New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Name and Address, 58957-58968 [2022-20836]

Download as PDF khammond on DSKJM1Z7X2PROD with RULES Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations given on the report forms and instructions. (a) Response required. A response is required from persons subject to the reporting requirements of the BE–13, Survey of New Foreign Direct Investment in the United States, contained herein, whether or not they are contacted by BEA. Also, a person, or their agent, who is contacted by BEA about reporting in this survey, either by sending them a report form or by written inquiry, must respond in writing pursuant to this section. This may be accomplished by filing the properly completed BE–13 report (BE–13A, BE– 13B, BE–13D, BE–13E, or BE–13 Claim for Exemption). (b) Who must report. A BE–13 report is required of any U.S. business enterprise, except certain private funds, see exception in paragraph (b)(4) of this section, in which: (1) A foreign direct investment in the United States relationship is created; (2) An existing U.S. affiliate of a foreign parent establishes a new U.S. business enterprise, expands its U.S. operations, or acquires a U.S. business enterprise; or (3) BEA requests a cost update (Form BE–13E) for a U.S. business enterprise that previously filed Form BE–13B or BE–13D. (4) Certain private funds are exempt from reporting on the BE–13 survey. If a U.S. business enterprise is a private fund and does not own, directly or indirectly, 10 percent or more of another business enterprise that is not also a private fund or a holding company, it is not required to file any BE–13 report except to indicate exemption from the survey if contacted by BEA. (c) Forms to be filed. Depending on the type of investment transaction, U.S. affiliates would report their information on one of five forms—BE–13A, BE–13B, BE–13D, BE–13E, or BE–13 Claim for Exemption. (1) Form BE–13A—report for a U.S. business enterprise when a foreign entity acquires a voting interest (directly, or indirectly through an existing U.S. affiliate) in that U.S. business enterprise including segments, operating units, or real estate; and (i) The total cost of the acquisition is greater than $3 million; and (ii) By this acquisition, the foreign entity now owns at least 10 percent of the voting interest (directly, or indirectly through an existing U.S. affiliate) in the acquired U.S. business enterprise. (2) Form BE–13B—report for a U.S. business enterprise when it is established by a foreign entity or by an VerDate Sep<11>2014 16:48 Sep 28, 2022 Jkt 256001 existing U.S. affiliate of a foreign parent; and (i) The expected total cost to establish the new U.S. business enterprise is greater than $3 million; and (ii) The foreign entity owns at least 10 percent of the voting interest (directly, or indirectly through an existing U.S. affiliate) in the new U.S. business enterprise. (3) Form BE–13D—report for an existing U.S. affiliate of a foreign parent when it expands its operations to include a new facility where business is conducted, and the expected total cost of the expansion is greater than $3 million. (4) Form BE–13E—report for a U.S. business enterprise that previously filed Form BE–13B or BE–13D. Form BE–13E collects updated cost information and will be collected annually for three years after the year of the establishment or expansion of the U.S. business enterprise. (5) Form BE–13 Claim for Exemption—report for a U.S. business enterprise that: (i) Was contacted by BEA but does not meet the requirements for filing Forms BE–13A, BE–13B, or BE–13D; or (ii) Whether or not contacted by BEA, met all requirements for filing Forms BE–13A, BE–13B, or BE–13D except the $3 million reporting threshold. (d) Due date. The BE–13 forms are due no later than 45 calendar days after the acquisition is completed, the new U. S. business enterprise is established, the expansion is begun, the cost update is requested, or a notification letter is received from BEA by a U.S. business enterprise that does not meet the filing requirements for the survey. § 227.201 58957 Disclosure requirements. * * * * * (z) Any written communication or broadcast script provided in accordance with § 227.206 or, if within 30 days of the initial filing of the offering statement, § 230.241 of this chapter. * * * * * [FR Doc. 2022–21290 Filed 9–28–22; 8:45 am] BILLING CODE 0099–10–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 515, 516, 520, 522, 524, 529, and 558 [Docket No. FDA–2022–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 Name and Address AGENCY: Food and Drug Administration, HHS. Final rule; technical amendments. ACTION: Regulation Crowdfunding, General Rules and Regulations The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January, February, and March 2022. 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 the accuracy of the regulations. DATES: This rule is effective September 29, 2022. 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, george.haibel@fda.hhs.gov. SUPPLEMENTARY INFORMATION: CFR Correction I. Approvals This rule is being published by the Office of the Federal Register to correct an editorial or technical error that appeared in the most recent annual revision of the Code of Federal Regulations. ■ In Title 17 of the Code of Federal Regulations, Parts 200 to 239, revised as of April 1, 2022, amend § 227.201 by adding paragraph (z) to read as follows: FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during January, February, and March 2022, 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 [FR Doc. 2022–21116 Filed 9–28–22; 8:45 am] BILLING CODE 3510–06–P SECURITIES AND EXCHANGE COMMISSION 17 CFR Part 227 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 SUMMARY: E:\FR\FM\29SER1.SGM 29SER1 58958 Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations 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/centerveterinary-medicine/cvm-foiaelectronic-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-drugproducts-green-book. FDA has verified the website addresses as of the date this document publishes in the Federal Register, but websites are subject to change over time. TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY, FEBRUARY, AND MARCH 2022 khammond on DSKJM1Z7X2PROD with RULES Approval date File No. Sponsor Product name Species Effect of the action Supplemental approval to establish withdrawal periods in accordance with repartitioning of acceptable daily intake; and to add fourth-stage larval indications for certain endoparasites of cattle. Original approval for the control of pain associated with osteoarthritis. Original approval for the control of postoperative pain associated with surgical procedures. Original approval as a generic copy of NADA 141–361. Public documents January 10, 2022 ............. 131–675 Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940. SAFE–GUARD (fenbendazole), Type A Medicated Article. Cattle ............... January 13, 2022 ............. 141–546 141–547 SOLENSIA (frunevetmab injection), Injectable Solution. ZORBIUM (buprenorphine transdermal solution), Transdermal Solution. Cats ................. January 20, 2022 ............. Zoetis Inc, 333 Portage St., Kalamazoo, MI 49007. Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140. January 25, 2022 ............. 200–707 TILMOVET AC (tilmicosin), Solution. Swine ............... January 28, 2022 ............. 200–716 MIDAMOX for Dogs (imidacloprid and moxidectin), Topical Solution. Dogs ................ Original approval as a generic copy of NADA 141–251. FOI Summary. February 7, 2022 ............. 200–665 Original approval as a generic copy of NADA 141–349. Original approval as a generic copy of NADA 140–916. FOI Summary. 200–717 INCREXXA 25 (tulathromycin injection), Injectable Solution. TIAGARD 12.5% (tiamulin hydrogen fumarate), Liquid Concentrate. Cattle and Swine. February 7, 2022 ............. February 7, 2022 ............. 200–718 Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str.,1113 Sofia, Bulgaria. Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom. Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140. Aurora Pharmaceutical, Inc,1196 Highway 3 South, Northfield, MN 55057–3009. ......do ................................ Dogs ................ Original approval as a generic copy of NADA 141–251. FOI Summary. February 9, 2022 ............. 200–715 Cattle and Swine. 200–720 Original approval as a generic copy of NADA 141–244. Original approval as a generic copy of NADA 140–441. FOI Summary. March 11, 2022 ................ March 23, 2022 ................ 200–723 Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940. Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom. ......do ................................ BARRIER for Dogs (imidacloprid and moxidectin), Topical Solution. AROVYN (tulathromycin injection), Injectable Solution. ENROFLOX (enrofloxacin), Chewable Tablets. Cattle and Swine. 200–721 ......do ................................ Original approval as a generic copy of NADA 141–244. Original approval as a generic copy of NADA 141–254. FOI Summary. March 28, 2022 ................ March 28, 2022 ................ 200–722 ......do ................................ TULIEVE (tulathromycin injection), Injectable Solution. MIDAMOX for Cats (imidacloprid and moxidectin), Topical Solution. FIROX (firocoxib), Chewable Tablets. FOI Summary. March 28, 2022 ................ 200–688 TENOTRYL (enrofloxacin), Injectable Solution. Cattle and Swine. March 30, 2022 ................ 141–551 Virbac AH, Inc., P.O .Box 162059, Fort Worth, TX 76161. Vetcare Oy, P.O. Box 26 (Liedontie 45), Ma¨ntsa¨la¨, Uusimaa, 04601, Finland. ZENALPHA (medetomidine and vatinoxan injection). Dogs ................ Original approval as a generic copy of NADA 141–230. Original approval as a generic copy of NADA 141–068. Original approval for use as a sedative and analgesic to facilitate clinical examination, clinical procedures, and minor surgical procedures. VerDate Sep<11>2014 16:48 Sep 28, 2022 Jkt 256001 PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 Cats ................. Swine ............... Dogs ................ Cats ................. Dogs ................ E:\FR\FM\29SER1.SGM 29SER1 FOI Summary. FOI Summary. FOI Summary. FOI Summary. FOI Summary. FOI Summary. FOI Summary. FOI Summary. Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations II. Withdrawals of Approval Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601, has requested that FDA withdraw approval of NADA 140–908 for VET–METH Bolus, a bolus containing sulfamethazine for use in cattle because the product is no longer manufactured or marketed. As provided in the regulatory text of this document, the animal drug regulations in 21 CFR 520.2260a are amended to reflect this action. Ridley USA, Inc., 111 W. Cherry St., Suite 500, Mankato, MN 56001, has requested that FDA withdraw approval of NADA 136–214 for VMS Bloat Blox, an oral dosage form containing polyoxyethylene (23) lauryl ether for use in beef and nonlactating dairy cattle because the product is no longer manufactured or marketed. As provided in the regulatory text of this document, the animal drug regulations in 21 CFR 520.1846 are amended to reflect this action. III. Changes of Sponsorship Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200, Peachtree Corners, GA 30092 has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200– 129 for Isoflurane, USP and ANADA 200–467 for Sevoflurane to Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211. As provided in the regulatory text, the animal drug regulations in 21 CFR 529.1186 and 529.2110, respectively, are amended to reflect these changes of sponsorship. khammond on DSKJM1Z7X2PROD with RULES IV. Change of Sponsor’s Name and Address Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478 has informed FDA that it has changed its name and address to Mylan Institutional, Inc., a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505. As provided in the regulatory text, the animal drug regulations in § 510.600(c) (21 CFR 510.600(c)) are amended to reflect this change of a sponsor’s name and address. V. Technical Amendments FDA is making the following amendments to improve the accuracy of the animal drug regulations: • Section 510.600 is amended to remove the entry for Halocarbon Products Corp. from, and add Vetcare Oy to, the list of sponsors of approved applications. The entries for Mylan Institutional, Inc. and Norbrook Laboratories Ltd. are revised as well. • 21 CFR 516.812 is amended to reflect a current drug labeler code for a VerDate Sep<11>2014 16:48 Sep 28, 2022 Jkt 256001 use of enrofloxacin injectable solution in cattle. • 21 CFR 520.88g is amended reflect a current sponsor drug labeler code and revised indications for use of tablets containing amoxicillin and clavulanate in dogs and cats. • 21 CFR 520.530 is amended to conform to content codified for animal drugs available by veterinary prescription. • 21 CFR 520.905a is amended to reflect revised conditions of use for fenbendazole suspension in horses. • 21 CFR 520.928 is amended to reflect correct directions for administration of firocoxib chewable tablets in dogs. • 21 CFR 520.1242a is amended to reflect revised indications for use of a levamisol powder in cattle and sheep. • 21 CFR 520.1720a is amended to correct an error in the strength of approved phenylbutazone boluses. • 21 CFR 520.1870 is amended to remove an undefined acronym in the conditions for use of praziquantel tablets. • 21 CFR 520.1872 is amended to conform to content codified for animal drugs available by veterinary prescription. • 21 CFR 520.2325a is amended to reflect instructions for use of sulfaquinoxaline powder and solution in poultry and cattle. • 21 CFR 520.2598 is amended to reflect revised indications for use for trilostane capsules in dogs. • 21 CFR 522.533 is amended to revise the indications for use of deslorelin injectable solution in mares. • 21 CFR 522.2615 is amended to reflect revised human food safety warnings for tripelennamine injectable solution in cattle. • 21 CFR 524.1001 is amended to correct a spelling error in the heading and specifications for fluralaner and moxidectin topical solution. • 21 CFR 524.2098 is amended to reflect all sponsors of approved applications for selamectin topical solution in dogs and cats. • 21 CFR 558.4 is amended in the Category II table to reflect the correct assay limits for Type C medicated feeds manufactured using nicarbazin powder. • 21 CFR 558.128 is amended to reflect the class of cattle and incorporation level for single-ingredient and combination-drug medicated feeds containing chlortetracycline used for control of anaplasmosis in cattle. • 21 CFR 558.633 is amended to clarify expiration dates for medicated feeds containing tylvalosin. PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 58959 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)), 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 Parts 515 and 516 Administrative practice and procedure, Animal drugs, Confidential business information, 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, 515, 516, 520, 522, 524, 529, and 558 are amended as follows: PART 510—NEW ANIMAL DRUGS 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. 