RESEARCH STUDIES ON MICROBIOLOGICAL HAZARDS ASSOCIATED WITH THE FOOD ANIMAL
PRODUCTION ENVIRONMENT, INCLUDING ANIMAL FEEDS

Release Date:  April 22, 1998

RFA:  FDA-CVM-98-1

Food and Drug Administration

Application Receipt Date:  June 1, 1998

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, including animal feeds.  Approximately $1.0 million will be
available in FY 1998.  FDA anticipates making six to twelve 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 three 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 are to be
submitted to:

Robert L. Robins
Grants Management Officer, (HFA-520)
Food and Drug Administration
5600 Fishers Lane, Room 3-40
Rockville, MD  20857
Telephone:  (301) 443-6170

For hand-carried or commercially delivered applications, the address is:
Parklawn Building
12420 Parklawn Drive, Room 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, Ph.D.
Office of Research, Center for Veterinary Medicine (HFV-502)
Food and Drug Administration
8401 Muirkirk Road
Laurel, MD  20708
Telephone:  (301) 827-8021

SUPPLEMENTARY INFORMATION

FDA, CVM is announcing the availability of funds for FY 1998 for awarding
cooperative agreements to support research studies on microbiological hazards
associated with the food animal production environment including 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 work place 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, Tel.
202-512-1800.

RESEARCH OBJECTIVES

Background

The 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 food borne disease to the greatest extent possible. 
Specifically, FSI mandates research be conducted to develop the means to
identify and characterize more rapidly and accurately food borne hazards, to
provide the tools for regulatory enforcement, and to develop interventions
that can be used as appropriate to prevent hazards at each step from
production to consumption of food.

The role of the 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 animal production environment including animal
feeds.  This research will include: (1) development and/or evaluation of
methods for the detection of human pathogens in the animal environment and
feeds,  (2) investigations of factors associated with the emergence,
transmission and carriage of human food borne 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.

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 quantitate 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 vs. 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.

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, October 31), except that 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
monitoring activities will be duly recorded in the official file and may be
available to the recipient upon request.

MECHANISM OF SUPPORT

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 Public Health Service, including the
provisions of 42 CFR Part 52 and 45 CFR Parts 74 and 92.  The regulations
promulgated under Executive Order 12372 do not apply to this program.

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 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.

Length of Support

The length of support will be for up to three 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.

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 an 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, and co-authorship of publications.

REVIEW PROCEDURE AND CRITERIA

Review Method

All applications submitted in response to this request for applications (RFA)
will first be reviewed by grants management and program staff for
responsiveness to this RFA.  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
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 the FDA or his designee.

Program Review Criteria

Applicants are strongly encouraged to contact the 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. Research Goals
and Objectives.

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

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 the 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 the PHS 398 application form in lieu of
the 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 receipt 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."

METHOD OF APPLICATION

Submission Instructions

Applications will be accepted during normal working hours, 8am to 4:30pm,
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), NATIONAL
INSTITUTES OF HEALTH (NIH).  Any application that is sent to the 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
https://grants.nih.gov/grants/funding/phs398/phs398.html; the forms can be found at
https://grants.nih.gov/grants/funding/phs398/forms_toc.html).  However, as noted above,
applications are not to be mailed to the NIH.  (Applicants are advised that
the FDA does not adhere to the page limitations or the type size and line
spacing requirements imposed by the NIH on its applications).  Applications
must be submitted via mail delivery as stated above.  FDA is unable to receive
applications via the Internet.

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 receipt 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 request for applications
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 (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 the PHS to the Office of Management and
Budget (OMB) and were approved and assigned OMB control number 0925-0001.

Legend

Unless disclosure is required by the Freedom of Information Act as amended (5
U.S.C. 552) 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.

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