PUBLIC MASTER FILE AVAILABLE

FDA has announced the availability of target animal safety and effectiveness, and human food safety data to be used in support of a new animal drug application (NADA) or supplemental NADA for the use of ceftiofur sodium sterile powder, reconstituted with sterile water, as an injectable for treating certain respiratory diseases of sheep. The data, contained in Public Master File (PMF) 5544, were compiled under the National Research Support Project-7 (NRSP-7), a national agricultural research program for obtaining clearances for use of new drugs in minor animal species and for special uses. Sponsors may submit NADAs or supplemental NADAs to the Document Control Section (HFV-199), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855. Additional information is available from Dr. Naba K. Das, Center for Veterinary Medicine (HFV-133), (301) 594-1659. Federal Register 9/19/96.