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

Release Date:  February 17, 2000

RFA:  FD-00-001

Food and Drug Administration

Letter of Intent:          April 3, 2000
Application Receipt Date:  April 17, 2000	

SUMMARY	

The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM) 
is announcing the availability of research funds for fiscal year (FY) 2000 
to study the microbiological hazards associated with the food animal 
production environment.  Approximately $600,000 will be available in FY 
2000.  FDA anticipates making three to six Cooperative Agreement awards at 
$100,000 to $200,000 per award per year (direct and indirect costs 
combined).  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 letters of intent by April 3, 2000.  Submit applications by April 17, 
2000.  If the date falls on a weekend or on a holiday, the date of 
submission will be extended to the following workday.

ADDRESSES

Application forms are available from, and completed applications should be 
submitted to: Cynthia M. Polit, Grants Management Specialist, (HFA-520), 
Food and Drug Administration, 5600 Fishers Lane, rm. 2129, Rockville, MD 
20857, Tel. 301-870-7180. (Applications hand-carried or commercially 
delivered should be addressed to 5630 Fishers Lane, HFA 520, rm. 2129, 
Rockville, MD 20857)

FOR FURTHER INFORMATION CONTACT

Regarding the administrative and financial management aspects of this 
notice: Cynthia M. Polit (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, Tel. (301) 827-8021.

SUPPLEMENTARY INFORMATION

FDA, CVM is announcing the availability of funds for FY 2000 for awarding 
cooperative agreements to support research studies on microbiological 
hazards associated with the food animal production environment.  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 5,000 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 identify and characterize more rapidly and accurately foodborne 
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 effect(s) of therapeutic and non-therapeutic antimicrobial use in food 
producing animals on commensal and foodborne bacterial pathogens.  This 
research will include: (1) 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, (2) 
investigations of the microbiological consequences of antimicrobial use in 
the animal production environment, including selection and elaboration of 
antimicrobial resistant foodborne 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 stimulate 
research on microbiological hazards associated with the food animal 
production environment.  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: (1) antimicrobial resistance development and 
dissemination in the animal production environment, (2) approaches to 
mitigate or minimize antimicrobial resistance, and (3) the impact of 
antimicrobial drug use on the carriage of foodborne pathogens and sentinel 
microorganisms used for monitoring programs.

Projects that fulfill any one or a combination of the following specific 
objectives will be considered for funding:

1.  Studies on the development, dissemination, transmission and persistence 
of antibiotic resistant bacteria and/or genetic determinants from these 
bacteria in the animal production environment.  The horizontal transmission 
of antimicrobial resistant bacteria and resistance genes in the animal and 
animal production environment is of special interest.  Also, the persistence 
of antimicrobial resistant foodborne pathogens and/or genes in the animal 
production environment after withdrawal of antimicrobials in of special 
interest.  FDA/CVM is interested in research in all food-producing animal 
species, but is especially interested in poultry and the poultry production 
environment

2.  Research on the mitigation/intervention strategies to decrease or 
minimize antimicrobial resistance in the animal production environment 
through the manipulation of drug use, altering drug dosage, use of 
competitive exclusion products, and/or rotation of antimicrobials used in 
beef cattle, dairy cattle, swine, poultry and aquaculture. 

3.  The effect of antimicrobial use on the carriage and/or shedding of 
foodborne pathogens (i.e., pathogen load) in the above listed animal 
species.

FDA anticipates funding at least one cooperative agreement for each of the 
objectives listed above contingent upon the quality of the application 
submissions and the availability of fiscal year 2000 funding.

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 
December 31, March 31, June 30, September 30), 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 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, 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 three objectives listed in Section II. Research 
Goals and Objectives.

2.  The proposed study is within the budget and costs have been adequately 
justified and fully documented;

3.  The rationale for the proposed study is sound and the study design is 
appropriate to address the objectives of the RFA;

4.  Laboratory and associated animal facilities are available and adequate;

5.  Support services, e.g., biostatistical computer, etc., are available and 
adequate, and

6.  The Principal Investigator and support staff have research experience, 
training and competence.

SUBMISSION REQUIREMENTS

The original and five copies of the completed Grant Application Form PHS 398 
(Rev. 4/98) or the original and two copies of the PHS 5161(Rev. 6/99) for 
State and local governments, with copies of the appendices for each of the 
copies, should be delivered to the Grants Management Office (address above). 
 State and local governments may choose to use the PHS 398 application form 
in lieu of the PHS 5161. Submit applications by April 17, 2000.  If the 
closing date falls on a weekend or if the date falls on a holiday, the 
submission date 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-FD-00-001.”

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes 
a descriptive title of the proposed research, the name, address, and 
telephone number of the Principal Investigator, the identities of other key 
personnel and participating institutions, and the number and title of the 
RFA in response to which the application may be submitted, Although a letter 
of intent is not required, is not binding, and does not enter into the 
review of a subsequent application, the information that it contains allows 
program staff to estimate the potential review workload and avoid conflict 
of interest in the review.

The letter of intent is to be submitted to David B. Batson at the address 
listed under “For Further Information Contact” section by the letter of 
intent receipt date listed in the Dates section.

METHOD OF APPLICATION

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 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 
http://grants.nih.gov/grants/funding/phs398/phs398.html; the forms can be found at 
http://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. 4/98).  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. 6/99) or Form PHS 398 (Rev. 4/98).

The face page of the application should reflect the request for applications 
number RFA-FD-00-001. 

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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