[Federal Register Volume 84, Number 166 (Tuesday, August 27, 2019)]
[Notices]
[Pages 44898-44899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18415]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10697]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid 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 September 26, 2019.

ADDRESSES: When commenting on the proposed information collections, 
please reference the document identifier or OMB control number. To be 
assured consideration, comments and recommendations must be received by 
the OMB desk officer via one of the following transmissions: OMB, 
Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax Number: (202) 395-5806 OR, Email: 
[email protected].
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' Website address at Website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
    1. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    2. Call the Reports Clearance Office at (410) 786-1326.

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: 
Medicare Coverage of Items and Services for Coverage with Evidence 
Development (CED); Use: The CED is a paradigm whereby 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. In making coverage decisions involving CED, 
CMS decides after a formal review of the medical literature to cover an 
item or service only in the context of an approved clinical study or 
when additional clinical data are collected to assess the 
appropriateness of an item or

[[Page 44899]]

service for use with a particular beneficiary. When an NCD requires CED 
under 1862(a)(1)(E), it is because the available evidence about a 
particular item or service is insufficient to support coverage outside 
the context of a well-designed clinical research study. Sponsors could 
build interim analyses and final analyses into their study design and 
communicate these results to CMS.
    Section 1142 of the Act describes the authority of the Agency for 
Healthcare Research and Quality (AHRQ) to conduct and support research 
on outcomes, effectiveness, and appropriateness of services and 
procedures to identify the most effective and appropriate means to 
prevent, diagnose, treat, and manage diseases, disorders, and other 
health conditions. That section includes a requirement that the 
Secretary assure that AHRQ research priorities under Section 1142 
appropriately reflect the needs and priorities of the Medicare program.
    The coordination of AHRQ priorities under section 1142 with the 
needs and priorities of the Medicare program is accomplished through 
direct collaboration between the AHRQ and CMS. AHRQ reviews all CED 
NCDs established under Section 1862(a)(1)(E) of the Act. Consistent 
with section 1142, AHRQ also indicates its support for clinical 
research studies that CMS determines address the CED questions and meet 
the general standards for CED studies. In order for CMS (or its 
designated entity) to determine if the Medicare coverage criteria are 
met, as described in our regulations, CMS (or its designated entity) 
must review the study protocol and supporting materials, as needed. 
Form Number: CMS-10697 (OMB control number: 0938-New); Frequency: 
Yearly; Affected Public: Private Sector (Business or other for-profits, 
Not-for-Profit Institutions); Number of Respondents: 15; Total Annual 
Responses: 15; Total Annual Hours: 15,000. (For policy questions 
regarding this collection contact Xiufen Sui at 410-786-3136.)

    Dated: August 22, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-18415 Filed 8-26-19; 8:45 am]
 BILLING CODE 4120-01-P