[Federal Register Volume 89, Number 95 (Wednesday, May 15, 2024)] [Rules and Regulations] [Pages 42354-42361] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2024-10586] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 529, 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, 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) and abbreviated new animal drug applications (ANADAs) during January, February, and March 2024. The animal drug regulations are also being amended to improve their accuracy and readability. DATES: This rule is effective May 15, 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 January, February, and March 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 (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOIA Summaries) under the Freedom of Information Act (FOIA). 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 January, February, and March 2024 Requiring Evidence of Safety and/or Effectiveness ---------------------------------------------------------------------------------------------------------------- Sponsor (drug Effect of the 21 CFR Date of approval File No. labeler code) Product name action section ---------------------------------------------------------------------------------------------------------------- January 11, 2024............ 200-766 Aurora EQUICOXIB Original approval 520.929 Pharmaceutical, (firocoxib) Oral as a generic copy Inc., 1196 Solution. of NADA 141-253. Highway 3 South, Northfield, MN 55057-3009 (051072). [[Page 42355]] January 12, 2024............ 200-768 Huvepharma EOOD, RAVANTAGE 9 and Original approval 558.500 5th Floor, 3A RAVANTAGE 45 as a generic copy Nikolay Haytov (ractopamine of NADA 140-863. Str., 1113 Sofia, hydrochloride) Bulgaria (016592). Type A Medicated Articles. January 12, 2024............ 200-767 Felix Carprofen Tablets. Original approval 520.304 Pharmaceuticals as a generic copy Pvt. Ltd., 25-28 of NADA 141-053. North Wall Quay, Dublin 1, Ireland (086101). January 30, 2024............ 200-769 ZyVet Animal SELAMECTIN Topical Original approval 524.2098 Health, Inc., 73 Solution. as a generic copy Route 31N, of NADA 141-152. Pennington, NJ 08534 (086117). February 13, 2024........... 141-575 Boehringer VETMEDIN Original approval 520.1782 Ingelheim Animal (pimobendan oral for management of Health USA, Inc., solution) the signs of 3239 Satellite Solution. mild, moderate, Blvd., Duluth, GA or severe 30096 (000010). congestive heart failure in dogs. February 22, 2024........... 200-749 Ceva Sante KESIUM Original approval 520.88g Animale, 10 (amoxicillin and as a generic copy Avenue de la clavulanate of NADA 055-099. Ballasti[egrave]r potassium e, 33500 tablets) Chewable Libourne, France Tablets. (013744). March 1, 2024............... 200-772 Parnell CONTRASED Original approval 522.147 Technologies Pty. (atipamezole as a generic copy Ltd., unit 4, 476 hydrochloride) of NADA 141-033. Gardeners Rd., Injectable Alexandria, New Solution. South Wales 2015, Australia (068504). March 15, 2024.............. 141-579 Dechra Ltd. DUOTIC Original approval 524.2338 Snaygill (terbinafine and for treatment of Industrial betamethasone otitis externa in Estate, Keighley acetate otic gel) dogs, associated Road, Skipton, Otic Gel. with susceptible North Yorkshire, strains of yeast BD23 2RW, United (Malassezia Kingdom (043264). pachydermatis). ---------------------------------------------------------------------------------------------------------------- II. Withdrawals of Approval Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096 (drug labeler code 000010) requested that FDA withdraw approval of the five 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 January, February, and March 2024 ------------------------------------------------------------------------ Date of withdrawal of 21 CFR approval File No. Product name section ------------------------------------------------------------------------ March 4, 2024............... 