Proposed Data Collection Submitted for Public Comment and Recommendations, 51345-51348 [2024-13227]
Download as PDF
<![CDATA[
Federal Register / Vol. 89, No. 117 / Monday, June 17, 2024 / Notices
notice will be summarized for, and
included with, the OGE Generic
Clearance request. The comments will
also become a matter of public record.
Approved: June 11, 2024.
Shelley K. Finlayson,
Acting Director, U.S. Office of Government
Ethics.
[FR Doc. 2024–13189 Filed 6–14–24; 8:45 am]
BILLING CODE 6345–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–24–1310; Docket No. CDC–2024–
0051]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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 Public Health Laboratory Testing
for Emerging Antimicrobial Resistance
and Fungal Threats. This data collection
is designed to allow CDC to test and
characterize, antimicrobial resistant
bacteria and fungal isolates.
DATES: CDC must receive written
comments on or before August 16, 2024.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2024–
0051 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
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:00 Jun 14, 2024
Jkt 262001
(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: omb@
cdc.gov.
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
Public Health Laboratory Testing for
Emerging Antimicrobial Resistance and
Fungal Threats (OMB Control No. 0920–
1310, Exp. 5/31/2026)—Revision—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
51345
Background and Brief Description
State and Local laboratory testing
capacity is implemented by the
Department of Health and Human
Services (HHS), Centers for Disease
Control and Prevention (CDC) in
response to the Executive Order 13676
of September 18, 2014, the National
Strategy of September 2014 and to
implement the National Action Plan of
October 2020 for Combating Antibiotic
Resistant Bacteria. Data collected
throughout this network is also
authorized by Section 301 of the Public
Health Service Act (42 U.S.C. 241).
The Antimicrobial Resistance
Laboratory Network (AR Lab Network)
is made up of jurisdictional public
health laboratories (i.e., all 50 states,
five large cities, and Puerto Rico). These
public health laboratories will be
equipped to detect and characterize
isolates as described. Carbapenemaseproducing organisms: equipped to
detect and characterize carbapenemresistant Enterobacterales (CRE),
carbapenem-resistant Pseudomonas
aeruginosa (CRPA), and carbapenemresistant Acinetobacter baumannii
(CRAB) isolates and detect
carbapenemase-producing organisms
(CPOs) from screening swabs.
Characterization of these resistant
bacteria, which are typically identified
in clinical laboratories, is often limited
despite the fact they are becoming more
prevalent, particularly in healthcare
settings. The proposed laboratory testing
will allow for additional testing and
characterization, including use of
validated high-quality methods. Isolate
characterization includes organism
identification, antimicrobial
susceptibility testing (AST) to confirm
carbapenem resistance and determine
susceptibility to new drugs of
therapeutic and epidemiological
importance, a phenotypic method to
detect carbapenemase enzyme
production, and molecular testing (e.g.,
whole genome sequencing [WGS]) to
identify the resistance mechanism(s).
Screening swabs will undergo molecular
testing to identify carbapenemase genes
present. Results from this laboratory
testing will be used to: (1) identify
targets for infection control; (2) detect
new types of resistance; (3) characterize
geographical distribution of resistance;
(4) determine whether resistance
mechanisms are spreading among
organisms, people, and facilities; and (5)
provide data that informs state and local
public health surveillance and
prevention activities and priorities.
Additionally, participating
jurisdictional public health laboratories
will also participate in reference
E:\FR\FM\17JNN1.SGM
17JNN1
khammond on DSKJM1Z7X2PROD with NOTICES
51346
Federal Register / Vol. 89, No. 117 / Monday, June 17, 2024 / Notices
identification of Candida spp. A subset
of these laboratories will also conduct
testing on Candida isolates and
screening swabs, and Aspergillus
fumigatus. The capacity to test for
fungal pathogens at local clinical and
public health laboratories is limited,
and therefore the proposed laboratory
testing will truly build infrastructure
and ensure that validated high-quality
methodologies are used. Fungal isolate
characterization includes identification,
antifungal testing to determine
susceptibility to new drugs of
therapeutic and epidemiological
importance. Screening swabs will
undergo the same series of validated
tests, after Candida spp. are grown from
the swab. Results from this laboratory
testing will be used locally to: (1)
support infection control, efforts; (2)
monitor resistance; (3) characterize
geographical distribution of resistance;
and (5) provide data that informs state
and local public health surveillance and
prevention activities and priorities.
