{"description":"Documents matching '\"artificial intelligence\" transparency'","count":369,"total_pages":19,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=%22artificial+intelligence%22+transparency&format=json&page=2","results":[{"title":"Request for Information (RFI) on Modernizing the National Vulnerability Database in the Age of Artificial Intelligence","type":"Notice","abstract":"The National Institute of Standards and Technology (NIST) established and operates the National Vulnerability Database (NVD), which provides the U.S. government repository of standards-based vulnerability management data. NIST seeks stakeholder input on opportunities, challenges, and priorities for modernizing the NVD in an evolving cybersecurity landscape increasingly shaped by artificial intelligence (AI) and machine-consumable security data. NIST's goal is to improve the NVD's scalability, automation, interoperability, transparency, and utility.","document_number":"2026-16371","html_url":"https://www.federalregister.gov/documents/2026/08/12/2026-16371/request-for-information-rfi-on-modernizing-the-national-vulnerability-database-in-the-age-of","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-12/pdf/2026-16371.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16371.pdf?1786452307","publication_date":"2026-08-12","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":"National Institute of Standards and Technology","name":"National Institute of Standards and Technology","id":352,"url":"https://www.federalregister.gov/agencies/national-institute-of-standards-and-technology","json_url":"https://www.federalregister.gov/api/v1/agencies/352","parent_id":54,"slug":"national-institute-of-standards-and-technology"}],"excerpts":"standards-based vulnerability management data. NIST seeks stakeholder input on opportunities, challenges, and priorities for modernizing the NVD in an evolving cybersecurity landscape increasingly shaped by artificial intelligence (AI) and machine-consumable security data. NIST's goal is to improve the NVD's scalability, automation, interoperability, transparency, and utility. \n \n \n DATES: \n Comments in response to this notice must be received on or before October 13, 2026, at 11:59 p.m. Eastern Time. Submissions received after that date may not be considered"},{"title":"Disclosure and Transparency of Artificial Intelligence-Generated Content in Political Advertisements","type":"Proposed Rule","abstract":"In this document, the Federal Communications Commission (Commission or FCC) initiates a proceeding to provide greater transparency regarding the use of artificial intelligence-generated content in political advertising. Specifically, the Commission proposes to require radio and television broadcast stations; cable operators, Direct Broadcast Satellite (DBS) providers, and Satellite Digital Audio Radio Service (SDARS) licensees engaged in origination programming; and permit holders transmitting programming pursuant to section 325(c) of the Communications Act of 1934 (Act), to provide an on-air announcement for all political ads (including both candidate ads and issue ads) that contain artificial intelligence (AI)-generated content disclosing the use of such content in the ad. The Commission also propose to require these licensees and regulatees to include a notice in their online political files for all political ads that include AI-generated content disclosing that the ad contains such content.","document_number":"2024-16977","html_url":"https://www.federalregister.gov/documents/2024/08/05/2024-16977/disclosure-and-transparency-of-artificial-intelligence-generated-content-in-political-advertisements","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-05/pdf/2024-16977.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-16977.pdf?1722602712","publication_date":"2024-08-05","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":"intelligence, such as a human voice. While the Commission has not yet adopted a specific definition of “artificial intelligence,” various organizations and statutes have defined AI. In October 2023, President Biden's \n Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence \n (E.O. 14110, 88 FR 75191 (November 1, 2023)) drew upon a statutory definition of AI established by the National Artificial Intelligence Initiative in 2021 and set forth in 15 U.S.C. 9401(3), which defines AI as “a machine-based system"},{"title":"Framework for Artificial Intelligence Diffusion","type":"Rule","abstract":"With this interim final rule, the Commerce Department's Bureau of Industry and Security (BIS) revises the Export Administration Regulations' (EAR) controls on advanced computing integrated circuits (ICs) and adds a new control on artificial intelligence (AI) model weights for certain advanced closed-weight dual-use AI models. In