New Animal Drugs; Change of Sponsor, 13542-13546 [2014-04937]

Download as PDF 13542 Federal Register / Vol. 79, No. 47 / Tuesday, March 11, 2014 / Rules and Regulations leavened baked snack foods at levels not to exceed 400 IU of vitamin D2 per 100 g in the finished food). The labeling requirement in § 172.381(d) ensures that when vitamin D2 bakers yeast is used to make products, the manufacturer will have the information necessary to use the additive in conformance with the provisions of the regulation. The second objection from AB Mauri asserts that if FDA is going to approve vitamin D2 supplementation in baked products at higher levels than are currently permitted by the regulations, it should do so in a way that permits better control of vitamin D levels in finished products by considering the use of vitamin D3 instead. AB Mauri questions whether vitamin D2 is as effective for humans as vitamin D3 at similar levels, and cites two peerreviewed journal articles to support this claim. Our evaluation of the petition was based solely on the safety of the proposed use of vitamin D2 bakers yeast in yeast-containing baked goods. Therefore, expanding the scope of the final rule to provide for the safe use of vitamin D3 is beyond the scope of the petition submitted by Lallemand. If AB Mauri is interested in obtaining approval for the expanded use of vitamin D3 in food, they may do so by petitioning FDA for this use in accordance with section 409(b) of the FD&C Act. IV. Summary and Conclusions Section 409 of the FD&C Act requires that a food additive be shown to be safe prior to marketing. Under 21 CFR 170.3(i), a food additive is ‘‘safe’’ if there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use. In the final rule authorizing the use of vitamin D2 bakers yeast, we concluded that the data presented by the petitioner to establish safety of the additive demonstrate that vitamin D2 bakers yeast is safe for its intended use in yeast-leavened baked products at levels not to exceed 400 IU of vitamin D2 per 100 g in the finished food. The petitioner has the burden to demonstrate the safety of the additive to gain FDA approval. Once we make a finding of safety, the burden shifts to an objector, who must come forward with evidence that calls into question our conclusion (see section 409(f)(1) of the FD&C Act). After evaluating the objections from AB Mauri, we have concluded that the objections do not provide any basis for us to reconsider our decision to issue the final rule authorizing the use of vitamin D2 bakers yeast as a dual purpose nutrient supplement and leavening agent in yeast-containing baked products at levels not to exceed 400 IU of vitamin D2 per 100 g in the finished food. Accordingly, we are not making any changes in response to the objections. Dated: March 4, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–05060 Filed 3–10–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Final rule; technical amendment. ACTION: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 110 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) for new animal drug for use in animal feed from Pfizer, Inc., including its several subsidiaries and divisions, to Zoetis, Inc. SUMMARY: DATES: This rule is effective March 11, 2014. FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855; 240–276–8300, steven.vaughn@fda.hhs.gov. Pfizer, Inc., 235 E. 42d St., New York, NY 10017, and its wholly owned subsidiaries Alpharma, LLC; Fort Dodge Animal Health, Division of Wyeth; Fort Dodge Animal Health, Division of Wyeth Holdings Corp.; and its division, Pharmacia & Upjohn Co., have informed FDA that they have transferred ownership of, and all rights and interest in, the 110 approved NADAs and 14 approved ANADAs in Table 1 to Zoetis, Inc., 333 Portage St., Kalamazoo, MI 4900. SUPPLEMENTARY INFORMATION: 21 CFR Part 558 [Docket No. FDA–2014–N–0002] New Animal Drugs; Change of Sponsor AGENCY: Food and Drug Administration, HHS. TABLE 1—NADAS AND ANADAS TRANSFERRED FROM PFIZER, INC., TO ZOETIS, INC. mstockstill on DSK4VPTVN1PROD with RULES File No. 007–616 011–116 012–375 012–680 013–747 033–950 034–085 034–254 035–688 035–805 036–361 039–077 039–402 039–417 040–209 041–647 041–648 041–649 ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ VerDate Mar<15>2010 Product name HISTOSTAT 50 (nitarsone) Type A Medicated Article. ZOAMIX (zoalene) Type A Medicated Article. ALBAMIX (novobiocin) Type A Medicated Article. PHARMASTATIN 20 (nystatin) Type A Medicated Article. Zoalene 90 Medicated Coccidiostat. Sulfamerazine In Fish Grade. LINCOMIX (lincomycin) Type A Medicated Article. MGA (melengestrol acetate) Type A Medicated Article. AUREOMIX Granular 500 (pen G, CTC, sulfamethazine) Type A Medicated Article. AUREO S 700 Granular (CTC and sulfamethazine) Type A Medicated Article. Amprolium and ethopabate/CTC (chlortetracycline)/sodium sulfate. CSP (chlortetracycline, sulfathiazole, and penicillin G procaine) 250 and 500 Type A Medicated Articles. MGA 500 (melengestrol acetate) Liquid Type A Medicated Article. DECCOX (decoquinate) Type A Medicated Article. ROFENAID 40 (sulfadimethoxine and ormetoprim) Type A Medicated Article. AUREOMIX S 700–A (CTC and sulfamethazine) Type A Medicated Article. AUREOMIX S 700–D (CTC and sulfamethazine) Type A Medicated Article. AUREOMIX S 700–G (CTC and sulfamethazine) Type A Medicated Article. 16:00 Mar 10, 2014 Jkt 232001 PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 E:\FR\FM\11MRR1.SGM 11MRR1 Federal Register / Vol. 79, No. 47 / Tuesday, March 11, 2014 / Rules and Regulations TABLE 1—NADAS AND ANADAS TRANSFERRED FROM PFIZER, INC., TO ZOETIS, INC.—Continued mstockstill on DSK4VPTVN1PROD with RULES File No. 041–650 041–651 041–652 041–653 041–654 044–820 044–972 045–348 045–444 046–415 046–592 046–666 046–699 046–718 046–719 046–920 047–261 047–262 048–486 048–761 048–762 048–763 048–954 049–287 055–040 065–020 091–668 091–749 092–482 092–507 092–522 093–106 096–298 096–933 097–085 097–505 098–452 100–901 101–689 103–758 107–347 107–996 114–794 121–553 124–309 125–476 128–686 133–334 134–284 134–830 135–746 137–537 138–456 138–792 138–870 138–904 138–941 138–992 138–995 139–075 139–192 139–235 139–876 140–288 140–443 140–579 140–853 140–859 140–865 141–025 141–059 141–083 ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ VerDate Mar<15>2010 Product name AUREOMIX S 700–E (CTC and sulfamethazine) Type A Medicated Article. AUREOMIX S 700–F (CTC and sulfamethazine) Type A Medicated Article. AUREOMIX S 700–C–2 (CTC and sulfamethazine) Type A Medicated Article. AUREOMIX S 700–B (CTC and sulfamethazine) Type A Medicated Article. AUREOMIX S 700–H (CTC and sulfamethazine) Type A Medicated Article. AMPROL PLUS (amprolium and ethopabate)/LINCOMIX (lincomycin). LINCOMIX (lincomycin)/COYDEN (clopidol). ALBAC (bacitracin zinc)/DECCOX (decoquinate). CHLORMAX (chlortetracycline)/DECCOX (decoquinate). Tylosin Type A Medicated Articles. BMD (bacitracin methylene disalicylate) Type A Medicated Articles. Penicillin G Procaine Type A Medicated Articles. CHLORMAX (chlortetracycline) Type A Medicated Articles. MGA (liquid) (melengestrol acetate)/TERRAMYCIN (oxytetracycline). MGA (dry) (melengestrol acetate)/TERRAMYCIN (oxytetracycline). BACIFERM (bacitracin zinc) Type A Medicated Articles. DECCOX (decoquinate)/LINCOMIX (lincomycin). DECCOX (decoquinate)/LINCOMIX (lincomycin). ROBENZ (robenidine) Type A Medicated Article. AUREOMYCIN (chlortetracycline) Type A Medicated Article. Chlortetracycline Type A Medicated Article. Chlortetracycline Type A Medicated Article. ZOAMIX (zoalene)/LINCOMIX (lincomycin). PFICHLOR (chlortetracycline) Type A Medicated Article. SF Mix 66 (chlortetracycline) Type A Medicated Article. Micro CTC (chlortetracycline) 100 Type A Medicated Article. CHLORMAX SP (chlortetracycline) 250 and 500 Type A Medicated Articles. TYLAN 40 Plus Sulfa-G. COBAN (monensin)/LINCOMIX (lincomycin). ROBENZ/Aureomycin 500 Gm. COBAN (monensin)/LINCOMIX (lincomycin). ROBENZ (robenidine)/LINCOMIX (lincomycin). AVATEC and BOVATEC (lasalocid) Type A Medicated Articles. ROBENZ (robenidine)/Bacitracin Zn. Bacitracin MD/ROBENZ (robenidine). LINCOMIX (lincomycin) Type A Medicated Articles. ALBAC 50 (bacitracin zinc) Type A Medicated Article. PFICHLOR (chlortetracycline) 100S Milk Replacer Type A Medicated Article. AVATEC (lasalocid)/LINCOMIX (lincomycin). TERRAMYCIN (oxytetracycline) Type A Medicated Article. CHEQUE (mibolerone) Medicated Dog Food. AVATEC (lasalocid)/FORTRACIN (lasalocid). AMPROL HI–E (amprolium and ethopabate)/BACIFERM (bacitracin zinc). AUREOMYCIN (chlortetracycline)/COBAN (monensin). MGA 100 and 200 (melengestrol acetate)/RUMENSIN (monensin). MGA 500 (melengestrol acetate)/RUMENSIN (monensin). BIO–COX (salinomycin) Type A Medicated Article. Virginiamycin Type A Medicated Article. BIO–COX (salinomycin)/FLAVOMYCIN (bambermycins). ALBAC (bacitracin zinc)/COBAN (monensin). BIO–COX (salinomycin)/BMD (bacitracin methylene disalicylate). BIO–COX (salinomycin)/LINCOMIX (lincomycin). COBAN (monensin)/BMD (bacitracin methylene disalicylate). MGA 100 and 200 (melengestrol)/RUMENSIN (monensin)/TYLAN (tylosin). MGA 500 (melengestrol acetate)/BOVATEC (lasalocid)/TYLAN (tylosin). MGA (melengestrol acetate)/BOVATEC (lasalocid)/TYLAN (tylosin). LINCOMIX (lincomycin)/BANMINTH (pyrantel). MGA 200 (melengestrol acetate)/BOVATEC (lasalocid)/TYLAN (tylosin). MGA (melengestrol acetate)/TYLAN (tylosin). CYGRO (maduramicin) Type A Medicated Article. MGA 500 (melengestrol acetate)/TYLAN (tylosin). BACIFERM (bacitracin zinc)/BIO–COX (salinomycin). MGA 200 (melengestrol acetate)/BOVATEC (lasalocid). MGA 500 (melengestrol acetate)/BOVATEC (lasalocid). HYGROMIX 1.6 (hygromycin B) Premix. BOVATEC (lasalocid)/TERRAMYCIN (oxytetracycline). BMD (bacitracin methylene disalicylate)/MONTEBAN (naracin). AUREOMYCIN (chlortetracycline)/BIO–COX (salinomycin). BACIFERM or ALBAC (bacitracin zinc)/MONTEBAN (naracin). CATTLYST (laidlomycin) Type A Medicated Article. BMD (bacitracin methylene disalicylate)/CTC (chlortetracycline). AVATEC (lasalocid)/BACIFERM (bacitracin zinc). 16:00 Mar 10, 2014 Jkt 232001 PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 E:\FR\FM\11MRR1.SGM 11MRR1 13543 13544 Federal Register / Vol. 79, No. 47 / Tuesday, March 11, 2014 / Rules and Regulations TABLE 1—NADAS AND ANADAS TRANSFERRED FROM PFIZER, INC., TO ZOETIS, INC.—Continued File No. 141–085 141–088 141–102 141–109 141–124 141–132 141–136 141–140 141–144 141–147 141–148 141–149 141–150 141–154 141–156 141–179 141–181 141–185 141–201 141–250 200–140 200–167 200–204 200–205 200–210 200–212 200–213 200–218 200–223 200–242 200–261 200–262 200–263 200–478 ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ ........................ Product name BMD (bacitracin methylene disalicylate)/ZOAMIX (zoalene). HISTOSTAT (nitarsone)/BMD (bacitracin methylene disalicylate). BMD (bacitracin methylene disalicylate)/DECCOX (decoquinate). AVATEC (lasalocid)/BACIFERM (bacitracin zinc). BMD (bacitracin methylene disalicylate)/MAXIBAN (naracin and nicarbazin). HISTOSTAT (nitarsone)/ALBAC (bacitracin zinc). BMD (bacitracin methylene disalicylate)/BIO–COX (salinomycin). BMD (bacitracin methylene disalicylate)/COBAN (monensin). BMD (bacitracin methylene disalicylate)/SAFE–GUARD (fenbendazole). DECCOX (decoquinate)/CHLORMAX (chlortetracycline). DECCOX (decoquinate)/RUMENSIN (monensin). DECCOX (decoquinate)/RUMENSIN (monensin)/TYLAN (tylosin). AVATEC (lasalocid)/STAFAC (virginiamycin). BMD (bacitracin methylene disalicylate)/ROBENZ (robenidine). BMD (bacitracin methylene disalicylate)/AMPROL (amprolium). BMD (bacitracin methylene disalicylate)/AVATEC (lasalocid). ALBAC (bacitracin zinc)/AVATEC (lasalocid). DECCOX (decoquinate)/AUREOMYCIN (chlortetracycline). CATTLYST (laidlomycin)/AUREOMYCIN (chlortetracycline). BOVATEC (lasalocid)/AUREOMYCIN (chlortetracycline). AUREOZOL (pen G, CTC, sulfathiazole) Type A Medicated Article. AUREOZOL 500 Granular (pen G, CTC, sulfathiazole) Type A Medicated Article. ALBAC (bacitracin zinc)/BIO–COX (salinomycin). ALBAC (bacitracin zinc)/AMPROL HI–E (amprolium and ethopabate). ALBAC (bacitracin zinc)/SACOX (salinomycin). ALBAC (bacitracin zinc)/ROBENZ. ALBAC (bacitracin zinc)/DECCOX (decoquinate). ALBAC (bacitracin zinc)/COYDEN 25 (clopidol). ALBAC 50 (bacitracin zinc) Type A Medicated Article. BMD (bacitracin methylene disalicylate)/AUREOMYCIN (chlortetracycline). CHLORMAX (chlortetracycline)/BIO–COX (salinomycin). CHLORMAX (chlortetracycline)/SACOX (salinomycin). CHLORMAX (chlortetracycline)/COBAN (monensin). ALBAC 50 (bacitracin zinc)/NICARB (nicarbazin). Accordingly, the Agency is amending the regulations in 21 CFR part 558 to reflect these transfers of ownership. In addition, the regulations are being amended to make minor corrections. This is being done to increase the accuracy and readability of the regulations. 