# 2026-11989: HRSA Seeks Comments on New 340B Rebate Data Forms

2026-11989, 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, is a Federal Register notice from Health and Human Services Department, Health Resources and Services Administration published 2026-06-15, effective Comments on this ICR should be received no later than July 15, 2026.; PRIA reads it as touching household money (as of 2026-06-22).

- Canonical: https://policyrisk.com/federal-register/2026-11989
- As of: 2026-06-22
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-11989
- Title: 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
- Type: Notice
- Agencies: Health and Human Services Department; Health Resources and Services Administration
- Citation: 91 FR 35989
- Published: 2026-06-15
- Effective: Comments on this ICR should be received no later than July 15, 2026.
- Comments close: 2026-07-15
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-06-22

## In one line

HRSA Seeks Comments on New 340B Rebate Data Forms

## Summary

HRSA is rolling out a new 340B Rebate Model Pilot Program that changes how drug manufacturers offer discounts to certain health care providers. This means drug companies will submit plans and sales data, while health providers will request rebates differently. If you’re involved in the 340B program, get ready to share info and comment by July 15, 2026—this could impact how discounts and rebates flow, but no new costs are expected.

## Abstract

In compliance with the Paperwork Reduction Act (PRA) of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

## Effects PRIA read

- Large reporting burden for covered entities: cost, high. If you run a covered entity (for example, a hospital, health center, or pharmacy) the Pilot would require you to submit claims-level data to manufacturers. HRSA estimates 15,249 covered entities will each submit 52 responses per year at 5 hours per response, totaling 3,964,740 annual burden hours a…
- Manufacturers must submit plans and monthly reports: cost, low. Manufacturers that participate must submit a Pilot Program plan and monthly purchase reports to the 340B Prime Vendor. HRSA estimates 11 manufacturers will each submit one plan (8 hours) and 12 monthly purchase reports per year (2 hours each), totaling 352 burden hours for manufacturers.
- Pilot limited to certain negotiated-price manufacturers: mixed, low. HRSA states the Pilot scope is limited to manufacturers with current Medicare Drug Price Negotiation Program Agreements for the initial price applicability years (IPAY) 2026 and 2027. Only those qualifying manufacturers may submit plans to participate.

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## Sources
- [2026-11989 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/15/2026-11989/agency-information-collection-activities-proposed-collection-public-comment-request-information)
- [2026-11989 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-15/pdf/2026-11989.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2026-11989 (as of 2026-06-22).