The Health Resources and Services Administration (HRSA) on Wednesday extended by 30 days the deadline to submit comments (PDF) on its 340B Rebate Model Pilot Program request for information (RFI) to April 20. In the RFI, HRSA seeks input on potential 340B rebate models on issues including administrative costs, anticipated staffing impacts, systems and infrastructure investments necessary to implement a rebate model, and the impact of a rebate model on payment timing and cash flow for covered entities [refer to Washington Highlights, Feb. 13].
HRSA also issued an information collection request (ICR) on Thursday, seeking comments on the burden associated with reporting data under a 340B Rebate Model Pilot Program. Specifically, the agency seeks feedback on the accuracy of its estimates of the burden for drug manufacturers and 340B covered entities to produce required data under a potential rebate model. The agency expects each covered entity to submit 52 responses annually, according to the request, with each response requiring five hours to complete. Comments on the ICR are due April 27.