[Federal Register Volume 88, Number 54 (Tuesday, March 21, 2023)]
[Notices]
[Pages 16983-16984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05784]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10847]


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 (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 May 22, 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-10847 Information Collection Request for Negotiation Data Elements 
under Sections 11001 and 11002 of the Inflation Reduction Act

    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

[[Page 16984]]

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: 
Information Collection Request for Negotiation Data Elements under 
Sections 11001 and 11002 of the Inflation Reduction Act; 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 maximum fair prices (``MFPs''), defined at 
1191(c)(3) of the Act, for certain high expenditure, single source 
selected drugs covered under Medicare Part B and Part D. For the first 
year of the Negotiation Program, the Secretary of Health and Human 
Services (the ``Secretary'') will select 10 Part D high expenditure, 
single source drugs for negotiation.
    The statute requires that CMS consider certain data from Primary 
Manufacturers as part of the negotiation process. These data include 
the data required to calculate non-FAMP for selected drugs for the 
purpose of establishing a ceiling price, as outlined in section 
1193(a)(4)(A), and the negotiation factors outlined in section 
1194(e)(1) for the purpose of formulating offers and counteroffers 
process pursuant to section 1193(a)(4)(B). Some of these data are held 
by the Primary Manufacturer and are not currently available to CMS. 
Data described in section 1194(e)(1) and 1193(a)(4) must be submitted 
by the Primary Manufacturer.
    Section 1194(e)(2) requires CMS to consider certain data on 
alternative treatments to the selected drug. Because the statute does 
not specify where these data come from, CMS will allow for optional 
submission from Primary Manufacturers and the public. CMS will 
additionally review existing literature, conduct internal analyses, and 
consult subject matter and clinical experts on the factors listed in 
1194(e)(2) to ensure consideration of such factors. Manufacturers may 
optionally submit this information as part of their Negotiation Data 
Elements Information Collection Request Form. The public may optionally 
submit evidence about alternative treatments. Form Number: CMS-10847 
(OMB control number: 0938-New); Frequency: Occasionally; Affected 
Public Sector: Individuals and Households, Private Sector (Business or 
other for-profits and Not-for-profit institutions); Number of 
Respondents: 3,300; Total Annual Responses: 3,300; Total Annual Hours: 
17,000. (For policy questions regarding this collection contact Lara 
Strawbridge at 410-786-6880).

    Dated: March 16, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-05784 Filed 3-20-23; 8:45 am]
BILLING CODE 4120-01-P