
[Federal Register Volume 79, Number 61 (Monday, March 31, 2014)]
[Rules and Regulations]
[Pages 17859-17860]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06994]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2014-N-0002]


Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug 
Applications for Combination Drug Medicated Feeds Containing an 
Arsenical Drug; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correcting amendments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a 
document amending the animal drug regulations to reflect the withdrawal 
of approval of new animal drug applications (NADAs) that appeared in 
the Federal Register of February 27, 2014 (79 FR 10976). That document 
listed an NADA for which a withdrawal of approval (WOA) was not 
intended and failed to remove all conditions of use associated with the 
withdrawn NADAs. This correction is being made to improve the accuracy 
of the animal drug regulations.

DATES: This correction is effective March 31, 2014.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9019, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is correcting a document amending the 
animal drug regulations to reflect the WOA of NADAs that appeared in 
the Federal Register of February 27, 2014 (79 FR 10976). That document 
listed an NADA for which a WOA was not intended and failed to remove 
all

[[Page 17860]]

conditions of use associated with the withdrawn NADAs. This correction 
is being made to improve the accuracy of the animal drug regulations.
    In the preamble in rule FR Doc. 2014-02617 published on February 
27, 2014 (79 FR 10976), make the following corrections:
    On page 10976, in the second column, in the 4th line of the 
``SUMMARY'' section, remove ``69'' and replace with ``68''.
    On page 10977, appearing near the end of the page, ``Huvepharma AD, 
5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria, has requested 
that FDA withdraw approval of the following 16 NADAs and 8 ANADAs'', is 
corrected to read ``Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 
1113 Sofia, Bulgaria, has requested that FDA withdraw approval of the 
following 15 NADAs and 8 ANADAs''; and on the same page in the table, 
the entry ``013-461 3-NITRO (roxarsone)/AMPROL Plus (amprolium and 
ethopabate).'' is removed. 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 
corrected by making the following correcting amendments.

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.  558.195  [Amended]

0
2. In Sec.  558.195, remove paragraph (e)(1)(vii).


Sec.  558.355  [Amended]

0
3. In Sec.  558.355, remove and reserve paragraph (b)(3).

0
4. In Sec.  558.635, revise paragraphs (d)(4)(v), (d)(4)(vi), and 
(d)(4)(vii) to read as follows:


Sec.  558.635  Virginiamycin.

* * * * *
    (d) * * *
    (4) * * *
    (v) Monensin as in Sec.  558.355.
    (vi) Salinomycin as in Sec.  558.550.
    (vii) Semduramicin as in Sec.  558.555.

    Dated: March 25, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-06994 Filed 3-28-14; 8:45 am]
BILLING CODE 4160-01-P


