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

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URL: https://www.frixlaw.com/law-library/documents/fr%3A98-13918

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** May 27, 1998
- **Citation:** 63 FR 29016

## Text

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.

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SUMMARY: The Food and Drug Administration (FDA), Center for Food Safety
and Applied Nutrition (CFSAN) is announcing the availability of
research funds for fiscal year (FY) 1998 to conduct research to support
the reduction of the incidence of foodborne illness, specifically to
support: The development of sampling methods to enhance the detection,
and more specifically the enumeration, of low levels of pathogens in
foods; the development of intervention strategies for consumers to
improve food safety in the home; and total genome sequence analyses of
the pathogen Escherichia coli O157:H7, towards a molecular definition
of microbial virulence and pathogenicity. Approximately $700,000 will
be available in FY 1998. FDA anticipates making three to five awards at
$100,000 to $200,000 (direct and indirect costs) per award per year.
Support of these agreements may be up to 3 years. The number of
agreements funded will depend on the quality of the applications
received and the availability of Federal funds to support the project.
After the first year, additional years of noncompetitive support are
predicated upon performance and the availability of Federal FY funds.
FDA is mandated by the President's Food Safety Initiatiative (FSI) to
reduce the incidence of foodborne illness to the greatest extent
feasible.

DATES: Submit applications by July 13, 1998. If the closing 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.
ADDRESSES: Application forms are available from, and completed
applications should be submitted to: Robert L. Robins, Division of
Contracts and Procurement Management (HFA-520), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-6170.
(Applications hand-carried or commercially delivered should be
addressed to 5630 Fishers Lane, rm. 2129, Rockville, MD 20852.)

FOR FURTHER INFORMATION CONTACT:
Regarding the administrative and financial management aspects of
this notice: Robert L. Robins (address above).
Regarding the programmatic aspects of this notice: Robert L.
Buchanan, Center for Food Safety and Applied Nutrition, Food and Drug
Administration (HFS-500), 200 C St. SW., Washington DC 20204, 202-205-
5053.
SUPPLEMENTARY INFORMATION: FDA will support the research studies
covered by this notice under section 301 of the Public Health Service
Act (the PHS Act) (42 U.S.C. 241). FDA's research program is described
in the Catalog of Federal Domestic Assistance, No. 93.103.
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.
PHS urges applicants to submit work plans that address specific
objectives of ``Healthy People 2000.'' Potential applicants may obtain
a copy of ``Healthy People 2000 (Full Report, stock No. 017-00100474-0)
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325, 202-512-1800.

[[Page 29017]]