2. In § 510.600: a. In the table in paragraph (c)(1), remove the entry for ‘‘Halocarbon ■ ■ E:\FR\FM\29SER1.SGM 29SER1 58960 Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations Products Corp.’’; revise the entries for ‘‘Mylan Institutional, Inc.’’ and ‘‘Norbrook Laboratories Ltd.’’; and add in alphabetical order an entry for ‘‘Vetcare Oy’’; and ■ b. In the table in paragraph (c)(2), remove the entry for ‘‘012164’’; revise the entries for ‘‘051079’’ and ‘‘055529’’; and add in numerical order an entry for ‘‘086155’’. The revisions and additions read as follows: § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * (c) * * * (1) * * * * * Drug labeler code Firm name and address * * * * * * Mylan Institutional, Inc., a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505 ........................................................ * * * * * * * Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom ................................. * * * * * * * Vetcare Oy, P.O. Box 26 (Liedontie 45), Ma¨ntsa¨la¨, Uusimaa, 04601, Finland .................................................................................. * * * * * * 051079 055529 086155 * * * * (2) * * * Drug labeler code Firm name and address * 051079 ......... * * * * Mylan Institutional, Inc., a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505. * 055529 ......... * * * * * Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom. * * 086155 ......... * * * * Vetcare Oy, P.O. Box 26 (Liedontie 45), Ma¨ntsa¨la¨, Uusimaa, 04601, Finland. * * * * * * * § 516.812 3. The authority citation for part 515 continues to read as follows: ■ Authority: 21 U.S.C. 360b, 371. 4. In § 515.10, revise paragraph (a) to read as follows: PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS khammond on DSKJM1Z7X2PROD with RULES § 515.10 Medicated feed mill license applications. PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES 16:48 Sep 28, 2022 Jkt 256001 7. The authority citation for part 520 continues to read as follows: ■ (a) Medicated feed mill license applications (Form FDA 3448) may be obtained from the Public Health Service, Consolidated Forms and Publications Distribution Center, Washington Commerce Center, 3222 Hubbard Rd., Landover, MD 20785, or electronically from the Center for Veterinary Medicine at: https://www.fda.gov/animalveterinary/animal-food-feeds/ medicated-feeds. * * * * * VerDate Sep<11>2014 [Amended] 6. In § 516.812, in paragraph (b), remove ‘‘000859’’ and in its place add ‘‘058198’’. ■ ■ 5. The authority citation for part 516 continues to read as follows: * Authority: 21 U.S.C. 360ccc–1, 360ccc–2, 371. PART 515—MEDICATED FEED MILL LICENSE ■ * Authority: 21 U.S.C. 360b. 8. In § 520.88g, revise paragraphs (b)(2), (c)(1)(ii), and (c)(2)(ii) to read as follows: ■ § 520.88g Amoxicillin trihydrate and clavulanate potassium tablets. * * * * * (b) * * * (2) Nos. 017033 and 069043 for use of tablets as in paragraph (c) of this section. (c) * * * (1) * * * (ii) Indications for use. Treatment of skin and soft tissue infections such as wounds, abscesses, cellulitis, PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 superficial/juvenile and deep pyoderma due to susceptible strains of the following organisms: Beta-lactamaseproducing Staphylococcus aureus, nonbeta-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., and E. coli. Periodontal infections due to susceptible strains of both aerobic and anaerobic bacteria. * * * * * (2) * * * (ii) Indications for use. Treatment of skin and soft tissue infections such as wounds, abscesses, and cellulitis/ dermatitis due to susceptible strains of the following organisms: Betalactamase-producing Staphylococcus aureus, non-beta-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella spp. Urinary tract infections (cystitis) due to susceptible strains of E. coli. * * * * * E:\FR\FM\29SER1.SGM 29SER1 Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations § 520.530 [Amended] § 520.812 Enrofloxacin. * * * * * (b) * * * (1) No. 058198 for use of products described in paragraph (a) of this section. * * * * * (3) Nos. 055529 and 086101 for use of product described in paragraph (a)(2) of this section. * * * * * ■ 11. In § 520.905a, revise paragraphs (e)(1)(ii) and (iii) to read as follows: § 520.905a Fenbendazole suspension. * * * * * (e) * * * (1) * * * (ii) Indications for use. For the treatment and control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris, Triodontophorus species), small strongyles (Cyathostomum species, Cylicocyclus species, Cylicostephanus species, Cylicodontophorus species), pinworms (Oxyuris equi) and ascarids (Parascaris equorum). (iii) Limitations. Do not use in horses intended for human consumption. * * * * * ■ 12. In § 520.928, revise the section heading and paragraphs (a), (b), and (c)(1)(i) to read as follows: khammond on DSKJM1Z7X2PROD with RULES § 520.928 Firocoxib. (a) Specifications—(1) Each chewable tablet contains 57 or 227 milligrams (mg) firocoxib. (2) Each tablet contains 57 mg firocoxib. (b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows: (1) Nos. 000010 and 055529 for use of products described in paragraph (a)(1) as in paragraph (c)(1) of this section; and (2) No. 000010 for use of the product described in paragraph (a)(2) as in paragraph (c)(2) of this section. (c) * * * (1) * * * (i) Amount. 5 mg/kg (2.27 mg/lb) body weight. Administer once daily as needed for osteoarthritis and for 3 days as needed for postoperative pain and inflammation associated with soft-tissue and orthopedic surgery. Administer approximately 2 hours before soft tissue or orthopedic surgery. * * * * * VerDate Sep<11>2014 16:48 Sep 28, 2022 13. In § 520.1242a, revise paragraph (b)(3) to read as follows: ■ 9. In § 520.530, remove paragraph (c) and redesignate paragraph (d) as paragraph (c). ■ 10. In § 520.812, revise paragraphs (b)(1) and (3) to read as follows: ■ Jkt 256001 § 520.1242a Levamisol powder. * * * * * (b) * * * (3) No. 016592 for use of 46.8- and 544.5-g packages as in paragraphs (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) and (e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of this section. * * * * * ■ 14. In § 520.1720a, revise paragraph (a) to read as follows: § 520.1720a boluses. Phenylbutazone tablets and (a) Specifications. Each tablet contains 100, 200, or 400 milligrams (mg), or 1 gram (g) phenylbutazone. Each bolus contains 1, 2, or 4 g phenylbutazone. * * * * * § 520.1846 ■ [Removed] 15. Remove § 520.1846. § 520.1870 [Amended] 16. In § 520.1870, in paragraph (c)(2)(iii), in the third sentence, remove ‘‘OTC’’ and in its place add ‘‘over the counter’’. ■ 17. In § 520.1872, revise paragraph (c)(1)(iii) and add reserved paragraph (c)(2) to read as follows: ■ § 520.1872 Praziquantel, pyrantel pamoate, and febantel tablets. * * * * * (c) * * * (1) * * * (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] ■ 18. Revise § 520.2260a to read as follows: § 520.2260a boluses. Sulfamethazine oblets and (a) Specifications. Each oblet or bolus contains: (1) 2.5, 5, or 15 grams sulfamethazine. (2) 5 grams sulfamethazine. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use of products described in paragraph (a) of this section. (1) No. 016592 for use of products described in paragraph (a)(1) of this section. (2) No. 054771 for use of product described in paragraph (a)(2) of this section. (c) Related tolerances. See § 556.670 of this chapter. (d) Conditions of use. (1) Oblets and boluses described in paragraph (a)(1) of this section: PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 58961 (i) Amount. Administer as a single dose 100 milligrams per pound (mg/lb) of body weight the first day and 50 mg/ lb of body weight on each following day. (ii) Indications for use. (A) Beef cattle and nonlactating dairy cattle. For the treatment of bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) (Pasteurella spp.), colibacillosis (bacterial scours) (Escherichia coli), necrotic pododermatitis (foot rot) (Fusobacterium necrophorum), calf diphtheria (Fusobacterium necrophorum), acute mastitis (Streptococcus spp.), acute metritis (Streptococcus spp.), and coccidiosis (Eimeria bovis and E. zurnii). (B) Horses. For the treatment of bacterial pneumonia (secondary infections associated with Pasteurella spp.), strangles (Streptococcus equi), and bacterial enteritis (Escherichia coli). (iii) Limitations. Administer daily until animal’s temperature and appearance are normal. If symptoms persist after using for 2 or 3 days consult a veterinarian. Fluid intake must be adequate. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed 5 consecutive days. Follow dosages carefully. Do not treat cattle within 10 days of slaughter. Do not use in female dairy cattle 20 months of age or older. Use of sulfamethazine in this class of cattle may cause milk residues. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Do not use in horses intended for human consumption. (2) Boluses described in paragraph (a)(2) of this section: (i) Amount. Administer 10 grams (2 boluses) of sulfamethazine per 100 pounds of body weight the first day, then 5 grams (1 bolus) of sulfamethazine per 100 pounds of body weight daily for up to 4 additional consecutive days. (ii) Indications for use. (A) Ruminating beef and dairy calves. For treatment of the following diseases caused by organisms susceptible to sulfamethazine: bacterial scours (colibacillosis) caused by Escherichia coli; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum; bacterial pneumonia associated with Pasteurella spp.; and coccidiosis caused by Eimeria bovis and E. zurnii. (B) [Reserved] (iii) Limitations. Do not administer for more than 5 consecutive days. Do not treat calves within 11 days of slaughter. Do not use in calves to be slaughtered under 1 month of age or in calves being E:\FR\FM\29SER1.SGM 29SER1 58962 Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations fed an all milk diet. Do not use in female dairy cattle 20 months of age or older; such use may cause drug residues in milk. Administer with adequate supervision. Follow recommended dosages carefully. Fluid intake must be adequate. If symptoms persist after 2 or 3 days, consult a veterinarian. ■ 19. In § 520.2325a, revise paragraphs (c)(4)(iii) and (d) to read as follows: § 520.2325a solution. Sulfaquinoxaline powder and * * * * * (c) * * * (4) * * * (iii) In lieu of treatment as provided in paragraph (c)(4)(ii) of this section, administer 1 teaspoon of 25 percent sulfaquinoxaline soluble powder per day for each 125 pounds of body weight for 3 to 5 days in drinking water. (d) Limitations. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Not for use in lactating dairy cattle. Do not give to chickens, turkeys, or cattle within 10 days of slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. ■ 20. In § 520.2455, revise paragraph (b)(3) to read as follows: § 520.2455 Tiamulin. * * * * * (b) * * * (3) Nos. 016592, 051072, 051311, and 061133 for product described in paragraph (a)(2) of this section. * * * * * ■ 21. In § 520.2471, revise paragraph (b) to read as follows: § 520.2471 Tilmicosin. * * * * * (b) Sponsors. See Nos. 016592 and 058198 in § 510.600(c) of this chapter. * * * * * ■ 22. In § 520.2598, revise paragraph (c)(2) to read as follows: § 520.2598 Trilostane. khammond on DSKJM1Z7X2PROD with RULES * * * * (c) * * * (2) Indications for use. For the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism in dogs. * * * * * PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 23. The authority citation for part 522 continues to read as follows: VerDate Sep<11>2014 16:48 Sep 28, 2022 Jkt 256001 24. In § 522.533, revise paragraphs (c)(1)(ii) and (c)(2)(ii) to read as follows: § 522.533 Deslorelin. * * * * * (c) * * * (1) * * * (ii) Indications for use. For inducing ovulation within 48 hours in estrous mares with an ovarian follicle greater than 30 millimeters (mm) in diameter. * * * * * (c) * * * (2) * * * (ii) Indications for use. For inducing ovulation within 48 hours in cyclic estrous mares with an ovarian follicle between 30 and 40 mm in diameter. * * * * * ■ 25. In § 522.812, revise paragraph (b)(2) to read as follows: § 522.812 Enrofloxacin. * * * * * (b) * * * (2) Nos. 051311, 055529, 058005, 058198, and 061133 for use of product described in paragraph (a)(2) of this section as in paragraphs (e)(2) and (3) of this section. * * * * * ■ 26. Add § 522.1008 to read as follows: § 522.1008 Frunevetmab. Medetomidine and vatinoxan. (a) Specifications. Each milliliter of solution contains 0.5 milligrams (mg) medetomidine hydrochloride and 10 mg vatinoxan hydrochloride. (b) Sponsor. See No. 086155 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Administer by intramuscular injection a dose based on body surface area (BSA). Calculate the dose using 1 mg medetomidine per square meter (/m2) BSA or use the dosing table provided in labeling. PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 (2) Indications for use. For use as a sedative and analgesic in dogs to facilitate clinical examination, clinical procedures, and minor surgical procedures. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. ■ 28. In § 522.2615, revise paragraph (d)(3)(iii) to read as follows: § 522.2615 Tripelennamine. * * * * * (d) * * * (3) * * * (iii) Limitations. Milk taken during treatment and for 24 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 4 days following the last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in preruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian. ■ 29. In § 522.2630, revise paragraphs (b)(1) and (2) to read as follows: § 522.2630 Tulathromycin. * (a) Specifications. Each milliliter (mL) of solution contains 7 milligrams (mg) frunevetmab. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Cats—(i) Amount. Administer once a month by subcutaneous injection the full contents of one or two 1-mL vials to achieve a minimum dosage of 0.45 mg/lb (1 mg/ kg) body weight. (ii) Indications for use. For the control of pain associated with osteoarthritis in cats. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] ■ 27. Add § 522.1338 to read as follows: § 522.1338 * ■ Authority: 21 U.S.C. 360b. ■ * * * * (b) * * * (1) Nos. 000061, 013744, 051311, 054771, 055529, 058198, and 061133 for use of product described in paragraph (a)(1) as in paragraphs (d)(1)(i), (d)(1)(ii), (d)(1)(iii)(A), and (d)(2) of this section. (2) Nos. 013744, 051311, 054771, and 058198 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 30. The authority citation for part 524 continues to read as follows: ■ Authority: 21 U.S.C. 360b. ■ 31. Add § 524.230 to read as follows: § 524.230 Buprenorphine. (a) Specifications. Each milliliter (mL) of solution contains 20 milligrams (mg) buprenorphine. The drug is supplied in tubes containing 0.4 mL (8 mg) or 1.0 mL (20 mg). (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Conditions of use in cats—(1) Amount. Administer topically to the dorsal cervical area at the base of the skull a single dose of 1.2 to 3.1 mg/lb E:\FR\FM\29SER1.SGM 29SER1 58963 Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations (2.7 to 6.7 mg/kg) approximately 1 to 2 hours before surgery. (2) Indications for use. For the control of postoperative pain associated with surgical procedures in cats. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Buprenorphine is a Schedule III controlled substance. ■ 32. In § 524.1001, revise the section heading and paragraph (a) to read as follows: § 524.1001 § 524.2098 Fluralaner and moxidectin. (a) Specifications. Each milliliter of solution contains 280 milligram (mg) fluralaner and 14 mg moxidectin. Each individually packaged tube contains either 112.5 mg fluralaner and 5.6 mg moxidectin; 250 mg fluralaner and 12.5 mg moxidectin; or 500 mg fluralaner and 25 mg moxidectin. * * * * * ■ 33. In § 524.1146, revise paragraphs (b)(1) and (2) to read as follows: § 524.1146 described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section. (2) Nos. 017030, 051072, 055529, 058198, and 061651 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section. * * * * * ■ 34. In § 524.2098, revise paragraph (b) to read as follows: Imidacloprid and moxidectin. * Selamectin. * * * * * (b) Sponsors. See Nos. 051072, 054771, 055529, 061133, and 061651 in § 510.600(c) of this chapter. * * * * * 37. In § 529.2110, revise paragraph (b) to read as follows: ■ § 529.2110 Sevoflurane. * * * * * (b) Sponsors. See Nos. 017033, 054771, and 066794 in § 510.600(c) of this chapter. * * * * * PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 38. The authority citation for part 558 continues to read as follows: ■ PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 35. The authority citation for part 529 continues to read as follows: ■ ■ Authority: 21 U.S.C. 360b. 36. In § 529.1186, revise paragraph (b) to read as follows: ■ * * * * (b) * * * (1) Nos. 017030, 051072, 055529, 058198, and 061651 for use of product (b) Sponsors. See Nos. 017033, 054771, 065085, and 066794 in § 510.600(c) of this chapter. * * * * * § 529.1186 Isoflurane. * * * * 39. In § 558.4, in paragraph (d), in the ‘‘Category II’’ table, revise the entry for ‘‘Nicarbazin (powder)’’ to read as follows: § 558.4 Requirement of a medicated feed mill license. * * * * (d) * * * * * CATEGORY II Assay limits percent 1 type A Drug * * * Nicarbazin (powder) ................................................... * * * * * * * *. * * § 558.128 ■ * Chlortetracycline amount * (iii) to provide 0.5 mg/lb of body weight daily. VerDate Sep<11>2014 * 16:48 Sep 28, 2022 * * * 9.08 g/lb (2.00%) ....................................................... * * * * * * 40. In § 558.128, revise paragraphs (e)(4)(iii) and (xli) to read as follows: khammond on DSKJM1Z7X2PROD with RULES 96–104 * Chlortetracycline. * * (e) * * * Assay limits percent 1 type B/ C2 Type B maximum (100x) * * (4) * * * Indications for use Limitations * ................................................ * * Beef cattle (over 700 lb): For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline. * Feed to provide chlortetracycline at the rate of 0.5 mg per pound of body weight daily. Withdraw 48 hours prior to slaughter. To sponsor Nos. 054771 and 069254: Zero withdrawal time. PO 00000 Frm 00017 * * Combination in grams/ton Jkt 256001 * 85–115/80–120 Fmt 4700 Sfmt 4700 E:\FR\FM\29SER1.SGM 29SER1 Sponsor * 054771 066104 069254 58964 Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations Combination in grams/ton Chlortetracycline amount * * * (xli) 25 to 2,800 g/ton to proLasalocid, 30 to 181.8; vide 350 mg/head/day. melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg/head/day melengestrol acetate. * * * * * * * *. * * * * * * Limitations * * Growing beef heifers fed in confinement for slaughter under 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline, control of coccidiosis caused by Eimeria bovis and E. zuernii, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). * The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 2,800 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 350 mg chlortetracycline per head per day and 1 mg lasalocid per 2.2 lb. of body weight daily with a maximum of 360 mg lasalocid per head per day. See § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. * * headings, and paragraphs (e)(2)(i) and (e)(3) through (5) to read as follows: * 41. In § 558.258, revise paragraph (e)(1), paragraph (e)(2) table column ■ khammond on DSKJM1Z7X2PROD with RULES Indications for use Fenbendazole grams per ton Combination grams per ton Indications for use (i) 14.5 ..................................... ................................................ (ii) [Reserved] .......................... ................................................ Growing turkeys: For the treatment and control of gastrointestinal worms: roundworms, adults and larvae (Ascaridia dissimilis); cecal worms, adults and larvae (Heterakis gallinarum), an important vector of Histomonas meleagridis (Blackhead). ................................................ VerDate Sep<11>2014 16:48 Sep 28, 2022 Jkt 256001 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 Sponsor * § 558.258 * 054771 * Fenbendazole. * * (e) * * * (1) * * * * * Limitations Feed continuously as the sole ration for 6 days. For growing turkeys only. ................................................ E:\FR\FM\29SER1.SGM * 29SER1 Sponsor 000061 ........................ 58965 Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations (2) Swine. Fenbendazole grams per ton Combination grams per ton Indications for use Limitations (i) 10 to 300 ...................... ......................... Swine: For the treatment and control of Lungworms: adult (Metastrongylus apri and M. pudendotectus); Gastrointestinal worms: adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris suum); adult nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); and Kidney worms: adult and larvae (Stephanurus dentatus). Feed as the sole ration to provide 9 mg/kg of body weight (4.08 mg/ lb) over a period of 3 to 12 consecutive days. Swine must not be slaughtered for human consumption within 4 days following last treatment with this drug product. * * * * * * Sponsor 000061 * (3) Cattle. Fenbendazole grams per ton Indications for use Limitations (i) 200 to 1,000 .............. Dairy and beef cattle: For the treatment and control of: Lungworms: adult (Dictyocaulus viviparus); Stomach worms: adult brown stomach worms (Ostertagia ostertagi), adult and fourth-stage larvae barberpole worms (Haemonchus contortus), fourth-stage larvae barberpole worms (H. placei), and adult and fourth-stage larvae small stomach worms (Trichostrongylus axei); Intestinal worms (adult and fourth-stage larvae): hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata and C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum). ............................................................................... Feed as the sole ration for 1 day to provide 5 mg/kg body weight (2.27 mg/lb). Milk taken during treatment and for 60 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. 000061 ............................................................................... ........................ (ii) [Reserved] ................ khammond on DSKJM1Z7X2PROD with RULES (iii) Top dress medicated feed—(A) Proprietary formulas. The following feed can be manufactured only per an Sponsor approved proprietary formula and specifications: Fenbendazole concentration Indications for use Limitations (1) 2.27 g/lb ................... Beef and dairy cattle: For the treatment and control of: Lungworms: adult (Dictyocaulus viviparus); Stomach worms: adult brown stomach worms (Ostertagia ostertagi), adult and fourth-stage larvae barberpole worms (Haemonchus contortus), fourth-stage larvae barberpole worms (H. placei), and adult and fourth-stage larvae small stomach worms (Trichostrongylus axei); Intestinal worms (adult and fourth-stage larvae): hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata and C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum). ............................................................................... Feed as a top dress for 1 day to provide 5 mg/ kg body weight (2.27 mg/lb). Milk taken during treatment and for 60 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. 000061 ............................................................................... ........................ (2) [Reserved] ................ (B) [Reserved] VerDate Sep<11>2014 16:48 Sep 28, 2022 (iv) Free-choice medicated feeds—(A) Proprietary formulas (21 CFR Jkt 256001 PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 Sponsor 510.455(e)(2)). The following feeds can be manufactured only per an approved proprietary formula and specifications: E:\FR\FM\29SER1.SGM 29SER1 58966 Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations Fenbendazole concentration Indications for use Limitations (1) 12,100 g/ton mineral Beef cattle on pasture: For the treatment and control of: Lungworms: adult (Dictyocaulus viviparus); Stomach worms: adult brown stomach worms (Ostertagia ostertagi), adult and fourth-stage larvae barberpole worms (Haemonchus contortus), fourth-stage larvae barberpole worms (H. placei), and adult and fourth-stage larvae small stomach worms (Trichostrongylus axei); Intestinal worms (adult and fourth-stage larvae): hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata and C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum). Beef cattle on pasture: For the treatment and control of: Lungworms: adult (Dictyocaulus viviparus); Stomach worms: adult brown stomach worms (Ostertagia ostertagi), adult and fourth-stage larvae barberpole worms (Haemonchus contortus), fourth-stage larvae barberpole worms (H. placei), and adult and fourth-stage larvae small stomach worms (Trichostrongylus axei); Intestinal worms (adult and fourth-stage larvae): hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata and C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum). Feed free-choice at the rate of 0.0375 lb per 100 pounds of body weight over a 3- to 6-day period to provide a total of 2.27 mg fenbendazole per pound of body weight. Not for use in dairy cattle. Beef cattle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. 000061 Feed free-choice at the rate of 0.10 lb (1.6 oz) per 100 pounds of body weight over a 3- to 6day period, to deliver a total of 2.27 mg fenbendazole per pound of body weight. Not for use in dairy cattle. Beef cattle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. 000061 (2) 2.27 g/lb mineral ...... (B) Published formulas (§ 510.455(e)(1) of this chapter). The following feeds can be manufactured only per one of the formulas and specifications published below: (1) Amount. 