Document ID: FDA-2015-N-0002-0057
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of New
Animal Drug Applications; Nitarsone
Posted Date: 2015-12-18T05:00Z

[Federal Register Volume 80, Number 243 (Friday, December 18, 2015)]
[Rules and Regulations]
[Pages 78970-78971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31828]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2015-N-0002]

New Animal Drugs for Use in Animal Feed; Withdrawal of Approval 
of New Animal Drug Applications; Nitarsone

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of three new animal drug applications (NADAs) providing for the use of 
nitarsone in medicated feed for chickens and turkeys. This action is 
being taken at the sponsor's request because these products are no 
longer manufactured or marketed.

[[Page 78971]]

DATES: Withdrawal of approval is effective December 31, 2015.

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5761, sujaya.dessai@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Zoetis Inc., 333 Portage St., Kalamazoo, MI 
49007 has requested that FDA withdraw approval of the following NADAs 
that provide for the use of nitarsone in medicated feed for chickens 
and turkeys because the products are no longer manufactured or 
marketed:

------------------------------------------------------------------------
                                                              21 CFR
          File No.                   Product name             Section
------------------------------------------------------------------------
007-616....................  HISTOSTAT 50 (nitarsone)            558.369
                              Type A Medicated Article.
141-088....................  HISTOSTAT 50 (nitarsone)/           558.369
                              BMD (bacitracin methylene
                              disalicylate).
141-132....................  HISTOSTAT 50/ALBAC                  558.369
                              (bacitracin zinc).
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    Therefore, under authority delegated to the Commissioner of Food 
and Drugs and redelegated to the Center for Veterinary Medicine, and in 
accordance with 21 CFR 514.116 Notice of withdrawal of approval of 
application, notice is given that approval of NADAs 007-616, 141-088, 
and 141-132, and all supplements and amendments thereto, is hereby 
withdrawn, effective December 31, 2015.
    Elsewhere in this issue of the Federal Register, FDA is amending 
the animal drug regulations to reflect the voluntary withdrawal of 
approval of these applications.

    Dated: December 11, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-31828 Filed 12-17-15; 8:45 am]
 BILLING CODE 4164-01-P