Notices. Notice
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/register/2003/07/10/03-17440·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Notice of Approval of New Animal Drug Applications; Chlortetracycline AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is providing notice that in 2001 it approved a supplemental new animal drug application
(NADA)filed by Alpharma, Inc. The supplemental NADA provided for use of chlortetracycline Type A medicated articles to make Type B and Type C medicated swine feeds for the control of porcine proliferative enteropathies (ileitis). The applicable section of the regulation did not require amendment. FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: *jgotthar@cvm.fda.gov* . SUPPLEMENTARY INFORMATION: In accordance with section 512(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(i)) and 21 CFR 514.105(a) and 514.106(a), FDA is providing notice that in 2001 it approved a supplemental NADA that was not the subject of a final rule. A final rule was not published because 21 CFR 558.128 did not require amendment. On November 15, 2001, FDA approved a supplement filed by Alpharma, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024 to NADA 48-761 for AUREOMYCIN (chlortetracycline) Type A medicated articles. The supplemental NADA provided for use of AUREOMYCIN Type A medicated articles to make Type B and Type C medicated swine feeds for the control of porcine proliferative enteropathies (ileitis) caused by *Lawsonia intracellularis* susceptible to chlortetracycline. No new data were submitted. The necessary amendment to 21 CFR 558.128 was made in a final rule (65 FR 45881, July 26, 2000) for the 2000 supplemental approval of the identical claim for Alpharma, Inc.'s CHLORMAX (chlortetracycline) Type A medicated articles, approved under NADA 046-699. A freedom of information summary containing approved product labeling may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Dated: June 25, 2003. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 03-17440 Filed 7-9-03; 8:45 am]
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