New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene Disalicylate; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; correcting amendments.

SUMMARY:

The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) that appeared in the Federal Register of August 18, 2004 (69 FR 51172). FDA is removing the drug labeler code for Pennfield Oil Co. in the entry for use of single-ingredient bacitracin methylene disalicylate (BMD) in swine feed, which was added in error during document formatting; and is adding the approved source of BMD in the entry for use of BMD in combination with chlortetracycline. These corrections are being made so the BMD regulations accurately reflect approved new animal drug applications.

DATES:

This rule is effective September 27, 2004.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-4567, e-mail: ghaibel@ cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

For the reasons set forth in the preamble, FDA is correcting 21 CFR part 558 to read as follows:

List of Subjects in 21 CFR Part 558

• Animal drugs
• Animal feeds

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

2. Section 558.76 is amended in the table by revising paragraph (d)(1)(iv) to read as follows:

(d) * * *

(1) * * *