[Federal Register Volume 89, Number 231 (Monday, December 2, 2024)] [Rules and Regulations] [Pages 95101-95108] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2024-28061] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, and 558 [Docket No. FDA-2024-N-0002] New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor AGENCY: Food and Drug Administration, HHS. [[Page 95102]] 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 2024. The animal drug regulations are also being amended to improve their accuracy and readability. DATES: This rule is effective December 2, 2024. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine, 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 2024, 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 and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval under the Freedom of Information Act. These documents, along with marketing exclusivity and patent information, may be obtained at Animal Drugs @FDA: https://animaldrugsatfda.fda.gov/adafda/views/#/search. Table 1--Original and Supplemental NADAs and ANADAs Approved During July, August, and September 2024 Requiring Evidence of Safety and/or Effectiveness ---------------------------------------------------------------------------------------------------------------- Sponsor (drug Effect of the 21 CFR Date of approval File No. labeler code \1\) Product name action section ---------------------------------------------------------------------------------------------------------------- July 2, 2024............... 200-788 Bimeda Animal MOXISOLV Injection Original approval 522.1450 Health Ltd. (moxidectin). as a generic copy (061133). of NADA 141-220. July 8, 2024............... 200-771 Norbrook FELANORM Original approval 520.1372 Laboratories, Ltd. (methimazole) Oral as a generic copy (055529). Solution. of NADA 141-292. August 15, 2024............ 200-770 Pharmgate Inc. DERACIN Original approval 558.128 (069254). (chlortetracycline as a generic copy ) and MGA of NADA 141-530. (melengestrol acetate) Type C medicated feeds. August 26, 2024............ 200-783 Huvepharma EOOD COXIDIN 90 Original approval 558.355 (016592). (monensin) Type C as a generic copy medicated feeds. of NADA 038-878 and NADA 130-736. September 5, 2024.......... 200-795 Felix CARPROFEN Soft Original approval 520.304 Pharmaceuticals Chewable Tablets as a generic copy Pvt. Ltd. (086101). (carprofen). of NADA 141-111. September 5, 2024.......... 200-773 Cronus Pharma TULAJECT 100 Original approval 522.2630 Specialties India (tulathromycin as a generic copy Private Ltd. injection) of NADA 141-224. (069043). Injectable Solution. September 10, 2024......... 200-774 Do................. TULAJECT 25 Original approval Do. (tulathromycin as a generic copy injection) of NADA 141-349. Injectable Solution. September 19, 2024......... 141-585 Elanco US Inc. ZENRELIA Original approval 520.1136 (058198). (ilunocitinib for control of tablet). pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs. September 23, 2024......... 200-776 Pharmgate Inc. DERACIN Original approval 558.128 (069254. (chlortetracycline as a generic copy ), BOVATEC of NADA 141-531. (lasalocid), and MGA (melengestrol acetate) Type C medicated feeds. ---------------------------------------------------------------------------------------------------------------- \1\ See 21 CFR 510.600(c) for sponsor addresses. II. Withdrawals of Approval Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861 (drug labeler code 054925) requested that FDA withdraw approval of the two NADAs listed in table 2 because the products are no longer manufactured or marketed. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions. Table 2--Applications for Which Approval Was Voluntarily Withdrawn During July, August, and September 2024 ------------------------------------------------------------------------ Date of withdrawal of 21 CFR approval File No. Product name section ------------------------------------------------------------------------ August 8, 2024............. 