{"description":"Documents matching 'compliance guidance expectations detailed consistently'","count":4318,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=compliance+guidance+expectations+detailed+consistently&format=json&page=2","results":[{"title":"Quality Management System Information for Certain Premarket Submission Reviews; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled \"Quality Management System Information for Certain Premarket Submission Reviews.\" The medical device current good manufacturing practice (CGMP) requirements, previously in the quality system regulation (QS regulation) and now the quality management system regulation (QMSR), have been amended effective February 2, 2026, to align more closely with the international consensus standard for devices by incorporating by reference an international standard specific for device quality management systems. This draft guidance document is intended to assist FDA staff and medical device manufacturers in understanding FDA expectations about preparing and maintaining a Quality Management System (QMS) and providing the information required to be included in certain marketing submissions regarding a QMS, in line with the QMSR. This draft guidance is not final nor is it for implementation at this time.","document_number":"2025-19947","html_url":"https://www.federalregister.gov/documents/2025/11/17/2025-19947/quality-management-system-information-for-certain-premarket-submission-reviews-draft-guidance-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-17/pdf/2025-19947.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-19947.pdf?1763127914","publication_date":"2025-11-17","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":"manufacturers in understanding FDA <span class=\"match\">expectations</span> about preparing and maintaining a QMS and providing the information required to be included in certain marketing submissions regarding a QMS, in line with the QMSR. In addition, this draft <span class=\"match\">guidance</span> is intended to make recommendations regarding information included in these marketing submissions that may help FDA determine <span class=\"match\">compliance</span> with QMSR. \n This draft <span class=\"match\">guidance</span> is being issued <span class=\"match\">consistent</span> with FDA's good <span class=\"match\">guidance</span> practices regulation (21 CFR 10.115). The draft <span class=\"match\">guidance</span>, when finalized, will represent"},{"title":"Q1 Stability Testing of Drug Substances and Drug Products; International Council for Harmonisation; 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 \"Q1 Stability Testing of Drug Substances and Drug Products.\" The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance outlines stability data expectations for drug substances and drug products to support drug product marketing, including marketing authorization applications and, where applicable, drug master files. This draft guidance is a consolidated revision of the ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E, and Q5C series of stability guidances, published November 2003, March 1996, May 1997, January 2003, June 2004, and July 1996, respectively. The revision also provides stability related guidance for product categories such as advanced therapy medicinal products, vaccines, and other complex biological products including combination products that were not previously covered under the existing stability guidances. The draft guidance is intended to provide an internationally harmonized approach to conducting and presenting data on stability testing for drug substances and drug products, as well as providing alternative, scientifically justified approaches that may be encountered due to scientific considerations and characteristics of the data being evaluated.","document_number":"2025-11552","html_url":"https://www.federalregister.gov/documents/2025/06/24/2025-11552/q1-stability-testing-of-drug-substances-and-drug-products-international-council-for-harmonisation","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-24/pdf/2025-11552.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-11552.pdf?1750682712","publication_date":"2025-06-24","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":"OMB control number 0910-0572. \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.regulations.gov, https://www.fda.gov/drugs/<span class=\"match\">guidance</span>-<span class=\"match\">compliance</span>-regulatory-information/<span class=\"match\">guidances</span>-drugs, https://www.fda.gov/vaccines-blood-biologics/<span class=\"match\">guidance</span>-<span class=\"match\">compliance</span>-regulatory-information-biologics/biologics-<span class=\"match\">guidances</span>, \n or \n https://www.fda.gov/regulatory-information/search-fda-<span class=\"match\">guidance</span>-documents. \n \n \n Dated: June 18, 2025. \n Grace R. Graham, \n Deputy Commissioner for Policy, Legislation, and International"},{"title":"Psychedelic Drugs: Considerations for Clinical Investigations; 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 titled \"Psychedelic Drugs: Considerations for Clinical Investigations.