A subset of jurisdictions will perform
routine antimicrobial susceptibility
testing for N. gonorrhoeae. Also, a
subset of local and state public health
laboratories in the AR Lab Network will
be using validated agar dilution and/or
gradient strip diffusion assays to assess
the levels of susceptibility in gonococcal
isolates to 10 different antimicrobial
agents. Several identified resistance
isolates will undergo high-quality whole
genome sequencing. AST and WGS data
are critical for public health actions and
for gonorrhea control efforts including
gonococcal antimicrobial resistance
surveillance, and to curtail the spread of
antimicrobial-resistant N. gonorrhoeae.
In addition to the testing that is done
throughout the AR Lab Network,
performance measures are collected
from each laboratory, to ensure that
participating laboratories are making
progress. The purpose of collecting
performance measures is to facilitate
informed decision-making for the AR
Lab Network, to improve the technical
assistance provided to the participating
AR Lab Network partners, and to
measure progress across the AR Lab
Network.
CDC’s AR Lab Network supports
nationwide lab capacity to rapidly
detect antimicrobial resistance and
inform local public health responses to
prevent spread and protect people. It
closes the gap between local laboratory
capabilities and the data needed to
combat antimicrobial resistance by
providing comprehensive lab capacity
and infrastructure for detecting
antimicrobial-resistant pathogens
(germs), advanced technology, like DNA
sequencing, and rapid sharing of
VerDate Sep<11>2014
17:00 Jun 14, 2024
Jkt 262001
actionable data to drive infection
control responses and help treat
infections. This infrastructure allows
the public health community to rapidly
detect emerging antimicrobial-resistant
threats in healthcare, food, and the
community, mount a comprehensive
local response, and better understand
these deadly threats to quickly contain
them.
Funded State and Local Public Health
Laboratories will provide the following
information to the Division of
Healthcare Quality Promotion (DHQP)
Program Office at CDC about
carbapenemase-producing organisms:
1. Annually, participating laboratories
will submit a summary report
describing testing methods and volume.
These reports will be submitted through
REDCap. And are to be used by DHQP
to determine the ability of each
laboratory to confirm and characterize
targeted AR organisms and their overall
capacity to support state healthcareassociated infection (HAI)/AR
prevention programs.
2. Annually, participating laboratories
will provide Performance Measures data
through the Epidemiology and
Laboratory Capacity performance
measures portal. Data will be used to
indicate progress made toward program
objectives and challenges encountered.
3. Participating laboratories will
report all testing results to CDC, at least
monthly, by CSV or Health Level 7
(HL7) using an online web-portal
transmission. This information will be
used to: (1) provide data for state and
local infection prevention programs; (2)
identify new types of antimicrobial
resistant organisms; (3) identify new
resistance mechanisms in targeted
organisms; (4) describe the spread of
targeted resistance mechanisms; and (5)
identify geographical distribution of
antimicrobial resistance or other
epidemiological trends. Participating
laboratories will utilize secure public
health messaging protocols to transfer
results data to CDC and submitting
facilities and clinical laboratories. For
messaging to CDC, these protocols will
be based in Association of Public Health
Laboratories (APHL) Informatics
Messaging Services (AIMS) platform.
The AIMS platform is a secure
environment that provides shared
services to assist public health
laboratories in the transport, validation
and routing of electronic data. AIMS is
transitioning to the use of HL7
messaging for data to be transmitted in
real-time, allowing more frequent
reporting or results while
simultaneously lessening burden on
public health laboratories.
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
4. Detection of targeted resistant
organisms and resistance mechanisms
that pose an immediate threat to patient
safety and require rapid infection
control, facility assessments, and/or
additional diagnostics, an immediate
communication to the local healthcareassociated infection program in the
jurisdictional public health department
and CDC is needed. The ‘‘AR Lab
Network Alerts’’ encompass targeted AR
threats that include new and rare
plasmid-mediated (‘‘jumping’’)
carbapenemase genes, isolates resistant
to all drugs tested, and detection of
human reservoirs for transmission.
These alerts must be sent within one
working day of detection. Participating
laboratories will utilize REDCap to
communicate these findings. The
elements of these messages will include
the unique public health laboratory
specimen ID and a summary of its
testing results to date.
Sites participating in Candida
identification testing will also provide
the following to the Division of
Foodborne, Waterborne, and
Environmental Diseases (DFWED)
Mycotics Program Office at CDC:
1. Annually, participating laboratories
will provide Performance Measures data
through the Epidemiology and
Laboratory Capacity performance
measures portal. Data will be used to
indicate progress made toward program
objectives and challenges encountered.
