[Federal Register Volume 88, Number 157 (Wednesday, August 16, 2023)] [Rules and Regulations] [Pages 55559-55571] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2023-17454] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 500, 510, 516, 520, 522, 524, 526, 529, 556 and 558 [Docket No. FDA-2023-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 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), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (cNADAs) during April, May, and June 2023. 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 their accuracy and readability. DATES: This rule is effective August 16, 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, ANADAs, and cNADAs during April, May, and June 2023, 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 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, ANADAs, and cNADAs Approved During April, May, and June 2023 Requiring Evidence of Safety and/or Effectiveness -------------------------------------------------------------------------------------------------------------------------------------------------------- 21 CFR Approval date File No. Sponsor Product name Effect of the action Public documents section -------------------------------------------------------------------------------------------------------------------------------------------------------- April 5, 2023................... 200-612 Bimeda Animal Health BIMASONE Original approval for FOI Summary 522.960c Ltd., 1B The Herbert (flumethasone) the treatment of Building, The Park, Injectable Solution. various inflammatory Carrickmines, Dublin conditions in horses, 18, Ireland. dogs, and cats as a generic copy of NADA 030-414. April 10, 2023.................. 038-439 Phibro Animal Health TERRAMYCIN for Fish Supplemental approval FOI Summary 558.450 Corp., GlenPointe (oxytetracycline) for the control of Centre East, 3d Floor, Type A Medicated mortality due to 300 Frank W. Burr Article. columnaris disease in Blvd., Suite 21, catfish and Teaneck, NJ 07666. freshwater-reared salmonids. [[Page 55560]] April 20, 2023.................. 141-570 Boehringer Ingelheim NEXGARD COMBO Original approval for FOI Summary 524.838 Animal Health USA, (esafoxolaner, prevention of Inc., 3239 Satellite eprinomectin, and heartworm disease; Blvd., Duluth, GA praziquantel) Topical for treatment and 30096. Solution. prevention of flea infestations, treatment and control of tick infestations, roundworms, hookworms, and tapeworms in cats and kittens. May 1, 2023..................... 141-571 Elanco US Inc., 2500 VARENZIN-CA1 Conditional approval FOI Summary 516.1449 Innovation Way, (molidustat oral for the control of Greenfield, IN 46140. suspension). nonregenerative anemia associated with chronic kidney disease (CKD) in cats. May 5, 2023..................... 141-562 Zoetis Inc., 333 LIBRELA (bedinvetmab Original approval for FOI Summary 522.158 Portage St., injection) Injectable the control of pain Kalamazoo, MI 49007. Solution. associated with osteoarthritis in dogs. May 10, 2023.................... 200-748 Huvepharma EOOD, 5th PENNCHLOR Original approval for FOI Summary 558.128 Floor, 3A Nikolay (chlortetracycline multiple indications Haytov Str., 1113 Type A medicated in beef calves 2 Sofia, Bulgaria. article) and MONOVET months of age and (monensin Type A older and in growing medicated article) to beef steers and be used in the heifers fed in manufacture of Type B confinement for and Type C medicated slaughter as a feeds. generic copy of NADA 141-564. May 25, 2023.................... 200-750 Cronus Pharma DORAJECT (doramectin Original approval for FOI Summary 522.770 Specialities India injection) Injectable treatment and control Private Ltd., Sy No-99/ Solution. of internal and 1, M/s GMR Hyderabad external parasites of Aviation SEZ Ltd., cattle and swine as a Mamidipalli Village, generic copy of NADA Shamshabad Mandal, 141-061. Ranga Reddy, Hyderabad, Telangana, 501218, India. June 9, 2023.................... 141-555 Zoetis Inc., 333 APOQUEL CHEWABLE Original approval for FOI Summary 520.1604 Portage St., (oclacitinib tablet) control of pruritus Kalamazoo, MI 49007. Tablets. associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. June 21, 2023................... 141-406 Boehringer Ingelheim NEXGARD (afoxolaner) Supplemental approval FOI Summary 520.43 Animal Health USA, Chewable Tablet. for Asian longhorned Inc., 3239 Satellite tick. Blvd., Duluth, GA 30096. June 22, 2023................... 200-751 Pegasus Laboratories, Firocoxib Chewable Original approval for FOI Summary 520.928 Inc., 8809 Ely Rd., Tablets for Dogs the control of pain Pensacola, FL 32514. (firocoxib). and inflammation associated with osteoarthritis and for the control of postoperative pain and inflammation associated with soft- tissue and orthopedic surgery in dogs as a generic copy of NADA 141-230. -------------------------------------------------------------------------------------------------------------------------------------------------------- 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 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 April, May, and June 2023 To Change the Marketing Status of Antimicrobial Animal Drug Products From OTC to Rx ---------------------------------------------------------------------------------------------------------------- 21 CFR Approval date File No. Sponsor Product name section ---------------------------------------------------------------------------------------------------------------- April 14, 2023.................... 200-147 Huvepharma EOOD, 5th GENTAPOULT (gentamicin) 522.1044 Floor, 3A Nikolay Haytov Injectable Solution. Str., 1113 Sofia, Bulgaria. April 24, 2023.................... 065-481 Cronus Pharma Chlortetracycline 520.443 Specialities India Pneumonia/Calf Scour Private Ltd., Sy No-99/ Bolus. 1, M/s GMR Hyderabad Aviation SEZ Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, India. April 24, 2023.................... 200-128 Huvepharma EOOD, 5th AGRIMYCIN 200 522.1660a Floor, 3A Nikolay Haytov (oxytetracycline HCl) Str., 1113 Sofia, Injectable Solution. Bulgaria. [[Page 55561]] April 28, 2023.................... 108-963 Cronus Pharma MEDAMYCIN 100 522.1662 Specialities India (oxytetracycline HCl) Private Ltd., Sy No-99/ Injectable Solution. 1, M/s GMR Hyderabad Aviation SEZ Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, India. April 28, 2023.................... 097-452 Do....................... OXYJECT 100 522.1662 (oxytetracycline HCl) Injectable Solution. April 28, 2023.................... 047-278 Do....................... OXY-TET 50 522.1662 (oxytetracycline HCl) Injectable Solution. April 28, 2023.................... 