[Federal Register Volume 89, Number 79 (Tuesday, April 23, 2024)]
[Notices]
[Pages 30367-30370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08597]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-24-0666; Docket No. CDC-2024-0030]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled National Healthcare Safety 
Network (NHSN). NHSN 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 June 24, 2024.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0030 by either of the following methods:
     Federal eRulemaking Portal: www.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;

[[Page 30368]]

    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submissions of responses; and
    5. Assess information collection costs.

Proposed Project

    National Healthcare Safety Network (NHSN) (OMB Control No. 0920-
0666, Exp. 12/31/2026)--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 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 eight components: 
Patient Safety (PS), Healthcare Personnel Safety (HPS), Biovigilance 
(BV), Long-Term Care Facility (LTCF), Outpatient Procedure (OPC), 
Dialysis, Neonatal, and Medication Safety Component.
    Data reported under the Patient Safety Component are used to 
determine the magnitude of the healthcare-associated adverse events and 
trends in the rates of 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 Healthcare 
Personnel Safety 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 Biovigilance 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 Long-Term Care Facility 
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 because of their prematurity. This component currently has one 
module, which includes Late Onset-Sepsis and Meningitis. The Medication 
Safety Component tracks medication safety and adverse drug events that 
are among the most common causes of iatrogenic harm in U.S. hospitals.
    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

[[Page 30369]]

National Nursing Home Quality Collaborative, which focuses on 
recruiting nursing homes to report HAI data to NHSN and to retain their 
continued participation.
    The ICR was previously approved in March 2024 for 2,433,165 burden 
hours. The proposed changes in this new ICR include revisions to 80 
existing data collection forms and three new forms. In this Revision, 
CDC requests OMB approval for an estimated annual burden 3,635,534 
hours.

