Notice2024-27490
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
November 25, 2024
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 89 Issue 227 (Monday, November 25, 2024)</title>
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[Federal Register Volume 89, Number 227 (Monday, November 25, 2024)]
[Notices]
[Pages 92940-92941]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-27490]
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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 December 26, 2024.
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: Revision of a currently
approved collection; Title of Information Collection: Negotiation Data
[[Page 92941]]
Elements and Drug Price Negotiation Process for Initial Price
Applicability Year 2027 under sections 11001 and 11002 of the Inflation
Reduction Act Information Collection Request (ICR) (CMS-10849, OMB
0938-1452); 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, 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
second year of the Negotiation Program, the Secretary of Health and
Human Services (the ``Secretary'') will select up to 15 high
expenditure, single source drugs covered under Part D for negotiation.
Negotiation Data Elements: The statute requires that CMS consider
certain data from Primary Manufacturers as part of the negotiation
process. To the extent that more than one entity meets the statutory
definition of manufacturer (specified in section 1193(a)(1) of the Act)
for a selected drug for purposes of initial price applicability year
2027, CMS will designate the entity that holds the New Drug
Application(s) (NDA(s))/Biologics License Application(s) (BLA(s)) for
the selected drug to be ``the manufacturer'' of the selected drug
(hereinafter the ``Primary Manufacturer''). The Primary Manufacturer's
data submissions include non-FAMP and related data for selected drugs
for the purpose of establishing a ceiling price, as outlined in section
1193(a)(4)(A) of the Act, and the negotiation factors outlined in
section 1194(e)(1) of the Act for the purpose of formulating offers and
counteroffers process pursuant to section 1193(a)(4)(B) of the Act.
Some of these data are held by the Primary Manufacturer and are not
currently available to CMS. Data described in sections 1194(e)(1) and
1193(a)(4) of the Act must be submitted by the Primary Manufacturer.
Section 1194(e)(2) of the Act requires CMS to consider certain data
on selected drugs and their alternative treatments. 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
section 1194(e)(2) of the Act. Primary Manufacturers may optionally
submit this information as part of their Negotiation Data Elements
Information Collection Request Form. The public may also optionally
submit evidence about the selected drugs and their alternative
treatments.
Drug Price Negotiation Process: Any MFPs that are negotiated for
the drugs selected for the second year of the Negotiation Program will
apply beginning in initial price applicability year 2027. For initial
price applicability year 2027, the negotiation period begins on the
earlier of the date that the Primary Manufacturer enters into a
Medicare Drug Price Negotiation Program Agreement or February 28, 2025.
Section 1194(b)(2)(C) of the Act provides that if the Primary
Manufacturer does not accept CMS' written initial offer, the Primary
Manufacturer may submit an optional written counteroffer no later than
30 days after the date of receipt of CMS' 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 2027 in
accordance with section 1194(b)(2)(C) of the Act, the Primary
Manufacturer must submit the Statutory Written Counteroffer Form. Form
Number: CMS-10849 (OMB control number: 0938-1452); Frequency: Once;
Affected Public: Private sector, Business or other for-profit; Number
of Respondents: 340; Total Annual Responses: 340; Total Annual Hours:
23,764 (For policy questions regarding this collection contact
Elisabeth Daniel at 667-290-8793.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-27490 Filed 11-22-24; 8:45 am]
BILLING CODE 4120-01-P
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