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 List of Subjects in 21 CFR Part 558 Animal drugs, Animal feeds. mstockstill on DSK4VPTVN1PROD with RULES 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 part 558 is amended as follows: PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: ■ Authority: 21 U.S.C. 360b, 371. VerDate Mar<15>2010 16:00 Mar 10, 2014 Jkt 232001 § 558.76 [Amended] 2. In § 558.76, in paragraph (a), remove ‘‘046573’’ and in its place add ‘‘054771’’; and in the table in paragraph (d)(1), in the ‘‘Limitations’’ column and in the ‘‘Sponsor’’ column, remove ‘‘046573’’ wherever it occurs and in its place add ‘‘054771’’. wherever it occurs and in its place add ‘‘054771’’; ■ d. In paragraph (e)(6)(iv), remove ‘‘per head’’ and in its place add ‘‘per pound of body weight’’; and ■ e. In paragraph (e)(6)(v), remove ‘‘046573’’ and in its place add ‘‘054771’’. § 558.78 § 558.140 ■ [Amended] 3. In § 558.78, in paragraph (b), remove ‘‘046573’’ and in its place add ‘‘054771’’; and in the table in paragraph (d)(1), in the ‘‘Sponsor’’ column, remove ‘‘046573’’ wherever it occurs and in its place add ‘‘054771’’; and in paragraph (d)(2)(ii), remove ‘‘046573’’ and in its place add ‘‘054771’’. ■ § 558.128 [Amended] 4. Amend § 558.128 as follows: a. In paragraph (b)(1), remove ‘‘046573’’ and in its place add ‘‘054771’’; ■ b. In the tables in paragraphs (e)(1), (e)(2), (e)(3), and (e)(5), in the ‘‘Sponsor’’ column, remove ‘‘046573’’ wherever it occurs and in its place add ‘‘054771’’; ■ c. In the table in paragraph (e)(4), in the ‘‘Limitations’’ column and in the ‘‘Sponsor’’ column, remove ‘‘046573’’ ■ ■ PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 [Amended] 5. In § 558.140, in paragraph (a), remove ‘‘046573’’ and in its place add ‘‘054771’’; and revise paragraph (c)(3) to read as follows: ■ § 558.140 Chlortetracycline and sulfamethazine. * * * * * (c) * * * (3) Limitations. Feed for 28 days, withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. § 558.145 [Amended] 6. In § 558.145, in paragraph (a)(1), remove ‘‘046573’’ and in its place add ‘‘054771’’; and in paragraph (a)(2) remove ‘‘046573 and 048164’’ and in its place add ‘‘Nos. 048164 and 054771’’. ■ E:\FR\FM\11MRR1.SGM 11MRR1 Federal Register / Vol. 79, No. 47 / Tuesday, March 11, 2014 / Rules and Regulations § 558.155 [Amended] ‘‘000004’’ where it occurs and in its place add ‘‘054771’’; and in paragraphs (e)(2)(v), (e)(3)(v), and (e)(4)(v), remove ‘‘046573’’ and in its place add ‘‘054771’’. 7. In § 558.155, in paragraphs (a)(1) and (2), remove ‘‘046573’’ and in its place add ‘‘054771’’. ■ § 558.175 [Amended] 8. In § 558.175, in the table in paragraph (d), in the ‘‘Limitations’’ column and in the ‘‘Sponsor’’ column, remove ‘‘046573’’ wherever it occurs and in its place add ‘‘054771’’; and in paragraph (d)(6), in the ‘‘Sponsor’’ column, remove ‘‘000009’’ and in its place add ‘‘054771’’. ■ § 558.195 9. In § 558.195, in paragraph (b), remove ‘‘046573’’ and in its place add ‘‘054771’’; in the tables in paragraphs (e)(1), (e)(2), and (e)(3), in the ‘‘Limitations’’ column and in the ‘‘Sponsor’’ column, remove ‘‘046573’’ wherever it occurs and in its place add ‘‘054771’’; and in the table in paragraph (e)(1), in the ‘‘Limitations’’ column and in the ‘‘Sponsor’’ column, remove ‘‘000009’’ wherever it occurs and in its place add ‘‘054771’’. [Amended] 10. In § 558.198, in the tables in paragraphs (d)(1) and (2), in the ‘‘Limitations’’ column, remove ‘‘046573’’ wherever it occurs and in its place add ‘‘054771’’. ■ § 558.258 [Amended] 11. In § 558.258, in the tables in paragraphs (e)(2)(vi) and (vii), in the ‘‘Limitations’’ column and in the ‘‘Sponsor’’ column, remove ‘‘046573’’ and in its place add ‘‘054771’’; and in paragraphs (e)(2)(ii) through (v), in the ‘‘Limitations’’ column, remove ‘‘000009’’ and in its place add ‘‘054771’’. ■ § 558.305 [Amended] 12. In § 558.305, in paragraph (b), remove ‘‘046573’’ and in its place add ‘‘054771’’; and in the table in paragraph (e) in the ‘‘Sponsor’’ column, remove ‘‘046573’’ wherever it occurs and in its place add ‘‘054771’’. ■ § 558.311 [Amended] 13. In § 558.311, in paragraphs (b)(1) through (4) and (6) and (7), remove ‘‘046573’’ and in its place add ‘‘054771’’; in the table in paragraph (e)(1), in the ‘‘Limitations’’ column and in the ‘‘Sponsor’’ column, remove ‘‘046573’’ wherever it occurs and in its place add ‘‘054771’’, in the ‘‘Limitations’’ column, remove ‘‘000009’’ where it occurs and in its place add ‘‘054771’’, in the ‘‘Limitations’’ column, remove mstockstill on DSK4VPTVN1PROD with RULES ■ VerDate Mar<15>2010 16:00 Mar 10, 2014 Jkt 232001 [Amended] 14. In § 558.325, in paragraphs (a)(1) and (c)(3)(i), remove ‘‘000009’’ and in its place add ‘‘054771’’; and in the tables in paragraphs (d)(1) and (2), in the ‘‘Sponsor’’ column, remove ‘‘000009’’ wherever it occurs and in its place add ‘‘054771’’. ■ § 558.340 [Amended] ■ § 558.198 § 558.325 [Amended] 15. In § 558.340, in paragraph (a), remove ‘‘046573’’ and in its place add ‘‘No. 054771’’. ■ § 558.342 [Amended] ‘‘046573’’ and in its place add ‘‘054771’’. § 558.364 § 558.366 21. In § 558.366, in the table in paragraph (d), in the ‘‘Limitations’’ column and in the ‘‘Sponsor’’ column, remove ‘‘046573’’ wherever it occurs and in its place add ‘‘054771’’ and in paragraph (d), in the ‘‘Limitations’’ column, remove ‘‘000009’’ wherever it occurs and in its place add ‘‘054771’’. § 558.348 § 558.415 17. In § 558.348, in paragraph (a), remove ‘‘000009’’ and in its place add ‘‘No. 054771’’. ■ § 558.355 [Amended] 18. In § 558.355, in paragraphs (b)(8), (b)(9), and (b)(11), remove ‘‘046573’’ and in its place add ‘‘054771’’; in paragraphs (f)(1)(iii)(b), (f)(1)(iv)(b), (f)(1)(v)(b), (f)(1)(vii)(b), (f)(1)(xiv)(b), (f)(1)(xxv)(b), (f)(1)(xxix)(b), (f)(1)(xxx)(b), (f)(2)(ii)(b), (f)(2)(iii)(b), (f)(4)(ii)(b), (f)(4)(iii)(b), (f)(4)(iv)(b), (f)(4)(v)(b), remove ‘‘046573’’ and in its place add ‘‘054771’’; and revise paragraph (f)(1)(i)(b) to read as follows: ■ § 558.355 Monensin. * * * * * (f) * * * (1) * * * (i) * * * (b) Limitations. Feed continuously as the sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. * * * * * § 558.363 [Amended] 19. In § 558.363, in paragraphs (a)(6) and (a)(7), remove ‘‘046573’’ and in its place add ‘‘054771’’; in paragraph (d)(1)(vi)(B) and (d)(1)(x)(B), remove ■ PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 [Amended] ■ § 558.369 [Amended] [Amended] 20. In § 558.364, in paragraph (a), remove ‘‘000009’’ and in its place add ‘‘054771’’; and in the table in paragraph (d), in the ‘‘Sponsor’’ column, remove ‘‘000009’’ wherever it occurs and in its place add ‘‘054771’’. ■ 16. In § 558.342, in paragraph (b)(1), remove ‘‘000009’’ and in its place add ‘‘054771’’; in the table in paragraph (e)(1), in the ‘‘Limitations’’ column and in the ‘‘Sponsor’’ column, remove ‘‘000009’’ wherever it occurs and in its place add ‘‘054771’’, and in the ‘‘Limitations’’ column, remove ‘‘046573’’ wherever it occurs and in its place add ‘‘054771’’. ■ 13545 [Amended] 22. In § 558.369, in paragraph (a), remove ‘‘046573’’ and in its place add ‘‘054771’’. ■ § 558.415 [Amended] 23. In § 558.415, redesignate paragraphs (b) and (c) as paragraphs (c) and (d); revise paragraph (a); and add new paragraph (b) to read as follows: ■ Novobiocin. (a) Specifications. Type A medicated article containing 25 grams of novobiocin activity per pound. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. * * * * * ■ 24. In § 558.430, redesignate paragraphs (b) and (c) as paragraphs (c) and (d); revise paragraph (a); and add new paragraph (b) to read as follows: ■ § 558.430 Nystatin. (a) Specifications. Type A medicated article containing 20 grams of nystatin activity per pound. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. * * * * * § 558.460 [Amended] 25. In § 558.460, in paragraph (b), remove ‘‘046573’’ and in its place add ‘‘054771’’; and in the table in paragraph (d)(1)(i), in the ‘‘Sponsor’’ column, remove ‘‘000069, 046573’’ and in its place add ‘‘054771, 066104’’; and in paragraphs (d)(1)(ii) and (iii), in the ‘‘Sponsor’’ column, remove ‘‘Do.’’ and in its place add ‘‘054771, 066104’’. ■ § 558.464 [Amended] 26. In § 558.464, in paragraphs (a)(1) and (2), remove ‘‘000069’’ and in its place add ‘‘054771’’. ■ E:\FR\FM\11MRR1.SGM 11MRR1 13546 § 558.485 Federal Register / Vol. 79, No. 47 / Tuesday, March 11, 2014 / Rules and Regulations [Amended] 27. In § 558.485, in paragraph (b)(7), remove ‘‘000069 and 017135’’ and in its place add ‘‘017135 and 054771’’; and in paragraph (e)(1)(xii)(C), remove ‘‘000009’’ and in its place add ‘‘054771’’. ■ paragraph (b)(54), remove ‘‘046573’’ and in its place add ‘‘054771’’; and add paragraph (b)(10) to read as follows: § 558.625 Tylosin. 28. In § 558.500, in paragraphs (e)(2)(viii) and (x), in the ‘‘Limitations’’ column, remove ‘‘000009’’ and in its place add ‘‘054771’’. * * * * (b) * * * (10) To No. 012286: 0.4, 0.8, and 1.6 grams per pound, paragraph (f)(1)(vi)(a) of this section; 20, 40, and 100 grams per pound, paragraphs (f)(1)(i) through (vi) of this section. * * * * * § 558.515 § 558.630 § 558.500 [Amended] ■ [Amended] * 36. In § 558.630, in paragraph (b)(5), remove ‘‘046573’’ and in its place add ‘‘054771’’. 29. In § 558.515, in paragraph (a), remove ‘‘046573’’ and in its place add ‘‘054771’’; in the table in paragraph (d), in the ‘‘Sponsor’’ column, remove ‘‘046573’’ wherever it occurs and in its place add ‘‘054771’’ and in the ‘‘Sponsor’’ column, remove ‘‘000009’’ where it occurs and in its place add ‘‘054771’’. ■ § 558.550 ■ ■ [Amended] 30. In § 558.550, in paragraphs (b)(1), (d)(1)(iii)(c), (d)(1)(vi)(c), (d)(1)(vii)(c), (d)(1)(xvi)(c), (d)(1)(xx)(C), (d)(1)(xxi)(C), (d)(1)(xxii)(B), (d)(1)(xxiii)(b), (d)(3)(ii)(B), (d)(3)(iii)(B), (d)(3)(v)(B), (d)(4)(i)(b), remove ‘‘046573’’ and in its place add ‘‘054771’’; and in paragraph (d)(1)(xiii)(c), remove ‘‘000009’’ and in its place add ‘‘054771’’. ■ § 558.555 [Amended] 31. In § 558.555, in paragraphs (d)(2), (d)(3), (d)(4), and (d)(8), in the ‘‘Limitations’’ column, remove ‘‘046573’’ and in its place add ‘‘054771’’. ■ § 558.575 32. In § 558.575, in paragraph (a)(1), remove ‘‘046573’’ and in its place add ‘‘054771’’. § 558.582 [Amended] [Amended] 35. In § 558.625, remove and reserve paragraphs (b)(57) and (83); in ■ VerDate Mar<15>2010 16:00 Mar 10, 2014 Jkt 232001 [Amended] 38. In § 558.680, in paragraph (b), remove ‘‘046573’’ and in its place add ‘‘054771’’. Dated: February 28, 2014. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 2014–04937 Filed 3–10–14; 8:45 am] BILLING CODE 4160–01–P EQUAL EMPLOYMENT OPPORTUNITY COMMISSION 29 CFR Part 1625 RIN 3046–AA58 The EEOC is correcting a cross-reference in its regulation concerning the requirements for a valid waiver of an individual’s right to file a lawsuit under the Older Workers Benefit Protection Act (OWBPA) amendments to the Age Discrimination in Employment Act (ADEA). This is a technical correction. DATES: Effective Date: March 11, 2014. FOR FURTHER INFORMATION CONTACT: Carol R. Miaskoff, Assistant Legal Counsel, or Raymond L. Peeler, Senior Attorney-Advisor, at (202) 663–4640 (voice) or (202) 663–7026 (TTY). Requests for this document in an SUMMARY: 34. In paragraph (e)(1)(iii) of § 558.600, in the ‘‘Indications for use’’ column, remove ‘‘susceptible’’ wherever it occurs and in its place add ‘‘sensitive’’; in the ‘‘Limitations’’ column, add ‘‘Use as only source of tiamulin.’’; and in the ‘‘Limitations’’ column, remove ‘‘046573’’ and in its place add ‘‘054771’’. § 558.625 § 558.680 Equal Employment Opportunity Commission. ACTION: Correcting Amendments. 33. In § 558.582, in paragraph (a), remove ‘‘046573’’ and in its place add ‘‘054771’’. ■ [Amended] 37. In § 558.635, in paragraph (a)(2), remove ‘‘046573’’ and in its place add ‘‘054771’’. ■ AGENCY: [Amended] ■ § 558.600 § 558.635 Waivers of Rights and Claims in Settlement of a Charge or Lawsuit Under the Age Discrimination in Employment Act; Corrections [Amended] ■ mstockstill on DSK4VPTVN1PROD with RULES [Amended] PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 alternative format should be made to the Office of Communications and Legislative Affairs at (202) 663–4191 (voice) or (202) 663–4494 (TTY), or the Publications Information Center at 1– 800–669–3362 (toll free). SUPPLEMENTARY INFORMATION: Background In the Older Workers Benefit Protection Act of 1990 (OWBPA), Congress established requirements for the knowing and voluntary release of claims under the Age Discrimination in Employment Act (ADEA).1 The OWBPA set basic requirements for all waivers of ADEA rights, and it imposed extra requirements when employers sought such waivers in connection with an exit incentive or group termination program. To implement the OWBPA, the EEOC issued a final negotiated rule at 29 CFR 1625.22 in 1998.2 Need for Correction The EEOC now corrects a crossreference in 29 CFR 1625.22(g)(3), the provision that states the basic requirements for waiving ADEA rights when settling an ADEA charge or lawsuit. Where subsection (g)(3) should cross reference the rule’s ‘‘knowing and voluntary’’ requirements applicable to all ADEA waivers, it instead references the rule’s additional requirements for group termination programs. Therefore, the EEOC now replaces the incorrect language in 29 CFR 1625.22(g)(3) (‘‘set out in paragraph (f) of this section’’), with language referencing the rule’s general waiver requirements (‘‘set out in paragraphs (b), (c), and (d) of this section.’’). Changes to Authority Citation This rule also contains several changes to the existing authority citation for 29 CFR Part 1625. Some of these changes update existing citations to comply with Federal Register formatting conventions. Others streamline and consolidate several references to the Age Discrimination in Employment Act. The revisions also add Executive Order 12067 due to its discussion of the EEOC’s leadership role in age discrimination in employment and the EEOC’s responsibilities with respect to federal regulations concerning employment discrimination. Retrospective Regulatory Review Although the EEOC’s rulemaking on waivers of rights and claims under the 1 Public Law 101–433, 104 Stat. 978 (codified at 29 U.S.C. 626(f)). 2 63 FR 30624, 30631 (June 5, 1998) (EEOC Final Rule for Waiver of Rights and Claims under the ADEA). E:\FR\FM\11MRR1.SGM 11MRR1

