[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)] [Rules and Regulations] [Pages 18114-18125] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2020-06688] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 500, 510, 520, 522, 524, 526, 556, and 558 [Docket No. FDA-2019-N-0002] New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsors' Name and Addresses 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 October, November, and December 2019. FDA is informing the public of the availability [[Page 18115]] 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 of the regulations. DATES: This rule is effective March 30, 2020. 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, [email protected]. SUPPLEMENTARY INFORMATION: I. Approval Actions FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during October, November, and December 2019, 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/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book. Table 1--Original and Supplemental NADAs and ANADAs Approved During October, November, and December 2019 -------------------------------------------------------------------------------------------------------------------------------------------------------- Approval date File No. Sponsor Product name Species Effect of the action Public documents -------------------------------------------------------------------------------------------------------------------------------------------------------- October 11, 2019..... 200-652 Huvepharma EOOD, 5th Monensin and Cattle............ Original approval for use of FOI Summary. Floor, 3A Nikolay decoquinate Type B MONOVET 90 (monensin Type A Haytov Str., 1113 and Type C medicated article) with Sophia, Bulgaria. medicated feeds. DECCOX (decoquinate) Type A medicated articles in the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141-148 October 11, 2019..... 200-653 Do................... Monensin, tylosin Cattle............ Original approval for use of FOI Summary. phosphate, and MONOVET 90 (monensin Type A decoquinate Type B medicated article) with and Type C TYLOVET (tylosin phosphate) medicated feeds. and DECCOX (decoquinate) Type A medicated articles in the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141-149 October 11, 2019..... 200-654 Do................... Monensin and Cattle............ Original approval for use of FOI Summary. tilmicosin MONOVET 90 (monensin Type A phosphate Type B medicated article) with and Type C TILMOVET (tilmicosin medicated feeds. phosphate) Type A medicated article in the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141-343 October 11, 2019..... 200-655 Do................... Monensin and Cattle............ Original approval for use of FOI Summary. tilmicosin MONOVET 90 (monensin Type A phosphate Type B medicated article) with and Type C PULMOTIL (tilmicosin medicated feeds. phosphate) Type A medicated article in the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141-343 October 11, 2019..... 200-656 Do................... Monensin, tylosin Cattle............ Original approval for use of FOI Summary. phosphate, and MONOVET 90 (monensin Type A decoquinate Type B medicated article) with TYLAN and Type C (tylosin phosphate) and medicated feeds. DECCOX (decoquinate) Type A medicated articles in the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141-149 October 11, 2019..... 200-658 Do................... Monensin and Cattle............ Original approval for use of FOI Summary. melengestrol MONOVET 90 (monensin Type A acetate Type C medicated article) with MGA medicated feeds. (melengestrol acetate Type A medicated article) in the manufacture of Type C medicated feeds as a generic copy of NADA 125-476 October 11, 2019..... 200-659 Do................... Monensin, Cattle............ Original approval for use of FOI Summary. ractopamine MONOVET 90 (monensin Type A hydrochloride, and medicated article) with melengestrol ACTOGAIN (ractopamine acetate Type C hydrochloride Type A medicated feeds. medicated article) and MGA (melengestrol acetate Type A medicated articles) in the manufacture of Type C medicated feeds as a generic copy of NADA 141-234 October 11, 2019..... 200-660 Do................... Monensin, tylosin Cattle............ Original approval for use of FOI Summary. phosphate, and MONOVET 90 (monensin Type A melengestrol medicated article) with acetate Type C TYLOVET (tylosin phosphate) medicated feeds. Type A medicated article, and MGA (melengestrol acetate Type A medicated article) in the manufacture of Type C medicated feeds as a generic copy of NADA 138-870 [[Page 18116]] October 11, 2019..... 200-661 Do................... Monensin, tylosin Cattle............ Original approval for use of FOI Summary. phosphate, and MONOVET 90 (monensin Type A melengestrol medicated article) with TYLAN acetate Type C (tylosin phosphate) Type A medicated feeds. medicated article, and MGA (melengestrol acetate Type A medicated article) in the manufacture of Type C medicated feeds as a generic copy of NADA 138-870 October 11, 2019..... 200-662 Do................... Monensin and Cattle............ Original approval for use of FOI Summary. ractopamine MONOVET 90 (monensin Type A hydrochloride Type medicated article) with B and Type C ACTOGAIN (ractopamine medicated feeds. hydrochloride Type A medicated article) in the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141-225 October 29, 2019..... 200-635 Mizner Bioscience Clomipramine Dogs.............. Original approval as a generic FOI Summary. LLC, 225 NE Mizner Hydrochloride copy of NADA 141-120 Blvd., Suite 760, Tablets. Boca Raton, FL 33432. November 14, 2019.... 