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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Extends Comment Period for MUMS Indexing Rule

FDA Veterinarian Newsletter 2006 Volume XVII, No IV

The Food and Drug Administration (FDA) has announced that it is extending the period for comments on the proposed rule for establishing a drug “Index” under the Minor Use and Minor Species Animal Health Act (MUMS Act).

The 30-day extension means that the comment period will extend until December 20, 2006.

The indexing proposal, which FDA released for comment in August, would permit drug companies to legally market unapproved new animal drugs mostly for minor species that are not used for food. (Exceptions are possible in cases in which a drug could be used for early life stages of food animals, e.g., fish eggs, oyster spat).

The rule will primarily help drug manufacturers legally market drugs sold in pet stores and drugs intended for use in wildlife and zoo animals.

Interested persons may submit to the Division of Dockets Management written or electronic comments on this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number 2006N-0067. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.