[Federal Register Volume 68, Number 61 (Monday, March 31, 2003)]
[Rules and Regulations]
[Pages 15369-15370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7533]


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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.

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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 Bayer 
Corp., Agriculture Division, Animal Health to Bayer HealthCare LLC, 
Animal Health Division.

DATES: This rule is effective March 31, 2003.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Bayer Corp., Agriculture Division, Animal 
Health, P.O. Box 390, Shawnee Mission, KS 66201, has informed FDA of a 
change of name to Bayer HealthCare LLC, Animal Health Division. 
Accordingly, the agency is amending the regulations in 21 CFR 
510.600(c) 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

0
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. Section 510.600 is amended in the table in paragraph (c)(1) by 
removing the entry for ``Bayer Corp.'' and by alphabetically adding an 
entry for ``Bayer HealthCare LLC''; and in the table in paragraph 
(c)(2) by revising the entry for ``000859'' 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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                                * * * * *
Bayer HealthCare LLC, Animal Health           000859
 Division, P.O. Box 390, Shawnee Mission, KS
 66201.
                                * * * * *
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    (2) * * *

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      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *

[[Page 15370]]

 
000859                       Bayer HealthCare LLC, Animal Health
                              Division, P.O. Box 390, Shawnee Mission,
                              KS 66201
                                * * * * *
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    Dated: March 21, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-7533 Filed 3-28-03; 8:45 am]
BILLING CODE 4160-01-S