\" Because interest in the therapeutic potential of psychedelic drugs has been increasing and designing clinical trials to evaluate these compounds presents unique challenges, FDA developed the draft guidance to present foundational aspects for sponsors to consider. This final guidance provides general considerations for sponsors developing psychedelic drugs for the treatment of medical conditions (e.g., psychiatric disorders, substance use disorders) and discusses recommendations for clinical investigations psychedelic drugs. This guidance finalizes the draft guidance of the same title issued on June 26, 2023.","document_number":"2026-14158","html_url":"https://www.federalregister.gov/documents/2026/07/14/2026-14158/psychedelic-drugs-considerations-for-clinical-investigations-guidance-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-14/pdf/2026-14158.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-14158.pdf?1783946717","publication_date":"2026-07-14","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":"considerations for data collection, data generation, and patient monitoring.\n \n This <span class=\"match\">guidance</span> finalizes the draft <span class=\"match\">guidance</span> of the same title issued on June 26, 2023 (88 FR 41407). FDA considered docket comments received in response to the draft <span class=\"match\">guidance</span> as part of this revision. To enhance clarity, a few revisions were made in this revised version. \n This <span class=\"match\">guidance</span> is being issued <span class=\"match\">consistent</span> with FDA's good <span class=\"match\">guidance</span> practices regulation (21 CFR 10.115). The <span class=\"match\">guidance</span> represents the current thinking of FDA on “Psychedelic Drugs: Considerations for Clinical"},{"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":"comments received and revised the <span class=\"match\">guidance</span> as appropriate in response to the comments, including adding a definitions section to provide clarity on commonly used terms in the <span class=\"match\">guidance</span>, updating examples of manual and automated testing, and adding examples throughout the <span class=\"match\">guidance</span> that apply the concepts in the <span class=\"match\">guidance</span> to different types of software.\n \n This <span class=\"match\">guidance</span> is being issued <span class=\"match\">consistent</span> with FDA's good <span class=\"match\">guidance</span> practices regulation (21 CFR 10.115). The <span class=\"match\">guidance</span> represents the current thinking of FDA on Computer Software Assurance for Production and"},{"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":"definition of a “<span class=\"match\">guidance</span> document.” The Department declines to change the definition of a “<span class=\"match\">guidance</span> document” 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> document.\n \n This final rule reinstates procedures regarding the review and clearance of <span class=\"match\">guidance</span> documents rescinded by the 2021 amendments. The procedures ensure that all <span class=\"match\">guidance</span> documents receive legal review and, when appropriate, Office of the Secretary review. One commenter suggested that all <span class=\"match\">guidance</span> documents (not"},{"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> document 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 <span class=\"match\">consistent</span> 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> document, the contents of this <span class=\"match\">guidance</span> document do not have the force and effect of law and do not bind the public in any way. The"},{"title":"Guidance for Resolution Plan Submissions of Domestic Triennial Full Filers","type":"Notice","abstract":"The Board and the FDIC (together, the agencies) are adopting this final guidance for the 2025 and subsequent resolution plan submissions by certain domestic banking organizations. The final guidance is meant to assist these firms in developing their resolution plans, which are required to be submitted under the Dodd-Frank Wall Street Reform and Consumer Protection Act, as amended (the Dodd-Frank Act), and the jointly issued implementing regulation (the Rule). The scope of application of the final guidance is domestic triennial full filers (specified firms or firms), which are domestic Category II and III banking organizations. The final guidance describes the agencies' expectations, depending on the resolution strategy chosen by the firm, regarding a number of key vulnerabilities in plans for an orderly resolution under the U.S. Bankruptcy Code (i.e., capital; liquidity; governance mechanisms; operational; legal entity rationalization; and insured depository institution (IDI) resolution, if applicable). The final guidance modifies and clarifies certain aspects of the proposed guidance based on the agencies' consideration of comments to the proposal, additional analysis, and further assessment of the business and risk profiles of the firms.","document_number":"2024-18191","html_url":"https://www.federalregister.gov/documents/2024/08/15/2024-18191/guidance-for-resolution-plan-submissions-of-domestic-triennial-full-filers","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-15/pdf/2024-18191.