[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)] [Rules and Regulations] [Pages 14893-14908] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2023-03649] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 526, 528, and 558 [Docket No. FDA-2022-N-0002] New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor 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 July, August, and September 2022. 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 improve the accuracy and readability of the regulations. DATES: This rule is effective March 10, 2023. 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. Approvals FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during July, August, and September 2022, 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, 240-402-7500. Persons with access to the internet may obtain these documents at the CVM [[Page 14894]] 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. FDA has verified the website addresses as of the date this document publishes in the Federal Register, but websites are subject to change over time. Table 1--Original and Supplemental NADAs and ANADAs Approved During July, August, and September 2022 Requiring Evidence of Safety and/or Effectiveness -------------------------------------------------------------------------------------------------------------------------------------------------------- 21 CFR Approval date File No. Sponsor Product name Effect of the action Public documents section -------------------------------------------------------------------------------------------------------------------------------------------------------- July 18, 2022.................. 141-043 Zoetis Inc., 333 SYNOVEX Choice and Supplemental approval FOI Summary, EA, FONSI.... 522.2478 Portage St., SYNOVEX Plus of a reimplantation Kalamazoo, MI 49007. (trenbolone acetate program for growing and estradiol beef steers and benzoate implants) heifers fed in Implants. confinement for slaughter for increased rate of weight gain for up to 200 days. July 18, 2022.................. 141-348 Zoetis Inc., 333 SYNOVEX ONE Feedlot Supplemental approval FOI Summary, EA, FONSI.... 522.2478 Portage St., (trenbolone acetate of a reimplantation Kalamazoo, MI 49007. and estradiol program for growing benzoate extended- beef steers and release implants) heifers fed in Implants. confinement for slaughter for increased rate of weight gain for up to 200 days. July 19, 2022.................. 200-724 Huvepharma EOOD, 5th Lubabegron, monensin, Original approval for FOI Summary............... 558.625 Floor, 3A Nikolay and tylosin Type C use of EXPERIOR Haytov Str., 1113 medicated feeds. (lubabegron Type A Sofia, Bulgaria. medicated article) with MONOVET (monensin Type A medicated article) and TYLOVET (tylosin phosphate Type A medicated article) in the manufacture of Type C medicated cattle feeds as a generic copy of NADA 141-512. July 19, 2022.................. 200-725 Huvepharma EOOD, 5th Lubabegron and Original approval for FOI Summary............... 558.330 Floor, 3A Nikolay monensin Type C use of EXPERIOR Haytov Str., 1113 medicated feeds. (lubabegron Type A Sofia, Bulgaria. medicated article) with MONOVET (monensin Type A medicated article) in the manufacture of Type C medicated cattle feeds as a generic copy of NADA 141-514. July 28, 2022.................. 141-564 Pharmgate, Inc., 1800 Chlortetracycline and Original approval for FOI Summary............... 558.128 Sir Tyler Dr., monensin Type C use of PENNCHLOR Wilmington, NC 28405. medicated feeds. (chlortetracycline Type A medicated article) and RUMENSIN (monensin Type A medicated article) in the manufacture of Type C medicated cattle feeds. July 29, 2022.................. 200-726 Pegasus Laboratories, Firocoxib Tablets for Original approval for FOI Summary............... 520.928 Inc., 8809 Ely Rd., Horses (firocoxib the control of pain Pensacola, FL 32514. tablets). and inflammation associated with osteoarthritis in horses as a generic copy of NADA 141-458. July 29, 2022.................. 200-727 Felix Pharmaceuticals Meloxicam 5 mg/mL Original approval for FOI Summary............... 522.1367 Pvt. Ltd., 25-28 Solution for the control of pain North Wall Quay, Injection. and inflammation in Dublin, 1, Ireland. dogs and cats as a generic copy of NADA 141-219. August 9, 2022................. 141-459 Intervet, Inc., 2 BRAVECTO (fluralaner Supplemental approval FOI Summary............... 524.998 Giralda Farms, topical solution) for for the treatment Madison, NJ 07940. Cats. and control of Asian longhorned tick infestations for 12 weeks in cats and kittens. August 9, 2022................. 141-518 Intervet, Inc., 2 BRAVECTO PLUS Supplemental approval FOI Summary............... 524.1001 Giralda Farms, (fluralaner and for the treatment Madison, NJ 07940. moxidectin topical and control of Asian solution) for Cats. longhorned tick infestations for 2 months in cats and kittens. August 11, 2022................ 141-565 Pharmgate, Inc., 1800 Bacitracin and Original approval of FOI Summary............... 558.355 Sir Tyler Dr., monensin Type C PENNITRACIN MD Wilmington, NC 28405. medicated feeds. (bacitracin Type A medicated article) and COBAN (monensin Type A medicated article) to be used in the manufacture of Type C medicated feeds for the prevention of mortality caused by necrotic enteritis, or for increased rate of weight gain and improved feed efficiency, and as an aid in the prevention of coccidiosis in broiler chickens, laying hen replacement chickens, and layer breeder replacement chickens. September 6, 2022.............. 141-462 Phibro Animal Health Virginiamycin and Original approval of FOI Summary............... 558.635 Corp., GlenPointe narasin Type C STAFAC Centre East, 3d medicated feeds. (virginiamycin Type Floor, 300 Frank W A medicated article) Burr Blvd., Suite 21, and MONTEBAN Teaneck, NJ 07666. (narasin Type A medicated article) to be used in the manufacture of Type C medicated feeds for the prevention of necrotic enteritis and coccidiosis in broiler chickens. [[Page 14895]] September 6, 2022.............. 141-429 Phibro Animal Health Virginiamycin, Original approval of FOI Summary............... 558.635 Corp., GlenPointe narasin, and STAFAC Centre East, 3d nicarbazin Type C (virginiamycin Type Floor, 300 Frank W medicated feeds. A medicated article) Burr Blvd., Suite 21, and MAXIBAN (narasin Teaneck, NJ 07666. and nicarbazin Type A medicated article) to be used in the manufacture of Type C medicated feeds for the prevention of necrotic enteritis and coccidiosis in broiler chickens. September 9, 2022.............. 141-553 Zoetis Inc, 333 VALCOR (doramectin and Original approval for FOI Summary............... 522.772 Portage St., levamisole injection) the treatment and Kalamazoo, MI 49007. Injectable Solution. control of certain gastrointestinal roundworms, lungworms, eyeworms, grubs, sucking lice, and mange mites in cattle; and for revising the tolerance for residues of doramectin in the target tissue, cattle liver. September 28, 2022............. 200-719 Vetoquinol USA, Inc., SIMPLERA (florfenicol, Original approval for FOI Summary............... 524.957 4250 N Sylvania Ave., terbinafine, the treatment of Fort Worth, TX 76137. mometasone furoate) otitis externa in Otic Solution. dogs as a generic copy of NADA 141-440. September 29, 2022............. 200-694 Bimeda Animal Health SPECTOGARD Original approval for FOI Summary............... 522.2121 Ltd., 1B The Herbert (spectinomycin the treatment of Building, The Park, sulfate) Injectable bovine respiratory Carrickmines, Dublin Solution. disease as a generic 18, Ireland. copy of NADA 141-077. -------------------------------------------------------------------------------------------------------------------------------------------------------- Also, FDA is amending the animal drug regulations to reflect approval of supplemental applications, as listed in table 2, to change the marketing status of dosage form antimicrobial animal drug products from over-the-counter (OTC) to by veterinary prescription (Rx). These applications were submitted in voluntary compliance with the goals of the FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative as identified by guidance for industry #263, ``Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the- Counter,'' June 11, 2021 (https://www.fda.gov/media/130610/download). Table 2--Supplemental Applications Approved During July, August, and September 2022, To Change the Marketing Status of Antimicrobial Animal Drug Products From OTC to Rx ---------------------------------------------------------------------------------------------------------------- Approval date File No. Sponsor Product name 21 CFR section ---------------------------------------------------------------------------------------------------------------- July 7, 2022.................. 