[Federal Register Volume 85, Number 115 (Monday, June 15, 2020)]
[Notices]
[Pages 36207-36211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12809]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-0666; Docket No. CDC-2020-0065]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the CDC's 
National Healthcare Safety Network (NHSN). 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.

DATES: CDC must receive written comments on or before August 14, 2020.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0065 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office,

[[Page 36208]]

Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

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. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    National Healthcare Safety Network (NHSN) (OMB Control No. 0920-
0666)--Revision--National Center for Emerging and Zoonotic Infection 
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 provides facilities, states, regions, 
and the nation with data necessary to identify problem areas, measure 
the progress of prevention efforts, and ultimately eliminate 
healthcare-associated infections (HAIs) nationwide. NHSN allows 
healthcare facilities to track blood safety errors and various 
healthcare-associated infection prevention practice methods such as 
healthcare personnel influenza vaccine status and corresponding 
infection control adherence rates.
    NHSN currently has six components: Patient Safety (PS), Healthcare 
Personnel Safety (HPS), Biovigilance (BV), Long-Term Care Facility 
(LTCF), Outpatient Procedure (OPC), and the Dialysis Component. NHSN's 
planned Neonatal Component is expected to launch during the winter of 
2020/2021. This component will focus on premature neonates and the 
healthcare-associated events that occur as a result of their 
prematurity. This component will be released with one module, which 
includes Late Onset-Sepsis and Meningitis. Late-onset sepsis (LOS) and 
Meningitis are common complications of extreme prematurity. These 
infections are usually serious, causing a prolongation of hospital 
stay, increased cost, and risk of morbidity and mortality. The data for 
this module will be electronically submitted, and manual data entry 
will not be available. This will allow more hospital personnel to be 
available to care for patients and will reduce annual burden across 
healthcare facilities. Additionally, LOS data will be utilized for 
prevention initiatives.
    Data reported under the Patient Safety Component are used to 
determine the magnitude of the healthcare-associated adverse events and 
trends in the rates of the events, in the distribution of pathogens, 
and in the adherence to prevention practices. Data will help detect 
changes in the epidemiology of adverse events resulting from new 
medical therapies and changing patient risks. Additionally, reported 
data is being used to describe the epidemiology of antimicrobial use 
and resistance and to better understand the relationship of 
antimicrobial therapy to this rising problem.
    Approved as a New Emergency ICR (National Healthcare Safety Network 
(NHSN) Patient Impact Module for Coronavirus (COVID-19) Surveillance in 
Healthcare Facilities, OMB Control No. 0920-1290), NHSN launched a 
COVID-19 Module in the Patient Safety Component on March 27th, 2020. 
This Module is designed to collect facility-level COVID-19 data on 
cases, deaths, capacity, healthcare worker staffing shortages, and 
personal protective equipment and supplies from hospitals on a daily 
basis. Facility-level data collected through NSHN as part of the COVID-
19 Module 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.
    Under the Healthcare Personnel Safety Component, protocols and data 
on events--both positive and adverse--are used to determine (1) the 
magnitude of adverse events in healthcare personnel, and (2) compliance 
with immunization and sharps injuries safety guidelines. Under the 
Biovigilance Component, data on adverse reactions and incidents 
associated with blood transfusions are reported and analyzed to provide 
national estimates of adverse reactions and incidents. Under the Long-
Term Care Facility Component, data is captured from skilled nursing 
facilities. Reporting methods under the LTCF component have been 
created by using forms from the PS Component as a model with 
modifications to specifically address the specific characteristics of 
LTCF residents and the unique data needs of these facilities reporting 
into NHSN. A new form has been introduced for field testing- 
Respiratory Tract Infection (RTI)--not to be used by NHSN users, but as 
part of an EIP project with 4 EIP sites. Form title will be 
Denominators for Healthcare Associated Infections (HAIs): Respiratory 
Tract Infections. The purpose of this form is to allow testing prior to 
introducing a new module and forms to NHSN users. The CDC's 
Epidemiology Research & Innovations Branch (ERIB) team will use the 
form to perform field testing of variables to explore the utilization, 
applicability, and data collection burden associated with these 
variables. This process will inform areas of improvement prior to 
incorporating the new module, including protocol, forms, and 
instructions into NHSN. The estimated burden for this form is 20 
minutes, which is based on a similar denominator form. Also approved 
under New Emergency ICR 0920-1290, NHSN

