Unknown. Final rule; technical amendments

3,297 words·~15 min read·/register/2025/05/09/2025-08137

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2025-05-09.xml --- 90 89 Friday, May 9, 2025 Contents Civil Rights Civil Rights Commission NOTICES Hearings, Meetings, Proceedings, etc.: Oklahoma Advisory Committee, 19668 2025-08098 Coast Guard Coast Guard RULES Safety Zone: Fireworks Displays within the Fifth Coast Guard District; The Wharf, Washington, DC, 19647-19648 2025-08169 Key West Paddle Classic, Key West, FL, 19648-19650 2025-08170 Special Local Regulation:

Ohio River, Cincinnati, OH, 19645-19647 2025-08200 PROPOSED RULES Security Zone: Upper Mississippi River, Saint Louis, MO, 19665-19667 2025-08194 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List; Additions and Deletions, 19679-19683 2025-08177 2025-08183 Commodity Futures Commodity Futures Trading Commission NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Conflicts of Interest Policies and Procedures by Futures Commission Merchants and Introducing Brokers, 19687-19688 2025-08152 Daily Trade and Supporting Data Reports, 19686-19687 2025-08155 Futures Volume, Open Interest, Price, Deliveries, and Exchanges of Futures, 19683-19684 2025-08142 Real-Time Public Reporting and Block Trade, 19685-19686 2025-08154 Swap Data Recordkeeping and Reporting Requirements: Pre-Enactment and Transition Swaps, 19684-19685 2025-08141 Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 19789-19791 2025-08159 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Consumer Protections for Depository Institution Sales of Insurance, 19788-19789 2025-08206 Education Department Education Department NOTICES Applications for New Awards: Expanding Opportunity Through Quality Charter Schools Program—Grants to State Entities, 19694-19705 2025-08092 Expanding Opportunity through Quality Charter Schools Program—State Charter School Facilities Incentive Grant Program, 19689-19694 2025-08093 Fulbright-Hays Group Projects Abroad Program, Doctoral Dissertation Research Abroad Program, Faculty Research Abroad Fellowship Program;

Withdrawal, 19688-19689 2025-08109 Energy Department Energy Department See Federal Energy Regulatory Commission See National Nuclear Security Administration NOTICES Hearings, Meetings, Proceedings, etc.: Environmental Management Site-Specific Advisory Board, Nevada, 19705-19706 2025-08108 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Alabama; Administrative Corrections and VOC Definition, 19652-19658 2025-08091 Washington;

Southwest Clean Air Agency; Revisions to Excess Emissions, Startup, Shutdown, and General Requirements, 19650-19652 2025-07846 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Consolidation of Certain Reporting and Recordkeeping under Section 8 of the Toxic Substances Control Act, 19715-19716 2025-08190 Pesticide Data Call-Ins, 19712-19713 2025-08181 TSCA Section 5 Premanufacture Review of New Chemical Substances and Significant New Use Rules for New and Existing Chemical Substances, 19713-19714 2025-08191 Environmental Impact Statements;

Availability, etc., 19714-19715 2025-08166 Federal Aviation Federal Aviation Administration PROPOSED RULES Airworthiness Directives: Airbus Helicopters, 19660-19662 2025-08078 Airbus Helicopters Deutschland GmbH Helicopters, 19662-19664 2025-08075 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Amount of Aqueous Film Forming Foam Located at Part 139 Airports, 19780-19781 2025-08136 Airport Property: Malden Regional Airport and Industrial Park, Malden, MO, 19779-19780 2025-08121 Experimental Aircraft All Makes and Models Program, 19778-19779 2025-08167 Federal Site Providing Ground Safety Services and Oversight for Launch or Reentry Activities Conducted from a Commercial Site Located on Land Owned by a Federal Site, 19776-19778 2025-08097 Federal Deposit Federal Deposit Insurance Corporation NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 19789-19791 2025-08159 Federal Energy Federal Energy Regulatory Commission NOTICES Application: Eagle Creek Madison Hydro, LLC, 19708-19709 2025-08185 HGE Energy Storage 8, LLC, 19709 2025-08179 Environmental Issues: Golden Triangle Storage, LLC, Proposed Spindletop Expansion Project, 19709-19712 2025-08180 Federal Maritime Federal Maritime Commission NOTICES Filing of Petition: Exemption from Tariff Rate Publication Requirements, 19716-19717 2025-08211 Federal Railroad Federal Railroad Administration NOTICES Application for Approval of Discontinuance or Modification of a Railroad Signal System, 19782-19783 2025-08198 Petition for Extension of Waiver of Compliance, 19781-19782 2025-08197 Petition for Waiver of Compliance, 19782 2025-08199 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 19789-19791 2025-08159 Change in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 19718 2025-08189 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 19717-19718 2025-08187 Proposals to Engage in or to Acquire Companies Engaged in Permissible Nonbanking Activities, 19717 2025-08188 Food and Drug Food and Drug Administration RULES Medical Devices: Clinical Chemistry and Clinical Toxicology Devices;

