[Federal Register Volume 60, Number 150 (Friday, August 4, 1995)] [Rules and Regulations] [Pages 39846-39847] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-19091] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, and 558 Animal Drugs, Feeds, and Related Products; Piperazine Adipate Powder, Diprenorphine Hydrochloride Injection, Etorphine Hydrochloride Injection, and Certain Nitrofuran and Buquinolate Products AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to remove those portions reflecting approval of 16 new animal drug applications (NADA's) held by Proctor & Gamble Pharmaceuticals, Inc., Happy Jack, Inc., and Lemmon Co. The NADA's provide for the use of piperazine adipate powder, diprenorphine hydrochloride (diprenorphine HCl) injection, etorphine HCl injection, certain nitrofuran dosage form products, and separately approved Type A medicated articles containing buquinolate or certain other drugs in manufacturing several Type C medicated feeds for chickens. In a notice published in the July 21, 1995, issue of the Federal Register, FDA is withdrawing approval of the NADA's. EFFECTIVE DATE: August 14, 1995. FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1722. SUPPLEMENTARY INFORMATION: In a notice published in the July 21, 1995, issue of the Federal Register (60 FR 37651), FDA is withdrawing approval of the following NADA's: ------------------------------------------------------------------------ NADA No. Drug name Sponsor name and address ------------------------------------------------------------------------ 10-158..... Furamazone, bismuth Proctor & Gamble subsalicylate bolus. Pharmaceuticals, Inc., P.O. Box 191, Norwich, NY 13815. 10-358..... Nitrofurantoin tablets and Do. boluses. 12-291..... Nitrofurantoin oral Do. suspension. 12-612..... Nitrofurazone, nifuroxime, Do. diperodon HCl ear solution. 34-716..... Buquinolate.................. Do. 35-314..... Buquinolate and bacitracin Do. zinc. 35-315..... Buquinolate, bacitracin zinc, Do. and penicillin. 35-317..... Buquinolate and penicillin... Do. 35-327..... Buquinolate, bacitracin Do. methylene disalicylate (bacitracin MD), and penicillin. 35-329..... Buquinolate and bacitracin MD Do. 38-657..... Buquinolate and Do. chlortetracycline. 39-925..... Buquinolate and roxarsone Do. combination. 39-926..... Buquinolate and roxarsone.... Do. 41-744..... Nitrofurantoin sodium Do. injection. 95-017..... Etorphine HCl injection and Lemmon Co., Sellersville, PA diprenorphine HCl injection. 18960. 115-580.... Piperazine adipate powder.... Happy Jack, Snow Hill, NC 28580. ------------------------------------------------------------------------ The sponsors requested withdrawal of approval of the NADA's. This final rule removes 21 CFR 520.1560, 520.1560a, 520.1560b, 520.1801, 520.1801a, and 522.1563; amends 21 CFR 522.723 and 522.883 to reflect the withdrawal of approval of these NADA's; removes and reserves 21 CFR 524.1580a and 558.105; and amends 21 CFR 558.62, 558.128, 558.325, 558.460, and 558.530. In addition, 21 CFR 510.600(c) is amended to remove the entries for Proctor & Gamble Pharmaceuticals, Inc., from the list of approved drug sponsors because it no longer holds any approved NADA's. 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. 21 CFR Part 558 Animal drugs, Animal feeds. 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, 524, and 558 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 ``Proctor & Gamble Pharmaceuticals, Inc.'' and in the table in paragraph (c)(2) by removing the entry for ``000149''. [[Page 39847]] 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). Sec. 520.1560 [Removed] 4. Section 520.1560 Nitrofurantoin oral dosage forms is removed. Sec. 520.1560a [Removed] 5. Section 520.1560a Nitrofurantoin oral suspension is removed. Sec. 520.1560b [Removed] 6. Section 520.1560b Nitrofurantoin tablets and boluses is removed. Sec. 520.1801 [Removed] 7. Section 520.1801 Piperazine adipate oral dosage forms is removed. Sec. 520.1801a [Removed] 8. Section 520.1801a Piperazine adipate powder is removed. PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 9. 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. 522.723 [Amended] 10. Section 522.723 Diprenorphine hydrochloride injection is amended in paragraph (c) by removing the phrase ``Nos. 010042 and 000693'' and adding in its place the phrase ``No. 010042''. Sec. 522.883 [Amended] 11. Section 522.883 Etorphine hydrochloride injection is amended in paragraph (c) by removing the phrase ``Nos. 010042 and 000693'' and adding in its place the phrase ``No. 010042''. Sec. 522.1563 [Removed] 12. Section 522.1563 Nitrofurantoin sodium injection is removed. PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 13. 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. 524.1580a [Removed] 14. Section 524.1580a Nitrofurazone-nifuroxime-diperodon hydrochloride ear solution is removed and reserved. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 15. The authority citation for 21 CFR part 558 continues to read as follows: Authority: Secs. 512, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b, 371). Sec. 558.62 [Amended] 16. Section 558.62 Arsanilic acid is amended by removing paragraph (c)(2)(v) and by redesignating paragraph (c)(2)(vi) as paragraph (c)(2)(v). Sec. 558.105 [Removed] 17. Section 558.105 Buquinolate is removed and reserved. Sec. 558.128 [Amended] 18. Section 558.128 Chlortetracycline is amended by removing and reserving paragraph (c)(5)(iii). Sec. 558.325 [Amended] 19. Section 558.325 Lincomycin is amended by removing and reserving paragraph (c)(3)(iv). Sec. 558.460 [Amended] 20. Section 558.460 Penicillin is amended by removing and reserving paragraph (c)(2)(v). Sec. 558.530 [Amended] 21. Section 558.530 Roxarsone is amended by removing and reserving paragraph (d)(3)(vii). Dated: July 13, 1995. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 95-19091 Filed 8-3-95; 8:45 am] BILLING CODE 4160-01-F