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Rule

New Animal Drugs for Use in Animal Feeds; Chlortetracycline

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Information about this document as published in the Federal Register.

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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.

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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: timothy.schell@fda.hhs.gov.

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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.

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List of Subjects in 21 CFR Part 558

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to

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PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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1. The authority citation for

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Authority: 21 U.S.C. 360b, 371.

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2. In § 558.128, in the table in paragraph (e)(2)(iii), in the “Indications for use” column, remove “

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Chlortetracycline.

(e) * * *

(4) * * *

Chlortetracycline amountIndications for useLimitationsSponsor
*         *         *         *         *         *         *
(iv) 10 mg/lb of body weight daily1. 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/tonCalves, 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/day1. 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.
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Dated: June 8, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

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[FR Doc. E9-13849 Filed 6-11-09; 8:45 am]

BILLING CODE 4160-01-S