[Federal Register Volume 89, Number 39 (Tuesday, February 27, 2024)] [Rules and Regulations] [Pages 14407-14412] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2024-03765] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 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, 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 2023. The animal drug regulations are also being amended to improve their accuracy and readability. DATES: This rule is effective February 27, 2024. 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 and ANADAs during October, November, and December 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 Animal Drugs @FDA: https://animaldrugsatfda.fda.gov/adafda/views/#/search. Table 1--Original and Supplemental NADAs and ANADAs Approved During October, November, and December 2023 Requiring Evidence of Safety and/or Effectiveness ---------------------------------------------------------------------------------------------------------------- Sponsor (drug Effect of the 21 CFR Date of approval File No. labeler code) Product name action section ---------------------------------------------------------------------------------------------------------------- October 11, 2023.............. 141-572 Virbac AH, Inc., AYRADIA Original approval 520.1425 P.O. Box 162059, (metronidazole) for the treatment Fort Worth, TX oral solution. of Giardia 76161 (051311). duodenalis infection in dogs. October 13, 2023.............. 141-336 ECO LLC, 344 AIVLOSIN Supplemental 520.2645 Nassau St., (tylvalosin approval adding Princeton, NJ tartrate) Water females intended 08540 (066916). Soluble Granules. for breeding to approved classes of swine. October 20, 2023.............. 141-564 Pharmgate Inc., PENNCHLOR Original approval 558.128 1800 Sir Tyler (chlortetracyclin for treatment of Rd., Wilmington, e Type A bacterial NC 28405 (069254). medicated enteritis and article) and pneumonia; and RUMENSIN for increased (monensin Type A rate of weight medicated gain or article). prevention and control of coccidiosis in replacement beef and dairy heifers. November 8, 2023.............. 200-758 Felix Enrofloxacin Original approval 522.812 Pharmaceuticals Injectable for treatment and Pvt. Ltd., 25-28 Solution. control of bovine North Wall Quay, respiratory Dublin 1, Ireland disease (BRD) in (086101). beef cattle and non-lactating dairy cattle and swine respiratory disease (SRD) and control of colibacillosis in groups or pens of weaned pigs, as a generic copy of NADA 141-068. [[Page 14408]] November 17, 2023............. 141-580 Orion Corp., BONQAT Original approval 520.1892 Orionintie 1, (pregabalin) Oral for alleviation 02200 Espoo, Solution. of acute anxiety Finland (052483). and fear associated with transportation and veterinary visits in cats. December 14, 2023............. 141-502 Zoetis Inc., 333 REVOLUTION PLUS Supplemental 524.2099 Portage St., (selamectin and approval for the Kalamazoo, MI sarolaner topical treatment and 49007 (054771). solution). control of tick infestations with Amblyomma americanum (lone star tick) in cats and kittens 8 weeks of age and older, and weighing 2.8 pounds or greater. December 21, 2023............. 200-760 Cronus Pharma FLORFENIJECT Original approval 522.955 Specialties India (florfenicol) for treatment of Private Ltd., Sy Injectable bovine No-99/1, M/s GMR Solution. respiratory Hyderabad disease (BRD) and Aviation SEZ bovine Ltd., Mamidipalli interdigital Village, phlegmon; and for Shamshabad the control of Mandal, Ranga respiratory Reddy, Hyderabad, disease in cattle Telangana, at high risk of 501218, India developing BRD, (069043). as a generic copy of NADA 141-063. December 22, 2023............. 200-762 Do................ CAROFENVET Original approval 522.304 (carprofen) for the relief of Injectable pain and Solution. inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries, as a generic copy of NADA 141-199. December 22, 2023............. 200-764 Do................ ENROPRO 22.7 Original approval 522.812 (enrofloxacin) for the Injectable management of Solution. diseases in dogs associated with bacteria susceptible to enrofloxacin, as a generic copy of NADA 140-913. December 22, 2023............. 200-765 Do................ ENROPRO 100 Original approval 522.812 (enrofloxacin) for treatment and Injectable control of bovine Solution. respiratory disease (BRD) in beef cattle and non-lactating dairy cattle and swine respiratory disease (SRD) and control of colibacillosis in groups or pens of weaned pigs, as a generic copy of NADA 141-068. ---------------------------------------------------------------------------------------------------------------- II. Withdrawals of Approval ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305- 3115 (drug labeler code 012286) requested that FDA withdraw approval of the four NADAs listed in table 2 because the products are no longer manufactured or marketed. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions. Table 2--Applications for Which Approval Was Voluntarily Withdrawn During October, November, and December 2023 ------------------------------------------------------------------------ Date of withdrawal of 21 CFR approval File No. New animal drug section ------------------------------------------------------------------------ November 14, 2023.......... 030-578 E-Z-EX Wormer Pellets n/a (thiabendazole). Do......................... 042-910 E-Z-EX WORMER 558.600 MINTRATE Block (thiabendazole) Mineral Protein Block. Do......................... 118-877 BAN-A-WORM (pyrantel n/a tartrate) Ton Pack. Do......................... 132-448 FLAVOMYCIN 558.95 (bambermycins) Type A Medicated Article. ------------------------------------------------------------------------ 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. The regulations cited in table 3 are amended to reflect these actions. Table 3--Applications for Which Ownership Was Transferred to Another Sponsor During October, November, and December 2023 ---------------------------------------------------------------------------------------------------------------- Transferring sponsor New sponsor (drug File No. Product name (drug labeler code) labeler code) 21 CFR section ---------------------------------------------------------------------------------------------------------------- 200-237............. Isoflurane, U.S.P....... Piramal Pharma Ltd., Piramal Critical Care, 529.1186 Ground Floor, Piramal Inc., 3850 Schelden Ananta, Agastya Circle, Bethlehem, PA Corporate Park, 18017 (066794). Mumbai, Maharashtra, 400070, India (065085). [[Page 14409]] 200-576............. Gentamicin Sulfate Akorn Operating Co. Domes Pharma S.A., ZAC 524.1044a Ophthalmic Solution. LLC, 5605 Centerpoint de Champ Lamet, 3 rue Ct., Suite A, Gurnee, Andre Citroen, Pont-du- IL 60031 (059399). Chateau, Auvergne- Rh[ocirc]ne-Alpes, 63430, France (086189). 200-670............. SENERGY (selamectin) Chanelle Virbac AH, Inc., P.O. 524.2098 Topical Solution. Pharmaceuticals Box 162059, Fort Manufacturing Ltd., Worth, TX 76161 Loughrea, County (051311). Galway, Ireland (061651). 200-700............. PARASEDGE Multi for Dogs Do..................... Do..................... 524.1146 (Imidacloprid and moxidectin). 200-701............. PARASEDGE Multi for Cats Do..................... Do..................... 524.1146 (Imidacloprid and moxidectin). ---------------------------------------------------------------------------------------------------------------- IV. Change of Sponsor Address Accord Healthcare, Inc. 1009 Slater Rd., Suite 210-B, Durham, NC 27703 (drug labeler code 016729 in 21 CFR 510.600(c)) has informed FDA that it has changed its address to 126 E Lincoln Ave., Rahway, NJ 07065. 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 520.1408 is revised to reflect all approved strengths of methylprednisolone tablets for dogs and cats. 21 CFR 556.730 is removed because there are no approved products containing thiabendazole for use in food-producing animals. 21 CFR 558.4(d) is being revised in the Category II table by removing the row entry for ``Thiabendazole'' because there are no longer any approved feed products for use in food-producing animals. 21 CFR 558.128 is revised to reflect withdrawal periods for different applications approved for use of chlortetracycline in cattle feed. 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 556 Animal drugs, Food. 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, 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, in the table in paragraph (c)(1), revise the entry for ``Accord Healthcare, Inc.''; and in the table in paragraph (c)(2), revise the entry for ``016729'' to read 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 ------------------------------------------------------------------------ * * * * * * * Accord Healthcare, Inc., 126 E Lincoln Ave., Rahway, NJ 016729 07065.................................................. * * * * * * * ------------------------------------------------------------------------ (2) * * * ------------------------------------------------------------------------ Drug labeler code Firm name and address ------------------------------------------------------------------------ * * * * * * * 016729..................... Accord Healthcare, Inc., 126 E Lincoln Ave., Rahway, NJ 07065. * * * * * * * ------------------------------------------------------------------------ [[Page 14410]] 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. 