{"description":"Documents matching 'seeking public draft general administration'","count":10000,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=seeking+public+draft+general+administration&format=json&page=2","results":[{"title":"E22 General Considerations for Patient Preference Studies; International Council for Harmonisation; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"E22 General Considerations for Patient Preference Studies.\" The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). When finalized, this guidance will provide general principles for the use, design, conduct, analysis, and submission of patient preference studies (PPS) aimed at informing drug development, regulatory submission and evaluation, drug approvals, and maintenance of such approvals.","document_number":"2026-02324","html_url":"https://www.federalregister.gov/documents/2026/02/06/2026-02324/e22-general-considerations-for-patient-preference-studies-international-council-for-harmonisation","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-06/pdf/2026-02324.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-02324.pdf?1770299111","publication_date":"2026-02-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"regulatory or statutory requirements are cited. \n In November 2025, the ICH Assembly endorsed the <span class=\"match\">draft</span> guideline entitled “E22 <span class=\"match\">General</span> Considerations for Patient Preference Studies” and agreed that the guideline should be made available for <span class=\"match\">public</span> comment. The <span class=\"match\">draft</span> guideline is the product of the Efficacy Expert Working Group of the ICH. Comments about this <span class=\"match\">draft</span> will be considered by FDA and the Efficacy Expert Working Group. \n The <span class=\"match\">draft</span> guidance outlines <span class=\"match\">general</span> harmonized considerations about the use, design, conduct, analysis, and submission of PPS"},{"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":"ACTION: \n Proposal; request for comments. \n \n \n SUMMARY: \n \n The <span class=\"match\">General</span> Services <span class=\"match\">Administration</span> (GSA) is <span class=\"match\">seeking</span> <span class=\"match\">public</span> comment on the <span class=\"match\">draft</span> of a new <span class=\"match\">General</span> Services <span class=\"match\">Administration</span> 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 <span class=\"match\">draft</span> clause to gather feedback from stakeholders before taking future action (\n e.g., \n deviation and/or formal rulemaking).\n \n \n \n DATES: \n \n \n Comment"},{"title":"Notice of Public Workshop and Notice of Availability of Draft Environmental Assessment for General Mitchell International Airport, Milwaukee, Wisconsin","type":"Notice","abstract":"The Federal Aviation Administration (FAA) announces the release of the Draft Environmental Assessment (Draft EA) for the proposed airport improvements at the General Mitchell International Airport (MKE). The purpose of the Draft EA is to evaluate the potential environmental impacts from the decommissioning of Runway 1R/19L and Runway 13/31; conversion of Runway 1R/19L south of Taxiway W into a parallel taxiway including lighting and pavement rehabilitation; removal of Taxiway G, Taxiway U, and Taxiway N connectors; and the removal of runway and taxiway pavement and electrical utilities. The FAA is issuing this notice to advise the public that the Draft EA will be made available for public comment and a public workshop will be held as part of the public involvement process for this project. FAA is seeking comments on the Draft EA.","document_number":"2024-22593","html_url":"https://www.federalregister.gov/documents/2024/10/16/2024-22593/notice-of-public-workshop-and-notice-of-availability-of-draft-environmental-assessment-for-general","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-16/pdf/2024-22593.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-22593.pdf?1728996315","publication_date":"2024-10-16","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 Aviation Administration","name":"Federal Aviation Administration","id":159,"url":"https://www.federalregister.gov/agencies/federal-aviation-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/159","parent_id":492,"slug":"federal-aviation-administration"}],"excerpts":"connectors; and the removal of runway and taxiway pavement and electrical utilities. The FAA is issuing this notice to advise the <span class=\"match\">public</span> that the <span class=\"match\">Draft</span> EA will be made available for <span class=\"match\">public</span> comment and a <span class=\"match\">public</span> workshop will be held as part of the <span class=\"match\">public</span> involvement process for this project. FAA is <span class=\"match\">seeking</span> comments on the <span class=\"match\">Draft</span> EA.