[Federal Register Volume 88, Number 85 (Wednesday, May 3, 2023)] [Rules and Regulations] [Pages 27693-27701] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2023-09212] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 516, 520, 522, 524, 526, 529, 556, and 558 [Docket No. FDA-2023-N-0002] New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications 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 January, February, and March 2023. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve their accuracy and readability. DATES: This rule is effective May 3, 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 January, February, and March 2023, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the office of the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. Persons with access to the internet may obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book. [[Page 27694]] Table 1--Original and Supplemental NADAs, ANADAs, and cNADAs Approved During January, February, and March 2023 Requiring Evidence of Safety and/or Effectiveness -------------------------------------------------------------------------------------------------------------------------------------------------------- 21 CFR Approval date File No. Sponsor Product name Effect of the action Public documents section -------------------------------------------------------------------------------------------------------------------------------------------------------- January 5, 2023................ 200-732 Felix Pharmaceuticals Carprofen Tablets Original approval for FOI Summary.............. 520.304 Pvt. Ltd., 25-28 (carprofen tablets) the relief of pain North Wall Quay, Caplets. and inflammation Dublin 1, Ireland. associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs as a generic copy of NADA 141-053. January 11, 2023............... 200-611 Akorn Operating DETOMISED (detomidine Original approval as a FOI Summary.............. 522.536 Company LLC, 5605 hydrochloride) sedative and Centerpoint Ct., Injectable Solution. analgesic to Suite A, Gurnee, IL facilitate minor 60031. surgical and diagnostic procedures in horses as a generic copy of NADA 140-862. January 11, 2023............... 200-738 Aurora Pharmaceutical, DECTOGARD (doramectin Original approval for FOI Summary.............. 524.770 Inc., 1196 Highway 3 topical solution) treatment and control South, Northfield, MN Topical Solution. of internal and 55057-3009. external parasites of cattle as a generic copy of NADA 141-095. January 12, 2023............... 141-426 Intervet, Inc., 2 BRAVECTO (fluralaner) Supplemental approval FOI Summary.............. 520.998 Giralda Farms, Chewable tablets. for the treatment and Madison, NJ 07940. control of Asian long horned tick infestations for 12 weeks in dogs and puppies. January 12, 2023............... 200-721 Norbrook Laboratories MIDAMOX for Cats Supplemental approval FOI Summary.............. 524.1146 Ltd., Carnbane (imidacloprid and for prevention of Industrial Estate, moxidectin) Topical heartworm disease and Newry, County Down, Solution. treatment of flea BT35 6QQ, United infestations in Kingdom. ferrets as a generic copy of NADA 141-254. January 12, 2023............... 200-733 Felix Pharmaceuticals Marbofloxacin Chewable Original approval for FOI Summary.............. 520.1310 Pvt. Ltd., 25-28 Tablets treatment of North Wall Quay, (marbofloxacin). infections in dogs Dublin 1, Ireland. and cats associated with bacteria susceptible to marbofloxacin as a generic copy of NADA 141-151. January 12, 2023............... 200-734 Do.................... Praziquantel Tablets Original approval for FOI Summary.............. 520.1870 (praziquantel). removal or removal and control of certain canine tapeworms as a generic copy of NADA 111-798. January 13, 2023............... 200-735 ZyVet Animal Health, Dexmedetomidine Original approval for FOI Summary.............. 522.558 Inc., 73 Route 31N, Hydrochloride use as a sedative, Pennington, NJ 08534. (dexmedetomidine analgesic, and hydrochloride) preanesthetic in dogs Injectable Solution. and cats as a generic copy of NADA 141-267. January 13, 2023............... 200-736 Do.................... Marbofloxacin Tablets Original approval for FOI Summary.............. 520.1310 (marbofloxacin). treatment of infections in dogs and cats associated with bacteria susceptible to marbofloxacin as a generic copy of NADA 141-151. February 2, 2023............... 200-737 Do.................... Enrofloxacin Original approval for FOI Summary.............. 520.812 (enrofloxacin) the management of Flavored diseases associated Antimicrobial Tablets. with bacteria susceptible to enrofloxacin in dogs and cats as a generic copy of NADA 140-441. February 2, 2023............... 