I. Background

FDA is mandated by the President's Food Safety Initiative (FSI) to
reduce the incidence of foodborne illness to the greatest extent
feasible. Even though the American food supply is among the safest in
the world, millions of Americans are stricken by illness each year
caused by the food they consume, and some 9,000 a year, primarily the
very young and elderly, die as a result. Research in food safety seeks
to reduce the incidence of foodborne illness by improving our ability
to detect and enumerate pathogens in the food supply and to find new
ways to control them. The President's FSI requires that 1998 funds be
used to develop rapid cost effective tests for the presence in foods of
pathogens and to develop technologies for preventing foodborne illness
through the control of pathogens.
FDA has continually sponsored research to improve the detection of
pathogens in foods. One area that may now be addressed is the problem
of detecting sporadically-occuring low-level pathogens in foods. A
caveat to employing existing detection regimens is the need to develop
effective sampling strategies. Therefore, one objective of this funding
initiative is the development of new approaches to sampling that will
allow the use of existing detection regimens for screening larger
sample volumes, thereby increasing the probability of detecting the
presence of low levels of a pathogen. The ideal sampling method would:
(1) Be nondestructive, (2) enhance the detection of multiple target
microorganisms at or below current regulatory limits, (3) provide
quantitative data of the level of the target pathogen to aid microbial
risk assessment, and (4) be capable of being automated.
FDA has continually sponsored research in intervention strategies
to mitigate the risk of foodborne illness. The initiative provides an
opportunity to expand the range of research questions addressed by FDA
in intervention strategies. The development of specific intervention
strategies that may be used by consumers or food service providers is a
priority need. A substantial number of disease outbreaks are associated
with food consumption in the home or food service facilities, and in
many of these incidences faulty food handling practices are identified
as contributing factors. Some of these practices may be addressed by
education. However, even with the strict adherence to recommended food
handling practices, there is a risk of pathogenic microorganisms
entering the home kitchen. Such hazards have traditionally been
controlled by cooking, but this is not an option for many foods (e.g.,
lettuce, fresh fruit). New methods or technologies are needed that can
empower the consumer and food service providers by providing them a
means to actively reduce the incidence and prevalence of pathogens on
foods that are not amenable to cooking. An effective intervention is
one that can consistently reduce the levels of target pathogens (i.e,
Salmonella typhimurium, Listeria monocytogenes, E. coli O157:H7,
Cyclospora cayetenensis, Cryptosporidium parvum) by at least 1,000-fold
under standardized test conditions. The funding initiative seeks to
develop these new methods or technologies.
FDA has continually sponsored research for characterization of
microbial virulence factors and the evolution of microbial survival and
growth, especially as it impacts pathogenesis. The initiative provides
an opportunity to expand the range of research questions addressed by
FDA in the virulence and evolution of E. coli O157:H7. This pathogen is
of special interest because of its virulence and resistance to
traditional methods of food preservation. FDA needs to better
understand the mechanisms of the pathogen's survival, growth, and
evolution, with respect to the factors associated with its
pathogenesis. An important tool for acquiring this information is the
sequence of the genome of the pathogen. It is expected that sequence
information of E. coli O157:H7 will provide unique insights into the
evolution of the pathogen, particularly in comparison with
nonpathogenic E. coli sequences. Further insights are anticipated with
respect to identifying sequences of deoxyribonucleic acid from other
organisms and deducing the mechanism of transfer based upon collateral
sequences. Proposed research should initiate a pathway to the eventual
development of rapid and sensitive methods for detection,
identification, and enumeration of this important pathogen.

II. Research Goals and Objectives

The specific objectives of this program will be: (1) The
development of sampling methods or strategies to facilitate existing
detection methods towards detecting, and more importantly enumerating,
low-level microbial pathogens in food; (2) the development of
intervention strategies for use by consumers in the home and by food
service providers that will reduce the incidence of food borne illness,
particularly that associated with fresh or minimally processed produce;
and (3) the expansion of knowledge of the genome of E. coli O157:H7,
towards a molecular definition of pathogen emergence and resistance to
traditional food processing/preservation practices.
Projects that fulfill any one of the following specific objectives
will be considered for funding. Applications may address only one
project objective; however, applicants may submit more than one
application for any of the following project objectives:

A. Project Objective 1

Project objective 1 is intended to develop sampling and statistical
methods that facilitate existing pathogen detection regimens to allow
the detection, and more importantly enumeration, of low-levels of
pathogens in or on foods, particularly fresh or minimally processed
produce. Projects will be considered that seek to develop new ways of
sampling large volumes of foods in a nondestructive or contaminating
manner and provide quantitative estimates of the level of the pathogen
to aid microbial risk assessment. Proposals may include any of a
variety of potential isolation, recovery, and/or concentration systems,
as long as they are suitable for use in food production, processing, or
preparation facilities. An ideal sampling plan should also consider not
only occurrence of pathogen(s), but also dispersion or distribution of
the pathogen in the food. These pathogen enumeration and distribution
data would aid reconstructing the estimated ingested dose that caused
illness, lending support to development of dose-response models in
microbial risk assessment. A plan for demonstrating the feasibility of
the developed methodology in contaminated foods collected under ``field
conditions'' should be included.

