Agency Forms Undergoing Paperwork Reduction Act Review, 24802-24805 [2023-08571]
Download as PDF
<![CDATA[
24802
Federal Register / Vol. 88, No. 78 / Monday, April 24, 2023 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2023–08570 Filed 4–21–23; 8:45 am]
BILLING CODE 4163–18–P
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2023–08579 Filed 4–21–23; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
Centers for Disease Control and
Prevention
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP)—RFA OH–23–
004, NIOSH Miner Safety and Health
Program—Western Mining States
Review, and RFA OH–23–005, NIOSH
Robotic Mining Review; Amended
Notice of Closed Meeting
Centers for Disease Control and
Prevention
Notice is hereby given of a change in
the meeting of the Disease, Disability,
and Injury Prevention and Control
Special Emphasis Panel (SEP)—RFA
OH–23–004, NIOSH Miner Safety and
Health Program—Western Mining States
Review, and RFA OH–23–005, NIOSH
Robotic Mining Review; May 25, 2023,
1 p.m.–5 p.m., EDT, teleconference, in
the original Federal Register notice. The
meeting was published in the Federal
Register on February 22, 2023, Volume
88, Number 35, page 10905.
The meeting is being amended to
change the Notice of Funding
Opportunity (NOFO) titles and should
read as follows:
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)—
RFA–OH–23–004, Miner Safety and
Health Training Program—Western
United States, and RFA–OH–23–005,
NIOSH Robotics and Intelligent Mining
Technology and Workplace Safety
Research (U60).
The meeting is closed to the public.
ddrumheller on DSK120RN23PROD with NOTICES1
FOR FURTHER INFORMATION CONTACT:
Michael Goldcamp, Ph.D., Scientific
Review Officer, Office of Extramural
Programs, National Institute for
Occupational Safety and Health, Centers
for Disease Control and Prevention,
1905 Willowdale Road, Morgantown,
West Virginia, 26506. Telephone: (304)
285–5951; Email: MGoldcamp@cdc.gov.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
VerDate Sep<11>2014
18:50 Apr 21, 2023
Jkt 259001
[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.
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
National Healthcare Safety Network
(NHSN) (OMB Control No. 0920–0666,
Exp. 7/31/2023)—Revision—National
Center for Emerging and Zoonotic
Infection Diseases (NCEZID), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The Division of Healthcare Quality
Promotion (DHQP), National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC) collects
data from healthcare facilities in the
National Healthcare Safety Network
(NHSN) under OMB Control Number
0920–0666. NHSN provides facilities,
states, regions, and the nation with data
necessary to identify problem areas,
measure the progress of prevention
efforts, and ultimately eliminate
healthcare-associated infections (HAIs)
nationwide. NHSN allows healthcare
facilities to track blood safety errors and
various healthcare-associated infection
prevention practice methods such as
healthcare personnel influenza vaccine
status and corresponding infection
control adherence rates. NHSN
currently has seven components:
Patient Safety (PS), Healthcare
Personnel Safety (HPS), Biovigilance
(BV), Long-Term Care Facility (LTCF),
Outpatient Procedure (OPC), Dialysis
Component, and the Neonatal
Component. NHSN has increasingly
served as the operating system for HAI
reporting compliance through
legislation established by the states. As
of April 2020, 36 states, the District of
Columbia and the City of Philadelphia,
Pennsylvania have opted to use NHSN
as their primary system for mandated
reporting. Reporting compliance is
completed by healthcare facilities in
their respective jurisdictions, with
E:\FR\FM\24APN1.SGM
24APN1
24803
Federal Register / Vol. 88, No. 78 / Monday, April 24, 2023 / Notices
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, longterm 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 ytypes of hepatitis B vaccines
administered to patients and staff
members at outpatient dialysis centers.
The changes increased total annualized
burden for NHSB from 1,584,651 hours
to 1,616,151 hours.