130-872 Nitrofurazone 524.1580c Anesthetic Dressing (nitrofurazone and butacaine sulfate). Do......................... 140-881 Nitrofurazone 524.1580a Soluble Dressing (nitrofurazone). ------------------------------------------------------------------------ III. Change of Sponsor Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767 has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200-420 for Ceftiofur Sodium Sterile Powder to Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211. As provided in the regulatory text, the animal drug regulations are amended to reflect this action. IV. Technical Amendments FDA is making the following amendments to improve the accuracy and readability of the animal drug regulations:21 CFR 510.600(c) is amended to remove Cephazone Pharma, LLC and Provetica LLC from the lists of sponsors of approved applications as these firms are no longer the sponsor of an approved application. 21 CFR 520.522 is amended to reflect a 2023 change of sponsorship for cyclosporine oral solution. 21 CFR 520.2090 is amended to revise the description of a tablet containing sarolaner, moxidectin, and pyrantel. [[Page 95103]] 21 CFR 522.2470 is being amended to reflect previous approval of additional indications for use of tiletamine and zolazepam. V. Legal Authority This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)). Although deemed 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'' and 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. List of Subjects 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Parts 520, 522, and 524 Animal drugs. 21 CFR Part 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, 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. Sec. 510.600 [Amended] 0 2. In Sec. 510.600, in the table in paragraph (c)(1), remove the entries for ``Cephazone Pharma, LLC'' and ``Provetica LLC''; and in the table in paragraph (c)(2), remove the entries for ``068330'' and ``086097''. PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 0 3. The authority citation for part 520 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 520.304 [Amended] 0 4. In Sec. 520.304, in paragraph (b)(2), add in numerical order the text ``086101''. Sec. 520.522 [Amended] 0 5. In Sec. 520.522 in paragraph (b)(4), remove the text ``086097'' and add in its place the text ``013744''. 0 6. Add Sec. 520.1136 to read as follows: Sec. 520.1136 Ilunocitinib. (a) Specifications. Each tablet contains 4.8, 6.4, 8.5, and 15 milligrams (mg) ilunocitinib. (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Amount. Administer orally 0.27 to 0.36 mg ilunocitinib/lb (0.6 to 0.8 mg ilunocitinib/kg) body weight, once daily, with or without food. (2) Indications for use. For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Sec. 520.1372 [Redesignated as Sec. 520.1375] 0 7. Redesignate Sec. 520.1372 as Sec. 520.1375 and revise the section heading to read as follows: Sec. 520.1375 Methimazole tablets. * * * * * 0 8. Add Sec. 520.1376 to read as follows: Sec. 520.1376 Methimazole solution. (a) Specifications. Each milliliter of solution contains 5 milligrams (mg) methimazole. (b) Sponsor. See No. 055529 in Sec. 510.600(c) of this chapter. (c) Conditions of use in cats--(1) Amount. Administer a starting dose of 2.5 mg every 12 hours. Following 3 weeks of treatment, the dose should be titrated to effect based on individual serum total T4 (TT4) levels and clinical response. Dose adjustments should be made in 2.5 mg increments with a maximum dosage of 20 mg per day divided, not to exceed 10 mg as a single dose. (2) Indications for use. For the treatment of hyperthyroidism. