Document ID: FDA-2014-N-0002-0014
Agency: fda
Document Type: Rule
Title: Zoetis Inc., Withdrawal of Approval of New Animal Drug Applications;
Chlortetracycline; Sulfathiazole; Penicillin
Posted Date: 2014-03-20T04:00Z

[Federal Register Volume 79, Number 54 (Thursday, March 20, 2014)]
[Rules and Regulations]
[Page 15541]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05882]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

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

Zoetis Inc., Withdrawal of Approval of New Animal Drug 
Applications; Chlortetracycline; Sulfathiazole; Penicillin

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) and two abbreviated new animal drug 
applications (ANADAs) for three-way, fixed-ratio combination drug Type 
A medicated articles containing chlortetracycline, sulfathiazole, and 
penicillin. This action is being taken at the sponsor's request because 
these products are no longer manufactured or marketed.

DATES: This rule is effective March 31, 2014.

FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-453-6843.

SUPPLEMENTARY INFORMATION: Zoetis Inc., 333 Portage St., Kalamazoo, MI 
49007 has requested that FDA withdraw approval of the following NADA 
and two ANADAs because the products are no longer manufactured or 
marketed:

------------------------------------------------------------------------
                NADA/ANADA                        Proprietary name
------------------------------------------------------------------------
039-077...................................  CSP 250 (chlortetracycline,
                                             sulfathiazole, and
                                             penicillin) Type A
                                             medicated article.
200-140...................................  AUREOZOL (chlortetracycline,
                                             sulfathiazole, and
                                             penicillin) Type A
                                             medicated article.
200-167...................................  AUREOZOL 500 Granular
                                             (chlortetracycline,
                                             sulfathiazole, and
                                             penicillin) Type A
                                             medicated article.
------------------------------------------------------------------------

    The NADAs listed were identified as being affected by guidance for 
industry (GFI) 213, ``New Animal Drugs and New Animal Drug 
Combination Products Administered in or on Medicated Feed or Drinking 
Water of Food-Producing Animals: Recommendations for Drug Sponsors for 
Voluntarily Aligning Product Use Conditions with GFI 209'', 
December 2013.
    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADA 039-077, ANADA 200-140, and ANADA 200-167, and 
all supplements and amendments thereto, is withdrawn, effective March 
31, 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 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.  558.4  [Amended]

0
2. In Sec.  558.4(d), in the ``Category II'' table, remove the entry 
for ``Sulfathiazole'' and its respective following entries.

Sec.  558.155  [Removed]

0
3. Remove Sec.  558.155.

    Dated: March 12, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-05882 Filed 3-19-14; 8:45 am]
BILLING CODE 4160-01-P