New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address, 6797-6804 [2025-01226]
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[Federal Register Volume 90, Number 12 (Tuesday, January 21, 2025)] [Rules and Regulations] [Pages 6797-6804] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2025-01226] [[Page 6797]] ======================================================================= ----------------------------------------------------------------------- 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 October, November, and December 2024. The animal drug regulations are also being amended to improve their accuracy and readability. DATES: This rule is effective January 21, 2025. 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. Approval of New Animal Drug Applications FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during October, November, and December 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 October, November, and December 2024 Requiring Evidence of Safety and/or Effectiveness -------------------------------------------------------------------------------------------------------------------------------------------------------- Sponsor (drug labeler 21 CFR Date of approval File No. code \1\) Product name Effect of the action section -------------------------------------------------------------------------------------------------------------------------------------------------------- October 7, 2024..................... 141-554 Boehringer Ingelheim NEXGARD PLUS (afoxolaner, Supplemental approval for 520.35 Animal Health USA, moxidectin, and pyrantel the treatment and control Inc. (000010) chewable tablets). of Asian longhorned tick infestations for 1 month in dogs and puppies. October 7, 2024..................... 141-581 Elanco US Inc. (058198) CREDELIO QUATTRO (lotilaner, Original approval for the 520.1287 moxidectin, praziquantel, prevention of heartworm and pyrantel chewable disease and for the tablets. treatment and control of roundworm, hookworm, and tapeworm infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations and the treatment and control of tick infestations for 1 month in dogs and puppies. October 18, 2024.................... 200-748 Huvepharma EOOD PENNCHLOR (chlortetracycline Original approval as a 558.128 (016592) Type A medicated article) generic copy of NADA 141- and MONOVET (monensin) Type 564. A medicated article) to be used in the manufacture of Type B and Type C medicated feeds. October 23, 2024.................... 141-589 Elanco US Inc. (058198) EXPERIOR (lubabegron Type A Original approval for 558.330 medicated article) and MGA increased rate of weight (melengestrol acetate Type gain, improved feed A medicated article) to be efficiency, suppression of used in the manufacture of estrus (heat), and for Type C medicated feeds. reduction of ammonia gas emissions per pound of live weight and hot carcass weight in growing beef heifers fed in confinement for slaughter during the last 14 to 91 days on feed. October 25, 2024.................... 141-590 Do. EXPERIOR (lubabegron Type A Original approval for 558.330 medicated article), increased rate of weight RUMENSIN (monensin Type A gain, improved feed medicated article), and MGA efficiency, suppression of (melengestrol acetate Type estrus (heat), for A medicated article) to be reduction of ammonia gas used in the manufacture of emissions per pound of Type C medicated feeds. live weight and hot carcass weight, and for the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii in growing beef heifers fed in confinement for slaughter during the last 14 to 91 days on feed. [[Page 6798]] October 25, 2024.................... 141-591 Do. EXPERIOR (lubabegron Type A Original approval for 558.625 medicated article), increased rate of weight RUMENSIN (monensin Type A gain, improved feed medicated article), TYLAN efficiency, suppression of (tylosin Type A medicated estrus (heat), for article), and MGA reduction of ammonia gas (melengestrol acetate Type emissions per pound of A medicated article) to be live weight and hot used in the manufacture of carcass weight, and for Type C medicated feeds. the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii and for reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium pyogenes in growing beef heifers fed in confinement for slaughter during the last 14 to 91 days on feed. November 6, 2024.................... 141-521 Zoetis Inc. (054771) SIMPARICA TRIO (sarolaner, Supplemental approval for 520.2090 moxidectin, and pyrantel the treatment and control chewable tablets). of tick infestations with Asian longhorned tick for 1 month in dogs and puppies. November 13, 2024................... 