{"description":"Documents matching 'previously published supplemental guidance documents'","count":10000,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=previously+published+supplemental+guidance+documents&format=json&page=2","results":[{"title":"Supplemental Guidance for Examination of Design Patent Applications Related to Computer-Generated Interfaces and Icons","type":"Notice","abstract":"The United States Patent and Trademark Office (USPTO) has recently received feedback that previously-issued guidance may unnecessarily limit flexibility for design applicants in the field of computer-generated interfaces and icons. Upon review, the USPTO has decided to update its guidance for determining whether a design claim including a computer-generated electronic image constitutes statutory subject matter. The USPTO is issuing this updated supplemental guidance to provide design patent applicants with more flexibility in choosing how to present a new, original, and ornamental design for a computer- generated interface or icon when filing a design patent application with the USPTO.","document_number":"2026-04987","html_url":"https://www.federalregister.gov/documents/2026/03/13/2026-04987/supplemental-guidance-for-examination-of-design-patent-applications-related-to-computer-generated","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-13/pdf/2026-04987.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-04987.pdf?1773319518","publication_date":"2026-03-13","agencies":[{"raw_name":"DEPARTMENT OF COMMERCE","name":"Commerce Department","id":54,"url":"https://www.federalregister.gov/agencies/commerce-department","json_url":"https://www.federalregister.gov/api/v1/agencies/54","parent_id":null,"slug":"commerce-department"},{"raw_name":"United States Patent and Trademark Office","name":"Patent and Trademark Office","id":402,"url":"https://www.federalregister.gov/agencies/patent-and-trademark-office","json_url":"https://www.federalregister.gov/api/v1/agencies/402","parent_id":54,"slug":"patent-and-trademark-office"}],"excerpts":"User Interfaces, \n 88 FR 80277 (November 17, 2023) and its corrected notice, 89 FR 5506 (January 29, 2024) (collectively, 2023 <span class=\"match\">Supplemental</span> <span class=\"match\">Guidance</span>). The 2023 <span class=\"match\">Supplemental</span> <span class=\"match\">Guidance</span> has been incorporated into section 1504.01(a), subsection (I) of the MPEP. The 2023 <span class=\"match\">Supplemental</span> <span class=\"match\">Guidance</span> did not provide <span class=\"match\">guidance</span> concerning designs involving PHVAR. The USPTO received 7 comments in response to the 2023 <span class=\"match\">Supplemental</span> <span class=\"match\">Guidance</span>, which can be found at \n https://www.regulations.gov/docket/PTO-P-2023-0047/comments. \n Several commenters suggested that the USPTO"},{"title":"Classification Categories for Certain Supplements Under Biosimilar User Fee Amendments III; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Classification Categories for Certain Supplements Under BsUFA III.\" This guidance provides recommendations for applicants on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements submitted to approved applications for biosimilar and interchangeable biosimilar products under the Public Health Service Act (PHS Act). The commitment letter associated with the Biosimilar User Fee Amendments of 2022 (BsUFA III) sets forth these supplement classification categories and their associated review performance goals. This guidance is intended to help applicants identify the appropriate classification category and review goal date of the supplement being submitted. This guidance finalizes and replaces the draft guidance of the same title issued on August 11, 2023.","document_number":"2025-17290","html_url":"https://www.federalregister.gov/documents/2025/09/09/2025-17290/classification-categories-for-certain-supplements-under-biosimilar-user-fee-amendments-iii-guidance","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-09/pdf/2025-17290.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-17290.pdf?1757335513","publication_date":"2025-09-09","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027 \n .\n \n This <span class=\"match\">guidance</span> finalizes the draft <span class=\"match\">guidance</span> entitled “Classification Categories for Certain <span class=\"match\">Supplements</span> Under BsUFA III” issued on August 11, 2023 (88 FR 54626). FDA considered comments received on the draft <span class=\"match\">guidance</span> as the <span class=\"match\">guidance</span> was finalized. Changes from the draft to the final <span class=\"match\">guidance</span> include clarification that the <span class=\"match\">guidance</span> does not include recommendations for manufacturing-only <span class=\"match\">supplements</span> or for all <span class=\"match\">supplements</span> for safety-related updates to the labeling, clarification that applicants"},{"title":"Statistical Approaches To Establishing Bioequivalence; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Statistical Approaches to Establishing Bioequivalence.\" This guidance provides recommendations to sponsors and applicants planning to use equivalence criteria in analyzing bioequivalence (BE) studies for investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and amendments and supplements to these applications. The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations. This guidance finalizes the draft guidance of the same title issued on December 5, 2022, and replaces the guidance of the same title issued on February 2, 2001.","document_number":"2026-10705","html_url":"https://www.federalregister.gov/documents/2026/05/29/2026-10705/statistical-approaches-to-establishing-bioequivalence-guidance-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-29/pdf/2026-10705.