5 mg/kg body weight (2.27 mg/lb), including the following formulations: Ingredient 1 khammond on DSKJM1Z7X2PROD with RULES Sponsor Percent (i) Free-choice, dry Type C feed: Salt (sodium chloride) ........................................................................................................................... Monosodium phosphate ....................................................................................................................... Dried cane molasses ............................................................................................................................ Zinc sulfate ........................................................................................................................................... Copper sulfate ...................................................................................................................................... Fenbendazole 20% Type A article ....................................................................................................... (ii) Free-choice, dry Type C feed: Salt (sodium chloride) ........................................................................................................................... Dicalcium phosphate (18.5% P) ........................................................................................................... Calcium carbonate (38% Ca) ............................................................................................................... Magnesium oxide (56% Mg) ................................................................................................................ Zinc sulfate ........................................................................................................................................... Mineral oil ............................................................................................................................................. Dried cane molasses (46% sugars) ..................................................................................................... Potassium iodide .................................................................................................................................. Fenbendazole 20% Type A article ....................................................................................................... (iii) Free-choice, liquid Type C feed 2: Cane molasses 3 ................................................................................................................................... Water .................................................................................................................................................... Urea solution, 55% ............................................................................................................................... Phosphoric acid 75% (feed grade) ....................................................................................................... Xantham gum ....................................................................................................................................... Trace minerals 4 .................................................................................................................................... Vitamin premix 4 .................................................................................................................................... Fenbendazole 20% Type A article ....................................................................................................... International Feed No. 59.00 31.16 3.12 0.76 0.45 5.51 6–04–152 6–04–288 4–04–695 6–05–556 6–01–720 n/a 35.93 32.44 15.93 10.14 1.47 1.00 0.98 0.01 2.10 6–04–152 6–00–080 6–01–069 6–02–756 6–05–556 8–03–123 4–04–695 6–03–759 n/a 80.902 9.36 7.05 2.00 0.20 0.20 0.01 0.278 4–13–251 n/a 5–05–707 6–03–707 8–15–818 n/a n/a n/a 1 Formulation modifications require FDA approval prior to marketing. Selenium is not approved for use in the liquid, free-choice formulations described in paragraph (e)(3)(iv)(B) of this section. Free-choice cattle feeds containing selenium must comply with published regulations (see 21 CFR 573.920). VerDate Sep<11>2014 16:48 Sep 28, 2022 Jkt 256001 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 E:\FR\FM\29SER1.SGM 29SER1 Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations 58967 2 The labeling for the liquid free-choice Type C medicated feed must bear an expiration date of 12 weeks after the date of manufacture. percentage of cane molasses and water in the formulation may be adjusted as needed to bring the brix value of the molasses to the industry standard of 79.5 brix. 4 The contents of any added vitamin and trace mineral may be varied; however, they should be comparable to those used by the manufacturer for other free-choice cattle feeds. 3 The (2) Indications for use. As in paragraph (e)(3)(i) of this section. (3) Limitations. Feed a total of 5 mg of fenbendazole per kg (2.27 mg/lb) of body weight to cattle over a 3- to 6-day period. Milk taken during treatment and for 60 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in preruminating calves. (4) Horses. Fenbendazole grams per ton Indications for use Limitations (i) 4,540 ......................... 5 mg/kg body weight (2.27 mg/lb) for the control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris, Triodontophorus spp.), small strongyles (Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp.), and pinworms (Oxyuris equi); 10 mg/kg body weight (4.54 mg/lb) for the control of ascarids (Parascaris equorum). (ii) [Reserved] ................ ............................................................................... Feed at the rate of 0.1 lb of feed per 100 lb of body weight to provide 2.27 mg fenbendazole/ lb of body weight in a 1-day treatment or 0.2 lb of feed per 100 lb of body weight to provide 4.54 mg fenbendazole/lb of body weight in a 1-day treatment. All horses must be eating normally to ensure that each animal consumes an adequate amount of the medicated feed. Do not use in horses intended for human consumption. ............................................................................... ........................ Sponsor Sponsor 000061 (5) Zoo and wildlife animals. Fenbendazole grams per ton Indications for use Limitations (i) Feral swine (Sus scrofa):. 90 to 325 ............... Use as a complete feed at a rate to provide 3 mg/ kg/day for 3 consecutive days. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season. 000061 (ii) Ruminants (subfamily Antilopinae, Hippotraginae, Caprinae). 50 to 300 ............... Use as a complete feed at a rate to provide 2.5 mg/kg/day for 3 consecutive days. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season. 000061 (iii) Rocky mountain bighorn sheep (Ovis c. canadensis). 375 to 1,000 .......... For the treatment and control of kidney worm (Stephanurus dentatus), roundworm (Ascaris suum), nodular worm (Oesophagostomum dentatum). For the treatment and control of small stomach worm (Trichostrongylus spp.), thread necked intestinal worm (Nematodirus spp.), barberpole worm (Haemonchus spp.), whipworm (Trichuris spp.). For the treatment and control of Protostrongylus spp.. Use as a complete feed at a rate to provide 10 mg/kg/day for 3 consecutive days. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season. 000061 khammond on DSKJM1Z7X2PROD with RULES Species/Class VerDate Sep<11>2014 16:48 Sep 28, 2022 Jkt 256001 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 E:\FR\FM\29SER1.SGM 29SER1 58968 Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations * * * § 558.633 * * [Amended] 42. In § 558.633, in paragraph (d)(3), remove the first sentence. ■ Dated: September 20, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–20836 Filed 9–28–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 300 [TD 9966] RIN 1545–BQ17 User Fees Relating to Enrolled Agents and Enrolled Retirement Plan Agents Internal Revenue Service (IRS), Treasury. ACTION: Final regulations. AGENCY: These final regulations amend existing regulations relating to user fees for enrolled agents and enrolled retirement plan agents. The final regulations increase the renewal user fee for enrolled retirement plan agents from $67 to $140. In addition, the final regulations increase both the enrollment and renewal of enrollment user fees for enrolled agents from $67 to $140. These regulations affect individuals who are or apply to become enrolled agents and individuals who are enrolled retirement plan agents. The Independent Offices Appropriation Act of 1952 authorizes charging user fees. DATES: Effective date: These regulations are effective October 31, 2022. Applicability date: For the date of applicability, see §§ 300.5(d), 300.6(d), and 300.09(d). FOR FURTHER INFORMATION CONTACT: Mark Shurtliff at (202) 317–6845 (not a toll-free number). SUPPLEMENTARY INFORMATION: SUMMARY: khammond on DSKJM1Z7X2PROD with RULES Background This document contains amendments to the regulations in 26 CFR part 300— User Fees. On March 1, 2022, a notice of proposed rulemaking (REG–114209– 21) and notice of public hearing was published in the Federal Register (87 FR 11366). The document proposed amending the regulations relating to the user fees for enrolled agents and enrolled retirement plan agents. The document proposed increasing the amount of the renewal user fee for VerDate Sep<11>2014 16:48 Sep 28, 2022 Jkt 256001 enrolled retirement plan agents from $67 to $140. In addition, the document proposed increasing both the enrollment and renewal of enrollment user fees for enrolled agents from $67 to $140. The document contains a detailed explanation of the legal background and user fee calculations regarding the amendments to these regulations. Six comments responding to the notice of proposed rulemaking were received, including comments from the National Association of Enrolled Agents (NAEA). On May 3, 2022, representatives from the NAEA, Department of the Treasury (Treasury Department), the IRS, and the Small Business Administration (SBA), held a teleconference to listen to NAEA’s comments about the proposed rulemaking. In addition, two requests to speak at the scheduled public hearing were received. A public hearing was held on May 11, 2022. After consideration of the written comments, teleconference comments, and testimony at the public hearing, the Treasury Department and the IRS have decided to adopt without modification the regulations proposed by the notice of proposed rulemaking. Summary of Comments The six comments submitted in response to the notice of proposed rulemaking and a summary of the teleconference comments are available at www.regulations.gov or upon request. Some of the comments that were submitted did not seek modification or clarification of the user fee as set forth in the proposed regulations. One commenter expressed concern with how the special enrollment examination for enrolled agents (EA SEE) is being administered. The commenter also recommended using the user fees in these regulations to provide resources for tax professionals that would improve the service they provide to their clients. The user fees in these regulations are not used by the Treasury Department or the IRS to administer the EA SEE, or to provide resources for tax professionals that improve the service they provide to their clients. Therefore, comments regarding the EA SEE and additional resources identified by the commenter are outside the scope of these regulations. Another commenter suggested that the IRS should raise the amount of the user fee to apply for or renew a preparer tax identification number (PTIN) in order to (1) lower the cost of user fees relating to enrolled agents and (2) encourage more individuals to become enrolled agents. These regulations do not relate to the PTIN user fee or the PTIN program. PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 Therefore, comments regarding the PTIN program and related user fees are outside the scope of these regulations. Finally, one commenter suggested that it is inconsistent for the IRS to charge user fees in order to administer the enrollment and renewal of enrollment program but not charge user fees for other programs (for example, participation in the Annual Filing Season Program). Again, comments regarding programs other than the enrollment and renewal of enrollment program are outside the scope of these regulations. The summary of comments below addresses those comments that make recommendations concerning or seeking clarification of the user fees set forth in the proposed regulations relating to the user fees for enrolled agents and enrolled retirement plan agents. A. Amount of User Fees Four commenters expressed concern with the overall amount of the proposed enrollment and renewal of enrollment user fees and requested information regarding why the user fees are required. The Independent Offices Appropriation Act of 1952 (IOAA) (31 U.S.C. 9701) authorizes each agency to promulgate regulations establishing the charge for services provided by the agency. The IOAA states that the services provided by an agency should be self-sustaining to the extent possible. 31 U.S.C. 9701(a). The IOAA provides that user fee regulations are subject to policies prescribed by the President, which are currently set forth in the Office of Management and Budget (OMB) Circular A–25 (OMB Circular), 58 FR 38142 (July 15, 1993). Section 6a(1) of OMB Circular A–25 states that when a service offered by a Federal agency provides special benefits to identifiable recipients beyond those accruing to the general public, the agency should establish a user fee to recover the full cost of providing the service. An agency that seeks to impose a user fee for government-provided services must calculate the full cost of providing those services. In accordance with OMB Circular A– 25, the IRS Return Preparer Office (RPO) completed its 2021 biennial review of the enrollment and renewal of enrollment user fees associated with enrolled agents and enrolled retirement plan agents. As discussed in the notice of proposed rulemaking, during its review the RPO took into account the increase in labor, benefits, and overhead costs incurred in connection with providing enrollment services to individuals who enroll or renew E:\FR\FM\29SER1.SGM 29SER1