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-18191.pdf?1723639525","publication_date":"2024-08-15","agencies":[{"raw_name":"FEDERAL RESERVE SYSTEM","name":"Federal Reserve System","id":188,"url":"https://www.federalregister.gov/agencies/federal-reserve-system","json_url":"https://www.federalregister.gov/api/v1/agencies/188","parent_id":null,"slug":"federal-reserve-system"},{"raw_name":"FEDERAL DEPOSIT INSURANCE CORPORATION","name":"Federal Deposit Insurance Corporation","id":164,"url":"https://www.federalregister.gov/agencies/federal-deposit-insurance-corporation","json_url":"https://www.federalregister.gov/api/v1/agencies/164","parent_id":null,"slug":"federal-deposit-insurance-corporation"}],"excerpts":"resolution plan <span class=\"match\">guidance</span> contained certain limitations on similar PCS framework <span class=\"match\">expectations</span>,\n 37 \n \n and the final <span class=\"match\">guidance</span> adopts that language to clarify the scope of said <span class=\"match\">expectations</span>.\n \n \n \n 37 \n  2020 FBO <span class=\"match\">Guidance</span> at 85 FR 83572-73.\n \n \n \n Third, the proposed PCS <span class=\"match\">guidance</span> for firms that adopt an SPOE strategy contained several references to “various currencies.” The agencies note that in the finalization of the 2020 FBO <span class=\"match\">Guidance</span>, the agencies revised similar language in response to a comment requesting that certain aspects of that <span class=\"match\">guidance</span> be made"},{"title":"Guidance for Resolution Plan Submissions of Foreign Triennial Full Filers","type":"Notice","abstract":"The Board and the FDIC (together, the agencies) are adopting this final guidance for the 2025 and subsequent resolution plan submissions by certain foreign banking organizations (FBOs). The final guidance is meant to assist these firms in developing their resolution plans, which are required to be submitted under the Dodd-Frank Wall Street Reform and Consumer Protection Act, as amended (the Dodd-Frank Act), and the jointly issued implementing regulation (the Rule). The scope of application of the final guidance is foreign triennial full filers (specified firms or firms), which are foreign Category II and III banking organizations, and the guidance supersedes the joint Guidance for Resolution Plan Submissions of Certain Foreign-Based Covered Companies. The final guidance describes the agencies' expectations, depending on the resolution strategy chosen by the firm, regarding a number of key vulnerabilities in plans for an orderly resolution under the U.S. Bankruptcy Code (i.e., group resolution plan; capital; liquidity; governance mechanisms; operational; legal entity rationalization and separability; branches; and insured depository institution (IDI) resolution, if applicable). The final guidance modifies and clarifies certain aspects of the proposed guidance based on the agencies' consideration of comments to the proposal, additional analysis, and further assessment of the business and risk profiles of the firms.","document_number":"2024-18186","html_url":"https://www.federalregister.gov/documents/2024/08/15/2024-18186/guidance-for-resolution-plan-submissions-of-foreign-triennial-full-filers","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-15/pdf/2024-18186.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-18186.pdf?1723639524","publication_date":"2024-08-15","agencies":[{"raw_name":"FEDERAL RESERVE SYSTEM","name":"Federal Reserve System","id":188,"url":"https://www.federalregister.gov/agencies/federal-reserve-system","json_url":"https://www.federalregister.gov/api/v1/agencies/188","parent_id":null,"slug":"federal-reserve-system"},{"raw_name":"FEDERAL DEPOSIT INSURANCE CORPORATION","name":"Federal Deposit Insurance Corporation","id":164,"url":"https://www.federalregister.gov/agencies/federal-deposit-insurance-corporation","json_url":"https://www.federalregister.gov/api/v1/agencies/164","parent_id":null,"slug":"federal-deposit-insurance-corporation"}],"excerpts":"standards issued pursuant to that section, such as resolution planning <span class=\"match\">guidance</span>; contended that the proposal was too similar to the 2019 U.S. GSIB <span class=\"match\">Guidance</span> or 2020 Proposed FBO <span class=\"match\">Guidance</span>; and