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10705.pdf?1779972316","publication_date":"2026-05-29","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"on how to use these approaches both generally and in specific situations. This <span class=\"match\">guidance</span> finalizes the draft <span class=\"match\">guidance</span> of the same title issued on December 5, 2022, and replaces the <span class=\"match\">guidance</span> of the same title issued on February 2, 2001. \n \n \n DATES: \n \n The announcement of the <span class=\"match\">guidance</span> is <span class=\"match\">published</span> in the \n Federal Register \n on May 29, 2026.\n \n \n \n ADDRESSES: \n You may submit either electronic or written comments on Agency <span class=\"match\">guidances</span> at any time as follows: \n \n Electronic Submissions \n Submit electronic comments in the following way: \n \n • \n Federal"},{"title":"Administrative Rulemaking, Guidance, and Enforcement Procedures","type":"Rule","abstract":"This final rule reinstates and expounds upon procedural reforms for the Department's rulemakings, guidance documents, and enforcement actions rescinded by a final rule published by the Department on April 2, 2021, \"Administrative Rulemaking, Guidance, and Enforcement Procedures.\" Accordingly, this final rule revises and updates the Department's internal policies and procedures relating to the issuance of rulemaking documents. In addition, this final rule updates the Department's procedural requirements governing the review and clearance of guidance documents, and the initiation and conduct of enforcement actions, including administrative enforcement proceedings and judicial enforcement actions brought in Federal court.","document_number":"2026-08144","html_url":"https://www.federalregister.gov/documents/2026/04/27/2026-08144/administrative-rulemaking-guidance-and-enforcement-procedures","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-27/pdf/2026-08144.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08144.pdf?1777034711","publication_date":"2026-04-27","agencies":[{"raw_name":"DEPARTMENT OF TRANSPORTATION","name":"Transportation Department","id":492,"url":"https://www.federalregister.gov/agencies/transportation-department","json_url":"https://www.federalregister.gov/api/v1/agencies/492","parent_id":null,"slug":"transportation-department"},{"raw_name":"Office of the Secretary of Transportation","name":"Transportation Department","id":492,"url":"https://www.federalregister.gov/agencies/transportation-department","json_url":"https://www.federalregister.gov/api/v1/agencies/492","parent_id":null,"slug":"transportation-department"},{"raw_name":"Pipeline and Hazardous Materials Safety Administration","name":"Pipeline and Hazardous Materials Safety Administration","id":408,"url":"https://www.federalregister.gov/agencies/pipeline-and-hazardous-materials-safety-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/408","parent_id":492,"slug":"pipeline-and-hazardous-materials-safety-administration"},{"raw_name":"Federal Motor Carrier Safety Administration","name":"Federal Motor Carrier Safety Administration","id":181,"url":"https://www.federalregister.gov/agencies/federal-motor-carrier-safety-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/181","parent_id":492,"slug":"federal-motor-carrier-safety-administration"},{"raw_name":"National Highway Traffic Safety Administration","name":"National Highway Traffic Safety Administration","id":345,"url":"https://www.federalregister.gov/agencies/national-highway-traffic-safety-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/345","parent_id":492,"slug":"national-highway-traffic-safety-administration"},{"raw_name":"Federal Transit Administration","name":"Federal Transit Administration","id":193,"url":"https://www.federalregister.gov/agencies/federal-transit-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/193","parent_id":492,"slug":"federal-transit-administration"}],"excerpts":"of a “<span class=\"match\">guidance</span> <span class=\"match\">document</span>.” The Department declines to change the definition of a “<span class=\"match\">guidance</span> <span class=\"match\">document</span>” in this final rule but notes that if such a reinterpretation otherwise satisfies the definition, then it would be a <span class=\"match\">guidance</span> <span class=\"match\">document</span>.\n \n This final rule reinstates procedures regarding the review and clearance of <span class=\"match\">guidance</span> <span class=\"match\">documents</span> rescinded by the 2021 amendments. The procedures ensure that all <span class=\"match\">guidance</span> <span class=\"match\">documents</span> receive legal review and, when appropriate, Office of the Secretary review. One commenter suggested that all <span class=\"match\">guidance</span> <span class=\"match\">documents</span> (not just"},{"title":"EPA's Clean Water Act (CWA) Financial Capability Assessment (FCA) Guidance; Request for Comment","type":"Notice","abstract":"The U.S. Environmental Protection Agency (EPA) invites written feedback on its Clean Water Act (CWA) Financial Capability Assessment (FCA) Guidance. The FCA Guidance provides information on how to assess a community's financial capability as part of negotiating implementation schedules under both permits and enforcement agreements. In addition, the FCA Guidance identifies specific methodologies, supplementing the Interim Economic Guidance for Water Quality Standards (1995; https://www.epa.gov/system/files/documents/2024-01/interim- economic-guidance-water-quality-standards-workbook-1995.pdf), that