E9-13849. 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 revised Blue Bird labeling for chlortetracycline Type A medicated articles used to formulate Type B and Type C medicated feeds in various classes of livestock and poultry.

DATES:

This rule is effective June 12, 2009.

FOR FURTHER INFORMATION CONTACT:

Timothy Schell, Center for Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8116, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Alpharma Inc., 440 Rte. 22, Bridgewater, NJ 08807, filed a supplement to NADA 46-699 that provides revised Blue Bird labeling for CHLORMAX (chlortetracycline) Type A medicated articles used to formulate Type B and Type C medicated feeds in various classes of livestock and poultry. The supplemental NADA is approved as of May 22, 2009, and the regulations are amended in § 558.128 (21 CFR 558.128) to reflect the approval.

In addition, § 558.128 is amended to differentiate certain withdrawal times in cattle for two chlortetracycline Type A medicated articles sponsored by Alpharma Inc. under separate NADAs and to correct the spelling of a turkey pathogen.

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.

The agency 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 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, in the table in paragraph (e)(2)(iii), in the “Indications for use” column, remove “ meleagrides” and in its place add “meleagridis”; and revise paragraphs (e)(4)(iv), (e)(4)(v), and (e)(4)(ix) to read as follows:

§ 558.128

Chlortetracycline.

(e) * * *

(4) * * *

Chlortetracycline amount	Indications for use	Limitations	Sponsor
*         *         *         *         *         *         *
(iv) 10 mg/lb of body weight daily	1. Calves, beef and nonlactating dairy cattle; treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline.	Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Treat for not more than 5 d; in feed including milk replacers; withdraw 10 d prior to slaughter. To sponsor No. 048164: zero withdrawal time. See paragraph (d)(1) of this section.	012286, 048164, 066104.
	2. Calves (up to 250 lb): For the treatment of bacterial enteritis caused by E. coli susceptible to chlortetracycline.	See paragraph (d)(1) of this section.	012286, 046573, 048164, 066104.
(v) 500 to 4,000 g/ton	Calves, beef and nonlactating dairy cattle; treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline.	Feed continuously for not more than 5 days to provide 10 mg/lb body weight per day. To sponsor No. 046573 under NADA 046-699: 24-h withdrawal time. To sponsor No. 046573 under NADA 048-761: zero withdrawal time.	046573.
*         *         *         *         *         *         *
(ix) 350 mg/head/day	1. Beef cattle: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline.	Withdraw 48 h prior to slaughter. To sponsor No. 046573 under NADA 046-699: 48-h withdrawal time. To sponsor No. 046573 under NADA 048-761 and No. 048164: zero withdrawal time.	012286, 046573, 048164, 066104.
	2. Beef cattle (under 700 lb): For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline.	Withdraw 48 h prior to slaughter. To sponsor No. 046573 under NADA 046-699: 48-h withdrawal time. To sponsor No. 046573 under NADA 048-761 and No. 048164: zero withdrawal time.	012286, 046573, 048164, 066104.

Dated: June 8, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.