In this Revision, CDC requests OMB
approval to continue those changes for
three years. In addition, CDC requests
OMB approval to begin phased
implementation of two new questions
on Sex at Birth and Gender Identity,
which will replace the current Gender
question. The new questions will be
voluntary for the remainder of 2023 and
required in 2024. The proposed change
will be used to help assess the true
impact of sex at birth and gender
identify on HAIs, individually and in
combination with other risk factors, and
to inform public health programs. The
new questions will add one minute of
burden to 31 forms that are currently in
use, a total of 77,064 annualized burden
hours. The total estimated annualized
burden hours for NHSN will increase to
1,693,215 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
ddrumheller on DSK120RN23PROD with NOTICES1
Form number/name
57.100 NHSN Registration Form .................................................................................................
57.101 Facility Contact Information .............................................................................................
57.103 Patient Safety Component—Annual Hospital Survey .....................................................
57.104 Facility Administrator Change Request Form .................................................................
57.105 Group Contact Information ..............................................................................................
57.106 Patient Safety Monthly Reporting Plan ...........................................................................
57.108 Primary Bloodstream Infection (BSI) ...............................................................................
57.111 Pneumonia (PNEU) .........................................................................................................
57.112 Ventilator-Associated Event ............................................................................................
57.113 Pediatric Ventilator-Associated Event (PedVAE) ............................................................
57.114 Urinary Tract Infection (UTI) ............................................................................................
57.115 Custom Event ..................................................................................................................
57.116 Denominators for Neonatal Intensive Care Unit (NICU) .................................................
57.117 Denominators for Specialty Care Area (SCA)/Oncology (ONC) .....................................
57.118 Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA) ..........
57.120 Surgical Site Infection (SSI) ............................................................................................
57.121 Denominator for Procedure .............................................................................................
57.122 HAI Progress Report State Health Department Survey ..................................................
57.123 Antimicrobial Use and Resistance (AUR)—Microbiology Data Electronic Upload Specification Tables .........................................................................................................................
57.124 Antimicrobial Use and Resistance (AUR)—Pharmacy Data Electronic Upload Specification Tables ..........................................................................................................................
57.125 Central Line Insertion Practices Adherence Monitoring ..................................................
57.126 MDRO or CDI Infection Form ..........................................................................................
57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring .......
57.128 Laboratory-identified MDRO or CDI Event ......................................................................
57.129 Adult Sepsis .....................................................................................................................
VerDate Sep<11>2014
18:50 Apr 21, 2023
Jkt 259001
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
E:\FR\FM\24APN1.SGM
Number of
responses per
respondent
Average
burden per
response
(min/hour)
2,000
2,000
6,765
800
1,000
7,821
5,775
1,800
5,463
334
6,000
600
1,100
500
5,500
6,000
6,000
55
1
1
1
1
1
12
5
2
8
1
5
91
12
12
60
9
602
1
5/60
10/60
90/60
5/60
5/60
15/60
39/60
31/60
29/60
31/60
21/60
36/60
4/60
5/60
5/60
36/60
11/60
28/60
2,500
12
5/60
4,000
500
720
5,500
4,800
50
12
213
11
29
79
250
5/60
26/60
31/60
15/60
21/60
25/60
24APN1
24804
Federal Register / Vol. 88, No. 78 / Monday, April 24, 2023 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Form number/name
ddrumheller on DSK120RN23PROD with NOTICES1
57.135 Late Onset Sepsis/Meningitis Denominator Form: Data Table for monthly electronic
upload .......................................................................................................................................
57.136 Late Onset Sepsis/Meningitis Event Form: Data Table for Monthly Electronic Upload
57.137 Long-Term Care Facility Component—Annual Facility Survey ......................................
57.138 Laboratory-identified MDRO or CDI Event for LTCF ......................................................
57.139 MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF ..............
57.140 Urinary Tract Infection (UTI) for LTCF ............................................................................
57.141 Monthly Reporting Plan for LTCF ...................................................................................
57.142 Denominators for LTCF Locations ..................................................................................
57.143 Prevention Process Measures Monthly Monitoring for LTCF .........................................
57.150 LTAC Annual Survey .......................................................................................................
57.151 Rehab Annual Survey .....................................................................................................
57.200 Healthcare Personnel Safety Component Annual Facility Survey ..................................
57.204 Healthcare Worker Demographic Data ...........................................................................
57.205 Exposure to Blood/Body Fluids .......................................................................................
57.206 Healthcare Worker Prophylaxis/Treatment .....................................................................
57.207 Follow-Up Laboratory Testing .........................................................................................