can be used to consider economic impacts to public entities when determining water quality standards (WQS) variances and antidegradation reviews. In appropriate cases, these methodologies also inform decisions about revisions to designated uses. As part of the agency's commitment to implementing CWA objectives in an effective manner, EPA continues to enhance understanding of the issues surrounding FCAs for communities and seeks ways to improve the guidance. The agency will use this input to determine whether updates to the guidance are necessary to provide clear recommendations that accurately identify a community's financial capability. EPA is requesting comment on its CWA FCA guidance.","document_number":"2026-05864","html_url":"https://www.federalregister.gov/documents/2026/03/26/2026-05864/epas-clean-water-act-cwa-financial-capability-assessment-fca-guidance-request-for-comment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-26/pdf/2026-05864.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-05864.pdf?1774442720","publication_date":"2026-03-26","agencies":[{"raw_name":"ENVIRONMENTAL PROTECTION AGENCY","name":"Environmental Protection Agency","id":145,"url":"https://www.federalregister.gov/agencies/environmental-protection-agency","json_url":"https://www.federalregister.gov/api/v1/agencies/145","parent_id":null,"slug":"environmental-protection-agency"}],"excerpts":"the Current FCA <span class=\"match\">Guidance</span> \n II. Four Key Areas for FCA Revision \n III. Request for Public Comments \n \n EPA's Financial Capability Assessment <span class=\"match\">Guidance</span> \n I. Purpose of Revisions to the Current FCA <span class=\"match\">Guidance</span> \n \n This effort will revise, as needed, <span class=\"match\">previous</span> versions of the CWA FCA <span class=\"match\">Guidance</span>, including the draft <span class=\"match\">guidance</span> released in 2022 (\n https://www.regulations.gov/<span class=\"match\">document</span>/EPA-HQ-OW-2020-0426-0071 \n ) and the most recent <span class=\"match\">guidance</span> originally <span class=\"match\">published</span> in March 2023 and revised in March 2024 (\n https://www.epa.gov/system/files/<span class=\"match\">documents</span>/2023-01/cwa-fi"},{"title":"Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.\" This guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs), ANDA amendments, and ANDA supplements. In addition, this guidance describes how to meet the BE requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations. This guidance finalizes the draft guidance for industry of the same title issued on August 23, 2021.","document_number":"2026-10703","html_url":"https://www.federalregister.gov/documents/2026/05/29/2026-10703/bioequivalence-studies-with-pharmacokinetic-endpoints-for-drugs-submitted-under-an-abbreviated-new","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-29/pdf/2026-10703.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10703.pdf?1779972316","publication_date":"2026-05-29","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"conducted during the postapproval period for changes to a drug product approved under an ANDA.\n \n This <span class=\"match\">guidance</span> finalizes the draft <span class=\"match\">guidance</span> for industry of the same title issued on August 23, 2021 (86 FR 47117). FDA considered comments received on the draft <span class=\"match\">guidance</span> as the <span class=\"match\">guidance</span> was finalized. Changes from the draft to the final <span class=\"match\">guidance</span> include: (1) updates to align the recommendations in the <span class=\"match\">guidance</span> with the recommendations in the <span class=\"match\">guidance</span> for industry entitled “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms” issued on October"},{"title":"Rental Assistance Demonstration: Supplemental Guidance on Revised RAD Notice","type":"Notice","abstract":"The Rental Assistance Demonstration (RAD) provides the opportunity to test the conversion of assistance of public housing properties and other HUD-assisted properties to long-term, project- based Section 8 rental assistance. This Federal Register notice announces the posting of a supplement to the most current notice (Revised RAD Notice Revision 4, H-2019-09/PIH-2019-23 (HA)). As provided by the RAD Statute, this notice addresses the requirement that RAD may proceed after publication of notice of its terms in the Federal Register. This notice summarizes the key changes made to H-2019-09/PIH- 2019-23 (HA) through the RAD Supplemental Notice 4C, H-2025-01/PIH- 2025-03 (HA). This notice also meets the RAD statutory requirement to publish waivers and alternative requirements at least 10 days before effective, while this does not prevent the demonstration, as modified, from proceeding immediately.","document_number":"2025-11004","html_url":"https://www.federalregister.gov/documents/2025/06/16/2025-11004/rental-assistance-demonstration-supplemental-guidance-on-revised-rad-notice","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-16/pdf/2025-11004.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-11004.pdf?1749818726","publication_date":"2025-06-16","agencies":[{"raw_name":"DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT","name":"Housing and Urban Development Department","id":228,"url":"https://www.federalregister.gov/agencies/housing-and-urban-development-department","json_url":"https://www.federalregister.gov/api/v1/agencies/228","parent_id":null,"slug":"housing-and-urban-development-department"}],"excerpts":"(42 U.S.C. 1437f) (the 1937 Act).