141-518 Intervet, Inc., 2 BRAVECTO PLUS Cats.............. Original approval for the FOI Summary. Giralda Farms, (fluralaner and prevention of heartworm Madison, NJ 07940. moxidectin topical disease and for the treatment solution) Solution. of infections with intestinal roundworm and hookworm; kills adult fleas and is indicated for the treatment and prevention of flea infestations, and the treatment and control of tick infestations for 2 months in cats and kittens November 20, 2019.... 200-663 Norbrook Laboratories SELARID (selamectin) Dogs and cats..... Original approval as a generic FOI Summary. Ltd., Station Works, Topical Solution. copy of NADA 141-152 County Down, Newry, BT35 6JP, UK. November 25, 2019.... 141-513 Kindred Biosciences, ZIMETA (dipyrone Horses............ Original approval for control FOI Summary. Inc., 1555 Bayshore injection). of pyrexia in horses Hwy., Suite 200, Burlingame, CA 94010. December 9, 2019..... 141-528 Elanco US Inc., 2500 CREDELIO CAT Cats.............. Original approval for killing FOI Summary. Innovation Way, (lotilaner) adult fleas, and for the Greenfield, IN 46140. Chewable Tablets. treatment and prevention of flea infestations for 1 month in cats and kittens December 9, 2019..... 200-546 Bimeda Animal Health BIMAGARD 12.5% Swine............. Original approval as a generic FOI Summary. Ltd., 1B The Herbert (tiamulin hydrogen copy of NADA 140-916 Building, The Park, fumarate) Liquid Carrickmines, Concentrate for Dublin, 18, EI. Swine. December 19, 2019.... 200-615 Vetoquinol USA, Inc., IMOXI (imidacloprid Dogs.............. Original approval as a generic FOI Summary. 4250 N. Sylvania and moxidectin) copy of NADA 141-251 Ave., Fort Worth, TX Topical Solution 76137. for Dogs. December 30, 2019.... 111-636 Zoetis Inc., 333 LINCOMIX (lincomycin Honeybees......... Supplemental approval of a FOI Summary. Portage St., hydrochloride) tolerance for residues of Kalamazoo, MI 49007. Soluble Powder. lincomycin in honey December 30, 2019.... 008-862 Do................... TERRAMYCIN Honeybees......... Supplemental approval of a FOI Summary. (oxytetracycline tolerance for residues of hydrochloride) oxytetracycline in honey Soluble Powder. December 30, 2019.... 013-076 Elanco US Inc. 2500 TYLAN (tylosin Honeybees......... Supplemental approval of a FOI Summary. Innovation Way, tartrate) Soluble. tolerance for residues of Greenfield, IN 46140. tylosin in honey -------------------------------------------------------------------------------------------------------------------------------------------------------- II. Withdrawals of Approval Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland, has requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed: ------------------------------------------------------------------------ File No. Product name 21 CFR section ------------------------------------------------------------------------ 055-036....... PRINCILLIN (ampicillin 520.90c. trihydrate) Capsules. 055-050....... PRINCILLIN (ampicillin 520.90e. trihydrate) Soluble Powder. 055-056....... PRINCILLIN (ampicillin 520.90f. trihydrate) Bolus. 055-061....... PRINCILLIN ``125'' For Oral 520.90d. Suspension. 055-068....... BOVICLOX (cloxacillin benzathine) 526.464b. 065-013....... Dihydrostreptomycin 522.650. (dihydrostreptomycin sulfate). 065-493....... JETPEN (penicillin G benzathine 522.1696a. and penicillin G procaine) Aqueous Suspension. 065-500....... TANDEM PEN (penicillin G 522.1696b. procaine). ------------------------------------------------------------------------ [[Page 18117]] Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 055-036, 055-050, 055-056, 055-061, 055-068, 065-013, 065-493, and 065-500, and all supplements and amendments thereto, is withdrawn, effective March 30, 2020. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions. III. Changes of Sponsor Cooperative Research Farms, Box 69, Charlotteville, NY 12036, has informed FDA that it has transferred ownership of, and all rights and interest in, approved NADA 119-253 for Cattle Block M (monensin) a free-choice Type C medicated cattle feed to Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616. Following this change of sponsorship, Cooperative Research Farms is no longer the sponsor of an approved application. Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom, has informed FDA that it has transferred ownership of, and all rights and interest in, approved ANADA 200-273 for VETRO-GEN Veterinary Ophthalmic Ointment to Putney, Inc., One Monument Sq., suite 400, Portland, ME 04101. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria, has informed FDA that it has transferred ownership of, and all rights and interest in, approved NADA 141-472 for virginiamycin and diclazuril Type C medicated feed to Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140. Accordingly, we are amending the regulations to reflect these changes. IV. Change of Sponsors' Name and Addresses Putney, Inc., One Monument Sq., suite 400, Portland, ME 04101, has informed FDA that it has changed its name and address to Dechra Veterinary Products LLC, 7015 College Blvd., suite 525, Overland Park, KS 66211. In addition, Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137 has informed FDA that it has changed its address to PO Box 162059, Fort Worth, TX 76161. Accordingly, we are amending Sec. 510.600(c) (21 CFR 510.600(c)) to reflect these changes. V. Technical Amendments FDA is making the following amendments to improve the readability and accuracy of the animal drug regulations:The contact information in 21 CFR 500.1410, which provides for the incorporation by reference of the residue assay method for n- methyl-2-pyrrolidone, is being updated. We are removing entries for ``Strategic Veterinary Pharmaceuticals, Inc.'' from the lists of sponsors of approved applications in Sec. 510.600(c) and the drug labeler code for KC Pharmacal from 21 CFR 520.260. The indications for use of oxytetracycline