\n \n \n \n DATES: \n The <span class=\"match\">Draft</span> EA is available for <span class=\"match\">public</span> review beginning on September 23, 2024, and a <span class=\"match\">public</span> workshop will be held on October 23, 2024. Additional written comments may be filed with the project consultant, if received"},{"title":"Draft Guidance for Reducing Risk From Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonic Acid (PFOS) in Biosolids; Establishment of a Public Docket; Request for Feedback","type":"Notice","abstract":"The U.S. Environmental Protection Agency (EPA) is making available a draft memorandum that would, if finalized, provide guidance to operators of wastewater treatment plants (WWTPs) and related facilities, landowners and farmers, State and Tribal water agencies, and the public on ways to reduce potential risks posed by perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) in biosolids, as well as seeking feedback on potential next steps. The EPA is soliciting public comments on the draft memorandum and next steps for 60 days. This draft guidance memorandum does not have the force and effect of law, nor does it bind the public in any way. This draft guidance memorandum cannot be relied on by any person in litigation against the United States. The intent of draft guidance memorandum is to provide non-binding or voluntary recommendations for how to mitigate risks from PFOA and PFOS in sewage sludge and biosolids based on information currently available to the EPA.","document_number":"2026-13615","html_url":"https://www.federalregister.gov/documents/2026/07/06/2026-13615/draft-guidance-for-reducing-risk-from-perfluorooctanoic-acid-pfoa-and-perfluorooctane-sulfonic-acid","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-06/pdf/2026-13615.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13615.pdf?1782996325","publication_date":"2026-07-06","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":"of <span class=\"match\">draft</span> guidance and request for comment. \n \n \n SUMMARY: \n The U.S. Environmental Protection Agency (EPA) is making available a <span class=\"match\">draft</span> memorandum that would, if finalized, provide guidance to operators of wastewater treatment plants (WWTPs) and related facilities, landowners and farmers, State and Tribal water agencies, and the <span class=\"match\">public</span> on ways to reduce potential risks posed by perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) in biosolids, as well as <span class=\"match\">seeking</span> feedback on potential next steps. The EPA is soliciting <span class=\"match\">public</span> comments"},{"title":"M15 General Principles for Model-Informed Drug Development; 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 \"M15 General Principles for Model-Informed Drug Development.\" 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 discusses the multidisciplinary principles of model-informed drug development (MIDD). This includes recommendations on MIDD planning, model evaluation, and evidence documentation. The draft guidance also includes a harmonized framework for assessing evidence derived from MIDD. The draft guidance is intended to facilitate multidisciplinary understanding, appropriate use, and harmonized assessment of MIDD and its associated evidence.","document_number":"2024-31027","html_url":"https://www.federalregister.gov/documents/2024/12/30/2024-31027/m15-general-principles-for-model-informed-drug-development-international-council-for-harmonisation","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-30/pdf/2024-31027.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31027.pdf?1735307138","publication_date":"2024-12-30","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":"Drug <span class=\"match\">Administration</span> (FDA or Agency) is announcing the availability of a <span class=\"match\">draft</span> guidance for industry entitled “M15 <span class=\"match\">General</span> Principles for Model-Informed Drug Development.” The <span class=\"match\">draft</span> guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The <span class=\"match\">draft</span> guidance discusses the multidisciplinary principles of model-informed drug development (MIDD). This includes recommendations on MIDD planning, model evaluation, and evidence documentation. The <span class=\"match\">draft</span> guidance"},{"title":"Wilderness Administration and Resource Stewardship; Request for Information","type":"Notice","abstract":"The U.S. Fish and Wildlife Service (Service) seeks public comment on potential improvements to Part 610 of the Service Manual (Wilderness Stewardship), which provides policy direction for the review, planning, stewardship, and administration of wilderness areas managed by the Service. The Service is interested in receiving information and recommendations regarding whether updates, clarifications, or other revisions to existing wilderness stewardship policy may be appropriate. We invite comments from the public, and local, State, Tribal, U.S. Territories, and Federal agencies.","document_number":"2026-11956","html_url":"https://www.federalregister.gov/documents/2026/06/15/2026-11956/wilderness-administration-and-resource-stewardship-request-for-information","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-15/pdf/2026-11956.