\n \n \n HUD has <span class=\"match\">previously</span> <span class=\"match\">published</span> its waivers and alternative requirements for RAD on July 26, 2012 (77 FR 43850), July 2, 2013 (78 FR 39759), June 26, 2015 (80 FR 36830), January 19, 2017 (82 FR 6615), July 3, 2018 (83 FR 31169), October 10, 2019 (84 FR 54630), and August 21, 2023 (88 FR 56764). This notice only includes waivers and alternative requirements not <span class=\"match\">previously</span> <span class=\"match\">published</span>. This notice does not include waivers of regulations that were <span class=\"match\">previously</span> <span class=\"match\">published</span> or where regulatory references in the RAD Notice"},{"title":"Administrative Rulemaking, Guidance, and Enforcement Procedures","type":"Proposed Rule","abstract":"This NPRM proposes to reinstate and expound upon procedural reforms for the Department's rulemakings, guidance documents, and enforcement actions rescinded by a final rule published by the Department on April 2, 2021, \"Administrative Rulemaking, Guidance, and Enforcement Procedures.\" Accordingly, this proposed rule would revise and update the Department's internal policies and procedures relating to the issuance of rulemaking documents. In addition, this NPRM proposes updates to the Department's procedural requirements governing the review and clearance of guidance documents, and the initiation and conduct of enforcement actions, including administrative enforcement proceedings and judicial enforcement actions brought in Federal court.","document_number":"2025-08724","html_url":"https://www.federalregister.gov/documents/2025/05/16/2025-08724/administrative-rulemaking-guidance-and-enforcement-procedures","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-05-16/pdf/2025-08724.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-08724.pdf?1747313116","publication_date":"2025-05-16","agencies":[{"raw_name":"DEPARTMENT OF TRANSPORTATION","name":"Transportation Department","id":492,"url":"https://www.federalregister.gov/agencies/transportation-department","json_url":"https://www.federalregister.gov/api/v1/agencies/492","parent_id":null,"slug":"transportation-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"in this subpart, some OA <span class=\"match\">guidance</span> <span class=\"match\">documents</span> will require review and clearance by OGC. \n (b) <span class=\"match\">Guidance</span> proposed to be issued by a component of OST must be reviewed and cleared by OGC. \n \n \n § 5.29 \n \n DOT's review and clearance of <span class=\"match\">guidance</span> shall ensure that each <span class=\"match\">guidance</span> <span class=\"match\">document</span> proposed to be issued by an OA or component of OST satisfies the following requirements: \n (a) The <span class=\"match\">guidance</span> <span class=\"match\">document</span> complies with all relevant statutes and regulation (including any statutory deadlines for agency action); \n (b) The <span class=\"match\">guidance</span> <span class=\"match\">document</span> identifies or includes:"},{"title":"Guidance on Multimodal State Freight Plans and State Freight Advisory Committees","type":"Notice","abstract":"The Fixing America's Surface Transportation (FAST) Act included a provision requiring each State that receives funding under the National Highway Freight Program (NHFP) to develop a State Freight Plan (the Plan) that provides a comprehensive approach for the immediate and long-range planning activities and investments of the State with respect to freight, and meets all the required plan contents listed in the Act. The Infrastructure Investment and Jobs Act (IIJA) added several new required elements and updated procedures for State Freight Plans. This guidance document updates and replaces the prior guidance on State Freight Plans and State Freight Advisory Committees issued on January 12, 2023. It also updates the guidance to be consistent with recent Executive Orders issued by President Trump and DOT Orders issued by Secretary Duffy. Except for any requirements specified in the statutes cited in the guidance document, the contents of this guidance document do not have the force and effect of law and do not bind the public in any way. The contents will not be relied upon by the Department as a separate basis for affirmative enforcement action or other administrative penalty. Conformity with any recommendations in this guidance document, as distinct from statutory requirements, is voluntary only, and nonconformity will not affect rights and obligations under existing statutes.","document_number":"2026-03648","html_url":"https://www.federalregister.gov/documents/2026/02/24/2026-03648/guidance-on-multimodal-state-freight-plans-and-state-freight-advisory-committees","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-24/pdf/2026-03648.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-03648.pdf?1771854314","publication_date":"2026-02-24","agencies":[{"raw_name":"DEPARTMENT OF TRANSPORTATION","name":"Transportation Department","id":492,"url":"https://www.federalregister.gov/agencies/transportation-department","json_url":"https://www.federalregister.gov/api/v1/agencies/492","parent_id":null,"slug":"transportation-department"}],"excerpts":"elements and updated procedures for State Freight Plans. This <span class=\"match\">guidance</span> <span class=\"match\">document</span> updates and replaces the prior <span class=\"match\">guidance</span> on State Freight Plans and State Freight Advisory Committees issued on January 12, 2023. It also updates the <span class=\"match\">guidance</span> to be consistent with recent Executive Orders issued by President Trump and DOT Orders issued by Secretary Duffy. Except for any requirements specified in the statutes cited in the <span class=\"match\">guidance</span> <span class=\"match\">document</span>, the contents of this <span class=\"match\">guidance</span> <span class=\"match\">document</span> do not have the force and effect of law and do not bind the public in any way. The"},{"title":"Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products.