[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Pages 73288-73292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28031]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-22-0666]


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 September 27, 2021 to obtain 
comments from the public and affected agencies. CDC received four non-
substantive comments 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.

[[Page 73289]]

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. 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) 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. Additionally, 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. Members of the 
public may also 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.
    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 of 2020 for 5,943,401 
responses; 1,321,991 burden hours, and is due to expire on December 31, 
2023. The proposed changes in this new ICR include revisions to ten 
data collection forms. There are a total of 86 proposed data collection 
forms, but no new forms are being added at this time. The total 
estimated burden requested in this Revision is for 1,584,651 hours.

                                             Estimated Annual Burden
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
            Respondent type                Form number & name       respondents    responses per     response
                                                                                    respondent        (hour)
----------------------------------------------------------------------------------------------------------------
U.S. Healthcare Facilities/NHSN         57.100 NHSN Registration           2,000               1            5/60
 Participants.                           Form.
                                        57.101 Facility Contact            2,000               1           10/60
                                         Information.
                                        57.103 Patient Safety              6,765               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                     5,775               5           38/60
                                         Bloodstream 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).

[[Page 73290]]

 
                                        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                   55               1           28/60
                                         Report 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-                 1,998              24           20/60
                                         identified MDRO or CDI
                                         Event for LTCF.
                                        57.139 MDRO and CDI                1,998              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           2,011              12            5/60
                                         Plan for LTCF.
                                        57.142 Denominators for              339              12           35/60
                                         LTCF Locations.
                                        57.143 Prevention                    130              12            5/60
                                         Process Measures
                                         Monthly Monitoring for
                                         LTCF.
                                        57.150 LTAC Annual                   620               1           82/60
                                         Survey.
                                        57.151 Rehab Annual                1,340               1           82/60
                                         Survey.
                                        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 73291]]

 
                                        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                  7,200               1           12/60
                                         Dialysis 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                  1,730              12           75/60
                                         Process 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                    2,500              52           60/60
                                         Influenza Vaccination
                                         Cumulative Summary for
                                         Long-Term Care
                                         Facilities.
                                        Annual Healthcare                  5,000               1          120/60
                                         Personnel Influenza
                                         Vaccination Summary.
----------------------------------------------------------------------------------------------------------------



[[Page 73292]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-28031 Filed 12-23-21; 8:45 am]
BILLING CODE 4163-18-P