Document ID: FDA-2013-N-0002-0041
Agency: fda
Document Type: Rule
Title: Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid
Posted Date: 2013-11-26T05:00Z

[Federal Register Volume 78, Number 228 (Tuesday, November 26, 2013)]
[Rules and Regulations]
[Page 70496]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28256]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

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

Withdrawal of Approval of New Animal Drug Applications; Arsanilic 
Acid

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 of approval of a new animal 
drug application (NADA) for an arsanilic acid Type A medicated article 
at the sponsor's request because the product is no longer manufactured 
or marketed.

DATES: Withdrawal of approval is effective December 6, 2013.

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: john.bartkowiak@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Fleming Laboratories, Inc., P.O. Box 34384, 
Charlotte, NC 28234 has requested that FDA withdraw approval of NADA 
008-019 for PRO-GEN (arsanilic acid) Type A medicated article because 
the product, used to manufacture Type B and Type C medicated feeds, is 
no longer manufactured or marketed.
    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADA 008-019, and all supplements and amendments 
thereto, is withdrawn, effective December 6, 2013. 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 558

    Animal drugs, Animal feeds.

    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

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

Sec.  558.62  [Amended]

0
2. In Sec.  558.62, remove and reserve paragraphs (a)(1), (a)(2), 
(c)(1)(i), and (c)(1)(ii); and in paragraphs (c)(1)(iii), (c)(1)(iv), 
(c)(1)(v), (c)(1)(vi), and (c)(1)(vii), in the ``Arsanilic acid in 
grams per ton'' column, add ``90''.

    Dated: November 20, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-28256 Filed 11-25-13; 8:45 am]
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