[Federal Register Volume 61, Number 45 (Wednesday, March 6, 1996)] [Rules and Regulations] [Pages 8872-8873] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-5213] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, and 524 Animal Drugs, Feeds, and Related Products; 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 the change of sponsor for 28 approved new animal drug applications (NADA's) from Coopers Animal Health, Inc., to Mallinckrodt Veterinary, Inc. EFFECTIVE DATE: March 6, 1996. FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0213. SUPPLEMENTARY INFORMATION: Coopers Animal Health, Inc., 1201 Douglas Ave., Kansas City, KS 66103-1438, has informed FDA that it has transferred the ownership of, and all rights and interests in, the following approved NADA's to Mallinckrodt Veterinary, Inc., Mundelein, IL 60060. ------------------------------------------------------------------------ NADA No. Trade name Active ingredient ------------------------------------------------------------------------ 6-602...... A-H Tablets 25 milligrams Doxylamine Succinate (mg)/100 mg. 6-983...... A-H Injection................ Doxylamine Succinate, Chlorobutanol 10-987..... Butazolidin Tablets/Bolus.... Phenylbutazone 11-222..... Diquel Tablets............... Ethylisobutrazine Hydrochloride 11-575..... Butazolidin Injection 20%.... Phenylbutazone 11-877..... Jenotone Tablets............. Aminopromazine Fumarate 11-893..... Dermathycin Injection........ Thyroid Stimulating Hormone 15-182..... Canopar Tablets.............. Thenium Closylate 13-181..... Jenomycin Tablets............ Aminopromazine Fumarate, Neomycin Sulfate 34-477..... Jenotone Solution............ Aminopromazine Fumarate 35-016..... Scolaban 400................. Bunamidine Hydrochloride 35-265..... Diquel Solution.............. Ethylisobutrazine Hydrochloride 38-800..... Butazolidin Granules......... Phenylbutazone 44-757..... Prolate I-E.................. Phosmet 48-913..... Halox Wormer Drench.......... Haloxon 65-476..... Cortisporin Veterinary Bactricin ZN, Neomycin Ophthalmic Ointment. Sulfate, Polymyxin B Sulfate, Hydrocortisone Acetate 65-485..... Neosporin Ophthalmic Ointment Bactricin ZN, Neomycin Sulfate, Polymyxin B Sulfate 92-483..... Halox Bolus.................. Haloxon 95-614..... Tribrissen 30/120/480/960 Sulfadiazine, Trimethoprim Tablets. 97-288..... Imizol Equine Injection...... Imidocarb Dipropionate 101-161.... Thenatol PW Tablets.......... Thenium Closylate, Piperazine Phosphate 105-093.... Tribrissen 24% Injection..... Trimethoprim, Sulfadiazine Sodium 106-965.... Tribrissen 48% Injection..... Trimethoprim, Sulfadiazine 116-087.... Burazolidin Paste/Butazolidin/ Phenylbutazone Phenylzone/Bute. 120-326.... Filban Chewable Wafers....... Diethylcarbamazine Citrate 124-842.... Filban Tablets............... Diethylcarbamazine Citrate 131-918.... Tribrissen 400 Oral Paste.... Trimethoprim, Sulfadiazine 136-741.... Tribrissen 60 Oral Suspension Trimethoprim, Sulfadiazine ------------------------------------------------------------------------ The agency is amending 21 CFR 510.600(c)(1) and (c)(2), and parts 520, 522, and 524 to reflect the change of sponsor. 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: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e). Sec. 510.600 [Amended] -2. Section 510.600 is amended in the table in paragraph (c)(1) by removing the entry for ``Coopers Animal Health, Inc.''; and in the table in paragraph (c)(2) by removing the entry for ``017220''. PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS -3. The authority citation for 21 CFR part 520 continues to read as follows: Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b) . [[Page 8873]] Sec. 520.82a [Amended] 4. Section 520.82a Aminopropazine fumarate tablets is amended in paragraph (b) by removing ``017220'' and adding in its place ``011716''. Sec. 520.82b [Amended] 5. Section 520.82b Aminopropazine fumarate, neomycin sulfate tablets is amended in paragraph (b) by removing ``017220'' and adding in its place ``011716''. Sec. 520.222 [Amended] 6. Section 520.222 Bunamidine hydrochloride is amended in paragraph (c) by removing ``017220'' and adding in its place ``011716''. Sec. 520.622c [Amended] 7. Section 520.622c Diethylcarbamazine citrate chewable tablets is amended