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New Animal Drugs; Chloramphenicol, Inside the Closing Quotation Mark to ‘‘And’’ to Read ‘‘An’’

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New Animal Drugs; Chloramphenicol, Inside the Closing Quotation Mark to ‘‘And’’ to Read ‘‘An’’ Federal Register / Vol. 77, No. 21 / Wednesday, February 1, 2012 / Rules and Regulations 4895 Authority: 42 U.S.C. 4321–4370h, 7101– ■ c. In paragraph (f) introductory text, DEPARTMENT OF HEALTH AND 7352; E.O. 12009, 3 CFR 1978 Comp., p. 142. correct the words ‘‘In order to prepare’’ HUMAN SERVICES § 380.1 [Amended] to read ‘‘In preparing’’. ■ d. In paragraph (f)(2) introductory Food and Drug Administration ■ 47. In § 380.1, add the word ‘‘(NEPA)’’ text, change the ‘‘D’’ in the word after the words ‘‘the National ‘‘Documentation’’ to a lower case letter 21 CFR Parts 510, 520, 522, 524, 529, Environmental Policy Act of 1969’’ in ‘‘d’’. and 558 the first sentence and remove the year ■ e. In paragraph (i)(5), move the comma ‘‘(1986)’’ from the second sentence. following the closing quotation mark for [Docket No. FDA–2011–N–0003] § 380.3 [Corrected] the phrase ‘‘Upland Erosion Control, Revegetation and Maintenance Plan’’ ■ 48. In § 380.3(a)(1), correct the word New Animal Drugs; Chloramphenicol, inside the closing quotation mark to ‘‘and’’ to read ‘‘an’’. Diethylcarbamazine Citrate, read as ‘‘Upland Erosion Control, Hygromycin B, Methoxyflurane, § 380.4 [Corrected] Revegetation and Maintenance Plan,’’. Neomycin Sulfate, Penicillin G, ■ ■ 49. In § 380.4(a)(27), correct the word f. In paragraph (o)(12), remove the Phenylbutazone, Pyrantel Tartrate, ‘‘requires’’ to read ‘‘require’’. word ‘‘of’’ from the words ‘‘Identify of Tylosin Phosphate, and all codes’’. Sulfamethazine § 380.5 [Corrected] § 380.14 [Corrected] ■ 50. In § 380.5(b)(7), correct the AGENCY: Food and Drug Administration, ■ reference ‘‘§§ 4.30(b)(27) and 4.101– 54. In § 380.14(a) introductory text, HHS. 4.106’’ to read ‘‘§§ 4.30(b)(29) and correct the words ‘‘Commission take’’ to 4.101–4.108’’. read ‘‘Commission to take’’. ACTION: Final rule. § 380.15 [Corrected] § 380.6 [Corrected] SUMMARY: The Food and Drug ■ 51. In § 380.6(a)(3), correct the words ■ 55. In § 380.15(f)(5), correct the word Administration (FDA) is amending the ‘‘right-of-way’’ to read ‘‘rights-of-way’’. ‘‘above-ground’’ to read ‘‘aboveground’’. animal drug regulations to reflect the withdrawal of approval of 20 new § 380.8 [Amended] PART 385—RULES OF PRACTICE AND animal drug applications (NADAs). ■ 52. In § 380.8, remove the words PROCEDURE ‘‘Council on Environmental Quality’’ DATES: Withdrawal of approval is ■ and add, in their place, the word 56. The authority citation for Part 385 effective February 13, 2012. is revised to read as follows: ‘‘Council’’ and remove the telephone FOR FURTHER INFORMATION CONTACT: John number ‘‘(202) 219–8700’’ and add, in Authority: 5 U.S.C. 551–557; 15 U.S.C. Bartkowiak, Center for Veterinary 717–717z, 3301–3432; 16 U.S.C. 792–828c, its place, the telephone number ‘‘(202) Medicine (HFV–212),Food and Drug 502–8700’’. 