141-015 ENACARD (enalapril 520.804 maleate) Tablets. Do.......................... 141-096 DICURAL 520.645 (difloxacin hydrochloride) Tablets. Do.......................... 141-108 ETOGESIC 520.870 (etodolac) Tablets. Do.......................... 141-274 ETOGESIC 522.870 (etodolac) Injectable Solution. Do.......................... 141-421 DUOCARE 520.1198 (ivermectin and praziquantel) Paste. ------------------------------------------------------------------------ III. Changes of Sponsor The sponsors of the approved applications listed in table 3 have informed FDA that they have transferred ownership of, and all rights and interest in, these applications to another sponsor. The regulations cited in table 3 are amended to reflect these actions. Table 3--Applications for Which Ownership Was Transferred to Another Sponsor During January, February, and March 2024 ---------------------------------------------------------------------------------------------------------------- Transferring sponsor New sponsor (drug 21 CFR File No. Product name (drug labeler code) labeler code) section ---------------------------------------------------------------------------------------------------------------- 200-141........................ ATTANE (isoflurane).. Piramal Critical Piramal Pharma Ltd., 529.1186 Care, Inc., 3850 Ground floor, Schelden Circle, Piramal Ananta, Bethlehem, PA 18017 Agastya Corporate (066794). Park, Mumbai, Maharashtra--400070, India (065085). 200-237........................ Isoflurane, USP...... Do................... Do................... Do. 200-338........................ TRI-HEART (ivermectin Heska Corp., 3760 Diamond Animal 510.600 and pyrantel Rocky Mountain Ave., Health, Inc., 2538 520.1196 pamoate) Tablets. Loveland, CO 80538- SE 43rd St., Des 7084 (063604). Moines, IA 50327 (053701). 200-438........................ PETREM (sevoflurane). Piramal Critical Piramal Pharma Ltd., 529.2110 Care, Inc., 3850 Ground floor, Schelden Circle, Piramal Ananta, Bethlehem, PA 18017 Agastya Corporate (066794). Park, Mumbai, Maharashtra--400070, India (065085). ---------------------------------------------------------------------------------------------------------------- [[Page 42356]] IV. Change of Sponsor Address ECO LLC, 344 Nassau St., Princeton, NJ 08540 (drug labeler code 066916 in 21 CFR 510.600(c)) has informed FDA that it has changed its address to 11224 Aurora Ave., Urbandale, IA 50322. The entries in Sec. 510.600(c) are amended to reflect this action. V. Technical Amendments FDA is making the following amendments to improve the accuracy and readability of the animal drug regulations.21 CFR 510.600 is amended to remove entries for Heska Corp. and Piramal Critical Care, Inc. from the lists of sponsors of approved applications, to revise the entries for Cronus Pharma Specialities India Private Ltd. and ECO LLC; and to add entries for Diamond Animal Health, Inc. 21 CFR 522.840 is amended to reflect revisions to approved labeling for cattle implants containing estradiol. 21 CFR 522.1940 is amended to reflect the current format for regulations and revisions to approved labeling for cattle implants containing progesterone and estradiol benzoate. 21 CFR 522.2343 is amended to reflect revisions to approved labeling for cattle implants containing testosterone propionate and estradiol benzoate. 21 CFR 522.2477 is amended to reflect revisions to approved labeling for cattle implants containing trenbolone acetate and estradiol. 21 CFR 524.1193 is amended to reflect periods of persistent activity for an approved generic ivermectin topical solution used in cattle. 21 CFR 558.485 is amended to reflect an inclusion rate for pyrantel tartrate in medicated horse feeds. 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)). 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, 524, and 529 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, 529, and 558 are amended as follows: PART 510--NEW ANIMAL DRUGS 0 1. The authority citation for part 510 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 0 2. In Sec. 510.600: 0 a. In the table in paragraph (c)(1): 0 i. Add in alphabetical order an entry for ``Diamond Animal Health, Inc.''; 0 ii. Revise the entries for ``Cronus Pharma Specialities India Private Ltd.''; and ``ECO LLC''; and 0 iii. Remove the entries for ``Heska Corp.'' and ``Piramal Critical Care, Inc.''; 0 b. In the table in paragraph (c)(2), add an entry for ``053701''; remove the entries for ``063604'' and ``066794''; and revise the entries for ``066916'' and ``069043''. The revisions and additions read as follows: Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * * * (c) * * * (1) * * * ------------------------------------------------------------------------ Firm name and address Drug labeler code ------------------------------------------------------------------------ * * * * * * * Cronus Pharma Specialities India Private Ltd., 069043 Plot No.9(B), Survey No. 99/1, GMR Hyderabad Aviation SEZ Ltd., Mamidipalle Village, Balapur Mandal, Shamshabad, Rangareddy, Hyderabad, Telangana, 500108, India......................... * * * * * * * Diamond Animal Health, Inc., 2538 SE 43rd St., Des 053701 Moines, IA 50327................................. * * * * * * * ECO LLC, 11224 Aurora Ave., Urbandale, IA 50322... 