\" This document provides guidance on the appropriate use of Bayesian methods in clinical trials. The primary focus is on the use of Bayesian methods to support primary inference in pivotal clinical trials designed to support the effectiveness and safety of drug and biological products.","document_number":"2026-00325","html_url":"https://www.federalregister.gov/documents/2026/01/12/2026-00325/use-of-bayesian-methodology-in-clinical-trials-of-drug-and-biological-products-draft-guidance-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-01-12/pdf/2026-00325.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-00325.pdf?1767966312","publication_date":"2026-01-12","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"0910-0001 and 0910-0338, respectively. \n III. Electronic Access \n \n Persons with access to the internet may obtain the draft <span class=\"match\">guidance</span> at \n https://www.fda.gov/drugs/<span class=\"match\">guidance</span>-compliance-regulatory-information/<span class=\"match\">guidances</span>-drugs, \n \n https://www.fda.gov/regulatory-information/search-fda-<span class=\"match\">guidance</span>-<span class=\"match\">documents</span>, \n \n https://www.fda.gov/vaccines-blood-biologics/<span class=\"match\">guidance</span>-compliance-regulatory-information-biologics/biologics-<span class=\"match\">guidances</span>, \n or \n https://www.regulations.gov. \n \n \n \n Lowell M. Zeta, \n Acting Deputy Commissioner for Policy, Legislation, and International"},{"title":"M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms; International Council for Harmonisation; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms\" and the supplemental document entitled \"M13A Bioequivalence for Immediate- Release Solid Oral Dosage Forms: Questions and Answers.\" The guidance and supplemental questions and answers document were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance describes the scientific and technical aspects of study design and data analysis to support bioequivalence (BE) assessment of orally administered immediate-release solid oral dosage forms of pharmaceutical drugs, such as tablets, capsules, and granules/powders for oral suspension. The supplemental questions and answers document provides clarity to concepts covered in the guidance and rationales behind to facilitate implementation. The guidance is intended to provide globally harmonized scientific recommendations for conducting BE studies during both the development and postapproval phases of immediate-release solid oral dosage forms. The guidance replaces the draft guidance \"M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms\" issued on February 1, 2023.","document_number":"2024-25355","html_url":"https://www.federalregister.gov/documents/2024/10/31/2024-25355/m13a-bioequivalence-for-immediate-release-solid-oral-dosage-forms-international-council-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-31/pdf/2024-25355.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-25355.pdf?1730292354","publication_date":"2024-10-31","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":" \n This <span class=\"match\">guidance</span> finalizes the draft <span class=\"match\">guidance</span> issued on February 1, 2023. The final <span class=\"match\">guidance</span> includes clarification on the scientific and technical aspects of study design and data analysis to support BE assessment for orally administered immediate-release solid oral dosage forms. The <span class=\"match\">supplemental</span> questions and answers <span class=\"match\">document</span> provides further clarification and examples of the technical aspects of the main <span class=\"match\">guidance</span> in order to effectively implement the <span class=\"match\">guidance</span>. The internationally harmonized <span class=\"match\">guidance</span> and questions and answers <span class=\"match\">document</span> aim to increase"},{"title":"Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications.\" This guidance provides information to applicants on how FDA intends to use alternative tools to assess drug manufacturing facilities identified in a marketing application (i.e., a new drug application (NDA), an abbreviated new drug application (ANDA), a biologics license application (BLA), or a supplement to any of these types of applications). As part of the negotiations relating to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA), as described in \"PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027\" (PDUFA VII commitment letter) and \"Biosimilar Biological Product Reauthorization Performance Goals and Procedures for Fiscal Years 2023 Through 2027\" (BsUFA III commitment letter), FDA agreed to issue guidance on the use of alternative tools to assess manufacturing facilities named in pending applications and to incorporate best practices from the use of such tools during the Coronavirus Disease 2019 (COVID-19) pandemic. This guidance finalizes the draft guidance of the same title issued on September 22, 2023.","document_number":"2025-17698","html_url":"https://www.federalregister.gov/documents/2025/09/12/2025-17698/alternative-tools-assessing-drug-manufacturing-facilities-identified-in-pending-applications","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-12/pdf/2025-17698.