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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA PUBLISHES SUBSTANTIAL EVIDENCE PROPOSED RULE

FDA Veterinarian Newsletter January/February 1998 Volume XIII, No I

In the November 5, 1997, Federal Register, FDA published a proposed regulation to amend the definition of substantial evidence of effectiveness of new animal drugs. The purpose of this proposed regulation is to encourage the submission of new animal drug applications (NADA's) and supplemental NADA's for single ingredient and combination new animal drugs. The proposal also encourages dose range labeling. The proposed rule implements, in part, the Animal Drug Availability Act of 1996, which amended the Federal Food, Drug, and Cosmetic Act to provide for improvements in the process of approving and using animal drugs, and for other purposes.

The Federal Register notice for this proposed rule is available for review or downloading on CVM's Internet Website. Paper copies are available from the FDA Veterinarian.

Written comments on the proposed rule must be submitted by February 3, 1998. All comments should be sent to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Drive, Room 1-23, Rockville, MD 20857. Please identify comments with the Docket Number 97N-0435.

Questions about this rule may be directed to Herman M. Schoenemann, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-1638.