[Federal Register Volume 88, Number 74 (Tuesday, April 18, 2023)]
[Notices]
[Page 23680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08181]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers CMS-10849]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

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 (the 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 June 20, 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-10849 Drug Price Negotiation Process under Sections 11001 and 11002 
of the Inflation Reduction Act (IRA)

    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: Drug 
Price Negotiation Process under Sections 11001 and 11002 of the 
Inflation Reduction Act (IRA); 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 (the 
``Negotiation Program''), codified in sections 1191 through 1198 of the 
Social Security Act (``the Act''). The Act establishes the Negotiation 
Program to negotiate a maximum fair price (``MFP'') with manufacturers, 
defined at section 1191(c)(3) of the Act, for certain high expenditure, 
single source drugs covered under Medicare Part B and Part D 
(``selected drugs''). For the first year of the Negotiation Program, 
CMS will select up to ten Part D high expenditure, single source drugs 
for negotiation, which will be published September 1, 2023. The MFPs 
that are negotiated for these drugs will apply beginning in initial 
price applicability year 2026. The negotiation period for initial price 
applicability year 2026 begins October 1, 2023, or on the date when the 
manufacturer of a selected drug enters into a Medicare Drug Price 
Negotiation Program Agreement with CMS if that date is prior to October 
1, 2023.
    The statute provides that, after receiving CMS' written initial 
offer, the Primary Manufacturer may, in accordance with section 
1194(b)(2)(C) of the Act, submit an optional written counteroffer (if 
CMS' written initial offer is not accepted by the Primary Manufacturer) 
that must be submitted no later than 30 days after the date of receipt 
of the 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 process for initial price 
applicability year 2026, the Primary Manufacturer must submit the 
Counteroffer Form. Form Number: CMS-10849 (OMB control number: 0938-
New); Frequency: Once; Affected Public: Private Sector and Business or 
other for-profits; Number of Respondents: 10; Total Annual Responses: 
10; Total Annual Hours: 793. For policy questions regarding this 
collection contact Lara Strawbridge at (410) 786-6880.

    Dated: April 13, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-08181 Filed 4-17-23; 8:45 am]
BILLING CODE P