HRSA seeks comments on data collection for 340B Rebate Model Pilot Program
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
HRSA is asking OMB to approve a new information collection for a pilot program that would let participating drug manufacturers use rebates to deliver 340B ceiling prices on a limited set of drugs. The notice affects drug manufacturers, 340B covered entities such as hospitals and clinics, and compliance teams that track 340B pricing and reporting. Public comments are due by July 15, 2026.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Opens a 30-day public comment period on HRSA's proposed information collection
- Covers manufacturer pilot plans, manufacturer purchase data reports, and rebate request data from covered entities
- Supports HRSA monitoring of the proposed 340B Rebate Model Pilot Program and broader 340B program integrity
Obligations
What this law requires
Public commenters who wish to comment on HRSA's proposed information collection must submit written comments and recommendations through www.reginfo.gov under “Currently under Review—Open for Public Comments” or by using the search function.