New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsors' Name and Addresses, 18114-18125 [2020-06688]

Download as PDF 18114 Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations proposed rulemaking, providing an opportunity for public comment. will preempt in accordance with section 26(a) of the CPSA. G. Regulatory Flexibility Act K. Effective Date The Regulatory Flexibility Act (RFA) generally requires that agencies review proposed and final rules for their potential economic impact on small entities, including small businesses, and prepare regulatory flexibility analyses. 5 U.S.C. 603 and 604. The RFA applies to any rule that is subject to notice and comment procedures under section 553 of the APA. Id. As explained, the Commission has determined that notice and comment are not necessary for this direct final rule. Thus, the RFA does not apply. We also note the limited nature of this document, which merely updates the incorporation by reference to reflect the mandatory CPSC standard that takes effect under section 104 of the CPSIA. Under the procedure set forth in section 104(b)(4)(B) of the CPSIA, when a voluntary standard organization revises a standard upon which a consumer product safety standard was based, the revision becomes the CPSC standard within 180 days of notification to the Commission, unless the Commission determines that the revision does not improve the safety of the product, or the Commission sets a later date in the Federal Register. The statutory effective date of 180 days falls on July 4, 2020, a legal holiday and a weekend. Therefore, the Commission is setting the effective date of the rule on the next business day, July, 6, 2020. As discussed in the preceding section, this is a direct final rule. Unless we receive a significant adverse comment within 30 days, the rule will become effective on July 6, 2020. H. Paperwork Reduction Act The standard for children’s folding chairs and stools contains informationcollection requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The revisions made no changes to that section of the standard. Thus, the revisions will have no effect on the information-collection requirements related to the standard. I. Environmental Considerations The Commission’s regulations provide a categorical exclusion for the Commission’s rules from any requirement to prepare an environmental assessment or an environmental impact statement where they ‘‘have little or no potential for affecting the human environment.’’ 16 CFR 1021.5(c)(2). This rule falls within the categorical exclusion, so no environmental assessment or environmental impact statement is required. jbell on DSKJLSW7X2PROD with RULES J. Preemption Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that where a consumer product safety standard is in effect and applies to a product, no state or political subdivision of a state may either establish or continue in effect a requirement dealing with the same risk of injury unless the state requirement is identical to the federal standard. Section 26(c) of the CPSA also provides that states or political subdivisions of states may apply to the CPSC for an exemption from this preemption under certain circumstances. Section 104(b) of the CPSIA deems rules issued there under ‘‘consumer product safety rules.’’ Therefore, once a rule issued under section 104 of the CPSIA takes effect, it VerDate Sep<11>2014 16:27 Mar 31, 2020 Jkt 250001 L. The Congressional Review Act The Congressional Review Act (CRA; 5 U.S.C. 801–808) states that, before a rule may take effect, the agency issuing the rule must submit the rule, and certain related information, to each House of Congress and the Comptroller General. 5 U.S.C. 801(a)(1). The submission must indicate whether the rule is a ‘‘major rule.’’ The CRA states that the Office of Information and Regulatory Affairs (OIRA) determines whether a rule qualifies as a ‘‘major rule.’’ Pursuant to the CRA, this rule does not qualify as a ‘‘major rule,’’ as defined in 5 U.S.C. 804(2). To comply with the CRA, the Office of the General Counsel will submit the required information to each House of Congress and the Comptroller General. List of Subjects in 16 CFR Part 1232 Consumer protection, Imports, Incorporation by reference, Infants and children, Law enforcement, Safety, Toys. For the reasons stated above, the Commission amends Title 16 CFR chapter II as follows: PART 1232—SAFETY STANDARD FOR CHILDREN’S FOLDING CHAIRS AND STOOLS 1. Revise the authority citation for part 1232 to read as follows: ■ Authority: Sec. 104, Pub. L. 110–314, 122 Stat. 3016 (15 U.S.C. 2056a); Sec 3, Pub. L. 112–28, 125 Stat. 273. ■ 2. Revise § 1232.2 to read as follows: PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 § 1232.2 Requirements for children’s folding chairs and stools. Each children’s folding chair and stool shall comply with all applicable provisions of ASTM F2613–19, Standard Consumer Safety Specification for Children’s Chairs and Stools, approved on November 1, 2019. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy of this ASTM standard from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428–2959 USA; phone: 610–832– 9585; www.astm.org. A read-only copy of the standard is available for viewing on the ASTM website at https:// www.astm.org/READINGLIBRARY/. You may inspect a copy at the Division of the Secretariat, U.S. Consumer Product Safety Commission, Room 820, 4330 East-West Highway, Bethesda, MD 20814, telephone 301–504–7923, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fedreg.legal@ nara.gov, or go to: www.archives.gov/ federal-register/cfr/ibr-locations.html. Alberta E. Mills, Secretary, U.S. Consumer Product Safety Commission. [FR Doc. 2020–06334 Filed 3–31–20; 8:45 am] BILLING CODE 6355–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 500, 510, 520, 522, 524, 526, 556, and 558 [Docket No. FDA–2019–N–0002] New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsors’ Name and Addresses AGENCY: Food and Drug Administration, HHS. Final rule; technical amendments. ACTION: The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2019. FDA is informing the public of the availability SUMMARY: E:\FR\FM\01APR1.SGM 01APR1 Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy of the regulations. DATES: This rule is effective March 30, 2020. 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: I. Approval Actions FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during October, November, and December 2019, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the office of the Dockets 18115 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. 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-drugproducts-green-book. jbell on DSKJLSW7X2PROD with RULES TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER, NOVEMBER, AND DECEMBER 2019 Approval date File No. Sponsor Product name Species Effect of the action October 11, 2019. 200–652 Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. Monensin and decoquinate Type B and Type C medicated feeds. Cattle .......... October 11, 2019. 200–653 Do ................................... Monensin, tylosin phosphate, and decoquinate Type B and Type C medicated feeds. Cattle .......... October 11, 2019. 200–654 Do ................................... Monensin and tilmicosin phosphate Type B and Type C medicated feeds. Cattle .......... October 11, 2019. 200–655 Do ................................... Monensin and tilmicosin phosphate Type B and Type C medicated feeds. Cattle .......... October 11, 2019. 200–656 Do ................................... Monensin, tylosin phosphate, and decoquinate Type B and Type C medicated feeds. Cattle .......... October 11, 2019. 200–658 Do ................................... Monensin and melengestrol acetate Type C medicated feeds. Cattle .......... October 11, 2019. 200–659 Do ................................... Monensin, ractopamine hydrochloride, and melengestrol acetate Type C medicated feeds. Cattle .......... October 11, 2019. 200–660 Do ................................... Monensin, tylosin phosphate, and melengestrol acetate Type C medicated feeds. Cattle .......... Original approval for use of MONOVET 90 (monensin Type A medicated article) with DECCOX (decoquinate) Type A medicated articles in the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141–148 Original approval for use of MONOVET 90 (monensin Type A medicated article) with TYLOVET (tylosin phosphate) and DECCOX (decoquinate) Type A medicated articles in the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141–149 Original approval for use of MONOVET 90 (monensin Type A medicated article) with TILMOVET (tilmicosin phosphate) Type A medicated article in the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141–343 Original approval for use of MONOVET 90 (monensin Type A medicated article) with PULMOTIL (tilmicosin phosphate) Type A medicated article in the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141–343 Original approval for use of MONOVET 90 (monensin Type A medicated article) with TYLAN (tylosin phosphate) and DECCOX (decoquinate) Type A medicated articles in the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141–149 Original approval for use of MONOVET 90 (monensin Type A medicated article) with MGA (melengestrol acetate Type A medicated article) in the manufacture of Type C medicated feeds as a generic copy of NADA 125–476 Original approval for use of MONOVET 90 (monensin Type A medicated article) with ACTOGAIN (ractopamine hydrochloride Type A medicated article) and MGA (melengestrol acetate Type A medicated articles) in the manufacture of Type C medicated feeds as a generic copy of NADA 141–234 Original approval for use of MONOVET 90 (monensin Type A medicated article) with TYLOVET (tylosin phosphate) Type A medicated article, and MGA (melengestrol acetate Type A medicated article) in the manufacture of Type C medicated feeds as a generic copy of NADA 138–870 VerDate Sep<11>2014 16:27 Mar 31, 2020 Jkt 250001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\01APR1.SGM 01APR1 Public documents FOI Summary. FOI Summary. FOI Summary. FOI Summary. FOI Summary. FOI Summary. FOI Summary. FOI Summary. 18116 Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER, NOVEMBER, AND DECEMBER 2019—Continued Approval date File No. Sponsor October 11, 2019. 200–661 Do ................................... October 11, 2019. 200–662 October 29, 2019. 200–635 November 14, 2019. 141–518 November 20, 2019. 200–663 November 25, 2019. 141–513 December 9, 2019. 141–528 December 9, 2019. 200–546 December 19, 2019. 200–615 December 30, 2019. 111–636 December 30, 2019. 008–862 December 30, 2019. 013–076 Effect of the action Monensin, tylosin phosphate, and melengestrol acetate Type C medicated feeds. Cattle .......... FOI Summary. Do ................................... Monensin and ractopamine hydrochloride Type B and Type C medicated feeds. Cattle .......... Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432. Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940. Clomipramine Hydrochloride Tablets. Dogs ........... Original approval for use of MONOVET 90 (monensin Type A medicated article) with TYLAN (tylosin phosphate) Type A medicated article, and MGA (melengestrol acetate Type A medicated article) in the manufacture of Type C medicated feeds as a generic copy of NADA 138–870 Original approval for use of MONOVET 90 (monensin Type A medicated article) with ACTOGAIN (ractopamine hydrochloride Type A medicated article) in the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141–225 Original approval as a generic copy of NADA 141–120 BRAVECTO PLUS (fluralaner and moxidectin topical solution) Solution. Cats ............ FOI Summary. Norbrook Laboratories Ltd., Station Works, County Down, Newry, BT35 6JP, UK. Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite 200, Burlingame, CA 94010. Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140. Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin, 18, EI. Vetoquinol USA, Inc., 4250 N. Sylvania Ave., Fort Worth, TX 76137. Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. Do ................................... SELARID (selamectin) Topical Solution. Dogs and cats. Original approval for the prevention of heartworm disease and for the treatment of infections with intestinal roundworm and hookworm; kills adult fleas and is indicated for the treatment and prevention of flea infestations, and the treatment and control of tick infestations for 2 months in cats and kittens Original approval as a generic copy of NADA 141–152 ZIMETA (dipyrone injection). Horses ........ Original approval for control of pyrexia in horses FOI Summary. CREDELIO CAT (lotilaner) Chewable Tablets. BIMAGARD 12.5% (tiamulin hydrogen fumarate) Liquid Concentrate for Swine. Cats ............ Original approval for killing adult fleas, and for the treatment and prevention of flea infestations for 1 month in cats and kittens Original approval as a generic copy of NADA 140–916 FOI Summary. IMOXI (imidacloprid and moxidectin) Topical Solution for Dogs. LINCOMIX (lincomycin hydrochloride) Soluble Powder. TERRAMYCIN (oxytetracycline hydrochloride) Soluble Powder. TYLAN (tylosin tartrate) Soluble. Dogs ........... Original approval as a generic copy of NADA 141–251 FOI Summary. Honeybees Supplemental approval of a tolerance for residues of lincomycin in honey FOI Summary. Honeybees Supplemental approval of a tolerance for residues of oxytetracycline in honey FOI Summary. Honeybees Supplemental approval of a tolerance for residues of tylosin in honey FOI Summary. Elanco US Inc. 2500 Innovation Way, Greenfield, IN 46140. Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Swine ......... Ireland, has requested that FDA withdraw approval of the NADAs listed in the following table because the 055–036 055–050 055–056 055–061 055–068 065–013 065–493 065–500 PRINCILLIN (ampicillin trihydrate) Capsules ................................................................................................................... PRINCILLIN (ampicillin trihydrate) Soluble Powder ......................................................................................................... PRINCILLIN (ampicillin trihydrate) Bolus ......................................................................................................................... PRINCILLIN ‘‘125’’ For Oral Suspension ......................................................................................................................... BOVICLOX (cloxacillin benzathine) .................................................................................................................................. Dihydrostreptomycin (dihydrostreptomycin sulfate) .......................................................................................................... JETPEN (penicillin G benzathine and penicillin G procaine) Aqueous Suspension ....................................................... TANDEM PEN (penicillin G procaine) .............................................................................................................................. Jkt 250001 PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 FOI Summary. FOI Summary. FOI Summary. 21 CFR section Product name 16:27 Mar 31, 2020 FOI Summary. products are no longer manufactured or marketed: File No. VerDate Sep<11>2014 Public documents Species II. Withdrawals of Approval jbell on DSKJLSW7X2PROD with RULES Product name E:\FR\FM\01APR1.SGM 01APR1 520.90c. 520.90e. 520.90f. 520.90d. 526.464b. 522.650. 522.1696a. 522.1696b. Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 055–036, 055–050, 055–056, 055–061, 055–068, 065–013, 065–493, and 065–500, and all supplements and amendments thereto, is withdrawn, effective March 30, 2020. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions. III. Changes of Sponsor Cooperative Research Farms, Box 69, Charlotteville, NY 12036, has informed FDA that it has transferred ownership of, and all rights and interest in, approved NADA 119–253 for Cattle Block M (monensin) a free-choice Type C medicated cattle feed to Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616. Following this change of sponsorship, Cooperative Research Farms is no longer the sponsor of an approved application. Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom, has informed FDA that it has transferred ownership of, and all rights and interest in, approved ANADA 200–273 for VETRO–GEN Veterinary Ophthalmic Ointment to Putney, Inc., One Monument Sq., suite 400, Portland, ME 04101. