Notice2023-14176
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 3, 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 126 (Monday, July 3, 2023)</title>
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[Federal Register Volume 88, Number 126 (Monday, July 3, 2023)]
[Notices]
[Pages 42722-42723]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-14176]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10847]
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 2, 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>.
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:
Negotiation Data
[[Page 42723]]
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: Individuals and Households, Private Sector (Business or other
for-profits and Not-for-profit institutions); Number of Respondents:
3,300; Total Annual Responses: 3,000; Total Annual Hours: 17,000. (For
policy questions regarding this collection contact Lara Strawbridge at
410-786-6880.)
Dated: June 29, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2023-14176 Filed 6-30-23; 8:45 am]
BILLING CODE 4120-01-P
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