200-739 Do.................... Carprofen (carprofen) Original approval for FOI Summary.............. 520.304 Chewable Tablets. the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs as a generic copy of NADA 141-111. February 9, 2023............... 200-701 Chanelle PARASEDGE Multi for Supplemental approval FOI Summary.............. 524.1146 Pharmaceuticals Cats (imidacloprid for prevention of Manufacturing Ltd., and moxidectin) heartworm disease and Loughrea, County Topical Solution. treatment of flea Galway, Ireland. infestations in ferrets as a generic copy of NADA 141-254. [[Page 27695]] February 24, 2023.............. 200-741 Aurora Pharmaceutical, EPRIGARD Original approval for FOI Summary.............. 524.814 Inc., 1196 Highway 3 (eprinomectin) treatment and control South, Northfield, MN Topical Solution. of internal and 55057-3009. external parasites in cattle as a generic copy of NADA 141-079. March 21, 2023................. 200-743 Provetica LLC, 8735 MODULIS for Dogs Original approval for FOI Summary.............. 520.522 Rosehill Rd., Suite (cyclosporine oral the control of atopic 300, Lenexa, KS 66215. solution) USP dermatitis in dogs as MODIFIED. a generic copy of NADA 141-218. March 21, 2023................. 200-745 Parnell Technologies RESPIRMYCIN 25 Original approval for FOI Summary.............. 522.2630 Pty. Ltd., Unit 4, (tulathromycin the treatment of 476 Gardeners Rd., injection) Injectable respiratory disease Alexandria, New South Solution. in swine and calves Wales 2015, Australia. as a generic copy of NADA 141-349. March 29, 2023................. 200-744 Provetica LLC, 8735 MODULIS for Cats Original approval for FOI Summary.............. 520.522 Rosehill Rd., Suite (cyclosporine oral the control of feline 300, Lenexa, KS 66215. solution) USP allergic dermatitis MODIFIED. in cats as a generic copy of NADA 141-329. March 30, 2023................. 200-746 Norbrook Laboratories TAURAMOX (moxidectin) Original approval for FOI Summary.............. 522.1450 Ltd., Carnbane Injectable Solution. treatment and control Industrial Estate, of internal and Newry, County Down, external parasites in BT35 6QQ, United beef and nonlactating Kingdom. dairy cattle as a generic copy of NADA 141-220. March 31, 2023................. 200-747 ZyVet Animal Health, Maropitant Citrate Original approval for FOI Summary.............. 520.1315 Inc., 73 Route 31N, (maropitant citrate) the prevention of Pennington, NJ 08534. Tablets. acute vomiting and the prevention of vomiting due to motion sickness in dogs as a generic copy of NADA 141-262. -------------------------------------------------------------------------------------------------------------------------------------------------------- Also, FDA is amending the animal drug regulations to reflect approval of supplemental applications, as listed in table 2, to change the marketing status of dosage form antimicrobial animal drug products from over the counter (OTC) to by veterinary prescription (Rx). These applications were submitted in voluntary compliance with the goals of the FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative as identified by guidance for industry #263, ``Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the- Counter,'' June 11, 2021 (https://www.fda.gov/media/130610/download). Table 2--Supplemental Applications Approved During January, February, and March 2023 To Change the Marketing Status of Antimicrobial Animal Drug Products From OTC to Rx ---------------------------------------------------------------------------------------------------------------- 21 CFR Approval date File No. Sponsor Product name section ---------------------------------------------------------------------------------------------------------------- January 3, 2022....................... 200-274 Zoetis Inc., 333 LINCOMIX (lincomycin 522.1260 Portage St., hydrochloride) Kalamazoo, MI 49007. Injectable Solution. January 12, 2022...................... 012-123 Bimeda Animal Health GALLIMYCIN 100 522.820 Ltd., 1B The Herbert Injection Building, The Park, (erythromycin) Carrickmines, Dublin Injectable Solution. 18, Ireland. January 12, 2022...................... 130-952 Intervet, Inc., 2 GENTOCIN Pinkeye Spray 524.1044e Giralda Farms, (gentamicin) Topical Madison, NJ 07940. Spray. January 13, 2022...................... 008-774 Huvepharma EEOD, 5th SULMET (sodium 522.2260 Floor, 3A Nikolay sulfamethazine) Haytov Str., 1113 Injectable Solution. Sofia, Bulgaria. February 10, 2023..................... 065-506 Bimeda Animal Health COMBI-PEN-48 522.1696a Ltd., 1B The Herbert (penicillin G Building, The Park, benzathine and Carrickmines, Dublin penicillin G 18, Ireland. procaine) Injectable Suspension. February 14, 2023..................... 