Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 12 approved new animal drug applications (NADAs) from A. H. Robins Co. to Fort Dodge Animal Health, Division of Wyeth.
This rule is effective November 6, 2002.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Lonnie W. Luther, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: email@example.com.End Further Info End Preamble Start Supplemental Information
A. H. Robins Co., P.O. Box 518, Fort Dodge, IA 50501-0518, has informed FDA that it has transferred ownership of, and all rights and interest in, the following 12 approved NADAs to Fort Dodge Animal Health, Division of Wyeth, 800 Fifth St. NW., Fort Dodge, IA 50501:
|NADA Number||Product Name|
|098-640||ROBIZONE Injectable 20%|
Accordingly, the agency is amending the regulations in 21 CFR 520.88b, 520.88f, 520.1380, 520.1720a, 522.775, 522.1066, 522.1085, 522.1380, 522.1720, 522.2470, and 524.1600a to reflect the transfer of ownership and to reflect current format.
Following this change of sponsorship, A. H. Robins Co. is no longer the sponsor of any approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for A. H. Robins Co.
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 Subjects
List of Subjects
- Administrative practice and procedure
- Animal drugs
- Reporting and recordkeeping requirements
, 522, and 524End List of Subjects Start Amendment Part
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,End Amendment Part Start Part
PART 510—NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. Section 510.600End Amendment Part Start Part
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
3. The authority citation forEnd Amendment Part
4. Section 520.88bEnd Amendment Part
5. Section 520.88fEnd Amendment Part
6. Section 520.1380End Amendment Part
7. Section 520.1720aEnd Amendment Part Start Part
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
8. The authority citation forEnd Amendment Part
9. Section 522.775End Amendment Part
10. Section 522.1066End Amendment Part
11. Section 522.1085End Amendment Part
12. Section 522.1380End Amendment Part
13. Section 522.1720End Amendment Part
14. Section 522.2470End Amendment Part Start Part
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
15. The authority citation forEnd Amendment Part
16. Section 524.1600aEnd Amendment Part Start Signature
Dated: October 28, 2002.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 02-28156 Filed 11-5-02; 8:45 am]
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