New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship, 8967-8982 [2019-04226]

Download as PDF Federal Register / Vol. 84, No. 49 / Wednesday, March 13, 2019 / Rules and Regulations that is likely to exist or develop on products identified in this rulemaking action. 4F6430V00551, and S/N 16165 through 16169, S/N 16171, and S/N 17101 through 17121. Regulatory Findings We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed, I certify that this AD: 1. Is not a ‘‘significant regulatory action’’ under Executive Order 12866, 2. Is not a ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979), 3. Will not affect intrastate aviation in Alaska, and 4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket. (b) Unsafe Condition This AD defines the unsafe condition as failure of a T/R duplex bearing ball. This condition could result in premature degradation of the T/R duplex bearing, loss of T/R control, and subsequent loss of control of the helicopter. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: ■ Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): ■ amozie on DSK9F9SC42PROD with RULES 2019–05–03 Leonardo S.p.A.: Amendment 39–19585; Docket No. FAA–2019–0092; Product Identifier 2019–SW–022–AD. (a) Applicability This AD applies to the following helicopters, certificated in any category: (1) Model AB139 and AW139 helicopters with a tail rotor (T/R) duplex bearing part number (P/N) 3G6430V00153, and serial number (S/N) 16181 through 16225, S/N 16237 through 16259, S/N 17101 through 17110, S/N 17182 through 17194, S/N 17204 through 17217, and S/N 17251 through S/N 17260; and (2) Model AW169 and AW189 helicopters with a T/R duplex bearing P/N VerDate Sep<11>2014 16:11 Mar 12, 2019 Jkt 247001 (c) Effective Date This AD becomes effective March 28, 2019. (d) Compliance You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time. (e) Required Actions (1) Within 30 hours time-in-service, remove from service any T/R duplex bearing with a P/N and S/N listed in paragraphs (a)(1) or (a)(2) of this AD. (2) After the effective date of this AD, do not install a T/R duplex bearing with a P/N and S/N listed in paragraphs (a)(1) or (a)(2) of this AD on any helicopter. (f) Special Flight Permits Special flight permits are prohibited. (g) Alternative Methods of Compliance (AMOCs) (1) The Manager, Safety Management Section, Rotorcraft Standards Branch, FAA, may approve AMOCs for this AD. Send your proposal to: David Hatfield, Aviation Safety Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222–5110; email 9-ASWFTW-AMOC-Requests@faa.gov. (2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office, before operating any aircraft complying with this AD through an AMOC. (h) Additional Information (1) Leonardo Helicopters Service Bulletin (SB) Alert No. 139–571, Leonardo Helicopters SB Alert No. 169–134, and Leonardo Helicopters SB Alert No. 189–221, each dated February 1, 2019, which are not incorporated by reference, contain additional information about the subject of this AD. For service information identified in this AD, contact Leonardo S.p.A. Helicopters, Matteo Ragazzi, Head of Airworthiness, Viale G.Agusta 520, 21017 C.Costa di Samarate (Va) Italy; telephone +39–0331–711756; fax +39–0331–229046; or at https:// www.leonardocompany.com/-/bulletins. You may review a copy of the service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N–321, Fort Worth, TX 76177. (2) The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD No. No. 2019–0022, dated February 1, 2019, PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 8967 and corrected February 4, 2019. You may view the EASA AD on the internet at https:// www.regulations.gov by searching for and locating it in Docket No. FAA–2019–0092. (i) Subject Joint Aircraft Service Component (JASC) Code: 6400, Tail Rotor System. Issued in Fort Worth, Texas, on March 6, 2019. Lance T. Gant, Director, Compliance & Airworthiness Division, Aircraft Certification Service. [FR Doc. 2019–04529 Filed 3–12–19; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 526, 529, 556, and 558 [Docket No. FDA–2018–N–0002] New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship AGENCY: Food and Drug Administration, HHS. Final rule; technical amendments. ACTION: The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2018. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the readability of the regulations. DATES: This rule is effective March 13, 2019, except for amendatory instruction 25 to 21 CFR 520.2041, which is effective March 25, 2019. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV–6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–5689, george.haibel@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: I. Approval Actions FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during July, August, and September 2018, as listed E:\FR\FM\13MRR1.SGM 13MRR1 8968 Federal Register / Vol. 84, No. 49 / Wednesday, March 13, 2019 / Rules and Regulations in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the office of the Dockets Management Staff (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the internet may obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/ AboutFDA/CentersOffices/ OfficeofFoods/CVM/CVMFOIA ElectronicReadingRoom/default.htm. Marketing exclusivity and patent information may be accessed in FDA’s publication, Approved Animal Drug Products Online (Green Book) at: https://www.fda.gov/AnimalVeterinary/ Products/ApprovedAnimalDrug Products/default.htm. TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY, AUGUST, AND SEPTEMBER 2018 Approval date File No. July 2, 2018 ....... 200–624 July 6, 2018 ....... 200–495 July 11, 2018 ..... 138–952 July 13, 2018 ..... 200–484 July 13, 2018 ..... 141–406 July 30, 2018 ..... 200–608 August 3, 2018 .. 141–461 August 8, 2018 .. Sponsor Product name Public documents Species Effect of the action Modern Veterinary Thera- REVERTIDINE (atipamezole peutics, LLC, 14343 SW hydrochloride) Sterile 119th Ave., Miami, FL 33186. Injectable Solution. Norbrook Laboratories, Ltd., ENROFLOX 100 (enrofloxacin) Station Works, Newry BT35 Injectable Solution. 6JP, Northern Ireland. Elanco US Inc., 2500 Innova- MAXIBAN 72 (narasin and tion Way, Greenfield, IN nicarbazin) Type A medi46140. cated article. Dogs ............... Original approval as a generic copy of NADA 141–033. FOI Summary. Swine .............. FOI Summary. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. Merial, Inc., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096–4640. TYLOVET (tylosin phosphate) Type A medicated articles. Swine and cattle. NEXGARD (afoxolaner) Chewable Tablets. Dogs ............... Piedmont Animal Health, 204 Muirs Chapel Rd., Suite 200, Greensboro, NC 27410. Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS 66211. BAYTRIL (enrofloxacin) Chewable Tablets. Soft Dogs ............... Supplemental approval of additional indications and routes of administration. Supplemental approval of a revised tissue residue tolerance for nicarbazin and withdrawal period for narasin and nicarbazin Type C medicated feeds. Supplemental approval of a 40 g/lb strength Type A medicated article. Supplemental approval for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. Original approval as a generic copy of NADA 140–441. NOCITA (bupivacaine liposome injectable suspension). Cats ................ 141–439 Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140. INTEPRITY (avilamycin) Type A medicated article. Chickens ......... August 9, 2018 .. 200–630 COCCIAID (amprolium) 9.6% Oral Solution. Chickens and turkeys. August 10, 2018 141–488 Aurora Pharmaceutical, LLC, 1196 Highway 3 South, Northfield, MN 55057–3009. Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. Lincomycin and lasalocid Type C medicated feeds. Chickens ......... Chickens ......... FOI Summary EA/FONSI.1 FOI Summary. FOI Summary. FOI Summary. Supplemental approval to provide for use as a peripheral nerve block to provide regional postoperative analgesia following onychectomy in cats. Supplemental approval of a revised age restriction caution statement from 10 days to 18 days for use of avilamycin Type C medicated broiler feeds. Original approval as a generic copy of NADA 013–149. FOI Summary. Original approval for use of LINCOMIX (lincomycin) and AVATEC (lasalocid) Type A medicated articles in the manufacture of Type C medicated broiler chicken feeds for the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E maxima. FOI Summary. FOI Summary EA/FONSI.1 FOI Summary. amozie on DSK9F9SC42PROD with RULES 1 The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of no significant impact (FONSI). II. Change of Sponsorship Piedmont Animal Health, 204 Muirs Chapel Rd., Suite 200, Greensboro, NC 27410 has informed FDA that it has transferred ownership of, and all rights VerDate Sep<11>2014 16:11 Mar 12, 2019 Jkt 247001 and interest in, newly approved ANADA 200–608 for BAYTRIL (enrofloxacin) Soft Chewable Tablets to Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 Mission, KS 66201. Following this change of sponsorship, Piedmont Animal Health is no longer the sponsor of an approved application. Accordingly, it will not be added to the E:\FR\FM\13MRR1.SGM 13MRR1 Federal Register / Vol. 84, No. 49 / Wednesday, March 13, 2019 / Rules and Regulations list of sponsors of approved applications in § 510.600(c) (21 CFR 510.600(c)). Cronus Pharma LLC, 2 Tower Center Blvd., Suite 1101, East Brunswick, NJ 08816 has informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Cronus Pharma Specialities India Private Ltd., Sy No: File No. amozie on DSK9F9SC42PROD with RULES 011–531 011–674 012–469 031–512 033–803 035–918 039–483 040–848 043–606 045–143 047–278 047–712 048–010 048–237 048–271 049–032 055–002 065–461 065–481 065–486 065–491 092–837 093–516 094–170 097–452 098–569 099–618 108–963 117–689 123–815 125–797 126–236 126–676 127–627 128–069 132–028 135–771 136–212 137–310 138–869 140–442 141–245 200–023 200–029 200–165 200–178 200–193 200–248 200–265 200–287 200–297 200–298 200–365 200–382 99/1, M/s GMR Hyderabad Aviation SEZ L, Mamidipalli Village, Shamshabad Mandal, Ranga, Hyderabad, Telangana 501218, India: Product name ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... ............... DIZAN (dithiazanine iodide) Tablets. DIZAN (dithiazanine iodide) Powder. DIZAN (dithiazanine iodide) Suspension with Piperazine. ATGARD (dichlorvos) Swine Wormer. TASK (dichlorvos) Dog Anthelmintic. EQUIGARD (dichlorvos). BIO-TAL (thiamylal sodium). ATGARD C (dichlorvos) Swine Wormer. ATGARD V (dichlorvos) Swine Wormer. OXIJECT (oxytetracycline hydrochloride). BIO-MYCIN (oxytetracycline hydrochloride). BIZOLIN-100 (phenylbutazone). ANAPLEX (dichlorophene and toluene) Capsules. EQUIGEL (dichlorvos). TASK (dichlorvos) Tablets. ATGARD C (dichlorvos) Premix. TEVCOCIN (chloramphenicol). ANACETIN (chloramphenicol) Tablets. Chlortetracycline Calf Scour Boluses. CTC Bisulfate (chlortetracycline bisulfate) Soluble Powder. MEDICHOL (chloramphenicol) Tablets. NEMACIDE (diethylcarbamazine citrate) Oral Syrup. BIZOLIN (phenylbutazone) Injection 20%. Phenylbutazone Tablets, U.S.P. 100 mg. OXYJECT 100 (oxytetracycline hydrochloride). MEDACIDE-SDM (sulfadimethoxine) Injection 10%. BIZOLIN (phenylbutazone) 1-gram. MEDAMYCIN (oxytetracycline hydrochloride). NEUROSYN (primidone) Tablets. Dexamethasone Sodium Phosphate Injection. Nitrofurazone Dressing. Nitrofurazone Soluble Powder. D & T (dichlorophene and toluene) Worm Capsules. NEMACIDE-C (diethylcarbamazine citrate). NEMACIDE (diethylcarbamazine citrate) Chewable Tablets. ANESTATAL (thiamylal sodium). Methylprednisolene Tablets. Methylprednisolone Acetate Injection. Gentamicin Sulfate Injectable Solution. Triamcinolone Acetonide Suspension. Xylazine Hydrochloride Injection. TRIBUTAME (chloroquine phosphate, embutramid, lidocaine) Euthanasia Solution. Gentamicin Sulfate Solution 100 mg/mL. Ketamine Hydrochloride Injection. SDM Sulfadimethoxine Concentrated Solution 12.5%. Amikacin Sulfate Injection. Clindamycin Hydrochloride Oral Liquid. Pyrantel Pamoate Suspension. Praziquantel Tablets. GBC (gentamicin sulfate, betamethasone valerate, clotrimazole) Ointment. Ivermectin Chewable Tablets. Clindamycin Hydrochloride Capsules. ROBINUL (glycopyrrolate) Injection. Furosemide Syrup 1%. Following this change of sponsorship, Cronus Pharma LLC is no longer the sponsor of an approved application. Accordingly, it will be removed from the list of sponsors of approved applications in § 510.600(c). As a new sponsor of approved applications, VerDate Sep<11>2014 8969 16:11 Mar 12, 2019 Jkt 247001 Cronus Pharma Specialities India Private Ltd. will be added to § 510.600(c); however, as the drug labeler code was not changed, no further amendments are necessary. Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 Ireland has informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland: E:\FR\FM\13MRR1.SGM 13MRR1 amozie on DSK9F9SC42PROD with RULES 8970 Federal Register / Vol. 84, No. 49 / Wednesday, March 13, 2019 / Rules and Regulations 21 CFR section File No. Product name 010–092 010–346 012–123 035–157 035–455 035–456 038–661 044–756 046–780 049–187 055–059 065–383 065–505 065–506 092–150 093–515 095–218 096–671 096–672 098–288 099–169 099–604 099–605 099–606 099–607 101–690 107–506 109–305 118–032 118–550 118–979 119–141 120–615 122–447 124–241 126–504 130–136 138–405 140–582 140–583 141–420 200–050 200–069 200–103 200–115 200–117 200–144 200–146 200–176 200–247 200–253 200–312 200–313 200–317 200–318 200–326 200–328 200–350 200–364 200–368 200–374 200–376 200–377 200–380 GALLIMYCIN-100P (erythromycin thiocyanate) Type A Medicated Article ..................................................................... COMBUTHAL (pentobarbital sodium and thiopental sodium) Powder ............................................................................ GALLIMYCIN-100 (erythromycin ) Injectable ................................................................................................................... GALLIMYCIN PFC (erythromycin phosphate) Powder .................................................................................................... GALLIMYCIN-36 (erythromycin) Dry Cow Intramammary Infusion ................................................................................. GALLIMYCIN-36 (erythromycin) Sterile Intramammary Infusion ..................................................................................... SPECTOGARD (spectinomycin) Water Soluble Powder ................................................................................................. BUTATRON (phenylbutazone) Tablets ............................................................................................................................ PHEN-BUTA (phenylbutazone) Vet Injection ................................................................................................................... PHEN-BUTA (phenylbutazone) Vet Tablets ..................................................................................................................... VICETRON (chloramphenicol) Tablets ............................................................................................................................. UNIBIOTIC (penicillin G procaine) Intramammary Infusion ............................................................................................. PRO-PEN-G (penicillin G procaine) Injectable Suspension ............................................................................................. COMBI-PEN-48 (penicillin G benzathine and penicillin G procaine) Injectable Suspension .......................................... PURINA (pyrantel tartrate) Horse & Colt Wormer Pellets ............................................................................................... SPECTAM (spectinomycin) Tablets ................................................................................................................................. DEXIUM (dexamethasone) Tablets .................................................................................................................................. PHEN-BUTA-Vet (phenylbutazone) Injection ................................................................................................................... PHEN-BUTA (phenylbutazone) Vet Tablets ..................................................................................................................... PREDNIS-A-Vet (prednisolone sodium phosphate) Injection .......................................................................................... Oxytocin Injection ............................................................................................................................................................. DEX-A-VET (dexamethasone) Injection ........................................................................................................................... DEX-A-VET (dexamethasone) Injection ........................................................................................................................... DEXAMETH-A-Vet (dexamethasone ) Injection ............................................................................................................... DEXAMETH-A-Vet (dexamethasone) Injection ................................................................................................................ ERYTHRO-100 (erythromycin) Injection .......................................................................................................................... CARBAM (diethylcarbamazine citrate) Tablets ................................................................................................................ Oxytocin Injection ............................................................................................................................................................. PALATABS (diethylcarbamazine citrate) Tablets ............................................................................................................. FUROS-A-Vet (furosemide) .............................................................................................................................................. BUTATRON (phenylbutazone) Gel .................................................................................................................................. TRANQUAZINE (promazine hydrochloride) Injection ...................................................................................................... SUSTAIN III (sulfamethazine) Bolus ................................................................................................................................ FURA-SEPTIN (Nitrofurazone) Soluble Dressing ............................................................................................................ PVL Oxytocin Injection ..................................................................................................................................................... Nitrofurazone Ointment ..................................................................................................................................................... Oxytocin Injection ............................................................................................................................................................. Pyrilamine Maleate Injection ............................................................................................................................................. Oxytetracycline Hydrochloride Injection ........................................................................................................................... ACTH (adrenocorticotropic hormone) Gel ........................................................................................................................ TILDREN (tiludronate disodium) Powder for Injection ..................................................................................................... NEOMED (neomycin sulfate) Soluble Powder ................................................................................................................. FERTELIN (gonadorelin diacetate tetrahydrate) .............................................................................................................. PENAQUA Sol-G (penicillin G potassium, USP) Soluble Powder ................................................................................... GENTAMEX 100 (gentamicicn sulfate) ............................................................................................................................ OXYSHOT-LA (oxytetracycline) Injectable Solution ......................................................................................................... TETROXY HCA-280 (oxytetracycline hydrochloride) Soluble Powder ............................................................................ TETROXY 25 (oxytetracycline hydrochloride) Soluble Powder ....................................................................................... PRAZITECH (praziquantel) Injection ................................................................................................................................ TETROXY 343 (oxytetracycline hydrochloride) Soluble Powder ..................................................................................... PROSTAMATE (dinoprost tromethamine) Injectable Solution ......................................................................................... DEXIUM (dexamethasone) Injection ................................................................................................................................ LEVAMED (levamisole hydrochloride) Soluble Powder ................................................................................................... DEXIUM-SP (dexamethasone sodium phosphate) Injection ........................................................................................... BIMECTIN (ivermectin) Pour-On ...................................................................................................................................... BIMECTIN (ivermectin) Paste .......................................................................................................................................... Oxytocin Injection ............................................................................................................................................................. EXODUS (pyrantel pamoate) Paste ................................................................................................................................. SPECTOGARD SCOUR-CHEK (spectinomycin dihydrochloride pentahydrate) Oral Solution ....................................... LINCOMED 100 (lincomycin hydrochloride) Injectable Solution ...................................................................................... TETRAMED 324 HCA (tetracycline hydrochloride) Soluble Powder ............................................................................... SULFAMED-G (sulfadimethoxine) Soluble Powder ......................................................................................................... LINXMED-SP (lincomycin hydrochloride) Soluble Powder .............................................................................................. SPECLINX-50 (lincomycin hydrochloride monohydrate and spectinomycin dihydrochloride pentahydrate) Soluble Powder. LEVAMED (levamisole hydrochloride) Soluble Drench Powder ...................................................................................... FLUNAZINE (flunixin meglumine) Injection ...................................................................................................................... Griseofulvin Powder .......................................................................................................................................................... SMZ-Med 454 (sodium sulfamethazine) Soluble Powder ................................................................................................ BIMECTIN (ivermectin) Injection for Cattle and Swine .................................................................................................... BILOVET (tylosin tartrate) Soluble Powder ...................................................................................................................... TETROXY (oxytetracycline hydrochloride) Aquatic .......................................................................................................... AMPROMED (amprolium) For Cattle ............................................................................................................................... 