[[Page 36209]]

launched a COVID-19 Module in the Long-Term Care Component April 27th, 
2020. As with the COVID-19 Module in the PS Component, the LTC COVID-19 
Module is designed to collect facility-level COVID-19 data on cases, 
deaths, capacity, healthcare worker staffing shortages, and personal 
protective equipment and supplies from long-term care facilities on at 
least a weekly basis. Facility-level data collected through NSHN as 
part of the COVID-19 Module 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.
    The Dialysis Component offers a simplified user interface for 
dialysis users to streamline their data entry and analyses processes as 
well as provide options for expanding in the future to include dialysis 
surveillance in settings other than outpatient facilities. The 
Outpatient Procedure Component (OPC) gathers data on the impact of 
infections and outcomes related to operative procedures performed in 
Ambulatory Surgery Centers (ASCs). The OPC is used to monitor two event 
types: Same Day Outcome Measures and Surgical Site Infections (SSIs). 
NHSN has increasingly served as the operating system for HAI reporting 
compliance through legislation established by the states. As of April 
2020, 36 states, the District of Columbia and the City of Philadelphia, 
Pennsylvania have opted to use NHSN as their primary system for 
mandated reporting. Reporting compliance is completed by healthcare 
facilities in their respective jurisdictions, with emphasis on those 
states and municipalities acquiring varying consequences for failure to 
use NHSN. Additionally, healthcare facilities in five U.S. territories 
(Puerto Rico, American Samoa, the U.S. Virgin Islands, Guam, and the 
Northern Mariana Islands) are voluntarily reporting to NHSN. Additional 
territories are projected to follow with similar use of NHSN for 
reporting purposes.
    NHSN's data is used to aid in the tracking of HAIs and guide 
infection prevention activities/practices that protect patients. The 
Centers for Medicare and Medicaid Services (CMS) and other payers use 
these data to determine incentives for performance at healthcare 
facilities across the US and surrounding territories, and members of 
the public may use some protected data to inform their selection among 
available providers. Each of these parties is dependent on the 
completeness and accuracy of the data. CDC and CMS work closely and are 
fully committed to ensuring complete and accurate reporting, which are 
critical for protecting patients and guiding national, state, and local 
prevention priorities.
    CMS collects some HAI data and healthcare personnel influenza 
vaccination summary data, which is done on a voluntary basis as part of 
its Fee-for-Service Medicare quality reporting programs, while others 
may report data required by a federal mandate. Facilities that fail to 
report quality measure data are subject to partial payment reduction in 
the applicable Medicare Fee-for-Service payment system. CMS links their 
quality reporting to payment for Medicare-eligible acute care 
hospitals, inpatient rehabilitation facilities, long-term acute care 
facilities, oncology hospitals, inpatient psychiatric facilities, 
dialysis facilities, and ambulatory surgery centers. Facilities report 
HAI data and healthcare personnel influenza vaccination summary data to 
CMS via NHSN as part of CMS's quality reporting programs to receive 
full payment. Still, many healthcare facilities, even in states without 
HAI reporting legislation, submit limited HAI data to NHSN voluntarily. 
NHSN's data collection updates continue to support the incentive 
programs managed by CMS. For example, survey questions support 
requirements for CMS' quality reporting programs. Additionally, CDC has 
collaborated with CMS on a voluntary National Nursing Home Quality 
Collaborative, which focuses on recruiting nursing homes to report HAI 
data to NHSN and to retain their continued participation. This project 
has resulted in a significant increase in long-term care facilities 
reporting to NHSN.
    The ICR previously approved in December of 2019 for 5,352,360 
responses; 3,113,631 burden hours. The proposed changes in this new ICR 
include revisions to eight data collection forms and the addition of 
ten new forms for a total of 86 proposed data collection forms. In this 
Revision, CDC requests OMB approval for an estimated 2,365,743 annual 
burden hours.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
                 Form No. & name                     Number of     responses per   per response    Total burden
                                                    respondents     respondent      (min./hour)       (hours)
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57.100 NHSN Registration Form...................           2,000               1            5/60             167
57.101 Facility Contact Information.............           2,000               1           10/60             333
57.103 Patient Safety Component--Annual Hospital           6,765               1           55/60           6,201
 Survey.........................................
57.105 Group Contact Information................           1,000               1            5/60              83
57.106 Patient Safety Monthly Reporting Plan....           7,821              12           15/60          23,463
57.108 Primary Bloodstream Infection (BSI)......           5,775               5           38/60          18,288
57.111 Pneumonia (PNEU).........................           1,800               2           30/60          18,288
57.112 Ventilator-Associated Event..............           5,463               8           28/60          20,395
57.113 Pediatric Ventilator-Associated Event                 334               1           30/60             167
 (PedVAE).......................................
57.114 Urinary Tract Infection (UTI)............           6,000               5           20/60          10,000
57.115 Custom Event.............................             600              91           35/60          31,850
57.116 Denominators for Neonatal Intensive Care            1,100              12            4/60             880
 Unit (NICU)....................................
57.117 Denominators for Specialty Care Area                  500              12            5/60             503
 (SCA)/Oncology (ONC)...........................
57.118 Denominators for Intensive Care Unit                5,500              60            5/60          27,665
 (ICU)/Other locations (not NICU or SCA)........
57.120 Surgical Site Infection (SSI)............           6,000               9           35/60          31,500