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria, has informed FDA that it has transferred ownership of, and all rights and interest in, approved NADA 141– 472 for virginiamycin and diclazuril Type C medicated feed to Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140. Accordingly, we are amending the regulations to reflect these changes. jbell on DSKJLSW7X2PROD with RULES IV. Change of Sponsors’ Name and Addresses Putney, Inc., One Monument Sq., suite 400, Portland, ME 04101, has informed FDA that it has changed its name and address to Dechra Veterinary Products LLC, 7015 College Blvd., suite 525, Overland Park, KS 66211. In addition, Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137 has informed FDA that it has changed its address to PO Box 162059, Fort Worth, TX 76161. Accordingly, we are amending § 510.600(c) (21 CFR 510.600(c)) to reflect these changes. V. Technical Amendments FDA is making the following amendments to improve the readability and accuracy of the animal drug regulations: • The contact information in 21 CFR 500.1410, which provides for the VerDate Sep<11>2014 16:27 Mar 31, 2020 Jkt 250001 incorporation by reference of the residue assay method for n-methyl-2pyrrolidone, is being updated. • We are removing entries for ‘‘Strategic Veterinary Pharmaceuticals, Inc.’’ from the lists of sponsors of approved applications in § 510.600(c) and the drug labeler code for KC Pharmacal from 21 CFR 520.260. • The indications for use of oxytetracycline soluble powder in honey bees at 21 CFR 520.1660d are amended to reflect current labeling. • The single section for euthanasia injectable solutions at 21 CFR 522.900 is being removed and separate sections for the active pharmaceutical ingredients are added at 21 CFR 522.1697 and 522.2092. • The section heading in 21 CFR 524.1742 for ‘‘N-(Mercaptomethyl) phthalimide S-(O,O-dimethyl phosphorodithioate) emulsifiable liquid’’ is amended to read ‘‘Phosmet emulsifiable liquid’’. • The entries in 21 CFR parts 556 and 558 for coumaphos for which approval of the last approved application was withdrawn in 2018 (83 FR 48940, September 28, 2018) are being removed. • The entries in part 556 (21 CFR part 556) are being removed for tolerances of residues of erythromycin in swine tissues, of virginiamycin in turkey tissues, and of new animal drugs for which approval of their applications has been withdrawn. • Cross-references to related approved uses of new animal drugs in part 556 and to related tolerances for drugs approved for use in foodproducing animals in 21 CFR parts 520, 522, 524, and 558 are being corrected. • A redundant cross-reference for related tolerances in 21 CFR 558.355 for use of monensin in medicated feeds is being removed and reserved. • The acceptable daily intake of total residues of ivermectin and tolerances for residues of ivermectin in cattle liver and muscle in § 556.344 are being corrected. • The acceptable daily intake of total residues of tildipirosin in § 556.733 is being corrected. • The regulations in 21 CFR 520.2260b for sulfamethazine sustainedrelease boluses and in 21 CFR 522.1662a for oxytetracycline hydrochloride injection are being reformatted to present the tolerance cross-reference in a consistent location. • Typographical errors are being corrected wherever they have been found. VI. Legal Authority This final rule is issued under section 512(i) of the Federal Food, Drug, and PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 18117 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 500 Animal drugs, Animal feeds, Cancer, Incorporation by reference, Labeling, Packaging and containers, Polychlorinated biphenyls (PCBs). 21 CFR Parts 520, 522, 524, and 526 Animal drugs. 21 CFR Part 556 Animal drugs, Food. 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 500, 510, 520, 522, 524, 526, 556, and 558 are amended as follows: PART 500—GENERAL 1. The authority citation for part 500 continues to read as follows: ■ Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 360b, 371, 379e. 2. In § 500.1410, revise paragraph (a) to read as follows: ■ § 500.1410 N-methyl-2-pyrrolidone. (a) Standard for residues. No residues of n-methyl-2-pyrrolidone may be found in the uncooked edible tissues of cattle as determined by a method entitled ‘‘Method of Analysis: N-methyl-2- E:\FR\FM\01APR1.SGM 01APR1 18118 Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations pyrrolidone,’’ September 26, 2011, Center for Veterinary Medicine, Food and Drug Administration, which is incorporated by reference with the approval of the Director of the Federal Register under 5 U.S.C. 522(a) and 1 CFR part 51. To obtain a copy of the analytical method, please submit a Freedom of Information request to: https://www.accessdata.fda.gov/scripts/ foi/FOIRequest/requestinfo.cfm; or go to: https://www.fda.gov/about-fda/ center-veterinary-medicine/cvm-foiaelectronic-reading-room. You may inspect a copy at the office of the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 301–827–6860, between 9 a.m. and 4 p.m., Monday through Friday or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fedreg.legal@ nara.gov, or go to: www.archives.gov/ federal-register/cfr/ibr-locations.html. * * * * * PART 510—NEW ANIMAL DRUGS 3. The authority citation for part 510 continues to read as follows: ■ Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 4. In § 510.600: a. In the table in paragraph (c)(1): i. Remove the entry for ‘‘Cooperative Research Farms’’; ■ ii. Add entries for ‘‘Dechra Veterinary Products LLC’’ and ‘‘Mizner Bioscience LLC’’ in alphabetical order; ■ iii. Remove the entries for ‘‘Putney, Inc.’’ and ‘‘Strategic Veterinary Pharmaceuticals, Inc.’’; ■ ■ ■ iv. Revise the entry for ‘‘Virbac AH, Inc.’’; and ■ v. Add an entry for ‘‘Wildcat Feeds’’ in alphabetical order; and ■ b. In the table in paragraph (c)(2): ■ i. Revise the entry for ‘‘026637’’; ■ ii. Remove the entry for ‘‘051267’’; ■ iii. Revise the entry for ‘‘051311’’; ■ iv. Remove the entry for ‘‘054628’’; and ■ v. Add entries for ‘‘086039’’ and ‘‘086113’’ in numerical order. 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 * * * * * * Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211 ........................................................... * * * * * * * Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432 ............................................................................ * * * * * * * Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161 ................................................................................................................... * * * * * * * Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616 ..................................................................................................................... * * * * * * * 026637 086039 051311 086113 * (2) * * * Drug labeler code Firm name and address * * 026637 ............................................ * * * * Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211. * * * 051311 ............................................ * * * Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161. * * * 086039 ............................................ * * * * Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432. * * * 086113 ............................................ * * * Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616. * * * * * * * jbell on DSKJLSW7X2PROD with RULES PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 5. The authority citation for part 520 continues to read as follows: ■ Authority: 21 U.S.C. 360b. * § 520.88c * § § 520.90d and 520.90e [Amended] 6. In § 520.88c(c), remove ‘‘§ 556.510’’ and in its place add ‘‘§ 556.38’’. ■ § § 520.90b and 520.90c [Redesignated as §§ 520.90a and 520.90b] 7. Redesignate §§ 520.90b and 520.90c as §§ 520.90a and 520.90b. ■ VerDate Sep<11>2014 16:27 Mar 31, 2020 Jkt 250001 PO 00000 Frm 00014 Fmt 4700 * Sfmt 4700 ■ [Removed] 8. Remove §§ 520.90d and 520.90e. § 520.90f [Redesignated as § 520.90c and Amended] 9. Redesignate § 520.90f as § 520.90c and in newly redesignated § 520.90c, revise paragraphs (b) and (d) to read as follows: ■ E:\FR\FM\01APR1.SGM 01APR1 Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations § 520.90c Ampicillin boluses. * * * * * (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. * * * * * (d) Conditions of use in nonruminating calves—(1) Amount. 5 milligrams per pound of body weight twice daily not to exceed 4 days. (2) Indications for use. Oral treatment of bacterial enteritis (colibacillosis) caused by E. coli. (3) Limitations. Treated calves must not be slaughtered for food during treatment and for 7 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. § 520.260 [Amended] 10. In § 520.260(b)(2), remove ‘‘No. 038782 for 884 or 1,768 milligram or 4.42 gram capsules;’’. ■ § 520.455 [Amended] 11. In § 520.455(b), remove ‘‘No. 058198’’ and in its place add ‘‘Nos. 058198 and 086039’’. ■ § 520.1660d Oxytetracycline powder. * * * * * (d) * * * (2) * * * (ii) Indications for use. For control of American foulbrood caused by Paenibacillus larvae. * * * * * § § 520.1696b, 520.1696c, and 520.1696d [Redesignated as §§ 520.1696a, 520.1696b, and 520.1696c] 12. Redesignate §§ 520.903d and 520.903e as §§ 520.903c and 520.903d. 16. Redesignate §§ 520.1696b, 520.1696c, and 520.1696d as §§ 520.1696a, 520.1696b, and 520.1696c. § 520.1263c § 520.2218 § § 520.903d and 520.903e [Redesignated as §§ 520.903c and 520.903d] ■ [Redesignated as § 520.1263b] ■ ■ § 520.1286 § 520.2260b Lotilaner. (a) Specifications. Each chewable tablet contains: (1) For use in dogs: 56.25, 112.5, 225, 450, or 900 milligrams (mg) lotilaner; or (2) For use in cats: 12 or 48 mg lotilaner. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. Administer orally once a month at the recommended minimum dosage of 9 mg/lb (20 mg/kg). (ii) Indications for use. Kills adult fleas, and for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations (Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick)) for 1 month in dogs and puppies 8 weeks of age or older and weighing 4.4 pounds or greater. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. VerDate Sep<11>2014 16:27 Mar 31, 2020 Jkt 250001 [Amended] 17. In § 520.2218(c), remove ‘‘§§ 556.670 and 556.685’’ and in its place add ‘‘§§ 556.660, 556.670, and 556.685’’. 13. Redesignate § 520.1263c as § 520.1263b. ■ 14. Revise § 520.1286 to read as follows: ■ jbell on DSKJLSW7X2PROD with RULES (2) Cats—(i) Amount. Administer orally once a month at the recommended minimum dosage of 2.7 mg/lb (6 mg/kg). (ii) Indications for use. Kills adult fleas, and for the treatment and prevention of flea infestations (Ctenocephalides felis) for 1 month in cats and kittens 8 weeks of age or older and weighing 2 pounds or greater. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. ■ 15. In § 520.1660d, revise paragraph (d)(2)(ii) to read as follows: [Amended] 18. In § 520.2260b, redesignate paragraphs (a) through (f) and (g) as paragraphs (b) through (g) and (a), respectively. ■ 19. In § 520.2455, add paragraph (b)(4) to read as follows: ■ § 520.2455 Tiamulin. * * * * * (b) * * * (4) No. 061133 for product described in paragraph (a)(2) of this section. * * * * * PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 20. The authority citation for part 522 continues to read as follows: ■ Authority: 21 U.S.C. 360b. 21. In § 522.650, revise paragraph (b) to read as follows: ■ § 522.650 Dihydrostreptomycin sulfate injection. * PO 00000 * * Frm 00015 * Fmt 4700 * Sfmt 4700 18119 (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. * * * * * ■ 22. Add § 522.728 to read as follows: § 522.728 Dipyrone. (a) Specifications. Each milliliter of solution contains 500 milligrams (mg) dipyrone. (b) Sponsor. See No. 086078 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Administer 30 mg per kilogram of body weight (13.6 mg per pound) by intravenous injection, once or twice daily at a 12-hour interval for up to 3 days. (2) Indications for use. For control of pyrexia in horses. (3) Limitations. Do not use in horses intended for human consumption. Do not use in any food-producing animals, including lactating dairy animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian. § 522.900 ■ [Removed] 23. Remove § 522.900. § 522.1367 [Amended] 24. In § 522.1367(c)(1)(i), remove ‘‘§ 520.1350(c)’’ and in its place add ‘‘§ 520.1367(c)’’. ■ § 522.1662a [Amended] 25. In § 522.1662a: a. Redesignate paragraphs (a) through (e) as paragraphs (b) through (f); ■ b. Further redesignate newly redesignated paragraphs (c)(3)(i)(a) through (c) and (c)(3)(ii)(a) through (c) as paragraphs (c)(3)(i)(A) through (C) and (c)(3)(ii)(A) through (C), respectively; ■ c. Further redesignate newly redesignated paragraphs (e)(3)(i)(a) through (c) as paragraphs (e)(3)(i)(A) through (C); ■ d. Further redesignate newly redesignated paragraphs (e)(3)(ii)(a) and (b) and paragraphs (e)(3)(ii)(A) and (B); ■ e. Further redesignate newly redesignated paragraphs (e)(3)(iii)(a) through (c) as paragraphs (e)(3)(iii)(A) through (C); ■ f. In newly redesignated paragraph (e)(3)(iii)(C), remove ‘‘paragraph (d)(3)(iii)(c) of this section’’ and in its place add ‘‘this paragraph (e)(3)(iii)(C)’’; ■ g. Further redesignate newly redesignated paragraphs (f)(3)(i)(a) through (c) and (f)(3)(ii)(a) through (c) as paragraphs (f)(3)(i)(A) through (C) and (f)(3)(ii)(A) through (C), respectively; ■ h. Redesignate paragraphs (g)(3)(i)(a) through (c) and (g)(3)(ii)(a) through (c) as paragraphs (g)(3)(i)(A) through (C) ■ ■ E:\FR\FM\01APR1.SGM 01APR1 18120 Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations and (g)(3)(ii)(A) through (C), respectively; and ■ i. Redesignate paragraph (k) as paragraph (j) and paragraph (l) as paragraph (a). § 522.1696a [Amended] 26. In § 522.1696a(b)(1) and (2) and (d)(2)(iii), remove ‘‘, 055529,’’. ■ § 522.1696b [Amended] 27. In § 522.1696b: a. In paragraph (b)(1), remove ‘‘016592, 054771, and 055529’’ and in its place add ‘‘016592 and 054771’’; ■ b. Remove paragraphs (d)(2)(i)(A) and (B); and ■ c. In paragraph (d)(2)(iii)(B), remove ‘‘Nos. 000859 and 055529’’ and in its place add ‘‘No. 016592’’. ■ 28. Add § 522.1697 to read as follows: ■ ■ § 522.1697 jbell on DSKJLSW7X2PROD with RULES Secobarbital and dibucaine. (a) Specifications. Each milliliter (mL) of solution contains 400 milligram (mg) secobarbital sodium and 25 mg dibucaine hydrochloride. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Special considerations. Product labeling shall bear the following warning statements: ‘‘ENVIRONMENTAL HAZARD: This product is toxic to wildlife. Birds and mammals feeding on treated animals may be killed. Euthanized animals must be properly disposed of by deep burial, VerDate Sep<11>2014 16:27 Mar 31, 2020 Jkt 250001 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. Pentobarbital and phenytoin. (a) Specifications. Each milliliter (mL) of solution contains 390 milligrams (mg) pentobarbital sodium and 50 mg phenytoin sodium. (b) Sponsors. See Nos. 000061, 051311, and 054925 in § 510.600(c) of this chapter. (c) Special considerations. Product labeling shall bear the following warning statements: ‘‘ENVIRONMENTAL HAZARD: This product is toxic to wildlife. Birds and mammals feeding on treated animals may be killed. Euthanized animals must be properly disposed of by deep burial, incineration, or other method in compliance with State and local laws, to prevent consumption of carcass material by scavenging wildlife.’’ (d) Conditions of use in dogs—(1) Amount. Administer 1 mL per 10 pounds of body weight as a single, bolus intravenous or intracardiac injection. (2) Indications for use. For humane, painless, and rapid euthanasia. (3) Limitations. Do not use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. ■ 29. Add § 522.2092 to read as follows: § 522.2092 incineration, or other method in compliance with State and local laws, to prevent consumption of carcass material by scavenging wildlife.’’ (d) Conditions of use in dogs—(1) Amount. Administer 1 mL per 10 pounds of body weight as a single, bolus intravenous injection. (2) Indications for use. For humane, painless, and rapid euthanasia. (3) Limitations. Do not use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 31. Add an undesignated center heading before § 524.981 to read as follows: ■ Fluocinolone Topical and Otic Dosage Forms ■ 32. Add § 524.1001 to read as follows: § 524.1001 Furalaner and moxidectin. (a) Specifications. Each milliliter of solution contains 280 milligram (mg) furalaner and 14 mg moxidectin. Each individually packaged tube contains either 112.5 mg furalaner and 5.6 mg moxidectin; 250 mg furalaner and 12.5 mg moxidectin; or 500 mg furalaner and 25 mg moxidectin. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Administer topically as a single dose every 2 months to provide a minimum dose of 18.2 mg/lb (40 mg/kg) fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin. (2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati, 4th stage larvae, immature adults, and adults) and hookworm (Ancylostoma tubaeforme, 4th stage larvae, immature adults, and adults); kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations (Ixodes scapularis (blacklegged tick) and Dermacentor variabilis (American dog tick)) for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. ■ 33. In § 524.1146, revise paragraphs (a) and (b) to read as follows: PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 § 524.1146 Imidacloprid and moxidectin. (a) Specifications. Each milliliter of solution contains: (1) 100 milligrams (mg) imidacloprid and 25 mg moxidectin; or (2) 100 mg imidacloprid and 10 mg moxidectin. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter as follows: (1) Nos. 000859 and 017030 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section. (2) No. 000859 for use of product described in paragraph (a)(2) of this section as in paragraphs (d)(2) and (3) of this section. * * * * * ■ 34. In § 524.1742: ■ a. Revise the section heading; ■ b. Redesignate paragraphs (c) and (d) as paragraphs (d) and (c), respectively; ■ c. Add a heading for the table in newly redesignated paragraph (d)(1) introductory text; and ■ d. Further redesignate newly redesignated paragraphs (d)(1)(i)(a) and (b) as paragraphs (d)(1)(i)(A) and (B). The revision and addition reads as follows: § 524.1742 Phosmet emulsifiable liquid. * * * * * (d) * * * (1) * * * Table 1 to Paragraph (d)(1) * * * * * § 524.2098 [Amended] 35. In § 524.2098(b), remove ‘‘054771’’ and in its place add ‘‘Nos. 054771 and 055529’’. ■ PART 526—INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS 36. The authority citation for part 526 continues to read as follows: ■ Authority: 21 U.S.C. 360b. § 526.464b ■ [Removed] 37. Remove § 526.464b. § 526.464c [Redesignated as § 526.464b] 38. Redesignate § 526.464c as § 526.464b. ■ PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 39. The authority citation for part 556 continues to read as follows: ■ Authority: 21 U.S.C. 342, 360b, 371. § 556.40 [Amended] 40. In § 556.40(c), remove ‘‘§§ 520.90e, 520.90f, 522.90a, and 522.90b’’ and in ■ E:\FR\FM\01APR1.SGM 01APR1 Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations * § 556.165 § 556.510 [Amended] 41. In § 556.165(c), remove ‘‘§§ 526.464a, 526.464b, and 526.464c’’ and in its place add ‘‘§§ 526.464a and 526.464b’’. ■ § 556.168 ■ ■ ■ [Removed] [Amended] [Amended] 44. In § 556.304(c), remove ‘‘§§ 522.1077, 522.1079, and 522.1081’’ and in its place add ‘‘§§ 522.1079 and 522.1081’’. [Amended] 45. In § 556.344: a. In paragraph (a), remove ‘‘1 mg/kg’’ and in its place add ‘‘5 mg/kg’’; ■ b. In paragraph (b)(2)(i), remove ‘‘100 ppb’’ and in its place add ‘‘1.6 ppm’’; and ■ c. In paragraph (b)(2)(ii), remove ‘‘10 ppb’’ and in its place add ‘‘650 ppb’’. ■ 46. In § 556.360, add paragraph (b)(3) and revise paragraph (c) to read as follows: ■ ■ § 556.360 * * * * (b) * * * (3) Honey. 750 ppb. (c) Related conditions of use. See §§ 520.1263b, 522.1260, and 558.325 of this chapter. ■ 47. In § 556.500, add paragraph (b)(6) to read as follows: * Oxytetracycline. * * (b) * * * VerDate Sep<11>2014 * Jkt 250001 PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 56. The authority citation for part 558 continues to read as follows: ■ Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc–1, 371. 57. In § 558.55, add paragraph (d)(5) to read as follows: ■ § 558.55 Amprolium. 51. In § 556.685(c), remove ‘‘§§ 520.2325a, 520.2325b, and 558.586’’ and in its place add ‘‘§§ 520.2218, 520.2325a, 520.2325b, and 558.586’’. § 556.733 § 558.76 § 556.685 [Amended] ■ [Amended] 52. In § 556.733(a), remove ‘‘10 mg/kg’’ and in its place add ‘‘50 mg/kg’’. ■ 53. In § 556.746, add paragraph (b)(4) to read as follows: ■ Tylosin. * * * * * (b) * * * (4) Honey. 500 ppb. * * * * * § 556.750 PO 00000 Zilpaterol. * Frm 00017 * Fmt 4700 * Sfmt 4700 Bacitracin methylenedisalicylate. * * * * * (e) * * * (2) * * * (vii) Fenbendazole as in § 558.258. (viii) Halofuginone as in § 558.265. * * * * * (xi) Monensin as in § 558.355. * * * * * ■ 54. In § 556.750, remove paragraph (b)(4). ■ 55. In § 556.765, revise paragraph (b)(1) to read as follows: * * § 558.185 [Amended] ■ * 16:27 Mar 31, 2020 (b) * * * (1) Cattle. (i) Liver (target tissue): 12 ppb. (ii) Muscle: 10 ppb. * * * * * * * * * (d) * * * (5) Permitted combinations. Amprolium may also be used in combination with: (i) Virginiamycin as in § 558.635. (ii) [Reserved] ■ 58. In § 558.76, revise paragraphs (e)(2)(vii), (viii), and (xi) to read as follows: § 556.765 * [Amended] 50. In § 556.670, in paragraph (c), remove ‘‘§§ 520.2260a, 520.2260b, 520.2260c, 520.2261a, 520.2261b, 522.2260, 558.140, and 558.630’’ and in its place add ‘‘§§ 520.2218, 520.2260a, 520.2260b, 520.2260c, 520.2261a, 520.2261b, 522.2260, 558.140, and 558.630’’. § 556.746 Lincomycin. * § 556.500 [Amended] ■ ■ § 556.344 § 556.660 § 556.670 43. In § 556.230, remove paragraph (b)(3). ■ § 556.304 [Amended] 48. In § 556.510(c), remove ‘‘520.1696b’’ and in its place add ‘‘520.1696a’’. 49. In § 556.660(c), remove ‘‘§ 558.582’’ and in its place add ‘‘§§ 520.2218 and 558.582’’. 42. Remove § 556.168. § 556.230 jbell on DSKJLSW7X2PROD with RULES (6) Honey. 750 ppb. * * * * its place add ‘‘§§ 520.90c, 522.90a, and 522.90b’’. 18121 [Removed] 59. Remove § 558.185. 60. In § 558.195, revise paragraph (e)(2)(ii) to read as follows: ■ § 558.195 * Decoquinate. * * (e) * * * (2) * * * E:\FR\FM\01APR1.SGM 01APR1 * * 18122 Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations Decoquinate in grams/ton Combination in grams/ton Indications for use Limitations (ii) 12.9 to 90.8 .. * * Monensin, 5 to 30 ....... * * Cattle fed in confinement for slaughter: For prevention of coccidiosis caused by Eimeria bovis and E. zuernii; and for improved feed efficiency. * * Feed continuously as the sole ration to provide 22.7 mg of decoquinate per 100 lb of body weight per day and 50 to 360 mg of monensin per head per day. Feed at least 28 days during period of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to animals producing milk for food. Do not feed to lactating dairy cattle. Also see paragraph (d)(1) of this section and § 558.355(d)(9)(i). Monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter. * * * * § 558.342 ■ * * * * * 61. In § 558.342, revise paragraph (e)(1)(iv) to read as follows: * * Melengestrol. * * (e) * * * * (1) * * * * Combination in grams/ton Indications for use Limitations (iv) 0.25 to 0.5 ... * * Monensin, 10 to 40 ..... * * Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat); and for the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii.. * * Add at the rate of 0.5 to 2 lb/head/day a medicated feed (liquid or dry) containing 0.125 to 1 mg melengestrol acetate/lb to a feed containing 10 to 40 g of monensin per ton to provide 0.25 to 0.5 mg melengestrol acetate/ head/day and 0.14 to 0.42 mg monensin/lb body weight, depending on severity of coccidiosis challenge, up to 480 mg monensin/ head/day. See § 558.355(d). Monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter. * * * § 558.355 ■ * * * * * 62. In § 558.355, remove and reserve paragraph (e) and revise paragraph (f)(4)(iv) to read as follows: Monensin amount * (iv) 400 mg per pound of block (0.088%). * * * * * * Limitations * * Pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers): For increased rate of weight gain. * * * Provide 50 to 200 mg of monensin (2 to 8 ounces of block) per head per day, at least 1 block per 5 head of cattle. Feed blocks continuously. Do not feed salt or mineral supplements in addition to the blocks. Ingestion by cattle of monensin at levels of 600 mg per head per day and higher has been fatal. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section. * * § 558.500 ■ * * * * * 63. In § 558.500, revise paragraph (e)(2) to read as follows: 16:27 Mar 31, 2020 Jkt 250001 Frm 00018 * Fmt 4700 Sponsor * Ractopamine. * * (e) * * * PO 00000 * 016592, 054771, 058198 Monensin. * * (f) * * * (4) * * * * VerDate Sep<11>2014 * Sponsor Indications for use * * 016592, 054771. * Melengestrol acetate in mg/ head/day * jbell on DSKJLSW7X2PROD with RULES * Sponsor * (2) Cattle. * Sfmt 4700 E:\FR\FM\01APR1.SGM 01APR1 * 086113 * Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations Ractopamine in grams/ton Combination in grams/ton Indications for use Limitations (i) 8.2 to 24.6 ..... ..................................... Feed continuously as sole ration during the last 28 to 42 days on feed. 054771 058198 (ii) 8.2 to 24.6 ..... Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day.. ..................................... Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feed. Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feed, and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii. Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness during the last 28 to 42 days on feed. Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness during the last 28 to 42 days on feed, and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii. Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness during the last 28 to 42 days on feed, and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and for suppression of estrus (heat). Feed continuously as sole ration during the last 28 to 42 days on feed. See paragraph § 558.355(d). Ractopamine as provided by No. 058198 or 054771; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter. 016592 054771 058198 Feed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding. 054771 058198 Feed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding. See paragraph § 558.355(d). Ractopamine as provided by No. 058198 or 054771; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter. 016592 054771 058198 Feed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding. See §§ 558.342(d) and 558.355(d). Melengestrol acetate as provided by No. 058198 or 054771; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter. 016592 054771 058198 Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feed. Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feed, and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii. Top dress in a minimum of 1 lb of medicated feed. 054771 058198 Top dress ractopamine in a minimum of 1 lb of medicated feed during the last 28 to 42 days on feed. Not for animals intended for breeding. See § 558.355(d). Ractopamine as provided by No. 058198 or 054771; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter. 016592 054771 058198 (iii) 9.8 to 24.6 .... (iv) 9.8 to 24.6 .... Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day. (v) 9.8 to 24.6 .... Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus melengestrol acetate to provide 0.25 to 0.5 mg/head/day. ..................................... (vi) Not to exceed 800; to provide 70 to 400 mg/ head/day. (vii) Not to exceed 800; to provide 70 to 400 mg/head/ day. Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day. * § 558.618 ■ * * * * * 64. In § 558.618, revise paragraphs (e)(2)(ii) and (iii) to read as follows: jbell on DSKJLSW7X2PROD with RULES 18123 VerDate Sep<11>2014 17:01 Mar 31, 2020 Jkt 250001 Tilmicosin. * * (e) * * * PO 00000 Frm 00019 * Fmt 4700 (2) * * * * Sfmt 4700 E:\FR\FM\01APR1.SGM 01APR1 Sponsor 18124 Tilmicosin phosphate in grams/ton Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations Combination in grams/ton Indications for use Limitations * (ii) 568 to 757 * Monensin, 5 to 40 ....... * * Cattle fed in confinement for slaughter: For improved feed efficiency; and for the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10 percent of the animals in the group. (iii) 568 to 757 Monensin, 10 to 40 ..... Cattle fed in confinement for slaughter: For prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for the control of BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10 percent of the animals in the group. * * Feed continuously for 14 days to provide 12.5 mg tilmicosin/kg of bodyweight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. See § 558.355(d). Tilmicosin as provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter. Feed continuously for 14 days to provide 12.5 mg tilmicosin/kg of bodyweight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. See § 558.355(d). Tilmicosin as provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter. § 558.625 65. In § 558.625, revise paragraphs (e)(2)(vi) and (ix) to read as follows: jbell on DSKJLSW7X2PROD with RULES ■ * * Tylosin. * * Combination in grams/ton Indications for use Limitations * (vi) 8 to 10 .. * Monensin, 5 to 30 plus decoquinate, 13.6 to 22.7. * * Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for the prevention of coccidiosis caused by Eimeria bovis and E. zuernii; and for improved feed efficiency. * * Feed continuously as the sole ration to provide 22.7 mg of decoquinate per 100 lb body weight per day, 50 to 360 mg of monensin/ head/day, and 60 to 90 mg of tylosin/head/ day. Feed at least 28 days during period of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to animals producing milk for food. Do not feed to lactating dairy cattle. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin as provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; decoquinate as provided by No. 058198 in § 510.600(c) of this chapter. See §§ 558.311(d) and 558.355(d). 16:27 Mar 31, 2020 Jkt 250001 PO 00000 Frm 00020 Fmt 4700 * 016592 058198 016592 058198 (e) * * * (2) * * * * Tylosin grams/ton VerDate Sep<11>2014 Sponsor Sfmt 4700 E:\FR\FM\01APR1.SGM 01APR1 Sponsor * 016592 054771 18125 Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations Tylosin grams/ton Combination in grams/ton * (ix) 8 to 10 .. * Monensin, 10 to 40 plus melengestrol, 0.25 to 2.0. * Indications for use Limitations * * Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii; and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). * * Feed continuously as sole ration to heifers at a rate of 0.5 to 2 pounds per head per day to provide 0.25 to 0.5 mg/head/day melengestrol acetate and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/ head/day tylosin. The melengestrol acetate portion of this Type C medicated feed must be mixed into the complete feed containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin at feeding into the amount of complete feed consumed by an animal per day. A withdrawal time has not been established for preruminating calves. Do not use in calves to be processed for veal. Tylosin provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; melengestrol provided by No. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.342(d) and 558.355(d). * * § 558.635 66. In § 558.635, revise paragraph (e)(1)(iv) to read as follows: ■ * * * Virginiamycin. * * * Combination in grams/ton Indications for use Limitations * (iv) 20 ................. * Diclazuril, 0.91 ........... * * Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin; and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima late in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesions scores and improve performance and health of birds challenged with E. maxima. * * Feed continuously as the sole ration. Do not use in hens producing eggs for human food. Diclazuril as provided by No. 058198 in § 510.600(c) of this chapter. * * * * * * * Dated: March 25, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. * * DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 CFR Parts 520, 522, and 526 BILLING CODE 4164–01–P [Docket No. FDA–2019–N–0002] New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications AGENCY: Food and Drug Administration, HHS. 16:27 Mar 31, 2020 Jkt 250001 016592 054771 058198 * Sponsor * ACTION: * 058198 * Notification of withdrawal. The Food and Drug Administration (FDA) is withdrawing approval of eight new animal drug applications (NADAs) at the sponsor’s request because the products are no longer manufactured or marketed. SUMMARY: Food and Drug Administration [FR Doc. 2020–06688 Filed 3–30–20; 8:45 am] VerDate Sep<11>2014 * (e) * * * (1) * * * * Virginiamycin grams/ton * jbell on DSKJLSW7X2PROD with RULES * Sponsor PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 Withdrawal of approval is effective March 30, 2020 DATES: FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary Medicine (HFV–212), Food and Drug E:\FR\FM\01APR1.SGM 01APR1

