94-20066. Animal Drugs, Feeds, and Related Products; Ketamine Hydrochloride Injection, USP  

  • [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
    
    
    

Document Information

Published:
08/16/1994
Department:
Health and Human Services Department
Entry Type:
Uncategorized Document
Action:
Final rule.
Document Number:
94-20066
Dates:
August 16, 1994.
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: August 16, 1994
CFR: (3)
21 CFR 510.600(c)
21 CFR 510.600
21 CFR 522.1222a