2. Participating laboratories will
report all testing results to CDC,
requested at least monthly, by REDCap
or Health Level 7 (HL7) using an online
web-portal transmission. This
information will be used to: (1) identify
and track antifungal resistance and
emerging fungal pathogens; and (2) aid
public health departments and
healthcare facilities in rapidly
responding to fungal public health
threats and outbreaks. Participating
laboratories will utilize secure public
health messaging protocols to transfer
results data to CDC, submitting facilities
and clinical laboratories. For messaging
to CDC, these messaging protocols will
be based in REDCap or the AIMS
platform. The REDCap and AIMS
platforms are secure environments that
provide shared services to assist public
health laboratories in the transport,
validation and routing of electronic
data. AIMS is transitioning to the use of
HL7 messaging for data to be
transmitted in real-time, allowing more
frequent reporting of results while
simultaneously lessening burden on
public health laboratories.
Sites participating in detection and
characterization of AR Neisseria
gonorrhoeae, including antimicrobial
E:\FR\FM\17JNN1.SGM
17JNN1
51347
Federal Register / Vol. 89, No. 117 / Monday, June 17, 2024 / Notices
susceptibility testing of Neisseria
gonorrhoeae will provide the following
to the Division of STD Prevention
(DSTDP), STD Laboratory Reference and
Research Branch (SLRRB) at CDC:
1. Annually, participating laboratories
will provide Performance Measures data
through the Epidemiology and
Laboratory Capacity performance
measures portal. Data will be used to
indicate progress made toward program
objectives and challenges encountered.
2. Participating laboratories will
notify CDC DTSDP of any isolate(s)
identified to demonstrate an ‘‘alert’’ as
defined by SLRRB within one working
day. Laboratories will utilize REDCap to
communicate these findings. The
elements of these messages will include
the unique public health laboratory
specimen ID and a summary of
specimen testing results to date.
3. Participating laboratories will
report all testing results to CDC,
requested at least monthly, by email,
REDCap, or Health Level 7 (HL7) using
an online web-portal transmission. This
information will be used to: (1) identify
and track antimicrobial resistant
pathogens and emerging patterns of
resistance; and (2) aid public health
departments and healthcare facilities in
timely responding to antimicrobial
resistant public health threats and
outbreaks. Participating laboratories will
utilize secure public health messaging
protocols to transfer results data to CDC,
submitting facilities and clinical
laboratories. For messaging to CDC,
these messaging protocols will be based
in REDCap or the AIMS platform. The
REDCap and AIMS platforms are secure
environments that provide shared
services to assist public health
laboratories in the transport, validation,
and routing of electronic data. AIMS is
transitioning to the use of HL7
messaging for data to be transmitted in
real-time, allowing more frequent
reporting of results while
simultaneously lessening burden on
public health laboratories.
CDC requests a Revision to the data
collection that with an increase in
burden due to the building and
maintaining of HL7 and CSV data feeds.
Additionally, there has been a
significant increase of AR threats
identified through the AR Lab Network,
and the addition of laboratories testing
and taking on screening testing are
reflected in this submission. OMB
approval is requested for an estimated
57,993 annual burden hours of data
collection. There are no costs to
respondents other than their time to
participate.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Public Health Laboratories.
Public Health Laboratories.
Public Health Laboratories.
Public Health Laboratories.
Public Health Laboratories.
Public Health Laboratories.
Public Health Laboratories.
Public Health Laboratories.
khammond on DSKJM1Z7X2PROD with NOTICES
Public Health Laboratories.
Public Health Laboratories.
Public Health Laboratories.
Public Health Laboratories.
VerDate Sep<11>2014
Number of
respondents
Form name
I.1—ROUTINE TESTING BY GENERA IN JURISDICTION—Annual Evaluation and Performance Measurement Report.
I.2—EXPANDED DRUG SUSCEPTIBILITY
TESTING (ExAST) IN JURISDICTION—Annual Evaluation and Performance Measurement Report.
I.3—CANDIDA SPECIES IDENTIFICATION IN
JURISDICTION—Annual Evaluation and Performance Measurement Report.
I.4—HAIAR WHOLE GENOME SEQUENCING
(WGS) OF GRAM-NEGATIVE AR THREATS
IN JURISDICTION—Annual Evaluation and
Performance Measurement Report.
I.5—C. AURIS COLONIZATION SCREENING
IN JURISDICTION—Annual Evaluation and
Performance Measurement Report.