055-018 Huvepharma EOOD, 5th Chlortetracycline 520.443 Floor, 3A Nikolay (chlortetracycline Haytov Str., 1113 hydrochloride) Sofia, Bulgaria. Tablets, 25 mg. February 15, 2023..................... 033-157 Do.................... SPECTAM Scour-Halt 520.2123c (spectinomycin) Oral Solution. February 15, 2023..................... 040-040 Do.................... SPECTAM 522.2120 (spectinomycin) Injectable Solution. February 24, 2023..................... 065-010 Do.................... NOROCILLIN (penicillin 522.1696b G procaine) Injectable Suspension. March 1, 2023......................... 200-351 Do.................... Lincomycin Injectable, 522.1260 USP. March 1, 2023......................... 200-368 Do.................... Lincomycin Injectable, 522.1260 USP. March 1, 2023......................... 130-464 Intervet, Inc., 2 GARACIN Pig Pump 520.1044b Giralda Farms, (gentamicin) Oral Madison, NJ 07940. Solution. [[Page 27696]] March 9, 2023......................... 035-456 Bimeda Animal Health GALLIMYCIN-36 526.820 Ltd., 1B The Herbert (erythromycin) Building, The Park, Intramammary Solution. Carrickmines, Dublin 18, Ireland. March 13, 2023........................ 200-315 Sparhawk Laboratories, LINCOMYCIN 300 522.1260 Inc., 12340 Santa Fe (lincomycin Trail Dr., Lenexa, KS hydrochloride) 66215. Injectable Solution. March 16, 2023........................ 065-505 Bimeda Animal Health PRO-PEN-G (penicillin 522.1696b Ltd., 1B The Herbert G procaine) Building, The Park, Injectable Suspension. Carrickmines, Dublin 18, Ireland. March 20, 2023........................ 200-127 Zoetis Inc., 333 PROSPEC (spectinomycin 522.2120 Portage St., hydrochloride) Kalamazoo, MI 49007. Injectable Solution. March 25, 2023........................ 040-181 Huvepharma EOOD, 5th VETSULID 520.2200 Floor, 3A Nikolay (sulfachlorpyridazine Haytov Str., 1113 ) Oral Suspension. Sofia, Bulgaria. March 28, 2023........................ 065-081 HQ Specialty Pharma MASTI-CLEAR 526.1696 Corp., 120 Rte. 17 (penicillin G North, Suite 130, procaine) Suspension Paramus, NJ 07652. and GO-DRY (penicillin G procaine) Suspension. ---------------------------------------------------------------------------------------------------------------- II. Withdrawals of Approval Elanco US Inc. (Elanco), 2500 Innovation Way, Greenfield, IN 46140 has requested that FDA withdraw approval of conditionally approved NADA 141-527 for BAYTRIL 100-CA1 (enrofloxacin) Injectable Solution. Pursuant to Elanco's request, approval of their application was withdrawn on March 31, 2023. As provided in the regulatory text of this document, the animal drug regulations in 21 CFR 516.812 are removed to reflect this action. Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096 has requested that FDA withdraw approval of the 49 applications listed in table 3 because the products are no longer manufactured or marketed. As provided in the regulatory text of this document, the animal drug regulations are amended where appropriate to reflect this action. Table 3--Applications for Which Approval Was Voluntarily Withdrawn by FDA ---------------------------------------------------------------------------------------------------------------- File No. Product name 21 CFR cite ---------------------------------------------------------------------------------------------------------------- 006-623......................................... CAPARSOLATE (arsenamide sodium) Injectable Not Solution. codified 008-422......................................... SELEEN (selenium disulfide) Topical Suspension... 524.2101 010-424......................................... NALLINE (nalorphine hydrochloride) Injectable 522.1452 Solution. 011-080......................................... HYDELTRONE-TBA (prednisolone tertiary 522.1885 butylacetate) Injectable Suspension. 011-437......................................... HYDELTRONE (neomycin sulfate and prednisolone 524.1484j sodium phosphate) Ointment. 011-532......................................... SULFABROM (sulfabromomethazine sodium) Bolus..... 520.2170 011-678......................................... DIURIL (chlorothiazide) Tablets.................. 520.420 012-734......................................... DIURIL (chlorothiazide) Bolus.................... 520.420 013-022......................................... THIBENZOLE (thiabendazole) Sheep & Goat Wormer... 520.2380c 013-407......................................... EQUIZOLE (thiabendazole) Horse Wormer Top Dress.. 520.2380a 013-624......................................... Triamcinolone Acetonide Tablets.................. 520.2483 013-674......................................... HYDROZIDE (hydrochlorothiazide) Injectable 522.1150 Solution. 