conjunction with the expansion of these controls, which BIS has determined are necessary to protect U.S. national security and foreign policy interests, BIS is adding new license exceptions and updating the Data Center Validated End User authorization to facilitate the export, reexport, and transfer (in-country) of advanced computing (ICs) to end users in destinations that do not raise national security or foreign policy concerns. Together, these changes will cultivate secure ecosystems for the responsible diffusion and use of AI and advanced computing ICs.","document_number":"2025-00636","html_url":"https://www.federalregister.gov/documents/2025/01/15/2025-00636/framework-for-artificial-intelligence-diffusion","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-15/pdf/2025-00636.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-00636.pdf?1736775933","publication_date":"2025-01-15","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":"Bureau of Industry and Security","name":"Industry and Security Bureau","id":241,"url":"https://www.federalregister.gov/agencies/industry-and-security-bureau","json_url":"https://www.federalregister.gov/api/v1/agencies/241","parent_id":54,"slug":"industry-and-security-bureau"}],"excerpts":"noted, AI brings “profound risks,” from “disinformation to novel pathogens to bioweapons.” President Biden's National Security Memorandum on Advancing the United States' Leadership in Artificial Intelligence; Harnessing Artificial Intelligence to Fulfill National Security Objectives; and Fostering the Safety, Security, and Trustworthiness of Artificial Intelligence, issued on October 24, 2024, similarly explained the promise and perils of AI. “AI,” it stated, “if used appropriately and for its intended purpose, can offer great benefits. If misused"},{"title":"Advancing United States Leadership in Artificial Intelligence Infrastructure","type":"Presidential Document","abstract":null,"document_number":"2025-01395","html_url":"https://www.federalregister.gov/documents/2025/01/17/2025-01395/advancing-united-states-leadership-in-artificial-intelligence-infrastructure","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-17/pdf/2025-01395.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-01395.pdf?1737035143","publication_date":"2025-01-17","agencies":[{"raw_name":"EXECUTIVE OFFICE OF THE PRESIDENT","name":"Executive Office of the President","id":538,"url":"https://www.federalregister.gov/agencies/executive-office-of-the-president","json_url":"https://www.federalregister.gov/api/v1/agencies/538","parent_id":null,"slug":"executive-office-of-the-president"}],"excerpts":"use AI for future national-security missions, including through the work described in National Security Memorandum 25 of October 24, 2024 (Advancing the United States' Leadership in Artificial \n \n Intelligence; Harnessing Artificial Intelligence to Fulfill National Security Objectives; and Fostering the Safety, Security, and Trustworthiness of Artificial Intelligence) (NSM-25). It will also require the use of safeguards to improve the cyber, supply-chain, and physical security of the laboratories at which powerful AI is developed, stored, and used"},{"title":"General Services Acquisition Regulation; Acquisition of Information and Communication Technology; Notice of Listening Sessions and Request for Comments","type":"Proposed Rule","abstract":"The General Services Administration (GSA) is seeking public comment on the draft of a new General Services Administration Acquisition Regulation (GSAR) clause regarding basic safeguarding of data within Large Language Model Artificial Intelligence Systems (LLMs). Due to the complexity of the issue, GSA is publishing this notification and draft clause to gather feedback from stakeholders before taking future action (e.g., deviation and/or formal rulemaking).","document_number":"2026-12205","html_url":"https://www.federalregister.gov/documents/2026/06/17/2026-12205/general-services-acquisition-regulation-acquisition-of-information-and-communication-technology","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-17/pdf/2026-12205.