I.6—CARBAPENEMASE-PRODUCING ORGANISM (CPO) SCREENING IN JURISDICTION—Annual Evaluation and Performance
Measurement Report.
I.7—AZOLE RESISTANCE IN CLINICAL ASPERGILLUS FUMIGATUS ISOLATES—Annual Evaluation and Performance Measurement Report.
I.8—N. GONORRHOEAE WHOLE GENOME
SEQUENCING (WGS)—Annual Evaluation
and Performance Measurement Report.
I.9—GONOCOCCAL (GC) ANTIMICROBIAL
SUSCEPTIBILITY TESTING (AST) IN JURISDICTION—Annual Evaluation and Performance Measurement Report.
I.10—WHOLE GENOME SEQUENCING (WGS)
OF S. PNEUMONAIE—Annual Evaluation
and Performance Measurement Report.
I.11—CLOSTRIDIOIDES DIFFICILE (C.
DIFFICILE) TESTING IN JURISDICTION—
Annual Evaluation and Performance Measurement Report.
I.12—ANTIFUNGAL RESISTANT TINEA
DERMATOPHYTES—Annual Evaluation and
Performance Measurement Report.
17:00 Jun 14, 2024
Jkt 262001
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
Average
number of
responses per
respondent
Average
burden per
response
(in hours)
Total
burden
(in hours)
56
1
6/60
6
56
1
6/60
6
56
1
6/60
6
56
1
6/60
6
56
1
6/60
6
56
1
6/60
6
56
1
6/60
6
56
1
6/60
6
56
1
6/60
6
56
1
6/60
6
56
1
6/60
6
56
1
6/60
6
E:\FR\FM\17JNN1.SGM
17JNN1
51348
Federal Register / Vol. 89, No. 117 / Monday, June 17, 2024 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondents
Public Health Laboratories.
Public Health Laboratories.
Public Health Laboratories.
Public Health Laboratories.
Public Health Laboratories.
Public Health Laboratories.
Public Health Laboratories.
Public Health Laboratories.
Public Health Laboratories.
Public Health
tories.
Public Health
tories.
Public Health
tories.
Public Health
tories.
Public Health
tories.
Public Health
tories.
Public Health
tories.
Public Health
tories.
Public Health
tories.
LaboraLaboraLaboraLaboraLaboraLaboraLaboraLaboraLabora-
khammond on DSKJM1Z7X2PROD with NOTICES
Total ........................
Number of
respondents
Form name
I.13—ANTIMICROBIAL SUSCEPTIBILITY
TESTING (AST) OF INVASIVE
HAEMOPHILUS INFLUENZAE (H.
INFLUENZAE) IN JURISDICTION—Annual
Evaluation and Performance Measurement
Report.
I.14—MYCOPLASMA GENTALIUM (MG)—Annual Evaluation and Performance Measurement Report.
I.15—MOLECULAR Mtb TESTING—Annual
Evaluation and Performance Measurement
Report.
I.16—C. AURIS WHOLE GENOME SEQUENCING (WGS) IN JURISDICTION—Annual Evaluation and Performance Measurement Report.
I.17—MONITORIING CRE CRPA IN COMPANION ANIMALS TO FROM HUMANS—Annual Evaluation and Performance Measurement Report.
I.18—HEALTHCARE WASTEWATER-BASED
SURVEILLANCE—Annual Evaluation and
Performance Measurement Report.
I.19—COMMUNICATION AND COORDINATION OF ACTIONABLE EPI LAB DATA IN
JURISDICTION—Annual Evaluation and Performance Measurement Report.
I.20—CHARACTERIZATION OF THE CLINICAL
LABORATORY NETWORK IN JURISDICTION—Annual Evaluation and Performance
Measurement Report.
Annual Report of Bacterial Specimen Testing
Methods for Carbapenemase-producing Organisms.
Monthly Data Report Form for Carbapenemaseproducing Organisms.
Carbapenemase-producing Organisms Alert
Form.
Alert and Monthly Data Report Form for
Candida.
AR Lab Network Form for Phylogenetic Treelevel Mycotics Reporting.
AR Lab Network Form for Isolate/Specimenlevel Mycotics Testing.
AR Lab Network Alert and Monthly Data Report
Form for Neisseria gonorrhoeae.
HL7 Messages updates—IT Maintenance ..........
