[Federal Register Volume 63, Number 101 (Wednesday, May 27, 1998)]
[Notices]
[Pages 29016-29019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13918]


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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: ``<a href="http://
www.nih.gov">http://
www.nih.gov</a>.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