New Animal Drugs; Change of Sponsor, 48700-48703 [2016-17501]

Download as PDF 48700 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Rules and Regulations VOR MON PROGRAM—PHASE 2 CANDIDATE DISCONTINUANCE LIST (FY2021–FY2025)—Continued ID VOR Name City PSM .............................................................. PTW .............................................................. PUT ............................................................... PWL .............................................................. REC .............................................................. RKA ............................................................... ROA * ............................................................ SBY ............................................................... SFK ............................................................... SLT ............................................................... STW .............................................................. SUG .............................................................. SWL .............................................................. TAY * ............................................................. TDT ............................................................... TEB ............................................................... TGE * ............................................................. THS ............................................................... TRV ............................................................... UCA .............................................................. ULW .............................................................. VAN ............................................................... YRK ............................................................... PEASE ......................................................... POTTSTOWN .............................................. PUTNAM ..................................................... PAWLING .................................................... REVLOC ...................................................... ROCKDALE ................................................. ROANOKE ................................................... SALISBURY ................................................ STONYFORK .............................................. SLATE RUN ................................................ STILLWATER .............................................. SUGARLOAF MOUNTAIN .......................... SNOW HILL ................................................. TAYLOR ...................................................... TIDIOUTE .................................................... TETERBORO .............................................. TUSKEGEE ................................................. ST THOMAS ............................................... TREASURE ................................................. UTICA .......................................................... ELMIRA ....................................................... VANCE ........................................................ YORK .......................................................... PORTSMOUTH ........................................... POTTSTOWN .............................................. PUTNAM ..................................................... POUGHKEEPSIE ........................................ REVLOC ...................................................... ROCKDALE ................................................. ROANOKE ................................................... SALISBURY ................................................ STONYFORK .............................................. SLATE RUN ................................................ STILLWATER .............................................. ASHEVILLE ................................................. SNOW HILL ................................................. TAYLOR ...................................................... TIDIOUTE .................................................... TETERBORO .............................................. TUSKEGEE ................................................. ST THOMAS ............................................... VERO BEACH ............................................. UTICA .......................................................... ELMIRA ....................................................... VANCE ........................................................ YORK .......................................................... Issued in Washington, DC, on July 19, 2016. Leonixa Salcedo, VOR MON Program Manager, AJM–324. DATES: Pamela Peters, Program Analyst, U.S. Department of Labor, Room S–2312, 200 Constitution Avenue NW., Washington, DC 20210; telephone: (202) 693–5959 (this is not a toll-free number). SUPPLEMENTARY INFORMATION: DOL published a document in the Federal Register on July 1, 2016 (81 FR 43430), which made inadvertent revisions to the authority citation for part 655. In FR Doc. 2016–15378, published on July 1, 2016, (81 FR 43430), make the following correction: [FR Doc. 2016–17579 Filed 7–25–16; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF LABOR Employment and Training Administration 20 CFR Part 655 RIN 1290–AA31 Department of Labor Federal Civil Penalties Inflation Adjustment Act Catch-Up Adjustments; Correction Employment and Training Administration, Department of Labor. ACTION: Interim final rule; correction. AGENCY: The U.S. Department of Labor (DOL) is correcting an interim final rule published in the Federal Register on July 1, 2016 (81 FR 43430). The interim final rule adjusts the amounts of