141-502 Do..................... REVOLUTION PLUS (selamectin Supplemental approval for 524.2099 and sarolaner topical the prevention of tapeworm solution). infections as a direct result of killing vector fleas on the treated cat for 1 month in cats and kittens. November 14, 2024................... 200-803 Phibro Animal Health PAQFLOR (florfenicol) Type A Original approval as a 558.261 Corp. (066104) Medicated Article to be generic copy of NADA 141- used in the manufacture of 246. Type C medicated feeds. November 18, 2024................... 200-793 Parnell Technologies, PROPOFOLVET MULTIDOSE Original approval as a 522.2005 Pty., Ltd. (068504) (propofol injectable generic copy of NADA 141- emulsion). 098. November 18, 2024................... 200-805 Virbac AH, Inc. MEL 500 (melengestrol Original approval as a 558.342 (051311) acetate Type A liquid generic copy of NADA 039- medicated article) to be 402. used in the manufacture of Type C medicated feeds. November 20, 2024................... 200-636 Bimeda Animal Health, DORACIDE (doramectin topical Original approval as a 524.770 Ltd. (061133) solution). generic copy of NADA 141- 095. November 22, 2024................... 141-452 Zoetis Inc. (054771) SIMPARICA (sarolaner) Supplemental approval for 520.2086 Chewable Tablet. the treatment and control of tick infestations with Asian longhorned tick for 1 month in dogs and puppies. November 25, 2024................... 141-532 Intervet, Inc. (000061) BRAVECTO 1-MONTH Supplemental approval for 520.998 (fluralaner) Chewable the treatment and control Tablet. of Asian longhorned tick infestations for 1 month in dogs and puppies. December 19, 2024................... 141-043 Zoetis Inc. (054771) SYNOVEX CHOICE and SYNOVEX Supplemental approval of 522.2478 PRIMER (trenbolone acetate both products for and estradiol benzoate increased rate of weight implants) Implants. gain in growing beef steers and heifers on pasture (stocker, feeder, and slaughter). -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ See Sec. 510.600(c) (21 CFR 510.600(c)) for sponsor addresses. II. Withdrawal of Approval of New Animal Drug Applications Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861 (drug labeler code (054925) requested that FDA withdraw approval of NADA 140-810 for DERMA-VET (nystatin, neomycin sulfate, thiostrepton, triamcinolone acetonide) Ointment because the product is no longer manufactured or marketed. Accordingly, approval of NADA 140-810 was withdrawn effective December 23, 2024. The animal drug regulations do not require amendment as the sponsor's drug labeler code is not codified in 21 CFR 524.1600a. Mylan Institutional LLC, a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505 (drug labeler code 063286) requested that FDA withdraw approval of ANADA 200-257 for Ketamine HCL (ketamine hydrochloride injection, USP) Injectable Solution because the product is no longer manufactured or marketed. Accordingly, approval of ANADA 200-257 was withdrawn effective June 29, 2023. The animal drug regulations do not require amendment as the sponsor's drug labeler code was removed from 21 CFR 522.1222 in a rule that published August 16, 2023 (88 FR 55559 at 55564). III. Changes of Sponsor The sponsors of the approved applications listed in table 2 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 2 are amended to reflect these actions. [[Page 6799]] Table 2--Applications for Which Ownership was Transferred to Another Sponsor During October, November, and December 2024 -------------------------------------------------------------------------------------------------------------------------------------------------------- Transferring sponsor (drug New sponsor (drug labeler File No. Product name labeler code) code) 21 CFR section -------------------------------------------------------------------------------------------------------------------------------------------------------- 141-339............................... OVUGEL (triptorelin acetate) United-AH II LLC (051233) Aurora Pharmaceutical, Inc. 529.2620 Gel. (051072) 200-233............................... SUPERIORBUTE (phenylbutazone) Superior Equine Noble Pharma, LLC (086119) 520.1720e Powder. Pharmaceuticals, Inc. (027053) -------------------------------------------------------------------------------------------------------------------------------------------------------- IV. Change of Sponsor Address Pharmacosmos, Inc. (drug labeler code 042552 in Sec. 510.600(c)) has informed FDA that it has changed its address to 120 Headquarters Plz., Morristown, NJ 07960. 