045-143 Do....................... OXYJECT 50 522.1662 (oxytetracycline HCl) Injectable Solution. May 15, 2023...................... 140-270 Huvepharma EOOD, 5th SULFATECH SR 520.2260b Floor, 3A Nikolay Haytov (sulfamethazine Str., 1113 Sofia, sustained release bolus). Bulgaria. May 15, 2023...................... 200-306 Norbrook Laboratories Oxytetracycline Injection 522.1660a Ltd., Carnbane 200. Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom. May 16, 2023...................... 120-615 Bimeda Animal Health SUSTAIN III 520.2260b Ltd., 1B The Herbert (sulfamethazine) Calf Building, The Park, Bolus. Carrickmines, Dublin 18, Ireland. May 17, 2023...................... 200-224 Elanco US Inc., 2500 COMPONENT T-S with TYLAN; 522.2476 Innovation Way, COMPONENT T-H with TYLAN Greenfield, IN 46140. (trenbolone acetate and tylosin tartrate) Implants. May 19, 2023...................... 200-364 Bimeda Animal Health SPECTOGARD Scour-Chek 520.2123c Ltd., 1B The Herbert (spectinomycin Building, The Park, dihydrochloride Carrickmines, Dublin 18, pentahydrate) Oral Ireland. Solution. May 22, 2023...................... 035-455 Do....................... ERYTHRO-36 Dry 526.820 (erythromycin) IMM Infusion. May 22, 2023...................... 200-452 Norbrook Laboratories OXYTET 100 522.1662 Ltd., Carnbane (oxytetracycline HCl) Industrial Estate, Injectable Solution. Newry, County Down, BT35 6QQ, United Kingdom. May 26, 2023...................... 200-068 Huvepharma EOOD, 5th Oxytetracycline 522.1662 Floor, 3A Nikolay Haytov Hydrochloride Injection, Str., 1113 Sofia, 100 mg/mL. Bulgaria. May 30, 2023...................... 055-097 HQ Specialty Pharma DRY-MAST 526.1697 Corp., 120 Rte. 17 (dihydrostreptomycin North, Suite 130, sulfate and penicillin G Paramus, NJ 07652. procaine). May 31, 2023...................... 200-008 Boehringer Ingelheim BIO-MYCIN 200 522.1660a Animal Health USA, Inc., (oxytetracycline HCl) 3239 Satellite Blvd., Injectable Solution. Duluth, GA 30096. June 2, 2023...................... 065-383 Bimeda Animal Health FORMULA A-34; UNI BIOTIC 526.1696 Ltd., 1B The Herbert (penicillin G procaine) Building, The Park, 4 DOSE. Carrickmines, Dublin 18, Ireland. June 2, 2023...................... 200-537 Do....................... TETROXY-LA 522.1660a (oxytetracycline HCl) Injectable Solution. June 7, 2023...................... 200-154 Pharmgate Inc., 1800 Sir PENNOX 200 522.1660a Tyler Dr., Wilmington, (oxytetracycline HCl) NC 28405. Injectable Solution. June 8, 2023...................... 200-123 Huvepharma EOOD, 5th MAXIM-200 Injection 522.1660a Floor, 3A Nikolay Haytov (oxytetracycline HCl). Str., 1113 Sofia, Bulgaria. June 9, 2023...................... 200-117 Bimeda Animal Health OXYSHOT LA 522.1660a Ltd., 1B The Herbert (oxytetracycline HCl) Building, The Park, Injectable Solution. Carrickmines, Dublin 18, Ireland. June 15, 2023..................... 135-906 Elanco US Inc., 2500 COMPONENT E-H with TYLAN 522.2343 Innovation Way, (testosterone propionate Greenfield, IN 46140. and estradiol benzoate with tylosin tartrate) Implant. June 22, 2023..................... 200-221 Do....................... COMPONENT TE-G with 522.2477 TYLAN; COMPONENT TE-ID with TYLAN; COMPONENT TE- IS with TYLAN; COMPONENT TE-S with TYLAN (trenbolone acetate, estradiol, and tylosin tartrate) Implants. June 30, 2023..................... 200-346 Do....................... COMPONENT TE-200 with 522.2477 TYLAN; COMPONENT TE-H with TYLAN; COMPONENT TE- IH with TYLAN; (trenbolone acetate, estradiol, and tylosin tartrate) Implants. June 30, 2023..................... 110-315 Do....................... COMPONENT E-C with TYLAN; 522.1940 COMPONENT E-S with TYLAN (progesterone, estradiol benzoate, and tylosin tartrate) Implants. ---------------------------------------------------------------------------------------------------------------- II. Withdrawals of Approval The sponsors of the following files have requested that FDA withdraw approval of the applications listed in table 3 because the products are no longer manufactured or marketed. As provided in the regulatory text of this document, the cited animal drug regulations are amended to reflect these actions. Table 3--Applications for Which Approval Was Voluntarily Withdrawn During April, May, and June 2023 ------------------------------------------------------------------------ 21 CFR File No. Sponsor Product name section ------------------------------------------------------------------------ 140-954.................. Intervet, Inc., Type C 558.325 2 Giralda medicated Farms, swine feed Madison, NJ containing 07940. fenbendazole and lincomycin. 141-002.................. Boehringer OXY 1000 520.1660c Ingelheim (oxytetracycli Animal Health ne HCl) Calf USA, Inc., Bolus; OXY 500 3239 Satellite (oxytetracycli Blvd., Duluth, ne HCl) Calf GA 30096. Bolus. 200-191.................. Med-Pharmex, GENTASOL 529.1044b Inc., 2727 (gentamicin Thompson Creek sulfate Rd., Pomona, solution). CA 91767-1861. ------------------------------------------------------------------------ [[Page 55562]] III. Change of Sponsor Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140 has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 135-468 for CARBIGRAN 25 (nicarbazin) Type A Medicated Article to Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405. As provided in the regulatory text of this document, 21 CFR 558.366 is amended to reflect this action. IV. Change of Sponsor Address Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 has informed FDA that it has changed its address to 126 E. Lincoln Ave., Rahway, NJ 07065. As provided in the regulatory text of this document, the tabular listings in 21 CFR 510.600(c) are amended to reflect this action. V. Technical Amendments FDA is making the following amendments to improve the accuracy of the animal drug regulations.21 CFR 500.1410 and 522.1660a are amended to reflect the use of N-methyl-2-pyrrolidone as an excipient in a formulation of oxytetracycline injectable solution. 21 CFR 520.1484 is being revised to include use of neomycin administered in drinking water of turkeys. 21 CFR 520.1660a is being redesignated as 21 CFR 520.1664 to reflect the drug as a fixed-ratio combination of oxytetracycline and carbomycin. 21 CFR 520.1660b is being revised to reflect the format and content of a prescription drug. 21 CFR 520.2220b is amended to reflect revised conditions of use for sulfadimethoxine oral suspension in dogs and cats. 21 CFR 520.2220c is amended to reflect revised conditions of use for sulfadimethoxine tablets in dogs and cats. 21 CFR 520.2260b is amended to reflect current sponsors of sulfamethazine sustained-release boluses for use in cattle. 