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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Amends Rules on ADE Records and Reports

FDA Veterinarian Newsletter 2002 Volume XVII, No II

FDA's Center for Veterinary Medicine is amending the requirements for records and reports of adverse experiences (ADE) and other information for approved new animal drugs.

This interim final rule more clearly defines the kinds of information to be maintained and submitted by new animal drug applicants for a new animal drug application (NADA) or an abbreviated new animal drug application (ANADA). In addition, the interim final rule revises the timing and content of certain reports to enhance their usefulness. The regulation will provide for protection of public and animal health and reduce unnecessary recordkeeping and reporting requirements. This interim rule is effective August 5, 2002.

This interim final rule was published in the February 4, 2002, Federal Register and may be found on the FDA 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, 301-827-3800. Please send one self-addressed adhesive label to assist in processing your request.

Written or electronic comments on new information on the interim final rule and the information collection requirements should be submitted by April 5, 2002. Please note, the Agency will not consider any comments that have been previously submitted and considered during this rulemaking. Written comments should be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments should submitted at http://www.accessdata. fda.gov/scripts/oc/dockets/comment docket.cfm. All comments should be identified with Docket Number 88N-0038.

Further information on the Interim Final Rule may be found in the February 4, 2002, Federal Register and from Dr. William C. Keller, Center for Veterinary Medicine (HFV-210), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6641, or wkeller@cvm.fda.gov.