[Federal Register: June 25, 2003 (Volume 68, Number 122)]
[Notices]
[Page 37847-37850]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jn03-64]
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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:
rspringe@oc.fda.gov. 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:
john.newland@cfsan.fda.gov.
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
[[Page 37850]]
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