21 CFR 522.2680 is amended to reflect revised conditions of use for zeranol implants in beef cattle. 21 CFR 529.1044a is amended to reflect sponsors of approved applications for use of gentamicin solution for uterine infusion in mares. 21 CFR 556.110 and 556.500 are being revised to reflect redesignation of a combination drug containing oxytetracycline and carbomycin used in the drinking water of chickens. 21 CFR 558.68 is being revised to reflect approved feeding instructions for avilamycin and monensin two-way, combination drug Type C medicated chicken feed. 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, Labeling, Packaging and containers, Polychlorinated biphenyls (PCBs). 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Part 516 Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements. 21 CFR Parts 520, 522, 524, 526, and 529 Animal drugs. 21 CFR Part 556 Animal drugs, Dairy products, Foods, Meat and meat products. 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, 516, 520, 522, 524, 526, 529, 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 (c) to read as follows: Sec. 500.1410 N-methyl-2-pyrrolidone. * * * * * (c) Related conditions of use. See Sec. Sec. 522.814, 522.955, and 522.1660a of this chapter. 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, in the table in paragraph (c)(1), revise the entry for ``Intervet, Inc.'' and in the table in paragraph (c)(2), revise the entry for ``000061'' to read as follows: Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * * * (c) * * * (1) * * * [[Page 55563]] ------------------------------------------------------------------------ Firm name and address Drug labeler code ------------------------------------------------------------------------ * * * * * * * Intervet, Inc., 126 E Lincoln Ave., Rahway, NJ 000061 07065............................................ * * * * * * * ------------------------------------------------------------------------ (2) * * * ------------------------------------------------------------------------ Drug labeler code Firm name and address ------------------------------------------------------------------------ * * * * * * * 000061...................... Intervet, Inc., 126 E Lincoln Ave., Rahway, NJ 07065 * * * * * * * ------------------------------------------------------------------------ PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES 0 5. The authority citation for part 516 continues to read as follows: Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371. 0 6. Add Sec. 516.1449 to read as follows: Sec. 516.1449 Molidustat oral suspension. (a) Specifications. Each milliliter (mL) of suspension contains 25 milligrams (mg) molidustat sodium. (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Amount. Administer orally at a dosage of 5 mg/kg of body weight (2.3 mg/lb) daily for up to 28 consecutive days. (2) Indications for use. For the control of nonregenerative anemia associated with chronic kidney disease in cats. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling. PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 0 7. The authority citation for part 520 continues to read as follows: Authority: 21 U.S.C. 360b. 0 8. In Sec. 520.43, revise paragraphs (c)(1) and (2) to read as follows: Sec. 520.43 Afoxolaner. * * * * * (c) * * * (1) Amount. Administer orally once a month at a minimum dosage of 1.14 mg/pound (2.5 mg/kilogram). (2) Indications for use. Kills adult fleas and for the treatment and prevention of flea infestations (Ctenocephalides felis); and the treatment and control of Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for 1 month; and for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. * * * * * 0 9. In Sec. 520.443, revise paragraph (d)(1)(ii) to read as follows: Sec. 520.443 Chlortetracycline tablets and boluses. * * * * * (d) * * * (1) * * * (ii) Limitations. Administer bolus directly by mouth or crush and dissolve in milk or water for drenching or bucket feeding. Do not use for more than 5 days. Do not administer within 24 hours of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. * * * * * Sec. 520.928 [Amended] 0 10. In Sec. 520.928, in paragraph (b)(1), remove ``Nos. 000010 and 055529'' and add in its place ``Nos. 000010, 055246, and 055529''. 0 11. In Sec. 520.1484, revise paragraph (b)(3) and add paragraph (b)(4) to read as follows: Sec. 520.1484 Neomycin. * * * * * (b) * * * (3) Nos. 016592, 054771, and 058005 for use of product described in paragraph (a)(2) as in paragraph (e)(1) of this section. (4) No. 054925 for use of product described in paragraph (a)(2) as in paragraphs (e)(1) and (2) of this section. * * * * * Sec. 520.1604 [Amended] 0 12. In Sec. 520.1604, in paragraph (a), remove ``Each tablet contains'' and add in its place ``Each tablet or chewable tablet contains''. Sec. 520.1660a [Redesignated as Sec. 520.1664] 0 13. Redesignate Sec. 520.1660a as Sec. 520.1664. Sec. 520.1660a [Reserved] 0 14. Add reserved Sec. 520.1660a. 0 15. In Sec. 520.1660b, revise the section heading and paragraphs (a) and (c) to read as follows: Sec. 520.1660b Oxytetracycline capsules. (a) Specifications. Each capsule contains 125 or 250 milligrams (mg) oxytetracycline hydrochloride. * * * * * (c) Conditions of use in dogs and cats--(1) Amount. Administer orally 25 to 50 mg per pound of body weight per day in divided doses at 12-hour intervals. (2) Indications for use. For the treatment of bacterial pneumonia caused by Brucella bronchiseptica, tonsilitis caused by Streptococcus hemolyticus, bacterial enteritis caused by Escherichia coli, urinary tract infections caused by Escherichia coli, and wound infections caused by Staphylococcus aureus. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 16. In Sec. 520.1660c, revise the section heading and paragraphs (a), (b), and (d) to read as follows: [[Page 55564]] Sec. 520.1660c Oxytetracycline tablets. (a) Specifications. Each tablet contains 250 or 500 milligrams (mg) oxytetracycline hydrochloride. (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter. * * * * * (d) Conditions of use in beef and dairy cattle--(1) Amounts. 10 mg per pound of body weight every 12 hours for treatment; 5 mg per pound of body weight every 12 hours for control. (2) Indications for use. For treatment and control of bacterial enteritis caused by Salmonella typhimurium and Escherichia coli (colibacillosis) and bacterial pneumonia (shipping fever complex, pasteurellosis) caused by Pasteurella multocida. (3) Limitations. 