Document ID: FDA-2015-N-0002-0058
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]
[Page 78970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31827]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 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: 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 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.

DATES: This rule 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).
------------------------------------------------------------------------

    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADAs 007-616, 141-088, and 141-132, and all 
supplements and amendments thereto, is withdrawn, effective December 
31, 2015. 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

21 CFR Parts 556

    Animal drugs, Food.

21 CFR Parts 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 parts 556 and 
558 are amended as follows:

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
1. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority:  21 U.S.C. 342, 360b, 371.

Sec.  556.60  [Removed]

0
2. Remove Sec.  556.60.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

    Authority:  21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

Sec.  558.4  [Amended]

0
4. In Sec.  558.4(d), in the ``Category II'' table, remove the entry 
for ``Nitarsone''.

Sec.  558.76  [Amended]

0
5. In Sec.  558.76, remove and reserve paragraph (d)(3)(xiii).

Sec.  558.78  [Amended]

0
6. In Sec.  558.78, remove and reserve paragraph (d)(3)(vii).

Sec.  558.369  [Removed]

0
7. Remove Sec.  558.369.

    Dated: December 11, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-31827 Filed 12-17-15; 8:45 am]
 BILLING CODE 4164-01-P