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12205.pdf?1781613917","publication_date":"2026-06-17","agencies":[{"raw_name":"GENERAL SERVICES ADMINISTRATION","name":"General Services Administration","id":210,"url":"https://www.federalregister.gov/agencies/general-services-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/210","parent_id":null,"slug":"general-services-administration"}],"excerpts":"Background \n \n The rapid advancement and adoption of Large Language Model Artificial Intelligence (LLM) systems present both unprecedented opportunities and significant challenges for Federal agencies. As GSA establishes contracts for these technologies, ensuring the integrity, security, and appropriate handling of Government Data is paramount. This notification introduces a new GSAR clause, 552.239-7001, \n \n “Basic Safeguarding of Data within Large Language Model Artificial Intelligence Systems (LLMs),” to address these critical concerns. This clause may"},{"title":"Meeting of the President's Export Council","type":"Notice","abstract":"The President's Export Council (Council) will hold a meeting to discuss how artificial intelligence (AI) can contribute to the competitiveness of U.S. businesses operating in international markets. The Council will deliberate recommendations related to uses of AI that ensure transparency, foster growth and innovation, and facilitate trade while securing intellectual property and maintaining workforce stability. The final agenda will be posted at least one week in advance of the meeting on the Council's website at https://www.trade.gov/ presidents-export-council.","document_number":"2024-25755","html_url":"https://www.federalregister.gov/documents/2024/11/06/2024-25755/meeting-of-the-presidents-export-council","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-06/pdf/2024-25755.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-25755.pdf?1730814323","publication_date":"2024-11-06","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":"International Trade Administration","name":"International Trade Administration","id":261,"url":"https://www.federalregister.gov/agencies/international-trade-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/261","parent_id":54,"slug":"international-trade-administration"}],"excerpts":"ACTION: \n Notice of an open meeting. \n \n \n SUMMARY: \n \n The President's Export Council (Council) will hold a meeting to discuss how artificial intelligence (AI) can contribute to the competitiveness of U.S. businesses operating in international markets. The Council will deliberate recommendations related to uses of AI that ensure transparency, foster growth and innovation, and facilitate trade while securing intellectual property and maintaining workforce stability. The final agenda will be posted at least one week in advance of the meeting on the"},{"title":"Request for Comments on Draft Documents Responsive to NIST's Assignments Under Executive Order 14110 (Sections 4.1, 4.5, and 11)","type":"Notice","abstract":"The National Institute of Standards and Technology (NIST) requests comments on four draft documents responsive to NIST assignment under Executive Order 14110 on Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (AI) issued on October 30, 2023 (E.O. 14110): NIST AI 600-1, Artificial Intelligence Risk Management Framework: Generative Artificial Intelligence Profile; NIST SP 800-218A, Secure Software Development Practices for Generative AI and Dual-Use Foundation Models; NIST AI 100-5, A Plan for Global Engagement on AI Standards; and NIST AI 100-4, Reducing Risks Posed by Synthetic Content: An Overview of Technical Approaches to Digital Content Transparency.","document_number":"2024-09824","html_url":"https://www.federalregister.gov/documents/2024/05/07/2024-09824/request-for-comments-on-draft-documents-responsive-to-nists-assignments-under-executive-order-14110","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-07/pdf/2024-09824.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-09824.pdf?1714999813","publication_date":"2024-05-07","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":"National Institute of Standards and Technology","name":"National Institute of Standards and Technology","id":352,"url":"https://www.federalregister.gov/agencies/national-institute-of-standards-and-technology","json_url":"https://www.federalregister.gov/api/v1/agencies/352","parent_id":54,"slug":"national-institute-of-standards-and-technology"}],"excerpts":"and Trustworthy Development and Use of Artificial Intelligence (AI) issued on October 30, 2023 (E.O. 14110): NIST AI 600-1, Artificial Intelligence Risk Management Framework: Generative Artificial Intelligence Profile; NIST SP 800-218A, Secure Software Development Practices for Generative AI and Dual-Use Foundation Models; NIST AI 100-5, A Plan for Global Engagement on AI Standards; and NIST AI 100-4, Reducing Risks Posed by Synthetic Content: An Overview of Technical Approaches to Digital Content Transparency. \n \n \n DATES: \n Comments containing information"},{"title":"Digital Health Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Generative Artificial Intelligence-Enabled Digital Mental Health Medical Devices","type":"Notice","abstract":"The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Digital Health Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA. The meeting will be open to the public. FDA is establishing a docket for public comment.","document_number":"2025-17651","html_url":"https://www.federalregister.gov/documents/2025/09/12/2025-17651/digital-health-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-12/pdf/2025-17651.