[[Page 36210]]

 
57.121 Denominator for Procedure................           6,000             602           10/60         602,000
57.122 HAI Progress Report State Health                       55               1           28/60              26
 Department Survey..............................
57.123 Antimicrobial Use and Resistance (AUR)-             2,500              12            5/60           1,500
 Microbiology Data Electronic Upload
 Specification Tables...........................
57.124 Antimicrobial Use and Resistance (AUR)-             2,000              12            5/60           2,000
 Pharmacy Data Electronic Upload Specification
 Tables.........................................
57.125 Central Line Insertion Practices                      500             213           25/60          44,375
 Adherence Monitoring...........................
57.126 MDRO or CDI Infection Form...............             720              12           30/60           3,960
57.127 MDRO and CDI Prevention Process and                 5,500              29           15/60          39,875
 Outcome Measures Monthly Monitoring............
57.128 Laboratory-identified MDRO or CDI Event..           4,800              79           20/60         126,400
57.129 Adult Sepsis.............................              50             250           25/60           5,208
57.130 COVID-19 Module: Patient Impact and                 3,117             540           25/60         701,325
 Hospital Capacity..............................
57.131 COVID-19 Module: Healthcare Worker                  3,117             540           25/60         701,325
 Staffing.......................................
57.132 COVID-19 Module: Supplies................           3,117             540           25/60         701,325
57.135 Late Onset Sepsis/Meningitis Denominator              300              12            5/60             300
 Form: Data Table for monthly electronic upload.
57.136 Late Onset Sepsis/Meningitis Event Form:              300               4            5/60             100
 Data Table for Monthly Electronic Upload.......
57.137 Long-Term Care Facility Component--Annual           3,079               1            1/60              51
 Facility Survey................................
57.138 Laboratory-identified MDRO or CDI Event             1,998              24           12/60           9,590
 for LTCF.......................................
57.139 MDRO and CDI Prevention Process Measures            1,998              12           12/60           4,795
 Monthly Monitoring for LTCF....................
57.140 Urinary Tract Infection (UTI) for LTCF...             339              12           12/60             814
57.141 Monthly Reporting Plan for LTCF..........           2,011              12           12/60           4,826
57.142 Denominators for LTCF Locations..........             339              12          250/60             814
57.143 Prevention Process Measures Monthly                   130              12           12/60             312
 Monitoring for LTCF............................
57.144 LTCF COVID-19 Module: Resident Impact and          14,674              26           20/60         127,175
 Facility Capacity..............................
57.145 LTCF COVID-19 Module: Staff and Personnel          14,674              26           15/60          95,381
 Impact.........................................
57.146 LTCF COVID-19 Module: Supplies and PPE...          14,674              26            5/60          31,794
57.147 LTCF COVID-19 Module: Ventilator Capacity          14,674              26            5/60          31,794
 and Supplies...................................
57.150 LTAC Annual Survey.......................             620               1           10/60              10
57.151 Rehab Annual Survey......................           1,340               1           10/60             625
57.200 Healthcare Personnel Safety Component                  50               1          480/60             400
 Annual Facility Survey.........................
57.203 Healthcare Personnel Safety Monthly        ..............               1            5/60  ..............
 Reporting Plan.................................
57.204 Healthcare Worker Demographic Data.......              50             200           20/60           3,333
57.205 Exposure to Blood/Body Fluids............              50              50           60/60           2,500
57.206 Healthcare Worker Prophylaxis/Treatment..              50              30           15/60             375
57.207 Follow-Up Laboratory Testing.............              50              50           15/60             625
57.210 Healthcare Worker Prophylaxis/Treatment-               50              50           10/60             417
 Influenza......................................
57.300 Hemovigilance Module Annual Survey.......             500               1           85/60             708
57.301 Hemovigilance Module Monthly Reporting                500              12            1/60             100
 Plan...........................................
57.303 Hemovigilance Module Monthly Reporting                500              12           70/60           7,000
 Denominators...................................
57.305 Hemovigilance Incident...................             500              10           10/60             833
57.306 Hemovigilance Module Annual Survey--Non-              500               1           35/60             292
 acute care facility............................
57.307 Hemovigilance Adverse Reaction--Acute                 500               4           20/60             667
 Hemolytic Transfusion Reaction.................
57.308 Hemovigilance Adverse Reaction--Allergic              500               4           20/60             667
 Transfusion Reaction...........................
57.309 Hemovigilance Adverse Reaction--Delayed               500               1           20/60             167
 Hemolytic Transfusion Reaction.................
57.310 Hemovigilance Adverse Reaction--Delayed               500               2           20/60             333
 Serologic Transfusion Reaction.................
57.311 Hemovigilance Adverse Reaction--Febrile               500               4           20/60             667
 Non-hemolytic Transfusion Reaction.............
57.312 Hemovigilance Adverse Reaction--                      500               1           20/60             167
 Hypotensive Transfusion Reaction...............
57.313 Hemovigilance Adverse Reaction--Infection             500               1           20/60             167
57.314 Hemovigilance Adverse Reaction--Post                  500               1           20/60             167
 Transfusion Purpura............................
57.315 Hemovigilance Adverse Reaction--                      500               1           20/60             167
 Transfusion Associated Dyspnea.................
57.316 Hemovigilance Adverse Reaction--                      500               1           20/60             167
 Transfusion Associated Graft vs. Host Disease..
57.317 Hemovigilance Adverse Reaction--                      500               1           20/60             167
 Transfusion Related Acute Lung Injury..........
57.318 Hemovigilance Adverse Reaction--                      500               2           20/60             333
 Transfusion Associated Circulatory Overload....
57.319 Hemovigilance Adverse Reaction--Unknown               500               1           20/60             167
 Transfusion Reaction...........................
57.320 Hemovigilance Adverse Reaction--Other                 500               1           20/60             167
 Transfusion Reaction...........................
57.400 Outpatient Procedure Component--Annual                700               1           10/60             117
 Facility Survey................................
57.401 Outpatient Procedure Component--Monthly               700              12           15/60           2,100
 Reporting Plan.................................

