Agency Seeks Comments on Paperwork About Paperwork Reduction Act
Published Date: 1/15/2025
Notice
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.
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Analyzed Economic Effects
5 provisions identified: 4 benefits, 1 costs, 0 mixed.
ADR Remedy Available to Both Sides
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 ADR Panel for resolution.
New 340B ADR Claim Start Steps
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 description, and then upload supporting documents to a secure 340B ADR workspace. The rule requires filing any claim within 3 years of the alleged violation and HRSA estimates each initial submission takes about 2.5 hours.
Paperwork Estimate Increased to 15 Respondents
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
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
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. Stakeholders (covered entities and manufacturers) had previously submitted comments and HRSA considered those responses.
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