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 9. In Sec. 520.2090, revise paragraph (a)(1) to read as follows: Sec. 520.2090 Sarolaner, moxidectin, and pyrantel. (a) * * * (1) 3.0 milligrams (mg) sarolaner, 0.06 mg moxidectin, and 12.5 mg pyrantel (as pamoate salt); * * * * * PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 10. The authority citation for part 522 continues to read as follows: Authority: 21 U.S.C. 360b. 0 11. In Sec. 522.313c, revise paragraph (b) to read as follows: Sec. 522.313c Ceftiofur sodium. * * * * * (b) Sponsors. See Nos. 017033 and 054771 in Sec. 510.600(c) of this chapter. * * * * * 0 12. In Sec. 522.1450, revise paragraph (b) to read as follows: Sec. 522.1450 Moxidectin solution. * * * * * (b) Sponsors. See Nos. 055529, 058198, and 061133 in Sec. 510.600(c) of this chapter. * * * * * 0 13. In Sec. 522.2470, revise the section heading and paragraph (b) to read as follows: Sec. 522.2470 Tiletamine and zolazepam. * * * * * (b) Sponsors. See Nos. 017033, 051311, and 054771 in Sec. 510.600(c) of this chapter. * * * * * Sec. 522.2630 [Amended] 0 14. In Sec. 522.2630, in paragraphs (b)(1) and (2), add in numerical order the text ``069043''. PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0 15. The authority citation for part 524 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 524.1580a [Amended] 0 16. Amend Sec. 524.1580a in paragraph (b)(1) by removing the text ``054925''. Sec. 524.1580c [Removed] 0 17. Remove Sec. 524.1580c. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 18. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 0 19. In Sec. 558.128, revise paragraphs (e)(4)(ii), (vi), (viii), (xxviii), (xxxi), (xxxii), (xxxv), (xxxvi), (xxxix), (xli), (xlii), (l), (lii), (liv), (lvi), (lvii), (lix), and (lx) to read as follows: Sec. 558.128 Chlortetracycline. * * * * * (e) * * * (4) * * * [[Page 95104]] ---------------------------------------------------------------------------------------------------------------- Combination in Indications for Chlortetracycline amount grams/ton use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (ii) 5.83 to 14 g/ton to Melengestrol Growing beef Melengestrol acetate Type C 054771 provide 70 mg/head/day. acetate, 0.25 to heifers fed in top-dress medicated feed 069254 2 g/ton to confinement for must be top dressed or provide 0.25 to slaughter (over mixed at feeding with the 0.5 mg 400 lb): For Type C medicated feed melengestrol reduction of the containing 5.83 to 14 g/ton acetate per head incidence of chlortetracycline. per day. liver abscesses, Chlortetracycline as increased rate of provided by Nos. 054771 or weight gain, 069254; melengestrol as improved feed provided by No. 054771 in efficiency, and Sec. 510.600(c) of this suppression of chapter. estrus (heat). * * * * * * * (vi) 33.33 to 50 g/ton to Melengestrol Replacement beef Melengestrol acetate Type C 054771 provide 0.5 mg/lb of body acetate, 0.5 to 2 heifers over 700 top-dress medicated feed 069254 weight per day. g/ton to provide lb: For control must be top dressed or 0.5 mg of active mixed at feeding with the melengestrol infection of Type C medicated feed acetate per head anaplasmosis containing 33.33 to 50 g/ per day. caused by ton chlortetracycline. Anaplasma Feeding a Type C top-dress marginale medicated feed containing susceptible to melengestrol acetate shall chlortetracycline not exceed 24 days. and for Chlortetracycline as suppression of provided by Nos. 054771 or estrus (heat). 069254; melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. * * * * * * * (viii) 25 to 1,100 g/ton to Lasalocid, 30 to Replacement beef The melengestrol acetate 054771 provide 0.5 mg/lb of body 600; melengestrol heifers on Type C top-dress medicated 069254 weight daily. acetate, 0.5 to 2 pasture over 700 feed must be top dressed g/ton to provide pounds: For onto or mixed at feeding 0.5 mg/head/day control of active with a Type C medicated melengestrol infection of feed containing 25 to 1,100 acetate. anaplasmosis g/ton of chlortetracycline caused by and 30 to 600 g/ton Anaplasma lasalocid to provide 0.5 mg marginale chlortetracycline per lb susceptible to body weight per day and not chlortetracycline less than 60 mg or more , increased rate than 300 mg lasalocid per of weight gain, head per day in at least 1 and suppression pound of feed. Do not of estrus (heat). exceed 24 days of feeding. See Sec. 