013-954......................................... THIBENZOLE (thiabendazole) 20% Swine Premix...... 558.600 014-350......................................... OMNIZOLE (thiabendazole) Oral Liquid............. 520.2380b 015-123......................................... TBZ (thiabendazole) Cattle Wormer Oral Liquid.... 520.2380b 015-875......................................... TBZ 200 (thiabendazole) Medicated Feed Premix.... 558.600 030-103......................................... THIBENZOLE (thiabendazole) Oral Liquid........... 520.2380b 032-702......................................... PROM ACE (acepromazine maleate) Tablets.......... 520.23 033-127......................................... VETISULID (sulfachlorpyridazine) Bolus........... 520.2200 033-318......................................... VETISULID (sulfachlorpyridazine) Injectable 520.2200 Solution. 033-319......................................... VETISULID (sulfachlorpyridazine) Tablets......... 520.2200 034-114......................................... EQUIZOLE (thiabendazole) Oral Liquid............. 520.2380b 034-879......................................... DOPRAM-V (doxapram hydrochloride) Injectable 522.775 Solution. 035-631......................................... THIBENZOLE (thiabendazole) Pig Wormer............ 520.2380b 037-410......................................... EQUIZOLE A (thiabendazole and piperazine 520.2380e phosphate) Oral Liquid. 043-141......................................... THIBENZOLE 300 (thiabendazole) Medicated......... 558.600 044-654......................................... EQUIZOLE (thiabendazole) Horse Wormer Pellets.... 520.2380a 046-146......................................... VETALOG (triamcinolone acetonide) Cream.......... 524.2483 047-333......................................... EQUIZOLE A (thiabendazole and piperazine citrate) 520.2380d Oral Liquid. 048-487......................................... TBZ (thiabendazole) Wormer Paste 50%............. 520.2380b 049-461......................................... TBZ (thiabendazole) Wormer Paste 43%............. 520.2380b 055-021......................................... HETACIN K (hetacillin potassium) Capsules Vet.... 520.1130 055-022......................................... HETACIN K (hetacillin potassium) Tablets......... 520.1130 055-048......................................... HETACIN K (hetacillin potassium) Oral Liquid..... 520.1130 065-275......................................... Penicillin VK (penicillin V potassium) Filmtab 520.1696c Tablets 250 mg. 065-276......................................... VEESYN (penicillin V potassium) Granules for Oral 520.1696b Solution. 093-600......................................... VOREN (dexamethasone-21-isonicotinate) Suspension 522.542 [[Page 27697]] 094-642......................................... CAMVET (cambendazole) Suspension Horse Wormer.... 520.284a 095-642......................................... OXY-TET (oxytetracycline hydrochloride) 522.1662a Injectable Solution. 096-506......................................... CAMVET (cambendazole) Horse Wormer Pellets....... 520.284b 096-731......................................... CAMVET (cambendazole) Horse Wormer Paste 45%..... 520.284c 098-689......................................... EQUIZOLE (thiabendazole) 50% Wormer Paste........ 520.2380b 099-388......................................... VETALOG (triamcinolone acetonide) Oral Powder.... 520.2483 117-531......................................... Acepromazine Maleate Injection................... 522.23 127-443......................................... EQVALAN (ivermectin) Injectable Solution......... 522.1192 140-439......................................... EQVALAN (ivermectin) Oral Liquid For Horses...... 522.1195 141-180......................................... TORPEX (albuterol sulfate)....................... 529.40 200-361......................................... Acepromazine Maleate Injection................... 522.23 200-564......................................... Ivermectin Paste 1.87%........................... 520.1192 ---------------------------------------------------------------------------------------------------------------- III. Technical Amendments FDA is making the following amendments to improve the accuracy of the animal drug regulations.21 CFR 520.48 is amended to reflect the sponsors of products containing altrenogest for use in horses and swine. 21 CFR 520.2380 is removed and 21 CFR 558.600 revised to characterize a free-choice block containing thiabendazole as a new animal drug for use in cattle feed. 21 CFR 522.1077 is amended to reflect indications for use of gonadorelin in cattle. 21 CFR 522.1222 is amended to reflect sponsors of approved applications for use of ketamine in cats and subhuman primates. 