New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address, 64738-64744 [2018-27238]
Download as PDFAgencies
[Federal Register Volume 83, Number 242 (Tuesday, December 18, 2018)] [Rules and Regulations] [Pages 64738-64744] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2018-27238] [[Page 64738]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 556, and 558 [Docket No. FDA-2018-N-0002] New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address 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 April, May, and June 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 accuracy and readability of the regulations. DATES: This rule is effective December 18, 2018. 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 April, May, and June 2018, as listed 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 April, May, and June 2018 -------------------------------------------------------------------------------------------------------------------------------------------------------- Approval date File No. Sponsor Product name Species Effect of the action Public documents -------------------------------------------------------------------------------------------------------------------------------------------------------- May 4, 2018............. 141-481 Kindred Biosciences, MIRATAZ (mirtazapine Cats............. Original approval for the FOI Summary. Inc., 1555 Bayshore transdermal management of weight Hwy., Suite 200, ointment). loss in cats. Burlingame, CA 94010. May 15, 2018............ 141-501 Boehringer Ingelheim SEMINTRA Cats............. Original approval for the FOI Summary. Vetmedica, Inc., (telmisartan oral control of systemic 2621 North Belt solution). hypertension in cats. Hwy., St. Joseph, MO 64506-2002. May 25, 2018............ 141-063 Intervet, Inc., 2 NUFLOR Cattle........... Supplemental approval to FOI Summary. Giralda Farms, (florfenicol), provide human food Madison, NJ 07940. Injectable Solution. safety information for the use of the inactive ingredient n[dash]methyl- 2-pyrrolidone (NMP). May 31, 2018............ 141-495 Elanco US Inc., 2500 INTEPRITY Chickens......... Original approval for the FOI Summary. Innovation Way, (avilamycin) and prevention of mortality Greenfield, IN BIO-COX caused by necrotic 46140. (salinomycin enteritis and for the sodium) Type C prevention of medicated feeds. coccidiosis in broiler chickens. June 6, 2018............ 141-342 Jurox Pty. Ltd., 85 ALFAXAN Dogs and cats.... Supplemental approval FOI Summary. Gardiner Rd., (alfaxalone), providing for addition Rutherford, NSW Injectable Solution. of preservatives and use 2320, Australia. of a multidose vial. June 14, 2018........... 098-379 Merial, Inc., 3239 CYSTORELIN Cattle........... Supplemental approval for FOI Summary, EA/FONSI.\1\ Satellite Blvd., (gonadorelin), use with cloprostenol Bldg. 500, Duluth, Injectable Solution. sodium to synchronize GA 30096-4640. estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows and beef cows. -------------------------------------------------------------------------------------------------------------------------------------------------------- \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. Technical Amendments With the approval of NADA 141-481, Kindred Biosciences, Inc. is now the sponsor of an approved application. Accordingly, we are amending Sec. 510.600(c) to add the name, address, and drug labeler code of this sponsor. Piramal Healthcare Ltd., Piramal Tower, Ganpatrao Kadam Marg, Lower Parel, Mumbai-400 013, India, has informed FDA that it has changed its name and address to Piramal Enterprises Ltd., Ananta, Agastya Corporate Park, Opp Fire Brigade, Kamani Junction, LBS Mag Kurla (West), Mumbai, 400070, India. We are amending Sec. 510.600(c) to reflect this change. We are also making technical amendments to update the scientific name of a pathogenic bacterium and to accurately list the concentrations of active ingredients in an otic dosage form new animal drug. We are also making a technical amendment to correct the sponsor of epsiprantel tablets. These actions are being taken to improve the accuracy of the regulations. In addition, we are reformatting the regulations to create a tabular display of [[Page 64739]] the approved uses of narasin and a separate section for uses of a fixed-ratio, combination drug Type A medicated article containing narasin and nicarbazin. These actions are being taken to improve the readability, consistency, and accuracy of the regulations. III. 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)(A) because it is a ``rule of particular applicability.'' Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. 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, and 524 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, 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), alphabetically add an entry for ``Kindred Biosciences, Inc.'' and remove the entry for ``Piramal Healthcare Ltd.'' and add an entry for ``Piramal Enterprises Ltd.'' in its place; and in the table in paragraph (c)(2), revise the entry for ``065085'' and numerically add an entry for ``086078'' to 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 ------------------------------------------------------------------------ * * * * * * * Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite 086078 200, Burlingame, CA 94010.............................. * * * * * * * Piramal Enterprises Ltd., Ananta, Agastya Corporate 065085 Park, Opp Fire Brigade, Kamani Junction, LBS Mag Kurla (West), Mumbai, 400070, India.......................... * * * * * * * ------------------------------------------------------------------------ (2) * * * ------------------------------------------------------------------------ Drug labeler code Firm name and address ------------------------------------------------------------------------ * * * * * * * 065085.................. Piramal Enterprises Ltd., Ananta, Agastya Corporate Park, Opp Fire Brigade, Kamani Junction, LBS Mag Kurla (West), Mumbai, 400070, India. * * * * * * * 086078.................. Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite 200, Burlingame, CA 94010. * * * * * * * ------------------------------------------------------------------------ [[Page 64740]] PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 0 3. The authority citation for part 520 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 520.88f [Amended] 0 4. In Sec. 520.88f, in paragraph (c)(2), remove ``lacerations) due to S. aureus, Streptococcus spp., E. coli'' and in its place add ``lacerations) due to S. aureus, Enterococcus faecalis, E. coli''. Sec. 520.816 [Amended] 0 5. In Sec. 520.816, in paragraph (b), remove ``050604'' and in its place add ``054771''. 0 6. Add Sec. 520.2335 to read as follows: Sec. 520.2335 Telmisartan. (a) Specifications. Each milliliter of solution contains 10 milligrams (mg) telmisartan. (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Amount. Administer 1.5 mg/kilogram (kg) (0.68 mg/pound (lb)) orally twice daily for 14 days, followed by 2 mg/ kg (0.91 mg/lb) orally once daily. (2) Indications for use. For the control of systemic hypertension in cats. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 7. The authority citation for part 522 continues to read as follows: Authority: 21 U.S.C. 360b. 0 8. Revise Sec. 522.1077 to read as follows: Sec. 522.1077 Gonadorelin. (a) Specifications. Each milliliter (mL) of solution contains: (1) 43 micrograms ([mu]g) of gonadorelin as gonadorelin acetate; (2) 100 [mu]g of gonadorelin as gonadorelin acetate; (3) 43 [mu]g of gonadorelin as gonadorelin diacetate tetrahydrate; or (4) 50 [mu]g of gonadorelin as gonadorelin hydrochloride. (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this chapter. (1) No. 000061 for use of the 43-[mu]g/mL product described in paragraph (a)(1) as in paragraphs (d)(1)(i), (d)(1)(iv), and (d)(2) of this section. (2) No. 068504 for use of the 100-[mu]g/mL product described in paragraph (a)(2) as in paragraphs (d)(1)(ii), (d)(1)(v), and (d)(2) of this section. (3) No. 061623 for use of the 43-[mu]g/mL product described in paragraph (a)(3) as in paragraphs (d)(1)(i) and (d)(2) of this section. (4) No. 050604 for use of the 43-[mu]g/mL product described in paragraph (a)(3) as in paragraphs (d)(1)(i), (d)(1)(vi), and (d)(2) of this section. (5) No. 054771 for use of the 50-[mu]g/mL product described in paragraph (a)(4) as in paragraphs (d)(1)(iii), (d)(1)(vii), and (d)(2) of this section. (c) Special considerations. Concurrent luteolytic drug use is approved as follows: (1) Cloprostenol injection for use as in paragraph (d)(1)(iv) of this section as provided by No. 000061 in Sec. 510.600(c) of this chapter. (2) Cloprostenol injection for use as in paragraph (d)(1)(v) and (d)(1)(vi) of this section as provided by No. 000061 or No. 068504 in Sec. 510.600(c) of this chapter. (3) Dinoprost injection for use as in paragraph (d)(1)(vii) of this section as provided by No. 054771 in Sec. 510.600(c) of this chapter. (d) Conditions of use in cattle--(1) Indications for use and amounts--(i) For the treatment of ovarian follicular cysts in dairy cattle: Administer 