ASP Data Submission Notice for Medicare Part B Drugs - Comments Closed May 7

Content

ACTION:

Notice.

SUMMARY:

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to
publish notice in the
Federal Register
concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection
of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send
comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and
utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated
burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection
techniques or other forms of information technology to minimize the information collection burden.

DATES:

Comments on the collection(s) of information must be received by the OMB desk officer by May 7, 2026.

ADDRESSES:

Written comments and recommendations for the proposed information collection should be sent within 30 days of publication
of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using
the search function.

To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice,
please access the CMS PRA website by copying and pasting the following web address into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

FOR FURTHER INFORMATION CONTACT:

William Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office
of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information”
is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C.

  3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the 
  Federal Register
  concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection
  of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this
  notice that summarizes the following proposed collection(s) of information for public comment.

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals and Supporting Regulations in 42 CFR 414.800-806; Use: Section 1847A of the Social Security Act requires that the Medicare Part B payment amounts for covered drugs and biologicals not paid on a cost or prospective payment basis be based upon manufacturers' average sales price data submitted quarterly to CMS. The reporting requirements are specified in 42 CFR part 414, subpart J. This April 2026 iteration proposes to revise the Bona Fide Service Fee Certification form and revise our active burden estimates. Since some of the changes are substantive, this 30-day collection of information request is a continuation of the 60-day collection of information request that published in the Federal Register on December 30, 2025 (90 FR 61154). Form Number: CMS-10110 (OMB control number: 0938-0921); Frequency: Quarterly; Affected Public: Private Sector; Number of Respondents: 500; Total Annual Responses: 4,500; Total Annual Hours: 49,500. (For policy questions regarding this collection contact: Rebecca Ray at 667-414-0879 or Laura Kennedy at 410-786-3377.)

William N. Parham, III, Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2026-06725 Filed 4-6-26; 8:45 am] BILLING CODE 4120-01-P

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