B. Project Objective 2

Project objective 2 is intended to develop intervention methods or
technologies other than cooking that can be used by consumers in the
home or by operators of food service facilities. Proposed approaches
should provide consumers with new tools and methods that can enhance
the microbiological safety of foods, particularly fresh or minimally
processed produce, that is prepared in the home or food service
facilities by decreasing the level of pathogens in or on the food. The
proposed intervention strategy can be at any point between the
consumer's, or food service proprietor's, purchase of a

[[Page 29018]]

food or food ingredient and its consumption. The proposed intervention
strategy must be affordable and easy enough to perform so as to be
adopted by consumers. The estimated performance characteristics of the
proposed strategy, with respect to added safety, must be carefully
detailed in the proposal and validated during the research if the grant
is awarded. Validation will include testing with a variety of fresh
vegetables and fruit with at least two of the five pathogens mentioned
previously.

C. Project Objective 3

Project objective 3 is intended to provide genomic sequence data on
E. coli O157:H7. Preference will be given to applicants demonstrating
documented success of other genomic sequencing projects and well-
developed sequencing plans for areas of the genome that have special
relevance to food safety. Applicants must demonstrate that they can
apply the most recent technology cost-effectively to the production of
sequence data and show that they can adequately and efficiently
accumulate, store, and disseminate those data for future interpretation
and application. A commitment to and a plan for making the sequence
data publicly available by deposition into an accessible sequence data
base (GenBank and GSDB) within 3 months of data acquisition and
annotation, must be included in the project description.

D. Protection of Human Research Subjects

Some activities carried out by a recipient under this announcement
may be governed by Department of Health and Human Services (DHHS)
regulations for the protection of human research subjects (45 CFR 46).
These regulations require recipients to establish procedures for the
protection of subjects involved in any research activities. Prior to
funding and upon request of the Office for Protection from Research
Risks (OPRR), prospective recipients must have on file with OPRR an
assurance to comply with 45 CFR 46. This assurance to comply is called
an assurance document. It includes the designated Institutional Review
Board (IRB) for review and approval of procedures for carrying out any
research activities occurring in conjunction with this award. If an
applicable assurance document for the applicant is not already on file
with OPRR, a formal request for the required assurance will be issued
by OPRR at an appropriate point in the review process, prior to award,
and examples of required materials will be supplied at that time. No
applicant or performance site, without an approved and applicable
assurance on file with OPRR, may spend funds on human subject
activities or accrue subjects. No performance site, even with an OPRR-
approved and applicable assurance, may proceed without approval by OPRR
of an applicable assurance for the recipients. Applicants may wish to
contacting OPRR by facsimile (301-402-0527) to obtain preliminary
guidance on human subjects issues. When contacting OPRR, applicants
should provide their institutional affiliation, geographic location,
and all available request for application (RFA) citation information.

III. Reporting Requirements

A Program Progress Report and a Financial Status Report (FSR) (SF-
269) are required. An original FSR and two copies shall be submitted to
FDA's Grants Management Officer within 90 days of the budget expiration
date of the cooperative agreement. Failure to file the FSR (SF-269) on
time may be grounds for suspension or termination of the agreement.
Progress reports will be required quarterly within 30 days following
each Federal fiscal quarter (January 31, April 30, July 30, and October
31), except that the fourth report will serve as the annual report and
will be due 90 days after the budget expiration date. CFSAN program
staff will advise the recipient of the suggested format for the Program
Progress Report at the appropriate time. A final FSR (SF-269), 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. The results of these monitoring
activities will be duly 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 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.

B. Eligibility

These cooperative agreements are available to any public or private
nonprofit entity (including State and local units of government) and
any for-profit entity. For-profit entities must exclude fees or profit
from their request for support to receive grant 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

This agreement is planned 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/or (2) the availability of
Federal fiscal year funds.