encouraged <span class=\"match\">expectations</span> in the final <span class=\"match\">guidance</span> to be further differentiated based on size, risk and other factors. Several commenters also objected to <span class=\"match\">expectations</span> in the proposal that were proposed in the 2020 Proposed FBO <span class=\"match\">Guidance</span> but not finalized in the 2020 FBO <span class=\"match\">Guidance</span>—including <span class=\"match\">guidance</span> on group resolution plans, resolution capital adequacy and positioning"},{"title":"Third Party Contracting Guidance","type":"Notice","abstract":"The Federal Transit Administration (FTA) has made available on its website the final updated Third-Party Contracting Guidance Circular (C 4220.1G). The updated circular reflects statutory and regulatory changes that have occurred since the last update, provides additional non-binding guidance, and supersedes the previous Third-Party Contracting Guidance Circular C 4220.1F. This notice responds to the comments FTA received on the proposed circular, which was published in the Federal Register on November 27, 2024.","document_number":"2025-00992","html_url":"https://www.federalregister.gov/documents/2025/01/16/2025-00992/third-party-contracting-guidance","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-16/pdf/2025-00992.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-00992.pdf?1736948748","publication_date":"2025-01-16","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":"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":"Practices Procurement Manual (BPPM), as it serves as a valuable resource offering practical examples and <span class=\"match\">guidance</span> to assist recipients in navigating complex procurement requirements. The BPPM does not carry regulatory authority. It complements regulations and FTA's other <span class=\"match\">guidance</span> by providing illustrative scenarios and best practices. Recipients can use the BPPM as another <span class=\"match\">guidance</span> tool, applying their own judgment and analysis to ensure <span class=\"match\">compliance</span> with Federal procurement standards.\n \n \n Comment: \n An individual commenter suggested that in construction"},{"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":"elsewhere in this subpart, some OA <span class=\"match\">guidance</span> documents 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> document proposed to be issued by an OA or component of OST satisfies the following requirements: \n (a) The <span class=\"match\">guidance</span> document complies with all relevant statutes and regulation (including any statutory deadlines for agency action); \n (b) The <span class=\"match\">guidance</span> document identifies or includes:"},{"title":"National Standards for the Physical Inspection of Real Estate: Implementation Guidance and Inspection Standards for the HOME Investment Partnerships and Housing Trust Fund Programs","type":"Notice","abstract":"This notice serves as guidance to the \"Economic Growth Regulatory Relief and Consumer Protection Act: Implementation of National Standards for the Physical Inspection of Real Estate\" (NSPIRE) rule published May 11, 2023. The rule provided that HUD publish in the Federal Register an additional notice on the NSPIRE Standards for the HOME Investment Partnerships (HOME) and Housing Trust Fund (HTF) programs. In addition, this notice implements the property standards and inspection provisions in the \"HOME Investment Partnerships Program: Program Updates and Streamlining\" rule published on January 6, 2025. This notice also provides guidance to HOME participating jurisdictions and HTF grantees on how to develop HOME and HTF written property standards and inspect assisted projects in compliance with the NSPIRE final rule and the HOME final rule, as applicable.","document_number":"2026-07176","html_url":"https://www.federalregister.gov/documents/2026/04/14/2026-07176/national-standards-for-the-physical-inspection-of-real-estate-implementation-guidance-and-inspection","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-14/pdf/2026-07176.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07176.pdf?1776084316","publication_date":"2026-04-14","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":"Extension of NSPIRE <span class=\"match\">Compliance</span> Date for HCV, PBV, Section 8 Moderate Rehab and CPD Programs” (89 FR 55645), the <span class=\"match\">compliance</span> date was extended until October 1, 2025. Subsequently, HUD's notice at 90 FR 46912 further extended the <span class=\"match\">compliance</span> date to October 1, 2026. The HOME final rule was effective on February 5, 2025, with a one-year <span class=\"match\">compliance</span> period. However, the notice delayed the effective date of the 2025 HOME final rule until April 20, 2025, with a one-year <span class=\"match\">compliance</span> period. Due to the delay in publication of this notice, the <span class=\"match\">compliance</span> date for HOME"},{"title":"The Accreditation Scheme for Conformity Assessment Program; Draft Guidances for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of three draft guidance documents for the Accreditation Scheme for Conformity Assessment Program entitled \"The Accreditation Scheme for Conformity Assessment (ASCA) Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff;\" \"Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment--Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff;\" and \"Biocompatibility Testing of Medical Devices--Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff.