[Federal Register Volume 90, Number 136 (Friday, July 18, 2025)]
[Notices]
[Pages 33952-33957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-13512]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-25-0666; Docket No. CDC-2025-0091]
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.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
federal agencies the opportunity to comment on a continuing information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled National Healthcare Safety Network (NHSN). NHSN provides
facilities, states, regions, and the nation with data necessary to
identify problem areas, measure the progress of prevention efforts, and
ultimately eliminate healthcare-associated infections (HAIs)
nationwide.
DATES: CDC must receive written comments on or before September 16,
2025.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2025-
0091 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;
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. 12/31/2027)--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.
[[Page 33953]]
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 4 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 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.
The ICR was previously approved in April 2025 for 4,508,255 burden
hours. The proposed changes in this Revision include modifications to
67 existing data collection forms and the addition of three new forms.
CDC requests OMB approval for an estimated 4,453,792 annual burden
hours.
[[Page 33954]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form No. & name Number of responses per per response Total burden
respondents respondent (hours) (hours)
----------------------------------------------------------------------------------------------------------------
Infection Preventionist/ 57.100 NHSN 2,000 1 5/60 167
Microbiologist. Registration
Form.
Infection Preventionist/ 57.101 Facility 2,000 1 10/60 333
Microbiologist. Contact
Information.
Infection Preventionist/ 57.102 NHSN Help 26,400 1 2/60 880
Microbiologist. Desk Customer
Satisfaction
Survey.
Infection Preventionist/ 57.103 Patient 5,400 1 138/60 12420
Microbiologist. Safety
Component--Annu
al Hospital
Survey.
Infection Preventionist/ 57.104 NHSN 800 1 5/60 67
Microbiologist. Facility
Administrator
Change Request
Form.
Epidemiologists............... 57.105 Group 1,000 1 5/60 83
Contact
Information.
Infection Preventionist/ 57.106 Patient 7,821 12 15/60 23463
Microbiologist. Safety Monthly
Reporting Plan.
Infection Preventionist/ 57.108 Primary 6,000 12 43/60 51600
Microbiologist. Bloodstream
Infection (BSI).
Infection Preventionist/ 57.111 Pneumonia 1,800 2 33/60 1980
Microbiologist. (PNEU).
Infection Preventionist/ 57.112 5,463 8 31/60 22580
Microbiologist. Ventilator-
Associated
Event (VAE).
Infection Preventionist/ 57.113 Pediatric 334 1 33/60 184
Microbiologist. Ventilator-
Associated
Event (PedVAE).
Infection Preventionist/ 57.114 Urinary 6,000 12 25/60 30000
Microbiologist. Tract Infection
(UTI).
Infection Preventionist/ 57.115 Custom 600 91 38/60 34580
Microbiologist. Event.
Infection Preventionist/ 57.116 1,100 12 240/60 52800
Microbiologist. Denominators
for Neonatal
Intensive Care
Unit (NICU).
Infection Preventionist/ 57.117 500 12 300/60 30000
Microbiologist. Denominators
for Specialty
Care Area (SCA)/
Oncology (ONC).
Infection Preventionist/ 57.118 5,500 60 300/60 1650000
Microbiologist. Denominators
for Intensive
Care Unit (ICU)/
Other locations
(not NICU or
SCA).
Infection Preventionist/ 57.120 Surgical 3,800 12 13/60 9880
Microbiologist. Site Infection
(SSI).
Infection Preventionist/ 57.121 3,800 12 13/60 9880
Microbiologist. Denominator for
Procedure.
Epidemiologists............... 57.122 HAI 55 1 50/60 46
Progress Report
State Health
Department
Survey.
Pharmacist.................... 57.123 2,200 1 4800/60 176000
Antimicrobial
Use and
Resistance
(AUR)-
Microbiology
Data Electronic
Upload
Specification
Tables-Initial
Set-up.
Pharmacist.................... 57.123 3,300 2 120/60 13200
Antimicrobial
Use and
Resistance
(AUR)-
Microbiology
Data Electronic
Upload
Specification
Tables-Yearly
Maintenance.
Pharmacist.................... 57.123 5,500 12 5/60 5500
Antimicrobial
Use and
Resistance
(AUR)-
Microbiology
Data Electronic
Upload
Specification
Tables-Monthly.
Pharmacist.................... 57.124 1,500 1 2400/60 60000
Antimicrobial
Use and
Resistance
(AUR)-Pharmacy
Data Electronic
Upload
Specification
Tables-Initial
Set-up.
Pharmacist.................... 57.124 4,000 1 120/60 8000
Antimicrobial
Use and
Resistance
(AUR)-Pharmacy
Data Electronic
Upload
Specification
Tables-Yearly
Maintenance.