57.210 Healthcare Worker Prophylaxis/Treatment—Influenza ...................................................
57.300 Hemovigilance Module Annual Survey ...........................................................................
57.301 Hemovigilance Module Monthly Reporting Plan .............................................................
57.303 Hemovigilance Module Monthly Reporting Denominators ..............................................
57.305 Hemovigilance Incident ...................................................................................................
57.306 Hemovigilance Module Annual Survey—Non-acute care facility ....................................
57.307 Hemovigilance Adverse Reaction—Acute Hemolytic Transfusion Reaction ..................
57.308 Hemovigilance Adverse Reaction—Allergic Transfusion Reaction .................................
57.309 Hemovigilance Adverse Reaction—Delayed Hemolytic Transfusion Reaction ..............
57.310 Hemovigilance Adverse Reaction—Delayed Serologic Transfusion Reaction ...............
57.311 Hemovigilance Adverse Reaction—Febrile Non-hemolytic Transfusion Reaction .........
57.312 Hemovigilance Adverse Reaction—Hypotensive Transfusion Reaction .........................
57.313 Hemovigilance Adverse Reaction—Infection ..................................................................
57.314 Hemovigilance Adverse Reaction—Post Transfusion Purpura .......................................
57.315 Hemovigilance Adverse Reaction—Transfusion Associated Dyspnea ...........................
57.316 Hemovigilance Adverse Reaction—Transfusion Associated Graft vs. Host Disease .....
57.317 Hemovigilance Adverse Reaction—Transfusion Related Acute Lung Injury ..................
57.318 Hemovigilance Adverse Reaction—Transfusion Associated Circulatory Overload ........
57.319 Hemovigilance Adverse Reaction—Unknown Transfusion Reaction .............................
57.320 Hemovigilance Adverse Reaction—Other Transfusion Reaction ...................................
57.400 Outpatient Procedure Component—Annual Facility Survey ...........................................
57.401 Outpatient Procedure Component—Monthly Reporting Plan .........................................
57.402 Outpatient Procedure Component Same Day Outcome Measures ................................
57.403 Outpatient Procedure Component—Monthly Denominators for Same Day Outcome
Measures ..................................................................................................................................
57.404 Outpatient Procedure Component—SSI Denominator ...................................................
57.405 Outpatient Procedure Component—Surgical Site (SSI) Event .......................................
57.500 Outpatient Dialysis Center Practices Survey ..................................................................
57.501 Dialysis Monthly Reporting Plan .....................................................................................
57.502 Dialysis Event ..................................................................................................................
57.503 Denominator for Outpatient Dialysis ...............................................................................
57.504 Prevention Process Measures Monthly Monitoring for Dialysis ......................................
57.505 Dialysis Patient Influenza Vaccination ............................................................................
57.506 Dialysis Patient Influenza Vaccination Denominator .......................................................
57.507 Home Dialysis Center Practices Survey .........................................................................
Weekly Healthcare Personnel Influenza Vaccination Cumulative Summary for Non-LongTerm Care Facilities .................................................................................................................
Weekly Healthcare Personnel Influenza Vaccination Cumulative Summary for Long-Term
Care Facilities ..........................................................................................................................
Weekly Resident Influenza Vaccination Cumulative Summary for Long-Term Care Facilities ..
Annual Healthcare Personnel Influenza Vaccination Summary ..................................................
Monthly Survey Patient Days & Nurse Staffing ..........................................................................
VerDate Sep<11>2014
18:50 Apr 21, 2023
Jkt 259001
PO 00000
Frm 00054
Fmt 4703
Sfmt 9990
E:\FR\FM\24APN1.SGM
Number of
responses per
respondent
Average
burden per
response
(min/hour)
300
300
17,700
1,998
1,998
339
2,011
339
130
620
1,340
50
50
50
50
50
50
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
500
700
700
200
6
6
1
24
12
36
12
12
12
1
1
1
200
50
30
50
50
1
12
12
10
1
4
4
1
2
4
1
1
1
1
1
1
2
1
1
1
12
1
5/60
5/60
120/60
20/60
20/60
35/60
5/60
35/60
5/60
82/60
82/60
480/60
20/60
60/60
15/60
15/60
10/60
86/60
60/60
70/60
10/60
36/60
21/60
21/60
21/60
21/60
21/60
21/60
21/60
21/60
20/60
21/60
21/60
21/60
21/60
21/60
10/60
15/60
41/60
200
700
700
7,200
7,200
7,200
7,200
1,730
615
615
430
400
100
5
1
12
30
30
12
50
5
1
40/60
41/60
41/60
12/60
5/60
26/60
10/60
75/60
10/60
10/60
30/60
125
52
60/60
1,200
2,500
5,000
2,500
52
52
1
12
60/60
60/60
120/60
60/60
24APN1
Federal Register / Vol. 88, No. 78 / Monday, April 24, 2023 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10844]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by May 24, 2023.
