[Federal Register Volume 60, Number 129 (Thursday, July 6, 1995)]
[Rules and Regulations]
[Pages 35122-35123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16625]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522


Animal Drugs, Feeds, and Related Products; Xylazine 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 a supplemental new animal drug 
application (NADA) filed by Lloyd, Inc. The supplemental NADA provides 
for intravenous, intramuscular, or subcutaneous use of xylazine 
injection in cats to produce sedation accompanied by a shorter period 
of analgesia.

EFFECTIVE DATE: July 6, 1995.

FOR FURTHER INFORMATION CONTACT: Marcia K. Larkins, Center For 
Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-0614.

SUPPLEMENTARY INFORMATION: Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, 
IA 51601, is sponsor of NADA 139-236, which provides for intravenous, 
intramuscular, or subcutaneous use of AnaSed Xylazine 
Injection containing xylazine hydrochloride equivalent to 100 
milligrams (mg) xylazine per milliliter (mL) in horses and 20 mg/mL in 
dogs to produce sedation accompanied by a shorter period of analgesia. 
The supplement provides for use of 20 mg/mL xylazine in cats for the 
same indications. The drug is limited to use by or on the order of a 
licensed veterinarian.
     Supplemental NADA 139-236 is approved as a generic copy of Bayer's 
NADA 47-955 for Rompun (xylazine 20 mg/mL) injectable. The 
supplemental NADA is approved as of May 16, 1995, and the regulations 
are amended by revising 21 CFR 522.2662(b) to reflect the approval. The 
basis of approval is discussed in the freedom of information summary.
     Also, the firm has changed the name of the NADA sponsor from Vet-
A-Mix, Inc., to Lloyd, Inc. Because Lloyd, Inc., has not previously 
been listed in the animal drug regulations as the sponsor of an 
approved application, the agency is amending 21 CFR 510.600(c)(1) and 
(c)(2) to add entries for Lloyd, Inc.
    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 20857, between 9 a.m. and 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 
alphabetically adding a new entry for Lloyd, Inc., and in the table in 
paragraph (c)(2) by numerically adding a new entry for ``061690'' to 
read as follows:


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

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

                                                                        
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       Firm name and address-                 Drug labeler code         
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                      *      *      *      *      *                     
 Lloyd, Inc., 604 W. Thomas Ave.,     061690                            
 Shenandoah, IA 51601.                                                  
                      *      *      *      *      *                     
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     (2) *  *  *

                                                                        
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         Drug labeler code--                Firm name and address       
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                      *      *      *      *      *                     
 061690-...........................   Lloyd, Inc.,-604 W. Thomas Ave.,  
                                      Shenandoah, IA 51601              
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PART 522--IMPLANTATION AND INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

     3. 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).

Sec. 522.2662   [Amended]

    4. Section 522.2662 Xylazine hydrochloride injection is amended in 
paragraph (b) by revising the third sentence to read: ``See 061690 in 
Sec. 510.600(c) of this chapter for use in horses, dogs, and cats.''.


[[Page 35123]]

    Dated: June 23, 1995.
Andrew J. Beaulieau,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 95-16625 Filed 7-5-95; 8:45 am]
BILLING CODE 4160-01-F