[Federal Register Volume 63, Number 231 (Wednesday, December 2, 1998)]
[Rules and Regulations]
[Pages 66431-66432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32022]


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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 Tartrate

AGENCY: Food and Drug Administration, HHS.


[[Page 66432]]


ACTION: Final rule.

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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 Intervet, Inc. The ANADA provides for use 
of butorphanol tartrate injection for horses for the relief of pain 
associated with colic and postpartum pain in adult horses and 
yearlings.

EFFECTIVE DATE: December 2, 1998.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Intervet, Inc., 405 State St., P.O. Box 318, 
Millsboro, DE 19966-0318, filed ANADA 200-239 that provides for 
veterinary prescription use of Dolorex (butorphanol tartrate) 
injection intravenously for horses for the relief of pain associated 
with colic and postpartum pain in adult horses and yearlings.
    ANADA 200-239 is approved as a generic copy of Fort Dodge Animal 
Health's NADA 135-780 for Torbugesic for horses. The ANADA is 
approved as of September 28, 1998, and the regulations are amended in 
21 CFR 522.246(b) to reflect the approval. The basis for approval is 
discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of the application 
may be seen in the Dockets Management Branch (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.

List of Subjects in 21 CFR Part 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 part 522 is 
amended as follows:

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

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

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

    2. Section 522.246 is amended by revising paragraph (b) to read as 
follows:


Sec. 522.246  Butorphanol tartrate injection.

* * * * *
    (b) Sponsors. Approval to firms identified in Sec. 510.600(c) of 
this chapter for use as indicated:
    (1) See No. 057926 for use as in paragraph (c)(2) of this section.
    (2) See No. 000856 for use as in paragraphs (c)(1), (c)(2), and 
(c)(3) of this section.
* * * * *

    Dated: November 5, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-32022 Filed 12-1-98; 8:45 am]
BILLING CODE 4160-01-F