21 CFR 556.620 is removed because there are no longer any approved products containing sulfabromomethazine for use in food- producing animals. 21 CFR 556.730 is revised to reflect the removal of products containing thiabendazole for use in food-producing animals other than cattle. 21 CFR 558.311 is amended to reflect approved classes of pasture cattle for use of lasalocid medicated feeds. 21 CFR 558.455 is amended to reflect the approved conditions of use of medicated feeds containing oxytetracycline and neomycin in sheep. IV. Legal Authority This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), which requires Federal Register publication of ``notice[s] . . . effective as a regulation,'' of the conditions of use of approved new animal drugs. This rule sets forth technical amendments to the regulations to codify recent actions on approved new animal drug applications and corrections to improve the accuracy of the regulations, and as such does not impose any burden on regulated entities. Although denominated a rule pursuant to the FD&C Act, this document does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because it is a ``rule of particular applicability.'' Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive Order 12866, which defines a rule as ``an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.'' List of Subjects 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Part 516 Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements. 21 CFR Parts 520, 522, 524, 526, and 529 Animal drugs. 21 CFR Part 556 Animal drugs, Dairy products, Foods, Meat and meat products. 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 510, 516, 520, 522, 524, 526, 529, 556, 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 paragraph (c)(1), amend the table by adding an entry for ``Provetica LLC''; and 0 b. In paragraph (c)(2), amend the table by adding add an entry for ``086097''. The additions read as follows: Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * * * (c) * * * (1) * * * [[Page 27698]] ------------------------------------------------------------------------ Firm name and address Drug labeler code ------------------------------------------------------------------------ * * * * * * * Provetica LLC, 8735 Rosehill Rd., Suite 300, 086097 Lenexa, KS 66215................................. * * * * * * * ------------------------------------------------------------------------ (2) * * * ------------------------------------------------------------------------ Drug labeler code Firm name and address ------------------------------------------------------------------------ * * * * * * * 086097...................... Provetica LLC, 8735 Rosehill Rd., Suite 300, Lenexa, KS 66215. * * * * * * * ------------------------------------------------------------------------ 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. 516.812 [Removed] 0 4. Remove Sec. 516.812. PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 0 5. The authority citation for part 520 continues to read as follows: Authority: 21 U.S.C. 360b. 0 6. In Sec. 520.48, revise paragraph (b) to read as follows: Sec. 520.48 Altrenogest. * * * * * (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter: (1) Nos. 000061 and 051072 for use as in paragraph (d) of this section. (2) No. 061133 for use as in paragraph (d)(1) of this section. (3) No. 013744 for use as in paragraph (d)(2) of this section. * * * * * Sec. Sec. 520.284, 520.284a, 520.284b, and 520.284c [Removed] 0 7. Remove Sec. Sec. 520.284, 520.284a, 520.284b, and 520.284c. 0 8. In Sec. 520.304, revise paragraphs (b)(1) and (2) to read as follows: Sec. 520.304 Carprofen. * * * * * (b) * * * (1) Nos. 017033, 054771, 055529, 062250, and 086101 for use of products described in paragraph (a)(1) and (2) of this section as in paragraph (c) of this section. (2) Nos. 058198 and 086117 for use of product described in paragraph (a)(2) as in paragraph (c) of this section. * * * * * Sec. Sec. 520.420 [Removed] 0 9. Remove Sec. 520.420. 0 10. In Sec. 520.443, amend paragraph (d)(2)(ii) by adding a sentence at the end of the paragraph to read as follows: Sec. 520.443 Chlortetracycline tablets and boluses. * * * * * (d) * * * (2) * * * (ii) * * * Federal law restricts this drug to use by or on the order of a licensed veterinarian. * * * * * 0 11. In Sec. 520.522, add paragraph (b)(4) and revise (d)(2)(ii) to read as follows: Sec. 520.522 Cyclosporine. * * * * * (b) * * * (4) No. 086097 for use of product described in paragraph (a)(2) as in paragraph (d) of this section. * * * * * (d) * * * (2) * * * (ii) Indications for use. For the control of feline allergic dermatitis as manifested by excoriations (including facial and neck), miliary dermatitis, eosinophilic plaques, and self-induced alopecia in cats at least 6 months of age and at least 3 lbs (1.4 kg) in body weight. * * * * * Sec. 520.812 [Amended] 0 12. Amend Sec. 520.812 by: 0 a. In paragraph (b)(2), removing ``No. 017033'' and in its place adding ``Nos. 017033 and 086117''; and 0 b. Removing paragraph (b)(4). 