200–386 200–387 200–391 200–434 200–447 200–455 200–460 200–464 VerDate Sep<11>2014 17:52 Mar 12, 2019 Jkt 247001 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 E:\FR\FM\13MRR1.SGM 13MRR1 558.248. 522.2444b. 522.820. 520.823. 526.820. 526.820. 520.2123b. 520.1720a. 522.1720. 520.1720a. 520.390a. 526.1696a. 522.1696b. 522.1696a. 520.2046. 520.2123a. 520.540b. 522.1720. 520.1720a. 522.1883. 522.1680. 522.540. 522.540. 522.540. 522.540. 522.820. 520.622a. 522.1680. 520.622a. 522.1010. 520.1720d. 522.1962. 520.2260b. 524.1580a. 522.1680. 524.1580a. 522.1680. 522.2063. 522.1662a. 522.480. 522.2473. 520.1484. 522.1077. 520.1696b. 529.1044a. 522.1660a. 520.1660d. 520.1660d. 522.1870. 520.1660d. 522.690. 522.540. 520.1242a. 522.540. 524.1193. 520.1192. 522.1680. 520.2044. 520.2123c. 522.1260. 520.2345d. 520.2220a. 520.1263c. 520.1265. 520.1242a. 522.970. 520.1100. 520.2261b. 522.1192. 520.2640. 529.1660. 520.100. 8971 Federal Register / Vol. 84, No. 49 / Wednesday, March 13, 2019 / Rules and Regulations Product name 200–468 200–481 200–482 200–488 200–489 200–494 200–496 200–501 200–508 200–523 200–529 200–538 200–581 GENTAMED-P (gentamicin sulfate) for Poultry Injection ................................................................................................. OVAMED (altrenogest) Solution ....................................................................................................................................... AMPROMED (amprolium) for Calves ............................................................................................................................... AMPROMED P (amprolium) for Poultry ........................................................................................................................... FLUNAZINE-S (flunixin meglumine) Injection .................................................................................................................. GENTAMED (gentamicin sulfate) Soluble Powder .......................................................................................................... AMPROMED P (amprolium) for Poultry ........................................................................................................................... Praziquantel Injection ....................................................................................................................................................... BILOVET (tylosin) Injectable Solution .............................................................................................................................. SULFAMED (sulfadimethoxine) Injection ......................................................................................................................... XYLAMED (xylazine) Injection .......................................................................................................................................... CLINDAMED (clindamycin) Oral Drops ............................................................................................................................ FLUNAZINE (flunixin meglumine) Paste .......................................................................................................................... Following this change of sponsorship, Cross Vetpharm Group Ltd. is no longer the sponsor of an approved application. Accordingly, it will be removed from the list of sponsors of approved applications in § 510.600(c) (21 CFR 510.600(c)). As a new sponsor of approved applications, Bimeda Animal Health Ltd. will be added to § 510.600(c) and the regulations amended to reflect this action. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these changes of sponsorship. III. Withdrawals of Approval Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140, has requested that FDA withdraw approval of NADA 140– 939 for use of RUMENSIN (monensin) and TYLAN (tylosin phosphate) Type A medicated articles in the manufacture of combination drug Type C medicated cattle feeds because the product is no longer manufactured or marketed. Also, Sergeant’s Pet Care Products, Inc., 10077 S 134th St., Omaha, NE 68138 has requested that FDA withdraw approval of ANADA 200–600 for WORMX (pyrantel pamoate) Flavored Tablets because the product is no longer manufactured or marketed. Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 140–939 and ANADA 200– 600, and all supplements and amendments thereto, is withdrawn, effective March 25, 2019. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions. IV. Technical Amendments amozie on DSK9F9SC42PROD with RULES 21 CFR section File No. In addition, we are reformatting the regulations to present the approved conditions of use of halofuginone, monensin, and salinomycin in tabular format in the respective named sections of 21 CFR part 558. This action is being taken to improve the readability of the regulations. Reporting and recordkeeping requirements. V. Legal Authority This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.360b(i)), which requires Federal Register publication of ‘‘notice[s] . . . effective as a regulation,’’ of the conditions of use of approved new animal drugs. This rule sets forth technical amendments to the regulations to codify recent actions on approved new animal drug applications and corrections to improve the accuracy of the regulations, and as such does not impose any burden on regulated entities. Although denominated a rule pursuant to the FD&C Act, this document does not meet the definition of ‘‘rule’’ in 5 U.S.C. 804(3) because it is a ‘‘rule of particular applicability’’ under 5 U.S.C. 804(3)(A). Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801–808. Likewise, this is not a rule subject to Executive Order 12866, which defines a rule as ‘‘an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.’’ 21 CFR Part 556 List of Subjects 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, 21 CFR Parts 520, 522, 524, 526, and 529 Animal drugs. Animal drugs, Foods. 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, 21 CFR parts 510, 520, 522, 524, 526, 529, 556, and 558 are amended as follows: PART 510—NEW ANIMAL DRUGS 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. 2. In § 510.600, in the table in paragraph (c)(1), remove the entries for ‘‘Cronus Pharma LLC’’ and ‘‘Cross Vetpharm Group Ltd.’’ and alphabetically add entries for ‘‘Bimeda Animal Health Ltd.’’ and ‘‘Cronus Pharma Specialities India Private Ltd.’’; and in the table in paragraph (c)(2), numerically add an entry for ‘‘061133’’, remove the entry for ‘‘061623’’, and revise the entry for ‘‘069043’’. The additions and revisions read as follows: ■ § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * (c) * * * (1) * * * * * Drug labeler code Firm name and address * * * * * * Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland .................................................. VerDate Sep<11>2014 16:11 Mar 12, 2019 Jkt 247001 522.1044. 520.48. 520.100. 520.100. 522.970. 520.1044c. 520.100. 522.1870. 522.2640. 522.2220. 522.2662. 520.447. 520.970. PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 E:\FR\FM\13MRR1.SGM 13MRR1 * 061133 8972 Federal Register / Vol. 84, No. 49 / Wednesday, March 13, 2019 / Rules and Regulations Drug labeler code Firm name and address * * * * * * Cronus Pharma Specialities India Private Ltd., Sy No: 99/1, M/s GMR Hyderabad Aviation SEZ L, Mamidipalli Village, Shamshabad Mandal, Ranga, Hyderabad, Telangana, 501218, India ........................................................................................... * * * * * * 069043 * * * 061133 ............ * * * * * Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland. * * 069043 ............ * * * * * * Cronus Pharma Specialities India Private Ltd., Sy No: 99/1, M/s GMR Hyderabad Aviation SEZ L, Mamidipalli Village, Shamshabad Mandal, Ranga, Hyderabad, Telangana, 501218, India. (2) * * * Drug labeler code Firm name and address * * * * § 520.390a PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS * [Amended] § 520.823 7. In § 520.390a, in paragraph (b)(2)(i), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ 3. The authority citation for part 520 continues to read as follows: ■ § 520.447 Authority: 21 U.S.C. 360b. * [Amended] 4. In § 520.43, revise paragraph (c)(2) to read as follows: 8. In § 520.447, in paragraph (b), remove ‘‘061623’’ and in its place add ‘‘061133’’. § 520.43 § 520.540b * [Amended] 12. In § 520.823, in paragraph (b), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ § 520.970 [Amended] ■ ■ Afoxolaner. * * * * * (c) * * * (2) Indications for use. Kills adult fleas; for the treatment and prevention of flea infestations (Ctenocephalides felis); for the treatment and control of black-legged tick (Ixodes scapularis), American dog tick (Dermacentor variabilis), lone star tick (Amblyomma americanum), and brown dog tick (Rhipicephalus sanguineus) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for 1 month; and for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. * * * * * § 520.48 [Amended] 5. In § 520.48, in paragraph (b), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ amozie on DSK9F9SC42PROD with RULES § 520.100 [Amended] 6. In § 520.100, in paragraph (b)(1), remove ‘‘No. 016592’’ and in its place add ‘‘Nos. 016592 and 061133’’; and in paragraph (b)(2), remove ‘‘No. 066104’’ and in its place add ‘‘Nos. 051072 and 066104’’. ■ VerDate Sep<11>2014 16:11 Mar 12, 2019 Jkt 247001 [Amended] 9. In § 520.540b, in paragraph (b)(2), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ § 520.622a [Amended] 10. In § 520.622a, in paragraph (a)(3), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ 11. In § 520.812, revise paragraphs (a) and (b)(1) and (2) and add paragraph (b)(3) to read as follows: ■ § 520.812 Enrofloxacin. (a) Specifications—(1) Each tablet contains: (i) 2.7, 68.0, or 136.0 milligrams (mg) enrofloxacin; or (ii) 22.7, 68.0, 136.0, or 272 mg enrofloxacin. (2) Each soft chewable tablet contains 22.7, 68.0, or 136.0 mg enrofloxacin. (b) * * * (1) Nos. 000859 and 026637 for use of product described in paragraph (a)(1)(i) of this section. (2) No. 058198 for use of product described in paragraph (a)(1)(ii) of this section. (3) No. 000859 for use of product described in paragraph (a)(2) of this section. * * * * * PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 13. In § 520.970, in paragraph (b)(2), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ § 520.1044c [Amended] 14. In § 520.1044c, in paragraph (b)(2), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ § 520.1100 [Amended] 15. In § 520.1100, in paragraph (b)(2), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ § 520.1192 [Amended] 16. In § 520.1192, in paragraph (b)(2), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ § 520.1242a [Amended] 17. In § 520.1242a, in paragraph (b)(4), remove ‘‘059130’’ and in its place add ‘‘061133’’. ■ § 520.1263c [Amended] 18. In § 520.1263c, in paragraph (b)(2), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ § 520.1265 [Amended] 19. In § 520.1265, in paragraph (b)(2), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ E:\FR\FM\13MRR1.SGM 13MRR1 Federal Register / Vol. 84, No. 49 / Wednesday, March 13, 2019 / Rules and Regulations § 520.1484 [Amended] § 520.2261b 20. In § 520.1484, in paragraph (b)(2), remove ‘‘061623’’ and in its place add ‘‘061133’’. § 520.1660d § 520.2345d ■ [Amended] § 520.2640 22. In § 520.1696b, in paragraph (b), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ § 520.1720a [Amended] 23. In § 520.1720a, in paragraph (b)(3), remove ‘‘061623’’ and in its place add ‘‘061133’’. PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 36. The authority citation for part 522 continues to read as follows: ■ [Amended] 24. In § 520.1720d, in paragraph (b), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ § 520.2041 Authority: 21 U.S.C. 360b. § 522.147 [Amended] 25. Effective March 25, 2019, in § 520.2041, in paragraph (b), remove ‘‘066916, 017135,’’ and add in its place ‘‘017135’’. [Amended] 26. In § 520.2044, in paragraph (b)(3), remove ‘‘061623’’ and in its place add ‘‘061133’’. [Amended] 27. In § 520.2046, in paragraph (b)(2), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ § 520.2123a [Amended] 28. In § 520.2123a, in paragraph (b), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ § 520.2123b [Amended] 29. In § 520.2123b, in paragraph (b), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ § 520.2123c [Amended] § 522.540 [Amended] [Amended] 31. In § 520.2220a, in paragraph (b)(2), remove ‘‘061623’’ and in its place add ‘‘061133’’. 40. In § 522.540, in paragraphs (a)(2)(i), (b)(2), and (c)(2), remove ‘‘061623’’ and in its place add ‘‘061133’’. § 520.2260b § 522.690 [Amended] 32. In § 520.2260b, in paragraphs (c)(1) and (e)(1), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ 16:11 Mar 12, 2019 Enrofloxacin. * * * * * (b) * * * (1) Nos. 000859 and 055529 for use of product described in paragraph (a)(1) of this section as in paragraph (e)(1) of this section, and use of product described in paragraph (a)(2) of this section as in paragraphs (e)(2) and (3) of this section. * * * * * (e) * * * (3) * * * (i) * * * (A) Administer 7.5 mg/kg of body weight once, by intramuscular or subcutaneous injection behind the ear, for the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica, and Mycoplasma hyopneumoniae. (B) Administer 7.5 mg/kg of body weight once, by intramuscular or subcutaneous injection behind the ear, for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed. * * * * * § 522.820 [Amended] 43. In § 522.820, in paragraph (b), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ § 522.970 [Amended] 44. In § 522.970, in paragraph (b)(1), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ [Amended] 45. In § 522.1010, in paragraph (b)(2), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ § 522.1044 [Amended] ■ ■ VerDate Sep<11>2014 § 522.812 § 522.1010 39. In § 522.480, in paragraph (b)(1), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ 30. In § 520.2123c, in paragraph (b), remove ‘‘061623’’ and in its place add ‘‘061133’’. amozie on DSK9F9SC42PROD with RULES Bupivacaine. * * * * (c) Conditions of use—(1) Dogs—(i) Amount. Administer 5.3 mg/kg (0.4 mL/ kg) by infiltration injection into the tissue layers at the time of incisional closure. (ii) Indications for use. For singledose infiltration into the surgical site to provide local postoperative analgesia for cranial cruciate ligament surgery. (2) Cats—(i) Amount. Administer 5.3 mg/kg per forelimb (0.4 mL/kg per forelimb), for a total dose of 10.6 mg/kg/ cat, as a 4-point nerve block prior to onychectomy. (ii) Indications for use. For use as a peripheral nerve block to provide regional postoperative analgesia following onychectomy. § 522.480 [Amended] ■ § 520.2220a § 522.224 * ■ § 520.2046 [Amended] 37. In § 522.147, in paragraph (b), remove ‘‘No. 052483’’ and in its place add ‘‘Nos. 015914 and 052483’’. ■ 38. In § 522.224, revise paragraph (c) to read as follows: ■ ■ § 520.2044 [Amended] 35. In § 520.2640, in paragraph (b)(2), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ ■ § 520.1720d [Amended] 34. In § 520.2345d, in paragraph (b)(4), remove ‘‘061623’’ and in its place add ‘‘061133’’; and in paragraphs (d)(1)(iii) and (d)(2)(iii), remove ‘‘059130, and 061623’’ and in its place add ‘‘and 061133’’. [Amended] 42. In § 522.812, revise paragraph (b)(1); remove paragraph (b)(2) and redesignate paragraph (b)(3) as paragraph (b)(2); remove paragraph (e)(3)(i)(B) and redesignate paragraph (e)(3)(i)(C) as (e)(3)(i)(B); and revise paragraphs (e)(3)(i)(A) and newly designated (e)(3)(i)(B). The revisions read as follows: ■ ■ 21. In § 520.1660d, in paragraphs (b)(5), (b)(7), (d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), (d)(1)(ii)(C)(3), and (d)(1)(iii)(C), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ § 520.1696b [Amended] 33. In § 520.2261b, in paragraph (b), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ 8973 Jkt 247001 § 522.1077 [Amended] 41. In § 522.690, in paragraph (b)(3), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ PO 00000 Frm 00021 Fmt 4700 46. In § 522.1044, in paragraph (b)(4), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ Sfmt 4700 [Amended] 47. In § 522.1077, in paragraph (b)(3), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ E:\FR\FM\13MRR1.SGM 13MRR1 8974 § 522.1192 Federal Register / Vol. 84, No. 49 / Wednesday, March 13, 2019 / Rules and Regulations [Amended] § 522.2220 ■ § 522.1260 § 522.2444b [Amended] [Amended] 61. In § 522.2444b, in paragraph (b), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ § 522.1660a § 522.2473 § 529.1044a [Amended] 72. In § 529.1044a, in paragraph (b), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ § 529.1660 [Amended] 50. In § 522.1660a, in paragraph (b), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ 73. In § 529.1660, in paragraphs (b)(1) and (2), remove ‘‘061623’’ and in its place add ‘‘061133’’. § 522.1662a § 522.2640 PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD [Amended] [Amended] 62. In § 522.2473, in paragraph (b), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ [Amended] ■ § 522.1680 § 522.2662 [Amended] [Amended] 63. In § 522.2640, in paragraph (b)(2), remove ‘‘061623’’ and in its place add ‘‘061133’’. 51. In § 522.1662a, in paragraph (k)(2), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ ■ 74. The authority citation for part 556 continues to read as follows: ■ Authority: 21 U.S.C. 342, 360b, 371. [Amended] 75. In § 556.445, add paragraph (a) and revise paragraph (b) to read as follows: 52. In § 522.1680, in paragraph (b), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ 64. In § 522.2662, in paragraph (b)(2), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ § 522.1696a PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS § 556.445 ■ [Amended] 53. In § 522.1696a, in paragraphs (b)(1), (b)(2), and (d)(2)(iii), remove ‘‘061623’’ and in its place add ‘‘061133’’; and in paragraphs (d)(1)(ii) and (d)(2)(ii), remove ‘‘Conditions of use’’ and in its place add ‘‘Indications for use’’. ■ § 522.1696b 65. The authority citation for part 524 continues to read as follows: ■ Authority: 21 U.S.C. 360b. § 524.1193 § 522.1720 66. In § 524.1193, in paragraph (b)(1), remove ‘‘061623’’ and in its place add ‘‘061133’’. § 524.1580a [Amended] 55. In § 522.1720, in paragraph (b)(2), remove ‘‘061623’’ and in its place add ‘‘061133’’. [Amended] 68. The authority citation for part 526 continues to read as follows: § 526.820 [Amended] § 526.1696a [Amended] 58. In § 522.1962, in paragraph (b)(2), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ § 522.2063 [Amended] 59. In § 522.2063, in paragraph (b)(2), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ VerDate Sep<11>2014 16:11 Mar 12, 2019 [Amended] 69. In § 526.820, in paragraph (b), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ 57. In § 522.1883, in paragraph (b), remove ‘‘061623’’ and in its place add ‘‘061133’’. Jkt 247001 Nicarbazin. (a) Acceptable daily intake (ADI). The ADI for total residues of nicarbazin (4,4′dinitrocarbanilide and 2-hydroxy-4,6dimethylpyrimidine) is 200 micrograms per kilogram of body weight per day. (b) Tolerance. The tolerance for 4,4′dinitrocarbanilide (marker residue) is: (1) Chickens—Liver (target tissue): 52 ppm. (2) [Reserved] * * * * * PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 76. The authority citation for part 558 continues to read as follows: ■ Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc–1, 371. 77. In § 558.4, in paragraph (d), in the ‘‘Category I’’ table, revise the entry for ‘‘Narasin’’, alphabetically add an entry for ‘‘Nicarbazin (granular)’’ followed immediately by an indented entry for ‘‘Narasin’’; and in the ‘‘Category II’’ table, remove the entry for ‘‘Narasin’’ and revise the entry for ‘‘Nicarbazin (powder)’’. The revisions and addition read as follows: ■ Authority: 21 U.S.C. 360b. ■ § 522.1962 PART 526—INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS ■ 56. In § 522.1870, in paragraph (b), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ § 522.1883 [Amended] 67. In § 524.1580a, in paragraph (b)(1), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ ■ § 522.1870 [Amended] ■ [Amended] 54. In § 522.1696b, in paragraphs (b)(2), (d)(2)(i)(A), and (d)(2)(iii)(A), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ amozie on DSK9F9SC42PROD with RULES 60. In § 522.2220, in paragraph (b)(3), remove ‘‘061623’’ and in its place add ‘‘061133’’. 49. In § 522.1260, in paragraph (b)(4), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ Authority: 21 U.S.C. 360b. [Amended] 48. In § 522.1192, in paragraph (b)(2), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ [Amended] 70. In § 526.1696a, in paragraph (c), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS § 558.4 Requirement of a medicated feed mill license. 71. The authority citation for part 529 continues to read as follows: * ■ PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 * * (d) * * * E:\FR\FM\13MRR1.SGM 13MRR1 * * 8975 Federal Register / Vol. 84, No. 49 / Wednesday, March 13, 2019 / Rules and Regulations CATEGORY I * * * Narasin ............................................................................................... Nicarbazin (granular) .......................................................................... Narasin ............................................................................................... * Type B maximum (200x) Assay limits percent 1 Type A Drug * * * 90–110 90–110 90–110 Assay limits percent 1 Type B/C 2 * * 9.0 g/lb (1.98%) ........................... 9.0 g/lb (1.98%) ........................... 9.0 g/lb (1.98%) ........................... * * * * 85–115/75–125. 85–115/75–125. 85–115/75–125. * 1 Percent of labeled amount. given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C medicated feed. 2 Values CATEGORY II * * * Nicarbazin (powder) ........................................................................... * Type B maximum (100x) Assay limits percent 1 Type A Drug * * * 90–110 Assay limits percent 1 Type B/C 2 * * 9.08 g/lb (2.00%) ......................... * * * * 85–115/75–125. * 1 Percent of labeled amount. 2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C medicated feed. * * § 558.68 * * * ‘‘Limitations’’ column, remove ‘‘sponsor No. 069254’’ and in its place add ‘‘sponsor Nos. 054771 and 069254’’. [Amended] 78. In § 558.68, in paragraph (e)(1)(i), in the ‘‘Limitations’’ column, remove ‘‘10 days of age’’ and in its place add ‘‘18 days of age’’. ■ § 558.128 [Amended] 79. In § 558.128, in paragraph (e)(4)(iv), in the row for ‘‘1.’’, in the amozie on DSK9F9SC42PROD with RULES ■ § 558.248 [Amended] 80. In § 558.248, in paragraph (b), remove ‘‘061623’’ and in its place add ‘‘061133’’. ■ 81. In § 558.265, revise paragraphs (b) and (d) to read as follows: ■ § 558.265 Halofuginone. * * * * * (b) Sponsor. See No. 016592 in § 510.600(c) of this chapter. * * * * * (d) Conditions of use. It is used in feed as follows: (1) Chickens— Halofuginone in grams/ton Combination in grams/ton Indications for use Limitations (i) 2.72 ............... ................................. Feed continuously as sole ration. Do not feed to layers. Withdraw 4 days before slaughter. 016592 (ii) 2.72 .............. Bacitracin methylenedisalicylate, 10 to 50. Feed continuously as sole ration. Do not feed to layers. Withdraw 5 days before slaughter. 016592 (iii) 2.72 .............. Bambermycins, 1 to 2. Feed continuously as sole ration. Do not feed to layers. Withdraw 5 days before slaughter. 016592 (iv) 2.72 ............. ................................. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; for improved feed efficiency. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E, acervulina, E. brunetti, E. mivati, and E. maxima; for increased rate of weight gain and improved feed efficiency. Replacement broiler breeder chickens and replacement cage laying chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati/E. mitis, and E. brunetti. Feed continuously as sole ration to replacement cage laying chickens until 20 weeks of age. Feed continuously as sole ration to replacement broiler breeder chickens until 16 weeks of age. Do not feed to laying chickens or water fowl. Withdraw 4 days before slaughter. 016592 VerDate Sep<11>2014 16:11 Mar 12, 2019 Jkt 247001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\FR\FM\13MRR1.SGM 13MRR1 Sponsor 8976 Federal Register / Vol. 84, No. 49 / Wednesday, March 13, 2019 / Rules and Regulations (2) Turkeys— Halofuginone in grams/ton Combination in grams/ton Indications for use Limitations (i) 1.36 to 2.72 ... ................................. Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to layers or water fowl. 016592 (ii) 1.36 to 2.72 .. Bacitracin methylenedisalicylate, 10 to 50. Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or water fowl. 016592 (iii) 1.36 to 2.72 Bambermycins, 2 .... Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis. Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain. Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain. Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or waterfowl. 016592 (3) Halofuginone may also be used in combination with: (i) Lincomycin as in § 558.325. (ii) [Reserved] 82. In § 558.311, redesignate paragraphs (e)(5)(ii) through (v) as paragraphs (e)(5)(iii) and (vi), and add ■ Lincomycin grams/ton * (vi) 2 .......... * Lasalocid, 68 to 113 * * * § 558.311 § 558.325 * Lasalocid. * * * * * (e) * * * (5) * * * (ii) Lincomycin as in § 558.325. * * * * * * Lincomycin. * * (e) * * * (1) * * * * * Indications for use Limitations * * Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E maxima. * * Feed as the sole ration. Type C feed must be used within 4 weeks of manufacture. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Lasalocid as provided by No. 054771 in § 510.600 of this chapter. * * § 558.355 * 84. In § 558.355, revise paragraph (b), add paragraph (c), and revise paragraph (f) to read as follows: ■ amozie on DSK9F9SC42PROD with RULES ■ * * 83. In § 558.325, add paragraph (e)(1)(vi) to read as follows: new paragraph (e)(5)(ii) to read as follows: Combination in grams/ton Sponsor * Monensin. * * * * * (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. Sponsors * Combination in grams/ton Indications for use Limitations (i) 90 to 110 .. .................................. Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. (ii) 90 to 110 .. .................................. Replacement chickens intended for use as cage layers: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. 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. Feed continuously as the sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. 16:11 Mar 12, 2019 Jkt 247001 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 054771 * (c) Related tolerances. See § 556.420 of this chapter. * * * * * (f) Conditions of use. It is used as follows: (1) Chickens— Monensin in grams/ton VerDate Sep<11>2014 * E:\FR\FM\13MRR1.SGM 13MRR1 Sponsor 058198 058198 Federal Register / Vol. 84, No. 49 / Wednesday, March 13, 2019 / Rules and Regulations amozie on DSK9F9SC42PROD with RULES Monensin in grams/ton Combination in grams/ton Indications for use Limitations (iii) 90 to 110 Bacitracin methylenedisalicylate, 4 to 50. Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for improved feed efficiency. (iv) 90 to 110 Bacitracin methylenedisalicylate, 4 to 50. (v) 90 to 110 Bacitracin methylenedisalicylate, 5 to 25. Replacement chickens intended for use as cage layers: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency. Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency. (vi) 90 to 110 Bacitracin methylenedisalicylate, 50. Feed continuously as 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. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. Monensin sodium provided by No. 058198, bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously as 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. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. Monensin sodium provided by No. 058198, bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter. (vii) 90 to 110 Bacitracin zinc, 4 to 50. (viii) 90 to 110 Bacitracin zinc, 10 ... Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency. (ix) 90 to 110 Bacitracin zinc, 10 to 30. Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for improved feed efficiency. (x) 90 to 110 Bambermycins, 1 to 2. Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency. Broiler and replacement chickens intended for use as cage layers: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for improved feed efficiency, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency. Feed continuously as 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. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously as 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. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously as 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. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously as sole ration. Do not feed to laying chickens. Bambermycins provided by No. 016592 in § 510.600(c) of this chapter. (2) Turkeys— VerDate Sep<11>2014 16:11 Mar 12, 2019 Jkt 247001 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 E:\FR\FM\13MRR1.SGM 13MRR1 8977 Sponsor 054771 054771 058198 054771 054771 058198 058198 016592, 058198 8978 Federal Register / Vol. 84, No. 49 / Wednesday, March 13, 2019 / Rules and Regulations Monensin in grams/ton Combination in grams/ton Indications for use Limitations (i) 54 to 90 .... .................................. Growing turkeys: For the prevention of coccidiosis caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis. (ii) 54 to 90 .... Bacitracin methylenedisalicylate, 4 to 50. Growing turkeys: For the prevention of coccidiosis caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain and improved feed efficiency. (iii) 54 to 90 ... Bacitracin methylenedisalicylate, 200. Growing turkeys: For the prevention of coccidiosis caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, and as an aid in the control of transmissible enteritis complicated by organisms susceptible to bacitracin methylenedisalicylate. (iv) 54 to 90 ... Bambermycins, 1 to 2. Growing turkeys: For the prevention of coccidiosis in turkeys caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, and for improved feed efficiency. (v) 54 to 90 ... Bambermycins, 2 ..... Growing turkeys: For the prevention of coccidiosis caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain and improved feed efficiency. For growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. For growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. For growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. For growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. For growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. Sponsor 058198 058198 058198 058198 058198 amozie on DSK9F9SC42PROD with RULES (3) Cattle— Monensin in grams/ton Indications for use Limitations (i) 5 to 40 .......... Cattle fed in confinement for slaughter: For improved feed efficiency. (ii) 10 to 40 ........ Cattle fed in confinement for slaughter: For prevention and control of coccidiosis due to E. bovis and E. zuernii. Feed continuously in complete feed at a rate of 50 to 480 milligrams of monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day). Feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending upon the severity of challenge, up to maximum of 480 milligrams per head per day. VerDate Sep<11>2014 16:11 Mar 12, 2019 Jkt 247001 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 E:\FR\FM\13MRR1.SGM 13MRR1 Sponsor 058198 058198 Federal Register / Vol. 84, No. 49 / Wednesday, March 13, 2019 / Rules and Regulations Monensin in grams/ton Indications for use Limitations (iii) 10 to 200 ..... Calves excluding veal calves: For prevention and control of coccidiosis due to E. bovis and E. zuernii. (iv) 11 to 22 ....... Dairy cows: For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake). (v) 11 to 400 ..... Dairy cows: For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake). (vi) 15 to 400 ..... Growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers): For increased rate of weight gain, and for prevention and control of coccidiosis due to E. bovis and E. zuernii. (vii) 25 to 400 .... For improved feed efficiency, and for prevention and control of coccidiosis due to E. bovis and E. zuernii. Feed at a rate of 0.14 to 1.0 milligram monensin per pound of body weight per day, depending upon the severity of challenge, up to maximum of 200 milligrams per head per day. Feed continuously to dry and lactating dairy cows in a total mixed ration (‘‘complete feed’’). See special labeling considerations in paragraph (d) of this section. Feed continuously to dry and lactating dairy cows in a component feeding system (including top dress). The Type C medicated feed must be fed in a minimum of 1 lb of feed to provide 185 to 660 mg/ head/day monensin to lactating cows or 115 to 410 mg/head/day monensin to dry cows. See special labeling considerations in paragraph (d) of this section. For increased rate of weight gain, feed at a rate of 50 to 200 milligrams monensin per head per day in not less than 1 pound of feed or, after the 5th day, feed at a rate of 400 milligrams per head per day every other day in not less than 2 pounds of feed. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending on severity of challenge, up to 200 milligrams per head per day. During first 5 days of feeding, cattle should receive no more than 100 milligrams per day in not less than 1 pound of feed. Feed to mature reproducing beef cows. Feed as supplemental feed, either hand-fed in a minimum of 1 pound of feed or mixed in a total ration. For improved feed efficiency, feed continuously at a rate of 50 to 200 milligrams monensin per head per day. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending upon severity of challenge, up to a maximum of 200 milligrams per head per day. During first 5 days of feeding, cattle should receive no more than 100 milligrams per head per day. 8979 Sponsor 058198 058198 058198 058198 058198 (4) Free-choice cattle feeds— Monensin amount Indications for use Limitations (i) 150 milligrams Pasture cattle (slaughter, stocker, feeder, and dairy per pound of and beef replacement heifers): For increased rate protein-mineral of weight gain, and for prevention and control of block (0.033%). coccidiosis caused by E. bovis and E. zuernii in pasture cattle which may require supplemental feed. amozie on DSK9F9SC42PROD with RULES (ii) 175 milliPasture cattle (slaughter, stocker, and feeder): For grams per increased rate of weight gain. pound of protein-mineral block (0.038%). (iii) 400 milliPasture cattle (slaughter, stocker, feeder, and dairy grams per and beef replacement heifers): For increased rate pound of proof weight gain. tein-mineral block (0.088%). VerDate Sep<11>2014 16:11 Mar 12, 2019 Jkt 247001 PO 00000 Frm 00027 Fmt 4700 Provide 50 to 200 milligrams of monensin (0.34 to 1.33 pounds of block) per head per day, at least 1 block per 10 to 12 head of cattle. Roughage must be available at all times. Do not allow animals access to other protein blocks, salt or mineral, while being fed this product. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section. Provide 40 to 200 milligrams of monensin (0.25 to 1.13 pounds or 4 to 18 ounces of block) per head per day, at least 1 block per 4 head of cattle. Do not allow cattle access to salt or mineral while being fed this product. Ingestion by cattle of monensin at levels of 600 milligrams per head per day and higher has been fatal. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section. Provide 80 to 200 milligrams of monensin (0.2 to 0.5 pounds of block) per head per day, at least 1 block per 5 head of cattle. Feed blocks continuously. Do not feed salt or minerals containing salt. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section. Sfmt 4700 E:\FR\FM\13MRR1.SGM 13MRR1 Sponsor 058198 017800 067949 8980 Federal Register / Vol. 84, No. 49 / Wednesday, March 13, 2019 / Rules and Regulations Monensin amount Indications for use Limitations (iv) 400 milligrams per pound of block (0.088%). Pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers): For increased rate of weight gain. (v) In free-choice Type C medicated feeds to provide 50 to 200 mg per head per day. Growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers): For increased rate of weight gain; for prevention and control of coccidiosis due to E. bovis and E. zuernii. (vi) 1,620 grams per ton of mineral granules as specified in paragraph (f)(4)(vi)(A) of this section. Growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers): For increased rate of weight gain, and for prevention and control of coccidiosis due to E. bovis and E. zuernii. Provide 50 to 200 milligrams of monensin (2 to 8 ounces of block) per head per day, at least 1 block per 5 head of cattle. Feed blocks continuously. Do not feed salt or mineral supplements in addition to the blocks. Ingestion by cattle of monensin at levels of 600 milligrams per head per day and higher has been fatal. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section. During the first 5 days of feeding, cattle should receive no more than 100 milligrams per day. Do not feed additional salt or minerals. Do not mix with grain or other feeds. Monensin is toxic to cattle when consumed at higher than approved levels. Stressed and/or feed- and/or water-deprived cattle should be adapted to the pasture and to unmedicated supplement before using the monensin medicated supplement. The product’s effectiveness in cull cows and bulls has not been established. See paragraph (d) of this section for other required label warnings. Feed at a rate of 50 to 200 milligrams per head per day. During the first 5 days of feeding, cattle should receive no more than 100 milligrams per day. Do not feed additional salt or minerals. Do not mix with grain or other feeds. Monensin is toxic to cattle when consumed at higher than approved levels. Stressed and/or feed- and/or waterdeprived cattle should be adapted to the pasture and to unmedicated mineral supplement before using the monensin mineral supplement. The product’s effectiveness in cull cows and bulls has not been established. Sponsor 051267 058198 058198 (A) Specifications. Use as free-choice Type C medicated feed formulated as mineral granules as follows: Ingredient Percent Monocalcium phosphate (21% phosphorus, 15% calcium) .................................................................................... Sodium chloride (salt) .............................................................................................................................................. Dried cane molasses ............................................................................................................................................... Ground limestone (33% calcium) or calcium carbonate (38% calcium) ................................................................. Cane molasses ........................................................................................................................................................ Processed grain by-products (as approved by AAFCO) ......................................................................................... Vitamin/trace mineral premix 1 ................................................................................................................................. Monensin Type A article, 90.7 grams per pound .................................................................................................... Antidusting oil .......................................................................................................................................................... 29.49 24.37 20.0 13.75 3.0 5.0 2.5 0.89 1.0 International feed No. 6–01–082 6–04–152 4–04–695 6–02–632 4–04–696 ........................ ........................ ........................ ........................ 1 Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18). (B) [Reserved] (5) Bobwhite quail— Monensin in grams/ton Indications for use amozie on DSK9F9SC42PROD with RULES (i) 73 .................. (ii) [Reserved] .... VerDate Sep<11>2014 Limitations Growing bobwhite quail: For the prevention of coc- Feed continuously in complete feed at a rate of 50 cidiosis caused by Eimeria dispersa and E. lettyae. to 480 milligrams of monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day). ..................................................................................... ..................................................................................... 16:11 Mar 12, 2019 Jkt 247001 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 E:\FR\FM\13MRR1.SGM 13MRR1 Sponsor 058198 ........................ 8981 Federal Register / Vol. 84, No. 49 / Wednesday, March 13, 2019 / Rules and Regulations (6) Goats— Monensin in grams/ton Indications for use Limitations (i) 5 to 40 .......... For the prevention of coccidiosis caused by Eimeria crandallis, E. christenseni, and E. ninakohlyakimovae. (ii) [Reserved] .... ..................................................................................... Feed only to goats being fed in confinement. Do not feed to lactating goats. See paragraph (d)(13) of this section for provisions for monensin liquid Type C goat feeds. ..................................................................................... (7) Monensin may also be used in combination with: (i) Avilamycin as in § 558.68. (ii) Chlortetracycline as in § 558.128. (iii) Decoquinate as in § 558.195. (iv) Lincomycin as in § 558.325. (v) Melengestrol acetate as in § 558.342. Narasin and nicarbazin in grams/ton (i) 27 to 45 of each drug. * * * Narasin and nicarbazin. * * (d) * * * (1) * * * * * ........................ Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati. Feed continuously as the sole ration. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. The two drugs can be combined only at a 1:1 ratio for the 27 to 45 grams per ton range. Only granular nicarbazin as provided by No. 058198 in § 510.600(c) of this chapter may be used in the combination. * * § 558.550 * 86. In § 558.550, revise paragraph (b), add paragraph (c), revise paragraph (d), and add paragraph (e) to read as follows: ■ amozie on DSK9F9SC42PROD with RULES § 558.364 Limitations * * Salinomycin. * * * * * (b) Sponsor. See No. 016592 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.592 of this chapter. ........................ 85. In § 558.364, revise paragraph (d)(1)(i) to read as follows: Indications for use * 058198 ■ Combination in grams/ton * * (vi) Oxytetracycline as in § 558.450. (vii) Ractopamine alone or in combination as in § 558.500. (viii) Tilmicosin as in § 558.618. (ix) Tylosin as in § 558.625. (x) Virginiamycin as in § 558.635. (xi) Zilpaterol alone or in combination as in § 558.665. Sponsor Sponsor * 058198 * (d) Special considerations. Not approved for use with pellet binders. (e) Conditions of use. It is used as follows: (1) Chickens— Salinomycin in grams/ton Combination in grams/ton Indications for use Limitations (i) 40 to 60 ....... ................................. Feed continuously as sole ration. Do not feed to laying hens producing eggs for human consumption. May be fatal if accidentally fed to adult turkeys or horses. 016592 (ii) 40 to 60 ...... Bacitracin methylenedisalicylate, 4 to 50. Broiler, roaster, and replacement (breeder and layer) chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati. Broiler, roaster, and replacement (breeder and layer) chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency. 016592 054771 (iii) 40 to 60 ..... Bacitracin methylenedisalicylate, 50. Feed continuously as sole ration. Do not feed to laying chickens. May be fatal if fed to adult turkeys or horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously as sole ration. Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) in this chapter. VerDate Sep<11>2014 16:11 Mar 12, 2019 Jkt 247001 Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 E:\FR\FM\13MRR1.SGM 13MRR1 Sponsor 054771 8982 Federal Register / Vol. 84, No. 49 / Wednesday, March 13, 2019 / Rules and Regulations Salinomycin in grams/ton Combination in grams/ton Indications for use Limitations (iv) 40 to 60 ..... Bacitracin methylenedisalicylate, 100 to 200. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. (v) 40 to 60 ...... Bacitracin zinc, 10 to 50. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain. (vi) 40 to 60 ..... Bambermycins, 1 to 3. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for improved feed efficiency. Feed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 grams per ton). Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) in this chapter. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously as sole ration. Do not feed to laying chickens. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Salinomycin and bambermycins as provided by No. 016592 in § 510.600(c) in this chapter. Sponsor 054771 016592 054771 016592 (2) Game birds— Salinomycin in grams/ton Combination in grams per ton Indications for use Limitations Sponsor (i) 50 ................ ................................. Quail: For the prevention of coccidiosis caused by E. dispersa and E. lettyae. ........................ (ii) [Reserved] .. ................................. ................................................................... Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to laying hens producing eggs for human consumption. May be fatal if accidentally fed to adult turkeys or horses. ................................................................... (3) Salinomycin may also be used in combination with: (i) Chlortetracycline as in § 558.128. (ii) Lincomycin as in § 558.325. (iii) Oxytetracycline as in § 558.450. (iv) Virginiamycin as in § 558.635. Dated: March 5, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. 87. In § 558.625, revise paragraphs (b)(1) through (4) to read as follows: DEPARTMENT OF HEALTH AND HUMAN SERVICES § 558.625 Food and Drug Administration ■ Tylosin. amozie on DSK9F9SC42PROD with RULES * * * * * (b) * * * (1) No. 016592: Type A medicated articles containing 40 or 100 grams per pound (g/lb). (2) No. 054771: Type A medicated article containing 40 g/lb. (3) No. 058198: Type A medicated articles containing 10, 40, or 100 g/lb. (4) No. 066104: Type A medicated articles containing 20 or 40 g/lb. * * * * * VerDate Sep<11>2014 16:11 Mar 12, 2019 Jkt 247001 [FR Doc. 2019–04226 Filed 3–12–19; 8:45 am] BILLING CODE 4164–01–P 21 CFR Part 520 [Docket No. FDA–2018–N–0002] New Animal Drugs; Withdrawal of Approval of New Animal Drug Application AGENCY: Food and Drug Administration, HHS. ACTION: Notification of withdrawal. The Food and Drug Administration (FDA) is withdrawing SUMMARY: PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 ........................ approval of a new animal drug application (NADA) and an abbreviated new animal drug application (ANADA) at the sponsors’ request because these products are no longer manufactured or marketed. DATES: Withdrawal of approval is effective March 25, 2019. FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–5761, sujaya.dessai@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140, has requested that FDA withdraw approval of NADA 140–939 for use of RUMENSIN (monensin) and TYLAN (tylosin phosphate) Type A medicated articles in the manufacture of combination drug Type C medicated cattle feeds because the product is no longer manufactured or marketed. E:\FR\FM\13MRR1.SGM 13MRR1