Pharmacist.................... 57.124 5,500 12 5/60 5500
Antimicrobial
Use and
Resistance
(AUR)-Pharmacy
Data Electronic
Upload
Specification
Tables-Monthly.
Infection Preventionist/ 57.126 MDRO or 720 12 33/60 4752
Microbiologist. CDI Infection
Form.
Infection Preventionist/ 57.127 MDRO and 5,500 29 15/60 39875
Microbiologist. CDI Prevention
Process and
Outcome
Measures
Monthly
Monitoring.
Infection Preventionist/ 57.128 4,800 12 23/60 22080
Microbiologist. Laboratory-
identified MDRO
or CDI Event.
Infection Preventionist/ 57.129 Adult 50 12 28/60 280
Microbiologist. Sepsis.
Infection Preventionist/ 57.130 3,650 365 35/60 777146
Microbiologist. Infectious
Diseases of
Public Health
Concern.
Information Technology........ 57.132 Patient 5,500 1 1620/60 148500
Safety
Component
Digital Measure
Reporting Plan
(HOB, HT-CDI,
VTE, Adult
Sepsis, RPS,
NVAP)-IT
Initial Set up.
[[Page 33955]]
Information Technology........ 57.132 Patient 5,500 1 1200/60 110000
Safety
Component
Digital Measure
Reporting Plan
(HOB, HT-CDI,
VTE, Adult
Sepsis, RPS,
NVAP)-IT Yearly
Maintenance.
Infection Preventionist/ 57.132 Patient 5,500 4 10/60 3667
Microbiologist. Safety
Component
Digital Measure
Reporting Plan
(HOB, HT-CDI,
VTE, Adult
Sepsis, RPS,
NVAP)-Infection
Preventionist.
Infection Preventionist/ 57.132 Patient 5,500 365 2/60 66917
Microbiologist. Safety Digital
Reporting Plan
(RPS CSV).
Infection Preventionist/ 57.133 Patient 3,500 1 10/60 583
Microbiologist. Safety
Attestation.
Infection Preventionist/ 57.137 Long-Term 6,270 1 135/60 14108
Microbiologist. Care Facility
Component--Annu
al Facility
Survey.
Infection Preventionist/ 57.138 286 24 22/60 2517
Microbiologist. Laboratory-
identified MDRO
or CDI Event
for LTCF.
Infection Preventionist/ 57.139 MDRO and 738 12 10/60 1476
Microbiologist. CDI Prevention
Process
Measures
Monthly
Monitoring for
LTCF.
Infection Preventionist/ 57.140 Urinary 373 24 37/60 5520
Microbiologist. Tract Infection
(UTI) for LTCF.
Infection Preventionist/ 57.141 Monthly 546 12 5/60 546
Microbiologist. Reporting Plan
for LTCF.
Infection Preventionist/ 57.142 724 12 35/60 5068
Microbiologist. Denominators
for LTCF
Locations.
Infection Preventionist/ 57.143 434 12 5/60 434
Microbiologist. Prevention
Process
Measures
Monthly
Monitoring for
LTCF.
Infection Preventionist/ 57.145 Long Term 16,500 12 5/60 16500
Microbiologist. Care
Antimicrobial
Use (LTC-AU)
Module-Digital
Upload
Specification
Tables.
Infection Preventionist/ 57.150 LTAC 395 1 100/60 658
Microbiologist. Annual Survey.
Infection Preventionist/ 57.151 Rehab 395 1 84/60 553
Microbiologist. Annual Survey.
Occupational Health RN/ 57.211 Weekly 117 12 25/60 585
Specialist. Healthcare
Personnel
Influenza
Vaccination
Cumulative
Summary for Non-
Long-Term Care
Facilities-
Manual.
Occupational Health RN/ 57.211 Weekly 3,080 12 20/60 12320
Specialist. Healthcare
Personnel
Influenza
Vaccination
Cumulative
Summary for Non-
Long-Term Care
Facilities-.CSV.
Occupational Health RN/ 57.214 Annual 22,440 1 120/60 44880
Specialist. Healthcare
Personnel
Influenza
Vaccination
Summary-Manual.
Occupational Health RN/ 57.214 Annual 1,920 1 55/60 1760
Specialist. Healthcare
Personnel
Influenza
Vaccination
Summary-.CSV.
Occupational Health RN/ 57.215 Seasonal 15,426 1 45/60 11570
Specialist. Survey on
Influenza
Vaccination
Programs for
Healthcare
Personnel.
Medical/Clinical Laboratory 57.300 57 1 30/60 29
Technologist. Hemovigilance
Module Annual
Survey.
Medical/Clinical Laboratory 57.301 Adverse 47 5 20/60 78
Technologist. Reaction
Investigaton
Form.
Medical/Clinical Laboratory 57.302 3 1 5/60 1
Technologist. Transfusion
Transmitted
Infections
(TTI) Rapid
Alert Form.