ADDRESSES: Written 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.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:50 Apr 21, 2023
Jkt 259001
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
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. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Small Biotech
Exception; Use: Under the authority in
sections 11001 and 11002 of the
Inflation Reduction Act of 2022 (Pub. L.
117–169), the Centers for Medicare &
Medicaid Services (CMS) is
implementing the Medicare Drug Price
Negotiation Program, codified in
sections 1191 through 1198 of the Social
Security Act (the Act). In accordance
with section 1192(d)(2) of the Act, the
term ‘‘negotiation-eligible drug’’
excludes, with respect to the initial
price applicability years 2026, 2027, and
2028, a qualifying single source drug
that meets the requirements for the
exception for small biotech drugs (the
‘‘Small Biotech Exception’’).
This information is required in order
for CMS to accurately identify whether
a given drug meets the criteria for the
Small Biotech Exception in accordance
with section 1192(d)(2) of the Act. To
ensure that only covered Part D drugs
that meet the requirements for the Small
Biotech Exception are excluded from
the term ‘‘negotiation-eligible drug,’’ a
manufacturer that seeks the Small
Biotech Exception for its covered Part D
drug (‘‘Submitting Manufacturer’’) must
submit information to CMS about the
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
24805
company and its products in order for
the drug to be considered for the
exception. If the Submitting
Manufacturer seeks the Small Biotech
Exception for a covered Part D drug it
acquired after December 31, 2021, the
Submitting Manufacturer must also
submit information related to the
separate entity that had the Medicare
Coverage Gap Discount Program
agreement for the drug on December 31,
2021. The Information Collection
Request Form for the Small Biotech
Exception must be submitted to CMS
before CMS establishes the selected
drug list for initial price applicability
year 2026. Form Number: CMS–10844
(OMB control number: 0938-New);
Frequency: Once; Affected Public:
Private sector, Business or other forprofit; Number of Respondents: 10;
Total Annual Responses: 10; Total
Annual Hours: 68.5. (For policy
questions regarding this collection
contact Corey Rosenberg at 410–786–
9763.)
Dated: April 19, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–08600 Filed 4–21–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Intent To Award a Single-Source
Supplement To Provide the National
Aging Network With Timely, Relevant,
High-Quality Opportunities To Further
Enhance Knowledge, Awareness and
Models Related to Falls Prevention
ACTION:
Notice.
The Administration for
Community Living (ACL) announces the
intent to award a single-source
supplement to the current cooperative
agreement held by the National Council
on Aging (NCOA) for the National Falls
Prevention Resource Center. The
purpose of this program is to advance
the development and expansion of
technical assistance, education, and
resources to increase public awareness
about the risk of falls and how to
prevent them; increase the number of
older adults and adults with disabilities
who participate in evidence-based
community falls prevention programs;
and support the integration and
sustainability of evidence-based falls
prevention programs within community
integrated health networks.
SUMMARY:
E:\FR\FM\24APN1.SGM
24APN1
]]>Agencies
[Federal Register Volume 88, Number 78 (Monday, April 24, 2023)]
[Notices]
[Pages 24802-24805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08571]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-23-0666]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled ``National Healthcare Safety Network (NHSN)''
to the Office of Management and Budget (OMB) for review and approval.
