[Federal Register Volume 59, Number 143 (Wednesday, July 27, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-18309]


[[Page Unknown]]

[Federal Register: July 27, 1994]


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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; 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 SmithKline Beecham Animal Health, to Walco 
International, Inc.

EFFECTIVE DATE: July 27, 1994.

FOR FURTHER INFORMATION CONTACT: Benjamin A. Puyot, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1646.

SUPPLEMENTARY INFORMATION: SmithKline Beecham Animal Health, 1600 Paoli 
Pike, West Chester, PA 19380, has informed FDA that it has transferred 
ownership of, and all rights and interests in, approved NADA 065-488 to 
Walco International, Inc., 15 West Putnam, Porterville, CA 93257. In 
addition, Walco has not previously been listed in 21 CFR 510.600(c)(1) 
as a sponsor of an approved NADA. That section is amended to add 
entries for the firm. Furthermore, in the Federal Register of October 
8, 1991, FDA published a document to reflect a change of sponsor from 
Beecham Animal Health (Drug labeler code 000029) to SmithKline Beecham 
Animal Health (Drug labeler code 053571). The current 21 CFR 
522.1696a(b)(1) and (b)(2) does not reflect that change. This document 
removes the entry for Beecham in 21 CFR 522.1696a(b) and adds in its 
place the entry for Walco International, Inc., the new sponsor. 
Accordingly, the agency is amending the regulations in 21 CFR 
510.600(c)(1) and (c)(2) and 21 CFR 522.1696a(b)(1) and (b)(2) to 
reflect those changes.

List of Subjects

21 CFR Part 510

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

21 CFR 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 ``Walco International, Inc.'' and 
in the table in paragraph (c)(2) by numerically adding a new entry for 
``049185'' to read as follows:


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

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

------------------------------------------------------------------------
        Firm name and address                 Drug labeler code         
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                                  *****                                 
Walco International, Inc., 15 West    049185                            
 Putnam, Porterville, CA 93257.                                         
                                  *****                                 
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    (2) * * *

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         Drug labeler code                  Firm Name and address       
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                                  *****                                 
049185.............................  Walco International, Inc., 15 West 
                                      Putnam, Porterville, CA 93257.    
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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).

Sec. 522.1696a  [Amended]

    4. Section 522.1696a Penicillin G benzathine and penicillin G 
procaine sterile suspension is amended in paragraph (b)(1) and (b)(2) 
by removing ``000029'' and adding in its place ``049185''.

    Dated: July 20, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 94-18309 Filed 7-26-94; 8:45 am]
BILLING CODE 4160-01-F