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11956.pdf?1781268312","publication_date":"2026-06-15","agencies":[{"raw_name":"DEPARTMENT OF THE INTERIOR","name":"Interior Department","id":253,"url":"https://www.federalregister.gov/agencies/interior-department","json_url":"https://www.federalregister.gov/api/v1/agencies/253","parent_id":null,"slug":"interior-department"},{"raw_name":"Fish and Wildlife Service","name":"Fish and Wildlife Service","id":197,"url":"https://www.federalregister.gov/agencies/fish-and-wildlife-service","json_url":"https://www.federalregister.gov/api/v1/agencies/197","parent_id":253,"slug":"fish-and-wildlife-service"}],"excerpts":"610 consists of the following five chapters: \n \n • \n 610 FW 1: \n <span class=\"match\">General</span> Overview of Wilderness Stewardship Policy, provides an overview and foundation for implementing the Wilderness Act and the National Wildlife Refuge System <span class=\"match\">Administration</span> Act of 1966, as amended;\n \n \n • \n 610 FW 2: \n Wilderness <span class=\"match\">Administration</span> and Resource Stewardship, provides specific direction and guidance on <span class=\"match\">administration</span> of refuge wilderness, including stewardship of natural and cultural resources, <span class=\"match\">public</span> uses, and fire;\n \n \n • \n 610 FW 3: \n Wilderness Stewardship Planning"},{"title":"Notice of Availability of Draft NPDES New Hampshire Medium Wastewater Treatment Facility General Permit","type":"Notice","abstract":"The Director of the Water Division, U.S. Environmental Protection Agency--Region 1 (EPA), is providing a Notice of Availability for the Draft National Pollutant Discharge Elimination System (NPDES) New Hampshire Medium Wastewater Treatment Facility General Permit (NH Medium WWTF GP) for discharges to certain Class B waters of the State of New Hampshire. This Draft NPDES NH Medium WWTF GP (\"Draft General Permit\") establishes effluent limitations and requirements, effluent and ambient monitoring requirements, reporting requirements, and standard conditions for 21 eligible facilities that are currently covered by individual NPDES permits (see Attachment E of the Draft General Permit for a list of eligible WWTFs). The Draft General Permit is available on EPA Region 1's website at https:// www.epa.gov/npdes-permits/region-1-draft-new-hampshire-medium- wastewater-treatment-facility-general-permit. The Fact Sheet for the Draft General Permit sets forth principal facts and the significant factual, legal, methodological, and policy questions considered in the development of the Draft General Permit and is also available at this website.","document_number":"2024-26247","html_url":"https://www.federalregister.gov/documents/2024/11/13/2024-26247/notice-of-availability-of-draft-npdes-new-hampshire-medium-wastewater-treatment-facility-general","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-13/pdf/2024-26247.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-26247.pdf?1731419128","publication_date":"2024-11-13","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":"covered by individual NPDES permits (see Attachment E of the <span class=\"match\">Draft</span> <span class=\"match\">General</span> Permit for a list of eligible WWTFs). The <span class=\"match\">Draft</span> <span class=\"match\">General</span> Permit is available on EPA Region 1's website at \n https://www.epa.gov/npdes-permits/region-1-<span class=\"match\">draft</span>-new-hampshire-medium-wastewater-treatment-facility-<span class=\"match\">general</span>-permit. \n The Fact Sheet for the <span class=\"match\">Draft</span> <span class=\"match\">General</span> Permit sets forth principal facts and the significant factual, legal, methodological, and policy questions considered in the development of the <span class=\"match\">Draft</span> <span class=\"match\">General</span> Permit and is also available at this website.\n \n \n \n DATES:"},{"title":"Agency Information Collection Activities: 2026 Election Administration and Voting Survey","type":"Notice","abstract":"In compliance with the Paperwork Reduction Act of 1995, the Election Assistance Commission (EAC) announces an information collection and seeks public comment on the provisions thereof. The EAC intends to submit this proposed information collection (2026 Election Administration and Voting Survey, or EAVS) to the Director of the Office of Management and Budget for approval. The 2026 EAVS asks election officials questions concerning voting and election administration, including the following topics: voter registration; overseas and military voting; voting by mail; early in-person voting; polling operations; provisional voting; voter participation; election technology; election policy; and other related issues.","document_number":"2026-07930","html_url":"https://www.federalregister.gov/documents/2026/04/23/2026-07930/agency-information-collection-activities-2026-election-administration-and-voting-survey","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-23/pdf/2026-07930.