[Federal Register Volume 59, Number 157 (Tuesday, August 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20066]


[[Page Unknown]]

[Federal Register: August 16, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 510 and 522

 

Animal Drugs, Feeds, and Related Products; Ketamine Hydrochloride 
Injection, USP

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 American Veterinary Products, Inc. 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 subhuman primates for restraint.

EFFECTIVE DATE: August 16, 1994.

FOR FURTHER INFORMATION CONTACT: Charles W. Francis, Center For 
Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1617.

SUPPLEMENTARY INFORMATION: American Veterinary Products, Inc., 749 
South Lemay, suite A3-231, Fort Collins, CO 80524, filed ANADA 200-073 
which provides for intramuscular use of Ketamine Hydrochloride 
Injection, USP, 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 subhuman primates for restraint. The 
drug is limited to use by or on the order of a licensed veterinarian.
    American Veterinary Products' ANADA 200-073 for Ketamine 
Hydrochloride Injection, USP, is approved as a generic copy of Fort 
Dodge's NADA 045-290 for Vetalar/ Ketaset (ketamine 
hydrochloride injection, USP). The ANADA is approved as of July 21, 
1994, and the regulations are amended by revising 21 CFR 
522.1222a(c)(1) to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    In addition, American Veterinary Products, Inc., has not previously 
been listed in 21 CFR 510.600(c)(1) and (c)(2) as sponsor of an 
approved application. That section is amended to add entries for the 
firm.
    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, between 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

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: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (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 
adding alphabetically a new entry for American Vetrinary Products, 
Inc., and in the table in paragraph (c)(2) by adding numerically a new 
entry for ``045984'' to read as follows:


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

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

------------------------------------------------------------------------
                                                                 Drug   
                   Firm name and address                       labeler  
                                                                 code   
------------------------------------------------------------------------
                                  *****                                 
                  American Veterinary Products, Inc., 749               
                   South Lemay, Suite A3-231, Fort Collins,             
                   CO 80524................................       045984
                                  *****                                 
------------------------------------------------------------------------

    (2) *  *  *

------------------------------------------------------------------------
         Drug labeler code                  Firm name and address       
------------------------------------------------------------------------
                                  *****                                 
045984.............................  American Veterinary Products, Inc.,
                                      749 South Lemay, Suite A3-231,    
                                      Fort Collins, CO 80524.           
                                  *****                                 
------------------------------------------------------------------------

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 revising paragraph (c) to read 
as follows:


Sec. 522.1222a  Ketamine hydrochloride injection.

*  *  *  *  *
    (c) Sponsors. (1) See Nos. 000856, 057319, and 045984 in 
Sec. 510.600(c) of this chapter.
*  *  *  *  *

    Dated: August 8, 1994.
Richard H. Teske,
Deputy Director, Premarket Review, Center for Veterinary Medicine.
[FR Doc. 94-20066 Filed 8-15-94; 8:45 am]
BILLING CODE 4160-01-F