[Federal Register Volume 65, Number 144 (Wednesday, July 26, 2000)]
[Rules and Regulations]
[Pages 45877-45878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18871]


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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 Abbott Laboratories. The ANADA provides 
for intramuscular use of ketamine hydrochloride injection in cats for 
restraint or as the sole anesthetic agent for diagnostic or minor, 
brief, surgical procedures that do not require skeletal muscle 
relaxation, and in nonhuman primates for restraint. The drug is for 
veterinary prescription use only.

[[Page 45878]]


DATES: This rule is effective July 26, 2000.

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: Abbott Laboratories, Chemical and 
Agricultural Products Division, 1401 Sheridan Rd., North Chicago, IL 
60064-6316, filed ANADA 200-279 that provides for intramuscular use of 
KetafloTM (ketamine hydrochloride injection, USP) containing 
the equivalent of 100 milligrams of ketamine base per milliliter (mg/
mL) of sterile solution. The product is for veterinary prescription 
use, in cats for restraint or as the sole anesthetic agent for 
diagnostic or minor, brief, surgical procedures that do not require 
skeletal muscle relaxation, and in nonhuman primates for restraint.
    Approval of Abbott Laboratories' ANADA 200-279 for 
KetafloTM (ketamine hydrochloride injection, USP) is as a 
generic copy of Fort Dodge Laboratories' NADA 45-290 for 
Vetalar (ketamine hydrochloride injection equivalent to 100 
mg/mL ketamine). The ANADA is approved as of June 13, 2000, and the 
regulations are amended in 21 CFR 522.1222a(c) to reflect the approval. 
The basis of 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 this 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.
    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.

    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 adding the number ``000074,'' after the number 
``000010,''.

    Dated: July 17, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-18871 Filed 7-25-00; 8:45 am]
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