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07930.pdf?1776861919","publication_date":"2026-04-23","agencies":[{"raw_name":"ELECTION ASSISTANCE COMMISSION","name":"Election Assistance Commission","id":127,"url":"https://www.federalregister.gov/agencies/election-assistance-commission","json_url":"https://www.federalregister.gov/api/v1/agencies/127","parent_id":null,"slug":"election-assistance-commission"}],"excerpts":"Paperwork Reduction Act of 1995, the Election Assistance Commission (EAC) announces an information collection and <span class=\"match\">seeks</span> <span class=\"match\">public</span> comment on the provisions thereof. The EAC intends to submit this proposed information collection (2026 Election <span class=\"match\">Administration</span> and Voting Survey, or EAVS) to the Director of the Office of Management and Budget for approval. The 2026 EAVS asks election officials questions concerning voting and election <span class=\"match\">administration</span>, including the following topics: voter registration; overseas and military voting; voting by mail; early in-person"},{"title":"M15 General Principles for Model-Informed Drug Development; 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 \"M15 General Principles for Model-Informed Drug Development.\" The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance provides general recommendations for the planning, model evaluation, and documentation of evidence derived from model-informed drug development (MIDD). It establishes a harmonized assessment framework (including the associated terminology) for the MIDD evidence. It also provides recommendations for related regulatory interactions, reporting, and submission. This guideline is intended to facilitate a multidisciplinary understanding of MIDD and associated evidence generation. The guidance finalizes the draft guidance of the same title issued on December 30, 2024.","document_number":"2026-11112","html_url":"https://www.federalregister.gov/documents/2026/06/03/2026-11112/m15-general-principles-for-model-informed-drug-development-international-council-for-harmonisation","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-03/pdf/2026-11112.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11112.pdf?1780404319","publication_date":"2026-06-03","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":"announcing the availability of a <span class=\"match\">draft</span> guidance entitled “M15 <span class=\"match\">General</span> Principles for Model-Informed Drug Development.” The notice gave interested persons an opportunity to submit comments by February 28, 2025.\n \n After consideration of the comments received and revisions to the guideline, a final <span class=\"match\">draft</span> of the guideline was submitted to the ICH Assembly and endorsed by the regulatory agencies in February 2026. \n This guidance finalizes the <span class=\"match\">draft</span> guidance of the same title issued on December 30, 2024. The guidance provides <span class=\"match\">general</span> recommendations for the planning"},{"title":"E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials; 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 \"E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials.\" 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 is intended to provide general principles on the conduct of clinical trials that include pregnant and breastfeeding women to inform evidence-based decisions on safe and effective use of medicinal products by these populations. The draft guidance includes approaches to generating data that support informed decision-making on the safety, dosing, and efficacy of medicinal products during pregnancy and breastfeeding. Additionally, the draft guidance includes recommendations for recruiting and retaining pregnant and breastfeeding women in clinical trials, while reducing burden and harm on these participants.","document_number":"2025-13680","html_url":"https://www.federalregister.gov/documents/2025/07/21/2025-13680/e21-inclusion-of-pregnant-and-breastfeeding-women-in-clinical-trials-international-council-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-21/pdf/2025-13680.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-13680.pdf?1752842718","publication_date":"2025-07-21","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"},{"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 availability. \n \n \n SUMMARY: \n The Food and Drug <span class=\"match\">Administration</span> (FDA or Agency) is announcing the availability of a <span class=\"match\">draft</span> guidance for industry entitled “E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials.” The <span class=\"match\">draft</span> guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The <span class=\"match\">draft</span> guidance is intended to provide <span class=\"match\">general</span> principles on the conduct of clinical trials that include pregnant and breastfeeding women"},{"title":"Agency