[Federal Register Volume 71, Number 229 (Wednesday, November 29, 2006)]
[Rules and Regulations]
[Pages 69010-69011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-20250]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510


New Animal Drugs; Change of Sponsor's Name

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor's name from Bertek 
Pharmaceuticals, Inc., to Mylan Bertek Pharmaceuticals, Inc.

DATES: This rule is effective November 29, 2006.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug

[[Page 69011]]

Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, 
e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Bertek Pharmaceuticals, Inc., 12720 Dairy 
Ashford, Sugar Land, TX 77478, has informed FDA that it has changed its 
name to Mylan Bertek Pharmaceuticals, Inc. Accordingly, the agency is 
amending the regulations in 21 CFR 510.600 to reflect the change.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 510

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

0
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 part 510 is 
amended as follows:

PART 510--NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600 in the table in paragraph (c)(1) remove the entry 
for ``Bertek Pharmaceuticals, Inc.'' and alphabetically add a new entry 
for ``Mylan Bertek Pharmaceuticals, Inc.''; and in the table in 
paragraph (c)(2) revise the entry for ``062794'' 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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                                * * * * *
Mylan Bertek Pharmaceuticals, Inc., 12720     062794
 Dairy Ashford, Sugar Land, TX 77478.
                                * * * * *
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    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
062794                       Mylan Bertek Pharmaceuticals, Inc., 12720
                              Dairy Ashford, Sugar Land, TX 77478
                                * * * * *
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    Dated: November 16, 2006.
Bernadette Dunham,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. E6-20250 Filed 11-28-06; 8:45 am]
BILLING CODE 4160-01-S