Average
number of
responses per
respondent
Total
burden
(in hours)
56
1
6/60
6
56
1
6/60
6
56
1
6/60
6
56
1
6/60
6
56
1
6/60
6
56
1
6/60
6
56
1
6/60
6
56
1
6/60
6
56
1
2
112
56
1,302
20/60
24,304
56
214
3/60
599
Up to 56
1,671
20/60
31,192
Up to 56
30
6/60
168
Up to 56
30
6/60
168
Up to 56
202
6/60
1,131
32
4
20/60
43
Implementation of new HL7 messages—IT Initial
Set up.
CSV files updates for Carbapenemase-producing organisms—IT Maintenance.
11
4
3
132
24
1
1
24
..............................................................................
........................
........................
........................
57,993
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. 2024–13227 Filed 6–14–24; 8:45 am]
BILLING CODE 4163–18–P
VerDate Sep<11>2014
Average
burden per
response
(in hours)
17:00 Jun 14, 2024
Jkt 262001
PO 00000
Frm 00049
Fmt 4703
Sfmt 9990
E:\FR\FM\17JNN1.SGM
17JNN1
]]>Agencies
[Federal Register Volume 89, Number 117 (Monday, June 17, 2024)]
[Notices]
[Pages 51345-51348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13227]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-24-1310; Docket No. CDC-2024-0051]
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 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 Public Health Laboratory Testing
for Emerging Antimicrobial Resistance and Fungal Threats. This data
collection is designed to allow CDC to test and characterize,
antimicrobial resistant bacteria and fungal isolates.
DATES: CDC must receive written comments on or before August 16, 2024.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0051 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
Public Health Laboratory Testing for Emerging Antimicrobial
Resistance and Fungal Threats (OMB Control No. 0920-1310, Exp. 5/31/
2026)--Revision--National Center for Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
State and Local laboratory testing capacity is implemented by the
Department of Health and Human Services (HHS), Centers for Disease
Control and Prevention (CDC) in response to the Executive Order 13676
of September 18, 2014, the National Strategy of September 2014 and to
implement the National Action Plan of October 2020 for Combating
Antibiotic Resistant Bacteria. Data collected throughout this network
is also authorized by Section 301 of the Public Health Service Act (42
U.S.C. 241).
The Antimicrobial Resistance Laboratory Network (AR Lab Network) is
made up of jurisdictional public health laboratories (i.e., all 50
states, five large cities, and Puerto Rico). These public health
laboratories will be equipped to detect and characterize isolates as
described. Carbapenemase-producing organisms: equipped to detect and
characterize carbapenem-resistant Enterobacterales (CRE), carbapenem-
resistant Pseudomonas aeruginosa (CRPA), and carbapenem-resistant
Acinetobacter baumannii (CRAB) isolates and detect carbapenemase-
producing organisms (CPOs) from screening swabs. Characterization of
these resistant bacteria, which are typically identified in clinical
laboratories, is often limited despite the fact they are becoming more
prevalent, particularly in healthcare settings. The proposed laboratory
testing will allow for additional testing and characterization,
including use of validated high-quality methods. Isolate
characterization includes organism identification, antimicrobial
susceptibility testing (AST) to confirm carbapenem resistance and
determine susceptibility to new drugs of therapeutic and
epidemiological importance, a phenotypic method to detect carbapenemase
enzyme production, and molecular testing (e.g., whole genome sequencing
[WGS]) to identify the resistance mechanism(s). Screening swabs will
undergo molecular testing to identify carbapenemase genes present.
Results from this laboratory testing will be used to: (1) identify
targets for infection control; (2) detect new types of resistance; (3)
characterize geographical distribution of resistance; (4) determine
whether resistance mechanisms are spreading among organisms, people,
and facilities; and (5) provide data that informs state and local
public health surveillance and prevention activities and priorities.
Additionally, participating jurisdictional public health
laboratories will also participate in reference
[[Page 51346]]
identification of Candida spp. A subset of these laboratories will also
conduct testing on Candida isolates and screening swabs, and
Aspergillus fumigatus. The capacity to test for fungal pathogens at
local clinical and public health laboratories is limited, and therefore
the proposed laboratory testing will truly build infrastructure and
ensure that validated high-quality methodologies are used. Fungal
isolate characterization includes identification, antifungal testing to
determine susceptibility to new drugs of therapeutic and
epidemiological importance. Screening swabs will undergo the same
series of validated tests, after Candida spp. are grown from the swab.
Results from this laboratory testing will be used locally to: (1)
support infection control, efforts; (2) monitor resistance; (3)
characterize geographical distribution of resistance; and (5) provide
data that informs state and local public health surveillance and
prevention activities and priorities.