\" In accordance with amendments made by the FDA User Fee Reauthorization Act of 2022 (FUFRA), part of the Medical Device User Fee Amendments of 2022 (MDUFA V), FDA was directed to conclude the Pilot Accreditation Scheme for Conformity Assessment Program by the end of fiscal year 2023 and continue to operate the program (hereafter referred to as the ASCA Program) consistent with the amended FD&C Act. FDA is publishing these draft guidance documents which, when finalized, are intended to provide updates to improve the ASCA Program. These draft guidance documents are not final nor for implementation at this time.","document_number":"2024-21673","html_url":"https://www.federalregister.gov/documents/2024/09/23/2024-21673/the-accreditation-scheme-for-conformity-assessment-program-draft-guidances-for-industry","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-23/pdf/2024-21673.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-21673.pdf?1726836324","publication_date":"2024-09-23","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":"commitments and <span class=\"match\">expectations</span>. \n These draft <span class=\"match\">guidances</span> are being issued <span class=\"match\">consistent</span> with FDA's good <span class=\"match\">guidance</span> practices regulation (21 CFR 10.115). The draft <span class=\"match\">guidances</span>, when finalized, will represent the current thinking of FDA on the ASCA Program. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. \n II. Electronic Access \n \n Persons interested in obtaining a copy of the draft <span class=\"match\">guidance</span> may do so by downloading"},{"title":"Permitted Payment Stablecoin Issuer Anti-Money Laundering/Countering the Financing of Terrorism Program and Sanctions Compliance Program Requirements","type":"Proposed Rule","abstract":"The Department of the Treasury's Financial Crimes Enforcement Network (FinCEN) and Office of Foreign Assets Control (OFAC) are jointly issuing this proposed rule to implement provisions of the Guiding and Establishing National Innovation for U.S. Stablecoins Act (GENIUS Act). Specifically, it implements the GENIUS Act's directive to treat permitted payment stablecoin issuers (PPSIs) as financial institutions for purposes of the Bank Secrecy Act, proposes anti-money laundering obligations for PPSIs, and proposes certain specific obligations required by the GENIUS Act for PPSIs. It also implements the GENIUS Act's directive to require PPSIs to maintain effective sanctions compliance programs.","document_number":"2026-06963","html_url":"https://www.federalregister.gov/documents/2026/04/10/2026-06963/permitted-payment-stablecoin-issuer-anti-money-launderingcountering-the-financing-of-terrorism","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-10/pdf/2026-06963.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-06963.pdf?1775738715","publication_date":"2026-04-10","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":"Office of Foreign Assets Control","name":"Foreign Assets Control Office","id":203,"url":"https://www.federalregister.gov/agencies/foreign-assets-control-office","json_url":"https://www.federalregister.gov/api/v1/agencies/203","parent_id":497,"slug":"foreign-assets-control-office"},{"raw_name":"Financial Crimes Enforcement Network","name":"Financial Crimes Enforcement Network","id":194,"url":"https://www.federalregister.gov/agencies/financial-crimes-enforcement-network","json_url":"https://www.federalregister.gov/api/v1/agencies/194","parent_id":497,"slug":"financial-crimes-enforcement-network"}],"excerpts":"cornerstone of OFAC's public outreach to all regulated industries, the <span class=\"match\">compliance</span> <span class=\"match\">guidance</span> and <span class=\"match\">expectations</span> <span class=\"match\">detailed</span> in the 2019 <span class=\"match\">Compliance</span> Framework <span class=\"match\">consistently</span> form the basis of OFAC's published <span class=\"match\">guidance</span> (\n e.g., \n sanctions advisories, <span class=\"match\">compliance</span> communiqués, and frequently asked questions), as well as specific <span class=\"match\">guidance</span> issued in response to public inquiries.