HRSA: Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: 340B Rebate Model Pilot Program Application, Implementation, and Evaluation, OMB Number 0906-NEW

Federal Register

Jun 15, 2026

Notice from the Health Resources and Services Administration (HRSA) seeking comments on a proposed information collection request (ICR) titled "340B Rebate Model Pilot Program Application, Implementation, and Evaluation, OMB No. 0906-NEW." HRSA's Office of Pharmacy Affairs (OPA) intends to introduce a revised 340B Rebate Model Pilot Program (Pilot) as a mechanism for qualifying drug manufacturers, who wish to participate, to effectuate the 340B ceiling price on a limited set of drugs sold to covered entities using rebates. This ICR includes the collection of proposed rebate model plans from qualifying drug manufacturers, the ongoing collection of sales data from drug manufacturers to allow OPA to monitor implementation of the Pilot and enhance 340B program integrity and compliance monitoring, and the collection of data submitted by covered entities to manufacturers to request a rebate under a potential Pilot. Comments are due by July 15, 2026.

Healthcare business and finance · Healthcare facilities · Pharmacy and prescription drugs · Policy · Reimbursement and payment models