Federal Register, Volume 63 Issue 188 (Tuesday, September 29, 1998)

[Federal Register Volume 63, Number 188 (Tuesday, September 29, 1998)]
[Rules and Regulations]
[Pages 51822-51823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25910]


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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; Ketamine 
Hydrochloride Injection

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 Lloyd, Inc. The ANADA provides for 
veterinary prescription use of ketamine hydrochloride injection in cats 
for restraint or as an anesthetic and in subhuman primates for 
restraint.

EFFECTIVE DATE: September 29, 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: Lloyd, Inc., 604 W. Thomas Ave., P.O. Box A, 
Shenandoah, IA 51601-0130, filed ANADA 200-055 that provides for 
veterinary prescription use of VetaKet^TM ketamine 
hydrochloride injection, intramuscularly, in cats for restraint or as 
sole anesthetic agent for diagnostic or minor, brief surgical 
procedures that do not require skeletal muscle relaxation and in 
subhuman primates for restraint.
    Lloyd, Inc.'s ANADA 200-055 ketamine hydrochloride injection is 
approved as a generic copy of Fort Dodge Animal Health's NADA 45-290 
Vetalar (ketamine hydrochloride injection). The ANADA is 
approved as of August 3, 1998, and the regulations are amended in 21 
CFR 522.1222a(c) 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 data and information 
submitted to support approval of this application may be seen in the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers La., 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.

Sec. 522.1222a   [Amended]

    2. Section 522.1222a Ketamine hydrochloride injection is amended in 
paragraph (c) by removing ``and

[[Page 51823]]

059130'' and by adding in its place ``059130, and 061690.''


    Dated: August 27, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-25910 Filed 9-28-98; 8:45 am]
BILLING CODE 4160-01-F