Information Collection Activities; Proposals, Submissions, and Approvals; 2026 Election Administration and Voting Survey","type":"Notice","abstract":"In compliance with the Paperwork Reduction Act of 1995, the Election Assistance Commission (EAC) announces an information collection and seeks public comment on the provisions thereof. The EAC intends to submit this proposed information collection (2026 Election Administration and Voting Survey, or EAVS) to the Director of the Office of Management and Budget for approval. The 2026 EAVS asks election officials questions concerning voting and election administration, including the following topics: Voter registration; overseas and military voting; voting by mail; early in-person voting; polling operations; provisional voting; voter participation; election technology; election policy; and other related issues.","document_number":"2026-00303","html_url":"https://www.federalregister.gov/documents/2026/01/12/2026-00303/agency-information-collection-activities-proposals-submissions-and-approvals-2026-election","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-01-12/pdf/2026-00303.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-00303.pdf?1767966309","publication_date":"2026-01-12","agencies":[{"raw_name":"ELECTION ASSISTANCE COMMISSION","name":"Election Assistance Commission","id":127,"url":"https://www.federalregister.gov/agencies/election-assistance-commission","json_url":"https://www.federalregister.gov/api/v1/agencies/127","parent_id":null,"slug":"election-assistance-commission"}],"excerpts":"Paperwork Reduction Act \n of 1995, the Election Assistance Commission (EAC) announces an information collection and <span class=\"match\">seeks</span> <span class=\"match\">public</span> comment on the provisions thereof. The EAC intends to submit this proposed information collection (2026 Election <span class=\"match\">Administration</span> and Voting Survey, or EAVS) to the Director of the Office of Management and Budget for approval. The 2026 EAVS asks election officials questions concerning voting and election <span class=\"match\">administration</span>, including the following topics: Voter registration; overseas and military voting; voting by mail; early in-person"},{"title":"Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies.\" This draft guidance describes considerations regarding a comparative clinical study or studies with efficacy endpoints (a comparative efficacy study or CES) intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting a marketing application under the Public Health Service Act (PHS Act).","document_number":"2025-20380","html_url":"https://www.federalregister.gov/documents/2025/11/20/2025-20380/scientific-considerations-in-demonstrating-biosimilarity-to-a-reference-product-updated","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-20/pdf/2025-20380.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-20380.pdf?1763559916","publication_date":"2025-11-20","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":"copies of the <span class=\"match\">draft</span> guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug <span class=\"match\">Administration</span>, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the \n SUPPLEMENTARY INFORMATION \n section for electronic access to the <span class=\"match\">draft</span> guidance document.\n \n \n FOR FURTHER INFORMATION CONTACT: \n \n Mustafa Unlu, Center for Drug Evaluation and Research (HF-22), Food and Drug <span class=\"match\">Administration</span>, 10903 New"},{"title":"M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines; 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 \"M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines.\" 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 general principles on planning, designing, and analyzing observational (noninterventional) pharmacoepidemiological studies that utilize fit-for-purpose data for safety assessment of medicines (drugs, vaccines, and other biological products). The draft guidance includes recommendations and high-level best practices for the conduct of these studies. The draft guidance is intended to streamline the development and regulatory assessment of postmarketing pharmacoepidemiological safety studies that include Real-World Data. This guidance also seeks to improve the ability of the study protocol and/or results to be accepted across health authorities and support decision making in response to study results.","document_number":"2024-14717","html_url":"https://www.federalregister.gov/documents/2024/07/05/2024-14717/m14-general-principles-on-plan-design-and-analysis-of-pharmacoepidemiological-studies-that-utilize","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-07-05/pdf/2024-14717.