Notice2025-23507
Agency Information Collection Activities: Proposed Collection; 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 22, 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 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 60 days for public comment on the proposed action. 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.
Full Text
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<title>Federal Register, Volume 90 Issue 243 (Monday, December 22, 2025)</title>
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[Federal Register Volume 90, Number 243 (Monday, December 22, 2025)]
[Notices]
[Pages 59835-59836]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23507]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-R-305 and CMS-367a-e]
Agency Information Collection Activities: Proposed Collection;
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 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 60 days for public comment on
the proposed action. 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
[[Page 59836]]
collection techniques or other forms of information technology to
minimize the information collection burden.
DATES: Comments must be received by February 20, 2026.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number. To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
<a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier:
__/OMB Control Number: __ Room C4-26-05, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850.
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 N. Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
Under the 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 requires federal agencies
to publish a 60-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.
Information Collections
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: External Quality
Review (EQR) of Medicaid and Children's Health Insurance Program (CHIP)
Managed Care, EQR Protocols, and Supporting Regulations; Use: Most
contracts between a state Medicaid agency and their managed care plan
must provide for an annual External Quality Review (EQR). The annual
EQR is conducted by an independent external quality review organization
(EQRO). States must provide the EQRO with information obtained through
methods consistent with the protocols specified by CMS. The information
is used by the EQRO to determine the quality of care furnished by the
managed care plans in the state. The publicly posted EQR results allows
Medicaid/CHIP enrollees and potential enrollees to make informed
choices regarding the selection of their providers. It also provides
advocacy organizations, researchers, and other interested parties
access to information on the quality of care provided to Medicaid
beneficiaries enrolled in Medicaid/CHIP managed care. States use the
information during their oversight of these organizations. Form Number:
CMS-R-305 (OMB control number: 0938-0786); Frequency: Annually and one-
time; Affected Public: Private sector and State, Local or Tribal
Governments; Number of Respondents: 681; Number of Responses: 7,236;
Total Annual Hours: 887,086. (For policy questions regarding this
collection contact Carrie Hanlon at 410-786-1660.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicaid Drug
Program; Use: Labelers transmit drug product and pricing data to CMS
within 30 days after the end of each calendar month and quarter. CMS
calculates the unit rebate amount (URA) and the unit rebate offset
amount (UROA) for each new drug application (NDC) and distributes to
all State Medicaid agencies. States use the URA to invoice the labeler
for rebates and the UROA to report onto CMS-64. The monthly data is
used to calculate Federal Upper Limit (FUL) prices for applicable drugs
and for states that opt to use this data to establish their pharmacy
reimbursement methodology. Form Number: CMS-367a-e (OMB control number:
0938-0578); Frequency: Monthly, quarterly, and on occasion; Affected
Public: Private sector; Number of Respondents: 840; Total Annual
Responses: 16,160; Total Annual Hours: 606,932. (For policy questions
regarding this collection contact Robert Giles at 667-290-8626.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-23507 Filed 12-19-25; 8:45 am]
BILLING CODE 4120-01-P
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