[Federal Register Volume 86, Number 184 (Monday, September 27, 2021)]
[Notices]
[Pages 53309-53312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20846]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-0666; Docket No. CDC-2021-0100]


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 a proposed 
information collection project titled National Healthcare Safety 
Network (NHSN). NHSN is the nation's most widely used healthcare-
associated infection tracking system, providing facilities, states, 
regions, and the nation with data needed to identify problem areas, 
measure progress of prevention efforts, and ultimately eliminate 
healthcare-associated infections.

DATES: CDC must receive written comments on or before November 26, 
2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0100 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, Mailstop H21-8, 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, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, Mailstop H21-8, 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

[[Page 53310]]

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;
    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; and
    5. Assess information collection costs.

Proposed Project

    National Healthcare Safety Network (NHSN) (OMB Control No. 0920-
0666, Exp. 12/31/2023)--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) (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 
2021, and 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 (LOS) and Meningitis. LOS and Meningitis are common 
complications of extreme prematurity. These infections result in a 
prolongation of hospital stay, increased cost, and risk of morbidity 
and mortality. The data for this module will be electronically 
submitted, allowing more hospital personnel to be available to care for 
patients and reducing 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 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.
    Under the Healthcare Personnel Safety Component (HPS), 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.
    The Biovigilance (BV) Component collects data on adverse reactions 
and incidents associated with blood transfusions. Data is reported and 
analyzed to provide national estimates of adverse reactions and 
incidents.
    Under the Long-Term Care Facility (LTCF) 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. The Respiratory Tract Infection Form 
(RTI), titled ``Denominators for Healthcare Associated Infections 
(HAIs): Respiratory Tract Infections,'' will not to be used by NHSN 
users, but rather as part of an EIP project with 4 EIP sites. 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 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 U.S. 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,

[[Page 53311]]

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.
    NHSN was previously approved in December 2020 for 1,321,991 burden 
hours. The proposed changes in this new ICR include revisions to 10 
data collection forms and no new forms for a total of 86 proposed data 
collection forms. In this Revision, CDC requests OMB approval for an 
estimated 1,718,591 annual burden hours.

                                        Estimated Annualized Burden Hours
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                                                                     Number of      Avg. burden
               Form number & name                    Number of     responses per   per response    Total burden
                                                    respondents     respondent        (hours)         (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           90/60          10,148
 Survey.........................................
57.104 Facility Administrator Change Request                 800               1            5/60              67
 Form...........................................
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           1,800
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             500
 (SCA)/Oncology (ONC)...........................
57.118 Denominators for Intensive Care Unit                5,500              60            5/60          27,500
 (ICU)/Other locations (not NICU or SCA)........
57.120 Surgical Site Infection (SSI)............           6,000               9           35/60          31,500
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           2,500
 Microbiology Data Electronic Upload
 Specification Tables...........................
57.124 Antimicrobial Use and Resistance (AUR)--            2,500              12            5/60           2,500
 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              11           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
57.135 Late Onset Sepsis/Meningitis Denominator              300               6            5/60             150
 Form: Data Table for monthly electronic upload.
57.136 Late Onset Sepsis/Meningitis Event Form:              300               6            5/60             150
 Data Table for Monthly Electronic Upload.......
57.137 Long-Term Care Facility Component--Annual          17,700               1          120/60          35,400
 Facility Survey................................
57.138 Laboratory-identified MDRO or CDI Event             1,998              24           20/60          15,984
 for LTCF.......................................
57.139 MDRO and CDI Prevention Process Measures            1,998              12           20/60           7,992
 Monthly Monitoring for LTCF....................
57.140 Urinary Tract Infection (UTI) for LTCF...             339              36           35/60           7,119
57.141 Monthly Reporting Plan for LTCF..........            2011              12            5/60           2,011
57.142 Denominators for LTCF Locations..........             339              12           35/60           2,373
57.143 Prevention Process Measures Monthly                   130              12            5/60             130
 Monitoring for LTCF............................
57.150 LTAC Annual Survey.......................             620               1           82/60             847
57.151 Rehab Annual Survey......................           1,340               1           82/60           1,831
57.200 Healthcare Personnel Safety Component                  50               1          480/60             400
 Annual Facility Survey.........................
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           60/60           6,000
 Plan...........................................
57.303 Hemovigilance Module Monthly Reporting                500              12           70/60           7,000
 Denominators...................................
57.305 Hemovigilance Incident...................             500              10           10/60             833

[[Page 53312]]

 
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.................................
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           12/60           1,440
 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           36000
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
Weekly Healthcare Personnel Influenza                        125              52           60/60           6,500
 Vaccination Cumulative Summary for Non-Long-
 Term Care Facilities...........................
Weekly Healthcare Personnel Influenza                      1,200              52           60/60          62,400
 Vaccination Cumulative Summary for Long-Term
 Care Facilities................................
Weekly Resident Influenza Vaccination Cumulative           2,500              52           60/60         130,000
 Summary for Long-Term Care Facilities..........
Annual Healthcare Personnel Influenza                      5,000               1          120/60          10,000
 Vaccination Summary............................
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............       1,718,591
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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. 2021-20846 Filed 9-24-21; 8:45 am]
BILLING CODE 4163-18-P