civil penalties assessed or enforced in its regulations pursuant to the Federal Civil Penalties Inflation Adjustment Act of 1990 as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. That document inadvertently provided an incorrect authority citation when revising the general authority section for 20 CFR part 655. This document corrects the interim final rule by revising the appropriate authority section. rmajette on DSK2TPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 13:45 Jul 25, 2016 Jkt 238001 Effective Date: August 1, 2016. FOR FURTHER INFORMATION CONTACT: PART 655—TEMPORARY EMPLOYMENT OF FOREIGN WORKERS IN THE UNITED STATES [Corrected] 1. On page 43448, in the second and third columns, in part 655—Temporary Employment of Foreign Workers in the United States, the general authority citation is corrected to read as follows: ■ Authority: Section 655.0 issued under 8 U.S.C. 1101(a)(15)(E)(iii), 1101(a)(15)(H)(i) and (ii), 8 U.S.C. 1103(a)(6), 1182(m), (n) and (t), 1184(c), (g), and (j), 1188, and 1288(c) and (d); sec. 3(c)(1), Pub. L. 101–238, 103 Stat. 2099, 2102 (8 U.S.C. 1182 note); sec. 221(a), Pub. L. 101–649, 104 Stat. 4978, 5027 (8 U.S.C. 1184 note); sec. 303(a)(8), Pub. L. 102– 232, 105 Stat. 1733, 1748 (8 U.S.C. 1101 note); sec. 323(c), Pub. L. 103–206, 107 Stat. 2428; sec. 412(e), Pub. L. 105–277, 112 Stat. 2681 (8 U.S.C. 1182 note); sec. 2(d), Pub. L. 106–95, 113 Stat. 1312, 1316 (8 U.S.C. 1182 note); 29 U.S.C. 49k; Pub. L. 107–296, 116 Stat. 2135, as amended; Pub. L. 109–423, 120 Stat. 2900; 8 CFR 214.2(h)(4)(i); and 8 CFR 214.2(h)(6)(iii). PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 ST NH PA CT NY PA NY VA MD PA PA NJ NC MD FL PA NJ AL PA FL NY NY SC KY Subpart A issued under 8 CFR 214.2(h). Subpart B issued under 8 U.S.C. 1101(a)(15)(H)(ii)(a), 1184(c), and 1188; and 8 CFR 214.2(h). Subparts F and G issued under 8 U.S.C. 1288(c) and (d); sec. 323(c), Pub. L. 103–206, 107 Stat. 2428; and 28 U.S.C. 2461 note, Pub. L. 114–74 at section 701. Subparts H and I issued under 8 U.S.C. 1101(a)(15)(H)(i)(b) and (b)(1), 1182(n) and (t), and 1184(g) and (j); sec. 303(a)(8), Pub. L. 102–232, 105 Stat. 1733, 1748 (8 U.S.C. 1101 note); sec. 412(e), Pub. L. 105–277, 112 Stat. 2681; 8 CFR 214.2(h); and 28 U.S.C. 2461 note, Pub. L. 114–74 at section 701. Subparts L and M issued under 8 U.S.C. 1101(a)(15)(H)(i)(c) and 1182(m); sec. 2(d), Pub. L. 106–95, 113 Stat. 1312, 1316 (8 U.S.C. 1182 note); Pub. L. 109–423, 120 Stat. 2900; and 8 CFR 214.2(h). Signed at Washington, DC this 20th day of July, 2016. Thomas E. Perez, Secretary, U.S. Department of Labor. [FR Doc. 2016–17552 Filed 7–25–16; 8:45 am] BILLING CODE 4510–HL–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, and 558 [Docket No. FDA–2014–N–0002] New Animal Drugs; Change of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: E:\FR\FM\26JYR1.SGM Final rule. 26JYR1 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Rules and Regulations The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 57 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) from Elanco Animal Health, A Division of Eli Lilly & Co. to Elanco US, Inc. SUMMARY: DATES: This rule is effective July 26, 2016. FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–0571, steven.vaughn@fda.hhs.gov. 48701 Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285 has informed FDA that it has transferred ownership of, and all rights and interest in, the 71 approved NADAs and ANADAs in table 1 to Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140. SUPPLEMENTARY INFORMATION: TABLE 1—NADAS AND ANADAS TRANSFERRED FROM ELANCO ANIMAL HEALTH, A DIVISION OF ELI LILLY & CO. TO ELANCO US, INC. File No. rmajette on DSK2TPTVN1PROD with RULES 010–918 011–948 012–491 012–548 012–965 013–076 013–162 013–388 015–166 038–878 041–275 047–933 049–463 095–735 104–646 106–964 110–315 115–732 118–123 118–980 126–050 127–507 130–736 135–468 135–906 138–952 140–863 140–872 140–926 140–929 140–937 140–942 140–947 140–955 141–064 141–277 141–298 141–321 141–110 141–164 141–170 141–172 141–198 141–221 141–224 141–225 141–234 141–290 141–233 ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... 141–301 141–337 141–340 141–343 141–361 141–392 141–438 141–439 ......................... ......................... ......................... ......................... ......................... ......................... ......................... ......................... VerDate Sep<11>2014 21 CFR Section Product name HYGROMIX 8 (hygromycin B) Type A medicated article ....................................................................... HYGROMIX 2.4 (hygromycin B) Type A medicated article .................................................................... TYLAN 100 (tylosin) Injection ................................................................................................................. TYLAN (tylosin phosphate)/HYGROMIX (hygromycin B) ....................................................................... TYLAN (tylosin) Injection ........................................................................................................................ TYLAN (tylosin tartrate) Soluble Powder ................................................................................................ TYLAN Premix No. 10 (tylosin phosphate) Type A medicated article ................................................... TYLAN (tylosin phosphate)/HYGROMIX (hygromycin B) ....................................................................... TYLAN 100 Premix (tylosin phosphate) Type A medicated article ........................................................ COBAN 45, 60, 90, 110 (monensin) Type A medicated article ............................................................. TYLAN 40 Sulfa-G (tylosin phosphate and sulfamethazine) Type A medicated article ........................ COBAN (monensin)/BACIFERM (bacitracin Zn) .................................................................................... COBAN (monensin)/BMD (bacitracin methylenedisalicyclate) ............................................................... RUMENSIN 80 and 90 (monensin) Type A medicated article ............................................................... RUMENSIN (monensin)/TYLAN (tylosin phosphate) .............................................................................. APRALAN (apramycin sulfate) Soluble Powder ..................................................................................... COMPONENT E–C or E–S (progesterone and estradiol benzoate) with TYLAN ................................. STRESNIL (azaperone) Injection ............................................................................................................ COMPUDOSE 200 (estradiol); ENCORE (COMPUDOSE 400) ............................................................ MONTEBAN (narasin) Type A medicated article ................................................................................... APRALAN 75 (apramycin sulfate) Soluble Powder ................................................................................ TYLAN 5, 10, 20, 40 Sulfa-G (tylosin phosphate and sulfamethazine) Type A medicated article ........ COBAN (monensin) Type A medicated article ....................................................................................... Nicarbazin Type A medicated article ...................................................................................................... COMPONENT E–H (estradiol benzoate and testosterone propionate) with TYLAN ............................. MAXIBAN (narasin and nicarbazin) Type A medicated article ............................................................... PAYLEAN 9 and 45 (ractopamine HCl) Type A medicated article ........................................................ POSILAC (sometribove Zn) Injectable Suspension ................................................................................ BMD (bacitracin methylenedisalicyclate)/MAXIBAN (narasin and nicarbazin) ....................................... MICOTIL 300 (tilmicosin phosphate) Injectable Solution ....................................................................... BMD (bacitracin methylenedisalicyclate)/COBAN (monensin) ............................................................... FLAVOMYCIN (bambermycins)/MAXIBAN (narasin and nicarbazin) ..................................................... LINCOMIX (lincomycin HCl)/MAXIBAN (narasin and nicarbazin) .......................................................... COBAN (monensin)/FLAVOMYCIN (bambermycins) ............................................................................. PULMOTIL 90 (tilmicosin phosphate) Type A medicated article ........................................................... COMFORTIS (spinosad) Tablets ............................................................................................................ SUROLAN (miconazole nitrate, polymyxin B sulfate, prednisolone acetate) Otic Suspension ............. TRIFEXIS (spinosad and milbemycin oxime) Tablets ............................................................................ COBAN (monensin)/STAFAC (virginiamycin) ......................................................................................... COBAN (monensin)/TYLAN (tylosin phosphate) .................................................................................... MONTEBAN (narasin)/TYLAN (tylosin phosphate) ................................................................................ PAYLEAN (ractopamine HCl)/TYLAN (tylosin phosphate) ..................................................................... TYLAN (tylosin phosphate)/BIO–COX (salinomycin sodium) ................................................................. OPTAFLEXX 45 (ractopamine HCl) Type A medicated article .............................................................. OPTAFLEXX (ractopamine HCl)/RUMENSIN (monensin)/TYLAN (tylosin phosphate) ......................... OPTAFLEXX (ractopamine HCl) RUMENSIN (monensin) ..................................................................... OPTAFLEXX (ractopamine HCl)/RUMENSIN (monensin)/MGA (melengestrol acetate) ....................... TOPMAX 9 (ractopamine HCl) Type A medicated article ...................................................................... OPTAFLEXX (ractopamine HCl)/RUMENSIN (monensin)/TYLAN (tylosin phosphate)/MGA (melengestrol acetate). TOPMAX (ractopamine HCl)/COBAN (monensin) .................................................................................. RECUVYA (fentanyl) Topical Solution .................................................................................................... SKYCIS 100 (narasin) Type A medicated article ................................................................................... PULMOTIL 90 (tilmicosin phosphate)/RUMENSIN 90 (monensin) ........................................................ PULMOTIL AC (tilmicosin phosphate) Concentrate Solution ................................................................. IMPRESTOR (pegbovigrastim) Injection ................................................................................................ KAVAULT (avilamycin) Type A medicated article .................................................................................. INTEPRITY (avilamycin) Type A medicated article ................................................................................ 