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-14717.pdf?1720010722","publication_date":"2024-07-05","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":"In May 2024, the ICH Assembly endorsed the <span class=\"match\">draft</span> guideline entitled “M14 <span class=\"match\">General</span> Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines” and agreed that the guideline should be made available for <span class=\"match\">public</span> comment. The <span class=\"match\">draft</span> guideline is the product of the Quality Expert Working Group of the ICH. Comments about this <span class=\"match\">draft</span> will be considered by FDA and the Quality Expert Working Group. \n This <span class=\"match\">draft</span> guidance provides <span class=\"match\">general</span> considerations and recommendations for use"},{"title":"Information Collection; Timber Sale Contract Operations and Administration","type":"Notice","abstract":"In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension with revision of the currently approved information collection, 0596-0225, Timber Sale Contract Operations and Administration.","document_number":"2025-05413","html_url":"https://www.federalregister.gov/documents/2025/03/28/2025-05413/information-collection-timber-sale-contract-operations-and-administration","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-03-28/pdf/2025-05413.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-05413.pdf?1743079525","publication_date":"2025-03-28","agencies":[{"raw_name":"DEPARTMENT OF AGRICULTURE","name":"Agriculture Department","id":12,"url":"https://www.federalregister.gov/agencies/agriculture-department","json_url":"https://www.federalregister.gov/api/v1/agencies/12","parent_id":null,"slug":"agriculture-department"},{"raw_name":"Forest Service","name":"Forest Service","id":209,"url":"https://www.federalregister.gov/agencies/forest-service","json_url":"https://www.federalregister.gov/api/v1/agencies/209","parent_id":12,"slug":"forest-service"}],"excerpts":"the confidentiality of the communication will be treated as <span class=\"match\">public</span> comments that may be made available to the <span class=\"match\">public</span> notwithstanding the inclusion of the routine notice. \n \n The <span class=\"match\">public</span> may inspect the <span class=\"match\">draft</span> supporting statement and/or comments received on the World Wide Web/internet site at: \n https://www.fs.usda.gov/forestmanagement/products/contracts.shtml. \n The <span class=\"match\">public</span> may request an electronic copy of the <span class=\"match\">draft</span> supporting statement and/or any \n \n comments received be sent via return email. Requests should be emailed to \n sm.fs.TSAdminForms@usda"},{"title":"M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-Interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines; 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 \"General Principles on Planning, Designing, Analyzing, and Reporting of Non- interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines.\" The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance outlines general principles on planning, designing, analyzing, and reporting non-interventional studies that utilize real-world data for safety assessment of medicines (i.e., drugs, vaccines, and other biological products). The recommendations in this guidance, while focused on safety, are applicable to non-interventional studies assessing effectiveness and are aligned and complementary with the FDA's other guidances on the generation real world evidence. The guidance includes recommendations and high-level best practices for the conduct of these studies, including articulating the research question, selecting appropriate data sources, defining key variables, addressing potential biases and confounding, conducting analyses, reporting, and submission. The guidance is intended to streamline the development and regulatory assessment of postmarketing non-interventional safety studies that include real-world data. The guidance replaces the draft guidance \"M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines\" issued in July 2024. FDA is also announcing the withdrawal of the guidance entitled \"Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets,\" published May 2013.","document_number":"2026-04253","html_url":"https://www.federalregister.gov/documents/2026/03/04/2026-04253/m14-general-principles-on-planning-designing-analyzing-and-reporting-of-non-interventional-studies","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-04/pdf/2026-04253.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-04253.pdf?1772545516","publication_date":"2026-03-04","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 availability of a <span class=\"match\">draft</span> guidance entitled “M14 <span class=\"match\">General</span> Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines.” The notice gave interested persons an opportunity to submit comments by September 3, 2024.\n \n After consideration of the comments received and revisions to the guideline, the final <span class=\"match\">draft</span> of the guideline was submitted to the ICH Assembly and endorsed by the regulatory agencies in September 2025. \n This guidance finalizes the <span class=\"match\">draft</span> guidance issued on July"},{"title":"International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: General Recommendations; 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 (GFI) #90 entitled \"Effectiveness of Anthelmintics: General Recommendations.