# 2025-00831: Agency Seeks Comments on Paperwork About Paperwork Reduction Act 2025-00831, Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; 340B Drug Pricing Program; Initiation of the Administrative Dispute Resolution Process, is a Federal Register notice from an unnamed agency published 2025-01-15, effective 2025-02-14 (as of 2026-06-08). - Canonical: https://policyrisk.com/federal-register/2025-00831 - As of: 2026-06-08 - Plain-text twin of the page above; the HTML and this file carry the same facts. ## Facts - Document number: 2025-00831 - Title: Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; 340B Drug Pricing Program; Initiation of the Administrative Dispute Resolution Process - Type: Notice - Agencies: unknown - Citation: unknown - Published: 2025-01-15 - Effective: 2025-02-14 - Comments close: not stated - Significant: no - Touches household money: no - Regulation identifier numbers: none - Last updated: 2026-06-08 ## In one line Agency Seeks Comments on Paperwork About Paperwork Reduction Act ## Summary The Health Resources and Services Administration (HRSA) is asking for public feedback on a new process to help settle disputes in the 340B Drug Pricing Program, which helps certain health providers get medicines at lower prices. If you’re involved with this program, now’s the time to share your thoughts before February 14, 2025. This step aims to make resolving pricing disagreements smoother and fairer, with no immediate cost changes but better clarity ahead. ## Abstract In compliance with the Paperwork Reduction Act 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 - New 340B ADR Claim Start Steps: benefit, low. If you are a covered entity or a drug manufacturer participating in the 340B Program, to start an Administrative Dispute Resolution (ADR) claim you must email HRSA's Office of Pharmacy Affairs with the petitioner and opposing party 340B ID or Labeler code, contact information, and a brief descripti… - ADR Remedy Available to Both Sides: benefit, medium. The 340B ADR process is a statutory remedy that is open to all manufacturers and all covered entities that participate in the 340B Drug Pricing Program to resolve claims of overcharge, diversion, or duplicate discounts. HRSA will review initial submissions and, if complete, assign claims to a 340B… - Paperwork Estimate Increased to 15 Respondents: cost, low. HRSA updated its estimate for this information collection from 10 respondents to 15 respondents over the next three years. HRSA estimates 15 total responses annually, at 2.5 hours per response, for a total annualized burden of 37.5 hours. - Only ADR Initiation Covered by PRA: benefit, low. HRSA's information collection request covers only the initiation of the 340B ADR process and the initial uploading of documents; once a claim is assigned to a 340B ADR Panel, subsequent steps and correspondence are exempt from Paperwork Reduction Act (PRA) requirements under 44 U.S.C. 3518(c). - Public Comment Deadline for ICR: benefit, low. HRSA submitted the Information Collection Request to OMB and is accepting public comments on the 340B ADR initiation process; comments must be received no later than February 14, 2025 via www.reginfo.gov. 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