A subset of jurisdictions will perform routine antimicrobial
susceptibility testing for N. gonorrhoeae. Also, a subset of local and
state public health laboratories in the AR Lab Network will be using
validated agar dilution and/or gradient strip diffusion assays to
assess the levels of susceptibility in gonococcal isolates to 10
different antimicrobial agents. Several identified resistance isolates
will undergo high-quality whole genome sequencing. AST and WGS data are
critical for public health actions and for gonorrhea control efforts
including gonococcal antimicrobial resistance surveillance, and to
curtail the spread of antimicrobial-resistant N. gonorrhoeae.
In addition to the testing that is done throughout the AR Lab
Network, performance measures are collected from each laboratory, to
ensure that participating laboratories are making progress. The purpose
of collecting performance measures is to facilitate informed decision-
making for the AR Lab Network, to improve the technical assistance
provided to the participating AR Lab Network partners, and to measure
progress across the AR Lab Network.
CDC's AR Lab Network supports nationwide lab capacity to rapidly
detect antimicrobial resistance and inform local public health
responses to prevent spread and protect people. It closes the gap
between local laboratory capabilities and the data needed to combat
antimicrobial resistance by providing comprehensive lab capacity and
infrastructure for detecting antimicrobial-resistant pathogens (germs),
advanced technology, like DNA sequencing, and rapid sharing of
actionable data to drive infection control responses and help treat
infections. This infrastructure allows the public health community to
rapidly detect emerging antimicrobial-resistant threats in healthcare,
food, and the community, mount a comprehensive local response, and
better understand these deadly threats to quickly contain them.
Funded State and Local Public Health Laboratories will provide the
following information to the Division of Healthcare Quality Promotion
(DHQP) Program Office at CDC about carbapenemase-producing organisms:
1. Annually, participating laboratories will submit a summary
report describing testing methods and volume. These reports will be
submitted through REDCap. And are to be used by DHQP to determine the
ability of each laboratory to confirm and characterize targeted AR
organisms and their overall capacity to support state healthcare-
associated infection (HAI)/AR prevention programs.
2. Annually, participating laboratories will provide Performance
Measures data through the Epidemiology and Laboratory Capacity
performance measures portal. Data will be used to indicate progress
made toward program objectives and challenges encountered.
3. Participating laboratories will report all testing results to
CDC, at least monthly, by CSV or Health Level 7 (HL7) using an online
web-portal transmission. This information will be used to: (1) provide
data for state and local infection prevention programs; (2) identify
new types of antimicrobial resistant organisms; (3) identify new
resistance mechanisms in targeted organisms; (4) describe the spread of
targeted resistance mechanisms; and (5) identify geographical
distribution of antimicrobial resistance or other epidemiological
trends. Participating laboratories will utilize secure public health
messaging protocols to transfer results data to CDC and submitting
facilities and clinical laboratories. For messaging to CDC, these
protocols will be based in Association of Public Health Laboratories
(APHL) Informatics Messaging Services (AIMS) platform. The AIMS
platform is a secure environment that provides shared services to
assist public health laboratories in the transport, validation and
routing of electronic data. AIMS is transitioning to the use of HL7
messaging for data to be transmitted in real-time, allowing more
frequent reporting or results while simultaneously lessening burden on
public health laboratories.
4. Detection of targeted resistant organisms and resistance
mechanisms that pose an immediate threat to patient safety and require
rapid infection control, facility assessments, and/or additional
diagnostics, an immediate communication to the local healthcare-
associated infection program in the jurisdictional public health
department and CDC is needed. The ``AR Lab Network Alerts'' encompass
targeted AR threats that include new and rare plasmid-mediated
(``jumping'') carbapenemase genes, isolates resistant to all drugs
tested, and detection of human reservoirs for transmission. These
alerts must be sent within one working day of detection. Participating
laboratories will utilize REDCap to communicate these findings. The
elements of these messages will include the unique public health
laboratory specimen ID and a summary of its testing results to date.
Sites participating in Candida identification testing will also
provide the following to the Division of Foodborne, Waterborne, and
Environmental Diseases (DFWED) Mycotics Program Office at CDC:
1. Annually, participating laboratories will provide Performance
Measures data through the Epidemiology and Laboratory Capacity
performance measures portal. Data will be used to indicate progress
made toward program objectives and challenges encountered.