Agencies

[Federal Register Volume 79, Number 47 (Tuesday, March 11, 2014)]
[Rules and Regulations]
[Pages 13542-13546]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04937]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2014-N-0002]


New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for 110 approved new 
animal drug applications (NADAs) and 14 approved abbreviated new animal 
drug applications (ANADAs) for new animal drug for use in animal feed 
from Pfizer, Inc., including its several subsidiaries and divisions, to 
Zoetis, Inc.

DATES: This rule is effective March 11, 2014.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855; 240-276-8300, 
steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 E. 42d St., New York, NY 
10017, and its wholly owned subsidiaries Alpharma, LLC; Fort Dodge 
Animal Health, Division of Wyeth; Fort Dodge Animal Health, Division of 
Wyeth Holdings Corp.; and its division, Pharmacia & Upjohn Co., have 
informed FDA that they have transferred ownership of, and all rights 
and interest in, the 110 approved NADAs and 14 approved ANADAs in Table 
1 to Zoetis, Inc., 333 Portage St., Kalamazoo, MI 4900.

Table 1--NADAs and ANADAs Transferred From Pfizer, Inc., to Zoetis, Inc.
------------------------------------------------------------------------
           File No.                           Product name
------------------------------------------------------------------------
007-616......................  HISTOSTAT 50 (nitarsone) Type A Medicated
                                Article.
011-116......................  ZOAMIX (zoalene) Type A Medicated
                                Article.
012-375......................  ALBAMIX (novobiocin) Type A Medicated
                                Article.
012-680......................  PHARMASTATIN 20 (nystatin) Type A
                                Medicated Article.
013-747......................  Zoalene 90 Medicated Coccidiostat.
033-950......................  Sulfamerazine In Fish Grade.
034-085......................  LINCOMIX (lincomycin) Type A Medicated
                                Article.
034-254......................  MGA (melengestrol acetate) Type A
                                Medicated Article.
035-688......................  AUREOMIX Granular 500 (pen G, CTC,
                                sulfamethazine) Type A Medicated
                                Article.
035-805......................  AUREO S 700 Granular (CTC and
                                sulfamethazine) Type A Medicated
                                Article.
036-361......................  Amprolium and ethopabate/CTC
                                (chlortetracycline)/sodium sulfate.
039-077......................  CSP (chlortetracycline, sulfathiazole,
                                and penicillin G procaine) 250 and 500
                                Type A Medicated Articles.
039-402......................  MGA 500 (melengestrol acetate) Liquid
                                Type A Medicated Article.
039-417......................  DECCOX (decoquinate) Type A Medicated
                                Article.
040-209......................  ROFENAID 40 (sulfadimethoxine and
                                ormetoprim) Type A Medicated Article.
041-647......................  AUREOMIX S 700-A (CTC and sulfamethazine)
                                Type A Medicated Article.
041-648......................  AUREOMIX S 700-D (CTC and sulfamethazine)
                                Type A Medicated Article.
041-649......................  AUREOMIX S 700-G (CTC and sulfamethazine)
                                Type A Medicated Article.

[[Page 13543]]

