[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Notices]
[Pages 45218-45219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14985]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-116 and CMS-2746]


Agency Information Collection Activities: Proposed Collection; 
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 (the 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 60 days for public 
comment on the proposed action. Interested persons are invited to send 
comments regarding our burden estimates 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 must be received by September 12, 2023.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
https://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number: __, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    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: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION:

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).


[[Page 45219]]


CMS-116 Clinical Laboratory Improvement Amendments (CLIA) Application 
Form and Supporting Regulations
CMS-2746 End Stage Renal Disease Death Notification

    Under the 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 requires federal agencies 
to publish a 60-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.

Information Collection

    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Clinical 
Laboratory Improvement Amendments (CLIA) Application Form and 
Supporting Regulations; Use: Section 353 (b) of the Public Health 
Service Act specifies that the laboratory must submit an application in 
such form and manner as the Secretary shall prescribe that describes 
the characteristics of the laboratory and examinations and procedures 
performed by the laboratory. The application must be completed by 
entities performing laboratory's testing specimens for diagnostic or 
treatment purposes. This information is vital to the certification 
process. In this revision, the majority of changes were minor changes 
to the form and accompanying instructions to facilitate the completion 
and data entry of the form. We anticipate that the changes will not 
increase the time to complete the form. Form Number: CMS-116 (OMB 
control number: 0938-0581); Frequency: Biennially and Occasionally; 
Affected Public: Private Sector--Business or other for-profits and Not-
for-profit institutions; Number of Respondents: 64,598; Total Annual 
Responses: 64,598; Total Annual Hours: 64,598. (For policy questions 
regarding this collection contact Kimberly Weaver at 410-786-3366.)
    2. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title of Information Collection: End 
Stage Renal Disease Death Notification; Use: The ESRD Death 
Notification form (CMS-2746) is completed by all Medicare-approved ESRD 
facilities upon death of an ESRD patient. Its primary purpose is to 
collect fact of death and cause of death of ESRD patients. The ESRD 
Program Management and Medical Information System (PMMIS) has the 
responsibility of collecting, maintaining, and disseminating, on a 
national basis, uniform data pertaining to ESRD patients and their 
treatment of care. All renal facilities approved to participate in the 
ESRD program are required by Public Law 95-292 to supply data to this 
system.
    Federal regulations require that the ESRD Networks examine the 
mortality rates of every Medicare-approved facility within its area of 
responsibility. CMS-2746 provides the necessary data to assist the ESRD 
Networks in making decisions that result in improved patient care and 
in cost-effective distribution of ESRD resources. The data is used by 
the ESRD Networks to verify facility deaths and to monitor facility 
performance. The form is also used by health care planning agencies and 
researchers to determine survival rates by diagnoses. This request is 
to revise the form to better align with the common verbiage used on 
standardized forms, by other Federal agencies, including the Census 
Bureau. Form Number: CMS-2746 (OMB control number: 0938-0448); 
Frequency: Yearly; Affected Public: Private Sector (Business or other 
for-profits, Not-for-Profit Institutions); Number of Respondents: 
7,726; Total Annual Responses: 101,491; Total Annual Hours: 50,746. 
(For policy questions regarding this collection contact Christina 
Goatee at 410-786-6689.)

    Dated: July 11, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-14985 Filed 7-13-23; 8:45 am]
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