[Federal Register Volume 67, Number 72 (Monday, April 15, 2002)]
[Notices]
[Pages 18227-18230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-9098]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Food Safety Research; Availability of Cooperative Agreements; 
Request for Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA), in this request for 
applications (RFA), is announcing the availability of approximately 
$750,000 in research funds for fiscal year (FY) 2002. These funds will 
be used to support collaborative research efforts between the Center 
for Food Safety and Applied Nutrition (CFSAN) and scientists and to 
complement and accelerate ongoing research in five project areas in 
order to reduce the incidence of foodborne illness and to protect the 
nations's food supply, food additives, and dietary supplements.

DATES: Submit applications by May 30, 2002.

ADDRESSES: Submit completed applications to Maura Stephanos, Grants 
Management Specialist, Grants Management Staff (HFA-520), Division of 
Contracts and Procurement Management, Food and Drug Administration, 
5600 Fishers Lane, rm. 2129, Rockville, MD 20857, 301-827-7183, FAX 
301-827-7106, e-mail: [email protected]. Application forms are 
available either from Maura Stephanos (address above) or on the 
Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html. 
NOTE: Do not send applications to the Center for Scientific Research 
(CSR), National Institutes of Health (NIH).

FOR FURTHER INFORMATION CONTACT: Regarding the administrative and 
financial management aspects of this notice: Maura Stephanos (address 
above).
    Regarding the programmatic aspects of this notice: John W. Newland, 
Microbial Research Coordinator, Office of Science (HFS-06), 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 and 
quantitate foodborne pathogens, toxins and chemicals that could 
jeopardize the security of the food supply, and to find new and 
improved ways to control these agents. CFSAN supports multiyear 
cooperative agreements intended to help achieve these research goals of 
reducing the incidence of foodborne illness and ensuring the integrity 
of foods, food additives, and dietary supplements. 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, and 
stimulate fruitful interactions between FDA scientists and those within 
the greater research community.
    In continuation of this effort, CFSAN will provide FY 2002 funds to 
be used for research to help enhance the following capabilities of the 
agency: The ability to detect and control the presence of human 
pathogens, food allergens, toxins, and other bioactive compounds that 
may be present in FDA-regulated products; and the development of a 
framework by which the possible risk posed by potential high threat 
agents that might be used to adulterate particular foods, food 
additives, and dietary supplements can be ranked and systematically 
evaluated.
    FDA is announcing the availability of research funds for FY 2002 to 
support research in the following five project categories: (1) 
Development and implementation of a risk-ranking framework to evaluate 
potential high threat microbiological agents, toxins, and chemicals in 
food; (2) practical application of laboratory based biosensor detection 
technology to detect and analyze microbiological agents, food 
allergens, toxins, and other bioactive compounds in foods, food 
additives, and dietary supplements; (3) multi-residue capillary gas 
chromatographic/mass spectrometric (GC/MS) technique for the detection 
of chemicals that may be present as contaminants in foods, food 
additives, and dietary supplements; (4) evaluation of the efficacy of 
multiple heat treatments used during the production of dairy products 
relative to the inactivation of bacterial spores; and (5) development 
of a bioinformatic approach, using predictive algorithms and protein 
sequence databases (structural proteomics), to identify the potential 
allergenicity of food proteins. Approximately $750,000 will be 
available in FY 2002. Of this amount,

[[Page 18228]]

$500,000 will be available for projects 1 through 4 detailed in section 
II ``Research Goals and Objectives'' of this document, and $250,000 
will be available for project 5 also detailed in section II ``Research 
Goals and Objectives'' of this document. For projects 1 through 4, FDA 
anticipates making up to three awards of $100,000 to $200,000 (direct 
plus indirect costs) per award per year. Support of these agreements 
may be up to 3 years in duration with the total budget amount not to 
exceed $200,000 (direct plus indirect costs) per year or a total of 
$600,000 for a 3-year award.
    For project 5, FDA anticipates making one award up to $250,000 
(direct plus indirect costs) per year. Support for this project may be 
up to 3 years in duration with a total budget amount not to exceed 
$250,000 (direct plus indirect costs) per year or a total of $750,000 
for a 3-year award. Any application received that exceeds the amounts 
stated above 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 
assurance that awards will be made in each of the five project 
categories. After the first year, additional years of noncompetitive 
support are predicated upon performance and the availability of Federal 
funds.
    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 hard copy of the ``Healthy People 2010'' 
objectives, vols. I and II, conference edition (B0074) for $22 per set, 
by writing to the Office of Disease Prevention and Health Promotion 
(ODPHP) Communication Support Center (Center), P.O. Box 37366, 
Washington, DC 20013-7366. Each of the 28 chapters of ``Healthy People 
2010'' is priced at $2 per copy. Telephone orders can be placed at the 
Center by calling 301-468-5690. The Center also sells the complete 
conference edition in CD-ROM format (B0071) for $5. This publication is 
also available on the Internet at http://health.gov/healthypeople. 
Internet viewers should select ``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. It should be emphasized that in 
all of the following projects, there is a particular desire to promote 
the development of improved techniques for either the detection, 
control, or risk ranking of microbiological agents, toxins, allergens 
and chemicals in food. Such agents include but are not limited to, 
Bacillus anthracis, Yersinia pestis, Francisella tularensis, 
Clostridium botulinum, Salmonella Enterica, pathogenic Escherichia 
coli, acetylcholinesterase inhibitors, botulinum toxins, abrin, 
tricothecenes, rodenticides, amanitine, and other natural toxins. None 
of the five projects should involve human research subjects that are 
not exempt from the Department of Health and Human Services (DHHS) 
regulations (45 CFR part 46) for the protection of human research 
subjects. The projects and their objectives are as follows.