066916 * * * * * * * ------------------------------------------------------------------------ (2) * * * ------------------------------------------------------------------------ Drug labeler code Firm name and address ------------------------------------------------------------------------ * * * * * * * 053701...................... Diamond Animal Health, Inc., 2538 SE 43rd St., Des Moines, IA 50327. * * * * * * * 066916...................... ECO LLC, 11224 Aurora Ave., Urbandale, IA 50322. * * * * * * * 069043...................... Cronus Pharma Specialities India Private Ltd., Plot No.9(B), Survey No. 99/1, GMR Hyderabad Aviation SEZ Ltd., Mamidipalle Village, Balapur Mandal, Shamshabad, Rangareddy, Hyderabad, Telangana, 500108, India. * * * * * * * ------------------------------------------------------------------------ [[Page 42357]] PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 0 3. The authority citation for part 520 continues to read as follows: Authority: 21 U.S.C. 360b. 0 4. In Sec. 520.88g, revise the section heading and paragraph (a), and add paragraph (b)(3) to read as follows: Sec. 520.88g Amoxicillin and clavulanate potassium tablets. (a) Specifications. Each tablet or chewable tablet contains amoxicillin and clavulanate potassium equivalent to 50 milligrams (mg) amoxicillin and 12.5 mg clavulanic acid, 100 mg amoxicillin and 25 mg clavulanic acid, 200 mg amoxicillin and 50 mg clavulanic acid, or 300 mg amoxicillin and 75 mg clavulanic acid. (b) * * * (3) No. 013744 for use of chewable tablets as in paragraph (c) of this section. * * * * * 0 5. In Sec. 520.304: 0 i. Add paragraph (a)(4); 0 ii. Revise paragraph (b)(1); and 0 iii. Add paragraph (b)(4). The additions and revision read as follows: Sec. 520.304 Carprofen. (a) * * * (4) Each flavored tablet contains 25, 75, or 100 mg carprofen. (b) * * * (1) Nos. 017033, 054771, 055529, and 062250 for use of products described in paragraphs (a)(1) and (a)(2) of this section as in paragraph (c) of this section. * * * * * (4) No. 086101 for use of product described in paragraphs (a)(1), (a)(2), and (a)(4) of this section as in paragraph (c) of this section. * * * * * Sec. 520.645 [Removed] 0 6. Remove Sec. 520.645. Sec. 520.804 [Removed] 0 7. Remove Sec. 520.804. Sec. 520.870 [Removed] 0 8. Remove Sec. 520.870. 0 9. Amend Sec. 520.928 by revising the section heading to read as follows: Sec. 520.928 Firocoxib tablets. 0 10. Add Sec. 520.929 to read as follows: Sec. 520.929 Firocoxib solution. (a) Specifications. Each milliliter of solution contains 9 milligram (mg) firocoxib. (b) Sponsors. See No. 051072 in Sec. 510.600(c) of this chapter. (c) Conditions of use in horses--(1) Amount. Administer 0.1 mg per kilogram (0.045 mg per pound) of body weight once daily for up to 14 days. (2) Indications for use. For the control of pain and inflammation associated with osteoarthritis. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 11. In Sec. 520.1196, revise paragraph (b) to read as follows: Sec. 520.1196 Ivermectin and pyrantel tablets. * * * * * (b) Sponsors. See Nos. 000010, 051311, and 053701 in Sec. 510.600(c) of this chapter. * * * * * Sec. 520.1198 [Amended] 0 12. In Sec. 520.1198, remove paragraphs (a)(3) and (b)(3). 0 13. Amend Sec. 520.1780 by revising the section heading to read as follows: Sec. 520.1780 Pimobendan tablets. 