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-17651.pdf?1757594715","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":" \n \n Agenda: \n The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform.\n \n On November 6, 2025, the Committee will discuss and make recommendations on the topic of “Generative Artificial Intelligence-Enabled Digital Mental Health Medical Devices.” Many of these medical devices pose novel risks and, as mental health devices continue to evolve in complexity, regulatory approaches ideally will also evolve to accommodate these novel challenges and opportunities to"},{"title":"Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; 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 \"Artificial Intelligence Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.\" This draft guidance, when finalized, will provide recommendations regarding the contents of marketing submissions for devices that include artificial intelligence (AI)-enabled device software functions including documentation and information that will support FDA's evaluation of safety and effectiveness. To support the development of appropriate documentation for FDA's assessment of the device, this draft guidance also proposes recommendations for the design, development, and implementation of AI- enabled devices that sponsors may wish to consider using throughout the total product lifecycle (TPLC). This draft guidance is not final nor is it for implementation at this time.","document_number":"2024-31543","html_url":"https://www.federalregister.gov/documents/2025/01/07/2024-31543/artificial-intelligence-enabled-device-software-functions-lifecycle-management-and-marketing","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31543.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31543.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":"availability. \n \n \n SUMMARY: \n The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Artificial Intelligence Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” This draft guidance, when finalized, will provide recommendations regarding the contents of marketing submissions for devices that include artificial intelligence (AI)-enabled device software functions including documentation and information that will support FDA's evaluation of safety and effectiveness"},{"title":"Reforming the High-Cost Program for an All-IP Future, Connect America Fund: A National Broadband Plan for Our Future High-Cost Universal Support","type":"Proposed Rule","abstract":"In this document, the Federal Communications Commission (FCC or Commission) adopted a Notice of Proposed Rulemaking (NPRM) that kicks off a process to examine how the Commission can make some of its high-cost mechanisms even more efficient and effective into the future. Ensuring a predictable High-Cost Program for years to come--call it High-Cost Modernization--will provide continuing support for our Build America Agenda, supercharge American leadership in Artificial Intelligence (AI) by efficiently supporting the broadband-capable networks upon which AI-enhanced applications and services will be delivered and accessed, and will help accelerate the transition to Internet Protocol (IP) networks.","document_number":"2026-11353","html_url":"https://www.federalregister.gov/documents/2026/06/05/2026-11353/reforming-the-high-cost-program-for-an-all-ip-future-connect-america-fund-a-national-broadband-plan","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-05/pdf/2026-11353.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11353.pdf?1780577120","publication_date":"2026-06-05","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":"proceeding, and must be filed in their native format (\n e.g., \n .doc, .xml, .ppt, searchable .pdf). Participants in this proceeding should familiarize themselves with the Commission's \n ex parte \n rules.\n \n \n Providing Accountability Through Transparency Act. \n Consistent with the Providing Accountability Through Transparency Act, Public Law 118-9, a summary of this document will be available on \n https://www.fcc.gov/proposed-rulemakings. \n \n I. Introduction \n The Commission's Universal Service Fund (USF or Fund) High-Cost Program plays a critical role in"},{"title":"Implications of Artificial Intelligence Technologies on Protecting Consumers From Unwanted Robocalls and Robotexts","type":"Proposed Rule","abstract":"In this document, the Federal Communications Commission (Commission or FCC) proposes steps to protect consumers from the abuse of Artificial Intelligence (AI) in robocalls alongside actions that clear the path for positive uses of AI, including its use to improve access to the telephone network for people with disabilities. Specifically, the