A. Project 1: Development and Implementation of a Risk-Ranking 
Framework to Evaluate Potential High Threat Microbiological Agents, 
Toxins, and Chemicals in Food

    A risk-ranking framework is needed to facilitate the evaluation and 
ranking of potential high threat microbiological agents, toxins, and 
chemicals that can be used to contaminate food. The framework will 
include a model for quantitatively or semiquantitatively comparing and 
determining the potential threats of these agents and the ability to 
evaluate intervention or control points for food industry, 
manufacturers/processing, warehouses, transport, retail, etc., to 
protect the food supply. Implementation of the framework would include 
using existing and newly developed lists of agents and systematically 
ranking threats. Criteria used in the framework for ranking purposes 
could include but would not be limited to, compatibility with food as a 
vehicle, toxicity (or needed dose), accessibility, and likelihood of 
effect (illness).

B. Project 2: Practical Application of Laboratory Based Biosensor 
Detection Technology to Detect and Analyze Microbiological Agents, Food 
Allergens, Toxins, and Other Bioactive Compounds in Foods, Food 
Additives, and Dietary Supplements

    The objective of this project is to obtain customer ready 
technology that combines immunoassay capture techniques with 
appropriate detector technology, such as an optical transducer or a 
mass spectrometer for use in the rapid detection and identification of 
microbiological agents and toxins in FDA-regulated products (i.e., 
food). This will provide a new detection methodology critical to FDA's 
food surveillance programs, which are designed to keep hazardous 
substances out of the food supply. Research must specifically focus on 
the detection of a variety of microbial agents, toxins, and other 
bioactive compounds in a number of different food matrices. The 
analytical method resulting from this research will provide an 
accurate, fast, and cost-effective means of screening food products.

C. Project 3: Multi-Residue Capillary Gas Chromatographic/Mass 
Spectrometric (GC/MS) Technique for the Detection of Chemicals That May 
Be Present as Contaminants in Foods, Food Additives and Dietary 
Supplements

    The objective of this project is the development of an analytical 
technique, based on GC/MS, which can be used for the identification of 
a number of chemical toxins in foods. The awardee will produce a single 
validated procedure that can be used to screen various foods, food 
additives, and dietary supplements for a number of chemical toxins. The 
method will be capable of identifying a number of classes of chemical 
agents including but not limited to pesticides, rodenticides, and 
mycotoxins in these FDA-regulated products (i.e., food). This research 
will provide a new analytical methodology critical to FDA's food 
surveillance programs, which are designed to identify and avoid 
possible hazardous substances in the food supply.

D. Project 4: Evaluation of the Efficacy of Multiple Heat Treatments 
Used During the Production of Dairy Products Relative to the 
Inactivation of Bacterial Spores

    Multiple heat treatments are used during the manufacture of a 
variety of dairy products. For example, in the production of most 
cheeses there are two to four heating steps (milk pasteurization, 
cooking and primary

[[Page 18229]]

fermentation, secondary fermentation, and extruding). Pasteurization 
may in some instances heat-shock spores into germination. A study is 
sought to determine whether the effect of multiple heat treatments in 
the production of these products is sufficient to destroy vegetative 
cells and/or spores and possible toxins that might arise from the 
presence of spores of C. botulinum and B. anthracis.

