Notice2023-08571
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 24, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 88 Issue 78 (Monday, April 24, 2023)</title>
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[Federal Register Volume 88, Number 78 (Monday, April 24, 2023)]
[Notices]
[Pages 24802-24805]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
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Number of Average burden
Form number/name Number of responses per per response
respondents respondent (min/hour)
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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
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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
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</html>Indexed from Federal Register on April 24, 2023.
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