2. Participating laboratories will report all testing results to
CDC, requested at least monthly, by REDCap or Health Level 7 (HL7)
using an online web-portal transmission. This information will be used
to: (1) identify and track antifungal resistance and emerging fungal
pathogens; and (2) aid public health departments and healthcare
facilities in rapidly responding to fungal public health threats and
outbreaks. Participating laboratories will utilize secure public health
messaging protocols to transfer results data to CDC, submitting
facilities and clinical laboratories. For messaging to CDC, these
messaging protocols will be based in REDCap or the AIMS platform. The
REDCap and AIMS platforms are secure environments that provide shared
services to assist public health laboratories in the transport,
validation and routing of electronic data. AIMS is transitioning to the
use of HL7 messaging for data to be transmitted in real-time, allowing
more frequent reporting of results while simultaneously lessening
burden on public health laboratories.
Sites participating in detection and characterization of AR
Neisseria gonorrhoeae, including antimicrobial
[[Page 51347]]
susceptibility testing of Neisseria gonorrhoeae will provide the
following to the Division of STD Prevention (DSTDP), STD Laboratory
Reference and Research Branch (SLRRB) at CDC:
1. Annually, participating laboratories will provide Performance
Measures data through the Epidemiology and Laboratory Capacity
performance measures portal. Data will be used to indicate progress
made toward program objectives and challenges encountered.
2. Participating laboratories will notify CDC DTSDP of any
isolate(s) identified to demonstrate an ``alert'' as defined by SLRRB
within one working day. Laboratories will utilize REDCap to communicate
these findings. The elements of these messages will include the unique
public health laboratory specimen ID and a summary of specimen testing
results to date.
3. Participating laboratories will report all testing results to
CDC, requested at least monthly, by email, REDCap, or Health Level 7
(HL7) using an online web-portal transmission. This information will be
used to: (1) identify and track antimicrobial resistant pathogens and
emerging patterns of resistance; and (2) aid public health departments
and healthcare facilities in timely responding to antimicrobial
resistant public health threats and outbreaks. Participating
laboratories will utilize secure public health messaging protocols to
transfer results data to CDC, submitting facilities and clinical
laboratories. For messaging to CDC, these messaging protocols will be
based in REDCap or the AIMS platform. The REDCap and AIMS platforms are
secure environments that provide shared services to assist public
health laboratories in the transport, validation, and routing of
electronic data. AIMS is transitioning to the use of HL7 messaging for
data to be transmitted in real-time, allowing more frequent reporting
of results while simultaneously lessening burden on public health
laboratories.
CDC requests a Revision to the data collection that with an
increase in burden due to the building and maintaining of HL7 and CSV
data feeds. Additionally, there has been a significant increase of AR
threats identified through the AR Lab Network, and the addition of
laboratories testing and taking on screening testing are reflected in
this submission. OMB approval is requested for an estimated 57,993
annual burden hours of data collection. There are no costs to
respondents other than their time to participate.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average number Average burden
Type of respondents Form name Number of of responses per response Total burden
respondents per respondent (in hours) (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Public Health Laboratories..................... I.1--ROUTINE TESTING BY GENERA IN 56 1 6/60 6
JURISDICTION--Annual Evaluation and
Performance Measurement Report.
Public Health Laboratories..................... I.2--EXPANDED DRUG SUSCEPTIBILITY 56 1 6/60 6
TESTING (ExAST) IN JURISDICTION--
Annual Evaluation and Performance
Measurement Report.
Public Health Laboratories..................... I.3--CANDIDA SPECIES IDENTIFICATION IN 56 1 6/60 6
JURISDICTION--Annual Evaluation and
Performance Measurement Report.
Public Health Laboratories..................... I.4--HAIAR WHOLE GENOME SEQUENCING 56 1 6/60 6
(WGS) OF GRAM-NEGATIVE AR THREATS IN
JURISDICTION--Annual Evaluation and
Performance Measurement Report.
Public Health Laboratories..................... I.5--C. AURIS COLONIZATION SCREENING IN 56 1 6/60 6
JURISDICTION--Annual Evaluation and
Performance Measurement Report.
Public Health Laboratories..................... I.6--CARBAPENEMASE-PRODUCING ORGANISM 56 1 6/60 6
(CPO) SCREENING IN JURISDICTION--
Annual Evaluation and Performance
Measurement Report.
Public Health Laboratories..................... I.7--AZOLE RESISTANCE IN CLINICAL 56 1 6/60 6
ASPERGILLUS FUMIGATUS ISOLATES--Annual
Evaluation and Performance Measurement
Report.
