Read twice and referred to the Committee on Environment and Public Works.

Original title: “S 5409: Environmental Health Restoration Act of 2026”

On September 14, a bipartisan coalition of Representatives introduced the Priority for Pediatric Cures Act, which would make the Rare Pediatric Disease Priority Review Voucher (PRV) Program permanent.

Original title: “Bipartisan Bill Aims to Make the Rare Pediatric Disease PRV Program Permanent”

The FDA aims to leverage the expertise of qualified research institutions paired with drug sponsors to lessen the risk of clinical holds during the investigational new drug review process and expedite the path to first-in-human development in the U.S. The initial application period will close on Oct. 30.

Original title: “FDA opens Operation TrialBlazer for applications, hoping to reshore early trials”

Safety and access were top of mind at Monday’s public hearing exploring the regulation of psychedelic therapies. "The medicine opens the door,” NeuroAlchemy co-founder Michaela Vogt said during the meeting, but many other factors will ensure this new drug class can benefit patients.

Original title: “Stakeholders urge FDA to define data, treatment standards as psychedelic drugs near market”

The Administrator of the World Trade Center (WTC) Health Program has received a petition (Petition 048a) to add "peripheral vascular disease" (referred to herein as "peripheral artery disease") to the List of WTC-Related Health Conditions. Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that there is insufficient evidence available to support taking further action at this time regarding peripheral artery dis

Original title: “World Trade Center Health Program; Petition 048a-Peripheral Artery Disease; Finding of Insufficient Evidence”

The Administrator of the World Trade Center (WTC) Health Program has received two petitions (Petitions 048 and 051a) to add "stroke" to the List of WTC-Related Health Conditions. Upon reviewing the scientific and medical literature, including information provided by the petitioners, the Administrator has determined that there is insufficient evidence available to support taking further action regarding stroke at this time. The Administrator also finds that insufficient evidence exists to request

Original title: “World Trade Center Health Program; Petitions 048 and 051a-Stroke; Finding of Insufficient Evidence”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S4737)

Original title: “SRES 853: A resolution recognizing suicide as a serious public health problem and expressing support for the designation of September 8, 2026, as "988 Day" and the role of 988 Suicide and Crisis Lifeline.”

The Food and Drug Administration (FDA, the Agency, or we) is establishing a public docket to collect feedback on statistical considerations for rare disease clinical investigations. This docket is open in conjunction with a Rare disease Innovation, Science, and Exploration (RISE) Workshop on the same topic. Feedback is welcome both on the attached pre-read documents and on the content covered in the Workshop itself.

Original title: “Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments”

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), is requesting a 3-year extension of the Multistate Financial Institution Data Match (MSFIDM) with Federally Assisted State Transmitted (FAST) Levy (Office of Management and Budget #: 0970-0196, expiration January 31, 2027). OCSE revised the MSFIDM handbook and the FAST Levy record specifications. Burden estimates were reduced by 32.71 percent to reflect the expected estimated number of respondents and

Original title: “Proposed Information Collection Activity; Multistate Financial Institution Data Match With Federally Assisted State Transmitted Levy”

After years of price pressures, the trade group argues “the economics of generics have deteriorated to the point where sustainability of the industry is in peril.”

Original title: “AAM sounds alarm on ‘unsustainable, race to the bottom’ for generics and biosimilars”

Despite the passage of landmark ... of all rare diseases still have zero FDA-approved therapeutic treatments. The primary bottleneck preventing curative breakthroughs is not a lack of scientific understanding; the genetic mutations causing many monogenic pediatric disorders have been mapped down to the exact nucleotide pair. The crisis is an operational and regulatory brick wall: the pediatric orphan disease trial enrollment ... Despite the passage of landmark legislation like the US Orphan Drug Act of 1983 and European orphan medicinal product regulations (which provide lucrative research tax credits, fee waivers, and extended market exclusivity periods), over ninety-five percent of all rare diseases still have zero FDA-approved therapeutic treatments. The primary bottleneck preventing curative breakthroughs is not a lack of scientific understanding; the genetic mutations causing many monogenic pediatric disorders have been mapped down to the exact nucleotide pair. The crisis is an operational and regulatory brick wall: the pediatric orphan disease trial enrollment deficit. An investigative breakdown of pediatric drug development reveals how hyper-fragmented patient populations, non-standardized electronic health data, and cross-border regulatory silos stall clinical trials for childhood rare diseases. If a pharmaceutical sponsor attempts to recruit thirty pediatric patients for an orphan trial, they must activate dozens of clinical hospital sites across five continents, multiplying trial initiation costs into the tens of millions of dollars. The human and ethical stakes of pediatric rare disease trials are excruciating. "In pediatric rare diseases, the statistical tools of 20th-century medicine break down completely; if your regulatory framework demands a 500-patient randomized placebo trial when only 100 children exist on the planet, you are legally condemning an entire generation of children to death. - Director of Pediatric Rare Disease Consortium, National Institutes of Health" To break this methodological deadlock, advanced statistical methodologies and decentralized global patient federations are reforming rare disease drug development. The FDA has expanded its acceptance of Bayesian adaptive clinical trial designs, which allow researchers to leverage external data from synthetic control arms and real-world evidence (RWE) to maximize statistical power from microscopic patient cohorts of ten to twenty children.

Original title: “Streamlinefeed”

Heading into an FDA hearing on Monday regarding the future of psychedelic treatments, public comments show wide support for further exploring the therapeutic potential of these compounds—to match rising support within the agency.

Original title: “Psychedelic therapies ride wave of public favor into FDA hearing”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 10359: To amend the Federal Food, Drug, and Cosmetic Act to permanently extend the authority of the Secretary of Health and Human Services to award priority review vouchers for rare pediatric disease products.”

Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Workforce, 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 10369: To amend title XVIII of the Social Security Act, and the Employee Retirement Income Security Act of 1974, to create certain requirements with respect to pharmacy benefit managers.”

Referred to the House Committee on Education and Workforce.

Original title: “HR 10373: Protecting Workers' Wages from Medical Debt Act”

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 10376: To amend title XVIII of the Social Security Act to establish reporting and transparency requirements for data related to telehealth services under the Medicare program.”

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 10374: To require the Secretary of Health and Human Services to continue the Part D Premium Stabilization Demonstration under the Medicare program.”

Referred to the House Committee on Education and Workforce.

Original title: “HR 10358: To assist survivors of stroke and other debilitating health occurrences in returning to work.”

As the world's largest public funder of biomedical research, the National Institutes of Health (NIH) is committed to ensuring that gold-standard science is conducted under gold-standard biosafety conditions. To achieve this goal, NIH is proposing a new policy that modernizes and strengthens biosafety practices to ensure that oversight keeps pace with evolving risks. NIH is requesting public input on a new, comprehensive biosafety policy proposal that, when finalized, will replace the current NIH

Original title: “Draft NIH Biosafety Policy for Research Involving Biohazards”

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Office of Science Policy (OSP), in the Office of the Director (OD), the National Institutes of Health (NIH) 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; NIH Electronic Application System for NIH Certificates of Confidentiality (CoC)”