[Federal Register Volume 87, Number 246 (Friday, December 23, 2022)]
[Notices]
[Pages 78969-78971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28004]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30-Day-23-0666]


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)'' 
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 August 26, 2022 to 
obtain comments from the public and affected agencies. CDC received one 
comment 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) (OMB Control No. 0920-
0666, Exp. 1/31/2025)--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 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 Component; and 
the Neonatal Component. 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

[[Page 78970]]

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 collection was previously approved in January of 2022 for 
1,321,991 burden hours. The proposed changes to NHSN include revisions 
to 41 existing data collection forms. CDC requests OMB approval for an 
estimated 1,614,651 annual burden hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of        Average
                                                                     Number of     responses per    burden per
         Type of respondent                 Form No. & name         respondents     respondent     response  (in
                                                                                    (in hours)        hours)
----------------------------------------------------------------------------------------------------------------
NHSN Participant....................  57.100 NHSN Registration             2,000               1            5/60
                                       Form.
                                      57.101 Facility Contact              2,000               1           10/60
                                       Information.
                                      57.103 Patient Safety                 6765               1           90/60
                                       Component--Annual
                                       Hospital Survey.
                                      57.104 Facility                        800               1            5/60
                                       Administrator Change
                                       Request Form.
                                      57.105 Group Contact                 1,000               1            5/60
                                       Information.
                                      57.106 Patient Safety                7,821              12           15/60
                                       Monthly Reporting Plan.
                                      57.108 Primary Bloodstream           5,775               5           38/60
                                       Infection (BSI).
                                      57.111 Pneumonia (PNEU)...           1,800               2           30/60
                                      57.112 Ventilator-                   5,463               8           28/60
                                       Associated Event.
                                      57.113 Pediatric                       334               1           30/60
                                       Ventilator-Associated
                                       Event (PedVAE).
                                      57.114 Urinary Tract                 6,000               5           20/60
                                       Infection (UTI).
                                      57.115 Custom Event.......             600              91           35/60
                                      57.116 Denominators for              1,100              12            4/60
                                       Neonatal Intensive Care
                                       Unit (NICU).
                                      57.117 Denominators for                500              12            5/60
                                       Specialty Care Area (SCA)/
                                       Oncology (ONC).
                                      57.118 Denominators for              5,500              60            5/60
                                       Intensive Care Unit (ICU)/
                                       Other locations (not NICU
                                       or SCA).
                                      57.120 Surgical Site                 6,000               9           35/60
                                       Infection (SSI).
                                      57.121 Denominator for               6,000             602           10/60
                                       Procedure.
                                      57.122 HAI Progress Report              55               1           28/60
                                       State Health Department
                                       Survey.
                                      57.123 Antimicrobial Use             2,500              12            5/60
                                       and Resistance (AUR)-
                                       Microbiology Data
                                       Electronic Upload
                                       Specification Tables.
                                      57.124 Antimicrobial Use             2,500              12            5/60
                                       and Resistance (AUR)-
                                       Pharmacy Data Electronic
                                       Upload Specification
                                       Tables.
                                      57.125 Central Line                    500             213           25/60
                                       Insertion Practices
                                       Adherence Monitoring.
                                      57.126 MDRO or CDI                     720              11           30/60
                                       Infection Form.
                                      57.127 MDRO and CDI                  5,500              29           15/60
                                       Prevention Process and
                                       Outcome Measures Monthly
                                       Monitoring.
                                      57.128 Laboratory-                   4,800              79           20/60
                                       identified MDRO or CDI
                                       Event.
                                      57.129 Adult Sepsis.......              50             250           25/60
                                      57.135 Late Onset Sepsis/              300               6            5/60
                                       Meningitis Denominator
                                       Form: Data Table for
                                       monthly electronic upload.
                                      57.136 Late Onset Sepsis/              300               6            5/60
                                       Meningitis Event Form:
                                       Data Table for Monthly
                                       Electronic Upload.
                                      57.137 Long-Term Care               17,700               1          120/60
                                       Facility Component--
                                       Annual Facility Survey.
                                      57.138 Laboratory-                    1998              24           20/60
                                       identified MDRO or CDI
                                       Event for LTCF.
                                      57.139 MDRO and CDI                   1998              12           20/60
                                       Prevention Process
                                       Measures Monthly
                                       Monitoring for LTCF.
                                      57.140 Urinary Tract                   339              36           35/60
                                       Infection (UTI) for LTCF.
                                      57.141 Monthly Reporting              2011              12            5/60
                                       Plan for LTCF.
                                      57.142 Denominators for                339              12           35/60
                                       LTCF Locations.
                                      57.143 Prevention Process              130              12            5/60
                                       Measures Monthly
                                       Monitoring for LTCF.
                                      57.150 LTAC Annual Survey.             620               1           82/60
                                      57.151 Rehab Annual Survey           1,340               1           82/60
                                      57.200 Healthcare                       50               1          480/60
                                       Personnel Safety
                                       Component Annual Facility
                                       Survey.
                                      57.204 Healthcare Worker                50             200           20/60
                                       Demographic Data.
                                      57.205 Exposure to Blood/               50              50           60/60
                                       Body Fluids.
                                      57.206 Healthcare Worker                50              30           15/60
                                       Prophylaxis/Treatment.
                                      57.207 Follow-Up                        50              50           15/60
                                       Laboratory Testing.
                                      57.210 Healthcare Worker                50              50           10/60
                                       Prophylaxis/Treatment-
                                       Influenza.
                                      57.300 Hemovigilance                   500               1           85/60
                                       Module Annual Survey.
                                      57.301 Hemovigilance                   500              12           60/60
                                       Module Monthly Reporting
                                       Plan.
                                      57.303 Hemovigilance                   500              12           70/60
                                       Module Monthly Reporting
                                       Denominators.
                                      57.305 Hemovigilance                   500              10           10/60
                                       Incident.
                                      57.306 Hemovigilance                   500               1           35/60
                                       Module Annual Survey--Non-
                                       acute care facility.
                                      57.307 Hemovigilance                   500               4           20/60
                                       Adverse Reaction--Acute
                                       Hemolytic Transfusion
                                       Reaction.
                                      57.308 Hemovigilance                   500               4           20/60
                                       Adverse Reaction--
                                       Allergic Transfusion
                                       Reaction.