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. * * * * * * * (xxviii) 500 to 4,000 g/ton to Lasalocid, 30 to Replacement dairy The melengestrol acetate 054771 provide 10 mg/lb of body 600: Melengestrol heifers on Type C top-dress medicated 069254 weight daily. acetate, 0.5 to 2 pasture less than feed must be top dressed g/ton to provide 20 months of age onto or mixed at feeding 0.5 mg/head/day and replacement with a Type C medicated melengestrol beef heifers on feed containing 500 to acetate. pasture: For 4,000 g/ton of treatment of chlortetracycline and 30 to bacterial 600 g/ton lasalocid to enteritis caused provide 10 mg by Escherichia chlortetracycline per lb coli and body weight per day and not bacterial less than 60 mg or more pneumonia caused than 300 mg lasalocid per by Pasteurella head per day in at least 1 multocida pound of feed for not more organisms than 5 days. After susceptible to completing feeding of this chlortetracycline combination, continue , increased rate feeding a Type C top-dress of weight gain, medicated feed containing and suppression melengestrol acetate alone of estrus (heat). for a total time not exceeding 24 days of feeding. See Sec. 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254, lasalocid and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. * * * * * * * (xxxi) 500 to 4,000 g/ton to Melengestrol Growing beef Melengestrol acetate Type C 054771 provide 10 mg/lb of body acetate, 0.25 to heifers fed in top-dress medicated feed 069254 weight daily. 2 g/ton to confinement for must be top dressed onto or provide 0.25 to slaughter: For mixed at feeding with a 0.5 mg the treatment of Type C medicated feed melengestrol bacterial containing 500 to 4,000 g/ acetate per head enteritis caused ton chlortetracycline for per day. by Escherichia not more than 5 days. After coli and completing feeding of this bacterial combination, continue pneumonia caused feeding a Type C top-dress by Pasteurella medicated feed containing multocida melengestrol acetate alone. organisms Chlortetracycline as susceptible to provided by Nos. 054771 or chlortetracycline 069254; melengestrol as , increased rate provided by No. 054771 in of weight gain, Sec. 510.600(c) of this improved feed chapter. efficiency, and suppression of estrus (heat). [[Page 95105]] (xxxii) 500 to 4,000 g/ton to Melengestrol Replacement dairy Melengestrol acetate Type C 054771 provide 10 mg/lb of body acetate, 0.5 to 2 heifers less than top-dress medicated feed 069254 weight daily. g/ton to provide 20 months of age must be top dressed or 0.5 mg and replacement mixed at feeding with a melengestrol beef heifers: For Type C medicated feed acetate per head the treatment of containing 500 to 4,000 g/ per day. bacterial ton chlortetracycline for enteritis caused not more than 5 days. After by Escherichia completing feeding of this coli and combination, continue bacterial feeding a Type C top-dress pneumonia caused medicated feed containing by Pasteurella melengestrol acetate alone multocida for a total time not organisms exceeding 24 days. Use in susceptible to dairy heifers less than 20 chlortetracycline months of age may cause , and for drug residues in milk and/ suppression of or in calves born to these estrus (heat). cows. A withdrawal period has not been established for this product in pre- ruminating calves. Do not use in calves to be processed for veal. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. * * * * * * * (xxxv) 4,000 to 20,000 g/ton to Melengestrol Growing beef Top dress 0.5 to 2 pounds of 054771 provide 10 mg/lb of body acetate, 0.25 to heifers fed in this medicated feed 069254 weight per day. 2 g/ton to confinement for containing both drugs onto provide 0.25 to slaughter: For or mix at feeding with a 0.5 mg the treatment of non-medicated feed for not melengestrol bacterial more than 5 days to provide acetate per head enteritis caused 10 mg chlortetracycline per per day. by Escherichia pound of body weight per coli and day. After completing bacterial feeding of this pneumonia caused combination, continue by Pasteurella feeding a Type C top-dress