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U.S. Department of Health and Human Services

Animal & Veterinary

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PUBLICATIONS - January/February 1999

FDA Veterinarian Newsletter January/February 1999 Volume XIV, No I

FDA Veterinarian Index Available

A topical index for the 1998 FDA Veterinarian is now available. Readers who wish to obtain a copy of the Index may call or write the FDA Veterinarian.

Antimicrobial Susceptibility Monitoring Report Available

The Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), and Centers for Disease Control and Prevention (CDC) report entitled "National Antimicrobial Susceptibility Monitoring Program -- Veterinary Isolates, April, 1998" is now available from CVM's Internet Home Page. Copies are also available by calling or writing the FDA Veterinarian.

The emergence of resistance to antimicrobials has compromised control of many bacterial pathogens and is a global problem. Additionally, multiple drug resistance has emerged among many bacterial strains, including Salmonella species. The development of resistant pathogenic bacteria occurs from the human, animal, and environmental uses of antimicrobials. Food animals are commonly exposed to antimicrobials for therapeutic indications and to improve feed efficiency and weight gain. The intestinal flora of animals that have been exposed to antimicrobial agents can serve as a reservoir of resistant bacteria, and these organisms may be present on animal derived food products.

FDA, USDA, and CDC established the National Antimicrobial Resistance Monitoring System (NARMS) in January 1996 to monitor changes in antimicrobial susceptibilities of zoonotic pathogens from human and animal clinical specimens, from healthy farm animals, and from carcasses of food-producing animals at slaughter.

This report summarizes the percentage of isolates collected during calendar year 1997 that were susceptible, intermediate, or resistant to 17 antimicrobials. These antimicrobials were chosen to be representative of common antimicrobials (or classes of antimicrobials) used in animal and human medicine.

Questions about the report may be directed to Ms. Teresa Thomas, Center for Veterinary Medicine (HFV-218 ), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-6741, e-mail: TThomas@bangate.fda.gov.

Framework Document Available

A document entitled "A Proposed Framework for Evaluating and Assuring the Human Safety of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals" is available for review and comment. This document sets out a risk-based framework for evaluating the microbial safety of antimicrobial drugs intended for use in food-producing animals.

This document is the second step in the Agency's consideration of issues related to use of antimicrobial drugs in food-producing animals. The first step was a draft guidance document entitled, "Evaluation of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals." (63 FR 64094) which FDA made available to the public in November.

The Proposed Framework document will be discussed at the next meeting of the Food and Drug Administration's (FDA's) Veterinary Medicine Advisory Committee (VMAC), which is expected to be held in early 1999.

Copies of "A Proposed Framework for Evaluating and Assuring the Human Safety of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals" may be obtained from CVM's Internet Home Page or by calling or writing the FDA Veterinarian.

Written comments on the document should be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments should be identified with the full title of the document and the Docket Number 98D-1146.