Agencies

[Federal Register Volume 84, Number 49 (Wednesday, March 13, 2019)]
[Rules and Regulations]
[Pages 8967-8982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04226]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 526, 529, 556, and 558

[Docket No. FDA-2018-N-0002]


New Animal Drugs; Approval of New Animal Drug Applications; 
Withdrawal of Approval of New Animal Drug Applications; Changes of 
Sponsorship

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
animal drug regulations to reflect application-related actions for new 
animal drug applications (NADAs) and abbreviated new animal drug 
applications (ANADAs) during July, August, and September 2018. FDA is 
informing the public of the availability of summaries of the basis of 
approval and of environmental review documents, where applicable. The 
animal drug regulations are also being amended to make technical 
amendments to improve the readability of the regulations.

DATES: This rule is effective March 13, 2019, except for amendatory 
instruction 25 to 21 CFR 520.2041, which is effective March 25, 2019.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-5689, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during July, August, and September 2018, 
as listed

[[Page 8968]]

in table 1. In addition, FDA is informing the public of the 
availability, where applicable, of documentation of environmental 
review required under the National Environmental Policy Act (NEPA) and, 
for actions requiring review of safety or effectiveness data, summaries 
of the basis of approval (FOI Summaries) under the Freedom of 
Information Act (FOIA). These public documents may be seen in the 
office of the Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday. Persons with access 
to the internet may obtain these documents at the CVM FOIA Electronic 
Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing 
exclusivity and patent information may be accessed in FDA's 
publication, Approved Animal Drug Products Online (Green Book) at: 
https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                          Table 1--Original and Supplemental NADAs and ANADAs Approved During July, August, and September 2018
--------------------------------------------------------------------------------------------------------------------------------------------------------
      Approval date        File No.          Sponsor              Product name             Species          Effect of the action     Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 2, 2018.............   200-624  Modern Veterinary       REVERTIDINE            Dogs.................  Original approval as   FOI Summary.
                                      Therapeutics, LLC,      (atipamezole                                  a generic copy of
                                      14343 SW 119th Ave.,    hydrochloride)                                NADA 141-033.
                                      Miami, FL 33186.        Sterile Injectable
                                                              Solution.
July 6, 2018.............   200-495  Norbrook Laboratories,  ENROFLOX 100           Swine................  Supplemental approval  FOI Summary.
                                      Ltd., Station Works,    (enrofloxacin)                                of additional
                                      Newry BT35 6JP,         Injectable Solution.                          indications and
                                      Northern Ireland.                                                     routes of
                                                                                                            administration.
July 11, 2018............   138-952  Elanco US Inc., 2500    MAXIBAN 72 (narasin    Chickens.............  Supplemental approval  FOI Summary EA/
                                      Innovation Way,         and nicarbazin) Type                          of a revised tissue    FONSI.\1\
                                      Greenfield, IN 46140.   A medicated article.                          residue tolerance
                                                                                                            for nicarbazin and
                                                                                                            withdrawal period
                                                                                                            for narasin and
                                                                                                            nicarbazin Type C
                                                                                                            medicated feeds.
July 13, 2018............   200-484  Huvepharma EOOD, 5th    TYLOVET (tylosin       Swine and cattle.....  Supplemental approval  FOI Summary.
                                      Floor, 3A Nikolay       phosphate) Type A                             of a 40 g/lb
                                      Haytov Str., 1113       medicated articles.                           strength Type A
                                      Sophia, Bulgaria.                                                     medicated article.
July 13, 2018............   141-406  Merial, Inc., 3239      NEXGARD (afoxolaner)   Dogs.................  Supplemental approval  FOI Summary.
                                      Satellite Blvd.,        Chewable Tablets.                             for the prevention
                                      Bldg. 500, Duluth, GA                                                 of Borrelia
                                      30096-4640.                                                           burgdorferi
                                                                                                            infections as a
                                                                                                            direct result of
                                                                                                            killing Ixodes
                                                                                                            scapularis vector
                                                                                                            ticks.
July 30, 2018............   200-608  Piedmont Animal         BAYTRIL                Dogs.................  Original approval as   FOI Summary.
                                      Health, 204 Muirs       (enrofloxacin) Soft                           a generic copy of
                                      Chapel Rd., Suite       Chewable Tablets.                             NADA 140-441.
                                      200, Greensboro, NC
                                      27410.
August 3, 2018...........   141-461  Aratana Therapeutics,   NOCITA (bupivacaine    Cats.................  Supplemental approval  FOI Summary.
                                      Inc., 11400 Tomahawk    liposome injectable                           to provide for use
                                      Creek Pkwy., Leawood,   suspension).                                  as a peripheral
                                      KS 66211.                                                             nerve block to
                                                                                                            provide regional
                                                                                                            postoperative
                                                                                                            analgesia following
                                                                                                            onychectomy in cats.
August 8, 2018...........   141-439  Elanco US Inc., 2500    INTEPRITY              Chickens.............  Supplemental approval  FOI Summary EA/
                                      Innovation Way,         (avilamycin) Type A                           of a revised age       FONSI.\1\
                                      Greenfield, IN 46140.   medicated article.                            restriction caution
                                                                                                            statement from 10
                                                                                                            days to 18 days for
                                                                                                            use of avilamycin
                                                                                                            Type C medicated
                                                                                                            broiler feeds.
August 9, 2018...........   200-630  Aurora Pharmaceutical,  COCCIAID (amprolium)   Chickens and turkeys.  Original approval as   FOI Summary.
                                      LLC, 1196 Highway 3     9.6% Oral Solution.                           a generic copy of
                                      South, Northfield, MN                                                 NADA 013-149.
                                      55057-3009.
August 10, 2018..........   141-488  Zoetis Inc., 333        Lincomycin and         Chickens.............  Original approval for  FOI Summary.
                                      Portage St.,            lasalocid Type C                              use of LINCOMIX
                                      Kalamazoo, MI 49007.    medicated feeds.                              (lincomycin) and
                                                                                                            AVATEC (lasalocid)
                                                                                                            Type A medicated
                                                                                                            articles in the
                                                                                                            manufacture of Type
                                                                                                            C medicated broiler
                                                                                                            chicken feeds for
                                                                                                            the control of
                                                                                                            necrotic enteritis
                                                                                                            caused or
                                                                                                            complicated by
                                                                                                            Clostridium spp. or
                                                                                                            other organisms
                                                                                                            susceptible to
                                                                                                            lincomycin, and for
                                                                                                            the prevention of
                                                                                                            coccidiosis caused
                                                                                                            by Eimeria tenella,
                                                                                                            E. necatrix, E.
                                                                                                            acervulina, E.
                                                                                                            brunetti, E. mivati,
                                                                                                            and E maxima.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
  no significant impact (FONSI).