multocida medicated feed containing organisms melengestrol acetate alone. susceptible to A withdrawal period has not chlortetracycline been established for this , and for product in pre-ruminating increased rate of calves. Do not use in weight gain, calves to be processed for improved feed veal. Chlortetracycline as efficiency, and provided by Nos. 054771 or suppression of 069254; melengestrol as estrus (heat). provided by No. 054771 in Sec. 510.600(c) of this chapter. (xxxvi) 4,000 to 20,000 g/ton Melengestrol Replacement dairy Top dress 0.5 to 2 pounds of 054771 to provide 10 mg/lb of body acetate, 0.5 to 2 heifers less than this medicated feed 069254 weight per day. g/ton to provide 20 months of age containing both drugs onto 0.5 mg and replacement or mix at feeding with a melengestrol beef heifers: For non-medicated feed for not acetate per head the treatment of more than 5 days to provide per day. bacterial 10 mg chlortetracycline per enteritis caused pound of body weight per by Escherichia day. After completing coli and feeding of this bacterial combination, continue pneumonia caused feeding a Type C top-dress by Pasteurella medicated feed containing multocida melengestrol acetate alone organisms for a total time not susceptible to exceeding 24 days. Use in chlortetracycline dairy heifers less than 20 , and for months of age may cause suppression of drug residues in milk and/ estrus (heat). or in calves born to these cows. A withdrawal period has not been established for this product in pre- ruminating calves. Do not use in calves to be processed for veal. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. * * * * * * * (xxxix) 50 to 350 g/ton to Melengestrol Replacement beef Melengestrol acetate Type C 054771 provide 350 mg/head/day. acetate, 0.5 to 2 heifers under 700 top-dress medicated feed 069254 g/ton to provide lb: For control must be top dressed or 0.5 mg of active mixed at feeding with the melengestrol infection of Type C medicated feed acetate per head anaplasmosis containing 50 to 350 g/ton per day. caused by chlortetracycline for up to Anaplasma 24 days of feeding. marginale Chlortetracycline as susceptible to provided by Nos. 054771 or chlortetracycline 069254; melengestrol as and for provided by No. 054771 in suppression of Sec. 510.600(c) of this estrus (heat). chapter. * * * * * * * (xli) 20 to 350 g/ton to Melengestrol Growing beef Melengestrol acetate Type C 054771 provide 350 mg/head/day. acetate, 0.25 to heifers fed in top-dress medicated feed 069254 2 g/ton to confinement for must be top dressed onto or provide 0.25 to slaughter: For mixed at feeding with the 0.5 mg control of Type C medicated feed melengestrol bacterial containing 20 to 350 g/ton acetate per head pneumonia chlortetracycline. per day. associated with Chlortetracycline as shipping fever provided by Nos. 054771 or complex caused by 069254; melengestrol as Pasteurella spp. provided by No. 054771 in susceptible to Sec. 510.600(c) of this chlortetracycline chapter. , increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). [[Page 95106]] (xlii) 20 to 350 g/ton to Melengestrol Replacement dairy Melengestrol acetate Type C 054771 provide 350 mg/head/day. acetate, 0.5 to 2 heifers less than top-dress medicated feed 069254 g/ton to provide 20 months of age must be top dressed or 0.5 mg and replacement mixed at feeding with the melengestrol beef heifers: For Type C medicated feed acetate per head control of containing 20 to 350 g/ton per day. bacterial chlortetracycline. Feeding pneumonia a Type C top-dress associated with medicated feed containing shipping fever melengestrol acetate shall complex caused by not exceed 24 days of Pasteurella spp. feeding. Use in dairy susceptible to heifers less than 20 months chlortetracycline of age may cause drug and suppression residues in milk and/or in of estrus (heat). calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. * * * * * * * (l) 25 to 700 g/ton to provide Lasalocid, 30 to Replacement beef The melengestrol acetate 054771 350 mg/head/day. 