Notice2025-20748
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
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Published
November 24, 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 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.
Full Text
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<title>Federal Register, Volume 90 Issue 224 (Monday, November 24, 2025)</title>
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[Federal Register Volume 90, Number 224 (Monday, November 24, 2025)]
[Notices]
[Pages 52955-52956]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-20748]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10849]
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 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 December 24, 2025.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 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 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: <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.
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: Drug Price
Negotiation for Initial Price Applicability Year 2028 under Sections
11001 and 11002 of the Inflation Reduction Act; 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
[[Page 52956]]
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 for negotiation
and renegotiation, 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; Total Annual Responses: 405; Total Annual
Hours: 47,620. (For policy 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. 2025-20748 Filed 11-21-25; 8:45 am]
BILLING CODE 4120-01-P
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