\n \n \n \n 285 \n  \n See \n OFAC, \n A Framework for OFAC <span class=\"match\">Compliance</span> Commitments \n (May 2, 2019) [hereinafter \n 2019 <span class=\"match\">Compliance</span> Framework \n ], available at \n https://ofac.treasury.gov/media/16331/download"},{"title":"Clean Water Act Hazardous Substance Facility Response Plans: Compliance Date Delay and Changes To Reflect Administration Policy","type":"Proposed Rule","abstract":"The Environmental Protection Agency (EPA) is proposing to delay the compliance date for Facility Response Plan (FRP) requirements as well as to make language modifications to align with the Administration's climate change and environmental justice policies in Executive Order 14148 of January 20, 2025. These requirements are for onshore non-transportation-related facilities that could reasonably be expected to cause substantial harm to the environment from a CWA hazardous substance worst case discharge to navigable waters, adjoining shorelines, or the exclusive economic zone. This delay action is necessary to allow the Agency to consider implementation and compliance assistance tools that regulated parties may be able to take advantage of when complying with the new requirements. EPA notes that it cannot quantify the number, nature, and magnitude of covered discharges that may occur during the proposed rule delay period.","document_number":"2026-04388","html_url":"https://www.federalregister.gov/documents/2026/03/05/2026-04388/clean-water-act-hazardous-substance-facility-response-plans-compliance-date-delay-and-changes-to","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-05/pdf/2026-04388.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-04388.pdf?1772631912","publication_date":"2026-03-05","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":"provide tools and <span class=\"match\">compliance</span> assistance to help the regulated community comply with these new requirements. While EPA considered this need when establishing the <span class=\"match\">compliance</span> date in the final rule, the proposed delay in this action is necessary to fully assess and consider the range of <span class=\"match\">compliance</span> assistance tools that may be needed to best support implementation of the new requirements. The Agency proposal to extend the <span class=\"match\">compliance</span> date by three years is based on timeframe <span class=\"match\">expectations</span> for the Agency to consider implementation and <span class=\"match\">compliance</span> assistance tools"},{"title":"Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for Food and Drug Administration-Regulated Medical 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 \"Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.\" The purpose of this guidance is to provide FDA's expectations for, and recommendations on, use of a standardized approach for collecting and reporting race and ethnicity data in submissions including information collected and reported from clinical studies and clinical trials for FDA-regulated medical products. Using standard terminology for race and ethnicity helps ensure that data are collected and reported consistently in submissions to FDA. This draft guidance revises the final guidance for industry and FDA staff entitled \"Collection of Race and Ethnicity Data in Clinical Trials\" issued on October 26, 2016.","document_number":"2024-01782","html_url":"https://www.federalregister.gov/documents/2024/01/30/2024-01782/collection-of-race-and-ethnicity-data-in-clinical-trials-and-clinical-studies-for-food-and-drug","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-01-30/pdf/2024-01782.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-01782.pdf?1706535922","publication_date":"2024-01-30","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":"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>-<span class=\"match\">compliance</span>-regulatory-information/<span class=\"match\">guidances</span>-drugs, https://www.fda.gov/vaccines-blood-biologics/<span class=\"match\">guidance</span>-<span class=\"match\">compliance</span>-regulatory-information-biologics/biologics-<span class=\"match\">guidances</span>, https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/<span class=\"match\">guidance</span>-documents-medical-devices-and-radiation-emitting-products, https://www.fda.gov/regulatory-information/search-fda-<span class=\"match\">guidance</span>-documents, or https://www.regulations.gov. \n \n \n Dated: January"},{"title":"Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Comment Request","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products.