Classification of the Breast Milk Macronutrients Test System, 19627-19629 2025-08147 Clinical Chemistry and Clinical Toxicology Devices; Classification of the Voriconazole Test System, 19625-19627 2025-08148 Hematology and Pathology Devices; Classification of the Coagulation System for the Measurement of Whole Blood Viscoelastic Properties in Perioperative Patients, 19629-19631 2025-08151 Immunology and Microbiology Devices; Classification of the Cytomegalovirus Nucleic Acid Detection Device for Congenital Cytomegalovirus Infection, 19634-19636 2025-08146 Immunology and Microbiology Devices;

Classification of the Device to Detect and Identify Microbial Nucleic Acids by Fluorescence In Situ Hybridization in Clinical Specimens, 19636-19638 2025-08150 Immunology and Microbiology Devices; Classification of the Device to Detect and Measure Non-Microbial Analytes to Aid in the Detection and Identification of Localized Human Infections, 19641-19643 2025-08144 Immunology and Microbiology Devices; Classification of the Device to Detect Nucleic Acids from Non-Viral Microorganism(s) Causing Sexually Transmitted Infections and Associated Resistance Marker(s), 19631-19634 2025-08149 Immunology and Microbiology Devices;

Classification of the DNA-Based Test to Measure Minimal Residual Disease in Hematological Malignancies, 19638-19641 2025-08143 Immunology and Microbiology Devices; Classification of the Microbial Nucleic Acid Storage and Stabilization Device, 19644-19645 2025-08145 New Animal Drugs: Approval of New Animal Drug Applications, Withdrawal of Approval of New Animal Drug Application, Change of Sponsor; Technical Amendments, 19623-19625 2025-08137 PROPOSED RULES Food Labeling: Front-of-Package Nutrition Information;

Extension of Comment Period, 19664-19665 2025-08204 NOTICES Drug Products not Withdrawn from Sale for Reasons of Safety or Effectiveness: Vosol (Acetic Acid, Glacial) 2 Percent Otic Solution/Drops; and Other Drug Products, 19721-19722 2025-08207 Hearings, Meetings, Proceedings, etc.: Stakeholder Consultation on the Prescription Drug User Fee Act Reauthorization, 19724 2025-08209 Prescription Drug User Fee Act VII: Independent Assessment of Communication through Product Quality Information Requests during Application Review, 19722-19724 2025-08208 General Services General Services Administration RULES Federal Management Regulation;

Nondiscrimination Clarification in the Federal Workplace; Rescission, 19658-19659 2025-08129 NOTICES Environmental Impact Statements; Availability, etc.: Grand Portage Land Port of Entry Modernization and Expansion Project in Grand Portage, MN, Floodplain and Wetlands Assessment and Statement of Findings, 19719-19721 2025-07964 New Federal Courthouse in Hartford, CT, 19718-19719 2025-08090 Health and Human Health and Human Services Department See Food and Drug Administration See National Institutes of Health Homeland Homeland Security Department See Coast Guard Housing Housing and Urban Development Department NOTICES Privacy Act;

Systems of Records, 19726-19728 2025-08135 Interior Interior Department See Land Management Bureau Internal Revenue Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 19791-19792 2025-08096 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: 1-Hydroxyethylidene-1, 1-Diphosphonic Acid from the People's Republic of China, 19668-19670 2025-08210 Certain Crystalline Silicon Photovoltaic Products from the People's Republic of China, 19670-19672 2025-08162 Certain Steel Threaded Rod from the People's Republic of China, 19675-19676 2025-08165 Passenger Vehicle and Light Truck Tires from the Republic of Korea, 19673-19675 2025-08205 Utility Scale Wind Towers from the Republic of Korea, 19672-19673 2025-08164 Export Trade Certificate of Review, 19676-19677 2025-08106 Sales at Less Than Fair Value;