\" This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this guidance is to provide study design recommendations that will facilitate the universal acceptance of the generated effectiveness data to fulfill the national/regional requirements for anthelmintic drugs in animal species.","document_number":"2026-12678","html_url":"https://www.federalregister.gov/documents/2026/06/24/2026-12678/international-cooperation-on-harmonisation-of-technical-requirements-for-registration-of-veterinary","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-24/pdf/2026-12678.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12678.pdf?1782218715","publication_date":"2026-06-24","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":"(87 FR 49853), FDA published the notice of availability for a <span class=\"match\">draft</span> guidance entitled “International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: <span class=\"match\">General</span> Recommendations (Revision 1); <span class=\"match\">Draft</span> Guidance for Industry; Availability” giving interested persons until October 11, 2022, to comment on the <span class=\"match\">draft</span> guidance. After consideration of the comments received and revisions to the guideline, a final <span class=\"match\">draft</span> of the guideline was submitted to the VICH Steering Committee"},{"title":"Evaluation of the Appropriateness of Public-Private Partnership Project Delivery, Including Value for Money or Comparable Analyses; Infrastructure Investment and Jobs Act","type":"Notice","abstract":"The Build America Bureau (the Bureau) and the Federal Highway Administration (FHWA) are issuing guidance to help the public understand statutory requirements to evaluate the appropriateness of using public-private partnerships (P3s) to deliver infrastructure projects. This guidance intends to inform project sponsors of the Bureau's implementation of the evaluation requirements when seeking Federal credit assistance through the Transportation Infrastructure Finance and Innovation Act of 1998 (TIFIA) and the Railroad Rehabilitation and Improvement Financing (RRIF) credit assistance programs and FHWA's implementation of the major project financial plan requirement to perform detailed value for money (VfM) analysis. The guidance does not contain any new criteria, does not impose any new legal requirements, and has no legal effect. This final guidance also addresses the comments received on the draft guidance published in the Federal Register on November 13, 2024.","document_number":"2026-04134","html_url":"https://www.federalregister.gov/documents/2026/03/03/2026-04134/evaluation-of-the-appropriateness-of-public-private-partnership-project-delivery-including-value-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-03/pdf/2026-04134.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-04134.pdf?1772459107","publication_date":"2026-03-03","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":"where the <span class=\"match\">public</span> sponsor is not directly <span class=\"match\">seeking</span> TIFIA or RRIF credit assistance but anticipates that its preferred bidder might do so.\n \n \n If the <span class=\"match\">public</span> sponsor cannot define a workable <span class=\"match\">public</span> delivery option, the <span class=\"match\">public</span> sponsor can demonstrate compliance with statutory requirements by documenting before signing a concession agreement why it cannot complete a meaningful VfM or comparable analysis and why it decided to use a P3 delivery option. \n \n D. \n Auditing and <span class=\"match\">Public</span> Information. \n Transparency is an integral part of proper <span class=\"match\">public</span> sector decision"},{"title":"The NCUA Staff Draft 2026-2027 Budget","type":"Notice","abstract":"The NCUA's staff draft \"detailed business-type budget\" is being made available for public review as required by federal statute. The proposed resources will finance the agency's annual operations and capital projects, both of which are necessary for the agency to accomplish its mission of protecting the system of cooperative credit and its member-owners through effective chartering, supervision, regulation, and insurance. Comment instructions are included in the supplementary information section. The schedule for a public hearing about the budget will be announced in a future notice.","document_number":"2025-18856","html_url":"https://www.federalregister.gov/documents/2025/09/29/2025-18856/the-ncua-staff-draft-2026-2027-budget","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-29/pdf/2025-18856.