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PMF 005-440 - Letter

The contact information provided in this letter may no longer be valid due to the passage of time. If you have questions about any of the PMFs in development, please contact AskCVM@fda.hhs.gov.

PMF 5440 A-0000

Alistair Webb, Ph.D.
Southern Region NRSP-7 coordinator
Environmental Toxicology
College of Veterinary Medicine
University of Florida
Gainesville, Florida 32611-0925

Dear Dr. Webb:

We refer to your Public Master File (PMF) 5440 dated November 27, 1992, and all amendments up to and including the October 17, 1996, submission in which you provided efficacy, target animal safety, human food safety and environmental data, and information on clorsulon for use in the treatment of adult liver fluke (Fasciola hepatica) in goats.

We have completed our review of the data contained in the PMF, and find the data provide a satisfactory basis for the approval of an NADA or supplemental NADA.

A notice of the satisfactory data contained in this PMF will be published in the FEDERAL REGISTER. These data supplied by the NRSP-7 were obtained with public funds and are, therefore, available for public disclosure and use by any sponsor.

An NADA or supplemental NADA should include, in addition to a reference to the PMF, drug labeling and other information needed for approval, such as data supporting extrapolation from a major species in which the drug is currently approved, or authorized reference to such data, and data concerning manufacturing methods, facilities, and controls, and information addressing potential environmental impacts (including occupational) of the manufacturing process.

Sincerely yours,

Michael J. Blackwell, D.V.M., M.P.H.
Deputy Director, Center for
Veterinary Medicine

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