520.1408, revise paragraph (b) to read as follows: Sec. 520.1408 Methylprednisolone. * * * * * (b) Sponsors. See Nos. 054771 and 069043 in Sec. 510.600(c) of this chapter. * * * * * 0 5. Add Sec. 520.1425 to read as follows: Sec. 520.1425 Metronidazole. (a) Specifications. Each milliliter of suspension contains 125 milligrams (mg) metronidazole. (b) Sponsor. See No. 051311 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Amount. Administer 25 mg per kilogram (11.3 mg per pound) of body weight twice daily for 5 consecutive days. (2) Indications for use. For the treatment of Giardia duodenalis infection in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 6. Add Sec. 520.1892 to read as follows: Sec. 520.1892 Pregabalin. (a) Specifications. Each milliliter (mL) of solution contains 50 milligrams (mg) pregabalin. (b) Sponsor. See No. 052483 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Amount. Administer orally as a single dose of 5 mg/kg (0.1 mL/kg) approximately 1.5 hours before the start of the transportation or veterinary visit. (2) Indications for use. For alleviation of acute anxiety and fear associated with transportation and veterinary visits. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 7. In Sec. 520.2645, revise paragraph (d)(2) to read as follows: Sec. 520.2645 Tylvalosin. * * * * * (d) * * * (2) Indications for use. For control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine intended for slaughter and female swine intended for breeding in buildings experiencing an outbreak of PPE; and for control of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae in groups of swine intended for slaughter and female swine intended for breeding in buildings experiencing an outbreak of SRD. * * * * * PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 8. The authority citation for part 522 continues to read as follows: Authority: 21 U.S.C. 360b. 0 9. In Sec. 522.304, revise paragraph (b) to read as follows: Sec. 522.304 Carprofen. * * * * * (b) Sponsors. See Nos. 016729, 017033, 054771, 055529, and 069043 in Sec. 510.600(c) of this chapter. * * * * * 0 10. In Sec. 522.812, revise paragraphs (b)(1) and (2) to read as follows: Sec. 522.812 Enrofloxacin. * * * * * (b) * * * (1) Nos. 016729, 017033, 055529, 058198, 069043, and 086101 for use of product described in paragraph (a)(1) as in paragraph (e)(1) of this section; and (2) Nos. 051311, 055529, 058005, 058198, 061133, 069043, and 086101 for use of product described in paragraph (a)(2) as in paragraphs (e)(2) and (3) of this section. * * * * * 0 11. In Sec. 522.955, revise paragraph (b)(3) and the second sentence in paragraph (d)(1)(ii)(C) to read as follows: Sec. 522.955 Florfenicol. * * * * * (b) * * * (3) Nos. 058005, 058198, and 069043 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(1)(ii) of this section. * * * * * (d) * * * (1) * * * (ii) * * * (C) Limitations. * * * Nos. 000061, 058005, 058198, and 069043: Animals intended for human consumption must not be slaughtered within 38 days of subcutaneous treatment. * * * * * * * * PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0 12. The authority citation for part 524 continues to read as follows: Authority: 21 U.S.C. 360b. 0 13. In 524.1044a, revise paragraph (b) to read as follows: Sec. 524.1044a Gentamicin ophthalmic solution. * * * * * (b) Sponsors. See Nos. 000061 and 086189 in Sec. 510.600(c) of this chapter. * * * * * 0 14. In 524.1146, revise paragraphs (b)(1) and (2) to read as follows: Sec. 524.1146 Imidacloprid and moxidectin. * * * * * (b) * * * (1) Nos. 017030, 051072, 051311, 055529, and 058198 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section. (2) Nos. 017030, 051072, 051311, 055529, and 058198 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section. * * * * * 0 15. In 524.2098, revise paragraph (b) to read as follows: Sec. 524.2098 Selamectin. * * * * * (b) Sponsors. See Nos. 051072, 051311, 054771, 055529, and 061133 in Sec. 510.600(c) of this chapter. * * * * * 0 16. In 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. Kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations; 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), the treatment and control of ear mite (Otodectes cynotis) infestations; and the treatment and control of roundworm (Toxocara cati) and intestinal hookworm (Ancylostoma tubaeforme) infections in cats and kittens 8 weeks of age 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: [[Page 14411]] Authority: 21 U.S.C. 360b. 0 18. In Sec. 529.1186, revise paragraph (b) to read as follows: Sec. 529.1186 Isoflurane. * * * * * (b) Sponsors. See Nos. 017033, 054771, and 066794 in Sec. 510.600(c) of this chapter. * * * * * PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 0 19. The authority citation for part 556 continues to read as follows: Authority: 21 U.S.C. 342, 360b, 371. Sec. 556.730 [Removed] 0 20. Remove Sec. 556.730. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 21. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. Sec. 558.4 [Amended] 0 22. Amend Sec. 558.4, by removing the entry for ``Thiabendazole'' in the Category II'' table in paragraph (d). 