E8-27646. Oral Dosage Form New Animal Drugs; Amprolium; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Correcting amendments.

SUMMARY:

The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) that appeared in the Federal Register of August 6, 2008 (73 FR 45610). FDA is correcting a paragraph designating the sponsors of approved applications for oral dosage forms of amprolium. This correction is being made to improve the accuracy of the animal drug regulations.

DATES:

This rule is effective November 20, 2008.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

For reasons set forth in this preamble, FDA is correcting 21 CFR part 520 as follows:

List of Subjects in 21 CFR Part 520

• Animal drugs

Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is corrected by making the following amendment:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 520 continues to read as follows:

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

§ 520.100

[Corrected]

2. In § 520.100(b)(2), remove “Nos. 051311 and 066104” and add in its place “No. 66104”.

Dated: October 17, 2008.

Bernadette Dunham,

Director, Center for Veterinary Medicine.