600; melengestrol heifers on Type C top-dress medicated 069254 acetate, 0.5 to 2 pasture: For feed must be top dressed g/ton to provide control of onto or mixed at feeding 0.5 mg/head/day bacterial with a Type C medicated melengestrol pneumonia feed containing 25 to 700 g/ acetate. associated with ton of chlortetracycline shipping fever and 30 to 600 g/ton complex caused by lasalocid to provide 350 mg Pasteurella spp. chlortetracycline per head susceptible to daily and not less than 60 chlortetracycline mg or more than 300 mg , increased rate lasalocid per head daily in of weight gain, at least 1 pound of feed. and suppression Do not exceed 24 days of of estrus (heat). feeding. See Sec. 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. * * * * * * * (lii) 25 to 700 g/ton to Lasalocid, 30 to Replacement beef The melengestrol acetate 054771 provide 350 mg/head/day. 600; melengestrol heifers on Type C top-dress medicated 069254 acetate, 0.5 to 2 pasture under 700 feed must be top dressed g/ton to provide pounds: For onto or mixed at feeding 0.5 mg/head/day control of active with a Type C medicated melengestrol infection of feed containing 25 to 700 g/ acetate. anaplasmosis ton of chlortetracycline caused by and 30 to 600 g/ton Anaplasma lasalocid to provide 350 mg marginale chlortetracycline per head susceptible to daily and not less than 60 chlortetracycline mg or more than 300 mg , increased rate lasalocid per head daily in of weight gain, at least 1 pound of feed. and suppression Do not exceed 24 days of of estrus (heat). feeding. See Sec. 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. * * * * * * * (liv) 25 to 2,800 g/ton to Lasalocid, 30 to Growing beef The melengestrol acetate 054771 provide 350 mg/head/day. 181.8; heifers fed in Type C top-dress medicated 069254 melengestrol confinement for feed must be top dressed acetate, 0.25 to slaughter under onto or mixed at feeding 2 g/ton to 700 pounds: For with a Type C medicated provide 0.25 to control of active feed containing 25 to 2,800 0.5 mg/head/day infection of g/ton of chlortetracycline melengestrol anaplasmosis and 30 to 181.8 g/ton acetate. caused by lasalocid to provide 350 mg Anaplasma chlortetracycline per head marginale per day and 1 mg lasalocid susceptible to per 2.2 lb. of body weight chlortetracycline daily with a maximum of 360 , control of mg lasalocid per head per coccidiosis day. See Sec. 558.311(d) caused by Eimeria of this chapter. bovis and E. Chlortetracycline as zuernii, provided by Nos. 054771 or increased rate of 069254; lasalocid and weight gain, melengestrol as provided by improved feed No. 054771 in Sec. efficiency, and 510.600(c) of this chapter. suppression of estrus (heat). * * * * * * * (lvi) 25 to 2,800 g/ton to Lasalocid, 30 to Growing beef The melengestrol acetate 054771 provide 350 mg/head/day. 181.8; heifers fed in Type C top-dress medicated 069254 melengestrol confinement for feed must be top dressed acetate, 0.25 to slaughter up to onto or mixed at feeding 2 g/ton to 800 pounds: For with a Type C medicated provide 0.25 to control of feed containing 25 to 2,800 0.5 mg/head/day bacterial g/ton of chlortetracycline melengestrol pneumonia and 30 to 181.8 g/ton acetate. associated with lasalocid to provide 350 mg shipping fever chlortetracycline per head complex caused by daily and 1 mg lasalocid Pasteurella spp. per 2.2 lb. of body weight susceptible to daily with a maximum of 360 chlortetracycline mg lasalocid per head per , control of day. SeeSec. 