[Federal Register Volume 60, Number 123 (Tuesday, June 27, 1995)]
[Rules and Regulations]
[Pages 33109-33110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15594]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 an abbreviated new animal drug 
application (ANADA) filed by Chanelle Pharmaceuticals Manufacturing 
Ltd. The ANADA provides for intravenous and intramuscular use of 
xylazine injection in horses and intramuscular use in Cervidae spp. to 
produce sedation accompanied by a shorter period of analgesia.

EFFECTIVE DATE: June 27, 1995.

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

SUPPLEMENTARY INFORMATION: Chanelle Pharmaceuticals Manufacturing Ltd., 
Loughrea, County Galway, Ireland, filed ANADA 200-139 which provides 
for intravenous and intramuscular use of Chanazine (100 
milligrams/milliliter (mg/mL)) Injectable (xylazine hydrochloride 
equivalent to 100 mg xylazine per mL) in horses and intramuscular use 
in Cervidae spp. (fallow deer, mule deer, Sika deer, white-tailed deer, 
and elk) to produce sedation accompanied by a shorter period of 
analgesia. The drug is limited to use by or on the order of a licensed 
veterinarian.
    -Approval of ANADA 200-139 for Chanelle's Chanazine 
(xylazine 100 mg/mL) Injectable is as a generic copy of Miles' NADA 
047-956 for Rompun (xylazine 100 mg/mL) Injectable. The ANADA 
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.
    -In addition, Chanelle Pharmaceuticals Manufacturing Ltd. has not 
previously been listed in the animal drug regulations as the sponsor of 
an approved application. At this time, 21 CFR 510.600(c) is amended to 
add entries for the firm. [[Page 33110]] 
    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 ``Chanelle Pharmaceuticals 
Manufacturing Ltd.,'' and in the table in paragraph (c)(2) by 
numerically adding a new entry for ``061651'' 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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                      *      *      *      *      *                     
Chanelle Pharmaceuticals              061651                            
 Manufacturing Ltd., Loughrea,                                          
 County Galway, Ireland.                                                
                      *      *      *      *      *                     
------------------------------------------------------------------------

    (2) *  *  *

                                                                        
------------------------------------------------------------------------
         Drug labeler code                  Firm name and address       
------------------------------------------------------------------------
                      *      *      *      *      *                     
061651.............................  Chanelle Pharmaceuticals           
                                      Manufacturing Ltd., Loughrea,     
                                      County Galway, Ireland            
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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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    -4. Section 522.2662 is amended by revising the first sentence in 
paragraph (b) to read as follows:


Sec. 522.2662   Xylazine hydrochloride injection.

 * * * * *
     (b) Sponsor. See 000856 and 061651 in Sec. 510.600(c) of this 
chapter for use as horses, wild deer, and elk. *  *  *
-* * * * *

    Dated: June 15, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-15594 Filed 6-26-95; 8:45 am]
BILLING CODE 4160-01-F