[Federal Register Volume 88, Number 78 (Monday, April 24, 2023)]
[Notices]
[Pages 24802-24805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08571]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-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. 7/31/2023)--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) 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 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

[[Page 24803]]

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 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.
    In January 2023, CDC obtained emergency OMB approval for a number 
of changes, effective immediately (Exp. 7/31/2023). These changes 
included the addition of a new Monthly Survey on Patient Days & Nurse 
Staffing, as well as minor changes to 14 information collection forms. 
The changes primarily supported clarifications to use of CIDTs, HAI 
forms with susceptibility reporting requirements, vendor information, 
testing options for UTI events, and all y-types of hepatitis B vaccines 
administered to patients and staff members at outpatient dialysis 
centers. The changes increased total annualized burden for NHSB from 
1,584,651 hours to 1,616,151 hours.
    In this Revision, CDC requests OMB approval to continue those 
changes for three years. In addition, CDC requests OMB approval to 
begin phased implementation of two new questions on Sex at Birth and 
Gender Identity, which will replace the current Gender question. The 
new questions will be voluntary for the remainder of 2023 and required 
in 2024. The proposed change will be used to help assess the true 
impact of sex at birth and gender identify on HAIs, individually and in 
combination with other risk factors, and to inform public health 
programs. The new questions will add one minute of burden to 31 forms 
that are currently in use, a total of 77,064 annualized burden hours. 
The total estimated annualized burden hours for NHSN will increase to 
1,693,215 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
                        Form number/name                             Number of     responses per   per response
                                                                    respondents     respondent      (min/hour)
----------------------------------------------------------------------------------------------------------------
57.100 NHSN Registration Form...................................           2,000               1            5/60
57.101 Facility Contact Information.............................           2,000               1           10/60
57.103 Patient Safety Component--Annual Hospital Survey.........           6,765               1           90/60
57.104 Facility Administrator Change Request Form...............             800               1            5/60
57.105 Group Contact Information................................           1,000               1            5/60
57.106 Patient Safety Monthly Reporting Plan....................           7,821              12           15/60
57.108 Primary Bloodstream Infection (BSI)......................           5,775               5           39/60
57.111 Pneumonia (PNEU).........................................           1,800               2           31/60
57.112 Ventilator-Associated Event..............................           5,463               8           29/60
57.113 Pediatric Ventilator-Associated Event (PedVAE)...........             334               1           31/60
57.114 Urinary Tract Infection (UTI)............................           6,000               5           21/60
57.115 Custom Event.............................................             600              91           36/60
57.116 Denominators for Neonatal Intensive Care Unit (NICU).....           1,100              12            4/60
57.117 Denominators for Specialty Care Area (SCA)/Oncology (ONC)             500              12            5/60
57.118 Denominators for Intensive Care Unit (ICU)/Other                    5,500              60            5/60
 locations (not NICU or SCA)....................................
57.120 Surgical Site Infection (SSI)............................           6,000               9           36/60
57.121 Denominator for Procedure................................           6,000             602           11/60
57.122 HAI Progress Report State Health Department Survey.......              55               1           28/60
57.123 Antimicrobial Use and Resistance (AUR)--Microbiology Data           2,500              12            5/60
 Electronic Upload Specification Tables.........................
57.124 Antimicrobial Use and Resistance (AUR)--Pharmacy Data               4,000              12            5/60
 Electronic Upload Specification Tables.........................
57.125 Central Line Insertion Practices Adherence Monitoring....             500             213           26/60
57.126 MDRO or CDI Infection Form...............................             720              11           31/60
57.127 MDRO and CDI Prevention Process and Outcome Measures                5,500              29           15/60
 Monthly Monitoring.............................................
57.128 Laboratory-identified MDRO or CDI Event..................           4,800              79           21/60
57.129 Adult Sepsis.............................................              50             250           25/60

[[Page 24804]]

