[Federal Register Volume 85, Number 183 (Monday, September 21, 2020)]
[Notices]
[Pages 59313-59315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20760]



[[Page 59313]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 Day-20-20LW]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled National Healthcare Safety Network (NHSN) 
Coronavirus (COVID-19) Surveillance in Healthcare Facilities, to the 
Office of Management and Budget (OMB) for review and approval. CDC 
previously published a ``Proposed Data Collection Submitted for Public 
Comment and Recommendations'' notice on April 16, 2020 to obtain 
comments from the public and affected agencies. CDC has received six 
comments related to the previous notice. This notice serves to allow an 
additional 30 days for public and affected agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (a) Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    (b) Evaluate the accuracy of the agencies estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    (c) Enhance the quality, utility, and clarity of the information to 
be collected;
    (d) Minimize the burden of the collection of information on those 
who are to respond, including, through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., permitting 
electronic submission of responses; and
    (e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct 
written comments and/or suggestions regarding the items contained in 
this notice to the Attention: CDC Desk Officer, Office of Management 
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 
395-5806. Provide written comments within 30 days of notice 
publication.

Proposed Project

    National Healthcare Safety Network (NHSN) Coronavirus (COVID-19) 
Surveillance in Healthcare Facilities--New--National Center for 
Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    The Division of Healthcare Quality Promotion (DHQP), National 
Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers 
for Disease Control and Prevention (CDC) collects data from healthcare 
facilities in the National Healthcare Safety Network (NHSN) under OMB 
Control Number 0920-0666. NHSN is a public health surveillance system 
that collects, analyzes, reports, and makes available data for 
monitoring, measuring, and responding to healthcare associated 
infections (HAIs), antimicrobial use and resistance, blood transfusion 
safety events, and the extent to which healthcare facilities adhere to 
infection prevention practices and antimicrobial stewardship.
    On March 11, 2020, the World Health Organization declared COVID-19 
a pandemic, and the President of the United States (U.S.) proclaimed 
the outbreak a national emergency on March 13, 2020. As rates of 
infection continue to rise across the U.S., healthcare facilities and 
public health departments are facing significant strain on patient care 
and infection prevention efforts.
    In response to the COVID-19 pandemic, NHSN has planned and 
introduced new COVID-19 modules in the Patient Safety Component, Long-
term Care and Dialysis Components that enable hospitals, long-term care 
facilities and ambulatory hemodialysis facilities to report daily 
COVID-19 patient counts to NHSN, and NHSN in turn will enable state and 
local health departments to gain immediate access to the COVID-19 data 
reported by healthcare facilities in their jurisdictions via existing 
NHSN groups. NHSN's role as a shared platform for HAI surveillance 
provides a valuable foundation for COVID-19 surveillance. This 
information is used to inform the overall real-time COVID-19 response 
efforts and possible resource allocation, including an understanding of 
cases that are community-acquired versus healthcare-associated. CDC and 
health departments alike will use this surveillance data to prioritize 
the allocation of resources and response efforts.
    The COVID-19 Module in the Patient Safety Component was used for 
daily reporting by approximately 60% of the nation's hospitals from 
late March until July 15th, 2020. The July 13, 2020 HHS Guidance for 
Hospital Reporting and FAQ removed NHSN as a reporting option for 
hospitals to continue fulfilling the HHS and White House requested 
COVID-19 data reporting.
    NHSN released the COVID-19 Module in the existing NHSN Long Term 
Care (LTC) Component on April 27, 2020, to collect data from long term 
care facilities (LTCFs) on confirmed and suspected resident COVID-19 
cases and deaths, number of beds and access to testing, staff and 
personnel shortages and cases of COVID-19 and deaths, personal 
protective equipment availability, and ventilator availability. As with 
the initial data collection tool approved under Emergency OMB Control 
No. 0920-1290, facility-level data collected through NHSN as part of 
the COVID-19 modules are being made available to a broader set of 
federal, state, and local agency data users than data typically 
collected by NHSN. Specifically, COVID-19 data at the state, county, 
territory, and facility level submitted to NHSN will continue to be 
used for public health emergency response activities by CDC's emergency 
COVID-19 response, by the U.S. Department of Health and Human Services' 
(HHS) COVID-19 tracking system maintained in the Office of the 
Assistant Secretary of Preparedness and Response as part of the 
National Response Coordination Center at the Federal Emergency 
Management Agency (FEMA), and by the White House Coronavirus Task 
Force.
    COVID-19 poses an unprecedented threat to older populations living 
in long-term care facilities, as well as healthcare and non-healthcare 
workers taking care of these residents and their homes. Examples of 
LTCFs include nursing homes, chronic care facilities for the 
developmentally disabled, skilled nursing facilities, and assisted 
living facilities. As rates of infection and resulting mortality across 
LTCFs continue to rise across the nation, LTCFs are facing significant 
barriers in facility capacity, staffing, and supplies, such as personal 
protective equipment.

