[Federal Register Volume 89, Number 87 (Friday, May 3, 2024)]
[Notices]
[Pages 36821-36822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09699]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: 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 2, 2024.

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 
http://www.regulations.gov. 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: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing

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 Small Biotech Exception and Biosimilar Delay Information 
Collection Request (ICR) for Initial Price Applicability Year 2027

    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 Collection

    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Small Biotech 
Exception and Biosimilar Delay Information Collection Request (ICR) for 
Initial Price Applicability Year 2027; 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 
and Biosimilar Delay Information Collection Request for Initial Price 
Applicability Year 2027 must be submitted to CMS before CMS establishes 
the selected drug list for initial price applicability year 2027.
    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 only covered Part D drugs that meet the requirements for the SBE 
are excluded from the term ``negotiation-eligible drug,'' a 
manufacturer that seeks the SBE for its covered Part D drug 
(``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 covered 
Part D drug 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. 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

[[Page 36822]]

``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 
2027 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 of biosimilar market entry that meets the 
requirements for the Biosimilar Delay, 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 of Biosimilar market 
entry within two years of the statutorily-defined selected drug 
publication date for initial price applicability year 2027. Form 
Number: CMS-10844 (OMB control number: 0938-1443); Frequency: Once; 
Affected Public: Private sector, Business or other for-profit; Number 
of Respondents: 25; Number of Responses: 25; Total Annual Hours: 415. 
(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. 2024-09699 Filed 5-2-24; 8:45 am]
BILLING CODE 4120-01-P