[Federal Register Volume 88, Number 126 (Monday, July 3, 2023)]
[Notices]
[Pages 42722-42723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14176]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10847]


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 August 2, 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: 
Negotiation Data

[[Page 42723]]

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: Individuals and Households, Private Sector (Business or other 
for-profits and Not-for-profit institutions); Number of Respondents: 
3,300; Total Annual Responses: 3,000; Total Annual Hours: 17,000. (For 
policy questions regarding this collection contact Lara Strawbridge at 
410-786-6880.)

    Dated: June 29, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-14176 Filed 6-30-23; 8:45 am]
BILLING CODE 4120-01-P