This PDF is the current document as it appeared on Public Inspection on 12/26/2013 at 08:45 am.
Food and Drug Administration, HHS.
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.
Withdrawal of approval is effective January 6, 2014.Start Further Info
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, firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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:
|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.|
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that approval of NADAs 005-414, 006-019, 006-081, 008-274, and 093-025, and all supplements and amendments thereto, is withdrawn, effective January 6, 2014.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.Start List of Subjects
List of Subjects in 21 CFR Part 520End List of Subjects
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:Start Part
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. Remove §§ 520.2087, 520.2088, and 520.2089.End Amendment Part Start Signature
Dated: December 20, 2013.
Director, Center for Veterinary Medicine.
[FR Doc. 2013-30838 Filed 12-26-13; 8:45 am]
BILLING CODE 4160-01-P0134