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-17698.pdf?1757594721","publication_date":"2025-09-12","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"been approved under OMB control number 0910-0338. \n III. Electronic Access \n \n Persons with access to the internet may obtain the <span class=\"match\">guidance</span> at\n https://www.fda.gov/drugs/<span class=\"match\">guidance</span>-compliance-regulatory-information/<span class=\"match\">guidances</span>-drugs, https://www.fda.gov/vaccines-blood-biologics/<span class=\"match\">guidance</span>-compliance-regulatory-information-biologics/biologics-<span class=\"match\">guidances</span>, https:/www.fda.gov/regulatory-information/search-fda-<span class=\"match\">guidance</span>-<span class=\"match\">documents</span>, \n or \n https://www.regulations.gov. \n \n \n Grace R. Graham, \n Deputy Commissioner for Policy, Legislation, and International Affairs"},{"title":"Notice of Availability: Supplemental Guidance for CPSC Chronic Hazard Guidelines","type":"Notice","abstract":"The Consumer Product Safety Commission (Commission or CPSC) is announcing the availability of final supplemental guidance for its Chronic Hazard Guidelines. This supplemental guidance contains two guidance documents, one for the use of benchmark dose methodology in risk assessment and the other for the analysis of uncertainty and variability in risk assessment.","document_number":"2024-08604","html_url":"https://www.federalregister.gov/documents/2024/04/23/2024-08604/notice-of-availability-supplemental-guidance-for-cpsc-chronic-hazard-guidelines","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-04-23/pdf/2024-08604.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-08604.pdf?1713789922","publication_date":"2024-04-23","agencies":[{"raw_name":"CONSUMER PRODUCT SAFETY COMMISSION","name":"Consumer Product Safety Commission","id":84,"url":"https://www.federalregister.gov/agencies/consumer-product-safety-commission","json_url":"https://www.federalregister.gov/api/v1/agencies/84","parent_id":null,"slug":"consumer-product-safety-commission"}],"excerpts":"release of the <span class=\"match\">guidance</span>, technical details of benchmark dose modeling, how to determine risk assessment approaches in the context of the <span class=\"match\">guidance</span>, and the citation of references after the 2008 peer review of the <span class=\"match\">supplemental</span> <span class=\"match\">guidance</span>. \n \n Comment 1: \n NCHR noted that time has passed since a draft of the <span class=\"match\">Supplemental</span> <span class=\"match\">Guidance</span> was peer reviewed in 2008.\n \n \n Response 1: \n Although the <span class=\"match\">Supplemental</span> <span class=\"match\">Guidance</span> might have been finalized earlier, the methods and approaches described in the Chronic Hazard Guidelines and the <span class=\"match\">Supplemental</span> <span class=\"match\">Guidance</span> are neither"},{"title":"Certification Process for Designated Medical Gases; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"Certification Process for Designated Medical Gases.\" This guidance explains how FDA administers the certification process and describes the annual reporting requirements for designated medical gases (DMGs). Specifically, the guidance discusses what products qualify as DMGs, who must submit a certification request, what information must be submitted, and how FDA will evaluate and act on the request. This draft guidance is being issued to reflect new and revised regulations in several areas to reduce the regulatory burden, as appropriate, for the medical gas industry. This draft guidance revises and replaces the draft guidance of the same name issued in November 2015, which was withdrawn on December 18, 2025.","document_number":"2026-02789","html_url":"https://www.federalregister.gov/documents/2026/02/12/2026-02789/certification-process-for-designated-medical-gases-draft-guidance-for-industry-availability-agency","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02789.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-02789.pdf?1770817508","publication_date":"2026-02-12","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"download at \n https://www.regulations.gov/search?filter=FDA-2012-D-1197. \n \n \n All Agency <span class=\"match\">guidance</span> <span class=\"match\">documents</span> are issued in accordance with our good <span class=\"match\">guidance</span> practice regulations in 21 CFR 10.115, which provide for public comment at any time. We maintain a searchable <span class=\"match\">guidance</span> database on our website at \n https://www.fda.gov/regulatory-information/search-fda-<span class=\"match\">guidance</span>-<span class=\"match\">documents</span> \n that utilizes topic-specific search terms. We intend to finalize the <span class=\"match\">guidance</span> <span class=\"match\">document</span> upon OMB approval of the attendant information collection.\n \n The use of cover letters"},{"title":"Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for immediate implementation entitled \"Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).\" FDA is issuing this guidance to assist establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations for screening donors for evidence of, and risk factors for, infection with Mycobacterium tuberculosis (Mtb), the organism that causes tuberculosis. The guidance also recommends additional steps that HCT/P establishments should take to reduce risk of transmission of Mtb until such time as appropriate FDA-licensed, approved, or cleared donor screening tests are available for use to test donors for Mtb infection. The guidance identifies Mtb as a relevant communicable disease agent or disease (RCDAD) and supplements the recommendations contained in other donor eligibility guidance documents for donors of HCT/Ps. This guidance is being issued to address the urgent public health need to reduce the risk of transmission of Mtb by HCT/Ps.","document_number":"2024-31544","html_url":"https://www.federalregister.gov/documents/2025/01/07/2024-31544/recommendations-to-reduce-the-risk-of-transmission-of-mycobacterium-tuberculosis-by-human-cells","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31544.