Agencies

[Federal Register Volume 87, Number 188 (Thursday, September 29, 2022)]
[Rules and Regulations]
[Pages 58957-58968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20836]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 515, 516, 520, 522, 524, 529, and 558

[Docket No. FDA-2022-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 Name and Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
animal drug regulations to reflect application-related actions for new 
animal drug applications (NADAs) and abbreviated new animal drug 
applications (ANADAs) during January, February, and March 2022. 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 the accuracy 
of the regulations.

DATES: This rule is effective September 29, 2022.

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 January, February, and March 2022, 
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

[[Page 58958]]

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.
    FDA has verified the website addresses as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.

                          Table 1--Original and Supplemental NADAs and ANADAs Approved During January, February, and March 2022
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                  Effect of the
         Approval date             File No.          Sponsor            Product name            Species               action          Public  documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
January 10, 2022...............      131-675  Intervet, Inc., 2     SAFE-GUARD            Cattle.............  Supplemental         ....................
                                               Giralda Farms,        (fenbendazole),                            approval to
                                               Madison, NJ 07940.    Type A Medicated                           establish
                                                                     Article.                                   withdrawal periods
                                                                                                                in accordance with
                                                                                                                repartitioning of
                                                                                                                acceptable daily
                                                                                                                intake; and to add
                                                                                                                fourth-stage
                                                                                                                larval indications
                                                                                                                for certain
                                                                                                                endoparasites of
                                                                                                                cattle.
January 13, 2022...............      141-546  Zoetis Inc, 333       SOLENSIA              Cats...............  Original approval    FOI Summary.
                                               Portage St.,          (frunevetmab                               for the control of
                                               Kalamazoo, MI 49007.  injection),                                pain associated
                                                                     Injectable Solution.                       with
                                                                                                                osteoarthritis.
January 20, 2022...............      141-547  Elanco US Inc., 2500  ZORBIUM               Cats...............  Original approval    FOI Summary.
                                               Innovation Way,       (buprenorphine                             for the control of
                                               Greenfield, IN        transdermal                                postoperative pain
                                               46140.                solution),                                 associated with
                                                                     Transdermal                                surgical
                                                                     Solution.                                  procedures.
January 25, 2022...............      200-707  Huvepharma EOOD, 5th  TILMOVET AC           Swine..............  Original approval    FOI Summary.
                                               Floor, 3A Nikolay     (tilmicosin),                              as a generic copy
                                               Haytov Str.,1113      Solution.                                  of NADA 141-361.
                                               Sofia, Bulgaria.
January 28, 2022...............      200-716  Norbrook              MIDAMOX for Dogs      Dogs...............  Original approval    FOI Summary.
                                               Laboratories Ltd.,    (imidacloprid and                          as a generic copy
                                               Carnbane Industrial   moxidectin),                               of NADA 141-251.
                                               Estate, Newry,        Topical Solution.
                                               County Down, BT35
                                               6QQ, United Kingdom.
February 7, 2022...............      200-665  Elanco US Inc., 2500  INCREXXA 25           Cattle and Swine...  Original approval    FOI Summary.
                                               Innovation Way,       (tulathromycin                             as a generic copy
                                               Greenfield, IN        injection),                                of NADA 141-349.
                                               46140.                Injectable Solution.
February 7, 2022...............      200-717  Aurora                TIAGARD 12.5%         Swine..............  Original approval    FOI Summary.
                                               Pharmaceutical,       (tiamulin hydrogen                         as a generic copy
                                               Inc,1196 Highway 3    fumarate), Liquid                          of NADA 140-916.
                                               South, Northfield,    Concentrate.
                                               MN 55057-3009.
February 7, 2022...............      200-718  ......do............  BARRIER for Dogs      Dogs...............  Original approval    FOI Summary.
                                                                     (imidacloprid and                          as a generic copy
                                                                     moxidectin),                               of NADA 141-251.
                                                                     Topical Solution.
February 9, 2022...............      200-715  Intervet, Inc., 2     AROVYN                Cattle and Swine...  Original approval    FOI Summary.
                                               Giralda Farms,        (tulathromycin                             as a generic copy
                                               Madison, NJ 07940.    injection),                                of NADA 141-244.
                                                                     Injectable Solution.
March 11, 2022.................      200-720  Norbrook              ENROFLOX              Dogs...............  Original approval    FOI Summary.
                                               Laboratories Ltd.,    (enrofloxacin),                            as a generic copy
                                               Carnbane Industrial   Chewable Tablets.                          of NADA 140-441.
                                               Estate, Newry,
                                               County Down, BT35
                                               6QQ, United Kingdom.
March 23, 2022.................      200-723  ......do............  TULIEVE               Cattle and Swine...  Original approval    FOI Summary.
                                                                     (tulathromycin                             as a generic copy
                                                                     injection),                                of NADA 141-244.
                                                                     Injectable Solution.
March 28, 2022.................      200-721  ......do............  MIDAMOX for Cats      Cats...............  Original approval    FOI Summary.
                                                                     (imidacloprid and                          as a generic copy
                                                                     moxidectin),                               of NADA 141-254.
                                                                     Topical Solution.
March 28, 2022.................      200-722  ......do............  FIROX (firocoxib),    Dogs...............  Original approval    FOI Summary.
                                                                     Chewable Tablets.                          as a generic copy
                                                                                                                of NADA 141-230.
March 28, 2022.................      200-688  Virbac AH, Inc., P.O  TENOTRYL              Cattle and Swine...  Original approval    FOI Summary.
                                               .Box 162059, Fort     (enrofloxacin),                            as a generic copy
                                               Worth, TX 76161.      Injectable Solution.                       of NADA 141-068.
March 30, 2022.................      141-551  Vetcare Oy, P.O. Box  ZENALPHA              Dogs...............  Original approval    FOI Summary.
                                               26 (Liedontie 45),    (medetomidine and                          for use as a
                                               M[auml]nts[auml]l[a   vatinoxan                                  sedative and
                                               uml], Uusimaa,        injection).                                analgesic to
                                               04601, Finland.                                                  facilitate
                                                                                                                clinical
                                                                                                                examination,
                                                                                                                clinical
                                                                                                                procedures, and
                                                                                                                minor surgical
                                                                                                                procedures.
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 58959]]

II. Withdrawals of Approval

    Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601, has 
requested that FDA withdraw approval of NADA 140-908 for VET-METH 
Bolus, a bolus containing sulfamethazine for use in cattle because the 
product is no longer manufactured or marketed. As provided in the 
regulatory text of this document, the animal drug regulations in 21 CFR 
520.2260a are amended to reflect this action.
    Ridley USA, Inc., 111 W. Cherry St., Suite 500, Mankato, MN 56001, 
has requested that FDA withdraw approval of NADA 136-214 for VMS Bloat 
Blox, an oral dosage form containing polyoxyethylene (23) lauryl ether 
for use in beef and nonlactating dairy cattle because the product is no 
longer manufactured or marketed. As provided in the regulatory text of 
this document, the animal drug regulations in 21 CFR 520.1846 are 
amended to reflect this action.

III. Changes of Sponsorship

    Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200, 
Peachtree Corners, GA 30092 has informed FDA that it has transferred 
ownership of, and all rights and interest in, ANADA 200-129 for 
Isoflurane, USP and ANADA 200-467 for Sevoflurane to Dechra Veterinary 
Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211. 
As provided in the regulatory text, the animal drug regulations in 21 
CFR 529.1186 and 529.2110, respectively, are amended to reflect these 
changes of sponsorship.

IV. Change of Sponsor's Name and Address

    Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 
77478 has informed FDA that it has changed its name and address to 
Mylan Institutional, Inc., a Viatris Company, 3711 Collins Ferry Rd., 
Morgantown, WV 26505. As provided in the regulatory text, the animal 
drug regulations in Sec.  510.600(c) (21 CFR 510.600(c)) are amended to 
reflect this change of a sponsor's name and address.

V. Technical Amendments

    FDA is making the following amendments to improve the accuracy of 
the animal drug regulations:
     Section 510.600 is amended to remove the entry for 
Halocarbon Products Corp. from, and add Vetcare Oy to, the list of 
sponsors of approved applications. The entries for Mylan Institutional, 
Inc. and Norbrook Laboratories Ltd. are revised as well.
     21 CFR 516.812 is amended to reflect a current drug 
labeler code for a use of enrofloxacin injectable solution in cattle.
     21 CFR 520.88g is amended reflect a current sponsor drug 
labeler code and revised indications for use of tablets containing 
amoxicillin and clavulanate in dogs and cats.
     21 CFR 520.530 is amended to conform to content codified 
for animal drugs available by veterinary prescription.
     21 CFR 520.905a is amended to reflect revised conditions 
of use for fenbendazole suspension in horses.
     21 CFR 520.928 is amended to reflect correct directions 
for administration of firocoxib chewable tablets in dogs.
     21 CFR 520.1242a is amended to reflect revised indications 
for use of a levamisol powder in cattle and sheep.
     21 CFR 520.1720a is amended to correct an error in the 
strength of approved phenylbutazone boluses.
     21 CFR 520.1870 is amended to remove an undefined acronym 
in the conditions for use of praziquantel tablets.
     21 CFR 520.1872 is amended to conform to content codified 
for animal drugs available by veterinary prescription.
     21 CFR 520.2325a is amended to reflect instructions for 
use of sulfaquinoxaline powder and solution in poultry and cattle.
     21 CFR 520.2598 is amended to reflect revised indications 
for use for trilostane capsules in dogs.
     21 CFR 522.533 is amended to revise the indications for 
use of deslorelin injectable solution in mares.
     21 CFR 522.2615 is amended to reflect revised human food 
safety warnings for tripelennamine injectable solution in cattle.
     21 CFR 524.1001 is amended to correct a spelling error in 
the heading and specifications for fluralaner and moxidectin topical 
solution.
     21 CFR 524.2098 is amended to reflect all sponsors of 
approved applications for selamectin topical solution in dogs and cats.
     21 CFR 558.4 is amended in the Category II table to 
reflect the correct assay limits for Type C medicated feeds 
manufactured using nicarbazin powder.
     21 CFR 558.128 is amended to reflect the class of cattle 
and incorporation level for single-ingredient and combination-drug 
medicated feeds containing chlortetracycline used for control of 
anaplasmosis in cattle.
     21 CFR 558.633 is amended to clarify expiration dates for 
medicated feeds containing tylvalosin.

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)), 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 Parts 515 and 516

    Administrative practice and procedure, Animal drugs, Confidential 
business information, 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, 515, 516, 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), remove the entry for ``Halocarbon

[[Page 58960]]

Products Corp.''; revise the entries for ``Mylan Institutional, Inc.'' 
and ``Norbrook Laboratories Ltd.''; and add in alphabetical order an 
entry for ``Vetcare Oy''; and
0
b. In the table in paragraph (c)(2), remove the entry for ``012164''; 
revise the entries for ``051079'' and ``055529''; and add in numerical 
order an entry for ``086155''.
    The revisions and additions 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
------------------------------------------------------------------------
 
                              * * * * * * *
Mylan Institutional, Inc., a Viatris Company, 3711                051079
 Collins Ferry Rd., Morgantown, WV 26505................
 
                              * * * * * * *
Norbrook Laboratories Ltd., Carnbane Industrial Estate,           055529
 Newry, County Down, BT35 6QQ, United Kingdom...........
 
                              * * * * * * *
Vetcare Oy, P.O. Box 26 (Liedontie 45),                           086155
 M[auml]nts[auml]l[auml], Uusimaa, 04601, Finland.......
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
051079......................  Mylan Institutional, Inc., a Viatris
                               Company, 3711 Collins Ferry Rd.,
                               Morgantown, WV 26505.
 
                              * * * * * * *
055529......................  Norbrook Laboratories Ltd., Carnbane
                               Industrial Estate, Newry, County Down,
                               BT35 6QQ, United Kingdom.
 
                              * * * * * * *
086155......................  Vetcare Oy, P.O. Box 26 (Liedontie 45),
                               M[auml]nts[auml]l[auml], Uusimaa, 04601,
                               Finland.
 
                              * * * * * * *
------------------------------------------------------------------------

PART 515--MEDICATED FEED MILL LICENSE

0
3. The authority citation for part 515 continues to read as follows:

    Authority:  21 U.S.C. 360b, 371.

