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[Federal Register Volume 89, Number 227 (Monday, November 25, 2024)]
[Notices]
[Pages 92940-92941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27490]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10849]

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 December 26, 2024.

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: Revision of a currently 
approved collection; Title of Information Collection: Negotiation Data

[[Page 92941]]

Elements and Drug Price Negotiation Process for Initial Price 
Applicability Year 2027 under sections 11001 and 11002 of the Inflation 
Reduction Act Information Collection Request (ICR) (CMS-10849, OMB 
0938-1452); 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''). 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 
second year of the Negotiation Program, the Secretary of Health and 
Human Services (the ``Secretary'') will select up to 15 high 
expenditure, single source drugs covered under Part D for negotiation.
    Negotiation Data Elements: The statute requires that CMS consider 
certain data from Primary Manufacturers as part of the negotiation 
process. To the extent that more than one entity meets the statutory 
definition of manufacturer (specified in section 1193(a)(1) of the Act) 
for a selected drug for purposes of initial price applicability year 
2027, CMS will designate the entity that holds the New Drug 
Application(s) (NDA(s))/Biologics License Application(s) (BLA(s)) for 
the selected drug to be ``the manufacturer'' of the selected drug 
(hereinafter the ``Primary Manufacturer''). The Primary Manufacturer's 
data submissions include non-FAMP and related data for selected drugs 
for the purpose of establishing a ceiling price, as outlined in section 
1193(a)(4)(A) of the Act, and the negotiation factors outlined in 
section 1194(e)(1) of the Act for the purpose of formulating offers and 
counteroffers process pursuant to section 1193(a)(4)(B) of the Act. 
Some of these data are held by the Primary Manufacturer and are not 
currently available to CMS. Data described in sections 1194(e)(1) and 
1193(a)(4) of the Act must be submitted by the Primary Manufacturer.
    Section 1194(e)(2) of the Act requires CMS to consider certain data 
on selected drugs and their alternative treatments. 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 
section 1194(e)(2) of the Act. Primary Manufacturers may optionally 
submit this information as part of their Negotiation Data Elements 
Information Collection Request Form. The public may also optionally 
submit evidence about the selected drugs and their alternative 
treatments.
    Drug Price Negotiation Process: Any MFPs that are negotiated for 
the drugs selected for the second year of the Negotiation Program will 
apply beginning in initial price applicability year 2027. For initial 
price applicability year 2027, the negotiation period begins on the 
earlier of the date that the Primary Manufacturer enters into a 
Medicare Drug Price Negotiation Program Agreement or February 28, 2025.
    Section 1194(b)(2)(C) of the Act provides that if the Primary 
Manufacturer does not accept CMS' written initial offer, the Primary 
Manufacturer may submit an optional written counteroffer no later than 
30 days after the date of receipt of CMS' 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 2027 in 
accordance with section 1194(b)(2)(C) of the Act, the Primary 
Manufacturer must submit the Statutory Written Counteroffer Form. Form 
Number: CMS-10849 (OMB control number: 0938-1452); Frequency: Once; 
Affected Public: Private sector, Business or other for-profit; Number 
of Respondents: 340; Total Annual Responses: 340; Total Annual Hours: 
23,764 (For policy questions regarding this collection contact 
Elisabeth Daniel at 667-290-8793.)

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-27490 Filed 11-22-24; 8:45 am]
BILLING CODE 4120-01-P
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