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31544.pdf?1736171123","publication_date":"2025-01-07","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"control number 0910-0543. \n III. Electronic Access \n \n Persons with access to the internet may obtain the <span class=\"match\">guidance</span> at \n https://www.fda.gov/vaccines-blood-biologics/<span class=\"match\">guidance</span>-compliance-regulatory-information-biologics/biologics-<span class=\"match\">guidances</span>, https://www.fda.gov/regulatory-information/search-fda-<span class=\"match\">guidance</span>-<span class=\"match\">documents</span>, \n or \n https://www.regulations.gov. \n Use the FDA website listed in the <span class=\"match\">previous</span> sentence to find the most current version of the <span class=\"match\">guidance</span>.\n \n \n Dated: December 27, 2024. \n Kimberlee Trzeciak, \n Deputy Commissioner for Policy, Legislation, and"},{"title":"Updated Staple Food Stocking Standards for Retailers in the Supplemental Nutrition Assistance Program","type":"Rule","abstract":"This rule codifies a new framework for determining distinct staple food varieties for meeting staple food stocking requirements for retailer participation in the Supplemental Nutrition Assistance Program (SNAP). This rule is needed to implement the previously codified provision of the Agricultural Act of 2014 which increased the minimum number of staple food varieties a SNAP retailer must carry from three to seven in each of four staple food categories and the number of food categories for which at least one perishable variety must be provided from two to three. These changes aim to ensure that SNAP retailers can effectively serve SNAP participants by offering a wider variety of staple foods.","document_number":"2026-09137","html_url":"https://www.federalregister.gov/documents/2026/05/08/2026-09137/updated-staple-food-stocking-standards-for-retailers-in-the-supplemental-nutrition-assistance","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-08/pdf/2026-09137.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-09137.pdf?1778157912","publication_date":"2026-05-08","agencies":[{"raw_name":"DEPARTMENT OF AGRICULTURE","name":"Agriculture Department","id":12,"url":"https://www.federalregister.gov/agencies/agriculture-department","json_url":"https://www.federalregister.gov/api/v1/agencies/12","parent_id":null,"slug":"agriculture-department"},{"raw_name":"Food and Nutrition Service","name":"Food and Nutrition Service","id":200,"url":"https://www.federalregister.gov/agencies/food-and-nutrition-service","json_url":"https://www.federalregister.gov/api/v1/agencies/200","parent_id":12,"slug":"food-and-nutrition-service"}],"excerpts":"Analysis (RIA) for this rulemaking was <span class=\"match\">published</span> as part of the docket in Supporting <span class=\"match\">Documents</span> on \n www.regulations.gov. \n A summary of the RIA follows. This rule is considered an E.O. 14192 regulatory action.\n \n Regulatory Impact Analysis \n \n Need for Action: \n In response to section 765 of the Consolidated Appropriation Act of 2017 and corresponding sections in subsequent enacted appropriations, the United States Department of Agriculture (the Department) Food and Nutrition Service (FNS) is revising the <span class=\"match\">Supplemental</span> Nutrition Assistance Program (SNAP)"},{"title":"Computer Software Assurance for Production and Quality System Software; Guidance for Industry and Food and Drug Administration Staff; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Computer Software Assurance for Production and Quality System Software.\" FDA is issuing this guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system. FDA believes that these recommendations will help foster the adoption and use of innovative technologies that promote patient access to high-quality medical devices and help manufacturers to keep pace with the dynamic, rapidly changing technology landscape, while promoting compliance with laws and regulations implemented by FDA.","document_number":"2025-18468","html_url":"https://www.federalregister.gov/documents/2025/09/24/2025-18468/computer-software-assurance-for-production-and-quality-system-software-guidance-for-industry-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-24/pdf/2025-18468.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-18468.pdf?1758631511","publication_date":"2025-09-24","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"interested in obtaining a copy of the <span class=\"match\">guidance</span> may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health <span class=\"match\">guidance</span> <span class=\"match\">documents</span> is available at \n https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/<span class=\"match\">guidance</span>-<span class=\"match\">documents</span>-medical-devices-and-radiation-emitting-products \n . This <span class=\"match\">guidance</span> <span class=\"match\">document</span> is also available at \n https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-<span class=\"match\">guidance</span>-<span class=\"match\">documents</span>, \n or \n https://www.fda.gov/vacc"},{"title":"Agency Information Collection Activities; Comment Request on U.S. Trust and Estate Income Tax Returns and Related Forms, Schedules, Attachments, and Published Guidance","type":"Notice","abstract":"In accordance with the Paperwork Reduction Act of 1995, the IRS is inviting comments on the information collection request outlined in this notice.","document_number":"2025-13802","html_url":"https://www.federalregister.gov/documents/2025/07/23/2025-13802/agency-information-collection-activities-comment-request-on-us-trust-and-estate-income-tax-returns","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-23/pdf/2025-13802.