[Federal Register Volume 88, Number 233 (Wednesday, December 6, 2023)] [Rules and Regulations] [Pages 84696-84704] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2023-26545] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 516, 520, 522, 524, 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 July, August, and September 2023. The animal drug regulations are also being amended to improve their accuracy and readability. DATES: This rule is effective December 6, 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 July, August, and September 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 (FOIA Summaries) under the Freedom of Information Act (FOIA). These documents, along with marketing exclusivity and patent information, may be obtained at AnimalDrugs@FDA: https://animaldrugsatfda.fda.gov/adafda/views/#/search. Table 1--Original and Supplemental NADAs, ANADAs, and CNADAs Approved During July, August, and September 2023 Requiring Evidence of Safety and/or Effectiveness ---------------------------------------------------------------------------------------------------------------- Effect of the Approval date File No. Sponsor Product name action 21 CFR section ---------------------------------------------------------------------------------------------------------------- July 6, 2023................. 200-752 Cronus Pharma DEXMEDVET Original 522.558 Specialties (dexmedetomidi approval as a India Private ne sedative, Ltd., Sy No-99/ hydrochloride) analgesic, and 1, M/s GMR Injectable preanesthetic Hyderabad Solution. in dogs and Aviation SEZ cats as a Ltd., generic copy Mamidipalli of NADA 141- Village, 267. Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, India. July 11, 2023................ 200-753 Do............. CROPAMEZOLE Original 522.147 (atipamezole approval for hydrochloride) reversal of Injectable sedation and Solution. analgesia in dogs as a generic copy of NADA 141- 033. July 19, 2023................ 141-554 Boehringer NEXGARD PLUS Original 520.35 Ingelheim (afoxolaner, approval for Animal Health moxidectin, the USA, Inc., and pyrantel prevention, 3239 Satellite chewable treatment, and Blvd., Duluth, tablets). control of GA30096. internal and external parasites in dogs. August 3, 2023............... 200-755 Felix Firocoxib Original 520.928 Pharmaceutical Chewable approval for s Pvt. Ltd., Tablets. the control of 25-28 North pain and Wall Quay, inflammation Dublin 1, associated Ireland. with osteoarthritis and for the control of postoperative pain and inflammation associated with soft- tissue and orthopedic surgery as a generic copy of NADA 141- 230. [[Page 84697]] August 3, 2023............... 200-756 Ceva Sante FIRODYL Original 520.928 Animale, 10 (firocoxib) approval for Avenue de la Chewable the control of Ballasti[egrav Tablets. pain and e]re, 33500 inflammation Libourne, associated France. with osteoarthritis and for the control of postoperative pain and inflammation associated with soft- tissue and orthopedic surgery as a generic copy of NADA 141- 230. August 10, 2023.............. 141-568 Boehringer SENVELGO Original 520.2654 Ingelheim (velagliflozin approval to Animal Health oral solution). improve USA, Inc., glycemic 3239 Satellite control in Blvd., Duluth, otherwise GA30096. healthy cats with diabetes mellitus not previously treated with insulin. August 31, 2023.............. 200-757 ZyVet Animal Acepromazine Original 520.23 Health, Inc., Maleate approval as an 73 Route 31N, Tablets aid in Pennington, NJ (acepromazine tranquilizatio 08534. maleate n and as a tablets). preanesthetic agent in dogs as a generic copy of NADA 117-532. September 6, 2023............ 141-578 Genus FIDOQUEL-CA1 Conditional 516.1760 Lifesciences (phenobarbital approval for Inc., 700 N tablets). the control of Fenwick St., seizures Allentown, PA associated 18109. with idiopathic epilepsy in dogs. September 20, 2023........... 200-310 Parnell ESTROPLAN Supplemental 522.460 Technologies (cloprostenol approval for Pty. Ltd., injection) use with Unit 4, 476 Injectable gonadorelin to Gardeners Rd., Solution. synchronize Alexandria, estrous cycles New South to allow for Wales 2015, fixed time Australia. artificial insemination (FTAI) in lactating dairy cows as a generic copy of NADA 113- 645. ---------------------------------------------------------------------------------------------------------------- II. Withdrawals of Approval Oasmia Pharmaceutical AB, Vallongatan 1, Uppsala, 75228 Sweden requested that FDA withdraw conditional approval of CNADA 141-422 for PACCAL VET-CA1 (paclitaxel for injection) because the product is no longer manufactured or marketed. Also, Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861 requested that FDA withdraw approval of the eight abbreviated applications 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 2023 ---------------------------------------------------------------------------------------------------------------- File No. New animal drug 21 CFR section ---------------------------------------------------------------------------------------------------------------- 200-190...................................... GENTORAL (gentamicin sulfate) Concentrate 520.1044a Solution. 