# [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 15 approved new animal drug applications (NADAs) from Cyanamid Agricultural de Puerto Rico, Inc., to Fort Dodge Animal Health.
**DATES:**
This rule is effective October 10, 2002.
**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 protected]* .
**SUPPLEMENTARY INFORMATION:**
Cyanamid Agricultural de Puerto Rico, Inc., P.O. Box 243, Manati, PR 00701, has informed FDA that it has transferred ownership of, and all rights and interest in, the following 15 approved NADAs to Fort Dodge Animal Health, A Division of American Cyanamid Co., P.O. Box 1339, Fort Dodge, IA 50501:
| NADA Number | Trade Name |
| --- | --- |
| 039-356 | RIPERCOL L Bolus; TRAMISOL Cattle Wormer Bolus |
| 039-357 | RIPERCOL L Soluble Drench Powder |
| 042-740 | RIPERCOL L; TRAMISOL Soluble Drench Powder for Sheep |
| 042-837 | RIPERCOL L Wormer Oblets; TRAMISOL Sheep Wormer Oblets |
| 044-015 | TRAMISOL Type A Medicated Article |
| 045-455 | TRAMISOL Type A Medicated Article |
| 045-513 | RIPERCOL L |
| 049-553 | RIPERCOL L |
| 092-237 | RIPERCOL L-Piperazine Soluble |
| 093-688 | RIPERCOL L-Piperazine |
| 101-079 | TRAMISOL 10% Pig Wormer; TRAMISOL Hog Wormer |
| 102-437 | TRAMISOL Injectable Solution |
| 104-184 | STYQUIN |
| 107-085 | TRAMISOL |
| 126-237 | TRAMISOL Gel |
Accordingly, the agency is amending the regulations in 21 CFR 520.1242a, 520.1242b, 520.1242c, 520.1242e, 520.1242f, 522.234, 522.1244, and 558.315 to reflect the transfer of ownership and to reflect current format.
Following this change of sponsorship, Cyanamid Agricultural de Puerto Rico, Inc., is no longer the sponsor of any approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for Cyanamid Agricultural de Puerto Rico, Inc.
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**
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
Animal drugs.
Animal drugs, Animal feeds.
**21 CFR Part 510**
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, 520, 522, and 558 are 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.
**21 CFR Part 510**
§ 510.600
2. Section 510.600 *Names, addresses, and drug labeler codes of sponsors of approved applications* is amended in the table in paragraph (c)(1) by removing the entry for “Cyanamid Agricultural de Puerto Rico, Inc.” and in the table in paragraph (c)(2) by removing the entry for “043781”.
**21 CFR Part 520**
**PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS**
3. The authority citation for 21 CFR part 520 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 520**
§ 520.1242a
4. Section 520.1242a *Levamisole hydrochloride drench and drinking water* is amended in paragraph (b)(1) by removing “043781” and by adding in its place “No. 053501”.
**21 CFR Part 520**
§ 520.1242b
5. Section 520.1242b *Levamisole hydrochloride tablet or oblet (bolus)* is amended in paragraph (c) by removing “043781” and by adding in its place “053501”.
**21 CFR Part 520**
§ 520.1242c
6. Section 520.1242c *Levamisole hydrochloride and piperazine dihydrochloride* is amended in paragraph (b) by removing “043781” and by adding in its place “053501”.
**21 CFR Part 520**
§ 520.1242e
7. Section 520.1242e *Levamisole hydrochloride effervescent tablets* is amended in paragraph (b) by removing “043781” and by adding in its place “053501”.
**21 CFR Part 520**
§ 520.1242f
8. Section 520.1242f *Levamisole hydrochloride gel* is amended in paragraph (b) by removing “043781” and by adding in its place “053501”.
**21 CFR Part 522**
**PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS**
9. The authority citation for 21 CFR part 522 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 522**
§ 522.234
10. Section 522.234 *Butamisole hydrochloride* is amended in paragraph (b) by removing “043781” and by adding in its place “053501”.
**21 CFR Part 522**
§ 522.1244
11. Section 522.1244 *Levamisole phosphate injection* is amended in paragraph (b) by removing “043781” and by adding in its place “053501”.
**21 CFR Part 558**
**PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS**
12. The authority citation for 21 CFR part 558 continues to read as follows:
**Authority:**
21 U.S.C. 360b, 371.
**21 CFR Part 558**
§ 558.315
13. Section 558.315 *Levamisole hydrochloride (equivalent)* is amended in paragraph (a) by removing “043781” and by adding in its place “No. 053501”.
Dated: September 26, 2002.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.