558.311(d) coccidiosis of this chapter. caused by Eimeria Chlortetracycline as bovis and E. provided by Nos. 054771 or zuernii, 069254; lasalocid and increased rate of melengestrol as provided by weight gain, No. 054771 in Sec. improved feed 510.600(c) of this chapter. efficiency, and suppression of estrus (heat). [[Page 95107]] (lvii) 25 to 2,800 g/ton to Lasalocid, 30 to Replacement beef The melengestrol acetate 054771 provide 350 mg/head/day. 181.8; heifers up to 800 Type C top-dress medicated 069254 melengestrol pounds: For feed must be top dressed acetate, 0.5 to 2 control of onto or mixed at feeding g/ton to provide bacterial with a Type C medicated 0.5 mg/head/day pneumonia feed containing 25 to 2,800 melengestrol associated with g/ton of chlortetracycline acetate. shipping fever and 30 to 181.8 g/ton complex caused by lasalocid to provide 350 mg Pasteurella spp. chlortetracycline per head susceptible to daily and 1 mg lasalocid chlortetracycline per 2.2 lb. of body weight , control of daily with a maximum of 360 coccidiosis mg lasalocid per head per caused by Eimeria day. Do not exceed 24 days bovis and E. of feeding. See Sec. zuernii, and 558.311(d) of this chapter. suppression of Chlortetracycline as estrus (heat). provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. * * * * * * * (lix) 500 to 4,000 g/ton to Lasalocid, 30 to Growing beef The melengestrol acetate 054771 provide 10 mg/lb of body 181.8; heifers fed in Type C top-dress medicated 069254 weight daily. melengestrol confinement for feed must be top dressed acetate, 0.25 to slaughter up to onto or mixed at feeding 2 g/ton to 800 pounds: For with a Type C medicated provide 0.25 to the treatment of feed containing 500 to 0.5 mg/head/day bacterial 4,000 g/ton of melengestrol enteritis caused chlortetracycline and 30 to acetate. by Escherichia 181.8 g/ton lasalocid to coli and provide 10 mg bacterial chlortetracycline per lb of pneumonia caused body weight per day and 1 by Pasteurella mg lasalocid per 2.2 lb of multocida body weight per day with a organisms maximum of 360 mg lasalocid susceptible to per head per day for not chlortetracycline more than 5 days of , control of feeding. After completing coccidiosis feeding of this caused by Eimeria combination, continue bovis and E. feeding a Type C top-dress zuernii, medicated feed containing increased rate of melengestrol acetate alone. weight gain, See Sec. 558.311(d) of improved feed this chapter. efficiency, and Chlortetracycline as suppression of provided by Nos. 054771 or estrus (heat). 069254; lasalocid and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. (lx) 500 to 4,000 g/ton to Lasalocid, 30 to Replacement dairy The melengestrol acetate 054771 provide 10 mg/lb of body 181.8; heifers up to 800 Type C top-dress medicated 069254 weight daily. melengestrol pounds and less feed must be top dressed acetate, 0.5 to 2 than 20 months of onto or mixed at feeding g/ton to provide age and with a Type C medicated 0.5 mg/head/day replacement beef feed containing 500 to melengestrol heifers up to 800 4,000 g/ton of acetate. pounds: For the chlortetracycline and 30 to treatment of 181.8 g/ton lasalocid to bacterial provide 10 mg enteritis caused chlortetracycline per lb of by Escherichia body weight per day and 1 coli and mg lasalocid per 2.2 lb of bacterial body weight per day with a pneumonia caused maximum of 360 mg lasalocid by Pasteurella per head per day for not multocida more than 5 days. After organisms completing feeding of this susceptible to combination, continue chlortetracycline feeding a Type C top-dress , control of medicated feed containing coccidiosis melengestrol acetate alone. caused by Eimeria See Sec. 558.311(d) of bovis and E. this chapter. zuernii, and Chlortetracycline as suppression of provided by Nos. 054771 or estrus (heat). 069254; lasalocid and melengestrol as provided by No. 054771 in Sec. 510.600(c) of this chapter. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * 0 20. In Sec. 558.355: 0 a. Revise paragraphs (b)(1) and (2); 0 b. Revise the headings for paragraphs (d)(9)(i) and (ii) and (d)(10)(i) and (ii); 0 c. Redesignate paragraph (f) as paragraph (e); 0 d. Revise newly redesignated paragraphs (e)(1)(i) and (ii), (e)(2)(i), and (e)(5); 0 e. Remove newly redesignated paragraph (e)(6); and 0 f. Redesignate newly redesignated paragraph (e)(7) as paragraph (e)(6). The revisions read as follows: Sec. 558.355 Monensin. * * * * * (b) * * * (1) No. 058198 for use as in paragraph (e) of this section. (2) No. 016592 for use of a Type A medicated article containing 90.7 grams monensin, USP, per pound as in paragraphs (e)(1)(i), (e)(1)(ii), (e)(2)(i), (e)(3), (e)(4)(v), and (e)(5) of this section. * * * * * (d) * * * (9) * * * (i) Cattle (as described in paragraphs (e)(3)(i) through (iii), (vi), and (vii); and (e)(4)(i) through (vi) of this section). * * * (ii) Dairy cows (as described in paragraphs (e)(3)(iv) and (v) of this section).