13:45 Jul 25, 2016 Jkt 238001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\26JYR1.SGM 26JYR1 558.274 558.274 522.2640 558.274 522.2640 520.2640 558.625 558.274 558.625 558.355 558.630 558.355 558.355 558.355 558.355 520.110 522.1940 522.150 522.840 558.363 520.110 558.630 558.355 558.366 522.842 558.366 558.500 522.2112 558.366 522.2471 558.355 558.366 558.366 558.355 558.618 520.2130 524.1445 520.2134 558.355 558.355 558.363 558.500 558.550 558.500 558.500 558.500 558.500 558.500 558.500 558.500 524.916 558.363 558.618 520.2471 522.1684 558.68 558.68 48702 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Rules and Regulations TABLE 1—NADAS AND ANADAS TRANSFERRED FROM ELANCO ANIMAL HEALTH, A DIVISION OF ELI LILLY & CO. TO ELANCO US, INC.—Continued 21 CFR Section File No. Product name 200–221 ......................... COMPONENT TE–G (trenbolone acetate and estradiol); COMPONENT TE–G with TYLAN; COMPONENT TE–ID with TYLAN; COMPONENT TE–IS; COMPONENT TE–IS with TYLAN; COMPONENT TE–S; COMPONENT TE–S with TYLAN. COMPONENT T–H (trenbolone acetate) with TYLAN; COMPONENT T–S with TYLAN ..................... HEIFERMAX 500 (melengestrol acetate) Type A medicated article ...................................................... COMPONENT TE–200 (trenbolone acetate and estradiol); COMPONENT TE–200 with TYLAN; COMPONENT TE–H; COMPONENT TE–H with TYLAN, COMPONENT TE–H. HEIFERMAX 500 (melengestrol acetate)/RUMENSIN (monensin)/TYLAN (tylosin phosphate) ........... HEIFERMAX 500 (melengestrol acetate) Liquid Premix/RUMENSIN (monensin) ................................ HEIFERMAX (melengestrol acetate)/OPTAFLEXX (ractopamine HCl)/RUMENSIN (monensin)/ TYLAN (tylosin phosphate). HEIFERMAX 500 (melengestrol acetate) Liquid Premix/TYLAN (tylosin phosphate) ........................... HEIFERMAX 500 (melengestrol acetate) Liquid Premix/BOVATEC (lasalocid)/TYLAN (tylosin phosphate). HEIFERMAX 500 (melengestrol acetate)/OPTAFLEXX (ractopamine HCl)/RUMENSIN (monensin) ... HEIFERMAX 500 (melengestrol acetate)/BOVATEC (lasalocid) ........................................................... HEIFERMAX 500 (melengestrol acetate)/ZILMAX (zilpaterol)/RUMENSIN (monensin) ........................ HEIFERMAX 500 (melengestrol acetate)/ZILMAX (zilpaterol)/RUMENSIN (monensin)/TYLAN (tylosin phosphate). HEIFERMAX 500 (melengestrol acetate)/ZILMAX (zilpaterol) ............................................................... 200–224 ......................... 200–343 ......................... 200–346 ......................... 200–375 ......................... 200–422 ......................... 200–424 ......................... 200–427 ......................... 200–430 ......................... 200–448 200–451 200–479 200–480 ......................... ......................... ......................... ......................... 200–483 ......................... Accordingly, the Agency is amending the regulations in 21 CFR parts 520, 522, 524, and 558 to reflect these changes of sponsorship. Following these changes of sponsorship, Elanco Animal Health, A Division of Eli Lilly & Co. is no longer the sponsor of any approved application. Accordingly, the regulations are being amended to remove this firm from the lists of sponsors of approved applications in 21 CFR 510.600(c). 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. PART 510—NEW ANIMAL DRUGS Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. § 510.600 2. In § 510.600, in the table in paragraph (c)(1), remove the entry for ‘‘Elanco Animal Health, A Division of Eli Lilly & Co.’’; and in the table in paragraph (c)(2), remove the entry for ‘‘000986’’. ■ PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for part 520 continues to read as follows: ■ 21 CFR Part 510 § 520.110 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. ■ 21 CFR Parts 520, 522, and 524 rmajette on DSK2TPTVN1PROD with RULES [Amended] Authority: 21 U.S.C. 360b. ■ § 520.2130 13:45 Jul 25, 2016 § 520.2134 Jkt 238001 558.342 558.342 558.342 558.342 558.342 558.500 558.342 558.665 558.665 558.665 [Amended] 8. In § 520.2640, in paragraph (b)(1), remove ‘‘000986’’ and in its place add ‘‘058198’’. PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 9. The authority citation for part 522 continues to read as follows: ■ Authority: 21 U.S.C. 360b. § 522.150 [Amended] [Amended] 10. In § 522.150, in paragraph (b), remove ‘‘000986’’ and in its place add ‘‘058198’’. ■ § 522.840 [Amended] 11. In § 522.840, in paragraph (b), remove ‘‘000986’’ and in its place add ‘‘058198’’. ■ § 522.842 [Amended] 12. In § 522.842, in paragraph (a)(2), remove ‘‘000986’’ and in its place add ‘‘058198’’. ■ § 522.1684 5. In § 520.2130, in paragraph (b), remove ‘‘000986’’ and in its place add ‘‘058198’’. 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: VerDate Sep<11>2014 [Amended] 4. In § 520.110, in paragraph (b), remove ‘‘000986’’ and in its place add ‘‘058198’’. 