CDC previously published a ``Proposed Data Collection Submitted for
Public Comment and Recommendations'' notice on August 26, 2022 to
obtain comments from the public and affected agencies. CDC received one
comment related to the previous notice. This notice serves to allow an
additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) Minimize the burden of the collection of information on those
who are to respond, including, through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
Proposed Project
National Healthcare Safety Network (NHSN) (OMB Control No. 0920-
0666, Exp. 7/31/2023)--Revision--National Center for Emerging and
Zoonotic Infection Diseases (NCEZID), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Division of Healthcare Quality Promotion (DHQP), National
Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers
for Disease Control and Prevention (CDC) collects data from healthcare
facilities in the National Healthcare Safety Network (NHSN) under OMB
Control Number 0920-0666. NHSN provides facilities, states, regions,
and the nation with data necessary to identify problem areas, measure
the progress of prevention efforts, and ultimately eliminate
healthcare-associated infections (HAIs) nationwide. NHSN allows
healthcare facilities to track blood safety errors and various
healthcare-associated infection prevention practice methods such as
healthcare personnel influenza vaccine status and corresponding
infection control adherence rates. NHSN currently has seven components:
Patient Safety (PS), Healthcare Personnel Safety (HPS),
Biovigilance (BV), Long-Term Care Facility (LTCF), Outpatient Procedure
(OPC), Dialysis Component, and the Neonatal Component. NHSN has
increasingly served as the operating system for HAI reporting
compliance through legislation established by the states. As of April
2020, 36 states, the District of Columbia and the City of Philadelphia,
Pennsylvania have opted to use NHSN as their primary system for
mandated reporting. Reporting compliance is completed by healthcare
facilities in their respective jurisdictions, with
[[Page 24803]]
emphasis on those states and municipalities acquiring varying
consequences for failure to use NHSN. Additionally, healthcare
facilities in five U.S. territories (Puerto Rico, American Samoa, the
U.S. Virgin Islands, Guam, and the Northern Mariana Islands) are
voluntarily reporting to NHSN. Additional territories are projected to
follow with similar use of NHSN for reporting purposes.
NHSN data is used to aid in the tracking of HAIs and guide
infection prevention activities/practices that protect patients. The
Centers for Medicare and Medicaid Services (CMS) and other payers use
these data to determine incentives for performance at healthcare
facilities across the US and surrounding territories, and members of
the public may use some protected data to inform their selection among
available providers. Each of these parties is dependent on the
completeness and accuracy of the data. CDC and CMS work closely and are
fully committed to ensuring complete and accurate reporting, which are
critical for protecting patients and guiding national, state, and local
prevention priorities. CMS collects some HAI data and healthcare
personnel influenza vaccination summary data, which is done on a
voluntary basis as part of its Fee-for-Service Medicare quality
reporting programs, while others may report data required by a federal
mandate. Facilities that fail to report quality measure data are
subject to partial payment reduction in the applicable Medicare Fee-
for-Service payment system. CMS links their quality reporting to
payment for Medicare-eligible acute care hospitals, inpatient
rehabilitation facilities, long-term acute care facilities, oncology
hospitals, inpatient psychiatric facilities, dialysis facilities, and
ambulatory surgery centers. Facilities report HAI data and healthcare
personnel influenza vaccination summary data to CMS via NHSN as part of
CMS's quality reporting programs to receive full payment. Still, many
healthcare facilities, even in states without HAI reporting
legislation, submit limited HAI data to NHSN voluntarily.
NHSN's data collection updates continue to support the incentive
programs managed by CMS. For example, survey questions support
requirements for CMS' quality reporting programs. Additionally, CDC has
collaborated with CMS on a voluntary National Nursing Home Quality
Collaborative, which focuses on recruiting nursing homes to report HAI
data to NHSN and to retain their continued participation.
In January 2023, CDC obtained emergency OMB approval for a number
of changes, effective immediately (Exp. 7/31/2023). These changes
included the addition of a new Monthly Survey on Patient Days & Nurse
Staffing, as well as minor changes to 14 information collection forms.
The changes primarily supported clarifications to use of CIDTs, HAI
forms with susceptibility reporting requirements, vendor information,
testing options for UTI events, and all y-types of hepatitis B vaccines
administered to patients and staff members at outpatient dialysis
centers. The changes increased total annualized burden for NHSB from
1,584,651 hours to 1,616,151 hours.
