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Rule

New Animal Drugs; Change of Sponsor

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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.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for seven approved new animal drug applications (NADAs) for clopidol Type A medicated articles and combination drug medicated chicken and turkey feeds from Aventis Animal Nutrition, Inc., to Merial Ltd.

DATES:

This rule is effective April 14, 2003.

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FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0209.

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SUPPLEMENTARY INFORMATION:

Aventis Animal Nutrition, Inc., 3480 Preston Ridge Rd., suite 650, Alpharetta, GA 30005-8891, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 34-393, 40-264, 41-541, 44-016, 46-209, 49-934, and 99-150 for clopidol Type A medicated articles and certain combination clearances for use in medicated feeds for chickens and turkeys to Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640. Accordingly, the agency is amending the regulations in § 558.175 (21 CFR 558.175) to reflect the transfer of ownership. Section 558.175 is also being changed to a table format.

Following the change of sponsor of these NADAs, Aventis Animal Nutrition, Inc., is no longer the sponsor of any approved applications. Therefore, 21 CFR 510.600(c) is being amended to remove the entries for this sponsor.

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

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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 the Center for Veterinary Medicine,

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PART 510—NEW ANIMAL DRUGS

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1. The authority citation for

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Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

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[Amended]
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2. Section 510.600

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PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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3. The authority citation for

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

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4. Section 558.175 is revised to read as follows:

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Clopidol.

(a) Specifications. Type A medicated article containing 25 percent clopidol.

(b) Approvals. See No. 050604 in § 510.600(c) of this chapter.

(c) [Reserved]

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(d)

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Clopidol in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(1) 113.5Broiler chickens and re-placement chickens intended for use as caged layers: As an aid in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivatiDo not feed to chickens over 16 weeks of age050604
(2) 113.5Bacitracin methylene disalicylate 4 to 50Broiler chickens: As in paragraph (d)(1) of this section; for increased rate of weight gainFeed continuously as the sole ration from the time chicks are placed in floor pens until slaughter. Do not feed to chickens over 16 weeks of age; bacitracin methylene disalicylate as provided by No. 046573 in § 510.600(c) of this chapter050604
(3) 113.5Bacitracin 4 to 25 plus roxarsone 45.4Broiler chickens: As in paragraph (d)(1) of this section; for growth promotion, feed efficiency; improved pigmentation, and increased rate of weight gainDo not feed to chickens over 16 weeks of age; withdraw 5 days before slaughter; as sole source of organic arsenic; as bacitracin methylene disalicylate or bacitracin zinc provided by No. 046573 in § 510.600(c) of this chapter046573 050604
(4) 113.5Bacitracin zinc 5 to 25Broiler chickens: As in paragraph (d)(1) of this section; for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration; bacitracin zinc as provided by No. 046573 in § 510.600(c) of this chapter046573 050604
(5) 113.5Chlortetracycline 100 to 200Broiler and replacement chickens: As in paragraph (d)(1) of this section; for control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracyclineFeed continuously as sole ration from the time chicks are placed in floor pens for 7 to 14 days050604
(6) 113.5Lincomycin 2 to 4Broiler chickens: As in paragraph (d)(1) of this section; for increased rate of weight gain and improved feed efficiencyDo not feed to chickens over 16 weeks of age; as lincomycin hydrochloride monohydrate000009
(7) 113.5Roxarsone 45.4Broiler and replacement chickens intended for use as caged layers: As in paragraph (d)(1) of this section; for growth promotion, feed efficiency; and improved pigmentationDo not feed to chickens over 16 weeks of age; withdraw 5 days before slaughter; as sole source of organic arsenic050604
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(8) 227Broiler and replacement chickens intended for use as caged layers: As in paragraph (d)(1) of this sectionFeed continuously as the sole ration; feed up to 16 weeks of age if intended for use as caged layers; withdraw 5 days before slaughter if given at the level of 0.025 percent in feed or reduce level to 0.0125 percent 5 days before slaughter050604
(9) 113.5 or 227Turkeys: As an aid in the prevention of leucocytozoonosis caused by Leucocytozoon smithiFor turkeys grown for meat purposes only; feed continuously as the sole ration at 0.0125 or 0.025 percent clopidol depending on management practices, degree of exposure, and amount of feed eaten; withdraw 5 days before slaughter050604
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Dated: March 25, 2003.

Steven D. Vaughn,

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

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[FR Doc. 03-9028 Filed 4-11-03; 8:45 am]

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