 
57.135 Late Onset Sepsis/Meningitis Denominator Form: Data Table             300               6            5/60
 for monthly electronic upload..................................
57.136 Late Onset Sepsis/Meningitis Event Form: Data Table for               300               6            5/60
 Monthly Electronic Upload......................................
57.137 Long-Term Care Facility Component--Annual Facility Survey          17,700               1          120/60
57.138 Laboratory-identified MDRO or CDI Event for LTCF.........           1,998              24           20/60
57.139 MDRO and CDI Prevention Process Measures Monthly                    1,998              12           20/60
 Monitoring for LTCF............................................
57.140 Urinary Tract Infection (UTI) for LTCF...................             339              36           35/60
57.141 Monthly Reporting Plan for LTCF..........................           2,011              12            5/60
57.142 Denominators for LTCF Locations..........................             339              12           35/60
57.143 Prevention Process Measures Monthly Monitoring for LTCF..             130              12            5/60
57.150 LTAC Annual Survey.......................................             620               1           82/60
57.151 Rehab Annual Survey......................................           1,340               1           82/60
57.200 Healthcare Personnel Safety Component Annual Facility                  50               1          480/60
 Survey.........................................................
57.204 Healthcare Worker Demographic Data.......................              50             200           20/60
57.205 Exposure to Blood/Body Fluids............................              50              50           60/60
57.206 Healthcare Worker Prophylaxis/Treatment..................              50              30           15/60
57.207 Follow-Up Laboratory Testing.............................              50              50           15/60
57.210 Healthcare Worker Prophylaxis/Treatment--Influenza.......              50              50           10/60
57.300 Hemovigilance Module Annual Survey.......................             500               1           86/60
57.301 Hemovigilance Module Monthly Reporting Plan..............             500              12           60/60
57.303 Hemovigilance Module Monthly Reporting Denominators......             500              12           70/60
57.305 Hemovigilance Incident...................................             500              10           10/60
57.306 Hemovigilance Module Annual Survey--Non-acute care                    500               1           36/60
 facility.......................................................
57.307 Hemovigilance Adverse Reaction--Acute Hemolytic                       500               4           21/60
 Transfusion Reaction...........................................
57.308 Hemovigilance Adverse Reaction--Allergic Transfusion                  500               4           21/60
 Reaction.......................................................
57.309 Hemovigilance Adverse Reaction--Delayed Hemolytic                     500               1           21/60
 Transfusion Reaction...........................................
57.310 Hemovigilance Adverse Reaction--Delayed Serologic                     500               2           21/60
 Transfusion Reaction...........................................
57.311 Hemovigilance Adverse Reaction--Febrile Non-hemolytic                 500               4           21/60
 Transfusion Reaction...........................................
57.312 Hemovigilance Adverse Reaction--Hypotensive Transfusion               500               1           21/60
 Reaction.......................................................
57.313 Hemovigilance Adverse Reaction--Infection................             500               1           21/60
57.314 Hemovigilance Adverse Reaction--Post Transfusion Purpura.             500               1           21/60
57.315 Hemovigilance Adverse Reaction--Transfusion Associated                500               1           20/60
 Dyspnea........................................................
57.316 Hemovigilance Adverse Reaction--Transfusion Associated                500               1           21/60
 Graft vs. Host Disease.........................................
57.317 Hemovigilance Adverse Reaction--Transfusion Related Acute             500               1           21/60
 Lung Injury....................................................
57.318 Hemovigilance Adverse Reaction--Transfusion Associated                500               2           21/60
 Circulatory Overload...........................................
57.319 Hemovigilance Adverse Reaction--Unknown Transfusion                   500               1           21/60
 Reaction.......................................................
57.320 Hemovigilance Adverse Reaction--Other Transfusion                     500               1           21/60
 Reaction.......................................................
57.400 Outpatient Procedure Component--Annual Facility Survey...             700               1           10/60
57.401 Outpatient Procedure Component--Monthly Reporting Plan...             700              12           15/60
57.402 Outpatient Procedure Component Same Day Outcome Measures.             200               1           41/60
57.403 Outpatient Procedure Component--Monthly Denominators for              200             400           40/60
 Same Day Outcome Measures......................................
57.404 Outpatient Procedure Component--SSI Denominator..........             700             100           41/60
57.405 Outpatient Procedure Component--Surgical Site (SSI) Event             700               5           41/60
57.500 Outpatient Dialysis Center Practices Survey..............           7,200               1           12/60
57.501 Dialysis Monthly Reporting Plan..........................           7,200              12            5/60
57.502 Dialysis Event...........................................           7,200              30           26/60
57.503 Denominator for Outpatient Dialysis......................           7,200              30           10/60
57.504 Prevention Process Measures Monthly Monitoring for                  1,730              12           75/60
 Dialysis.......................................................
57.505 Dialysis Patient Influenza Vaccination...................             615              50           10/60
57.506 Dialysis Patient Influenza Vaccination Denominator.......             615               5           10/60
57.507 Home Dialysis Center Practices Survey....................             430               1           30/60
Weekly Healthcare Personnel Influenza Vaccination Cumulative                 125              52           60/60
 Summary for Non-Long-Term Care Facilities......................
Weekly Healthcare Personnel Influenza Vaccination Cumulative               1,200              52           60/60
 Summary for Long-Term Care Facilities..........................
Weekly Resident Influenza Vaccination Cumulative Summary for               2,500              52           60/60
 Long-Term Care Facilities......................................
Annual Healthcare Personnel Influenza Vaccination Summary.......           5,000               1          120/60
Monthly Survey Patient Days & Nurse Staffing....................           2,500              12           60/60
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[[Page 24805]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2023-08571 Filed 4-21-23; 8:45 am]
BILLING CODE 4163-18-P