[[Page 59314]]

These barriers pose significant risk of COVID-19 transmission and 
infections. Understanding the facilitators and barriers that impact 
these vulnerable populations is critical to the effective pandemic 
response across LTCFs.
    The objectives of the data collection are to: (1) Determine the 
impact of COVID-19 among residents and facility workers, including 
morbidity and mortality (2) determine the nursing home capacity for 
housing suspected and confirmed cases, including in-house testing 
abilities; (3) identify staffing shortages among care givers and other 
facility personnel; (4) identify personal protective availability in 
the facility; and (5) to identify the availability and use of 
mechanical ventilators in LTCF with ventilator dependent units.
    In support of filling the gaps in COVID-19 data from nursing homes, 
the Centers for Medicare and Medicaid Services (CMS) and CDC are 
partnering in an unprecedented data coordination effort with U.S. 
nursing homes to help fight COVID-19. On May 8, 2020, CMS published an 
Interim Final Rule with Comment Period that requires nursing homes to 
report cases of COVID-19 directly to CDC via NHSN. CMS also requires 
nursing homes to fully cooperate with CDC surveillance efforts around 
COVID-19 spread and will make the data publicly available. Failure to 
report a case of COVID-19 or persons under investigation (PUI), may 
result in an enforcement action. CMS is now requiring LTCFs report at a 
minimum the following data to NHSN no less than weekly:
    (1) Facility name, address and CMS Certification Number;
    (2) Number of beds in the facility;
    (3) Current census of the facility;
    (4) Number of current residents who are confirmed cases;
    (5) Number of current residents who are suspected cases; and
    (6) Number of deaths among residents who are either confirmed 
COVID-19 cases or suspected COVID-19 cases.
    (7) Number of staff with suspected and confirmed COVID-19.
    (8) Staffing shortages.
    (9) PPE shortages.
    CMS introduced this reporting requirement for national surveillance 
of COVID-19 in nursing homes. Long-term care facilities are primarily 
responsible for ensuring, in real time, they have adequate staffing and 
are taking measures to mitigate any infectious disease occurrences 
among residents or staff. CMS' role is to hold facilities accountable 
for the care they provide to their residents. CMS is also providing 
technical assistance to nursing homes through a variety of mechanisms 
based on needs identified via this data collection. Finally, the 
associated enforcement is focused on ensuring facilities report their 
data to NHSN in order inform CDC, FEMA, the White House Coronavirus 
Task Force, and public health departments at all levels of the 
magnitude of the pandemic, as well as resource allocation and medical 
capacity in nursing homes.
    In Fall 2020, NHSN plans to release a COVID-19 Dialysis Module in 
the existing NHSN Dialysis Component. This Module will be used to 
collect voluntarily-reported data from ambulatory hemodialysis 
facilities on confirmed and suspected patient COVID-19 cases and 
deaths, staff and personnel shortages and cases of COVID-19 and deaths, 
personal protective equipment availability, and access to diagnostic 
testing. As with the LTC Module, facility-level data collected through 
NHSN as part of the COVID-19 Modules are being made available to a 
broader set of federal, state, and local agency data users than data 
typically collected by NHSN. Specifically, COVID-19 data at the state, 
county, territory, and facility level submitted to NHSN will continue 
to be used for public health emergency response activities by CDC's 
emergency COVID-19 response, by the U.S. Department of Health and Human 
Services' (HHS) COVID-19 tracking system maintained in the Office of 
the Assistant Secretary of Preparedness and Response as part of the 
National Response Coordination Center at the Federal Emergency 
Management Agency (FEMA), and by the White House Coronavirus Task 
Force. There will be no cost to respondents other than their time to 
complete the COVID-19 Module data fields on a weekly basis.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
        Type of respondents                   Form name             respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
LTCF personnel.....................  NHSN and Secure Access               11,500               1           60/60
                                      Management Services (SAMS)
                                      enrollment.
LTCF personnel.....................  COVID-19 Module, Long Term           11,621              52           40/60
                                      Care Facility: Resident
                                      Impact and Facility
                                      Capacity form (57.144).
Business and financial operations    COVID-19 Module, Long Term            1,870              52           40/60
 occupations.                         Care Facility: Resident
                                      Impact and Facility
                                      Capacity form (57.144).
State and local health department    COVID-19 Module, Long Term            1,870              52           40/60
 occupations.                         Care Facility: Resident
                                      Impact and Facility
                                      Capacity form (57.144).
LTCF personnel.....................  COVID-19 Module, Long Term            5,811               1           40/60
                                      Care Facility Resident
                                      Impact and Facility
                                      Capacity form (57.144)
                                      (retrospective data entry).
Business and financial operations    COVID-19 Module, Long Term              935               1           40/60
 occupations.                         Care Facility Resident
                                      Impact and Facility
                                      Capacity form (57.144)
                                      (retrospective data entry).
State and local health department    COVID-19 Module, Long Term              935               1           40/60
 occupations.                         Care Facility Resident
                                      Impact and Facility
                                      Capacity form (57.144)
                                      (retrospective data entry).
LTCF personnel.....................  COVID-19 Module, Long Term           11,621              52           15/60
                                      Care Facility: Staff and
                                      Personnel Impact form
                                      (57.145).
Business and financial operations    COVID-19 Module, Long Term            1,870              52           15/60
 occupations.                         Care Facility: Staff and
                                      Personnel Impact form
                                      (57.145).
State and local health department    COVID-19 Module, Long Term            1,870              52           15/60
 occupations.                         Care Facility: Staff and
                                      Personnel Impact form
                                      (57.145).
LTCF personnel.....................  COVID-19 Module, Long Term            5,811               1           15/60
                                      Care Facility Staff and
                                      Personnel Impact form
                                      (57.145) (retrospective
                                      data entry).

