72 FR 89 pgs. 26288-26289 - New Animal Drugs; Change of Sponsor's Name and Address
Type: RULEVolume: 72Number: 89Pages: 26288 - 26289
FR document: [FR Doc. E7-8870 Filed 5-8-07; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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.
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.
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.
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 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:
§ 510.600 Names, 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) * * *
| Drug 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