 
041-650......................  AUREOMIX S 700-E (CTC and sulfamethazine)
                                Type A Medicated Article.
041-651......................  AUREOMIX S 700-F (CTC and sulfamethazine)
                                Type A Medicated Article.
041-652......................  AUREOMIX S 700-C-2 (CTC and
                                sulfamethazine) Type A Medicated
                                Article.
041-653......................  AUREOMIX S 700-B (CTC and sulfamethazine)
                                Type A Medicated Article.
041-654......................  AUREOMIX S 700-H (CTC and sulfamethazine)
                                Type A Medicated Article.
044-820......................  AMPROL PLUS (amprolium and ethopabate)/
                                LINCOMIX (lincomycin).
044-972......................  LINCOMIX (lincomycin)/COYDEN (clopidol).
045-348......................  ALBAC (bacitracin zinc)/DECCOX
                                (decoquinate).
045-444......................  CHLORMAX (chlortetracycline)/DECCOX
                                (decoquinate).
046-415......................  Tylosin Type A Medicated Articles.
046-592......................  BMD (bacitracin methylene disalicylate)
                                Type A Medicated Articles.
046-666......................  Penicillin G Procaine Type A Medicated
                                Articles.
046-699......................  CHLORMAX (chlortetracycline) Type A
                                Medicated Articles.
046-718......................  MGA (liquid) (melengestrol acetate)/
                                TERRAMYCIN (oxytetracycline).
046-719......................  MGA (dry) (melengestrol acetate)/
                                TERRAMYCIN (oxytetracycline).
046-920......................  BACIFERM (bacitracin zinc) Type A
                                Medicated Articles.
047-261......................  DECCOX (decoquinate)/LINCOMIX
                                (lincomycin).
047-262......................  DECCOX (decoquinate)/LINCOMIX
                                (lincomycin).
048-486......................  ROBENZ (robenidine) Type A Medicated
                                Article.
048-761......................  AUREOMYCIN (chlortetracycline) Type A
                                Medicated Article.
048-762......................  Chlortetracycline Type A Medicated
                                Article.
048-763......................  Chlortetracycline Type A Medicated
                                Article.
048-954......................  ZOAMIX (zoalene)/LINCOMIX (lincomycin).
049-287......................  PFICHLOR (chlortetracycline) Type A
                                Medicated Article.
055-040......................  SF Mix 66 (chlortetracycline) Type A
                                Medicated Article.
065-020......................  Micro CTC (chlortetracycline) 100 Type A
                                Medicated Article.
091-668......................  CHLORMAX SP (chlortetracycline) 250 and
                                500 Type A Medicated Articles.
091-749......................  TYLAN 40 Plus Sulfa-G.
092-482......................  COBAN (monensin)/LINCOMIX (lincomycin).
092-507......................  ROBENZ/Aureomycin 500 Gm.
092-522......................  COBAN (monensin)/LINCOMIX (lincomycin).
093-106......................  ROBENZ (robenidine)/LINCOMIX
                                (lincomycin).
096-298......................  AVATEC and BOVATEC (lasalocid) Type A
                                Medicated Articles.
096-933......................  ROBENZ (robenidine)/Bacitracin Zn.
097-085......................  Bacitracin MD/ROBENZ (robenidine).
097-505......................  LINCOMIX (lincomycin) Type A Medicated
                                Articles.
098-452......................  ALBAC 50 (bacitracin zinc) Type A
                                Medicated Article.
100-901......................  PFICHLOR (chlortetracycline) 100S Milk
                                Replacer Type A Medicated Article.
101-689......................  AVATEC (lasalocid)/LINCOMIX (lincomycin).
103-758......................  TERRAMYCIN (oxytetracycline) Type A
                                Medicated Article.
107-347......................  CHEQUE (mibolerone) Medicated Dog Food.
107-996......................  AVATEC (lasalocid)/FORTRACIN (lasalocid).
114-794......................  AMPROL HI-E (amprolium and ethopabate)/
                                BACIFERM (bacitracin zinc).
121-553......................  AUREOMYCIN (chlortetracycline)/COBAN
                                (monensin).
124-309......................  MGA 100 and 200 (melengestrol acetate)/
                                RUMENSIN (monensin).
125-476......................  MGA 500 (melengestrol acetate)/RUMENSIN
                                (monensin).
128-686......................  BIO-COX (salinomycin) Type A Medicated
                                Article.
133-334......................  Virginiamycin Type A Medicated Article.
134-284......................  BIO-COX (salinomycin)/FLAVOMYCIN
                                (bambermycins).
134-830......................  ALBAC (bacitracin zinc)/COBAN (monensin).
135-746......................  BIO-COX (salinomycin)/BMD (bacitracin
                                methylene disalicylate).
137-537......................  BIO-COX (salinomycin)/LINCOMIX
                                (lincomycin).
138-456......................  COBAN (monensin)/BMD (bacitracin
                                methylene disalicylate).
138-792......................  MGA 100 and 200 (melengestrol)/RUMENSIN
                                (monensin)/TYLAN (tylosin).
138-870......................  MGA 500 (melengestrol acetate)/BOVATEC
                                (lasalocid)/TYLAN (tylosin).
138-904......................  MGA (melengestrol acetate)/BOVATEC
                                (lasalocid)/TYLAN (tylosin).
138-941......................  LINCOMIX (lincomycin)/BANMINTH
                                (pyrantel).
138-992......................  MGA 200 (melengestrol acetate)/BOVATEC
                                (lasalocid)/TYLAN (tylosin).
138-995......................  MGA (melengestrol acetate)/TYLAN
                                (tylosin).
139-075......................  CYGRO (maduramicin) Type A Medicated
                                Article.
139-192......................  MGA 500 (melengestrol acetate)/TYLAN
                                (tylosin).
139-235......................  BACIFERM (bacitracin zinc)/BIO-COX
                                (salinomycin).
139-876......................  MGA 200 (melengestrol acetate)/BOVATEC
                                (lasalocid).
140-288......................  MGA 500 (melengestrol acetate)/BOVATEC
                                (lasalocid).
140-443......................  HYGROMIX 1.6 (hygromycin B) Premix.
140-579......................  BOVATEC (lasalocid)/TERRAMYCIN
                                (oxytetracycline).
140-853......................  BMD (bacitracin methylene disalicylate)/
                                MONTEBAN (naracin).
140-859......................  AUREOMYCIN (chlortetracycline)/BIO-COX
                                (salinomycin).
140-865......................  BACIFERM or ALBAC (bacitracin zinc)/
                                MONTEBAN (naracin).
141-025......................  CATTLYST (laidlomycin) Type A Medicated
                                Article.
141-059......................  BMD (bacitracin methylene disalicylate)/
                                CTC (chlortetracycline).
141-083......................  AVATEC (lasalocid)/BACIFERM (bacitracin
                                zinc).

[[Page 13544]]

 
141-085......................  BMD (bacitracin methylene disalicylate)/
                                ZOAMIX (zoalene).
141-088......................  HISTOSTAT (nitarsone)/BMD (bacitracin
                                methylene disalicylate).
141-102......................  BMD (bacitracin methylene disalicylate)/
                                DECCOX (decoquinate).
141-109......................  AVATEC (lasalocid)/BACIFERM (bacitracin
                                zinc).
141-124......................  BMD (bacitracin methylene disalicylate)/
                                MAXIBAN (naracin and nicarbazin).
141-132......................  HISTOSTAT (nitarsone)/ALBAC (bacitracin
                                zinc).
141-136......................  BMD (bacitracin methylene disalicylate)/
                                BIO-COX (salinomycin).
141-140......................  BMD (bacitracin methylene disalicylate)/
                                COBAN (monensin).
141-144......................  BMD (bacitracin methylene disalicylate)/
                                SAFE-GUARD (fenbendazole).
141-147......................  DECCOX (decoquinate)/CHLORMAX
                                (chlortetracycline).
141-148......................  DECCOX (decoquinate)/RUMENSIN (monensin).
141-149......................  DECCOX (decoquinate)/RUMENSIN (monensin)/
                                TYLAN (tylosin).
141-150......................  AVATEC (lasalocid)/STAFAC
                                (virginiamycin).
141-154......................  BMD (bacitracin methylene disalicylate)/
                                ROBENZ (robenidine).
141-156......................  BMD (bacitracin methylene disalicylate)/
                                AMPROL (amprolium).
141-179......................  BMD (bacitracin methylene disalicylate)/
                                AVATEC (lasalocid).
141-181......................  ALBAC (bacitracin zinc)/AVATEC
                                (lasalocid).
141-185......................  DECCOX (decoquinate)/AUREOMYCIN
                                (chlortetracycline).
141-201......................  CATTLYST (laidlomycin)/AUREOMYCIN
                                (chlortetracycline).
141-250......................  BOVATEC (lasalocid)/AUREOMYCIN
                                (chlortetracycline).
200-140......................  AUREOZOL (pen G, CTC, sulfathiazole) Type
                                A Medicated Article.
200-167......................  AUREOZOL 500 Granular (pen G, CTC,
                                sulfathiazole) Type A Medicated Article.
200-204......................  ALBAC (bacitracin zinc)/BIO-COX
                                (salinomycin).
200-205......................  ALBAC (bacitracin zinc)/AMPROL HI-E
                                (amprolium and ethopabate).
200-210......................  ALBAC (bacitracin zinc)/SACOX
                                (salinomycin).
200-212......................  ALBAC (bacitracin zinc)/ROBENZ.
200-213......................  ALBAC (bacitracin zinc)/DECCOX
                                (decoquinate).
200-218......................  ALBAC (bacitracin zinc)/COYDEN 25
                                (clopidol).
200-223......................  ALBAC 50 (bacitracin zinc) Type A
                                Medicated Article.
200-242......................  BMD (bacitracin methylene disalicylate)/
                                AUREOMYCIN (chlortetracycline).
200-261......................  CHLORMAX (chlortetracycline)/BIO-COX
                                (salinomycin).
200-262......................  CHLORMAX (chlortetracycline)/SACOX
                                (salinomycin).
200-263......................  CHLORMAX (chlortetracycline)/COBAN
                                (monensin).
200-478......................  ALBAC 50 (bacitracin zinc)/NICARB
                                (nicarbazin).
------------------------------------------------------------------------

