[Federal Register Volume 59, Number 116 (Friday, June 17, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14708]


[[Page Unknown]]

[Federal Register: June 17, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 Boehringer Ingelheim Animal Health, Inc., to 
Phoenix Scientific, Inc.
EFFECTIVE DATE: June 17, 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: Boehringer Ingelheim Animal Health, Inc., 
2621 North Belth Hwy., St. Joseph, MO 64506-2002, has informed FDA that 
it has transferred ownership of, and all rights and interests in NADA 
99-169 for Oxytocin Injection to Phoenix Scientific, Inc., 3915 South 
48th St. Terrace, P.O. Box 6457, St. Joseph, MO, 64506-0457. 
Accordingly, the agency is amending the regulations in 21 CFR 
510.600(c)(1) and (c)(2) and in 21 CFR 522.1680(b) to reflect the 
change of sponsor.

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 ``Phoenix Scientific, Inc.'' and 
in the table in paragraph (c)(2) by numerically adding a new entry for 
``059130'' 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   
------------------------------------------------------------------------
                                  *****                                 
Phoenix Scientific, Inc. 3915 South 48th St. Terrace, P.O.              
 Box 6457, St. Joseph, MO 64506-0457.......................       059130
                                  *****                                 
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
         Drug labeler code                  Firm name and address       
------------------------------------------------------------------------
                                  *****                                 
059130............................  Phoenix Scientific, Inc. 3915 South 
                                     48th St. Terrace, P.O. Box 6457,   
                                     St. Joseph, MO 64506-0457          
                                  *****                                 
------------------------------------------------------------------------

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. 522.1680  [Amended]

    4. Section 522.1680 Oxytocin injection is amended in paragraph (b) 
by removing ``000010'' and ``and 058639'' and by adding ``058639, and 
059130'' before the word ``in''.

    Dated: June 9, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 94-14708 Filed 6-16-94; 8:45 am]
BILLING CODE 4160-01-F