E6-15103. New Animal Drugs for Use in Animal Feeds; Chlortetracycline

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule, technical amendment.

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 supplemental NADA provides for use of an approved Type A medicated article containing chlortetracycline to formulate a free-choice loose mineral Type C medicated feed for beef and nonlactating dairy cattle.

DATES:

This rule is effective September 13, 2006.

FOR FURTHER INFORMATION CONTACT:

Eric S. Dubbin, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0232, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Alpharma Inc., One Executive Dr., Fort Lee, NJ 07024, filed NADA 48-761 for use of AUREOMYCIN 90 Granular (chlortetracycline) Type A medicated article to formulate a free-choice loose mineral Type C medicated feed for beef and nonlactating dairy cattle as an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline. The supplemental NADA is approved as of July 28, 2006, and the regulations are amended in 21 CFR 558.128 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 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.

The agency has determined under 21 CFR 25.33(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 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. In § 558.128, redesignate paragraph (e)(6) as paragraph (e)(7); and add new paragraph (e)(6) to read as follows:

§ 558.128

Chlortetracycline.

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(e) * * *

(6) It is used as a free-choice, loose mineral Type C feed as follows:

(i) Specifications.

Ingredient	Percent	International Feed No.
Dicalcium Phosphate	46.20	6-26-335
Sodium Chloride (Salt)	15.00	6-04-152
Magnesium Oxide	10.67	6-02-756
Cottonseed Meal	10.00	5-01-625
Trace Mineral/Vitamin Premix1	3.80
Calcium Carbonate	3.50	6-01-069
Dried Cane Molasses	3.00	4-04-695
Potassium Chloride	2.00	6-03-755
Mineral Oil	2.00	8-03-123
Iron Oxide	0.50	6-02-431
Chlortetracycline Type A medicated article (90 gram/lb)	3.33
1 Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).

(ii) Amount. 6,000 grams per ton.

(iii) Indications for use. Beef and nonlactating dairy cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.

(iv) Limitations. Feed continuously on a free-choice basis at a rate of 0.5 to 2.0 mg chlortetracycline per head per day.

(v) Sponsor. See No. 046573 in § 510.600(c) of this chapter.

* * * * *

Dated: August 30, 2006.

Steven D. Vaughn,

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