21 CFR Part 558 522.2476 558.342 522.2477 ■ 1. The authority citation for part 510 continues to read as follows: ■ List of Subjects Animal drugs. § 520.2640 522.2477 [Amended] [Amended] 13. In § 522.1684, in paragraph (b), remove ‘‘000986’’ and in its place add ‘‘058198’’. ■ § 522.1940 6. In § 520.2134, in paragraph (b), remove ‘‘000986’’ and in its place add ‘‘058198’’. § 520.2471 § 522.2112 [Amended] ■ ■ [Amended] 7. In § 520.2471, in paragraph (b), remove ‘‘000986’’ and in its place add ‘‘058198’’. ■ PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 14. In § 522.1940, in paragraph (a)(2), remove ‘‘000986’’ and in its place add ‘‘058198’’. [Amended] 15. In § 522.2112, in paragraph (b), remove ‘‘000986’’ and in its place add ‘‘058198’’. ■ E:\FR\FM\26JYR1.SGM 26JYR1 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Rules and Regulations § 522.2471 [Amended] § 558.355 16. In § 522.2471, in paragraph (b), remove ‘‘000986’’ and in its place add ‘‘058198’’. ■ § 22.2476 [Amended] 17. In § 522.2476, in paragraph (a)(1), remove ‘‘021641’’ and in its place add ‘‘058198’’. ■ § 522.2477 [Amended] 18. In § 522.2477, in paragraph (b)(1), remove ‘‘000986’’ and in its place add ‘‘058198’’. ■ § 522.2640 19. In § 522.2640, in paragraph (b)(1), remove ‘‘000986’’ and in its place add ‘‘058198’’. PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS Authority: 21 U.S.C. 360b. [Amended] 21. In § 524.916, in paragraph (b), remove ‘‘000986’’ and in its place add ‘‘058198’’. ■ 22. In § 524.1445, in paragraph (b), remove ‘‘000986’’ and in its place add ‘‘058198’’. PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 23. The authority citation for part 558 continues to read as follows: ■ Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc–1, 371. [Amended] [Amended] 25. In § 558.274, in paragraph (a)(1), remove ‘‘000986’’ and in its place add ‘‘058198’’; and in paragraphs (c)(1)(i) and (ii) and (c)(2)(i) and (ii), in the ‘‘Sponsor’’ column, remove ‘‘000986’’ and in its place add ‘‘058198’’. rmajette on DSK2TPTVN1PROD with RULES ■ [Amended] 26. In § 558.342, in paragraph (b)(2), remove ‘‘000986’’ and in its place add ‘‘058198’’; and in paragraphs (e)(1)(i) through (iv) and (e)(1)(ix) and (x), in the ‘‘Sponsor’’ column, remove ‘‘000986’’ and in its place add ‘‘058198’’. ■ VerDate Sep<11>2014 13:45 Jul 25, 2016 Jkt 238001 [Amended] 29. In § 558.366, in paragraph (b), remove ‘‘000986’’ and in its place add ‘‘058198’’; and in paragraph (d), in the six row entries beginning in the ‘‘Nicarbazin in grams per ton’’ column with ‘‘27 to 45’’, in the ‘‘Limitations’’ and ‘‘Sponsor’’ columns, remove ‘‘000986’’ wherever it occurs and in its place add ‘‘058198’’. [Amended] 30. In § 558.500, in paragraph (b), remove ‘‘000986 and 054771’’ and in its place add ‘‘054771 and 058198’’; and in paragraphs (e)(1)(i) through (iv) and (e)(2)(i) through (xiii), in the ‘‘Limitations’’ and ‘‘Sponsor’’ columns, remove ‘‘000986’’ wherever it occurs and in its place add ‘‘058198’’; and in paragraphs (e)(3)(i) through (iv), in the ‘‘Sponsor’’ column, remove ‘‘000986’’ wherever it occurs and in its place add ‘‘058198’’. ■ § 558.550 24. In § 558.68, in paragraph (b), remove ‘‘000986’’ and in its place add ‘‘058198’’. ■ § 558.342 [Amended] 28. In § 558.363, in paragraphs (a)(1), (3), and (8), and in paragraphs (d)(1)(ii)(B), (d)(1)(iii)(B), (d)(1)(iv)(B), (d)(1)(v)(B), and (d)(1)(vi)(B), remove ‘‘000986’’ and in its place add ‘‘058198’’. § 558.500 [Amended] ■ § 558.274 § 558.363 ■ 20. The authority citation for part 524 continues to read as follows: § 558.68 27. In § 558.355, in paragraphs (b)(1) and (2), (b)(4) through (9), (b)(11) and (12), and (b)(14), in paragraphs (f)(1)(xiii)(b), (f)(1)(xxi)(b), (f)(1)(xxii)(b), (f)(1)(xxviii)(b), (f)(1)(xxix)(b), (f)(1)(xxxi)(b), paragraphs (f)(3)(i)(b)(2)(iii), (f)(3)(ii)(b), (f)(3)(xii)(b), in paragraphs (f)(4)(ii)(b) and (f)(4)(iii)(b), and in paragraph (f)(6)(i)(b)(2)(iii), remove ‘‘000986’’ and in its place add ‘‘058198’’. ■ § 558.366 ■ § 524.1445 § 558.630 ■ [Amended] ■ § 524.916 [Amended] [Amended] 31. In § 558.550, in paragraph (d)(1)(xxii)(B), remove ‘‘000986 and 016592’’ and in its place add ‘‘016592 and 058198’’. ■ § 558.618 [Amended] 32. In § 558.618, in paragraph (b), remove ‘‘000986 and 016592’’ and in its place add ‘‘016592 and 058198’’; and in paragraphs (e)(1)(i) and (e)(2)(i) through (iii), in the ‘‘Sponsor’’ column, remove ‘‘000986’’ and in its place add ‘‘058198’’. ■ § 558.625 [Amended] 33. In § 558.625, in paragraph (b)(1), remove ‘‘To 000986’’ and in its place add ‘‘No. 058198’’. ■ PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 48703 [Amended] 34. In § 558.630, in paragraph (b)(1), remove ‘‘000986’’ and in its place add ‘‘058198’’. ■ § 558.665 [Amended] 35. In § 558.665, in paragraphs (e)(2), (3), (4), (5), (6), (8), (10), (11), and (12), in the ‘‘Limitations’’ column, remove ‘‘000986’’ wherever it occurs and in its place add ‘‘058198’’; and in paragraphs (e)(2), (3), (4), and (6), in the ‘‘Sponsor’’ column, remove ‘‘000986’’ and in its place add ‘‘058198’’. ■ Dated: July 20, 2016. William T. Flynn, Acting Director, Center for Veterinary Medicine. [FR Doc. 2016–17501 Filed 7–25–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 890 [Docket No. FDA–2000–N–0158] Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes AGENCY: Food and Drug Administration, HHS. ACTION: Final order. The Food and Drug Administration (FDA) is issuing a final order to reclassify iontophoresis devices intended for any other purposes, which are preamendments class III devices (regulated under product code EGJ), into class II (special controls) and to amend the device identification to clarify that devices intended to deliver specific drugs are not considered part of this regulatory classification. DATES: This order is effective on July 26, 2016. FOR FURTHER INFORMATION CONTACT: Jismi Johnson, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1524, Silver Spring, MD 20993, 301–796– 6424, jismi.johnson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background—Regulatory Authorities The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94– 295), the Safe Medical Devices Act of 1990 (Pub. L. 101–629), the Food and Drug Administration Modernization Act E:\FR\FM\26JYR1.SGM 26JYR1