* * * (10) * * * (i) Cattle (as described in paragraphs (e)(3)(i) through (iii), (vi), and (vii); and (e)(4)(i) through (vi) of this section). * * * (ii) Dairy cows (as described in paragraphs (e)(3)(iv) and (v) of this section).* * * * * * * * (e) * * * (1) * * * [[Page 95108]] ---------------------------------------------------------------------------------------------------------------- Monensin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 90 to 110........... ........................ Broiler chickens: Feed continuously as the 016592 As an aid in the sole ration. Not for 058198 prevention of broiler breeder replacement coccidiosis caused chickens. Do not feed to by E. necatrix, E. chickens over 16 weeks of tenella, E. age. Do not feed to laying acervulina, E. chickens. In the absence of brunetti, E. coccidiosis in broiler mivati, and E. chickens the use of maxima. monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. (ii) 90 to 110.......... ........................ Laying hen Feed continuously as the 016592 replacement sole ration. Not for 058198 chickens and layer broiler breeder replacement breeder chickens. Do not feed to replacement chickens over 16 weeks of chickens: As an age. Do not feed to laying aid in the chickens. In the absence of prevention of coccidiosis in broiler coccidiosis caused chickens the use of by E. necatrix, E. monensin with no withdrawal tenella, E. period may limit feed acervulina, E. intake resulting in reduced brunetti, E. weight gain. Do not allow mivati, and E. horses, other equines, maxima. mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. * * * * * * * ---------------------------------------------------------------------------------------------------------------- (2) * * * ---------------------------------------------------------------------------------------------------------------- Monensin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 54 to 90............ ........................ Growing turkeys: For growing turkeys only. 016592 For the prevention Feed continuously as sole 058198 of coccidiosis ration. Some strains of caused by E. turkey coccidia may be adenoeides, E. monensin tolerant or meleagrimitis, and resistant. Not for broiler E.gallopavonis. breeder replacement chickens. Do not feed to laying hens. Do not feed to chickens over 16 weeks of age. Monensin may interfere with development of immunity to turkey coccidiosis. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. * * * * * * * ---------------------------------------------------------------------------------------------------------------- (5) Minor species-- ---------------------------------------------------------------------------------------------------------------- Monensin in grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 73........................... Growing bobwhite quail: For Feed continuously as sole ration. Not 016592 the prevention of for broiler breeder replacement 058198 coccidiosis caused by chickens. Do not feed to laying Eimeria dispersa and E. hens. Do not feed to chickens over lettyae. 16 weeks of age. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. (ii) 20.......................... Goats maintained in Feed continuously. Do not feed to 016592 confinement: For the lactating goats. See paragraph 058198 prevention of coccidiosis (d)(11) of this section for caused by Eimeria provisions for monensin liquid Type crandallis, E. C goat feeds. christenseni, and E. ninakohlyakimovae. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * Dated: November 20, 2024. P. Ritu Nalubola, Associate Commissioner for Policy. [FR Doc. 2024-28061 Filed 11-29-24; 8:45 am] BILLING CODE 4164-01-P