Notice2023-05784
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
March 21, 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 54 (Tuesday, March 21, 2023)</title>
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[Federal Register Volume 88, Number 54 (Tuesday, March 21, 2023)]
[Notices]
[Pages 16983-16984]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<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-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
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