041-629 Zoetis Inc., 333 SPECTOGARD 520.2123c. Portage St., (spectinomycin) Kalamazoo, MI 49007. Solution. July 7, 2022.................. 055-072 Do.................. ALBACILLIN 526.1698. (penicillin G procaine and novobiocin sodium) Intramammary Infusion. July 19, 2022................. 041-245 Do.................. ALBON 522.2220. (sulfadimethoxine) Injection 40%. July 29, 2022................. 055-098 Do.................. ALBADRY PLUS 526.1698. (penicillin G procaine and novobiocin sodium) Intramammary Infusion. July 29, 2022................. 012-965 Elanco US Inc., 2500 TYLAN 50 (tylosin) 522.2640. Innovation Way, Injection and TYLAN Greenfield, IN 200 (tylosin) 46140. Injection. July 29, 2022................. 011-060 Zoetis Inc., 333 TERRAMYCIN 520.1660c. Portage St., (oxytetracycline Kalamazoo, MI 49007. HCl) Tablets. July 29, 2022................. 140-909 Do.................. SULKA-S 520.2260a. (sulfamethazine) Bolus. July 29, 2022................. 094-114 Do.................. TERRAMYCIN 100 522.1662a. (oxytetracycline HCl) Injectable Solution; and LIQUAMYCIN 100 (oxytetracycline HCl) Injectable Solution. August 3, 2022................ 037-586 Do.................. ERYTHROMAST 36 526.820. (erythromycin) Intramammary Infusion. August 5, 2022................ 065-124 Do.................. Tetracycline Not codified. Intramuscular Vet (tetracycline) Injection. August 11, 2022............... 031-944 Do.................. DYNAMXYIN 522.2340. (sulfomyxin) Injectable. August 16, 2022............... 065-130 Do.................. CRYSTALLINE PRO 522.1696b. PENICILLIN G (penicillin G procaine) Injectable Suspension. August 30, 2022............... 099-402 Do.................. OXYVET and AQUACHEL 522.1662a. (oxytetracycline hydrochloride) Injectable Solution. September 22, 2022............ 008-763 Do.................. TERRAMYCIN 524.1662b. (oxytetracycline hydrochloride and polymyxin B sulfate) Ophthalmic Ointment. September 23, 2022............ 091-127 Do.................. OXYVET Injection 522.1662a. (oxytetracycline hydrochloride) Injectable Solution. September 23, 2022............ 048-287 Huvepharma EEOD, 5th Oxytetracycline 50 522.1662a. Floor, 3A Nikolay (oxytetracycline Haytov Str., 1113 hydrochloride) Sofia, Bulgaria. Injectable Solution. ---------------------------------------------------------------------------------------------------------------- [[Page 14896]] II. Changes of Sponsorship The sponsors of the following approved applications have informed FDA that they have transferred ownership of, and all rights and interest in, the applications to another sponsor, as listed in table 3. Table 3--Changes of Sponsorship During July, August, and September 2022 ---------------------------------------------------------------------------------------------------------------- 21 CFR File No. Product name Transferring sponsor New sponsor section ---------------------------------------------------------------------------------------------------------------- 039-583........................ GRANULEX V (balsam Mylan Institutional, Cronus Pharma 524.2620. Peru oil, castor oil, Inc., 12720 Dairy Specialities India trypsin). Ashford Rd., Sugar Private Ltd., Sy No- Land, TX 77478. 99/1, M/s GMR Hyderabad Aviation SEZ Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, India. 141-513........................ ZIMETA (dipyrone) Kindred Biosciences, Dechra, Ltd., 522.728. Injectable Solution. Inc., 1555 Bayshore Snaygill Industrial Hwy., Suite 200, Estate, Keighley Burlingame, CA 94010. Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom. ---------------------------------------------------------------------------------------------------------------- Following these changes of sponsorship, Kindred Biosciences, Inc. is no longer the sponsor of an approved application. Accordingly, the drug labeler code for this firm will be removed from Sec. 510.600(c) (21 CFR 510.600(c)). III. Withdrawals of Approval LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702 has requested that FDA withdraw approval of NADA 141-294 for a Bc6 rDNA construct in GTC 155-92 Goats because the product is no longer manufactured or marketed. As provided in the regulatory text of this document, the animal drug regulations in 21 CFR 528.1070 are amended to reflect this action and in Sec. 510.600(c) to reflect that LFB USA, Inc. is no longer the sponsor of an approved application. IV. Change of Sponsor Name and Address Akorn Animal Health, Inc., 1925 West Field Ct., Suite 300, Lake Forest, IL 60045 has informed FDA that it has changed its name and address to Akorn Operating Co. LLC, 5605 Centerpoint Ct., Suite A, Gurnee, IL 60031. As provided in the regulatory text, Sec. 510.600(c) is amended to reflect this change. V. Technical Amendments FDA is making the following amendments to improve the accuracy of the animal drug regulations:21 CFR 510.600(c) is amended to revise the names and addresses of Akorn Animal Health, Inc.; Mylan Institutional, Inc.; and Mylan Institutional LLC in the list of sponsors of approved applications and to remove Kindred Biosciences, Inc. 21 CFR 520.154a is amended to add instructions for administration of bacitracin methylenedisalicylate soluble powder in drinking water of chickens, turkeys, and swine. 21 CFR 522.840 is amended to reflect revised conditions of use for estradiol sustained-release implants in beef steers and heifers. 21 CFR 522.1372 is amended to reflect the correct volume of mepivacaine solution for nerve blocks used in horses. 21 CFR 522.1702 is redesignated to list it in a correct alphabetical sequence. 21 CFR 558.128 is amended to reflect the correct terminology for chlortetracycline Type C free-choice cattle feeds used for control of anaplasmosis. 21 CFR 558.258 is amended to reflect approved conditions of use for free-choice fenbendazole protein and mineral blocks in beef cattle. 21 CFR 558.330 is amended to add a previously uncodified concentration of lubabegron Type A medicated article for use in the manufacture of Type C feeds for beef steers and heifers fed in confinement for slaughter. 21 CFR 558.366 is amended to correctly describe the target class for nicarbazin medicated chicken feeds. 21 CFR 558.450 is amended to revise the instructions for use of oxytetracycline medicated feeds in breeding swine. 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 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Parts 520, 522, 524, 526, and 528 Animal drugs. 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 510, 520, 522, 524, 526, 528, 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: 0 a. In the table in paragraph (c)(1), revise the entry for ``Akorn Animal Health, Inc.'', remove the entries for ``Kindred Biosciences, Inc.'' and ``LFB USA, Inc.'', and revise the entries for ``Mylan Institutional, Inc.'' and ``Mylan Institutional LLC''; and 0 b. In the table in paragraph (c)(2), revise the entries for ``051079'', ``059399'', and ``063286'' and remove the entries for ``086047'' and ``086078''. The revisions read as follows: [[Page 14897]] Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * * * (c) * * * (1) * * * ------------------------------------------------------------------------ Drug labeler Firm name and address code ------------------------------------------------------------------------ * * * * * * * Akorn Operating Co. LLC, 5605 Centerpoint Ct., Suite A, 059399 Gurnee, IL 60031....................................... * * * * * * * Mylan Institutional, Inc., 12720 Dairy Ashford Rd., 051079 Sugar Land, TX 77478................................... Mylan Institutional LLC, a Viatris Company, 3711 Collins 063286 Ferry Rd., Morgantown, WV 26505........................ * * * * * * * ------------------------------------------------------------------------ (2) * * * ------------------------------------------------------------------------ Drug labeler code Firm name and address ------------------------------------------------------------------------ * * * * * * * 051079....................... Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478. * * * * * * * 059399....................... Akorn Operating Co. LLC, 5605 Centerpoint Ct., Suite A, Gurnee, IL 60031. * * * * * * * 063286....................... Mylan Institutional LLC, a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505 * * * * * * * ------------------------------------------------------------------------ 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. 520.154a: 0 a. Redesignate paragraphs (d)(1) and (2) as paragraphs (d)(2) and (1), respectively; 0 b. In newly redesignated paragraphs (d)(1)(i)(B), (d)(1)(ii)(B), and (d)(2)(iii), add a sentence to the end of the paragraph; and 0 c. Revise paragraph (d)(3)(iii). The additions and revision read as follows: Sec. 520.154a Bacitracin methylenedisalicylate. * * * * * (d) * * * (1) * * * (i) * * * (B) * * * Use as the sole source of drinking water. (ii) * * * (B) * * * Use as the sole source of drinking water. (2) * * * (iii) * * * Use as the sole source of drinking water. (3) * * * (iii) Limitations. Prepare a fresh solution daily. Use as the sole source of drinking water. Treatment not to exceed 14 days. Not to be given to swine that weigh more than 250 pounds. * * * * * Sec. 520.928 [Amended] 0 5. In Sec. 520.928, in paragraph (b)(2), remove ``No. 000010'' and in its place add ``Nos. 000010 and 055246''. 