Health

Agency Information Collection Activities: Submission for OMB Review; Comment Request

🇺🇸United States··Notice·Medium Impact·View source ↗

AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.

🇬🇧 English

The Centers for Medicare & Medicaid Services (CMS) is requesting public comments regarding its intention to collect information under the Paperwork Reduction Act of 1995. This notice outlines the process for public input on proposed information collections, such as the Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs. The agency is inviting comments on the burden estimate and the utility of the information collection, and specific details including deadlines and instructions for submitting comments are provided.

AI-generated summary. May contain errors. Refer to official sources for legal decisions.

Key Changes

  • Revision of the Bona Fide Service Fee Certification form
  • Update on burden estimates
  • Continuation of previous information collection notice

Obligations

What this law requires

high

Manufacturers must submit Average Sales Price (ASP) data for Medicare Part B drugs and biologicals to CMS on a quarterly basis

Manufacturers of drugs and biologicals covered under Medicare Part B
reporting
high

Manufacturers must submit Bona Fide Service Fee Certification form (CMS-10110) as part of ASP data submission

Manufacturers of drugs and biologicals covered under Medicare Part B
reporting
high

CMS must publish a 30-day notice in the Federal Register before submitting any information collection request to OMB for approval

Centers for Medicare & Medicaid Services (CMS)
operational
high

CMS must obtain approval from the Office of Management and Budget (OMB) for each collection of information conducted or sponsored

Centers for Medicare & Medicaid Services (CMS)
licensing
low

Members of the public must submit comments on proposed information collections by the specified deadline (May 7, 2026 for this collection)

Any interested persons wishing to comment on the information collection
reporting

Affected Parties

Manufacturers of Medicare Part B DrugsPublic commenters

Tags

CMS,Medicare,information collection