Notice2023-15713
Agency Information Collection Activities: Submission for OMB Review; 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
July 25, 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 (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.
Full Text
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<title>Federal Register, Volume 88 Issue 141 (Tuesday, July 25, 2023)</title>
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[Federal Register Volume 88, Number 141 (Tuesday, July 25, 2023)]
[Notices]
[Pages 47880-47881]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-15713]
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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 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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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: <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>.
[[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
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</html>Indexed from Federal Register on July 25, 2023.
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