document proposes to: define AI-generated calls, adopt new rules that would require callers disclose to consumers when they receive an AI-generated call, adopt protections for consumers to ensure that callers adequately apprise them of their use of AI- generated calls when consumers affirmatively consent to receive such calls, adopt protections to ensure that positive uses of AI that have already helped people with disabilities use the telephone network can thrive without threat of Telephone Consumer Protection Act (TCPA) liability. The document also seeks additional comment and information on developing technologies that can alert consumers to unwanted or illegal calls and texts, including AI-generated calls.","document_number":"2024-19028","html_url":"https://www.federalregister.gov/documents/2024/09/10/2024-19028/implications-of-artificial-intelligence-technologies-on-protecting-consumers-from-unwanted-robocalls","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-10/pdf/2024-19028.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-19028.pdf?1725885915","publication_date":"2024-09-10","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":"information collection requirements contained herein should be submitted to the Federal Communications Commission via email to \n PRA@fcc.gov \n and to Cathy Williams, FCC, via email to \n Cathy.Williams@fcc.gov. \n \n \n Providing Accountability Through Transparency Act: \n The Providing Accountability Through Transparency Act, Public Law 118-9, requires each agency, in providing notice of a rulemaking, to post online a brief plain-language summary of the proposed rule. The required summary of the NPRM is \n \n available at \n https://www.fcc.gov/proposed-rulemakings"},{"title":"Final Priority and Definitions-Secretary's Supplemental Priority and Definitions on Career Pathways and Workforce Readiness","type":"Rule","abstract":"The Department of Education (Department) announces a final priority and definitions for use in currently authorized discretionary grant programs or programs that may be authorized in the future. The Secretary may choose to use the entire priority for a grant program or a particular competition or use one or more of the priority's component parts. This priority and definitions augment the initial set of three Secretary's Supplemental Priorities on Evidence-Based Literacy, Educational Choice, and Returning Education to the States published as final priorities on September 9, 2025; the additional Secretary's Supplemental Priorities on Meaningful Learning Opportunities, published as a final priority on February 12, 2026, and Advancing Artificial Intelligence in Education, published as a final priority elsewhere in this issue of the Federal Register; and the additional proposed Secretary's Supplemental Priority on Promoting Patriotic Education published as a proposed priority on September 17, 2025.","document_number":"2026-07084","html_url":"https://www.federalregister.gov/documents/2026/04/13/2026-07084/final-priority-and-definitions-secretarys-supplemental-priority-and-definitions-on-career-pathways","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-13/pdf/2026-07084.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07084.pdf?1775825116","publication_date":"2026-04-13","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":"Educational Choice, and Returning Education to the States published as final priorities on September 9, 2025; the additional Secretary's Supplemental Priorities on Meaningful Learning Opportunities, published as a final priority on February 12, 2026, and Advancing Artificial Intelligence in Education, published as a final priority elsewhere in this issue of the \n Federal Register \n ; and the additional proposed Secretary's Supplemental Priority on Promoting Patriotic Education published as a proposed priority on September 17, 2025.\n \n \n \n DATES: "},{"title":"AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is issuing this request for information to solicit input on a proposed pilot program to assess how artificial intelligence (AI)-enabled technologies can improve efficiency, speed, and quality of decision- making in early phase clinical trials. Early-phase clinical trials represent a critical bottleneck in drug development, often characterized by high uncertainty, limited patient populations, and inefficient decision- making processes. This pilot program aims to explore how advances in AI and data science can improve trial efficiency, enhance safety monitoring, facilitate dose selection decisions, and enable more informed early go/no-go decisions (e.g., a regulatory decision as to whether a Phase 1 study may proceed) while maintaining FDA's rigorous scientific and regulatory standards and promoting trustworthy AI systems. The pilot program will be guided by principles aligned with the National Institute of Standards and Technology (NIST) AI Risk Management Framework (AI RMF).","document_number":"2026-08281","html_url":"https://www.federalregister.gov/documents/2026/04/29/2026-08281/ai-enabled-optimization-of-early-phase-clinical-trials-pilot-program-request-for-information","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-29/pdf/2026-08281.