01-10621. Oral Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride Soluble Powder

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Alpharma, Inc. The NADA which provides for a revised withdrawal time for use of oxytetracycline hydrochloride soluble powder in the drinking water of turkeys and swine.

DATES:

This rule is effective April 30, 2001.

FOR FURTHER INFORMATION CONTACT:

Janis R. Messenheimer, Center for Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7578.

SUPPLEMENTARY INFORMATION:

Alpharma, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filed a supplement to NADA 130-435 that provides for use of Oxytet (oxytetracycline HCl) Soluble for making medicated drinking water for the treatment of various bacterial diseases of livestock. The NADA provides for a zero-day slaughter withdrawal time after the use of the product in drinking water of turkeys and swine. The supplemental application is approved as of November 29, 2000, and the regulations are amended in 21 CFR 520.1660d to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (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.

The agency has determined under 21 CFR 25.24(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

List of Subject in 21 CFR Part 520

Animal drugs.

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 520 is amended as follows:

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.

§ 520.1660d

[Amended]

2. Section 520.1660d Oxytetracycline hydrochloride soluble powder is amended in the sixth sentence in paragraphs (d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), and (d)(1)(ii)(C)(3) by removing “046573”; in the last sentence in paragraphs (d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), and (d)(1)(ii)(C)(3) by removing “No. 053389” and by adding in its place “Nos. 046573 and 053389”; and in the fourth sentence in paragraph (d)(1)(iii)(C) by removing “Nos. 046573 and 057561” and by adding in its place “No. 057561 and zero days those products sponsored by No. 046573.”

Dated: April 16, 2001.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.