II. Change of Sponsorship

    Piedmont Animal Health, 204 Muirs Chapel Rd., Suite 200, 
Greensboro, NC 27410 has informed FDA that it has transferred ownership 
of, and all rights and interest in, newly approved ANADA 200-608 for 
BAYTRIL (enrofloxacin) Soft Chewable Tablets to Bayer HealthCare LLC, 
Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201. 
Following this change of sponsorship, Piedmont Animal Health is no 
longer the sponsor of an approved application. Accordingly, it will not 
be added to the

[[Page 8969]]

list of sponsors of approved applications in Sec.  510.600(c) (21 CFR 
510.600(c)).
    Cronus Pharma LLC, 2 Tower Center Blvd., Suite 1101, East 
Brunswick, NJ 08816 has informed FDA that it has transferred ownership 
of, and all rights and interest in, the following applications to 
Cronus Pharma Specialities India Private Ltd., Sy No: 99/1, M/s GMR 
Hyderabad Aviation SEZ L, Mamidipalli Village, Shamshabad Mandal, 
Ranga, Hyderabad, Telangana 501218, India:

------------------------------------------------------------------------
           File No.                           Product name
------------------------------------------------------------------------
011-531......................  DIZAN (dithiazanine iodide) Tablets.
011-674......................  DIZAN (dithiazanine iodide) Powder.
012-469......................  DIZAN (dithiazanine iodide) Suspension
                                with Piperazine.
031-512......................  ATGARD (dichlorvos) Swine Wormer.
033-803......................  TASK (dichlorvos) Dog Anthelmintic.
035-918......................  EQUIGARD (dichlorvos).
039-483......................  BIO-TAL (thiamylal sodium).
040-848......................  ATGARD C (dichlorvos) Swine Wormer.
043-606......................  ATGARD V (dichlorvos) Swine Wormer.
045-143......................  OXIJECT (oxytetracycline hydrochloride).
047-278......................  BIO-MYCIN (oxytetracycline
                                hydrochloride).
047-712......................  BIZOLIN-100 (phenylbutazone).
048-010......................  ANAPLEX (dichlorophene and toluene)
                                Capsules.
048-237......................  EQUIGEL (dichlorvos).
048-271......................  TASK (dichlorvos) Tablets.
049-032......................  ATGARD C (dichlorvos) Premix.
055-002......................  TEVCOCIN (chloramphenicol).
065-461......................  ANACETIN (chloramphenicol) Tablets.
065-481......................  Chlortetracycline Calf Scour Boluses.
065-486......................  CTC Bisulfate (chlortetracycline
                                bisulfate) Soluble Powder.
065-491......................  MEDICHOL (chloramphenicol) Tablets.
092-837......................  NEMACIDE (diethylcarbamazine citrate)
                                Oral Syrup.
093-516......................  BIZOLIN (phenylbutazone) Injection 20%.
094-170......................  Phenylbutazone Tablets, U.S.P. 100 mg.
097-452......................  OXYJECT 100 (oxytetracycline
                                hydrochloride).
098-569......................  MEDACIDE-SDM (sulfadimethoxine) Injection
                                10%.
099-618......................  BIZOLIN (phenylbutazone) 1-gram.
108-963......................  MEDAMYCIN (oxytetracycline
                                hydrochloride).
117-689......................  NEUROSYN (primidone) Tablets.
123-815......................  Dexamethasone Sodium Phosphate Injection.
125-797......................  Nitrofurazone Dressing.
126-236......................  Nitrofurazone Soluble Powder.
126-676......................  D & T (dichlorophene and toluene) Worm
                                Capsules.
127-627......................  NEMACIDE-C (diethylcarbamazine citrate).
128-069......................  NEMACIDE (diethylcarbamazine citrate)
                                Chewable Tablets.
132-028......................  ANESTATAL (thiamylal sodium).
135-771......................  Methylprednisolene Tablets.
136-212......................  Methylprednisolone Acetate Injection.
137-310......................  Gentamicin Sulfate Injectable Solution.
138-869......................  Triamcinolone Acetonide Suspension.
140-442......................  Xylazine Hydrochloride Injection.
141-245......................  TRIBUTAME (chloroquine phosphate,
                                embutramid, lidocaine) Euthanasia
                                Solution.
200-023......................  Gentamicin Sulfate Solution 100 mg/mL.
200-029......................  Ketamine Hydrochloride Injection.
200-165......................  SDM Sulfadimethoxine Concentrated
                                Solution 12.5%.
200-178......................  Amikacin Sulfate Injection.
200-193......................  Clindamycin Hydrochloride Oral Liquid.
200-248......................  Pyrantel Pamoate Suspension.
200-265......................  Praziquantel Tablets.
200-287......................  GBC (gentamicin sulfate, betamethasone
                                valerate, clotrimazole) Ointment.
200-297......................  Ivermectin Chewable Tablets.
200-298......................  Clindamycin Hydrochloride Capsules.
200-365......................  ROBINUL (glycopyrrolate) Injection.
200-382......................  Furosemide Syrup 1%.
------------------------------------------------------------------------

    Following this change of sponsorship, Cronus Pharma LLC is no 
longer the sponsor of an approved application. Accordingly, it will be 
removed from the list of sponsors of approved applications in Sec.  
510.600(c). As a new sponsor of approved applications, Cronus Pharma 
Specialities India Private Ltd. will be added to Sec.  510.600(c); 
however, as the drug labeler code was not changed, no further 
amendments are necessary.
    Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, 
Ireland has informed FDA that it has transferred ownership of, and all 
rights and interest in, the following applications to Bimeda Animal 
Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 
18, Ireland:

[[Page 8970]]



------------------------------------------------------------------------
   File No.                Product name               21 CFR  section
------------------------------------------------------------------------
010-092.......  GALLIMYCIN-100P (erythromycin      558.248.
                 thiocyanate) Type A Medicated
                 Article.
010-346.......  COMBUTHAL (pentobarbital sodium    522.2444b.
                 and thiopental sodium) Powder.
012-123.......  GALLIMYCIN-100 (erythromycin )     522.820.
                 Injectable.
035-157.......  GALLIMYCIN PFC (erythromycin       520.823.
                 phosphate) Powder.
035-455.......  GALLIMYCIN-36 (erythromycin) Dry   526.820.
                 Cow Intramammary Infusion.
035-456.......  GALLIMYCIN-36 (erythromycin)       526.820.
                 Sterile Intramammary Infusion.
038-661.......  SPECTOGARD (spectinomycin) Water   520.2123b.
                 Soluble Powder.
044-756.......  BUTATRON (phenylbutazone) Tablets  520.1720a.
046-780.......  PHEN-BUTA (phenylbutazone) Vet     522.1720.
                 Injection.
049-187.......  PHEN-BUTA (phenylbutazone) Vet     520.1720a.
                 Tablets.
055-059.......  VICETRON (chloramphenicol)         520.390a.
                 Tablets.
065-383.......  UNIBIOTIC (penicillin G procaine)  526.1696a.
                 Intramammary Infusion.
065-505.......  PRO-PEN-G (penicillin G procaine)  522.1696b.
                 Injectable Suspension.
065-506.......  COMBI-PEN-48 (penicillin G         522.1696a.
                 benzathine and penicillin G
                 procaine) Injectable Suspension.
092-150.......  PURINA (pyrantel tartrate) Horse   520.2046.
                 & Colt Wormer Pellets.
093-515.......  SPECTAM (spectinomycin) Tablets..  520.2123a.
095-218.......  DEXIUM (dexamethasone) Tablets...  520.540b.
096-671.......  PHEN-BUTA-Vet (phenylbutazone)     522.1720.
                 Injection.
096-672.......  PHEN-BUTA (phenylbutazone) Vet     520.1720a.
                 Tablets.
098-288.......  PREDNIS-A-Vet (prednisolone        522.1883.
                 sodium phosphate) Injection.
099-169.......  Oxytocin Injection...............  522.1680.
099-604.......  DEX-A-VET (dexamethasone)          522.540.
                 Injection.
099-605.......  DEX-A-VET (dexamethasone)          522.540.
                 Injection.
099-606.......  DEXAMETH-A-Vet (dexamethasone )    522.540.
                 Injection.
099-607.......  DEXAMETH-A-Vet (dexamethasone)     522.540.
                 Injection.
101-690.......  ERYTHRO-100 (erythromycin)         522.820.
                 Injection.
107-506.......  CARBAM (diethylcarbamazine         520.622a.
                 citrate) Tablets.
109-305.......  Oxytocin Injection...............  522.1680.
118-032.......  PALATABS (diethylcarbamazine       520.622a.
                 citrate) Tablets.
118-550.......  FUROS-A-Vet (furosemide).........  522.1010.
118-979.......  BUTATRON (phenylbutazone) Gel....  520.1720d.
119-141.......  TRANQUAZINE (promazine             522.1962.
                 hydrochloride) Injection.
120-615.......  SUSTAIN III (sulfamethazine)       520.2260b.
                 Bolus.
122-447.......  FURA-SEPTIN (Nitrofurazone)        524.1580a.
                 Soluble Dressing.
124-241.......  PVL Oxytocin Injection...........  522.1680.
126-504.......  Nitrofurazone Ointment...........  524.1580a.
130-136.......  Oxytocin Injection...............  522.1680.
138-405.......  Pyrilamine Maleate Injection.....  522.2063.
140-582.......  Oxytetracycline Hydrochloride      522.1662a.
                 Injection.
140-583.......  ACTH (adrenocorticotropic          522.480.
                 hormone) Gel.
141-420.......  TILDREN (tiludronate disodium)     522.2473.
                 Powder for Injection.
200-050.......  NEOMED (neomycin sulfate) Soluble  520.1484.
                 Powder.
200-069.......  FERTELIN (gonadorelin diacetate    522.1077.
                 tetrahydrate).
200-103.......  PENAQUA Sol-G (penicillin G        520.1696b.
                 potassium, USP) Soluble Powder.
200-115.......  GENTAMEX 100 (gentamicicn          529.1044a.
                 sulfate).
200-117.......  OXYSHOT-LA (oxytetracycline)       522.1660a.
                 Injectable Solution.
200-144.......  TETROXY HCA-280 (oxytetracycline   520.1660d.
                 hydrochloride) Soluble Powder.
200-146.......  TETROXY 25 (oxytetracycline        520.1660d.
                 hydrochloride) Soluble Powder.
200-176.......  PRAZITECH (praziquantel)           522.1870.
                 Injection.
200-247.......  TETROXY 343 (oxytetracycline       520.1660d.
                 hydrochloride) Soluble Powder.
200-253.......  PROSTAMATE (dinoprost              522.690.
                 tromethamine) Injectable
                 Solution.
200-312.......  DEXIUM (dexamethasone) Injection.  522.540.
200-313.......  LEVAMED (levamisole                520.1242a.
                 hydrochloride) Soluble Powder.
200-317.......  DEXIUM-SP (dexamethasone sodium    522.540.
                 phosphate) Injection.
200-318.......  BIMECTIN (ivermectin) Pour-On....  524.1193.
200-326.......  BIMECTIN (ivermectin) Paste......  520.1192.
200-328.......  Oxytocin Injection...............  522.1680.
200-350.......  EXODUS (pyrantel pamoate) Paste..  520.2044.
200-364.......  SPECTOGARD SCOUR-CHEK              520.2123c.
                 (spectinomycin dihydrochloride
                 pentahydrate) Oral Solution.
200-368.......  LINCOMED 100 (lincomycin           522.1260.
                 hydrochloride) Injectable
                 Solution.
200-374.......  TETRAMED 324 HCA (tetracycline     520.2345d.
                 hydrochloride) Soluble Powder.
200-376.......  SULFAMED-G (sulfadimethoxine)      520.2220a.
                 Soluble Powder.
200-377.......  LINXMED-SP (lincomycin             520.1263c.
                 hydrochloride) Soluble Powder.
200-380.......  SPECLINX-50 (lincomycin            520.1265.
                 hydrochloride monohydrate and
                 spectinomycin dihydrochloride
                 pentahydrate) Soluble Powder.
200-386.......  LEVAMED (levamisole                520.1242a.
                 hydrochloride) Soluble Drench
                 Powder.
200-387.......  FLUNAZINE (flunixin meglumine)     522.970.
                 Injection.
200-391.......  Griseofulvin Powder..............  520.1100.
200-434.......  SMZ-Med 454 (sodium                520.2261b.
                 sulfamethazine) Soluble Powder.
200-447.......  BIMECTIN (ivermectin) Injection    522.1192.
                 for Cattle and Swine.
200-455.......  BILOVET (tylosin tartrate)         520.2640.
                 Soluble Powder.
200-460.......  TETROXY (oxytetracycline           529.1660.
                 hydrochloride) Aquatic.
200-464.......  AMPROMED (amprolium) For Cattle..  520.100.

[[Page 8971]]

 
200-468.......  GENTAMED-P (gentamicin sulfate)    522.1044.
                 for Poultry Injection.
200-481.......  OVAMED (altrenogest) Solution....  520.48.
200-482.......  AMPROMED (amprolium) for Calves..  520.100.
200-488.......  AMPROMED P (amprolium) for         520.100.
                 Poultry.
200-489.......  FLUNAZINE-S (flunixin meglumine)   522.970.
                 Injection.
200-494.......  GENTAMED (gentamicin sulfate)      520.1044c.
                 Soluble Powder.
200-496.......  AMPROMED P (amprolium) for         520.100.
                 Poultry.
200-501.......  Praziquantel Injection...........  522.1870.
200-508.......  BILOVET (tylosin) Injectable       522.2640.
                 Solution.
200-523.......  SULFAMED (sulfadimethoxine)        522.2220.
                 Injection.
200-529.......  XYLAMED (xylazine) Injection.....  522.2662.
200-538.......  CLINDAMED (clindamycin) Oral       520.447.
                 Drops.
200-581.......  FLUNAZINE (flunixin meglumine)     520.970.
                 Paste.
------------------------------------------------------------------------

    Following this change of sponsorship, Cross Vetpharm Group Ltd. is 
no longer the sponsor of an approved application. Accordingly, it will 
be removed from the list of sponsors of approved applications in Sec.  
510.600(c) (21 CFR 510.600(c)). As a new sponsor of approved 
applications, Bimeda Animal Health Ltd. will be added to Sec.  
510.600(c) and the regulations amended to reflect this action. As 
provided in the regulatory text of this document, the animal drug 
regulations are amended to reflect these changes of sponsorship.

III. Withdrawals of Approval

    Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140, has 
requested that FDA withdraw approval of NADA 140-939 for use of 
RUMENSIN (monensin) and TYLAN (tylosin phosphate) Type A medicated 
articles in the manufacture of combination drug Type C medicated cattle 
feeds because the product is no longer manufactured or marketed.
    Also, Sergeant's Pet Care Products, Inc., 10077 S 134th St., Omaha, 
NE 68138 has requested that FDA withdraw approval of ANADA 200-600 for 
WORMX (pyrantel pamoate) Flavored Tablets because the product is no 
longer manufactured or marketed.
    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADA 140-939 and ANADA 200-600, and all supplements 
and amendments thereto, is withdrawn, effective March 25, 2019. As 
provided in the regulatory text of this document, the animal drug 
regulations are amended to reflect these actions.

IV. Technical Amendments

    In addition, we are reformatting the regulations to present the 
approved conditions of use of halofuginone, monensin, and salinomycin 
in tabular format in the respective named sections of 21 CFR part 558. 
This action is being taken to improve the readability of the 
regulations.

V. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.360b(i)), which requires 
Federal Register publication of ``notice[s] . . . effective as a 
regulation,'' of the conditions of use of approved new animal drugs. 
This rule sets forth technical amendments to the regulations to codify 
recent actions on approved new animal drug applications and corrections 
to improve the accuracy of the regulations, and as such does not impose 
any burden on regulated entities.
    Although denominated a rule pursuant to the FD&C Act, this document 
does not meet the definition of ``rule'' in 5 U.S.C. 804(3) because it 
is a ``rule of particular applicability'' under 5 U.S.C. 804(3)(A). 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive 
Order 12866, which defines a rule as ``an agency statement of general 
applicability and future effect, which the agency intends to have the 
force and effect of law, that is designed to implement, interpret, or 
prescribe law or policy or to describe the procedure or practice 
requirements of an agency.''

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, 524, 526, and 529

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

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, 21 CFR parts 
510, 520, 522, 524, 526, 529, 556, 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.


0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the 
entries for ``Cronus Pharma LLC'' and ``Cross Vetpharm Group Ltd.'' and 
alphabetically add entries for ``Bimeda Animal Health Ltd.'' and 
``Cronus Pharma Specialities India Private Ltd.''; and in the table in 
paragraph (c)(2), numerically add an entry for ``061133'', remove the 
entry for ``061623'', and revise the entry for ``069043''.
    The additions and revisions read as follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                              * * * * * * *
Bimeda Animal Health Ltd., 1B The Herbert Building, The           061133
 Park, Carrickmines, Dublin 18, Ireland.................

[[Page 8972]]

 
 
                              * * * * * * *
Cronus Pharma Specialities India Private Ltd., Sy No: 99/         069043
 1, M/s GMR Hyderabad Aviation SEZ L, Mamidipalli
 Village, Shamshabad Mandal, Ranga, Hyderabad,
 Telangana, 501218, India...............................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
    Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
061133..................  Bimeda Animal Health Ltd., 1B The Herbert
                           Building, The Park, Carrickmines, Dublin 18,
                           Ireland.
 
                              * * * * * * *
069043..................  Cronus Pharma Specialities India Private Ltd.,
                           Sy No: 99/1, M/s GMR Hyderabad Aviation SEZ
                           L, Mamidipalli Village, Shamshabad Mandal,
                           Ranga, Hyderabad, Telangana, 501218, India.
 
                              * * * * * * *
------------------------------------------------------------------------

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.


0
4. In Sec.  520.43, revise paragraph (c)(2) to read as follows:


Sec.  520.43  Afoxolaner.

* * * * *
    (c) * * *
    (2) Indications for use. Kills adult fleas; for the treatment and 
prevention of flea infestations (Ctenocephalides felis); for the 
treatment and control of black-legged tick (Ixodes scapularis), 
American dog tick (Dermacentor variabilis), lone star tick (Amblyomma 
americanum), and brown dog tick (Rhipicephalus sanguineus) infestations 
in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body 
weight or greater, for 1 month; and for the prevention of Borrelia 
burgdorferi infections as a direct result of killing Ixodes scapularis 
vector ticks.
* * * * *


Sec.  520.48  [Amended]

0
5. In Sec.  520.48, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.


