Document ID: FDA-2010-N-0002-0038
Agency: fda
Document Type: Rule
Title: Animal Drugs, Feeds, and Related Products: Withdrawal of Approval of a New Animal Drug Application; Buquinolate; Coumaphos
Posted Date: 2010-05-05T04:00Z

[Federal Register: May 5, 2010 (Volume 75, Number 86)]
[Rules and Regulations]               
[Page 24394]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05my10-7]                         

[[Page 24394]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558

[Docket No. FDA-2010-N-0002]

 
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval 
of a New Animal Drug Application; Buquinolate; Coumaphos

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 by removing those portions that reflect approval of 
two new animal drug applications (NADAs). In a notice published 
elsewhere in this issue of the Federal Register, FDA is withdrawing 
approval of these NADAs.

DATES:  This rule is effective May 17, 2010.

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, e-mail: john.bartkowiak@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Purina Mills, Inc., P.O. Box 66812, St. 
Louis, MO 63166-6812 has requested that FDA withdraw approval of NADA 
42-117 for Purina 6 Day Worm-Kill Concentrate (coumaphos) because the 
product is no longer manufactured or marketed.
    In addition, Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 
235 East 42d St., New York, NY 10017 has requested that FDA withdraw 
approval of NADA 45-738 for use of LINCOMIX (lincomycin) and BONAID 
(buquinolate) single-ingredient Type A medicated articles to make two-
way, combination drug Type C medicated broiler feed because buquinolate 
is no longer manufactured or marketed.
    In a notice published elsewhere in this issue of the Federal 
Register, FDA gave notice that approval of NADA 42-117 and NADA 45-738, 
and all supplements and amendments thereto, is withdrawn, effective May 
17, 2010. As provided in the regulatory text of this document, the 
animal drug regulations are amended to reflect these withdrawals of 
approval.
    In 1995, the approval of NADA 34 716 for BONAID Type A medicated 
article was voluntarily withdrawn (60 FR 37651, July 21, 1995) and 
approved conditions of use for buquinolate and all its approved 
combinations in 21 CFR 558.105, including combination with lincomycin 
under NADA 45-738, were removed (60 FR 39847, July 21, 1995). At this 
time, the tolerances for residues of buquinolate in edible products of 
chickens and its listing as a Category I drug in 21 CFR 558.4 are being 
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

21 CFR Part 556

    Animal drugs, Foods.

21 CFR Part 558

    Animal drugs, Animal feeds.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 
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.  556.90  [Removed]

0
2. Remove Sec.  556.90.

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. 360b, 371.

Sec.  558.4  [Amended]

0
4. In Sec.  558.4, in paragraph (d), in the ``Category I'' table, 
remove the entry for ``Buquinolate''.

Sec.  558.185  [Amended]

0
5. In Sec.  558.185, remove paragraph (b)(2) and redesignate paragraph 
(b)(3) as paragraph (b)(2).

    Dated: April 30, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-10564 Filed 5-4-10; 8:45 am]
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