soluble powder in honey bees at 21 CFR 520.1660d are amended to reflect current labeling. The single section for euthanasia injectable solutions at 21 CFR 522.900 is being removed and separate sections for the active pharmaceutical ingredients are added at 21 CFR 522.1697 and 522.2092. The section heading in 21 CFR 524.1742 for ``N- (Mercaptomethyl) phthalimide S-(O,O-dimethyl phosphorodithioate) emulsifiable liquid'' is amended to read ``Phosmet emulsifiable liquid''. The entries in 21 CFR parts 556 and 558 for coumaphos for which approval of the last approved application was withdrawn in 2018 (83 FR 48940, September 28, 2018) are being removed. The entries in part 556 (21 CFR part 556) are being removed for tolerances of residues of erythromycin in swine tissues, of virginiamycin in turkey tissues, and of new animal drugs for which approval of their applications has been withdrawn. Cross-references to related approved uses of new animal drugs in part 556 and to related tolerances for drugs approved for use in food-producing animals in 21 CFR parts 520, 522, 524, and 558 are being corrected. A redundant cross-reference for related tolerances in 21 CFR 558.355 for use of monensin in medicated feeds is being removed and reserved. The acceptable daily intake of total residues of ivermectin and tolerances for residues of ivermectin in cattle liver and muscle in Sec. 556.344 are being corrected. The acceptable daily intake of total residues of tildipirosin in Sec. 556.733 is being corrected. The regulations in 21 CFR 520.2260b for sulfamethazine sustained-release boluses and in 21 CFR 522.1662a for oxytetracycline hydrochloride injection are being reformatted to present the tolerance cross-reference in a consistent location. Typographical errors are being corrected wherever they have been found. VI. 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 500 Animal drugs, Animal feeds, Cancer, Incorporation by reference, Labeling, Packaging and containers, Polychlorinated biphenyls (PCBs). 21 CFR Parts 520, 522, 524, and 526 Animal drugs. 21 CFR Part 556 Animal drugs, Food. 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 500, 510, 520, 522, 524, 526, 556, and 558 are amended as follows: PART 500--GENERAL 0 1. The authority citation for part 500 continues to read as follows: Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 360b, 371, 379e. 0 2. In Sec. 500.1410, revise paragraph (a) to read as follows: Sec. 500.1410 N-methyl-2-pyrrolidone. (a) Standard for residues. No residues of n-methyl-2-pyrrolidone may be found in the uncooked edible tissues of cattle as determined by a method entitled ``Method of Analysis: N-methyl-2- [[Page 18118]] pyrrolidone,'' September 26, 2011, Center for Veterinary Medicine, Food and Drug Administration, which is incorporated by reference with the approval of the Director of the Federal Register under 5 U.S.C. 522(a) and 1 CFR part 51. To obtain a copy of the analytical method, please submit a Freedom of Information request to: https://www.accessdata.fda.gov/scripts/foi/FOIRequest/requestinfo.cfm; or go to: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. You may inspect a copy at the office of the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 301-827-6860, between 9 a.m. and 4 p.m., Monday through Friday or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html. * * * * * PART 510--NEW ANIMAL DRUGS 0 3. 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 4. In Sec. 510.600: 0 a. In the table in paragraph (c)(1): 0 i. Remove the entry for ``Cooperative Research Farms''; 0 ii. Add entries for ``Dechra Veterinary Products LLC'' and ``Mizner Bioscience LLC'' in alphabetical order; 0 iii. Remove the entries for ``Putney, Inc.'' and ``Strategic Veterinary Pharmaceuticals, Inc.''; 0 iv. Revise the entry for ``Virbac AH, Inc.''; and 0 v. Add an entry for ``Wildcat Feeds'' in alphabetical order; and 0 b. In the table in paragraph (c)(2): 0 i. Revise the entry for ``026637''; 0 ii. Remove the entry for ``051267''; 0 iii. Revise the entry for ``051311''; 0 iv. Remove the entry for ``054628''; and 0 v. Add entries for ``086039'' and ``086113'' in numerical order. The revisions and additions 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 ------------------------------------------------------------------------ * * * * * * * Dechra Veterinary Products LLC, 7015 College Blvd., 026637 Suite 525, Overland Park, KS 66211..................... * * * * * * * Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, 086039 Boca Raton, FL 33432................................... * * * * * * * Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161.... 051311 * * * * * * * Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616..... 086113 * * * * * * * ------------------------------------------------------------------------ (2) * * * ---------------------------------------------------------------------------------------------------------------- Drug labeler code Firm name and address ---------------------------------------------------------------------------------------------------------------- * * * * * * * 026637................................. Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211. * * * * * * * 051311................................. Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161. * * * * * * * 086039................................. Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432. * * * * * * * 086113................................. Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616. * * * * * * * ---------------------------------------------------------------------------------------------------------------- PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 0 5. The authority citation for part 520 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 520.88c [Amended] 0 6. In Sec. 520.88c(c), remove ``Sec. 556.510'' and in its place add ``Sec. 556.38''. Sec. Sec. 520.90b and 520.90c [Redesignated as Sec. Sec. 520.90a and 520.90b] 0 7. Redesignate Sec. Sec. 520.90b and 520.90c as Sec. Sec. 520.90a and 520.90b. Sec. Sec. 520.90d and 520.90e [Removed] 0 8. Remove Sec. Sec. 520.90d and 520.90e. Sec. 520.90f [Redesignated as Sec. 520.90c and Amended] 0 9. Redesignate Sec. 520.90f as Sec. 520.90c and in newly redesignated Sec. 520.90c, revise paragraphs (b) and (d) to read as follows: [[Page 18119]] Sec. 520.90c Ampicillin boluses. * * * * * (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter. * * * * * (d) Conditions of use in nonruminating calves--(1) Amount. 5 milligrams per pound of body weight twice daily not to exceed 4 days. (2) Indications for use. Oral treatment of bacterial enteritis (colibacillosis) caused by E. coli. (3) Limitations. Treated calves must not be slaughtered for food during treatment and for 7 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Sec. 520.260 [Amended] 0 10. In Sec. 520.260(b)(2), remove ``No. 038782 for 884 or 1,768 milligram or 4.42 gram capsules;''. Sec. 520.455 [Amended] 0 11. In Sec. 520.455(b), remove ``No. 058198'' and in its place add ``Nos. 058198 and 086039''. Sec. Sec. 520.903d and 520.903e [Redesignated as Sec. Sec. 520.903c and 520.903d] 0 12. Redesignate Sec. Sec. 520.903d and 520.903e as Sec. Sec. 520.903c and 520.903d. Sec. 520.1263c [Redesignated as Sec. 520.1263b] 0 13. Redesignate Sec. 520.1263c as Sec. 520.1263b. 0 14. Revise Sec. 520.1286 to read as follows: Sec. 520.1286 Lotilaner. (a) Specifications. Each chewable tablet contains: (1) For use in dogs: 56.25, 112.5, 225, 450, or 900 milligrams (mg) lotilaner; or (2) For use in cats: 12 or 48 mg lotilaner. (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Dogs--(i) Amount. Administer orally once a month at the recommended minimum dosage of 9 mg/lb (20 mg/kg). (ii) Indications for use. Kills adult fleas, and for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations (Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick)) for 1 month in dogs and puppies 8 weeks of age or older and weighing 4.4 pounds or greater. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats--(i) Amount. Administer orally once a month at the recommended minimum dosage of 2.7 mg/lb (6 mg/kg). (ii) Indications for use. Kills adult fleas, and for the treatment and prevention of flea infestations (Ctenocephalides felis) for 1 month in cats and kittens 8 weeks of age or older and weighing 2 pounds or greater. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 15. In Sec. 520.1660d, revise paragraph (d)(2)(ii) to read as follows: Sec. 520.1660d Oxytetracycline powder. * * * * * (d) * * * (2) * * * (ii) Indications for use. For control of American foulbrood caused by Paenibacillus larvae. * * * * * Sec. Sec. 520.1696b, 520.1696c, and 520.1696d [Redesignated as Sec. Sec. 520.1696a, 520.1696b, and 520.1696c] 0 16. Redesignate Sec. Sec. 520.1696b, 520.1696c, and 520.1696d as Sec. Sec. 520.1696a, 520.1696b, and 520.1696c. Sec. 520.2218 [Amended] 0 17. In Sec. 520.2218(c), remove ``Sec. Sec. 556.670 and 556.685'' and in its place add ``Sec. Sec. 556.660, 556.670, and 556.685''. Sec. 520.2260b [Amended] 0 18. In Sec. 520.2260b, redesignate paragraphs (a) through (f) and (g) as paragraphs (b) through (g) and (a), respectively. 0 19. In Sec. 520.2455, add paragraph (b)(4) to read as follows: Sec. 520.2455 Tiamulin. * * * * * (b) * * * (4) No. 061133 for product described in paragraph (a)(2) of this section. * * * * * PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 20. The authority citation for part 522 continues to read as follows: Authority: 21 U.S.C. 360b. 0 21. In Sec. 522.650, revise paragraph (b) to read as follows: Sec. 522.650 Dihydrostreptomycin sulfate injection. * * * * * (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter. * * * * * 0 22. Add Sec. 522.728 to read as follows: Sec. 522.728 Dipyrone. (a) Specifications. Each milliliter of solution contains 500 milligrams (mg) dipyrone. (b) Sponsor. See No. 086078 in Sec. 510.600(c) of this chapter. (c) Conditions of use in horses--(1) Amount. Administer 30 mg per kilogram of body weight (13.6 mg per pound) by intravenous injection, once or twice daily at a 12-hour interval for up to 3 days. (2) Indications for use. For control of pyrexia in horses. (3) Limitations. Do not use in horses intended for human consumption. Do not use in any food-producing animals, including lactating dairy animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Sec. 522.900 [Removed] 0 23. Remove Sec. 522.900. Sec. 522.1367 [Amended] 0 24. In Sec. 522.1367(c)(1)(i), remove ``Sec. 520.1350(c)'' and in its place add ``Sec. 520.1367(c)''. Sec. 522.1662a [Amended] 0 25. In Sec. 522.1662a: 0 a. Redesignate paragraphs (a) through (e) as paragraphs (b) through (f); 0 b. Further redesignate newly redesignated paragraphs (c)(3)(i)(a) through (c) and (c)(3)(ii)(a) through (c) as paragraphs (c)(3)(i)(A) through (C) and (c)(3)(ii)(A) through (C), respectively; 0 c. Further redesignate newly redesignated paragraphs (e)(3)(i)(a) through (c) as paragraphs (e)(3)(i)(A) through (C); 0 d. Further redesignate newly redesignated paragraphs (e)(3)(ii)(a) and (b) and paragraphs (e)(3)(ii)(A) and (B); 0 e. Further redesignate newly redesignated paragraphs (e)(3)(iii)(a) through (c) as paragraphs (e)(3)(iii)(A) through (C); 0 f. In newly redesignated paragraph (e)(3)(iii)(C), remove ``paragraph (d)(3)(iii)(c) of this section'' and in its place add ``this paragraph (e)(3)(iii)(C)''; 0 g. Further redesignate newly redesignated paragraphs (f)(3)(i)(a) through (c) and (f)(3)(ii)(a) through (c) as paragraphs (f)(3)(i)(A) through (C) and (f)(3)(ii)(A) through (C), respectively; 0 h. Redesignate paragraphs (g)(3)(i)(a) through (c) and (g)(3)(ii)(a) through (c) as paragraphs (g)(3)(i)(A) through (C) [[Page 18120]] and (g)(3)(ii)(A) through (C), respectively; and 0 i. Redesignate paragraph (k) as paragraph (j) and paragraph (l) as paragraph (a). Sec. 522.1696a [Amended] 0 26. In Sec. 522.1696a(b)(1) and (2) and (d)(2)(iii), remove ``, 055529,''. Sec. 522.1696b [Amended] 0 27. In Sec. 522.1696b: 0 a. In paragraph (b)(1), remove ``016592, 054771, and 055529'' and in its place add ``016592 and 054771''; 0 b. Remove paragraphs (d)(2)(i)(A) and (B); and 0 c. In paragraph (d)(2)(iii)(B), remove ``Nos. 000859 and 055529'' and in its place add ``No. 016592''. 