0 6. In Sec. 520.1660c, revise the section heading and paragraph (d)(3) to read as follows: Sec. 520.1660c Oxytetracycline hydrochloride tablets and boluses. * * * * * (d) * * * (3) Limitations--(i) For No. 000010: Dosage should continue until the animal returns to normal and for 24 hours to 48 hours after symptoms have subsided. Treatment should not exceed 4 consecutive days. Do not exceed 500 milligrams per 100 pounds of body weight every 12 hours (10 milligrams per pound daily). (ii) For No. 054771: Discontinue treatment 7 days prior to slaughter. Not for use in lactating dairy cattle. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 7. In Sec. 520.2123c, revise paragraph (d)(3) to read as follows: Sec. 520.2123c Spectinomycin solution. * * * * * (d) * * * (3) Limitations. Do not administer to pigs over 15 lb body weight or over 4 weeks of age. Do not administer within 21 days of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 8. In Sec. 520.2260a, revise paragraph (d)(2)(iii) to read as follows: Sec. 520.2260a Sulfamethazine oblets and boluses. * * * * * (d) * * * (2) * * * (iii) Limitations. Do not administer for more than 5 consecutive days. Do not treat calves within 11 days of slaughter. Do not use in calves to be slaughtered under 1 month of age or in calves being fed an all milk diet. Do not use in female dairy cattle 20 months of age or older; such use may cause drug residues in milk. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [[Page 14898]] PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 9. The authority citation for part 522 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 522.728 [Amended] 0 10. In 522.728, in paragraph (b), remove ``086078'' and in its place add ``043264''. 0 11. Add Sec. 522.772 to read as follows: Sec. 522.772 Doramectin and levamisole. (a) Specifications. Each milliliter of solution contains 5 milligrams (mg) of doramectin and 150 mg levamisole hydrochloride. (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter. (c) Related tolerances. See Sec. Sec. 556.222 and 556.350 of this chapter. (d) Conditions of use--(1) Cattle--(i) Amount. Inject subcutaneously in the neck as a single dose at a dosage of 0.2 mg doramectin (0.91 mg/lb) and 6 mg of levamisole hydrochloride per kg (2.72 mg/lb) of body weight. (ii) Indications for use. For treatment and control of gastrointestinal roundworms (adults and fourth stage larvae): Ostertagia ostertagi (including inhibited larvae), O. lyrata, Haemonchus placei, Trichostrongylus axei, T. colubriformis, T. longispicularis, Cooperia oncophora, C. pectinata, C. punctata, C. surnabada, Bunostomum phlebotomum (adults only), Strongyloides papillosus (adults only), Oesophagostomum radiatum, Trichuris spp. (adults only) and Nematodirus helvetianus (adults only); lungworms (adults and fourth stage larvae): Dictyocaulus viviparus; eyeworms (adults): Thelazia spp.; grubs (parasitic stages): Hypoderma bovis and H. lineatum; sucking lice: Haematopinus eurysternus, Linognathus vituli, and Solenopotes capillatus; mange mites: Psoroptes bovis and Sarcoptes scabiei in beef cattle 2 months of age and older and replacement dairy heifers less than 20 months of age. Not for use in beef bulls intended for breeding over 1 year of age, dairy calves, and veal calves. (iii) Limitations. Cattle must not be slaughtered for human consumption within 15 days following last treatment with this drug product. Not for use in female dairy cattle 20 months of age or older, including dry dairy cows; use in these cattle may cause drug residues in milk and/or in calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre- ruminating calves. (2) [Reserved] 0 12. In Sec. 522.840, revise paragraphs (d)(1) and (2) and remove paragraph (d)(3). The revisions read as follows: Sec. 522.840 Estradiol. * * * * * (d) * * * (1) Amounts and indications for use--(i) 25.7-mg extended-release implant. Insert one implant for increased rate of weight gain for up to 200 days in beef steer calves 2 months of age and older; for increased rate of weight gain for up to 200 days in growing beef steers and heifers on pasture (stocker, feeder, and slaughter); and for increased rate of weight gain and improved feed efficiency for up to 200 days in growing beef steers and heifers fed in confinement for slaughter. (ii) 43.9-mg extended-release implant. Insert one implant for increased rate of weight gain for up to 400 days in beef steer calves 2 months of age and older; for increased rate of weight gain for up to 400 days in growing beef steers and heifers on pasture (stocker, feeder, and slaughter); and for increased rate of weight gain and improved feed efficiency for up to 400 days in growing beef steers and heifers fed in confinement for slaughter. (2) Limitations. For subcutaneous ear implantation only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant within each separate production phase (beef steer calves 2 months of age and older, growing beef steers on pasture (stocker, feeder, and slaughter), growing beef steers and heifers fed in confinement for slaughter). Safety and effectiveness following reimplantation have not been evaluated. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. 0 13. In Sec. 522.1367, revise paragraph (b) to read as follows: Sec. 522.1367 Meloxicam. * * * * * (b) Sponsors. See Nos. 000010, 016729, 017033, 055529, and 086101 in Sec. 510.600(c) of this chapter. * * * * * Sec. 522.1372 [Amended] 0 14. In Sec. 522.1372, in paragraph (c)(1), remove ``3 to 5 mL'' and in its place add ``3 to 15 mL''. Sec. Sec. 522.1662a and 522.1662b [Redesignated as Sec. 522.1662 and Sec. 522.1663] 0 15. Redesignate Sec. Sec. 522.1662a and 522.1662b as Sec. Sec. 522.1662 and 522.1663, respectively. 0 16. In newly redesignated Sec. 522.1662: 0 a. Revise the section heading; 0 b. Add headings to paragraphs (b)(3)(i) through (iii); 0 c. Remove paragraph (b)(3)(iv); and 0 d. Revise paragraphs (d), (e), (f), and (i)(1) through (3). The revisions and additions read as follows: Sec. 522.1662 Oxytetracycline. * * * * * (b) * * * (3) * * * (i) Amount. * * * (ii) Indications for use. * * * (iii) Limitations. * * * * * * * * (d)(1) Specifications. Each milliliter of solution contains 100 mg of oxytetracycline hydrochloride. (2) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter. (3) Conditions of use in beef cattle and nonlactating dairy cattle--(i) Amount. Administer 3 to 5 mg of oxytetracycline per pound of body weight per day by intramuscular injection, not to exceed a total of 4 consecutive days. Administer 5 mg/lb of body weight per day for treatment of anaplasmosis, severe foot-rot, or severe cases of other indicated diseases, not to exceed a total of 4 consecutive days. (ii) Indications for use. For treatment of diseases due to oxytetracycline-susceptible organisms as follows: Pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus spp., foot-rot and diphtheria caused by Fusobacterium necrophorum, bacterial enteritis (scours) caused by Escherichia coli, wooden tongue caused by Actinobacillus lignieresii, leptospirosis caused by Leptospira pomona, and wound infections and acute metritis caused by Staphylococcus spp. and Streptococcus spp. For treatment of anaplasmosis caused by Anaplasma marginale and anthrax caused by Bacillus anthracis. (iii) Limitations. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Discontinue treatment at least 15 days [[Page 14899]] prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (e)(1) Specifications. Each milliliter of solution contains 50 mg of oxytetracycline hydrochloride. (2) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter. (3) Conditions of use in beef cattle and nonlactating dairy cattle. It is used as follows: (i) Amount. Administer by intravenous or intramuscular injection at 3 to 5 mg/lb of body weight per day, not exceed a total of 4 consecutive days. (ii) Indications for use. For treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus spp.; foot-rot and diphtheria caused by Spherophorus necrophorus; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresii; leptospirosis caused by Leptospira pomona; wound infections and acute metritis caused by staphylococcal and streptococcal organisms; and treatment of anaplasmosis caused by Anaplasma marginale and anthrax caused by Bacillus anthracis. (iii) Limitations. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Discontinue treatment at least 22 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (4) Conditions of use in swine. It is used in swine as follows: (i) Amount. Administer by intramuscular injection at 3 to 5 mg/lb of body weight per day to swine, not to exceed a total of 4 consecutive days. Administered to sows at 3 mg/lb of body weight approximately 8 hours before farrowing or immediately after farrowing. (ii) Indications for use. It is used for the treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli; pneumonia caused by Pasteurella multocida; and leptospirosis caused by Leptospira pomona. Administered to sows as an aid in the control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli. (iii) Limitations. Discontinue treatment at least 22 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (5) Poultry (broilers, turkeys, and breeding chickens). It is used as follows: (i) Amount. Administer subcutaneously to chickens and turkeys according to age as directed on labeling. (ii) Indications for use. For the treatment of air sacculitis (air- sac disease, chronic respiratory disease) caused by Mycoplasma gallisepticum and Escherichia coli; fowl cholera caused by Pasteurella multocida; infectious sinusitis caused by Mycoplasma gallisepticum; and infectious synovitis caused by Mycoplasma synoviae. (iii) Limitations. Do not administer to laying hens unless the eggs are used for hatching only. Discontinue treatment at least 5 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (f)(1) Specifications. Each milliliter of solution contains 100 mg of oxytetracycline hydrochloride. (2) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter. (3) Conditions of use in beef cattle and nonlactating dairy cattle--(i) Amount. Administer 3 to 5 mg of oxytetracycline per pound of body weight per day by intramuscular injection, not to exceed a total of 4 consecutive days. Administer 5 mg/lb of body weight per day for treatment of anaplasmosis, severe foot-rot, or severe cases of other indicated diseases, not to exceed a total of 4 consecutive days. (ii) Indications for use. For treatment of diseases due to oxytetracycline-susceptible organisms as follows: Pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus spp., foot-rot and diphtheria caused by Fusobacterium necrophorum, bacterial enteritis (scours) caused by Escherichia coli, wooden tongue caused by Actinobacillus lignieresii, leptospirosis caused by Leptospira pomona, and wound infections and acute metritis caused by Staphylococcus spp. and Streptococcus spp. For treatment of anaplasmosis caused by Anaplasma marginale and anthrax caused by Bacillus anthracis. (iii) Limitations. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Discontinue treatment at least 15 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. * * * * * (i) * * * (1) Specifications. Each milliliter of solution contains 50 milligrams (mg) of oxytetracycline hydrochloride. (2) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter. (3) Conditions of use in beef cattle, beef calves, nonlactating dairy cattle, and dairy calves--(i) Amount. Administer 3 to 5 mg/lb body weight per day by intramuscular injection not to exceed a total of 4 consecutive days. (ii) Indications for use. For treatment of bacterial pneumonia and shipping fever complex associated with Pasteurella spp.; foot-rot and diphtheria caused by Spherophorus necrophorus; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresii; wound infections and acute metritis caused by staphylococcal and streptococcal organisms susceptible to oxytetracycline. (iii) Limitations. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Discontinue treatment at least 18 days before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. * * * * * 0 17. In Sec. 522.1696b, revise paragraphs (b)(2), (d)(1)(i), and (d)(2)(iii)(B) and add paragraph (d)(2)(iii)(C) to read as follows: Sec. 522.1696b Penicillin G procaine aqueous suspension. * * * * * (b) * * * (2) Nos. 055529 and 061133 for use as in paragraph (d)(2) of this section. * * * * * (d) * * * (1) * * * (i) Amount. 10,000 units per pound body weight daily by intramuscular injection. * * * * * (2) * * * (iii) * * * (B) For Nos. 016592 and 055529: Treatment should not exceed 4 consecutive days. A withdrawal period has not been established for this product in pre-ruminating calves. Discontinue treatment for the following number of days before slaughter: Cattle--10; sheep--9; and swine--7. (C) For No. 054771: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Sec. 522.1702 [Redesignated as Sec. 522.1698] 0 18. Redesignate Sec. 522.1702 as Sec. 522.1698. Sec. 522.2121 [Amended] 0 19. In Sec. 522.2121, in paragraph (b), remove ``No. 054771'' and in its place add ``Nos. 054771 and 061133''. [[Page 14900]] 0 20. In Sec. 522.2220, revise paragraph (d)(4)(iii) to read as follows: Sec. 522.2220 Sulfadimethoxine. * * * * * (d) * * * (4) * * * (iii) Limitations. Milk taken from animals during treatment and for 60 hours (5 milkings) after the latest treatment must not be used for food. Do not administer within 5 days of slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 21. In Sec. 522.2340, revise paragraph (e)(4) to read as follows: Sec. 522.2340 Sulfomyxin. * * * * * (e) * * * (4) Not for use in laying hens; do not treat chickens within 5 days of slaughter. Do not treat turkeys within 7 days of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 22. Revise Sec. 522.2478 to read as follows: Sec. 522.2478 Trenbolone acetate and estradiol benzoate. (a) Specifications. (1) Each implant consists of: (i) 100 milligrams (mg) trenbolone acetate and 14 mg estradiol benzoate (one implant consisting of four pellets, each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate) per implant dose. (ii) 200 mg trenbolone acetate and 28 mg estradiol benzoate (one implant consisting of eight pellets, each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate) per implant dose. (2) Each extended-release implant consists of: (i) 150 mg trenbolone acetate and 21 mg estradiol benzoate (one implant consisting of six pellets with a porous polymer film coating, each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate) per implant dose. (ii) 200 mg trenbolone acetate and 28 mg estradiol benzoate (one implant consisting of eight pellets with a porous polymer film coating, each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate) per implant dose. (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter. (c) Related tolerances. See Sec. Sec. 556.240 and 556.739 of this chapter. (d) Conditions of use--(1) Growing beef steers and heifers fed in confinement for slaughter--(i) Amounts and indications for use--(A) An implant containing 100 mg trenbolone acetate and 14 mg estradiol benzoate as described in paragraph (a)(1)(i) of this section for increased rate of weight gain in growing beef steers fed in confinement for slaughter and for increased rate of weight gain and improved feed efficiency in growing beef heifers fed in confinement for slaughter. For increased rate of weight gain for up to 200 days in a reimplantation program where an implant as described in paragraph (a)(1)(i) of this section is the first implant and an implant as described in paragraph (a)(1)(i) or (ii) or (a)(2)(ii) of this section is administered 60 to 120 days later. (B) An implant containing 200 mg trenbolone acetate and 28 mg estradiol benzoate as described in paragraph (a)(1)(ii) of this section for increased rate of weight gain and improved feed efficiency in growing beef steers fed in confinement for slaughter and for increased rate of weight gain in growing beef heifers fed in confinement for slaughter. For increased rate of weight gain for up to 200 days in a reimplantation program where an implant as described in paragraph (a)(1)(i) of this section is the first implant and an implant as described in paragraph (a)(1)(ii) of this section is administered 60 to 120 days later. (C) An extended-release implant containing 150 mg trenbolone acetate and 21 mg estradiol benzoate as described in paragraph (a)(2)(i) of this section for increased rate of weight gain for up to 200 days. (D) An extended-release implant containing 200 mg trenbolone acetate and 28 mg estradiol benzoate as described in paragraph (a)(2)(ii) of this section for increased rate of weight gain and improved feed efficiency for up to 200 days. For increased rate of weight gain for up to 200 days in a reimplantation program where an implant as described in paragraph (a)(1)(i) of this section is the first implant and an implant as described in paragraph (a)(2)(ii) of this section is administered 60 to 120 days later. (ii) Limitations. Implant pellets subcutaneously in ear only. Other than as described on the labeling, this implant is not approved for repeated implantation (reimplantation) with any other cattle ear implant in growing beef steers and heifers fed in confinement for slaughter as safety and effectiveness have not been evaluated. