# [Amended]
**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 for 12 approved new animal drug applications (NADA's) from Merial Ltd. to Phoenix Scientific, Inc.
**DATES:**
This rule is effective July 26, 2000.
**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.
**SUPPLEMENTARY 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 | BUTATRON
(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.
**List of Subjects in 21 CFR Parts 520 and 522**
Animal drugs.
**21 CFR Part 520**
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 520 and 522 are amended as follows:
**PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS**
1. The authority citation for 21 CFR part 520 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 520**
§ 520.1485
2. Section 520.1485 *Neomycin sulfate oral solution* is amended in paragraph (b) by removing “050604”.
**21 CFR Part 520**
§ 520.2122
3. Section 520.2122 *Spectinomycin dihydrochloride oral solution* is amended in paragraph (b)(1) by removing “050604” and adding in its place “059130”.
**21 CFR Part 522**
**PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS**
4. The authority citation for 21 CFR part 522 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 522**
§ 522.390
5. Section 522.390 *Chloramphenicol injection* is amended in paragraph (b) by removing “050604” and adding in its place “059130”.
**21 CFR Part 522**
§ 522.540
6. Section 522.540 *Dexamethasone injection* is amended in paragraphs (d)(2)(i) and (e)(2) by removing “050604” and adding in its place “059130”.
**21 CFR Part 522**
§ 522.1044
7. Section 522.1044 *Gentamicin sulfate injection* is amended in paragraph (b)(4) by removing “050604” and adding in its place “059130”.
**21 CFR Part 522**
§ 522.1183
8. Section 522.1183 *Iron hydrogenated dextran injection* is amended in paragraph (e)(1) by removing “050604” and adding in its place “059130”.
**21 CFR Part 522**
§ 522.1662a
9. Section 522.1662a *Oxytetracycline hydrochloride injection* is amended in paragraph (i)(2) by removing “050604” and adding in its place “059130”.
**21 CFR Part 522**
§ 522.1680
10. Section 522.1680 *Oxytocin injection* is amended in paragraph (b) by removing “050604” and adding in its place “059130”.
**21 CFR Part 522**
§ 522.2120
11. Section 522.2120 *Spectinomycin dihydrochloride injection* is amended in paragraph (b) by removing “050604” and adding in its place “059130”.
Dated: July 18, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.