0
4. In Sec.  515.10, revise paragraph (a) to read as follows:


Sec.  515.10  Medicated feed mill license applications.

    (a) Medicated feed mill license applications (Form FDA 3448) may be 
obtained from the Public Health Service, Consolidated Forms and 
Publications Distribution Center, Washington Commerce Center, 3222 
Hubbard Rd., Landover, MD 20785, or electronically from the Center for 
Veterinary Medicine at: https://www.fda.gov/animal-veterinary/animal-food-feeds/medicated-feeds.
* * * * *

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
5. The authority citation for part 516 continues to read as follows:

    Authority:  21 U.S.C. 360ccc-1, 360ccc-2, 371.


Sec.  516.812   [Amended]

0
6. In Sec.  516.812, in paragraph (b), remove ``000859'' and in its 
place add ``058198''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
7. The authority citation for part 520 continues to read as follows:

    Authority:  21 U.S.C. 360b.

0
8. In Sec.  520.88g, revise paragraphs (b)(2), (c)(1)(ii), and 
(c)(2)(ii) to read as follows:


Sec.  520.88g  Amoxicillin trihydrate and clavulanate potassium 
tablets.

* * * * *
    (b) * * *
    (2) Nos. 017033 and 069043 for use of tablets as in paragraph (c) 
of this section.
    (c) * * *
    (1) * * *
    (ii) Indications for use. Treatment of skin and soft tissue 
infections such as wounds, abscesses, cellulitis, superficial/juvenile 
and deep pyoderma due to susceptible strains of the following 
organisms: Beta-lactamase-producing Staphylococcus aureus, non-beta-
lactamase-producing Staphylococcus aureus, Staphylococcus spp., 
Streptococcus spp., and E. coli. Periodontal infections due to 
susceptible strains of both aerobic and anaerobic bacteria.
* * * * *
    (2) * * *
    (ii) Indications for use. Treatment of skin and soft tissue 
infections such as wounds, abscesses, and cellulitis/dermatitis due to 
susceptible strains of the following organisms: Beta-lactamase-
producing Staphylococcus aureus, non-beta-lactamase-producing 
Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., E. 
coli, and Pasteurella spp. Urinary tract infections (cystitis) due to 
susceptible strains of E. coli.
* * * * *

[[Page 58961]]

Sec.  520.530   [Amended]

0
9. In Sec.  520.530, remove paragraph (c) and redesignate paragraph (d) 
as paragraph (c).

0
10. In Sec.  520.812, revise paragraphs (b)(1) and (3) to read as 
follows:


Sec.  520.812   Enrofloxacin.

* * * * *
    (b) * * *
    (1) No. 058198 for use of products described in paragraph (a) of 
this section.
* * * * *
    (3) Nos. 055529 and 086101 for use of product described in 
paragraph (a)(2) of this section.
* * * * *

0
11. In Sec.  520.905a, revise paragraphs (e)(1)(ii) and (iii) to read 
as follows:


Sec.  520.905a  Fenbendazole suspension.

* * * * *
    (e) * * *
    (1) * * *
    (ii) Indications for use. For the treatment and control of large 
strongyles (Strongylus edentatus, S. equinus, S. vulgaris, 
Triodontophorus species), small strongyles (Cyathostomum species, 
Cylicocyclus species, Cylicostephanus species, Cylicodontophorus 
species), pinworms (Oxyuris equi) and ascarids (Parascaris equorum).
    (iii) Limitations. Do not use in horses intended for human 
consumption.
* * * * *

0
12. In Sec.  520.928, revise the section heading and paragraphs (a), 
(b), and (c)(1)(i) to read as follows:


Sec.  520.928  Firocoxib.

    (a) Specifications--(1) Each chewable tablet contains 57 or 227 
milligrams (mg) firocoxib.
    (2) Each tablet contains 57 mg firocoxib.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter as 
follows:
    (1) Nos. 000010 and 055529 for use of products described in 
paragraph (a)(1) as in paragraph (c)(1) of this section; and
    (2) No. 000010 for use of the product described in paragraph (a)(2) 
as in paragraph (c)(2) of this section.
    (c) * * *
    (1) * * *
    (i) Amount. 5 mg/kg (2.27 mg/lb) body weight. Administer once daily 
as needed for osteoarthritis and for 3 days as needed for postoperative 
pain and inflammation associated with soft-tissue and orthopedic 
surgery. Administer approximately 2 hours before soft tissue or 
orthopedic surgery.
* * * * *

0
13. In Sec.  520.1242a, revise paragraph (b)(3) to read as follows:


Sec.  520.1242a   Levamisol powder.

* * * * *
    (b) * * *
    (3) No. 016592 for use of 46.8- and 544.5-g packages as in 
paragraphs (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) and (e)(2)(i), 
(e)(2)(ii)(B), and (e)(2)(iii) of this section.
* * * * *

0
14. In Sec.  520.1720a, revise paragraph (a) to read as follows:


Sec.  520.1720a   Phenylbutazone tablets and boluses.

    (a) Specifications. Each tablet contains 100, 200, or 400 
milligrams (mg), or 1 gram (g) phenylbutazone. Each bolus contains 1, 
2, or 4 g phenylbutazone.
* * * * *


Sec.  520.1846  [Removed]

0
15. Remove Sec.  520.1846.


Sec.  520.1870   [Amended]

0
16. In Sec.  520.1870, in paragraph (c)(2)(iii), in the third sentence, 
remove ``OTC'' and in its place add ``over the counter''.

0
17. In Sec.  520.1872, revise paragraph (c)(1)(iii) and add reserved 
paragraph (c)(2) to read as follows:


Sec.  520.1872   Praziquantel, pyrantel pamoate, and febantel tablets.

* * * * *
    (c) * * *
    (1) * * *
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

0
18. Revise Sec.  520.2260a to read as follows:


Sec.  520.2260a   Sulfamethazine oblets and boluses.

    (a) Specifications. Each oblet or bolus contains:
    (1) 2.5, 5, or 15 grams sulfamethazine.
    (2) 5 grams sulfamethazine.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use of products described in paragraph (a) of this section.
    (1) No. 016592 for use of products described in paragraph (a)(1) of 
this section.
    (2) No. 054771 for use of product described in paragraph (a)(2) of 
this section.
    (c) Related tolerances. See Sec.  556.670 of this chapter.
    (d) Conditions of use. (1) Oblets and boluses described in 
paragraph (a)(1) of this section:
    (i) Amount. Administer as a single dose 100 milligrams per pound 
(mg/lb) of body weight the first day and 50 mg/lb of body weight on 
each following day.
    (ii) Indications for use. (A) Beef cattle and nonlactating dairy 
cattle. For the treatment of bacterial pneumonia and bovine respiratory 
disease complex (shipping fever complex) (Pasteurella spp.), 
colibacillosis (bacterial scours) (Escherichia coli), necrotic 
pododermatitis (foot rot) (Fusobacterium necrophorum), calf diphtheria 
(Fusobacterium necrophorum), acute mastitis (Streptococcus spp.), acute 
metritis (Streptococcus spp.), and coccidiosis (Eimeria bovis and E. 
zurnii).
    (B) Horses. For the treatment of bacterial pneumonia (secondary 
infections associated with Pasteurella spp.), strangles (Streptococcus 
equi), and bacterial enteritis (Escherichia coli).
    (iii) Limitations. Administer daily until animal's temperature and 
appearance are normal. If symptoms persist after using for 2 or 3 days 
consult a veterinarian. Fluid intake must be adequate. Treatment should 
continue 24 to 48 hours beyond the remission of disease symptoms, but 
not to exceed 5 consecutive days. Follow dosages carefully. Do not 
treat cattle within 10 days of slaughter. Do not use in female dairy 
cattle 20 months of age or older. Use of sulfamethazine in this class 
of cattle may cause milk residues. A withdrawal period has not been 
established in preruminating calves. Do not use in calves to be 
processed for veal. Do not use in horses intended for human 
consumption.
    (2) Boluses described in paragraph (a)(2) of this section:
    (i) Amount. Administer 10 grams (2 boluses) of sulfamethazine per 
100 pounds of body weight the first day, then 5 grams (1 bolus) of 
sulfamethazine per 100 pounds of body weight daily for up to 4 
additional consecutive days.
    (ii) Indications for use. (A) Ruminating beef and dairy calves. For 
treatment of the following diseases caused by organisms susceptible to 
sulfamethazine: bacterial scours (colibacillosis) caused by Escherichia 
coli; necrotic pododermatitis (foot rot) and calf diphtheria caused by 
Fusobacterium necrophorum; bacterial pneumonia associated with 
Pasteurella spp.; and coccidiosis caused by Eimeria bovis and E. 
zurnii.
    (B) [Reserved]
    (iii) Limitations. Do not administer for more than 5 consecutive 
days. Do not treat calves within 11 days of slaughter. Do not use in 
calves to be slaughtered under 1 month of age or in calves being

[[Page 58962]]

fed an all milk diet. Do not use in female dairy cattle 20 months of 
age or older; such use may cause drug residues in milk. Administer with 
adequate supervision. Follow recommended dosages carefully. Fluid 
intake must be adequate. If symptoms persist after 2 or 3 days, consult 
a veterinarian.

0
19. In Sec.  520.2325a, revise paragraphs (c)(4)(iii) and (d) to read 
as follows:


Sec.  520.2325a  Sulfaquinoxaline powder and solution.

* * * * *
    (c) * * *
    (4) * * *
    (iii) In lieu of treatment as provided in paragraph (c)(4)(ii) of 
this section, administer 1 teaspoon of 25 percent sulfaquinoxaline 
soluble powder per day for each 125 pounds of body weight for 3 to 5 
days in drinking water.
    (d) Limitations. A withdrawal period has not been established in 
preruminating calves. Do not use in calves to be processed for veal. 
Not for use in lactating dairy cattle. Do not give to chickens, 
turkeys, or cattle within 10 days of slaughter for food. Do not 
medicate chickens or turkeys producing eggs for human consumption. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

0
20. In Sec.  520.2455, revise paragraph (b)(3) to read as follows:


Sec.  520.2455   Tiamulin.

* * * * *
    (b) * * *
    (3) Nos. 016592, 051072, 051311, and 061133 for product described 
in paragraph (a)(2) of this section.
* * * * *

0
21. In Sec.  520.2471, revise paragraph (b) to read as follows:


Sec.  520.2471  Tilmicosin.

* * * * *
    (b) Sponsors. See Nos. 016592 and 058198 in Sec.  510.600(c) of 
this chapter.
* * * * *

0
22. In Sec.  520.2598, revise paragraph (c)(2) to read as follows:


Sec.  520.2598   Trilostane.

* * * * *
    (c) * * *
    (2) Indications for use. For the treatment of pituitary-dependent 
and adrenal-dependent hyperadrenocorticism in dogs.
* * * * *

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
23. The authority citation for part 522 continues to read as follows:

    Authority:  21 U.S.C. 360b.

0
24. In Sec.  522.533, revise paragraphs (c)(1)(ii) and (c)(2)(ii) to 
read as follows:


Sec.  522.533  Deslorelin.

* * * * *
    (c) * * *
    (1) * * *
    (ii) Indications for use. For inducing ovulation within 48 hours in 
estrous mares with an ovarian follicle greater than 30 millimeters (mm) 
in diameter.
* * * * *
    (c) * * *
    (2) * * *
    (ii) Indications for use. For inducing ovulation within 48 hours in 
cyclic estrous mares with an ovarian follicle between 30 and 40 mm in 
diameter.
* * * * *

0
25. In Sec.  522.812, revise paragraph (b)(2) to read as follows:


Sec.  522.812   Enrofloxacin.

* * * * *
    (b) * * *
    (2) Nos. 051311, 055529, 058005, 058198, and 061133 for use of 
product described in paragraph (a)(2) of this section as in paragraphs 
(e)(2) and (3) of this section.
* * * * *

0
26. Add Sec.  522.1008 to read as follows:


Sec.  522.1008   Frunevetmab.

