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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA PROPOSED RULE AND DRAFT GUIDANCE ON MANUFACTURING CHANGES

FDA Veterinarian Newsletter November/December 1999 Volume XIV, No VI

In the October 1, 1999, Federal Register, FDA published a proposed rule to amend regulations on supplements and other changes to an approved new animal drug application (NADA) or abbreviated new animal drug application (ANADA) to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997. This proposed rule would require manufacturers to validate the effect of any manufacturing change on the identity, strength, quality, purity, and potency of a new animal drug as those factors relate to the safety or effectiveness of the product. The proposal identifies changes requiring submission and approval of a supplement prior to the distribution of the new animal drug made using the change, changes requiring the submission of a supplement at least 30 days prior to the distribution of the new animal drug, changes requiring the submission of a supplement at the time of distribution, and changes to be described in an annual report.

Interested persons may submit written comments on the proposed rule by December 15, 1999, to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Written comments on the information collection requirements may be submitted to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th St. NW., Room 10235, Washington, DC 20503, Attn.: Wendy Taylor, Desk Officer.

Also, in the October 1, 1999, Federal Register, FDA announced the availability of a draft guidance entitled, "Guidance for Industry: Chemistry, Manufacturing and Control Changes to an Approved NADA or ANADA" (Guidance Document #83.) This draft guidance is intended to provide recommendations to holders of new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) on how they should report changes to such applications in accordance with the proposed regulation.

Copies of this draft guidance document may be obtained from CVM's Guidelines and Guidances Page or by calling or writing the FDA Veterinarian.

Interested persons may submit written comments on the draft guidance document to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Written comments should be submitted by December 15, 1999, and should be identified with the full title of the draft guidance document and docket number 99D-1651.

Further information about the proposed rule and the draft guidance document is contained in the October 1, 1999, Federal Register and from Dr. Dennis M. Bensley, Jr., Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-6956.