Agencies

[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)]
[Rules and Regulations]
[Pages 48700-48703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17501]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, and 558

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


New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

[[Page 48701]]

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for 57 approved new 
animal drug applications (NADAs) and 14 approved abbreviated new animal 
drug applications (ANADAs) from Elanco Animal Health, A Division of Eli 
Lilly & Co. to Elanco US, Inc.

DATES: This rule is effective July 26, 2016.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-402-0571, 
steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285 has 
informed FDA that it has transferred ownership of, and all rights and 
interest in, the 71 approved NADAs and ANADAs in table 1 to Elanco US, 
Inc., 2500 Innovation Way, Greenfield, IN 46140.

   Table 1--NADAs and ANADAs Transferred From Elanco Animal Health, a
             Division of Eli Lilly & Co. to Elanco US, Inc.
------------------------------------------------------------------------
                                                              21 CFR
            File No.                   Product name           Section
------------------------------------------------------------------------
010-918........................  HYGROMIX 8 (hygromycin          558.274
                                  B) Type A medicated
                                  article.
011-948........................  HYGROMIX 2.4                    558.274
                                  (hygromycin B) Type A
                                  medicated article.
012-491........................  TYLAN 100 (tylosin)            522.2640
                                  Injection.
012-548........................  TYLAN (tylosin                  558.274
                                  phosphate)/HYGROMIX
                                  (hygromycin B).
012-965........................  TYLAN (tylosin)                522.2640
                                  Injection.
013-076........................  TYLAN (tylosin                 520.2640
                                  tartrate) Soluble
                                  Powder.
013-162........................  TYLAN Premix No. 10             558.625
                                  (tylosin phosphate)
                                  Type A medicated
                                  article.
013-388........................  TYLAN (tylosin                  558.274
                                  phosphate)/HYGROMIX
                                  (hygromycin B).
015-166........................  TYLAN 100 Premix                558.625
                                  (tylosin phosphate)
                                  Type A medicated
                                  article.
038-878........................  COBAN 45, 60, 90, 110           558.355
                                  (monensin) Type A
                                  medicated article.
041-275........................  TYLAN 40 Sulfa-G                558.630
                                  (tylosin phosphate and
                                  sulfamethazine) Type A
                                  medicated article.
047-933........................  COBAN (monensin)/               558.355
                                  BACIFERM (bacitracin
                                  Zn).
049-463........................  COBAN (monensin)/BMD            558.355
                                  (bacitracin
                                  methylenedisalicyclate
                                  ).
095-735........................  RUMENSIN 80 and 90              558.355
                                  (monensin) Type A
                                  medicated article.
104-646........................  RUMENSIN (monensin)/            558.355
                                  TYLAN (tylosin
                                  phosphate).
106-964........................  APRALAN (apramycin              520.110
                                  sulfate) Soluble
                                  Powder.
110-315........................  COMPONENT E-C or E-S           522.1940
                                  (progesterone and
                                  estradiol benzoate)
                                  with TYLAN.
115-732........................  STRESNIL (azaperone)            522.150
                                  Injection.
118-123........................  COMPUDOSE 200                   522.840
                                  (estradiol); ENCORE
                                  (COMPUDOSE 400).
118-980........................  MONTEBAN (narasin) Type         558.363
                                  A medicated article.
126-050........................  APRALAN 75 (apramycin           520.110
                                  sulfate) Soluble
                                  Powder.
127-507........................  TYLAN 5, 10, 20, 40             558.630
                                  Sulfa-G (tylosin
                                  phosphate and
                                  sulfamethazine) Type A
                                  medicated article.
130-736........................  COBAN (monensin) Type A         558.355
                                  medicated article.
135-468........................  Nicarbazin Type A               558.366
                                  medicated article.
135-906........................  COMPONENT E-H                   522.842
                                  (estradiol benzoate
                                  and testosterone
                                  propionate) with TYLAN.
138-952........................  MAXIBAN (narasin and            558.366
                                  nicarbazin) Type A
                                  medicated article.
140-863........................  PAYLEAN 9 and 45                558.500
                                  (ractopamine HCl) Type
                                  A medicated article.
140-872........................  POSILAC (sometribove           522.2112
                                  Zn) Injectable
                                  Suspension.
140-926........................  BMD (bacitracin                 558.366
                                  methylenedisalicyclate
                                  )/MAXIBAN (narasin and
                                  nicarbazin).
140-929........................  MICOTIL 300 (tilmicosin        522.2471
                                  phosphate) Injectable
                                  Solution.
140-937........................  BMD (bacitracin                 558.355
                                  methylenedisalicyclate
                                  )/COBAN (monensin).
140-942........................  FLAVOMYCIN                      558.366
                                  (bambermycins)/MAXIBAN
                                  (narasin and
                                  nicarbazin).
140-947........................  LINCOMIX (lincomycin            558.366
                                  HCl)/MAXIBAN (narasin
                                  and nicarbazin).
140-955........................  COBAN (monensin)/               558.355
                                  FLAVOMYCIN
                                  (bambermycins).
141-064........................  PULMOTIL 90 (tilmicosin         558.618
                                  phosphate) Type A
                                  medicated article.
141-277........................  COMFORTIS (spinosad)           520.2130
                                  Tablets.
141-298........................  SUROLAN (miconazole            524.1445
                                  nitrate, polymyxin B
                                  sulfate, prednisolone
                                  acetate) Otic
                                  Suspension.
141-321........................  TRIFEXIS (spinosad and         520.2134
                                  milbemycin oxime)
                                  Tablets.
141-110........................  COBAN (monensin)/STAFAC         558.355
                                  (virginiamycin).
141-164........................  COBAN (monensin)/TYLAN          558.355
                                  (tylosin phosphate).
141-170........................  MONTEBAN (narasin)/             558.363
                                  TYLAN (tylosin
                                  phosphate).
141-172........................  PAYLEAN (ractopamine            558.500
                                  HCl)/TYLAN (tylosin
                                  phosphate).
141-198........................  TYLAN (tylosin                  558.550
                                  phosphate)/BIO-COX
                                  (salinomycin sodium).
141-221........................  OPTAFLEXX 45                    558.500
                                  (ractopamine HCl) Type
                                  A medicated article.
141-224........................  OPTAFLEXX (ractopamine          558.500
                                  HCl)/RUMENSIN
                                  (monensin)/TYLAN
                                  (tylosin phosphate).
141-225........................  OPTAFLEXX (ractopamine          558.500
                                  HCl) RUMENSIN
                                  (monensin).
141-234........................  OPTAFLEXX (ractopamine          558.500
                                  HCl)/RUMENSIN
                                  (monensin)/MGA
                                  (melengestrol acetate).
141-290........................  TOPMAX 9 (ractopamine           558.500
                                  HCl) Type A medicated
                                  article.
141-233........................  OPTAFLEXX (ractopamine          558.500
                                  HCl)/RUMENSIN
                                  (monensin)/TYLAN
                                  (tylosin phosphate)/
                                  MGA (melengestrol
                                  acetate).
141-301........................  TOPMAX (ractopamine             558.500
                                  HCl)/COBAN (monensin).
141-337........................  RECUVYA (fentanyl)              524.916
                                  Topical Solution.
141-340........................  SKYCIS 100 (narasin)            558.363
                                  Type A medicated
                                  article.
141-343........................  PULMOTIL 90 (tilmicosin         558.618
                                  phosphate)/RUMENSIN 90
                                  (monensin).
141-361........................  PULMOTIL AC (tilmicosin        520.2471
                                  phosphate) Concentrate
                                  Solution.
141-392........................  IMPRESTOR                      522.1684
                                  (pegbovigrastim)
                                  Injection.
141-438........................  KAVAULT (avilamycin)             558.68
                                  Type A medicated
                                  article.
141-439........................  INTEPRITY (avilamycin)           558.68
                                  Type A medicated
                                  article.