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 includes but is
not limited to the following:
1. FDA will appoint project officers who will actively monitor the
FDA supported program under each award.
2. FDA will establish a project advisory group which will provide
guidance and direction to the project officer with regard to the
scientific approaches and methodology that may be used by the
investigator.
3. FDA scientists will collaborate with the recipient and have
final approval on experimental protocols. This collaboration may
include protocol design, data analysis, interpretation of findings, co-
authorship 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. If
applications are found to be nonresponsive, 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

[[Page 29019]]

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

The funding priority categories are as follows:
Project Objective 1-first priority
Project Objective 2-second priority
Project Objective 3-third priority
All comments received on these funding priority categories will be
taken into consideration and will receive a written response.
Applicants must clearly state in their applications which of the
previously listed established funding priority categories is relevant
to their proposed project. Applications will be grouped, reviewed, and
ranked within each funding priority category. Funding priority will
start with the highest ranked applications under each of the three
objectives, then the second highest, etc., until available funds have
been exhausted. All applications will be evaluated by program and
grants management staff for responsiveness. Applications considered
nonresponsive will be returned to the applicant, without being
reviewed. Applicants are strongly encouraged to contact FDA to resolve
any questions regarding criteria prior to the submission of their
application. All questions of a technical or scientific nature must be
directed to the CFSAN program staff and all questions of an
administrative or financial nature must be directed to the grants
management staff. (See FOR FURTHER INFORMATION CONTACT caption at the
beginning of this document.) Applications will be reviewed and scored
on the following criteria:
1. Research should be proposed on microbiological sampling or
intervention strategies that is within one of the three objectives
listed in section II of this document;
2. Whether the proposed study is within the budget and costs have
been adequately justified and fully documented;
3. Soundness of the rationale for the proposed study and
appropriateness of the study design to address the objectives of the
RFA;
4. Availability and adequacy of laboratory facilities and
equipment;
5. Availability and adequacy of support services (e.g.,
biostatistical computer, data bases, etc.,); and
6. Research experience, training, and competence of the principal
investigator and support staff.

VII. Submission Requirements

The original and five copies of the completed Grant Application
Form PHS 398 (Rev. 5/95) or the original and two copies of Form PHS
5161 (Rev. 7/92) for State and local governments, with copies of the
appendices for each of the copies, should be delivered to Robert L.
Robins (address above). State and local governments may choose to use
Form PHS 398 in lieu of the Form PHS 5161. The application closing date
is July 13, 1998. 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 work day. No supplemental or addendum material will be
accepted after the closing date. The outside of the mailing package and
item 2 of the application face page should be labeled, ``Response to
RFA FDA CFSAN-98-2, Project Objective 1 (2 or 3).''

VIII. Method of Application

A. Submission Instructions

Applications will be accepted during normal working hours, 8 a.m.
to 4:30 p.m., Monday through Friday, on or before the established
closing date. Applications will be considered received on time if sent
or mailed on or before the closing 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), National Institutes of Health (NIH). Any application that is
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 forms can be
found on NIH home page on the Internet (address: ``http://
www.nih.gov.grants/funding/phs398/phs398.html''; the forms can be found
at ``http://www.nih.gov/grants/funding/phs398/forms-toc.html'').
However, as noted previously, applications are not to be mailed to NIH.
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. Applications must be submitted via mail delivery as
stated previously. FDA is unable to receive applications via the
Internet.

B. Format for Application

Submission of the application must be on Grant Application Form PHS
398 (Rev. 5/95). All ``General Instructions'' and ``Specific
Instructions'' in the application kit should be followed with the
exception of the closing dates and the mailing label address. Do not
send applications to the CSR, NIH. Applications from State and local
governments may be submitted on Form PHS 5161 (Rev. 7/92) or Form PHS
398 (Rev. 5/95).
The face page of the application should reflect the RFA number RFA-
FDA-CFSAN-98-2, Project Objective 1 (2 or 3).
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.

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 which 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: May 18, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-13918 Filed 5-26-98; 8:45 am]
BILLING CODE 4160-01-F

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A98-13918. Public record. Not legal advice.