[Federal Register Volume 88, Number 160 (Monday, August 21, 2023)]
[Notices]
[Pages 56827-56830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17924]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-23-0666; Docket No. CDC-2023-0068]


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 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 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.

DATES: CDC must receive written comments on or before October 20, 2023.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0068 by either of the following methods:
     Federal eRulemaking Portal: ww.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 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 www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.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, MS H21-8, Atlanta, Georgia 30329; Telephone: 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;
    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. 6/30/2026)--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

[[Page 56828]]

Diseases (NCEZID), Centers for Disease Control and Prevention (CDC) 
collects data from healthcare facilities in the National Healthcare 
Safety Network (NHSN) (OMB Control No. 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 
seven components: Patient Safety (PS), Healthcare Personnel Safety 
(HPS), Biovigilance (BV), Long-Term Care Facility (LTCF), Outpatient 
Procedure (OPC), Dialysis, and Neonatal Component.
    Data reported under the PS 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. Under the HPS 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 BV 
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 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)--will not to be used by NHSN users, but as part of an EIP 
project with four EIP sites. The Form is titled 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 Dialysis 
Component offers a simplified user interface for dialysis users to 
streamline their data entry and analysis 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). The Neonatal Component 
focuses on premature neonates and the healthcare associated events that 
occur as a result of their prematurity. This component currently has 
one module, which includes Late Onset-Sepsis and Meningitis. NHSN has 
increasingly served as the operating system for HAI reporting 
compliance through legislation established by the States. As of July 
2023, 37 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, 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.
    The NHSN data collection was previously approved in June of 2023 
for 6,209,922 responses and 1,693,215 annual burden hours. The proposed 
changes in this Revision include modifications to 15 existing data 
collection forms and one new form. CDC requests OMB approval for an 
estimated annual burden 1,524,039 hours. There is no cost to 
respondents other than their time to participate.

[[Page 56829]]



                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
               Form number & 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           5,311               1          135/60          11,950
 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....           6,387              12           15/60          19,161
57.108 Primary Bloodstream Infection (BSI)......           5,775               5           38/60          18,288
57.111 Pneumonia (PNEU).........................           1,800               2           30/60            1800
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)-             5,500              12            5/60           5,500
 Microbiology Data Electronic Upload
 Specification Tables...........................
57.124 Antimicrobial Use and Resistance (AUR)-             5,500              12            5/60           5,500
 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          122/60          35,990
 Facility Survey................................
57.138 Laboratory-identified MDRO or CDI Event             1,086              24           20/60           8,688
 for LTCF.......................................
57.139 MDRO and CDI Prevention Process Measures            1,019              12           20/60           4,076
 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..........           1,099              12           15/60           3,297
57.142 Denominators for LTCF Locations..........             714              12           35/60           4,998
57.143 Prevention Process Measures Monthly                   357              12            5/60             357
 Monitoring for LTCF............................
57.150 LTAC Annual Survey.......................             392               1           89/60             581
57.151 Rehab Annual Survey......................           1,160               1           89/60           1,721
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
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..

[[Page 56830]]

 
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                350               1           10/60             117
 Facility Survey................................
57.401 Outpatient Procedure Component--Monthly               350              12           15/60           1,050
 Reporting Plan.................................
57.402 Outpatient Procedure Component Same Day                50               1           40/60              33
 Outcome Measures...............................
57.403 Outpatient Procedure Component--Monthly                50             400           40/60          13,333
 Denominators for Same Day Outcome Measures.....
57.404 Outpatient Procedure Component--SSI                   300             100           10/60           5,000
 Denominator....................................
57.405 Outpatient Procedure Component--Surgical              300              36           35/60           6,300
 Site (SSI) Event...............................
57.500 Outpatient Dialysis Center Practices                7,400               1          125/60          15,417
 Survey.........................................
57.501 Dialysis Monthly Reporting Plan..........           7,400              12            5/60           7,400
57.502 Dialysis Event...........................           7,400              30           27/60          99,900
57.503 Denominator for Outpatient Dialysis......           7,400              24           10/60          29,600
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            3075
 Denominator....................................
57.507 Home Dialysis Center Practices Survey....             450               1           36/60             270
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............................
Healthcare-facility onset, antibiotic-treated              7,821               1           10/60           1,304
 Clostridioides difficile (C. difficile)
 Infection (HT-CDI) Event Module Annual
 Reporting Plan.................................
                                                 ---------------------------------------------------------------
    Total Estimated Annual Burden Hours.........  ..............  ..............  ..............       1,524,039
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2023-17924 Filed 8-18-23; 8:45 am]
BILLING CODE 4163-18-P