in paragraph (b)(5) by removing ``017220'' and adding in its place ``011716''. Sec. 520.784 [Amended] 8. Section 520.784 Doxylamine succinate tablets is amended in paragraph (b) by removing ``017220'' and adding in its place ``011716''. Sec. 520.863 [Amended] 9. Section 520.863 Ethylisobutrazine hydrochloride tablets is amended in paragraph (b) by removing ``017220'' and adding in its place ``011716''. Sec. 520.1120a [Amended] 10. Section 520.1120a Haloxon drench is amended in paragraph (c) by removing ``017220'' and adding in its place ``011716''. Sec. 520.1120b [Amended] 11. Section 520.1120b Haloxon boluses is amended in paragraph (c) by removing ``017220'' and adding in its place ``011716''. Sec. 520.1720a [Amended] 12. Section 520.1720a Phenylbutazone tablets and boluses is amended in paragraph (b)(1) by removing ``017220'' and adding in its place ``011716''. Sec. 520.1720b [Amended] 13. Section 520.1720b Phenylbutazone granules is amended in paragraph (b) by removing ``017220'' and adding in its place ``011716''. Sec. 520.1720c [Amended] 14. Section 520.1720c Phenylbutazone paste is amended in paragraph (b) by removing ``017220'' and adding in its place ``011716''. Sec. 520.1805 [Amended] 15. Section 520.1805 Piperazine phosphate with thenium closylate tablets is amended in paragraph (b) by removing ``017220'' and adding in its place ``011716''. Sec. 520.2362 [Amended] 16. Section 520.2362 Thenium closylate tablets is amended in paragraph (c) by removing ``017220'' and adding in its place ``011716''. Sec. 520.2610 [Amended] 17. Section 520.2610 Trimethoprim and sulfadiazine tablets is amended in paragraph (b) by removing ``017220'' and adding in its place ``011716''. Sec. 520.2611 [Amended] 18. Section 520.2611 Trimethoprim and sulfadiazine oral paste is amended in paragraph (b) by removing ``017220'' and adding in its place ``011716''. Sec. 520.2612 [Amended] 19. Section 520.2612 Trimethoprim and sulfadiazine oral suspension is amended in paragraph (b) by removing ``017220'' and adding in its place ``011716''. PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 20. The authority citation for 21 CFR Part 522 continues to read as follows: Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b). Sec. 522.82 [Amended] -21. Section 522.82 Aminopropazine fumarate sterile solution injection is amended in paragraph (b) by removing ``017220'' and adding in its place ``011716''. Sec. 522.784 [Amended] -22. Section 522.784 Doxylamine succinate injection is amended in paragraph (b) by removing ``017220'' and adding in its place ``011716''. Sec. 522.863 [Amended] -23. Section 522.863 Ethylisobutrazine hydrochloride injection is amended in paragraph (b) by removing ``017220'' and adding in its place ``011716''. Sec. 522.1155 [Amended] -24. Section 522.1155 Imidocarb dipropionate sterile powder is amended in paragraph (b) by removing ``017220'' and adding in its place ``011716''. Sec. 522.1720 [Amended] -25. Section 522.1720 Phenylbutazone injection is amended in paragraph (b)(1) by removing ``017220'' and adding in its place ``011716''. Sec. 522.2610 [Amended] -26. Section 522.2610 Trimethoprim and sulfadiazine sterile suspension is amended in paragraphs (a)(2) and (b)(2) by removing ``017220'' and adding in its place ``011716''. PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS -27. The authority citation for 21 CFR part 524 continues to read as follows: Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b). Sec. 524.154 [Amended] -28. Section 524.154 Bacitracin or bacitracin zinc-neomycin sulfate-polymyxin B sulfate ophthalmic ointment is amended in paragraph (a)(2) by removing ``017220'' and adding in its place ``011716''. Sec. 524.155 [Amended] -29. Section 524.155 Bacitracin zinc-polymyxin B sulfate neomycin sulfate-hydrocortisone or hydrocortisone acetate ophthalmic ointment is amended in paragraph (a)(1) by removing ``017220'' and adding in its place ``011716''. Sec. 524.1742 [Amended] -30. Section 524.1742 N-(Mercaptomethyl) phthalimide S-(O,O- dimethyl phosphorodithioate) emulsifiable liquid is amended in paragraph (b) by removing ``017220'' and adding in its place ``011716''. Dated: February 28, 1996. Robert C. Livingston, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 96-5213 Filed 3-5-96; 8:45 am] BILLING CODE 4160-01-F