2601–2645; 28 U.S.C. 2461; 31 U.S.C. 3701, 9701; 42 U.S.C. 7101–7352, 16441, 16451– Administration, 7519 Standish Pl., § 380.12 [Amended] 16463; 49 U.S.C. 60502; 49 App. U.S.C. 1–85 Rockville, MD 20855, 240–276–9079, ■ 53. In § 380.12: (1988). email: [email protected]. ■ a. In paragraphs (b)(1) and (b)(5), § 385.2201 [Corrected] SUPPLEMENTARY INFORMATION: The remove the period at the end of the ■ sponsors of the 20 approved NADAs sentence for each paragraph and add, in 57. In § 385.2201(c)(1), italicize the words ‘‘Contested on-the-record listed in table 1 of this document have their place, a semi-colon. requested that FDA withdraw approval ■ b. In paragraph (e)(3), correct the proceeding’’. because the products are no longer phrase ‘‘affected acreage’’ to read [FR Doc. 2012–1307 Filed 1–31–12; 8:45 am] manufactured or marketed: ‘‘acreage’’. BILLING CODE 6717–01–P TABLE 1—VOLUNTARY REQUESTS FOR WITHDRAWAL OF APPROVAL (WOA) OF 20 NADAS Trade name Application No. (drug) Applicant NADA 014–485 ........................................ METOPHANE Inhalation (methoxyflurane) ........... Medical Developments, International, Ltd., P.O. Box 21, Sandown Village, 3171 VIC Australia. NADA 032–322........................................ LIQUISONE F with Cerumene Evsco Pharmaceuticals, an Affiliate of IGI, Inc., (hexamethyltetracosane, prednisolone, tetra- Box 209, Harding Hwy., Buena, NJ 08310. caine, neomycin sulfate). NADA 044–655........................................ NEOMYCANE Ophthalmic Ointment (neomycin Evsco Pharmaceuticals, an Affiliate of IGI, Inc., sulfate). Box 209, Harding Hwy., Buena, NJ 08310. NADA 045–288 ........................................ OPTISONE (neomycin sulfate, prednisolone ace- Evsco Pharmaceuticals, an Affiliate of IGI, Inc., tate). Box 209, Harding Hwy., Buena, NJ 08310. NADA 049–890 ........................................ NORCO T–2 Pre-Pak (tylosin phosphate) ............ Norco Mills of Norfolk, Inc., P.O. Box 56, Norfolk, NE 68701. NADA 055–034 ........................................ CHLORASOL (chloramphenicol) ........................... Evsco Pharmaceuticals, an Affiliate of IGI, Inc., Box 209, Harding Hwy., Buena, NJ 08310. NADA 055–052 ........................................ Chlora-Tabs 100 (chloramphenicol) ...................... Evsco Pharmaceuticals, an Affiliate of IGI, Inc., Box 209, Harding Hwy., Buena, NJ 08310. NADA 065–158 ........................................ CHLORICOL (chloramphenicol) ............................ Evsco Pharmaceuticals, an Affiliate of IGI, Inc., Box 209, Harding Hwy., Buena, NJ 08310. NADA 065–259........................................ CHLORASONE Ophthalmic Ointment (chlor- Evsco Pharmaceuticals, an Affiliate of IGI, Inc., amphenicol, prednisolone acetate). Box 209, Harding Hwy., Buena, NJ 08310. VerDate Mar<15>2010 16:14 Jan 31, 2012 Jkt 226001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\01FER1.SGM 01FER1 tkelley on DSK3SPTVN1PROD with RULES 4896 Federal Register / Vol. 77, No. 21 / Wednesday, February 1, 2012 / Rules and Regulations TABLE 1—VOLUNTARY REQUESTS FOR WITHDRAWAL OF APPROVAL (WOA) OF 20 NADAS—Continued Trade name Application No. (drug) Applicant NADA 065–488 ........................................ BENZA–PEN (penicillin G benzathine, penicillin Walco International, Inc., 15 West Putnam, G procaine). Porterville, CA 93257. NADA 095–953........................................ MOORMABOOST TY 4000 Medicated (tylosin ADM Alliance Nutrition, Inc., 1000 North 30th St., phosphate). Quincy, IL 62305–3115. NADA 100–689 ........................................ DIFIL Syrup (diethylcarbamazine citrate) .............. Evsco Pharmaceuticals, an Affiliate of IGI, Inc., Box 209, Harding Hwy., Buena, NJ 08310. NADA 100–690 ........................................ DIFIL Tablets (diethylcarbamazine citrate) ........... Evsco Pharmaceuticals, an Affiliate of IGI, Inc., Box 209, Harding Hwy., Buena, NJ 08310. NADA 107–957........................................ TYLAN 20 Sulfa-G (tylosin phosphate and ADM Alliance Nutrition, Inc., 1000 North 30th St., sulfamethazine). Quincy, IL 62305–3115. NADA 111–069........................................ TYLAN 40 Sulfa-G (tylosin phosphate and ADM Alliance Nutrition, Inc., 1000 North 30th St., sulfamethazine). Quincy, IL 62305–3115. NADA 131–956........................................ TYLAN Sulfa-G (tylosin phosphate and ADM Alliance Nutrition, Inc., 1000 North 30th St., sulfamethazine). Quincy, IL 62305–3115. NADA 131–957 ........................................ TYLAN 40 (tylosin phosphate) .............................. ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305–3115. NADA 133–490 ........................................ Ban-D-Wormer II BANMINTH (pyrantel tartrate) .. ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305–3115. NADA 140–842 ........................................ HYGROMIX 2.4 Premix (hygromycin B) ............... ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305–3115. NADA 140–958 ........................................ EQUIPHEN Paste (phenylbutazone) 520.1720c .. Luitpold Pharmaceuticals, Inc., Animal Health Di- vision, Shirley, NY 11967. In a notice published elsewhere in 21 CFR Part 558 (b) Sponsors. See § 510.600(c) of this this issue of the Federal Register, FDA Animal drugs, Animal feeds. chapter: gave notice that approval of NADAs Therefore, under the Federal Food, (1) For use as in paragraphs (c)(1), 014–485, 032–322, 044–655, 045–288, (c)(2)(i), and (c)(3) of this section: 049–890, 055–034, 055–052, 065–158, Drug, and Cosmetic Act and under the authority delegated to the Commissioner (i) No. 000010 for 100-, 250-, and 500- 065–259, 065–488, 095–953, 100–689, mg; and 1- and 2.5-g tablets; 100–690, 107–957, 111–069, 131–956, of Food and Drugs and redelegated to 131–957, 133–490, 140–842, and 140– the Center for Veterinary Medicine, 21 (ii) No. 000856 for 100-, 250-, and 958, and all supplements and CFR parts 510, 520, 522, 524, 529, and 500-mg tablets; amendments thereto, is withdrawn, 558 are amended as follows: (iii) No. 000069 for 250-mg tablets. effective February 13, 2012. As provided PART 510—NEW ANIMAL DRUGS (2) For use as in paragraphs (c)(1), in the regulatory text of this document, (c)(2)(ii), and (c)(3) of this section: the animal drug regulations are ■ 1. The authority citation for 21 CFR (i) No. 061623 for 50-, 100-, 250-, and amended to reflect these withdrawals of part 510 continues to read as follows: 500-mg; and 1-g tablets; approval and a current format. Authority: 21 U.S.C. 321, 331, 351, 352, (ii) [Reserved] Following these withdrawals of 353, 360b, 371, 379e. (c) Conditions of use in dogs—(1) approval, Evsco Pharmaceuticals, an § 510.600 [Amended]
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