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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Announces Public Meeting And Availability Of Draft Guidance On Antimicrobial Resistance

September 11, 2002

FDA's Center for Veterinary Medicine (CVM) will convene a public meeting on October 2, 2002, to discuss the "Draft Guidance for Industry: Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern" (Guidance #152). The public meeting will be held from 9:00 a.m. to 5:00 p.m. at the DoubleTree Hotel, 1750 Rockville Pike, Rockville, MD, 20852. The purpose of the meeting is to discuss the draft guidance document and provide an opportunity for questions and comments from stakeholders. The notice of availability for the draft guidance and the notice of the public meeting is scheduled to be published in the September 13, 2002 Federal Register.

The draft guidance document outlines a risk analysis methodology as a process for evaluating antimicrobial resistance concerns as part of the pre-approval safety evaluation of a new animal drug. If the drug sponsor elects to use this risk analysis methodology, it may use this guidance and the methodology described to conduct a qualitative risk assessment to help evaluate antimicrobial resistance concerns as part of an overall pre-approval safety evaluation of their proposed new animal drug product. The draft guidance is posted on the FDA/CVM Home Page. Single copies of the guidance may be obtained by writing to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855. Please send a self-addressed adhesive label to assist in processing your request.

Registration for the meeting is free and is required. Early registration is encouraged. Persons who need special accommodations for a disability should contact the DoubleTree Hotel at least 7 days in advance of the meeting. Registration information and an agenda are available on the CVM Home Page . Additional information about the meeting will be posted on this website before the meeting.

General inquiries about the meeting may be directed to Aleta Sindelar, CVM, (HFV-3) at 301-827-4515. Individuals who wish to speak during the public comment period should contact Anna Roy, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 301-827-2947, Fax 301-827-4335. Since time is limited, CVM encourages those wishing to speak to contact CVM and submit a short summary of their presentation by September 25, 2002; faxed copies of presentations are permissible. CVM also encourages consolidation of like-minded presentations to provide sufficient opportunity for public comment at the meeting. Individuals who wish their comments to be considered during the meeting may submit written or electronic comments by September 25, 2002.

Submit written or electronic comments on the draft guidance document within 75 days of the date the document is published in the Federal Register. Written comments should be sent to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be submitted . All comments should include the title of the draft guidance document and Docket Number 98D-1146.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855