[Federal Register Volume 88, Number 141 (Tuesday, July 25, 2023)]
[Notices]
[Pages 47880-47881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15713]


=======================================================================
-----------------------------------------------------------------------

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.

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

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 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.

[[Page 47881]]


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: 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 10 high expenditure, single source drugs covered 
by Medicare Part D 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 begins on the earlier of the date that the Primary Manufacturer 
enters into a Medicare Drug Price Negotiation Program Agreement or, for 
initial price applicability year 2026, 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: 2,043. (For policy questions regarding this 
collection contact Lara Strawbridge at 410-786-6880.)

    Dated: July 20, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-15713 Filed 7-24-23; 8:45 am]
BILLING CODE 4120-01-P