0 14. Add Sec. 520.1782 to read as follows: Sec. 520.1782 Pimobendan solution. (a) Specifications. Each milliliter of solution contains 1.5 milligrams (mg) pimobendan. (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter. (c) Conditions of use in dogs--(1) Amount. Administer orally at a total daily dose of 0.23 mg/lb (0.5 mg/kg) body weight. The total daily dose should be divided into two equal portions administered approximately 12 hours apart (i.e., morning and evening). (2) Indications for use. For the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM); for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 15. The authority citation for part 522 continues to read as follows: Authority: 21 U.S.C. 360b. 0 16. In Sec. 522.147, revise paragraph (b) to read as follows: Sec. 522.147 Atipamezole. * * * * * (b) Sponsors. See Nos. 015914, 052483, 068504, and 069043 in Sec. 510.600(c) of this chapter. * * * * * 0 17. In Sec. 522.840, revise paragraph (d) to read as follows: Sec. 522.840 Estradiol. * * * * * (d) Conditions of use--(1) Beef steer calves 2 months of age and older--(i) Amount and indications for use. (A) An extended-release implant containing 25.7 mg estradiol for increased rate of weight gain for up to 200 days. (B) An extended-release implant containing 43.9 mg estradiol for increased rate of weight gain for up to 400 days. (ii) Limitations. For subcutaneous ear implantation only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in beef steer calves 2 months of age and older. Safety and effectiveness following reimplantation have not been evaluated. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. (2) Growing beef steers and heifers on pasture (stocker, feeder, and slaughter)--(i) Amount and indications for use. (A) An extended- release implant containing 25.7 mg estradiol for increased rate of weight gain for up to 200 days. (B) An extended-release implant containing 43.9 mg estradiol for increased rate of weight gain for up to 400 days. (ii) Limitations. For subcutaneous ear implantation only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef steers and heifers on pasture (stocker, feeder, and slaughter). Safety and effectiveness following reimplantation have not been evaluated. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. (3) Growing beef steers and heifers fed in confinement for slaughter--(i) Amount and indications for use. (A) An [[Page 42358]] extended-release implant containing 25.7 mg estradiol for increased rate of weight gain and improved feed efficiency for up to 200 days. (B) An extended-release implant containing 43.9 mg estradiol for increased rate of weight gain and improved feed efficiency for up to 400 days. (ii) Limitations. For subcutaneous ear implantation only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef steers and heifers fed in confinement for slaughter. Safety and effectiveness following reimplantation have not been evaluated. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Sec. 522.870 [Removed] 0 18. Remove Sec. 522.870. 0 19. Revise Sec. 522.1940 to read as follows: Sec. 522.1940 Progesterone and estradiol benzoate. (a) Specifications--(1) Each implant consists of progesterone and estradiol benzoate. (i) 100 mg progesterone and 10 mg estradiol benzoate (one implant consisting of four pellets, each containing 25 mg progesterone and 2.5 mg estradiol benzoate). (ii) 200 mg progesterone and 20 mg estradiol benzoate (one implant consisting of eight pellets, each containing 25 mg progesterone and 2.5 mg estradiol benzoate). (2) Each implant consists of progesterone and estradiol benzoate and tylosin tartrate. (i) 100 mg progesterone, 10 mg estradiol benzoate, and 29 mg tylosin tartrate (one implant consisting of four pellets, each containing 25 mg progesterone and 2.5 mg estradiol benzoate, and one pellet containing 29 mg tylosin tartrate). (ii) 200 mg progesterone, 20 mg estradiol benzoate, and 29 mg tylosin tartrate (one implant consisting of eight pellets, each containing 25 mg progesterone and 2.5 mg estradiol benzoate, and one pellet containing 29 mg tylosin tartrate). (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for use as in paragraph (c) of this section: (1) No. 054771 for use as in paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2)(i)(A), (B), (C), and (e)(2)(ii) of this section. (2) No. 058198 for use as in paragraphs (e)(1)(i)(A), (e)(1)(i)(B), (e)(1)(ii), and (e)(3) of this section. (c) Related tolerances. See Sec. Sec. 556.240 and 556.540 of this chapter. (d) Special considerations. Labeling of implants described in paragraphs (a)(2)(i) and (a)(2)(ii) for