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08281.pdf?1777389315","publication_date":"2026-04-29","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":"cited in FDA's Draft Guidance for Industry on Considerations for the Use of AI to Support Regulatory Decision-Making for Drugs and Biological Products):\n \n The term “artificial intelligence” means a machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments. Artificial intelligence systems use machine and human-based inputs to— \n (A) perceive real and virtual environments; \n (B) abstract such perceptions into models through analysis in an automated"},{"title":"Workshop To Consider Artificial Intelligence in Drug and Biological Product Development; Public Workshop","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop titled \"Artificial Intelligence (AI) in Drug & Biological Product Development.\" Convened and supported by a cooperative agreement between FDA and the Clinical Trials Transformation Initiative (CTTI), the purpose of the public workshop is to bring drug developers and AI experts together to discuss guiding principles for the responsible use of AI in the development of safe and effective drugs and biological products. The workshop format will include presentations and panel discussions.","document_number":"2024-15125","html_url":"https://www.federalregister.gov/documents/2024/07/10/2024-15125/workshop-to-consider-artificial-intelligence-in-drug-and-biological-product-development-public","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-07-10/pdf/2024-15125.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-15125.pdf?1720529130","publication_date":"2024-07-10","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":"ACTION: \n Notice of public workshop. \n \n \n SUMMARY: \n The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop titled “Artificial Intelligence (AI) in Drug & Biological Product Development.” Convened and supported by a cooperative agreement between FDA and the Clinical Trials Transformation Initiative (CTTI), the purpose of the public workshop is to bring drug developers and AI experts together to discuss guiding principles for the responsible use of AI in the development of safe and effective drugs"},{"title":"Request for Information: Executive Branch Agency Handling of Commercially Available Information Containing Personally Identifiable Information","type":"Notice","abstract":"As part of its implementation of Executive order, Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, the Office of Management and Budget (OMB) is requesting public input on issues related to Federal agency collection, processing, maintenance, use, sharing, dissemination, and disposition of commercially available information (CAI) containing personally identifiable information (PII).","document_number":"2024-23773","html_url":"https://www.federalregister.gov/documents/2024/10/16/2024-23773/request-for-information-executive-branch-agency-handling-of-commercially-available-information","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-16/pdf/2024-23773.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-23773.pdf?1728996319","publication_date":"2024-10-16","agencies":[{"raw_name":"OFFICE OF MANAGEMENT AND BUDGET","name":"Management and Budget Office","id":280,"url":"https://www.federalregister.gov/agencies/management-and-budget-office","json_url":"https://www.federalregister.gov/api/v1/agencies/280","parent_id":null,"slug":"management-and-budget-office"}],"excerpts":"without their knowledge or consent.” \n 4 \n \n As highlighted in Executive Order 14110, such privacy risks may be further exacerbated by artificial intelligence (AI) facilitating the collection or use of information about individuals, and the making of inferences about individuals. The readout from the White House roundtable addresses that concern as well, noting that “[r]ecent advancements in artificial intelligence, attendees cautioned, have rapidly expanded data brokers' abilities to draw inferences about individuals' lifestyles, desires, and weaknesses"},{"title":"Final Priority and Definitions-Secretary's Supplemental Priority and Definitions on Promoting Patriotic Education","type":"Notice","abstract":"The Department of Education (Department) announces a final priority and definitions for use in currently authorized discretionary grant programs or programs that may be authorized in the future. The Secretary may choose to use