[[Page 78971]]

 
                                      57.309 Hemovigilance                   500               1           20/60
                                       Adverse Reaction--Delayed
                                       Hemolytic Transfusion
                                       Reaction.
                                      57.310 Hemovigilance                   500               2           20/60
                                       Adverse Reaction--Delayed
                                       Serologic Transfusion
                                       Reaction.
                                      57.311 Hemovigilance                   500               4           20/60
                                       Adverse Reaction--Febrile
                                       Non-hemolytic Transfusion
                                       Reaction.
                                      57.312 Hemovigilance                   500               1           20/60
                                       Adverse Reaction--
                                       Hypotensive Transfusion
                                       Reaction.
                                      57.313 Hemovigilance                   500               1           20/60
                                       Adverse Reaction--
                                       Infection.
                                      57.314 Hemovigilance                   500               1           20/60
                                       Adverse Reaction--Post
                                       Transfusion Purpura.
                                      57.315 Hemovigilance                   500               1           20/60
                                       Adverse Reaction--
                                       Transfusion Associated
                                       Dyspnea.
                                      57.316 Hemovigilance                   500               1           20/60
                                       Adverse Reaction--
                                       Transfusion Associated
                                       Graft vs. Host Disease.
                                      57.317 Hemovigilance                   500               1           20/60
                                       Adverse Reaction--
                                       Transfusion Related Acute
                                       Lung Injury.
                                      57.318 Hemovigilance                   500               2           20/60
                                       Adverse Reaction--
                                       Transfusion Associated
                                       Circulatory Overload.
                                      57.319 Hemovigilance                   500               1           20/60
                                       Adverse Reaction--Unknown
                                       Transfusion Reaction.
                                      57.320 Hemovigilance                   500               1           20/60
                                       Adverse Reaction--Other
                                       Transfusion Reaction.
                                      57.400 Outpatient                      700               1           10/60
                                       Procedure Component--
                                       Annual Facility Survey.
                                      57.401 Outpatient                      700              12           15/60
                                       Procedure Component--
                                       Monthly Reporting Plan.
                                      57.402 Outpatient                      200               1           40/60
                                       Procedure Component Same
                                       Day Outcome Measures.
                                      57.403 Outpatient                      200             400           40/60
                                       Procedure Component--
                                       Monthly Denominators for
                                       Same Day Outcome Measures.
                                      57.404 Outpatient                      700             100           40/60
                                       Procedure Component--SSI
                                       Denominator.
                                      57.405 Outpatient                      700               5           40/60
                                       Procedure Component--
                                       Surgical Site (SSI) Event.
                                      57.500 Outpatient Dialysis           7,200               1           12/60
                                       Center Practices Survey.
                                      57.501 Dialysis Monthly              7,200              12            5/60
                                       Reporting Plan.
                                      57.502 Dialysis Event.....           7,200              30           25/60
                                      57.503 Denominator for               7,200              30           10/60
                                       Outpatient Dialysis.
                                      57.504 Prevention Process            1,730              12           75/60
                                       Measures Monthly
                                       Monitoring for Dialysis.
                                      57.505 Dialysis Patient                615              50           10/60
                                       Influenza Vaccination.
                                      57.506 Dialysis Patient                615               5           10/60
                                       Influenza Vaccination
                                       Denominator.
                                      57.507 Home Dialysis                   430               1           30/60
                                       Center Practices Survey.
                                      Weekly Healthcare                      125              52           60/60
                                       Personnel Influenza
                                       Vaccination Cumulative
                                       Summary for Non-Long-Term
                                       Care Facilities.
                                      Weekly Healthcare                    1,200              52           60/60
                                       Personnel Influenza
                                       Vaccination Cumulative
                                       Summary for Long-Term
                                       Care Facilities.
                                      Weekly Resident Influenza            2,500              52           60/60
                                       Vaccination Cumulative
                                       Summary for Long-Term
                                       Care Facilities.
                                      Annual Healthcare                    5,000               1          120/60
                                       Personnel Influenza
                                       Vaccination Summary.
                                      Monthly Survey Patient               2,500              12           60/60
                                       Days & Nurse Staffing.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2022-28004 Filed 12-22-22; 8:45 am]
BILLING CODE 4163-18-P