[[Page 36211]]

 
57.402 Outpatient Procedure Component Same Day               200               1           40/60             133
 Outcome Measures...............................
57.403 Outpatient Procedure Component--Monthly               200             400           40/60          53,333
 Denominators for Same Day Outcome Measures.....
57.404 Outpatient Procedure Component--SSI                   700             100           40/60          46,667
 Denominator....................................
57.405 Outpatient Procedure Component--Surgical              700               5           40/60           2,333
 Site (SSI) Event...............................
57.500 Outpatient Dialysis Center Practices                7,200               1          127/60          15,240
 Survey.........................................
57.501 Dialysis Monthly Reporting Plan..........           7,200              12            5/60           7,200
57.502 Dialysis Event...........................           7,200              30           25/60          90,000
57.503 Denominator for Outpatient Dialysis......           7,200              30           10/60          14,400
57.504 Prevention Process Measures Monthly                 1,730              12           75/60          25,950
 Monitoring for Dialysis........................
57.505 Dialysis Patient Influenza Vaccination...             615              50           10/60           5,125
57.506 Dialysis Patient Influenza Vaccination                615               5           10/60             513
 Denominator....................................
57.507 Home Dialysis Center Practices Survey....             430               1           30/60             215
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............       2,365,743
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-12809 Filed 6-12-20; 8:45 am]
 BILLING CODE 4163-18-P