Document ID: FDA-2008-N-0039-0047
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Butorphanol
Posted Date: 2008-06-02T04:00Z

[Federal Register: June 2, 2008 (Volume 73, Number 106)]
[Rules and Regulations]               
[Page 31357-31358]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jn08-4]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

 
Implantation or Injectable Dosage Form New Animal Drugs; 
Butorphanol

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of an abbreviated new animal drug 
application (ANADA) filed by Lloyd, Inc. The ANADA provides for the 
veterinary prescription use of butorphanol tartrate injectable solution 
in horses for the relief of pain.

DATES: This rule is effective June 2, 2008.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Lloyd, Inc., 604 West Thomas Ave., 
Shenandoah, IA 51601, filed ANADA 200-332 that provides for the 
veterinary prescription use of BUTORPHIC (butorphanol tartrate) 
Injection in horses for the relief of pain associated with colic and 
postpartum pain. Lloyd, Inc.'s BUTORPHIC Injection is approved as a 
generic copy of TORBUGESIC, sponsored by Fort Dodge Animal Health, 
Division of Wyeth, under NADA 135-780. The ANADA is approved as of May 
1, 2008, and 21 CFR 522.246 is amended to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application may be seen in the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    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 Part 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

[[Page 31358]]

the Center for Veterinary Medicine, 21 CFR part 522 is amended as 
follows:

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

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

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

Sec.  522.246   [Amended]

0
2. In paragraph (b)(3) of Sec.  522.246, remove ``057926 and 059130'' 
and in its place add ``057926, 059130, and 061690''.

    Dated: May 21, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-12160 Filed 5-30-08; 8:45 am]

BILLING CODE 4160-01-S