Notice2025-23924
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 30, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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 also required to publish notice in the Federal Register concerning each proposed collection of information before the agency's request is submitted to OMB for approval.
Full Text
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<title>Federal Register, Volume 90 Issue 246 (Tuesday, December 30, 2025)</title>
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[Federal Register Volume 90, Number 246 (Tuesday, December 30, 2025)]
[Notices]
[Page 61154]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23924]
[[Page 61154]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10110]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
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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 also required to publish notice
in the Federal Register concerning each proposed collection of
information before the agency's request is submitted to OMB for
approval.
DATES: Comments on the collection(s) of information must be received by
the OMB desk officer by March 2, 2026.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 60 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 60-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: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</a>.
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.
Interested persons are invited to send comments regarding our
burden estimates 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.
Information Collection
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:
The revisions in this iteration are associated with our November 5,
2025 (90 FR 49266) CY 2026 Physician Fee Schedule (PFS) final rule
(CMS-1832-F, OMB 0938-AV50). In this Federal Register notice we are
soliciting public comment on the subject ASP collection of information
request that is set out in the aforementioned supporting statement and
associated attachments (see DATES and ADDRESSES for details).
This solicitation for public review and comment is an additional
comment period that is specific to the aforementioned supporting
statement and attachments. This notice provides an additional 60-day
comment period that will not be supplemented with a subsequent 30-day
notice or comment period.
The CY 2026 PFS final rule revised Sec. 414.804(a)(5) adding
submission requirements for ASP data reporting to include: (1)
reasonable assumptions for calculating the manufacturer's ASP,
including a summary of the methodology used to determine fair market
value for fee arrangements as described at Sec. 414.804 and (2)
warranty or certification letter from the recipient of a fee from a
manufacturer as evidence that a fee was not passed on in accordance
with submission requirements at Sec. 414.804.
Currently, in the absence of specific guidance in statute or
Federal regulations, the manufacturer may make reasonable assumptions
in its calculations of the manufacturer's ASP, consistent with the
general requirements and intent of the law, Federal regulations, and
the manufacturer's customary business practices. The reasonable
assumptions explain the methodology used by the manufacturer to
calculate ASP.
The rule specifies that for sales beginning January 1, 2026, the
reasonable assumptions document, which is currently submitted
voluntarily by some manufacturers along with ASP data, is a required
component of the quarterly ASP data submission. The warranty or
certification from the recipient of a bona fide service fee is a new
document that we finalized to be required as evidence of whether or not
a fee was passed on. As discussed in the final rule, the new
requirements are effective for sales occurring on or after January 1,
2026; that data would be due to CMS by April 30, 2026, and used in the
July 2026 Medicare Part B Drug Payment Limit File.
Form Number: CMS-10110 (OMB control number: 0938-0921); Frequency:
Quarterly; Affected Public: Private Sector; Number of Respondents: 500;
Total Annual Responses: 2,000; Total Annual Hours: 33,495. (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. 2025-23924 Filed 12-29-25; 8:45 am]
BILLING CODE 4120-01-P
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