Read twice and referred to the Committee on Energy and Natural Resources.

Original title: “S 5630: Stop Orphaned Wells Act”

The Department of Health and Human Services (HHS) provides notice of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines) using Urine and the laboratories currently certified to meet the standards of the Mandatory Guidelines using Oral Fluid.

Original title: “Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies”

The U.S. Attorney’s Office for the Middle District of Florida and the Criminal Division of the U.S. Department of Justice today announced federal charges against Swapnadip Roy, 33, and Vicky Ramancha, 37, both Indian nationals.

Original title: “FDA Investigation Leads to Charges Against Two Indian Nationals Involved in Transnational Counterfeit Drug Distribution Scheme ”

In fiscal year (FY) 2026, a Congressional Report accompanying the Consolidated Appropriations Act, 2026 (Pub. L. 119-75) included additional funding for the Innovation on Maternal Health program specifically to "support the development and implementation of a resource kit for providers, as well as correctional custody and healthcare staff, who care for pregnant, birthing and postpartum women who are incarcerated" (Senate Report 119-55). HRSA is awarding supplemental funding in the amount of $750

Original title: “AIM Incarcerated Women Resource Kit”

On July 1, 2026, HRSA published a notice in the Federal Register to solicit comments on proposed modifications to the Living Organ Donation Reimbursement Program (LODRP or Program) eligibility guidelines in response to the Honor Our Living Donors (HOLD) Act. The HOLD Act, enacted in February 2026, prohibits consideration of an organ recipient's household income in determining a living organ donor's eligibility for reimbursement. This notice responds to the comments received and finalizes the Pro

Original title: “Modification of Living Organ Donation Reimbursement Program Eligibility Guidelines in Response To Honor Our Living Donors Act”

The Food and Drug Administration (FDA or Agency) has determined that SULFADIAZINE (sulfadiazine) tablet, 500 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for SULFADIAZINE (sulfadiazine) tablet, 500 mg, if all other legal and regulatory requirements are met.

Original title: “Determination That SULFADIAZINE (Sulfadiazine) Tablet, 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness”

Read twice and referred to the Committee on Finance.

Original title: “S 5586: Ensuring Accurate Payments to Specialty Pharmacies Act”

This document revises and restates the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services, Office of the General Counsel (OGC). Issuance of this Statement of Organization rescinds all prior Statements of Organization.

Original title: “Statement of Organization, Functions, and Delegations of Authority”

This document corrects technical and typographical errors in the final rule that appeared in the Federal Register on August 4, 2026 titled "Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates; Requirements for Quality Programs; Other Policy Changes; and Adoption of Updated Versions of Certain Health Information Technology Standards."

Original title: “Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates; Requirements for Quality Programs; Other Policy Changes; and Adoption of Updated Versions of Certain Health Information Technology Standards; Correction”

Biomarker testing, referrals, screening, treatment access, and clinical trial barriers were examined during this recent IVBM. A new type of eye drug matched standard anti-VEGF therapy in a large trial for diabetic macular edema, a disease affecting 1.6 million Americans. Ahmed pointed to the financial toxicity of indefinite continuous BTK inhibitor therapy, saying she is increasingly drawn to fixed-duration venetoclax-BTK combinations that give patients a defined treatment end point. That tension between drug cost and payment structure extends well beyond CLL, noted Cassaday, Bardin, and Huang, as expensive novel agents increasingly collide with inpatient bundled payment models. To work around this, clinicians have resorted to administering drugs in the outpatient setting under 340B pricing before same-day inpatient admission or discharging and readmitting patients specifically to access outpatient drug coverage. Huang detailed the complexity of triplet regimens, such as Bruton tyrosine kinase (BTK) inhibitors combined with venetoclax and obinutuzumab (Gazyva; Genentech) for relapsed mantle cell disease. This includes overlapping myelosuppression, TLS risk, and infection management.

Original title: “Overcoming Barriers to Precision Care and Patient Access | AJMC”

FDA is carefully reviewing its experience implementing the Premarket Tobacco Product Application (PMTA) rule, as well as recent judicial developments, including a federal lawsuit filed in the U.S. District Court for the Northern District of Texas challenging the current regulatory framework.

Original title: “FDA intends to evaluate changes to the PMTA regulatory framework”

What changed and how will it effect rare disease therapy development?

Original title: “The Updated Substantial Evidence Guidance”

The key issues for industry and FDA as the Orphan Drug Act hits its 40th anniversary. The key issues for industry and FDA as the Orphan Drug Act hits its 40th anniversary. ... As patients and the public health community mark the 40th anniversary of the Orphan Drug Act of 1983, biopharma companies and FDA officials are acknowledging continued challenges in testing, approving, and producing new treatments for critical conditions affecting small patient populations. And recent legislation has established an initiative to accelerate the development of more effective treatments for amyotrophic lateral sclerosis (ALS) through an FDA Rare Neurodegenerative Disease grants program].5 The awards aim to cover R&D costs of new therapies for ALS and a range of rare neurogenerative diseases in adults and children, as spelled out in an FDA action plan issued in June 2022. Efforts to advance rare disease treatments, however, may be stymied by the ongoing legal battle that has raised challenges to FDA policies governing the scope of orphan drug exclusivity policy. Despite that court ruling, FDA has insisted that it will continue to tie orphan drug exclusivity only to approved uses or indications.6 The agency has pressed Congress to enact legislation to clarify this stance, but so far has failed to gain action on Capitol Hill. The program has led to market approval of more than 600 therapies to treat serious diseases affecting less than 200,000 patients in the US, investment spurred by grants and tax credits to help fund very small clinical trials, exemptions from hefty user fees, plus seven years added of marketing exclusivity for approved orphans and more incentives for developing rare disease treatments for children.1 · FDA notes that orphan therapies accounted for more than half of novel new drugs approved in 2022, and that the agency already has approved two notable rare disease treatments this year.

Original title: “Kudos and Hurdles in Tackling Rare Diseases | Applied Clinical Trials Online”

Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Education and Workforce, and Natural Resources, 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 10616: Public Access to HHS Health Data Act of 2026”

In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying an existing system of records maintained by the Office of Refugee Resettlement (ORR) within HHS' Administration for Children and Families (ACF), System No. 09-80-0321, ORR Unaccompanied Children Bureau (UCB) Administrative Program Records. The system of records covers records about unaccompanied children, their intended sponsors, and members of the intended s

Original title: “Privacy Act of 1974; System of Records”

Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”

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 Public Health Emergency Preparedness (PHEP) Cooperative Agreement. This request propos

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 Colorectal Cancer Control Program (CRCCP) Monitoring Activities. CDC is requesting a

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

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

Original title: “Submission for OMB Review; 30-Day Comment Request; Generic Clearance for NIH Citizen Science and Crowdsourcing Projects (Office of the Director)”

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

Original title: “Submission for OMB Review; 30-Day Comment Request;”