Sec.  520.100  [Amended]

0
6. In Sec.  520.100, in paragraph (b)(1), remove ``No. 016592'' and in 
its place add ``Nos. 016592 and 061133''; and in paragraph (b)(2), 
remove ``No. 066104'' and in its place add ``Nos. 051072 and 066104''.


Sec.  520.390a  [Amended]

0
7. In Sec.  520.390a, in paragraph (b)(2)(i), remove ``061623'' and in 
its place add ``061133''.


Sec.  520.447  [Amended]

0
8. In Sec.  520.447, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.


Sec.  520.540b  [Amended]

0
9. In Sec.  520.540b, in paragraph (b)(2), remove ``061623'' and in its 
place add ``061133''.


Sec.  520.622a  [Amended]

0
10. In Sec.  520.622a, in paragraph (a)(3), remove ``061623'' and in 
its place add ``061133''.

0
11. In Sec.  520.812, revise paragraphs (a) and (b)(1) and (2) and add 
paragraph (b)(3) to read as follows:


Sec.  520.812  Enrofloxacin.

    (a) Specifications--(1) Each tablet contains:
    (i) 2.7, 68.0, or 136.0 milligrams (mg) enrofloxacin; or
    (ii) 22.7, 68.0, 136.0, or 272 mg enrofloxacin.
    (2) Each soft chewable tablet contains 22.7, 68.0, or 136.0 mg 
enrofloxacin.
    (b) * * *
    (1) Nos. 000859 and 026637 for use of product described in 
paragraph (a)(1)(i) of this section.
    (2) No. 058198 for use of product described in paragraph (a)(1)(ii) 
of this section.
    (3) No. 000859 for use of product described in paragraph (a)(2) of 
this section.
* * * * *


Sec.  520.823  [Amended]

0
12. In Sec.  520.823, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.


Sec.  520.970  [Amended]

0
13. In Sec.  520.970, in paragraph (b)(2), remove ``061623'' and in its 
place add ``061133''.


Sec.  520.1044c  [Amended]

0
14. In Sec.  520.1044c, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.


Sec.  520.1100  [Amended]

0
15. In Sec.  520.1100, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.


Sec.  520.1192  [Amended]

0
16. In Sec.  520.1192, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.


Sec.  520.1242a  [Amended]

0
17. In Sec.  520.1242a, in paragraph (b)(4), remove ``059130'' and in 
its place add ``061133''.


Sec.  520.1263c  [Amended]

0
18. In Sec.  520.1263c, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.


Sec.  520.1265  [Amended]

0
19. In Sec.  520.1265, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.

[[Page 8973]]

Sec.  520.1484  [Amended]

0
20. In Sec.  520.1484, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.


Sec.  520.1660d  [Amended]

0
21. In Sec.  520.1660d, in paragraphs (b)(5), (b)(7), (d)(1)(ii)(A)(3), 
(d)(1)(ii)(B)(3), (d)(1)(ii)(C)(3), and (d)(1)(iii)(C), remove 
``061623'' and in its place add ``061133''.


Sec.  520.1696b  [Amended]

0
22. In Sec.  520.1696b, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.


Sec.  520.1720a  [Amended]

0
23. In Sec.  520.1720a, in paragraph (b)(3), remove ``061623'' and in 
its place add ``061133''.


Sec.  520.1720d  [Amended]

0
24. In Sec.  520.1720d, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.


Sec.  520.2041  [Amended]

0
25. Effective March 25, 2019, in Sec.  520.2041, in paragraph (b), 
remove ``066916, 017135,'' and add in its place ``017135''.


Sec.  520.2044  [Amended]

0
26. In Sec.  520.2044, in paragraph (b)(3), remove ``061623'' and in 
its place add ``061133''.


Sec.  520.2046  [Amended]

0
27. In Sec.  520.2046, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.


Sec.  520.2123a  [Amended]

0
28. In Sec.  520.2123a, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.


Sec.  520.2123b  [Amended]

0
29. In Sec.  520.2123b, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.


Sec.  520.2123c  [Amended]

0
30. In Sec.  520.2123c, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.


Sec.  520.2220a  [Amended]

0
31. In Sec.  520.2220a, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.


Sec.  520.2260b  [Amended]

0
32. In Sec.  520.2260b, in paragraphs (c)(1) and (e)(1), remove 
``061623'' and in its place add ``061133''.


Sec.  520.2261b  [Amended]

0
33. In Sec.  520.2261b, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.


Sec.  520.2345d  [Amended]

0
34. In Sec.  520.2345d, in paragraph (b)(4), remove ``061623'' and in 
its place add ``061133''; and in paragraphs (d)(1)(iii) and 
(d)(2)(iii), remove ``059130, and 061623'' and in its place add ``and 
061133''.


Sec.  520.2640  [Amended]

0
35. In Sec.  520.2640, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.

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

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

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


Sec.  522.147  [Amended]

0
37. In Sec.  522.147, in paragraph (b), remove ``No. 052483'' and in 
its place add ``Nos. 015914 and 052483''.

0
38. In Sec.  522.224, revise paragraph (c) to read as follows:


Sec.  522.224  Bupivacaine.

* * * * *
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 5.3 mg/kg 
(0.4 mL/kg) by infiltration injection into the tissue layers at the 
time of incisional closure.
    (ii) Indications for use. For single-dose infiltration into the 
surgical site to provide local postoperative analgesia for cranial 
cruciate ligament surgery.
    (2) Cats--(i) Amount. Administer 5.3 mg/kg per forelimb (0.4 mL/kg 
per forelimb), for a total dose of 10.6 mg/kg/cat, as a 4-point nerve 
block prior to onychectomy.
    (ii) Indications for use. For use as a peripheral nerve block to 
provide regional postoperative analgesia following onychectomy.


Sec.  522.480  [Amended]

0
39. In Sec.  522.480, in paragraph (b)(1), remove ``061623'' and in its 
place add ``061133''.


Sec.  522.540  [Amended]

0
40. In Sec.  522.540, in paragraphs (a)(2)(i), (b)(2), and (c)(2), 
remove ``061623'' and in its place add ``061133''.


Sec.  522.690  [Amended]

0
41. In Sec.  522.690, in paragraph (b)(3), remove ``061623'' and in its 
place add ``061133''.

0
42. In Sec.  522.812, revise paragraph (b)(1); remove paragraph (b)(2) 
and redesignate paragraph (b)(3) as paragraph (b)(2); remove paragraph 
(e)(3)(i)(B) and redesignate paragraph (e)(3)(i)(C) as (e)(3)(i)(B); 
and revise paragraphs (e)(3)(i)(A) and newly designated (e)(3)(i)(B).
    The revisions read as follows:


Sec.  522.812  Enrofloxacin.

* * * * *
    (b) * * *
    (1) Nos. 000859 and 055529 for use of product described in 
paragraph (a)(1) of this section as in paragraph (e)(1) of this 
section, and use of product described in paragraph (a)(2) of this 
section as in paragraphs (e)(2) and (3) of this section.
* * * * *
    (e) * * *
    (3) * * *
    (i) * * *
    (A) Administer 7.5 mg/kg of body weight once, by intramuscular or 
subcutaneous injection behind the ear, for the treatment and control of 
swine respiratory disease (SRD) associated with Actinobacillus 
pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, 
Streptococcus suis, Bordetella bronchiseptica, and Mycoplasma 
hyopneumoniae.
    (B) Administer 7.5 mg/kg of body weight once, by intramuscular or 
subcutaneous injection behind the ear, for the control of 
colibacillosis in groups or pens of weaned pigs where colibacillosis 
associated with Escherichia coli has been diagnosed.
* * * * *


Sec.  522.820  [Amended]

0
43. In Sec.  522.820, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.


Sec.  522.970  [Amended]

0
44. In Sec.  522.970, in paragraph (b)(1), remove ``061623'' and in its 
place add ``061133''.


Sec.  522.1010  [Amended]

0
45. In Sec.  522.1010, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.


Sec.  522.1044  [Amended]

0
46. In Sec.  522.1044, in paragraph (b)(4), remove ``061623'' and in 
its place add ``061133''.


Sec.  522.1077  [Amended]

0
47. In Sec.  522.1077, in paragraph (b)(3), remove ``061623'' and in 
its place add ``061133''.

[[Page 8974]]

Sec.  522.1192  [Amended]

0
48. In Sec.  522.1192, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.


Sec.  522.1260  [Amended]

0
49. In Sec.  522.1260, in paragraph (b)(4), remove ``061623'' and in 
its place add ``061133''.


Sec.  522.1660a  [Amended]

0
50. In Sec.  522.1660a, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.


Sec.  522.1662a  [Amended]

0
51. In Sec.  522.1662a, in paragraph (k)(2), remove ``061623'' and in 
its place add ``061133''.


Sec.  522.1680  [Amended]

0
52. In Sec.  522.1680, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.


Sec.  522.1696a  [Amended]

0
53. In Sec.  522.1696a, in paragraphs (b)(1), (b)(2), and (d)(2)(iii), 
remove ``061623'' and in its place add ``061133''; and in paragraphs 
(d)(1)(ii) and (d)(2)(ii), remove ``Conditions of use'' and in its 
place add ``Indications for use''.


Sec.  522.1696b  [Amended]

0
54. In Sec.  522.1696b, in paragraphs (b)(2), (d)(2)(i)(A), and 
(d)(2)(iii)(A), remove ``061623'' and in its place add ``061133''.


Sec.  522.1720  [Amended]

0
55. In Sec.  522.1720, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.


Sec.  522.1870  [Amended]

0
56. In Sec.  522.1870, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.


Sec.  522.1883  [Amended]

0
57. In Sec.  522.1883, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.


Sec.  522.1962  [Amended]

0
58. In Sec.  522.1962, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.


Sec.  522.2063  [Amended]

0
59. In Sec.  522.2063, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.


Sec.  522.2220  [Amended]

0
60. In Sec.  522.2220, in paragraph (b)(3), remove ``061623'' and in 
its place add ``061133''.


Sec.  522.2444b  [Amended]

0
61. In Sec.  522.2444b, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.


Sec.  522.2473  [Amended]

0
62. In Sec.  522.2473, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.


Sec.  522.2640  [Amended]

0
63. In Sec.  522.2640, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.


Sec.  522.2662  [Amended]

0
64. In Sec.  522.2662, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.

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

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

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


Sec.  524.1193  [Amended]

0
66. In Sec.  524.1193, in paragraph (b)(1), remove ``061623'' and in 
its place add ``061133''.


Sec.  524.1580a  [Amended]

0
67. In Sec.  524.1580a, in paragraph (b)(1), remove ``061623'' and in 
its place add ``061133''.

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

0
68. The authority citation for part 526 continues to read as follows:

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


Sec.  526.820  [Amended]

0
69. In Sec.  526.820, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.


Sec.  526.1696a  [Amended]

0
70. In Sec.  526.1696a, in paragraph (c), remove ``061623'' and in its 
place add ``061133''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
71. The authority citation for part 529 continues to read as follows:

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


Sec.  529.1044a  [Amended]

0
72. In Sec.  529.1044a, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.


Sec.  529.1660  [Amended]

0
73. In Sec.  529.1660, in paragraphs (b)(1) and (2), remove ``061623'' 
and in its place add ``061133''.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
74. The authority citation for part 556 continues to read as follows:

    Authority: 21 U.S.C. 342, 360b, 371.


0
75. In Sec.  556.445, add paragraph (a) and revise paragraph (b) to 
read as follows:


Sec.  556.445  Nicarbazin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
nicarbazin (4,4'-dinitrocarbanilide and 2-hydroxy-4,6-
dimethylpyrimidine) is 200 micrograms per kilogram of body weight per 
day.
    (b) Tolerance. The tolerance for 4,4'-dinitrocarbanilide (marker 
residue) is:
    (1) Chickens--Liver (target tissue): 52 ppm.
    (2) [Reserved]
* * * * *

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

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

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


0
77. In Sec.  558.4, in paragraph (d), in the ``Category I'' table, 
revise the entry for ``Narasin'', alphabetically add an entry for 
``Nicarbazin (granular)'' followed immediately by an indented entry for 
``Narasin''; and in the ``Category II'' table, remove the entry for 
``Narasin'' and revise the entry for ``Nicarbazin (powder)''.
    The revisions and addition read as follows:


Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

[[Page 8975]]



                                                   Category I
----------------------------------------------------------------------------------------------------------------
                                                Assay limits                                      Assay limits
                    Drug                      percent \1\ Type      Type B maximum (200x)       percent \1\ Type
                                                     A                                              B/C \2\
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Narasin....................................             90-110  9.0 g/lb (1.98%).............     85-115/75-125.
Nicarbazin (granular)......................             90-110  9.0 g/lb (1.98%).............     85-115/75-125.
Narasin....................................             90-110  9.0 g/lb (1.98%).............     85-115/75-125.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
  range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
  These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B
  medicated feed with lower assay limits to make a Type C medicated feed.


                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                                Assay limits                                      Assay limits
                    Drug                      percent \1\ Type      Type B maximum (100x)       percent \1\ Type
                                                     A                                              B/C \2\
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Nicarbazin (powder)........................             90-110  9.08 g/lb (2.00%)............     85-115/75-125.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
  range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
  These values (ranges) have been assigned to provide for the possibility of dilution of a Type B medicated feed
  with lower assay limits to make a Type C medicated feed.

* * * * *


Sec.  558.68  [Amended]

0
78. In Sec.  558.68, in paragraph (e)(1)(i), in the ``Limitations'' 
column, remove ``10 days of age'' and in its place add ``18 days of 
age''.


Sec.  558.128  [Amended]

0
79. In Sec.  558.128, in paragraph (e)(4)(iv), in the row for ``1.'', 
in the ``Limitations'' column, remove ``sponsor No. 069254'' and in its 
place add ``sponsor Nos. 054771 and 069254''.


Sec.  558.248  [Amended]

0
80. In Sec.  558.248, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.

0
81. In Sec.  558.265, revise paragraphs (b) and (d) to read as follows:


Sec.  558.265  Halofuginone.

* * * * *
    (b) Sponsor. See No. 016592 in Sec.  510.600(c) of this chapter.
* * * * *
    (d) Conditions of use. It is used in feed as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                  Combination in
   Halofuginone in grams/ton        grams/ton        Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 2.72......................  .................  Broiler chickens: For   Feed continuously as           016592
                                                    the prevention of       sole ration. Do not
                                                    coccidiosis caused by   feed to layers.
                                                    Eimeria tenella, E.     Withdraw 4 days
                                                    necatrix, E.            before slaughter.
                                                    acervulina, E.
                                                    brunetti, E. mivati,
                                                    and E. maxima.
(ii) 2.72.....................  Bacitracin         Broiler chickens: For   Feed continuously as           016592
                                 methylenedisalic   the prevention of       sole ration. Do not
                                 ylate, 10 to 50.   coccidiosis caused by   feed to layers.
                                                    Eimeria tenella, E.     Withdraw 5 days
                                                    necatrix, E.            before slaughter.
                                                    acervulina, E.
                                                    brunetti, E. mivati,
                                                    and E. maxima; for
                                                    improved feed
                                                    efficiency.
(iii) 2.72....................  Bambermycins, 1    Broiler chickens: For   Feed continuously as           016592
                                 to 2.              the prevention of       sole ration. Do not
                                                    coccidiosis caused by   feed to layers.
                                                    Eimeria tenella, E.     Withdraw 5 days
                                                    necatrix, E,            before slaughter.
                                                    acervulina, E.
                                                    brunetti, E. mivati,
                                                    and E. maxima; for
                                                    increased rate of
                                                    weight gain and
                                                    improved feed
                                                    efficiency.
(iv) 2.72.....................  .................  Replacement broiler     Feed continuously as           016592
                                                    breeder chickens and    sole ration to
                                                    replacement cage        replacement cage
                                                    laying chickens: For    laying chickens
                                                    the prevention of       until 20 weeks of
                                                    coccidiosis caused by   age. Feed
                                                    Eimeria tenella, E.     continuously as sole
                                                    necatrix, E.            ration to
                                                    acervulina, E.          replacement broiler
                                                    maxima, E. mivati/E.    breeder chickens
                                                    mitis, and E.           until 16 weeks of
                                                    brunetti.               age. Do not feed to
                                                                            laying chickens or
                                                                            water fowl. Withdraw
                                                                            4 days before
                                                                            slaughter.
----------------------------------------------------------------------------------------------------------------


[[Page 8976]]

    (2) Turkeys--

----------------------------------------------------------------------------------------------------------------
                                  Combination in
   Halofuginone in grams/ton        grams/ton        Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 1.36 to 2.72..............  .................  Growing turkeys: For    Feed continuously as           016592
                                                    the prevention of       sole ration.
                                                    coccidiosis caused by   Withdraw 7 days
                                                    Eimeria adenoeides,     before slaughter. Do
                                                    E. meleagrimitis, and   not feed to layers
                                                    E. gallopavonis.        or water fowl.
(ii) 1.36 to 2.72.............  Bacitracin         Growing turkeys: For    Feed continuously as           016592
                                 methylenedisalic   the prevention of       sole ration.
                                 ylate, 10 to 50.   coccidiosis caused by   Withdraw 7 days
                                                    Eimeria adenoeides,     before slaughter. Do
                                                    E. meleagrimitis, and   not feed to laying
                                                    E. gallopavonis, and    chickens or water
                                                    for increased rate of   fowl.
                                                    weight gain.
(iii) 1.36 to 2.72............  Bambermycins, 2..  Growing turkeys: For    Feed continuously as           016592
                                                    the prevention of       sole ration.
                                                    coccidiosis caused by   Withdraw 7 days
                                                    Eimeria adenoeides,     before slaughter. Do
                                                    E. meleagrimitis, and   not feed to laying
                                                    E. gallopavonis, and    chickens or
                                                    for increased rate of   waterfowl.
                                                    weight gain.
----------------------------------------------------------------------------------------------------------------

    (3) Halofuginone may also be used in combination with:
    (i) Lincomycin as in Sec.  558.325.
    (ii) [Reserved]

0
82. In Sec.  558.311, redesignate paragraphs (e)(5)(ii) through (v) as 
paragraphs (e)(5)(iii) and (vi), and add new paragraph (e)(5)(ii) to 
read as follows:


Sec.  558.311  Lasalocid.