use in paragraphs (e)(1)(i)(B), (e)(1)(ii), (e)(3)(i), and (e)(3)(ii) of this section shall bear the following: ``Federal law restricts this drug to use by or on the order of a licensed veterinarian.'' (e) Conditions of use--(1) Beef calves 45 days of age and older and weighing up to 400 lbs--(i) Amounts and indications for use. (A) An implant containing 100 mg progesterone and 10 mg estradiol benzoate as described in paragraph (a)(1)(i) of this section for increased rate of weight gain. (B) An implant containing 100 mg progesterone, 10 mg estradiol benzoate, and 29 mg tylosin tartrate as described in paragraph (a)(2)(i) of this section for increased rate of weight gain. (ii) Limitations. Implant pellets subcutaneously in ear only. Other than when used as described in (e)(2)(i)(B) of this section, the implant as described in paragraph (a)(1)(i) of this section is not approved for repeated implantation (reimplantation). The implant as described in paragraph (a)(2)(i) of this section is not approved for repeated implantation (reimplantation) with this or any other cattle ear implant. Do not use in beef calves less than 45 days of age, dairy calves, and veal calves because effectiveness and safety have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or calves born to these cows. (2) Growing beef steers fed in confinement for slaughter--(i) Amounts and indications for use. (A) An implant containing 200 mg progesterone and 20 mg estradiol benzoate as described in paragraph (a)(1)(ii) of this section for increased rate of weight gain and improved feed efficiency. (B) An implant containing 200 mg progesterone and 20 mg estradiol benzoate as described in paragraph (a)(1)(ii) of this section for increased rate of weight gain in a reimplantation program where an implant as described in paragraph (a)(1)(i) of this section is the first implant and an implant as described in paragraph (a)(1)(ii) of this section is administered approximately 70 days later. (C) An implant containing 200 mg progesterone and 20 mg estradiol benzoate as described in paragraph (a)(1)(ii) of this section for increased rate of weight gain in a reimplantation program where an implant as described in paragraph (a)(1)(ii) of this section is the first implant and an implant as described in paragraph (a)(1)(ii) of this section is administered approximately 70 days later. (ii) Limitations. Implant pellets subcutaneously in ear only. Other than when used as described in paragraphs (e)(2)(i)(B) or (C) of this section, the implant described in paragraph (a)(1)(ii) of this section is not approved for repeated implantation (reimplantation) with any other cattle ear implant in growing beef steers and heifers fed in confinement for slaughter as safety and effectiveness have not been evaluated. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or calves born to these cows. (3) Growing beef steers weighing 400 lbs or more--(i) Amounts and indications for use. An implant containing 200 mg progesterone, 20 mg estradiol benzoate, and 29 mg tylosin tartrate as described in paragraph (a)(2)(ii) of this section for increased rate of weight gain and improved feed efficiency. (ii) Limitations. The implant as described in paragraph (a)(2)(ii) of this section is not approved for repeated implantation (reimplantation) with this or any other cattle ear implant. 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. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or calves born to these cows. 0 20. Revise Sec. 522.2343 to 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 paragraph (d)(1) of this section. (2) No. 058198 for use as in paragraph (d)(2) of this section. (b) Related tolerances. See Sec. Sec. 556.240 and 556.710 of this chapter. (c) Special considerations. Labeling of the implants described in paragraph (d)(2) of this section shall bear the following: ``Federal law restricts this drug to use by or on the order of a licensed veterinarian.'' (d) Conditions of use--(1) Growing beef heifers fed in confinement for [[Page 42359]] slaughter--(i) Amounts and indications for use. An implant containing 200 mg testosterone propionate and 20 mg estradiol benzoate (one implant consisting of eight pellets, each containing 25 mg testosterone propionate and 2.5 mg estradiol benzoate) for increased rate of weight gain and improved feed efficiency. (ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. (2) Growing beef heifers weighing 400 lbs or more--(i) Amounts and indications for use. An implant containing 200 mg testosterone propionate, 20 mg estradiol benzoate, and 29 mg tylosin tartrate (one implant consisting of eight pellets, each containing 25 mg testosterone propionate and 2.5 mg estradiol benzoate, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency. (ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. 