0 28. Add Sec. 522.1697 to read as follows: Sec. 522.1697 Pentobarbital and phenytoin. (a) Specifications. Each milliliter (mL) of solution contains 390 milligrams (mg) pentobarbital sodium and 50 mg phenytoin sodium. (b) Sponsors. See Nos. 000061, 051311, and 054925 in Sec. 510.600(c) of this chapter. (c) Special considerations. Product labeling shall bear the following warning statements: ``ENVIRONMENTAL HAZARD: This product is toxic to wildlife. Birds and mammals feeding on treated animals may be killed. Euthanized animals must be properly disposed of by deep burial, incineration, or other method in compliance with State and local laws, to prevent consumption of carcass material by scavenging wildlife.'' (d) Conditions of use in dogs--(1) Amount. Administer 1 mL per 10 pounds of body weight as a single, bolus intravenous or intracardiac injection. (2) Indications for use. For humane, painless, and rapid euthanasia. (3) Limitations. Do not use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 29. Add Sec. 522.2092 to read as follows: Sec. 522.2092 Secobarbital and dibucaine. (a) Specifications. Each milliliter (mL) of solution contains 400 milligram (mg) secobarbital sodium and 25 mg dibucaine hydrochloride. (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter. (c) Special considerations. Product labeling shall bear the following warning statements: ``ENVIRONMENTAL HAZARD: This product is toxic to wildlife. Birds and mammals feeding on treated animals may be killed. Euthanized animals must be properly disposed of by deep burial, incineration, or other method in compliance with State and local laws, to prevent consumption of carcass material by scavenging wildlife.'' (d) Conditions of use in dogs--(1) Amount. Administer 1 mL per 10 pounds of body weight as a single, bolus intravenous injection. (2) Indications for use. For humane, painless, and rapid euthanasia. (3) Limitations. Do not use in animals intended for food. 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 30. The authority citation for part 524 continues to read as follows: Authority: 21 U.S.C. 360b. 0 31. Add an undesignated center heading before Sec. 524.981 to read as follows: Fluocinolone Topical and Otic Dosage Forms 0 32. Add Sec. 524.1001 to read as follows: Sec. 524.1001 Furalaner and moxidectin. (a) Specifications. Each milliliter of solution contains 280 milligram (mg) furalaner and 14 mg moxidectin. Each individually packaged tube contains either 112.5 mg furalaner and 5.6 mg moxidectin; 250 mg furalaner and 12.5 mg moxidectin; or 500 mg furalaner and 25 mg moxidectin. (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Amount. Administer topically as a single dose every 2 months to provide a minimum dose of 18.2 mg/lb (40 mg/kg) fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin. (2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati, 4th stage larvae, immature adults, and adults) and hookworm (Ancylostoma tubaeforme, 4th stage larvae, immature adults, and adults); kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations (Ixodes scapularis (black-legged tick) and Dermacentor variabilis (American dog tick)) for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 33. In Sec. 524.1146, revise paragraphs (a) and (b) to read as follows: Sec. 524.1146 Imidacloprid and moxidectin. (a) Specifications. Each milliliter of solution contains: (1) 100 milligrams (mg) imidacloprid and 25 mg moxidectin; or (2) 100 mg imidacloprid and 10 mg moxidectin. (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this chapter as follows: (1) Nos. 000859 and 017030 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section. (2) No. 000859 for use of product described in paragraph (a)(2) of this section as in paragraphs (d)(2) and (3) of this section. * * * * * 0 34. In Sec. 524.1742: 0 a. Revise the section heading; 0 b. Redesignate paragraphs (c) and (d) as paragraphs (d) and (c), respectively; 0 c. Add a heading for the table in newly redesignated paragraph (d)(1) introductory text; and 0 d. Further redesignate newly redesignated paragraphs (d)(1)(i)(a) and (b) as paragraphs (d)(1)(i)(A) and (B). The revision and addition reads as follows: Sec. 524.1742 Phosmet emulsifiable liquid. * * * * * (d) * * * (1) * * * Table 1 to Paragraph (d)(1) * * * * * Sec. 524.2098 [Amended] 0 35. In Sec. 524.2098(b), remove ``054771'' and in its place add ``Nos. 054771 and 055529''. PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS 0 36. The authority citation for part 526 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 526.464b [Removed] 0 37. Remove Sec. 526.464b. Sec. 526.464c [Redesignated as Sec. 526.464b] 0 38. Redesignate Sec. 526.464c as Sec. 526.464b. PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 0 39. The authority citation for part 556 continues to read as follows: Authority: 21 U.S.C. 342, 360b, 371. Sec. 556.40 [Amended] 0 40. In Sec. 556.40(c), remove ``Sec. Sec. 520.90e, 520.90f, 522.90a, and 522.90b'' and in [[Page 18121]] its place add ``Sec. Sec. 520.90c, 522.90a, and 522.90b''. Sec. 556.165 [Amended] 0 41. In Sec. 556.165(c), remove ``Sec. Sec. 526.464a, 526.464b, and 526.464c'' and in its place add ``Sec. Sec. 526.464a and 526.464b''. Sec. 556.168 [Removed] 0 42. Remove Sec. 556.168. Sec. 556.230 [Amended] 0 43. In Sec. 556.230, remove paragraph (b)(3). Sec. 556.304 [Amended] 0 44. In Sec. 556.304(c), remove ``Sec. Sec. 522.1077, 522.1079, and 522.1081'' and in its place add ``Sec. Sec. 522.1079 and 522.1081''. Sec. 556.344 [Amended] 0 45. In Sec. 556.344: 0 a. In paragraph (a), remove ``1 [mu]g/kg'' and in its place add ``5 [mu]g/kg''; 0 b. In paragraph (b)(2)(i), remove ``100 ppb'' and in its place add ``1.6 ppm''; and 0 c. In paragraph (b)(2)(ii), remove ``10 ppb'' and in its place add ``650 ppb''. 