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 17. In Sec. 520.2220b, revise paragraphs (c)(1) and (2) to read as follows: Sec. 520.2220b Sulfadimethoxine suspension. * * * * * (c) * * * (1) Amount. Administer orally 25 mg per pound of body weight, followed by 12.5 mg per pound of body weight daily until the animal is free of clinical signs for 48 hours. (2) Indications for use. For the treatment of sulfadimethoxine- susceptible bacterial infections in dogs and cats and enteritis associated with coccidiosis in dogs. * * * * * 0 18. In Sec. 520.2220c, revise paragraphs (d)(1) and (2) to read as follows: Sec. 520.2220c Sulfadimethoxine tablet. * * * * * (d) * * * (1) Amount. Administer orally 25 mg per pound of body weight, followed by 12.5 mg per pound of body weight daily until the animal is free of clinical signs for 48 hours. (2) Indications for use. For the treatment of sulfadimethoxine- susceptible bacterial infections in dogs and cats and enteritis associated with coccidiosis in dogs. * * * * * 0 19. In Sec. 520.2260b, revise paragraphs (d)(2)(iii), (f)(2)(iii), and (g)(2)(iii) and remove paragraph (h). The revisions read as follows: Sec. 520.2260b Sulfamethazine sustained-release boluses. * * * * * (d) * * * (2) * * * (iii) Limitations. Do not use in female dairy cattle 20 months of age or older. Use of sulfamethazine in this class of cattle may cause milk residues. Do not treat animals within 12 days of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. * * * * * (f) * * * (2) * * * (iii) Limitations. For use in ruminating replacement calves only. Do not slaughter animals for food for at least 12 days after the last dose. Exceeding two consecutive doses may cause violative tissue residue to remain beyond the withdrawal time. Do not use in calves under 1 month of age or calves being fed an all milk diet. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (g) * * * (2) * * * (iii) Limitations. For use in beef cattle and nonlactating dairy cattle only. Do not slaughter animals for food for at least 8 days after the last dose. Do not use in lactating dairy cattle. Do not administer more than two consecutive doses. Federal law restricts this drug to use by or on the order of a licensed veterinarian. PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 20. The authority citation for part 522 continues to read as follows: Authority: 21 U.S.C. 360b. 0 21. Add Sec. 522.158 to read as follows: Sec. 522.158 Bedinvetmab. (a) Specifications. Each single-use vial contains 5, 10, 15, 20, or 30 milligrams (mg) bedinvetmab in an extractable volume of 1 milliliter. (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Amount. Administer 0.23 mg/pound (0.5 mg/kilogram) body weight monthly by subcutaneous injection. (2) Indications for use. For the control of pain associated with osteoarthritis in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 22. In Sec. 522.770, revise paragraphs (b), (d)(1)(iii), and (d)(2)(iii) to read as follows: Sec. 522.770 Doramectin. * * * * * (b) Sponsors. See Nos. 054771 and 069043 in Sec. 510.600(c) of this chapter. * * * * * (d) * * * (1) * * * (iii) Limitations. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Administer as a single subcutaneous or intramuscular injection. Do not slaughter cattle for human consumption within 35 days of treatment. Not for use in female dairy cattle 20 months of age or older. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. (2) * * * (iii) Limitations. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Administer as a single intramuscular injection. Do not slaughter swine for human consumption within 24 days of treatment. 0 23. In Sec. 522.960c, revise paragraphs (b) and (c)(1)(iii) to read as follows: Sec. 522.960c Flumethasone solution. * * * * * (b) Sponsors. See Nos. 054771 and 061133 in Sec. 510.600(c) of this chapter. (c) * * * (1) * * * (iii) Limitations. Not for use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. * * * * * Sec. 522.1222 [Amended] 0 24. In Sec. 522.1222, in paragraph (b), remove ``063286,''. 0 25. In Sec. 522.1660a: 0 a. Revise paragraph (c); 0 b. Remove paragraph (d); 0 c. Redesignate paragraph (e) as paragraph (d); and 0 d. Revise newly redesignated paragraphs (d)(1)(ii) and (d)(2)(ii). The revisions read as follows: Sec. 522.1660a Oxytetracycline solution, 200 milligrams/milliliter. * * * * * (c) Related tolerances. See Sec. 556.500 of this chapter; and for No. 061133, see also Sec. 500.1410 of this chapter. (d) * * * (1) * * * (ii) Limitations. Discontinue treatment at least 28 days prior to slaughter. Milk taken from animals during treatment and for 96 hours after the last treatment [[Page 55565]] must not be used for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) * * * (ii) Limitations. Administer intramuscularly. Do not inject more than 5 mL per site in adult swine. Discontinue treatment at least 28 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 26. In Sec. 522.1662, revise paragraphs (b), (c), (g), (h), and (j) to read as follows: Sec. 522.1662 Oxytetracycline. * * * * * (b)(1) Specifications. Each milliliter (mL) of solution contains 50 milligrams (mg) oxytetracycline hydrochloride. (2) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter. (3) Conditions of use--(i) Amount. Administer 3 to 5 mg per pound of body weight (mg/lb) per day by intramuscular injection. Leptospirosis, severe foot-rot, and severe forms of the indicated diseases should be treated with 5 mg/lb per day. Treatment should be continued for 24 to 48 hours following remission of clinical signs of disease, not to exceed 4 consecutive days. Not more than 10 mL should be injected per injection site in adult cattle, and only 2 mL per injection site in calves weighing 100 pounds or less. (ii) Indications for use. Beef cattle, beef calves, nonlactating dairy cattle, and dairy calves; for treatment of diseases due to oxytetracycline-susceptible organisms as follows: Pneumonia and shipping fever complex (Pasteurella spp., Haemophilus spp., Klebsiella spp.), bacterial enteritis (scours) (Escherichia coli), foot-rot (Spherophorus necrophorus), diphtheria (Spherophorus necrophorus), wooden tongue (Actinobacillus lignieresii), leptospirosis (Leptospira pomona), and wound infections and acute metritis caused by Staphylococcus spp. and Streptococcus spp. (iii) Limitations. Discontinue treatment at least 20 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (c)(1) Specifications. Each milliliter (mL) of solution contains 50 or 100 milligrams (mg) oxytetracycline hydrochloride. (2) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter. (3) Conditions of use--(i) Beef cattle and nonlactating dairy cattle--(A) Amount. Administer 3 to 5 mg per pound of body weight (mg/ lb) per day; 5 mg/lb per day for the