[[Page 48702]]

 
200-221........................  COMPONENT TE-G                 522.2477
                                  (trenbolone acetate
                                  and estradiol);
                                  COMPONENT TE-G with
                                  TYLAN; COMPONENT TE-ID
                                  with TYLAN; COMPONENT
                                  TE-IS; COMPONENT TE-IS
                                  with TYLAN; COMPONENT
                                  TE-S; COMPONENT TE-S
                                  with TYLAN.
200-224........................  COMPONENT T-H                  522.2476
                                  (trenbolone acetate)
                                  with TYLAN; COMPONENT
                                  T-S with TYLAN.
200-343........................  HEIFERMAX 500                   558.342
                                  (melengestrol acetate)
                                  Type A medicated
                                  article.
200-346........................  COMPONENT TE-200               522.2477
                                  (trenbolone acetate
                                  and estradiol);
                                  COMPONENT TE-200 with
                                  TYLAN; COMPONENT TE-H;
                                  COMPONENT TE-H with
                                  TYLAN, COMPONENT TE-H.
200-375........................  HEIFERMAX 500                   558.342
                                  (melengestrol acetate)/
                                  RUMENSIN (monensin)/
                                  TYLAN (tylosin
                                  phosphate).
200-422........................  HEIFERMAX 500                   558.342
                                  (melengestrol acetate)
                                  Liquid Premix/RUMENSIN
                                  (monensin).
200-424........................  HEIFERMAX (melengestrol         558.342
                                  acetate)/OPTAFLEXX
                                  (ractopamine HCl)/
                                  RUMENSIN (monensin)/
                                  TYLAN (tylosin
                                  phosphate).
200-427........................  HEIFERMAX 500                   558.342
                                  (melengestrol acetate)
                                  Liquid Premix/TYLAN
                                  (tylosin phosphate).
200-430........................  HEIFERMAX 500                   558.342
                                  (melengestrol acetate)
                                  Liquid Premix/BOVATEC
                                  (lasalocid)/TYLAN
                                  (tylosin phosphate).
200-448........................  HEIFERMAX 500                   558.500
                                  (melengestrol acetate)/
                                  OPTAFLEXX (ractopamine
                                  HCl)/RUMENSIN
                                  (monensin).
200-451........................  HEIFERMAX 500                   558.342
                                  (melengestrol acetate)/
                                  BOVATEC (lasalocid).
200-479........................  HEIFERMAX 500                   558.665
                                  (melengestrol acetate)/
                                  ZILMAX (zilpaterol)/
                                  RUMENSIN (monensin).
200-480........................  HEIFERMAX 500                   558.665
                                  (melengestrol acetate)/
                                  ZILMAX (zilpaterol)/
                                  RUMENSIN (monensin)/
                                  TYLAN (tylosin
                                  phosphate).
200-483........................  HEIFERMAX 500                   558.665
                                  (melengestrol acetate)/
                                  ZILMAX (zilpaterol).
------------------------------------------------------------------------

    Accordingly, the Agency is amending the regulations in 21 CFR parts 
520, 522, 524, and 558 to reflect these changes of sponsorship.
    Following these changes of sponsorship, Elanco Animal Health, A 
Division of Eli Lilly & Co. is no longer the sponsor of any approved 
application. Accordingly, the regulations are being amended to remove 
this firm from the lists of sponsors of approved applications in 21 CFR 
510.600(c).
    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

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

0
1. The authority citation for part 510 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry 
for ``Elanco Animal Health, A Division of Eli Lilly & Co.''; and in the 
table in paragraph (c)(2), remove the entry for ``000986''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for part 520 continues to read as follows:

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


Sec.  520.110  [Amended]

0
4. In Sec.  520.110, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.


Sec.  520.2130  [Amended]

0
5. In Sec.  520.2130, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.


Sec.  520.2134  [Amended]

0
6. In Sec.  520.2134, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.


Sec.  520.2471  [Amended]

0
7. In Sec.  520.2471, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.


Sec.  520.2640  [Amended]

0
8. In Sec.  520.2640, in paragraph (b)(1), remove ``000986'' and in its 
place add ``058198''.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
9. The authority citation for part 522 continues to read as follows:

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


Sec.  522.150  [Amended]

0
10. In Sec.  522.150, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.


Sec.  522.840  [Amended]

0
11. In Sec.  522.840, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.


Sec.  522.842  [Amended]

0
12. In Sec.  522.842, in paragraph (a)(2), remove ``000986'' and in its 
place add ``058198''.