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been established. A withdrawal period has not been established for this product in pre- ruminating calves. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. The extended-release implant described in paragraph (a)(2)(i) of this section, used as described in paragraph (d)(1)(i)(C) of this section, is not approved for repeated implantation (reimplantation) with this or any other cattle ear implant. (2) Growing beef steers and heifers on pasture (stocker, feeder, and slaughter)--(i) Amounts and indications for use. An extended- release implant containing 150 mg trenbolone acetate and 21 mg estradiol benzoate as described in paragraph (a)(2)(i) of this section for increased rate of weight gain for up to 200 days. (ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant. Safety and effectiveness following reimplantation have not been evaluated. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been established. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. 0 23. In Sec. 522.2640, revise paragraphs (b)(1), (e)(1)(iii), and (e)(2)(iii) to read as follows: Sec. 522.2640 Tylosin. * * * * * (b) * * * (1) No. 058198 for use of 50- or 200-mg/mL solutions as in paragraph (e) of this section. * * * * * (e) * * * (1) * * * (iii) Limitations. Cattle intended for human consumption must not be slaughtered within 21 days of the last use of this drug product. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. This product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in preruminating calves. For No. 058198: Federal law [[Page 14901]] restricts this drug to use by or on the order of a licensed veterinarian. (2) * * * (iii) Limitations. Swine intended for human consumption must not be slaughtered within 14 days of the last use of this drug product. For No. 058198: 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 24. The authority citation for part 524 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 524.957 [Amended] 0 25. In Sec. 524.957, in paragraph (b), remove ``No. 058198'' and in its place add ``Nos. 017030 and 058198''. 0 26. In Sec. 524.998, revise paragraph (c)(2)(ii) to read as follows: Sec. 524.998 Fluralaner. * * * * * (c) * * * (2) * * * (ii) Indications for use. Kills adult fleas; for the treatment and prevention of flea infestations (C. felis) and the treatment and control of I. scapularis (black-legged tick) and Haemaphysalis longicornis (Asian longhorned tick) infestations for 12 weeks in cats and kittens 6 months of age and older, and weighing 2.6 lb or greater; for the treatment and control of D. variabilis (American dog tick) infestations for 8 weeks in cats and kittens 6 months of age and older, and weighing 2.6 lb or greater. * * * * * 0 27. In Sec. 524.1001, revise paragraph (c)(2) to read as follows: Sec. 524.1001 Fluralaner and moxidectin. * * * * * (c) * * * (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, fourth-stage larvae, immature adults, and adults) and hookworm (Ancylostoma tubaeforme, fourth-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), Dermacentor variabilis (American dog tick), and Haemaphysalis longicornis (Asian longhorned tick)) for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater. * * * * * 0 28. In Sec. 524.1662b, revise paragraph (c)(3) to read as follows: Sec. 524.1662b Oxytetracycline and polymyxin B ophthalmic ointment. * * * * * (c) * * * (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Sec. 524.2620 [Amended] 0 29. In Sec. 524.2620, in paragraph (b)(1), remove ``051079'' and in its place add ``069043''. PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS 0 30. The authority citation for part 526 continues to read as follows: Authority: 21 U.S.C. 360b. 0 31. In Sec. 526.820, revise paragraphs (d)(3) and (e)(3) to read as follows: Sec. 526.820 Erythromycin. * * * * * (d) * * * (3) Limitations. Milk taken from animals during treatment and for 36 hours (3 milkings) after the latest treatment must not be used for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (e) * * * (3) Limitations. For use in dry cows only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 32. In Sec. 526.1698, revise paragraphs (d)(3) and (e)(3) to read as follows: Sec. 526.1698 Penicillin G procaine and novobiocin. * * * * * (d) * * * (3) Limitations. For udder instillation in lactating cows only. Do not milk for at least 6 hours after treatment; thereafter, milk at regular intervals. Milk taken from treated animals within 72 hours (6 milkings) after the latest treatment must not be used for food. Treated animals must not be slaughtered for food for 15 days following the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (e) * * * (3) Limitations. For udder instillation in dry cows only. Do not use less than 30 days prior to calving. Milk from treated cows must not be used for food during the first 72 hours after calving. Treated animals must not be slaughtered for food for 30 days following udder infusion. Federal law restricts this drug to use by or on the order of a licensed veterinarian. PART 528--INTENTIONAL GENOMIC ALTERATIONS IN ANIMALS 0 33. The authority citation for part 528 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 528.1070 [Removed] 0 34. Remove Sec. 528.1070. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 35. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 0 36. In Sec. 558.128: 0 a. Redesignate paragraphs (e)(4)(x) through (xlvii) as paragraphs (e)(4)(xxi) through (lviii); 0 b. Redesignate paragraphs (e)(4)(vii) through (ix) as paragraphs (e)(4)(xv) through (xvii); 0 c. Redesignate paragraphs (e)(4)(iii) through (vi) as paragraphs (e)(4)(v) through (viii); 0 d. Revise newly redesignated paragraph (e)(4)(xv); and 0 e. Add new paragraphs (e)(4)(iii) and (iv), (ix) through (xiv), and (xviii) through (xx). The revision and additions read as follows: Sec. 558.128 Chlortetracycline. * * * * * (e) * * * (4) * * * [[Page 14902]] -------------------------------------------------------------------------------------------------------------------------------------------------------- Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor -------------------------------------------------------------------------------------------------------------------------------------------------------- * * * * * * * (iii) 7 to 17.5 g/ton............ Monensin, 5 to 40.......... Growing beef steers and Feed as the sole ration to provide 70 mg 069254 heifers fed in chlortetracycline per head per day and 50 to 480 mg confinement for monensin per head per day. No additional slaughter over 400 lb: improvement in feed efficiency has been shown from For reduction of the feeding monensin at levels greater than 30 grams incidence of liver per ton (360 mg monensin per head per day). For use abscesses and for in dry feeds only. Not for use in liquid feed improved feed supplements. Do not allow horses or other equines efficiency. access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetracycline by No. 069254 in Sec. 510.600(c) of this chapter. (iv) 7 to 17.5 g/ton............. Monensin, 10 to 40......... Growing beef steers and Feed as the sole ration to provide 70 mg 069254 heifers fed in chlortetracycline per head per day and 0.14 to 0.42 confinement for mg monensin per lb. body weight per day to provide, slaughter over 400 lb: depending upon severity of coccidiosis challenge, For reduction of the up to 480 mg monensin per head per day. For use in incidence of liver dry feeds only. Not for use in liquid feed abscesses and for supplements. Do not allow horses or other equines prevention and control access to feed containing monensin. Ingestion of of coccidiosis due to monensin by horses has been fatal. Monensin Eimeria bovis and medicated cattle and goat feeds are safe for use in Eimeria zuernii. cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetracycline by No. 069254 in Sec. 510.600(c) of this chapter. * * * * * * * (ix) 33.33 to 66.67 g/ton........ Monensin, 5 to 40.......... Growing beef steers and Feed as the sole ration to provide 0.5 mg 069254 heifers fed in chlortetracycline per lb. body weight per day and confinement for 50 to 480 mg monensin per head per day. No slaughter over 700 lb: additional improvement in feed efficiency has been For control of active shown from feeding monensin at levels greater than infection of 30 grams per ton (360 mg monensin per head per anaplasmosis caused by day). For use in dry feeds only. Not for use in Anaplasma marginale liquid feed supplements. Do not allow horses or susceptible to other equines access to feed containing monensin. chlortetracycline and Ingestion of monensin by horses has been fatal. for improved feed Monensin medicated cattle and goat feeds are safe efficiency. for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetracycline by No. 069254 in Sec. 510.600(c) of this chapter. (x) 33.33 to 66.67 g/ton......... Monensin, 10 to 40......... Growing beef steers and Feed as the sole ration to provide 0.5 mg 069254 heifers fed in chlortetracycline per lb. body weight per day and confinement for 0.14 to 0.42 mg monensin per lb. body weight per slaughter over 700 lb: day to provide, depending upon severity of For control of active coccidiosis challenge, up to 480 mg monensin per infection of head per day. For use in dry feeds only. Not for anaplasmosis caused by use in liquid feed supplements. Do not allow horses Anaplasma marginale or other equines access to feed containing susceptible to monensin. Ingestion of monensin by horses has been chlortetracycline and fatal. Monensin medicated cattle and goat feeds are for the prevention and safe for use in cattle and goats only. Consumption control of coccidiosis by unapproved species may result in toxic due to Eimeria bovis reactions. Do not exceed the levels of monensin and Eimeria zuernii. recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetracycline by No. 069254 in Sec. 510.600(c) of this chapter. [[Page 14903]] (xi) 50 to 117 g/ton............. Monensin, 7.14 to 40....... Growing beef steers and Feed as the sole ration to provide 350 mg 069254 heifers fed in chlortetracycline per head per day and 50 to 480 mg confinement for monensin per head per day. No additional slaughter under 700 lb: improvement in feed efficiency has been shown from For control of active feeding monensin at levels greater than 30 grams infection of per ton (360 mg monensin per head per day). For use anaplasmosis caused by in dry feeds only. Not for use in liquid feed Anaplasma marginale supplements. Do not allow horses or other equines susceptible to access to feed containing monensin. Ingestion of chlortetracycline and monensin by horses has been fatal. Monensin for improved feed medicated cattle and goat feeds are safe for use in efficiency. cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetracycline by No. 069254 in Sec. 510.600(c) of this chapter. (xii) 50 to 117 g/ton............ Monensin, 10 to 40......... Growing beef steers and Feed as the sole ration to provide 350 mg 069254 heifers fed in chlortetracycline per head per day and 0.14 to 0.42 confinement for mg monensin per lb. body weight per day to provide, slaughter under 700 lb: depending upon severity of coccidiosis challenge, For control of active up to 480 mg monensin per head per day. For use in infection of dry feeds only. Not for use in liquid feed anaplasmosis caused by supplements. Do not allow horses or other equines Anaplasma marginale access to feed containing monensin. Ingestion of susceptible to monensin by horses has been fatal. Monensin chlortetracycline and medicated cattle and goat feeds are safe for use in for the prevention and cattle and goats only. Consumption by unapproved control of coccidiosis species may result in toxic reactions. Do not due to Eimeria bovis exceed the levels of monensin recommended in the and Eimeria zuernii. feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetracycline by No. 069254 in Sec. 510.600(c) of this chapter. (xiii) 50 to 117 g/ton........... Monensin, 7.14 to 40....... Growing beef steers and Feed as the sole ration to provide 350 mg 069254 heifers fed in chlortetracycline per head per day and 50 to 480 mg confinement for monensin per head per day. No additional slaughter: For the improvement in feed efficiency has been shown from control of bacterial feeding monensin at levels greater than 30 grams pneumonia associated per ton (360 mg monensin per head per day). For use with shipping fever in dry feeds only. Not for use in liquid feed complex caused by supplements. Do not allow horses or other equines Pasteurella spp. access to feed containing monensin. Ingestion of susceptible to monensin by horses has been fatal. Monensin chlortetracycline and medicated cattle and goat feeds are safe for use in for improved feed cattle and goats only. Consumption by unapproved efficiency. species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetracycline by No. 069254 in Sec. 510.600(c) of this chapter. (xiv) 50 to 117 g/ton............ Monensin, 10 to 40......... Growing beef steers and Feed as the sole ration to provide 350 mg 069254 heifers fed in chlortetracycline per head per day and 0.14 to 0.42 confinement for mg monensin per lb. body weight per day to provide, slaughter: For the depending upon severity of coccidiosis challenge, control of bacterial up to 480 mg monensin per head per day. For use in pneumonia associated dry feeds only. Not for use in liquid feed with shipping fever supplements. Do not allow horses or other equines complex caused by access to feed containing monensin. Ingestion of Pasteurella spp. monensin by horses has been fatal. Monensin susceptible to medicated cattle and goat feeds are safe for use in chlortetracycline and cattle and goats only. Consumption by unapproved for the prevention and species may result in toxic reactions. Do not control of coccidiosis exceed the levels of monensin recommended in the due to Eimeria bovis feeding directions, as reduced average daily gains and Eimeria zuernii. may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetracycline by No. 069254 in Sec. 510.600(c) of this chapter. (xv) to provide 0.5 to 2.0 mg/lb ........................... Beef cattle and In Type C free-choice cattle feeds such as feed 054771 of body weight daily. nonlactating dairy blocks or salt-mineral mixes manufactured from 069254 cattle: As an aid in approved Type A articles. See paragraph (d)(4) of the control of active this section. infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline. [[Page 14904]] * * * * * * * (xviii) 400 to 2,000 g/ton....... Monensin, 5 to 40.......... Growing beef steers and Feed as the sole ration to provide 10 mg 069254 heifers fed in chlortetracycline per lb. body weight per day. confinement for Treat for not more than 5 days, then continue slaughter: For feeding monensin Type C medicated feed alone. No treatment of bacterial additional improvement in feed efficiency has been enteritis caused by shown from feeding monensin at levels greater than Escherichia coli and 30 grams per ton (360 mg monensin per head per bacterial pneumonia day). For use in dry feeds only. Not for use in caused by Pasteurella liquid feed supplements. Do not allow horses or multocida susceptible other equines access to feed containing monensin. to chlortetracycline; Ingestion of monensin by horses has been fatal. for improved feed Monensin medicated cattle and goat feeds are safe efficiency. for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetracycline by No. 069254 in Sec. 510.600(c) of this chapter. (xix) 400 to 2,000 g/ton......... Monensin, 5 to 40.......... Growing beef steers and Feed as the sole ration to provide 10 mg 069254 heifers: For treatment chlortetracycline per lb. body weight per day and of bacterial enteritis 0.14 to 0.42 mg monensin per lb. body weight per caused by Escherichia day to provide, depending upon severity of the coli and bacterial coccidiosis challenge, up to 480 mg monensin per pneumonia caused by head per day. Treat for not more than 5 days, then Pasteurella multocida continue feeding monensin Type C medicated feed susceptible to alone. For use in dry feeds only. Not for use in chlortetracycline; and liquid feed supplements. Do not allow horses or for the prevention and other equines access to feed containing monensin. control of coccidiosis Ingestion of monensin by horses has been fatal. due to Eimeria bovis Monensin medicated cattle and goat feeds are safe and Eimeria zuernii. for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetracycline by No. 069254 in Sec. 510.600(c) of this chapter. (xx) 400 to 2,000 g/ton.......... Monensin, 10 to 200........ Beef calves 2 months of Feed as the sole ration to provide 10 mg 069254 age and older: For chlortetracycline per lb. body weight per day and treatment of bacterial 0.14 to 1.00 mg monensin per lb. body weight per enteritis caused by day to provide, depending upon severity of Escherichia coli and coccidiosis challenge, up to 200 mg of monensin per bacterial pneumonia head per day. Feed for not more than 5 days, then caused by Pasteurella continue to feed monensin Type C medicated feed multocida susceptible alone. For use in dry feeds only. Not for use in to chlortetracycline; liquid feed supplements. Do not allow horses or and for the prevention other equines access to feed containing monensin. and control of Ingestion of monensin by horses has been fatal. coccidiosis due to Monensin medicated cattle and goat feeds are safe Eimeria bovis and for use in cattle and goats only. Consumption by Eimeria zuernii. unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetracycline by No. 069254 in Sec. 510.600(c) of this chapter. * * * * * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- * * * * * 0 37. In Sec. 558.258, add paragraphs (e)(3)(iv)(A)(3) and (4) to read as follows: Sec. 558.258 Fenbendazole. (e) * * * (3) * * * (iv) * * * (A) * * * [[Page 14905]] ---------------------------------------------------------------------------------------------------------------- Fenbendazole concentration Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (3) 750 mg/lb of protein Beef cattle: For the Feed free choice at a rate of 0.1 pound of 000061 block (to provide 5 mg/kg treatment and control of: block per 100 pounds of body weight per body weight (2.27 mg/lb)). Lungworms: adult day for 3 days to deliver a total of 2.27 (Dictyocaulus viviparus); mg fenbendazole per pound of body weight. Stomach worms: adult Cattle must not be slaughtered for human brown stomach worms consumption within 16 days following last (Ostertagia ostertagi), treatment with this drug product. Not for adult and fourth-stage use in female dairy cattle 20 months of larvae barberpole worms age or older, including dry dairy cows. (Haemonchus contortus), Use in these cattle may cause drug fourth-stage larvae residues in milk and/or in calves born to barberpole worms (H. these cows or heifers. Not for use in beef placei), and adult and calves less than 2 months of age, dairy fourth-stage larvae small calves, and veal calves. A withdrawal stomach worms period has not been established for this (Trichostrongylus axei); product in pre-ruminating calves. Intestinal worms (adult and fourth-stage larvae): hookworms (Bunostomum phlebotomum), thread- necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata and C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum). (4) 750 mg/lb of molasses Beef cattle: For the Feed free choice at a rate of 0.1 pound of 000061 block (to provide 5 mg/kg treatment and control of: block per 100 pounds of body weight per body weight (2.27 mg/lb)). Lungworms: adult day for 3 days to deliver a total of 2.27 (Dictyocaulus viviparus); mg fenbendazole per pound of body weight. Stomach worms: adult Cattle must not be slaughtered for human brown stomach worms consumption within 11 days following last (Ostertagia ostertagi), treatment with this drug product. Not for adult and fourth-stage use in female dairy cattle 20 months of larvae barberpole worms age or older, including dry dairy cows. (Haemonchus contortus), Use in these cattle may cause drug fourth-stage larvae residues in milk and/or in calves born to barberpole worms (H. these cows or heifers. Not for use in beef placei), and adult and calves less than 2 months of age, dairy fourth-stage larvae small calves, and veal calves. A withdrawal stomach worms period has not been established for this (Trichostrongylus axei); product in pre-ruminating calves. Intestinal worms (adult and fourth-stage larvae): hookworms (Bunostomum phlebotomum), thread- necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata and C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum). ---------------------------------------------------------------------------------------------------------------- * * * * * 0 38. In Sec. 558.330, revise paragraphs (a) and (d)(1)(ii) and (iii) to read as follows: Sec. 558.330 Lubabegron. (a) Specifications. Each pound of Type A medicated article contains 4.54 grams (10 grams per kilogram) or 22.7 grams (50 grams per kilogram) of lubabegron as lubabegron fumarate. * * * * * (d) * * * (1) * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- Lubabegron fumarate in grams/ton Combination in grams/ton Indications for use Limitations Sponsor -------------------------------------------------------------------------------------------------------------------------------------------------------- * * * * * * * (ii) 1.25 to 4.54................ Monensin, 5 to 40.......... Beef steers and heifers Feed continuously as the sole ration to provide 13 016592 fed in confinement for to 90 mg lubabegron/head/day and 50 to 480 mg 058198 slaughter: For monensin/head/day during the last 14 to 91 days on reduction of ammonia feed. No additional improvement in feed efficiency gas emissions per pound has been shown from feeding monensin at levels of live weight and hot greater than 30 g/ton (360 mg monensin/head/day). A carcass weight and for decrease in dry matter intake may be noticed in improved feed some animals receiving lubabegron. Lubabegron has efficiency during the not been approved for use in breeding animals last 14 to 91 days on because safety and effectiveness have not been feed. evaluated in these animals. Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal. [[Page 14906]] (iii) 1.25 to 4.54............... Monensin, 10 to 40......... Beef steers and heifers Feed continuously as the sole ration to provide 13 016592 fed in confinement for to 90 mg lubabegron/head/day and 0.14 to 0.42 mg 058198 slaughter: For monensin/lb body weight per day, depending upon reduction of ammonia severity of coccidiosis challenge, during the last gas emissions per pound 14 to 91 days on feed. A decrease in dry matter of live weight and hot intake may be noticed in some animals receiving carcass weight; and for lubabegron. Lubabegron has not been approved for prevention and control use in breeding animals because safety and of coccidiosis due to effectiveness have not been evaluated in these Eimeria bovis and E. animals. Do not allow horses or other equines zuernii during the last access to feed containing lubabegron and monensin. 14 to 91 days on feed. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal. * * * * * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- 0 39. In Sec. 558.355, redesignate paragraphs (f)(1)(iv), (v), and (vi) through (x) as paragraphs (f)(1)(vi), (vii), and (x) through (xiv), respectively, and add new paragraphs (f)(1)(iv), (v), (viii), and (ix) to read as follows: Sec. 558.355 Monensin. * * * * * (f) * * * (1) * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- Monensin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor -------------------------------------------------------------------------------------------------------------------------------------------------------- * * * * * * * (iv) 90 to 110................... Bacitracin Broiler chickens: As an Feed as the sole ration throughout the feeding 069254 methylenedisalicylate, 4 aid in the prevention period. Do not feed to laying chickens. Do not feed to 50. of coccidiosis caused to chickens over 16 weeks of age. Do not allow by Eimeria necatrix, E. horses, other equines, mature turkeys, or guinea tenella, E. acervulina, fowl access to feed containing monensin. Ingestion E. brunetti, E. mivati, of monensin by horses and guinea fowl has been and E. maxima, and for fatal. In the absence of coccidiosis in broiler increased rate of chickens, the use of monensin with no withdrawal weight gain and period may limit feed intake resulting in reduced improved feed weight gain. Not for broiler breeder replacement efficiency. chickens. Monensin provided by No. 058198, bacitracin methylenedisalicylate provided by No. 069254 in Sec. 510.600(c) of this chapter. (v) 90 to 110.................... Bacitracin Laying hen replacement Feed as the sole ration throughout the feeding 069254 methylenedisalicylate, 4 chickens and layer period. Do not feed to laying chickens. Do not feed to 50. breeder replacement to chickens over 16 weeks of age. Do not allow chickens: As an aid in horses, other equines, mature turkeys, or guinea the prevention of fowl access to feed containing monensin. Ingestion coccidiosis caused by of monensin by horses and guinea fowl has been Eimeria necatrix, E. fatal. Not for broiler breeder replacement tenella, E. acervulina, chickens. Monensin provided by No. 058198, E. brunetti, E. mivati, bacitracin methylenedisalicylate provided by No. and E. maxima, and for 069254 in Sec. 510.600(c) of this chapter. increased rate of weight gain and improved feed efficiency. * * * * * * * (viii) 90 to 110................. Bacitracin Broiler chickens: As an Feed as the sole ration for 28 to 35 days, starting 069254 methylenedisalicylate, 50. aid in the prevention from the time chicks are placed for brooding. Do of coccidiosis caused not feed to laying chickens. Do not feed to by Eimeria necatrix, E. chickens over 16 weeks of age. Do not allow horses, tenella, E. acervulina, other equines, mature turkeys, or guinea fowl E. brunetti, E. mivati, access to feed containing monensin. Ingestion of and E. maxima, and for monensin by horses and guinea fowl has been fatal. the prevention of In the absence of coccidiosis in broiler chickens, mortality caused by the use of monensin with no withdrawal period may necrotic enteritis limit feed intake resulting in reduced weight gain. associated with Not for broiler breeder replacement chickens. Clostridium perfringens. Monensin provided by No. 058198, bacitracin methylenedisalicylate provided by No. 069254 in Sec. 510.600(c) of this chapter. (ix) 90 to 110................... Bacitracin Laying hen replacement Feed as the sole ration for 28 to 35 days, starting 069254 methylenedisalicylate, 50. chickens and layer from the time chicks are placed for brooding. Do breeder replacement not feed to laying chickens. Do not feed to chickens: As an aid in chickens over 16 weeks of age. Do not allow horses, the prevention of other equines, mature turkeys, or guinea fowl coccidiosis caused by access to feed containing monensin. Ingestion of Eimeria necatrix, E. monensin by horses and guinea fowl has been fatal. tenella, E. acervulina, Not for broiler breeder replacement chickens. E. brunetti, E. mivati, Monensin provided by No. 058198, bacitracin and E. maxima, and for methylenedisalicylate provided by No. 069254 in the prevention of Sec. 510.600(c) of this chapter. mortality caused by necrotic enteritis associated with Clostridium perfringens. [[Page 14907]] * * * * * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- * * * * * 0 40. In Sec. 558.364, add paragraph (d)(2)(ii) to read as follows: Sec. 558.364 Naracin and nicarbazin. * * * * * (d) * * * (2) * * * (ii) Virginiamycin as in Sec. 558.635. 