treatment of anaplasmosis, severe foot-rot, and severe cases of other indicated diseases. For 50-mg/mL solution, administer intramuscularly or intravenously; for 100-mg/mL solution, administer intramuscularly only. Treatment should be continued for 24 to 48 hours following remission of clinical signs of disease, not to exceed 4 consecutive days. (B) Indications for use. For treatment of diseases due to oxytetracycline-susceptible organisms as follows: Pneumonia and shipping fever complex associated with Pasteurella spp., Haemophilus spp., and Klebsiella 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, anaplasmosis caused by Anaplasma marginale; and wound infections and acute metritis caused by Staphylococcus spp. and Streptococcus spp. (C) Limitations. Exceeding the highest recommended dose of 5 mg/lb, administering at recommended levels for more than 4 consecutive days, and/or exceeding 10 mL intramuscularly per injection site may result in antibiotic residues beyond the withdrawal time. Discontinue treatment at least 18 days prior to slaughter. Not for use in lactating dairy cattle. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (ii) Swine--(A) Amount. Administer 3 to 5 mg/lb per day by intramuscular injection. Sows: Administer 3 mg/lb by intramuscular injection approximately 8 hours before farrowing or immediately after completion of farrowing. (B) Indications for use. For treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli, pneumonia caused by Pasteurella multocida, and leptospirosis caused by Leptospira pomona. Sows: as an aid in control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli. (C) Limitations. Do not inject more than 5 mL per injection site. Do not use for more than 4 consecutive days. Discontinue treatment at least 26 days before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. * * * * * (g)(1) Specifications. Each milliliter (mL) of solution contains 100 milligrams (mg) oxytetracycline hydrochloride. (2) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter. (3) Conditions of use. For the treatment of diseases due to oxytetracycline-susceptible organisms as follows: (i) Beef cattle, beef calves, nonlactating dairy cattle, and dairy calves--(A) Amount. Administer 3 to 5 mg/lb body weight per day by intramuscular, intravenous, or subcutaneous injection. In severe forms of the indicated diseases, administer 5 mg/lb body weight per day. Continue treatment 24 to 48 hours following remission of clinical signs of disease, not to exceed 4 consecutive days. (B) Indications for use. For the treatment of pneumonia and shipping fever complex associated with Pasteurella spp., Haemophilus spp., or Klebsiella spp. (C) Limitations. Do not inject more than 10 mL per intramuscular injection site in adult cattle, and no more than 1 mL per site in calves weighing 100 pounds or less. Do not slaughter cattle for 13 days after intramuscular or intravenous treatment, or 2 days after subcutaneous treatment. Exceeding the highest recommended dosage or duration of treatment (not more than 4 consecutive days) may result in residues beyond the withdrawal period. A withdrawal period has not been established for use of 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. (ii) Swine--(A) Amount. Administer 3 to 5 mg/lb body weight per day by intramuscular injection. Sows: Administer 3 mg/lb body weight once, by intramuscular injection, approximately 8 hours before farrowing or immediately after completion of farrowing. (B) Indications for use. For treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli, pneumonia caused by Pasteurella multocida, and leptospirosis caused by Leptospira pomona. Sows: As an aid in control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli. (C) Limitations. Do not inject more than 5 mL per site. Discontinue treatment at least 20 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (h)(1) Specifications. Each milliliter (mL) of solution contains 50 or 100 milligrams (mg) oxytetracycline hydrochloride. (2) Sponsors. See No. 069043 in Sec. 510.600(c) of this chapter for use of 50- and 100-mg/mL solution and Nos. 016592 and 055529 in Sec. 510.600(c) of this chapter for use of 100-mg/mL solution. (3) Conditions of use in beef cattle, beef calves, nonlactating dairy cattle, [[Page 55566]] and dairy calves--(i) Amount. Administer 3 to 5 mg/lb body weight per day by intramuscular injection; 5 mg/lb body weight per day for treatment of severe forms of the indicated diseases. (ii) Indications for use. For treatment of bacterial pneumonia and shipping fever complex associated with Pasteurella spp., foot-rot and calf diphtheria caused by Fusobacterium necrophorum, bacterial enteritis (scours) caused by Escherichia coli, wooden tongue caused by Actinobacillus lignieresii; and wound infections and acute metritis caused by Staphylococcus spp. and Streptococcus spp. (iii) Limitations. Do not inject more than 10 mL per site in adult cattle. Reduce the volume administered per injection site according to age and body size. In calves weighing 100 pounds or less, do not inject more than 2 mL per site. Discontinue treatment at least 22 days before slaughter. Not for use in lactating dairy animals. 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. * * * * * (j)(1) Specifications. Each milliliter (mL) of solution contains either 50 or 100 milligrams (mg) of oxytetracycline hydrochloride. (2) Sponsor. See No. 061133 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/lb body weight daily by intravenous injection. Administer 5 mg/lb for anaplasmosis, severe foot rot, and severe forms of other diseases. Treatment should be continued 24 to 48 hours following remission of clinical signs of disease, but not to exceed 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, anaplasmosis caused by Anaplasma marginale and anthrax caused by Bacillus anthracis; and acute metritis and wound infections caused by staphylococcal and streptococcal organisms. (iii) Limitations. Not for use in lactating dairy cattle. Discontinue use at least 19 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 27. In Sec. 522.1940, revise paragraph (a), redesignate paragraph (c) as paragraph (d), and add new paragraph (c). The revision and addition read as follows: Sec. 522.1940 Progesterone and estradiol benzoate. (a) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for use as in paragraph (d) of this section. (1) No. 054771 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii) and (iii), (d)(2)(i)(A), (d)(2)(ii) and (iii), and (d)(3) of this section. (2) No. 058198 for use as in paragraphs (d)(1) and (2) of this section. * * * * * (c) Special considerations. Labeling of implants described in paragraphs (d)(1)(i)(B) and (d)(2)(i)(B) of this section shall bear the following: ``Federal law restricts this drug to use by or on the order of a licensed veterinarian.''