-
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 InfoFOR 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 InformationSUPPLEMENTARY 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 Start Printed Page 78355 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.
Start List of SubjectsList 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:
End Amendment Part Start PartPART 510—NEW ANIMAL DRUGS
End Part Start Amendment Part1. The authority citation for 21 CFR part 510 continues to read as follows:
End Amendment PartStart Amendment Part[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”.
End Amendment Part Start PartPART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part3. The authority citation for 21 CFR part 520 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]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 PartStart Amendment Part[Amended]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 PartStart Amendment Part[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”.
End Amendment PartStart Amendment Part[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”.
End Amendment PartStart Amendment Part[Amended]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 PartStart Amendment Part[Amended]9. Section 520.530 Cythioate oral liquid is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.
End Amendment PartStart Amendment Part[Amended]10. Section 520.531 Cythioate tablets is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.
End Amendment PartStart Amendment Part[Amended]11. Section 520.2184 Sodium sulfachloropyrazine monohydrate is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.
End Amendment PartStart Amendment Part[Amended]12. Section 520.2240a Sulfaethoxypyridazine drinking water is amended in paragraph (c) by removing “010042” and by adding in its place “053501”.
End Amendment PartStart Amendment Part[Amended]13. Section 520.2240b Sulfaethoxypyridazine tablets is amended in paragraph (c) by removing “010042” and by adding in its place “053501”.
End Amendment PartStart Amendment Part[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”.
End Amendment PartStart Amendment Part[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”.
End Amendment PartStart Amendment Part[Amended]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 PartStart Amendment Part[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”.
End Amendment PartStart Amendment Part[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”.
End Amendment Part Start PartPART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part19. The authority citation for 21 CFR part 522 continues to read as follows:
End Amendment PartStart Amendment Part[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”.
End Amendment PartStart Amendment Part[Amended]21. Section 522.2240 Sulfaethoxypyridazine is amended in paragraph (c) by removing “010042” and by adding in its place “053501”.
End Amendment PartStart Amendment Part[Amended]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 PartPART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part23. The authority citation for 21 CFR part 524 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]24. Section 524.1240 Levamisole is amended in paragraph (b) by removing “010042” and by adding in its place “053501”.
End Amendment Part Start SignatureStart Printed Page 78356End Signature End Supplemental InformationDated: 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
Document Information
- Effective Date:
- 12/24/2002
- Published:
- 12/24/2002
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Action:
- Final rule.
- Document Number:
- 02-32345
- Dates:
- This rule is effective December 24, 2002.
- Pages:
- 78354-78356 (3 pages)
- PDF File:
- 02-32345.pdf
- CFR: (20)
- 21 CFR 510.600
- 21 CFR 520.44
- 21 CFR 520.530
- 21 CFR 520.531
- 21 CFR 520.2184
- More ...