86 [mu]g gonadorelin (No. 000061) or 100 [mu]g gonadorelin diacetate tetrahydrate (Nos. 061623 and 050604) by intramuscular or intravenous injection. (ii) For the treatment of ovarian follicular cysts in dairy cattle: Administer 100 [mu]g gonadorelin by intramuscular or intravenous injection. (iii) For the treatment of ovarian follicular cysts in cattle: Administer 100 [mu]g gonadorelin by intramuscular injection. (iv) For use with cloprostenol injection to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows: Administer to each cow 86 [mu]g gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 [mu]g cloprostenol by intramuscular injection, followed 30 to 72 hours later by 86 [mu]g gonadorelin by intramuscular injection. (v) For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows and beef cows: Administer to each cow 100 [mu]g gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 [mu]g cloprostenol by intramuscular injection, followed 30 to 72 hours later by 100 [mu]g gonadorelin by intramuscular injection. (vi) For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows and beef cows: Administer to each cow 100 [mu]g gonadorelin diacetate tetrahydrate by intramuscular injection, followed 6 to 8 days later by 500 [mu]g cloprostenol by intramuscular injection, followed 30 to 72 hours later by 100 [mu]g gonadorelin diacetate tetrahydrate by intramuscular injection. (vii) For use with dinoprost injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows: Administer to each cow 100 to 200 [mu]g gonadorelin by intramuscular injection, followed 6 to 8 days later by 25 mg dinoprost by intramuscular injection, followed 30 to 72 hours later by 100 to 200 [mu]g gonadorelin by intramuscular injection. (2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0 9. The authority citation for part 524 continues to read as follows: Authority: 21 U.S.C. 360b. 0 10. In Sec. 524.957, revise paragraph (a) to read as follows: Sec. 524.957 Florfenicol, terbinafine, and mometasone otic solution. (a) Specifications. Each single-dose, prefilled dropperette contains 1 milliliter (mL) of a solution containing 16.6 milligrams (mg) florfenicol, 14.8 mg terbinafine (equivalent to 16.6 mg terbinafine hydrochloride), and 2.2 mg mometasone furoate. * * * * * 0 11. Add Sec. 524.1448 to read as follows: Sec. 524.1448 Mirtazapine transdermal ointment. (a) Specifications. Each gram of ointment contains 20 milligrams (mg) mirtazapine. (b) Sponsor. See No. 086078 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Amount. Administer topically by applying a 1.5 inch ribbon of ointment (approximately 2 mg) on the inner pinna of the cat's ear once daily for 14 days. Alternate the daily application of ointment between the left and right inner pinna of the ears. (2) Indications for use. For the management of weight loss in cats. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 0 12. The authority citation for part 556 continues to read as follows: [[Page 64741]] Authority: 21 U.S.C. 342, 360b, 371. 0 13. In Sec. 556.428, add paragraph (c) to read as follows: Sec. 556.428 Narasin. * * * * * (c) Related conditions of use. See Sec. Sec. 558.363 and 558.364 of this chapter. 0 14. Revise Sec. 556.445 to read as follows: Sec. 556.445 Nicarbazin. (a) [Reserved] (b) Tolerances. A tolerance of 4 parts per million is established for residues of nicarbazin in uncooked chicken muscle, liver, skin, and kidney. (c) Related conditions of use. See Sec. Sec. 558.364 and 558.366 of this chapter. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 15. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 0 16. In Sec. 558.68, revise paragraph (e)(1)(ii) and add paragraph (e)(1)(v) to read as follows: Sec. 558.68 Avilamycin. * * * * * (e) * * * (1) * * * ---------------------------------------------------------------------------------------------------------------- Combination in Indications for Avilamycin in grams/ton grams/ton use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (ii) 13.6 to 40.9....... Monensin, 90 to Broiler chickens: Feed as the sole ration for 21 058198 110. For the consecutive days. To assure prevention of responsible antimicrobial drug mortality caused use in broiler chickens, by necrotic treatment administration must enteritis begin on or before 10 days of associated with age. See Sec. 558.355(d) of Clostridium this chapter. Monensin as perfringens; and provided by No. 058198 in Sec. as an aid in the 510.600(c) of this chapter. prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. * * * * * * * (v) 13.6 to 40.9........ Salinomycin Broiler chickens: Feed as the sole ration for 21 058198 sodium, 40 to 60. For the consecutive days. Feed to prevention of chickens that are at risk of mortality caused developing, but not yet showing by necrotic clinical signs of, necrotic enteritis enteritis associated with associated with Clostridium perfringens. Not Clostridium approved for use with pellet perfringens; and binders. To assure responsible for the antimicrobial drug use in prevention of broiler chickens, treatment coccidiosis administration must begin on or caused by Eimeria before 10 days of age. The tenella, E. safety of avilamycin has not necatrix, E. been established in chickens acervulina, E. intended for breeding purposes. maxima, E. Avilamycin has not been brunetti, and E. demonstrated to be effective in mivati. broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication. Do not feed to laying hens producing eggs for human consumption. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by No. 016592 in Sec. 510.600(c) of this chapter. ---------------------------------------------------------------------------------------------------------------- * * * * * 0 17. In Sec. 558.76, remove and reserve paragraph (e)(1)(viii); redesignate paragraphs (e)(2)(xiii) through (xvii) as paragraphs (e)(2)(xiv) through (xviii); add new paragraph (e)(2)(xiii); and revise newly redesignated paragraph (e)(2)(xiv). The addition and revision read as follows: Sec. 558.76 Bacitracin methylendisalicylate. * * * * * (e) * * * (2) * * * (xiii) Narasin and nicarbazin as in Sec. 558.364. (xiv) Nicarbazin as in Sec. 558.366. * * * * * 0 18. In Sec. 558.78, add paragraph (d)(3)(vii) to read as follows: Sec. 558.78 Bacitracin zinc. * * * * * (d) * * * (3) * * * (vii) Nicarbazin as in Sec. 558.366. * * * * * 0 19. In Sec. 558.95, revise paragraph (d)(5)(viii); redesignate paragraphs (d)(5)(ix) through (xi) as paragraphs (d)(5)(x) through (xii); and add new paragraph (d)(5)(ix). The revision and addition read as follows: Sec. 558.95 Bambermycins. * * * * * (d) * * * (5) * * * (viii) Narasin as in Sec. 558.363. (ix) Narasin and nicarbazin as in Sec. 558.364. * * * * * Sec. 558.128 [Amended] 0 20. In Sec. 558.128, in paragraph (e)(3)(iv), in the ``Limitations'' column, at the end of the second sentence, add ``Chlortetracycline and bacitracin methylenedisalicylate as provided by No. 054771 in Sec. 510.600(c) of this chapter.'' Sec. 558.325 [Amended] 0 21. In Sec. 558.325, in paragraph (e)(1)(iv), in the ``Combination in grams/ton'' column, remove ``Decoquinate, 2.72'' and in its place add ``Decoquinate, 27.2''. 0 22. Revise Sec. 558.363 to read as follows: Sec. 558.363 Narasin. (a) Specifications. Type A medicated articles containing 36, 45, 54, 72, and 90 grams narasin per pound. (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter. (c) Tolerances. See Sec. 556.428 of this chapter. (d) Special considerations. An expiration date of 2 months (8 weeks) is required for narasin Type C medicated swine feeds. (e) Conditions of use. It is used as follows: (1) Chickens-- [[Page 64742]] ---------------------------------------------------------------------------------------------------------------- Combination in grams/ Narasin grams/ton ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 54 to 90.............. ..................... Broiler chickens: For For broiler chickens 058198 prevention of only. Feed continuously coccidiosis caused as sole ration. Do not by Eimeria necatrix, allow adult turkeys, E. tenella, E. horses, or other equines acervulina, E. access to narasin brunetti, E. mivati, formulations. Ingestion and E. maxima. of narasin by these species has been fatal. (ii) 54 to 72............. Bacitracin Broiler chickens: For For broiler chickens 054771 methylenedisalicylat prevention of only. Feed continuously e, 10 to 50. coccidiosis caused as sole ration. Do not by Eimeria necatrix, feed to laying hens. Do E. tenella, E. not allow adult turkeys, acervulina, E. horses, or other equines brunetti, E. mivati, access to narasin and E. maxima, and formulations. Ingestion for increased rate of narasin by these of weight gain and species has been fatal. improved feed Bacitracin efficiency. methylenedisalicylate as provided by No. 054771 in Sec. 510.600(c) of this chapter. (iii) 54 to 72............ Bacitracin zinc, 4 to Broiler chickens: For For broiler chickens 054771 50. prevention of only. Feed continuously coccidiosis caused as sole ration. Do not by Eimeria necatrix, allow adult turkeys, E. tenella, E. horses, or other equines acervulina, E. access to narasin brunetti, E. mivati, formulations. Ingestion and E. maxima, and of narasin by these for increased rate species has been fatal. of weight gain and Bacitracin zinc as improved feed provided by No. 054771 efficiency. in Sec. 510.600(c) of this chapter. (iv) 54 to 72............. Bambermycins, 1 to 2. Broiler chickens: For For broiler chickens 016592 prevention of only. Feed continuously coccidiosis caused as sole ration. Do not by Eimeria necatrix, allow adult turkeys, E. tenella, E. horses, or other equines acervulina, E. access to narasin brunetti, E. mivati, formulations. Ingestion and E. maxima, and of narasin by these for increased rate species has been fatal. of weight gain and Bambermycins as provided improved feed by No. 016592 in Sec. efficiency. 510.600(c) of this chapter. ---------------------------------------------------------------------------------------------------------------- (2) Swine-- ---------------------------------------------------------------------------------------------------------------- Combination in grams/ Narasin grams/ton ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 13.6 to 27.2.......... ..................... Growing-finishing Feed continuously for at 058198 swine: For increased least 4 weeks to swine rate of weight gain during the growing- when fed for at finishing period as the least 4 weeks. sole ration. No increased benefit in rate of weight gain has been shown when narasin concentrations in the diet are greater than 13.6 g/ton. Effectiveness has not been demonstrated when fed for durations less than 4 weeks. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Not approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Swine being fed with narasin should not have access to feeds containing pleuromutilins (e.g., tiamulin) as adverse reactions may occur. If signs of toxicity occur, discontinue use. (ii) 18.1 to 27.2......... ..................... Growing-finishing Feed continuously for at 058198 swine: For increased least 4 weeks to swine rate of weight gain during the growing- and improved feed finishing period as the efficiency when fed sole ration. No for at least 4 weeks. increased benefit in rate of weight gain has been shown when narasin concentrations in the diet are greater than 13.6 g/ton. Effectiveness has not been demonstrated when fed for durations less than 4 weeks. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Not approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Swine being fed with narasin should not have access to feeds containing pleuromutilins (e.g., tiamulin) as adverse reactions may occur. If signs of toxicity occur, discontinue use. ---------------------------------------------------------------------------------------------------------------- (3) Narasin single-ingredient Type A medicated articles may also be used in combination with: (i) Avilamycin as in Sec. 558.68. (ii) [Reserved] Sec. 558.364 [Redesignated as Sec. 558.365] 0 23. Redesignate Sec. 558.364 as Sec. 558.365. 0 24. Add new Sec. 558.364 to read as follows: Sec. 558.364 Narasin and nicarbazin. (a) Specifications. A fixed-ratio, combination drug Type A medicated article containing 36 grams narasin and 36 grams nicarbazin per pound. (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter. (c) Tolerances. See Sec. Sec. 556.428 and 556.445 of this chapter. (d) Conditions of use. It is used as follows: (1) Chickens-- [[Page 64743]] ---------------------------------------------------------------------------------------------------------------- Narasin and nicarbazin Combination in grams/ grams/ton ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 27 to 45 of each drug. ..................... Broiler chickens: For Feed continuously as sole 058198 prevention of ration. Do not feed to coccidiosis caused laying hens. Withdraw 5 by Eimeria tenella, days before slaughter. E. necatrix, E. Do not allow adult acervulina, E. turkeys, horses, or maxima, E. brunetti, other equines access to and E. mivati. narasin formulations. Ingestion of narasin by these species has been fatal. (ii) 27 to 45 of each drug Bacitracin Broiler chickens: For Feed continuously as sole 058198 methylenedisalicylat prevention of ration. Do not feed to e, 4 to 50. coccidiosis caused laying hens. Withdraw 5 by Eimeria tenella, days before slaughter. E. necatrix, E. Do not allow turkeys, acervulina, E. horses, or other equines maxima, E. brunetti, access to formulations and E. mivati, and containing narasin. for increased rate Ingestion of narasin by of weight gain and these species has been improved feed fatal. Bacitracin