E9-28468. Oral Dosage Form New Animal Drugs; Chlortetracycline 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 an abbreviated new animal drug application (ANADA) filed by Alpharma Inc. The ANADA provides for use of generic chlortetracycline soluble powder to make medicated drinking water for cattle, swine, chickens, and turkeys for the treatment of several bacterial diseases.

DATES:

This rule is effective November 30, 2009.

FOR FURTHER INFORMATION CONTACT:

John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Alpharma Inc., 440 Route 22, Bridgewater, NJ 08807, filed ANADA 200-441 that provides for the use of A-MYCIN (chlortetracycline) Soluble Powder to make medicated drinking water for cattle, swine, chickens, and turkeys for the treatment of several bacterial diseases. Alpharma Inc.'s A-MYCIN Soluble Powder is approved as a generic copy of Fort Dodge Animal Health, A Division of Wyeth Holdings Corp.'s AUREOMYCIN (chlortetracycline) Soluble Powder, approved under NADA 65-440. The ANADA is approved as of October 9, 2009, and the regulations are amended in 21 CFR 520.445b to reflect the approval.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 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 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.

FDA has determined under 21 CFR 25.33 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 Subjects 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.

2. In § 520.445b, revise paragraph (b)(2) to read as follows:

§ 520.445b

Chlortetracycline powder.

(b) * * *

(2) Nos. 046573 and 053501 for use as in paragraph (d) of this section.

Dated: November 23, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.