Determinations, Investigations, etc.: Certain Corrosion-Resistant Steel Products from the Republic of Turkiye, 19677-19679 2025-08163 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Certain Wearable Electronic Devices with ECG Functionality and Components Thereof, 19729-19730 2025-08196 Fiberglass Door Panels from China, 19730 2025-08103 Judicial Conference Judicial Conference of the United States NOTICES Hearings, Meetings, Proceedings, etc.:

Advisory Committee on Appellate Rules, 19730 2025-08215 Advisory Committee on Civil Rules, 19730-19731 2025-08217 Advisory Committee on Criminal Rules, 19731 2025-08213 Labor Department Labor Department See Workers Compensation Programs Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Standard Job Corps Contractor Information Gathering; Correction, 19731 2025-08105 Land Land Management Bureau NOTICES Plats of Survey: Colorado, 19728-19729 2025-08099 Maritime Maritime Administration NOTICES Use of Foreign-Built Small Passenger Vessel in United States Coastwise Trade:

M/V Above Average, 19787-19788 2025-08172 M/V Almeda, 19786-19787 2025-08173 M/V My Three Gills, 19783-19784 2025-08175 S/V Frida, 19784-19785 2025-08174 S/V Goodnight Moon, 19785-19786 2025-08171 National Archives National Archives and Records Administration NOTICES Hearings, Meetings, Proceedings, etc.: National Industrial Security Program Policy Advisory Committee, 19732-19733 2025-08127 National Institute National Institutes of Health NOTICES Hearings, Meetings, Proceedings, etc.:

Center for Scientific Review, 19725-19726 2025-08184 Licenses; Exemptions, Applications, Amendments, etc.: Government Owned Inventions, Single Source-Detector Separation Approach to Calculate Tissue Oxygen Saturation, 19725 2025-08178 Energy National Nuclear National Nuclear Security Administration NOTICES Environmental Impact Statements; Availability, etc.: Plutonium Pit Production, 19706-19708 2025-08140 National Oceanic National Oceanic and Atmospheric Administration PROPOSED RULES Taking or Importing of Marine Mammals:

Military Readiness Activities in the Atlantic Fleet Training and Testing Study Area, 19858-20077 2025-07780 NOTICES Hearings, Meetings, Proceedings, etc.: Pacific Fishery Management Council, 19679 2025-08176 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Environmental Impact Statements; Availability, etc.: Perry Nuclear Power Plant, Unit 1, Vistra Operations Co., LLC., 19734-19735 2025-08192 Meetings; Sunshine Act, 19733 2025-08252 Permits; Applications, Issuances, etc.:

Long Mott Energy, LLC; Long Mott Generating Station, 19733-19734 2025-07728 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 19735 2025-08186 Postal Service Postal Service NOTICES Privacy Act; Systems of Records, 19735-19738 2025-08214 Presidential Documents Presidential Documents ADMINISTRATIVE ORDERS Central African Republic; Continuation of National Emergency (Notice of May 7, 2025), 19621 2025-08311 Syria; Continuation of National Emergency (Notice of May 7, 2025), 19619-19620 2025-08310 Yemen;

Continuation of National Emergency (Notice of May 7, 2025), 20079-20081 2025-08382 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 19771-19772 2025-08122 Application: AGTB Fund Manager, LLC, et al., 19748-19749 2025-08101 Blackstone Private Credit Fund, et al., 19755-19756 2025-08100 Credit Suisse Services AG, et al., Temporary Order, 19744-19748 2025-08125 First Eagle Private Credit Fund, et al., 19763-19764 2025-08102 Self-Regulatory Organizations;