0 13. In Sec. 520.998, revise paragraph (c)(2)(i) to read as follows: Sec. 520.998 Fluralaner. * * * * * (c) * * * (2) * * * (i) Chewable tablets described in paragraph (a)(1) of this section. Kills adult fleas; for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations (Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick)) for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lbs or greater; and for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lbs or greater. * * * * * 0 14. Amend Sec. 520.1044b by adding a sentence at the end of paragraph (d)(3) to read as follows: Sec. 520.1044b [Amended] * * * * * (d) * * * (3) * * * Federal law restricts this drug to use by or on the order of a licensed veterinarian. Sec. 520.1130 [Removed] 0 15. Remove Sec. Sec. 520.1130. Sec. 520.1195 [Amended] 0 16. In Sec. 520.1195, in paragraph (b)(1), remove ``000010,''. 0 17. In Sec. 520.1310, revise paragraphs (a) and (b) to read as follows: [[Page 27699]] Sec. 520.1310 Marbofloxacin. (a) Specifications. Each tablet or chewable tablet contains 25, 50, 100, or 200 milligrams (mg) marbofloxacin. (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for use as in paragraph (d) of this section: (1) Nos. 017033, 054771, and 086117 for use of tablets. (2) No. 086101 for use of chewable tablets. * * * * * 0 18. In Sec. 520.1315, revise paragraph (b) to read as follows: Sec. 520.1315 Maropitant. * * * * * (b) Sponsors. See Nos. 054771 and 086117 in Sec. 510.600(c) of this chapter. * * * * * Sec. 520.1696b [Removed] 0 19. Remove Sec. 520.1696b. 0 20. In Sec. 520.1696c, revise paragraph (b) to read as follows: Sec. 520.1696c Penicillin V tablets. * * * * * (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter. * * * * * Sec. 520.1870 [Amended] 0 21. In Sec. 520.1870, in paragraph (b)(2), remove ``No. 069043'' and in its place add ``Nos. 069043 and 086101''. 0 22. In Sec. 520.2200, revise paragraph (a)(2), remove paragraph (a)(3), revise paragraphs (d)(1)(i) and (d)(2)(i), and remove (d)(3) to read as follows: Sec. 520.2200 Sulfachlorpyridazine. (a) * * * (2) Each milliliter (mL) of suspension contains 50 milligrams (mg) of sodium sulfachlorpyridazine. * * * * * (d) * * * (1) * * * (i) Amount. Administer 30 to 45 mg sulfachlorpyridazine powder per pound (/lb) of body weight per day in milk or milk replacer in divided doses twice daily for 1 to 5 days. * * * * * (2) * * * (i) Amount. Administer 20 to 35 mg/lb body weight per day in divided doses twice daily for 1 to 5 days in drinking water or an oral suspension containing 50 mg per mL. * * * * * Sec. Sec. 520.1696b, 520.2170, 520.2380, 520.2380a, 520.2380b, 520.2380c, 520.2380d and 520.2380e [Removed] 0 23. Remove Sec. Sec. 520.1696b, 520.2170, 520.2380, 520.2380a, 520.2380b, 520.2380c, 520.2380d and 520.2380e. Sec. 520.2380f [Redesignated] 0 24. Redesignate Sec. 520.2380f as Sec. 520.2382. Sec. 520.2483 [Removed] 0 25. Remove Sec. 520.2483. PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 26. The authority citation for part 522 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 522.536 [Amended] 0 27. In Sec. 522.536, in paragraph (b), remove ``Nos. 015914 and 052483'' and in its place add ``Nos. 015914, 052483, and 059399''. Sec. 522.542 [Removed] 0 28. Remove Sec. 522.542. Sec. 522.558 [Amended] 0 29. In Sec. 522.558, in paragraph (b)(1), remove ``Nos. 017033 and 059399'' and in its place add ``Nos. 017033, 059399, and 086117''. Sec. 522.775 [Removed] 0 30. Remove Sec. 522.775. 0 31. Amend Sec. 522.820 by adding a sentence at the end of paragraph (d)(3)(iii) to read as follows: Sec. 522.820 Erythromycin. * * * * * (d) * * * (3) * * * (iii) * * * Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 32. In Sec. 522.1077, revise paragraphs (b)(2), (d)(1)(iv), and (e)(1)(i) to read as follows: Sec. 522.1077 Gonadorelin. * * * * * (b) * * * (2) No. 068504 for use of the 100-[micro]g/mL product described in paragraph (a)(2) as in paragraphs (d)(1)(i) and (iv) of this section. * * * * * (d) * * * (1) * * * (iv) Dinoprost injection for use as in paragraph (e)(1)(vi) of this section as provided by No. 054771 in Sec. 510.600(c) of this chapter. * * * * * (e) * * * (1) * * * (i) For the treatment of ovarian follicular cysts in dairy cattle: Administer 86 [micro]g gonadorelin (No. 000061), or 100 [micro]g gonadorelin diacetate tetrahydrate (Nos. 000010 and 061133), or 100 [micro]g gonadorelin (as gonadorelin acetate; No. 068504) by intramuscular or intravenous injection. * * * * * Sec. 522.1150 [Removed] 0 33. Remove Sec. 522.1150. 