E. Project 5: Development of Bioinformatic Approachs, Using Predictive 
Algorithms and Protein Sequence Databases (Structural Proteomics), to 
Identify the Potential Allergenicity of Food Proteins

    The objective of this project is to identify Immunoglobulin E 
(IgE)-binding epitopes or other structural characteristics of known 
food allergens to establish structure-prediction algorithms, which will 
eventually allow scientists to predict structure and function from 
protein sequence. For this project, the prediction of structure and 
function from sequence is focused on establishing the potential 
allergenicity of food proteins or to identify previously unknown food 
allergens. An evaluation of the feasibility of bioinformatic approaches 
to characterize or rank the potential allergenicity of food proteins 
could be modeled after predictive capabilities of currently available 
methods or databases for identification of IgG- or Major 
Histocompatability Complex (MHC)- binding epitopes or pharmaceutical 
target binding sites. This research should lead to the development of 
rapid methods for evaluation of potential food allergens (e.g, in 
bioengineered foods and ingredients) and be directed toward validation 
of these methods using biological systems, such as enzyme immunoassay 
or other quantitative methods.

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. NIH's 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

    The length of support will be for up to 3 years. Funding beyond the 
first year will be noncompetitive and will depend on: (1) Satisfactory 
performance during the preceding year and (2) availability of Federal 
FY funds.

IV. Reporting Requirements

    Annual Financial Status Reports (FSR) (SF-269) are required. An 
original FSR and two copies shall be submitted to FDA's Grants 
Management Officer (address same as given above for Grants Management 
Specialist) within 90 days of the budget expiration date of the 
cooperative agreement. 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 except that the fourth 
quarterly report which will serve as the annual report and will be due 
90 days after the budget expiration date. For continuing agreements, an 
annual Program Progress Report is also required. Submission of the 
noncompeting continuation application (PHS 2590) will be considered as 
the annual Program Progress Report. 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 Washington, DC. Travel costs for this 
requirement should be specifically requested by the applicant as part 
of their 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 and the Project Advisory Group. 
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. A record of these monitoring activities 
will be duly 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 a 
substantive involvement in the programmatic activities of all the 
projects funded under this 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: (a) Methodological approaches to be used, (b) procedures 
and techniques to be performed, (c) sampling plans proposed, (d) 
interpretation of results, and (e) microorganisms and commodities to be 
used.
    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

A. Review Method

    All applications submitted in response to this RFA will first be 
reviewed by grants management and program staff for responsiveness. To 
be responsive, an application must: (1) Be received by the specified 
due date; (2) be submitted in accordance with section III.B 
``Eligibility,'' section VII ``Submission Requirements,'' and section 
VIII.A ``Submission Instructions'' all of this document; (3) not exceed 
the recommended funding amount stated in section I of this document; 
(4) address only one of the five project categories identified in this 
RFA; (5) address specific requirements of individual projects as stated 
in section II ``Research Goals and Objectives'' of this document; and 
(6) bear the original signatures of both the Principal Investigator and 
the Institution's/Organization's Authorized

[[Page 18230]]

Official. If applications are found to be not responsive to this 
announcement, they will be returned to the applicant without further 
consideration.
    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.
    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 
designee.

B. Review Criteria

    Applicants must clearly state in their application for which of the 
requested projects they are applying. All applications will be 
evaluated by program and grants management staff for responsiveness. 
Applications will be reviewed and ranked within each project category. 
There is no assurance that awards will be made in each of the five 
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 (See 
the FOR FURTHER INFORMATION CONTACT section of this document for 
addresses.), and all questions of an administrative or financial nature 
should be directed to Maura Stephanos of the Grants Management Staff 
(address above).
    All applications will be reviewed and scored on the following 
criteria:
    1. Soundness of the scientific rationale for the proposed study and 
appropriateness of the study design and its ability to address all of 
the objectives of the RFA;
    2. Availability and adequacy of laboratory facilities, equipment, 
and support services, e.g., bio-statistics computational support, 
databases, etc.;
    3. Research experience, training, and competence of the principal 
investigator and support staff; and
    4. Whether the proposed study is within the budget guidelines and 
proposed costs have been adequately justified and fully documented.

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, with copies of the 
appendices for each of the copies, should be delivered to Maura 
Stephanos (address above). State and local governments may choose to 
use the PHS 398 application form in lieu of PHS 5161-1. The application 
receipt date is May 30, 2002. 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-02-1, (insert Project #1, 2, 3, 4, or 5 ).''

VIII. Method of Application

A. Submission Instructions

    Applications will be accepted during normal business hours, from 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 (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 
above. 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 NIH on its 
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). 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 request for 
applications number, RFA-FDA-CFSAN-02-1, (insert Project #1, 2, 3, 4, 
or 5).
    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 Form PHS 398 and 
the instructions have been submitted by 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.

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 that have 
been specifically identified by page number, paragraph, etc., by the 
applicant as containing restricted information shall not be used or 
disclosed except for evaluation purposes.

    Dated: March 29, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-9098 Filed 4-12-02; 8:45 am]
BILLING CODE 4160-01-S