00-18871. Implantation or Injectable Dosage Form New Animal Drugs; Ketamine Hydrochloride Injection

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

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.

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 Ketaflo^TM (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 Ketaflo^TM (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.

§ 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.