0 34. In Sec. 522.1192, remove and reserve paragraph (a)(1), and revise paragraphs (b)(1) and (2), remove and reserve paragraph (e)(1), and revise paragraph (e)(2)(i) to read as follows: Sec. 522.1192 Ivermectin. * * * * * (b) * * * (1) Nos. 000010, 016592, 055529, 058005, and 061133 for use of the product described in paragraph (a)(2) of this section as in paragraphs (e)(2) through (e)(5) of this section; and (2) No. 000010 for use of the product described in paragraph (a)(3) of this section as in paragraphs (e)(3) and (e)(6) of this section. * * * * * (e) * * * (2) * * * (i) Amount. 200 micrograms per kilogram ([micro]g/kg) of body weight by subcutaneous injection. * * * * * Sec. 522.1222 [Amended] 0 35. In Sec. 522.1222, revise paragraph (b) by adding, in numeric sequence, ``00010,''. 0 36. In Sec. 522.1450, revise paragraphs (a), (b), and (e) to read as follows: Sec. 522.1450 Moxidectin solution. (a) Specifications. Each milliliter (mL) of solution contains 10 milligrams (mg) moxidectin. (b) Sponsors. See Nos. 055529 and 058198 in Sec. 510.600(c) of this chapter. * * * * * (e) Conditions of use in cattle--(1) Amount. Administer by subcutaneous injection 1 mL for each 110 pounds (lb) (50 kilograms (kg)) body weight to provide 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight. (2) Indications for use. Beef and nonlactating dairy cattle: For treatment and control of Gastrointestinal roundworms: Ostertagia ostertagi (adults, fourth-stage larvae, and inhibited larvae), Haemonchus placei (adults), Trichostrongylus axei (adults and fourth- stage larvae), Trichostrongylus colubriformis (adults and fourth-stage larvae), Cooperia oncophora (adults), Cooperia pectinata (adults), Cooperia punctata (adults and fourth-stage larvae), Cooperia spatulata (adults), Cooperia surnabada (adults [[Page 27700]] and fourth-stage larvae), Nematodirus helvetianus (adults), Oesophagostomum radiatum (adults and fourth-stage larvae), Trichuris spp. (adults); Lungworms: Dictyocaulus viviparus (adults and fourth- stage larvae); Cattle grubs: Hypoderma bovis and Hypoderma lineatum; Mites: Psoroptes ovis (Psoroptes communis var. bovis); Lice: Linognathus vituli and Solenopotes capillatus. For protection from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 42 days after treatment, with Haemonchus placei for 35 days after treatment, and with Ostertagia ostertagi and Trichostrongylus axei for 14 days after treatment. (3) Limitations. Cattle must not be slaughtered for human consumption within 21 days of treatment. This drug product 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. A withdrawal period has not been established for preruminating calves. Do not use in calves to be processed for veal. Sec. 522.1696b [Amended] 0 37. In Sec. 522.1696b, amend paragraph (d)(2)(iii)(C), by removing ``For Nos. 054771 and 055529:''. Sec. 522.1885 [Removed] 0 38. Remove Sec. 522.1885. 0 39. Amend Sec. 522.2120 by adding a sentence at the end of paragraph (d)(1)(ii) to read follows: Sec. 522.2120 Spectinomycin hydrochloride. * * * * * (d) * * * (1) * * * (ii) * * * Federal law restricts this drug to use by or on the order of a licensed veterinarian. * * * * * Sec. 522.2200 [Removed] 0 40. Remove Sec. 522.2200. 0 41. In 522.2630, revise paragraph (b)(2) to read as follows: Sec. 522.2630 Tulathromycin. * * * * * (b) * * * (2) Nos. 013744, 051311, 054771, 058198, and 068504 for use of product described in paragraph (a)(2) as in paragraphs (d)(1)(i), (d)(1)(ii)(B), (d)(1)(iii)(B), and (d)(2) of this section. * * * * * PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0 42. The authority citation for part 524 continues to read as follows: Authority: 21 U.S.C. 360b. 0 43. In Sec. 524.770, revise paragraph (b) to read as follows: Sec. 524.770 Doramectin. * * * * * (b) Sponsors. See Nos. 051072 and 054771 in Sec. 510.600(c) of this chapter. * * * * * 0 44. In Sec. 524.814, revise paragraphs (b) and (e)(1) to read as follows: Sec. 524.814 Eprinomectin. * * * * * (b) Sponsors. See Nos. 000010, 051072, and 055529 in Sec. 510.600(c) of this chapter. * * * * * (e) * * * (1) Amount. Apply 5 mg (1 mL) per 10 kilograms (kg) of body weight (500 micrograms/kg) topically along backbone from withers to tailhead. * * * * * Sec. 524.1044e [Amended] 0 45. Amend Sec. 524.1044e by adding a sentence at the end of paragraph (d)(3) to read as follows: Sec. 524.1044e Gentamicin spray. * * * * * (d) * * * (3) * * * Federal law restricts this drug to use by or on the order of a licensed veterinarian. Sec. 524.1146 [Amended] 0 46. In Sec. 524.1146, in paragraph (b)(3), remove ``Nos. 051072 and 058198'' and in its place add ``Nos. 051072, 055529, 058198, and 061651''. Sec. 524.1484j [Removed] 0 47. Remove Sec. 524.1484j. Sec. 524.2101 [Amended] 0 48. In Sec. 524.2101, in paragraph (b), remove ``000010, 000061,'' and in its place add ``000061''. Sec. 524.2483 [Amended] 0 49. In Sec. 524.2483, in paragraph (b), remove ``Nos. 000010 and 054925'' and in its place add ``No. 054925''. PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS 0 50. The authority citation for part 526 continues to read as follows: Authority: 21 U.S.C. 360b. 0 51. Amend Sec. 526.1696 by adding a sentence at the end of paragraph (d)(3) and paragraph (e)(3) to read as follows: Sec. 526.1696 Penicillin G procaine. * * * * * (d) * * * (3) * * * For No. 042791: Federal law restricts this drug to use by or on the order of a licensed veterinarian. (e) (3) * * * For No. 042791: 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 52. The authority citation for part 529 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 529.40 [Removed] 0 53. Remove Sec. 529.40. PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 0 54. The authority citation for part 556 continues to read as follows: Authority: 21 U.S.C. 342, 360b, 371. Sec. 556.620 [Removed] 0 55. Remove Sec. 556.620. 0 56. Revise Sec. 556.730 to read as follows: Sec. 556.730 Thiabendazole. (a) [Reserved] (b) Tolerances. The tolerances for thiabendazole are: (1) Cattle--(i) Edible tissues (excluding milk): 0.1 ppm. (ii) Milk: 0.05 ppm. (2) [Reserved] (c) Related conditions of use. See Sec. 558.600. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 57. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 0 58. In Sec. 558.311, revise paragraph (e)(3)(iii) to read as follows: Sec. 558.311 Lasalocid. * * * * * (e) * * * (3) * * * [[Page 27701]] ---------------------------------------------------------------------------------------------------------------- Lasalocid amount Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (iii) Not less than 60 mg or more than Pasture cattle (slaughter, Feed continuously at a rate 054771 300 mg of lasalocid per head per day. stocker, feeder cattle, of not less than 60 mg or and beef replacement more than 300 mg of heifers): For increased lasalocid per head per day rate of weight gain. when on pasture. The drug must be contained in at least 1 pound of feed. Daily intakes of lasalocid in excess of 200 mg/head/ day have not been shown to be more effective than 200 mg/head/day. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * 0 50. In Sec. 558.455, revise paragraph (e)(5) to read as follows: Sec. 558.455 Oxytetracycline and neomycin. * * * * * (e) * * * (5) Sheep. It is used in feed as follows: ---------------------------------------------------------------------------------------------------------------- Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors ---------------------------------------------------------------------------------------------------------------- (i) To provide 10 mg/lb of body weight Sheep: For treatment of Feed continuously for 7 to 066104 daily. bacterial enteritis caused 14 days. Treatment should 069254 by Escherichia coli and continue 24 to 48 hours bacterial pneumonia caused beyond remission of by Pasteurella multocida clinical signs of disease. susceptible to Withdraw 5 days before oxytetracycline; treatment slaughter. and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin. ---------------------------------------------------------------------------------------------------------------- (ii) [Reserved] 0 59. Revise Sec. 558.600 to read as follows: Sec. 558.600 Thiabendazole. (a) Specifications. Mineral protein block containing 3.3 percent thiabendazole. (b) Sponsor. See No. 012286 in Sec. 510.600(c) of this chapter. (c) Related tolerances. See Sec. 556.730 of this chapter. (d) Special considerations. See Sec. 500.25 of this chapter. (e) Conditions of use in cattle--(1) Amount. Provide free-choice to cattle on pasture or range accustomed to mineral protein block feeding for 3 days. Cattle should consume at a recommended level of 0.11 pound per 100 pounds of body weight per day. Animals maintained under conditions of constant worm exposure may require re-treatment within 2 to 3 weeks. (2) Indications for use. For control of infections of gastrointestinal roundworms (Trichostrongylus, Haemonchus, Ostertagia, and Cooperia). (3) Limitations. Milk taken from animals during treatment and within 96 hours (8 milkings) after the latest treatment must not be used for food. Do not treat cattle within 3 days of slaughter. Dated: April 26, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023-09212 Filed 5-2-23; 8:45 am] BILLING CODE 4164-01-P