[Federal Register Volume 65, Number 251 (Friday, December 29, 2000)]
[Notices]
[Pages 83040-83041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-33372]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Veterinary Antimicrobial Decision Support System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) Center for Veterinary 
Medicine (CVM) announces that funds may be available to support an 
unsolicited grant application submitted by Iowa State University. The 
applicant has requested funds to develop a web-based, peer-reviewed 
antimicrobial decision support system centered on therapeutic 
applications that will allow food animal veterinary practitioners to 
utilize all available information in the construction of antimicrobial 
regimens.

FOR FURTHER INFORMATION CONTACT:
    Regarding the administrative and financial management aspects of 
this notice: Peggy L. Jones, Division of Contracts and Procurement 
Management (HFA-520), Food and Drug Administration, 5600 Fishers Lane, 
rm. 2129, Rockville, MD 20857, 301-827-7160. Correspondence hand-
carried or commercially delivered should be addressed to 5630 Fishers 
Lane (HFA-520), rm. 2129, Rockville, MD 20857.
    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:

I. Purpose of the Project

    The specific aims of the project are as follows: (1) Perform 
extensive literature searches to identify pharmacokinetic, 
pharmacodynamic, clinical trial, antimicrobial pathogen susceptibility, 
regulatory, food safety, and approval process information pertinent to 
the veterinary antimicrobial decision support system (VADS); (2) 
develop and apply standard operating procedures for

[[Page 83041]]

evaluating the quality and reliability of information and data for use 
in developing the VADS system contents; (3) apply the principles of 
pharmacology in constructing therapeutic regimens for use when approved 
antimicrobial products are not effective as labeled; (4) design a 
relational database allowing a user to efficiently search the VADS 
system for label and extralabel regimens based on therapeutic 
applications, and to then review regulatory and food safety information 
applicable to these regimens; and (5) subject the VADS system content 
to review prior to release and then constantly upgrade the content on 
the basis of new information and review by users.

II. Eligible Applicants

    Assistance may only be provided to Iowa State University because of 
the following:
    1. Iowa State University is the only organization that submitted an 
unsolicited application for the purpose stated above.
    2. The project proposed by the applicant is unique and innovative 
in that pharmacokinetic, pharmacodynamic, clinical trial, and pathogen 
susceptibility information will be interpreted by clinical 
pharmacologists and reviewed by other experts in the appropriate fields 
prior to inclusion in the system. Users may either use the information 
as provided or examine the transparent development process used in 
constructing the system. In addition, by compiling available 
information to support prudent antimicrobial use, the VADS system will 
emphasize what information is not available, thereby aiding researchers 
in targeting research goals.
    3. The team assembled to carry out the proposed work is uniquely 
qualified to achieve the goals of this application. Their combined 
experience encompasses practice in academic, general, and specialized 
production medicine settings as well as demonstrated competence in the 
application of clinical pharmacology and informatics in veterinary 
medicine. Support for the research team and the VADS system project has 
already been expressed in the form of start up funding provided by 
veterinary and producer organizations.

III. Funding

    We anticipate that approximately $250,000 may be made available in 
fiscal year (FY) 2001 to support this project. If funded the award will 
begin sometime in FY 2001 and will be made for a 12-month budget period 
within a project period of up to 5 years. Funding estimates may change. 
Continuation awards within an approved project period will be made on 
the basis of satisfactory progress as evidenced by required reports and 
the availability of funds.

    Dated: December 22, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-33372 Filed 12-28-01; 8:45 am]
BILLING CODE: 4160-01-S