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Priority Review Voucher for LOARGYS Rare Pediatric Disease Product

FDA issued a priority review voucher to Aeglea BioTherapeutics for LOARGYS (pegzilarginase-nbln), a rare pediatric disease product designated for arginase deficiency. This voucher grants the holder priority FDA review for a future drug marketing application and is transferable. The document is a routine notice under the Rare Pediatric Disease Priority Review Voucher Program.

Administrative Practices and Formal Hearings Information Collection

FDA issued a notice seeking public comment on an information collection request regarding administrative practices and formal hearings. The agency is requesting feedback on how it manages formal hearing procedures and administrative processes. Comments must be submitted by June 8, 2026.

Rural Health Care Services Outreach Program Measures

HRSA is seeking public comments on proposed measures for the Rural Health Care Services Outreach Program under OMB No. 0906-0009-Revision. The notice requests input on information collection requirements affecting entities participating in rural health outreach. Comments must be submitted by June 8, 2026.

Information Collection Activities Submission for OMB Review

CMS published a notice submitting information collection activities to OMB for review under the Paperwork Reduction Act. The notice solicits public comments on proposed and existing data collection requirements administered by the agency. Regulated parties have 30 days to submit comments.

Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention published a routine Paperwork Reduction Act notice seeking public comment on agency information collection requirements. The notice announces a 30-day comment period for unspecified CDC forms. No new compliance obligations are created by this administrative procedure.

Proposed Data Collection Under Paperwork Reduction Act

The CDC published a Federal Register notice seeking public comments on a proposed data collection under the Paperwork Reduction Act. The notice requests input on information collection burden hours and related requirements. Comments must be submitted by June 8, 2026.

WTC Health Program Denies Petitions on Hepatic Steatosis

The CDC's World Trade Center Health Program Administrator has denied Petitions 029, 034, 035, and 062, which requested the addition of hepatic steatosis (fatty liver disease) as a covered health condition under the program. The finding of insufficient evidence was published in the Federal Register (91 FR 17650). This decision affects WTC responders and survivors seeking coverage for this condition.

Proposed Data Collection Submitted for Public Comment

The CDC has published a notice in the Federal Register proposing a new data collection for public comment. The notice invites feedback from the public and relevant stakeholders on the proposed collection. Comments must be submitted by June 8, 2026.

WISeR Model Prior Authorization Technical Correction

CMS issued a correction notice correcting typographical and technical errors in the July 1, 2025 Federal Register notice regarding the WISeR (Wasteful and Inappropriate Services Reduction) Model prior authorization requirements. The corrections refine the lists of Local Coverage Determination (LCD) codes for specific services including Epidural Steroid Injections, Vertebral Compression Fracture procedures, Fusion surgeries, and Sleep Apnea treatments. The corrections are effective April 6, 2026, with applicability to WISeR items and services implemented on January 1, 2026.

Public Data Asset Release Under OPEN Government Data Act

CMS announced the release of seven public data assets containing Original Medicare utilization and payment data aggregated by provider and service, including physician services, inpatient/outpatient hospitals, Part D prescribers, DMEPOS, and Medicaid provider spending. The datasets are released in open, machine-readable formats under an open license pursuant to the OPEN Government Data Act. CMS evaluated privacy protections under HIPAA, 21st Century Cures Act, and 42 CFR Part 2, determining the data has been de-identified and appropriately limited to mitigate re-identification risk.