form PHS 
398 (Rev. 4/98 or Rev. 5/01) or PHS 5161-1 (Rev. 7/00) for State and 
local government applicants. All ``General Instructions'' and 
``Specific Instructions'' in the application kit should be followed 
with the exception of the receipt dates and the mailing label address.
    The face page of the application should reflect the RFA number, 
RFA-FDA-CFSAN-03-[ ], (insert Project  1, 2, 3, or 4 within 
the brackets).
    Data included in the application, if identified by the applicant as 
trade secret or confidential commercial information, will be given 
treatment as such to the extent permitted by the Freedom of Information 
Act (5 U.S.C. 552(b)(4)) and FDA's implementing regulations (21 CFR 
20.61).
    Information collection requirements requested on Form PHS 398 and 
the instructions have been submitted by

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PHS to the Office of Management and Budget (OMB) and were approved and 
assigned OMB control number 0925-0001. The requirements requested on 
Form PHS 5161-1 were approved and assigned OMB control number 0348-
0043.

    Dated: June 19, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-15964 Filed 6-24-03; 8:45 am]
BILLING CODE 4160-01-S