Proposed Rule Changes: Cboe BZX Exchange, Inc., 19741-19744, 19764-19768 2025-08114 2025-08120 Fixed Income Clearing Corp., 19755, 19761-19763 2025-08116 2025-08119 Nasdaq ISE, LLC, 19750-19755 2025-08113 Nasdaq Stock Market LLC, 19772-19773 2025-08118 National Securities Clearing Corp., 19769-19771 2025-08112 NYSE American LLC, 19756-19761 2025-08115 NYSE Arca, Inc., 19749-19750 2025-08111 The Depository Trust Co., 19738-19741 2025-08117 State Department State Department NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Foreign Diplomatic Services Application, 19773-19774 2025-08126 Culturally Significant Objects Imported for Exhibition: Northern Lights, 19774 2025-08128 Now Showing: Youssef Nabil's I Saved My Belly Dancer, 19774 2025-08216 Surface Transportation Surface Transportation Board NOTICES Exemption: Abandonment; Lake State Railway Co., Saginaw County, MI, 19775-19776 2025-08182 Acquisition and Operation; Portland and Western Railroad, Inc., Port of Tillamook Bay, 19775 2025-08161 Transportation Department Transportation Department See Federal Aviation Administration See Federal Railroad Administration See Maritime Administration Treasury Treasury Department See Comptroller of the Currency See Internal Revenue Service NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Homeowner Assistance Fund Program Quarterly and Annual Report Forms, 19792 2025-08107 U.S. Sentencing United States Sentencing Commission NOTICES Sentencing Guidelines for United States Courts, 19798-19856 2025-07785 Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guaranteed or Insured Loan Reporting Requirements, 19794-19795 2025-08158 Requests for Nominations:

Advisory Committee on Minority Veterans, 19793-19794 2025-08156 Veterans and Community Oversight and Engagement Board, 19792-19793 2025-08153 Workers' Workers Compensation Programs Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Pharmacy Billing Requirement, 19731-19732 2025-08104 Separate Parts In This Issue Part II United States Sentencing Commission, 19798-19856 2025-07785 Part III Commerce Department, National Oceanic and Atmospheric Administration, 19858-20077 2025-07780 Part IV Presidential Documents, 20079-20081 2025-08382 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.

To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription. 90 89 Friday, May 9, 2025 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 516, 520, 522, and 524 [Docket No. FDA-2025-N-0002] New Animal Drugs; Approval of New Animal Drug Applications;

Withdrawal of Approval of New Animal Drug Application; Change of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendments. SUMMARY: The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during January, February, and March 2025.

The animal drug regulations are also being amended to improve their accuracy and readability. DATES: This rule is effective May 9, 2025. FOR FURTHER INFORMATION CONTACT: Barbara Leotta, DVM, Deputy Office Director, Office of New Animal Product Evaluation Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0605, *Barbara.Leotta@fda.hhs.gov.* SUPPLEMENTARY INFORMATION: I. Approval of New Animal Drug Applications FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during January, February, and March 2025, as listed in table 1.