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-13802.pdf?1753188308","publication_date":"2025-07-23","agencies":[{"raw_name":"DEPARTMENT OF THE TREASURY","name":"Treasury Department","id":497,"url":"https://www.federalregister.gov/agencies/treasury-department","json_url":"https://www.federalregister.gov/api/v1/agencies/497","parent_id":null,"slug":"treasury-department"},{"raw_name":"Internal Revenue Service","name":"Internal Revenue Service","id":254,"url":"https://www.federalregister.gov/agencies/internal-revenue-service","json_url":"https://www.federalregister.gov/api/v1/agencies/254","parent_id":497,"slug":"internal-revenue-service"}],"excerpts":"inefficiencies caused by sub-optimal choices related to tax deductions or credits, or psychological costs. \n Proposed PRA Submission to OMB \n \n Title: \n U.S. Trust and Estate Income Tax Returns and Related Forms, Schedules, Attachments, and <span class=\"match\">Published</span> <span class=\"match\">Guidance</span>.\n \n \n OMB Number: \n 1545-0092.\n \n \n Form Numbers and <span class=\"match\">Published</span> <span class=\"match\">Guidance</span>: \n 1041, 1041 A, 1041 ES, 1041 ES (OCR), 1041 N, 1041 QFT, 1041 SCH D, 1041 SCH I, 1041 SCH J, 1041 SCH K-1, 1041 T, 1041 V, 172, 461, 926, 965 A, 970, 982, 1040 SCH C, 1040 SCH E, 1040 SCH F, 1040 SCH H, 1045, 1065 SCH D, 1065 SCH"},{"title":"Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled \"Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.\" The guidance focuses on frequently asked questions about the new dietary ingredient notification submission and review process. The guidance is intended to help manufacturers and distributors of new dietary ingredients and dietary supplements prepare and submit new dietary ingredient notifications to FDA.","document_number":"2024-04718","html_url":"https://www.federalregister.gov/documents/2024/03/06/2024-04718/dietary-supplements-new-dietary-ingredient-notification-procedures-and-timeframes-guidance-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-03-06/pdf/2024-04718.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-04718.pdf?1709646329","publication_date":"2024-03-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"availability of a final <span class=\"match\">guidance</span> for industry entitled “Dietary <span class=\"match\">Supplements</span>: New Dietary Ingredient Notification Procedures and Timeframes: <span class=\"match\">Guidance</span> for Industry.” The <span class=\"match\">guidance</span> focuses on frequently asked questions about the new dietary ingredient notification submission and review process. The <span class=\"match\">guidance</span> is intended to help manufacturers and distributors of new dietary ingredients and dietary <span class=\"match\">supplements</span> prepare and submit new dietary ingredient notifications to FDA. \n \n \n DATES: \n \n The announcement of the <span class=\"match\">guidance</span> is <span class=\"match\">published</span> in the \n Federal Register"},{"title":"Final Priorities and Definitions-Secretary's Supplemental Priorities and Definitions on Evidence-Based Literacy, Education Choice, and Returning Education to the States","type":"Rule","abstract":"The Department of Education (Department) announces three priorities and related definitions for use in currently authorized discretionary grant programs or programs that may be authorized in the future. The Secretary may choose to use an entire priority for a grant program or a particular competition or use one or more of the priority's component parts. These priorities and definitions replace the Secretary's supplemental priorities published in the Federal Register on December 10, 2021 (86 FR 70612) and all other agency-wide supplemental priorities published prior to January 20, 2025.","document_number":"2025-17310","html_url":"https://www.federalregister.gov/documents/2025/09/09/2025-17310/final-priorities-and-definitions-secretarys-supplemental-priorities-and-definitions-on","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-09/pdf/2025-17310.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-17310.pdf?1757335516","publication_date":"2025-09-09","agencies":[{"raw_name":"DEPARTMENT OF EDUCATION","name":"Education Department","id":126,"url":"https://www.federalregister.gov/agencies/education-department","json_url":"https://www.federalregister.gov/api/v1/agencies/126","parent_id":null,"slug":"education-department"}],"excerpts":"under \n FOR FURTHER INFORMATION CONTACT \n , individuals with disabilities can obtain this <span class=\"match\">document</span> in an accessible format. The Department will provide the requestor with an accessible format that may include Rich Text Format (RTF) or text format (txt), a thumb drive, an MP3 file, braille, large print, audiotape, compact disc, or another accessible format.\n \n \n Electronic Access to This <span class=\"match\">Document</span>: \n The official version of this <span class=\"match\">document</span> is the <span class=\"match\">document</span> <span class=\"match\">published</span> in the \n Federal Register \n . You may access the official edition of the \n Federal Register"}]}