[Federal Register Volume 61, Number 244 (Wednesday, December 18, 1996)]
[Rules and Regulations]
[Pages 66580-66581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32067]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520


Animal Drugs, Feeds, and Related Products; Change of Sponsor

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 a change of sponsor for a new animal drug 
application (NADA) from Mallinckrodt Veterinary, Inc., to Veterinary 
Specialties, Inc.

EFFECTIVE DATE: December 18, 1996.

FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0213.

SUPPLEMENTARY INFORMATION: Mallinckrodt Veterinary, Inc., Mundelein, IL 
60060, has informed FDA that it has transferred ownership of, and all 
rights and interests in, NADA 65-107 for entromycin powder to 
Veterinary Specialties, Inc., 387 North Valley Ct., Barrington, IL 
60010. Accordingly, the agency is amending the regulations in 21 CFR 
510.600(c)(1) and (c)(2) by alphabetically adding a new listing for 
Veterinary Specialties, Inc. The agency is also amending 21 CFR 
520.154b to reflect the transfer of ownership.

List of Subjects

21 CFR Part 510

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

21 CFR Part 520

    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 
520 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 ``Veterinary Specialties, Inc.'' 
and in the table in paragraph (c)(2) by numerically adding a new entry 
for ``062925'' 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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                      *      *      *      *      *                     
Veterinary Specialties, Inc., 387    062925                             
 North Valley Ct., Barrington, IL                                       
 60010                                                                  
                      *      *      *      *      *                     
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    (2) * * *

                                                                        
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         Drug labeler code                  Firm Name and address       
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                      *      *      *      *      *                     
062925                               Veterinary Specialties, Inc., 387  
                                      North Valley Ct., Barrington, IL  
                                      60010                             
                      *      *      *      *      *                     
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[[Page 66581]]

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).


Sec. 520.154b  [Amended]

    4. Section 520.154b Soluble bacitracin methylene disalicylate and 
streptomycin sulfate oral powder is amended in paragraph (b) by 
removing ``011716'' and adding in its place ``062925''.

    Dated: December 5, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-32067 Filed 12-17-96; 8:45 am]
BILLING CODE 4160-01-F