Agencies

[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Rules and Regulations]
[Pages 18114-18125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06688]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 500, 510, 520, 522, 524, 526, 556, and 558

[Docket No. FDA-2019-N-0002]


New Animal Drugs; Approval of New Animal Drug Applications; 
Withdrawal of Approval of New Animal Drug Applications; Change of 
Sponsor; Change of Sponsors' Name and Addresses

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
animal drug regulations to reflect application-related actions for new 
animal drug applications (NADAs) and abbreviated new animal drug 
applications (ANADAs) during October, November, and December 2019. FDA 
is informing the public of the availability

[[Page 18115]]

of summaries of the basis of approval and of environmental review 
documents, where applicable. The animal drug regulations are also being 
amended to make technical amendments to improve the accuracy of the 
regulations.

DATES: This rule is effective March 30, 2020.

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. Approval Actions

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during October, November, and December 
2019, as listed in table 1. In addition, FDA is informing the public of 
the availability, where applicable, of documentation of environmental 
review required under the National Environmental Policy Act (NEPA) and, 
for actions requiring review of safety or effectiveness data, summaries 
of the basis of approval (FOI Summaries) under the Freedom of 
Information Act (FOIA). These public documents may be seen in the 
office of the Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday. 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.

                        Table 1--Original and Supplemental NADAs and ANADAs Approved During October, November, and December 2019
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Approval date       File No.         Sponsor             Product name            Species            Effect of the action         Public  documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
October 11, 2019.....    200-652  Huvepharma EOOD, 5th   Monensin and          Cattle............  Original approval for use of    FOI Summary.
                                   Floor, 3A Nikolay      decoquinate Type B                        MONOVET 90 (monensin Type A
                                   Haytov Str., 1113      and Type C                                medicated article) with
                                   Sophia, Bulgaria.      medicated feeds.                          DECCOX (decoquinate) Type A
                                                                                                    medicated articles in the
                                                                                                    manufacture of Type B and
                                                                                                    Type C medicated feeds as a
                                                                                                    generic copy of NADA 141-148
October 11, 2019.....    200-653  Do...................  Monensin, tylosin     Cattle............  Original approval for use of    FOI Summary.
                                                          phosphate, and                            MONOVET 90 (monensin Type A
                                                          decoquinate Type B                        medicated article) with
                                                          and Type C                                TYLOVET (tylosin phosphate)
                                                          medicated feeds.                          and DECCOX (decoquinate) Type
                                                                                                    A medicated articles in the
                                                                                                    manufacture of Type B and
                                                                                                    Type C medicated feeds as a
                                                                                                    generic copy of NADA 141-149
October 11, 2019.....    200-654  Do...................  Monensin and          Cattle............  Original approval for use of    FOI Summary.
                                                          tilmicosin                                MONOVET 90 (monensin Type A
                                                          phosphate Type B                          medicated article) with
                                                          and Type C                                TILMOVET (tilmicosin
                                                          medicated feeds.                          phosphate) Type A medicated
                                                                                                    article in the manufacture of
                                                                                                    Type B and Type C medicated
                                                                                                    feeds as a generic copy of
                                                                                                    NADA 141-343
October 11, 2019.....    200-655  Do...................  Monensin and          Cattle............  Original approval for use of    FOI Summary.
                                                          tilmicosin                                MONOVET 90 (monensin Type A
                                                          phosphate Type B                          medicated article) with
                                                          and Type C                                PULMOTIL (tilmicosin
                                                          medicated feeds.                          phosphate) Type A medicated
                                                                                                    article in the manufacture of
                                                                                                    Type B and Type C medicated
                                                                                                    feeds as a generic copy of
                                                                                                    NADA 141-343
October 11, 2019.....    200-656  Do...................  Monensin, tylosin     Cattle............  Original approval for use of    FOI Summary.
                                                          phosphate, and                            MONOVET 90 (monensin Type A
                                                          decoquinate Type B                        medicated article) with TYLAN
                                                          and Type C                                (tylosin phosphate) and
                                                          medicated feeds.                          DECCOX (decoquinate) Type A
                                                                                                    medicated articles in the
                                                                                                    manufacture of Type B and
                                                                                                    Type C medicated feeds as a
                                                                                                    generic copy of NADA 141-149
October 11, 2019.....    200-658  Do...................  Monensin and          Cattle............  Original approval for use of    FOI Summary.
                                                          melengestrol                              MONOVET 90 (monensin Type A
                                                          acetate Type C                            medicated article) with MGA
                                                          medicated feeds.                          (melengestrol acetate Type A
                                                                                                    medicated article) in the
                                                                                                    manufacture of Type C
                                                                                                    medicated feeds as a generic
                                                                                                    copy of NADA 125-476
October 11, 2019.....    200-659  Do...................  Monensin,             Cattle............  Original approval for use of    FOI Summary.
                                                          ractopamine                               MONOVET 90 (monensin Type A
                                                          hydrochloride, and                        medicated article) with
                                                          melengestrol                              ACTOGAIN (ractopamine
                                                          acetate Type C                            hydrochloride Type A
                                                          medicated feeds.                          medicated article) and MGA
                                                                                                    (melengestrol acetate Type A
                                                                                                    medicated articles) in the
                                                                                                    manufacture of Type C
                                                                                                    medicated feeds as a generic
                                                                                                    copy of NADA 141-234
October 11, 2019.....    200-660  Do...................  Monensin, tylosin     Cattle............  Original approval for use of    FOI Summary.
                                                          phosphate, and                            MONOVET 90 (monensin Type A
                                                          melengestrol                              medicated article) with
                                                          acetate Type C                            TYLOVET (tylosin phosphate)
                                                          medicated feeds.                          Type A medicated article, and
                                                                                                    MGA (melengestrol acetate
                                                                                                    Type A medicated article) in
                                                                                                    the manufacture of Type C
                                                                                                    medicated feeds as a generic
                                                                                                    copy of NADA 138-870

