[Federal Register Volume 60, Number 185 (Monday, September 25, 1995)]
[Rules and Regulations]
[Page 49339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23600]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; Ketamine 
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 Fermenta Animal Health Co. The ANADA 
provides for intramuscular use of ketamine hydrochloride injection in 
cats for restraint and to produce anesthesia that is suitable for 
diagnostic or minor surgical procedures that do not require skeletal 
muscle relaxation and in nonhuman primates for restraint.

EFFECTIVE DATE: September 25, 1995.

FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, Center for Veterinary 
Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1616.

SUPPLEMENTARY INFORMATION: Fermenta Animal Health Co., P.O. Box 338, 
15th and Oak Sts., Elwood, KS 66024, filed ANADA 200-029, which 
provides for intramuscular use of ketamine hydrochloride injection 
(equivalent to 100 milligrams/milliliter (mg/mL) ketamine) in cats for 
restraint and to produce anesthesia that is suitable for diagnostic or 
minor surgical procedures that do not require skeletal muscle 
relaxation and in nonhuman primates for restraint. The drug is limited 
to use by or on the order of a licensed veterinarian.
    Fermenta Animal Health's ANADA 200-029 for ketamine hydrochloride 
injection (equivalent to 100 mg/mL ketamine) is approved as a generic 
copy of Fort Dodge Laboratories' NADA 045-290 for Vetalar /
Ketaset (ketamine hydrochloride injection equivalent to 100 
mg/mL ketamine). The ANADA is approved as of August 16, 1995, 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 addition, Sec. 522.1222a is amended by removing and reserving 
paragraphs (a) and (d).
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20855, from 9 a.m. to 4 p.m., Monday 
through Friday.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above), between 9 a.m. and 4 p.m., Monday 
through Friday.

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

    2. Section 522.1222a is amended by removing and reserving 
paragraphs (a) and (d), and by revising paragraph (c) to read as 
follows:


Sec. 522.1222a  Ketamine hydrochloride injection.

    (a) [Reserved]
* * * * *
    (c) Sponsors. See Nos. 000856, 045984, 054273, and 057319 in 
Sec. 510.600(c) of this chapter.
    (d) [Reserved]
* * * * *

    Dated: September 8, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-23600 Filed 9-22-95; 8:45 am]
BILLING CODE 4160-01-F