[Federal Register Volume 62, Number 103 (Thursday, May 29, 1997)]
[Rules and Regulations]
[Pages 29013-29014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14102]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529


Certain Other Dosage Form New Animal Drugs; Halothane

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 to reflect approval of an abbreviated new animal drug 
application (ANADA) filed by Halocarbon Laboratories, Division of 
Halocarbon Products Corp. The ANADA provides for the use of halothane 
for induction and maintenance of general anesthesia in dogs, cats, and 
other non-food animals.

EFFECTIVE DATE: May 29, 1997.

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: Halocarbon Laboratories, Division of 
Halocarbon Products Corp., 887 Kinderkamack Rd., P.O. Box 661, River 
Ridge, NJ 07661, has filed ANADA 200-200, which provides for the use of 
halothane for induction and maintenance of general anesthesia in dogs, 
cats, and other non-food animals.
    The ANADA is approved as a generic copy of Fort Dodge Laboratories, 
Inc.'s, NADA 14-170 Halothane. ANADA 200-200 is approved as of April 
10, 1997, and the regulations are amended in 21 CFR 529.1115(b) to 
reflect the approval. The basis for approval is discussed in the 
freedom of information summary.

[[Page 29014]]

    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 this application 
may be seen in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.24(d)(1)(i) 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 529

    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 529 is 
amended as follows:

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 529 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).


Sec. 529.1115  [Amended]

    2. Section 529.1115 Halothane is amended in paragraph (b) by adding 
after ``000856'' the phrase ``and 012164''.

    Dated: May 19, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-14102 Filed 5-28-97; 8:45 am]
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