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.Sec. 510.600(c) is amended to remove entries for Superior Equine Pharmaceuticals, Inc. and United-AH II, LLC from the lists of sponsors of approved applications as these firms are no longer sponsors of an approved application. 21 CFR 522.2630(b) is amended to present the sequence of drug labeler codes for tulathromycin injectable solutions. 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), revise the entry for ``Pharmacosmos, Inc.'' and remove the entries for ``Superior Equine Pharmaceuticals, Inc.'' and ``United-AH II, LLC''; and 0 b. In the table in paragraph (c)(2): 0 i. Remove the entry for ``027053''; 0 ii. Revise the entry for ``042552''; and 0 iii. Remove the entry for ``051233''. The revision reads as follows: Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * * * (c) * * * (1) * * * ------------------------------------------------------------------------ Drug labeler Firm name and address code ------------------------------------------------------------------------ * * * * * * * Pharmacosmos, Inc., 120 Headquarters Plz., Morristown, 042552 NJ 07960............................................... * * * * * * * ------------------------------------------------------------------------ (2) * * * ------------------------------------------------------------------------ Drug labeler code Firm name and address ------------------------------------------------------------------------ * * * * * * * 042552............................... Pharmacosmos, Inc., 120 Headquarters Plz., Morristown, NJ 07960. * * * * * * * ------------------------------------------------------------------------ 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. 520.35, revise paragraphs (a) and (c)(2) to read as follows: Sec. 520.35 Afoxolaner, moxidectin, and pyrantel. (a) Specifications. Each chewable tablet contains: (1) 9.375 milligrams (mg) afoxolaner, 45 micrograms (mcg) moxidectin, and 18.75 mg pyrantel (as pamoate salt); (2) 18.75 mg afoxolaner, 90 mcg moxidectin, and 37.5 mg pyrantel (as pamoate salt); [[Page 6800]] (3) 37.5 mg afoxolaner, 180 mcg moxidectin, and 75 mg pyrantel (as pamoate salt); (4) 75 mg afoxolaner, 360 mcg moxidectin, and 150 mg pyrantel (as pamoate salt); or (5) 150 mg afoxolaner, 720 mcg moxidectin, and 300 mg pyrantel (as pamoate salt). * * * * * (c) * * * (2) Indications for use. 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), Amblyomma americanum (lone star tick), and Haemaphysalis longicornis (longhorned tick) infestations for 1 month in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater. * * * * * 0 5. In Sec. 520.998, revise paragraph (c)(2)(ii) to read as follows: Sec. 520.998 Fluralaner. * * * * * (c) * * * (2) * * * (ii) Chewable tablets described in paragraph (a)(2) of this section. Kills adult fleas; for the treatment and prevention of flea infestations (C. felis), and the treatment and control of tick infestations (I. scapularis (black-legged tick), D. variabilis (American dog tick), R. sanguineus (brown dog tick), and H. longicornis (Asian longhorned tick)) for 1 month in dogs and puppies 8 weeks of age and older, and weighing 4.4 lb or greater; and for the treatment and control of A. americanum (lone star tick) infestations for 1 month in dogs and puppies 6 months of age and older, and weighing 4.4 lb or greater. * * * * * 0 6. Add Sec. 520.1287 to read as follows: Sec. 520.1287 Lotilaner, moxidectin, praziquantel, and pyrantel. (a) Specifications. Each chewable tablet contains: (1) 56.25 milligrams (mg) lotilaner, 0.056 mg moxidectin, 14.25 mg praziquantel, and 14.25 mg pyrantel (as pamoate salt); (2) 112.5 mg lotilaner, 0.113 mg moxidectin, 28.5 mg praziquantel, and 28.5 mg pyrantel (as pamoate salt); (3) 225 mg lotilaner, 0.225 mg moxidectin, 57 mg praziquantel, and 57 mg pyrantel (as pamoate salt); (4) 450 mg lotilaner, 0.45 mg moxidectin, 114 mg praziquantel, and 114 mg pyrantel (as pamoate salt); or (5) 900 mg lotilaner, 0.9 mg moxidectin, 228 mg praziquantel, and 228 mg pyrantel (as pamoate salt). (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Amount. Administer orally once a month, at the minimum dosage of 9 mg/lb (20 mg/kg) lotilaner, 0.009 mg/lb (0.02 mg/kg) moxidectin, 2.28 mg/lb (5 mg/kg) praziquantel, and 2.28 mg/lb (5 mg/kg) pyrantel (as pamoate salt). (2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina), hookworm (adult Uncinaria stenocephala), and tapeworm (Dipylidium caninum, Taenia pisiformis and Echinococcus granulosus) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations (Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick)) for 1 month in dogs and puppies 8 weeks of age and older, and weighing 3.3 pounds or greater. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Sec. 520.1720e [Amended] 0 7. In Sec. 520.1720e, in paragraph (b)(1), remove the text ``027053'' and in its place add the text ``086119''. 0 8. In Sec. 520.2086, revise paragraphs (c)(1) and (2) to read as follows: Sec. 520.2086 Sarolaner. * * * * * (c) * * * (1) Amount. Administer orally once a month at the recommended minimum dosage of 0.91 mg/lb (2 mg/kg). (2) Indications for use. Kills adult fleas, and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations (Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black- legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick)) for 1 month in dogs 6 months of age or older and weighing 2.8 pounds or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. * * * * * 0 9. In Sec. 520.2090, revise paragraph (c)(2) to read as follows: Sec. 520.2090 Sarolaner, moxidectin, and pyrantel. * * * * * (c) * * * (2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina) and hookworm (L4, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala) infections. Kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick) for 1 month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. * * * * * 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. 522.2005: 0 a. Revise paragraph (b); 0 b. Revise the heading for paragraph (c); 0 c. Revise paragraph (c)(2); and 0 d. Add paragraph (d). The revisions and addition read as follows: Sec. 522.2005 Propofol. * * * * * [[Page 6801]] (b) * * * (1) No. 086064 for use as in paragraphs (c)(1), (c)(2)(i), (c)(3), (d)(1), (d)(2)(i), and (d)(3) of this section. (2) No. 054771 for use as in paragraphs (c)(1), (c)(2)(ii), (c)(3), (d)(1), (d)(2)(ii), and (d)(3) of this section. (3) Nos. 054771 and 068504 for use as in paragraphs (c)(1), (c)(2)(iii), and (c)(3) of this section. * * * * * (c) Conditions of use in dogs-- * * * * * (2) Indications for use. (i) As a single injection to provide general anesthesia for short procedures; for induction and maintenance of general anesthesia using incremental doses to effect; and for induction of general anesthesia where maintenance is provided by inhalant anesthetics. (ii) For induction of general anesthesia; for maintenance of anesthesia for up to 20 minutes; and for induction of general anesthesia followed by maintenance with an inhalant anesthetic. (iii) For induction and maintenance of general anesthesia; and for induction of general anesthesia followed by maintenance with an inhalant anesthetic. * * * * * (d) Conditions of use in cats--(1) Amount. Administer by intravenous injection according to label directions. The use of preanesthetic medication reduces propofol dose requirements. (2) Indications for use. (i) As a single injection to provide general anesthesia for short procedures; for induction and maintenance of general anesthesia using incremental doses to effect; and for induction of general anesthesia where maintenance is provided by inhalant anesthetics. (ii) For induction and maintenance of general anesthesia; and for induction of general anesthesia followed by maintenance with an inhalant anesthetic. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 12. In Sec. 522.2478, revise paragraph (d)(2) to read as follows: Sec. 522.2478 Trenbolone acetate and estradiol benzoate. * * * (d) * * * (2) Growing beef steers and heifers on pasture (stocker, feeder, and slaughter)--(i) Amounts and indications for use. (A) An implant containing 50 mg trenbolone acetate and 7 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 trenbolone acetate and 14 mg estradiol benzoate as described in paragraph (a)(1)(ii) of this section for increased rate of weight gain. (C) An extended-release implant containing 150 mg trenbolone acetate and 21 mg estradiol benzoate as described in paragraph (a)(2)(i) of this section for increased rate of weight gain for up to 200 days. (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). Safety and effectiveness following reimplantation have not been evaluated. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been established. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. * * * * * Sec. 522.2630 [Amended] 0 13. In Sec. 522.2630, in paragraphs (b)(1) and (2), remove the text ``and 068504, 069043'' and add in its place the text ``068504, and 069043''. PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0 14. The authority citation for part 524 continues to read as follows: Authority: 21 U.S.C. 360b. 0 15. In Sec. 524.770, revise paragraph (b) to read as follows: Sec. 524.770 Doramectin. * * * * * (b) Sponsors. See Nos. 051072, 054771, and 061133 in Sec. 510.600(c) of this chapter. * * * * * 0 16. In Sec. 524.2099, revise paragraph (c)(2) to read as follows: Sec. 524.2099 Selamectin and sarolaner. * * * * * (c) * * * (2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis, the treatment and control of roundworm (Toxocara cati) and intestinal hookworm (Ancylostoma tubaeforme) infections, and the treatment and control of ear mite (Otodectes cynotis) infestations. Kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, the prevention of Dipylidium caninum (tapeworm) infections as a direct result of killing Ctenocephalides felis vector fleas on the treated cat, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), and Ixodes scapularis (black-legged tick) for 1 month in cats and kittens 8 weeks and older, and weighing 2.8 pounds or greater. * * * * * PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 0 17. The authority citation for part 529 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 529.2620 [Amended] 0 18. In Sec. 529.2620, in paragraph (b), remove the text ``051233'' and in its place add the text ``051072''. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 19. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 0 20. In Sec. 558.128, revise paragraphs (e)(4)(xxi) and (xxii) to read as follows: Sec. 558.128 Chlortetracycline. * * * * * (e) * * * (4) * * * [[Page 6802]] ---------------------------------------------------------------------------------------------------------------- Combination in Indications for Chlortetracycline amount grams/ton use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (xxi) 400 to 2,000 g/ton........ Monensin, 15 to 84. Replacement beef For replacement 069254, 016592 and dairy beef and dairy heifers: For heifers not treatment of currently being bacterial fed monensin: enteritis caused Feed as the sole by Escherichia ration for not coli and more than 5 days bacterial to provide 10 mg pneumonia caused chlortetracycline by Pasteurella per pound of body multocida weight per day susceptible to and 0.14 to 0.42 chlortetracycline mg monensin per ; and for the pound of body prevention and weight per day, control of depending upon coccidiosis severity of caused by Eimeria challenge, to bovis and Eimeria provide 50 to 100 zuernii. mg monensin per head per day in a minimum of 1 pound of Type C medicated feed. After 5 days, continue to feed monensin Type C medicated feed alone to provide 50 to 200 mg monensin per head per day in a minimum of 1 pound of Type C medicated feed.. For replacement beef and dairy heifers currently being fed monensin: Feed as the sole ration for not more than 5 days to provide 10 mg chlortetracycline per pound of body weight per day and 0.14 to 0.42 mg monensin per pound of body weight per day, depending upon severity of challenge, to provide 50 to 200 mg monensin per head per day in a minimum of 1 pound of Type C medicated feed. After 5 days, continue to feed monensin Type C medicated feed alone. This drug is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Monensin as provided by No. 058198 or 016592; chlortetracycline by No. 069254 in Sec. 510.600(c) of this chapter. (xxii) 400 to 2,000 g/ton....... Monensin, 15 to 400 Replacement beef For replacement 0692544, 0165924 and dairy beef and dairy heifers: For heifers not treatment of currently being bacterial fed monensin: enteritis caused Feed as the sole by Escherichia ration for not coli and more than 5 days bacterial to provide 10 mg pneumonia caused chlortetracycline by Pasteurella per pound of body multocida weight per day susceptible to and 50 to 100 mg chlortetracycline monensin per head ; and for per day in a increased rate of minimum of 1 weight gain. pound of Type C medicated feed. After 5 days, continue to feed monensin Type C medicated feed alone to provide 50 to 200 mg monensin per head per day in a minimum of 1 pound of Type C medicated feed.. For replacement beef and dairy heifers currently being fed monensin: Feed as the sole ration for not more than 5 days to provide 10 mg chlortetracycline per pound of body weight per day and 50 to 200 mg monensin per head per day in a minimum of 1 pound of Type C medicated feed. After 5 days, continue to feed monensin Type C medicated feed alone. This drug is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Monensin as provided by No. 058198 or 016592; chlortetracycline by No. 069254 in Sec. 510.600(c) of this chapter. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * 0 21. In Sec. 558.261, revise paragraph (b) to read as follows: Sec. 558.261 Florfenicol. * * * * * (b) Sponsors. See sponsor numbers as in Sec. 510.600(c) of this chapter. (1) No. 000061 for use of products described in paragraph (a) of this section as in paragraph (e) of this section. (2) No. 066104 for use of product described in paragraph (a)(2) of this section as in paragraph (e)(2) of this section. * * * * * 0 22. In Sec. 558.330: 0 a. Redesignate paragraph (d) as paragraph (e); 0 b. Add new paragraph (d); and 0 c. Revise newly redesignated paragraph (e). The addition and revision read as follows: Sec. 558.330 Lubabegron. * * * * * (d) Special considerations. Labeling shall bear the following caution statements: (1) Lubabegron has not been approved for use in breeding animals because [[Page 6803]] safety and effectiveness have not been evaluated in these animals. (2) Do not allow horses or other equines access to feed containing lubabegron. (3) A decrease in dry matter intake may be noticed in some animals receiving lubabegron. (e) Conditions of use. (1) It is used in cattle feed as follows: ---------------------------------------------------------------------------------------------------------------- Lubabegron (as lubabegron Combination in Indications for fumarate) in grams/ton grams/ton use Limitations Sponsors ---------------------------------------------------------------------------------------------------------------- (i) 1.25 to 4.54................ ................... Beef steers and Feed continuously 058198 heifers fed in as the sole confinement for ration to provide slaughter: For 13 to 90 mg reduction of lubabegron/head/ ammonia gas day during the emissions per last 14 to 91 pound of live days on feed. See weight and hot special labeling carcass weight considerations in during the last paragraph (d) of 14 to 91 days on this section.. feed. (ii) 1.25 to 4.54............... Melengestrol Growing beef Melengestrol 058198 acetate, 0.25 to 2 heifers fed in acetate Type C g/ton. confinement for top-dress slaughter: For medicated feed increased rate of (0.5 to 2 lb(s) weight gain, per head per day) improved feed must be top efficiency, dressed onto or suppression of mixed at feeding estrus (heat), with a Type C and for reduction medicated feed of ammonia gas containing 1.25 emissions per to 4.54 g/ton pound of live lubabegron to weight and hot provide 0.25 to carcass weight 0.5 mg during the last melengestrol 14 to 91 days on acetate and 13 to feed. 90 mg lubabegron per head per day. Feed as the sole ration during the last 14 to 91 days on feed. See special labeling considerations in paragraph (d) of this section and in Sec. 558.342(d). Lubabegron fumarate as provided by No. 058198; melengestrol acetate as provided by No. 054771 in Sec. 510.600(c) of this chapter.. (iii) 1.25 to 4.54.............. Monensin, 5 to 40.. Beef steers and Feed continuously 016592, 058198 heifers fed in as sole ration to confinement for provide 13 to 90 slaughter: For mg lubabegron/ reduction of head/day and 50 ammonia gas to 480 mg emissions per monensin/head/day pound of live during the last weight and hot 14 to 91 days on carcass weight feed. No and for improved additional feed efficiency improvement in during the last feed efficiency 14 to 91 days on has been shown feed. from feeding monensin at levels greater than 30 g/ton (360 mg monensin/ head/day). See special labeling considerations in paragraph (d) of this section and in Sec. 558.355(d). Lubabegron fumarate as provided by No. 058198; monensin as provided by No. 016592 or 058198 in Sec. 510.600(c) of this chapter.. (iv) 1.25 to 4.54............... Monensin, 10 to 40. Beef steers and Feed continuously 016592, 058198 heifers fed in as the sole confinement for ration to provide slaughter: For 13 to 90 mg reduction of lubabegron/head/ ammonia gas day and 0.14 to emissions per 0.42 mg monensin/ pound of live lb body weight weight and hot per day, carcass weight; depending upon and for severity of prevention and coccidiosis control of challenge, during coccidiosis due the last 14 to 91 to Eimeria bovis days on feed. See and E. zuernii special labeling during the last considerations in 14 to 91 days on paragraph (d) of feed. this section and in Sec. 558.355(d). Lubabegron fumarate as provided by No. 058198; monensin as provided by No. 016592 or 058198 in Sec. 510.600(c) of this chapter.. (v) 1.25 to 4.54................ Monensin, 10 to 40 Growing beef Melengestrol 058198 and melengestrol heifers fed in acetate Type C acetate, 0.25 to 2. confinement for top-dress slaughter: For medicated feed increased rate of (0.5 to 2 lb(s) weight gain, per head per day) improved feed must be top efficiency, dressed onto or suppression of mixed at feeding estrus (heat), with a Type C for reduction of medicated feed ammonia gas containing 1.25 emissions per to 4.54 g/ton pound of live lubabegron and 10 weight and hot to 40 g/ton carcass weight, monensin, to and for the provide 0.25 to prevention and 0.5 mg control of melengestrol coccidiosis acetate and 13 to caused by Eimeria 90 mg lubabegron bovis and Eimeria per head per day, zuernii during and 0.14 to 0.42 the last 14 to 91 mg monensin per days on feed. pound of body weight per day, depending upon severity of challenge, up to a maximum of 480 mg monensin per head per day. Feed as the sole ration during the last 14 to 91 days on feed. See special labeling considerations in paragraph (d) of this section, and in Sec. Sec. 558.342(d) and 558.355(d). Lubabegron fumarate and monensin as provided by No. 058198; melengestrol acetate as provided by No. 054771 in Sec. 510.600(c) of this chapter.. ---------------------------------------------------------------------------------------------------------------- (2) Lubabegron may also be used in combination with: (i) [Reserved] (ii) Tylosin as in Sec. 558.625. 0 23. In Sec. 558.342: 0 a. Add paragraphs (b)(1) and (2); and 0 b. Revise paragraphs (e)(1)(i) and (ii). The addition and revision read as follows: Sec. 558.342 Melengestrol. * * * * * (b) * * * [[Page 6804]] (1) No. 054771 for use of products described in paragraph (a)(1) of this section: (2) Nos. 016592, 051311, 054771, and 058198 for use of product described in paragraph (a)(2) of this section. * * * * * (e) * * * (1) * * * ---------------------------------------------------------------------------------------------------------------- Melengestrol acetate in mg/head/ Combination in Indications for day grams/ton use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (i) 0.25 to 0.5................. ................... Heifers fed in Administer 0.5 to 016592, 051311, confinement for 2.0 pounds (lb)/ 054771, 058198 slaughter: For head/day of increased rate of medicated feed weight gain, containing 0.125 improved feed to 1.0 mg efficiency, and melengestrol suppression of acetate/lb to estrus (heat).. provide 0.25 to 0.5 mg melengestrol acetate/head/day.. (ii) 0.5........................ ................... Heifers intended Administer 0.5 to 016592, 051311, for breeding: For 2.0 lb/head/day 054771, 058198 suppression of of Type C feed estrus (heat). containing 0.25 to 1.0 mg melengestrol acetate/lb to provide 0.5 mg melengestrol acetate/head/day. Do not exceed 24 days of feeding. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * 0 24. In Sec. 558.625: 0 a. Redesignate paragraphs (e)(2)(ix) through (xvii) as paragraphs (e)(2)(x) through (xviii); and 0 b. Add new paragraph (e)(2)(ix). The addition reads as follows: Sec. 558.625 Tylosin. * * * * * (e) * * * (2) * * * ---------------------------------------------------------------------------------------------------------------- Combination in Indications for Tylosin grams/ton grams/ton use Limitations Sponsors ---------------------------------------------------------------------------------------------------------------- * * * * * * * (ix) 8 to 10.................... Monensin, 10 to 40 Growing beef Feed as the sole 058198 plus lubabegron heifers fed in ration during the (as lubebegron confinement for last 14 to 91 fumarate), 1.25 to slaughter: For days on feed. 4.54, plus increased rate of Melengestrol melengestrol weight gain, acetate Type C acetate, 0.25 to improved feed top-dress 2.0. efficiency, medicated feed suppression of (0.5 to 2.0 lb estrus (heat), per head per day) for reduction of must be top ammonia gas dressed onto or emissions per mixed at feeding pound of live with a Type C weight and hot medicated feed carcass weight, containing 8 to for the 10 g/ton tylosin, prevention and 1.25 to 4.54 g/ control of ton lubabegron, coccidiosis and 10 to 40 g/ caused by Eimeria ton monensin, to bovis and Eimeria provide 0.25 to zuernii, and for 0.5 mg reduction of melengestrol incidence of acetate, 60 to 90 liver abscesses mg tylosin per associated with head per day, 13 Fusobacterium to 90 mg necrophorum and lubabegron per Arcanobacterium head per day, and pyogenes during 0.14 to 0.42 mg the last 14 to 91 monensin per days on feed. pound of body weight per day, depending on severity of challenge, up to 480 mg monensin per head per day. See special labeling considerations in Sec. Sec. 558.330(d), 558.342(d), and 558.355(d). Tylosin as provided by No. 016592 or 058198; lubabegron fumarate and monensin as provided by No. 058198; melengestrol acetate as provided in No. 054771 in Sec. 510.600(c) of this chapter. * * * * * * * ---------------------------------------------------------------------------------------------------------------- Dated: January 14, 2025. P. Ritu Nalubola, Associate Commissioner for Policy. [FR Doc. 2025-01226 Filed 1-17-25; 8:45 am] BILLING CODE 4164-01-P
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