Document ID: FDA-2010-N-0002-0045
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feeds: Florfenicol
Posted Date: 2010-06-17T04:00Z

[Federal Register: June 17, 2010 (Volume 75, Number 116)]
[Rules and Regulations]               
[Page 34361]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17jn10-13]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2010-N-0002]

 
New Animal Drugs for Use in Animal Feeds; Florfenicol

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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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 Intervet, Inc. The supplemental NADA 
provides for the manufacture of florfenicol Type B medicated swine 
feeds.

DATES:  This rule is effective June 17, 2010.

FOR FURTHER INFORMATION CONTACT:  Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8341, email: 
cindy.burnsteel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Intervet, Inc., 56 Livingston Ave., 
Roseland, NJ 07068, filed a supplement to NADA 141-264 for use of 
NUFLOR (florfenicol) Antibiotic Type A Medicated Article for Swine by 
veterinary feed directive that provides for the manufacture of Type B 
medicated swine feeds. The supplemental NADA is approved as of May 13, 
2010, and the regulations are amended in 21 CFR 558.4 to reflect the 
approval.
    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.

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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, 21 CFR part 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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1. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

Sec.  558.4   [Amended]

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2. In paragraph (d) of Sec.  558.4, in the ``Category II'' table, in 
the ``Type B maximum (100x)'' column, in the entry for ``Florfenicol'', 
remove ``Swine feed: n/a'' and in its place add ``Swine feed: 9.1 g/lb 
(2.0%)''.

    Dated: June 14, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2010-14611 Filed 6-16-10; 8:45 am]
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