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-18856.pdf?1758890718","publication_date":"2025-09-29","agencies":[{"raw_name":"NATIONAL CREDIT UNION ADMINISTRATION","name":"National Credit Union Administration","id":335,"url":"https://www.federalregister.gov/agencies/national-credit-union-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/335","parent_id":null,"slug":"national-credit-union-administration"}],"excerpts":"agency that releases a detailed <span class=\"match\">draft</span> budget and solicits <span class=\"match\">public</span> comments on it. As required by statute, before adopting a budget, the NCUA presents a <span class=\"match\">draft</span> budget to the <span class=\"match\">public</span> on the agency's website and in the \n Federal Register \n , allowing credit unions and the <span class=\"match\">public</span> to provide feedback to the Board on the budget. The Board also holds a <span class=\"match\">public</span> hearing on the <span class=\"match\">draft</span> budget.\n \n The NCUA Board reviews the comments from the <span class=\"match\">public</span> and evaluates other considerations, including any direction from the <span class=\"match\">Administration</span>, in arriving at a final budget."},{"title":"Wireline Competition Bureau and Office of Economics and Analytics Seek Comment on Proposed 2026 Mandatory Data Collection for Incarcerated People's Communications Services","type":"Proposed Rule","abstract":"In this document, the Wireline Competition Bureau (WCB) and the Office of Economics and Analytics (OEA) of the Federal Communications Commission (Commission) seek comment on the contours and specific requirements of the proposed 2026 Mandatory Data Collection for incarcerated people's communications services (IPCS). Consistent with the Commission's direction, in this document, we seek comment on proposals to modify the Commission's previous data collection to obtain data and information necessary for the Commission to set permanent rate caps for audio and video ICPS and, to the extent practicable, lessen the reporting burdens on ICPS providers.","document_number":"2026-12234","html_url":"https://www.federalregister.gov/documents/2026/06/17/2026-12234/wireline-competition-bureau-and-office-of-economics-and-analytics-seek-comment-on-proposed-2026","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-17/pdf/2026-12234.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12234.pdf?1781613919","publication_date":"2026-06-17","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":"policies and rules proposed in the <span class=\"match\">Public</span> Notice. The Supplemental IRFA is set forth in section IV below. The Commission requests written <span class=\"match\">public</span> comments on the Supplemental IRFA. Comments must be identified as responses to the Supplemental IRFA and must be filed by the deadlines for comments provided in this <span class=\"match\">Public</span> Notice. The Commission will send a copy of this <span class=\"match\">Public</span> Notice, including the Supplemental IRFA, to the Chief Counsel for Advocacy of the Small Business <span class=\"match\">Administration</span>. In addition, summaries of this <span class=\"match\">Public</span> Notice and the Supplemental IRFA"},{"title":"National Oceanic and Atmospheric Administration (NOAA) Availability for Public Comment on NCA6 Draft Prospectus; Call for Authors and Contributors, Technical Inputs; and Notice of Public Engagement","type":"Notice","abstract":"NOAA is publishing this notice on behalf of the U.S. Global Change Research Program (USGCRP), which seeks public comment on the proposed themes and framework of the Sixth National Climate Assessment (NCA6) as indicated by the Draft Prospectus presented in Part I. Based on input received from this notice, USGCRP will develop an annotated outline, which will be released for public comment at a later date. This notice also requests nominations for volunteer contributors and submission of technical inputs (Parts II and III) and provides notice of planned public engagement events (Part IV) for NCA6.","document_number":"2024-09575","html_url":"https://www.federalregister.gov/documents/2024/05/02/2024-09575/national-oceanic-and-atmospheric-administration-noaa-availability-for-public-comment-on-nca6-draft","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-02/pdf/2024-09575.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-09575.pdf?1714567537","publication_date":"2024-05-02","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"}],"excerpts":"IV. Notice of Planned <span class=\"match\">Public</span> Engagement Opportunities for NCA6 \n Multiple opportunities for <span class=\"match\">public</span> engagement to inform NCA6 will be presented throughout the report's development. The following planned <span class=\"match\">public</span> engagement schedule is presented to notify the <span class=\"match\">public</span> of these coming opportunities. The time ranges proposed are subject to change based on the timing of various development stages for NCA6. \n <span class=\"match\">Public</span> call for comments on the <span class=\"match\">Draft</span> Prospectus (Q2 2024) \n <span class=\"match\">Public</span> call for authors and technical inputs (Q2 2024) \n <span class=\"match\">Public</span> comment on NCA6 annotated"}]}