* * * * *
    (e) * * *
    (5) * * *
    (ii) Lincomycin as in Sec.  558.325.
* * * * *

0
83. In Sec.  558.325, add paragraph (e)(1)(vi) to read as follows:


Sec.  558.325  Lincomycin.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                                  Combination in
     Lincomycin grams/ton           grams/ton        Indications for use        Limitations          Sponsors
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(vi) 2........................  Lasalocid, 68 to   Broiler chickens: For   Feed as the sole               054771
                                 113.               the control of          ration. Type C feed
                                                    necrotic enteritis      must be used within
                                                    caused or complicated   4 weeks of
                                                    by Clostridium spp.     manufacture. Not for
                                                    or other organisms      use in laying hens,
                                                    susceptible to          breeding chickens,
                                                    lincomycin, and for     or turkeys. Do not
                                                    the prevention of       allow rabbits,
                                                    coccidiosis caused by   hamsters, guinea
                                                    Eimeria tenella, E.     pigs, horses, or
                                                    necatrix, E.            ruminants access to
                                                    acervulina, E.          feeds containing
                                                    brunetti, E. mivati,    lincomycin.
                                                    and E maxima.           Ingestion by these
                                                                            species may result
                                                                            in severe
                                                                            gastrointestinal
                                                                            effects. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600 of this
                                                                            chapter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
84. In Sec.  558.355, revise paragraph (b), add paragraph (c), and 
revise paragraph (f) to read as follows:


Sec.  558.355  Monensin.

* * * * *
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.420 of this chapter.
* * * * *
    (f) Conditions of use. It is used as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                  Combination in
     Monensin in grams/ton          grams/ton        Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 90 to 110.................  .................  Broiler chickens: As    Feed continuously as           058198
                                                    an aid in the           the sole ration. In
                                                    prevention of           the absence of
                                                    coccidiosis caused by   coccidiosis, the use
                                                    E. necatrix, E.         of monensin with no
                                                    tenella, E.             withdrawal period
                                                    acervulina, E.          may limit feed
                                                    brunetti, E. mivati,    intake resulting in
                                                    and E. maxima.          reduced weight gain.
                                                                            Do not feed to
                                                                            laying chickens.
(ii) 90 to 110................  .................  Replacement chickens    Feed continuously as           058198
                                                    intended for use as     the sole ration. Do
                                                    cage layers: As an      not feed to chickens
                                                    aid in the prevention   over 16 weeks of
                                                    of coccidiosis caused   age. Do not feed to
                                                    by E. necatrix, E.      laying chickens.
                                                    tenella, E.
                                                    acervulina, E.
                                                    brunetti, E. mivati,
                                                    and E. maxima.

[[Page 8977]]

 
(iii) 90 to 110...............  Bacitracin         Broiler chickens: As    Feed continuously as           054771
                                 methylenedisalic   an aid in the           sole ration. In the
                                 ylate, 4 to 50.    prevention of           absence of
                                                    coccidiosis caused by   coccidiosis, the use
                                                    E. necatrix, E.         of monensin with no
                                                    tenella, E.             withdrawal period
                                                    acervulina, E.          may limit feed
                                                    brunetti, E. mivati,    intake resulting in
                                                    and E. maxima, and      reduced weight gain.
                                                    for improved feed       Do not feed to
                                                    efficiency.             laying chickens.
                                                                            Bacitracin
                                                                            methylenedisalicylat
                                                                            e provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(iv) 90 to 110................  Bacitracin         Replacement chickens    Feed continuously as           054771
                                 methylenedisalic   intended for use as     sole ration. Do not
                                 ylate, 4 to 50.    cage layers: As an      feed to chickens
                                                    aid in the prevention   over 16 weeks of
                                                    of coccidiosis caused   age. Do not feed to
                                                    by E. necatrix, E.      laying chickens.
                                                    tenella, E.             Monensin sodium
                                                    acervulina, E.          provided by No.
                                                    brunetti, E. mivati,    058198, bacitracin
                                                    and E. maxima, and      methylenedisalicylat
                                                    for increased rate of   e provided by No.
                                                    weight gain and         054771 in Sec.
                                                    improved feed           510.600(c) of this
                                                    efficiency.             chapter.
(v) 90 to 110.................  Bacitracin         Broiler chickens: As    Feed continuously as           058198
                                 methylenedisalic   an aid in the           sole ration. In the
                                 ylate, 5 to 25.    prevention of           absence of
                                                    coccidiosis caused by   coccidiosis, the use
                                                    E. necatrix, E.         of monensin with no
                                                    tenella, E.             withdrawal period
                                                    acervulina, E.          may limit feed
                                                    brunetti, E. mivati,    intake resulting in
                                                    and E. maxima, and      reduced weight gain.
                                                    for increased rate of   Do not feed to
                                                    weight gain and         laying chickens.
                                                    improved feed           Bacitracin
                                                    efficiency.             methylenedisalicylat
                                                                            e provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(vi) 90 to 110................  Bacitracin         Broiler and             Feed continuously as           054771
                                 methylenedisalic   replacement chickens    sole ration. Do not
                                 ylate, 50.         intended for use as     feed to chickens
                                                    cage layers: As an      over 16 weeks of
                                                    aid in the prevention   age. Do not feed to
                                                    of coccidiosis caused   laying chickens.
                                                    by E. necatrix, E.      Monensin sodium
                                                    tenella, E.             provided by No.
                                                    acervulina, E.          058198, bacitracin
                                                    brunetti, E. mivati,    methylenedisalicylat
                                                    and E. maxima, and      e provided by No.
                                                    for improved feed       054771 in Sec.
                                                    efficiency, and as an   510.600(c) of this
                                                    aid in the prevention   chapter.
                                                    of necrotic enteritis
                                                    caused or complicated
                                                    by Clostridium spp.
                                                    or other organisms
                                                    susceptible to
                                                    bacitracin.
(vii) 90 to 110...............  Bacitracin zinc,   Broiler chickens: As    Feed continuously as           054771
                                 4 to 50.           an aid in the           sole ration. In the
                                                    prevention of           absence of
                                                    coccidiosis caused by   coccidiosis, the use
                                                    E. necatrix, E.         of monensin with no
                                                    tenella, E.             withdrawal period
                                                    acervulina, E.          may limit feed
                                                    brunetti, E. mivati,    intake resulting in
                                                    and E. maxima, and      reduced weight gain.
                                                    for increased rate of   Do not feed to
                                                    weight gain and         laying chickens.
                                                    improved feed           Bacitracin zinc
                                                    efficiency.             provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(viii) 90 to 110..............  Bacitracin zinc,   Broiler chickens: As    Feed continuously as           058198
                                 10.                an aid in the           sole ration. In the
                                                    prevention of           absence of
                                                    coccidiosis caused by   coccidiosis, the use
                                                    E. necatrix, E.         of monensin with no
                                                    tenella, E.             withdrawal period
                                                    acervulina, E.          may limit feed
                                                    brunetti, E. mivati,    intake resulting in
                                                    and E. maxima, and      reduced weight gain.
                                                    for increased rate of   Do not feed to
                                                    weight gain and         laying chickens.
                                                    improved feed           Bacitracin zinc
                                                    efficiency.             provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(ix) 90 to 110................  Bacitracin zinc,   Broiler chickens: As    Feed continuously as           058198
                                 10 to 30.          an aid in the           sole ration. In the
                                                    prevention of           absence of
                                                    coccidiosis caused by   coccidiosis, the use
                                                    E. necatrix, E.         of monensin with no
                                                    tenella, E.             withdrawal period
                                                    acervulina, E.          may limit feed
                                                    brunetti, E. mivati,    intake resulting in
                                                    and E. maxima, and      reduced weight gain.
                                                    for improved feed       Do not feed to
                                                    efficiency.             laying chickens.
                                                                            Bacitracin zinc
                                                                            provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(x) 90 to 110.................  Bambermycins, 1    Broiler chickens: As    Feed continuously as   016592, 058198
                                 to 2.              an aid in the           sole ration. Do not
                                                    prevention of           feed to laying
                                                    coccidiosis caused by   chickens.
                                                    E. necatrix, E.         Bambermycins
                                                    tenella, E.             provided by No.
                                                    acervulina, E.          016592 in Sec.
                                                    brunetti, E. mivati,    510.600(c) of this
                                                    and E. maxima, and      chapter.
                                                    for increased rate of
                                                    weight gain and
                                                    improved feed
                                                    efficiency.
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys--

[[Page 8978]]



----------------------------------------------------------------------------------------------------------------
                                  Combination in
     Monensin in grams/ton          grams/ton        Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 54 to 90..................  .................  Growing turkeys: For    For growing turkeys            058198
                                                    the prevention of       only. Feed
                                                    coccidiosis caused by   continuously as sole
                                                    E. adenoeides, E.       ration. Some strains
                                                    meleagrimitis, and E.   of turkey coccidia
                                                    gallopavonis.           may be monensin
                                                                            tolerant or
                                                                            resistant. Monensin
                                                                            may interfere with
                                                                            development of
                                                                            immunity to turkey
                                                                            coccidiosis. Do not
                                                                            allow horses, other
                                                                            equines, mature
                                                                            turkeys, or guinea
                                                                            fowl access to feed
                                                                            containing monensin.
                                                                            Ingestion of
                                                                            monensin by horses
                                                                            and guinea fowl has
                                                                            been fatal.
(ii) 54 to 90.................  Bacitracin         Growing turkeys: For    For growing turkeys            058198
                                 methylenedisalic   the prevention of       only. Feed
                                 ylate, 4 to 50.    coccidiosis caused by   continuously as sole
                                                    E. adenoeides, E.       ration. Some strains
                                                    meleagrimitis, and E.   of turkey coccidia
                                                    gallopavonis, and for   may be monensin
                                                    increased rate of       tolerant or
                                                    weight gain and         resistant. Monensin
                                                    improved feed           may interfere with
                                                    efficiency.             development of
                                                                            immunity to turkey
                                                                            coccidiosis. Do not
                                                                            allow horses, other
                                                                            equines, mature
                                                                            turkeys, or guinea
                                                                            fowl access to feed
                                                                            containing monensin.
                                                                            Ingestion of
                                                                            monensin by horses
                                                                            and guinea fowl has
                                                                            been fatal.
                                                                            Bacitracin
                                                                            methylenedisalicylat
                                                                            e as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(iii) 54 to 90................  Bacitracin         Growing turkeys: For    For growing turkeys            058198
                                 methylenedisalic   the prevention of       only. Feed
                                 ylate, 200.        coccidiosis caused by   continuously as sole
                                                    E. adenoeides, E.       ration. Some strains
                                                    meleagrimitis, and E.   of turkey coccidia
                                                    gallopavonis, and as    may be monensin
                                                    an aid in the control   tolerant or
                                                    of transmissible        resistant. Monensin
                                                    enteritis complicated   may interfere with
                                                    by organisms            development of
                                                    susceptible to          immunity to turkey
                                                    bacitracin              coccidiosis. Do not
                                                    methylenedisalicylate.  allow horses, other
                                                                            equines, mature
                                                                            turkeys, or guinea
                                                                            fowl access to feed
                                                                            containing monensin.
                                                                            Ingestion of
                                                                            monensin by horses
                                                                            and guinea fowl has
                                                                            been fatal.
                                                                            Bacitracin
                                                                            methylenedisalicylat
                                                                            e as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(iv) 54 to 90.................  Bambermycins, 1    Growing turkeys: For    For growing turkeys            058198
                                 to 2.              the prevention of       only. Feed
                                                    coccidiosis in          continuously as sole
                                                    turkeys caused by E.    ration. Some strains
                                                    adenoeides, E.          of turkey coccidia
                                                    meleagrimitis, and E.   may be monensin
                                                    gallopavonis, and for   tolerant or
                                                    improved feed           resistant. Monensin
                                                    efficiency.             may interfere with
                                                                            development of
                                                                            immunity to turkey
                                                                            coccidiosis.
                                                                            Bambermycins as
                                                                            provided by No.
                                                                            016592 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(v) 54 to 90..................  Bambermycins, 2..  Growing turkeys: For    For growing turkeys            058198
                                                    the prevention of       only. Feed
                                                    coccidiosis caused by   continuously as sole
                                                    E. adenoeides, E.       ration. Some strains
                                                    meleagrimitis, and E.   of turkey coccidia
                                                    gallopavonis, and for   may be monensin
                                                    increased rate of       tolerant or
                                                    weight gain and         resistant. Monensin
                                                    improved feed           may interfere with
                                                    efficiency.             development of
                                                                            immunity to turkey
                                                                            coccidiosis.
                                                                            Bambermycins as
                                                                            provided by No.
                                                                            016592 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
----------------------------------------------------------------------------------------------------------------

    (3) Cattle--

----------------------------------------------------------------------------------------------------------------
        Monensin in grams/ton              Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 5 to 40.........................  Cattle fed in confinement     Feed continuously in                  058198
                                       for slaughter: For improved   complete feed at a rate of
                                       feed efficiency.              50 to 480 milligrams of
                                                                     monensin per head per day.
                                                                     No additional improvement
                                                                     in feed efficiency has been
                                                                     shown from feeding monensin
                                                                     at levels greater than 30
                                                                     grams per ton (360
                                                                     milligrams per head per
                                                                     day).
(ii) 10 to 40.......................  Cattle fed in confinement     Feed at a rate of 0.14 to             058198
                                       for slaughter: For            0.42 milligram per pound of
                                       prevention and control of     body weight per day,
                                       coccidiosis due to E. bovis   depending upon the severity
                                       and E. zuernii.               of challenge, up to maximum
                                                                     of 480 milligrams per head
                                                                     per day.