0 23. In Sec. 558.95, revise paragraphs (b), (e)(2)(i) and (ii), and (e)(3)(i) and (ii) to read as follows: Sec. 558.95 Bambermycins. * * * * * (b) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter. * * * * * (e) * * * (2) * * * ------------------------------------------------------------------------ Bambermycins in grams/ton Indications for use Limitations Sponsor ------------------------------------------------------------------------ (i) 1 to 2.... Growing turkeys: For Feed continuously as 016592 improved feed the sole ration. efficiency. (ii) 2........ Growing turkeys: For Feed continuously as 016592 increased rate of the sole ration. weight gain and improved feed efficiency. ------------------------------------------------------------------------ (3) * * * ------------------------------------------------------------------------ Bambermycins in grams/ton Indications for use Limitations Sponsor ------------------------------------------------------------------------ (i) 2......... Growing-finishing Feed continuously as 016592 swine: For increased the sole ration. rate of weight gain and improved feed efficiency. (ii) 2 to 4... Growing-finishing Feed continuously as 016592 swine: For improved the sole ration. feed efficiency. ------------------------------------------------------------------------ * * * * * 0 24. In Sec. 558.128: 0 a. Revise paragraphs (e)(4)(xvi) and (xvii); 0 b. Redesignate paragraphs (e)(4)(xxi) through (lviii) as paragraphs (e)(4)(xxiii) through (lx); and 0 c. Add new paragraphs (e)(4)(xxi) and (xxii). The revision and additions read as follows: Sec. 558.128 Chlortetracycline. * * * * * (e) * * * (4) * * * ---------------------------------------------------------------------------------------------------------------- Combination in grams/ Chlortetracycline amount ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (xvi) to provide 10 mg/lb of body .................... Calves, beef and Feed approximately 054771 weight daily. nonlactating dairy 400 g/ton, varying 066104 cattle: For with body weight 069254 treatment of and feed bacterial enteritis consumption to caused by provide 10 mg/lb Escherichia coli and per day. Treat for bacterial pneumonia not more than 5 caused by days. To sponsor Pasteurella No. 054771 (NADAs multocida organisms 048-761 and 046- susceptible to 699) and to sponsor chlortetracycline. No. 069254 (ANADA 200-510): May be mixed in the cattle's daily ration or administered as a top-dress. In feed including milk replacers withdraw 10 days prior to slaughter. To sponsor No. 054771 under NADA 046-699: 24-hour withdrawal period. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: Zero withdrawal period. See paragraph (d)(3) of this section. (xvii) to provide 10 mg/lb of body .................... Calves (up to 250 A withdrawal period 066104 weight daily. lb): For the has not been treatment of established for bacterial enteritis this product in pre- caused by ruminating calves. Escherichia coli Do not use in susceptible to calves to be chlortetracycline. processed for veal. [[Page 14412]] * * * * * * * (xxi) 400 to 2,000 g/ton.......... Monensin, 15 to 84.. Replacement beef and For replacement beef 069254 dairy heifers: For and dairy heifers treatment of not currently being bacterial enteritis fed monensin: Feed caused by as the sole ration Escherichia coli and for not more than 5 bacterial pneumonia days to provide 10 caused by mg Pasteurella chlortetracycline multocida per pound of body susceptible to weight per day and chlortetracycline; 0.14 to 0.42 mg and for the monensin per pound prevention and of body weight per control of day, depending upon coccidiosis caused severity of by Eimeria bovis and challenge, to Eimeria zuernii. provide 50 to 100 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. A withdrawal period has not been established for this product in pre- ruminating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, 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 and For replacement beef 069254 dairy heifers: For and dairy heifers treatment of not currently being bacterial enteritis fed monensin: Feed caused by as the sole ration Escherichia coli and for not more than 5 bacterial pneumonia days to provide 10 caused by mg Pasteurella chlortetracycline multocida per pound of body susceptible to weight per day and chlortetracycline; 50 to 100 mg and for increased monensin per head rate of weight gain. 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 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. A withdrawal period has not been established for this product in pre- ruminating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetracycline by No. 069254 in Sec. 510.600(c) of this chapter. * * * * * * * ---------------------------------------------------------------------------------------------------------------- Sec. 558.600 [Removed] 0 25. Remove Sec. 558.600. Dated: February 20, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024-03765 Filed 2-26-24; 8:45 am] BILLING CODE 4164-01-P