-
Start Preamble
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
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.Start Printed Page 26289
Start Further InfoFOR 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.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY 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.
Start List of SubjectsList 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:
End Amendment Part Start PartPART 510—NEW ANIMAL DRUGS
End Part Start Amendment Part1. The authority citation for 21 CFR part 510 continues to read as follows:
End Amendment Part Start Amendment Part2. 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:
End Amendment PartNames, addresses, and drug labeler codes of sponsors of approved applications.* * * * *(c) * * *
(1) * * *
Firm name and address Drug labeler code * * * * * Abraxis Pharmaceutical Products, a Div. of Abraxis Bioscience, 6133 River Rd., suite 500, Rosemont, IL 60018 063323 * * * * * (2) * * *
Start SignatureDrug labeler code Firm name and address * * * * * 063323 Abraxis Pharmaceutical Products, a Div. of Abraxis Bioscience, 6133 River Rd., suite 500, Rosemont, IL 60018 * * * * * 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
Document Information
- Effective Date:
- 5/9/2007
- Published:
- 05/09/2007
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Action:
- Final rule.
- Document Number:
- E7-8870
- Dates:
- This rule is effective May 9, 2007.
- Pages:
- 26288-26289 (2 pages)
- Topics:
- Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements
- PDF File:
- e7-8870.pdf
- CFR: (1)
- 21 CFR 510.600