[Federal Register Volume 88, Number 78 (Monday, April 24, 2023)]
[Notices]
[Page 24805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08600]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10844]


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 May 24, 2023.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain . 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: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

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: 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 
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: April 19, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-08600 Filed 4-21-23; 8:45 am]
BILLING CODE 4120-01-P