[Federal Register Volume 67, Number 69 (Wednesday, April 10, 2002)]
[Rules and Regulations]
[Pages 17282-17284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8569]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522


Implantation or Injectable Dosage Form New Animal Drugs; Ketamine 
Hydrochloride

AGENCY: Food and Drug Administration, HHS.

[[Page 17283]]


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 original abbreviated new 
animal drug application (ANADA) filed by Vetrepharm Research, Inc. The 
ANADA provides for veterinary prescription use of an injectable 
solution of ketamine hydrochloride in cats and subhuman primates.

DATES: This rule is effective April 10, 2002.

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: Vetrepharm Research, Inc., 119 Rowe Rd., 
Athens, GA 30601, filed ANADA 200-257 that provides for veterinary 
prescription use of Ketamine HCL, an injectable solution of ketamine 
hydrochloride, in cats and subhuman primates for restraint.
    ANADA 200-257 is approved as of November 9, 2001, and the 
regulations are amended in 21 CFR 522.1222a to reflect the approval. 
The basis of approval is discussed in the freedom of information 
summary.
    In addition, Vetrepharm Research, Inc., has not been previously 
listed in the animal drug regulations as a sponsor of an approved 
application. At this time, 21 CFR 510.600(c) is being amended to add 
entries for this sponsor.
    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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

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 parts 510 and 
522 are amended as follows:

PART 510--NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
    2. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding an entry for ``Vetrepharm Research, Inc.'' and in 
the table in paragraph (c)(2) by numerically adding an entry for 
``064847'' to read as follows:


Sec. 510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * * 
    (1) * * * 

------------------------------------------------------------------------
         Firm name and address                  Drug labeler code
------------------------------------------------------------------------
 
*                  *                  *                  *
                  *                  *                  *
 
Vetrepharm Research, Inc., 119 Rowe      064847
 Rd., Athens,  GA 30601.
 
*                  *                  *                  *
                  *                  *                  *
 
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    (2) * * * 

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
*                  *                  *                  *
                  *                  *                  *
 
064847.......................  Vetrepharm Research, Inc., 119 Rowe Rd.,
                                Athens, GA 30601
 
*                  *                  *                  *
                  *                  *                  *
 
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PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.
    4. Section 522.1222a is revised to read as follows:


Sec. 522.1222a  Ketamine.

    (a) Specifications. Each milliliter contains ketamine hydrochloride 
equivalent to 100 milligrams (mg) ketamine base activity.
    (b) Sponsors. See Nos. 000010, 000074, 000856, 059130, 061690, 
064408, and 064847 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Cats--(i) Amount. 5 to 15 mg/pound body 
weight intramuscularly, depending on the effect desired.
    (ii) Indications for use. For restraint or as the sole anesthetic 
agent in diagnostic or minor, brief surgical procedures that

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do not require skeletal muscle relaxation.
    (2) Subhuman primates--(i) Amount. 3 to 15 mg/kilogram body weight 
intramuscularly, depending upon the species, general condition, and age 
of the subject.
    (ii) Indications for use. For restraint.

    Dated: February 27, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-8569 Filed 4-9-02; 8:45 am]
BILLING CODE 4160-01-S