200-241...................................... LINCOSOL (lincomycin hydrochloride) Soluble 520.1263b Powder. 200-245...................................... DERMA-VET (neomycin sulfate, nystatin, 524.1600a thiostrepton, triamcinolone acetonide) Cream. 200-275...................................... MEDALONE (triamcinolone acetonide) Cream...... 524.2483 200-289...................................... NEOSOL-ORAL (neomycin sulfate) Concentrate 520.1484 Solution. 200-292...................................... IVERSOL (ivermectin) Liquid for Horses........ 520.1195 200-299...................................... IVER-ON (ivermectin) Topical Solution......... 524.1193 200-456...................................... Dexamethasone Solution........................ 522.540 ---------------------------------------------------------------------------------------------------------------- III. Change 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. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions. Table 3--Applications for Which Ownership Was Transferred to Another Sponsor During July, August, and September 2023 ---------------------------------------------------------------------------------------------------------------- File No. Product name Transferring sponsor New sponsor 21 CFR section ---------------------------------------------------------------------------------------------------------------- 141-342................ ALFAXAN Multidose Jurox Pty. Ltd., 85 Zoetis Inc., 333 522.52 (alfaxalone) Gardiner St., Portage St., injectable solution. Rutherford, NSW Kalamazoo, MI 49007. 2320, Australia. [[Page 84698]] 200-699................ Dexmedetomidine Akorn Operating Co. Parnell Technologies 522.558 hydrochloride LLC, 5605 Pty. Ltd., Unit 4, injection. Centerpoint Ct., 476 Gardeners Rd., Suite A, Gurnee, IL Alexandria, New 60031. South Wales 2015, Australia. 200-614................ Pentobarbital sodium Do................... Noble Pharma, LLC, 522.1700 and phenytoin sodium 4602 Domain Dr., injectable solution. Menomonie, WI 54751. 141-559................ Pentosan polysulfate Anzac Animal Health, Dechra, Ltd., 522.1704 sodium injectable LLC, 218 Millwell Snaygill Industrial solution. Dr., Suite B, Estate, Keighley Maryland Heights, MO Rd., Skipton, North 63043. Yorkshire, BD23 2RW, United Kingdom. 200-553................ Bacitracin, neomycin, Akorn Operating Co. Domes Pharma S.A., 524.154 polymyxin B LLC, 5605 ZAC de Champ Lamet, ophthalmic ointment. Centerpoint Ct., 3 rue Andre Citroen, Suite A, Gurnee, IL Pont-du-Chateau, 60031. Auvergne-Rh[ocirc]ne- Alpes, 63430, FRANCE. ---------------------------------------------------------------------------------------------------------------- As provided in the regulatory text of this document, the animal drug regulations cited in table 3 are amended to reflect these actions. IV. Change of Sponsor Address Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525 has informed FDA that it has changed its address to 3760 Rocky Mountain Ave., Loveland, CO 80538-7084. 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 of the animal drug regulations.21 CFR 510.600 is amended to reflect sponsors of approved applications by adding entries for Domes Pharma S.A., Genus Lifesciences, Inc., and Noble Pharma, LLC, by revising the entry for Heska Corp., and by removing the entries for Jurox Pty. Ltd. and Oasmia Pharmaceutical AB. 21 CFR 520.23 is amended to reflect approved strengths of acepromazine maleate tablets for dogs and cats. 21 CFR 522.460 is amended to reflect current labeling for cloprostenol injectable solution for use in cattle. 21 CFR 522.2640 is amended to reflect the approved strengths of generic tylosin injectable solutions. 21 CFR 558.330 is amended to reflect the sponsors of drugs approved for use in combination medicated feeds containing lubebegron and monensin. 21 CFR 558.355 is amended to reflect the classes of pasture cattle approved for use of a monensin free-choice block. 21 CFR 558.625 is amended to reflect the sponsors of drugs approved for use in combination medicated feeds containing lubebegron, monensin, and tylosin. 