In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act

(NEPA)and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOIA Summaries) under the Freedom of Information Act (FOIA). These documents, along with marketing exclusivity and patent information, may be obtained at Animal Drugs @FDA: *https://animaldrugsatfda.fda.gov/adafda/views/#/search.* Table 1—Original and Supplemental NADAs and ANADAs Approved During January, February, and March 2025 Requiring Evidence of Safety and/or Effectiveness Date of approval File No. Sponsor (drug labeler code 1 ) Product name Effect of the action 21 CFR section January 13, 2025 200-626 Bimeda Animal Health Ltd. (061133) EPRIMECTIN Pour-On (eprinomectin) Original approval as a generic copy of NADA 141-079 524.814 February 25, 2025 200-742 Hikma Pharmaceuticals USA, Inc. (086194 Tulathromycin Injection (tulathromycin injection) Injectable Solution Original approval as a generic copy of NADA 141-244 522.2630 1 See 21 CFR 510.600(c) for sponsor addresses. II. Withdrawal of Approval of New Animal Drug Applications Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096 (drug labeler code 000010) requested that FDA withdraw approval of ANADA 200-088 for SEDAZINE (xylazine hydrochloride) Injectable Solution because the product is no longer manufactured or marketed. Accordingly, approval of ANADA 200-088 was withdrawn effective December 10, 2023. The animal drug regulations are being amended to reflect this action. III. Changes of Sponsor The sponsors of the approved applications listed in table 3 have informed FDA that they have transferred ownership of, and all rights and interest in, these applications to another sponsor. The regulations cited in table 2 are amended to reflect these actions. Table 2—Applications for Which Ownership Was Transferred to Another Sponsor During January, February, and March 2025 File No. Product name Transferring sponsor (drug labeler code) New sponsor (drug labeler code) 21 CFR section 200-379 VETPROFEN (carprofen) Caplets Belcher Pharmaceuticals, Inc. (051233) Ajenat Pharmaceuticals, LLC (082983) 520.304 200-578 Carprofen Flavored Tablets (carprofen) Do Do 520.304 IV. Technical Amendments FDA is making the following amendments to improve the accuracy and readability of the animal drug regulations. • 21 CFR 510.600(c) is amended to remove entries for Belcher Pharmaceuticals, LLC, as the firm is no longer the sponsor of approved applications, and to add entries for Ajenat Pharmaceuticals, LLC and Hikma Pharmaceuticals USA, Inc. • 21 CFR 522.772 is amended to present an accurate list of bovine parasites. • 21 CFR 522.2005 is amended to introduce sponsor drug labeler codes for approved propofol injectable solution. • 21 CFR 522.2630(c) is amended to present the sequence of drug labeler codes for tulathromycin injectable solutions. V. Legal Authority This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)). Although deemed a rule pursuant to the FD&C Act, this document does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a “rule of particular applicability” and is not subject to the congressional review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive Order 12866. List of Subjects 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Part 516 Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements. 21 CFR Parts 520, 522, and 524 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 510, 516, 520, 522, and 524 are amended as follows: PART 510—NEW ANIMAL DRUGS 1. The authority citation for part 510 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 2. In § 510.600: a. In the table in paragraph (c)(1): i. Remove the entry for “Belcher Pharmaceuticals, LLC”; ii. Add an entry for “Ajenat Pharmaceuticals, LLC”; and iii. Add an entry for “Hikma Pharmaceuticals USA, Inc.”; and b. In the table in paragraph (c)(2): i Remove the entry for “062250”; and ii Add entries for “082983” and “086194”. The additions read as follows: § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.

(c)* * *

(1)* * * Firm name and address Drug labeler code * * * * * * * Ajenat Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Suite 210, Largo, FL 33777 082983 * * * * * * * Hikma Pharmaceuticals USA, Inc., 2 Esterbrook Ln., Cherry Hill, NJ 08003 086194 * * * * * * *

(2)* * * Drug labeler code Firm name and address * * * * * * * 082983 Ajenat Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Suite 210, Largo, FL 33777 * * * * * * * 086194 Hikma Pharmaceuticals USA, Inc., 2 Esterbrook Ln., Cherry Hill, NJ 08003 * * * * * * * PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES 3. The authority citation for part 516 continues to read as follows: Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371. 4. Add § 516.2106 to subpart E to read as follows: § 516.2106 Sirolimus.

(a)*Specifications.* Each sustained-release tablet contains 0.4, 1.2, or 2.4 milligrams

(mg)sirolimus.

(b)*Sponsor.* See No. 086169 in § 510.600(c) of this chapter.

(c)*Conditions of use in cats* —(1) *Amount.* Administer orally once weekly at a dose of 0.3 mg/kilogram of bodyweight.

(2)*Indications for use.* For the management of ventricular hypertrophy in cats with subclinical hypertrophic cardiomyopathy (HCM).

(3)*Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling. 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. § 520.304 [Amended] 6. In § 520.304, in paragraph (b)(1), remove the text “062250” and in its place add the text “082983”. PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 7. The authority citation for part 522 continues to read as follows: Authority: 21 U.S.C. 360b. § 522.772 [Amended] 8. In § 522.772, in paragraph (d)(1)(ii), remove the text “ *Oncophora, Cooperia pectinata* (adults only)” and in its place add the text “ *Cooperia oncophora, C. pectinata* (adults only)” 9. In § 522.2005, revise paragraph

(b)introductory text to read as follows: § 522.2005 Propofol.

(b)*Sponsors.* See sponsor numbers in § 510.600(c) of this chapter. § 522.2662 [Amended] 10. In § 522.2662, in paragraph (b)(2), remove the text “Nos. 000010 and 061133” and in its place add the text “No. 061133”. PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 11. The authority citation for part 524 continues to read as follows: Authority: 21 U.S.C. 360b. § 524.814 [Amended] 12. In § 524.814, in paragraph (b), remove the text “and 055529” and in its place add the text “055529, and 061133”. Dated: May 5, 2025. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2025-08137 Filed 5-8-25; 8:45 am]

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