[[Page 18116]]

 
October 11, 2019.....    200-661  Do...................  Monensin, tylosin     Cattle............  Original approval for use of    FOI Summary.
                                                          phosphate, and                            MONOVET 90 (monensin Type A
                                                          melengestrol                              medicated article) with TYLAN
                                                          acetate Type C                            (tylosin phosphate) Type A
                                                          medicated feeds.                          medicated article, and MGA
                                                                                                    (melengestrol acetate Type A
                                                                                                    medicated article) in the
                                                                                                    manufacture of Type C
                                                                                                    medicated feeds as a generic
                                                                                                    copy of NADA 138-870
October 11, 2019.....    200-662  Do...................  Monensin and          Cattle............  Original approval for use of    FOI Summary.
                                                          ractopamine                               MONOVET 90 (monensin Type A
                                                          hydrochloride Type                        medicated article) with
                                                          B and Type C                              ACTOGAIN (ractopamine
                                                          medicated feeds.                          hydrochloride Type A
                                                                                                    medicated article) in the
                                                                                                    manufacture of Type B and
                                                                                                    Type C medicated feeds as a
                                                                                                    generic copy of NADA 141-225
October 29, 2019.....    200-635  Mizner Bioscience      Clomipramine          Dogs..............  Original approval as a generic  FOI Summary.
                                   LLC, 225 NE Mizner     Hydrochloride                             copy of NADA 141-120
                                   Blvd., Suite 760,      Tablets.
                                   Boca Raton, FL 33432.
November 14, 2019....    141-518  Intervet, Inc., 2      BRAVECTO PLUS         Cats..............  Original approval for the       FOI Summary.
                                   Giralda Farms,         (fluralaner and                           prevention of heartworm
                                   Madison, NJ 07940.     moxidectin topical                        disease and for the treatment
                                                          solution) Solution.                       of infections with intestinal
                                                                                                    roundworm and hookworm; kills
                                                                                                    adult fleas and is indicated
                                                                                                    for the treatment and
                                                                                                    prevention of flea
                                                                                                    infestations, and the
                                                                                                    treatment and control of tick
                                                                                                    infestations for 2 months in
                                                                                                    cats and kittens
November 20, 2019....    200-663  Norbrook Laboratories  SELARID (selamectin)  Dogs and cats.....  Original approval as a generic  FOI Summary.
                                   Ltd., Station Works,   Topical Solution.                         copy of NADA 141-152
                                   County Down, Newry,
                                   BT35 6JP, UK.
November 25, 2019....    141-513  Kindred Biosciences,   ZIMETA (dipyrone      Horses............  Original approval for control   FOI Summary.
                                   Inc., 1555 Bayshore    injection).                               of pyrexia in horses
                                   Hwy., Suite 200,
                                   Burlingame, CA 94010.
December 9, 2019.....    141-528  Elanco US Inc., 2500   CREDELIO CAT          Cats..............  Original approval for killing   FOI Summary.
                                   Innovation Way,        (lotilaner)                               adult fleas, and for the
                                   Greenfield, IN 46140.  Chewable Tablets.                         treatment and prevention of
                                                                                                    flea infestations for 1 month
                                                                                                    in cats and kittens
December 9, 2019.....    200-546  Bimeda Animal Health   BIMAGARD 12.5%        Swine.............  Original approval as a generic  FOI Summary.
                                   Ltd., 1B The Herbert   (tiamulin hydrogen                        copy of NADA 140-916
                                   Building, The Park,    fumarate) Liquid
                                   Carrickmines,          Concentrate for
                                   Dublin, 18, EI.        Swine.
December 19, 2019....    200-615  Vetoquinol USA, Inc.,  IMOXI (imidacloprid   Dogs..............  Original approval as a generic  FOI Summary.
                                   4250 N. Sylvania       and moxidectin)                           copy of NADA 141-251
                                   Ave., Fort Worth, TX   Topical Solution
                                   76137.                 for Dogs.
December 30, 2019....    111-636  Zoetis Inc., 333       LINCOMIX (lincomycin  Honeybees.........  Supplemental approval of a      FOI Summary.
                                   Portage St.,           hydrochloride)                            tolerance for residues of
                                   Kalamazoo, MI 49007.   Soluble Powder.                           lincomycin in honey
December 30, 2019....    008-862  Do...................  TERRAMYCIN            Honeybees.........  Supplemental approval of a      FOI Summary.
                                                          (oxytetracycline                          tolerance for residues of
                                                          hydrochloride)                            oxytetracycline in honey
                                                          Soluble Powder.
December 30, 2019....    013-076  Elanco US Inc. 2500    TYLAN (tylosin        Honeybees.........  Supplemental approval of a      FOI Summary.
                                   Innovation Way,        tartrate) Soluble.                        tolerance for residues of
                                   Greenfield, IN 46140.                                            tylosin in honey
--------------------------------------------------------------------------------------------------------------------------------------------------------

II. Withdrawals of Approval

    Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, 
Northern Ireland, has requested that FDA withdraw approval of the NADAs 
listed in the following table because the products are no longer 
manufactured or marketed:

------------------------------------------------------------------------
   File No.                Product name               21 CFR  section
------------------------------------------------------------------------
055-036.......  PRINCILLIN (ampicillin             520.90c.
                 trihydrate) Capsules.
055-050.......  PRINCILLIN (ampicillin             520.90e.
                 trihydrate) Soluble Powder.
055-056.......  PRINCILLIN (ampicillin             520.90f.
                 trihydrate) Bolus.
055-061.......  PRINCILLIN ``125'' For Oral        520.90d.
                 Suspension.
055-068.......  BOVICLOX (cloxacillin benzathine)  526.464b.
065-013.......  Dihydrostreptomycin                522.650.
                 (dihydrostreptomycin sulfate).
065-493.......  JETPEN (penicillin G benzathine    522.1696a.
                 and penicillin G procaine)
                 Aqueous Suspension.
065-500.......  TANDEM PEN (penicillin G           522.1696b.
                 procaine).
------------------------------------------------------------------------


[[Page 18117]]

    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADAs 055-036, 055-050, 055-056, 055-061, 055-068, 
065-013, 065-493, and 065-500, and all supplements and amendments 
thereto, is withdrawn, effective March 30, 2020. As provided in the 
regulatory text of this document, the animal drug regulations are 
amended to reflect these actions.

III. Changes of Sponsor

    Cooperative Research Farms, Box 69, Charlotteville, NY 12036, has 
informed FDA that it has transferred ownership of, and all rights and 
interest in, approved NADA 119-253 for Cattle Block M (monensin) a 
free-choice Type C medicated cattle feed to Wildcat Feeds, 215 NE 
Strait Ave., Topeka, KS 66616. Following this change of sponsorship, 
Cooperative Research Farms is no longer the sponsor of an approved 
application.
    Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, 
North Yorkshire, BD23 2RW, United Kingdom, has informed FDA that it has 
transferred ownership of, and all rights and interest in, approved 
ANADA 200-273 for VETRO-GEN Veterinary Ophthalmic Ointment to Putney, 
Inc., One Monument Sq., suite 400, Portland, ME 04101.
    Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, 
Bulgaria, has informed FDA that it has transferred ownership of, and 
all rights and interest in, approved NADA 141-472 for virginiamycin and 
diclazuril Type C medicated feed to Elanco US Inc., 2500 Innovation 
Way, Greenfield, IN 46140.
    Accordingly, we are amending the regulations to reflect these 
changes.

IV. Change of Sponsors' Name and Addresses

    Putney, Inc., One Monument Sq., suite 400, Portland, ME 04101, has 
informed FDA that it has changed its name and address to Dechra 
Veterinary Products LLC, 7015 College Blvd., suite 525, Overland Park, 
KS 66211. In addition, Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, 
TX 76137 has informed FDA that it has changed its address to PO Box 
162059, Fort Worth, TX 76161. Accordingly, we are amending Sec.  
510.600(c) (21 CFR 510.600(c)) to reflect these changes.

V. Technical Amendments

    FDA is making the following amendments to improve the readability 
and accuracy of the animal drug regulations:
     The contact information in 21 CFR 500.1410, which provides 
for the incorporation by reference of the residue assay method for n-
methyl-2-pyrrolidone, is being updated.
     We are removing entries for ``Strategic Veterinary 
Pharmaceuticals, Inc.'' from the lists of sponsors of approved 
applications in Sec.  510.600(c) and the drug labeler code for KC 
Pharmacal from 21 CFR 520.260.
     The indications for use of oxytetracycline soluble powder 
in honey bees at 21 CFR 520.1660d are amended to reflect current 
labeling.
     The single section for euthanasia injectable solutions at 
21 CFR 522.900 is being removed and separate sections for the active 
pharmaceutical ingredients are added at 21 CFR 522.1697 and 522.2092.
     The section heading in 21 CFR 524.1742 for ``N-
(Mercaptomethyl) phthalimide S-(O,O-dimethyl phosphorodithioate) 
emulsifiable liquid'' is amended to read ``Phosmet emulsifiable 
liquid''.
     The entries in 21 CFR parts 556 and 558 for coumaphos for 
which approval of the last approved application was withdrawn in 2018 
(83 FR 48940, September 28, 2018) are being removed.
     The entries in part 556 (21 CFR part 556) are being 
removed for tolerances of residues of erythromycin in swine tissues, of 
virginiamycin in turkey tissues, and of new animal drugs for which 
approval of their applications has been withdrawn.
     Cross-references to related approved uses of new animal 
drugs in part 556 and to related tolerances for drugs approved for use 
in food-producing animals in 21 CFR parts 520, 522, 524, and 558 are 
being corrected.
     A redundant cross-reference for related tolerances in 21 
CFR 558.355 for use of monensin in medicated feeds is being removed and 
reserved.
     The acceptable daily intake of total residues of 
ivermectin and tolerances for residues of ivermectin in cattle liver 
and muscle in Sec.  556.344 are being corrected.
     The acceptable daily intake of total residues of 
tildipirosin in Sec.  556.733 is being corrected.
     The regulations in 21 CFR 520.2260b for sulfamethazine 
sustained-release boluses and in 21 CFR 522.1662a for oxytetracycline 
hydrochloride injection are being reformatted to present the tolerance 
cross-reference in a consistent location.
     Typographical errors are being corrected wherever they 
have been found.

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 500

    Animal drugs, Animal feeds, Cancer, Incorporation by reference, 
Labeling, Packaging and containers, Polychlorinated biphenyls (PCBs).

21 CFR Parts 520, 522, 524, and 526

    Animal drugs.

21 CFR Part 556

    Animal drugs, Food.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
500, 510, 520, 522, 524, 526, 556, and 558 are amended as follows:

PART 500--GENERAL

0
1. The authority citation for part 500 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 
360b, 371, 379e.


0
2. In Sec.  500.1410, revise paragraph (a) to read as follows:


Sec.  500.1410  N-methyl-2-pyrrolidone.

