Skip to Content

Rule

New Animal Drugs; Change of Sponsor

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

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 NumberTrade Name
006-084SULMET Drinking Water Solution
008-774SULMET Solution Injectable
011-582VETAMOX Soluble Powder
011-644FELAC
013-957S.E.Z. Drinking Water 6.25%
015-160Sodium Sulfachloropyrazine Solution
033-342PROBAN Cythioate Tablets 30 mg
033-606PROBAN Oral Liquid
033-653S.E.Z. Drinking Water Solution
033-654S.E.Z. Oblets 15 g
033-655S.E.Z. Intravenous Solution
047-033S.E.Z. C-R Oblets 15 g
055-012AUREOMYCIN Sulmet Soluble Powder
055-018AUREOMYCIN Tablets 25 mg
055-020AUREOMYCIN Soluble Powder
055-039AUREOMYCIN Soluble Oblets
065-071AUREOMYCIN Soluble Powder
065-269POLYOTIC Soluble Powder
065-270POLYOTIC Oblets
065-313BACIFERM Soluble 50
065-440AUREOMYCIN Soluble Powder Concentrate
065-441POLYOTIC Soluble Powder Concentrate
122-271SULMET Oblets
122-272SULMET Soluble Powder
Start Printed Page 78355
140-844TRAMISOL 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.

Start List of Subjects

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
End 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, 21 CFR parts 510, 520, 522, and 524 are amended as follows:

End Amendment Part Start Part

PART 510—NEW ANIMAL DRUGS

End Part Start Amendment Part

1. The authority citation for 21 CFR part 510 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

End Authority
[Amended]
Start Amendment Part

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”.

End Amendment Part Start Part

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

3. The authority citation for 21 CFR part 520 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 360b.

End Authority
[Amended]
Start Amendment Part

4. Section 520.44 Acetazolamide sodium soluble powder is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.

End Amendment Part
[Amended]
Start Amendment Part

5. Section 520.154c Bacitracin zinc soluble powder is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.

End Amendment Part
[Amended]
Start Amendment Part

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”.

End Amendment Part
[Amended]
Start Amendment Part

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”.

End Amendment Part
[Amended]
Start Amendment Part

8. Section 520.445c Chlortetracycline tablets and boluses is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.

End Amendment Part
[Amended]
Start Amendment Part

9. Section 520.530 Cythioate oral liquid is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.

End Amendment Part
[Amended]
Start Amendment Part

10. Section 520.531 Cythioate tablets is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.

End Amendment Part
[Amended]
Start Amendment Part

11. Section 520.2184 Sodium sulfachloropyrazine monohydrate is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.

End Amendment Part
[Amended]
Start Amendment Part

12. Section 520.2240a Sulfaethoxypyridazine drinking water is amended in paragraph (c) by removing “010042” and by adding in its place “053501”.

End Amendment Part
[Amended]
Start Amendment Part

13. Section 520.2240b Sulfaethoxypyridazine tablets is amended in paragraph (c) by removing “010042” and by adding in its place “053501”.

End Amendment Part
[Amended]
Start Amendment Part

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”.

End Amendment Part
[Amended]
Start Amendment Part

15. Section 520.2261a Sulfamethazine sodium drinking water solution is amended in paragraph (a) by removing “010042” and by adding in its place “053501”.

End Amendment Part
[Amended]
Start Amendment Part

16. Section 520.2261b Sulfamethazine sodium soluble powder is amended in paragraph (a) by removing “010042” and by adding in its place “053501”.

End Amendment Part
[Amended]
Start Amendment Part

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”.

End Amendment Part
[Amended]
Start Amendment Part

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”.

End Amendment Part Start Part

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

19. The authority citation for 21 CFR part 522 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 360b.

End Authority
[Amended]
Start Amendment Part

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”.

End Amendment Part
[Amended]
Start Amendment Part

21. Section 522.2240 Sulfaethoxypyridazine is amended in paragraph (c) by removing “010042” and by adding in its place “053501”.

End Amendment Part
[Amended]
Start Amendment Part

22. Section 522.2260 Sulfamethazine injectable solution is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.

End Amendment Part Start Part

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

23. The authority citation for 21 CFR part 524 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 360b.

End Authority
[Amended]
Start Amendment Part

24. Section 524.1240 Levamisole is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.

End Amendment Part Start Signature
Start Printed Page 78356

Dated: November 8, 2002.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

End Signature End Supplemental Information

[FR Doc. 02-32345 Filed 12-23-02; 8:45 am]

BILLING CODE 4160-01-S