Notice2025-08423
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
May 13, 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 91 (Tuesday, May 13, 2025)</title>
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[Federal Register Volume 90, Number 91 (Tuesday, May 13, 2025)]
[Notices]
[Pages 20305-20307]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08423]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10844]
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 July 14, 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="https://www.regulations.gov">https://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 20306]]
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-10844 Negotiation Program Drug Selection 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 with of a
currently approved collection; Title of Information Collection:
Negotiation Program Drug Selection for Initial Price Applicability Year
2028 under Sections 11001 and 11002 of the Inflation Reduction Act
Information Collection Request; 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
information collection request forms for the Small Biotech Exception,
the Biosimilar Delay, and the Selection of Renegotiation-Eligible Drugs
for initial price applicability year 2028 must be submitted to CMS
before CMS establishes the selected drug list for initial price
applicability year 2028.
Small Biotech Exception: In accordance with section 1192(d)(2) of
the Act, the term ``negotiation-eligible drug'' excludes, with respect
to the initial price applicability years 2026, 2027, and 2028, a
qualifying single source drug that meets the requirements for the
exception for small biotech drugs (the ``Small Biotech Exception,'' or
``SBE''). This information is required in order for CMS to accurately
identify whether a given drug meets the criteria for the Small Biotech
Exception in accordance with section 1192(d)(2) of the Act. To ensure
that drugs payable under Part B and/or drugs covered under Part D that
meet the requirements for the SBE are excluded from the term
``negotiation-eligible drug,'' a manufacturer that seeks the SBE for
its drug payable under Part B and/or covered under Part D (``Submitting
Manufacturer'') must submit information to CMS about the company and
its products in order for the drug to be considered for the exception.
If the Submitting Manufacturer seeks the SBE for a drug payable under
Part B and/or covered under Part D it acquired after December 31, 2021,
the Submitting Manufacturer must also submit information related to the
separate entity that had the Medicare Coverage Gap Discount Program
agreement for the drug on December 31, 2021, for drugs covered under
Part D and information related to the holder of the New Drug
Application(s) (NDA)(s) or Biologics License Applications(s) (BLA)(s)
as of December 31, 2021 for drugs payable under Part B. If the
Submitting Manufacturer was acquired by another entity after December
31, 2021, the Submitting Manufacturer must provide information
regarding that acquiring entity for CMS to assess whether the
acquisition triggers the limitation at section 1192(d)(2)(B)(ii) of the
Act.
Biosimilar Delay: In accordance with section 1192(f)(1)(B) of the
Act, the manufacturer of a biosimilar biological product (``Biosimilar
Manufacturer'' of a ``Biosimilar'') may submit a request, prior to the
selected drug publication date, for CMS' consideration to delay the
inclusion of a negotiation-eligible drug that includes the reference
product for the Biosimilar (such a negotiation-eligible drug is herein
referred to as a ``Reference Drug'') on the selected drug list for a
given initial price applicability year (the ``Biosimilar Delay''). This
information is required in order for CMS to accurately determine if a
drug meets the criteria for the Biosimilar Delay for initial price
applicability year 2028 in accordance with section 1192(f) of the Act.
To ensure that the delay of selection and negotiation of biologics is
only applied if there is a high likelihood that the Biosimilar will be
licensed and marketed, a Biosimilar Manufacturer that seeks the
Biosimilar Delay must submit information to CMS related to the
Biosimilar. This information includes identifying information for the
Biosimilar and the Reference Drug; the licensure status of the
Biosimilar; attestations that the Biosimilar Manufacturer is not the
same or treated as the same entity as the Reference Manufacturer, that
the Biosimilar Manufacturer and the Reference Manufacturer (who is the
manufacturer of the Reference Drug) have not entered into an agreement
that requires or incentivizes the Biosimilar Manufacturer to submit the
Biosimilar Delay, or directly or indirectly restricts the quantity of
the Biosimilar that may be sold in the United States over a specified
period of time; and documentation specified under section 1192(f)(3) of
the Act to demonstrate there is a high likelihood that the Biosimilar
will be licensed and marketed within two years of the statutorily-
defined selected drug publication date for initial price applicability
year 2028.
Selection of Renegotiation-Eligible Drugs: Section 1194(f) of the
Act establishes the requirements governing the identification of
renegotiation-eligible drugs and selection of drugs for renegotiation.
CMS will offer Primary Manufacturers \1\ the voluntary option to submit
information to CMS to inform CMS' determinations of which selected
drugs qualify as a renegotiation-eligible drug and may be selected for
renegotiation in accordance with section 1194(f)(3) of the Act.
Specifically, section 1194(f)(2)(D) of the Act instructs CMS to
identify whether a selected drug is eligible for renegotiation because
a new indication has been added to the selected drug and based on a
material change to any of the factors listed in section 1194(e) of the
Act. Form
[[Page 20307]]
Number: CMS-10844 (OMB control number 0938-1443); Frequency: Once;
Affected Public: Private Sector, Business, and Not-for Profits; Number
of Respondents: 65; Number of Responses: 65; Total Annual Hours:
3,677.50. (For questions regarding this collection contact Elisabeth
Daniel at 667-290-8793.)
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\1\ 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'').
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-08423 Filed 5-9-25; 8:45 am]
BILLING CODE 4120-01-P
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