    (a) Specifications. Each milliliter (mL) of solution contains 7 
milligrams (mg) frunevetmab.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Cats--(i) Amount. Administer once a 
month by subcutaneous injection the full contents of one or two 1-mL 
vials to achieve a minimum dosage of 0.45 mg/lb (1 mg/kg) body weight.
    (ii) Indications for use. For the control of pain associated with 
osteoarthritis in cats.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

0
27. Add Sec.  522.1338 to read as follows:


Sec.  522.1338  Medetomidine and vatinoxan.

    (a) Specifications. Each milliliter of solution contains 0.5 
milligrams (mg) medetomidine hydrochloride and 10 mg vatinoxan 
hydrochloride.
    (b) Sponsor. See No. 086155 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer by intramuscular 
injection a dose based on body surface area (BSA). Calculate the dose 
using 1 mg medetomidine per square meter (/m\2\) BSA or use the dosing 
table provided in labeling.
    (2) Indications for use. For use as a sedative and analgesic in 
dogs to facilitate clinical examination, clinical procedures, and minor 
surgical procedures.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
28. In Sec.  522.2615, revise paragraph (d)(3)(iii) to read as follows:


Sec.  522.2615  Tripelennamine.

* * * * *
    (d) * * *
    (3) * * *
    (iii) Limitations. Milk taken during treatment and for 24 hours 
after the last treatment must not be used for human consumption. Cattle 
must not be slaughtered for human consumption within 4 days following 
the last treatment with this drug product. Not for use in beef calves 
less than 2 months of age, dairy calves, and veal calves. A withdrawal 
period has not been established for this product in pre-ruminating 
calves. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

0
29. In Sec.  522.2630, revise paragraphs (b)(1) and (2) to read as 
follows:


Sec.  522.2630  Tulathromycin.

* * * * *
    (b) * * *
    (1) Nos. 000061, 013744, 051311, 054771, 055529, 058198, and 061133 
for use of product described in paragraph (a)(1) as in paragraphs 
(d)(1)(i), (d)(1)(ii), (d)(1)(iii)(A), and (d)(2) of this section.
    (2) Nos. 013744, 051311, 054771, and 058198 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
30. The authority citation for part 524 continues to read as follows:

    Authority:  21 U.S.C. 360b.

0
31. Add Sec.  524.230 to read as follows:


Sec.  524.230  Buprenorphine.

    (a) Specifications. Each milliliter (mL) of solution contains 20 
milligrams (mg) buprenorphine. The drug is supplied in tubes containing 
0.4 mL (8 mg) or 1.0 mL (20 mg).
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in cats--(1) Amount. Administer topically to 
the dorsal cervical area at the base of the skull a single dose of 1.2 
to 3.1 mg/lb

[[Page 58963]]

(2.7 to 6.7 mg/kg) approximately 1 to 2 hours before surgery.
    (2) Indications for use. For the control of postoperative pain 
associated with surgical procedures in cats.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. Buprenorphine is a Schedule III 
controlled substance.

0
32. In Sec.  524.1001, revise the section heading and paragraph (a) to 
read as follows:


Sec.  524.1001  Fluralaner and moxidectin.

    (a) Specifications. Each milliliter of solution contains 280 
milligram (mg) fluralaner and 14 mg moxidectin. Each individually 
packaged tube contains either 112.5 mg fluralaner and 5.6 mg 
moxidectin; 250 mg fluralaner and 12.5 mg moxidectin; or 500 mg 
fluralaner and 25 mg moxidectin.
* * * * *

0
33. In Sec.  524.1146, revise paragraphs (b)(1) and (2) to read as 
follows:


Sec.  524.1146   Imidacloprid and moxidectin.

* * * * *
    (b) * * *
    (1) Nos. 017030, 051072, 055529, 058198, and 061651 for use of 
product described in paragraph (a)(1) of this section as in paragraph 
(d)(1) of this section.
    (2) Nos. 017030, 051072, 055529, 058198, and 061651 for use of 
product described in paragraph (a)(2) of this section as in paragraph 
(d)(2) of this section.
* * * * *

0
34. In Sec.  524.2098, revise paragraph (b) to read as follows:


Sec.  524.2098  Selamectin.

* * * * *
    (b) Sponsors. See Nos. 051072, 054771, 055529, 061133, and 061651 
in Sec.  510.600(c) of this chapter.
* * * * *

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
35. The authority citation for part 529 continues to read as follows:

    Authority: 21 U.S.C. 360b.

0
36. In Sec.  529.1186, revise paragraph (b) to read as follows:


Sec.  529.1186   Isoflurane.

* * * * *
    (b) Sponsors. See Nos. 017033, 054771, 065085, and 066794 in Sec.  
510.600(c) of this chapter.
* * * * *

0
37. In Sec.  529.2110, revise paragraph (b) to read as follows:


Sec.  529.2110  Sevoflurane.

* * * * *
    (b) Sponsors. See Nos. 017033, 054771, and 066794 in Sec.  
510.600(c) of this chapter.
* * * * *

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
38. The authority citation for part 558 continues to read as follows:

    Authority:  21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

0
39. In Sec.  558.4, in paragraph (d), in the ``Category II'' table, 
revise the entry for ``Nicarbazin (powder)'' to read as follows:


Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                               Assay limits                                       Assay limits
                    Drug                        percent \1\        Type B maximum  (100x)       percent \1\ type
                                                  type A                                            B/C \2\
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Nicarbazin (powder).........................          96-104  9.08 g/lb (2.00%)..............      85-115/80-120
 
                                                  * * * * * * *
* * * * * * *...............................
----------------------------------------------------------------------------------------------------------------

* * * * *

0
40. In Sec.  558.128, revise paragraphs (e)(4)(iii) and (xli) to read 
as follows:


Sec.  558.128   Chlortetracycline.

* * * * *
    (e) * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
                                     Combination  in
     Chlortetracycline amount           grams/ton       Indications for use      Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iii) to provide 0.5 mg/lb of      ...................  Beef cattle (over    Feed to provide              054771
 body weight daily.                                      700 lb): For         chlortetracycline           066104
                                                         control of active    at the rate of 0.5          069254
                                                         infection of         mg per pound of
                                                         anaplasmosis         body weight daily.
                                                         caused by            Withdraw 48 hours
                                                         Anaplasma            prior to
                                                         marginale            slaughter. To
                                                         susceptible to       sponsor Nos.
                                                         chlortetracycline.   054771 and 069254:
                                                                              Zero withdrawal
                                                                              time.
 

[[Page 58964]]

 
                                                  * * * * * * *
(xli) 25 to 2,800 g/ton to         Lasalocid, 30 to     Growing beef         The melengestrol             054771
 provide 350 mg/head/day.           181.8;               heifers fed in       acetate Type C top-
                                    melengestrol         confinement for      dress medicated
                                    acetate, 0.25 to 2   slaughter under      feed must be top
                                    g/ton to provide     700 pounds: For      dressed onto or
                                    0.25 to 0.5 mg/      control of active    mixed at feeding
                                    head/day             infection of         with a Type C
                                    melengestrol         anaplasmosis         medicated feed
                                    acetate.             caused by            containing 25 to
                                                         Anaplasma            2,800 g/ton of
                                                         marginale            chlortetracycline
                                                         susceptible to       and 30 to 181.8 g/
                                                         chlortetracycline,   ton lasalocid to
                                                         control of           provide 350 mg
                                                         coccidiosis caused   chlortetracycline
                                                         by Eimeria bovis     per head per day
                                                         and E. zuernii,      and 1 mg lasalocid
                                                         increased rate of    per 2.2 lb. of
                                                         weight gain,         body weight daily
                                                         improved feed        with a maximum of
                                                         efficiency, and      360 mg lasalocid
                                                         suppression of       per head per day.
                                                         estrus (heat).       See Sec.
                                                                              558.311(d) of this
                                                                              chapter.
                                                                              Chlortetracycline,
                                                                              lasalocid, and
                                                                              melengestrol as
                                                                              provided by No.
                                                                              054771 in Sec.
                                                                              510.600(c) of this
                                                                              chapter.
 
                                                  * * * * * * *
* * * * * * *....................
----------------------------------------------------------------------------------------------------------------

* * * * *

0
41. In Sec.  558.258, revise paragraph (e)(1), paragraph (e)(2) table 
column headings, and paragraphs (e)(2)(i) and (e)(3) through (5) to 
read as follows:


Sec.  558.258  Fenbendazole.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                                    Combination grams
    Fenbendazole grams per ton           per ton        Indications for use      Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 14.5.........................  ...................  Growing turkeys:     Feed continuously            000061
                                                         For the treatment    as the sole ration
                                                         and control of       for 6 days. For
                                                         gastrointestinal     growing turkeys
                                                         worms: roundworms,   only.
                                                         adults and larvae
                                                         (Ascaridia
                                                         dissimilis); cecal
                                                         worms, adults and
                                                         larvae (Heterakis
                                                         gallinarum), an
                                                         important vector
                                                         of Histomonas
                                                         meleagridis
                                                         (Blackhead).
(ii) [Reserved]..................  ...................  ...................  ...................  ..............
----------------------------------------------------------------------------------------------------------------


[[Page 58965]]

    (2) Swine.

----------------------------------------------------------------------------------------------------------------
                                  Combination grams
   Fenbendazole grams per ton          per ton         Indications for use        Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 to 300..................  ..................  Swine: For the           Feed as the sole            000061
                                                      treatment and control    ration to provide
                                                      of Lungworms: adult      9 mg/kg of body
                                                      (Metastrongylus apri     weight (4.08 mg/
                                                      and M. pudendotectus);   lb) over a period
                                                      Gastrointestinal         of 3 to 12
                                                      worms: adult and         consecutive days.
                                                      larvae (L3, 4 stages--   Swine must not be
                                                      liver, lung,             slaughtered for
                                                      intestinal forms)        human consumption
                                                      large roundworms         within 4 days
                                                      (Ascaris suum); adult    following last
                                                      nodular worms            treatment with
                                                      (Oesophagostomum         this drug product.
                                                      dentatum, O.
                                                      quadrispinulatum);
                                                      adult small stomach
                                                      worms (Hyostrongylus
                                                      rubidus); adult and
                                                      larvae (L2, 3, 4
                                                      stages--intestinal
                                                      mucosal forms)
                                                      whipworms (Trichuris
                                                      suis); and Kidney
                                                      worms: adult and
                                                      larvae (Stephanurus
                                                      dentatus).
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

    (3) Cattle.