In this Revision, CDC requests OMB approval to continue those
changes for three years. In addition, CDC requests OMB approval to
begin phased implementation of two new questions on Sex at Birth and
Gender Identity, which will replace the current Gender question. The
new questions will be voluntary for the remainder of 2023 and required
in 2024. The proposed change will be used to help assess the true
impact of sex at birth and gender identify on HAIs, individually and in
combination with other risk factors, and to inform public health
programs. The new questions will add one minute of burden to 31 forms
that are currently in use, a total of 77,064 annualized burden hours.
The total estimated annualized burden hours for NHSN will increase to
1,693,215 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form number/name Number of responses per per response
respondents respondent (min/hour)
----------------------------------------------------------------------------------------------------------------
57.100 NHSN Registration Form................................... 2,000 1 5/60
57.101 Facility Contact Information............................. 2,000 1 10/60
57.103 Patient Safety Component--Annual Hospital Survey......... 6,765 1 90/60
57.104 Facility Administrator Change Request Form............... 800 1 5/60
57.105 Group Contact Information................................ 1,000 1 5/60
57.106 Patient Safety Monthly Reporting Plan.................... 7,821 12 15/60
57.108 Primary Bloodstream Infection (BSI)...................... 5,775 5 39/60
57.111 Pneumonia (PNEU)......................................... 1,800 2 31/60
57.112 Ventilator-Associated Event.............................. 5,463 8 29/60
57.113 Pediatric Ventilator-Associated Event (PedVAE)........... 334 1 31/60
57.114 Urinary Tract Infection (UTI)............................ 6,000 5 21/60
57.115 Custom Event............................................. 600 91 36/60
57.116 Denominators for Neonatal Intensive Care Unit (NICU)..... 1,100 12 4/60
57.117 Denominators for Specialty Care Area (SCA)/Oncology (ONC) 500 12 5/60
57.118 Denominators for Intensive Care Unit (ICU)/Other 5,500 60 5/60
locations (not NICU or SCA)....................................
57.120 Surgical Site Infection (SSI)............................ 6,000 9 36/60
57.121 Denominator for Procedure................................ 6,000 602 11/60
57.122 HAI Progress Report State Health Department Survey....... 55 1 28/60
57.123 Antimicrobial Use and Resistance (AUR)--Microbiology Data 2,500 12 5/60
Electronic Upload Specification Tables.........................
57.124 Antimicrobial Use and Resistance (AUR)--Pharmacy Data 4,000 12 5/60
Electronic Upload Specification Tables.........................
57.125 Central Line Insertion Practices Adherence Monitoring.... 500 213 26/60
57.126 MDRO or CDI Infection Form............................... 720 11 31/60
57.127 MDRO and CDI Prevention Process and Outcome Measures 5,500 29 15/60
Monthly Monitoring.............................................
57.128 Laboratory-identified MDRO or CDI Event.................. 4,800 79 21/60
57.129 Adult Sepsis............................................. 50 250 25/60
[[Page 24804]]
57.135 Late Onset Sepsis/Meningitis Denominator Form: Data Table 300 6 5/60
for monthly electronic upload..................................
57.136 Late Onset Sepsis/Meningitis Event Form: Data Table for 300 6 5/60
Monthly Electronic Upload......................................
57.137 Long-Term Care Facility Component--Annual Facility Survey 17,700 1 120/60
57.138 Laboratory-identified MDRO or CDI Event for LTCF......... 1,998 24 20/60
57.139 MDRO and CDI Prevention Process Measures Monthly 1,998 12 20/60
Monitoring for LTCF............................................
57.140 Urinary Tract Infection (UTI) for LTCF................... 339 36 35/60
57.141 Monthly Reporting Plan for LTCF.......................... 2,011 12 5/60
57.142 Denominators for LTCF Locations.......................... 339 12 35/60
57.143 Prevention Process Measures Monthly Monitoring for LTCF.. 130 12 5/60
57.150 LTAC Annual Survey....................................... 620 1 82/60
57.151 Rehab Annual Survey...................................... 1,340 1 82/60
57.200 Healthcare Personnel Safety Component Annual Facility 50 1 480/60
Survey.........................................................