\" In accordance with its mission of protecting, promoting, and advancing public health, FDA's Center for Drug Evaluation and Research (CDER), in collaboration with the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Veterinary Medicine (CVM), the Oncology Center of Excellence (OCE), the Office of Combination Products (OCP), and the Office of Inspections and Investigations (OII), is issuing this draft guidance to provide recommendations to industry on the use of artificial intelligence (AI) to produce information or data intended to support regulatory decision-making regarding the safety, effectiveness, or quality for drug and biological products.","document_number":"2024-31542","html_url":"https://www.federalregister.gov/documents/2025/01/07/2024-31542/considerations-for-the-use-of-artificial-intelligence-to-support-regulatory-decision-making-for-drug","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31542.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31542.pdf?1736171122","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":"the internet may obtain an electronic version of the draft <span class=\"match\">guidance</span> at \n https://www.fda.gov/drugs/<span class=\"match\">guidance</span>-<span class=\"match\">compliance</span>-regulatory-information/<span class=\"match\">guidances</span>-drugs, https://www.fda.gov/vaccines-blood-biologics/<span class=\"match\">guidance</span>-<span class=\"match\">compliance</span>-regulatory-information-biologics/biologics-<span class=\"match\">guidances</span>, https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/<span class=\"match\">guidance</span>-documents-medical-devices-and-radiation-emitting-products, https://www.fda.gov/regulatory-information/search-fda-<span class=\"match\">guidance</span>-documents, \n or \n https://www.regulations.gov. \n \n \n Dated:"},{"title":"Community Reinvestment Act: Simplified Strategic Plan Process for Community Banks","type":"Proposed Rule","abstract":"The Office of the Comptroller of the Currency (OCC or agency) is proposing supplemental guidance on a simplified strategic plan process for community banks interested in requesting that the OCC evaluate their Community Reinvestment Act (CRA) performance under a strategic plan. The proposed simplified strategic plan process is designed to make the strategic plan option more accessible to and less burdensome for community banks.","document_number":"2025-23547","html_url":"https://www.federalregister.gov/documents/2025/12/22/2025-23547/community-reinvestment-act-simplified-strategic-plan-process-for-community-banks","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-22/pdf/2025-23547.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-23547.pdf?1766151917","publication_date":"2025-12-22","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":"Office of the Comptroller of the Currency","name":"Comptroller of the Currency","id":80,"url":"https://www.federalregister.gov/agencies/comptroller-of-the-currency","json_url":"https://www.federalregister.gov/api/v1/agencies/80","parent_id":497,"slug":"comptroller-of-the-currency"}],"excerpts":"This supplemental proposed <span class=\"match\">guidance</span> (proposed <span class=\"match\">guidance</span>) has been reviewed for <span class=\"match\">compliance</span> with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 \n et seq. \n ). In accordance with the PRA, the OCC may not conduct or sponsor, and an organization is not required to respond to, an information collection unless the information collection displays a currently valid Office of Management and Budget (OMB) control number. The OCC has reviewed the proposed <span class=\"match\">guidance</span> and has determined that certain aspects of the proposed <span class=\"match\">guidance</span> constitute a collection"},{"title":"Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin; 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 \"Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.\" The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance is intended to describe risk-based principles and mitigation strategies to assure the viral safety of biotechnology products, including the data necessary to submit in a marketing application. The guidance also finalizes the updates based on advances in scientific knowledge and regulatory expectations to the first version of the ICH guidance for industry \"Q5A Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin,\" issued in September 1998. Lastly, the guidance replaces the draft guidance \"Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin\" issued on November 14, 2022.","document_number":"2024-00407","html_url":"https://www.federalregister.gov/documents/2024/01/11/2024-00407/q5ar2-viral-safety-evaluation-of-biotechnology-products-derived-from-cell-lines-of-human-or-animal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-01-11/pdf/2024-00407.