[Federal Register Volume 66, Number 172 (Wednesday, September 5, 2001)]
[Rules and Regulations]
[Pages 46367-46368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22167]


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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 and Address

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 and address for 
Baxter Pharmaceutical Products, Inc.

DATES: This rule is effective September 5, 2001.

ADDRESSES: Lonnie W. Luther, Center for Veterinary Medicine (HFV-102), 
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 
301-827-0209.

SUPPLEMENTARY INFORMATION: Baxter Pharmaceutical Products, Inc., 110 
Allen Rd., Liberty Corner, NJ 07938, has informed FDA of a change of 
name and address to Baxter Healthcare Corp., 95 Spring St., New 
Providence, NJ 07974. Accordingly, the agency is amending the 
regulations in 21 CFR 510.600(c)(1) and (c)(2) to reflect the changes.
    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.

    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

    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.

    2. Section 510.600 is amended in the table in paragraph (c)(1) by 
revising the entry for ``Baxter Pharmaceutical Products, Inc.'' and in 
the table in paragraph (c)(2) by revising the entry for ``010019'' 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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*                  *                  *                  *
                  *                  *                  *
Baxter Healthcare Corp., 95 Spring   010019
 St., New Providence, NJ 07974
 
*                  *                  *                  *
                  *                  *                  *
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    (2) * * * 

[[Page 46368]]



------------------------------------------------------------------------
         Drug labeler code                   Firm name and address
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*                  *                  *                  *
                  *                  *                  *
010019                               Baxter Healthcare Corp., 95 Spring
                                      St., New Providence, NJ 07974
 
*                  *                  *                  *
                  *                  *                  *
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    Dated: August 23, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-22167 Filed 9-4-01; 8:45 am]
BILLING CODE 4160-01-S