[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Rules and Regulations]
[Page 78716]
From the Federal Register Online via the Government Publishing 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, [email protected].
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and all supplements and amendments thereto, is withdrawn, effective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
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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]
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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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