Notice2023-08181
Agency Information Collection Activities: Proposed Collection; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 18, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 74 (Tuesday, April 18, 2023)</title>
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[Federal Register Volume 88, Number 74 (Tuesday, April 18, 2023)]
[Notices]
[Page 23680]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-08181]
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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.
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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 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
<a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</a>.
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
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