0 46. In Sec. 556.360, add paragraph (b)(3) and revise paragraph (c) to read as follows: Sec. 556.360 Lincomycin. * * * * * (b) * * * (3) Honey. 750 ppb. (c) Related conditions of use. See Sec. Sec. 520.1263b, 522.1260, and 558.325 of this chapter. 0 47. In Sec. 556.500, add paragraph (b)(6) to read as follows: Sec. 556.500 Oxytetracycline. * * * * * (b) * * * (6) Honey. 750 ppb. * * * * * Sec. 556.510 [Amended] 0 48. In Sec. 556.510(c), remove ``520.1696b'' and in its place add ``520.1696a''. Sec. 556.660 [Amended] 0 49. In Sec. 556.660(c), remove ``Sec. 558.582'' and in its place add ``Sec. Sec. 520.2218 and 558.582''. Sec. 556.670 [Amended] 0 50. In Sec. 556.670, in paragraph (c), remove ``Sec. Sec. 520.2260a, 520.2260b, 520.2260c, 520.2261a, 520.2261b, 522.2260, 558.140, and 558.630'' and in its place add ``Sec. Sec. 520.2218, 520.2260a, 520.2260b, 520.2260c, 520.2261a, 520.2261b, 522.2260, 558.140, and 558.630''. Sec. 556.685 [Amended] 0 51. In Sec. 556.685(c), remove ``Sec. Sec. 520.2325a, 520.2325b, and 558.586'' and in its place add ``Sec. Sec. 520.2218, 520.2325a, 520.2325b, and 558.586''. Sec. 556.733 [Amended] 0 52. In Sec. 556.733(a), remove ``10 [mu]g/kg'' and in its place add ``50 [mu]g/kg''. 0 53. In Sec. 556.746, add paragraph (b)(4) to read as follows: Sec. 556.746 Tylosin. * * * * * (b) * * * (4) Honey. 500 ppb. * * * * * Sec. 556.750 [Amended] 0 54. In Sec. 556.750, remove paragraph (b)(4). 0 55. In Sec. 556.765, revise paragraph (b)(1) to read as follows: Sec. 556.765 Zilpaterol. * * * * * (b) * * * (1) Cattle. (i) Liver (target tissue): 12 ppb. (ii) Muscle: 10 ppb. * * * * * PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 56. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 0 57. In Sec. 558.55, add paragraph (d)(5) to read as follows: Sec. 558.55 Amprolium. * * * * * (d) * * * (5) Permitted combinations. Amprolium may also be used in combination with: (i) Virginiamycin as in Sec. 558.635. (ii) [Reserved] 0 58. In Sec. 558.76, revise paragraphs (e)(2)(vii), (viii), and (xi) to read as follows: Sec. 558.76 Bacitracin methylenedisalicylate. * * * * * (e) * * * (2) * * * (vii) Fenbendazole as in Sec. 558.258. (viii) Halofuginone as in Sec. 558.265. * * * * * (xi) Monensin as in Sec. 558.355. * * * * * Sec. 558.185 [Removed] 0 59. Remove Sec. 558.185. 0 60. In Sec. 558.195, revise paragraph (e)(2)(ii) to read as follows: Sec. 558.195 Decoquinate. * * * * * (e) * * * (2) * * * [[Page 18122]] -------------------------------------------------------------------------------------------------------------------------------------------------------- Combination in grams/ Decoquinate in grams/ton ton Indications for use Limitations Sponsor -------------------------------------------------------------------------------------------------------------------------------------------------------- * * * * * * * (ii) 12.9 to 90.8................... Monensin, 5 to 30...... Cattle fed in confinement Feed continuously as the 016592, 054771. for slaughter: For sole ration to provide 22.7 prevention of coccidiosis mg of decoquinate per 100 caused by Eimeria bovis and lb of body weight per day E. zuernii; and for and 50 to 360 mg of improved feed efficiency. monensin per head per day. Feed at least 28 days during period of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to animals producing milk for food. Do not feed to lactating dairy cattle. Also see paragraph (d)(1) of this section and Sec. 558.355(d)(9)(i). Monensin as provided by No. 016592 or 058198 in Sec. 510.600(c) of this chapter. * * * * * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- * * * * * 0 61. In Sec. 558.342, revise paragraph (e)(1)(iv) to read as follows: Sec. 558.342 Melengestrol. * * * * * (e) * * * (1) * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- Combination in grams/ Melengestrol acetate in mg/head/day ton Indications for use Limitations Sponsor -------------------------------------------------------------------------------------------------------------------------------------------------------- * * * * * * * (iv) 0.25 to 0.5.................... Monensin, 10 to 40..... Heifers fed in confinement Add at the rate of 0.5 to 2 016592, 054771, 058198 for slaughter: For lb/head/day a medicated increased rate of weight feed (liquid or dry) gain, improved feed containing 0.125 to 1 mg efficiency, and suppression melengestrol acetate/lb to of estrus (heat); and for a feed containing 10 to 40 the prevention and control g of monensin per ton to of coccidiosis due to provide 0.25 to 0.5 mg Eimeria bovis and E. melengestrol acetate/head/ zuernii.. day and 0.14 to 0.42 mg monensin/lb body weight, depending on severity of coccidiosis challenge, up to 480 mg monensin/head/ day. See Sec. 558.355(d). Monensin as provided by No. 016592 or 058198 in Sec. 510.600(c) of this chapter. * * * * * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- * * * * * 0 62. In Sec. 558.355, remove and reserve paragraph (e) and revise paragraph (f)(4)(iv) to read as follows: Sec. 558.355 Monensin. * * * * * (f) * * * (4) * * * ---------------------------------------------------------------------------------------------------------------- Monensin amount Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (iv) 400 mg per pound of block Pasture cattle Provide 50 to 200 mg of 086113 (0.088%). (slaughter, monensin (2 to 8 ounces stocker, feeder, of block) per head per and dairy and beef day, at least 1 block replacement per 5 head of cattle. heifers): For Feed blocks increased rate of continuously. Do not weight gain. feed salt or mineral supplements in addition to the blocks. Ingestion by cattle of monensin at levels of 600 mg 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. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * 0 63. In Sec. 558.500, revise paragraph (e)(2) to read as follows: Sec. 558.500 Ractopamine. * * * * * (e) * * * (2) Cattle. [[Page 18123]] ---------------------------------------------------------------------------------------------------------------- Combination in Indications for Ractopamine in grams/ton grams/ton use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 8.2 to 24.6................ .................. Cattle fed in Feed continuously as 054771 confinement for sole ration during the 058198 slaughter: For last 28 to 42 days on increased rate of feed. weight gain and improved feed efficiency during the last 28 to 42 days on feed. (ii) 8.2 to 24.6............... Monensin 10 to 40 Cattle fed in Feed continuously as 016592 to provide 0.14 confinement for sole ration during the 054771 to 0.42 mg slaughter: For last 28 to 42 days on 058198 monensin/lb of increased rate of feed. See paragraph body weight, weight gain and Sec. 558.355(d). depending on improved feed Ractopamine as severity of efficiency during provided by No. 058198 coccidiosis the last 28 to 42 or 054771; monensin as challenge, up to days on feed, and provided by No. 016592 480 mg/head/day.. for prevention or 058198 in Sec. and control of 510.600(c) of this coccidiosis due chapter. to Eimeria bovis and E. zuernii. (iii) 9.8 to 24.6.............. .................. Cattle fed in Feed continuously as 054771 confinement for sole ration during the 058198 slaughter: For last 28 to 42 days on increased rate of feed. Not for animals weight gain, intended for breeding. improved feed efficiency, and increased carcass leanness during the last 28 to 42 days on feed. (iv) 9.8 to 24.6............... Monensin 10 to 40 Cattle fed in Feed continuously as 016592 to provide 0.14 confinement for sole ration during the 054771 to 0.42 mg slaughter: For last 28 to 42 days on 058198 monensin/lb of increased rate of feed. Not for animals body weight, weight gain, intended for breeding. depending on improved feed See paragraph Sec. severity of efficiency, and 558.355(d). coccidiosis increased carcass Ractopamine as challenge, up to leanness during provided by No. 058198 480 mg/head/day. the last 28 to 42 or 054771; monensin as days on feed, and provided by No. 016592 for prevention or 058198 in Sec. and control of 510.600(c) of this coccidiosis due chapter. to Eimeria bovis and E. zuernii. (v) 9.8 to 24.6................ Monensin 10 to 40 Heifers fed in Feed continuously as 016592 to provide 0.14 confinement for sole ration during the 054771 to 0.42 mg slaughter: For last 28 to 42 days on 058198 monensin/lb of increased rate of feed. Not for animals body weight, weight gain, intended for breeding. depending on improved feed See Sec. Sec. severity of efficiency, and 558.342(d) and coccidiosis increased carcass 558.355(d). challenge, up to leanness during Melengestrol acetate 480 mg/head/day, the last 28 to 42 as provided by No. plus melengestrol days on feed, and 058198 or 054771; acetate to for prevention monensin as provided provide 0.25 to and control of by No. 016592 or 0.5 mg/head/day. coccidiosis due 058198 in Sec. to Eimeria bovis 510.600(c) of this and E. zuernii, chapter. and for suppression of estrus (heat). (vi) Not to exceed 800; to .................. Cattle fed in Top dress in a minimum 054771 provide 70 to 400 mg/head/day. confinement for of 1 lb of medicated 058198 slaughter: For feed. increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feed. (vii) Not to exceed 800; to Monensin 10 to 40 Cattle fed in Top dress ractopamine 016592 provide 70 to 400 mg/head/day. to provide 0.14 confinement for in a minimum of 1 lb 054771 to 0.42 mg slaughter: For of medicated feed 058198 monensin/lb of increased rate of during the last 28 to body weight, weight gain and 42 days on feed. Not depending on improved feed for animals intended severity of efficiency during for breeding. See Sec. coccidiosis the last 28 to 42 558.355(d). challenge, up to days on feed, and Ractopamine as 480 mg/head/day. for prevention provided by No. 058198 and control of or 054771; monensin as coccidiosis due provided by No. 016592 to Eimeria bovis or 058198 in Sec. and E. zuernii. 510.600(c) of this chapter. ---------------------------------------------------------------------------------------------------------------- * * * * * 0 64. In Sec. 558.618, revise paragraphs (e)(2)(ii) and (iii) to read as follows: Sec. 558.618 Tilmicosin. * * * * * (e) * * * (2) * * * [[Page 18124]] ---------------------------------------------------------------------------------------------------------------- Tilmicosin phosphate in grams/ Combination in Indications for ton grams/ton use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (ii) 568 to 757................ Monensin, 5 to 40. Cattle fed in Feed continuously for 016592 confinement for 14 days to provide 058198 slaughter: For 12.5 mg tilmicosin/kg improved feed of bodyweight/day. The efficiency; and safety of tilmicosin for the control has not been of bovine established in cattle respiratory intended for breeding disease (BRD) purposes. This drug associated with product is not Mannheimia approved for use in haemolytica, female dairy cattle 20 Pasteurella months of age or multocida, and older. Use in these Histophilus somni cattle may cause drug in groups of residues in milk. This cattle fed in drug product is not confinement for approved for use in slaughter, where calves intended to be active BRD has processed for veal. A been diagnosed in withdrawal period has at least 10 not been established percent of the in pre-ruminating animals in the calves. Cattle group. intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. See Sec. 558.355(d). Tilmicosin as provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198 in Sec. 510.600(c) of this chapter. (iii) 568 to 757............... Monensin, 10 to 40 Cattle fed in Feed continuously for 016592 confinement for 14 days to provide 058198 slaughter: For 12.5 mg tilmicosin/kg prevention and of bodyweight/day. The control of safety of tilmicosin coccidiosis due has not been to Eimeria bovis established in cattle and E. zuernii; intended for breeding and for the purposes. This drug control of BRD product is not associated with approved for use in Mannheimia female dairy cattle 20 haemolytica, months of age or Pasteurella older. Use in these multocida, and cattle may cause drug Histophilus somni residues in milk. This in groups of drug product is not cattle fed in approved for use in confinement for calves intended to be slaughter, where processed for veal. A active BRD has withdrawal period has been diagnosed in not been established at least 10 in pre-ruminating percent of the calves. Cattle animals in the intended for human group. consumption must not be slaughtered within 28 days of the last treatment with this drug product. See Sec. 558.355(d). Tilmicosin as provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198 in Sec. 510.600(c) of this chapter. ---------------------------------------------------------------------------------------------------------------- 0 65. In Sec. 558.625, revise paragraphs (e)(2)(vi) and (ix) to read as follows: Sec. 558.625 Tylosin. * * * * * (e) * * * (2) * * * ---------------------------------------------------------------------------------------------------------------- Combination in Indications for Tylosin grams/ton grams/ton use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (vi) 8 to 10................... Monensin, 5 to 30 Cattle fed in Feed continuously as 016592 plus decoquinate, confinement for the sole ration to 054771 13.6 to 22.7. slaughter: For provide 22.7 mg of reduction of decoquinate per 100 lb incidence of body weight per day, liver abscesses 50 to 360 mg of caused by monensin/head/day, and Fusobacterium 60 to 90 mg of tylosin/ necrophorum and head/day. Feed at Arcanobacterium least 28 days during pyogenes; for the period of exposure to prevention of coccidiosis or when it coccidiosis is likely to be a caused by Eimeria hazard. Do not feed to bovis and E. animals producing milk zuernii; and for for food. Do not feed improved feed to lactating dairy efficiency. cattle. A withdrawal time has not been established for pre- ruminating calves. Do not use in calves to be processed for veal. Tylosin as provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; decoquinate as provided by No. 058198 in Sec. 510.600(c) of this chapter. See Sec. Sec. 558.311(d) and 558.355(d). [[Page 18125]] * * * * * * * (ix) 8 to 10................... Monensin, 10 to 40 Heifers fed in Feed continuously as 016592 plus confinement for sole ration to heifers 054771 melengestrol, slaughter: For at a rate of 0.5 to 2 058198 0.25 to 2.0. reduction of pounds per head per incidence of day to provide 0.25 to liver abscesses 0.5 mg/head/day caused by melengestrol acetate Fusobacterium and 0.14 to 0.42 mg necrophorum and monensin/lb body Arcanobacterium weight per day, (Actinomyces) depending on the pyogenes; for severity of the prevention and coccidiosis challenge, control of up to 480 mg/head/day coccidiosis and 60 to 90 mg/head/ caused by Eimeria day tylosin. The bovis and E. melengestrol acetate zuernii; and for portion of this Type C increased rate of medicated feed must be weight gain, mixed into the improved feed complete feed efficiency, and containing 10 to 40 g/ suppression of ton monensin and 8 to estrus (heat). 10 g/ton tylosin at feeding into the amount of complete feed consumed by an animal per day. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; melengestrol provided by No. 054771 or 058198 in Sec. 510.600(c) of this chapter. See Sec. Sec. 558.342(d) and 558.355(d). * * * * * * * ---------------------------------------------------------------------------------------------------------------- 0 66. In Sec. 558.635, revise paragraph (e)(1)(iv) to read as follows: Sec. 558.635 Virginiamycin. * * * * * (e) * * * (1) * * * ---------------------------------------------------------------------------------------------------------------- Combination in Indications for Virginiamycin grams/ton grams/ton use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (iv) 20........................ Diclazuril, 0.91.. Broiler chickens: Feed continuously as 058198 For prevention of the sole ration. Do necrotic not use in hens enteritis caused producing eggs for by Clostridium human food. Diclazuril perfringens as provided by No. susceptible to 058198 in Sec. virginiamycin; 510.600(c) of this and for the chapter. prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima late in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesions scores and improve performance and health of birds challenged with E. maxima. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * Dated: March 25, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020-06688 Filed 3-30-20; 8:45 am] BILLING CODE 4164-01-P