[[Page 8979]]

 
(iii) 10 to 200.....................  Calves excluding veal         Feed at a rate of 0.14 to             058198
                                       calves: For prevention and    1.0 milligram monensin per
                                       control of coccidiosis due    pound of body weight per
                                       to E. bovis and E. zuernii.   day, depending upon the
                                                                     severity of challenge, up
                                                                     to maximum of 200
                                                                     milligrams per head per day.
(iv) 11 to 22.......................  Dairy cows: For increased     Feed continuously to dry and          058198
                                       milk production efficiency    lactating dairy cows in a
                                       (production of marketable     total mixed ration
                                       solids-corrected milk per     (``complete feed''). See
                                       unit of feed intake).         special labeling
                                                                     considerations in paragraph
                                                                     (d) of this section.
(v) 11 to 400.......................  Dairy cows: For increased     Feed continuously to dry and          058198
                                       milk production efficiency    lactating dairy cows in a
                                       (production of marketable     component feeding system
                                       solids-corrected milk per     (including top dress). The
                                       unit of feed intake).         Type C medicated feed must
                                                                     be fed in a minimum of 1 lb
                                                                     of feed to provide 185 to
                                                                     660 mg/head/day monensin to
                                                                     lactating cows or 115 to
                                                                     410 mg/head/day monensin to
                                                                     dry cows. See special
                                                                     labeling considerations in
                                                                     paragraph (d) of this
                                                                     section.
(vi) 15 to 400......................  Growing cattle on pasture or  For increased rate of weight          058198
                                       in dry lot (stocker and       gain, feed at a rate of 50
                                       feeder cattle and dairy and   to 200 milligrams monensin
                                       beef replacement heifers):    per head per day in not
                                       For increased rate of         less than 1 pound of feed
                                       weight gain, and for          or, after the 5th day, feed
                                       prevention and control of     at a rate of 400 milligrams
                                       coccidiosis due to E. bovis   per head per day every
                                       and E. zuernii.               other day in not less than
                                                                     2 pounds of feed. For
                                                                     prevention and control of
                                                                     coccidiosis, feed at a rate
                                                                     of 0.14 to 0.42 milligram
                                                                     per pound of body weight
                                                                     per day, depending on
                                                                     severity of challenge, up
                                                                     to 200 milligrams per head
                                                                     per day. During first 5
                                                                     days of feeding, cattle
                                                                     should receive no more than
                                                                     100 milligrams per day in
                                                                     not less than 1 pound of
                                                                     feed.
(vii) 25 to 400.....................  For improved feed             Feed to mature reproducing            058198
                                       efficiency, and for           beef cows. Feed as
                                       prevention and control of     supplemental feed, either
                                       coccidiosis due to E. bovis   hand-fed in a minimum of 1
                                       and E. zuernii.               pound of feed or mixed in a
                                                                     total ration. For improved
                                                                     feed efficiency, feed
                                                                     continuously at a rate of
                                                                     50 to 200 milligrams
                                                                     monensin per head per day.
                                                                     For prevention and control
                                                                     of coccidiosis, feed at a
                                                                     rate of 0.14 to 0.42
                                                                     milligram per pound of body
                                                                     weight per day, depending
                                                                     upon severity of challenge,
                                                                     up to a maximum of 200
                                                                     milligrams per head per
                                                                     day. During first 5 days of
                                                                     feeding, cattle should
                                                                     receive no more than 100
                                                                     milligrams per head per day.
----------------------------------------------------------------------------------------------------------------

    (4) Free-choice cattle feeds--

----------------------------------------------------------------------------------------------------------------
          Monensin  amount                 Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 150 milligrams per pound of       Pasture cattle (slaughter,    Provide 50 to 200 milligrams          058198
 protein-mineral block (0.033%).       stocker, feeder, and dairy    of monensin (0.34 to 1.33
                                       and beef replacement          pounds of block) per head
                                       heifers): For increased       per day, at least 1 block
                                       rate of weight gain, and      per 10 to 12 head of
                                       for prevention and control    cattle. Roughage must be
                                       of coccidiosis caused by E.   available at all times. Do
                                       bovis and E. zuernii in       not allow animals access to
                                       pasture cattle which may      other protein blocks, salt
                                       require supplemental feed.    or mineral, while being fed
                                                                     this product. The
                                                                     effectiveness of this block
                                                                     in cull cows and bulls has
                                                                     not been established. See
                                                                     paragraph (d)(10)(i) of
                                                                     this section.
(ii) 175 milligrams per pound of      Pasture cattle (slaughter,    Provide 40 to 200 milligrams          017800
 protein-mineral block (0.038%).       stocker, and feeder): For     of monensin (0.25 to 1.13
                                       increased rate of weight      pounds or 4 to 18 ounces of
                                       gain.                         block) per head per day, at
                                                                     least 1 block per 4 head of
                                                                     cattle. Do not allow cattle
                                                                     access to salt or mineral
                                                                     while being fed this
                                                                     product. Ingestion by
                                                                     cattle of monensin at
                                                                     levels of 600 milligrams
                                                                     per head per day and higher
                                                                     has been fatal. The
                                                                     effectiveness of this block
                                                                     in cull cows and bulls has
                                                                     not been established. See
                                                                     paragraph (d)(10)(i) of
                                                                     this section.
(iii) 400 milligrams per pound of     Pasture cattle (slaughter,    Provide 80 to 200 milligrams          067949
 protein-mineral block (0.088%).       stocker, feeder, and dairy    of monensin (0.2 to 0.5
                                       and beef replacement          pounds of block) per head
                                       heifers): For increased       per day, at least 1 block
                                       rate of weight gain.          per 5 head of cattle. Feed
                                                                     blocks continuously. Do not
                                                                     feed salt or minerals
                                                                     containing salt. The
                                                                     effectiveness of this block
                                                                     in cull cows and bulls has
                                                                     not been established. See
                                                                     paragraph (d)(10)(i) of
                                                                     this section.

[[Page 8980]]

 
(iv) 400 milligrams per pound of      Pasture cattle (slaughter,    Provide 50 to 200 milligrams          051267
 block (0.088%).                       stocker, feeder, and dairy    of monensin (2 to 8 ounces
                                       and beef replacement          of block) per head per day,
                                       heifers): For increased       at least 1 block per 5 head
                                       rate of weight gain.          of cattle. Feed blocks
                                                                     continuously. Do not feed
                                                                     salt or mineral supplements
                                                                     in addition to the blocks.
                                                                     Ingestion by cattle of
                                                                     monensin at levels of 600
                                                                     milligrams per head per day
                                                                     and higher has been fatal.
                                                                     The effectiveness of this
                                                                     block in cull cows and
                                                                     bulls has not been
                                                                     established. See paragraph
                                                                     (d)(10)(i) of this section.
(v) In free-choice Type C medicated   Growing cattle on pasture or  During the first 5 days of            058198
 feeds to provide 50 to 200 mg per     in dry lot (stocker and       feeding, cattle should
 head per day.                         feeder cattle and dairy and   receive no more than 100
                                       beef replacement heifers):    milligrams per day. Do not
                                       For increased rate of         feed additional salt or
                                       weight gain; for prevention   minerals. Do not mix with
                                       and control of coccidiosis    grain or other feeds.
                                       due to E. bovis and E.        Monensin is toxic to cattle
                                       zuernii.                      when consumed at higher
                                                                     than approved levels.
                                                                     Stressed and/or feed- and/
                                                                     or water-deprived cattle
                                                                     should be adapted to the
                                                                     pasture and to unmedicated
                                                                     supplement before using the
                                                                     monensin medicated
                                                                     supplement. The product's
                                                                     effectiveness in cull cows
                                                                     and bulls has not been
                                                                     established. See paragraph
                                                                     (d) of this section for
                                                                     other required label
                                                                     warnings.
(vi) 1,620 grams per ton of mineral   Growing cattle on pasture or  Feed at a rate of 50 to 200           058198
 granules as specified in paragraph    in dry lot (stocker and       milligrams per head per
 (f)(4)(vi)(A) of this section.        feeder cattle and dairy and   day. During the first 5
                                       beef replacement heifers):    days of feeding, cattle
                                       For increased rate of         should receive no more than
                                       weight gain, and for          100 milligrams per day. Do
                                       prevention and control of     not feed additional salt or
                                       coccidiosis due to E. bovis   minerals. Do not mix with
                                       and E. zuernii.               grain or other feeds.
                                                                     Monensin is toxic to cattle
                                                                     when consumed at higher
                                                                     than approved levels.
                                                                     Stressed and/or feed- and/
                                                                     or water-deprived cattle
                                                                     should be adapted to the
                                                                     pasture and to unmedicated
                                                                     mineral supplement before
                                                                     using the monensin mineral
                                                                     supplement. The product's
                                                                     effectiveness in cull cows
                                                                     and bulls has not been
                                                                     established.
----------------------------------------------------------------------------------------------------------------

    (A) Specifications. Use as free-choice Type C medicated feed 
formulated as mineral granules as follows:

------------------------------------------------------------------------
                                                           International
               Ingredient                     Percent        feed No.
------------------------------------------------------------------------
Monocalcium phosphate (21% phosphorus,             29.49        6-01-082
 15% calcium)...........................
Sodium chloride (salt)..................           24.37        6-04-152
Dried cane molasses.....................            20.0        4-04-695
Ground limestone (33% calcium) or                  13.75        6-02-632
 calcium carbonate (38% calcium)........
Cane molasses...........................             3.0        4-04-696
Processed grain by-products (as approved             5.0  ..............
 by AAFCO)..............................
Vitamin/trace mineral premix \1\........             2.5  ..............
Monensin Type A article, 90.7 grams per             0.89  ..............
 pound..................................
Antidusting oil.........................             1.0  ..............
------------------------------------------------------------------------
\1\ Content of vitamin and trace mineral premixes may be varied.
  However, they should be comparable to those used for other free-choice
  feeds. Formulation modifications require FDA approval prior to
  marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine
  dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides
  Sec. 651.100 (CPG 7125.18).

    (B) [Reserved]
    (5) Bobwhite quail--

----------------------------------------------------------------------------------------------------------------
        Monensin in grams/ton              Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 73..............................  Growing bobwhite quail: For   Feed continuously in                  058198
                                       the prevention of             complete feed at a rate of
                                       coccidiosis caused by         50 to 480 milligrams of
                                       Eimeria dispersa and E.       monensin per head per day.
                                       lettyae.                      No additional improvement
                                                                     in feed efficiency has been
                                                                     shown from feeding monensin
                                                                     at levels greater than 30
                                                                     grams per ton (360
                                                                     milligrams per head per
                                                                     day).
(ii) [Reserved].....................  ............................  ............................  ..............
----------------------------------------------------------------------------------------------------------------


[[Page 8981]]

    (6) Goats--

----------------------------------------------------------------------------------------------------------------
        Monensin in grams/ton              Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 5 to 40.........................  For the prevention of         Feed only to goats being fed          058198
                                       coccidiosis caused by         in confinement. Do not feed
                                       Eimeria crandallis, E.        to lactating goats. See
                                       christenseni, and E.          paragraph (d)(13) of this
                                       ninakohlyakimovae.            section for provisions for
                                                                     monensin liquid Type C goat
                                                                     feeds.
(ii) [Reserved].....................  ............................  ............................  ..............
----------------------------------------------------------------------------------------------------------------

    (7) Monensin may also be used in combination with:
    (i) Avilamycin as in Sec.  558.68.
    (ii) Chlortetracycline as in Sec.  558.128.
    (iii) Decoquinate as in Sec.  558.195.
    (iv) Lincomycin as in Sec.  558.325.
    (v) Melengestrol acetate as in Sec.  558.342.
    (vi) Oxytetracycline as in Sec.  558.450.
    (vii) Ractopamine alone or in combination as in Sec.  558.500.
    (viii) Tilmicosin as in Sec.  558.618.
    (ix) Tylosin as in Sec.  558.625.
    (x) Virginiamycin as in Sec.  558.635.
    (xi) Zilpaterol alone or in combination as in Sec.  558.665.

0
85. In Sec.  558.364, revise paragraph (d)(1)(i) to read as follows:


Sec.  558.364  Narasin and nicarbazin.

* * * * *
    (d) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
  Narasin and nicarbazin in       Combination in
          grams/ton                 grams/ton        Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 27 to 45 of each drug....  ...................  Broiler chickens: For  Feed continuously as           058198
                                                     prevention of          the sole ration. Do
                                                     coccidiosis caused     not feed to laying
                                                     by Eimeria tenella,    hens. Do not allow
                                                     E. necatrix, E.        adult turkeys,
                                                     acervulina, E.         horses, or other
                                                     maxima, E. brunetti,   equines access to
                                                     and E. mivati.         formulations
                                                                            containing narasin.
                                                                            Ingestion of narasin
                                                                            by these species has
                                                                            been fatal. The two
                                                                            drugs can be
                                                                            combined only at a
                                                                            1:1 ratio for the 27
                                                                            to 45 grams per ton
                                                                            range. Only granular
                                                                            nicarbazin as
                                                                            provided by No.
                                                                            058198 in Sec.
                                                                            510.600(c) of this
                                                                            chapter may be used
                                                                            in the combination.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
86. In Sec.  558.550, revise paragraph (b), add paragraph (c), revise 
paragraph (d), and add paragraph (e) to read as follows:


Sec.  558.550  Salinomycin.

* * * * *
    (b) Sponsor. See No. 016592 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.592 of this chapter.
    (d) Special considerations. Not approved for use with pellet 
binders.
    (e) Conditions of use. It is used as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                  Combination in
   Salinomycin in grams/ton         grams/ton        Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 40 to 60..................  .................  Broiler, roaster, and   Feed continuously as           016592
                                                    replacement (breeder    sole ration. Do not
                                                    and layer) chickens:    feed to laying hens
                                                    For the prevention of   producing eggs for
                                                    coccidiosis caused by   human consumption.
                                                    Eimeria tenella, E.     May be fatal if
                                                    necatrix, E.            accidentally fed to
                                                    acervulina, E.          adult turkeys or
                                                    maxima, E. brunetti,    horses.
                                                    and E. mivati.
(ii) 40 to 60.................  Bacitracin         Broiler, roaster, and   Feed continuously as           016592
                                 methylenedisalic   replacement (breeder    sole ration. Do not           054771
                                 ylate, 4 to 50.    and layer) chickens:    feed to laying
                                                    For the prevention of   chickens. May be
                                                    coccidiosis caused by   fatal if fed to
                                                    Eimeria tenella, E.     adult turkeys or
                                                    necatrix, E.            horses. Salinomycin
                                                    acervulina, E.          as provided by No.
                                                    maxima, E. brunetti,    016592; bacitracin
                                                    and E. mivati, and      methylenedisalicylat
                                                    for increased rate of   e as provided by No.
                                                    weight gain and         054771 in Sec.
                                                    improved feed           510.600(c) of this
                                                    efficiency.             chapter.
(iii) 40 to 60................  Bacitracin         Broiler chickens: For   Feed continuously as           054771
                                 methylenedisalic   the prevention of       sole ration. Do not
                                 ylate, 50.         coccidiosis caused by   feed to laying
                                                    Eimeria tenella, E.     chickens. May be
                                                    necatrix, E.            fatal if fed to
                                                    acervulina, E.          adult turkeys or to
                                                    maxima, E. brunetti,    horses. Salinomycin
                                                    and E. mivati, and as   as provided by No.
                                                    an aid in the           016592; bacitracin
                                                    prevention of           methylenedisalicylat
                                                    necrotic enteritis      e as provided by No.
                                                    caused or complicated   054771 in Sec.
                                                    by Clostridium spp.     510.600(c) in this
                                                    or other organisms      chapter.
                                                    susceptible to
                                                    bacitracin.

[[Page 8982]]

 
(iv) 40 to 60.................  Bacitracin         Broiler chickens: For   Feed continuously as           054771
                                 methylenedisalic   the prevention of       sole ration. To
                                 ylate, 100 to      coccidiosis caused by   control necrotic
                                 200.               Eimeria tenella, E.     enteritis, start
                                                    necatrix, E.            medication at first
                                                    acervulina, E.          clinical signs of
                                                    maxima, E. brunetti,    disease; vary dosage
                                                    and E. mivati, and as   based on the
                                                    an aid in the control   severity of
                                                    of necrotic enteritis   infection;
                                                    caused or complicated   administer
                                                    by Clostridium spp.     continuously for 5
                                                    or other organisms      to 7 days or as long
                                                    susceptible to          as clinical signs
                                                    bacitracin.             persist, then reduce
                                                                            bacitracin to
                                                                            prevention level (50
                                                                            grams per ton). Do
                                                                            not feed to laying
                                                                            chickens. May be
                                                                            fatal if fed to
                                                                            adult turkeys or to
                                                                            horses. Salinomycin
                                                                            as provided by No.
                                                                            016592; bacitracin
                                                                            methylenedisalicylat
                                                                            e as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) in this
                                                                            chapter.
(v) 40 to 60..................  Bacitracin zinc,   Broiler chickens: For   Feed continuously as           016592
                                 10 to 50.          the prevention of       sole ration. Not              054771
                                                    coccidiosis caused by   approved for use
                                                    Eimeria tenella, E.     with pellet binders.
                                                    necatrix, E.            Do not feed to
                                                    acervulina, E.          layers. May be fatal
                                                    maxima, E. brunetti,    if accidentally fed
                                                    and E. mivati, and      to adult turkeys or
                                                    for increased rate of   horses. Bacitracin
                                                    weight gain.            zinc as provided by
                                                                            No. 054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(vi) 40 to 60.................  Bambermycins, 1    Broiler chickens: For   Feed continuously as           016592
                                 to 3.              the prevention of       sole ration. Do not
                                                    coccidiosis caused by   feed to laying
                                                    Eimeria tenella, E.     chickens. Not
                                                    necatrix, E.            approved for use
                                                    acervulina, E.          with pellet binders.
                                                    maxima, E. brunetti,    May be fatal if
                                                    and E. mivati, and      accidentally fed to
                                                    for improved feed       adult turkeys or
                                                    efficiency.             horses. Salinomycin
                                                                            and bambermycins as
                                                                            provided by No.
                                                                            016592 in Sec.
                                                                            510.600(c) in this
                                                                            chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Game birds--

----------------------------------------------------------------------------------------------------------------
                                  Combination in
   Salinomycin in grams/ton       grams per ton      Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 50........................  .................  Quail: For the          Feed continuously as   ..............
                                                    prevention of           sole ration. Not
                                                    coccidiosis caused by   approved for use
                                                    E. dispersa and E.      with pellet binders.
                                                    lettyae.                Do not feed to
                                                                            laying hens
                                                                            producing eggs for
                                                                            human consumption.
                                                                            May be fatal if
                                                                            accidentally fed to
                                                                            adult turkeys or
                                                                            horses.
(ii) [Reserved]...............  .................  ......................  .....................  ..............
----------------------------------------------------------------------------------------------------------------

    (3) Salinomycin may also be used in combination with:
    (i) Chlortetracycline as in Sec.  558.128.
    (ii) Lincomycin as in Sec.  558.325.
    (iii) Oxytetracycline as in Sec.  558.450.
    (iv) Virginiamycin as in Sec.  558.635.

0
87. In Sec.  558.625, revise paragraphs (b)(1) through (4) to read as 
follows:


Sec.  558.625  Tylosin.

* * * * *
    (b) * * *
    (1) No. 016592: Type A medicated articles containing 40 or 100 
grams per pound (g/lb).
    (2) No. 054771: Type A medicated article containing 40 g/lb.
    (3) No. 058198: Type A medicated articles containing 10, 40, or 100 
g/lb.
    (4) No. 066104: Type A medicated articles containing 20 or 40 g/lb.
* * * * *

    Dated: March 5, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04226 Filed 3-12-19; 8:45 am]
BILLING CODE 4164-01-P

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