[Federal Register Volume 72, Number 89 (Wednesday, May 9, 2007)]
[Rules and Regulations]
[Pages 26288-26289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8870]


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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 from American 
Pharmaceutical Partners, Inc., to Abraxis Pharmaceuticals Products and 
to change the sponsor's mailing address.

DATES: This rule is effective May 9, 2007.

[[Page 26289]]


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: American Pharmaceuticals Partners, Inc., 
2045 North Cornell Ave., Melrose Park, IL 60160, has informed FDA of a 
change of name and mailing address to Abraxis Pharmaceutical Products, 
a Div. of Abraxis Bioscience, 6133 River Rd., suite 500, Rosemont, Il 
60018. Accordingly, the agency is amending the regulations in 21 CFR 
510.600(c) to reflect these 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.

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 ``American Pharmaceuticals Partners, Inc.'' and 
alphabetically adding a new entry for ``Abraxis Pharmaceutical 
Products''; and in the table in paragraph (c)(2) by revising the entry 
for ``063323'' 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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                                * * * * *
Abraxis Pharmaceutical Products, a Div. of       063323
 Abraxis Bioscience, 6133 River Rd., suite 500,
 Rosemont, IL 60018.
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
    Drug labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
063323..................  Abraxis Pharmaceutical Products, a Div. of
                           Abraxis Bioscience, 6133 River Rd., suite
                           500, Rosemont, IL 60018
                                * * * * *
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    Dated: May 1, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-8870 Filed 5-8-07; 8:45 am]
BILLING CODE 4160-01-S