[[Page 59315]]

 
Business and financial operations    COVID-19 Module, Long Term              935               1           15/60
 occupations.                         Care Facility Staff and
                                      Personnel Impact form
                                      (57.145) (retrospective
                                      data entry).
State and local health department    COVID-19 Module, Long Term              935               1           15/60
 occupations.                         Care Facility Staff and
                                      Personnel Impact form
                                      (57.145) (retrospective
                                      data entry).
LTCF personnel.....................  COVID-19 Module, Long Term           11,621              52           15/60
                                      Care Facility: Supplies &
                                      Personal Protective
                                      Equipment form (57.146).
Business and financial operations    COVID-19 Module, Long Term            1,870              52           15/60
 occupations.                         Care Facility: Supplies &
                                      Personal Protective
                                      Equipment form (57.146).
State and local health department    COVID-19 Module, Long Term            1,870              52           15/60
 occupations.                         Care Facility: Supplies &
                                      Personal Protective
                                      Equipment form (57.146).
LTCF personnel.....................  COVID-19 Module, Long Term           11,621              52            5/60
                                      Care Facility: Ventilator
                                      Capacity & Supplies form
                                      (57.147).
Business and financial operations    COVID-19 Module, Long Term            1,870              52            5/60
 occupations.                         Care Facility: Ventilator
                                      Capacity & Supplies form
                                      (57.147).
State and local health department    COVID-19 Module, Long Term            1,870              52            5/60
 occupations.                         Care Facility: Ventilator
                                      Capacity & Supplies form
                                      (57.147).
Microbiologist (IP)................  COVID-19 Dialysis Component           4,900             104           20/60
                                      Form.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-20760 Filed 9-18-20; 8:45 am]
BILLING CODE 4163-18-P