    Accordingly, the Agency is amending the regulations in 21 CFR part 
558 to reflect these transfers of ownership. In addition, the 
regulations are being amended to make minor corrections. This is being 
done to increase the accuracy and readability of the regulations.
    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

List of Subjects in 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 part 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

Sec.  558.76  [Amended]

0
2. In Sec.  558.76, in paragraph (a), remove ``046573'' and in its 
place add ``054771''; and in the table in paragraph (d)(1), in the 
``Limitations'' column and in the ``Sponsor'' column, remove ``046573'' 
wherever it occurs and in its place add ``054771''.


Sec.  558.78  [Amended]

0
3. In Sec.  558.78, in paragraph (b), remove ``046573'' and in its 
place add ``054771''; and in the table in paragraph (d)(1), in the 
``Sponsor'' column, remove ``046573'' wherever it occurs and in its 
place add ``054771''; and in paragraph (d)(2)(ii), remove ``046573'' 
and in its place add ``054771''.


Sec.  558.128  [Amended]

0
4. Amend Sec.  558.128 as follows:
0
a. In paragraph (b)(1), remove ``046573'' and in its place add 
``054771'';
0
b. In the tables in paragraphs (e)(1), (e)(2), (e)(3), and (e)(5), in 
the ``Sponsor'' column, remove ``046573'' wherever it occurs and in its 
place add ``054771'';
0
c. In the table in paragraph (e)(4), in the ``Limitations'' column and 
in the ``Sponsor'' column, remove ``046573'' wherever it occurs and in 
its place add ``054771'';
0
d. In paragraph (e)(6)(iv), remove ``per head'' and in its place add 
``per pound of body weight''; and
0
e. In paragraph (e)(6)(v), remove ``046573'' and in its place add 
``054771''.


Sec.  558.140  [Amended]

0
5. In Sec.  558.140, in paragraph (a), remove ``046573'' and in its 
place add ``054771''; and revise paragraph (c)(3) to read as follows:


Sec.  558.140  Chlortetracycline and sulfamethazine.

* * * * *
    (c) * * *
    (3) Limitations. Feed for 28 days, withdraw 7 days prior to 
slaughter. A withdrawal period has not been established for this 
product in pre-ruminating calves. Do not use in calves to be processed 
for veal.


Sec.  558.145  [Amended]

0
6. In Sec.  558.145, in paragraph (a)(1), remove ``046573'' and in its 
place add ``054771''; and in paragraph (a)(2) remove ``046573 and 
048164'' and in its place add ``Nos. 048164 and 054771''.

[[Page 13545]]

Sec.  558.155  [Amended]

0
7. In Sec.  558.155, in paragraphs (a)(1) and (2), remove ``046573'' 
and in its place add ``054771''.


Sec.  558.175  [Amended]

0
8. In Sec.  558.175, in the table in paragraph (d), in the 
``Limitations'' column and in the ``Sponsor'' column, remove ``046573'' 
wherever it occurs and in its place add ``054771''; and in paragraph 
(d)(6), in the ``Sponsor'' column, remove ``000009'' and in its place 
add ``054771''.


Sec.  558.195  [Amended]

0
9. In Sec.  558.195, in paragraph (b), remove ``046573'' and in its 
place add ``054771''; in the tables in paragraphs (e)(1), (e)(2), and 
(e)(3), in the ``Limitations'' column and in the ``Sponsor'' column, 
remove ``046573'' wherever it occurs and in its place add ``054771''; 
and in the table in paragraph (e)(1), in the ``Limitations'' column and 
in the ``Sponsor'' column, remove ``000009'' wherever it occurs and in 
its place add ``054771''.


Sec.  558.198  [Amended]

0
10. In Sec.  558.198, in the tables in paragraphs (d)(1) and (2), in 
the ``Limitations'' column, remove ``046573'' wherever it occurs and in 
its place add ``054771''.


Sec.  558.258  [Amended]

0
11. In Sec.  558.258, in the tables in paragraphs (e)(2)(vi) and (vii), 
in the ``Limitations'' column and in the ``Sponsor'' column, remove 
``046573'' and in its place add ``054771''; and in paragraphs 
(e)(2)(ii) through (v), in the ``Limitations'' column, remove 
``000009'' and in its place add ``054771''.


Sec.  558.305  [Amended]

0
12. In Sec.  558.305, in paragraph (b), remove ``046573'' and in its 
place add ``054771''; and in the table in paragraph (e) in the 
``Sponsor'' column, remove ``046573'' wherever it occurs and in its 
place add ``054771''.


Sec.  558.311  [Amended]

0
13. In Sec.  558.311, in paragraphs (b)(1) through (4) and (6) and (7), 
remove ``046573'' and in its place add ``054771''; in the table in 
paragraph (e)(1), in the ``Limitations'' column and in the ``Sponsor'' 
column, remove ``046573'' wherever it occurs and in its place add 
``054771'', in the ``Limitations'' column, remove ``000009'' where it 
occurs and in its place add ``054771'', in the ``Limitations'' column, 
remove ``000004'' where it occurs and in its place add ``054771''; and 
in paragraphs (e)(2)(v), (e)(3)(v), and (e)(4)(v), remove ``046573'' 
and in its place add ``054771''.


Sec.  558.325  [Amended]

0
14. In Sec.  558.325, in paragraphs (a)(1) and (c)(3)(i), remove 
``000009'' and in its place add ``054771''; and in the tables in 
paragraphs (d)(1) and (2), in the ``Sponsor'' column, remove ``000009'' 
wherever it occurs and in its place add ``054771''.


Sec.  558.340  [Amended]

0
15. In Sec.  558.340, in paragraph (a), remove ``046573'' and in its 
place add ``No. 054771''.


Sec.  558.342  [Amended]

0
16. In Sec.  558.342, in paragraph (b)(1), remove ``000009'' and in its 
place add ``054771''; in the table in paragraph (e)(1), in the 
``Limitations'' column and in the ``Sponsor'' column, remove ``000009'' 
wherever it occurs and in its place add ``054771'', and in the 
``Limitations'' column, remove ``046573'' wherever it occurs and in its 
place add ``054771''.


