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 (NADA's) from Merial Ltd. to Phoenix Scientific, Inc.
This rule is effective July 26, 2000.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Thomas J. McKay, Center for Veterinary Medicine (HFV-102), Food and Drug Start Printed Page 45877Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0213.End Further Info End Preamble Start Supplemental Information
Merial Ltd., 2100 Ronson Rd., Iselin, NJ 08830-3077, has informed FDA that it has transferred ownership of, and all rights and interests in, the following approved NADA's to Phoenix Scientific, Inc., 3915 South 48th St. Terrace, PO Box 6457, St. Joseph, MO 64506-0457:
|NADA No.||Product Name|
|033-157||SPECTAM® (spectinomycin) Scour Halt|
|040-040||SPECTAM® (spectinomycin) Injection|
|045-416||BUTATRONTM (phenylbutazone) Injection|
|048-287||Oxytetracycline-50 (oxytetracycline) Injection|
|055-002||TEVOCIN (chloramphenicol) Injection|
|093-483||SPECTAM® (spectinomycin) Injectable|
|119-142||PVL Iron Dextran Injectable|
|123-815||Dexamethasone Sodium Phosphate Injection|
|124-241||PVL Oxytocin Injection|
|128-089||ZONOMETH (dexamethasone) Sterile Solution|
|200-147||GENTA-JECT® (gentamicin sulfate) Injection|
|200-153||NEO 200 (neomycin sulfate) Oral Solution|
Accordingly, the agency is amending the regulations in parts 520 and 522 (21 CFR parts 520 and 522) in §§ 520.1485, 520.2122, 522.390, 522.540, 522.1044, 522.1183, 522.1662a, 522.1680, and 522.2120 to reflect the transfer of ownership. An entry for Phoenix Scientific, Inc., already exists in § 522.1720 Phenylbutazone Injection following the approval of a supplemental ANADA 200-126 (61 FR 54332, October 18, 1996).
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 in 21 CFR Parts 520 and 522End 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 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. Section 520.1485End Amendment Part
3. Section 520.2122End Amendment Part Start Part
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
4. The authority citation forEnd Amendment Part
5. Section 522.390End Amendment Part
6. Section 522.540End Amendment Part
7. Section 522.1044End Amendment Part
8. Section 522.1183End Amendment Part
9. Section 522.1662aEnd Amendment Part
10. Section 522.1680End Amendment Part
11. Section 522.2120End Amendment Part Start Signature
Dated: July 18, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 00-18828 Filed 7-25-00; 8:45 am]