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Rule

New Animal Drugs For Use in Animal Feeds; Tylosin

Document Details

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 approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA provides for an alternate feeding regimen for tylosin phosphate in Type C medicated swine feeds used for the control of swine proliferative enteropathies.

DATES:

This rule is effective December 12, 2006.

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FOR FURTHER INFORMATION CONTACT:

Joan C. Gotthardt, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: joan.gotthardt@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 12-491 that provides for use of TYLAN (tylosin phosphate) Type A medicated articles. The supplement provides for an alternate feeding regimen for the control of swine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis. In addition, Elanco Animal Health revised the names of other enteric pathogens of swine to reflect changes in the scientific nomenclature for these bacteria. The supplemental NADA is approved as of November 7, 2006, and the regulations in 21 CFR 558.625 are amended 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.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies for 3 years of marketing exclusivity beginning November 7, 2006.

FDA 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.

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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 the Center for Veterinary Medicine,

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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 § 558.625, revise paragraphs (f)(1)(i)(

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Tylosin.

(f) * * *

(1) * * *

(i) * * *

(b) Indications for use. For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes.

(vi) * * *

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(b) * * *

(1) Indications for use. For control of swine dysentery associated with Brachyspira hyodysenteriae, and for control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis.

(c) * * *

(1) Indications for use. For treatment and control of swine dysentery associated with B. hyodysenteriae.

(e) * * *

(1) Indications for use. For control of porcine proliferative enteropathies (ileitis) associated with L. intracellularis.

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Dated: November 29, 2006.

David R. Newkirk,

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

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[FR Doc. E6-21021 Filed 12-11-06; 8:45 am]

BILLING CODE 4160-01-S