                                        Estimated Annualized Burden Hours
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                                                                     Number of      Avg. burden
               Form number & name                    Number of     responses per   per response    Total burden
                                                    respondents     respondent    (min./hour 60)      (hours)
----------------------------------------------------------------------------------------------------------------
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           5,400               1          137/60          12,330
 Survey.........................................
57.104 NHSN Facility Administrator Change                    800               1            5/60              67
 Request Form...................................
57.105 Group Contact Information................           1,000               1            5/60              83
57.106 Patient Safety Monthly Reporting Plan....           7,821              12           15/60          23,463
57.108 Primary Bloodstream Infection (BSI)......           6,000              12           30/60          36,000
57.111 Pneumonia (PNEU).........................           1,800               2           29/60           1,740
57.112 Ventilator-Associated Event (VAE)........           5,463               8           28/60          20,395
57.113 Pediatric Ventilator-Associated Event                 334               1           31/60             173
 (PedVAE).......................................
57.114 Urinary Tract Infection (UTI)............           6,000              12           20/60          24,000
57.115 Custom Event.............................             600              91           35/60          31,850
57.116 Denominators for Neonatal Intensive Care            1,100              12          240/60          52,800
 Unit (NICU)....................................
57.117 Denominators for Specialty Care Area                  500              12          300/60          30,000
 (SCA)/Oncology (ONC)...........................
57.118 Denominators for Intensive Care Unit                5,500              60          300/60       1,650,000
 (ICU)/Other locations (not NICU or SCA)........
57.120 Surgical Site Infection (SSI)............           3,800              12           11/60           8,360
57.121 Denominator for Procedure................           3,800              12           11/60           8,360
57.122 HAI Progress Report State Health                       55               1           50/60              46
 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           26/60          46,150
 Adherence Monitoring...........................
57.126 MDRO or CDI Infection Form...............             720              12           30/60           4,320
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              12           20/60          19,200
57.129 Adult Sepsis.............................              50              12           25/60             250
57.132 Patient Safety Component Digital Measure            5,500               1        1,620/60         148,500
 Reporting Plan (HOB, HT-CDI, VTE, Adult Sepsis,
 RPS, NVAP)--IT Initial Set up..................
57.132 Patient Safety Component Digital Measure            5,500               1        1,200/60         110,000
 Reporting Plan (HOB, HT-CDI, VTE, Adult Sepsis,
 RPS, NVAP)--IT Yearly Maintenance..............
57.132 Patient Safety Component Digital Measure            5,500               4           10/60           3,667
 Reporting Plan (HOB, HT-CDI, VTE, Adult Sepsis,
 RPS, NVAP)--Infection Preventionist............
57.132 Patient Safety Digital Reporting Plan               5,500             365            2/60          66,917
 (RPS CSV)......................................
57.137 Long-Term Care Facility Component--Annual           6,270               1          128/60          13,376
 Facility Survey................................
57.138 Laboratory-identified MDRO or CDI Event               286              24           20/60           2,288
 for LTCF.......................................
57.139 MDRO and CDI Prevention Process Measures              738              12           10/60           1,476
 Monthly Monitoring for LTCF....................
57.140 Urinary Tract Infection (UTI) for LTCF...             373              24           35/60           5,222
57.141 Monthly Reporting Plan for LTCF..........             546              12            5/60             546
57.142 Denominators for LTCF Locations..........             724              12           35/60           5,068
57.143 Prevention Process Measures Monthly                   434              12            5/60             434
 Monitoring for LTCF............................
57.144 Resident Respiratory Pathogens Even Form.          16,500              24           25/60         165,000
57.145 Long Term Care Antimicrobial Use (LTC-AU)          16,500              12            5/60          16,500
 Module CDA.....................................
57.150 LTAC Annual Survey.......................             395               1          102/60             672
57.151 Rehab Annual Survey......................             395               1          102/60             672
57.204 Healthcare Worker Demographic Data.......              50             200           20/60           3,333
57.211 Weekly Healthcare Personnel Influenza               8,000               8           60/60          64,000
 Vaccination Cumulative Summary for Non-Long-
 Term Care Facilities...........................
57.214 Annual Healthcare Personnel Influenza              22,000               1          120/60          44,000
 Vaccination Summary............................
57.215 Seasonal Survey on Influenza Vaccination           15,426               1           45/60          11,570
 Programs for Healthcare Personnel..............
57.300 Hemovigilance Module Annual Survey.......              63               1           85/60              89
57.301 Hemovigilance Module Monthly Reporting                108              12            1/60              22
 Plan...........................................
57.302 Hemovigilance Module Monthly Incident                   9              12           30/60              54
 Summary........................................
57.303 Hemovigilance Module Monthly Reporting                102              12           70/60           1,428
 Denominators...................................
57.305 Hemovigilance Incident...................              13              77           10/60             167
57.306 Hemovigilance Module Annual Survey--Non-               20               1           35/60              12
 acute care facility............................
57.307 Hemovigilance Adverse Reaction--Acute                   8               2           20/60               5
 Hemolytic Transfusion Reaction.................
57.308 Hemovigilance Adverse Reaction--Allergic               50              11           20/60             183
 Transfusion Reaction...........................

[[Page 30370]]

