Document ID: FDA-2013-N-0002-0044
Agency: fda
Document Type: Rule
Title: Withdrawal of Approval of New Animal Drug Applications; Roxarsone
Posted Date: 2013-12-27T05:00Z

[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Rules and Regulations]
[Page 78716]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30838]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2013-N-0002]

Withdrawal of Approval of New Animal Drug Applications; Roxarsone

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 the withdrawal approval of five new animal 
drug applications (NADAs) for roxarsone oral dosage form products at 
the sponsor's request because the products are no longer manufactured 
or marketed.

DATES: Withdrawal of approval is effective January 6, 2014.

FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9079, john.bartkowiak@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Zoetis Inc., 333 Portage St., Kalamazoo, MI 
49007 has requested that FDA withdraw approval of the following five 
NADAs for roxarsone oral dosage form products, used to make medicated 
drinking water for chickens, turkeys, and swine, because the products 
are no longer manufactured or marketed:

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               NADA                           Proprietary name
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005-414..........................  REN-O-SAL (roxarsone) Tablets.
006-019..........................  Zuco Poultry Tablets.
006-081..........................  Korum Improved Formula.
008-274..........................  Pig Scour Tablets.
093-025..........................  3-NITRO (roxarsone) Soluble.
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    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADAs 005-414, 006-019, 006-081, 008-274, and 093-025, 
and all supplements and amendments thereto, is withdrawn, effective 
January 6, 2014. As provided in the regulatory text of this document, 
the animal drug regulations are amended to reflect these voluntary 
withdrawals of approval.
    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 520

    Animal drugs.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

Sec. Sec.  520.2087, 520.2088, and 520.2089  [Removed]

0
2. Remove Sec. Sec.  520.2087, 520.2088, and 520.2089.

    Dated: December 20, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-30838 Filed 12-26-13; 8:45 am]
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