Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the change of sponsor for 13 new animal drug applications (NADA's) from I. D. Russell Co., Laboratories to Alpharma Inc.
This rule is effective February 29, 2000.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Thomas J. McKay, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0213.End Further Info End Preamble Start Supplemental Information
I. D. Russell Co., Laboratories, 1301 Iowa Ave., Longmont, CO 80501, has informed FDA that it has transferred the ownership of, and all rights and interest in, the following approved NADA's to Alpharma Inc., One Executive Dr., Fort Lee, NJ 07024: Start Printed Page 10705
|NADA No.||Product name|
|6-019||Zuco Poultry Tabs|
|200-274||Lincomycin Injectable 30%|
The agency is amending parts 510 and 520 (21 CFR parts 510 and 520) to reflect the change of sponsor. The agency is amending § 510.600(c)(1) and (c)(2) to remove the sponsor name for I. D. Russell Co., Laboratories because the firm no longer is the holder of any approved NADA's.
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 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
End List of Subjects
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 parts 510 and 520 are amended as follows:Start Part
PART 510 NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part Start 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 520.1263cEnd Amendment Part
5. Section 520.1660dEnd Amendment Part
6. Section 520.1696bEnd Amendment Part
7. Section 520.2088End Amendment Part
8. Section 520.2089End Amendment Part
9. Section 520.2325aEnd Amendment Part Start Signature
Dated: February 16, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 00-4668 Filed 2-28-00; 8:45 am]
BILLING CODE 4160-01-F