    (a) Standard for residues. No residues of n-methyl-2-pyrrolidone 
may be found in the uncooked edible tissues of cattle as determined by 
a method entitled ``Method of Analysis: N-methyl-2-

[[Page 18118]]

pyrrolidone,'' September 26, 2011, Center for Veterinary Medicine, Food 
and Drug Administration, which is incorporated by reference with the 
approval of the Director of the Federal Register under 5 U.S.C. 522(a) 
and 1 CFR part 51. To obtain a copy of the analytical method, please 
submit a Freedom of Information request to: https://www.accessdata.fda.gov/scripts/foi/FOIRequest/requestinfo.cfm; or go 
to: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. You may inspect a copy at the office of the 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, 301-827-6860, between 9 
a.m. and 4 p.m., Monday through Friday or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, email [email protected], or go to: 
www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *

PART 510--NEW ANIMAL DRUGS

0
3. 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
4. In Sec.  510.600:
0
a. In the table in paragraph (c)(1):
0
i. Remove the entry for ``Cooperative Research Farms'';
0
ii. Add entries for ``Dechra Veterinary Products LLC'' and ``Mizner 
Bioscience LLC'' in alphabetical order;
0
iii. Remove the entries for ``Putney, Inc.'' and ``Strategic Veterinary 
Pharmaceuticals, Inc.'';
0
iv. Revise the entry for ``Virbac AH, Inc.''; and
0
v. Add an entry for ``Wildcat Feeds'' in alphabetical order; and
0
b. In the table in paragraph (c)(2):
0
i. Revise the entry for ``026637'';
0
ii. Remove the entry for ``051267'';
0
iii. Revise the entry for ``051311'';
0
iv. Remove the entry for ``054628''; and
0
v. Add entries for ``086039'' and ``086113'' in numerical order.
    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
------------------------------------------------------------------------
 
                              * * * * * * *
Dechra Veterinary Products LLC, 7015 College Blvd.,               026637
 Suite 525, Overland Park, KS 66211.....................
 
                              * * * * * * *
Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760,            086039
 Boca Raton, FL 33432...................................
 
                              * * * * * * *
Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161....          051311
 
                              * * * * * * *
Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616.....          086113
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

----------------------------------------------------------------------------------------------------------------
           Drug labeler code                                      Firm name and address
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
026637.................................  Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland
                                          Park, KS 66211.
 
                                                  * * * * * * *
051311.................................  Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161.
 
                                                  * * * * * * *
086039.................................  Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL
                                          33432.
 
                                                  * * * * * * *
086113.................................  Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


Sec.  520.88c  [Amended]

0
6. In Sec.  520.88c(c), remove ``Sec.  556.510'' and in its place add 
``Sec.  556.38''.


Sec.  Sec.  520.90b and 520.90c  [Redesignated as Sec. Sec.  520.90a 
and 520.90b]

0
7. Redesignate Sec. Sec.  520.90b and 520.90c as Sec. Sec.  520.90a and 
520.90b.


Sec.  Sec.  520.90d and 520.90e  [Removed]

0
8. Remove Sec. Sec.  520.90d and 520.90e.


Sec.  520.90f  [Redesignated as Sec.  520.90c and Amended]

0
9. Redesignate Sec.  520.90f as Sec.  520.90c and in newly redesignated 
Sec.  520.90c, revise paragraphs (b) and (d) to read as follows:

[[Page 18119]]

Sec.  520.90c  Ampicillin boluses.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *
    (d) Conditions of use in nonruminating calves--(1) Amount. 5 
milligrams per pound of body weight twice daily not to exceed 4 days.
    (2) Indications for use. Oral treatment of bacterial enteritis 
(colibacillosis) caused by E. coli.
    (3) Limitations. Treated calves must not be slaughtered for food 
during treatment and for 7 days after the last treatment. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.


Sec.  520.260  [Amended]

0
10. In Sec.  520.260(b)(2), remove ``No. 038782 for 884 or 1,768 
milligram or 4.42 gram capsules;''.


Sec.  520.455  [Amended]

0
11. In Sec.  520.455(b), remove ``No. 058198'' and in its place add 
``Nos. 058198 and 086039''.


Sec.  Sec.  520.903d and 520.903e  [Redesignated as Sec. Sec.  520.903c 
and 520.903d]

0
12. Redesignate Sec. Sec.  520.903d and 520.903e as Sec. Sec.  520.903c 
and 520.903d.


Sec.  520.1263c  [Redesignated as Sec.  520.1263b]

0
13. Redesignate Sec.  520.1263c as Sec.  520.1263b.

0
14. Revise Sec.  520.1286 to read as follows:


Sec.  520.1286  Lotilaner.

    (a) Specifications. Each chewable tablet contains:
    (1) For use in dogs: 56.25, 112.5, 225, 450, or 900 milligrams (mg) 
lotilaner; or
    (2) For use in cats: 12 or 48 mg lotilaner.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer orally once 
a month at the recommended minimum dosage of 9 mg/lb (20 mg/kg).
    (ii) Indications for use. Kills adult fleas, and for the treatment 
and prevention of flea infestations (Ctenocephalides felis), and the 
treatment and control of tick infestations (Amblyomma americanum (lone 
star tick), Dermacentor variabilis (American dog tick), Ixodes 
scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog 
tick)) for 1 month in dogs and puppies 8 weeks of age or older and 
weighing 4.4 pounds or greater.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer orally once a month at the 
recommended minimum dosage of 2.7 mg/lb (6 mg/kg).
    (ii) Indications for use. Kills adult fleas, and for the treatment 
and prevention of flea infestations (Ctenocephalides felis) for 1 month 
in cats and kittens 8 weeks of age or older and weighing 2 pounds or 
greater.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
15. In Sec.  520.1660d, revise paragraph (d)(2)(ii) to read as follows:


Sec.  520.1660d  Oxytetracycline powder.

* * * * *
    (d) * * *
    (2) * * *
    (ii) Indications for use. For control of American foulbrood caused 
by Paenibacillus larvae.
* * * * *


Sec.  Sec.  520.1696b, 520.1696c, and 520.1696d  [Redesignated as 
Sec. Sec.  520.1696a, 520.1696b, and 520.1696c]

0
16. Redesignate Sec. Sec.  520.1696b, 520.1696c, and 520.1696d as 
Sec. Sec.  520.1696a, 520.1696b, and 520.1696c.


Sec.  520.2218  [Amended]

0
17. In Sec.  520.2218(c), remove ``Sec. Sec.  556.670 and 556.685'' and 
in its place add ``Sec. Sec.  556.660, 556.670, and 556.685''.


Sec.  520.2260b  [Amended]

0
18. In Sec.  520.2260b, redesignate paragraphs (a) through (f) and (g) 
as paragraphs (b) through (g) and (a), respectively.

0
19. In Sec.  520.2455, add paragraph (b)(4) to read as follows:


Sec.  520.2455  Tiamulin.

* * * * *
    (b) * * *
    (4) No. 061133 for product described in paragraph (a)(2) of this 
section.
* * * * *

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

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

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


0
21. In Sec.  522.650, revise paragraph (b) to read as follows:


Sec.  522.650  Dihydrostreptomycin sulfate injection.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *

0
22. Add Sec.  522.728 to read as follows:


Sec.  522.728  Dipyrone.

    (a) Specifications. Each milliliter of solution contains 500 
milligrams (mg) dipyrone.
    (b) Sponsor. See No. 086078 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 30 mg per 
kilogram of body weight (13.6 mg per pound) by intravenous injection, 
once or twice daily at a 12-hour interval for up to 3 days.
    (2) Indications for use. For control of pyrexia in horses.
    (3) Limitations. Do not use in horses intended for human 
consumption. Do not use in any food-producing animals, including 
lactating dairy animals. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.


Sec.  522.900  [Removed]

0
23. Remove Sec.  522.900.


Sec.  522.1367  [Amended]

0
24. In Sec.  522.1367(c)(1)(i), remove ``Sec.  520.1350(c)'' and in its 
place add ``Sec.  520.1367(c)''.


Sec.  522.1662a  [Amended]

0
25. In Sec.  522.1662a:
0
a. Redesignate paragraphs (a) through (e) as paragraphs (b) through 
(f);
0
b. Further redesignate newly redesignated paragraphs (c)(3)(i)(a) 
through (c) and (c)(3)(ii)(a) through (c) as paragraphs (c)(3)(i)(A) 
through (C) and (c)(3)(ii)(A) through (C), respectively;
0
c. Further redesignate newly redesignated paragraphs (e)(3)(i)(a) 
through (c) as paragraphs (e)(3)(i)(A) through (C);
0
d. Further redesignate newly redesignated paragraphs (e)(3)(ii)(a) and 
(b) and paragraphs (e)(3)(ii)(A) and (B);
0
e. Further redesignate newly redesignated paragraphs (e)(3)(iii)(a) 
through (c) as paragraphs (e)(3)(iii)(A) through (C);
0
f. In newly redesignated paragraph (e)(3)(iii)(C), remove ``paragraph 
(d)(3)(iii)(c) of this section'' and in its place add ``this paragraph 
(e)(3)(iii)(C)'';
0
g. Further redesignate newly redesignated paragraphs (f)(3)(i)(a) 
through (c) and (f)(3)(ii)(a) through (c) as paragraphs (f)(3)(i)(A) 
through (C) and (f)(3)(ii)(A) through (C), respectively;
0
h. Redesignate paragraphs (g)(3)(i)(a) through (c) and (g)(3)(ii)(a) 
through (c) as paragraphs (g)(3)(i)(A) through (C)

[[Page 18120]]

and (g)(3)(ii)(A) through (C), respectively; and
0
i. Redesignate paragraph (k) as paragraph (j) and paragraph (l) as 
paragraph (a).


Sec.  522.1696a  [Amended]

0
26. In Sec.  522.1696a(b)(1) and (2) and (d)(2)(iii), remove ``, 
055529,''.


Sec.  522.1696b  [Amended]

0
27. In Sec.  522.1696b:
0
a. In paragraph (b)(1), remove ``016592, 054771, and 055529'' and in 
its place add ``016592 and 054771'';
0
b. Remove paragraphs (d)(2)(i)(A) and (B); and
0
c. In paragraph (d)(2)(iii)(B), remove ``Nos. 000859 and 055529'' and 
in its place add ``No. 016592''.

0
28. Add Sec.  522.1697 to read as follows:


Sec.  522.1697  Pentobarbital and phenytoin.

    (a) Specifications. Each milliliter (mL) of solution contains 390 
milligrams (mg) pentobarbital sodium and 50 mg phenytoin sodium.
    (b) Sponsors. See Nos. 000061, 051311, and 054925 in Sec.  
510.600(c) of this chapter.
    (c) Special considerations. Product labeling shall bear the 
following warning statements: ``ENVIRONMENTAL HAZARD: This product is 
toxic to wildlife. Birds and mammals feeding on treated animals may be 
killed. Euthanized animals must be properly disposed of by deep burial, 
incineration, or other method in compliance with State and local laws, 
to prevent consumption of carcass material by scavenging wildlife.''
    (d) Conditions of use in dogs--(1) Amount. Administer 1 mL per 10 
pounds of body weight as a single, bolus intravenous or intracardiac 
injection.
    (2) Indications for use. For humane, painless, and rapid 
euthanasia.
    (3) Limitations. Do not use in animals intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

0
29. Add Sec.  522.2092 to read as follows:


Sec.  522.2092  Secobarbital and dibucaine.

    (a) Specifications. Each milliliter (mL) of solution contains 400 
milligram (mg) secobarbital sodium and 25 mg dibucaine hydrochloride.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. Product labeling shall bear the 
following warning statements: ``ENVIRONMENTAL HAZARD: This product is 
toxic to wildlife. Birds and mammals feeding on treated animals may be 
killed. Euthanized animals must be properly disposed of by deep burial, 
incineration, or other method in compliance with State and local laws, 
to prevent consumption of carcass material by scavenging wildlife.''
    (d) Conditions of use in dogs--(1) Amount. Administer 1 mL per 10 
pounds of body weight as a single, bolus intravenous injection.
    (2) Indications for use. For humane, painless, and rapid 
euthanasia.
    (3) Limitations. Do not use in animals intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

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 an undesignated center heading before Sec.  524.981 to read as 
follows:
Fluocinolone Topical and Otic Dosage Forms

0
32. Add Sec.  524.1001 to read as follows:


Sec.  524.1001  Furalaner and moxidectin.

