Document ID: FDA-2009-N-0270-0001
Agency: fda
Document Type: Rule
Title: Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications
Posted Date: 2009-07-22T04:00Z

[Federal Register: July 22, 2009 (Volume 74, Number 139)]
[Rules and Regulations]               
[Page 36111]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jy09-4]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 522

[Docket No. FDA-2009-N-0270]

 
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval 
of New Animal Drug Applications

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) and an abbreviated new animal 
drug application (ANADA). In a notice published elsewhere in this issue 
of the Federal Register, FDA is withdrawing approval of these NADAs and 
ANADA.

DATES: This rule is effective August 3, 2009.

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: The following sponsors have requested that 
FDA withdraw approval of the two NADAs and ANADA listed in table 1 of 
this document because the products are no longer manufactured or 
marketed:

                                 Table 1.
------------------------------------------------------------------------
                                                   21 CFR Cite Affected
        Sponsor             NADA/ANADA Number      (Sponsor Drug Labeler
                              Product (Drug)               Code)
------------------------------------------------------------------------
Wellmark International,  NADA 141-162             520.1390 (011536)
 1501 East Woodfield     Zodiac Fleatrol Flea
 Rd., suite 200, West     Caps (S-methoprene)
 Schaumburg, IL 60173
------------------------------------------------------------------------
IDEXX Pharmaceuticals,   NADA 141-178             520.1498 (065274)
 Inc., 7009 Albert Pick  NAVIGATOR Paste
 Rd., Greensboro, NC      (nitazoxanide)
 27409
------------------------------------------------------------------------
Abbott Laboratories,     ANADA 200-279            522.1222a (000074)
 North Chicago, IL       KETAFLO Injection
 60064                    (ketamine HCl, USP)
------------------------------------------------------------------------

    In a notice published elsewhere in this issue of the Federal 
Register, FDA gave notice that approval of NADAs 141-162 and 141-178, 
and ANADA 200-279, and all supplements and amendments thereto, are 
withdrawn, effective August 3, 2009. As provided in the regulatory text 
of this document, the animal drug regulations are amended to reflect 
the withdrawal 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 Parts 520 and 522

    Animal drugs.

0
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 520 and 
522 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

Sec.  520.1390  [Removed]

0
2. Remove Sec.  520.1390.

Sec.  520.1498  [Removed]

0
3. Remove Sec.  520.1498.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
4. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

Sec.  522.1222a  [Amended]

0
5. In paragraph (b) of Sec.  522.1222a, remove ``000074,''.

    Dated: July 14, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-17409 Filed 7-21-09; 8:45 am]

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