the entire priority for a grant program or a particular competition or use one or more of the priority's component parts. The final priority and definitions augment the initial set of three Secretary's Supplemental Priorities on Evidence-Based Literacy, Educational Choice, and Returning Education to the States published as final priorities on September 9, 2025 (90 FR 43514); the Secretary's Supplemental Priority on Meaningful Learning Opportunities, published as a final priority on February 12, 2026 (91 FR 6625); the Secretary's Supplemental Priority on Advancing Artificial Intelligence in Education, published as a final priority on April 13, 2026 (91 FR 18774); and the Secretary's Supplemental Priority and Definitions on Career Pathways and Workforce Readiness, published as a final priority on April 13, 2026 (91 FR 18780).","document_number":"2026-10347","html_url":"https://www.federalregister.gov/documents/2026/05/22/2026-10347/final-priority-and-definitions-secretarys-supplemental-priority-and-definitions-on-promoting","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-22/pdf/2026-10347.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10347.pdf?1779367519","publication_date":"2026-05-22","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":"States published as final priorities on September 9, 2025 (90 FR 43514); the Secretary's Supplemental Priority on Meaningful Learning Opportunities, published as a final priority on February 12, 2026 (91 FR 6625); the Secretary's Supplemental Priority on Advancing Artificial Intelligence in Education, published as a final priority on April 13, 2026 (91 FR 18774); and the Secretary's Supplemental Priority and Definitions on Career Pathways and Workforce Readiness, published as a final priority on April 13, 2026 (91 FR 18780). \n \n \n DATES: \n The final"},{"title":"Statement of Organization, Functions, and Delegations of Authority","type":"Notice","abstract":"The Centers for Medicare and Medicaid Services (CMS), Office of Health Technology and Products (OHTP), has been established. This new organizational component will provide enterprise leadership and oversight for CMS healthcare technology modernization, digital products, and transformation of platforms and services supporting Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and other CMS-administered programs, in close coordination with the CMS Chief Information Officer (CIO) and subject to CIO-led enterprise information technology (IT) governance, cybersecurity, enterprise architecture, and capital planning and investment control responsibilities, as well as CIO-led digital service delivery, customer experience, and public digital experience responsibilities under applicable law.","document_number":"2026-11743","html_url":"https://www.federalregister.gov/documents/2026/06/11/2026-11743/statement-of-organization-functions-and-delegations-of-authority","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-11/pdf/2026-11743.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11743.pdf?1781095520","publication_date":"2026-06-11","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":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"support for priority initiatives. \n • Leads enterprise strategy and implementation of artificial intelligence across CMS digital products and platforms, and advises the CMS Administrator and senior leadership on Artificial Intelligence (AI) opportunities, risks, and governance, in coordination with the CIO as required under statutory responsibilities. \n • Advances patient experience, innovation, and responsible use of emerging technologies, including artificial intelligence, to improve service delivery, program integrity, and health outcomes. \n • Advises"},{"title":"Artificial Intelligence and Copyright","type":"Notice","abstract":"The United States Copyright Office is undertaking a study of the copyright law and policy issues raised by artificial intelligence (\"AI\") systems. To inform the Office's study and help assess whether legislative or regulatory steps in this area are warranted, the Office seeks comment on these issues, including those involved in the use of copyrighted works to train AI models, the appropriate levels of transparency and disclosure with respect to the use of copyrighted works, and the legal status of AI-generated outputs.","document_number":"2023-18624","html_url":"https://www.federalregister.gov/documents/2023/08/30/2023-18624/artificial-intelligence-and-copyright","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-08-30/pdf/2023-18624.