----------------------------------------------------------------------------------------------------------------
     Fenbendazole grams per ton            Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 200 to 1,000....................  Dairy and beef cattle: For    Feed as the sole ration for           000061
                                       the treatment and control     1 day to provide 5 mg/kg
                                       of: Lungworms: adult          body weight (2.27 mg/lb).
                                       (Dictyocaulus viviparus);     Milk taken during treatment
                                       Stomach worms: adult brown    and for 60 hours after the
                                       stomach worms (Ostertagia     last treatment must not be
                                       ostertagi), adult and         used for human consumption.
                                       fourth-stage larvae           Cattle must not be
                                       barberpole worms              slaughtered for human
                                       (Haemonchus contortus),       consumption within 13 days
                                       fourth-stage larvae           following last treatment
                                       barberpole worms (H.          with this drug product. Not
                                       placei), and adult and        for use in beef calves less
                                       fourth-stage larvae small     than 2 months of age, dairy
                                       stomach worms                 calves, and veal calves. A
                                       (Trichostrongylus axei);      withdrawal period has not
                                       Intestinal worms (adult and   been established for this
                                       fourth-stage larvae):         product in pre-ruminating
                                       hookworms (Bunostomum         calves.
                                       phlebotomum), thread-necked
                                       intestinal worms
                                       (Nematodirus helvetianus),
                                       small intestinal worms
                                       (Cooperia punctata and C.
                                       oncophora), bankrupt worms
                                       (Trichostrongylus
                                       colubriformis), and nodular
                                       worms (Oesophagostomum
                                       radiatum).
(ii) [Reserved].....................  ............................  ............................  ..............
----------------------------------------------------------------------------------------------------------------

    (iii) Top dress medicated feed--(A) Proprietary formulas. The 
following feed can be manufactured only per an approved proprietary 
formula and specifications:

----------------------------------------------------------------------------------------------------------------
     Fenbendazole concentration            Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 2.27 g/lb.......................  Beef and dairy cattle: For    Feed as a top dress for 1             000061
                                       the treatment and control     day to provide 5 mg/kg body
                                       of: Lungworms: adult          weight (2.27 mg/lb). Milk
                                       (Dictyocaulus viviparus);     taken during treatment and
                                       Stomach worms: adult brown    for 60 hours after the last
                                       stomach worms (Ostertagia     treatment must not be used
                                       ostertagi), adult and         for human consumption.
                                       fourth-stage larvae           Cattle must not be
                                       barberpole worms              slaughtered for human
                                       (Haemonchus contortus),       consumption within 13 days
                                       fourth-stage larvae           following last treatment
                                       barberpole worms (H.          with this drug product. Not
                                       placei), and adult and        for use in beef calves less
                                       fourth-stage larvae small     than 2 months of age, dairy
                                       stomach worms                 calves, and veal calves. A
                                       (Trichostrongylus axei);      withdrawal period has not
                                       Intestinal worms (adult and   been established for this
                                       fourth-stage larvae):         product in pre-ruminating
                                       hookworms (Bunostomum         calves.
                                       phlebotomum), thread-necked
                                       intestinal worms
                                       (Nematodirus helvetianus),
                                       small intestinal worms
                                       (Cooperia punctata and C.
                                       oncophora), bankrupt worms
                                       (Trichostrongylus
                                       colubriformis), and nodular
                                       worms (Oesophagostomum
                                       radiatum).
(2) [Reserved]......................  ............................  ............................  ..............
----------------------------------------------------------------------------------------------------------------

    (B) [Reserved]
    (iv) Free-choice medicated feeds--(A) Proprietary formulas (21 CFR 
510.455(e)(2)). The following feeds can be manufactured only per an 
approved proprietary formula and specifications:

[[Page 58966]]



----------------------------------------------------------------------------------------------------------------
     Fenbendazole concentration            Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 12,100 g/ton mineral............  Beef cattle on pasture: For   Feed free-choice at the rate          000061
                                       the treatment and control     of 0.0375 lb per 100 pounds
                                       of: Lungworms: adult          of body weight over a 3- to
                                       (Dictyocaulus viviparus);     6-day period to provide a
                                       Stomach worms: adult brown    total of 2.27 mg
                                       stomach worms (Ostertagia     fenbendazole per pound of
                                       ostertagi), adult and         body weight. Not for use in
                                       fourth-stage larvae           dairy cattle. Beef cattle
                                       barberpole worms              must not be slaughtered for
                                       (Haemonchus contortus),       human consumption within 13
                                       fourth-stage larvae           days following last
                                       barberpole worms (H.          treatment with this drug
                                       placei), and adult and        product. Not for use in
                                       fourth-stage larvae small     beef calves less than 2
                                       stomach worms                 months of age, dairy
                                       (Trichostrongylus axei);      calves, and veal calves. A
                                       Intestinal worms (adult and   withdrawal period has not
                                       fourth-stage larvae):         been established for this
                                       hookworms (Bunostomum         product in pre-ruminating
                                       phlebotomum), thread-necked   calves.
                                       intestinal worms
                                       (Nematodirus helvetianus),
                                       small intestinal worms
                                       (Cooperia punctata and C.
                                       oncophora), bankrupt worms
                                       (Trichostrongylus
                                       colubriformis), and nodular
                                       worms (Oesophagostomum
                                       radiatum).
(2) 2.27 g/lb mineral...............  Beef cattle on pasture: For   Feed free-choice at the rate          000061
                                       the treatment and control     of 0.10 lb (1.6 oz) per 100
                                       of: Lungworms: adult          pounds of body weight over
                                       (Dictyocaulus viviparus);     a 3- to 6-day period, to
                                       Stomach worms: adult brown    deliver a total of 2.27 mg
                                       stomach worms (Ostertagia     fenbendazole per pound of
                                       ostertagi), adult and         body weight. Not for use in
                                       fourth-stage larvae           dairy cattle. Beef cattle
                                       barberpole worms              must not be slaughtered for
                                       (Haemonchus contortus),       human consumption within 13
                                       fourth-stage larvae           days following last
                                       barberpole worms (H.          treatment with this drug
                                       placei), and adult and        product. Not for use in
                                       fourth-stage larvae small     beef calves less than 2
                                       stomach worms                 months of age, dairy
                                       (Trichostrongylus axei);      calves, and veal calves. A
                                       Intestinal worms (adult and   withdrawal period has not
                                       fourth-stage larvae):         been established for this
                                       hookworms (Bunostomum         product in pre-ruminating
                                       phlebotomum), thread-necked   calves.
                                       intestinal worms
                                       (Nematodirus helvetianus),
                                       small intestinal worms
                                       (Cooperia punctata and C.
                                       oncophora), bankrupt worms
                                       (Trichostrongylus
                                       colubriformis), and nodular
                                       worms (Oesophagostomum
                                       radiatum).
----------------------------------------------------------------------------------------------------------------

    (B) Published formulas (Sec.  510.455(e)(1) of this chapter). The 
following feeds can be manufactured only per one of the formulas and 
specifications published below:
    (1) Amount. 5 mg/kg body weight (2.27 mg/lb), including the 
following formulations:

 
------------------------------------------------------------------------
                                                         International
          Ingredient \1\                 Percent            Feed No.
------------------------------------------------------------------------
(i) Free-choice, dry Type C feed:
    Salt (sodium chloride)........              59.00           6-04-152
    Monosodium phosphate..........              31.16           6-04-288
    Dried cane molasses...........               3.12           4-04-695
    Zinc sulfate..................               0.76           6-05-556
    Copper sulfate................               0.45           6-01-720
    Fenbendazole 20% Type A                      5.51                n/a
     article......................
(ii) Free-choice, dry Type C feed:
    Salt (sodium chloride)........              35.93           6-04-152
    Dicalcium phosphate (18.5% P).              32.44           6-00-080
    Calcium carbonate (38% Ca)....              15.93           6-01-069
    Magnesium oxide (56% Mg)......              10.14           6-02-756
    Zinc sulfate..................               1.47           6-05-556
    Mineral oil...................               1.00           8-03-123
    Dried cane molasses (46%                     0.98           4-04-695
     sugars)......................
    Potassium iodide..............               0.01           6-03-759
    Fenbendazole 20% Type A                      2.10                n/a
     article......................
(iii) Free-choice, liquid Type C
 feed \2\:
    Cane molasses \3\.............             80.902           4-13-251
    Water.........................               9.36                n/a
    Urea solution, 55%............               7.05           5-05-707
    Phosphoric acid 75% (feed                    2.00           6-03-707
     grade).......................
    Xantham gum...................               0.20           8-15-818
    Trace minerals \4\............               0.20                n/a
    Vitamin premix \4\............               0.01                n/a
    Fenbendazole 20% Type A                     0.278                n/a
     article......................
------------------------------------------------------------------------
\1\ Formulation modifications require FDA approval prior to marketing.
  Selenium is not approved for use in the liquid, free-choice
  formulations described in paragraph (e)(3)(iv)(B) of this section.
  Free-choice cattle feeds containing selenium must comply with
  published regulations (see 21 CFR 573.920).

[[Page 58967]]

 
\2\ The labeling for the liquid free-choice Type C medicated feed must
  bear an expiration date of 12 weeks after the date of manufacture.
\3\ The percentage of cane molasses and water in the formulation may be
  adjusted as needed to bring the brix value of the molasses to the
  industry standard of 79.5 brix.
\4\ The contents of any added vitamin and trace mineral may be varied;
  however, they should be comparable to those used by the manufacturer
  for other free-choice cattle feeds.

    (2) Indications for use. As in paragraph (e)(3)(i) of this section.
    (3) Limitations. Feed a total of 5 mg of fenbendazole per kg (2.27 
mg/lb) of body weight to cattle over a 3- to 6-day period. Milk taken 
during treatment and for 60 hours after the last treatment must not be 
used for human consumption. Cattle must not be slaughtered for human 
consumption within 13 days following last treatment with this drug 
product. Not for use in beef calves less than 2 months of age, dairy 
calves, and veal calves. A withdrawal period has not been established 
for this product in pre-ruminating calves.
    (4) Horses.

----------------------------------------------------------------------------------------------------------------
     Fenbendazole grams per ton            Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 4,540...........................  5 mg/kg body weight (2.27 mg/ Feed at the rate of 0.1 lb            000061
                                       lb) for the control of        of feed per 100 lb of body
                                       large strongyles              weight to provide 2.27 mg
                                       (Strongylus edentatus, S.     fenbendazole/lb of body
                                       equinus, S. vulgaris,         weight in a 1-day treatment
                                       Triodontophorus spp.),        or 0.2 lb of feed per 100
                                       small strongyles              lb of body weight to
                                       (Cyathostomum spp.,           provide 4.54 mg
                                       Cylicocyclus spp.,            fenbendazole/lb of body
                                       Cylicostephanus spp.), and    weight in a 1-day
                                       pinworms (Oxyuris equi); 10   treatment. All horses must
                                       mg/kg body weight (4.54 mg/   be eating normally to
                                       lb) for the control of        ensure that each animal
                                       ascarids (Parascaris          consumes an adequate amount
                                       equorum).                     of the medicated feed. Do
                                                                     not use in horses intended
                                                                     for human consumption.
(ii) [Reserved].....................  ............................  ............................  ..............
----------------------------------------------------------------------------------------------------------------

    (5) Zoo and wildlife animals.

----------------------------------------------------------------------------------------------------------------
                                 Fenbendazole grams    Indications for
         Species/Class                 per ton               use               Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
(i) Feral swine (Sus scrofa):..  90 to 325.........  For the treatment   Use as a complete feed           000061
                                                      and control of      at a rate to provide 3
                                                      kidney worm         mg/kg/day for 3
                                                      (Stephanurus        consecutive days.
                                                      dentatus),          Prior withdrawal of
                                                      roundworm           feed or water is not
                                                      (Ascaris suum),     necessary. Retreatment
                                                      nodular worm        may be required in 6
                                                      (Oesophagostomum    weeks. Do not use 14
                                                      dentatum).          days before or during
                                                                          the hunting season.
(ii) Ruminants (subfamily        50 to 300.........  For the treatment   Use as a complete feed           000061
 Antilopinae, Hippotraginae,                          and control of      at a rate to provide
 Caprinae).                                           small stomach       2.5 mg/kg/day for 3
                                                      worm                consecutive days.
                                                      (Trichostrongylus   Prior withdrawal of
                                                      spp.), thread       feed or water is not
                                                      necked intestinal   necessary. Retreatment
                                                      worm (Nematodirus   may be required in 6
                                                      spp.), barberpole   weeks. Do not use 14
                                                      worm (Haemonchus    days before or during
                                                      spp.), whipworm     the hunting season.
                                                      (Trichuris spp.).
(iii) Rocky mountain bighorn     375 to 1,000......  For the treatment   Use as a complete feed           000061
 sheep (Ovis c. canadensis).                          and control of      at a rate to provide
                                                      Protostrongylus     10 mg/kg/day for 3
                                                      spp..               consecutive days.
                                                                          Prior withdrawal of
                                                                          feed or water is not
                                                                          necessary. Retreatment
                                                                          may be required in 6
                                                                          weeks. Do not use 14
                                                                          days before or during
                                                                          the hunting season.
----------------------------------------------------------------------------------------------------------------


[[Page 58968]]

* * * * *


Sec.  558.633  [Amended]

0
42. In Sec.  558.633, in paragraph (d)(3), remove the first sentence.

    Dated: September 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20836 Filed 9-28-22; 8:45 am]
BILLING CODE 4164-01-P


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