Sec.  558.348  [Amended]

0
17. In Sec.  558.348, in paragraph (a), remove ``000009'' and in its 
place add ``No. 054771''.


Sec.  558.355  [Amended]

0
18. In Sec.  558.355, in paragraphs (b)(8), (b)(9), and (b)(11), remove 
``046573'' and in its place add ``054771''; in paragraphs 
(f)(1)(iii)(b), (f)(1)(iv)(b), (f)(1)(v)(b), (f)(1)(vii)(b), 
(f)(1)(xiv)(b), (f)(1)(xxv)(b), (f)(1)(xxix)(b), (f)(1)(xxx)(b), 
(f)(2)(ii)(b), (f)(2)(iii)(b), (f)(4)(ii)(b), (f)(4)(iii)(b), 
(f)(4)(iv)(b), (f)(4)(v)(b), remove ``046573'' and in its place add 
``054771''; and revise paragraph (f)(1)(i)(b) to read as follows:


Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (1) * * *
    (i) * * *
    (b) Limitations. Feed continuously as the sole ration. In the 
absence of coccidiosis, the use of monensin with no withdrawal period 
may limit feed intake resulting in reduced weight gain. Do not feed to 
laying chickens.
* * * * *


Sec.  558.363  [Amended]

0
19. In Sec.  558.363, in paragraphs (a)(6) and (a)(7), remove 
``046573'' and in its place add ``054771''; in paragraph (d)(1)(vi)(B) 
and (d)(1)(x)(B), remove ``046573'' and in its place add ``054771''.


Sec.  558.364  [Amended]

0
20. In Sec.  558.364, in paragraph (a), remove ``000009'' and in its 
place add ``054771''; and in the table in paragraph (d), in the 
``Sponsor'' column, remove ``000009'' wherever it occurs and in its 
place add ``054771''.


Sec.  558.366  [Amended]

0
21. In Sec.  558.366, in the table in paragraph (d), in the 
``Limitations'' column and in the ``Sponsor'' column, remove ``046573'' 
wherever it occurs and in its place add ``054771'' and in paragraph 
(d), in the ``Limitations'' column, remove ``000009'' wherever it 
occurs and in its place add ``054771''.


Sec.  558.369  [Amended]

0
22. In Sec.  558.369, in paragraph (a), remove ``046573'' and in its 
place add ``054771''.


Sec.  558.415  [Amended]

0
23. In Sec.  558.415, redesignate paragraphs (b) and (c) as paragraphs 
(c) and (d); revise paragraph (a); and add new paragraph (b) to read as 
follows:


Sec.  558.415  Novobiocin.

0
(a) Specifications. Type A medicated article containing 25 grams of 
novobiocin activity per pound.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *

0
24. In Sec.  558.430, redesignate paragraphs (b) and (c) as paragraphs 
(c) and (d); revise paragraph (a); and add new paragraph (b) to read as 
follows:


Sec.  558.430  Nystatin.

    (a) Specifications. Type A medicated article containing 20 grams of 
nystatin activity per pound.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *


Sec.  558.460  [Amended]

0
25. In Sec.  558.460, in paragraph (b), remove ``046573'' and in its 
place add ``054771''; and in the table in paragraph (d)(1)(i), in the 
``Sponsor'' column, remove ``000069, 046573'' and in its place add 
``054771, 066104''; and in paragraphs (d)(1)(ii) and (iii), in the 
``Sponsor'' column, remove ``Do.'' and in its place add ``054771, 
066104''.


Sec.  558.464  [Amended]

0
26. In Sec.  558.464, in paragraphs (a)(1) and (2), remove ``000069'' 
and in its place add ``054771''.

[[Page 13546]]

Sec.  558.485  [Amended]

0
27. In Sec.  558.485, in paragraph (b)(7), remove ``000069 and 017135'' 
and in its place add ``017135 and 054771''; and in paragraph 
(e)(1)(xii)(C), remove ``000009'' and in its place add ``054771''.


Sec.  558.500  [Amended]

0
28. In Sec.  558.500, in paragraphs (e)(2)(viii) and (x), in the 
``Limitations'' column, remove ``000009'' and in its place add 
``054771''.


Sec.  558.515  [Amended]

0
29. In Sec.  558.515, in paragraph (a), remove ``046573'' and in its 
place add ``054771''; in the table in paragraph (d), in the ``Sponsor'' 
column, remove ``046573'' wherever it occurs and in its place add 
``054771'' and in the ``Sponsor'' column, remove ``000009'' where it 
occurs and in its place add ``054771''.


Sec.  558.550  [Amended]

0
30. In Sec.  558.550, in paragraphs (b)(1), (d)(1)(iii)(c), 
(d)(1)(vi)(c), (d)(1)(vii)(c), (d)(1)(xvi)(c), (d)(1)(xx)(C), 
(d)(1)(xxi)(C), (d)(1)(xxii)(B), (d)(1)(xxiii)(b), (d)(3)(ii)(B), 
(d)(3)(iii)(B), (d)(3)(v)(B), (d)(4)(i)(b), remove ``046573'' and in 
its place add ``054771''; and in paragraph (d)(1)(xiii)(c), remove 
``000009'' and in its place add ``054771''.


Sec.  558.555  [Amended]

0
31. In Sec.  558.555, in paragraphs (d)(2), (d)(3), (d)(4), and (d)(8), 
in the ``Limitations'' column, remove ``046573'' and in its place add 
``054771''.


Sec.  558.575  [Amended]

0
32. In Sec.  558.575, in paragraph (a)(1), remove ``046573'' and in its 
place add ``054771''.


Sec.  558.582  [Amended]

0
33. In Sec.  558.582, in paragraph (a), remove ``046573'' and in its 
place add ``054771''.


Sec.  558.600  [Amended]

0
34. In paragraph (e)(1)(iii) of Sec.  558.600, in the ``Indications for 
use'' column, remove ``susceptible'' wherever it occurs and in its 
place add ``sensitive''; in the ``Limitations'' column, add ``Use as 
only source of tiamulin.''; and in the ``Limitations'' column, remove 
``046573'' and in its place add ``054771''.


Sec.  558.625  [Amended]

0
35. In Sec.  558.625, remove and reserve paragraphs (b)(57) and (83); 
in paragraph (b)(54), remove ``046573'' and in its place add 
``054771''; and add paragraph (b)(10) to read as follows:


Sec.  558.625  Tylosin.

* * * * *
    (b) * * *
    (10) To No. 012286: 0.4, 0.8, and 1.6 grams per pound, paragraph 
(f)(1)(vi)(a) of this section; 20, 40, and 100 grams per pound, 
paragraphs (f)(1)(i) through (vi) of this section.
* * * * *


Sec.  558.630  [Amended]

0
36. In Sec.  558.630, in paragraph (b)(5), remove ``046573'' and in its 
place add ``054771''.


Sec.  558.635  [Amended]

0
37. In Sec.  558.635, in paragraph (a)(2), remove ``046573'' and in its 
place add ``054771''.


Sec.  558.680  [Amended]

0
38. In Sec.  558.680, in paragraph (b), remove ``046573'' and in its 
place add ``054771''.

    Dated: February 28, 2014.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.

[FR Doc. 2014-04937 Filed 3-10-14; 8:45 am]
BILLING CODE 4160-01-P

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