0 21. Revise Sec. 522.2477 to read as follows: Sec. 522.2477 Trenbolone acetate and estradiol. (a) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for uses as in paragraph (d) of this section. (1) No. 058198 for use in paragraphs (d)(1)(i)(B), (d)(1)(ii), (d)(2)(i)(B), (d)(2)(i)(D), (d)(2)(ii), (d)(3)(i)(B), (d)(3)(i)(D), (d)(3)(ii), (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) of this section. (2) No. 000061 for use in paragraphs (d)(1)(i)(A), (d)(1)(i)(C), (d)(1)(ii), (d)(2)(i)(A), (d)(2)(i)(C), (d)(2)(i)(E), (d)(2)(ii), (d)(3)(i)(A), (d)(3)(i)(C), (d)(3)(i)(E), (d)(3)(ii), (d)(4)(i)(A), and (d)(4)(ii) of this section. (3) No. 054771 for use in paragraphs (d)(2)(i)(A), (C), (d)(2)(ii), (d)(4)(i)(A), and (d)(4)(ii) of this section. (b) Related tolerances. See Sec. Sec. 556.240 and 556.739 of this chapter. (c) Special considerations. Labeling of implants described in paragraphs (d)(1)(i)(B), (d)(2)(i)(B), (d)(2)(i)(D), (d)(3)(i)(B), (d)(3)(i)(D), and (d)(4)(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.'' (d) Conditions of use--(1) Growing beef steers and heifers fed in confinement for slaughter--(i) Amounts and indications. (A) An implant containing 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of 10 pellets each containing 20 mg trenbolone acetate and 2 mg estradiol) for increased rate of weight gain and improved feed efficiency. (B) An implant containing 200 mg trenbolone acetate, 20 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of 10 pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol, and 1 pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency. (C) An extended- and delayed-release implant containing 200 mg trenbolone acetate and 20 mg estradiol (1 implant consisting of 10 coated pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol) for increased rate of weight gain and improved feed efficiency during 70 to 200 days after implantation. (ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef steers and heifers fed in confinement for slaughter. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or calves born to these cows. (2) Growing beef steers fed in confinement for slaughter--(i) Amounts and indications. (A) An implant containing 80 mg trenbolone acetate and 16 mg estradiol (one implant consisting of four pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol) for increased rate of weight gain and improved feed efficiency. (B) An implant containing 80 mg trenbolone acetate, 16 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of four pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency. (C) An implant containing 120 mg trenbolone acetate and 24 mg estradiol (one implant consisting of six pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol) for increased rate of weight gain and improved feed efficiency. (D) An implant containing 120 mg trenbolone acetate, 24 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of six pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency. (E) An extended-release implant containing 200 mg trenbolone acetate and 40 mg estradiol (one implant consisting of six coated pellets and four uncoated pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol) for increased rate of weight gain and improved feed efficiency for up to 200 days after implantation. (ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef steers fed in confinement for slaughter. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or calves born to these cows. (3) Growing beef heifers fed in confinement for slaughter--(i) Amounts and indications. (A) An implant containing 80 mg trenbolone acetate and 8 mg estradiol (one implant consisting of four pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol) for increased rate of weight gain. (B) An implant containing 80 mg trenbolone acetate, 8 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of four pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency. (C) An implant containing 140 mg trenbolone acetate and 14 mg estradiol (one implant consisting of seven pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol) for increased rate of weight gain and improved feed efficiency. [[Page 42360]] (D) An implant containing 140 mg trenbolone acetate, 14 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of seven pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency. (E) An extended-release implant containing 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of six coated pellets and four uncoated pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol) for increased rate of weight gain and improved feed efficiency for up to 200 days after implantation. (ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef heifers fed in confinement for slaughter. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or calves born to these cows. (4) Growing beef steers and heifers on pasture (stocker, feeder, and slaughter)--(i) Amounts and indications for use. (A) An implant containing 40 mg trenbolone acetate and 8 mg estradiol (one implant consisting of two pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol) for increased rate of weight gain. (B) An implant containing 40 mg trenbolone acetate, 8 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of two pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain. (ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef steers and heifers on pasture (stocker, feeder, and slaughter). Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or calves born to these cows. PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0 22. The authority citation for part 524 continues to read as follows: Authority: 21 U.S.C. 360b. 0 23. In Sec. 524.1193: 0 a. Revise paragraph (b); 0 b. Remove paragraph (d); 0 c. Redesignate paragraph (e) as paragraph (d) and revise newly redesignated paragraphs (d)(2) and (d)(3). The revisions read as follows: Sec. 524.1193 Ivermectin topical solution. * * * * * (b) Sponsors. See Nos. 000010, 016592, 055529, 058829, and 061133 in Sec. 510.600(c) of this chapter for use as in paragraph (d) of this section. * * * * * (d) * * * (2) Indications for use. It is used for the treatment and control of: Gastrointestinal roundworms (adults and fourth-stage larvae) Ostertagia ostertagi (including inhibited stage), Haemonchus placei, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. surnabada, Oesophagostomum radiatum (adults); Strongyloides papillosus, Trichuris spp.; lungworms (adults and fourth- stage larvae) Dictyocaulus viviparus; cattle grubs (parasitic stages) Hypoderma bovis, H. lineatum; mites Sarcoptes scabiei var. bovis; lice Linognathus vituli, Haematopinus eurysternus, Damalinia bovis, Solenoptes capillatus; and horn flies Haematobia irritans. It controls infections and prevents reinfection with O. radiatum and D. viviparus for 28 days after treatment, C. punctata and T. axei for 21 days after treatment, O. ostertagi, H. placei, C. oncophora, and C. surnabada for 14 days after treatment, and D. bovis for 56 days after treatment. (3) Limitations. Do not treat cattle within 48 days of slaughter. Do not use on female dairy cattle of breeding age or on calves to be processed for veal. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. 0 24. In Sec. 524.2098, revise paragraph (b) to read as follows: Sec. 524.2098 Selamectin. * * * * * (b) Sponsors. See Nos. 051072, 051311, 054771, 055529, 061133, and 086117 of this chapter. * * * * * 0 25. Add Sec. 524.2338 to read as follows: Sec. 524.2338 Terbinafine and betamethasone acetate. (a) Specifications. Each milliliter of gel contains 10 milligrams (mg) terbinafine and 1 mg betamethasone acetate. (b) Sponsor. See No. 043264 in Sec. 510.600(c) of this chapter. (c) Conditions of use in dogs--(1) Amount. Administer one dose (1 tube) per affected ear(s) and repeat administration in 7 days. (2) Indications for use. For the treatment of otitis externa in dogs, associated with susceptible strains of yeast (Malassezia pachydermatis). (3) Limitations. 