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 Part 516 Administrative practice and procedure, Animal drugs, Confidential business information, 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, 516, 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. 0 2. In Sec. 510.600, in the table in paragraph (c)(1), add entries for ``Domes Pharma S.A.'', ``Genus Lifesciences, Inc.'', and ``Noble Pharma, LLC''; revise the entry for ``Heska Corp.''; and remove the entries for ``Jurox Pty. Ltd.'' and ``Oasmia Pharmaceutical AB''. 0 3. In the table in paragraph (c)(2), remove the entries for ``049480'' and ``052818'', revise the entry for ``063604'', and add entries for ``064950'', ``086119'', and ``086189''. The revisions 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 ------------------------------------------------------------------------ * * * * * * * Domes Pharma S.A., ZAC de Champ Lamet, 3 rue Andre 086189 Citroen, Pont-du-Chateau, Auvergne-Rh[ocirc]ne- Alpes, 63430, FRANCE................................ [[Page 84699]] * * * * * * * Genus Lifesciences Inc., 700 N Fenwick St., 064950 Allentown, PA 18109................................. * * * * * * * Heska Corp., 3760 Rocky Mountain Ave., Loveland, CO 063604 80538-7084.......................................... * * * * * * * Noble Pharma, LLC, 4602 Domain Dr., Menomonie, WI 086119 54751............................................... * * * * * * * ------------------------------------------------------------------------ (2) * * * ------------------------------------------------------------------------ Drug labeler code Firm name and address ------------------------------------------------------------------------ * * * * * * * 063604........................ Heska Corp., 3760 Rocky Mountain Ave., Loveland, CO 80538-7084. * * * * * * * 064950........................ Genus Lifesciences Inc., 700 N Fenwick St., Allentown, PA 18109. * * * * * * * 086119........................ Noble Pharma, LLC, 4602 Domain Dr., Menomonie, WI 54751. * * * * * * * 086189........................ Domes Pharma S.A., ZAC de Champ Lamet, 3 rue Andre Citroen, Pont-du-Chateau, Auvergne-Rh[ocirc]ne-Alpes, 63430, FRANCE. * * * * * * * ------------------------------------------------------------------------ PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES 0 3. The authority citation for part 516 continues to read as follows: Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371. Sec. 516.1684 [Removed] 0 4. Remove Sec. 516.1684. 0 5. Add Sec. 516.1760 to subchapter E to read as follows: Sec. 516.1760 Phenobarbital. (a) Specifications. Each tablet contains 16.2, 32.4, 64.8, or 97.2 milligrams (mg) phenobarbital. (b) Sponsor. See No. 064950 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Amount. Administer phenobarbital as tablets given orally twice a day at the minimum dosage of 2.5 mg per kilogram of body weight (mg/kg) and may be titrated to effect to a maximum dosage of 5 mg/kg. The dosage of phenobarbital tablets should be adjusted based on monitoring the clinical response of the individual patient. (2) Indications for use. For the control of seizures associated with idiopathic epilepsy in dogs. (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 6. The authority citation for part 520 continues to read as follows: Authority: 21 U.S.C. 360b. 0 7. In Sec. 520.23, revise paragraphs (a) and (b) to read as follows: Sec. 520.23 Acepromazine. (a) Specifications. Each tablet contains 10 or 25 milligrams (mg) acepromazine maleate. (b) Sponsors. See Nos. 000010 and 086117 in Sec. 510.600(c) of this chapter. * * * * * 0 8. Add Sec. 520.35 to read as follows: Sec. 520.35 Afoxolaner, moxidectin, and pyrantel. (a) Specifications. Each chewable tablet contains 9.375 milligrams (mg) afoxolaner, 45 micrograms (mcg) moxidectin, and 18.75 mg pyrantel; 18.75 mg afoxolaner, 90 mcg moxidectin, and 37.5 mg pyrantel; 37.5 mg afoxolaner, 180 mcg moxidectin, and 75 mg pyrantel; 75 mg afoxolaner, 360 mcg moxidectin, and 150 mg pyrantel; or 150 mg afoxolaner, 720 mcg moxidectin, and 300 mg pyrantel. (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Amount. Administer orally once a month at the minimum dose of 1.14 mg/lb (2.5 mg/kg) afoxolaner, 5.45 mcg/lb (12 mcg/kg) moxidectin, and 2.27 mg/lb (5.0 mg/kg) pyrantel. For heartworm disease prevention, give once monthly for at least 6 months after last exposure to mosquitoes. (2) Indications for use in dogs. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala) and roundworm (Toxocara canis and Toxascaris leonina) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis (American dog tick), and Amblyomma americanum (lone star tick) infestations for 1 month in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater. [[Page 84700]] (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Sec. 520.928 [Amended] 0 9. In Sec. 520.928, in paragraph (b)(1), remove ``Nos. 000010, 055246, and 055529'' and in its place add ``Nos. 000010, 013744, 055246, 055529, and 086101''. Sec. 520.1044a [Amended] 0 10. In Sec. 520.1044a, in paragraph (b), remove ``Nos. 000061 and 054925'' and in its place add ``No. 000061''. 0 11. In Sec. 520.1195, revise paragraph (b)(1) to read as follows: Sec. 520.1195 Ivermectin liquid. * * * * * (b) * * * (1) Nos. 058005 and 058198 for use of product described in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section. * * * * * 0 12. In Sec. 520.1263b, revise paragraphs (b)(2) and (d)(1)(iii) to read as follows: Sec. 520.1263b Lincomycin powder. * * * * * (b) * * * (2) Nos. 016592 and 076475 for use as in paragraphs (d)(1) and (2) of this section. * * * * * (d) * * * (1) * * * (iii) Limitations. Discard medicated drinking water if not used within 2 days. Prepare fresh stock solution daily. Do not use for more than 10 days. If clinical signs of disease have not improved within 6 days, discontinue treatment and reevaluate diagnosis. The safety of lincomycin has not been demonstrated in pregnant swine or swine intended for breeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian. * * * * * Sec. 520.1484 [Amended] 0 13. In Sec. 520.1484, in paragraph (b)(1), remove ``Nos. 054771 and 054925'' and in its place add ``No. 054771''; and remove paragraph (b)(4). 0 14. Add Sec. 520.2654 to read as follows: Sec. 520.2654 Velagliflozin. (a) Specifications. Each milliliter of solution contains 15 milligrams (mg) velagliflozin. (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Amount. Administer orally 0.45 mg per pound of body weight (1 mg per kilogram) velagliflozin once daily. (2) Indications for use. To improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin. (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. Sec. 522.52 [Amended] 0 16. In Sec. 522.52, in paragraph (b), remove ``049480'' and in its place add ``054771''. 0 17. In Sec. 522.147, revise paragraphs (b), (c)(1), and (2) to read as follows: Sec. 522.147 Atipamezole. * * * * * (b) Sponsors. See Nos. 015914, 052483, and 069043 in Sec. 510.600(c) of this chapter. (c) * * * (1) Amount. Administer 3,750 mcg/m\2\ intramuscularly for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride and 5,000 mcg/m\2\ intramuscularly for the reversal of intramuscular dexmedetomidine hydrochloride or medetomidine hydrochloride. (2) Indications for use. For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride and medetomidine hydrochloride. * * * * * 0 18. In Sec. 522.460, revise paragraphs (b) and (c) to read as follows: Sec. 522.460 Cloprostenol. * * * * * (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter. (1) No. 000061 for use of product described in paragraph (a)(1) of this section as in paragraphs (c)(1)(i) and (c)(2) of this section. (2) No. 000061 for use of product described in paragraph (a)(2) as in paragraphs (c)(1)(ii) through (viii) and (c)(2) of this section. (3) No. 068504 for use of product described in paragraph (a)(2) as in paragraphs (c)(1)(ii) through (vii), (c)(1)(ix), and (c)(2) of this section. (c) Conditions of use in cattle--(1) Amount and indications for use. (i) Administer 375 [micro]g by intramuscular injection to induce abortion in pregnant feedlot heifers from 1 week after mating until 4\1/2\ months of gestation. (ii) Administer 500 [micro]g by intramuscular injection for unobserved or non-detected estrus in beef cows, lactating dairy cows, and replacement beef and dairy heifers. (iii) Administer 500 [micro]g by intramuscular injection for treatment of pyometra or chronic endometritis in beef cows, lactating dairy cows, and replacement beef and dairy heifers. (iv) Administer 500 [micro]g by intramuscular injection for treatment of mummified fetus in beef cows, lactating dairy cows, and replacement beef and dairy heifers. (v) Administer 500 [micro]g by intramuscular injection for treatment of luteal cysts in beef cows, lactating dairy cows, and replacement beef and dairy heifers. (vi) Administer 500 [micro]g by intramuscular injection for abortion of beef cows, lactating dairy cows, and replacement beef and dairy heifers from 1 week after mating until 5 months of gestation. Not for use in heifers placed in feedlots. (vii) Administer 500 [micro]g by intramuscular injection as a single injection regimen or double injection regimen with a second injection 11 days after the first injection, for estrus synchronization in beef cows, lactating dairy cows, and replacement beef and dairy heifers. (viii) For use with gonadorelin acetate to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows: administer to each cow 86 [micro]g gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 [micro]g cloprostenol by intramuscular injection, followed 30 to 72 hours later by 86 [micro]g gonadorelin by intramuscular injection. Gonadorelin acetate as provided in Sec. 522.1077(a)(1) of this chapter. (ix) For use with gonadorelin to synchronize estrous cycles to allow for FTAI in lactating dairy cows: administer to each cow by intramuscular injection, followed 6 to 8 days later by 500 [micro]g cloprostenol by intramuscular injection, followed 30 to 72 hours later by gonadorelin by intramuscular injection. Gonadorelin as provided in Sec. 522.1077(a)(1) through (3) of this chapter. (2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Sec. 522.540 [Amended] 0 19. In Sec. 522.540, in paragraph (a)(2)(ii), remove ``Sponsors. See Nos. [[Page 84701]] 054925 and 058005'' and in its place add ``No. 058005''. Sec. 522.558 [Amended] 0 20. In Sec. 522.558, in paragraph (b)(1), remove ``Nos. 017033, 059399, and 086117'' and in its place add ``Nos. 017033, 068504, 069043, and 086117''. Sec. 522.1700 [Amended] 0 21. In Sec. 522.1700, in paragraph (b), remove ``059399'' and in its place add ``086119''. Sec. 522.1704 [Amended] 0 22. In Sec. 522.1704, in paragraph (b), remove ``086073'' and in its place add ``043264''. 0 23. In Sec. 522.2640, revise paragraphs (b)(1) and (2) to read as follows: Sec. 522.2640 Tylosin. * * * * * (b) * * * (1) Nos. 016592 and 058198 for use of 50- or 200-mg/mL solutions as in paragraph (e) of this section. (2) No. 061133 for use of a 200-mg/mL solution as in paragraphs (e)(1) and (2) of this section. * * * * * PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0 24. The authority citation for part 524 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 524.154 [Amended] 0 25. In Sec. 524.154, in paragraph (b)(2), remove ``059399'' and in its place add ``086189''. Sec. 524.1193 [Amended] 0 26. In Sec. 524.1193, in paragraph (b)(2), remove ``Nos. 016592 and 054925'' and in its place add ``No. 016592''. 0 27. In Sec. 524.1600a, revise paragraph (b) to read as follows: Sec. 524.1600a Nystatin, neomycin, thiostrepton, and triamcinolone ointment. * * * * * (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter: (1) For petrolatum base ointments: Nos. 025463 and 054771; or (2) For vanishing cream base ointments: Nos. 025463 and 054771. * * * * * Sec. 524.2483 [Removed] 0 28. Remove Sec. 524.2483. 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. 558.330, revise paragraphs (d)(1)(ii) and (iii) and (d)(2)(i) and (ii) to read as follows: Sec. 558.330 Lubabegron. * * * * * (d) * * * (1) * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- Lubabegron fumarate in grams/ton Combination in grams/ton Indications for use Limitations Sponsor -------------------------------------------------------------------------------------------------------------------------------------------------------- * * * * * * * (ii) 1.25 to 4.54..................... Monensin, 5 to 40........ Beef steers and heifers Feed continuously as the sole ration to 016592, 058198 fed in confinement for provide 13 to 90 mg lubabegron/head/ slaughter: for reduction day and 50 to 480 mg monensin/head/day of ammonia gas emissions during the last 14 to 91 days on feed. per pound of live weight No additional improvement in feed and hot carcass weight efficiency has been shown from feeding and for improved feed monensin at levels greater than 30 g/ efficiency during the ton (360 mg monensin/head/day). A last 14 to 91 days on decrease in dry matter intake may be feed. noticed in some animals receiving lubabegron. Lubabegron has not been approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in Sec. 558.355(d) of this chapter. Lubabegron fumarate as provided by No. 058198, monensin as provided by No. 016592 or 058198 in Sec. 510.600(c) of this chapter. [[Page 84702]] (iii) 1.25 to 4.54.................... Monensin, 10 to 40....... Beef steers and heifers Feed continuously as the sole ration to 016592, 058198 fed in confinement for provide 13 to 90 mg lubabegron/head/ slaughter: for reduction day and 0.14 to 0.42 mg monensin/lb of ammonia gas emissions body weight per day, depending upon per pound of live weight severity of coccidiosis challenge, and hot carcass weight; during the last 14 to 91 days on feed. and for prevention and A decrease in dry matter intake may be control of coccidiosis noticed in some animals receiving due to Eimeria bovis and lubabegron. Lubabegron has not been E. zuernii during the approved for use in breeding animals last 14 to 91 days on because safety and effectiveness have feed. not been evaluated in these animals. Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in Sec. 558.355(d) of this chapter. Lubabegron fumarate as provided by No. 058198, monensin as provided by No. 016592 or 058198 in Sec. 510.600(c) of this chapter. -------------------------------------------------------------------------------------------------------------------------------------------------------- (2) * * * (i) Monensin as in Sec. 558.355. (ii) Tylosin in Sec. 558.625. 0 31. In Sec. 558.355, revise paragraph (f)(4)(iv) to read as follows: Sec. 558.355 Monensin. * * * * * (f) * * * (4) * * * ---------------------------------------------------------------------------------------------------------------- Monensin amount Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (iv) 400 mg per pound of block........ Growing beef steers and Provide 50 to 200 mg of 086113 heifers on pasture monensin (2 to 8 ounces of (stocker, feeder, and block) per head per day, in slaughter) and beef at least one block per five replacement heifers): head of cattle. Feed blocks for increased rate of continuously. Do not feed weight gain. salt of mineral supplements in addition to this block. Discontinue feeding if block consumption falls below 2 ounces or rises above 8 ounces daily. See paragraph (d)(10)(i) of this section.. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * 0 32. In Sec. 558.625, revise paragraphs (e)(2)(vii) and (viii) to read as follows: Sec. 558.625 Tylosin. * * * * * (e) * * * (2) * * * [[Page 84703]] -------------------------------------------------------------------------------------------------------------------------------------------------------- Tylosin grams/ton Combination in grams/ton Indications for use Limitations Sponsor -------------------------------------------------------------------------------------------------------------------------------------------------------- * * * * * * * (vii) 8 to 10......................... Monensin, 5 to 40 plus Beef steers and heifers Feed continuously as sole ration to 016592, 058198 lubabegron fumarate, fed in confinement for provide 13 to 90 mg lubabegron/head/ 1.25 to 4.54. slaughter: for reduction day, 50 to 480 mg monensin/head/day, of ammonia gas emissions and 60 to 90 mg tylosin/head/day per pound of live weight during the last 14 to 91 days on feed. and hot carcass weight; No additional improvement in feed for reduction of efficiency has been shown from feeding incidence of liver monensin at levels greater than 30 g/ abscesses associated ton (360 mg monensin/head/day). A with Fusobacterium decrease in dry matter intake may be necrophorum and noticed in some animals receiving Arcanobacterium pyogenes lubabegron. Lubabegron has not been and for improved feed approved for use in breeding animals efficiency during the because safety and effectiveness have last 14 to 91 days on not been evaluated in these animals. feed. Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in Sec. 558.355(d) of this chapter. Tylosin as provided by No. 016592 or 058198, monensin as provided by No. 016592 or 058198, lubabegron fumarate as provided by No. 058198 in Sec. 510.600(c) of this chapter. (viii) 8 to 10........................ Monensin, 10 to 40 plus Beef steers and heifers Feed continuously as sole ration to 016592, 058198 lubabegron fumarate, fed in confinement for provide 13 to 90 mg lubabegron/head/ 1.25 to 4.54. slaughter: for reduction day, 0.14 to 0.42 mg monensin/lb body of ammonia gas emissions weight per day, depending upon per pound of live weight severity of coccidiosis challenge, up and hot carcass weight, to 480 mg/head/day, and 60 to 90 mg for reduction of tylosin/head/day during the last 14 to incidence of liver 91 days on feed. A decrease in dry abscesses associated matter intake may be noticed in some with Fusobacterium animals receiving lubabegron. necrophorum and Lubabegron has not been approved for Arcanobacterium pyogenes use in breeding animals because safety and for prevention and and effectiveness have not been control of coccidiosis evaluated in these animals. Do not due to Eimeria bovis and allow horses or other equines access E. zuernii during the to feed containing lubabegron and last 14 to 91 days on monensin. Ingestion of monensin by feed. horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in Sec. 558.355(d) of this chapter. Tylosin as provided by No. 016592 or 058198, monensin as provided by No. 016592 or 058198, lubabegron fumarate as provided by No. 058198 in Sec. 510.600(c) of this chapter. * * * * * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 84704]] * * * * * Dated: November 29, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023-26545 Filed 12-5-23; 8:45 am] BILLING CODE 4164-01-P