# [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 25 approved new animal drug applications (NADAs) from American Cyanamid to Fort Dodge Animal Health.
**DATES:**
This rule is effective December 24, 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:**
American Cyanamid, Division of American Home Products, P.O. Box 1339, Fort Dodge, IA 50501, has informed FDA that it has transferred ownership of, and all rights and interest in, the following 25 approved NADAs to Fort Dodge Animal Health, Division of American Cyanamid Co., P.O. Box 1339, Fort Dodge, IA 50501:
| NADA | Trade Name |
| --- | --- |
| 006-084 | SULMET Drinking Water |
| 008-774 | SULMET Solution Injectable |
| 011-582 | VETAMOX Soluble Powder |
| 011-644 | FELAC |
| 013-957 | S.E.Z. Drinking Water 6.25% |
| 015-160 | Sodium Sulfachloropyrazine |
| 033-342 | PROBAN Cythioate Tablets 30 mg |
| 033-606 | PROBAN Oral Liquid |
| 033-653 | S.E.Z. Drinking Water Solution |
| 033-654 | S.E.Z. Oblets 15 g |
| 033-655 | S.E.Z. Intravenous Solution |
| 047-033 | S.E.Z. C-R Oblets 15 g |
| 055-012 | AUREOMYCIN Sulmet Soluble Powder |
| 055-018 | AUREOMYCIN Tablets 25 mg |
| 055-020 | AUREOMYCIN Soluble Powder |
| 055-039 | AUREOMYCIN Soluble Oblets |
| 065-071 | AUREOMYCIN Soluble Powder |
| 065-269 | POLYOTIC Soluble Powder |
| 065-270 | POLYOTIC Oblets |
| 065-313 | BACIFERM Soluble 50 |
| 065-440 | AUREOMYCIN Soluble Powder Concentrate |
| 065-441 | POLYOTIC Soluble Powder Concentrate |
| 122-271 | SULMET Oblets |
| 122-272 | SULMET Soluble Powder |
| 140-844 | TRAMISOL Pour-On |
Accordingly, the agency is amending the regulations in 21 CFR 520.44, 520.154c, 520.445a, 520.445b, 520.445c, 520.530, 520.531, 520.2184, 520.2240a, 520.2240b, 520.2260a, 520.2261a, 520.2261b, 520.2345c, 520.2345d, 522.940, 522.2240, 522.2260, and 524.1240 to reflect the transfer of ownership and to reflect current format.
Following this change of sponsorship, American Cyanamid is no longer the sponsor of any approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for American Cyanamid.
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.
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 524 are amended as follows:
**21 CFR Part 510**
**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 “American Cyanamid” and in the table in paragraph (c)(2) by removing the entry for “010042”.
**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**
§ 520.44
4. Section 520.44 *Acetazolamide sodium soluble powder* is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.
**21 CFR Part 520**
§ 520.154c
5. Section 520.154c *Bacitracin zinc soluble powder* is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.
**21 CFR Part 520**
§ 520.445a
6. Section 520.445a *Chlortetracycline bisulfate/sulfamethazine bisulfate soluble powder* is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.
**21 CFR Part 520**
§ 520.445b
7. Section 520.445b *Chlortetracycline powder (chlortetracycline hydrochloride or chlortetracycline bisulfate)* is amended in paragraphs (b) and (d)(4)(iii)(C) by removing “010042” and by adding in its place “053501”.
**21 CFR Part 520**
§ 520.445c
8. Section 520.445c *Chlortetracycline tablets and boluses* is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.
**21 CFR Part 520**
§ 520.530
9. Section 520.530 *Cythioate oral liquid* is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.
**21 CFR Part 520**
§ 520.531
10. Section 520.531 *Cythioate tablets* is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.
**21 CFR Part 520**
§ 520.2184
11. Section 520.2184 *Sodium sulfachloropyrazine monohydrate* is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.
**21 CFR Part 520**
§ 520.2240a
12. Section 520.2240a *Sulfaethoxypyridazine drinking water* is amended in paragraph (c) by removing “010042” and by adding in its place “053501”.
**21 CFR Part 520**
§ 520.2240b
13. Section 520.2240b *Sulfaethoxypyridazine tablets* is amended in paragraph (c) by removing “010042” and by adding in its place “053501”.
**21 CFR Part 520**
§ 520.2260a
14. Section 520.2260a *Sulfamethazine oblet, tablet, and bolus* is amended in paragraph (a)(1) by removing “010042” and by adding in its place “053501”.
**21 CFR Part 520**
§ 520.2261a
15. Section 520.2261a *Sulfamethazine sodium drinking water solution* is amended in paragraph (a) by removing “010042” and by adding in its place “053501”.
**21 CFR Part 520**
§ 520.2261b
16. Section 520.2261b *Sulfamethazine sodium soluble powder* is amended in paragraph (a) by removing “010042” and by adding in its place “053501”.
**21 CFR Part 520**
§ 520.2345c
17. Section 520.2345c *Tetracycline boluses* is amended in paragraph (b) in the first sentence by removing “010042” and by adding in its place “053501”.
**21 CFR Part 520**
§ 520.2345d
18. Section 520.2345d *Tetracycline hydrochloride soluble powder* is amended in paragraphs (a)(3), (d)(1)(iii), and (d)(2)(iii) by removing “010042” and by adding in its place “053501”.
**21 CFR Part 522**
**PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS**
19. The authority citation for 21 CFR part 522 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 522**
§ 522.940
20. Section 522.940 *Colloidal ferric oxide injection* is amended in paragraph (c)(1) by removing “010042 and 017800” and by adding in its place “017800 and 053501”.
**21 CFR Part 522**
§ 522.2240
21. Section 522.2240 *Sulfaethoxypyridazine* is amended in paragraph (c) by removing “010042” and by adding in its place “053501”.
**21 CFR Part 522**
§ 522.2260
22. Section 522.2260 *Sulfamethazine injectable solution* is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.
**21 CFR Part 524**
**PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS**
23. The authority citation for 21 CFR part 524 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 524**
§ 524.1240
24. Section 524.1240 *Levamisole* is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.
Dated: November 8, 2002.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.