[Federal Register: May 9, 2007 (Volume 72, Number 89)]
[Rules and Regulations]
[Page 26288-26289]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09my07-4]
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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:
david.newkirk@fda.hhs.gov.
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
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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.
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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) * * *
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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.
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * *
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