efficiency. methylenedisalicylate as provided by No. 054771 in Sec. 510.600(c) of this chapter. (iii) 27 to 45 of each Bacitracin Broiler chickens: For Feed continuously as sole 054771 drug. methylenedisalicylat prevention of ration. Withdraw 5 days e, 50. coccidiosis caused before slaughter. Do not by Eimeria tenella, feed to laying hens. Do E. necatrix, E. not allow turkeys, acervulina, E. horses, or other equines maxima, E. brunetti, access to formulations and E. mivati, and containing narasin. as an aid in the Ingestion of narasin by prevention of these species has been necrotic enteritis fatal. Bacitracin caused or methylenedisalicylate as complicated by provided by No. 054771 Clostridium spp. or in Sec. 510.600(c) of other organisms this chapter. susceptible to bacitracin. (iv) 27 to 45 of each drug Bacitracin Broiler chickens: For To control necrotic 054771 methylenedisalicylat prevention of enteritis, start e, 100 to 200. coccidiosis caused medication at first by Eimeria tenella, clinical signs of E. necatrix, E. disease; vary dosage acervulina, E. based on the severity of maxima, E. brunetti, infection; administer and E. mivati, and continuously for 5 to 7 as an aid in the days or as long as control of necrotic clinical signs persist, enteritis caused or then reduce bacitracin complicated by to prevention level (50 Clostridium spp. or g/ton). Do not feed to other organisms laying hens. Withdraw 5 susceptible to days before slaughter. bacitracin. Do not allow turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Bacitracin methylenedisalicylate as provided by No. 054771 in Sec. 510.600(c) of this chapter. (v) 27 to 45 of each drug. Bambermycins, 1 to 2. Broiler chickens: As Feed continuously as sole 058198 an aid in preventing ration from time chicks outbreaks of cecal are placed on litter (Eimeria tenella) until past the time when and intestinal (E. coccidiosis is acervulina, E. ordinarily a hazard. Do maxima, E. necatrix, not use as a treatment and E. brunetti) for coccidiosis. Do not coccidiosis, and for feed to laying hens. increased rate of Withdraw 5 days before weight gain and slaughter. Do not allow improved feed turkeys, horses, or efficiency. other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Bambermycins as provided by No. 016592 in Sec. 510.600(c) of this chapter. ---------------------------------------------------------------------------------------------------------------- (2) Narasin and nicarbazin fixed-ratio, combination drug Type A medicated articles may also be used in combination with: (i) Avilamycin as in Sec. 558.68. (ii) [Reserved] 0 25. Revise Sec. 558.366 to read as follows: Sec. 558.366 Nicarbazin. (a) Specifications. Type A medicated articles containing 25 percent nicarbazin. (b) Sponsors. See Nos. 058198, 060728, and 066104 in Sec. 510.600(c) of this chapter for use as in paragraph (d) of this section. (c) Related tolerances. See Sec. 556.445 of this chapter. (d) Conditions of use. It is used as follows: (1) Chickens-- ---------------------------------------------------------------------------------------------------------------- Combination in grams Nicarbazin in grams per ton per ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 90.8 to 181.6.......... ...................... Broiler chickens: As Feed continuously as sole 066104 an aid in preventing ration from time chicks outbreaks of cecal are placed on litter (Eimeria tenella) and until past the time when intestinal (E. coccidiosis is ordinarily acervulina, E. a hazard. Do not use as a maxima, E. necatrix, treatment for outbreaks and E. brunetti) of coccidiosis. Do not coccidiosis. use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. (ii) 90.8 to 181.6......... Bacitracin Broiler chickens: As Feed continuously as sole 054771 methylenedisalicylate an aid in preventing ration from time chicks , 4 to 50. outbreaks of cecal are placed on litter (Eimeria tenella) and until past the time when intestinal (E. coccidiosis is ordinarily acervulina, E. a hazard. Do not use as a maxima, E. necatrix, treatment for outbreaks and E. brunetti) of coccidiosis. Do not coccidiosis, and for use in flushing mashes. increased rate of Do not feed to laying weight gain and hens. Withdraw 4 days improved feed before slaughter for use efficiency. levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Nicarbazin as provided by No. 066104; bacitracin methylenedisalicylate as provided by No. 054771 in Sec. 510.600(c) of this chapter. [[Page 64744]] (iii) 90.8 to 181.6........ Bacitracin Broiler chickens; As Feed continuously as sole 066104 methylenedisalicylate an aid in preventing ration from time chicks , 30. outbreaks of cecal are placed on litter (Eimeria tenella) and until past the time when intestinal (E. coccidiosis is ordinarily acervulina, E. a hazard. Do not use as a maxima, E. necatrix, treatment for and E. brunetti) coccidiosis. Do not use coccidiosis, and for in flushing mashes. Do increased rate of not feed to laying hens. weight gain and Withdraw 4 days before improved feed slaughter for use levels efficiency. at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Nicarbazin as provided by No. 066104; bacitracin methylenedisalicylate as provided by No. 054771 in Sec. 510.600(c) of this chapter. (iv) 90.8 to 181.6......... Bacitracin Broiler chickens: As Feed continuously as sole 054771 methylenedisalicylate an aid in preventing ration from time chicks 50. outbreaks of cecal are placed on litter (Eimeria tenella) and until past the time when intestinal (E. coccidiosis is ordinarily acervulina, E. a hazard. Do not use as a maxima, E. necatrix, treatment for outbreaks and E. brunetti) of coccidiosis. Do not coccidiosis, and as use in flushing mashes. an aid in the Do not feed to laying prevention of hens. Withdraw 4 days necrotic enteritis before slaughter for use caused or complicated levels at or below 113.5 by Clostridium spp. g/ton. Withdraw 5 days or other organisms before slaughter for use susceptible to levels above 113.5 g/ton. bacitracin. Nicarbazin as provided by No. 066104; bacitracin methylenedisalicylate as provided by No. 054771 in Sec. 510.600(c) of this chapter. (v) 113.5.................. ...................... Chickens: As an aid in Feed continuously as sole 058198 preventing outbreaks ration from time chicks 060728 of cecal (Eimeria are placed on litter tenella) and until past the time when intestinal (E. coccidiosis is ordinarily acervulina, E. a hazard. Do not use as a maxima, E. necatrix, treatment for and E. brunetti) coccidiosis. Do not use coccidiosis. in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter. (vi) 113.5................. Bacitracin Broiler chickens; aid Feed continuously as sole 060728 methylenedisalicylate in preventing ration from time chicks , 30. outbreaks of cecal are placed on litter (Eimeria tenella) and until past the time when intestinal (E. coccidiosis is ordinarily acervulina, E. a hazard. Do not use as a maxima, E. necatrix, treatment for and E. brunetti) coccidiosis. Do not use coccidiosis, and for in flushing mashes. Do increased rate of not feed to laying hens. weight gain and Withdraw 4 days before improved feed slaughter. Nicarbazin as efficiency. provided by No. 066104; bacitracin methylenedisalicylate as provided by No. 054771 in Sec. 510.600(c) of this chapter. (vii) 113.5................ Bacitracin zinc, 4 to Broiler chickens; aid For broiler chickens only. 054771 50. in preventing Feed continuously as sole 066104 outbreaks of cecal ration from time chicks (Eimeria tenella) and are placed on litter intestinal (E. until past the time when acervulina, E. coccidiosis is ordinarily maxima, E. necatrix, a hazard. Do not use in and E. brunetti) flushing mashes. Do not coccidiosis, and for feed to laying hens. increased rate of Withdraw 4 days before weight gain and slaughter. Nicarbazin as improved feed provided by No. 066104, efficiency. bacitracin zinc as provided by No. 054771 in Sec. 510.600(c) of this chapter. (viii) 113.5............... Bambermycins, 1 to 2.. Broiler chickens: As Feed continuously as sole 016592 an aid in preventing ration from time chicks outbreaks of cecal are placed on litter (Eimeria tenella) and until past the time when intestinal (E. coccidiosis is ordinarily acervulina, E. a hazard; do not use as a maxima, E. necatrix, treatment for and E. brunetti) coccidiosis. Do not use coccidiosis, and for in flushing mashes. Do increased rate of not feed to laying hens. weight gain and Withdraw 4 days before improved feed slaughter. Nicarbazin as efficiency. provided by No. 066104; bambermycins as provided by No. 016592 in Sec. 510.600(c) of this chapter. ---------------------------------------------------------------------------------------------------------------- (2) [Reserved] Sec. 558.485 [Amended] 0 26. In Sec. 558.485, in paragraph (e)(2), in the ``Limitations'' column, remove ``Not for use in horses intended for food.'' and in its place add ``Do not use in horses intended for human consumption.'' Dated: December 11, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-27238 Filed 12-17-18; 8:45 am] BILLING CODE 4164-01-P
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