    (a) Specifications. Each milliliter of solution contains 280 
milligram (mg) furalaner and 14 mg moxidectin. Each individually 
packaged tube contains either 112.5 mg furalaner and 5.6 mg moxidectin; 
250 mg furalaner and 12.5 mg moxidectin; or 500 mg furalaner and 25 mg 
moxidectin.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer topically as a single 
dose every 2 months to provide a minimum dose of 18.2 mg/lb (40 mg/kg) 
fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin.
    (2) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis and for the treatment of infections with 
intestinal roundworm (Toxocara cati, 4th stage larvae, immature adults, 
and adults) and hookworm (Ancylostoma tubaeforme, 4th stage larvae, 
immature adults, and adults); kills adult fleas and is indicated for 
the treatment and prevention of flea infestations (Ctenocephalides 
felis) and the treatment and control of tick infestations (Ixodes 
scapularis (black-legged tick) and Dermacentor variabilis (American dog 
tick)) for 2 months in cats and kittens 6 months of age and older and 
weighing 2.6 lb or greater.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

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


Sec.  524.1146  Imidacloprid and moxidectin.

    (a) Specifications. Each milliliter of solution contains:
    (1) 100 milligrams (mg) imidacloprid and 25 mg moxidectin; or
    (2) 100 mg imidacloprid and 10 mg moxidectin.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter as follows:
    (1) Nos. 000859 and 017030 for use of product described in 
paragraph (a)(1) of this section as in paragraph (d)(1) of this 
section.
    (2) No. 000859 for use of product described in paragraph (a)(2) of 
this section as in paragraphs (d)(2) and (3) of this section.
* * * * *

0
34. In Sec.  524.1742:
0
a. Revise the section heading;
0
b. Redesignate paragraphs (c) and (d) as paragraphs (d) and (c), 
respectively;
0
c. Add a heading for the table in newly redesignated paragraph (d)(1) 
introductory text; and
0
d. Further redesignate newly redesignated paragraphs (d)(1)(i)(a) and 
(b) as paragraphs (d)(1)(i)(A) and (B).
    The revision and addition reads as follows:


Sec.  524.1742  Phosmet emulsifiable liquid.

* * * * *
    (d) * * *
    (1) * * *
    Table 1 to Paragraph (d)(1)
* * * * *


Sec.  524.2098  [Amended]

0
35. In Sec.  524.2098(b), remove ``054771'' and in its place add ``Nos. 
054771 and 055529''.

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

0
36. The authority citation for part 526 continues to read as follows:

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


Sec.  526.464b  [Removed]

0
37. Remove Sec.  526.464b.


Sec.  526.464c  [Redesignated as Sec.  526.464b]

0
38. Redesignate Sec.  526.464c as Sec.  526.464b.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
39. The authority citation for part 556 continues to read as follows:

    Authority: 21 U.S.C. 342, 360b, 371.


Sec.  556.40  [Amended]

0
40. In Sec.  556.40(c), remove ``Sec. Sec.  520.90e, 520.90f, 522.90a, 
and 522.90b'' and in

[[Page 18121]]

its place add ``Sec. Sec.  520.90c, 522.90a, and 522.90b''.


Sec.  556.165  [Amended]

0
41. In Sec.  556.165(c), remove ``Sec. Sec.  526.464a, 526.464b, and 
526.464c'' and in its place add ``Sec. Sec.  526.464a and 526.464b''.


Sec.  556.168  [Removed]

0
42. Remove Sec.  556.168.


Sec.  556.230  [Amended]

0
43. In Sec.  556.230, remove paragraph (b)(3).


Sec.  556.304  [Amended]

0
44. In Sec.  556.304(c), remove ``Sec. Sec.  522.1077, 522.1079, and 
522.1081'' and in its place add ``Sec. Sec.  522.1079 and 522.1081''.


Sec.  556.344  [Amended]

0
45. In Sec.  556.344:
0
a. In paragraph (a), remove ``1 [mu]g/kg'' and in its place add ``5 
[mu]g/kg'';
0
b. In paragraph (b)(2)(i), remove ``100 ppb'' and in its place add 
``1.6 ppm''; and
0
c. In paragraph (b)(2)(ii), remove ``10 ppb'' and in its place add 
``650 ppb''.

0
46. In Sec.  556.360, add paragraph (b)(3) and revise paragraph (c) to 
read as follows:


Sec.  556.360  Lincomycin.

* * * * *
    (b) * * *
    (3) Honey. 750 ppb.
    (c) Related conditions of use. See Sec. Sec.  520.1263b, 522.1260, 
and 558.325 of this chapter.

0
47. In Sec.  556.500, add paragraph (b)(6) to read as follows:


Sec.  556.500  Oxytetracycline.

* * * * *
    (b) * * *
    (6) Honey. 750 ppb.
* * * * *


Sec.  556.510  [Amended]

0
48. In Sec.  556.510(c), remove ``520.1696b'' and in its place add 
``520.1696a''.


Sec.  556.660  [Amended]

0
49. In Sec.  556.660(c), remove ``Sec.  558.582'' and in its place add 
``Sec. Sec.  520.2218 and 558.582''.


Sec.  556.670  [Amended]

0
50. In Sec.  556.670, in paragraph (c), remove ``Sec. Sec.  520.2260a, 
520.2260b, 520.2260c, 520.2261a, 520.2261b, 522.2260, 558.140, and 
558.630'' and in its place add ``Sec. Sec.  520.2218, 520.2260a, 
520.2260b, 520.2260c, 520.2261a, 520.2261b, 522.2260, 558.140, and 
558.630''.


Sec.  556.685  [Amended]

0
51. In Sec.  556.685(c), remove ``Sec. Sec.  520.2325a, 520.2325b, and 
558.586'' and in its place add ``Sec. Sec.  520.2218, 520.2325a, 
520.2325b, and 558.586''.


Sec.  556.733  [Amended]

0
52. In Sec.  556.733(a), remove ``10 [mu]g/kg'' and in its place add 
``50 [mu]g/kg''.

0
53. In Sec.  556.746, add paragraph (b)(4) to read as follows:


Sec.  556.746  Tylosin.

* * * * *
    (b) * * *
    (4) Honey. 500 ppb.
* * * * *


Sec.  556.750  [Amended]

0
54. In Sec.  556.750, remove paragraph (b)(4).

0
55. In Sec.  556.765, revise paragraph (b)(1) to read as follows:


Sec.  556.765  Zilpaterol.

* * * * *
    (b) * * *
    (1) Cattle. (i) Liver (target tissue): 12 ppb.
    (ii) Muscle: 10 ppb.
* * * * *

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

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

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


0
57. In Sec.  558.55, add paragraph (d)(5) to read as follows:


Sec.  558.55  Amprolium.

* * * * *
    (d) * * *
    (5) Permitted combinations. Amprolium may also be used in 
combination with:
    (i) Virginiamycin as in Sec.  558.635.
    (ii) [Reserved]

0
58. In Sec.  558.76, revise paragraphs (e)(2)(vii), (viii), and (xi) to 
read as follows:


Sec.  558.76  Bacitracin methylenedisalicylate.

* * * * *
    (e) * * *
    (2) * * *
    (vii) Fenbendazole as in Sec.  558.258.
    (viii) Halofuginone as in Sec.  558.265.
* * * * *
    (xi) Monensin as in Sec.  558.355.
* * * * *


Sec.  558.185  [Removed]

0
59. Remove Sec.  558.185.


0
60. In Sec.  558.195, revise paragraph (e)(2)(ii) to read as follows:


Sec.  558.195  Decoquinate.

* * * * *
    (e) * * *
    (2) * * *

[[Page 18122]]



--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       Combination in  grams/
      Decoquinate in  grams/ton                 ton                 Indications for use               Limitations                     Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
(ii) 12.9 to 90.8...................  Monensin, 5 to 30......  Cattle fed in confinement     Feed continuously as the      016592, 054771.
                                                                for slaughter: For            sole ration to provide 22.7
                                                                prevention of coccidiosis     mg of decoquinate per 100
                                                                caused by Eimeria bovis and   lb of body weight per day
                                                                E. zuernii; and for           and 50 to 360 mg of
                                                                improved feed efficiency.     monensin per head per day.
                                                                                              Feed at least 28 days
                                                                                              during period of exposure
                                                                                              to coccidiosis or when it
                                                                                              is likely to be a hazard.
                                                                                              Do not feed to animals
                                                                                              producing milk for food. Do
                                                                                              not feed to lactating dairy
                                                                                              cattle. Also see paragraph
                                                                                              (d)(1) of this section and
                                                                                              Sec.   558.355(d)(9)(i).
                                                                                              Monensin as provided by No.
                                                                                              016592 or 058198 in Sec.
                                                                                              510.600(c) of this chapter.
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

0
61. In Sec.  558.342, revise paragraph (e)(1)(iv) to read as follows:


Sec.  558.342  Melengestrol.

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

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       Combination in  grams/
Melengestrol  acetate in mg/head/day            ton                 Indications for use               Limitations                     Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
(iv) 0.25 to 0.5....................  Monensin, 10 to 40.....  Heifers fed in confinement    Add at the rate of 0.5 to 2   016592, 054771, 058198
                                                                for slaughter: For            lb/head/day a medicated
                                                                increased rate of weight      feed (liquid or dry)
                                                                gain, improved feed           containing 0.125 to 1 mg
                                                                efficiency, and suppression   melengestrol acetate/lb to
                                                                of estrus (heat); and for     a feed containing 10 to 40
                                                                the prevention and control    g of monensin per ton to
                                                                of coccidiosis due to         provide 0.25 to 0.5 mg
                                                                Eimeria bovis and E.          melengestrol acetate/head/
                                                                zuernii..                     day and 0.14 to 0.42 mg
                                                                                              monensin/lb body weight,
                                                                                              depending on severity of
                                                                                              coccidiosis challenge, up
                                                                                              to 480 mg monensin/head/
                                                                                              day. See Sec.   558.355(d).
                                                                                              Monensin as provided by No.
                                                                                              016592 or 058198 in Sec.
                                                                                              510.600(c) of this chapter.
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

0
62. In Sec.  558.355, remove and reserve paragraph (e) and revise 
paragraph (f)(4)(iv) to read as follows:


Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
          Monensin amount            Indications for use         Limitations                   Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iv) 400 mg per pound of block      Pasture cattle        Provide 50 to 200 mg of    086113
 (0.088%).                           (slaughter,           monensin (2 to 8 ounces
                                     stocker, feeder,      of block) per head per
                                     and dairy and beef    day, at least 1 block
                                     replacement           per 5 head of cattle.
                                     heifers): For         Feed blocks
                                     increased rate of     continuously. Do not
                                     weight gain.          feed salt or mineral
                                                           supplements in addition
                                                           to the blocks. Ingestion
                                                           by cattle of monensin at
                                                           levels of 600 mg per
                                                           head per day and higher
                                                           has been fatal. The
                                                           effectiveness of this
                                                           block in cull cows and
                                                           bulls has not been
                                                           established. See
                                                           paragraph (d)(10)(i) of
                                                           this section.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
63. In Sec.  558.500, revise paragraph (e)(2) to read as follows:


Sec.  558.500  Ractopamine.

* * * * *
    (e) * * *
    (2) Cattle.

