Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications, 36111 [E9-17409]

Download as PDF Federal Register / Vol. 74, No. 139 / Wednesday, July 22, 2009 / Rules and Regulations industry of the business concern combined with its affiliates. * * * * * DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Dated: July 16, 2009. Karen Gordon Mills, Administrator. [FR Doc. E9–17323 Filed 7–17–09; 11:15 am] 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 BILLING CODE 8025–01–P AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. 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 36111 (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, email: 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. Sponsor NADA/ANADA Number Product (Drug) 21 CFR Cite Affected (Sponsor Drug Labeler Code) Wellmark International, 1501 East Woodfield Rd., suite 200, West Schaumburg, IL 60173 NADA 141–162 Zodiac Fleatrol Flea Caps (S-methoprene) 520.1390 (011536) NADA 141–178 NAVIGATOR Paste (nitazoxanide) 520.1498 (065274) ANADA 200–279 KETAFLO Injection (ketamine HCl, USP) 522.1222a (000074) IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd., Greensboro, NC 27409 Abbott Laboratories, North Chicago, IL 60064 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notice that approval of NADAs 141–162 and 141–178, and ANADA 200–279, and all supplements and amendments thereto, are withdrawn, effective August 3, 2009.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. 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: jlentini on DSKJ8SOYB1PROD with RULES ■ Authority: 21 U.S.C. 360b. § 520.1390 ■ [Removed] PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 4. The authority citation for 21 CFR part 522 continues to read as follows: ■ Authority: 21 U.S.C. 360b. § 522.1222a [Amended] 5. In paragraph (b) of § 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] BILLING CODE 4160–01–S 1. The authority citation for 21 CFR part 520 continues to read as follows: Jkt 217001 [Docket No. FDA–2009–N–0665] 3. Remove § 520.1498. ■ 18:20 Jul 21, 2009 21 CFR Parts 520 and 524 [Removed] PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS VerDate Nov<24>2008 Food and Drug Administration 2. Remove § 520.1390. § 520.1498 ■ DEPARTMENT OF HEALTH AND HUMAN SERVICES PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 New Animal Drugs; Change of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three new animal drug applications (NADAs) and one abbreviated new animal drug application (ANADA) from Virbac AH, Inc., to Cross Vetpharm Group Ltd. DATES: This rule is effective July 22, 2009. FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8307, email: david.newkirk@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Virbac AH, Inc., 3200 Meacham Blvd., Ft. E:\FR\FM\22JYR1.SGM 22JYR1

Agencies

[Federal Register Volume 74, Number 139 (Wednesday, July 22, 2009)]
[Rules and Regulations]
[Page 36111]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-17409]


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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.

-----------------------------------------------------------------------

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]
BILLING CODE 4160-01-S

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