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-18624.pdf?1693313133","publication_date":"2023-08-30","agencies":[{"raw_name":"LIBRARY OF CONGRESS","name":"Library of Congress","id":277,"url":"https://www.federalregister.gov/agencies/library-of-congress","json_url":"https://www.federalregister.gov/api/v1/agencies/277","parent_id":null,"slug":"library-of-congress"},{"raw_name":"Copyright Office","name":"Copyright Office, Library of Congress","id":87,"url":"https://www.federalregister.gov/agencies/copyright-office-library-of-congress","json_url":"https://www.federalregister.gov/api/v1/agencies/87","parent_id":277,"slug":"copyright-office-library-of-congress"}],"excerpts":"\n SUMMARY: \n The United States Copyright Office is undertaking a study of the copyright law and policy issues raised by artificial intelligence (“AI”) systems. To inform the Office's study and help assess whether legislative or regulatory steps in this area are warranted, the Office seeks comment on these issues, including those involved in the use of copyrighted works to train AI models, the appropriate levels of transparency and disclosure with respect to the use of copyrighted works, and the legal status of AI-generated outputs. \n \n \n DATES:"},{"title":"Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots","type":"Rule","abstract":"This final rule with comment period revises the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2026 based on our continuing experience with these systems. We also describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment systems. In addition, this final rule with comment period announces the closure of a teaching hospital and the opportunity to apply for available slots, and updates and refines the requirements for the Hospital Outpatient Quality Reporting Program, Rural Emergency Hospital Quality Reporting Program, Ambulatory Surgical Center Quality Reporting Program, Overall Hospital Quality Star Rating, and hospitals to make public their standard charge information and enforcement of hospital price transparency, as well as summarizes comments received in response to a request for information on measure concepts regarding Well-Being and Nutrition for consideration in future years for the OQR, REHQR, and ASCQR programs.","document_number":"2025-20907","html_url":"https://www.federalregister.gov/documents/2025/11/25/2025-20907/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-25/pdf/2025-20907.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-20907.pdf?1763759710","publication_date":"2025-11-25","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":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"Hospital Price Transparency—Data Dictionary GitHub Repository website for examples of how to encode standard charge information,\n 451 \n \n and additional guidance on CMS' HPT website.\n 452 \n \n \n \n \n 451 \n CMS, (2024, June), \n Hospital-Price-Transparency Examples, \n Hospital Price Transparency, GitHub. \n https://github.com/CMSgov/hospital-price-transparency/tree/master/examples. \n \n \n \n \n 452 \n CMS, (2025, May), \n Resources, \n Hospital Price Transparency website at \n https://www.cms.gov/priorities/key-initiatives/hospital-price-transparency/resources"},{"title":"Defense Industrial Base Adoption of Artificial Intelligence for Defense Applications; Notice of Availability","type":"Notice","abstract":"The DoD Office of Industrial Base Resilience seeks public comment on actions it can take to enable the Defense Industrial Base (DIB) to continue to adopt artificial intelligence (AI) for defense applications. Feedback from the public will guide the DoD in developing policies, initiatives, and resource distribution to ensure support for the DIB in integrating AI into defense systems. Public comments will also be used to formulate PA&T's Trusted AI Defense Industrial Base Roadmap.","document_number":"2024-11195","html_url":"https://www.federalregister.gov/documents/2024/05/22/2024-11195/defense-industrial-base-adoption-of-artificial-intelligence-for-defense-applications-notice-of","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-22/pdf/2024-11195.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-11195.pdf?1716295519","publication_date":"2024-05-22","agencies":[{"raw_name":"DEPARTMENT OF DEFENSE","name":"Defense Department","id":103,"url":"https://www.federalregister.gov/agencies/defense-department","json_url":"https://www.federalregister.gov/api/v1/agencies/103","parent_id":null,"slug":"defense-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"establishment of a resilient supply chain and DIB to safeguard U.S. economic prosperity and national security. Executive Order 14110, “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence” (available at \n https://www.federalregister.gov/documents/2023/11/01/2023-24283/safe-secure-and-trustworthy-development-and-use-of-artificial-intelligence \n ), highlights the importance of integrating AI securely and safely. The recently released National Defense Industrial Strategy (NDIS) (available at \n https://www.businessdefense.gov/NDIS"}]}