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 26. The authority citation for part 529 continues to read as follows: Authority: 21 U.S.C. 360b. 0 27. In Sec. 529.1186, revise paragraph (b) to read as follows: Sec. 529.1186 Isoflurane. * * * * * (b) Sponsors. See Nos. 017033, 054771, and 065085 in Sec. 510.600(c) of this chapter. * * * * * 0 28. In Sec. 529.2110, revise paragraph (b) to read as follows: Sec. 529.2110 Sevoflurane. * * * * * (b) Sponsors. See Nos. 017033, 054771, and 065085 in Sec. 510.600(c) of this chapter. * * * * * PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 29. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 0 30. In Sec. 558.485, revise (e)(2) to read as follows: Sec. 558.485 Pyrantel. * * * * * (e) * * * (2) Horses-- [[Page 42361]] ------------------------------------------------------------------------ Indications for Pyrantel tartrate g/ton use Limitation Sponsor ------------------------------------------------------------------------ (i) 120 to 1,200 to provide For prevention Feed 017135 1.2 mg/lb body weight. of Strongylus continuously 054771 vulgaris as the horse's larval daily grain infections; ration during control of the time that adult large the animal is strongyles (S. at risk of vulgaris, and exposure to S. edentatus), internal adult and 4th parasites. Do stage larvae not use in small horses strongyles intended for (Cyathostomum human spp., consumption. Cylicocyclus Consult your spp., veterinarian Cylicostephanu before using s spp., in severely Cylicodontopho debilitated rus spp., animals and Poteriostomum for assistance spp., and in the Triodontophoru diagnosis, s spp.), adult treatment, and and 4th stage control of larvae parasitism. pinworms (Oxyuris equi), and adult and 4th stage larvae ascarids (Parascaris equorum). ------------------------------------------------------------------------ (ii) Top dress medicated feed--(A) Proprietary Formulas. The following feed can be manufactured only per an approved proprietary formula and specifications: ------------------------------------------------------------------------ Indications for Pyrantel tartrate amount use Limitations Sponsor ------------------------------------------------------------------------ (1) 9.6 g/lb to provide 1.2 Prevention of Feed 017135 mg/lb body weight. Strongylus continuously 054771 vulgaris as a top dress larval during the infections; time that the control of animal is at adult large risk of strongyles (S. exposure to vulgaris, and internal S. edentatus), parasites. Do adult and 4th not use in stage larvae horses small intended for strongyles human (Cyathostomum consumption. spp., Consult your Cylicocyclus veterinarian spp., before using Cylicostephanu in severely s spp., debilitated Cylicodontopho animals and rus spp., for assistance Poteriostomum in the spp., and diagnosis, Triodontophoru treatment, and s spp.), adult control of and 4th stage parasitism. larvae pinworms (Oxyuris equi), and adult and 4th stage larvae ascarids (Parascaris equorum). (2) [Reserved]. ............... ............... ......... ------------------------------------------------------------------------ (B) [Reserved] * * * * * 0 31. In Sec. 558.500, revise (b)(1), (b)(2), and (e)(1)(i) to read as follows: Sec. 558.500 Ractopamine. * * * * * (b) * * * (1) Nos. 016592 and 058198: Type A medicated articles containing 9 or 45.4 grams per pound (g/lb) ractopamine hydrochloride. (2) Nos. 051311 and 054771: Type A medicated articles containing 45.4 g/lb ractopamine hydrochloride. * * * * * (e) * * * (1) * * * ---------------------------------------------------------------------------------------------------------------- Combination in Ractopamine in grams/ton grams/ton Indications for use Limitations Sponsors ---------------------------------------------------------------------------------------------------------------- (i) 4.5 to 9.0................... ................... For increased rate of Feed continuously 016592 weight gain, improved as sole ration. 054771 feed efficiency, and 058198 increased carcass leanness in finishing swine, weighing not less than 150 lb, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lb of gain prior to slaughter. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * Dated: May 9, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024-10586 Filed 5-14-24; 8:45 am] BILLING CODE 4164-01-P