The U.S. Department of Health and Human Services will conduct a virtual Tribal consultation on the proposed rule "Modifications to the HIPAA Privacy Rule to Support, and Remove Barriers to, Coordinated Care and Individual Engagement."

Original title: “Tribal Consultation on Proposed Modifications to the HIPAA Privacy Rule”

Original title: “Notice of Opportunity for Hearing on Compliance of Minnesota State Plan Provisions Concerning Program Integrity and Fraud, Waste, and Abuse With Title XIX (Medicaid) of the Social Security Act”

This document announces the updated Healthcare Common Procedure Coding System (HCPCS) codes on the Master List. It also announces updates to the HCPCS codes on the Required Face-to-Face and Written Order Prior to Delivery List and the Required Prior Authorization List.

Original title: “Medicare Program; Updates to the Master List of Items Potentially Subject to Face to Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements; Updates to the Required Face-to-Face Encounter and Written Order Prior to Delivery List; and Updates to the Required Prior Authorization List”

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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Disease Surveillance Program--II. Disease Summaries information collection. T

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 revision information collection project titled Maternal Mortality Review Information Application (MMRIA). MMRIA is a stand

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 proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Land Activity Illness and Death Reporting. This data collection is d

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 comments on a proposed information collection project titled Traveler-Based Genomic Surveillance Program (TGS) Traveler Questionnaire. The TGS p

Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”

Referred to the House Committee on Financial Services.

Original title: “HR 7030: Securing Facilities for Mental Health Services Act”

Forwarded by Subcommittee to Full Committee by Voice Vote.

Original title: “HR 7049: Improving Mental Health Care and Coordination for Homeless Veterans Act”

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 Evaluating the Impact of Training and Technical Assistance (TTA) Programs for NCCCP

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 Awardee Lead Profile Assessment (ALPA). The ALPA survey will serve to identify child

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 Aviation Activity Illness and Death Reporting. This data collection is designed to p

Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”

The rare disease community starts the year with renewed efforts to reauthorize the Rare Pediatric Disease Priority Review Voucher (PRV) Program. 2026 offers us unique opportunities to push the Give Kids a Chance Act over the finish line and ensure that our children receive lifesaving treatments.   On December 17, 2025, the Senate tried to pass The Give Kids a Chance Act, legislation […] The post Rare Disease Community Renews Efforts to Reauthorize the Rare Pediatric Disease Priority Review Vouch

Original title: “Rare Disease Community Renews Efforts to Reauthorize the Rare Pediatric Disease Priority Review Voucher”

The U.S. Food and Drug Administration today published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping drug developers make better use of available data, conduct more efficient clinical trials, and deliver safe and effective t

Original title: “FDA Issues Guidance on Modernizing Statistical Methods for Clinical Trials ”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products." This document provides guidance on the appropriate use of Bayesian methods in clinical trials. The primary focus is on the use of Bayesian methods to support primary inference in pivotal clinical trials designed to support the effectiveness and safety of drug and biological products.

Original title: “Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products; Draft Guidance for Industry; Availability”

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Original title: “Proposed Collection; 60-Day Comment Request, Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NCI)”

The U.S. Food and Drug Administration today announced it is sharing information about the agency’s flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies (CGT).

Original title: “FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation”

The Administration for Children and Families (ACF) Office of Planning, Research, and Evaluation (OPRE) is proposing a new data collection activity for the Evaluation of the Trafficking Victim Assistance Program (TVAP) and Aspire: Child Trafficking Victim Assistance Program (Aspire). The evaluation will examine the key characteristics and implementation of the programs, including the challenges, strengths, and successes.

Original title: “Submission for Office of Management and Budget Review; Evaluation of the Trafficking Victim Assistance Program (TVAP) and Aspire: Child Trafficking Victim Assistance Program (New Collection)”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 6989: Public Health Nursing Act”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZURZUVAE is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; ZURZUVAE”