. * * * * * 0 28. In Sec. 522.2343, revise paragraph (a), redesignate paragraph (c) as paragraph (d), and add new paragraph (c). The revision and addition read as follows: Sec. 522.2343 Testosterone propionate and estradiol benzoate. (a) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for use as in paragraph (d) of this section. (1) No. 054771 for use as in paragraphs (d)(1)(i) and (d)(2) and (3) of this section. (2) No. 058198 for use as in paragraph (d) of this section. * * * * * (c) Special considerations. Labeling of implants described in paragraph (d)(1)(ii) of this section shall bear the following: ``Federal law restricts this drug to use by or on the order of a licensed veterinarian.'' * * * * * 0 29. In Sec. 522.2476, revise paragraph (a), redesignate paragraph (c) as paragraph (d), and add new paragraph (c). The revision and addition read as follows: Sec. 522.2476 Trenbolone acetate. (a) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for use as in paragraph (d) of this section. (1) No. 000061 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii) and (iii), (d)(2)(i)(A), and (d)(2)(ii) and (iii) of this section. (2) No. 058198 for use as in paragraph (d) of this section. * * * * * (c) Special considerations. Labeling of implants described in paragraph (d)(1)(i)(B) and (d)(2)(i)(B) of this section shall bear the following: ``Federal law restricts this drug to use by or on the order of a licensed veterinarian.''. * * * * * 0 30. In Sec. 522.2477, redesignate paragraphs (b) and (c) as paragraphs (a) and (b) and add new paragraph (c) to read as follows: Sec. 522.2477 Trenbolone acetate and estradiol. * * * * * (c) Special considerations. Labeling of implants described in paragraphs (d)(1)(i)(B), (E), and (F), (d)(2)(i)(B), (E), and (F), and (d)(3)(i)(B) of this section shall bear the following: ``Federal law restricts this drug to use by or on the order of a licensed veterinarian.''. * * * * * 0 31. In Sec. 522.2680, revise paragraphs (d)(1)(ii)(A) and (B) and (d)(1)(iii) to read as follows: Sec. 522.2680 Zeranol. * * * * * (d) * * * (1) * * * (ii) * * * (A) Weaned beef calves, growing beef cattle, feedlot steers, and feedlot heifers: For increased rate of weight gain and improved feed conversion. (B) Suckling calves: For increased rate of weight gain. (iii) Limitations. Implant pellets subcutaneously only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant within a single production phase 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 evaluated. A withdrawal period has not been established for this product in preruminating calves. Do not use in replacement beef heifers after weaning or in bulls, dairy cows, or replacement dairy heifers. * * * * * PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0 32. The authority citation for part 524 continues to read as follows: Authority: 21 U.S.C. 360b. 0 33. Add Sec. 524.838 to read as follows: Sec. 524.838 Esafoxolaner, eprinomectin, and praziquantel. (a) Specifications. Each milliliter (mL) of topical solution contains 12 [[Page 55567]] milligrams (mg) esafoxolaner, 4 mg eprinomectin, and 83 mg praziquantel. (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Amount. Administer the entire contents of a provided unit applicator topically once a month at a minimum dose of 0.055 mL/lb (0.12 mL/kg), which delivers a minimum dose of 0.66 mg/ lb (1.45 mg/kg) esafoxolaner, 0.23 mg/lb (0.51 mg/kg) eprinomectin, and 4.55 mg/lb (10.0 mg/kg) praziquantel. (2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis. Kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, the treatment and control of Ixodes scapularis (black- legged tick) and Amblyomma americanum (lone star tick) infestations, and the treatment and control of roundworms (fourth-stage larval and adult Toxocara cati), hookworms (fourth-stage larval and adult Ancylostoma tubaeforme; adult Ancylostoma braziliense), and tapeworms (Dipylidium caninum) in cats and kittens 8 weeks of age and older, and weighing 1.8 lbs or greater. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS 0 34. The authority citation for part 526 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 526.1696 [Amended] 0 35. In Sec. 526.1696, in paragraphs (d)(3) and (e)(3), in the last sentence, remove ``For No. 042791:''. 0 36. In Sec. 526.1697, add a sentence to the end of paragraph (d)(3) to read as follows: Sec. 526.1697 Penicillin G procaine and dihydrostreptomycin. (d) * * * (3) * * * Federal law restricts this drug to use by or on the order of a licensed veterinarian. * * * * * PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 0 37. The authority citation for part 529 continues to read as follows: Authority: 21 U.S.C. 360b. 0 38. In Sec. 529.1044a, revise paragraph (b) to read as follows: Sec. 529.1044a Gentamicin solution for infusion. * * * * * (b) Sponsors. See Nos. 000061, 016592, 054771, 058005, 058198, 061133, and 069043 in Sec. 510.600(c) of this chapter. * * * * * 0 39. In 529.1044b, revise paragraph (c)(3) to read as follows: Sec. 529.1044b Gentamicin solution for dipping eggs. * * * * * (c) * * * (3) Limitations. Eggs which have been dipped in the drug shall not be used for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 0 40. The authority citation for part 556 continues to read as follows: Authority: 21 U.S.C. 342, 360b, 371. 0 41. In Sec. 556.110, revise paragraph (c) to read as follows: Sec. 556.110 Carbomycin. * * * * * (c) Related conditions of use. See Sec. 520.1664 of this chapter. 0 42. In Sec. 556.500, revise paragraph (c) to read as follows: Sec. 556.500 Oxytetracycline. * * * * * (c) Related conditions of use. See Sec. Sec. 520.1660c, 520.1660d, 520.1664, 522.1660a, 522.1660b, 522.1662, 522.1664, 529.1660, 558.450, and 558.455 of this chapter. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 43. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 0 44. In Sec. 558.68, revise paragraph (e)(1)(ii) to read as follows: Sec. 558.68 Avilamycin. * * * * * (e) * * * (1) * * * ---------------------------------------------------------------------------------------------------------------- Avilamycin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (ii) 13.6 to 40.9............ Monensin, 90 to 110......... Broiler chickens: Feed this complete 058198 For the prevention Type C medicated of mortality feed as the sole caused by necrotic ration for 21 enteritis consecutive days. associated with To assure Clostridium responsible perfringens; and antimicrobial drug as an aid in the use in broiler prevention of chickens, coccidiosis caused treatment by Eimeria administration necatrix, E. must begin on or tenella, E. before 18 days of acervulina, E. age. See Sec. brunetti, E. 558.355(d) of this mivati, and E. chapter. Monensin maxima. as provided by No. 058198 in Sec. 510.600(c) of this chapter. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * 0 45. In Sec. 558.128, revise paragraphs (e)(4)(iii) and (iv), (e)(4)(ix) through (xiv), and (e)(4)(xviii) through (xx) to read as follows: Sec. 558.128 Chlortetracycline. * * * * * (e) * * * (4) * * * [[Page 55568]] -------------------------------------------------------------------------------------------------------------------------------------------------------- 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 016592 heifers fed in mg chlortetracycline per head per day 069254 confinement for and 50 to 480 mg monensin per head per slaughter over 400 lb: day. No additional improvement in feed For reduction of the efficiency has been shown from feeding incidence of liver monensin at levels greater than 30 abscesses and for grams per ton (360 mg monensin per improved feed head per day). For use in dry feeds efficiency. only. Not for use in liquid feed supplements. Do not allow horses or other equines 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 preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 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 016592 heifers fed in mg chlortetracycline per head per day 069254 confinement for and 0.14 to 0.42 mg monensin per lb. slaughter over 400 lb: body weight per day to provide, For reduction of the depending upon severity of coccidiosis incidence of liver challenge, up to 480 mg monensin per abscesses and for head per day. For use in dry feeds prevention and control only. Not for use in liquid feed of coccidiosis due to supplements. Do not allow horses or Eimeria bovis and other equines access to feed Eimeria zuernii. 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 preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 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 016592 heifers fed in mg chlortetracycline per lb. body 069254 confinement for weight per day and 50 to 480 mg slaughter over 700 lbs: monensin per head per day. No For control of active additional improvement in feed infection of efficiency has been shown from feeding anaplasmosis caused by monensin at levels greater than 30 Anaplasma marginale grams per ton (360 mg monensin per susceptible to head per day). For use in dry feeds chlortetracycline and only. Not for use in liquid feed for improved feed supplements. Do not allow horses or efficiency. other equines 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 preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 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 016592 heifers fed in mg chlortetracycline per lb. body 069254 confinement for weight per day and 0.14 to 0.42 mg slaughter over 700 lbs: monensin per lb. body weight per day For control of active to provide, depending upon severity of infection of coccidiosis challenge, up to 480 mg anaplasmosis caused by monensin per head per day. For use in Anaplasma marginale dry feeds only. Not for use in liquid susceptible to feed supplements. Do not allow horses chlortetracycline and or other equines access to feed for the prevention and containing monensin. Ingestion of control of coccidiosis monensin by horses has been fatal. due to Eimeria bovis Monensin medicated cattle and goat and Eimeria zuernii. 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 preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in Sec. 510.600(c) of this chapter. [[Page 55569]] (xi) 50 to 117 g/ton............. Monensin, 7.14 to 40................... Growing beef steers and Feed as the sole ration to provide 350 016592 heifers fed in mg chlortetracycline per head per day 069254 confinement for and 50 to 480 mg monensin per head per slaughter under 700 day. No additional improvement in feed lbs: For control of efficiency has been shown from feeding active infection of monensin at levels greater than 30 anaplasmosis caused by grams per ton (360 mg monensin per Anaplasma marginale head per day). For use in dry feeds susceptible to only. Not for use in liquid feed chlortetracycline and supplements. Do not allow horses or for improved feed other equines access to feed efficiency. 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 preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 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 016592 heifers fed in mg chlortetracycline per head per day 069254 confinement for and 0.14 to 0.42 mg monensin per lb. slaughter under 700 body weight per day to provide, lbs: For control of depending upon severity of coccidiosis active infection of challenge, up to 480 mg monensin per anaplasmosis caused by head per day. For use in dry feeds Anaplasma marginale only. Not for use in liquid feed susceptible to supplements. Do not allow horses or chlortetracycline and other equines access to feed for the prevention and containing monensin. Ingestion of control of coccidiosis monensin by horses has been fatal. due to Eimeria bovis Monensin medicated cattle and goat and Eimeria zuernii. 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 preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 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 016592 heifers fed in mg chlortetracycline per head per day 069254 confinement for and 50 to 480 mg monensin per head per slaughter: For the day. No additional improvement in feed control of bacterial efficiency has been shown from feeding pneumonia associated monensin at levels greater than 30 with shipping fever grams per ton (360 mg monensin per complex caused by head per day). For use in dry feeds Pasteurella spp. only. Not for use in liquid feed susceptible to supplements. Do not allow horses or chlortetracycline and other equines access to feed for improved feed containing monensin. Ingestion of efficiency. 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 preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 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 016592 heifers fed in mg chlortetracycline per head per day 069254 confinement for and 0.14 to 0.42 mg monensin per lb. slaughter: For the body weight per day to provide, control of bacterial depending upon severity of coccidiosis pneumonia associated challenge, up to 480 mg monensin per with shipping fever head per day. For use in dry feeds complex caused by only. Not for use in liquid feed Pasteurella spp. supplements. Do not allow horses or susceptible to other equines access to feed chlortetracycline and containing monensin. Ingestion of for the prevention and monensin by horses has been fatal. control of coccidiosis Monensin medicated cattle and goat due to Eimeria bovis feeds are safe for use in cattle and and Eimeria zuernii. 