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Referred to the House Committee on Energy and Commerce.
Original title: “HR 9107: To amend the Patient Protection and Affordable Care Act to provide that qualified health plans are not required to use a provider network.”
Referred to the House Committee on Energy and Commerce.
Original title: “HR 9090: Advancing Menopause Care and Mid-Life Women’s Health Act”
Read twice and referred to the Committee on Finance.
Original title: “S 1186: Lower Drug Costs for Families Act”
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
Original title: “M15 General Principles for Model-Informed Drug Development; International Council for Harmonisation; Guidance for Industry; Availability”
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry titled "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers." This revised draft guidance, when finalized, will provide answers to common questions regarding the communication of health care economic information (HCEI) about approved prescription drugs and approved/ cleared (as defined in the guidance) medi
Original title: “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability”
The Food and Drug Administration (FDA or the Agency) is announcing a formal evidentiary public hearing on the proposal to refuse to approve the supplemental new drug application (sNDA) 205677- 004, submitted by Vanda Pharmaceuticals Inc. (Vanda) for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), to treat jet lag disorder. On October 11, 2022, the Director of FDA's Center for Drug Evaluation and Research (CDER) published a notice of opportunity for hearing on a proposal to refuse to approve
Original title: “Vanda Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon)”
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 16 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Original title: “Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications”
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following educational conference (public meeting) entitled "Third Annual Animal Drug User Fee Educational Conference." This is the third of five annual educational conferences FDA will host as described in the "Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2024 Through 2028." The purpose of this series of conferences is to provide educational sessions for stakeholders who are inte
Original title: “Third Annual Animal Drug User Fee Educational Conference; Public Meeting”
The Food and Drug Administration (FDA or we) is amending the final rule that published in the Federal Register of April 16, 2026. That final rule updated regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during October, November, and December of 2025. The final rule published with some inadvertent errors in the instructions for technical amendments. This document corrects those errors.
Original title: “New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address; Correction”
Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 13 - 11.
Original title: “HR 5498: Small Business Health Options Awareness Act of 2025”
Read twice and referred to the Committee on Armed Services.
Original title: “S 2448: Health Care Fairness for Military Families Act of 2025”
This is to inform the public that, on October 22, 2025, the United States District Court for the Southern District of Mississippi issued an order in Tennessee v. Kennedy, No. 1:24-cv-161-LG-BWR (S.D. Miss. Oct. 22, 2025), vacating portions of the final rule titled "Nondiscrimination in Health Programs and Activities," published May 6, 2024 (89 FR 37522). Specifically, the court vacated certain provisions of the regulation to the extent they expand Title IX's definition of sex discrimination to i
Original title: “Notice of Vacatur Regarding Certain Provisions of the 2024 Nondiscrimination in Health Programs and Activities Final Rule”
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled 2026 Ebola Entry Screening, Monitoring, & Traveler Feedback. This data collection will
Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Survey of Syringe Services Programs (NSSSP). This program was created to as
Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Use of the Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) Durin
Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”
Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”
Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Original title: “HR 4299: Protecting Patient Access to Cancer and Complex Therapies Act”