[[Page 18123]]



----------------------------------------------------------------------------------------------------------------
                                   Combination in      Indications for
   Ractopamine in  grams/ton          grams/ton              use               Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 8.2 to 24.6................  ..................  Cattle fed in       Feed continuously as             054771
                                                      confinement for     sole ration during the          058198
                                                      slaughter: For      last 28 to 42 days on
                                                      increased rate of   feed.
                                                      weight gain and
                                                      improved feed
                                                      efficiency during
                                                      the last 28 to 42
                                                      days on feed.
(ii) 8.2 to 24.6...............  Monensin 10 to 40   Cattle fed in       Feed continuously as             016592
                                  to provide 0.14     confinement for     sole ration during the          054771
                                  to 0.42 mg          slaughter: For      last 28 to 42 days on           058198
                                  monensin/lb of      increased rate of   feed. See paragraph
                                  body weight,        weight gain and     Sec.   558.355(d).
                                  depending on        improved feed       Ractopamine as
                                  severity of         efficiency during   provided by No. 058198
                                  coccidiosis         the last 28 to 42   or 054771; monensin as
                                  challenge, up to    days on feed, and   provided by No. 016592
                                  480 mg/head/day..   for prevention      or 058198 in Sec.
                                                      and control of      510.600(c) of this
                                                      coccidiosis due     chapter.
                                                      to Eimeria bovis
                                                      and E. zuernii.
(iii) 9.8 to 24.6..............  ..................  Cattle fed in       Feed continuously as             054771
                                                      confinement for     sole ration during the          058198
                                                      slaughter: For      last 28 to 42 days on
                                                      increased rate of   feed. Not for animals
                                                      weight gain,        intended for breeding.
                                                      improved feed
                                                      efficiency, and
                                                      increased carcass
                                                      leanness during
                                                      the last 28 to 42
                                                      days on feed.
(iv) 9.8 to 24.6...............  Monensin 10 to 40   Cattle fed in       Feed continuously as             016592
                                  to provide 0.14     confinement for     sole ration during the          054771
                                  to 0.42 mg          slaughter: For      last 28 to 42 days on           058198
                                  monensin/lb of      increased rate of   feed. Not for animals
                                  body weight,        weight gain,        intended for breeding.
                                  depending on        improved feed       See paragraph Sec.
                                  severity of         efficiency, and     558.355(d).
                                  coccidiosis         increased carcass   Ractopamine as
                                  challenge, up to    leanness during     provided by No. 058198
                                  480 mg/head/day.    the last 28 to 42   or 054771; monensin as
                                                      days on feed, and   provided by No. 016592
                                                      for prevention      or 058198 in Sec.
                                                      and control of      510.600(c) of this
                                                      coccidiosis due     chapter.
                                                      to Eimeria bovis
                                                      and E. zuernii.
(v) 9.8 to 24.6................  Monensin 10 to 40   Heifers fed in      Feed continuously as             016592
                                  to provide 0.14     confinement for     sole ration during the          054771
                                  to 0.42 mg          slaughter: For      last 28 to 42 days on           058198
                                  monensin/lb of      increased rate of   feed. Not for animals
                                  body weight,        weight gain,        intended for breeding.
                                  depending on        improved feed       See Sec.  Sec.
                                  severity of         efficiency, and     558.342(d) and
                                  coccidiosis         increased carcass   558.355(d).
                                  challenge, up to    leanness during     Melengestrol acetate
                                  480 mg/head/day,    the last 28 to 42   as provided by No.
                                  plus melengestrol   days on feed, and   058198 or 054771;
                                  acetate to          for prevention      monensin as provided
                                  provide 0.25 to     and control of      by No. 016592 or
                                  0.5 mg/head/day.    coccidiosis due     058198 in Sec.
                                                      to Eimeria bovis    510.600(c) of this
                                                      and E. zuernii,     chapter.
                                                      and for
                                                      suppression of
                                                      estrus (heat).
(vi) Not to exceed 800; to       ..................  Cattle fed in       Top dress in a minimum           054771
 provide 70 to 400 mg/head/day.                       confinement for     of 1 lb of medicated            058198
                                                      slaughter: For      feed.
                                                      increased rate of
                                                      weight gain and
                                                      improved feed
                                                      efficiency during
                                                      the last 28 to 42
                                                      days on feed.
(vii) Not to exceed 800; to      Monensin 10 to 40   Cattle fed in       Top dress ractopamine            016592
 provide 70 to 400 mg/head/day.   to provide 0.14     confinement for     in a minimum of 1 lb            054771
                                  to 0.42 mg          slaughter: For      of medicated feed               058198
                                  monensin/lb of      increased rate of   during the last 28 to
                                  body weight,        weight gain and     42 days on feed. Not
                                  depending on        improved feed       for animals intended
                                  severity of         efficiency during   for breeding. See Sec.
                                  coccidiosis         the last 28 to 42     558.355(d).
                                  challenge, up to    days on feed, and   Ractopamine as
                                  480 mg/head/day.    for prevention      provided by No. 058198
                                                      and control of      or 054771; monensin as
                                                      coccidiosis due     provided by No. 016592
                                                      to Eimeria bovis    or 058198 in Sec.
                                                      and E. zuernii.     510.600(c) of this
                                                                          chapter.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
64. In Sec.  558.618, revise paragraphs (e)(2)(ii) and (iii) to read as 
follows:


Sec.  558.618  Tilmicosin.

* * * * *
    (e) * * *
    (2) * * *

[[Page 18124]]



----------------------------------------------------------------------------------------------------------------
 Tilmicosin phosphate in grams/    Combination in      Indications for
              ton                     grams/ton              use               Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ii) 568 to 757................  Monensin, 5 to 40.  Cattle fed in       Feed continuously for            016592
                                                      confinement for     14 days to provide              058198
                                                      slaughter: For      12.5 mg tilmicosin/kg
                                                      improved feed       of bodyweight/day. The
                                                      efficiency; and     safety of tilmicosin
                                                      for the control     has not been
                                                      of bovine           established in cattle
                                                      respiratory         intended for breeding
                                                      disease (BRD)       purposes. This drug
                                                      associated with     product is not
                                                      Mannheimia          approved for use in
                                                      haemolytica,        female dairy cattle 20
                                                      Pasteurella         months of age or
                                                      multocida, and      older. Use in these
                                                      Histophilus somni   cattle may cause drug
                                                      in groups of        residues in milk. This
                                                      cattle fed in       drug product is not
                                                      confinement for     approved for use in
                                                      slaughter, where    calves intended to be
                                                      active BRD has      processed for veal. A
                                                      been diagnosed in   withdrawal period has
                                                      at least 10         not been established
                                                      percent of the      in pre-ruminating
                                                      animals in the      calves. Cattle
                                                      group.              intended for human
                                                                          consumption must not
                                                                          be slaughtered within
                                                                          28 days of the last
                                                                          treatment with this
                                                                          drug product. See Sec.
                                                                            558.355(d).
                                                                          Tilmicosin as provided
                                                                          by No. 016592 or
                                                                          058198; monensin as
                                                                          provided by No. 016592
                                                                          or 058198 in Sec.
                                                                          510.600(c) of this
                                                                          chapter.
(iii) 568 to 757...............  Monensin, 10 to 40  Cattle fed in       Feed continuously for            016592
                                                      confinement for     14 days to provide              058198
                                                      slaughter: For      12.5 mg tilmicosin/kg
                                                      prevention and      of bodyweight/day. The
                                                      control of          safety of tilmicosin
                                                      coccidiosis due     has not been
                                                      to Eimeria bovis    established in cattle
                                                      and E. zuernii;     intended for breeding
                                                      and for the         purposes. This drug
                                                      control of BRD      product is not
                                                      associated with     approved for use in
                                                      Mannheimia          female dairy cattle 20
                                                      haemolytica,        months of age or
                                                      Pasteurella         older. Use in these
                                                      multocida, and      cattle may cause drug
                                                      Histophilus somni   residues in milk. This
                                                      in groups of        drug product is not
                                                      cattle fed in       approved for use in
                                                      confinement for     calves intended to be
                                                      slaughter, where    processed for veal. A
                                                      active BRD has      withdrawal period has
                                                      been diagnosed in   not been established
                                                      at least 10         in pre-ruminating
                                                      percent of the      calves. Cattle
                                                      animals in the      intended for human
                                                      group.              consumption must not
                                                                          be slaughtered within
                                                                          28 days of the last
                                                                          treatment with this
                                                                          drug product. See Sec.
                                                                            558.355(d).
                                                                          Tilmicosin as provided
                                                                          by No. 016592 or
                                                                          058198; monensin as
                                                                          provided by No. 016592
                                                                          or 058198 in Sec.
                                                                          510.600(c) of this
                                                                          chapter.
----------------------------------------------------------------------------------------------------------------


0
65. In Sec.  558.625, revise paragraphs (e)(2)(vi) and (ix) to read as 
follows:


Sec.  558.625  Tylosin.

* * * * *
    (e) * * *
    (2) * * *

----------------------------------------------------------------------------------------------------------------
                                   Combination in      Indications for
       Tylosin grams/ton              grams/ton              use               Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(vi) 8 to 10...................  Monensin, 5 to 30   Cattle fed in       Feed continuously as             016592
                                  plus decoquinate,   confinement for     the sole ration to              054771
                                  13.6 to 22.7.       slaughter: For      provide 22.7 mg of
                                                      reduction of        decoquinate per 100 lb
                                                      incidence of        body weight per day,
                                                      liver abscesses     50 to 360 mg of
                                                      caused by           monensin/head/day, and
                                                      Fusobacterium       60 to 90 mg of tylosin/
                                                      necrophorum and     head/day. Feed at
                                                      Arcanobacterium     least 28 days during
                                                      pyogenes; for the   period of exposure to
                                                      prevention of       coccidiosis or when it
                                                      coccidiosis         is likely to be a
                                                      caused by Eimeria   hazard. Do not feed to
                                                      bovis and E.        animals producing milk
                                                      zuernii; and for    for food. Do not feed
                                                      improved feed       to lactating dairy
                                                      efficiency.         cattle. A withdrawal
                                                                          time has not been
                                                                          established for pre-
                                                                          ruminating calves. Do
                                                                          not use in calves to
                                                                          be processed for veal.
                                                                          Tylosin as provided by
                                                                          No. 016592 or 058198;
                                                                          monensin as provided
                                                                          by No. 016592 or
                                                                          058198; decoquinate as
                                                                          provided by No. 058198
                                                                          in Sec.   510.600(c)
                                                                          of this chapter. See
                                                                          Sec.  Sec.
                                                                          558.311(d) and
                                                                          558.355(d).
 

[[Page 18125]]

 
                                                  * * * * * * *
(ix) 8 to 10...................  Monensin, 10 to 40  Heifers fed in      Feed continuously as             016592
                                  plus                confinement for     sole ration to heifers          054771
                                  melengestrol,       slaughter: For      at a rate of 0.5 to 2           058198
                                  0.25 to 2.0.        reduction of        pounds per head per
                                                      incidence of        day to provide 0.25 to
                                                      liver abscesses     0.5 mg/head/day
                                                      caused by           melengestrol acetate
                                                      Fusobacterium       and 0.14 to 0.42 mg
                                                      necrophorum and     monensin/lb body
                                                      Arcanobacterium     weight per day,
                                                      (Actinomyces)       depending on the
                                                      pyogenes; for       severity of the
                                                      prevention and      coccidiosis challenge,
                                                      control of          up to 480 mg/head/day
                                                      coccidiosis         and 60 to 90 mg/head/
                                                      caused by Eimeria   day tylosin. The
                                                      bovis and E.        melengestrol acetate
                                                      zuernii; and for    portion of this Type C
                                                      increased rate of   medicated feed must be
                                                      weight gain,        mixed into the
                                                      improved feed       complete feed
                                                      efficiency, and     containing 10 to 40 g/
                                                      suppression of      ton monensin and 8 to
                                                      estrus (heat).      10 g/ton tylosin at
                                                                          feeding into the
                                                                          amount of complete
                                                                          feed consumed by an
                                                                          animal per day. A
                                                                          withdrawal time has
                                                                          not been established
                                                                          for pre-ruminating
                                                                          calves. Do not use in
                                                                          calves to be processed
                                                                          for veal. Tylosin
                                                                          provided by No. 016592
                                                                          or 058198; monensin as
                                                                          provided by No. 016592
                                                                          or 058198;
                                                                          melengestrol provided
                                                                          by No. 054771 or
                                                                          058198 in Sec.
                                                                          510.600(c) of this
                                                                          chapter. See Sec.
                                                                          Sec.   558.342(d) and
                                                                          558.355(d).
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------


0
66. In Sec.  558.635, revise paragraph (e)(1)(iv) to read as follows:


Sec.  558.635  Virginiamycin.

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

----------------------------------------------------------------------------------------------------------------
                                   Combination in      Indications for
    Virginiamycin grams/ton           grams/ton              use               Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iv) 20........................  Diclazuril, 0.91..  Broiler chickens:   Feed continuously as             058198
                                                      For prevention of   the sole ration. Do
                                                      necrotic            not use in hens
                                                      enteritis caused    producing eggs for
                                                      by Clostridium      human food. Diclazuril
                                                      perfringens         as provided by No.
                                                      susceptible to      058198 in Sec.
                                                      virginiamycin;      510.600(c) of this
                                                      and for the         chapter.
                                                      prevention of
                                                      coccidiosis
                                                      caused by Eimeria
                                                      tenella, E.
                                                      necatrix, E.
                                                      acervulina, E.
                                                      brunetti, E.
                                                      mitis (mivati),
                                                      and E. maxima.
                                                      Because
                                                      diclazuril is
                                                      effective against
                                                      E. maxima late in
                                                      its life cycle,
                                                      subclinical
                                                      intestinal
                                                      lesions may be
                                                      present for a
                                                      short time after
                                                      infection.
                                                      Diclazuril was
                                                      shown in studies
                                                      to reduce lesions
                                                      scores and
                                                      improve
                                                      performance and
                                                      health of birds
                                                      challenged with
                                                      E. maxima.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: March 25, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06688 Filed 3-30-20; 8:45 am]
BILLING CODE 4164-01-P