0 41. In Sec. 558.366, revise paragraph (d)(1)(i) and add paragraph (d)(2) to read as follows: Sec. 558.366 Nicarbazin. * * * * * (d) * * * (1) * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- Nicarbazin in grams per ton Combination in grams/ton Indications for use Limitations Sponsor -------------------------------------------------------------------------------------------------------------------------------------------------------- (i) 90.8 to 181.6................ ........................... Chickens: As an aid in Feed continuously as sole ration from time chicks 066104 preventing outbreaks of are placed on litter until past the time when cecal (Eimeria tenella) coccidiosis is ordinarily a hazard. Do not use as a and intestinal (E. treatment for outbreaks of coccidiosis. Do not use acervulina, E. maxima, in flushing mashes. Do not feed to laying hens. E. necatrix, and E. Withdraw 4 days before slaughter for use levels at brunetti) coccidiosis. or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. * * * * * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- (2) Nicarbazin single-ingredient Type A medicated articles may also be used in combination with: (i) [Reserved] (ii) Virginiamycin as in Sec. 558.635. 0 42. In Sec. 558.450: 0 a. Revise paragraph (e)(3)(i); 0 b. Redesignate paragraph (e)(3)(ii) as paragraph (e)(3)(iii); and 0 c. Add new paragraph (e)(3)(ii). The revision and addition read as follows: Sec. 558.450 Oxytetracycline. * * * * * (e) * * * (3) * * * ---------------------------------------------------------------------------------------------------------------- Combination in grams/ Oxytetracycline amount ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 10 mg/lb of body weight ..................... Swine: For treatment of Feed continuously 066104 daily. bacterial enteritis caused for 7 to 14 days. 069254 by E. coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline. (ii) 10 mg/lb of body weight ..................... Breeding swine: For control Feed continuously 066104 daily. and treatment of for not more than 069254 leptospirosis (reducing the 14 days. incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * 0 43. In Sec. 558.625, revise paragraphs (e)(2)(vii) and (viii) to read as follows: Sec. 558.625 Tylosin. * * * * * (e) * * * (2) * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- Tylosin grams/ton Combination in grams/ton Indications for use Limitations Sponsors -------------------------------------------------------------------------------------------------------------------------------------------------------- * * * * * * * (vii) 8 to 10................... Monensin, 5 to 40 plus Beef steers and Feed continuously as sole ration to provide 13 to 016592 lubabegron fumarate, 1.25 to heifers fed in 90 mg lubabegron/head/day, 50 to 480 mg monensin/ 058198 4.54. confinement for head/day, and 60 to 90 mg tylosin/head/day during slaughter: For the last 14 to 91 days on feed. No additional reduction of ammonia improvement in feed efficiency has been shown gas emissions per from feeding monensin at levels greater than 30 g/ pound of live weight ton (360 mg monensin/head/day). A decrease in dry and hot carcass matter intake may be noticed in some animals weight; for reduction receiving lubabegron. Lubabegron has not been of incidence of liver approved for use in breeding animals because abscesses associated safety and effectiveness have not been evaluated with Fusobacterium in these animals. Do not allow horses or other necrophorum and equines access to feed containing lubabegron and Arcanobacterium monensin. Ingestion of monensin by horses has pyogenes, and for been fatal. Monensin medicated cattle and goat improved feed feeds are safe for use in cattle and goats only. efficiency during the Consumption by unapproved species may result in last 14 to 91 days on toxic reactions. Feeding undiluted or mixing feed. errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal. [[Page 14908]] (viii) 8 to 10.................. Monensin, 10 to 40 plus Beef steers and Feed continuously as sole ration to provide 13 to 016592 lubabegron fumarate, 1.25 to heifers fed in 90 mg lubabegron/head/day, 0.14 to 0.42 mg 058198 4.54. confinement for monensin/lb body weight per day, depending upon slaughter: For severity of coccidiosis challenge, up to 480 mg/ reduction of ammonia head/day, and 60 to 90 mg tylosin/head/day during gas emissions per the last 14 to 91 days on feed. A decrease in dry pound of live weight matter intake may be noticed in some animals and hot carcass receiving lubabegron. Lubabegron has not been weight, for reduction approved for use in breeding animals because of incidence of liver safety and effectiveness have not been evaluated abscesses associated in these animals. Do not allow horses or other with Fusobacterium equines access to feed containing lubabegron and necrophorum and monensin. Ingestion of monensin by horses has Arcanobacterium been fatal. Monensin medicated cattle and goat pyogenes, and for feeds are safe for use in cattle and goats only. prevention and Consumption by unapproved species may result in control of toxic reactions. Feeding undiluted or mixing coccidiosis due to errors resulting in high concentrations of Eimeria bovis and E. monensin has been fatal to cattle and could be zuernii during the fatal to goats. Must be thoroughly mixed in feeds last 14 to 91 days on before use. Do not exceed the levels of monensin feed. recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal. * * * * * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- 0 44. In Sec. 558.635, redesignate paragraphs (e)(1)(vii) through (ix) as paragraphs (e)(1)(ix) through (xi), respectively, and add new paragraphs (e)(1)(vii) and (viii) to read as follows: Sec. 558.635 Virginiamycin. * * * * * (e) * * * (1) * * * ---------------------------------------------------------------------------------------------------------------- Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Sponsors ---------------------------------------------------------------------------------------------------------------- * * * * * * * (vii) 20..................... Narasin, 54 to 90........... Broiler chickens: Feed as the sole 066104 For prevention of ration for broiler necrotic enteritis chickens. Do not caused by feed to chickens Clostridium producing eggs for perfringens human consumption. susceptible to Do not allow adult virginiamycin and turkeys, horses, for the prevention or other equines of coccidiosis access to narasin caused by Eimeria formulations. necatrix, E. Ingestion of tenella, E. narasin by these acervulina, E. species has been brunetti, E. fatal. Naracin as mivati, and E. provided by No. maxima. 066104 in Sec. 510.600(c) of this chapter. (viii) 20.................... Narasin, 27 to 54 plus Broiler chickens: Feed as the sole 066104 nicarbazin, 27 to 54. For prevention of ration for broiler necrotic enteritis chickens. Do not caused by feed to chickens Clostridium producing eggs for perfringens human consumption. susceptible to Nicarbazin virginiamycin and medicated broilers for the prevention may show reduced of coccidiosis heat tolerance if caused by Eimeria exposed to high necatrix, E. temperature and tenella, E. high humidity. acervulina, E. Provide adequate brunetti, E. drinking water and mivati, and E. ventilation during maxima. these periods. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Naracin as provided by No. 066104 in Sec. 510.600(c) of this chapter. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * Dated: February 15, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023-03649 Filed 3-9-23; 8:45 am] BILLING CODE 4164-01-P