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-00407.pdf?1704894326","publication_date":"2024-01-11","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":"under OMB control number 0910-0119. \n III. Electronic Access \n \n Persons with access to the internet may obtain the <span class=\"match\">guidance</span> at \n https://www.regulations.gov, https://www.fda.gov/drugs/<span class=\"match\">guidance</span>-<span class=\"match\">compliance</span>-regulatory-information/<span class=\"match\">guidances</span>-drugs, \n \n https://www.fda.gov/vaccines-blood-biologics/<span class=\"match\">guidance</span>-<span class=\"match\">compliance</span>-regulatory-information-biologics/biologics-<span class=\"match\">guidances</span>, \n or \n https://www.fda.gov/regulatory-information/search-fda-<span class=\"match\">guidance</span>-documents. \n \n \n Dated: January 8, 2024. \n Lauren K. Roth, \n Associate Commissioner for Policy. \n \n \n [FR Doc. 2024-00407"},{"title":"Connect America Fund, Alaska Connect Fund, Connect America Fund-Alaska Plan et al.","type":"Rule","abstract":"In this document, the Federal Communications Commission (Commission) further refines the Alaska high-cost mobile-support programs to ensure efficient use of scarce universal service funds that will bring 5G-NR to Americans living, working, and traveling in Alaska. This document grants in part a Petition for Reconsideration and Clarification by GCI Communications Corp. (GCI) of the Alaska Connect Fund (ACF), granting it in part by modifying and clarifying several of its rules. These actions help better realign the requirements and expectations of the ACF with its intended universal service goals. This document also makes a clarifying correction to one ACF rule to better reflect its purpose expressed in the Alaska Connect Fund Order.","document_number":"2025-22437","html_url":"https://www.federalregister.gov/documents/2025/12/10/2025-22437/connect-america-fund-alaska-connect-fund-connect-america-fund-alaska-plan-et-al","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-10/pdf/2025-22437.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-22437.pdf?1765287914","publication_date":"2025-12-10","agencies":[{"raw_name":"FEDERAL COMMUNICATIONS COMMISSION","name":"Federal Communications Commission","id":161,"url":"https://www.federalregister.gov/agencies/federal-communications-commission","json_url":"https://www.federalregister.gov/api/v1/agencies/161","parent_id":null,"slug":"federal-communications-commission"}],"excerpts":"to advanced communications that are reasonably comparable to those services and rates available in urban areas. In the \n Alaska Connect Fund Order, \n the Commission required every participating mobile provider to certify its <span class=\"match\">compliance</span> with this statutory obligation in annual <span class=\"match\">compliance</span> filings and to demonstrate its <span class=\"match\">compliance</span> by showing that it publishes, on its publicly accessible website, at least one mobile broadband plan and at least one stand-alone voice plan that are: (1) substantially similar to a service plan offered by at least one different"},{"title":"Supporting the Head Start Workforce and Consistent Quality Programming","type":"Rule","abstract":"This final rule makes regulatory changes to the Head Start Program Performance Standards (HSPPS) to support and stabilize the Head Start workforce and improve the quality of services Head Start programs provide to children and families. These changes include requirements for wages and benefits, breaks for staff, and enhanced support for staff health and wellness. The changes also include enhancements to mental health services to better integrate mental health into every aspect of program service delivery. Enhancements are also included in the areas of family service worker family assignments, identifying and meeting community needs, ensuring child safety, services for pregnant women and other pregnant people, and alignment with State early childhood systems. Finally, the changes include minor clarifications to promote better transparency and clarity of understanding for grant recipients.","document_number":"2024-18279","html_url":"https://www.federalregister.gov/documents/2024/08/21/2024-18279/supporting-the-head-start-workforce-and-consistent-quality-programming","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-21/pdf/2024-18279.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-18279.pdf?1723821314","publication_date":"2024-08-21","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"}],"excerpts":"\n \n Effective date: \n August 21, 2024.\n \n \n <span class=\"match\">Compliance</span> date: \n The <span class=\"match\">compliance</span> date for many of the requirements in this final rule is October 21, 2024, or 60 days after this final rule is published in the \n Federal Register \n . However, there is a subset of requirements where we expect programs may need more time to implement the regulatory changes. In these cases, we specify an alternate timeline for <span class=\"match\">compliance</span>. See further discussion of these dates in the section entitled \n Effective and <span class=\"match\">Compliance</span> Dates. \n \n \n \n FOR FURTHER INFORMATION CONTACT:"}]}