Notice2025-11979
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
June 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 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 123 (Monday, June 30, 2025)</title>
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[Federal Register Volume 90, Number 123 (Monday, June 30, 2025)]
[Notices]
[Pages 27869-27870]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11979]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10849]
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 collection techniques or other forms of
information technology to minimize the information collection burden.
DATES: Comments must be received by August 29, 2025.
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.
[[Page 27870]]
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).
CMS-10849 Drug Price Negotiation for Initial Price Applicability Year
2028 under Sections 11001 and 11002 of the Inflation Reduction Act
Information Collection Request
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: Drug Price
Negotiation for Initial Price Applicability Year 2028 under Sections
11001 and 11002 of the Inflation Reduction Act Information Collection
Request (ICR) (CMS-10849, OMB 0938-1452); Use: Under the authority in
sections 11001 and 11002 of the Inflation Reduction Act of 2022 (Pub.
L. 117-169), the Centers for Medicare & Medicaid Services (CMS) is
implementing the Medicare Drug Price Negotiation Program, codified in
sections 1191 through 1198 of the Social Security Act (``the Act'').
The Act establishes the Negotiation Program to negotiate maximum fair
prices (``MFPs''), defined at 1191(c)(3) of the Act, for certain high
expenditure, single source selected drugs covered under Medicare Part B
and Part D. For the third cycle of the Negotiation Program, the
Secretary of Health and Human Services (the ``Secretary'') will select
up to 15 high expenditure, single source drugs payable under Part B
and/or covered under Part D for negotiation. In accordance with section
1194(f)(4) of the Act, CMS will also renegotiate MFPs for drugs
selected for renegotiation, if any, for initial price applicability
year 2028.
Negotiation Data Elements: The statute requires that CMS consider
certain data from Primary Manufacturers as part of the negotiation
process. To the extent that more than one entity meets the statutory
definition of manufacturer (specified in section 1193(a)(1) of the Act)
for a selected drug for purposes of initial price applicability year
2028, CMS will designate the entity that holds the New Drug
Application(s) (NDA(s))/Biologics License Application(s) (BLA(s)) for
the selected drug to be ``the manufacturer'' of the selected drug
(hereinafter the ``Primary Manufacturer''). The Primary Manufacturer's
data submissions include the non-Federal average manufacturer price and
related data for selected drugs for the purpose of establishing a
ceiling price, as outlined in section 1193(a)(4)(A) of the Act, and
information that the Secretary requires, pertaining to the negotiation
factors outlined in section 1194(e)(1) of the Act, for the purpose of
formulating offers and counteroffers pursuant to section 1193(a)(4)(B)
of the Act. Some of these data are held by the Primary Manufacturer and
are not currently available to CMS. Data described in sections
1194(e)(1) and 1193(a)(4) of the Act must be submitted by the Primary
Manufacturer.
Section 1194(e)(2) of the Act requires CMS to consider certain data
on selected drugs and their alternative treatments. Because the statute
does not specify where these data come from, CMS will allow for
optional submission from Primary Manufacturers and the public for drugs
selected for negotiation or renegotiation. CMS will additionally review
existing literature, conduct internal analyses, and consult subject
matter and clinical experts on the factors listed in section 1194(e)(2)
of the Act. Manufacturers may optionally submit this information as
part of their Negotiation Data Elements Information Collection Request
Form. The public may also optionally submit evidence about the selected
drugs and their alternative treatments.
Drug Price Negotiation and Renegotiation Process: Any MFPs that are
negotiated or renegotiated for these selected drugs will apply
beginning in initial price applicability year 2028. For initial price
applicability year 2028, the negotiation and renegotiation period
begins on the earlier of the date that the Primary Manufacturer enters
into a Medicare Drug Price Negotiation Program Agreement or February
28, 2026.
Section 1194(b)(2)(C) of the Act provides that if the Primary
Manufacturer does not accept CMS' written initial offer, the Primary
Manufacturer may submit an optional written counteroffer no later than
30 days after the date of receipt of CMS' written initial offer. If the
Primary Manufacturer chooses to develop and submit a written
counteroffer to CMS' written initial offer during the drug price
negotiation or renegotiation process for initial price applicability
year 2028, the Primary Manufacturer must submit the Counteroffer Form.
Form Number: CMS-10849 (OMB control number: 0938-1452); Frequency:
Once; Affected Public: Private sector, Business or other for-profit;
Number of Respondents: 405; Number of Responses: 405; Total Annual
Hours: 51,940. (For questions regarding this collection, contact
Elisabeth Daniel at 667-290-8793.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-11979 Filed 6-27-25; 8:45 am]
BILLING CODE 4120-01-P
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