Public Health Laboratories..................... I.8--N. GONORRHOEAE WHOLE GENOME 56 1 6/60 6
SEQUENCING (WGS)--Annual Evaluation
and Performance Measurement Report.
Public Health Laboratories..................... I.9--GONOCOCCAL (GC) ANTIMICROBIAL 56 1 6/60 6
SUSCEPTIBILITY TESTING (AST) IN
JURISDICTION--Annual Evaluation and
Performance Measurement Report.
Public Health Laboratories..................... I.10--WHOLE GENOME SEQUENCING (WGS) OF 56 1 6/60 6
S. PNEUMONAIE--Annual Evaluation and
Performance Measurement Report.
Public Health Laboratories..................... I.11--CLOSTRIDIOIDES DIFFICILE (C. 56 1 6/60 6
DIFFICILE) TESTING IN JURISDICTION--
Annual Evaluation and Performance
Measurement Report.
Public Health Laboratories..................... I.12--ANTIFUNGAL RESISTANT TINEA 56 1 6/60 6
DERMATOPHYTES--Annual Evaluation and
Performance Measurement Report.
[[Page 51348]]
Public Health Laboratories..................... I.13--ANTIMICROBIAL SUSCEPTIBILITY 56 1 6/60 6
TESTING (AST) OF INVASIVE HAEMOPHILUS
INFLUENZAE (H. INFLUENZAE) IN
JURISDICTION--Annual Evaluation and
Performance Measurement Report.
Public Health Laboratories..................... I.14--MYCOPLASMA GENTALIUM (MG)--Annual 56 1 6/60 6
Evaluation and Performance Measurement
Report.
Public Health Laboratories..................... I.15--MOLECULAR Mtb TESTING--Annual 56 1 6/60 6
Evaluation and Performance Measurement
Report.
Public Health Laboratories..................... I.16--C. AURIS WHOLE GENOME SEQUENCING 56 1 6/60 6
(WGS) IN JURISDICTION--Annual
Evaluation and Performance Measurement
Report.
Public Health Laboratories..................... I.17--MONITORIING CRE CRPA IN COMPANION 56 1 6/60 6
ANIMALS TO FROM HUMANS--Annual
Evaluation and Performance Measurement
Report.
Public Health Laboratories..................... I.18--HEALTHCARE WASTEWATER-BASED 56 1 6/60 6
SURVEILLANCE--Annual Evaluation and
Performance Measurement Report.
Public Health Laboratories..................... I.19--COMMUNICATION AND COORDINATION OF 56 1 6/60 6
ACTIONABLE EPI LAB DATA IN
JURISDICTION--Annual Evaluation and
Performance Measurement Report.
Public Health Laboratories..................... I.20--CHARACTERIZATION OF THE CLINICAL 56 1 6/60 6
LABORATORY NETWORK IN JURISDICTION--
Annual Evaluation and Performance
Measurement Report.
Public Health Laboratories..................... Annual Report of Bacterial Specimen 56 1 2 112
Testing Methods for Carbapenemase-
producing Organisms.
Public Health Laboratories..................... Monthly Data Report Form for 56 1,302 20/60 24,304
Carbapenemase-producing Organisms.
Public Health Laboratories..................... Carbapenemase-producing Organisms Alert 56 214 3/60 599
Form.
Public Health Laboratories..................... Alert and Monthly Data Report Form for Up to 56 1,671 20/60 31,192
Candida.
Public Health Laboratories..................... AR Lab Network Form for Phylogenetic Up to 56 30 6/60 168
Tree-level Mycotics Reporting.
Public Health Laboratories..................... AR Lab Network Form for Isolate/ Up to 56 30 6/60 168
Specimen-level Mycotics Testing.
Public Health Laboratories..................... AR Lab Network Alert and Monthly Data Up to 56 202 6/60 1,131
Report Form for Neisseria gonorrhoeae.
Public Health Laboratories..................... HL7 Messages updates--IT Maintenance... 32 4 20/60 43
Public Health Laboratories..................... Implementation of new HL7 messages--IT 11 4 3 132
Initial Set up.
Public Health Laboratories..................... CSV files updates for Carbapenemase- 24 1 1 24
producing organisms--IT Maintenance.
---------------------------------------------------------------
Total...................................... ....................................... .............. .............. .............. 57,993
--------------------------------------------------------------------------------------------------------------------------------------------------------
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. 2024-13227 Filed 6-14-24; 8:45 am]
BILLING CODE 4163-18-P
