2010-4205. New Animal Drugs for Use in Animal Feeds; Chlortetracycline

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 ADM Alliance Nutrition, Inc. The supplemental NADA provides for use of a higher concentration chlortetracycline Type A medicated article for the manufacture of medicated feeds for livestock and poultry.

DATES:

This rule is effective March 2, 2010.

FOR FURTHER INFORMATION CONTACT:

Cindy L. Burnsteel, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115, filed a supplement to NADA 48-480 that provides for the use of CHLORATET 50 (chlortetracycline), a Type A medicated article containing 50 grams of chlortetracycline per pound, for the manufacture of medicated feeds for livestock and poultry. The supplement provides for use of Type A medicated articles containing 90 or 100 grams of chlortetracycline per pound. The supplemental NADA is approved as of January 7, 2010, and the regulations are amended in 21 CFR 558.128 to reflect the approval.

Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required.

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 Subject 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. In § 558.128, revise paragraph (b)(2) to read as follows:

§ 558.128

Chlortetracycline.

(b) * * *

(2) No. 012286: 50, 90, or 100 grams per pound of Type A medicated article.

Dated: February 16, 2010.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.