 
57.309 Hemovigilance Adverse Reaction--Delayed                 9               2           20/60               6
 Hemolytic Transfusion Reaction.................
57.310 Hemovigilance Adverse Reaction--Delayed                19               5           20/60              32
 Serologic Transfusion Reaction.................
57.311 Hemovigilance Adverse Reaction--Febrile                85              13           20/60             368
 Non-hemolytic Transfusion Reaction.............
57.312 Hemovigilance Adverse Reaction--                       23               3           20/60              23
 Hypotensive Transfusion Reaction...............
57.313 Hemovigilance Adverse Reaction--Infection               2               2           20/60               1
57.314 Hemovigilance Adverse Reaction--Post                    1               1           20/60            0.33
 Transfusion Purpura............................
57.315 Hemovigilance Adverse Reaction--                       18               3           20/60              18
 Transfusion Associated Dyspnea.................
57.316 Hemovigilance Adverse Reaction--                        1               1           20/60            0.33
 Transfusion Associated Graft vs. Host Disease..
57.317 Hemovigilance Adverse Reaction--                        1               1           20/60            0.33
 Transfusion Related Acute Lung Injury..........
57.318 Hemovigilance Adverse Reaction--                       40               4           21/60              56
 Transfusion Associated Circulatory Overload....
57.319 Hemovigilance Adverse Reaction--Unknown                15               3           20/60              15
 Transfusion Reaction...........................
57.320 Hemovigilance Adverse Reaction--Other                  39               3           20/60              39
 Transfusion Reaction...........................
57.400 Outpatient Procedure Component -- Annual              350               1           10/60              58
 Ambulatory Surgery Center Survey...............
57.401 Outpatient Procedure Component--Monthly               350              12           10/60             700
 Reporting Plan.................................
57.402 Outpatient Procedure Component Same Day                50               1           40/60              33
 Outcome Measures...............................
57.403 Outpatient Procedure Component--                       50             400           20/60           6,667
 Denominators for Same Day Outcome Measures.....
57.404 Outpatient Procedure Component--SSI                   300             100           20/60          10,000
 Denominator....................................
57.405 Outpatient Procedure Component--Surgical              300              36           40/60           7,200
 Site (SSI) Event...............................
57.408 Monthly Survey Patient Days & Nurse                 2,500              12          300/60         150,000
 Staffing.......................................
57.500 Outpatient Dialysis Center Practices                6,900               1          150/60          17,250
 Survey.........................................
57.501 Dialysis Monthly Reporting Plan..........           7,400              12            5/60           7,400
57.502 Dialysis Event...........................           7,400              30           50/60         185,000
57.503 Denominator for Outpatient Dialysis......           7,400              12           10/60          14,800
57.504 Prevention Process Measures Monthly                 1,730              12           60/60          20,760
 Monitoring for Dialysis........................
57.507 Home Dialysis Center Practices Survey....             550               1           65/60             596
57.600 Neonatal Component FHIR Measure--Late               5,500               1         1620/60         148,500
 Onset Sepsis Meningitis (LOSMEN) Module--IT
 Initial Set up.................................
57.600 Neonatal Component FHIR Measure--Late               5,500               1        1,200/60         110,000
 Onset Sepsis Meningitis (LOSMEN) Module--IT
 Yearly Maintenance.............................
57.600 Neonatal Component FHIR Measure--Late               5,500               6            6/60           3,300
 Onset Sepsis Meningitis (LOSMEN) Module--
 Infection Preventionist........................
57.600 Neonatal Component Late Onset Sepsis                5,500              12            2/60           2,200
 Meningitis (LOSMEN) Module CDA Data Collection--
 Infection Preventionist........................
57.601 Late Onset Sepsis/Meningitis Denominator              300               6            5/60             150
 Form: Late Onset Sepsis/Meningitis Denominator
 Form: Data Table for monthly electronic upload.
57.602 Late Onset Sepsis/Meningitis Event Form:              300               6            6/60             180
 Data Table for Monthly Electronic Upload.......
57.700 Medication Safety--Digital Measure                  5,500               1        1,620/60         148,500
 Reporting Plan (HYPO, HAKI, ORAE)--IT Initial
 Set up.........................................
57.700 Medication Safety--Digital Measure                  5,500               1        1,200/60         110,000
 Reporting Plan (HYPO, HAKI, ORAE)--IT Yearly
 Maintenance....................................
57.700 Medication Safety--Digital Measure                  5,500               4           10/60           3,667
 Reporting Plan (HYPO, HAKI, ORAE)--Infection
 Preventionist..................................
57.701 Glycemic Control Module--HYPO Annual                   10               1          120/60              20
 Survey.........................................
Billing Code Data: 837I Upload..................           5,500               4            5/60           1,833
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............       3,635,534
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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. 2024-08597 Filed 4-22-24; 8:45 am]
BILLING CODE 4163-18-P