[Federal Register Volume 63, Number 73 (Thursday, April 16, 1998)]
[Notices]
[Pages 18921-18924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-10069]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Research Studies on Microbiological Hazards Associated with the 
Food Animal Production Environment Including Animal Feeds; 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 Veterinary 
Medicine (CVM) is announcing the availability of research funds for 
fiscal year (FY) 1998 to study the microbiological hazards associated 
with the food animal production environment which includes animal 
feeds. Approximately $1 million will be available in FY 1998. FDA 
anticipates making 6 to 12 Cooperative Agreement awards at $100,000 to 
$200,000 per award per year (direct and indirect costs). Support for 
these agreements may be for 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 projects.

DATES: Submit applications by June 1, 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, Grants 
Management Officer, Division of Contracts and Procurement Management 
(HFA-520), Food and Drug Administration, 5600 Fishers Lane, Park Bldg., 
rm. 3-40, Rockville, MD 20857, 301-443-6170. (Applications hand-carried 
or commercially delivered should be addressed to the Park Bldg., 12420 
Parklawn Dr., rm. 3-40, 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: David B. Batson, 
Center for Veterinary Medicine (HFV-502), Food and Drug Administration, 
8401 Muirkirk Rd., Laurel, MD 20708, 301-827-8021.
SUPPLEMENTARY INFORMATION:  FDA is announcing the availability of funds 
for FY 1998 for awarding cooperative

[[Page 18922]]

agreements to support research studies on microbiological hazards 
associated with the food animal production environment which includes 
animal feeds. 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 workplans 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.

I. Background

     FDA is mandated to assure the microbiological safety of foods, 
including those derived from animals. The President's Food Safety 
Initiative (FSI) of 1997 calls for increased allocation of resources 
for research by FDA to identify and investigate microbiological hazards 
associated with food produced by animal agriculture. 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. The goal of the FSI is to further reduce the incidence 
of foodborne disease to the greatest extent possible. Specifically, FSI 
mandates research be conducted to develop the means to: (1) Identify 
and characterize more rapidly and accurately foodborne hazards, (2) 
provide the tools for regulatory enforcement, and (3) to develop 
interventions that can be used as appropriate to prevent hazards at 
each step from production to consumption of food.
    The role of FDA's CVM in this research relates to microbial hazards 
associated with pre-harvest phases of food animal production, including 
aquaculture. The FSI specifically identifies a need for research 
addressing the microbial ecology of the food animal production 
environment which includes animal feeds. This research will include: 
(1) Development and/or evaluation of methods for the detection of human 
foodborne pathogens in the animal environment and feeds; (2) 
investigations of factors associated with the emergence, transmission, 
and carriage of human foodborne pathogens in or on food-producing 
animals and edible products derived from them; and (3) investigations 
of the microbiological consequences of the use of antibiotics in the 
animal production environment, including selection and elaboration of 
antibiotic resistant pathogens and possible interactions which would 
create conditions for increased pathogen carriage rates.

II. Research Goals and Objectives

     The specific objective of this research program will be to provide 
financial assistance to investigators conducting research on 
microbiological hazards associated with the food animal production 
environment, including animal feeds. It is of particular interest to 
FDA that this research advance scientific knowledge of human foodborne 
pathogens, such as salmonellae, Escherichia coli, and campylobacteria. 
Potential areas of investigation include transmission and fate in 
animal agriculture, antibiotic resistance development and dissemination 
in the animal production environment, and cultural/molecular methods 
evaluation/refinement for use in studying the microbiota of the animal 
production ecosystem.
     Projects that fulfill any one or a combination of the following 
specific objectives will be considered for funding:
    (1) Performance evaluation of the FDA Bacteriological Analytical 
Manual (BAM) cultural and molecular methods to identify and quanitate 
human foodborne pathogens in animal feeds, feed commodities, and the 
animal production environment, including feces, manure, and litter. 
Optimization of the methods found not to perform satisfactorily. 
Development and testing of rapid detection methods and sampling 
strategies for use in animal feeds and the animal production 
environment.
    (2) Conducting surveys to establish baseline data on human 
foodborne pathogen content in feeds and feed commodities. Work of this 
type is of particular interest if it compares feed at the site of 
manufacture versus feed at the farm. In addition, research to 
investigate survival characteristics of pathogens in feeds under 
various manufacturing and storage conditions is of interest. 
Identification of species/strain differences in survival/proliferation 
patterns in feeds is also a topic of concern.
    (3) Conducting research to investigate the fate and transmission 
dynamics of human foodborne pathogens, especially antibiotic resistant 
bacteria, after ingestion by an animal or animals or as an 
environmental contaminant in a herd or flock.
    (4) Research associated with human foodborne pathogen 
identification and carriage in fish (excluding protozoans) produced in 
various aquaculture conditions.
    (5) Research to develop background data on antibiotic resistance 
patterns and effects of antibiotics on human foodborne pathogen 
carriage rates associated with the animal production and aquaculture 
environments. Also investigations of the dynamic effects resulting from 
the introduction of specific antibiotics into animal production and 
aquaculture environments are of interest. Investigations of effects 
that antibiotic residues in the environment, including aquaculture 
ponds, may have on resistance development are also of interest.

 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 will be grounds for suspension or termination of the grant. 
Progress reports will be required quarterly within 30 days following 
each Federal fiscal quarter (January 31, April 30, July 30, and October 
31), except for the fourth report which will serve as the annual report 
and will be due 90 days after the budget expiration date. CVM 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

[[Page 18923]]

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 
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. 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 (2) the availability of 
Federal fiscal year appropriations.

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 request for applications (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; and
     (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, and 
co-authorship of publications.

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 applicants 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, and the final funding decisions will be made by the 
Commissioner of Food and Drugs or his designee.

B. Review Criteria

     Applicants are strongly encouraged to contact FDA to resolve any 
questions regarding criteria or administrative procedure prior to the 
submission of their application. All questions of a technical or 
scientific nature must be directed to the CVM contact and all questions 
of an administrative or financial nature must be directed to the Grants 
Management Officer. (See the ``For Further Information Contact'' 
section at the beginning of this document.) Responsiveness will be 
based on the following criteria:
    (1) Research should be proposed on microbiological hazards research 
that is within one or more of the five 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 and associated animal 
facilities;
    (5) Availability and adequacy of support services (e.g., 
biostatistical computer, 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 hand-carried or 
commercially delivered to Robert L. Robins (address above). State and 
local governments may choose to use Form PHS 398 in lieu of Form PHS 
5161. Submit applications by June 1, 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. 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 CVM-98-1''.

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, 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 the NIH home page on 
the Internet (address http://www.nih.gov/grants/phs398/phs398.html; the 
forms can be found at <a href="http://www.nih.gov/grants/phs398/forms_
toc.html">http://www.nih.gov/grants/phs398/forms_
toc.html</a>). However, as noted above, 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 above. 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''

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and ``Specific Instructions'' in the application kit should be followed 
with the exception of the receipt dates and the mailing label address. 
Do not send applications to 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-CVM-98-1.
     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 as determined by 
the freedom of information officials of the Department of Health and 
Human Services 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: April 10, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-10069 Filed 4-15-98; 8:45 am]
BILLING CODE 4160-01-F