57.204 Healthcare Worker Demographic Data....................... 50 200 20/60
57.205 Exposure to Blood/Body Fluids............................ 50 50 60/60
57.206 Healthcare Worker Prophylaxis/Treatment.................. 50 30 15/60
57.207 Follow-Up Laboratory Testing............................. 50 50 15/60
57.210 Healthcare Worker Prophylaxis/Treatment--Influenza....... 50 50 10/60
57.300 Hemovigilance Module Annual Survey....................... 500 1 86/60
57.301 Hemovigilance Module Monthly Reporting Plan.............. 500 12 60/60
57.303 Hemovigilance Module Monthly Reporting Denominators...... 500 12 70/60
57.305 Hemovigilance Incident................................... 500 10 10/60
57.306 Hemovigilance Module Annual Survey--Non-acute care 500 1 36/60
facility.......................................................
57.307 Hemovigilance Adverse Reaction--Acute Hemolytic 500 4 21/60
Transfusion Reaction...........................................
57.308 Hemovigilance Adverse Reaction--Allergic Transfusion 500 4 21/60
Reaction.......................................................
57.309 Hemovigilance Adverse Reaction--Delayed Hemolytic 500 1 21/60
Transfusion Reaction...........................................
57.310 Hemovigilance Adverse Reaction--Delayed Serologic 500 2 21/60
Transfusion Reaction...........................................
57.311 Hemovigilance Adverse Reaction--Febrile Non-hemolytic 500 4 21/60
Transfusion Reaction...........................................
57.312 Hemovigilance Adverse Reaction--Hypotensive Transfusion 500 1 21/60
Reaction.......................................................
57.313 Hemovigilance Adverse Reaction--Infection................ 500 1 21/60
57.314 Hemovigilance Adverse Reaction--Post Transfusion Purpura. 500 1 21/60
57.315 Hemovigilance Adverse Reaction--Transfusion Associated 500 1 20/60
Dyspnea........................................................
57.316 Hemovigilance Adverse Reaction--Transfusion Associated 500 1 21/60
Graft vs. Host Disease.........................................
57.317 Hemovigilance Adverse Reaction--Transfusion Related Acute 500 1 21/60
Lung Injury....................................................
57.318 Hemovigilance Adverse Reaction--Transfusion Associated 500 2 21/60
Circulatory Overload...........................................
57.319 Hemovigilance Adverse Reaction--Unknown Transfusion 500 1 21/60
Reaction.......................................................
57.320 Hemovigilance Adverse Reaction--Other Transfusion 500 1 21/60
Reaction.......................................................
57.400 Outpatient Procedure Component--Annual Facility Survey... 700 1 10/60
57.401 Outpatient Procedure Component--Monthly Reporting Plan... 700 12 15/60
57.402 Outpatient Procedure Component Same Day Outcome Measures. 200 1 41/60
57.403 Outpatient Procedure Component--Monthly Denominators for 200 400 40/60
Same Day Outcome Measures......................................
57.404 Outpatient Procedure Component--SSI Denominator.......... 700 100 41/60
57.405 Outpatient Procedure Component--Surgical Site (SSI) Event 700 5 41/60
57.500 Outpatient Dialysis Center Practices Survey.............. 7,200 1 12/60
57.501 Dialysis Monthly Reporting Plan.......................... 7,200 12 5/60
57.502 Dialysis Event........................................... 7,200 30 26/60
57.503 Denominator for Outpatient Dialysis...................... 7,200 30 10/60
57.504 Prevention Process Measures Monthly Monitoring for 1,730 12 75/60
Dialysis.......................................................
57.505 Dialysis Patient Influenza Vaccination................... 615 50 10/60
57.506 Dialysis Patient Influenza Vaccination Denominator....... 615 5 10/60
57.507 Home Dialysis Center Practices Survey.................... 430 1 30/60
Weekly Healthcare Personnel Influenza Vaccination Cumulative 125 52 60/60
Summary for Non-Long-Term Care Facilities......................
Weekly Healthcare Personnel Influenza Vaccination Cumulative 1,200 52 60/60
Summary for Long-Term Care Facilities..........................
Weekly Resident Influenza Vaccination Cumulative Summary for 2,500 52 60/60
Long-Term Care Facilities......................................
Annual Healthcare Personnel Influenza Vaccination Summary....... 5,000 1 120/60
Monthly Survey Patient Days & Nurse Staffing.................... 2,500 12 60/60
----------------------------------------------------------------------------------------------------------------
[[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
