Notice2026-18611
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
September 11, 2026
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 91 Issue 175 (Friday, September 11, 2026)</title>
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[Federal Register Volume 91, Number 175 (Friday, September 11, 2026)]
[Notices]
[Page 57892]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18611]
[[Page 57892]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10697]
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 October 13, 2026.
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.
Information Collections
1. Type of Information Collection Request: Reinstatement without
change of a previously approved collection; Title of Information
Collection: Medicare Coverage of Items and Services for Coverage with
Evidence Development; Use: This is a reinstatement package. In general,
in order for an item or service to be covered under Medicare, it must
meet the standard described in section 1862(a)(1)(A) of the Act--that
is, it must be reasonable and necessary for the diagnosis or treatment
of illness or injury or to improve the functioning of a malformed body
member.
When the available evidence is insufficient to demonstrate that the
items and services are reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve the functioning of a
malformed body member under section 1862(a)(1)(A) of the Act, CED has
been used to support evidence development for certain items and
services that are likely to show benefit for the Medicare population.
CED relies primarily on the statutory exception in section
1862(a)(1)(E) of the Act, which effectively permits Medicare payment
for items and services that are reasonable and necessary to carry out
research conducted pursuant to section 1142 of the Act. Items and
services that are not reasonable and necessary to carry out that
research are excluded.
CED has been a pathway whereby, after a CMS and AHRQ review,
Medicare covers items and services on the condition that they are
furnished in the context of approved clinical studies or with the
collection of additional clinical data. Any approved CED study
submission should satisfy each of the criteria ``1 -17'' provided in
the CMS Coverage with Evidence Development guidance document. Form
Number: CMS-10697 (OMB control number 0938-1387); Frequency: Annually;
Affected Public: Private sector--Not-for-profit institutions and
Businesses or other for-profits; Number of Respondents: 15; Total
Annual Responses: 15; Total Annual Hours: 1,500. (For policy questions
regarding this collection, contact Lori Ashby at 410-786-6322.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2026-18611 Filed 9-10-26; 8:45 am]
BILLING CODE 4169-69-P
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</html>Indexed from Federal Register on September 11, 2026.
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