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 preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in Sec. 510.600(c) of this chapter. [[Page 55570]] * * * * * * * (xviii) 400 to 2,000 g/ton....... Monensin, 5 to 40...................... Growing beef steers and Feed as the sole ration to provide 10 016592 heifers fed in mg chlortetracycline per lb. body 069254 confinement for weight per day and 50 to 480 mg slaughter: For monensin per head per day. Feed for treatment of bacterial not more than 5 days, then continue enteritis caused by feeding monensin Type C medicated feed Escherichia coli and alone. No additional improvement in bacterial pneumonia feed efficiency has been shown from caused by Pasteurella feeding monensin at levels greater multocida susceptible than 30 grams per ton (360 mg monensin to chlortetracycline; per head per day). For use in dry for improved feed feeds only. Not for use in liquid feed efficiency. supplements. Do not allow horses or other equines 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 preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in Sec. 510.600(c) of this chapter. (xix) 400 to 2,000 g/ton......... Monensin, 10 to 40..................... Growing beef steers and Feed as the sole ration to provide 10 016592 heifers: For treatment mg chlortetracycline per lb. body 069254 of bacterial enteritis weight per day and 0.14 to 0.42 mg caused by Escherichia monensin per lb. body weight per day coli and bacterial to provide, depending upon severity of pneumonia caused by the coccidiosis challenge, up to 480 Pasteurella multocida mg monensin per head per day. Feed for susceptible to not more than 5 days, then continue chlortetracycline; and feeding monensin Type C medicated feed for the prevention and alone. For use in dry feeds only. Not control of coccidiosis for use in liquid feed supplements. Do due to Eimeria bovis not allow horses or other equines and Eimeria zuernii. 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 preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 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 016592 age and older: For mg chlortetracycline per lb. body 069254 treatment of bacterial weight per day and 0.14 to 1.00 mg enteritis caused by monensin per lb. body weight per day Escherichia coli and to provide, depending upon severity of bacterial pneumonia coccidiosis challenge, up to 200 mg of caused by Pasteurella monensin per head per day. Feed for multocida susceptible not more than 5 days, then continue to to chlortetracycline; feed monensin Type C medicated feed and for the prevention alone. For use in dry feeds only. Not and control of for use in liquid feed supplements. Do coccidiosis due to not allow horses or other equines Eimeria bovis and access to feed containing monensin. Eimeria zuernii. 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 preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in Sec. 510.600(c) of this chapter. * * * * * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- Sec. 558.325 [Amended] 0 46. In Sec. 558.325, remove and reserve paragraphs (e)(2)(ii), (viii), and (xiii). 0 47. In Sec. 558.366, revise paragraphs (b) and (d)(1)(v) to read as follows: Sec. 558.366 Nicarbazin. * * * * * (b) Sponsors. See Nos. 060728, 066104, and 069254 in Sec. 510.600(c) of this chapter. * * * * * (d) * * * (1) * * * [[Page 55571]] ---------------------------------------------------------------------------------------------------------------- Combination in grams per Nicarbazin in grams per ton ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (v) 113.5..................... ......................... Chickens: As an aid Feed continuously as 060728 in preventing sole ration from 069254 outbreaks of cecal time chicks are (Eimeria tenella) placed on litter and intestinal (E. until past the time acervulina, E. when coccidiosis is maxima, E. ordinarily a necatrix, and E. hazard. Do not use brunetti) as a treatment for coccidiosis. coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * 0 48. In Sec. 558.450, revise paragraphs (e)(5)(iv) and (v) to read as follows: Sec. 558.450 Oxytetracycline. * * * * * (e) * * * (5) * * * ------------------------------------------------------------------------ Indications for Oxytetracycline amount use Limitations Sponsor ------------------------------------------------------------------------ * * * * * * * (iv) 2.5 to 3.75 g/100 lb 1. Freshwater- Administer in 066104 of fish/day. reared mixed ration salmonids: For for 10 days. control of Do not ulcer disease liberate fish caused by or slaughter Haemophilus fish for food piscium, for 21 days furunculosis following the caused by last Aeromonas administration salmonicida, of medicated bacterial feed. hemorrhagic septicemia caused by A. hydrophila, and pseudomonas disease. 2. Catfish: For Administer in 066104 control of mixed ration bacterial for 10 days. hemorrhagic Do not septicemia liberate fish caused by A. or slaughter hydrophila and fish for food pseudomonas for 21 days disease. following the last administration of medicated feed. Do not administer when water temperature is below 16.7 [deg]C (62 F). (v) 3.75 g/100 lb of fish/ 1. Freshwater- Administer in 066104 day. reared mixed ration salmonids: For for 10 days. control of Do not mortality due liberate fish to coldwater or slaughter disease fish for food associated for 21 days with following the Flavobacterium last psychrophilum administration or for control of medicated of mortality feed. due to columnaris disease associated with Flavobacterium columnare. 2. Freshwater- Feed for 10 066104 reared days. salmonids Immediate weighing up to release is 55 grams: For permitted marking the following last skeletal feeding of tissue. medicated feed. 3. Catfish: For Administer in 066104 control of mixed ration mortality due for 10 days. to columnaris Do not disease liberate fish associated or slaughter with fish for food Flavobacterium for 21 days columnare. following the last administration of medicated feed. Do not administer when water temperature is below 16.7 [deg]C (62 F). * * * * * * * ------------------------------------------------------------------------ Dated: August 9, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023-17454 Filed 8-15-23; 8:45 am] BILLING CODE 4164-01-P