[Federal Register Volume 88, Number 15 (Tuesday, January 24, 2023)]
[Notices]
[Pages 4184-4185]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01215]


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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 March 27, 2023.

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

    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: New collection (Request 
for a new OMB control number); Title of Information Collection: Small 
Biotech Exception; 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). 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'').
    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 Small 
Biotech Exception are excluded from the term ``negotiation-eligible 
drug,'' a manufacturer that seeks the Small Biotech Exception 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 Small Biotech Exception 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. The Information Collection Request Form for the Small Biotech

[[Page 4185]]

Exception must be submitted to CMS before CMS establishes the selected 
drug list for initial price applicability year 2026. Form Number: CMS-
10844 (OMB control number: 0938-New); Frequency: Once; Affected Public: 
Private sector, Business or other for-profit; Number of Respondents: 
10; Total Annual Responses: 10; Total Annual Hours: 68.5. (For policy 
questions regarding this collection contact Corey Rosenberg at 410-786-
9763.)

    Dated: January 18, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-01215 Filed 1-23-23; 8:45 am]
BILLING CODE 4120-01-P