[Federal Register Volume 67, Number 151 (Tuesday, August 6, 2002)]
[Rules and Regulations]
[Page 50802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19767]


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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 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 address for Endo 
Pharmaceuticals, Inc.

DATES: This rule is effective August 6, 2002.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-101), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Endo Pharmaceuticals, Inc., 223 Wilmington 
West Chester Pike, Chadds Ford, PA 19317, has informed FDA of a change 
of sponsor address to 100 Painters Dr., Chadds Ford, PA 19317. 
Accordingly, the agency is amending the regulations in 21 CFR 
510.600(c)(1) and (c)(2) to reflect the change of sponsor address.
    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 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 ``Endo Pharmaceuticals, Inc.'' and in the table 
in paragraph (c)(2) by revising the entry for ``060951'' 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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*                  *                  *                  *
                  *                  *                  *
Endo Pharmaceuticals, Inc., 100 Painters Dr.,    060951
 Chadds Ford, PA 19317.
*                  *                  *                  *
                  *                  *                  *
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    (2) * * * 

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            Drug labeler code                                      Firm name and address
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*                  *                  *                  *                  *                  *
                                                        *
060951...................................  Endo Pharmaceuticals, Inc., 100 Painters Dr., Chadds Ford, PA 19317
*                  *                  *                  *                  *                  *
                                                        *
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    Dated: July 19, 2002.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 02-19767 Filed 8-5-02; 8:45 am]
BILLING CODE 4160-01-S