[Federal Register Volume 65, Number 33 (Thursday, February 17, 2000)]
[Notices]
[Pages 8174-8177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3861]


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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; Availability of Coorperative 
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) 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 3 or 6 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 
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 letters of intent as soon as possible or 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, 301-827-7180. Applications 
hand-carried or commercially delivered should be addressed to 5630 
Fishers Lane (HFA-520), rm. 2129, Rockville, MD 20852.

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, 
Office of Research, Center for Veterinary Medicine (HFV-502), Food and 
Drug Administration, 8401 Muirkirk Rd., Laurel, MD 20708, 301-827-8021.

SUPPLEMENTARY INFORMATION: FDA's 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

[[Page 8175]]

``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 ensure 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: (1) Identify 
and characterize more rapidly and accurately foodborne hazards, (2) 
provide the tools for regulatory enforcement, and (3) 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 effect(s) of therapeutic and nontherapeutic 
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 
that would create conditions for increased pathogen carriage rates.

II. Research 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 Campylobacter. 
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 anyone 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 is of special interest. FDA's 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 FY 2000 funding.

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 (December 31, March 31, June 30, September 
30), except that the fourth report that 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.

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 promulgated 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 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.

C. Length of Support

    The length of support will be 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 FY appropriations.

V. Delineation of Substantive Involvement

    Inherent in the cooperative agreement award is substantive 
involvement by the

[[Page 8176]]

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.

VI. Review Procedure and Criteria

A. Review Method

    All applications submitted in response to this RFA's 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 Food and Drugs or her designee.

B. 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 person and all 
questions of an administrative or financial nature must be directed to 
the Grants Management Specialist (see For Further Information Contact 
section 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 
of this document;
    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.

VII. 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 FDA CVM-00-1''.

VIII. 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 (address 
above) by the letter of intent receipt date listed in the Dates section 
of this document.

IX. 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 
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 nonresponsive and returned to the applicant. Instructions for 
completing the application forms can be found on the NIH home page on 
the Internet at http://www.nih.gov/grants/phs398/phs398.html; the forms 
can be found at http://www.nih.gov/grants/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 or 
hand delivery as stated above. FDA is unable to receive applications 
through the Internet.

B. 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-FDA-CVM-00-1.
    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).

[[Page 8177]]

    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 the FOIA 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.

    Dated: February 8, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-3861 Filed 2-16-00; 8:45 am]
BILLING CODE 4160-01-F