Medical/Clinical Laboratory 57.303 3 1 60/60 3
Technologist. Transfusion
Transmitted
Infections
(TTI)
Investigation
Form.
Infection Preventionist/ 57.400 350 1 10/60 58
Microbiologist. Outpatient
Procedure
Component--Annu
al Ambulatory
Surgery Center
Survey.
Infection Preventionist/ 57.401 350 12 10/60 700
Microbiologist. Outpatient
Procedure
Component--Mont
hly Reporting
Plan.
Infection Preventionist/ 57.402 50 1 42/60 35
Microbiologist. Outpatient
Procedure
Component Same
Day Outcome
Measures.
[[Page 33956]]
Infection Preventionist/ 57.403 50 400 20/60 6667
Microbiologist. Outpatient
Procedure
Component--Deno
minators for
Same Day
Outcome
Measures.
Infection Preventionist/ 57.404 300 100 22/60 11000
Microbiologist. Outpatient
Procedure
Component--SSI
Denominator.
Infection Preventionist/ 57.405 300 36 39/60 7020
Microbiologist. Outpatient
Procedure
Component--Surg
ical Site (SSI)
Event.
Infection Preventionist/ 57.408 Monthly 2,500 12 300/60 150000
Microbiologist. Survey Patient
Days & Nurse
Staffing.
Infection Preventionist/ 57.500 6,900 1 149/60 17135
Microbiologist. Outpatient
Dialysis Center
Practices
Survey.
Infection Preventionist/ 57.501 Dialysis 7,400 12 5/60 7400
Microbiologist. Monthly
Reporting Plan.
Infection Preventionist/ 57.502 Dialysis 7,400 30 49/60 181300
Microbiologist. Event.
Infection Preventionist/ 57.503 7,400 12 10/60 14800
Microbiologist. Denominator for
Outpatient
Dialysis.
Infection Preventionist/ 57.504 1,730 12 60/60 20760
Microbiologist. Prevention
Process
Measures
Monthly
Monitoring for
Dialysis.
Infection Preventionist/ 57.507 Home 550 1 65/60 596
Microbiologist. Dialysis Center
Practices
Survey.
Information Technology........ 57.600 Neonatal 5,500 1 1620/60 148500
Component FHIR
Measure-Late
Onset Sepsis
Meningitis
(LOSMEN) Module-
IT Initial Set
up.
Information Technology........ 57.600 Neonatal 5,500 1 1200/60 110000
Component FHIR
Measure-Late
Onset Sepsis
Meningitis
(LOSMEN) Module-
IT Yearly
Maintenance.
Infection Preventionist/ 57.600 Neonatal 5,500 6 6/60 3300
Microbiologist. Component FHIR
Measure-Late
Onset Sepsis
Meningitis
(LOSMEN) Module-
Infection
Preventionist.
Infection Preventionist/ 57.600 Neonatal 5,500 12 2/60 2200
Microbiologist. Component Late
Onset Sepsis
Meningitis
(LOSMEN) Module
CDA Data
Collection-
Infection
Preventionist.
Infection Preventionist/ 57.601 Late 300 6 5/60 150
Microbiologist. Onset Sepsis/
Meningitis
Denominator
Form: Late
Onset Sepsis/
Meningitis
Denominator
Form: Data
Table for
monthly
electronic
upload.
Infection Preventionist/ 57.602 Late 300 6 5/60 150
Microbiologist. Onset Sepsis/
Meningitis
Event Form:
Data Table for
Monthly
Electronic
Upload.
Information Technology........ 57.700 5,500 1 1620/60 148500
Medication
Safety-Digital
Measure
Reporting Plan
(HYPO, HAKI,
ORAE)-IT
Initial Set up.
Information Technology........ 57.700 5,500 1 1200/60 110000
Medication
Safety-Digital
Measure
Reporting Plan
(HYPO, HAKI,
ORAE)-IT Yearly
Maintenance.
Infection Preventionist/ 57.700 5,500 4 10/60 3667
Microbiologist. Medication
Safety-Digital
Measure
Reporting Plan
(HYPO, HAKI,
ORAE)-Infection
Preventionist.
Infection Preventionist/ 57.701 10 1 180/60 30
Microbiologist. Medication
Safety
Component--Annu
al Hospital
Survey.
Registered Nurse.............. 57.800 Billing 5,500 4 5/60 1833
Code Data: 837I
Upload.
Epidemiologist................ 57.801 External 20 2 15/60 10
Validation
Summary Report.
Information Technology........ 57.802 Bed 25 1 20/60 8
Capacity-IT
Initial Set Up.
Information Technology........ 57.803 All 540 365 5/60 16425
Hazards.
----------------------------------------------------------------------------------------------------------------
[[Page 33957]]
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. 2025-13512 Filed 7-17-25; 8:45 am]
BILLING CODE 4163-18-P