67 FR 247 pgs. 78354-78356 - New Animal Drugs; Change of Sponsor
Type: RULEVolume: 67Number: 247Pages: 78354 - 78356
FR document: [FR Doc. 02-32345 Filed 12-23-02; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, and 524
New Animal Drugs; Change of Sponsor
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: lluther@cvm.fda.gov.
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 Number | Trade Name |
|---|---|
| 006-084 | SULMET Drinking Water Solution |
| 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 Solution |
| 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
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, and 524
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:
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.
§ 510.600 [Amended]
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".
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.
§ 520.44 [Amended]
4. Section 520.44 Acetazolamide sodium soluble powder is amended in paragraph (b) by removing "010042" and by adding in its place "053501".
§ 520.154c [Amended]
5. Section 520.154c Bacitracin zinc soluble powder is amended in paragraph (b) by removing "010042" and by adding in its place "053501".
§ 520.445a [Amended]
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".
§ 520.445b [Amended]
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".
§ 520.445c [Amended]
8. Section 520.445c Chlortetracycline tablets and boluses is amended in paragraph (b) by removing "010042" and by adding in its place "053501".
§ 520.530 [Amended]
9. Section 520.530 Cythioate oral liquid is amended in paragraph (b) by removing "010042" and by adding in its place "053501".
§ 520.531 [Amended]
10. Section 520.531 Cythioate tablets is amended in paragraph (b) by removing "010042" and by adding in its place "053501".
§ 520.2184 [Amended]
11. Section 520.2184 Sodium sulfachloropyrazine monohydrate is amended in paragraph (b) by removing "010042" and by adding in its place "053501".
§ 520.2240a [Amended]
12. Section 520.2240a Sulfaethoxypyridazine drinking water is amended in paragraph (c) by removing "010042" and by adding in its place "053501".
§ 520.2240b [Amended]
13. Section 520.2240b Sulfaethoxypyridazine tablets is amended in paragraph (c) by removing "010042" and by adding in its place "053501".
§ 520.2260a [Amended]
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".
§ 520.2261a [Amended]
15. Section 520.2261a Sulfamethazine sodium drinking water solution is amended in paragraph (a) by removing "010042" and by adding in its place "053501".
§ 520.2261b [Amended]
16. Section 520.2261b Sulfamethazine sodium soluble powder is amended in paragraph (a) by removing "010042" and by adding in its place "053501".
§ 520.2345c [Amended]
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".
§ 520.2345d [Amended]
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".
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.
§ 522.940 [Amended]
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".
§ 522.2240 [Amended]
21. Section 522.2240 Sulfaethoxypyridazine is amended in paragraph (c) by removing "010042" and by adding in its place "053501".
§ 522.2260 [Amended]
22. Section 522.2260 Sulfamethazine injectable solution is amended in paragraph (b) by removing "010042" and by adding in its place "053501".
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.
§ 524.1240 [Amended]
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.
[FR Doc. 02-32345 Filed 12-23-02; 8:45 am]
BILLING CODE 4160-01-S