Summary of Responses to 60 Day Public Comment on OMB No 0915-0327 15Dec2025

Summary of Responses to 60 Day Public Comment on OMB No 0915-0327 15Dec2025.xlsx

Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Ceiling Price Calculations

Summary of Responses to 60 Day Public Comment on OMB No 0915-0327 15Dec2025

OMB: 0915-0327

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Attachment IV - Summary of Comments Received on 0915-0327
ISSUE Summary of Comments Actions to Address Comments
Shipping Address Clarifications Some covered entities disagree with the additional clarifying questions identifying wholly owned pharmacies and health care service delivery sites. HRSA developed the new shipping address submission process to streamline communication with covered entities and improve efficiency. The policy on what qualifies as a shipping address remains unchanged.
New documentation requirements for STD entities. Some covered entities are concerned that the proposed documentation to support STD eligibility will strain small and community-based STD clinics with limited administrative staff and funding. The new requirements for STD covered entities are intended to improve transparency, program integrity, and enable HRSA to more effectively confirm and maintain eligibility for all stakeholders.
Request for technical assistance to implement STD written agreements Some entities are concerned about the timeline and support needed to comply with the STD written agreements. Therefore, they request that technical assistance be provided by OPA and/or Apexus to help implement these new requirements and an implementation period to execute the changes. HRSA understands the operational challenges described in the comments and will take these concerns into account; however this documentation is necessary to provide oversight. HRSA will continue to provide outreach and technical assistance to ensure covered entities understand documentation requirements and can comply with them in a timely manner.
Trial Balance Language Some stakeholders are concerned with the language update regarding entities that should submit a trial balance that clearly indicates unique and separate reimbursable outpatient costs and charges for each service being requested. They are concerned this will create a burden or result in inappropriate modification or termination. HRSA is clarifying the required elements of a trial balance for hospitals registering a child site to ensure compliance with program requirements. The criteria for what qualifies as a child site remain unchanged.
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