Sec.  522.1684  [Amended]

0
13. In Sec.  522.1684, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.


Sec.  522.1940  [Amended]

0
14. In Sec.  522.1940, in paragraph (a)(2), remove ``000986'' and in 
its place add ``058198''.


Sec.  522.2112  [Amended]

0
15. In Sec.  522.2112, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.

[[Page 48703]]

Sec.  522.2471  [Amended]

0
16. In Sec.  522.2471, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.


Sec.  22.2476  [Amended]

0
17. In Sec.  522.2476, in paragraph (a)(1), remove ``021641'' and in 
its place add ``058198''.


Sec.  522.2477  [Amended]

0
18. In Sec.  522.2477, in paragraph (b)(1), remove ``000986'' and in 
its place add ``058198''.


Sec.  522.2640  [Amended]

0
19. In Sec.  522.2640, in paragraph (b)(1), remove ``000986'' and in 
its place add ``058198''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
20. The authority citation for part 524 continues to read as follows:

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


Sec.  524.916  [Amended]

0
21. In Sec.  524.916, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.


Sec.  524.1445  [Amended]

0
22. In Sec.  524.1445, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.

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

0
23. The authority citation for part 558 continues to read as follows:

    Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.


Sec.  558.68  [Amended]

0
24. In Sec.  558.68, in paragraph (b), remove ``000986'' and in its 
place add ``058198''.


Sec.  558.274  [Amended]

0
25. In Sec.  558.274, in paragraph (a)(1), remove ``000986'' and in its 
place add ``058198''; and in paragraphs (c)(1)(i) and (ii) and 
(c)(2)(i) and (ii), in the ``Sponsor'' column, remove ``000986'' and in 
its place add ``058198''.


Sec.  558.342  [Amended]

0
26. In Sec.  558.342, in paragraph (b)(2), remove ``000986'' and in its 
place add ``058198''; and in paragraphs (e)(1)(i) through (iv) and 
(e)(1)(ix) and (x), in the ``Sponsor'' column, remove ``000986'' and in 
its place add ``058198''.


Sec.  558.355  [Amended]

0
27. In Sec.  558.355, in paragraphs (b)(1) and (2), (b)(4) through (9), 
(b)(11) and (12), and (b)(14), in paragraphs (f)(1)(xiii)(b), 
(f)(1)(xxi)(b), (f)(1)(xxii)(b), (f)(1)(xxviii)(b), (f)(1)(xxix)(b), 
(f)(1)(xxxi)(b), paragraphs (f)(3)(i)(b)(2)(iii), (f)(3)(ii)(b), 
(f)(3)(xii)(b), in paragraphs (f)(4)(ii)(b) and (f)(4)(iii)(b), and in 
paragraph (f)(6)(i)(b)(2)(iii), remove ``000986'' and in its place add 
``058198''.


Sec.  558.363  [Amended]

0
28. In Sec.  558.363, in paragraphs (a)(1), (3), and (8), and in 
paragraphs (d)(1)(ii)(B), (d)(1)(iii)(B), (d)(1)(iv)(B), (d)(1)(v)(B), 
and (d)(1)(vi)(B), remove ``000986'' and in its place add ``058198''.


Sec.  558.366  [Amended]

0
29. In Sec.  558.366, in paragraph (b), remove ``000986'' and in its 
place add ``058198''; and in paragraph (d), in the six row entries 
beginning in the ``Nicarbazin in grams per ton'' column with ``27 to 
45'', in the ``Limitations'' and ``Sponsor'' columns, remove ``000986'' 
wherever it occurs and in its place add ``058198''.


Sec.  558.500  [Amended]

0
30. In Sec.  558.500, in paragraph (b), remove ``000986 and 054771'' 
and in its place add ``054771 and 058198''; and in paragraphs (e)(1)(i) 
through (iv) and (e)(2)(i) through (xiii), in the ``Limitations'' and 
``Sponsor'' columns, remove ``000986'' wherever it occurs and in its 
place add ``058198''; and in paragraphs (e)(3)(i) through (iv), in the 
``Sponsor'' column, remove ``000986'' wherever it occurs and in its 
place add ``058198''.


Sec.  558.550  [Amended]

0
31. In Sec.  558.550, in paragraph (d)(1)(xxii)(B), remove ``000986 and 
016592'' and in its place add ``016592 and 058198''.


Sec.  558.618  [Amended]

0
32. In Sec.  558.618, in paragraph (b), remove ``000986 and 016592'' 
and in its place add ``016592 and 058198''; and in paragraphs (e)(1)(i) 
and (e)(2)(i) through (iii), in the ``Sponsor'' column, remove 
``000986'' and in its place add ``058198''.


Sec.  558.625  [Amended]

0
33. In Sec.  558.625, in paragraph (b)(1), remove ``To 000986'' and in 
its place add ``No. 058198''.


Sec.  558.630  [Amended]

0
34. In Sec.  558.630, in paragraph (b)(1), remove ``000986'' and in its 
place add ``058198''.


Sec.  558.665  [Amended]

0
35. In Sec.  558.665, in paragraphs (e)(2), (3), (4), (5), (6), (8), 
(10), (11), and (12), in the ``Limitations'' column, remove ``000986'' 
wherever it occurs and in its place add ``058198''; and in paragraphs 
(e)(2), (3), (4), and (6), in the ``Sponsor'' column, remove ``000986'' 
and in its place add ``058198''.

    Dated: July 20, 2016.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-17501 Filed 7-25-16; 8:45 am]
 BILLING CODE 4164-01-P

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